Orientable fastening system for a heart pump

Abstract

A system for fastening a heart pump implantable through a wall of a ventricle, the system comprising: - a female ring with an inner wall of concave shape; the female ring being intended to engage in a fixed manner with the wall of the ventricle, - a male ring with an outer wall of convex shape, complementary to the concave shape of the inner wall of the female ring; the male ring being at least partially inserted into the female ring in a pivoting manner; the male ring having a hollow region dimensioned to receive and fasten the heart pump rigidly, - a fastening device having a closed position, for holding the male ring immobile relative to the female ring in a given orientation, and an open position, for allowing a rotation of the male ring relative to the female ring.

Description

Description Title of the invention: Adjustable mounting system for heart pump.

[0001] technical field

[0002] The present invention relates to a system for fixing an implantable cardiac pump through a wall of a ventricle of a heart.

[0003] Prior art

[0004] In general, the present invention relates to intraventricular cardiac pumps intended to treat heart failure.

[0005] Heart failure is a pathological condition in which a patient's heart is unable to provide sufficient blood flow to meet the body's metabolic needs.

[0006] A heart 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.

[0007] This assistance can be temporary or long-term.

[0008] Before implantation, echocardiography is used to define the axis of the perforation to be made at the apical region of the ventricle. Each surgeon has varying degrees of skill in positioning the tip of the cardiac pump correctly under the aortic valve. It is recommended to position the device between 15 and 32 mm below the aortic valve to minimize disruption to the native ejection flow, which greatly helps to direct the flow induced by the cardiac pump.

[0009] However, for example, with a large heart, it is difficult to properly position the axis of the heart pump towards the aortic valve because the anchoring point of the heart pump is far from the aortic valve.

[0010] The document FR3103101 Al / US20220395680A1 describes a medical device for anchoring a heart pump in an opening in the ventricular wall of a heart. This device includes a connector fixed to the ventricular wall into which the heart pump, mounted on an insert fixed to the connector, is inserted.

[0011] Document FR3128885A1 / US20230145482A1 also describes a device for securing a heart pump within an opening in the ventricular wall of a heart. The heart pump is supported by a mounting tube designed to be inserted into a connector fixed to the wall. The mounting tube includes a locking and unlocking system allowing the heart pump to be moved along its axis of rotation as needed.

[0012] In prior art systems, the placement of the heart pump requires an ultrasound analysis to determine the correct axis along which the pump should be positioned. However, the actual placement does not always allow for precise alignment of the heart pump along the correct axis.

[0013] The present invention aims at a new anchoring system for the cardiac pump allowing orientation towards the aortic valve.

[0014] Another aim of the invention is to maintain the efficiency of the cardiac pump throughout the evolution of the heart's dimensions.

[0015] Description of the invention

[0016] At least one of the objectives is achieved with a system for attaching an implantable cardiac pump through the wall of a heart ventricle; this system includes: - a female ring having a concave inner wall; said female ring being intended to engage in a fixed manner with the ventricle wall, - a male ring having a convex outer wall complementary to the concave shape of the female ring's inner wall; said male ring being at least partially inserted into the female ring in a pivotal manner; said male ring having a hollow area dimensioned to receive and rigidly fix the heart pump, - a fixation device accessible from outside the ventricle when the cardiac pump is implanted, this fixation device having two positions, a closed position intended to keep the male ring immobile relative to the female ring in a given orientation, and an open position intended to allow rotation of the male ring relative to the female ring, rotation for which the axis of rotation of the male ring is deviated by a non-zero angle relative to the axis of rotation of the female ring.

[0017]

[0018] With the system according to the invention, the axis of rotation of the heart pump can be easily reoriented once or several times after implantation. This allows the pump's positioning to be adapted, particularly in response to changes in the patient's health. Indeed, a patient may recover all or part of their cardiac "mechanical" capacity. In critical situations, the heart's volume can increase considerably. After implantation, the heart's volume may decrease and return to its initial size. With each change in the patient's health, it may be necessary to reorient the heart pump.

