Assembly for assisting with the fitting of a heart pump

Abstract

The present invention relates to an assembly for assisting with the fitting of a heart pump, on a ventricular wall of a heart, comprising: - an attachment flange (10) which has a front face, a rear face and an opening (15) emerging onto the front and rear faces, this opening being delimited by an inner wall of the attachment flange (10), - a cut guiding part (17) intended to be received at least partially in the opening (15), the cut guiding part (17) having a front face, a rear face and at least one longitudinal opening (18) extending over at least a portion of the front face and emerging onto the rear face, the guide part being configured to allow a cutting element (19) to pass through each longitudinal opening (18) and to guide this cutting element along the axis defined by this corresponding longitudinal opening (18) in order to allow an incision to be made in the cardiac wall of this heart, when the attachment flange (10) is attached to the ventricular wall and the guide part is received in the opening in the attachment flange (10), - a guide wire, and - a centering device (21) which has a central opening (22) for the passage of the guide wire, this centering device being intended to center, by means of the guide wire, the attachment flange on the cardiac wall with respect to a cardiac valve of the heart.

Description

Heart pump implantation assistance kit - Technical field

[0001] The present invention relates to the field of ventricular assistance.

[0002] It relates more specifically to a set of assistance for the placement of a cardiac pump in an opening in a ventricular wall of a beating heart or a non-beating heart benefiting from extracorporeal circulation. Previous technique

[0003] Heart failure (HF) is a pathological condition in which a patient's heart is unable to provide sufficient blood flow 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 ventricle in order to increase blood flow in a way that is adapted to the individual's needs.

[0006] This assistance may be temporary while awaiting an available donor organ for a heart transplant.

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

[0008] In this case, ventricular assistance is used at the destination, meaning that the artificial heart pump is implanted long-term.

[0009] These heart pumps are therefore the subject of intense research aimed at improving the quality of life of patients with heart failure, as these pumps can remain active from several months to several years.

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

[0011] State-of-the-art implantable heart pumps are thus typically equipped with an integrated electric motor to ensure their operation, the rotational speed of the pump providing the necessary force to circulate blood from the weakened ventricle into the body's circulation.

[0012] Systems for implanting such pumps in an opening of a ventricular wall are also known.

[0013] These implantation systems generally include a tubular portion at the ends of which are placed, or formed, collars intended to be pressed against each opposite face of the ventricular wall after the tubular portion is introduced into an opening made in this ventricular wall with a coring tool.

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

[0015] Such collars thus make it possible to maintain in position the hollow tubular portion which then defines an orifice crossing the ventricular wall.

[0016] However, creating the opening in the ventricular wall remains a complex task for the practitioner, requiring great dexterity on their part.

[0017] It is also difficult to perform on a beating heart.

[0018] In addition, it is generally observed that the edges of the opening can be irregular, which can cause problems later on.

[0019] Indeed, regardless of the care taken by the practitioner performing the operation, the cross-shaped cut of the ventricular wall, freehand, using a scalpel, to widen the incision initially made to the size of the required orifice, provides pieces of unequal size.

[0020] When the operator cuts these uneven pieces using the core drilling tool, the force applied by the core head is not distributed evenly, which can lead to tearing. Object of the invention

[0021] The present invention aims to overcome the disadvantages of the prior art and to meet the constraints stated above by proposing a set of assistance for the placement of a cardiac pump, simple in its design and in its operating method, guaranteeing the achievement of a clean and neat cut of the heart wall.

