A VENOVENOUS ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULA

Abstract

This invention is related to a dual lumen triple brimmed venovenous ECMO (Extracorporeal Membrane Oxygenation) cannula (1).

Claims

1. A cannula for oxygenation of contaminated blood and returning the blood to patient characterized in that said cannula comprises: at least one body having a plurality of openings in which the blood is collected and sprayed, the body being in a double lumen structure with ends from which dirty blood leaves the body and the clean blood enters the body; at least one anti-bacterial coating located on the upper part of the body that is in contact with the patient's skin; more than one indicator that determines the level and that is located on the upper part of the body, in the opening wherein the blood is ejected and at the lower part of the body; at least one reinforced area that is resilient and resistant to breakage and located in the upper part of the body; at least one upper venous opening located on the body into which the venous blood enters; at least one arterial opening having an indicator wherein clean blood is ejected, at least one lower venous basket end located at the lower end of the body and having at least one basket end opening; at least one lower end hole on the body, which is located such that it is on the upper side of the lower venous basket end; at least one clamp securing the body on the patient's skin; a body that is elliptical in shape in order to increase the amount of blood sucked and is formed by non-concentric lumen placement wherein the lumen in the elliptical body that is used to inject blood has a circular cross section.

2. A cannula according to claim 1, characterized in that said cannula comprises a body comprising two ends connected with lumens and wherein said ends perform their functions separately at the upper part of the body and from which the venous blood exits and is returned back to the system after cleaning.

3. A cannula according to claim 1 characterized in that said cannula comprises a body comprising preferably two indicators on the upper region and there are upper venous openings in between the indicators from which the dirty blood enters.

4. A cannula according to claim 1, characterized in that said cannula comprises a body comprising two indicators located at the upper and lower part of the upper arterial openings.

5. A cannula according to claim 1, characterized in that said cannula comprises an arterial opening from which the clean blood is ejected and which is located on the body under the indicator located under the upper arterial opening.

6. A cannula according to claim 1, characterized in that said cannula comprises a bacterial coating located on the body between connection point of the ends and the indicator on top of the upper venous openings.

7. A cannula according to claim 1, characterized in that said cannula comprises a reinforced area that prevents breakage and is located between the connection point of the ends and the indicator on top of the upper venous openings.

8. A cannula according to claim 1, characterized in that said cannula comprises a body having an eliptical shape starting from the connection point of the ends until the arterial opening from which the clean blood is ejected.

9. A cannula according to claim 1, characterized in that said cannula comprises a bacterial coating made of a material such as silver or a similar material.

10. A cannula according to claim 9 characterized in that said cannula comprises an antibacterial coating located on the part of the body that is in contact with patient's skin preferably at the upper part of the indicator on the upper part of the body.

11. A cannula according to claim 1, characterized in that said cannula comprises an indicator that is a tape made up of a radio opaque material.

12. A cannula as in claim 1, characterized by indicators located at the top and bottom of the upper shed openings at the top of the body, indicating the beginning and end of openings.

13. A cannula according to claim 1, characterized in that said cannula comprises an indicator just above the lower venous basket end at the bottom of the body, that is the lower radiopaque indicator of the venous lumen.

14. A cannula according to claim 1, characterized in that said cannula comprises an indicator that is C shaped and defining the arterial opening and located on the opening on the body.

15. A cannula according to claim 1, characterized in that said cannula comprises a reinforced area that is elastic but resistant to breakage and used for preventing breakage of the body.

16. A cannula according to claim 1, characterized in that said cannula comprises an upper venous opening that is located on the top of the body and whose shape and number varies with respect to the size of the patient and which is used for introduction of contaminated blood.

17. A cannula according to claim 16, characterized in that said cannula comprises more than one round cross-sectioned upper venous openings between the two indicators located on the upper part of the body when the patient size is increased.

18. A cannula according to claim 16, characterized in that said cannula comprises upper venous openings which are located gradually on the body.

19. A cannula according to claim 16, characterized in that said cannula comprises elliptical cross-sectioned upper venous openings between the two indicators located on the upper part of the body where the patient size is reduced.

20. A cannula according to claim 19 characterized in that said cannula comprises holes that are extended through the body taking an elliptical shape.

