Device for fixing a heart pump and assembly for mounting a heart pump equipped with such a fixing device

Abstract

The present invention relates to a medical device for securing a heart pump in an opening in a ventricular wall of a heart, comprising a connector (10) intended to be attached to the ventricular wall. According to the present invention, the connector (10) comprises a connection flange (11) and a support skirt (12) extending from the connection flange (11), the support skirt (12) intended to be positioned outside the heart when the connection flange (11) is joined to the ventricular wall, the connector (10) defines a first opening for passage of a body part of an insert (14), the insert (14) being entirely rigid and defining a second opening for passage of a body of a heart pump, the insert (14) having a distal end intended to be positioned inside the heart when the insert (14) is attached to the connector (10) and a proximal end intended to be positioned outside the heart, and at least one element (19) for positionally locking / unlocking the insert (14) relative to the connector (10) when the insert (14) is introduced into the connector (10).

Description

Detailed Description of the Invention

[0001] [Technical field] The present invention relates to a device for securing a heart pump to an opening in the ventricular wall of a beating heart or a non-beating heart benefiting from extracorporeal circulation.

[0002] The present invention also relates to an assembly for mounting a heart pump incorporating such a fixation device.

[0003] [Prior Art] Heart failure (HF) is a pathological condition in which a patient's heart is unable to supply the blood flow rate required for the body's metabolic needs.

[0004] It is known to treat heart failure by implanting a ventricular assist device (VAD), which is an artificial heart pump.

[0005] This mechanical pump does not replace a functioning heart, but provides assistance to the weakened ventricle to increase the rate of blood flow in a manner suited to individual needs.

[0006] This assistance may be temporary while waiting for a graft to become available to perform a heart transplant.

[0007] However, a significant proportion of patients do not receive such grafts because they are not candidates for such transplantation, for example because of severe heart failure, or because suitable grafts are not available for these patients.

[0008] In this case, the intended solution is to use ventricular assist, i.e. an artificial heart pump is implanted long term.

[0009] These heart pumps are therefore the subject of intensive research aimed at improving the quality of life of patients with heart failure, since these pumps can remain functional for months to years.

[0010] Many advances have been made and ventricular assist devices are known today that are more compact, quieter and have increased service life.

[0011] Prior art implantable heart pumps therefore typically have an integrated electric motor to ensure their operation, and the rotational speed of the pump provides the force necessary to circulate blood from the weakened ventricle to the circulatory system.

[0012] Systems for implanting such pumps into openings in the ventricular wall are also known.

[0013] These injection systems typically include a tubular portion with a collar disposed or formed at the end thereof, each intended to be pressed against the opposite side of the ventricular wall after the tubular portion is introduced into an opening formed in the ventricular wall using a coring device.

[0014] For example, a hollow tubular portion is known having a first flange disposed at a proximal end and a self-expandable membrane disposed at a distal end. The self-expandable membrane is self-expandable between a first configuration, referred to as a deformation configuration, in which the membrane has a tubular shape, and a second configuration, referred to as an initial configuration, in which the membrane defines a second flange. The initial configuration is achieved when the distal end is introduced into the patient's heart.

[0015] Such a collar thus makes it possible to maintain in position the hollow tubular portion, which then defines an orifice passing through the ventricular wall.

[0016] At the end of this tubular portion, which is placed outside the heart, a heart pump is inserted which, once placed, ensures that the blood present in the ventricles is returned to the circulatory system.

[0017] Although giving good results, these implantation systems can be further improved.

[0018] In particular, they are difficult to perform and place on a beating heart: they require great dexterity on the part of the practitioner performing the intervention to ensure the success of the latter, which is a source of stress.

[0019] Therefore, there is a need for a fixation device of unique design that can overcome the above-mentioned shortcomings of the prior art.

[0020] OBJECTS OF THEINVENTION The present invention aims to overcome the drawbacks of the prior art and to meet the above-mentioned needs by making available a device for fixation of heart pumps, said device being simple in its design and its mode of operation, and being very reliable, whilst reducing the complexity of the surgical procedure.

[0021] The present invention also relates to a fixation device that ensures a complete seal between the inside and outside of the heart.

[0022] The invention further relates to an assembly for mounting in place a heart pump having a fixation device, which makes it possible to reduce the patient's blood loss during a surgical procedure and to improve the patient's recovery.

[0023] DISCLOSURE OF THEINVENTION To this end, the invention relates to a device for fixing a heart pump in an opening in a ventricular wall of the heart, said device comprising a connector intended to be attached to said ventricular wall.