[0022] Another object of the present invention is such an insertion assistance assembly that ensures the centering of the main axis of an anchoring ring on the aortic valve. Thus, when the heart pump is installed in an insert housed in this anchoring ring, it is perfectly aligned with the aortic valve. Description of the invention To this end, the invention relates to an assembly for assisting the placement of a cardiac pump on a ventricular wall of a heart, comprising: - an assembly flange, this assembly flange comprising a front face, a rear face and an opening onto said front and rear faces, this opening being delimited by an internal wall of said assembly flange, - a cutting guide piece intended to be received at least partially in the orifice, the cutting guide piece having a front face, a rear face and at least one longitudinal opening such as a groove, extending transversely over at least part of the front face and opening onto said rear face, said guide piece being configured to allow the passage of a cutting element such as a blade, through each longitudinal opening and to ensure the guidance of this cutting element along the axis defined by this longitudinal opening (corresponding in order to allow the incision of the cardiac wall of this heart, when the assembly flange is assembled to the ventricular wall and said guide piece is received in the orifice of the assembly flange, - a guide wire, and - a centering device having a central orifice for the passage of the guide wire, this centering device being intended to ensure, by means of the guide wire, the centering of the assembly flange on the cardiac wall in relation to a cardiac valve of the heart.

[0023] Naturally, this guidewire is designed to be received both within the heart's chambers and to extend outside of the heart. This guidewire is also called a "guidewire" in English. This guide wire will have been previously installed so as to extend from outside the heart wall through a heart valve, preferably the aortic valve, being centered or substantially centered on the latter.

[0024] Such an assembly flange forms one of the constituent elements of a connector, also known as an anchor ring, or fixing device, of a cardiac pump on a cardiac wall of a heart. It is advantageously made entirely from a biocompatible, non-toxic and sterile material.

[0025] Such a cardiac pump implantation assistance system is particularly suitable for an intervention on a beating heart or a non-beating heart benefiting from extracorporeal circulation.

[0026] Advantageously, such a placement assistance system ensures increased comfort for the surgical team during the procedure because this placement assistance system ensures particularly easy placement of the heart pump.

[0027] Preferably, this centering device is intended to be pressed against the cutting guide piece. It is advantageously positioned on the front face of the assembly flange so that it is visible to the operator, enabling the operator to center the flange on the heart wall.

[0028] Alternatively, this centering device can be formed by the cutting guide piece itself, which then has a central opening for the passage of a guide wire. Naturally, this opening is then partially surrounded by a reinforcement to ensure the guide wire is gripped and held in position, with the longitudinal cutting guide groove(s) extending from this central opening.

[0029] According to a particular embodiment of this cardiac pump implantation assistance assembly, the inner wall of said assembly flange comprises at least one removable assembly device. Thus, the assembly flange may include a removable assembly device such as a screw thread, and the cutting guide piece may lack one.

[0030] According to another particular embodiment of this heart pump implantation assistance assembly, the cutting guide piece includes at least one removable assembly device complementary to at least one removable assembly device of the inner wall of said assembly flange to ensure removable assembly of said guide piece inside the opening of said assembly flange.

[0031] If the cutting guide is simply placed and held in position within the opening, there is no need for a threaded hole on the guide, as another operator can hold it in place with a rod. While some blood will leak after the cut or incision, the procedure is performed more quickly. In the case of screw thread assembly, there is no need for a "third hand", or even assistance to hold the cutting guide piece in position.

[0032] According to yet another particular embodiment of this cardiac pump implantation assistance assembly, these detachable assembly devices of a first piece with a second piece can be chosen from the group comprising first and second complementary threads, assembly elements of complementary shapes by interlocking, retaining elements such as tenons placed protruding on the first piece and receiving elements such as hollow housings, the retaining elements and the receiving elements having complementary shapes or combinations of these elements.

[0033] Advantageously, the cutting guide piece having a round shape, the removable assembly device of said assembly flange is a first thread, or screw pitch, said complementary removable assembly device is a second complementary thread of said first thread to ensure their removable assembly, which is placed on the edge of said guide piece.

[0034] According to yet another embodiment of this cardiac pump implantation assistance assembly, this cutting guide piece has a single longitudinal opening forming a slot. Preferably, this longitudinal opening is intended to be centered on said central orifice of the centering device, when the latter is pressed against the front face of said cutting guide piece. This ensures a clean cut of the ventricular wall and the creation of a perfectly defined hole in this wall.

