CONNECTOR FOR FLUID COMMUNICATION BETWEEN TWO ANATOMICAL COMPARTMENTS

Abstract

A connector is provided for fluid communication between two anatomical compartments through at least one anatomical wall, wherein the connector comprises a neck adapted and configured to be positioned across the anatomical wall(s); primary means for securing the neck across the anatomical wall(s); and secondary means for securing the neck across the anatomical wall(s). A method for coupling two anatomical walls using said connector is also provided.

Claims

1. A connector for fluid communication between two anatomical compartments through at least one anatomical wall, wherein the connector comprises: a neck adapted and configured to be positioned across the anatomical wall(s); primary means for securing the neck across the anatomical wall(s); and secondary means for securing the neck across the anatomical wall(s).

2. The connector according to claim 1, wherein the connector can be arranged into a delivery configuration and into a working configuration in which the neck is secured across the anatomical wall(s).

3. The connector according to claim 1, wherein the primary securing means and/or the securing secondary means are movable from a delivery position to a working position in which the neck is secured across the anatomical wall(s).

4. The connector according to claim 1, wherein the secondary securing means is capable of securing the neck across the anatomical wall(s) before the primary securing means secures the neck across the anatomical wall(s).

5. The connector according to claim 1, wherein the primary securing means and/or the secondary securing means comprise a plurality of arms.

6. The connector according to claim 5, wherein the arms of the primary securing means and/or of the secondary securing means are deployable from a delivery configuration to a working configuration.

7. The connector according to claim 5, wherein each deployable arm is independently deployable.

8. The connector according to claim 5, wherein the arms extend from one or both ends of the neck.

9. The connector according to claim 5, wherein the primary securing means comprises two sets of arms, each set extending from an end of the neck.

10. The connector according to claim 5, wherein the secondary securing means comprises two sets of arms, each set extending from an end of the neck.

11. The connector according to claim 5, wherein the arms of the secondary securing means are adapted and configured to fit, in their working configuration, in a delivery catheter.

12. The connector according to claim 5, wherein a web of material extends between the arms.

13. The connector according to claim 5, wherein each arm forms a loop.

14. The connector according to claim 5, wherein each arm comprises one or more eyelets.

15. The connector according to claim 1, wherein the connector is configured and adapted to be coupled to an intracorporeal pump.

16. The connector according to claim 15, wherein the neck is flexible.

17. The connector according to claim 15, wherein the neck comprises is formed of a mesh structure.

18. The connector according to claim 15, wherein the neck comprises a tapered portion.

19. The connector according to claim 15, wherein the neck is covered or coated with a biocompatible impermeable membrane.

20. The connector according to claim 1, wherein the connector enables fluid communication between at least two anatomical walls.

21. The connector according to claim 1, wherein the primary securing means form a diffusor.

22. A connector for fluid communication between two anatomical compartments through at least one anatomical wall, wherein the connector comprises primary means for securing the connector across the anatomical wall(s); and secondary means for securing the connector across the anatomical wall(s).

23. The connector according to claim 22, further comprising at least one ring connected to the primary securing means and the secondary securing means.

24. An intracorporeal pump integrally formed with a connector according to claim 1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0096] The invention will be further described with reference to the drawings and figures, in which

[0097] FIG. 1 is a schematic representation (side view) of a first connector according to the present invention in its working configuration;

[0098] FIG. 2 is a schematic representation (top view) of the connector as shown in FIG. 1;

[0099] FIGS. 3A and 3B are partial schematic representations of the connector as shown in FIG. 1;

[0100] FIG. 4 is a schematic representation of the connector as shown in FIG. 1 in its delivery configuration;

[0101] FIG. 5 is a schematic representation (perspective view) of the connector as shown in FIG. 1cut and laid flat;

[0102] FIG. 6 are schematic representations (side views) of securing arms for use in connectors according to the present invention;

[0103] FIGS. 7A and 7B are schematic representations (top views) of securing arms for use in connectors according to the present invention;

[0104] FIG. 8 is a schematic representation of a second connector according to the present inventioncut and laid flat;

[0105] FIGS. 9A and 9B are schematic representations (perspective views) of a third connector according to the present invention, coupled with a pump;

[0106] FIG. 9C is a schematic representation (side view) of the connector as shown in FIG. 9A;

[0107] FIG. 10 is a schematic representation (bottom view) of the connector as shown in FIG. 9A;

[0108] FIG. 11 is a partial schematic representation of the connector as shown in FIG. 9A;

[0109] FIG. 12 is a schematic representation (side view) of a fourth connector according to the present invention in its working configuration;

[0110] FIG. 13 is a schematic representation (side view) of a fifth connector according to the present invention in its working configuration; and

[0111] FIGS. 14A to 14F illustrate a method for securing a connector according to the present invention across two anatomical walls.