[0019] To achieve this, the system according to the invention provides for inserting the heart pump through the male ring, the latter being orientable relative to the female ring, which remains fixed to the ventricle. Thus, the orientation of the pump is adjustable. The user can therefore modify the orientation of the heart pump if it is not properly oriented towards the aortic valve.

[0020] To change the orientation of the heart pump, simply loosen the fixation device, reorient the heart pump, and then lock the fixation device. There is no need to re-perforate the ventricle.

[0021] The rotation of the male ring relative to the female ring is made possible by friction or sliding of the convex outer wall of the female ring on the concave inner wall of the female ring.

[0022] The male ring is capable of pivoting relative to the female ring at an angle expected to be approximately 9 degrees. The female ring is designed to be fixed to the ventricle wall.

[0023] This allows for less constraint on precisely determining the rotation angle of the female ring during its placement on the ventricle. The adjustable orientation of the male ring compensates for any inaccurate positioning of the female ring during the installation of the female ring and the fixation system.

[0024] When the fastening device is in the open position, the male ring is not locked; it is left free to rotate but in cooperation with the female ring.

[0025] When the fastening device is in the closed position, the male ring is locked, i.e., immobile relative to the female ring.

[0026] With the system according to the invention, the orientation of the pump axis towards the aorta is optimized from 0 to several degrees.

[0027] Such a system makes it possible, in particular, to maintain a desired distance from the septum. Indeed, the septum, which is the wall between the left and right ventricles, can regain normal function (and therefore normal amplitude) and consequently could come into chronic contact with the heart's casing if the latter is positioned too close. By orienting the heart sufficiently far from the septum, any risk of further contact is avoided.

[0028] Furthermore, it is also necessary to avoid placing the heart pump too close to the anterior mitral valve, particularly in the open position, in diastole, during the filling phase.

[0029] The pump can be remotely reoriented using the guidance rod which is passed through a mini-thoracotomy reopening on the patient's ventricle remodeling.

[0030] The male ring and the heart pump are designed to be rigidly secured so that the orientation of the male ring's axis of rotation aligns with the orientation of the heart pump's flow ejection axis. In other words, the male ring and the heart pump are two separate components intended to be assembled removably, without any possibility of movement relative to each other when the heart pump is locked into the male ring.

[0031] According to one embodiment of the invention, the fastening device may include a clamping nut equipped with:

[0032] - a hollow central section for the passage of the heart pump,

[0033] - an internal shoulder to act as a stop and hold the male ring between the clamping nut and the female ring,

[0034] - a first thread intended to engage with a second thread present on the female ring, the tightening between the two threads causing pressure from the internal shoulder on the male ring.

[0035] The shoulder acts as a stop to prevent the male ring from coming out of the enclosure formed between the clamping nut and the female ring.

[0036] This locking nut is designed to press the male ring against the female ring and ensure a seal. By tightening the locking nut onto the female ring, the stop gradually presses the male ring against the female ring in a specific orientation until it locks into place.

[0037] According to an advantageous feature of the invention, the fastening device may further include a sealing gasket between the female ring and the male ring, this sealing gasket being inserted into a peripheral notch of the male ring.

[0038] Advantageously, the internal shoulder can be a removable collar capable of sliding on an external wall of the male ring. This allows for a stop made in one piece with the rest of the clamping nut, or in the form of a removable collar.

[0039] The external surface of the stop has a shape complementary to the external shape of the male ring.

[0040] According to an advantageous feature of the invention, the fastening device may further comprise an annular screw flange placed around an overlap area between the female ring and the clamping nut so that said screw flange prevents detachment between the clamping nut and the female ring.

[0041] This screw flange may have peripheral holes intended to receive a retaining clamp when tightening and / or loosening the clamping nut relative to the female ring.

