DEVICE FOR ANCHORING A CARDIAC PUMP AND ASSEMBLY FOR FITTING A CARDIAC PUMP PROVIDED WITH SUCH AN ANCHORING DEVICE

Abstract

A medical device for anchoring a cardiac pump in an opening of a ventricular wall of a heart, including a connector to be fitted to the ventricular wall. The connector includes a connection flange and a support skirt. The skirt is to be placed outside the heart when the flange is joined to the ventricular wall. The connector defines a first opening for a part of the body of an insert to pass through. The insert is rigid and defines a second opening for the body of the pump to pass through. The insert includes a distal end that is to be placed inside the heart and a proximal end that is to be placed outside the heart when the insert is joined to the connector. At least one element locks/unlocks the insert in position with respect to the connector when the insert has been introduced into the connector.

Claims

1. A medical device for anchoring a cardiac pump in an opening of a ventricular wall of a heart, comprising a connector intended to be mounted on said ventricular wall, characterized in that: this connector comprises a joining flange and a support skirt extending from this joining flange, this support skirt being intended to be placed outside the heart when the joining flange is joined to the ventricular wall, said medical anchoring device also comprises an insert, this connector defining a first opening for the passage of a part of the body of this insert, this insert being entirely rigid and defining a second opening for the passage of the body of the cardiac pump, this insert comprising a distal end intended to be placed inside the heart and a proximal end intended to be placed outside the heart when this insert is mounted on the connector, and at least one element for positionally locking/unlocking the insert with respect to the connector, when this insert has been introduced into the connector.

2. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that, with this connector comprising a reinforcing flange placed at its proximal end, the insert also has a reinforcing flange, said reinforcing flanges being intended to be pressed against each other when the insert is mounted on the connector.

3. The medical device for anchoring the cardiac pump as claimed in claim 2, characterized in that the locking/unlocking element is a clamping element passing laterally through the reinforcing flange of the connector in order to clamp the body of the insert, or a fixing element intended to join together the reinforcing flanges of the connector and of the insert.

4. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that the rigid insert (14) has a tubular portion, the longitudinal dimension of which allows the distal end of this insert to be placed inside the heart cavity when the insert is mounted on the connector.

5. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that the connector and/or the insert comprise one or more grooves, each of these receiving a seal, and in that the insert comprises one or more sealing elements to ensure a sealed join between this insert and the pump body intended to be inserted into the second opening.

6. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that the joining flange is made of a material making it possible to promote the growth or the attachment of cells, in order to reinforce its join with the ventricular wall.

7. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that the distal end of the insert is chamfered in order to facilitate its insertion through an orifice formed in the ventricular wall.

8. The medical device for anchoring the cardiac pump as claimed in claim 1, characterized in that the insert has a fixing element for locking the cardiac pump body in position when the latter has been introduced into the second opening.

9. An assembly for fitting a cardiac pump in place on a heart, comprising the medical device for anchoring the cardiac pump as claimed in claim 1 and a removable sheath having a non-return valve, or one-way valve, this sheath being intended to be mounted on at least the proximal end of the insert in order to prevent any loss of blood during the insertion or removal of a tool or of a cardiac pump.

10. The assembly for fitting the cardiac pump as claimed in claim 9, characterized in that this removable sheath is made of a flexible material so that it can sealingly cover at least the proximal end of the insert.

11. The assembly for fitting the cardiac pump as claimed in claim 9, characterized in that the removable sheath has a purge chamber, the non-return valve being placed at the proximal end of this sheath.

12. The assembly for fitting the cardiac pump as claimed in claim 1, characterized in that the removable sheath has a purge orifice for the evacuation of the air, a closure element making it possible to close this orifice.

13. A kit for the treatment of heart disease, comprising the medical device for anchoring the cardiac pump as claimed in claim 1 and a cardiac pump comprising a casing configured to be introduced through the second opening defined by the insert, while ensuring a seal with one or more sealing elements carried by the insert.

