Locking device for operating a lead device

Abstract

The present invention relates to a locking device and method for a two-step locking operation, wherein a distal fixation helix of a lead device is first extended by inserting a rotatable connector pin of a proximal connector of the lead device into a first cavity of a first portion of the locking device and applying a moderate (over-)torque to the connector pin by means of the locking device. Then, a very simple locking gesture (e.g., a sliding or pressing gesture) is applied to lock a rotationally coupled second portion of the locking device to the connector body in a second cavity of the second portion of the lock- ing device without any release of the moderated torque initially applied to the connector pin. This allows a physician or other user to apply and maintain a moderate (over-)torque at the connector pin after helix extension while turning / rotating the lead body via the connector end during a puncturing operation.

Description

[0001] LOCKING DEVICE FOR OPERATING A LEAD DEVICE

[0002] Field

[0003] The present application relates to a locking device and locking method for operating a lead device - such as but not limited to - a medical implantable cardiac lead with a rotatable connector pin.

[0004] Implantable medical devices, such as cardiac rhythm management (CRM) devices and neuromodulation devices, are used in a variety of therapeutic applications. In some applications, one or more medical implantable cardiac leads ("leads" in the following) are employed to deliver therapy from a pacing device (e.g., an implanted medical device) to tissues within a body. CRM systems may employ electrical leads implanted within a patient's heart. Such leads may be secured to a desired location in the heart by a mechanical fixation device. Such mechanical fixation devices may include a corkscrew-shaped device known as a helix (which also may be an electrode of the lead). The helix may be designed such that it is retracted into the lead during insertion and positioning within the heart. Once positioned, the helix is rotated to extend the helix and screw it into the heart muscle.

[0005] Helix rotation at the distal end of the lead may be driven by torque applied to a connector pin (e.g., an IS1 pin) located at the proximal end of the lead and transmitted through a conductor coil extending through the lead from the terminal pin to the helix. Connector pins are often quite small and have smooth, cylindrical surfaces.

[0006] The connector pin may be mechanically and electrically connected to a distal retractable screw (e.g., helical electrode) of a lead. By operating the connector pin, the distal retractable screw can be retracted or extended from a distal end of the lead. It allows, in particular, anchoring the distal retractable screw into cardiac tissue so as to secure the distal end of the lead. Hence, a rotation of the connector pin can allow screwing the distal retractable screw into cardiac tissue or other tissue.

[0007] However, the process of puncturing the tissue may create some counter torque to the helix penetrating the tissue, e.g., due to hazardous frictions. Thus, in a retractable mechanism, the helix may be caused to retract again into the housing of the distal lead tip, significantly limiting the puncture capacity of the system due to reduced helix motricity (i.e., drawing force by screwing movement). This forces the physician to stop the critical puncturing process, connect the fixation tool again to the connector pin (e.g., IS1 pin), perform several turns to fully extend the helix again, disconnect the fixation tool, and restart the critical puncture process. Often, this may happen twice or more times, defocusing the attention of the physician.

[0008] It is an object of the present invention to improve the above helix motricity problem.

[0009] This object is achieved by a locking device as claimed in claim 1 and by a method as claimed in claim 13.

[0010] According to a first aspect, a locking device is provided for operating a lead device with a rotatable connector pin which axially protrudes from a proximal end of a connector of the lead device, said locking device comprising:

[0011] - a first portion having a first cavity configured to accommodate and rotationally fix the connector pin to the first portion of the locking device; and

[0012] - a second portion having a second cavity configured to accommodate the proximal end of the connector of the lead device;

[0013] - wherein the locking device comprises a releasable locking mechanism for rotationally locking the proximal end of the connector of the lead device to the second portion of the locking device in the second cavity; and

[0014] - wherein the first portion and the second portion of the locking device are rotationally coupled to each other.

[0015] According to a second aspect, a method of operating a lead device with a rotatable connector pin which axially protrudes from a proximal end of a connector of the lead device is provided, the method comprising:

[0016] - inserting the connector pin into a first cavity of a first portion of a locking device to rotationally fix the connector pin to the first portion of the locking device;

[0017] - rotating the connector pin by means of the locking device;

[0018] - using a releasable locking mechanism of the locking device to rotationally lock the proximal end of the connector of the lead device in a second cavity of a second portion of the locking device to the second portion of the locking device; and - rotating the proximal end of the connector of the lead device by means of the locking device, wherein the first portion and the second portion of the locking device are rotationally coupled to each other.

[0019] Accordingly, the proposed locking device and method allow the physician or other user to apply and maintain a moderate (over-)torque at the connector pin after helix extension while he / she is puncturing by turning / rotating the lead body (via the connector end) and / or the connector pin without any complex handling gesture, even in cases of tiny dimensions. To achieve this, a two-step locking operation is proposed, where the helix is first extended by applying a moderate (over-)torque to the connector pin via the first portion of the locking device and then use a very simple locking gesture (e.g., a sliding or pressing gesture) to lock the second portion of the locking device and thus also the connector pin to the connector body without any release of this moderated torque initially applied to the connector pin.