[0042] Preferably, the flange is fixed to the female ring. Gripping pins can be provided to prevent relative movement of the flange with respect to the female ring during tightening or loosening.

[0043] Thus, when the retaining clamp grips the flange, it also indirectly grips the female ring. The role of the retaining clamp is to prevent the female ring from being pulled in a tightening or loosening motion relative to the male ring.

[0044] According to one embodiment, the retaining clamp may include two distal ends in the form of two arcs of a circle intended to embrace the screw flange on either side, each arc of a circle comprising at least one pin to be inserted into one of the peripheral holes of the screw flange.

[0045] Preferably, the two circular arcs are inscribed in a plane making a non-zero angle with a plane containing the rest of the retaining clamp.

[0046] This results in a curved retaining clamp, facilitating its insertion through a patient's abdomen during an operation and the orientation of its distal part to grip the band in a pincer motion.

[0047] Preferably, the retaining clip has an eyelet on an outer edge of at least a semicircle. This eyelet is a hole or receptacle intended to receive a tightening / loosening tool.

[0048] According to an advantageous feature of the invention, the system may further include a serrated screwdriver used when tightening and / or loosening the clamping nut in the presence of the retaining clamp; the serrated screwdriver comprises: - a point designed to fit inside one of the two eyelets of the retaining clip, - notches to engage with teeth made on an external perimeter of the clamping nut, screwing or unscrewing leading to said closed position or said open position of the fastening device.

[0049] By turning the screwdriver, the locking nut screws in or out relative to the female ring. Once screwed in, the male ring is locked and held in place.

[0050] Advantageously, the clamping nut can be made from a biocompatible material comprising a polymer from the polyetherketone (PEK), polyaryletherketone (PAEK), or polyetheretherketone (PEEK) family. Such a material can slide against the male and / or female ring, which may be made of titanium.

[0051] In one variant of the invention, the fastening device comprises:

[0052] - The fastening device includes: - an annular-shaped fixing flange positioned around the female ring and comprising an internal shoulder preventing the male ring from escaping when inserted into the female ring, the fixing flange having at least one threaded hole, - at least one fixing screw intended to be screwed into said at least one threaded hole, pass through the fixing flange, the female ring, until reaching the male ring and move it relative to the female ring.

[0053] In this variation, a small fixing screw is screwed directly through a thread in the mounting flange until it presses against the male ring. This small fixing screw passes through a hole in the female ring, so that the female ring is also held in place by the small fixing screw. In other words, the fixing screw secures the male ring by its tip (the point of the fixing screw) and secures the female ring by its shank (the shank of the fixing screw). As in the previous method, gripping pins can also be used to secure the female ring to the mounting flange.

[0054] According to the invention, the fixing flange may include a positioning mark for said at least one threaded hole.

[0055] Such a marker allows the user to locate the position of the fixing screw.

[0056] According to an advantageous embodiment of the invention, the fixing flange may include at least two threaded holes arranged at 90° to each other.

[0057] This allows for at least two points of contact to firmly hold the male ring in the closed position.

[0058] Preferably, at least one fixing screw shall have a stop preventing it from coming loose from its threaded hole.

[0059] According to one embodiment of the invention, the fastening device may comprise: - a locking ring to encircle the male and female rings, this locking ring having an adjustable perimeter, and - a quick-release locking system installed on the locking ring to ensure said closed position when the locking system is locked, and to ensure said open position when the locking system is unlocked.

[0060] In this embodiment, a sealing gasket and / or a shoulder can also be provided to prevent the male ring from passing through the locking ring.

[0061] The quick-release locking system can be a clip, a spring clip, a hook, a spring hook, a lever or a toggle lever, or a toggle closure.

[0062] According to another embodiment of the invention, the fastening device may comprise: - a bayonet ring to encircle the male ring, and - grooves, such as flutes or openings, and / or lugs, such as blades or pins, arranged on the bayonet ring and / or the female ring to ensure a bayonet-type fastening between the bayonet ring and the female ring, the male ring being held rigidly between the bayonet ring and the female ring.