DETAILED DESCRIPTION

[0112] The invention is described by way of examples, which are provided for illustrative purposes only. These examples should not be construed as intending to limit the scope of protection that is defined in the claims. For example, although various aspects have been described with respect to the heart and the circulatory system, this is not intended to be limiting, and is merely performed to provide an example of implementation. Aspects disclosed herein may be utilised in any medical device implantable within the human body, for example in the cardiovascular system, respiratory system, gastric system, neurological system, and the like, some examples including implantable pumps and drug delivery pumps. As used herein, the term means can be equivalently expressed as, or substituted with, any of the following terms: device, apparatus, structure, part, sub-part, assembly, sub-assembly, machine, mechanism, article, medium, material, appliance, equipment, system, body or similar wording.

[0113] Referring to FIG. 1, there is illustrated a connector 1 for fluid communication between two anatomical compartments C through at least one anatomical wall W, wherein the connector 1 comprises a neck 2 adapted and configured to be positioned across the anatomical wall(s) W; primary securing means 3A, 3B for securing the neck 2 across the anatomical wall(s) W; and secondary securing means 4A, 4B for securing the neck 2 across the anatomical wall(s) W.

[0114] In this embodiment, the two compartments C are the left atrium C.sub.1 and the ascending aorta C.sub.2, and the connector implantation site is at a location where the left atrium C.sub.1 and the aorta C.sub.2 are separated by the wall W.sub.1 of the left atrium C.sub.1 and the aortic wall W.sub.2 (i.e. two anatomical walls). The exemplified direction of insertion is from the left atrium C.sub.1 (proximal compartment) to the aorta C.sub.2 (distal compartment).

[0115] The primary and secondary securing means each comprises a plurality of arms 3,4 extending from the neck 2 of the connector 1. The primary securing means comprises a first set of arms 3A extending from one end of the neck (the aortic side) and a second set of arms 3B extending from the other end of the neck (the atrial side). The secondary securing means comprises a first set of arms 4A extending from one end of the neck (the aortic side) and a second set of arms 4B extending from the other end of the neck (the atrial side).

[0116] Hereinafter, the arms of the first set of arms 3A of the primary securing means will be referred to as long aortic arms 3A; the arms of second set of arms 3B of the primary securing means will be referred to as long atrial arms 3B; the arms of the first set of arms 4A of the secondary securing means will be referred to as short aortic arms 4A; the arms of second set of arms 4B of the secondary securing means will be referred to as short atrial arms 4B; bearing in mind that the present invention is not limited to left atrium/aorta procedures.

[0117] With reference to FIGS. 3A and 3B, the long aortic arms 3A comprise a substantially linear portion 5 connecting an eyelet 6 to the neck 2. The long atrial arms 3B are longer than the long aortic arms 3A, and comprise a substantially linear portion 5 connecting an eyelet 6 to the neck 2. The short aortic arms 4A comprise a substantially linear portion 5 connecting an eyelet 6 to the neck 2. The short atrial arms 4B are longer than short aortic arms 4A, and comprise a substantially linear portion 5 connecting two eyelets 6 to the neck 2.

[0118] FIG. 1 shows a connector 1 according to the present invention in its working configuration. The long and short aortic arms 3A, 4A extend substantially perpendicularly from the aortic end of the neck 2 so as to lie against and support the aortic wall W.sub.2. Part of the linear portion 5 of the long and short atrial arms 3B, 4B extend substantially perpendicularly from the atrial end of the neck 2 so as to lie against and support the atrial wall W.sub.1, whilst the remaining portion of the long and short atrial arms 3B, 4B extend away from the atrial wall W.sub.1 so as to form a shield which prevents surrounding tissues from hindering the channel of the neck 2.

[0119] FIG. 4 shows a connector 1 according to the present invention in its delivery configuration, in which the arms 3A, 3B, 4A, 4B extend substantially parallel relative to the neck 2 so as to fit, for example, in a delivery catheter 7.

[0120] The arms 3A, 3B, 4A, 4B are made of or comprise a shape memory metal, or other material which allows the arms to adopt a delivery configuration and a working configuration (which preferably differ from each other). The arms may or may not be made of the same material as the neck 2, preferably the same material if the arms and neck are integrally formed. In the examples included herein, the arms of the primary and secondary securing means are integrally formed with the neck 2 of the connector 1 but it could be envisaged that one or more or all arms are formed separately and movably connected to the neck 2.