[0020] An over-torque is to be understood as a total torque required to be applied by a physician or other user after full extension of the helix (out of the housing) to add some extra turns (e.g., 2 to 8) at the locking device to maintain a remaining torque onto the inner coil of the lead device in order to prevent undesirable helix retraction during puncture. This is to compensate torque elasticity of the inner coil.

[0021] Thereby, the physician can focus his / her attention to other critical parameters like ECG signal, Xray monitoring, impedance surveillance (to avoid perforation of the left side of the septum), timing measurements on electrocardiogram (ECG), and so on. And may even release his / her hand from the connector.

[0022] The proposed solutions can be achieved with a low-cost device that provides intuitive handling while IS1 connector components (especially the seals) and / or assembly of the lead device do not have to be modified.

[0023] According to a first option that can be combined with the above first or second aspects, the second cavity may be configured to rotationally fix the second portion to the proximal end of the connector of the lead device when inserted into the second cavity, wherein the locking mechanism is configured to allow the second portion to move with respect to the first portion in a distal direction to insert the proximal end of the connector of the lead device into the second cavity. Thereby, the releasable locking of the connector end can be achieved in a simple and intuitive manner by sliding the second portion over the connector end to rotationally fix the connector end to the locking device.

[0024] According to a second option that can be combined with the first option or the above first or second aspect, the rotational coupling between the first and second portions may be achieved by a protruding pin of the first portion that is configured to slide in a matched slit of the second portion. Thus, a predefined sliding range can be provided by the length of the slit in the second portion.

[0025] According to a third option that can be combined with the above first or second aspect, the locking mechanism may comprises a slidable elastic ring that surrounds the outer surface of the second portion and that can be moved over an opening between the surface of the second portion and the second cavity so that it presses through the opening onto an outer surface of the proximal end of the connector of the lead device to thereby rotationally couple the proximal end of the connector of the lead device to the locking device when inserted into the second cavity.

[0026] According to a fourth option that can be combined with the third option or the above first or second aspect, the second portion may comprise first and second ringshaped protrusions at a distal end and a proximal end of the second portion to limit a sliding range of the slidable ring. This allows to predefine a sliding range of the slidable elastic ring and prevent that the slidable elastic ring gets lost.

[0027] According to a fifth option that can be combined with above first or second aspect, the locking mechanism may be implemented by one or more deformable portion(s) in the housing of the second portion, which are configured to exert pressure on the outer surface of the proximal end of the connector when inserted into the second cavity. Thereby, the releasable locking of the connector end to the locking device can be achieved in a simple an intuitive manner by pressing the deformable portion(s) with a finger to rotationally couple the inserted connector end to the locking device.

[0028] According to a sixth option that can be combined with any one of the third to fifth options or the above first or second aspect, the first and second portions may be integrated in a single-piece locking device or releasably connectable to each other. Thus, the proposed locking device can be manufactured in a simple manner (e.g., by moulding) and a robust structure can be obtained. According to a seventh option that can be combined with any one of the first to sixth options or the above first or second aspect, the rotatable connector pin may be coupled to a retraction mechanism of a fixation helix at the distal end of the cardiac lead. Thereby, the locking device can be used to first extend the helix via the rotationally coupled connector pin and then maintain the torque applied to the connector pin while using the locking mechanism to establish an additional rotational coupling between the locking device and the connector end to convey a screwing torque to the helix.

[0029] According to an eighth option that can be combined with any one of the first to seventh options or the above first or aspect, the first and second cavities may be arranged to be aligned in axial direction of the connector to allow insertion of both the connector pin and the proximal end of the connector into a respective one of the first and second cavities. Thereby, a simple structure of the locking device for easy handling can be achieved.

[0030] According to a ninth option that can be combined with any one of the first to eighth options or the above first or second aspect, the first cavity may be configured to establish a rotational coupling to the connector pin by local deformation of the inner wall of the first cavity when the connector pin is inserted into the first cavity. Thus, the rotational coupling between the connector pin and the locking device can be achieved by simple press-fitting.

[0031] According to a tenth option that can be combined with any one of the first to ninth options or the above first or second aspect, the first portion of the locking device may comprise a concave funnel portion configured to allow insertion of a stylet to be further guided through the inserted connector pin and the connector to the distal end of the cardiac lead to assist in positioning a fixation helix. Thus, the locking device can be extended in a simple manner for use in connection with a stylet-based lead device.

