Gripping element for an implantable cardiac lead

Abstract

The subject matter of the present invention relates to a cardiac lead comprising a gripping element with a textured surface fixed at the proximal end of said lead. The present invention further relates to the gripping element itself and to its use for transmitting a rotational movement to such a lead along its longitudinal axis.

Description

Description Title of the invention: Gripping element for an implantable cardiac probe

[0001] The object of the present invention relates to a cardiac probe comprising a gripping element with a textured surface, fixed to the proximal part of said probe. The present invention further relates to the gripping element itself and its use for transmitting movement to such a probe, in particular rotational movement around its longitudinal axis, and thus transmitting a rotational torque.

[0002] EARLIER ART

[0003] The heart is a complex organ whose function is controlled by the application of precise electrical fields that cause specific muscles to contract at precise times to regulate the filling and ejection of blood into and out of the organ. The heart thus acts as a pump, ensuring blood circulation throughout the body. Structurally, the heart comprises four chambers (left and right atria and left and right ventricles) connected by four valves. However, sometimes the heart's function is impaired, necessitating the placement (more precisely, the implantation) of one or more medical devices that deliver electrical current(s) at the appropriate time(s) to ensure the organ's proper functioning.Such devices (such as implantable pacemakers and / or defibrillators) typically consist of an electronic unit configured for treatment by administering electrical current and a lead electrically connected to this unit. The unit is typically implanted away from the heart and is connected to it via the lead (typically via one of the veins supplying blood to the heart).

[0004] Such a probe is typically the component subjected to the greatest mechanical stress in the entire device (more than 100,000 heartbeats per day at an average of 70 beats per minute). This is why cardiac probes are extremely flexible to withstand the heartbeats without being damaged.

[0005] Furthermore, during lead implantation, precise placement within the heart is crucial to ensure effective delivery of electrical therapy. During implantation, the pacing lead is typically screwed into the cardiac tissue, for example, on the right ventricular side, specifically at the level of the septum (using, for instance, the recent "LBB" technique, for "left bundle branch," developed to directly capture conduction from the left bundle branch by penetrating the ventricular septum). Additionally, the distal end of the lead, which must be secured in the cardiac tissue, is more rigid than the lead body to facilitate implantation.

[0006] Thus, during implantation, the practitioner (such as a surgeon or electrophysiologist) must manipulate the probe in such a way as to induce a movement that allows the distal end of the probe to be screwed in. This screwing is typically achieved by rotating the probe around its longitudinal axis. However, as explained above, the probe must have significant longitudinal flexibility to accommodate cardiac pulsations and other movements throughout its lifespan. Furthermore, the probe's surface is typically smooth to facilitate its movement within the patient's body, or simply to prevent the implantation of foreign bodies with incomplete insertions that could harbor pathogenic organisms and cause infections.The challenge of the procedure lies in obtaining a probe with significant flexibility, particularly along its length, while also possessing sufficient torque transmission properties to allow for screwing in the distal end. Therefore, the practitioner performing the implantation uses specialized tools to help achieve the best possible placement.

[0007] For example, one such tool is a stylet that can be inserted fully into the lead to facilitate implantation. Inserting the stylet into a lumen of the lead allows it to connect the proximal to the distal end of the lead. Such a stylet, typically made of a metallic material with low flexibility, enables torque transmission. Thus, one of the stylet's roles is to stiffen the lead during implantation, particularly to aid in torque transmission (for example, when screwing the distal end into the cardiac chamber). For thin leads that lack an internal lumen for stylet insertion, a delivery catheter can also be used, into which the lead to be implanted is inserted.On the other hand, even if they help the practitioner to manipulate the probe he is trying to implant, these different solutions generally complicate the implantation operation and are not optimal solutions for torque transmission.

[0008] TECHNICAL PROBLEM

[0009] One of the aims of the present invention is to help the practitioner to manipulate the cardiac probe to be implanted, in particular to transmit to said probe a rotational movement around the longitudinal axis, and to help transmit torque to this cardiac probe during its implantation.

[0010] The object of the present invention is to solve, in particular, this technical problem.

[0011] SUMMARY OF THE INVENTION

[0012] An object according to the present invention relates to an implantable cardiac probe comprising a distal portion intended to be placed in a human heart and a proximal portion with a proximal end intended to be connected to an implantable electronic housing, characterized in that the proximal portion comprises a textured surface configured to facilitate the gripping and manipulation of said cardiac probe, particularly during its implantation.

[0013] The textured surface is designed to limit slippage during handling and thus allow for better gripping of the probe.