[0121] Examples of arm shapes are illustrated in FIGS. 6, 7A and 7B. The shape and dimensions of the arms can be adjusted depending on the requirements. The arms may be partially or completely straight, curved or bent relative to the anatomical wall W (see FIG. 6). They may comprise one or more linear portions 6 and/or one or more eyelets 5 (see FIGS. 7A and 7B). When the arms comprise two or more linear portions 6 (preferably two), the linear portions may be substantially parallel to each other.

[0122] In this embodiment, the neck 2 is substantially cylindrical. However, the neck 2 may comprise a tapered portion or be tapered, as illustrated in FIG. 13. The neck 13 preferably tapers from the atrial side to the aortic side to allow easy insertion as the pump P as it is initially inserted. Once the pump P is inserted the narrower side of neck taper may engage a step on the pump P to prevent the pump P from dislodging. In another embodiment, shown in FIG. 12, the connector 1 may be devoid of a neck and the arms are connected by a connecting means, such as a substantially ring-shaped connecting means. In other words, the neck 2 may simply be a connecting ring.

[0123] The neck 2 is made of a metal structure for example in the form of woven or shaped wiring. The neck 2 may comprise a repeating pattern which may for example be undulated (including but not limited to serpentine, sinusoidal, triangular, square, rectangular) as shown in FIG. 5 or a diamond-patterned mesh, as shown in FIG. 8. In the embodiment of FIG. 8, the neck 2 comprises a diamond-shaped pattern from which the arms extend longitudinally. Owing to the material and/or the pattern, the neck 2 is capable of expanding radially to accommodate and retain a pump P or other medical device therethrough. The neck 2 is also rigid enough to maintain the tissues surrounding the aperture in the anatomical wall(s) apart and maintaining the neck aperture opened.

[0124] The outer surface of the neck 2 is covered by an impermeable membrane (not shown) to prevent leakage of blood into the pericardial space, for example in the event that the atrial and aortic walls are not sufficiently pressed against each other. The neck 2 may be coated with a membrane and/or be partially or completely surrounded by an impermeable belt. Suitable materials include, but are not limited to, polymers such as polytetrafluoroethylene (pTFE), silicon, polyvinylidene fluorinated (PVDF) polymers, polyurethane and combinations thereof. Suitable application techniques include, but are not limited to, electro-spinning, electro-spun, dip coating techniques.

[0125] The neck 2 preferably comprises a septum or valve to allow, prevent and/or control the flow of fluid therethrough. The blood flow can therefore be adjusted and controlled, once the connector 1 is suitably implanted and during the delivery and until the implantation of the pump P. The neck 2 may comprise means for retaining the septum or valve, for example the neck 2 may comprise one or more retaining tabs on its inner surface. The neck 2 may comprises means for retaining the pump P and/or any other medical device, for example, the neck 2 may comprise a twist and lock or screw means on its inner surface. It may also be envisaged that the neck 2 comprises a coating membrane (not shown) which forms a valve to seal the opening of the neck 2 prior to the implantation of the intracorporeal pump.

[0126] Owing to its shape and structure, the connector according to the present invention is advantageously small or can be compressed to small dimensions such that it is possible to reduce the puncture size. It is easy to manipulate and can be used with patients with compromised or difficult anatomical structures.

[0127] A method according to the present invention will now be described by way of example with reference to a left-aorta connection.

[0128] The insertion devices (for example guide wire, needle, dilator, sheaths) are inserted by methods known in the art. For example, a needle carrying a guide wire is placed on the groin area of the patient, adjacent the femoral artery. Pressure is applied so that the patient's skin is punctured by the tip of the needle and pushed through the skin and tissues into the femoral artery. Once in place, the guide wire is advanced along the femoral artery and up the inferior vena cava. The guide wire exits the inferior vena cava and enters the right atrium. The septal puncture between the right and left atrium C.sub.1 can also be carried out by methods known in the art. A guide wire now extends from outside the patient, into the femoral artery through the skin puncture, the inferior vena cava, the right atrium, the atrial septum and the left atrium C.sub.1 lodged preferably in superior left pulmonary vein. Next, a large and steerable support sheath 8 can be deployed into the left atrium C.sub.1 over the wire to facilitate the final steps of the procedure. The puncture of the anatomical walls W.sub.1, W.sub.2 is carried out by pushing the atrial wall W.sub.1 against the aortic wall W.sub.2 using the support sheath 8 until the walls are contacting. A needle is pushed against and through the walls to create an opening, which can be subsequently widened using a dilator. A detailed procedure is illustrated in PCT application No. PCT/EP2015/055578.