[0032] Brief of the

[0033] To assist understanding of the present disclosure and to show how embodiments may be put into effect, reference is made by way of example to the accompanying drawings in which: Fig. 1 schematically shows a locking device according to various embodiments for operating a medical implantable cardiac lead with a proximal connector having a rotatable connector pin;

[0034] Fig. 2 schematically shows a perspective view of a more detailed example of a locking device with slidable second portion according to a first embodiment that can be used together with a stylet, in a non-locked state;

[0035] Fig. 3 schematically shows a perspective view of the locking device of the first embodiment when locked to a connector pin of the cardiac lead;

[0036] Fig. 4 schematically shows a side view with partial cross section of the locking device of the first embodiment in a non-locked state;

[0037] Fig. 5 schematically shows a side view with partial cross section of the locking device of the first embodiment when locked to the connector pin of the cardiac lead;

[0038] Fig. 6 schematically shows a perspective view with partial cut-out of first and second portions of the locking device of the first embodiment when locked to the connector pin of the cardiac lead;

[0039] Fig. 7 schematically shows a perspective view with partial cut-out of the second portion of the locking device of the first embodiment when locked to the connector pin of the cardiac lead;

[0040] Fig. 8 schematically shows a perspective view of the locking device of the first embodiment when locked to the connector pin of the cardiac lead;

[0041] Fig. 9 schematically shows a perspective view of the locking device of the first embodiment when locked to the connector pin of the cardiac lead during a sliding operation of the second portion;

[0042] Fig. 10 schematically shows a perspective view of the locking device of the first embodiment when locked to the connector pin and to a connector end of the cardiac lead after the sliding operation of the second portion;

[0043] Fig. 11 schematically shows a perspective view with partial cut-out of the second portion of the locking device of the first embodiment when locked to the connector pin and to the connector end of the cardiac lead;

[0044] Fig. 12 schematically shows a perspective view of another more detailed example of the locking device with slidable ring according to a second embodiment when locked to the connector pin of the cardiac lead; Fig. 13 schematically shows a perspective view of the locking device of the second embodiment when locked to the connector pin and to a connector end of the cardiac lead;

[0045] Fig. 14 schematically shows a side view of the locking device of the second embodiment with a locking movement of the slidable ring; and

[0046] Fig. 15 schematically shows a partially cross-sectional view of the locking device of the second embodiment when locked to the connector pin and to the connector end of the cardiac lead.

[0047] Detailed Description

[0048] In the following, embodiments of the present invention are described in more detail based on a locking device (e.g., multi locking tool) which enables a physician or other user to screw a distal electrode (e.g., helix) of a cardiac lead into the tissue of a patient's heart by selectively operating a connector pin and a connector end at the proximal end of a cardiac lead while maintaining an applied torque. More specifically, the physician is enabled to selectively lock / remove the locking device to / from a connector pin (e.g., an IS1 and / or a DF4 pin) and a connector end of the lead and to transmit torque to the connector pin and / or the connector end in an easy and intuitive manner.

[0049] Furthermore, throughout the present disclosure, "proximal" and "distal" are terms that are used to indicate distances from an operating end (reference point) of the lead device, where the physician or other user controls the screwing process. Proximal is closer to the operating end, while distal is further away (at a greater distance) from the operating end.

[0050] Fig. 1 schematically shows a locking device 20 according to various embodiments for operating a medical implantable cardiac lead 100 with a proximal connector 10 having a rotatable connector pin 12 that axially protrudes from the proximal connector end of the connector 10 and that is rotatably supported within the cardiac lead 100 and / or the connector 10.

[0051] The rotatable connector pin 12 may be coupled to a retraction mechanism of a fixation helix (not shown) at the distal end of the cardiac lead 100 and may thus rotate within the housing of the cardiac lead 100 during operation of the helix. The housing of the locking device 20 comprises a first portion 21 and a second portion 22 which are at least rotationally coupled, so that a torque applied to the first portion 21 is coupled to the second portions 22 and vice versa.

[0052] Furthermore, the first portion 21 comprises a first cavity 210 which is adapted to the outer shape of the connector pin 12 so as to accommodate at least an end portion of the connector pin 12 by insertion.

[0053] Additionally, the second portion 22 comprises a second cavity 220 which is adapted to the outer shape of the connector 10 so as to accommodate at least an end portion of the connector 10 by insertion.

[0054] The first and second cavities 210, 220 may be arranged or operable to be concentric or at least aligned to allow insertion of both the connector pin 12 and the (proximal end of the) connector 10 into the respective one of the first and second cavities 210, 220.

[0055] Additionally, a first locking mechanism 211 is provided for rotationally locking the connector pin 12 within the first cavity 210. The first locking mechanism 211 may be a fixed locking mechanism that may be achieved through friction (e.g., press fitting) or communicating locking elements at the connector pin 12 and the first cavity 210. Thus, when the connector pin 12 is inserted into the first cavity 210, it will be rotationally coupled to the first portion 21 to allows transfer of torque from the locking device 20 to the connector pin 12, e.g., via a manual turning / rotation force applied to the locking device 20. Alternatively, the first locking mechanism 211 may be a releasable locking mechanism (e.g., insertable or slidable locking element or mechanism, etc.) by which a user can active or release the locking function to control the transfer of torque from the locking device 20 to the connector pin 12.