[0063] In this embodiment, a sealing gasket and / or a shoulder can also be provided to prevent the male ring from passing through the bayonet ring.

[0064] The system according to the invention may advantageously include a fixation collar attached to the female ring and intended to be sutured to the outer wall of the ventricle. The female ring engages with the ventricle wall via this collar.

[0065] The fastening device is preferably non-abrasive and polished.

[0066] The system according to the invention may also include a slewing rod for moving the heart pump in the implanted position and when the fixation device is in the open position; the slewing rod being provided with a receptacle at its distal end, this receptacle being intended to engage with a proximal, non-ventricle end of the implanted heart pump.

[0067] Description of the figures and methods of implementation.

[0068] Other advantages and features of the invention will become apparent upon examination of the detailed description of a non-limiting embodiment and the accompanying drawings, in which:

[0069] Figure 1 is a schematic view illustrating an implanted cardiac pump a) with an unsuitable orientation, too close to the septum, b) with a corrected orientation after manipulation of the fixation system.

[0070] Figure 2 is a schematic view of the cardiac pump equipped with a fixation tube,

[0071] Figure 3 is a schematic view of an adjustable fixation system according to the invention, intended to receive the cardiac pump and its fixation tube,

[0072] Figure 4 is a schematic exploded view of the adjustable fastening system according to the invention,

[0073] Figure 5 is a schematic view of another adjustable fixation system according to the invention, equipped with a clamping nut, intended to receive the heart pump and its fixation tube.

[0074] Figure 6 includes in a) a schematic side view of the orientable fixing system of figure 5, in b) a schematic side view of the orientable fixing system of figure 5 with a different orientation relative to a),

[0075] Figure 7 is a schematic exploded view of the adjustable mounting system of Figure 5.

[0076] Figure 8 is a cross-sectional view of the adjustable mounting system shown in Figure 5.

[0077] Figure 9 is a schematic view of a retaining clamp holding a flange of the swiveling fastening system of Figure 5.

[0078] Figure 10 is a schematic view showing the retaining clip and a screwdriver for unlocking the rotating male ring relative to the female ring of the swiveling fixing system of Figure 5.

[0079] Figure 11 is a schematic view of the elements of Figure 10 except for the screwdriver, the male ring thus being free to rotate relative to the female ring.

[0080] Figure 12 is a schematic view of an example of a slewing rod fitted with a head adapted to manipulate a heart pump according to the invention,

[0081] Figure 13 is a schematic view showing the retaining clip and a screwdriver for locking the ring relative to the female ring of the swiveling fastening system in Figure 5, and

[0082] Figure 14 is a schematic view showing the cardiac pump inserted into a fixation system according to the invention with a different orientation than that of Figure 5.

[0083] The embodiments described below are not exhaustive; in particular, variants of the invention may be implemented comprising only a selection of features described hereafter, isolated from the other features described, if this selection of features is sufficient to confer a technical advantage or to differentiate the invention from the prior art. This selection includes at least one preferably functional feature without structural details, or with only a portion of the structural details if this portion alone is sufficient to confer a technical advantage or to differentiate the invention from the prior art.

[0084] In particular, all the variants and embodiments described are intended to be combined with each other in all combinations where there is no technical obstacle.

[0085] In the figures, elements common to several figures retain the same reference.

[0086] We will now describe a fixation system according to the invention for a cardiac pump. Such a pump assists the heart in its operation, while the heart continues to perform its own hemodynamic pumping function. The pump's objective is to add an additional amount of blood flow to the native blood flow during each systole. The heart continues to contribute its own blood flow, but a more satisfactory blood flow is achieved through the complementary action of the pump.