[0129] The connector 1 is inserted in the delivery catheter 7 in its delivery configuration. The arms 3A, 3B, 4A, 4B extends substantially parallel from the neck 2 so that they fit within the delivery catheter 7. The catheter 7 is pushed across the anatomical walls W.sub.1, W.sub.2 (FIG. 14A) and the connector 1 is gradually pushed forward (or the catheter is gradually pulled back) so as to exit the catheter 7.

[0130] First, the long aortic arms 3A (arms 3A of the primary securing means) partially exit the catheter 7. However, the short aortic arms 4A (arms 4A of the secondary securing means) will be fully exited and deployed first, so as to lie against the aortic wall W.sub.2 and secure the connector to said wall W.sub.2 (FIG. 14B). In this embodiment, the short aortic arms 4A deploy before the long aortic arms 3A, owing to their relatively shorter length. However, other mechanisms can be used to create this sequence. For example, the arms 3A may be shaped and sized so that they are partially or fully deployed in their delivery configuration in the insertion device; the arms 3A may comprise a hinge or other mechanism adapted to deploy arms 3A first.

[0131] Secondly, the long aortic arms 3A fully exit the delivery catheter 7 and deploy into their working configuration (FIG. 14C) so as to secure the connector to the aortic wall W.sub.2 and to provide support to said wall W.sub.2. The delivery catheter 7 is gradually pulled back to release the neck 2 of the connector 1, which is now positioned across the anatomical walls W.sub.1 and W.sub.2. Advantageously, the aortic arms 3A and 4A engage the aorta and provide counter traction to pull the aorta A onto the atrium LA during the deployment process.

[0132] Once the aortic arms 3A, 4A are deployed, the short atrial arms 4B (arms 4B of the secondary securing means) are released allowing the delivery catheter 7 to remain in contact with the atrial wall W.sub.1 and holding it against the aortic wall W.sub.2. The short atrial arms 4B can now secure the connector 1 to the atrial wall W1 (FIG. 14D) and support the wall W1 until the long atrial arms 3B are deployed.

[0133] Finally the long atrial arms (arms 3B of the primary securing means) are deployed, while the small atrial arms maintain pressure on the atrial wall to the aortic wall. The long atrial arms 3B secure the connector 1 to the atrial wall W.sub.1 (FIG. 14E) and to prevent surrounding tissues from hindering the opening of the neck 2. The long aortic arms 3A can prevent soft tissues in the aorta from being sucked into the pump and the long atrial arms 3B can keep the surface expanded to prevent atrial collapse.

[0134] Fluid flow can be prevent, allowed and/or controlled by using a septum or valve (not shown) incorporated in the connector 1, for example in the neck 2 of the connector 1. In another embodiment, the neck 2 may comprise or consist of a collapsible membrane, for example an impermeable membrane. In a first step of the implantation process, the connector 1 is secured to the anatomical wall W.sub.2, and as the delivery catheter is pulled back, the neck 2 collapses so that the puncture point is substantially closed and re-opened upon the introduction of a pump P or other medical device. Thus, this feature prevents any fluid passage, until the pump P is inserted.

[0135] A pump P or other medical device is delivered to the implantation site through the same or different delivery catheter 7 and coupled to the connector 1 (FIG. 14F). If the connector 1 comprises any retaining means (e.g. twist-and-lock or screw means), then these are used to secure the pump P to the connector 1.

[0136] The arms of the connector 1 provide compressive load onto the atrial and aortic wall tissues to seal the connection created and prevent blood leakage external to the heart. The arms 4A, 4B of the secondary securing means can be deployed inside the delivery catheter, for minimum support and to keep both adjacent compartments together until the long arms 3A, 3B are deployed. In addition, a septum or valve of the connector 1 prevents any uncontrolled blood loss, whilst the pump is being delivered, implanted and/or removed.

[0137] Thus, from the above description, it can be seen that the present invention provides a connector for establishing fluid communication between two anatomical compartments. The connector also enables a pump or other medical devices to be securely implanted across one or more anatomical walls. This can be achieved accurately and safely. The present invention provides a device which can establish fluid communication with minimal risk of blood leakage during the implantation procedure, and whilst providing support to the anatomical walls and tissues so as to prevent injury to the patient.