[0056] Moreover, a second locking mechanism 221 is provided for rotationally locking the (proximal end of the) connector 10 within the second cavity 220. The second locking mechanism 221 is provided to allow rotational coupling of the (proximal end of the) connector 10 to the second portion 22 and transfer of torque from the locking device 20 to the housing of the lead 100 through the connector 10, e.g., via a manual turning / rotation force applied to the locking device 20. The second locking mechanism 221 is a releasable locking mechanism (e.g., insertable or slidable locking element or mechanism, etc.) by which a user can activate or release the locking function to control the transfer of torque from the locking device 20 to the connector 10.

[0057] With the proposed two-part locking device 20, the cardiac lead 100 with the rotatable connector pin 12 can be operated by inserting the connector pin 12 into the first cavity 210 of the first portion 21 of the locking device 20 to rotationally fix the connector pin 12 to the first portion 21 of the locking device 20. This is achieved automatically (i.e., by insertion) or manually (i.e., by operating the releasable mechanism) by the first locking mechanism 211. In this state, the connector pin 12 can be rotated by means of the locking device 20 that is now rotationally locked to the connector pin 12 only.

[0058] Later (e.g., when the helix has been sufficiently extended), the releasable second locking mechanism 221 of the locking device 20 can be used to also rotationally lock the (proximal end of the) connector 10 (and thus also the housing of the cardiac lead 100) in the second cavity 220 of the second portion 21 of the locking device 20 to the second portion 21 of the locking device 20 while maintaining the torque applied to the connector pin 12 via the first locking mechanism 211. In this state where both the connector pin 12 and the connector 10 are rotationally coupled to the locking device 20, the connector 10 (i.e., the housing of the cardiac lead 100) can be rotated as well by means of the locking device 20, e.g., to start a puncturing operation by the helix into the tissue. Moreover, the physician may now also apply the puncture torque more distally on the lead body avoiding loss of torque transmission.

[0059] In the following, two more specific examples of the second locking mechanism 221 are described in connection with respective first and second embodiments.

[0060] Fig. 2 schematically shows a perspective view of a more detailed example of a locking device 20 with slidable second portion 22 according to the first embodiment that can be used together with a stylet 40, in a non-locked state.

[0061] A connector 10 (e.g., an IS1 connector) of a cardiac lead (not shown) comprises a rotatable cylindric connector pin 12, a first flexible sealing portion 14 and a second flexible sealing portion 16. The first and second sealing portions 14, 16 are configured to seal and allow press-fitting and rotational coupling of the connector 10 when inserted into a matched cylindrical second cavity (hidden by the housing of the second portion 22) of a substantially cylindrical second portion 22. Furthermore, a substantially cylindrical first portion 21 of the locking device 20 is arranged concentrically within the second portion 22, wherein the second portion 22 is configured to be slidable over the first portion 21 in proximal and distal axial direction. The first portion 21 comprises a cylindrical cavity 210 into which the connector pin 12 can be inserted to be press-fitted and thereby rotationally coupled. Rotational coupling between the first and second portions 21, 22 is achieved by a protruding axially elongated pin 212 of the first portion 21 that is configured to slide in a matched slit 214 of the second portion 22. Thereby, the first and second portions are allowed to slide with respect to each other in axial direction in an axial range defined by the axial length of the slit 214 and the axial length of the elongated pin 212.

[0062] The stylet 40 comprises a proximal handling portion 42 for manually operating the stylet by a physician or other user. The first portion 21 of the locking device 20 comprises a concave funnel portion (not shown in Fig. 2) into which the stylet 40 can be inserted to be further guided through the connector pin 12 and the connector 10 to the distal end of the cardiac lead to assist in positioning the distal end and the helix within the heart, e.g., by operating a pin driver of the cardiac lead.

[0063] The locking device 20 with the rotationally locked connector pin 12 or connector 10 can be rotated by a hand or tool of a physician or other user with an appropriate number of turns to extend or respectively screw the distal helix of the lead into heart tissue. Finally, the locking device 20 may be removed from the connector 10 and connector pin 12.

[0064] An electrical conductor may be disposed within a lumen within the body of the lead and extend from the connector pin 12 to the helix to provide both a physical connection and, in some embodiments, an electrical connection between the connector pin 12 and an electrode at the helix. The conductor may be at least partly in the form of a coil within the lead.

[0065] The connector pin 12 may rotate freely relative to the connector 10 and the body of the lead to transmit torque to the helix via the conductor.

[0066] In some embodiments, the body of the lead may be a tubular structure including one or more lumens (not shown). The distal end may include at least one electrode (not shown) and a helix electrode. The electrodes may be employed to electrically couple the lead with a patient's heart (not shown). The helix may also be used to electrically couple the lead with the heart.

[0067] As already mentioned above, torque can be selectively applied to the connector pin 12 and the connector 10 by using the locking device 20 to rotate the helix and anchor the distal end of the lead in the heart. For each type of the lead, a specific number of rotations of the connector pin 12, and a corresponding number of rotations of the helix, are necessary to successfully anchor the distal end in the heart tissue. Thus, the locking device 20 can be employed to lock the connector pin 12 or the connector 10 and rotate it, while the number of rotations is counted to determine when the helix is successfully expanded or inserted.

