Access device with dual inlet ports

Abstract

An access device for vascular grafts is disclosed. The access device can allow for the simultaneous insertion of two large-bore medical devices. The access device may include a body defining a common arm, a first proximal arm, and a second proximal arm. The common arm may include a common lumen extending from the distal end of the common arm to the proximal end of the common arm. The first arm may include a first lumen extending from the proximal end of the first arm to the common lumen. The second arm may include a second lumen extending from the proximal end of the second arm to the common lumen. The access device may include a plurality of hemostatic valves. A first hemostatic valve may be located at the proximal end of the first proximal arm. A second hemostatic valve may be located at the proximal end of the second proximal arm.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority to U.S. Provisional Patent Application No. 63 / 529,851, filed on July 31, 2023, the content of which is incorporated herein by reference in its entirety.

[0002] [Technical Field] The present disclosure relates to access devices for vascular grafts, particularly access devices that enable two large - bore devices to be inserted into a single vascular graft.

Background Art

[0003] Currently, there is no single access device that enables two large - bore devices to be inserted into a single vascular graft. A Y - shaped vascular graft can be used to achieve this task, but this can pose challenges for medical professionals during use.

Summary of the Invention

Means for Solving the Problems

[0004] In various aspects, an access device can be provided. The access device can include a body defining a common arm, a first proximal arm, and a second proximal arm. The common arm can include a common lumen extending from the distal end of the common arm to the proximal end of the common arm. The first proximal arm can include a first lumen extending from the proximal end of the first proximal arm to the common lumen. The second proximal arm can include a second lumen extending from the proximal end of the second proximal arm to the common lumen. The access device can include a plurality of hemostatic valves. The first hemostatic valve can be disposed at the proximal end of the first proximal arm. The second hemostatic valve can be disposed at the proximal end of the second proximal arm.

[0005] The access device can include a first Touhy-Borst valve connected to the proximal end of the first proximal arm. The access device can include a second Touhy-Borst valve connected to the proximal end of the second proximal arm.

[0006] The common lumen can have a circular cross-section. The common lumen can have an elliptical cross-section. The first eccentricity of the elliptical cross-section can be less than 0.6.

[0007] The distal end of the common arm can be configured to be directly connected to a vascular graft. The vascular graft can be, for example, a 10 mm vascular graft. The first lumen can have an inner diameter of at least 6 mm (including, for example, the equivalent diameter if the lumen does not have a circular cross-section). The second lumen can have an inner diameter of at least 6 mm (including, for example, the equivalent diameter if the lumen does not have a circular cross-section).

[0008] The axial length of the common lumen can be greater than or equal to the axial length of the first lumen. The axial length of the common lumen can also be shorter than the axial length of the first lumen. The minimum angle A formed between the central axis of the common lumen and the central axis of the first lumen can be 0 < A < 45°. In some embodiments, 0 < A < 20°. The minimum angle B formed between the central axis of the common lumen and the central axis of the second lumen can be 0 < B < 45°. In some embodiments, 0 < B < 20°.

[0009] The access device can include an adapter configured to be removably connected to the distal end of the body. The adapter can be configured to enable the body to be connected to vascular grafts of different sizes.

[0010] In various embodiments, access devices may be provided. An access device may include a body defining a common arm, a first proximal arm, and a second proximal arm. The common arm may have a common lumen extending from its distal end to its proximal end. The distal end of the common arm may be configured to be attached to a graft. The first proximal arm may have a first lumen extending from its proximal end to the common lumen. The second proximal arm may have a second lumen extending from its proximal end to the common lumen. The common arm may have a length of 0.5 to 3 times the length of each proximal arm.

[0011] The system may be provided in various embodiments. The system may include a vascular graft operably connected to the distal end of an access device, such as those disclosed herein.

[0012] The system may include a first medical device. The first medical device may be slidably inserted through a first lumen, a common lumen, and a vascular graft. The first medical device may have a maximum outer diameter of at least 6 mm. The first medical device may be a blood pump.

[0013] The system may include a second medical device. The second medical device may be slidably inserted through a second lumen and at least partially through a common lumen. The second medical device may have a maximum outer diameter of at least 6 mm. The second medical device may be a cannula.