[0014] Friction fixation has the advantage of being simple to implement by the practitioner, and allows easy removal of the grasping element by applying an appropriate withdrawal movement.

[0015] Another object according to the present invention relates to a gripping element for an implantable cardiac probe, said gripping element comprising a textured surface and a reception space for said implantable cardiac probe.

[0016] Thus, one of the advantages of the present invention is that it provides a simple-to-use, reversible attachment tool for grasping a cardiac probe. The textured surface, in particular, aids in the removal of this tool.

[0017] The present invention further relates to the use of a gripping element as described above to transmit rotation to an implantable cardiac probe around its longitudinal axis.

[0018] It has been observed that such a tool allows for rotational transmission to an implantable cardiac lead around its longitudinal axis without slippage in that direction of rotation. Somewhat surprisingly, when the user performs a withdrawal movement of the tool from the lead (i.e., by pulling it towards the proximal end of the lead), the tool withdraws easily compared to when performing rotational movements around the longitudinal axis of the lead.

[0019] DEFINITIONS

[0020] A cardiac catheter comprises several portions: a proximal portion, a mid-portion, and a distal portion. As explained above, the "distal portion" is the portion intended to be placed within the patient's heart.

[0021] The "proximal portion" is the terminal part of the lead, which is intended to be connected to the electronic device and which the practitioner will manipulate during the final phase of implantation, when screwing or positioning the distal portion into the patient's heart. The "mid-portion" is the portion of the lead placed between the distal and proximal portions.

[0022] The probe thus includes a "distal end," that is, the end of the probe on the distal side of the probe. The distal end is therefore shorter than the distal portion of the probe. Typically, the distal end of the probe includes a screw for its implantation in the cardiac tissue.

[0023] The probe thus includes a "proximal end," that is, the end of the probe on the proximal side of the probe. The proximal end is therefore shorter than the proximal portion of the probe. Typically, the proximal end of the probe includes a connector for its connection to the electronic control unit.

[0024] The longitudinal axis of a cardiac probe is the axis that extends from the proximal to the distal end of a cardiac probe, in particular the line running the entire length of said probe at its center, that is to say the set of points distributed over the entire length of the probe that are most buried in the probe (i.e. the furthest from the outer surface of the probe).

[0025] In the context of the present invention, the "gripping" element is understood to be an element configured to be grasped and manipulated by a user of the cardiac probe, such as a practitioner (like, it is recalled, a surgeon or an electrophysiologist), particularly during the implantation of said probe in a patient.

[0026] The gripping element is configured to allow torque transmission to the cardiac probe.

[0027] In the context of the present invention, "handle" is understood in its generic sense, namely, the act of holding an object in one's hands during use. Preferably, in the context of the present invention, the gripping element is configured to be grasped between at least two fingers of at least one user.

[0028] In the context of this invention, a "textured" surface is understood to mean a surface exhibiting at least one roughness, indentation, raised pattern, and / or undulation that differentiates it from the ideal expected surface. For example, in the case of a cardiac probe, the ideal expected surface is typically that of a flexible cylinder.

[0029] For the purposes of this invention, "reception space" means an element comprising a physical structure defining a volume that allows at least one other element to be accommodated, with or without contact, within that volume.

[0030] The term "torque," and in particular "torque transmission," is classically understood to mean the transmission of an eccentric force that rotates an object subjected to torsional resistance. In the context of the present invention, it refers to the transmission of the force that rotates the proximal end of the probe (for example, through the movements of the practitioner's hand) towards the distal end of the same probe. Torque is typically expressed in Newton meters (Nm).

[0031] DETAILED DESCRIPTION

[0032] A first object according to the present invention therefore relates to a cardiac probe as described above comprising a gripping element.

[0033] Advantageously, the cardiac probe comprises a probe body to which the gripping element is attached. Thus, the user can transmit torque directly to the probe body, which in turn transmits the torque to the distal end of the cardiac probe.

[0034] More advantageously, the gripping element attached to the probe body at least partially surrounds this probe body.

[0035] Thus, the transmission of torque to the probe body is facilitated.

[0036] Preferably, the gripping element is not in contact with the proximal end of the probe body (although it is positioned on a proximal portion of the probe body). The advantage is that this gripping element is not in contact with other proximal elements that could interfere with the user during implantation.

[0037] Preferably, a grasping element is a device having an opening configured for the insertion of a portion of a cardiac probe, such as a portion of the probe body, and of sufficient size for a user to grasp it with at least two fingers.

[0038] In one embodiment, the grasping element according to the present invention is also configured to connect to an incision made in a patient's vein.

