Device for anchoring a heart pump and assembly for assembling a heart pump provided with such an anchoring device

Abstract

The invention relates to a medical device for anchoring a heart pump in an opening in the wall of a ventricle of the heart, comprising a connector (10) intended to be fitted to said ventricle wall. According to the present invention, the connector (10) comprises a connecting flange (11) and a supporting skirt (12) extending from the connecting flange (11), wherein the supporting skirt (12) is intended to be placed outside the heart when the connecting flange (11) is engaged to the ventricular wall, the connector (10) defines a first opening for a portion of the body of an insert (14) to pass through, the insert (14) is completely rigid and defines a second opening for the body of the heart pump to pass through, the insert (14) comprises a distal end and a proximal end, the distal end being intended to be placed inside the heart and the proximal end being intended to be placed outside the heart, when the insert (14) is engaged to the connector (10), and at least one element (19) is used to lock / unlock the insert (14) in an appropriate position relative to the connector (10) when the insert (14) has been introduced into the connector (10).

Description

Technical Field

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

[0002] It also relates to an assembly for assembling a heart pump having such an anchoring device. Background Art

[0003] Heart failure (HF) is a pathological condition in which the patient's heart is unable to provide the blood flow rate necessary to meet 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 the heart, which continues to function, but provides assistance to the weakened ventricles to increase blood flow rate in a manner tailored to the individual's needs.

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

[0007] However, a significant proportion of patients will not receive such a transplant because they are not candidates for such a transplant, for example due to severe heart failure, or because no suitable grafts are available for these patients.

[0008] In this case, ventricular assist is used as the intended solution, that is, the long-term implantation of an artificial heart pump.

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

[0010] Many advances have been made, and smaller and quieter ventricular assist devices are known today, with extended service lives.

[0011] Therefore, prior art implantable heart pumps are usually equipped with an integrated electric motor to ensure their operation, the rotational speed of the pump providing the force necessary to circulate blood from the weakened ventricles to the circulatory system.

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

[0013] These implant systems generally comprise a tubular portion at the ends of which are placed or formed loops intended to each be pressed against opposite faces of the ventricular wall after the tubular portion has been introduced into an opening made in this ventricular wall by a coring device.

[0014] For example, a hollow tubular portion is known, at the proximal end of which a first flange is placed, and at the distal end a self-expanding membrane is placed, between a first configuration, called the deformed configuration, in which the membrane has a tubular shape, and a second configuration, called the initial configuration, in which it defines a second flange. This initial configuration is achieved when the distal end is introduced into the heart of a patient.

[0015] Such a collar thus makes it possible to maintain in place the hollow tubular portion which then defines an orifice through the wall of the ventricle.

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

[0017] Despite giving good results, these implant systems can be further improved.

[0018] Specifically, the implant system is difficult to implement and place on a beating heart. It requires great dexterity on the part of the treating physician to ensure its success, and is a source of stress.

[0019] There is therefore a need for an anchoring device whose original design makes it possible to overcome the drawbacks of the prior art already stated above.

[0020] Objectives of the present invention

[0021] The present invention aims to overcome the drawbacks of the prior art and to meet the above needs by making available a device for anchoring a heart pump that is simple in its design and its mode of operation and that reduces the complexity of the surgical treatment while being extremely reliable.

[0022] The invention also relates to such an anchoring device ensuring a complete seal between the inside and the outside of the heart.

[0023] The invention also relates to an assembly for mounting a heart pump in place, having such an anchoring device, this assembly making it possible to reduce the patient's blood loss during surgical treatment and to enhance the patient's recovery. Summary of the Invention

[0024] To this end, the invention relates to a device for anchoring a heart pump in an opening in the wall of a ventricle of the heart, comprising a connector intended to be mounted on this ventricle wall.

[0025] According to the present invention,

[0026] the connector comprises an engagement flange and a support skirt or tubular projection extending from the engagement flange, the support skirt being intended to be placed outside the heart when the engagement flange is engaged to the ventricular wall, the connector defining a first opening for a portion of the body of the inserter to pass through,

[0027] - the insert is completely rigid and defines a second opening for the passage of the body of the heart pump, the insert comprising a distal end and a proximal end, the distal end being intended to be placed inside the heart and the proximal end being intended to be placed outside the heart, the insert being mounted on the connector rigidly joined to the ventricular wall, and

[0028] At least one element for locking / unlocking the insert in position relative to the connector when the insert has been introduced into the connector.