[0087] The pump is preferably placed in the left ventricle at the level of the apex. Blood is drawn from the ventricle through orifices near the apex and then pumped towards the aortic valve. To achieve an optimized effect, i.e., one that is cost-effective in terms of energy consumption and physiological flow rates, the pump is synchronized with cardiac systole by capturing the left ventricular depolarization signal.

[0088]

[0089] In Figure 1, a) a pump 1 implanted in the left ventricle of a patient's heart 2 is shown. The pump comprises a base 3 connected, notably by cable, to a control unit (not shown). This pump is shown in general in Figure 2. It is equipped with a fixation tube 4 like the one described in document FR3128885A1 or its equivalent US20230145482A1. The fixation tube 4 of Figure 2 according to the present invention is referenced as element 18 in document FR3128885 A1. It is a fixation tube comprising a hollow main body of generally cylindrical shape having a distal end designed to protrude from the ventricular wall into the ventricular cavity. This fixing tube includes eyelets 4a for insertion of a tightening tool and a toothed wheel 4b to hold the heart pump 1 inserted inside the hollow main body.

[0090] However, any other method of securing the pump in an opening can be used. This could be a screw-on system, a clip, a magnetic system, or something else.

[0091]

[0092] In Figure 1, the heart pump 1 and its fixation tube 4 are inserted inside the fixation system 5 according to the invention. This fixation system 5 is fixed to the ventricular wall and provides a central opening through which the heart pump 1 and fixation tube 4 assembly is inserted. The fixation tube 4 is designed to engage with the fixation system 5 according to the invention. As mentioned above, other devices can be used. A heart pump without a fixation tube, or an equivalent, designed to engage directly with the fixation system 5, can also be considered. The fixation tube 4 has the advantage of allowing axial movement of the heart pump.

[0093] In Figure 1, at a), the cardiac pump 1 is inserted, but the pump head is too close to the septum 6, which is the wall separating the two ventricles of the heart. The pump is considered misaligned because the outflow is partially directed towards the septum, and the pump head risks coming into contact with it. This misalignment may be due to an initial incorrect placement or to a physiological change in the patient's heart after a certain period of pump use.

[0094] The fixation system 5 according to the invention is designed to reorient the cardiac pump 1, as shown in b) of Figure 1, so that the outflow from the cardiac pump is directed towards the aorta. To achieve this, a steerable fixation system 5 is provided; that is, the part attached to the cardiac pump is capable of forming an angle with the part fixed to the ventricle wall. In b) of Figure 1, the cardiac pump 1 has been straightened relative to its axis of rotation 7 in a) of Figure 1.

[0095] A first example of an embodiment, named 5', of the fastening system 5 according to the invention is shown in figure 3 in assembled position and in figure 4 in exploded position.

[0096] Referring to Figures 3 and 4, a fixation collar 8 is shown, designed to be attached to the ventricular wall by suture or stapling. It is advantageously made of a material that promotes cell growth or attachment to strengthen its bond with the ventricular wall. The fixation collar 8 can be made of Dacron® or polytetrafluoroethylene (PTFE).

[0097] A female ring 9 is inserted inside the flange 8. The female ring 9 includes a rim 9a with a diameter greater than the diameter of the central opening of the fixing flange 8, so as to form a stop preventing the female ring 9 from completely passing through the fixing flange 8. The rim 9a is intended to be wedged between the fixing flange 8 and the outer wall of the ventricle.

[0098] An annular mounting flange 10 is provided to press and hold the mounting collar 8 against the rim 9a of the female ring. This mounting flange 10 is a ring with a width greater than the width of the portion of the female ring 9 that protrudes from the mounting collar 8.

[0099] A sealing gasket 11 is to be inserted inside the female ring 9 to make the seal with the male ring 12.

[0100] The male ring 12 is designed to fit partially inside the female ring 9. To achieve this, the inner wall 9b of the female ring 9 is concave, while the outer wall of the male ring is convex. The width of the male ring 12 is greater than the width of the portion of the female ring 9 that protrudes from the mounting collar 8.