[0039] The surface of the gripping element according to the present invention has preferably been treated to be sterile and / or produced (and optionally stored) in a sterile environment.

[0040] In one embodiment, the grasping element is configured to anchor to a vein in the implanted patient. In this case, said grasping element may, for example, have an oblong shape and be locally and minimally textured, or have a suitable surface texture, particularly on a distal portion.

[0041] Preferably, the textured surface is included on a so-called gripping element that is integral with or fixed to said cardiac probe, in particular fixed by friction.

[0042] Advantageously, the gripping element is locked in rotation around the longitudinal axis of said cardiac probe.

[0043] Indeed, even if this component is not prevented from rotating, it will assist the user in manipulating the cardiac probe. However, if the component is prevented from rotating, the user will be able to more easily apply a rotational movement and transmit torque for probe implantation.

[0044] By "locked in rotation", it is understood in the context of the present invention that the gripping element is fixed in such a way that when the user grasps and manipulates it, then this element is fixed in rotation around the longitudinal axis of the probe.

[0045] In one embodiment, the gripping element is configured to be momentarily locked against rotation around the longitudinal axis of the cardiac probe. This can be achieved, for example, with a gripping element that is soft to the touch (such as rubber or silicone) to which a "textured surface," as defined above, will be inherently applied when the user applies pressure to it, for example, between their fingers.

[0046] Preferably, the gripping element is fixed to the probe body.

[0047] In the context of this invention, the term "lead body" refers to a portion of typically uniform diameter along its length located between the proximal (housing) and distal (heart) ends of the lead. The lead body comprises at least one electrical stimulation and / or sensing conductor that connects its proximal end to a distally located external interaction surface, such as the distal end of the lead. The lead conductors are insulated from the outside by one or more insulating coatings, typically made of silicone and / or polyurethane ("PU"). The lead conductors are isolated from each other within separate channels in the lead body.

[0048] Preferably, the gripping element is fixed reversibly.

[0049] Thus, the user can, in particular, move the gripping element on the cardiac probe and fix it wherever they want in order to facilitate implantation.

[0050] Preferably, the gripping element is removable from the probe.

[0051] Thus, the user can remove the gripping element when they deem it necessary, for example during or at the end of cardiac probe implantation.

[0052] From a practical standpoint, the grasping element can be removed, for example, by simply sliding it longitudinally along the cardiac catheter, preferably towards its proximal end. In one embodiment, the grasping element includes an opening along its length that allows the catheter to be removed. Advantageously, such an opening can be made using a material with easy-to-break properties, or by using a tool specifically designed to cut the grasping element when it is made of a flexible polymer material (in the same way, for example, that insertion catheters are removed).

[0053] Advantageously, the grasping element is configured to also anchor itself to and plug an incision made in a vein during the implantation of said cardiac probe.

[0054] Thus, the gripping element according to the present invention has the advantage of limiting the number of parts required to manufacture a cardiac probe.

[0055] Advantageously, the grasping element includes at least a pre-formed fracture line to facilitate its removal from the cardiac probe.

[0056] In a particular embodiment, the gripping element has a toothed wheel, preferably internal.

[0057] One of the advantages of such an embodiment is, for example, the possibility of offering users a means of transmitting a rotational movement only in one direction of rotation (in the same way that a ratchet screwdriver allows its user to choose the direction of rotation applied to a screw).

[0058] Furthermore, preferably, the serrated wheel is made of polymer(s), preferably elastomer(s), and is positioned within the grasping element to provide a damping effect. For example, such a serrated wheel, comprising at least one polymer and / or elastomer, is configured to provide a damping effect between a proximal sub-element of the grasping element according to the present invention and a distal sub-element of the grasping element according to the present invention, and / or to facilitate its removal from the cardiac lead. The term "proximal sub-element" of the grasping element means a sub-element constituting the grasping element located on the proximal side of the grasping element, that is, the side intended to be closest to the proximal end of the cardiac lead once the grasping element is in place.By "distal sub-element" of the grasping element, it is understood that it is a sub-element constituting the grasping element placed on the distal side of the grasping element, that is to say the side intended to be closest (to the grasping element) to the distal end of the cardiac probe once the grasping element is placed.

[0059] In one embodiment, the proximal sub-element of the grasping element and / or the distal sub-element of the grasping element include at least one pre-formed fracture line to facilitate their removal from the cardiac probe.

[0060] The serrated wheel may also have a pre-formed fracture line to further facilitate its removal from the cardiac probe.