[0029] Such devices for anchoring a heart pump in an opening in the wall of a ventricle of the heart are also referred to as anchoring rings or fixation devices for the heart pump.

[0030] It is advantageously made entirely of biocompatible, non-toxic and sterile materials.

[0031] Such devices are particularly suitable for treatment of beating hearts or non-beating hearts that benefit from extracorporeal circulation.

[0032] This anchoring device may therefore consist simply of: a connector capable of being mounted on the heart and defining an orifice, the insert being intended to be carried by this connector by passing a portion of its body through an opening formed in the heart wall, this opening being surrounded by this connector; and one or more elements that ensure that this insert is locked in the appropriate position relative to said connector when it has been mounted on this connector rigidly engaged to the wall of this ventricle.

[0033] Advantageously, such an anchoring device provides greater convenience to the surgical team during the operation, as it is particularly easy to fit in place. It also ensures enhanced patient safety, as a complete seal is achieved between the inside and outside of the patient's heart, i.e., a one-way valve type with two or three leaflets, a diaphragm or flap valve.

[0034] In the context of the present invention, the term "proximal" means the position closest to the medical professional or physician, while the term "distal" should be understood herein to mean the position farthest from such professional. In other words, the distal end of the element is the end that will first engage in the patient's heart, while its proximal end will be the end that will engage therein last.

[0035] According to a particular embodiment of the anchoring device, in which the connector comprises a reinforcement flange placed at its proximal end, the insert also has reinforcement flanges intended to press against each other when said insert is mounted on said connector.

[0036] According to another embodiment of the anchoring device, the locking / unlocking element is a clamping element passing transversely through the reinforcing flange of the connector in order to clamp the body of the insert, or a fixing element intended to join the connector to the reinforcing flange of the insert.

[0037] For example, the clamping element may be a screw.

[0038] Since this screw has an external thread, the through hole of the reinforcing flange has a thread complementary to the screw thread in order to ensure the engagement and movement of this screw and also the required sealing.

[0039] Alternatively, this clamping element may be a bayonet clamping system, the grooves of which will be located on the inner surface of the support skirt of the connector.

[0040] According to another embodiment of the anchoring device, said rigid insert has a tubular portion having a longitudinal dimension allowing said distal end of said insert to be placed inside a cardiac cavity when said insert is mounted on said connector.

[0041] According to a further embodiment of the anchoring device, said connector and / or said insert comprises one or more grooves, each of these grooves receiving a seal, preferably an O-ring seal.

[0042] According to another embodiment of the anchoring device, the insert comprises one or more sealing elements in order to ensure a sealed engagement between the insert and a pump body intended to be inserted into said second opening.

[0043] According to another embodiment of this anchoring device, said engagement flange is made of a material making it possible to promote the growth or attachment of cells in order to strengthen its engagement with said ventricular wall.

[0044] The material can also be sewn or stapled.

[0045] For illustrative purposes only, this engagement flange is Or made of polytetrafluoroethylene (PTFE).

[0046] According to another embodiment of the anchoring device, the distal end of the inserter is beveled to facilitate its insertion through an orifice formed in the ventricular wall.

[0047] According to a further embodiment of the anchoring device, the insert has a fixing element for locking the heart pump body in position when the heart pump body has been introduced into the second opening.

[0048] The invention also relates to an assembly for fitting a heart pump in an appropriate position on the heart, comprising an anchoring device as described above and a removable sheath having a check valve or a one-way valve, which sheath is intended to be mounted on at least the proximal end of the inserter in order to prevent any loss of blood during the insertion or removal of a tool such as a coring tool or the heart pump.

[0049] For example, after removal of the coring tool, this one-way valve closes and seals again.By way of example, it is a self-repairing membrane, also called a self-sealing membrane.

[0050] Advantageously, the removable sheath is made of a flexible material so that it can sealingly cover at least the proximal end of the insert.

[0051] This sheath may be inserted around the connector and the proximal end of the insert so as to cover these elements.

[0052] Advantageously, this sheath is made of silicone or any other flexible biocompatible material such as polyurethane (PU) or polyetheretherketone (PEEK).