[0068] Pacemaker or defibrillator leads connect the myocardial site of sensing or stimulation with the respective cardiac implantable electronic devices (CIEDs) or other medical devices. When replacing a CIED, the leads may remain in place and may be mounted individually to a new medical device. Occasionally, additional leads may be placed to address sensing or capture issues with existing leads. Since the late 1980s and early 1990s, unified industry standards IS1 and DF1 ensure interchangeability of generators and leads from different manufacturers, thus allowing the device system to be tailored to the individual patient's needs. Such leads may thus possess a bifurcation (single-coil lead; one IS1, one DF1) or a trifurcation (dual-coil leads; one IS1, two DF1) at their proximal end.

[0069] A new standard was formalized in March 2010, when the International Organization for Standardization (ISO) published its new standard ISO 27186.1 for active implantable medical device with four-pole connector system for implantable cardiac rhythm management devices. Its specifications apply to both low-energy (IS4) and high-energy (DF4) leads and ensures that IS4 / DF4 leads are compatible with future implanted devices.

[0070] Therefore, different connector pins (e.g., IS1 and DF4 pins) have different designs to which the first cavity 210 of the locking device 20 can be adapted to obtain various embodiments of an improved fixation tool 40 with modified design.

[0071] The locking device 20 may be made of a thermoplastic of relative high durometer, such as a polycarbonate or acrylonitrile butadiene styrene (ABS) having a Shore hardness of greater than 90D, and / or it may be made of a thermoplastic, thermoset, or cast material with a Shore hardness less than 90D. More flexible parts of the locking device 20, such as the walls of the first and second cavities 210, 220 may be made of, for example, silicone rubber with a Shore hardness less than 90D.

[0072] In an example of the locking device 20 of the embodiments described herein, the first cavity 210 may be adapted for use in connection with IS1 and DF4 connector pins or other terminal pins with similar diameters, wherein the diameter of the larger terminal pin (e.g., IS1 pin) ranges between 1.50mm and 1.65mm, in particular between 1.56mm and 1.62mm, while the diameter of the smaller terminal pin (e.g., DF4 pin) ranges between 1.30mm and 1.50mm, in particular between 1.34 and 1.40mm.

[0073] Fig. 3 schematically shows a perspective view of the locking device 20 of the first embodiment when locked to the connector pin 12 of the cardiac lead.

[0074] As can be gathered from Fig. 3, the connector pin 12 is inserted into the first cavity 210 of the first portion. Therefore, both cannot be seen in Fig. 3. Thus, the locking device 20 is locked onto the connector pin 12 and can be used to rotate the connector pin 12 but not the connector 10.

[0075] Fig. 4 schematically shows a side view with partial cross section of the locking device of the first embodiment in a non-locked state. Here, the connector pin 12 is not yet inserted into the first cavity 210. The stylet 40 extends through the locking device 20 in axial direction.

[0076] When the connector pin 12 is inserted into the first cavity 210, a temporary rotational link or coupling to the connector pin 12 is established by local deformation of the inner wall of the first cavity 210. The locking effect may optionally be improved by providing a conical shape of the first cavity 210 or longitudinal grooves on the inner surface of the first cavity 210 to absorb tolerances and / or improve press-fitting.

[0077] The cylindrical second cavity 220 of the second portion 22 corresponds to the shape of the first portion 21 without the sliding pins 212 located in the longitudinal slit (not shown) of the second portion 22. Thus, the first portion 21 is concentrically inserted into the second portion 22.

[0078] Fig. 5 schematically shows a side view with partial cross section of the locking device 20 of the first embodiment when locked to the connector pin 21 of the cardiac lead.

[0079] In Fig. 5, the connector pin 12 is fully inserted into the first cavity 210 and thereby rotationally locked to the locking device 20. The red arrow tips indicate the direction of pressure exerted on the connector pin 12. The connector pin 12 can now be rotated by means of the locking device 20.

[0080] Fig. 6 schematically shows a perspective view with partial cut-out of the first and second portions 21, 22 of the locking device 20 of the first embodiment when locked to the connector pin 12 of the cardiac lead. Due to the cut-out portion in Fig. 6, the elongated slit 214 that defines the range of axial movement of the sliding pin 212 of the first portion 21 within the second portion 22 can be seen. Thereby, a rotational coupling (lock) between the first and second portions 21, 22 is established.

[0081] It is noted that other options of establishing the rotational coupling can be provided, such as non-circular (e.g., hexagonal) male / female sections or grooves / tongues or the like.

[0082] Furthermore, the funnel 214 for supporting inserting of the stylet 40 can be seen at the proximal end of the first portion 21.

[0083] The funnel 214 facilitates the insertion of the stylet into the respective aperture of the first portion 21. Thereby, a physician or other user can be supported to guide the distal end (e.g., mandrel) of the stylet into the aperture of the first portion 21 and the connector pin 12. The funnel 214 prevents visual confusion so that the physician or other user will not hesitate to insert the distal end of the stylet 40 into the aperture of the locking device 20 by a forced axial movement, since the risk of breaking the connector pin 12 and / or an inner pin connection is reduced.