[0024] According to the present invention, the connector comprises a joining flange and a support skirt or tubular projection extending from the joining flange, the support skirt intended to be positioned on the outside of the heart when the joining flange is joined to the ventricular wall, the connector defining a first opening for passage of a portion of the insert body; - the insert is completely rigid and defines a second opening for the passage of the body of the heart pump, the insert having a distal end intended to be placed inside the heart when the insert is attached to a connector that is rigidly joined to the ventricular wall, and a proximal end intended to be placed outside the heart, - It comprises at least one element for positionally locking / unlocking the insert relative to the connector when the insert is introduced into the connector.

[0025] Such devices for securing the heart pump to an opening in the ventricular wall of the heart are also known as heart pump fixation rings or anchoring devices. It is advantageously made entirely from biocompatible, non-toxic and sterile materials.

[0026] Such devices are particularly suitable for intervention on beating hearts or non-beating hearts benefiting from extracorporeal circulation.

[0027] The fixation device may therefore simply consist of a connector that can be attached to the heart and that defines an orifice, an insert intended to be carried by the connector by having a part of its body passing through an opening formed in the heart wall, the opening being surrounded by the connector, and one or more elements that ensure locking of the position of the insert relative to the connector when the insert is attached to the connector that is firmly joined to the ventricular wall.

[0028] Advantageously, such a fixation device provides greater convenience for the surgical team during surgery, as the fixation device is particularly easy to get in place, and in one-way valve types with two or three leaflets, diaphragm or flap valves, a perfect seal between the inside and outside of the patient's heart is achieved, improving patient safety.

[0029] In the context of the present invention, the term "proximal" means the location closest to the medical practitioner or operator, whereas the term "distal" as used herein should be understood to mean furthest from said practitioner. In other words, the distal end of an element is the end that is first engaged with the patient's heart, while its proximal end is the end that is last engaged therewith.

[0030] According to a particular embodiment of the fastening device, the connector comprises a reinforcing flange arranged at its proximal end and the insert also has a reinforcing flange, which are intended to be pressed against one another when the insert is attached to the connector.

[0031] According to another embodiment of the fastening device, the locking / unlocking element is a clamping element which passes laterally through the reinforcing flange of the connector to clamp the body of the insert, or a fastening element intended to join the reinforcing flange of the connector and the reinforcing flange of the insert together. For example, the clamping element can be a screw. As the screw has an external thread, the through orifice in the reinforcing flange has a complementary thread to ensure engagement and movement of the screw, as well as the required sealing. Alternatively, the clamping element may be a bayonet clamping system, the groove of which may be located on the inner surface of the support skirt of the connector.

[0032] According to another embodiment of the fixation device, the rigid insert has a tubular portion whose longitudinal dimension allows a distal end of the insert to be positioned within the heart cavity when the insert is attached to the connector.

[0033] According to another embodiment of the fastening device, the connector and / or the insert comprises one or more grooves, each of which receives a seal, preferably an O-ring seal.

[0034] According to another embodiment of the fixing device, the insert comprises one or more sealing elements to ensure a sealed joint between the insert and the pump body intended to be inserted in the second opening.

[0035] According to another embodiment of the fixation device, the attachment flange is made of a material that allows promoting cell proliferation or adhesion in order to strengthen the attachment with the ventricular wall. The material may also be sutured or stapled. For purposes of illustration only, the mating flange may be made from Dacron® or polytetrafluoroethylene (PTFE).

[0036] According to another embodiment of the fixation device, the distal end of the insert is beveled to facilitate insertion of the insert through an orifice formed in the ventricular wall.

[0037] According to another embodiment of the fixation device, the insert comprises a fixation element for locking the heart pump body in position when the heart pump body is introduced into the second opening.

[0038] The present invention also relates to an assembly for mounting a heart pump in position on the heart, comprising a fixation device as described above and a removable sheath having a check valve or one-way valve, the sheath intended to be attached to at least the proximal end of the insert to prevent blood loss during insertion or removal of an instrument such as a coring tool or the heart pump.

[0039] When the coring tool is removed, in one embodiment, this one-way valve closes and reseals, e.g., it is a self-healing membrane, also called a self-sealing membrane.

[0040] Advantageously, the removable sheath is made from a flexible material so as to sealingly cover at least the proximal end of the insert. The sheath may be inserted around the proximal ends of the connector and insert, thereby covering these elements. Advantageously, this sheath is made of silicone resin or any other flexible biocompatible material such as polyurethane (PU) or polyetheretherketone (PEEK). Alternatively, the sheath can be rigid, for example by being made from titanium or polyetheretherketone (PEEK), and have a single thread or bayonet clamp system for fixing onto the support skirt of the connector and / or the reinforcing flange of the insert.

