DEVICE FOR PERCUTANEOUS DILATATIVE PUNCTURE TRACHEOTOMY

Description

[0001] The present invention relates to a device for percutaneous dilational puncture tracheotomy, wherein the device comprises a puncture cannula, a guide catheter, and a guide wire. The present invention also encompasses a set containing the device according to the invention for percutaneous dilational puncture tracheotomy, as well as a dilator for expanding the tracheostomy, and optionally, as further components, a scalpel, a predilator, an insertion aid for the guide wire, an arming catheter with a safety lock for the guide wire, a set of compresses, and / or a syringe.

[0002] Percutaneous dilational tracheostomy is a method for inserting a tracheostomy tube into a patient's trachea. As an alternative to surgical intervention, access to the trachea is first established using an over-the-needle catheter. This typically occurs between the second and third or third and fourth tracheal rings.

[0003] Examples of devices for percutaneous dilatational puncture tracheostomy are disclosed in European patent EP 2 301 618 and in US patent application US 2010 / 300451.

[0004] The individual components required for percutaneous dilational tracheostomy are typically offered in coordinated sets that contain, in addition to the over-the-needle catheter, other components that can be used during the procedure, such as a scalpel, a predilator, a dilator, a guidewire, an introducer for the guidewire, an arming catheter with a safety lock for the guidewire, a set of compresses and / or a syringe.

[0005] Over-the-needle catheters consist of a hollow, sharpened steel puncture cannula surrounded by a tightly fitting plastic guide catheter. Both the needle and catheter often have a connector, such as a female Luer connector, at the proximal end facing away from the patient. The puncture cannula provides sufficient rigidity for the guide catheter to be inserted into the patient.

[0006] After the over-the-needle catheter has been inserted, the puncture cannula is withdrawn from the guide catheter remaining in the patient so that a guide wire, the so-called Seldinger wire, can be inserted through the guide catheter into the trachea. The guide wire serves as a guide during dilation with designated dilators and during the subsequent insertion of the tracheostomy tube. This minimizes the risk of tracheal wall injury and ensures that the dilators and tracheostomy tube are actually inserted into the trachea and are not accidentally inserted into the trachea. False route land.

[0007] After the puncture cannula has been withdrawn from the guide catheter, there is a risk that the guide catheter remaining in the patient will kink. This can easily occur, especially if the user attempts to change the position or angle of the catheter relative to the position of the trachea after removing the stabilizing puncture cannula. Once the guide catheter is kinked, it is often no longer possible to pass the guide wire through the guide catheter, as the kink creates a constriction through which the guide wire cannot be pushed.

[0008] This situation often cannot be rescued by reinserting the already removed puncture cannula, as this can easily lead to the guide catheter being punctured by the reinserted cannula. In many cases, the puncture procedure is therefore repeated with a new over-the-needle catheter. If suitable components are not available, a new tracheostomy set is often opened, which naturally entails additional consumable costs.

[0009] In order to solve the problem described above, the present invention proposes a device for percutaneous dilatational puncture tracheotomy, as defined in independent claim 1, which device comprises, inter alia, a puncture cannula, a guide catheter and a guide wire, wherein the puncture cannula has a ground tip at its distal end, wherein the maximum outer diameter of the puncture cannula is less than the minimum inner diameter of the guide catheter, and wherein the puncture cannula can be inserted into the guide catheter so far that the ground tip of the puncture cannula projects beyond the distal end of the guide catheter, wherein the maximum diameter of the guide wire is less than the minimum inner diameter of the puncture cannula, so that the guide wire can be guided through the puncture cannula such that its end projects beyond the ground tip of the puncture cannula.

[0010] The advantage of the present invention is that the cross-sections of the puncture cannula, guide catheter, and guide wire are dimensioned such that the guide wire can be passed through the puncture cannula located in the guide catheter. It is therefore no longer necessary to withdraw the puncture cannula after the guide catheter has been inserted into the trachea in order to insert the guide wire. Thus, when using the device according to the invention, there is no risk of the catheter kinking, as it is stabilized by the puncture cannula even during guide wire insertion.