[0053] Alternatively, this sheath may be rigid, for example by being made of titanium or polyetheretherketone (PEEK).It will then have a single thread or a bayonet clamping system for fixing on the support skirt of the connector and / or the reinforcing flange of the insert.

[0054] Preferably, the removable sheath has a flushing chamber, and the non-return valve is placed at the proximal end of the sheath.

[0055] This flushing chamber is advantageously sized to accommodate the head of the coring tool.

[0056] Thus, while the proximal end of this sheath has a non-return valve, its distal end is open so as to be able to be introduced and surround at least the proximal end of the inserter.

[0057] Advantageously, the removable sheath has a flushing orifice for evacuating the air, the closing element making it possible to close this orifice in order to ensure the necessary seal.

[0058] The invention also relates to a kit for treating a cardiac condition comprising an anchoring device as described above and a heart pump comprising a housing configured to be introduced through a second orifice defined by the insert while ensuring a seal with one or more sealing elements carried by the insert.

[0059] Preferably, the heart pump comprises a turbine and an inductor, wherein the turbine is rotationally movable relative to the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Other advantages, objects and specific features of the present invention will become apparent from the following description, which is provided for illustrative purposes and is non-limiting and in which reference is made to the accompanying drawings, in which:

[0061] Figure 1

[0062] [ Figure 1 ] is a perspective view of a connector of an anchoring device according to a specific embodiment of the present invention;

[0063] Figure 2

[0064] [ Figure 2 ]yes Figure 1 A front view of an insert of an anchoring device;

[0065] Figure 3

[0066] [ Figure 3 ] is from Figure 1 a perspective view of the proximal end of the insert of the anchoring device showing the sealing element and the through hole in the flange to allow the passage of the clamping screw;

[0067] Figure 4

[0068] [ Figure 4 ] is installed on it Figure 1 An X-ray of the anchoring device and the heart used to assist the latter's heart pump;

[0069] Figure 5

[0070] [ Figure 5 ] shows the assembly assembly into which the heart pump is introduced. DETAILED DESCRIPTION

[0071] The drawings and descriptions below mainly contain certain characteristic elements, so that they can not only serve to better understand the invention but also contribute to its definition when appropriate.

[0072] First, it should be noted that the drawings are not drawn to scale.

[0073] Figures 1 to 3 An anchoring device is schematically shown according to a specific embodiment of the present invention.

[0074] This anchoring device has a connector 10 that can be mounted on the wall of a ventricle in the heart of a patient whose heart failure is to be treated.

[0075] This connector 10 includes a joining flange 11 , a tubular protrusion 12 axially extending from the joining flange, and a supporting flange 13 .

[0076] This engaging flange 11 is here intended to be fixed to the ventricular wall by suturing. Advantageously, it is made of a material that promotes the growth or attachment of cells so as to strengthen its bond to the ventricular wall.

[0077] The tubular protrusion 12 and the support flange 13 are made as a single piece from a rigid, non-thrombogenic material such as titanium.

[0078] This tubular protrusion 12 and the support flange 13 are intended to be placed outside the heart when the engagement flange 11 is engaged to the ventricular wall, this connector defining a first opening for a portion of the body of the inserter 14 to pass through.

[0079] A sealing element 15 comprising an O-ring is carried by the tubular projection 12 in order to seal the engagement between the connector 10 and the insert 14 .

[0080] This completely rigid insert 14 has a tubular part 16 and a reinforcing flange 17. Only the tubular part 16 of this insert 14 is intended to be introduced partially through the ventricular wall and to come into contact with this ventricular wall.

[0081] This insert 14 is produced here from polyetheretherketone (PEEK), but it can also be produced from titanium.

[0082] The outer surface of the insert 14 may have surface reliefs, such as one or more grids, in order to promote adhesion of myocardial tissue and to promote endothelialization, that is, tissue covering of the insert inside the ventricle.

[0083] The free end of this tubular part 16 or the distal end of this insert 14 is beveled in order to facilitate its introduction through the opening made in the ventricular wall by means of a coring tool (not shown).

[0084] This hollow insert 14 defines a second opening through which the body of the heart pump passes. Grooves for receiving O-rings 18 are placed in the inner surface of the insert 14 defining the second opening so as to cooperate with the outer surface of the heart pump housing in a manner that provides the required seal. These O-rings 18 can also be placed on the outer surface of the insert 14, for example, on the tubular part 16 at the bottom of the reinforcing flange 17.