[0101] To assemble the fastening system as shown in Figure 3, the seal 11 and the male ring 12 are inserted into the female ring 9. The fastening collar 8 is positioned against the rim 9a. The fastening flange 10 is then inserted around the protruding portion of the female ring 9 of the fastening collar 8, positioning the fastening collar 8 against the rim 9a. A rim 10a of the fastening flange 10 prevents the male ring from escaping the enclosure formed between the fastening flange 10 and the female ring 9.

[0102] At this stage, the male ring 12 can pivot by offsetting its axis of rotation relative to that of the female ring 9. Once the male ring 12 is oriented as desired, fixing screws 13 are used in threaded holes 14 to hold the male ring 12 stationary relative to the female ring 9. To do this, each fixing screw 13 passes through the female ring 9 via openings or notches 9c made in the female ring 9. Tightening the fixing screw 13 secures the assembly of the male ring 12, fixing flange 10, and female ring 9. Markings 15 are made around the perimeter of the fixing flange to indicate the position of the fixing screws 13.

[0103]

[0104] A second example of the embodiment of the fastening system 5 according to the invention is shown in figures 5 and 6 in assembled position and in figure 7 in exploded position.

[0105] Referring to Figures 5 to 8, a fixation collar 16 is shown, designed to be attached to the ventricular wall by suture or stapling. It is advantageously made of a material that promotes cell growth or attachment to strengthen its bond with the ventricular wall. The fixation collar 8 can be made of Dacron® or polytetrafluoroethylene (PTFE).

[0106] A female ring 17 is inserted inside the flange 16. The female ring 17 includes a rim 17a with a diameter greater than the diameter of the central opening of the fixing flange 16, so as to form a stop preventing the female ring 17 from completely passing through the fixing flange 16. The rim 17a is intended to be wedged between the fixing flange 16 and the outer wall of the ventricle.

[0107] An annular screw flange 18 is provided to press and hold the fixing collar 16 against the rim 17a of the female ring 17. This screw flange 18 has pins 18a to pinch the fixing collar 16 against the rim 17a.

[0108] Peripheral holes 18b are made around the perimeter of the screw flange 18.

[0109] Retaining screws 18c are provided to be screwed into threaded holes 18d made around the perimeter of the screw flange 18.

[0110] A sealing gasket 19 is to be inserted inside the female ring 17 to make the seal with the male ring 20.

[0111] The male ring 20 is designed to fit partially inside the female ring 17. To achieve this, the inner wall 17b of the female ring 17 is concave while the outer wall of the male ring 20 is convex.

[0112] For all embodiments, the male ring and the female ring are inscribed within the same sphere, one being part of the inner skin of this sphere, the other the outer skin.

[0113] To assemble the fastening system as shown in Figures 5 and 6, the sealing ring 19 and the male ring 20 are inserted into the female ring 17. The retaining flange 16 is positioned against the rim 17a. The screw flange 18 is then inserted around the protruding portion of the female ring 17 of the retaining flange 16, positioning the retaining flange 16 against the rim 17a. The protruding portion of the female ring 17 of the retaining flange 16 has a thread 17c on its outer surface. A clamping nut 21 is provided with a thread 21b on its inner surface. The partial screwing (without forcing) of the clamping nut 21 with the female ring 17 keeps the male ring 20 inside the enclosure formed by the clamping nut and the female ring 17 with a possibility of rotation for the male ring 20.A forced tightening of the clamping nut 21 with the female ring 17 keeps the male ring stationary relative to the female ring. To achieve this, the clamping nut includes an internal shoulder 22, preferably a removable collar, which applies axial and lateral force to the proximal side (farthest from the female ring) of the male ring to prevent movement.

[0114] In Figure 6, in a), the axis of rotation 24 of the male ring 20 and the axis of rotation 23 of the female ring 17 are collinear. In b), the axis of rotation 24 of the male ring 20 has rotated through an angle of 9° with respect to the axis of rotation 23 of the female ring 17.