[0011] This advantage cannot be achieved with conventional tracheostomy devices, as the inner diameter of the guide catheter is just large enough to allow the guidewire to pass through. On the other hand, with conventional tracheostomy devices, the inner diameter of the guide catheter is as small as possible to achieve the smallest possible cross-section during puncture.

[0012] For the reasons mentioned above, the inner diameter of the guide catheter in conventional tracheostomy devices is approximately 0.1 to 0.4 mm larger than the outer diameter of the guidewire. This results in the outer diameter of the guidewire being larger than the inner diameter of the puncture cannula in conventional tracheostomy devices. Therefore, it is not possible to push the guidewire through the puncture cannula with conventional tracheostomy devices.

[0013] In contrast, in the present invention, the guide catheter and puncture cannula are dimensioned so that the guide wire can be guided through the puncture cannula. In some embodiments of the invention, the guide wire for this purpose has a maximum diameter in the range of 1.0 to 1.5 mm, preferably in the range of 1.2 to 1.3 mm. In certain embodiments, the minimum inner diameter of the puncture cannula is 0.1 to 0.4 mm larger than the maximum diameter of the guide wire. In specific embodiments, the minimum inner diameter of the puncture cannula is 0.2 to 0.4 mm larger than the maximum diameter of the guide wire. In certain embodiments of the invention, the minimum inner diameter of the guide catheter is 0.05 to 0.3 mm larger than the maximum outer diameter of the puncture cannula.In specific embodiments, the minimum inner diameter of the guide catheter is 0.05 to 0.15 mm larger than the maximum diameter of the puncture cannula.

[0014] The puncture cannula consists of a hollow needle with a ground tip at its distal end. A connector is preferably located at the proximal end of the hollow needle. The guide catheter consists of a guide tube, which is preferably tapered at its distal end. A connector is also optionally located at the proximal end of the guide tube. Existing connectors are suitable for connection to a conventional medical tubing system (e.g., female Luer connector).

[0015] The terms "distal" and "proximal" are used in the context of the present invention from the perspective of a physician applying the tracheostomy device, i.e. the proximal end of the puncture cannula is the end that remains outside the patient's body after the puncture, while the distal end is inserted through the skin into the patient's trachea during the puncture.

[0016] Preferably, the ground tip of the puncture cannula extends 1 to 10 mm, particularly preferably 2 to 6 mm, beyond the distal end of the guide catheter. The lengths of the hollow needle and catheter tube, as well as the position and shape of the connectors on the puncture cannula and guide catheter, are selected accordingly.

[0017] The hollow needle of the puncture cannula preferably has a length in the range of 4 cm to 9 cm. The maximum outer diameter of the hollow needle is preferably in the range of 1.3 to 2.1 mm. In certain embodiments, the maximum outer diameter of the hollow needle is in the range of 1.5 to 2.0 mm. The minimum inner diameter of the hollow needle is preferably in the range of 1.1 to 1.9 mm. In certain embodiments, the minimum inner diameter of the hollow needle is in the range of 1.2 to 1.8 mm. The wall thickness of the hollow needle is preferably in the range of 0.1 to 0.2 mm.

[0018] Preferably, the catheter tube of the guide catheter has a length in the range of 3 cm to 8 cm. The maximum outer diameter of the catheter tube is preferably in the range of 1.5 to 2.5 mm. In certain embodiments, the maximum outer diameter of the catheter tube is in the range of 1.6 to 2.3 mm. The minimum inner diameter of the catheter tube is preferably in the range of 1.4 to 2.1 mm. In certain embodiments, the minimum inner diameter of the catheter tube is in the range of 1.6 to 1.9 mm. The wall thickness of the catheter tube of the guide catheter is preferably in the range of 0.1 to 0.2 mm.

[0019] In preferred embodiments, the hollow needle of the puncture cannula is made of metal, particularly preferably steel. The guide tube of the guide catheter is preferably made of plastic, preferably FEP (perfluoroethylene propylene). Connectors on the puncture cannula and / or the guide catheter are also preferably made of plastic. In particularly preferred embodiments, the guide tube and a connector arranged thereon are molded in one piece from a plastic material.

