DEVICE FOR PERCUTANEOUS DILATIONAL TRACHEOTOMY

20230102704 ยท 2023-03-30

Assignee

Inventors

Cpc classification

International classification

Abstract

To be able to prevent a situation in which, in percutaneous dilational tracheostomy, the guide catheter already inserted into the trachea can kink, a device for percutaneous dilational tracheostomy is disclosed which has a puncture needle, a guide catheter and a guidewire. The puncture needle has a ground tip at its distal end. The maximum external diameter of the puncture needle is smaller than the minimum internal diameter of the guide catheter, and the puncture needle is insertable so far into the guide catheter that the ground tip of the puncture needle protrudes beyond the distal end of the guide catheter. The maximum diameter of the guidewire is smaller than the minimum internal diameter of the puncture needle, with the result that the guidewire can be guided through the puncture needle such that its end protrudes beyond the ground tip of the puncture needle.

Claims

1. Device A device for percutaneous dilational tracheostomy, comprising: a puncture needle; a guide catheter; and a guidewire, wherein the puncture needle has a ground tip at its distal end, wherein the maximum outer diameter of the puncture needle is smaller than the minimum inner diameter of the guide catheter, wherein the puncture needle can be inserted 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 can be passed through the puncture needle such that its end projects beyond the ground tip of the puncture needle, and wherein, at its proximal end opposite to the ground tip, the lumen of the puncture needle widens in a funnel shape, or a connector, the lumen of which narrows in a funnel shape in the direction of the lumen of the puncture needle, is disposed at the proximal end of the puncture needle, or an adapter, the lumen of which narrows in a funnel shape in the direction of the lumen of the puncture needle, is disposed at the proximal end of the puncture needle.

2. The device according to claim 1, wherein 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. The device according to claim 1, wherein the minimum inner diameter of the puncture needle is 0.1 to 0.4 mm larger than the maximum diameter of the guidewire.

4. The device according to claim 1, wherein 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. The device according to claim 1, wherein the puncture needle is made of steel.

6. The device according to claim 1, wherein the guide catheter is made of plastic.

7. The device according to claim 1, wherein the guidewire is made of metal or plastic.

8. The device according to claim 1, wherein connectors are disposed at the proximal end of the puncture needle and the guide catheter, wherein the connector on the puncture needle is disposed in the connector on the guide catheter in a first stable insertion position such that the ground tip of the puncture needle projects 1 to 10 mm beyond the distal end of the guide catheter, and wherein, by turning or pulling on the connector of the puncture needle, the puncture needle is brought into a second stable insertion position in which the ground tip does not project beyond the guide catheter.

9. The device according to claim 1, wherein the end of the guidewire which projects beyond the end of the puncture needle when passed through the puncture needle is curved in a quarter to three-quarter circle.

10. (canceled)

11. A kit for percutaneous dilational tracheostomy, comprising: the device according to claim 1; and a dilator for expanding the tracheostoma, wherein the dilator comprises a dilatation region having a diameter which increases continuously in longitudinal direction and wherein a guide channel is provided in longitudinal direction in the dilator, the minimum inner diameter of which is larger than the maximum diameter of the guidewire, so that the guidewire can be passed through the guide channel.

12. The kit according to claim 11, further comprising a predilator 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, and wherein a guide channel is provided in longitudinal direction in the predilator, the minimum inner diameter of which 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.

13. The kit according to claim 11, wherein, at the end of the guidewire which projects beyond the end of the puncture needle when passed through the puncture needle, an insertion aid is disposed, which comprises a guide channel in longitudinal direction, the minimum inner diameter of which 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 section of the insertion aid.

14. The kit according to claim 11, further comprising: a scalpel, a predilator, a set of compresses, a reinforcement catheter, a tracheostomy tube, one or more insertion aids for a tracheostomy tube, and/or a syringe.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0035] Individual examples of the aforementioned specific embodiments of the invention are provided with reference to the appended FIGS. 1 to 5, wherein

[0036] FIG. 1 shows a plan view onto an embodiment of a device according to the invention for percutaneous dilational tracheostomy, wherein the device comprises a puncture needle, a guide catheter and a guidewire having a curved end, and wherein these three components are shown separately, i.e., not inserted into one another,

[0037] FIG. 2 shows the embodiment of the invention according to FIG. 1 in cross-section, wherein the puncture needle, the guide catheter and the guidewire are shown inserted into one another,

[0038] FIG. 3 shows the puncture needle and the guide catheter of an embodiment of the invention in cross-section, wherein the puncture needle is shown inserted into the guide catheter in two different positions,

[0039] FIG. 4 shows a cross-section through a puncture needle 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 disposed at the proximal end of the puncture needle and in the third state the puncture needle is shown with the guidewire passed through the puncture needle and inserted into the guide catheter, and

[0040] FIG. 5 is a plan view onto an embodiment of a set for percutaneous dilational tracheostomy, wherein the set comprises a puncture needle, a guide catheter and a guidewire, as well as a dilator, a scalpel, a predilator, an insertion aid for the guidewire, a reinforcement catheter with a safety lock for the guidewire, a set of compresses and a syringe.