[0061] Preferably, the textured surface and / or the gripping element (and / or at least one of its sub-elements), as appropriate, is made of a polymer and / or metallic material.

[0062] The advantages of polymer materials are numerous. Indeed, the flexibility of such materials is easily controlled, allowing for gripping elements of varying degrees of flexibility. Furthermore, polymer materials are easily molded (for example, by molding, extrusion, etc.) to create the desired embossed patterns.

[0063] Some users prefer tools with a firm feel made of metallic material. In this case, the gripping element can be made of metallic material. Furthermore, such a gripping element has the advantage, if desired, of being easily sterilized (for example, at high temperatures) to allow for reuse.

[0064] Preferably, the textured surface includes at least one raised and / or recessed pattern.

[0065] The textured surface can indeed take different forms and is also potentially configurable according to the user's wishes. Thus, some people prefer a gripping element with a textured surface including at least one raised and / or recessed pattern, better suited to their morphology and / or practice(s).

[0066] Advantageously, the gripping element comprises several sub-elements.

[0067] Thus, the object of the present invention further relates to a gripping element (as defined above) for an implantable cardiac probe, said gripping element comprising in particular a textured surface and a reception space for said implantable cardiac probe.

[0068] Advantageously, the reception area is configured to accommodate at least one portion of a cardiac probe.

[0069] Preferably, the space for the implantable cardiac lead passes completely through the grasping element.

[0070] Thus, such a gripping element completely surrounds the cardiac probe on one of its portions, which facilitates the handling of the entire "gripping element - cardiac probe" assembly for the user.

[0071] In one embodiment, the grasping element comprises at least one locking element, such as at least one opening or projection, configured to engage with at least one other complementary locking element attached to the implantable cardiac lead. Thus, the grasping element comprises a "lock-key" system consisting of at least one locking element engaged with at least one other complementary locking element, enabling it to be permanently or possibly temporarily secured.

[0072] Thus, the object of the present invention further relates to the use of a gripping element as defined above, to transmit a rotation to an implantable cardiac probe around its longitudinal axis.

[0073] FIGURES

[0074] [Fig.1] Figure 1 represents a perspective view of a proximal portion of a cardiac probe on which a gripping element according to the present invention has been placed.

[0075] [Fig. 2] Figure 2 represents a perspective view of a gripping element according to the present invention on a cardiac probe, placed distal to a proximal connector of such a cardiac probe.

[0076] [Fig. 3] Figure 3 represents a side view of a gripping element according to the present invention, the textured surface of which has several different patterns.

[0077] [Fig. 4] Figure 4 represents an exploded perspective view of a gripping element according to the present invention comprising a toothed wheel.

[0078] A detailed description of the figures is given below:

[0079] Figure 1 shows a proximal portion of a cardiac lead 1 with a grasping element 2 attached to a lead body 3 of the cardiac lead 1. This grasping element 2 comprises three distinct portions A, B, and C, each independently exhibiting a textured surface (each portion is hatched in Figure 1). The grasping element 2 can be configured to dock with a vein in the implanted patient. In this case, the grasping element 2 may have an oblong shape and be locally and minimally textured, or it may have a suitable surface texture on its distal portion (for example, the most distal portion C and possibly portion B adjacent to the most distal portion of the grasping element 2 in Figure 1).The cardiac lead 1 shown in Figure 1 further includes at its proximal end a connector 4 allowing it to be connected to an electronic device (not shown in Figure 1), for example, a pacemaker or defibrillator. Optionally, the connector 4 may also have a textured portion D (hatched in Figure 1) to facilitate gripping the cardiac lead 1. Also shown in Figure 1 is a stylet 5 inserted into the cardiac lead 1 and passing longitudinally through the connector 4 and the lead body 3.

[0080] Figure 2 shows a magnified view between the gripping element 2 (textured surface not shown in Figure 2) and the connector 4. The gripping element (which can be optimized to dock with a vein in an implanted patient) includes a locking element 6 designed to fit into a receiving space 7 in said connector 4. This configuration allows the gripping element 2 to be more easily moved along the probe body 3 and secured by means of the "locking element 6" and "receiving space 7" combination.

[0081] Figure 3 shows a gripping element comprising four different textured surfaces E, F, G, and H. The two types of patterns on textured surfaces E and F on the left half of Figure 3 consist of two different types of knurling, allowing for optimized gripping for a variety of movement types to be applied to the gripping element. The two types of patterns on textured surfaces G and H on the right half of Figure 3 consist of two types of grooves with differently oriented grooves, allowing for optimized gripping for precision movements on the axis(es) perpendicular to the grooves.

