WO2023084301A1

WO2023084301A1 - Air trapping y-connector

Info

Publication number: WO2023084301A1
Application number: PCT/IB2021/061284
Authority: WO
Inventors: Prashant Ramdas Wankhade
Original assignee: Prashant Ramdas Wankhade
Priority date: 2021-11-11
Filing date: 2021-12-03
Publication date: 2023-05-19

Abstract

A Y-connector device comprises a main passage that is fluid communication with a catheter, an anterior, middle, and a posterior air collection chamber which are positioned above the main passage and are connected to the main air trapping chamber which is positioned at the top, via anterior, middle and posterior air transits respectively. A side port that is attached to the middle air collection chamber is horizontal and is lying above the plane of the main passage. Air bubbles present in the media that is injected via the side port, upon reaching the middle air collection chamber floats due to low density and is directed upward towards the main air trapping chamber. Similarly, the air bubbles present in the anterior and posterior part of the main air passage are collected in anterior and posterior air collection chambers and directed upward towards the main air trapping chamber.

Description

AIR TRAPPING Y-CONNECTOR

FIELD OF INVENTION

[001] The present invention relates to a specialized Y-connector used in percutaneous interventions i.e., angiography and angioplasty for the prevention of air embolism. More specifically, a specially designed Y-connector that is able to trap the air traversing via both the ports, that is, contrast injection port and device negotiation port. The present invention is used in medical field, especially the interventional radiology and cardiology field.

BACKGROUND OF THE INVENTION

[002] In the systems that are usually followed to analyze blood vessels, angiography is an important process that is performed to review blood vessels for diagnosis of issues associated with the blood vessels and for deciding the appropriate treatment measures that should be considered for the same. A variety of liquid substances are used to analyze the system of arteries using catheters, where a user is allowed to view the inference of the analysis on a display device. Notwithstanding the merits of angiography, a severe complication that may occur during this method is air embolus. An accidental entry of air in an artery of the patient can cause air embolism because of reasons like improper monitoring and human errors. The resulting air embolism embolus may cause lethal damages to major organs of the patient, especially the heart and brain. Considering the usual Y-connector used in percutaneous interventions that is, angiography and angioplasty doesn’t have any air trapping mechanism.

[003] Patent number WO 2016/209177 Al addresses an 'Air trap device', that describes a system that prevents air embolus in angiography. The apparatus described in this patent WO 2016/209177 A 1 traps the air bubbles traveling through the port used for contrast media injection only. This apparatus cannot trap the air bubbles entering via the port used to negotiate the interventional devices because if it is attached beyond the usual Y -connector, then the angled tip guide wire can enter the conical-shaped chambers of the apparatus making distal negotiation difficult.

[004] Therefore, there is a need for a specially designed Y-connector that is able to trap the air traversing via both the ports, that is, contrast injection port and device negotiation port.

SUMMARY OF THE INVENTION

[005] This summary is provided to introduce a selection of concepts in a simplified form that are further disclosed in the detailed description of the invention. This summary is not intended to identify key or essential inventive concepts of the claimed subject matter, nor is it intended for determining the scope of the claimed subject matter.

[006] The present invention discloses a specially designed Y-connector that is able to trap the air traversing via both the ports i.e., contrast injection port and device negotiation port reducing chances of inadvertent life-threatening air embolism. The Y-connector device comprises a main passage that is fluid communication with a catheter, an anterior air collection chamber, a middle air collection chamber, and a posterior air collection chamber positioned above the main passage and in direct connection with the main passage. The anterior air collection chamber and the posterior air collection chamber are connected to a main air trapping chamber. The Y -connector device is rotatable via a Luer lock, wherein a side port that is attached to the middle air collection chamber is horizontal and a plane of floor of the side port is lying above a plane of roof of the main passage. The Y-connector device is rotatable via a 360- degree rotating male Luer lock, and wherein the main air trapping chamber is mandatorily positioned vertical and at the top, by rotating the apparatus. Air bubbles present in media that is injected through the catheter via the side port, upon reaching the middle air collection chamber, floats due to their low density and is directed upward towards the main air trapping chamber. The media is, for example, in saline or contrast media. Thereby, the saline or the contrast media entering a middle of the main passage from the middle air collection chamber is devoid of the air bubbles.