[0035] According to yet another embodiment of this cardiac pump implantation assistance assembly, this cutting guide piece includes two longitudinal openings arranged to form a cross, which is intended to be centered on said central orifice of the centering device, when the latter is pressed against the front face of said cutting guide piece. Advantageously, such a cross, also called an X shape, allows for the delimitation in the ventricular wall of pieces of the same size, ensuring a better distribution of forces when cutting this ventricular wall using the head of a coring tool.

[0036] According to yet another embodiment of this cardiac pump implantation assistance assembly, said or at least one of the longitudinal openings of said cutting guide piece opens onto a lateral edge of said piece. This makes it possible to allow the passage of a guide wire.

[0037] According to yet another embodiment of this cardiac pump implantation assistance assembly, said centering device is a flexible part such as a flexible washer, configured to bear against the inner wall of the assembly flange or the guide piece, the axis of symmetry of the orifice of the assembly flange thus passing through the central orifice of this centering device.

[0038] According to yet another embodiment of this cardiac pump implantation assistance assembly, said centering device includes a transverse groove extending from its central orifice to a lateral edge to allow the introduction or removal of a guide wire intended to pass through its central orifice. This transverse groove has a dimension smaller than the diameter of the guide wire to hold the latter in the central orifice, the said centering device being made of a flexible material to allow temporary deformation of this transverse groove and thus the withdrawal of the centering device from the guide wire.

[0039] According to yet another embodiment of this cardiac pump implantation assistance assembly, said assembly flange is a flanged assembly flange comprising a tubular element, preferably central, intended to protrude outside the heart, when the assembly flange is assembled to the ventricular wall, the inner wall of this tubular element comprising at least one removable assembly device.

[0040] According to yet another embodiment of this cardiac pump implantation assistance assembly, the face of the cutting guide piece intended to be placed on the side of the heart wall is flat or substantially flat. Advantageously, this ensures that it conforms to the heart wall when it is pressed against it.

[0041] According to yet another embodiment of this cardiac pump implantation assistance assembly, said assembly flange comprises at least two notches placed on its outer periphery, two of said notches being intended to cooperate simultaneously with corresponding protrusions of a gripping tool to ensure the gripping and holding of said assembly flange by means of this gripping tool.

[0042] According to yet another embodiment of this cardiac pump implantation assistance assembly, said cutting guide piece has on its front face, intended to be placed furthest from the ventricular wall, a collar comprising at least two cavities opening onto a single face and tapped for the attachment of the end of a gripping element such as a gripping rod whose end has a thread complementary to the thread of the cavities. Preferably, these cavities are evenly distributed on this collar.

[0043] According to yet another embodiment of this cardiac pump implantation assistance assembly, this assembly flange comprises a fixing flange to the heart wall, a tubular projection extending from this fixing flange and optionally a support flange.

[0044] When it includes a support flange, the tubular projection and this support flange are advantageously made in one piece from a rigid, non-thrombogenic material, such as titanium.

[0045] Preferably, this fixation flange is configured to be attached to the ventricular wall by suture. Alternatively, its constituent material may be stapled.

[0046] In the thickness of the assembly flange, there are advantageously orifices allowing the insertion of pins placed at the ends of a retaining clip. Gripping the body of the assembly flange, or fixation ring, while suturing or incising the heart wall allows the assembly flange to be held firmly in position and to provide counterforce when the heart wall is incised. The heart wall does not depress during the cut, which ensures a clean cut on a stable structure.

[0047] Advantageously, this fixation flange is made of a material that allows the adhesion and growth of endothelial cells. This material therefore aims to facilitate cell growth or attachment in order to strengthen the connection of this fixation flange with the ventricular wall of the heart. Brief description of the drawings

[0048] Other advantages, purposes, and special features of the present invention will become apparent from the following description, given for explanatory purposes only and not as a limitation, with reference to the accompanying drawings, in which: Fig. 1

[0049] [Fig. f] is a perspective view of a cardiac pump implantation assistance assembly according to a particular embodiment of the present invention; Fig. 2