[0084] The funnel 214 may alternatively be provided as single-part element moulded or removably fixed (e.g., clipped) to the first portion 21 of the locking device 20. The funnel 214 may be fixed to the first portion 21 either during manufacturing / assembly of the locking device or during use by the physician or other user for increased flexibility of use (e.g., optional use, pin-dependent use etc.).

[0085] In an example, a "dual-use" funnel 214 may be provided, that is capable of being used in a first mode (inserted directly on the connector pin 12) or in a second mode ("plugged" on the locking device 20).

[0086] Fig. 7 schematically shows a perspective view with partially cut out second portion 22 of the locking device 20 of the first embodiment when locked to the connector pin 12 of the cardiac lead. This view illustrates how the first and second portions 21, 22 are linked / coupled in rotation but allow axial sliding of the upper second portion 22 to be moved over the proximal end of the connector 10 to thereby insert the connector 10 into the second cavity 220 of the second portion 22.

[0087] Fig. 8 schematically shows a perspective view of the locking device 20 of the first embodiment when locked to the connector pin 12 of the cardiac lead.

[0088] The physician or other user can manually rotate the locking device 20 to thereby extend the helix at the distal end of the cardiac lead with moderate (over-)torque. Additionally, the physician or other user may hold the body of the connector 10 during the two operational steps of initially extending the helix via the connector pin 12 and then screwing the helix via the connector 10.

[0089] As can be gathered from Fig. 8, the surface of the outer second portion 22 may be structured with a hexagonal pattern at the distal portion to allow engaging a dedicated butterfly tool or crocodile clamp or other handling tool with a mouth opening adapted to the hexagonal pattern to adapt usage of the locking device 20 to conventional practice.

[0090] Additionally, the proximal portion of the second portion 22 may be structured with another polygonal or rough structure to improve friction or grip for manual operation.

[0091] The structures or patterns of the distal and proximal portions of the second portion 22 may be exchanged or only one of the structures or patterns may be provided over the whole surface or only a portion thereof.

[0092] Fig. 9 schematically shows a perspective view of the locking device 20 of the first embodiment when locked to the connector pin 21 of the cardiac lead during a sliding operation of the second portion 22.

[0093] As can be gathered from Fig. 9, the second portion 22 of the locking device 20 is moved over the connector 10 to thereby insert the proximal end of the connector 10 into the second cavity 220 while retracting the proximal end of the first portion 21 out of the second cavity 220. With this distal movement of the second portion 22 (second locking mechanism of Fig. 1), the proximal end of the connector 10 is press-fitted and thereby rotationally coupled or locked to the locking device 20 while still maintaining the rotational lock and torque of the first portion 21 to the connector pin 12. As the moderate (over-)torque at the connector pin 21 is maintained, the connector pin 12 is not released and the helix cannot retract between the first and second operational steps. Fig. 10 schematically shows a perspective view of the locking device 20 of the first embodiment when locked to the connector pin 12 and to the proximal end of the connector 10 of the cardiac lead after the sliding operation of the second portion 22. In this state, the physician or other user can use the locking device 20 to rotate both the cardiac lead (via the connector 10) and the connector pin 12 by manually turning the locking device 20.

[0094] Fig. 11 schematically shows a perspective view with partial cut-out of the second portion 22 of the locking device 20 of the first embodiment when locked to the connector pin 12 and to the proximal end of the connector 10 of the cardiac lead.

[0095] Here, both the proximal end of the connector 10 and the distal end of the first portion 21 are inserted in the second cavity 220 of the second portion 22 and a rotational link or lock is established with the body of the connector 10 by compressive friction (press-fitting) at the proximal sealing portion 14.

[0096] It is noted that both sealing portions 14 and 16 may be captured by the second cavity 220 by providing a longer second portion 22 with a longer second cavity 220 to reinforce the rotational link or lock.

[0097] In the following, a second embodiment of the locking device 20 with fixedly coupled first and second portions 21, 22 is described. The first and second portions 21, 22 may be moulded and integrated in a single-piece locking device 20 or may be releasably connectable to each other. They may be manufactured in the same way and made of the same material or material combinations, as mentioned above in connection with the first embodiment.

[0098] Fig. 12 schematically shows a perspective view of another more detailed example of the locking device 20 according to the second embodiment with slidable ring when locked to the connector pin (not shown) of the cardiac lead.

[0099] In the second embodiment, the second locking mechanism 221 of Fig. 1 is implemented by a slidable elastic ring 222 (e.g., made of silicon or rubber or another elastic material) that can be moved over at least one locking window 224 (i.e., an opening or through hole in the wall of the second cavity) to thereby exert pressure and friction on the proximal end of the connector 10 when inserted into the second cavity 220. Another window 215 (i.e., an opening or through hole) is provided in the first portion 21 to allow a physician or other user to check an insertion state of the connector 10 with its proximal connector pin 12 in the locking device 20.