[0020] The plastic of the guide tube can be made of either a transparent or non-transparent plastic material, optionally with one or more white or colored longitudinal stripes to facilitate endoscopic positioning. In certain embodiments, the plastic material of the guide tube contains an X-ray contrast agent (e.g., barium sulfate).

[0021] In certain embodiments in which connectors are arranged at the proximal end of the puncture cannula and guide catheter, the connector on the puncture cannula is arranged in the connector on the guide catheter in a first stable insertion position such that the ground tip of the puncture cannula protrudes 1 to 10 mm, particularly preferably 2 to 6 mm, beyond the distal end of the guide catheter. Preferably, in these embodiments, by pulling or turning the connector of the puncture cannula, the cannula can be brought into a second stable insertion position in which the ground tip no longer protrudes beyond the guide catheter.

[0022] To rotate the puncture cannula into a second, stable insertion position in which the ground tip does not protrude beyond the guide catheter, some embodiments feature an internal or external thread on the inner wall of the guide catheter connector and a corresponding external or internal thread on the outer wall of the puncture cannula connector. Alternatively, an internal thread is provided on the inner wall of the guide catheter connector or on the outer wall of the puncture cannula connector, and a protruding ridge or protrusion is provided on the respective other wall (outer wall of the guide catheter connector or inner wall of the puncture cannula connector), which can engage with the thread on the other wall.

[0023] Preferably, the coordinated geometry of the thread(s) or webs / noses defines at least two different locking positions, wherein in a first locking position the ground tip of the puncture cannula is held stable, projecting 1 to 10 mm, particularly preferably 2 to 6 mm, beyond the distal end of the guide catheter, and wherein in a second locking position the ground tip of the puncture cannula does not project beyond the guide catheter.

[0024] The guidewire is preferably made of metal or plastic. A preferred metal for the guidewire is steel, nitinol, or a combination thereof. Embodiments with a metal wire preferably have a plastic coating on the metal wire. In certain embodiments, the material of the plastic coating is Teflon (polytetrafluoroethylene) or FEP (perfluoroethylenepropylene). Certain embodiments are characterized in that the end of the guidewire, which protrudes beyond the end of the puncture cannula when passed through the puncture cannula, is bent in a quarter- to three-quarter-circle shape. This type of guidewire is often referred to as a guidewire.

[0025] In order to facilitate the insertion of the guide wire, in the first of the three alternative possibilities of the invention claimed in claim 1, the lumen of the hollow needle of the puncture cannula widens in a funnel-shaped manner in the proximal direction at the end of the puncture cannula opposite the ground tip.

[0026] In the second alternative embodiment of the invention claimed in claim 1, with a connector at the proximal end of the puncture cannula, the lumen of the connector preferably tapers in a funnel shape toward the lumen of the puncture cannula, so that the guide wire can be more easily inserted into the hollow needle. Particularly preferably, the inner wall of the connector at the proximal end of the hollow needle is flush with the hollow needle opening.

[0027] In the third alternative possibility of the invention claimed in claim 1, in which the lumen of a connector at the proximal end of the puncture cannula is essentially cylindrical, an adapter is preferably arranged precisely within the lumen of the connector, wherein the adapter itself has a lumen that tapers in a funnel shape toward the lumen of the puncture cannula so that the guide wire can be more easily inserted into the hollow needle. Particularly preferably, the inner wall of the adapter inserted into the connector at the proximal end of the hollow needle is flush with the hollow needle opening.

[0028] The present invention relates to a device for percutaneous dilational puncture tracheotomy, the device comprising a puncture cannula, a guide catheter, and a guide wire. In certain embodiments, this device is part of a set for percutaneous dilational puncture tracheotomy, which further comprises a dilator for expanding the tracheostomy. Such a dilator has a dilation region with a continuously increasing diameter in the longitudinal direction, and in certain embodiments, a guide channel is provided in the dilator in the longitudinal direction, the minimum inner diameter of which is larger than the maximum diameter of the guide wire, so that the guide wire can be passed through the guide channel.

[0029] In the dilation area, the outer diameter of the dilator preferably increases to 1.2 to 1.5 cm. In preferred embodiments, the minimum inner diameter of the dilator's guide channel is in the range of 1.0 to 3.0 mm.