21. A cannula according to claim 1, characterized in that said cannula comprises an arterial opening having a round or transverse or longitudinal elliptical cross-section and to which clean blood is ejected.

22. A cannula according to claim 1, characterized in that said cannula comprises arterial opening that minimizes the problem of hemolysis, that is, damage of blood elements by breaking by the curved structure of the arterial opening.

23. A cannula according to claim 1, characterized in that said cannula comprises lower venous basket end that has more than one hole, named as lower end holes on top of it.

24. A cannula according to claim 23 characterized in that said cannula comprises basket end openings located on the distal end of the venous lumen.

25. A cannula according to claim 1, wherein said cannula comprises lower end hole located under the body and above the lower venous end and whose number and shape varies with respect to the size of the patient.

26. A cannula according to claim 25, characterized in that where the patient size is enlarged, there are a plurality of round or elliptic cross sectioned lower end holes on top of the lower venous basket end below the body.

27. A cannula according to claim 25, characterized in that here the patient size is smaller, there are elliptic or round shaped lower end holes on top of the lower venous basket end below the body.

28. A cannula according to claim 1, characterized in that said cannula comprises an upper venous opening and a lower end hole that provide surface increase for blood suction so that there will be more suction power with a narrow body.

29. A cannula according to claim 1, characterized in that said cannula comprises upper venous openings and lower end holes located on both sides of the body.

30. A cannula according to claim 1, characterized in that said cannula comprise a clamp that can be attached to and detached from the body and can be tied to the skin of the patient through two ears that are present on the clamp with preferably a suture thread.

31. A cannula according to claim 30, characterized in that said cannula comprises a clamp that can be attached to and detached from the body via expanding said clamp with the help of the opening and elastic structure.

32. A cannula according to claim 30 characterized in that, said cannula comprises a clamp with two channels for stabilizing to the skin via winding of thread.

33. A cannula according to claim 1, characterized in that said cannula comprises a clamp used in the area that is between the reinforced area on the body and the lumen ends.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0022] To achieve the purpose of this invention, A Venovenous ECMO (Extracorporeal Membrane Oxygenation) Cannula is shown in the enclosed drawings and said drawings disclose;

[0023] FIG. 1. Side view of the large sized cannula according to present invention.

[0024] FIG. 2. Side view of the small sized cannula according to present invention.

[0025] FIG. 3. A cross-sectional view of arterial and venous cannula lumens of cannulas according to present invention.

[0026] FIG. 4. A view of the upper end venous openings (venous blood inlet holes) in large sized cannula according to present invention.

[0027] FIG. 5. A cross-sectional view of the arterial and venous lumens in the cannula of the present invention at the level of the upper venous openings (venous blood entry).

[0028] FIG. 6. A view of the upper end venous opening (venous blood entry) in cannula of the invention that is suitable for small sized patients.

[0029] FIG. 7. The lumen cross-section view at the level of lower venous end opening of the cannula according to present invention.

[0030] FIG. 8. The detailed top view and side view of the clamp used in the cannula.

[0031] The parts in the figures are numbered individually and their correspondences are given below. [0032] 1. Cannula [0033] 2. Body [0034] 3. Coating [0035] 4. Indicator [0036] 5. Reinforced area [0037] 6. Upper venous opening [0038] 7. Arterial opening [0039] 8. Lower venous basket end [0040] 9. Basket end opening [0041] 10. Lower end hole [0042] 11. Clamp

[0043] The ECMO cannula (1) of the present invention that enables oxygenation of the venous blood and then returning said blood back to the patient, in essence comprises; [0044] at least one body (2) having more than one openings in which the blood is collected and ejected, the body being in a double lumen structure with the ends wherein venous blood leaves and the clean blood enters, [0045] at least one anti-bacterial coating (3) located on the upper part of the body (2) that is in contact with the patient's skin, [0046] more than one indicator (4) that determines the level and that is located on the upper part of the body (2), in the opening wherein the blood is ejected and at the lower part of the body (2), [0047] at least one reinforced area (5) that is resilient and resistant to breakage and located in the upper part of the body (2), [0048] at least one upper venous opening (6) located on the body (2) into which the venous blood enters, [0049] at least one arterial opening (7) having an indicator (4) wherein clean blood is ejected, [0050] at least one lower venous basket end (8) located at the lower end of the body (2) and having at least one basket end opening (9), [0051] at least one lower end hole (10) on the body (2), which is located such that is on the upper side of the lower venous basket end (8), [0052] at least one clamp (11) securing the body (2) on the patient's skin.