[0041] Preferably, the removable sheath has a purge chamber and a check valve disposed at the proximal end of the sheath. The purge chamber is advantageously sized to accommodate the head of the coring tool. Thus, the proximal end of the sheath has a check valve, while its distal end is open to allow introduction and surrounding of at least the proximal end of the insert.

[0042] Advantageously, the removable sheath has a purge orifice for evacuating air and a closure element making it possible to close this orifice to ensure the required tightness.

[0043] The present invention also relates to a kit for treating cardiac disease, comprising a fixation device as described above and a cardiac pump including a casing configured to be introduced through a second opening defined by the insert, the casing ensuring a seal with one or more sealing elements carried by the insert.

[0044] Preferably, the heart pump comprises a turbine rotatably movable relative to the casing, and an inductor.

[0045] BRIEF DESCRIPTION OF THE DRAWINGS Other advantages, objects and particular features of the present invention will become apparent from the following description, given for purposes of illustration and not of limitation, and made with reference to the accompanying drawings.

[0046] FIG. 1 is a perspective view of a connector of a fixation device according to a specific embodiment of the present invention.

[0047] FIG. 2 is a front view of the insert of the fixation device of FIG.

[0048] FIG. 3 is a perspective view from the proximal end of the insert of the fixation device of FIG. 1, showing the sealing element and the through orifice in the flange to allow passage of the clamping screw.

[0049] FIG. 4 is an x-ray of a heart fitted with the fixation device of FIG. 1 and a heart pump to assist the fixation device.

[0050] FIG. 5 shows the mounting assembly into which the heart pump is installed. [Description of the embodiment] The drawings and the following description contain, for the most part, elements having specific characteristics, which therefore serve not only to better understand the invention, but also, where appropriate, to contribute to its definition.

[0051] First, please note that the drawings are not to scale.

[0052] 1 to 3 show diagrammatically a fixation device according to a particular embodiment of the invention.

[0053] The fixation device comprises a connector 10 which can be attached to the ventricular wall of the heart of a patient whose heart failure is to be treated.

[0054] The connector 10 comprises a mating flange 11 , a tubular projection 12 extending axially from the mating flange, and a support flange 13 .

[0055] This joining flange 11 is intended here to be fixed to the ventricular wall by means of sutures. It is advantageously made from a material that facilitates cell growth or adhesion in order to strengthen the joining with the ventricular wall.

[0056] The tubular projection 12 and the support flange 13 are integrally fabricated from a rigid, non-thrombogenic material, such as titanium.

[0057] The tubular projection 12 and the support flange 13 are intended to be placed on the outside of the heart when the joining flange 11 is joined to the ventricular wall, and the connector defines a first opening for the passage of a portion of the body of the insert 14.

[0058] A sealing element 15 , including an O-ring, is carried by the tubular projection 12 for sealing the interface between the connector 10 and the insert 14 .

[0059] The insert 14 is completely rigid and has a tubular portion 16 and a reinforcing flange 17. Only the tubular portion 16 of the insert 14 is intended to be introduced partially through and in contact with the ventricular wall. This insert 14 is here made of polyetheretherketone (PEEK), but could also be made of titanium. The outer surface of the insert 14 may have a surface relief, such as one or more meshes, to promote myocardial tissue attachment and promote endothelialization, i.e., tissue coverage of the insert within the ventricle.

[0060] The free end of the tubular portion 16, i.e., the distal end of the insert 14, is beveled to facilitate insertion through an opening made in the ventricular wall by a coring tool (not shown).

[0061] This hollow insert 14 defines a second opening for the passage of the body of the heart pump. Grooves for receiving O-rings 18 are arranged on the inner surface of the insert 14 that bounds the second opening, so as to cooperate with the outer surface of the casing of the heart pump to provide the necessary seal. These O-rings 18 can also be arranged on the outer surface of the insert 14, for example on the lower tubular portion 16 of the reinforcing flange 17.

[0062] The distal end of the insert 14 is intended to be placed inside the heart, while its proximal end, defined by a reinforcing flange 17, is intended to be placed outside the heart when attached to the connector 10.

[0063] The tubular projection 12 of the connector 10 has a through orifice and a clamping screw 19 inserted into the orifice, thereby allowing the body of the insert 14 to be positionally locked / unlocked relative to the connector 10 when the insert 14 is introduced into the connector 10 through the first opening.

[0064] This particularly simple fixation device makes it possible to receive and support the body of a heart pump used to assist this failing heart by fixing it to an opening formed in the ventricular wall of the heart.

[0065] To ensure operation of the heart pump 21, in particular its introduction into the fixation device, a removable sheath 20 having a check valve or a one-way valve is used to close the second opening defined by the insert 14.