[0082] Figure 4 depicts a grasping element 2 comprising a proximal element 8 (intended to be the element closest to the proximal end of the cardiac lead) having an opening 11 configured to accommodate at least a portion of the cardiac lead, such as the lead body (not shown here). Furthermore, as shown in Figure 4, the proximal element 8 has a proximal element body 13 and at least one locking element 12 (specifically, four locking elements as shown in Figure 4). The proximal element body 13 may have a textured surface, such as grooves 14, and an optional break line 15 to facilitate its removal from the cardiac lead, if necessary.

[0083] The grasping element 2 further comprises a distal element 9 (intended to be the element closest to the distal end of the cardiac lead) having an opening 18 configured to accommodate at least a portion of the cardiac lead, such as the lead body (not shown here). Furthermore, and as shown in Figure 4, the distal element 9 has a distal element body 16 and at least one locking element 17 (specifically, four locking elements as shown in Figure 4, three of which are visible). The distal element body 16 may have a textured surface (similar to that of the proximal element 8 – not shown here) and an optional break line 19 to facilitate its removal from the cardiac lead, if necessary.

[0084] In one embodiment, the proximal element 8 and the distal element 9 are made of at least one metallic material and configured so that the locking elements 12,17 of each are complementary to each other to allow at least one movement to be transferred from one element to the other.

[0085] In one embodiment, at least one of the proximal element 8 and the distal element 9 includes a ratchet mechanism to facilitate rotation (similar to a ratchet screwdriver). The ratchet mechanism may also have pre-formed fracture lines to facilitate its removal.

[0086] Optionally, a serrated wheel 10 is inserted between the proximal element 8 and the distal element 9. The serrated wheel 10 includes an opening 20 configured to accommodate at least a portion of the cardiac lead, such as the lead body (not shown here). Furthermore, as shown in Figure 4, the serrated wheel 10 has a wheel body 21 and at least one additional locking element 22 (specifically, eight additional locking elements 22 as shown in Figure 4). The additional locking elements 22 are configured, in particular, to be positioned between the locking elements 12, 17 of the proximal element 8 and the distal element 9. In one embodiment, the serrated wheel 10 is made of a polymer material, such as an elastomer, to provide a cushioning effect between the proximal element 8 and the distal element 9, and their respective locking elements 12, 17, and / or to facilitate its removal from the cardiac lead.The serrated wheel may also have a pre-formed fracture line (not shown here) to facilitate its removal from the cardiac probe.

[0087] It should be noted that these figures are merely illustrations of the present invention, which is not limited solely to the embodiments described.

Claims

Demands

1. Implantable cardiac lead comprising a distal portion intended to be placed in a human heart and a proximal portion with a proximal end intended to be connected to an implantable electronic device, characterized in that the proximal portion comprises a textured surface configured to facilitate the gripping and manipulation of said cardiac lead, particularly during its implantation.

2. Implantable cardiac probe according to claim 1, characterized in that the textured surface is included on a so-called gripping element integral with or fixed to said cardiac probe, in particular fixed by friction.

3. Implantable cardiac probe according to claim 2, characterized in that the grasping element is locked in rotation around the longitudinal axis of said cardiac probe.

4. Implantable cardiac probe according to any one of claims 2 or 3, characterized in that the grasping element is fixed reversibly.

5. Implantable cardiac probe according to any one of claims 2 to 4, characterized in that the grasping element is removable from the probe.

6. Cardiac probe according to any one of claims 2 to 5 characterized in that the grasping element is configured to also anchor and plug an incision made in a vein during implantation of said cardiac probe.

7. Implantable cardiac probe according to any one of claims 2 to 6, characterized in that the grasping element has a toothed wheel, preferably internal.

8. Implantable cardiac probe according to any one of the preceding claims, characterized in that the textured surface and / or the gripping element, if applicable, is made of a polymer and / or metallic material.

9. Implantable cardiac probe according to any one of the preceding claims, characterized in that the textured surface comprises at least one raised and / or recessed pattern.

10. A gripping element for an implantable cardiac lead, said gripping element comprising a textured surface and a receptacle for said implantable cardiac lead.

11. A gripping element according to claim 10, characterized in that the receptacle for said implantable cardiac lead passes through said gripping element.

12. A gripping element according to claim 10 or 11, characterized in that said gripping element comprises at least one locking element, such as at least one opening or projection, configured to engage with at least one other complementary locking element fixed to said implantable cardiac lead.

13. Use of a gripping element according to any one of claims 10 to 12 to transmit rotation to an implantable cardiac probe around its longitudinal axis.

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