[0053] In the cannula (1), the body (2) is elliptical in shape in order to increase the amount of blood sucked and is formed by non-concentric lumen placement. The lumen in the elliptical body (2) that is used to inject blood has a circular cross section.

[0054] The cannula of the invention (1) comprises two ends that perform their functions separately at the upper part of the body (2) and from which the venous blood exits and is returned back to the system after cleaning. The lumens located at the body (2), which are the continuation of the ends, extend contiguously after one point and after the arterial opening (7), and transforms into a single lumen from which the blood is sucked and stretches out to the lower part of the body (2). This way the body (2) has a structure that narrows down from upper part to lower part and has a thin lower venous basket end (8). There are preferably two indicators (4) located in the upper part of the body (2) and there is upper venous openings (6) between them and the venous blood enters the cannula from these openings. The body (2) comprises two indicators (4) located on the top and bottom of the upper venous opening (6). The arterial opening (7) from which the clean blood is ejected in on the body (2), at the lower part of the indicator (4) located under the upper venous openings (6). The anti-bacterial coating (5) is located on the body (2) between the junctions of the ends and the indicator (4) located in the upper part of the venous openings (6). The reinforced area (5) preventing breakage is located between the junction of the ends and the indicator (4) located at the upper part of the upper venous openings (6) (FIG. 1-2).

[0055] In the cannula of the present invention (1), the body (2) has an elliptical shape starting from the junction if the ends to the arterial opening (7) from which the clean blood is ejected. This leads to an increase in the surface area of the body (2) and the volume of venous lumen. A higher number of venous openings (6) that are bigger in size can be placed on the increase surface area of the body (2). The arterial lumen located in elliptical body (2) and from which the clean blood ejected has a circular section. (FIG. 3) In a preferred embodiment of the invention, the distal venous ends have a circular cross-section (FIG. 7). The lumens in the body (2) are not concentric, but have a lumen with circular cross-section in which the blood to be ejected proceeds.

[0056] In the present invention, the anti-bacterial coating (3) is preferably made of silver or to similar material. The anti-bacterial coating (3) is located on the part of the body (2) that is in contact with patient's skin preferably at the upper part of the indicator (4) on the upper part of the body (2). With the use of anti-bacterial coating (3), the risk of infecting the patient is reduced in long-term use.

[0057] In a preferred embodiment, the indicator (4) is a band made of radio opaque material. In a preferred embodiment; on the body (2) there are preferably four indicators (4). Indicators (4) located at the upper part of the body (2), at the top and bottom of upper venous openings (6) indicate the beginning and end of venous openings. The indicator (4) located just above the lower venous basket end (8) at the bottom of the body (2), is the lower radiopaque indicator of the venous lumen. On the body (2), the indicator (4) located in the arterial opening (7) is C-shaped and indicates the arterial opening. Said indicator (4) is used to direct the direction of the arterial opening (7) towards the heart valve. Indicators (4) are used to place the cannula (1) according to the natural structure of human biology and to maintain this convenient and efficient location.

[0058] In the cannula according to present invention (1), the reinforced area (5) used to prevent fracture of the body (2) is stretchable but resistant to breakage. In this way, twisting of the body (2) from the reinforced area (5) is prevented and thus the constriction or closing of the inner lumen and a decrease or stopping of the blood flow is prevented.

[0059] In a preferred embodiment of the invention, the upper venous opening (6) located at the top of the body (2) and used for entry of the venous blood can be in various shapes and numbers depending on the patient development. In the case where the patient size has increased, there are more than one round cross-sectioned upper venous openings (6) between the two indicators (4) located on the upper part of the body (2) (FIG. 6). Said upper venous openings (6) are located gradually on the body (2) (FIG. 5). In the case where the patient size is reduced, there are elliptical cross-sectioned upper venous openings (6) between the two indicators (4) located on the upper part of the body (2) (FIG. 7). Said upper venous openings (6) are elongated by extending along the body (2) and thus has an eliptical shape. This is because the amount of dirty blood coming from the upper part of the body is high because circulatory physiology changes in small-sized patients. With the design difference in small sized patients the surface area of the upper venous opening (6) is increased so that more blood is collected from the upper part of the body, thereby the performance of the cannula (1) is increased.