DETAILED DESCRIPTION OF PARTICULAR EMBODIMENTS

[0041] The following features or combinations of features are shown in detail in the above-mentioned figures.

[0042] FIG. 1 shows a plan view onto an embodiment of a device according to the invention for percutaneous dilational tracheostomy, wherein said device comprises a puncture needle 1, a guide catheter 5 and a guidewire 8. In the illustration of FIG. 1, the three components are shown separately, i.e., not inserted into one another. In the illustration of FIG. 1, the puncture needle 1 shows the exposed portion of the hollow needle 2 and also the cannula connector 3 disposed at the proximal end of the puncture needle. As is also common in the conventional puncture needles, a short proximal portion of the hollow needle 2 is surrounded by the cannula connector 3 and the hollow needle 2 is firmly connected to cannula connector 3 via the region which overlaps here.

[0043] 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 the catheter connector are made in one piece of plastic, so that the plastic material widens conically from the transition from the catheter tube 6 to the catheter connector 7 to then transition in proximal direction into a cylindrical portion.

[0044] The guidewire 8 is shown here considerably shortened and comprises a semi-circular curved end at its distal end 9.

[0045] FIG. 2 shows the embodiment of the invention which is broken down into separate components in FIG. 1 in the assembled state in cross-section. It can be clearly seen how the guidewire 8 extends through the hollow needle 2 of the puncture needle and how the hollow needle 2 of the puncture needle is disposed 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 projects beyond the distal end of the catheter tube 6.

[0046] The cross-sectional view of an embodiment of the invention shown in FIG. 3 shows two discrete stable insertion positions for the puncture needle inserted into the guide catheter. In the state shown above in FIG. 3, the puncture needle is in a first stable insertion position, which, as in the state described above for FIG. 2, is defined by a stop provided on the cannula connector. In this state, the ground tip 4 provided at the distal end of the hollow needle projects beyond the distal end of the catheter tube 6. In the state shown in the lower illustration of FIG. 3, the puncture needle is in a second stable insertion position in which the ground tip 4 at the distal end of the hollow needle does not project 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 needle relative to the guide catheter, the puncture needle can thus be moved from the aforementioned first stable insertion position into a second stable insertion position, as a result of which the ground tip 4 at the distal end of the puncture needle is pulled back into the lumen of the guide catheter.

[0047] FIG. 4 at the top shows a cross-section through a puncture needle of an embodiment of the invention, in which the inner wall of the cannula connector 3 tapers slightly conically in distal direction to the lumen of the hollow needle 2. However, a portion which extends perpendicular to the longitudinal direction of the hollow needle 2 remains around the proximal end of the hollow needle. When a guidewire is inserted, the end of the guidewire can abut these perpendicular surfaces, which makes it very difficult to insert the guidewire into the hollow needle. To avoid this, in this embodiment, an adapter 11 is provided that can be inserted into the lumen of the cannula connector 3 in a precisely fitting manner (see the figure in the middle), thus eliminating the above-described perpendicular surfaces to the right and the left of the hollow needle entry opening. For this purpose, the adapter 11 comprises a lumen which tapers in a funnel shape in the direction of the lumen of the puncture needle, so that the inner wall of the adapter is flush with the entry opening of the hollow needle 2.

[0048] If a guidewire 8 is now inserted into the puncture needle 1, it is guided along the inner wall of the adapter 11 directly into the entry opening of the hollow needle 2, which facilitates the insertion of the guidewire 8 into the puncture needle 1 significantly.

[0049] FIG. 5 shows a plan view onto an embodiment of a set 12 for percutaneous dilational tracheostomy, wherein, in addition to the puncture needle 1, the guide catheter 5 and the guidewire 8, this set 12 further includes a predilator 19, a dilator 13, an insertion aid for the guidewire 14, a scalpel 15, a reinforcement catheter with a safety lock for the guidewire 16, a syringe 17 and a set of compresses 18.

LIST OF REFERENCE SIGNS

[0050] 1. Puncture needle [0051] 2. Hollow needle [0052] 3. Cannula connector [0053] 4. Ground tip [0054] 5. Guide catheter [0055] 6. Catheter tube [0056] 7. Catheter connector [0057] 8. Guidewire [0058] 9. Curved end [0059] 10. Thread [0060] 11. Adapter [0061] 12. Tracheostomy set [0062] 13. Dilator [0063] 14. Insertion aid for the guidewire [0064] 15. Scalpel [0065] 16. Reinforcement catheter with safety lock [0066] 17. Syringe [0067] 18. Compresses [0068] 19. Predilator