[0115] Figure 8 shows a cross-sectional view of the adjustable fastening system 5 according to the invention. It can be seen that the sealing gasket 19 is inserted into a notch in the male ring on the distal side. The outer surface of the shoulder 22 is complementary to the outer surface of the male ring. The screw flange 18 overlaps a portion of the female ring 17 and a portion of the clamping nut 21. The retaining screws 18c are screwed through the clamping flange into a groove formed on the outer surface of the clamping nut 21 without bearing down on the latter. The retaining screws 18c serve only to prevent the clamping nut from coming loose when unscrewed. These retaining screws 18c do not prevent the rotation of the clamping nut 21.

[0116] the external surfaces of the clamping nut 21 and the female ring 17 to prevent the clamping flange from escaping.

[0117] The rotation and translation generated by tightening the clamping nut 21 will only cause the shoulder 22 to translate along arrow 25 in Figure 8. This translation will bring the male ring 20 into contact with the female ring 17 and will generate an axial and radial clamping force, along the red arrows 26 and 27. This clamping force will be proportional to the tightening torque applied to the clamping nut 21.

[0118]

[0119] Figures 9 to 14 illustrate different steps to change the orientation of an implanted heart pump.

[0120] To apply force to the clamping nut 21, a retaining clamp 28 is provided, comprising ends in the form of arcs of a circle to be placed around the clamping flange 18. Each arc of a circle has at least one pin 28a intended to fit into a peripheral hole 18b of the clamping flange 18, see the box in Figure 9. The user can thus grasp the clamping flange 18 and hold it fixed.

[0121] Figure 10 shows the fastening system 5 according to the invention carrying a tube 30 equivalent to a pump. While holding the clamp 28 tight, a serrated screwdriver 29 is used. The tip of the screwdriver is inserted into an eyelet 28b of the clamp 28. The serrated part of the screwdriver engages with teeth 21a of the clamping nut 21. By turning the screwdriver 29, the clamping nut 28 is loosened, which releases the stress on the male ring 20. In Figure 11, by manipulating the tube 30, the orientation of the male ring 20 is changed.

[0122] Figure 12 shows a schematic view of the heart pump 1 with its base 3. Also shown is an orientation rod 31 with a receptacle 31a designed to fit part of the base 3. The user can thus use the orientation rod to move the heart pump and define the desired orientation.

[0123] In Figure 13, screwdriver 29 is used again to tighten the locking nut and secure the male ring in the desired orientation. In Figure 14, we see that the orientation of the tube has been changed compared to the initial orientation in Figure 10.

[0124]

[0125] The present invention relates to an adjustable fixation system, for example, from 0 to 9° once the heart pump has been inserted into the ventricle. With such a system, the user can adjust the orientation of the heart pump if it is not optimally positioned towards the outflow valve, the aortic valve. There is no need to re-perforate the ventricle. The adjustable male ring corrects for displacement within a circle of 4.5 mm radius, thus allowing greater flexibility during the insertion of the heart pump into the ventricle.

[0126] The orientable fixation system according to the invention allows, once the cardiac pump is implanted within the ventricle, for the axis of the intraventricular cardiac pump to be reoriented as desired, in case this position justifies optimization in the X, Y and Z directions (lateral axis, anteroposterior axis, vertical axis, closer to or further from the aortic valve), intraoperatively or postoperatively on a small thoracic reopening.

[0127]

[0128] Of course, the invention is not limited to the examples just described. Many modifications can be made to these examples without departing from the scope of the present invention as described.