[0060] In the present invention, (1) the arterial opening (7) to which clean blood is ejected preferably has a round or transverse or longitudinal elliptical cross-section. In addition, the problem of hemolysis, that is, damage of blood elements by breaking, is minimized by the curved structure of the arterial opening (7) from which the blood exits.

[0061] In the cannula of the invention (1) the lower venous basket end (8) is located at the extreme end of the lower part of the body (2). On the upper part of the lower venous basket (8) there are more than one lower end holes named as lower end holes (10). In a preferred embodiment basket end openings (9) are located at the distal end of the venous lumen.

[0062] In a preferred embodiment of the invention, the number and shape of lower end hole (10) located under the body (2) and above the lower venous basket end hole (10) on the lower venous end (8) varies with respect to the size of the patient. In the case where the patient size is enlarged, there are a plurality of round or elliptic cross sectioned lower end holes (10) on top of the lower venous basket end (8) below the body (2). In the case where the patient size is smaller, there are elliptic or round shaped lower end holes (10) on top of the lower venous basket end (8) below the body (2) Said lower end holes 10 are elongated by extending along the body (2).

[0063] In the present invention, the number of the upper venous opening (6) and the lower end openings (1)0 used for suction is increased so as to increase the suction surface as a result which a cannula with a smaller body (2) provides more suction power and hence enhance the performance of the cannula (1). This way, the thinner cannula (1) provides better flow dynamics and facilitates ease of placement of the cannula (1). In the cannula according to invention(1) the upper venous opening (6) and lower end hole (10) are located on both sides of the body (2). This way, the amount of blood sucked and ejected into the system is kept in a way that does not disturb the body balance. With the help of the upper venous opening (6) and lower end hole (10) it is possible to withdraw blood from both the neck and the leg.

[0064] In the small cannula (1) designed according to the patient size, the ratio of the part comprising upper venous openings (6) located on the upper side of the body (2) and used for suction to the entire body of the cannula is more, whereas in big cannula (1) the suction part comprising lower end holes (10) located at the lower side of body (2) is more. The reason is in small children the ratio of upper body to lower body is in favor of upper body whereas as they grow up and take up adult sizes this ratio increases in favor of the lower body comprising the body and the legs.

[0065] In the cannula (1) of the present invention, the clamp (11) can be attached to and detached from the body (2) and with the help of two ears that are present on the clamp can be tied to the skin of the patient (11) with preferably a suture thread. The clamp (11) can be attached to and detached from the cannula (1) body (2) with the help of its opening and its elastic structure. Said clamp (11) comprises two channels that help fixing to the skin via winding of the suture. In a preferred embodiment of the invention the clamp (11) is used in the region that is between the reinforced area (5) and the lumen ends on the body (2).

[0066] In a preferred embodiment of the invention in the size of the body (2) designed according to the size of the patient, the distance between upper venous openings used for blood suction and lower end holes (6, 10) and the arterial openings (7) used for ejection of blood are kept in a way that would reduce the recirculation/shunt probability ratio. The cannula (1) of the invention the cross-sectioned body (2) constructs provide better flow performance. Additionally, with the cannula (1) the friction and turbulence is reduced and as a result the problem of damage to blood elements via fragmenting decreases. The possibility of varying the size of the cannula (1) according to the size of the patient not only provides increase in performance but also provides that the amount of blood sucked from the neck and leg of the patient is in accordance with the biology of the patient. The size of the cannula (1) can be changed according to the length/kg ratio and the size of the cannula (1) can be changed and also by creating a cannula (1) portfolio wherein the parameters such as cannula (1) length, arterial opening (7), upper venous opening (6), lower end hole (10) can be changed, the cannula (1) that is most suitable for the patient can be chosen. Furthermore, with the cannula (1) infant mortality is reduced by facilitating the use of venovenous ECMO in the patient group weighing less than 10 kilograms.

[0067] Around these basic concepts, it is possible to develop a wide variety of applications for the inventive subject the invention A venovenous ECMO (Extra corporeal Membrane Oxygenation) cannula (1), and the invention is not limited to the examples disclosed herein, but is essentially as specified in the claims.