14. The kit as claimed in claim 13, characterized in that the cardiac pump has a turbine, movable in rotation with respect to the casing, and an inductor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Other advantages, aims and particular features of the present disclosure will become clear from the following description, which is provided for explanatory purposes and is non-limiting and in which reference is made to the accompanying drawings, where:

[0061] FIG. 1 is a perspective view of a connector of an anchoring device according to a particular embodiment of the present disclosure;

[0062] FIG. 2 is a front view of the insert of the anchoring device of FIG. 1;

[0063] FIG. 3 is a perspective view, seen from the proximal end of the insert, of the anchoring device of FIG. 1, showing sealing elements and a through-orifice in the flange to allow the passage of a clamping screw;

[0064] FIG. 4 is an X-ray of a heart on which are mounted an anchoring device of FIG. 1 and a cardiac pump for assisting the latter;

[0065] FIG. 5 shows a fitting assembly in which a cardiac pump is introduced.

DETAILED DESCRIPTION

[0066] The drawings and the description below contain, for the most part, elements of certain character. They may therefore not only serve for better understanding the present disclosure, but also contribute to its definition, where appropriate.

[0067] First, it will be noted that the figures are not to scale.

[0068] FIGS. 1 to 3 schematically illustrate an anchoring device according to a particular embodiment of the present invention.

[0069] This anchoring device has a connector 10 which can be mounted on a ventricular wall of a heart of a patient whose heart failure is to be treated.

[0070] This connector 10 comprises a joining flange 11, a tubular projection 12 extending axially from this joining flange, and a support flange 13.

[0071] This joining flange 11 is here intended to be fixed to the ventricular wall by suturing. It is advantageously made of a material facilitating the growth or the attachment of cells, in order to reinforce its join with the ventricular wall.

[0072] The tubular projection 12 and the support flange 13 are made in one piece from a rigid non-thrombogenic material, for example of titanium.

[0073] This tubular projection 12 and the support flange 13 are intended to be placed outside the heart when the joining flange 11 is joined to the ventricular wall, this connector defining a first opening for the passage of a part of the body of an insert 14.

[0074] Sealing elements 15 comprising O-rings are carried by the tubular projection 12 in order to seal the join between the connector 10 and the insert 14.

[0075] This insert 14, which is entirely rigid, has a tubular part 16 and a reinforcing flange 17. Only the tubular part 16 of this insert 14 is intended to be introduced in part through the ventricular wall and to be in contact with this ventricular wall.

[0076] This insert 14 is here made of polyether ether ketone (PEEK), but it could also be made of titanium.

[0077] The outer surface of the insert 14 can have a surface relief, such as one or more meshes, in order to promote the adherence of the myocardial tissue and to promote endothelialization, that is to say tissue covering of the insert inside the ventricle.

[0078] The free end of this tubular part 16, or the distal end of this insert 14, is chamfered in order to facilitate its introduction through an opening made in the ventricular wall by means of a coring tool (not shown).

[0079] This hollow insert 14 defines a second opening for the passage of the body of a cardiac pump. Grooves receiving 0-rings 18 are placed in the inner surface of the insert 14 delimiting the second opening, in order to cooperate with the outer surface of the casing of a cardiac pump in such a way as to provide the required sealing. These O-rings 18 could also be placed on the outer surface of the insert 14, for example on the tubular part 16 at the foot of the reinforcing flange 17.

[0080] The distal end of this insert 14 is intended to be placed inside the heart while its proximal end, defined by the reinforcing flange 17, is intended to be placed outside the heart when it is mounted on connector 10.

[0081] The tubular projection 12 of the connector 10 has a through-orifice and a clamping screw 19 inserted in this orifice in order to allow the body of the insert 14 to be positionally locked/unlocked with respect to the connector 10, when this insert 14 has been introduced into the connector 10 through the first opening.

[0082] This particularly simple anchoring device makes it possible, by virtue of its anchoring in an opening made in the ventricular wall of a heart, to receive and support the body of a cardiac pump used to assist this failing heart.

[0083] To ensure the manipulation of a cardiac pump 21, and in particular its introduction into the anchoring device, a removable sheath 20 having a non-return valve, or one-way valve, is used to close the second opening defined by the insert 14.

[0084] The non-return valve permits the introduction and the removal of the body of a cardiac pump or of a coring tool with minimal loss of blood.

[0085] This sheath 20 is made of a flexible material, for example of silicone, in order to permit its introduction around support flange 13 and reinforcing flange 17. This sheath 20 is configured to cover these elements in a sealed manner.

[0086] It has a purge chamber (not shown), the size of which makes it possible in particular to accommodate the head of the coring tool after cutting the ventricular wall in order to form an opening.