[0100] In the state shown in Fig. 12, the connector pin 12 (hidden within the first portion 21) is fully inserted and locked (e.g., through friction or press-fitting) in the first cavity 210 (not shown) of the first portion 21, while the proximal end of the connector 10 is inserted but not yet locked in the second cavity 220. The physician or other user may hold the body of the connector 10 or lead in one hand and may use the other hand to rotate the locking device 20 together with the rotationally coupled or locked connector pin 12 to thereby extend the helix with moderate (over-)torque. In this state, the connector 10 and the lead are not rotationally coupled or locked to the locking device 20 and therefor do not receive any torque.

[0101] Respective ring-shaped protrusions 225 and 226 may be provided (integrated or fixedly attached) at the distal and proximal ends of the second portion 22 to limit the axial moving or sliding range of the slidable ring 222.

[0102] Fig. 13 schematically shows a perspective view of the locking device 20 of the second embodiment when locked to the connector pin 12 and via the slidable ring 224 to the proximal end of the connector 10 in the second cavity 220.

[0103] As the slidable ring 224 has been moved over the locking window 224 (e.g., by a pushing action of the physician or other user), the pressure and friction exerted on the outer surface of the connector 10 causes a rotational coupling or lock between the connector 10 and the locking device 20. More specifically, the slidable ring 224, which has been placed over the second portion 22 in a stretched state, shrinks on the locking window 224 due to its elastic property and thereby exerts sufficient friction (e.g., silicone / sil- icone surface pair) to block further rotation and thereby rotationally couple or lock the connector 10 to the locking device 20.

[0104] After rotating the connector 10 by means of the locking device 20, the physician or other user simply needs to push the sliding ring 222 out of the locking window 224 to release the rotational lock and remove the locking device 20 from the connector 10 and connector pin 12.

[0105] Fig. 14 schematically shows a side view of the locking device 20 of the second embodiment with the locking movement of the slidable ring. As can be gathered from Fig. 14, the slidable ring 222 is stretched in the nonlocked state and then shrinks in size when moved over the locking window 224.

[0106] Fig. 15 schematically shows a partially cross-sectional view of the locking device 20 of the second embodiment when locked to the connector pin 12 and to the proximal end of the connector 10.

[0107] This sideview shows two opposite locking windows 224 for a better locking friction by the slidable ring 222 which is shown in the locked state over the locking windows 224 and the non-locked state in an axially neighbouring location on the second portion 22 of the locking device 20.

[0108] Furthermore, the funnel 214 for inserting the stylet 40 is shown.

[0109] The connector 10 and the connector pin 12 are both fully inserted into the second cavity 220 and the first cavity 210. Both proximal and distal sealing portions 14, 16 of the connector 10 are press-fitted during insertion of the connector 10 into matched cavity portions of the locking device 20, which may be a single moulded component for a simplified manufacturing process.

[0110] In a modification of the second embodiment, the slidable ring 222 and the locking window(s) 224 may be replaced by (a) flexible and deformable housing portion(s) at the position(s) of the locking window(s) as second locking mechanism 221 of Fig. 1. The shape of the deformable housing portion may be adapted to the shape of a fingertip for intuitive use. Moreover, the surface of the deformable housing portion may have a rough pattern for better grip during use.

[0111] Thus, with the above modification of the second embodiment, the physician or other user releases manual pressure exerted on the deformable housing portions to release the rotationally coupling or lock to the connector pin 12 that is press-fitted into the first cavity 210. In this state, the helix can be extended (extracted) from the retracted position by manually rotating the locking device 20 with the inserted and rotationally fixed connector pin 12. When the second phase (puncturing) is intended, the physician or other user simply presses the deformable housing portion(s) with his finger(s) to thereby exert pressure (clamp) on the outer surface of the proximal end of the connector 10 via the inner wall of the deformable housing portions facing the second cavity 220. Other locking mechanisms with opposite functionality (i.e., release-based lock and pressure-based unlock) could be implemented in the second embodiment as the second locking mechanism 211 of Fig.l.

[0112] To summarize, a locking device and method for a two-step locking operation have been described, wherein a distal fixation helix of a lead device is first extended by inserting a rotatable connector pin of a proximal connector of the lead device into a first cavity of a first portion of the locking device and applying a moderate (over-)torque to the connector pin by means of the locking device. Then, a very simple locking gesture (e.g., a sliding or pressing gesture) is applied to lock a rotationally coupled second portion of the locking device to the connector body in a second cavity of the second portion of the locking device without any release of the moderated torque initially applied to the connector pin. This allows a physician or other user to apply and maintain a moderate (over-)torque at the connector pin after helix extension while turning / rotating the lead body via the connector end during a puncturing operation.