[0030] In certain embodiments of the set according to the invention, this additionally contains a scalpel, a predilator, an insertion aid for the guide wire, a set of compresses, an arming catheter with a safety lock for the guide wire and / or a syringe, and optionally a tracheostomy tube and / or insertion aids for inserting a tracheostomy tube.

[0031] In the embodiments of the set with predilator for dilating the tracheostomy, this predilator has an outer diameter that is larger than the outer diameter of the guide catheter and smaller than the mean outer diameter of the dilator, wherein a guide channel is provided in the longitudinal direction in the predilator, the minimum inner diameter of which is larger than the maximum diameter of the guide wire, so that the guide wire can be passed through the guide channel, wherein the minimum inner diameter of the guide channel of the predilator is 0.1 to 1.0 mm larger than the maximum diameter of the guide wire.

[0032] In versions of the set with an arming catheter, the outer diameter is smaller than the minimum inner diameter of the dilator, allowing the arming catheter to pass through the dilator's guide channel. The minimum inner diameter of the arming catheter is larger than the maximum diameter of the guidewire, allowing the guidewire to pass through the arming catheter. The minimum inner diameter of the arming catheter is 0.1 to 1.0 mm larger than the maximum diameter of the guidewire.

[0033] In the embodiments of the set with an insertion aid for the guide wire, the insertion aid for the guide wire is preferably arranged at the end of the guide wire which, when passed through the puncture cannula, protrudes beyond the end of the puncture cannula, wherein the insertion aid has a longitudinal and central guide channel whose minimum inner diameter is larger than the maximum diameter of the guide wire, such that the guide wire can be passed through the central guide channel, wherein one end of the guide channel opens into a conically tapered section of the insertion aid. This conically tapered section of the insertion aid is sized and shaped such that this section can be inserted into the proximal end of the puncture cannula, with or without a connector or with or without an adapter, in order to insert the guide wire more easily into the hollow needle.

[0034] For the purposes of original disclosure, it is noted that all features as they become apparent to a person skilled in the art from the present description, the drawings, and the claims, even if they were specifically described only in conjunction with certain other features, can be combined both individually and in any combination with other features or groups of features disclosed herein, unless this has been expressly excluded or technical circumstances make such combinations impossible or pointless. A comprehensive, explicit presentation of all conceivable combinations of features is omitted here solely for the sake of brevity and readability of the description.

[0035] Individual examples of the above-mentioned specific embodiments of the invention are described in the attached Figures 1 to 5 specified, where Figure 1 shows a plan view of an embodiment of a device according to the invention for percutaneous dilatational puncture tracheotomy, wherein the device comprises a puncture cannula, a guide catheter and a guide wire with a curved end, and wherein these three components are shown separately, ie not inserted into one another, Figure 2 shows the embodiment of the invention according to Figure 1in cross-section, wherein the puncture cannula, the guide catheter and the guide wire are shown inserted into one another, Figure 3 shows the puncture cannula and the guide catheter of an embodiment of the invention in cross-section, wherein the puncture cannula is shown inserted into the guide catheter in two different positions, Figure 4 shows a cross-section through a puncture cannula of an embodiment of the invention in three different states, wherein the first two states illustrate how an adapter is inserted into the lumen of the connector arranged at the proximal end of the puncture cannula and in the third state the puncture cannula is shown with the guide wire guided through the puncture cannula and inserted into the guide catheter, and Figure 5 shows a plan view of an embodiment of a set for percutaneous dilatational puncture tracheotomy, wherein the set comprises a puncture cannula,a guide catheter and a guide wire as well as a dilator, a scalpel, a predilator, a guide wire introducer, an arming catheter with a safety lock for the guide wire, a set of compresses and a syringe.

[0036] In detail, the following features or combinations of features are shown in the figures mentioned above.

[0037] In Figure 1 is a plan view of an embodiment of a device according to the invention for percutaneous dilatational puncture tracheotomy, said device comprising a puncture cannula 1, a guide catheter 5 and a guide wire 8. In the illustration of Figure 1 The three components are shown separately, ie not inserted into each other. In the illustration of Figure 1The exposed section of the hollow needle 2 and the cannula connector 3 arranged at the proximal end of the puncture cannula 1 can be seen. As is usual with conventional puncture cannulas, a short proximal section of the hollow needle 2 is encompassed by the cannula connector 3, and the hollow needle 2 is firmly connected to the cannula connector 3 by the overlapping area.