[0066] The check valve allows for the introduction and removal of the body of the heart pump or coring tool while minimizing blood loss.

[0067] The sheath 20 is made of a flexible material, for example silicone resin, so that it can be introduced around the support flange 13 and the reinforcing flange 17. The sheath 20 is configured to hermetically cover these elements.

[0068] It has a purge chamber (not shown) whose size allows it to accommodate in particular the head of the coring tool after cutting the ventricular wall and forming the opening. [Brief description of the drawings]

[0069] [Figure 1] 1 is a perspective view of a connector of a fixation device according to a specific embodiment of the present invention. [Diagram 2] FIG. 2 is a front view of the insert of the fixation device of FIG. 1. [Diagram 3] FIG. 2 is a perspective view from the proximal end of the insert of the fixation device of FIG. 1, showing the sealing element and the through orifice in the flange to allow passage of the clamping screw. [Figure 4] FIG. 2 is an x-ray view of a heart with the fixation device of FIG. 1 attached and a heart pump to assist the fixation device. [Diagram 5] 1 shows the mounting assembly with the heart pump installed.

Claims

1. 1. An assembly for mounting a heart pump in position in a heart, comprising a medical device for fixing said heart pump in an opening in a ventricular wall of the heart and a removable sheath (20) having a check valve or a one-way valve, The medical device comprises a connector (10) intended to be attached to the ventricular wall, - said connector (10) comprises a joining flange (11) and a support skirt (12) extending from said joining flange (11), said support skirt (12) being intended to be located on the outside of the heart when said joining flange (11) is joined to the ventricular wall; - the medical device also comprises an insert (14), the connector (10) defining a first opening for the passage of a portion of the body of the insert (14); - said insert (14) defines a second opening for the passage of a heart pump body, said insert (14) having a distal end intended to be placed inside the heart when said insert (14) is attached to the connector (10) and a proximal end intended to be placed outside the heart; - at least one element (19) for positionally locking / unlocking said insert (14) relative to said connector (10) when said insert (14) is introduced into said connector (10); The sheath (20) is intended to be attached to at least the proximal end of the insert (14) to prevent blood loss during insertion or removal of an instrument or heart pump, assembly.

2. 2. The assembly of claim 1, wherein the connector (10) comprises a reinforcing flange disposed at its proximal end and the insert (14) also has a reinforcing flange, the reinforcing flanges being intended to be pressed against one another when the insert (14) is mounted on the connector (10).

3. The locking / unlocking element (19) passes transversely through the reinforcing flange of the connector (10) to clamp the body of the insert (14).

3. An assembly according to claim 2, characterized in that it is a clamping element or a fastening element intended to connect together the reinforcing flange of the connector (10) and the reinforcing flange of the insert (14).

4. 4. The assembly of claim 1, wherein the insert (14) has a tubular portion, the longitudinal dimension of which enables the distal end of the insert (14) to be positioned within a heart cavity when the insert (14) is attached to the connector (10).

5. 5. An assembly according to any one of claims 1 to 4, characterized in that the connector (10) and / or the insert (14) comprise one or more grooves, each of which receives a seal, and the insert (14) comprises one or more sealing elements, so that a sealed joint is ensured between this insert (14) and the pump body intended to be inserted in the second opening.

6. An assembly according to any one of claims 1 to 5, characterized in that the joining flange (11) is made of a material making it possible to promote cell proliferation or adhesion in order to strengthen the joining with the ventricular wall.

7. An assembly according to any one of claims 1 to 6, characterized in that the distal end of the insert (14) is chamfered to facilitate insertion of the insert through an orifice formed in the ventricular wall.

8. 8. An assembly according to any one of claims 1 to 7, characterized in that the insert (14) comprises a fixing element for locking the heart pump body in position when the heart pump body is introduced into the second opening.

9. 2. The assembly according to claim 1, characterized in that the removable sheath (20) is made of a flexible material so that it can sealingly cover at least the proximal end of the insert (14).

10. 10. The assembly according to claim 1 or 9, characterized in that the removable sheath (20) has a purge chamber and the check valve is arranged at the proximal end of the sheath (20).

11. 11. An assembly according to any one of the preceding claims, characterized in that the removable sheath (20) comprises a purge orifice for evacuating air and a closing element making it possible to close said orifice.

12. 9. A kit for treating cardiac disease comprising an assembly according to any one of claims 1 to 8 and a cardiac pump (21) including a casing configured to be introduced through a second opening defined by the insert (14), the casing ensuring a tight seal with one or more sealing elements carried by the insert (14).

13. 13. The kit according to claim 12, characterized in that the heart pump (21) comprises a turbine which is rotatably movable relative to the casing, and an inductor.

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