[007] In an embodiment, the anterior air collection chamber and the posterior air collection chamber are broadly triangular in cross section with apex of a triangle positioned at the top. In an embodiment, the middle air collection chamber is connected to the main air trapping chamber via a middle air transit and the side port lies horizontal and is connected to the middle air collection chamber at a right posterolateral aspect. In an embodiment, the plane of the floor of the side port is positioned above the plane of the roof of the main passage so that the air bubbles traversing ahead through the side port marches upward towards the main air trapping chamber rather than the main passage.

[008] In an embodiment, the main air trapping chamber is substantially conical in shape and is positioned above and is connected to the anterior air collection chamber, the middle air collection chamber, and the posterior air collection chamber via anterior, middle, and posterior air transits. In an embodiment, the main air trapping chamber is connected to the anterior air collection chamber via an anterior air transit, to the middle air collection chamber via a middle air transit, and to the posterior air collection chamber via a posterior air transit. The main air trapping chamber comprises a nozzle at the top for removing the entrapped air from the air bubbles, wherein the nozzle comprises a single thread for screwing a cap.

[009] In an embodiment, the middle air collection chamber is connected to the main passage at its base and the main air trapping chamber at its roof. In an embodiment, the withdrawal of external devices, outside air is sucked inside the main passage due to negative pressure created within the closed assembly consisting of the catheter and the Y -connector device, wherein the air floats on fluid present inside the posterior main passage and is directed to the top of the posterior air collection chamber and then via the posterior air transit towards the main air trapping chamber. In an embodiment, any air that is left untrapped in the middle air collection chamber and the posterior air collection chamber, after reaching the anterior main passage is directed upward towards the anterior air collection chamber and subsequently towards the main air trapping chamber via anterior air transit. The air trapped inside the main air trapping chamber is then removed via the nozzle by unscrewing the cap.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The foregoing summary, as well as the following detailed description of the invention, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, exemplary constructions of the invention are shown in the drawings. However, the invention is not limited to the specific methods and components disclosed herein. The description of a method step or a component referenced by a numeral in a drawing is applicable to the description of that method step or component shown by that same numeral in any subsequent drawing herein.

[0011] FIG. 1 includes FIG. 1A that shows the side view and FIG. IB shows the top view of the Air trapping Y -connector.

[0012] FIG. 2 shows cross sections of the air trapping y-connector at various levels from A to O.

[0013] FIG 3 shows longitudinal sections of the air trapping y-connector at various levels from P to U.

[0014] FIG. 4 shows structure of the main air trapping chamber. [0015] FIG. 4A shows side view of the chamber which is positioned above the top of middle air collecting chamber which in turn is positioned above the top of main passage.

[0016] FIG 4B shows posterior view of main air trapping chamber.

[0017] FIG. 4C shows posterior view of main air trapping chamber devoid of the side port.

[0018] FIG. 5 shows 3 -dimensional structure of air collections chambers along with adjacent main passage.

[0019] FIG. 5A shows 3 -dimensional structure of the anterior air collection chamber positioned on the top of main passage.

[0020] FIG 5B shows 3 -dimensional structure of the middle air collection chamber positioned on the top of main passage.

[0021] FIG. 5C shows 3-dimensional structure of the posterior air collection chamber positioned on the top of main passage.

[0022] FIG. 6 illustrates the mechanism of working of the air trapping Y -connector apparatus.