[0050] [Fig. 2] is a perspective view of the assembly flange of the cardiac pump implantation assistance assembly illustrated in Fig. f; Fig. 3

[0051] [Fig. 3] is a top and perspective view of the centering device of the cardiac pump implantation assistance assembly of Fig. 1; Fig. 4

[0052] [Fig. 4] is a view of a gripping tool for the assembly flange of a cardiac pump implantation assistance assembly according to a particular embodiment; Fig. 5

[0053] [Fig. 5] shows the fixing flange of the cardiac pump implantation assistance assembly of Fig. 1 held by the grasping tool illustrated in Fig. 4. Fig. 6

[0054] [Fig. 6] shows one of the steps in the placement of a heart pump in which after installing a guide wire connecting the outside of the heart wall to the aortic valve, an assembly flange and a cutting guide piece of the placement assistance assembly illustrated in Fig. f are inserted along this guide wire;

[0055] [Fig. 7] shows an additional step in the fitting of a heart pump, to that illustrated in Fig. 6, in which the cutting guide piece is fitted into the opening of the assembly flange and a centering device is pressed against this guide piece after the guide wire has been inserted into its central orifice; Fig. 8

[0056] [Fig. 8] shows yet another later step in the placement of a heart pump, to that illustrated in Fig. 7, in which the assembly flange is assembled onto the heart wall by suturing; Fig. 9

[0057] [Fig. 9] shows yet another step in the placement of a heart pump, to that illustrated in Fig. 8, in which a coring tool is used to make a hole in the cardiac wall of the heart. Fig. 10

[0058] [Fig. 10] shows a cutting guide piece according to another embodiment of the invention, this guide piece being made entirely of titanium and having a single slot, the end of a gripping rod being engaged with the collar of this guide piece to ensure the gripping of the latter. Description of the implementation methods

[0059] The drawings and description below contain, for the most part, elements of a definite nature. They can therefore not only serve to better explain the present invention, but also contribute to its definition, if necessary.

[0060] Firstly, it should be noted that the figures are not to scale.

[0061] Figures 1 to 3 schematically illustrate a cardiac pump implantation assistance system according to a particular embodiment of the present invention.

[0062] This placement assistance kit includes an assembly flange 10 intended to be mounted on a ventricular wall of a heart of a patient whose heart failure is being treated.

[0063] This assembly flange 10 includes a fixing flange 11, a tubular projection 12 extending axially from this fixing flange and a support flange 13 open in its center.

[0064] This fixation flange 11 is intended to be attached to the ventricular wall by suture. It is advantageously made of a material that facilitates cell growth or attachment in order to strengthen its bond with the ventricular wall.

[0065] The tubular projection 12 and the support flange 13 are made in one piece from a rigid non-thrombogenic material, such as titanium.

[0066] This tubular projection 12 and the support flange 13 are placed outside the heart when the fixing flange 11 is assembled to the ventricular wall 14.

[0067] This tubular projection 12 and the support flange 13 define an orifice 15, or opening, in the assembly flange 10 extending longitudinally through the thickness of this flange. This orifice 15 thus opens onto the front and rear faces of the assembly flange 10.

[0068] The internal wall of the tubular projection 12 which surrounds or delimits part of this orifice 15 of the assembly flange 10 is equipped with a removable assembly device 16, here consisting of a first thread.

[0069] Similarly, this installation assistance assembly includes a cutting guide piece 17, equipped with a removable assembly device complementary to that of the inner wall of the assembly flange 10, allowing a removable assembly of the guide piece 17 in the orifice 15.

[0070] This cutting guide piece 17, being round in shape, is fitted with a second thread (not shown) located on its edge, which is complementary to the first thread to ensure their removable assembly.

[0071] Advantageously, the guide piece 17 is a solid piece having a front face, a rear face and a longitudinal groove 18, which extends transversely over at least a part of the front face of this guide piece 17 and opens at the same time onto its rear face.

[0072] This configuration allows the passage of a cutting element such as a blade 19 of a cutting instrument, for example a scalpel, through this longitudinal groove 18.