[0113] The embodiments and examples described herein are to be understood as illustrative examples of embodiments of the invention. As already mentioned, the shape, size and number of portions and / or cavities of the locking device may be adapted for different connector pins and / or connectors with different diameters and / or shapes to allow use of the locking device for other terminal pins by using the same single fixation tool. Moreover, other locking mechanisms for rotationally locking or coupling the connector pin or connector in respective cavities of the locking device may be used.

[0114] Any feature described in relation to any one example or embodiment may be used alone or in combination with other features. In addition, any feature described in relation to any one example or embodiment may also be used in combination with one or more features of any other of the examples or embodiments, or any combination of any other of the examples or embodiments. Furthermore, equivalents and modifications not described herein may also be employed within the scope of the invention as defined in the claims.

Claims

CLAIMS1. A locking device (20) for operating a lead device (100) with a rotatable connector pin (12) which axially protrudes from a proximal end of a connector (10) of the lead device (100), said locking device (20) comprising:- a first portion (21) having a first cavity (210) configured to accommodate and rotation- ally fix the connector pin (12) to the first portion (21) of the locking device (20); and- a second portion (22) having a second cavity (220) configured to accommodate the proximal end of the connector (10) of the lead device (100);- wherein the locking device (20) comprises a releasable locking mechanism (221) for rotationally locking the proximal end of the connector (10) of the lead device (100) to the second portion (22) of the locking device (20) in the second cavity (220); and- wherein the first portion (21) and the second portion (22) of the locking device (20) are rotationally coupled to each other.

2. The locking device (20) of claim 1, wherein the second cavity (220) is configured to rotationally fix the second portion (22) to the proximal end of the connector (10) of the lead device (100) when inserted into the second cavity (22), and wherein the locking mechanism (221) is configured to allow the second portion (22) to move with respect to the first portion (21) in a distal direction to insert the proximal end of the connector (10) of the lead device (100) into the second cavity (220).

3. The locking device (20) of claim 2, wherein the rotational coupling between the first and second portions (21, 22) is achieved by a protruding pin (212) of the first portion(21) that is configured to slide in a matched slit (214) of the second portion 22.

4. The locking device (20) of claim 1, wherein the locking mechanism (211) comprises a slidable elastic ring (222) that surrounds the outer surface of the second portion(22) and that can be moved over an opening (224) between the surface of the second portion (22) and the second cavity (220) so that it presses through the opening (224) onto an outer surface of the proximal end of the connector (10) of the lead device (100)to thereby rotationally couple the proximal end of the connector (10) of the lead device(100) to the locking device (20) when inserted into the second cavity (220).

5. The locking device (20) of claim 4, wherein the second portion (22) comprises first and second ring-shaped protrusions (225, 226) at a distal end and a proximal end of the second portion (22) to limit a sliding range of the slidable ring (222).

6. The locking device (20) of claim 1, wherein the locking mechanism (221) is implemented by one or more deformable portion(s) in the housing of the second portion (22), which are configured to exert pressure on the outer surface of the proximal end of the connector (10) when inserted into the second cavity (220).

7. The locking device (20) of any one of claims 4 to 6, wherein the first and second portions (21, 22) are integrated in a single-piece locking device (20) or releasably connectable to each other.

8. The locking device (20) of any one of preceding claims, wherein the rotatable connector pin (12) is coupled to a retraction mechanism of a fixation helix at the distal end of the cardiac lead (100).

9. The locking device (20) of any one of the preceding claims, wherein the connector pin (12) is an IS1 connector or a DF4 connector.

10. The locking device (20) of any one of the preceding claims, wherein the first and second cavities (210, 220) are arranged to be aligned in axial direction of the connector (10) to allow insertion of both the connector pin (12) and the proximal end of the connector (10) into a respective one of the first and second cavities (210, 220).

11. The locking device (20) of any one of the preceding claims, wherein the first cavity (210) is configured to establish a rotational coupling to the connector pin (12) by local deformation of the inner wall of the first cavity (210) when the connector pin (12) is inserted into the first cavity (210).

12. The locking device (20) of any one of the preceding claims, wherein the first portion (21) of the locking device (20) comprises a concave funnel portion (214) configured to allow insertion of a stylet (40) to be further guided through the inserted connector pin (12) and the connector (10) to the distal end of the cardiac lead (100) to assist in positioning a fixation helix.

13. A method of operating a lead device (100) with a rotatable connector pin (12) which axially protrudes from a proximal end of the connector (10) of the lead device (100), said method comprising:- inserting the connector pin (12) into a first cavity of a first portion (21) of a locking device (20) to rotationally fix the connector pin (12) to the first portion (21) of the locking device (20);- rotating the connector pin (212) by means of the locking device (20);- using a releasable locking mechanism (221) of the locking device (20) to rotationally lock the proximal end of the connector (10) of the lead device (100) in a second cavity (220) of a second portion (22) of the locking device (20) to the second portion (22) of the locking device (20); and- rotating the proximal end of the connector (10) of the lead device (100) by means of the locking device (20), wherein the first portion (21) and the second portion (22) of the locking device (20) are rotationally coupled to each other.

Images