DETAILED DESCRIPTION OF THE DRAWINGS

[0023] Exemplary embodiments will now be described. The disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and willfully convey its scope to those skilled in the art. The terminology used in the detailed description of the particular exemplary embodiments illustrated in the accompanying drawings is not intended to be limiting. In the drawings, like numbers refer to like elements.

[0024] FIG. 1 A shows the side view and FIG. IB shows the top view of the Air trapping Y-connector device 50. The air trapping y-connector device 50 comprises a usual rotating male luer lock 1 at the front end which enables 360-degree rotation of the catheter attached to it. Hub 3 is the usual assembly of the haemostatic valve and an opening at the hind side to negotiate various interventional devices through it. Main passage 2 enables passage of these interventional devices, contrast media, saline and various medications in liquid form through it towards the catheter. The anterior air collection chamber 12, middle air collection chamber 6, and posterior air collection chamber 14 are positioned above the main passage 2 and are in direct connection with it. The anterior air collection chamber 12 and posterior air collection chamber 14 are broadly triangular in cross section with apex of the triangle positioned at the top. Both anterior and posterior air collection chambersl2 and 14 respectively, are connected to the main air trapping chamber 8 via anterior air transit 13 and posterior air transit 15 respectively. Middle air collection chamber 6 is connected to main passage 2 at its base and the main air trapping chamber 8 at its roof. The Y-connector device 50 is rotatable via the 360- degree rotating male Luer lock 1, and wherein the main air trapping chamber 8 is mandatorily positioned vertical and at the top, by rotating the apparatus.

[0025] The anterior wall of the middle air trapping chamber 6 slants backward, whereas the posterior wall of the middle air trapping chamber 6 slants forward as they extend upwards so that the roof of the chamber is narrower compared to the base. Anterior and posterior walls of the middle air trapping chamber 6 are convexo-concave with convexity on the outer surface. Sidewalls of the middle air trapping chamber 6 are vertical and parallel to each other as they extend upward from the main passage. Middle air collection chamber 6 is connected to the main air trapping chamber 8 via middle air transit 7. The usual side port 4 of the Y- connector device 50 lies horizontal and is connected to middle collection chamber 6 at its right posterolateral aspect 5. The plane of the floor of the side port 4 is positioned above the plane of the roof of the main passage 2 so that the air bubbles traversing ahead through the side port 4 marches upward towards the main air trapping chamber 8 rather than the main passage 2. Main air trapping chamber 8 is nearly conical in shape and is positioned at the top and is connected to all three air collection chambers i.e., anterior air collection chamber 12, middle air collection chamber 6, and posterior air collection chamber 14 via anterior, middle, and posterior air transits 13, 7, and 15 respectively. The main air trapping chamber 8 has a nozzle 9 at the top for removing the entrapped air. The nozzle has a single thread 10 for screwing a cap 11.

[0026] Referring to FIGS. 2-4, FIG 2 shows cross sections of the device at various levels from A to O in alphabetical order. FIG. 3 shows longitudinal sections of device at various levels from P to U in alphabetical order. FIG. 4 shows structure of the main air trapping chamber 8. It appears nearly conical in shape. FIG. 4A shows side view of the chamber which is positioned above the top of middle air collecting chamber 6 which in turn is positioned above the top of main passage 2b. Main air trapping chamber 8 is connected to anterior air collection chamber 12 via anterior air transit 13, to middle air collection chamber 6 via middle air transit 7 and to the posterior air collection chamber 14 via posterior air transit 15. Main air trapping chamber 8 has a nozzle 9 at the top for removing the entrapped air. The nozzle has a single thread 10 for screwing a cap 11. FIG. 4b shows posterior view of main air trapping chamber 8. The usual side port 4 of the Y-connector device 50 lies horizontal and is connected to middle air collection chamber 6 at its right posterolateral aspect 5. Dotted line 16 is an imaginary line representing the roof of the main passage which is separating the main passage 2 from middle air collection chamber 6. The plane of the floor 18 of the side port 4 is positioned above the plane of the roof 17 of the main passage 2 so that the air bubbles traversing ahead through the side port 4 marches upward towards the main air trapping chamber 8 rather than the main passage 2. Posterior air collection chamber 14 is attached to the main air trapping chamber 8 via posterior air transit 15. FIG. 4c shows posterior view of main air trapping chamber 8 devoid of the side port. Posterior air collection chamberl4 is attached to the main air trapping chamber 8 via posterior air transit 15 and side port 4 is connected to the middle air collection chamber 6 at its posterolateral aspect 5.