[0014] In various embodiments, a kit may be provided. The kit may include an access device as disclosed herein and one or more adapters configured to be detachably coupled to the distal end of the access device.

[0015] Methods may be provided in various embodiments. A method may involve operably connecting a graft to an access device as disclosed herein, the access device may include a body defining a common arm, a first proximal arm, and a second proximal arm. The common lumen may extend from the distal end of the common arm to the proximal end of the common arm. The distal end of the common arm may be configured to be attached to a graft. The first proximal arm may have a first lumen extending from the proximal end of the first proximal arm to the common lumen. The second proximal arm may have a second lumen extending from the proximal end of the second proximal arm to the common lumen. [Brief explanation of the drawing]

[0016] [Figure 1] This is a diagram illustrating one embodiment of an access device. [Figure 2] This is a cross-sectional view of one embodiment of an access device. [Figure 3] This is a diagram of an alternative embodiment of the access device. [Figure 4] This is a diagram illustrating one embodiment of the system. [Figure 5A] This is a diagram illustrating an embodiment of a distal end connector on a common arm for connecting a device to a graft. [Figure 5B] This is a diagram illustrating an embodiment of a distal end connector on a common arm for connecting a device to a graft. [Figure 5C] This is a diagram illustrating an embodiment of a distal end connector on a common arm for connecting a device to a graft. [Modes for carrying out the invention]

[0017] The inventors recognized that there is no single access aid for inserting two large-diameter devices into a single vascular graft. In such cases, a Y-shaped vascular graft can be used to accomplish this task. The inventors further recognized that utilizing a single graft with a single aid equipped with a valve could allow for easier deployment and retrieval of the devices.

[0018] This specification discloses a dual-inlet port access device equipped with a self-sealing valve that can be joined to a single conduit. The two inlet ports are intended for simultaneous access of two large-bore devices, and the single joining conduit is intended to connect to a vascular graft. The access device may be configured to allow simultaneous insertion of two large-bore devices (e.g., an IMPELLA® blood pump from Abiomed, Inc. and an extracorporeal membrane oxygenation (ECMO) cannula) into a vascular graft.

[0019] Access devices can be provided in various embodiments. Referring to Figure 1, the access device (100) may include a common arm (110), a first proximal arm (120), and a body (105) defining a second proximal arm (122). Briefly referring to Figure 2, the common arm (110) may include a common lumen (210) extending from the distal end (111) of the common arm (and body) to the proximal end (211) of the common arm. The common lumen may have a circular cross-section. The common lumen may have an elliptical cross-section. In some embodiments, a circular shape may have the advantage of connecting seamlessly with the vascular graft and thus potentially reducing the risk of leakage. In some embodiments, an oval shape may have the advantage of allowing two circular cross-section devices to be placed side by side more easily and thus allowing larger devices to fit into the assistive device.

[0020] When the cross-sectional shape is elliptical, the first eccentricity of the formed ellipse should not be too large to enable hemostasis for the graft. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.1. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.2. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.3. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.4. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.5. In some embodiments, the first eccentricity of the elliptical cross-section can be less than 0.6.

[0021] The first proximal arm (120) can include a first lumen (212) that extends from the proximal end (112) of the first proximal arm to the common lumen. The second proximal arm (122) can include a second lumen (214) that extends from the proximal end (113) of the second proximal arm to the common lumen. The first lumen can have an inner diameter of at least 5 mm (including, for example, the equivalent diameter if the lumen does not have a circular cross-section). In some embodiments, the first lumen can have an inner diameter of at least 6 mm. In some embodiments, the first lumen can have an inner diameter of at least 7 mm. The second lumen can have an inner diameter of at least 5 mm (including, for example, the equivalent diameter if the lumen does not have a circular cross-section). In some embodiments, the second lumen can have an inner diameter of at least 6 mm. In some embodiments, the second lumen can have an inner diameter of at least 7 mm.

[0022] The access device can include a plurality of hemostatic valves. The hemostatic valves can be self-sealing. A first hemostatic valve (130) (see FIG. 4) can be disposed at the proximal end (112) of the first proximal arm. A second hemostatic valve (132) (see FIG. 4) can be disposed at the proximal end (113) of the second proximal arm.