[0038] The guide catheter 5 shown here also consists of two subunits, namely the catheter tube 6 and the catheter connector 7. In the plastic embodiment shown here, the catheter tube and catheter connector are made of one piece from plastic, so that the plastic material widens conically from the transition from the catheter tube 6 to the catheter connector 7, and then transitions into a cylindrical section in the proximal direction.

[0039] The guide wire 8 is shown here in a very shortened form and has a semicircularly bent end at its distal end 9.

[0040] Figure 2 shows the Figure 1 An embodiment of the invention disassembled into separate components in the assembled state in cross-section. It is clearly visible how the guide wire 8 runs through the hollow needle 2 of the puncture cannula and how the hollow needle 2 of the puncture cannula is arranged in the catheter tube 6 of the guide catheter. In the assembled state shown here, the distal end of the cannula connector 3 is inserted into the lumen of the catheter connector 7. A stop point provided on the cannula connector defines a position at which the distal end of the hollow needle 2 protrudes beyond the distal end of the catheter tube 6.

[0041] The cross-sectional view of an embodiment of the invention shown in Figure 3shows two discrete stable insertion positions for the puncture cannula inserted into the guide catheter. In the image shown above Figure 3 In the state shown, the puncture cannula is in a first stable insertion position, which is the same as in the Figure 2 described state is defined by a stop provided on the cannula connector, and in this state, the ground tip 4 provided on the distal end of the hollow needle protrudes beyond the distal end of the catheter tube 6. In the state shown in the lower illustration of Figure 3As shown, the puncture cannula is in a second stable insertion position in which the ground tip 4 at the distal end of the hollow needle does not protrude beyond the distal end of the catheter tube 6. This second stable insertion position is defined by the internal thread 10 provided on the inner wall of the catheter connector 7. By turning the puncture cannula against the guide catheter, the puncture cannula can be moved from the aforementioned first stable insertion position into a second stable insertion position, which results in the ground tip 4 at the distal end of the puncture cannula being retracted into the lumen of the guide catheter.

[0042] In Figure 4Shown above is a cross-section through a puncture cannula of an embodiment of the invention, in which the inner wall of the cannula connector 3 tapers slightly in the distal direction towards the lumen of the hollow needle 2. However, a section remains around the proximal hollow needle end that runs perpendicular to the longitudinal direction of the hollow needle 2. When inserting a guide wire, the end of the guide wire can strike these vertical surfaces, making inserting the guide wire into the hollow needle very difficult. To avoid this, this embodiment features an adapter 11 that can be precisely inserted into the lumen of the cannula connector 3 (see center of the illustration), eliminating the above-described vertical surfaces to the right and left of the hollow needle entry opening.For this purpose, the adapter 11 has a lumen that tapers in a funnel shape towards the lumen of the puncture cannula, so that the inner wall of the adapter is flush with the inlet opening of the hollow needle 2.

[0043] If a guide wire 8 is now inserted into the puncture cannula 1, it is guided along the inner wall of the adapter 11 directly into the entry opening of the hollow needle 2, which significantly facilitates the insertion of the guide wire 8 into the puncture cannula 1.

[0044] In Figure 5a plan view of an embodiment of a set 12 for percutaneous dilatational puncture tracheotomy is shown, wherein this set 12 contains, in addition to the puncture cannula 1, the guide catheter 5 and the guide wire 8, a predilator 19, a dilator 13, an insertion aid 14 for the guide wire 8, a scalpel 15, an arming catheter 16 with a safety lock for the guide wire 8, a syringe 17 and a set of compresses 18

[0045] The invention is defined by the appended claims. List of reference symbols:

[0046] 1 Puncture cannula 2 Hollow needle 3 Cannula connector 4 Ground tip 5 Guide catheter 6 Catheter tube 7 Catheter connector 8 Guide wire 9 Curved end 10 Thread 11 Adapter 12 Tracheostomy set 13 Dilator 14 Guide wire insertion aid 15 Scalpel 16 Armoring catheter with safety lock 17 Syringe 18 Compresses 19 Pre-dilator