[0027] FIG. 5 shows 3 -dimensional structure of air collections chambers along with adjacent main passage. FIG. 5A shows 3-dimensional structure of the anterior air collection chamber positioned on the top of main passage 2a. Dotted line 16a is an imaginary line representing the roof of the main passage which is separating the main passage 2a from anterior air collection chamber 12. Anterior air transit 13 connects anterior air collection chamber 12 to the main air trapping chamber 8. FIG. 5B shows 3 -dimensional structure of the middle air collection chamber positioned on the top of main passage 2b. Dotted line 16b is an imaginary line representing the roof of the main passage which is separating the main passage 2b from middle air collection chamber 6. Middle air transit 7 connects middle air collection chamber 6 to the main air trapping chamber 8. FIG. 5C shows 3-dimensional structure of the posterior air collection chamber positioned on the top of main passage 2c. Dotted line 16c is an imaginary line representing the roof of the main passage which is separating the main passage 2c from posterior air collection chamber 14. Posterior air transit 15 connects posterior air collection chamber 14 to the main air trapping chamber 8.

MECHANISM OF WORKING OF THE APPARATUS:

[0028] FIG. 6 illustrates the mechanism of working of the apparatus. While using the apparatus it is mandatory to keep the main air trapping chamber 8 vertical and at the top, which is facilitated by the 360- degree rotating male Luer lock 1. Once the diagnostic or guide catheter 19 which is connected to the ‘Y-connector with air trapping chamber’ is engaged to the desired destination, the 'Y- connector with air trapping chamber' can be rotated to acquire the desired above-mentioned position wherein main air trapping chamber stands vertical and, on the top. The mam passage 2 that is fluid communication with the catheter 19. Side port 4 attached to the middle air collection chamber 6 is horizontal and the plane of the floor of the side port 4 is lying above the plane of the roof of the main passage 6. FIG. 6A shows the air bubbles present in the saline or contrast injected via side port 4, upon reaching the middle air collection chamber 6, tend to float due to their low density and get directed upward towards the main air trapping chamber 8. Hence the contrast media or saline entering the middle main passage 2b from the middle air collection chamber 6 is devoid of the air bubbles.

[0029] The hemostatic valve present inside the hub 3 is opened up while introducing and withdrawing interventional devices through the hub. While the withdrawal of the devices, outside air may get sucked inside the main passage 2 due to negative pressure created within the closed assembly consisting of catheter 19 and Y-connector 50. FIG. 6B shows this air floats on the fluid inside the posterior main passage 2c and gets directed to the top of the posterior air collection chamber 14 and then via posterior air transit 15 towards the main air trapping chamber 8. FIG. 6C shows as the contrast media or saline traverse through the main passage 2 towards the guide catheter 19, any air left untrapped in the middle and posterior air collection chamber 6 and 14, after reaching the anterior main passage 2a gets directed upward towards the anterior air collection chamber 12 and subsequently towards the main air trapping chamber 8 via anterior air transit 13. FIG. 6D and E shows air trapped inside the main air trapping chamber 8 is then removed via nozzle 9 by unscrewing cap 11. FIG. 6F shows cap 11 is screwed again to nozzle 9 after removing the air. Thus, inadvertently entered air inside the Y -connector device 50 is prevented from entering the catheter preventing major mishaps.