[0023] Referring to FIG. 3, the hemostatic valve may include a Toy-Boost valve, and the access device may include a first Toy-Boost valve (320) connected to the proximal end of the first proximal arm. In some embodiments, the access device may include a second Toy-Boost valve (322) connected to the proximal end of the second proximal arm.

[0024] The distal end (111) of the common arm (110) may be configured to be directly connected to the vascular graft (190). Referring to FIG. 3, in some embodiments, the access device may include an adapter (310) at the distal end. The adapter may be configured to be removably connected to the distal end of the body. The adapter may be configured to allow the body to be connected to vascular grafts of different sizes. The vascular graft may be of any suitable size. In some embodiments, the vascular graft can be, for example, a 10 mm vascular graft. As understood, the clinician may select an appropriate size of the graft according to the patient's anatomical structure and the case of axial insertion.

[0025] In some embodiments, the common lumen can vary in length depending on the exact application. For example, in some embodiments, the axial length (330) (see Figure 3) of the common lumen can be greater than or equal to the axial length (331) of the first lumen (e.g., 1.5 times as long, 2 times as long, 3 times as long). In other embodiments, the axial length of the common lumen can be shorter than the axial length of the first lumen (e.g., 0.5 to 0.75 times the length). In some embodiments, the axial length of the common lumen is at least 3 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is less than 0.5 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 0.5 to 0.75 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 0.5 to 1 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 0.5 to 3 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 0.75 to 3 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 1 to 3 times the length of each of the first lumen and the second lumen. In some embodiments, the axial length of the common lumen is 1.5 to 3 times the length of each of the first lumen and the second lumen.

[0026] The common lumen, the first lumen, and the second lumen can be angled relative to each other. Referring to Figure 2, in some embodiments, the minimum angle (223) (A) formed between the central axis (220) of the common lumen and the central axis (221) of the first lumen can be 0° < A < 45°. In some embodiments, 0° < A < 20°. The minimum angle (224) (B) formed between the central axis (220) of the common lumen and the central axis (222) of the second lumen can be 0° < B < 45°. In some embodiments, 0° < B < 20°.

[0027] The system can be provided in various embodiments. Referring to Figure 4, the system may include a vascular graft (190) operably connected to the distal end (111) of an access device (100) as disclosed herein. For example, in some embodiments, the graft may be sutured onto the access device. In such embodiments, the access device may include a suture ring for connecting the graft to the access device. Briefly referring to Figure 5A, in other embodiments, the access device may include one or more notches (500), e.g., multiple notches, for connecting the access device to the graft. For example, in such embodiments, clips may be used to attach the graft to the access device (e.g., via the notches). Note that in Figure 5A, the notches are shown as multiple circumferential channels with a uniform depth extending radially inward from the outer surface, but in other embodiments, the channels may be formed by projections extending radially outward (or a combination thereof). Referring to Figure 5B, for example, other notch shapes or designs may be appropriate, including cases where each notch may include two or more opposite planes (510, 511). As is understood, the access device may have other suitable methods for connecting to the graft (see, for example, a notched connector (520) in Figure 5C). In some embodiments, the system may include a first medical device (410). The first medical device may be slidably inserted through the first lumen, common lumen, and vascular graft. The first medical device may have a maximum outer diameter of at least 6 mm. The first medical device may include a blood pump (414). The proximal end of the blood pump may be connected to the distal end of the catheter (412).

[0028] The system may include a second medical device (420). The second medical device may be slidably inserted through a second lumen and at least partially through a common lumen. The second medical device may be slidably inserted at least partially into a vascular graft.

[0029] The second medical device may have a maximum outer diameter of at least 6 mm. The second medical device may be a cannula.

[0030] In various embodiments, a kit may be provided. The kit may include an access device as disclosed herein and one or more adapters configured to be detachably coupled to the distal end of the access device.

[0031] Methods can be provided in various embodiments. A method may include operably connecting a graft (e.g., a vascular graft) to an access device as disclosed herein. The connection may be performed, for example, in vitro or in vivo, as necessary or desired. In some embodiments, the access device may be directly connected to the graft. In some embodiments, the access device may be indirectly connected to the graft via one or more adapters.