[0073] This ensures proper guidance of this cutting element 19 along the axis defined by the longitudinal groove 18, facilitating the cutting of the cardiac wall.

[0074] The front face of this guide piece 17 has a collar 20 which bears against the support flange 13 when this guide piece is mounted in the orifice 15 of the assembly flange 10. This configuration defines a housing in which a centering device 21 is temporarily housed.

[0075] This centering device 21, which here takes the form of a flexible washer, has a central orifice 22 for the passage of a guide wire.

[0076] The size of this washer is determined to ensure that it is held in position in the housing of the guide piece 17. The assembly is configured so that the central orifice 22 of this centering device 21 is centered on the axis of symmetry of the orifice 15 of the assembly flange 10.

[0077] This centering device 21 also includes a transverse groove 23 extending from its central orifice 22 to a lateral edge of the latter to allow the introduction or removal of a guide wire 24 intended to pass through its central orifice.

[0078] The longitudinal groove 18 of the guide piece 17 is advantageously centered on this central orifice 22 of the centering device 21, when the latter is pressed against the front face of this guide piece 17.

[0079] Preferably, this cutting guide piece 17 and / or the centering device 21 are made of titanium or of a surgically compatible plastic material such as polyetheretherketone (Peek).

[0080] As illustrated in Figures 1 and 2, this assembly flange 10 also has holes 25 distributed around its outer periphery. These holes are sized to receive two protrusions 26 located at one end of a clamp 27. This clamp 27 thus allows the operator to firmly grip this assembly flange 10 during the operation.

[0081] The cutting guide piece 17 also includes on its front face, a collar 20 comprising two tapped cavities 28 for fixing the end of a gripping element such as a gripping rod 29 whose end has a thread complementary to the thread of the tapped cavities 28.

[0082] Figure 6 illustrates one of the steps in the placement of a heart pump on a ventricular wall of a beating heart. This step involves incising the heart wall to introduce a guidewire, positioning this guidewire so that it connects the outside of the heart wall to the aortic valve via the main axis of the latter, so as to be centered on it, and inserting along this guidewire, on the outside of the heart, an assembly flange FO and a cutting guide piece 17 of the placement assistance assembly illustrated in Fig. 1.

[0083] Figure 7 shows an additional step in the process of implanting a heart pump, in continuity with that illustrated in Fig. 6. Here, the cutting guide piece 17 is assembled in a removable manner in the orifice 15 opening from the assembly flange 10, and then a centering device 21 is pressed against this guide piece 17 after the introduction of a guide wire into its central orifice.

[0084] Figure 8 shows a further step in the placement of a heart pump, beyond that illustrated in Figure 7. In this step, after bringing the assembly comprising the mounting flange 10, the guide piece 17, and the centering device 21 closer to the heart wall by sliding this assembly along the guide wire, and having thus ensured its centering relative to the center of the aortic valve, the mounting flange is then attached to the heart wall by suturing. It can then be observed that the axis of symmetry of its opening passes through, or very nearly through, the center of the aortic valve thanks to the placement of the centering device and the guide wire.

[0085] Figure 9 shows a further step in the placement of a cardiac pump, in addition to that illustrated in Fig. 8. Here, a coring tool 30, having a central aperture through which the guide wire 24 passes, is used to create a clean-edged hole in the cardiac wall 14 of the heart. This hole will later allow the insertion of a reinforcing insert, which will be supported by the assembly flange 10.

[0086] This reinforcement insert, with one end protruding inside the ventricle, will in turn support and secure the body of a heart pump. Once installed, this heart pump will return blood from the ventricle to the body's circulation.

[0087] Thanks to the implementation of the entire cardiac pump implantation assistance system, the latter will be aligned with the aortic valve.