[0030] The present disclosure has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departure from the scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present disclosure without departure from its scope. Therefore, it is intended that the present disclosure not be limited to the particular embodiment disclosed, but that the present disclosure will include all embodiments that fall within the scope of the appended claims.

Claims

CLAIMS I Claim:

1. A Y-connector device 50 comprising; a main passage 2 that is fluid communication with a catheter 19; an anterior air collection chamber 12, a middle air collection chamber 6, and a posterior air collection chamber 14 positioned above the main passage 2 and in direct connection with the main passage 2, wherein the anterior air collection chamber 12 and the posterior air collection chamber 14 are connected to a main air trapping chamber 8; the Y-connector device 50 is rotatable via a 360- degree rotating male Luer lock 1, and wherein the main air trapping chamber 8 is mandatorily positioned vertical and at the top, by rotating the Y -connector device 50; a side port 4 that is attached to the middle air collection chamber 6 is horizontal and a plane of floor of the side port 4 is lying above a plane of roof of the main passage 6, wherein media injected through the catheter 19 via the side port 4, wherein air bubbles formed in the media, upon reaching the middle air collection chamber 6, floats due to their low density and is directed upward towards the main air trapping chamber 8, and thereby the media entering a middle of the main passage from the middle air collection chamber 6 is devoid of the air bubbles.

2. The Y-connector device 50 as claimed in claim 1, wherein the anterior air collection chamber 12 and the posterior air collection chamber 14 are broadly triangular in cross section with apex of a triangle positioned at the top.

3. The Y-connector device 50 as claimed in claim 1, wherein the middle air collection chamber 6 is connected to the main air trapping chamber 8 via a middle air transit 7 and the side port 4 lies horizontal and is connected to the middle air collection chamber 6 at a right posterolateral aspect 5.

4. The Y-connector device 50 as claimed in claim 1, wherein the plane of the floor of the side port 4 is positioned above the plane of the roof of the main passage 2 so that the air bubbles traversing ahead through the side port 4 marches upward towards the main air trapping chamber 8 rather than the main passage 2.

5. The Y-connector device 50 as claimed in claim 1, wherein the main air trapping chamber 8 is substantially conical in shape and is positioned vertically and at the top and is connected to the anterior air collection chamber 12, the middle air collection chamber 6, and the posterior air collection chamber 14 via anterior, middle, and posterior air transits 13, 7 and 15 respectively.

6. The Y-connector device 50 as claimed in claim 5, wherein the main air trapping chamber 8 is connected to the anterior air collection chamber 12 via an anterior air transit 13, to the middle air collection chamber 6 via a middle air transit 7, and to the posterior air collection chamber 14 via a posterior air transit 15, wherein the main air trapping chamber 8 comprises a nozzle 9 at the top for removing the entrapped air from the air bubbles, wherein the nozzle 9 comprises a single thread 10 for screwing a cap 11.

7. The Y-connector device 50 as claimed in claim 1, wherein the middle air collection chamber 6 is connected to the main passage 2 at its base and the main air trapping chamber 8 at its roof.

8. The Y-connector device 50 as claimed in claim 1, wherein the withdrawal of external devices, outside air is sucked inside the main passage 2 due to negative pressure created within the closed assembly consisting of the catheter 19 and the Y -connector device 50, wherein the air floats on fluid present inside the posterior main passage 2c and gets directed to the top of the posterior air collection chamber 14 and then via the posterior air transit 15 towards the main air trapping chamber 8.

9. The Y-connector device 50 as claimed in claim 1, wherein any air that is left untrapped in the middle air collection chamber 6 and the posterior air collection chamber 14, after reaching the anterior main passage 2a is directed upward towards the anterior air collection chamber 12 and subsequently towards the main air trapping chamber 8 via anterior air transit 13, wherein the air trapped inside the main air trapping chamber 8 is then removed via the nozzle 9 by unscrewing the cap 11.