Claims

Demands

1. 1. A system (5, 5') for attaching a cardiac pump (1) implantable through a ventricle wall of a heart (2), this system comprising: - a female ring (9, 17) having a concave inner wall (9b, 17b); said female ring being intended to make fixed contact with the ventricle wall, - a male ring (12, 20) having an outer wall of convex shape complementary to the concave shape of the inner wall of the female ring (9, 17); said male ring (12, 20) being at least partially inserted into the female ring (9, 17) in a pivotal manner; said male ring (12, 20) having a hollow area dimensioned to rigidly receive and fix the heart pump (1), - a fixation device (10, 18, 21) accessible from outside the ventricle when the cardiac pump is implanted, this fixation device having two positions, a closed position intended to keep the male ring immobile relative to the female ring in a given orientation, and an open position intended to allow rotation of the male ring relative to the female ring, rotation for which the axis of rotation of the male ring is deviated by a non-zero angle relative to the axis of rotation of the female ring, characterized in that the fastening device comprises a clamping nut (21) equipped with: - a hollow central part for the passage of the heart pump, - an internal shoulder (22) to serve as a stop and to hold the male ring (20) between the tightening nut (21) and the female ring (17), - a first thread (21b) intended to engage with a second thread (17c) present on the female ring (17), the tightening between the two threads causing pressure from the internal shoulder (22) on the male ring (20).

2. 2. System according to claim 1, characterized in that the fastening device further comprises a sealing gasket (19) between the female ring (17) and the male ring (20), this sealing gasket (19) being inserted into a peripheral notch of the male ring.

3. 3. System according to claim 2, characterized in that the internal shoulder is a removable collar (22) capable of sliding on an external wall of the male ring (20).

4. 4. System according to any one of the preceding claims, characterized in that the fastening device further comprises an annular screw flange (18) placed around an overlap area between the female ring (17) and the clamping nut (21) such that said screw flange (18) prevents detachment between the clamping nut (21) and the female ring (17).

5. 5. System according to claim 4, characterized in that the screw flange (18) has peripheral holes (18b) intended to receive a retaining clip (28) when tightening and / or loosening the clamping nut (21) relative to the female ring (17).

6. 6. System according to claim 5, characterized in that the retaining clip (28) comprises two distal ends in the form of two arcs of a circle intended to embrace the screw flange (18) on either side, each arc of a circle comprising at least one pin (28a) to be inserted into one of the peripheral holes (18b) of the screw flange (18).

7. 7. System according to claim 6, characterized in that the two arcs of the circle are inscribed in a plane making a non-zero angle with a plane containing the remainder of the retaining clamp (28).

8. 8. System according to claim 6 or 7, characterized in that the retaining clip (28) has an eyelet (28b) on an outer edge of at least a semicircle.

9. 9. System according to claim 8, characterized in that it further comprises a serrated screwdriver (29) used when tightening and / or loosening the clamping nut (21) in the presence of the retaining clip (28), the serrated screwdriver (29) comprising: - a point intended to fit inside an eyelet (28b), - notches to engage with teeth (21a) made on an external perimeter of the clamping nut (21), screwing or unscrewing leading to said closed position or said open position of the fastening device.

10. 10. System according to any one of the preceding claims, characterized in that the clamping nut (21) is designed based on a biocompatible material comprising a polymer from the polyetherketone (PEK), polyaryletherketone (PAEK) or polyetheretherketone (PEEK) family.

11. 11. System according to any one of the preceding claims, characterized in that the quick-release locking system is a clip, a spring clip, a hook, a spring hook, a lever or a toggle lever, or a toggle closure.

12. 12. System according to any one of the preceding claims, characterized in that it comprises a fixing collar (8, 16) fixed to the female ring (9, 17) and intended to be sutured to the outer wall of the ventricle.

13. 13. A system according to any one of the preceding claims, characterized in that it comprises a slewing rod (31) for moving the cardiac pump (1) in the implanted position and when the fixation device is in the open position; the slewing rod (31) being provided with a receptacle (31a) at its distal end, this receptacle being intended to engage with a proximal, non-ventricle end (3) of the implanted cardiac pump.

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