[0032] [Implementation Method] (1) An access device, The main body, A common arm comprising a common lumen extending from the distal end to the proximal end of the common arm, wherein the distal end of the common arm is configured to be attached to a graft, A first proximal arm comprising a first lumen extending from the proximal end of the first proximal arm to the common lumen, A second proximal arm comprising a second lumen extending from the proximal end of the second proximal arm to the common lumen, The main body, which defines the main body, A plurality of hemostatic valves, including a first hemostatic valve located at the proximal end of the first proximal arm and a second hemostatic valve located at the proximal end of the second proximal arm, Access devices, including those mentioned above. (2) The access device according to embodiment 1, further comprising a first Toyoboost valve connected to the proximal end of the first proximal arm. (3) The access device according to embodiment 2, further comprising a second Toyoboost valve connected to the proximal end of the second proximal arm. (4) The access device according to any one of embodiments 1 to 3, wherein the common lumen has a circular cross-section. (5) The access device according to any one of embodiments 1 to 4, wherein the common lumen has an elliptical cross-section.

[0033] <00......(6) The access device according to embodiment 5, wherein the first eccentricity of the elliptical cross-section is less than 0.6. (7) The access device according to any one of embodiments 1 to 6, wherein the distal end of the common arm is configured to be directly connected to a vascular graft. (8) The access device according to embodiment......(9) The access device according to any one of embodiments 1 to 8, wherein each of the first lumen and the second lumen has an inner diameter of at least 6 mm. (9) The access device according to any one of embodiments 1 to 8, wherein each of the first lumen and the second lumen has an inner diameter of at least 6 mm. (10) The access device according to any one of embodiments 1 to 9, wherein the axial length of the common lumen is not less than the axial length of the first lumen.

[0034] [[ID=2...... (11) The access device according to any one of embodiments 1 to 10, wherein the axial length of the common lumen is shorter than the axial length of the first lumen. (12) The access device according to any one of embodiments 1 to 11, wherein the minimum angle A formed between the central axis of the common lumen and the central axis of the first lumen satisfies 0 < A < 45°. (13) The access device according to embodiment 12, wherein 0 < A < 20°. (14) The access device according to any one of embodiments 1 to 13, wherein the minimum angle B formed between the central axis of the common lumen and the central axis of the first lumen satisfies 0 < B < 45°. (15) The access device according to Embodiment 14, where 0 < B < 20°.

[0035] (16) The access device according to any one of Embodiments 1 to 15, further comprising an adapter configured to be removably connected to the distal end of the main body. (17) The access device according to any one of Embodiments 1 to 16, wherein the common arm includes at least one notch on an outer surface configured to be connected to the graft. (18) An access device, comprising: a main body, wherein the main body comprises: a common arm having a common lumen extending from the distal end to the proximal end of the common arm, and the distal end of the common arm is configured to be attached to a graft; a first proximal arm having a first lumen extending from the proximal end of the first proximal arm to the common lumen; a second proximal arm having a second lumen extending from the proximal end of the second proximal arm to the common lumen; defining The access device, wherein the common arm has a length that is 0.5 to 3 times the length of each proximal arm. (19) A system, comprising: the access device according to any one of Embodiments 1 to 18; a vascular graft operably connected to the distal end of the access device; and (20) The system according to Embodiment 19, further comprising a first medical device slidably inserted through the first lumen, the common lumen, and the vascular graft.

[0036] (21) The system according to Embodiment 20, wherein the first medical device has a maximum outer diameter of at least 6 mm. (22) The system according to embodiments 20 to 21, wherein the first medical device is a blood pump. (23) The system according to any one of embodiments 19 to 22, further comprising a second medical device that is slidably inserted through the second lumen and at least partially through the common lumen. (24) The system according to embodiment 23, wherein the second medical device has a maximum outer diameter of at least 6 mm. (25) The system according to embodiment 23 or 24, wherein the second medical device is a cannula.

[0037] (26) It is a kit, An access device according to any one of Embodiments 1 to 18, One or more adapters configured to be detachably connected to the distal end of the access device, A kit that includes this. (27) A method, This includes operably connecting the graft to an access device, the access device being A common arm comprising a common lumen extending from the distal end to the proximal end of the common arm, wherein the distal end of the common arm is configured to be attached to a graft, A first proximal arm comprising a first lumen extending from the proximal end of the first proximal arm to the common lumen, A second proximal arm comprising a second lumen extending from the proximal end of the second proximal arm to the common lumen, A method, including the main body, that defines the main body.