Claims

1. Device for percutaneous dilatational tracheostomy, wherein the device has a puncture needle (1), a guide catheter (5) and a guidewire (8), wherein the puncture needle has a ground tip (4) at its distal end, wherein the maximum outer diameter of the puncture needle is smaller than the minimum inner diameter of the guide catheter, and wherein the puncture needle is insertable so far into the guide catheter that the ground tip of the puncture needle projects beyond the distal end of the guide catheter, wherein the maximum diameter of the guidewire is smaller than the minimum inner diameter of the puncture needle, so that the guidewire (8) can be passed through the puncture needle (1) such that its end projects beyond the ground tip (4) of the puncture needle, characterized in that the lumen of the puncture needle, at the proximal end of the latter opposite the ground tip, widens in a funnel shape, or a connector (3) whose lumen tapers in a funnel shape in the direction of the lumen of the puncture needle is arranged at the proximal end of the puncture needle, or an adapter (11) whose lumen tapers in a funnel shape in the direction of the lumen of the puncture needle is arranged at the proximal end of the puncture needle.

2. Device according to Claim 1, characterized in that the guidewire has a maximum diameter in the range of 1.0 to 1.5 mm, preferably in the range of 1.2 to 1.3 mm.

3. Device according to Claim 1 or 2, characterized in that the minimum inner diameter of the puncture needle is 0.1 to 0.4 mm larger than the maximum diameter of the guidewire.

4. Device according to any one of the preceding claims, characterized in that the minimum inner diameter of the guide catheter is 0.05 to 0.3 mm larger than the maximum outer diameter of the puncture needle.

5. Device according to any one of the preceding claims, characterized in that the puncture needle is made of steel.

6. Device according to any one of the preceding claims, characterized in that the guide catheter is made of plastic.

7. Device according to any one of the preceding claims, characterized in that the guidewire is made of metal or plastic.

8. Device according to any one of the preceding claims, characterized in that connectors (3, 7) are arranged at the proximal end of puncture needle and guide catheter, wherein the connector (3) on the puncture needle is arranged in the connector (7) on the guide catheter in a first stable insertion position such that the ground tip of the puncture needle projects by 1 to 10 mm, particularly preferably by 2 to 6 mm, beyond the distal end of the guide catheter, and wherein, by pulling or turning the connector (3) of the puncture needle, the latter is brought into a second stable insertion position, in which the ground tip does not project beyond the guide catheter.

9. Device according to any one of the preceding claims, characterized in that that end of the guidewire projecting beyond the end of the puncture needle, in the state when passed through the puncture needle, has a curved shape from a quarter of a circle to three quarters of a circle.

10. Kit (12) for percutaneous dilatational tracheostomy, comprising a device according to any one of the preceding claims and a dilator (13) for expanding the tracheostoma, wherein the dilator has a dilatation region with a diameter that increases continuously in the longitudinal direction, and wherein a guide channel is provided in the longitudinal direction in the dilator, the minimum inner diameter of which guide channel is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel.

11. Kit according to Claim 10, characterized in that it additionally has a predilator (19) for expanding the tracheostoma, wherein the predilator has an outer diameter which is larger than the outer diameter of the guide catheter and smaller than the average diameter of the dilator (13), and wherein a guide channel is provided in the longitudinal direction in the predilator, the minimum inner diameter of which guide channel is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel, wherein the minimum inner diameter of the guide channel of the predilator is 0.1 to 1.0 mm larger than the maximum diameter of the guidewire.

12. Kit according to either of Claims 10 and 11, characterized in that an insertion aid (14) is arranged at that end of the guidewire projecting beyond the end of the puncture needle, in the state when passed through the puncture needle, which insertion aid has, in the longitudinal direction, a guide channel whose minimum inner diameter is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel, wherein one end of the guide channel opens into a conically tapering portion of the insertion aid.

13. Kit according to any one of Claims 10-12, characterized in that it additionally comprises a scalpel (15), the or a predilator (19), a set of compresses (18), a reinforcing catheter (16), a tracheostomy tube, one or more insertion aids for a tracheostomy tube and / or a syringe (17).