[0085] 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 said insert is mounted on the connector 10 .

[0086] The tubular projection 12 of the connector 10 has a through hole and a clamping screw 19 inserted in this orifice to allow the body of the insert 14 to be locked / unlocked in position relative to the connector 10 when this insert 14 has been introduced into the connector 10 through the first opening.

[0087] This particularly simple anchoring device makes it possible to anchor it in an opening formed in the wall of a ventricle of the heart to receive and support the body of a heart pump for assisting this failing heart.

[0088] In order to ensure the actuation of the heart pump 21 , and more precisely its introduction into the anchoring device, a removable sheath 20 with a non-return or one-way valve is used to close the second opening defined by the insert 14 .

[0089] The check valve permits the introduction and removal of the body of the heart pump or coring tool with minimal blood loss.

[0090] This sheath 20 is made of a flexible material such as silicone so as to allow it to be introduced around the support flange 13 and the reinforcement flange 17. This sheath 20 is configured to cover these elements in a sealed manner.

[0091] It has a flushing chamber (not shown) whose size makes it possible in particular to accommodate the head of a coring tool after the ventricular wall has been cut in order to form the opening.

Claims

1. An assembly for mounting a heart pump in position on a heart, the assembly comprising: A medical device for anchoring a heart pump in an opening in a ventricular wall of a heart, the medical device comprising: a connector configured to be mounted on the ventricular wall, the connector comprising an engagement flange and a support skirt extending from the engagement flange, the support skirt being configured to be positioned outside the heart when the engagement flange is engaged to the ventricular wall, an insert, the connector defining a first opening through which a portion of a body of the insert passes, the insert being substantially rigid and defining a second opening through which a body of the heart pump passes, the insert including a distal end and a proximal end, the distal end being configured to be positioned inside the heart when the insert is mounted on the connector, the proximal end being configured to be positioned outside the heart, the insert being made of polyetheretherketone or titanium, and at least one element for locking / unlocking the insert in position relative to the connector when the insert has been introduced into the connector; and A removable sheath having a check valve or one-way valve is configured to be mounted on at least the proximal end of the inserter to prevent any blood loss during insertion or removal of a tool or heart pump.

2. The assembly according to claim 1, wherein: In case the connector further comprises a reinforcement flange at its proximal end, the insert also has reinforcement flanges, which are configured to press against each other when the insert is mounted on the connector.

3. The assembly according to claim 2, wherein: The locking / unlocking element is a clamping element that passes transversely through the reinforcing flange of the connector to clamp the main body of the insert, or a fixing element configured to engage the connector and the reinforcing flange of the insert together.

4. The assembly according to claim 1, wherein: The rigid insert has a tubular portion having a longitudinal dimension that provides for placement of the distal end of the insert within a cardiac chamber when the insert is mounted on the connector.

5. The assembly according to claim 1, wherein: The connector and / or the insert comprises one or more grooves, each of which receives a seal, and the insert comprises one or more sealing elements to ensure a sealing engagement between the insert and a pump body configured to be inserted into the second opening.

6. The assembly according to claim 1, wherein: The engagement flange is made of a material configured to promote growth or attachment of cells so as to strengthen engagement of the engagement flange with the ventricular wall.

7. The assembly according to claim 1, wherein: The distal end of the insert is beveled to facilitate its insertion through an orifice formed in the ventricular wall.

8. The assembly according to claim 1, wherein: The insert has a fixing element for locking the heart pump body in position when the heart pump body has been introduced into the second opening.

9. The assembly according to claim 1, wherein: The removable sheath is made of a flexible material and is configured to seal at least a proximal end of the insert.

10. The assembly according to claim 1, wherein: The removable sheath has a flushing chamber, and the check valve is placed at the proximal end of the sheath.

11. The assembly according to claim 1, wherein: The removable sheath has a flushing port for evacuating air and a closing element configured to close the flushing port.

12. A kit for treating a heart disease, comprising an assembly according to claim 1 and a heart pump, the heart pump comprising a housing configured to be introduced through a second opening defined by an insert while ensuring a seal with one or more sealing elements carried by the insert.

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

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