Claims

1. An access device, The main body, A common arm comprising a common lumen extending from the distal end to the proximal end of the common arm, wherein the distal end of the common arm is configured to be attached to a graft, A first proximal arm comprising a first lumen extending from the proximal end of the first proximal arm to the common lumen, A second proximal arm comprising a second lumen extending from the proximal end of the second proximal arm to the common lumen, The main body, which defines the main body, A plurality of hemostatic valves, including a first hemostatic valve located at the proximal end of the first proximal arm and a second hemostatic valve located at the proximal end of the second proximal arm, Access devices, including those mentioned above.

2. The access device according to claim 1, further comprising a first toey-boast valve connected to the proximal end of the first proximal arm.

3. The access device according to claim 2, further comprising a second toey-boast valve connected to the proximal end of the second proximal arm.

4. The access device according to any one of claims 1 to 3, wherein the common lumen has a circular cross-section.

5. The access device according to any one of claims 1 to 3, wherein the common lumen has an elliptical cross-section.

6. The access device according to claim 5, wherein the first eccentricity of the elliptical cross-section is less than 0.

6.

7. The access device according to any one of claims 1 to 3, wherein the distal end of the common arm is configured to be directly connected to a vascular graft.

8. The access device according to claim 7, wherein the vascular graft is a 10 mm vascular graft.

9. The access device according to any one of claims 1 to 3, wherein the first lumen and the second lumen each have an inner diameter of at least 6 mm.

10. The access device according to any one of claims 1 to 3, wherein the axial length of the common lumen is greater than or equal to the axial length of the first lumen.

11. The access device according to any one of claims 1 to 3, wherein the axial length of the common lumen is shorter than the axial length of the first lumen.

12. The access device according to any one of claims 1 to 3, wherein the minimum angle A formed between the central axis of the common lumen and the central axis of the first lumen is 0 < A < 45°.

13. The access device according to claim 12, wherein 0 < A < 20°.

14. The access device according to any one of claims 1 to 3, wherein the minimum angle B formed between the central axis of the common lumen and the central axis of the first lumen is 0 < B < 45°.

15. The access device according to claim 14, wherein 0 < B < 20°.

16. The access device according to any one of claims 1 to 3, further comprising an adapter configured to be detachably connected to the distal end of the main body.

17. The access device according to any one of claims 1 to 3, wherein the common arm includes at least one notch on its outer surface configured to connect to the graft.

18. An access device, Including the main body, the main body is A common arm comprising a common lumen extending from the distal end to the proximal end of the common arm, wherein the distal end of the common arm is configured to be attached to a graft, A first proximal arm comprising a first lumen extending from the proximal end of the first proximal arm to the common lumen, A second proximal arm comprising a second lumen extending from the proximal end of the second proximal arm to the common lumen, Define the area, The common arm is an access device having a length that is 0.5 to 3 times the length of each proximal arm.

19. It is a system, The access device according to claim 1 or 18, A vascular graft operably connected to the distal end of the access device, A system that includes this.

20. The system according to claim 19, further comprising a first medical device slidably inserted through the first lumen, the common lumen, and the vascular graft.

21. The system according to claim 20, wherein the first medical device has a maximum outer diameter of at least 6 mm.

22. The system according to claim 20, wherein the first medical device is a blood pump.

23. The system according to claim 19, further comprising a second medical device slidably inserted through the second lumen and at least partially through the common lumen.

24. The system according to claim 23, wherein the second medical device has a maximum outer diameter of at least 6 mm.

25. The system according to claim 23, wherein the second medical device is a cannula.

26. It's a kit, The access device according to claim 1 or 18, One or more adapters configured to be detachably connected to the distal end of the access device, A kit that includes this.

27. It is a method, This includes operably connecting the graft to an access device, the access device being A common arm comprising a common lumen extending from the distal end to the proximal end of the common arm, wherein the distal end of the common arm is configured to be attached to a graft, A first proximal arm comprising a first lumen extending from the proximal end of the first proximal arm to the common lumen, A second proximal arm comprising a second lumen extending from the proximal end of the second proximal arm to the common lumen, A method, including the main body, that defines the main body.

Images