Claims

Demands

1. An assembly for assisting the placement of a cardiac pump on a ventricular wall of a heart, comprising: - an assembly flange (10), this assembly flange (10) comprising a front face, a rear face and an opening (15) leading to said front and rear faces, this opening being delimited by an internal wall of said assembly flange (10), - a cutting guide piece (17) intended to be received at least partially in the orifice (15), the cutting guide piece (17) having a front face, a rear face and at least one longitudinal opening (18) such as a groove, extending transversely over at least part of the front face and opening onto said rear face, said guide piece being configured to allow the passage of a cutting element such as a blade (19) through each longitudinal opening (18) and to guide this cutting element along the axis defined by this corresponding longitudinal opening (18) in order to allow the incision of the cardiac wall of this heart, when the assembly flange (10) is assembled to the ventricular wall and said guide piece is received in the orifice of the assembly flange (10), - a guide wire, and - a centering device (21) having a central orifice (22) for the passage of the guide wire, this centering device being intended to ensure, by means of the guide wire, the centering of the assembly flange on the cardiac wall in relation to a cardiac valve of the heart.

2. Installation assistance assembly according to claim 1, characterized in that the inner wall of said assembly flange (10) comprises at least one removable assembly device (16).

3. Installation assistance assembly according to the preceding claim, characterized in that the cutting guide piece (17) comprises at least one removable assembly device complementary to said at least one removable assembly device (16) from the inner wall of said assembly flange (10) to ensure a removable assembly of said guide piece inside the opening of said assembly flange (10).

4. Installation assistance assembly according to claim 2 or 3, characterized in that said cutting guide piece (17) has a round shape, the removable assembly device (16) of said assembly flange (10) is a first thread, said complementary removable assembly device being a second complementary thread of said first thread to ensure their removable assembly, which is placed on the edge of said guide piece.

5. Installation assistance assembly according to any one of the preceding claims, characterized in that said cutting guide piece (17) comprises a single longitudinal opening forming a slot, which is intended to be centered on said central orifice of the centering device (21), when the latter is pressed against the front face of said cutting guide piece (17).

6. Installation assistance assembly according to any one of the preceding claims, characterized in that said or at least one of the longitudinal openings of said cutting guide piece (17) opens onto a lateral edge of said piece.

7. Installation assistance assembly according to any one of the preceding claims, characterized in that said centering device (21) is a flexible part such as a flexible washer, configured to bear against the inner wall of the assembly flange or against the cutting guide piece (17), the axis of symmetry of the orifice of the assembly flange (10) passing through the central orifice of this centering device (21).

8. An assembly for assisting placement according to any one of the preceding claims, characterized in that said centering device (21) has a transverse groove (23) extending from its central orifice (22) to a lateral edge to allow the introduction or removal of a guide wire intended to pass through its central orifice.

9. An assembly for assisting placement according to any one of the preceding claims, characterized in that said assembly flange (10) is an assembly flange (10) with a collar comprising a tubular element, preferably central, intended to protrude outside the heart when the assembly flange (10) is assembled to the ventricular wall, the inner wall of this tubular element comprising at least one removable assembly device.

10. A placement assistance assembly according to any one of the preceding claims, characterized in that the face of the cutting guide piece (17) intended to be placed on the side of the cardiac wall is flat or substantially flat.

11. Installation assistance assembly according to any one of the preceding claims, characterized in that said assembly flange (10) comprises at least two notches (25) placed on its outer periphery, two of said notches being intended to cooperate at the same time with corresponding protrusions (26) of a gripping tool to ensure the gripping and holding of said assembly flange (10) by means of said gripping tool (27).

12. Installation assistance assembly according to any one of the preceding claims, characterized in that said cutting guide piece (17) has on its front face, a collar (20) comprising at least two cavities (28) opening onto a single face and tapped for the attachment of the end of a gripping element (29) such as a gripping rod, the end of which has a thread complementary to the thread of the cavities (28).

13. A placement assistance assembly according to any one of the preceding claims, characterized in that this assembly flange (10) comprises a fixation flange (11) to the cardiac wall, a tubular projection (12) extending from this fixation flange and optionally a support flange (13).

14. A placement assistance assembly according to the preceding claim, characterized in that said fixation flange (11) is configured to be fixed to the ventricular wall by suture or staple.

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