Multi-pin fixing tool

Abstract

The invention relates to a fixing tool for clamping and rotating a lead terminal pin of a medical implantable cardiac lead. The fixture includes a handle portion and a jaw portion wherein opposing inner surfaces of a pair of jaws of the jaw portion are shaped to form a cavity system between the pair of jaws, the cavity system including a first cavity positioned adjacent an opening at a distal end of the jaw portion and having a first width between the opposing inner surfaces and a second cavity positioned adjacent an opening at a distal end of the jaw portion and having a second width between the opposing inner surfaces. And a second cavity positioned adjacent to the first cavity and having a second width between the opposing inner surfaces that is less than the first width, and adapted to clamp, with the first cavity, a second lead terminal pin having a second diameter that is greater than the first diameter.

Description

Technical Field

[0001] This application relates to lead fixation tools, such as but not limited to medical clamps for gripping and rotating the lead terminal pins of medical implantable cardiac leads. Background Art

[0002] Implantable medical devices such as cardiac rhythm management (CRM) devices and neuromodulation devices are used in various therapeutic applications. In some applications, one or more medical implantable cardiac leads (hereinafter referred to as "leads") are employed to deliver therapy from the implanted medical device to tissue within the body. A CRM system may employ electrical leads implanted within a patient's heart. Such leads may be fixed to a desired location in the heart by a mechanical fixation device. Such a mechanical fixation device may include a helical device, called a helix (which may also be an electrode of the lead). The helix may be designed such that the helix retracts into the lead during insertion and positioning within the heart. Once positioned, the helix is rotated to cause the helix to extend and screw the helix into the myocardial tissue.

[0003] Rotation of the helix located at the distal end of the lead may be driven by torque applied to a lead terminal pin located at the proximal end of the lead and transmitted through a conductor coil that extends from the terminal pin through the lead to the helix. Lead terminal pins are typically very small and have a smooth cylindrical surface. This presents some difficulty in applying the desired amount of torque for the number of rotations required to ensure proper placement of the helix.

[0004] The lead terminal pin may be mechanically and electrically connected to a distal retractable screw (such as a helical electrode) of the lead. By operating the lead terminal pin, the distal retractable screw may be retracted or extended from the distal end of the lead. In particular, the distal retractable screw can be anchored in cardiac tissue to fix the distal end of the lead. Thus, rotation of the lead terminal pin can effect screwing the distal retractable screw into the cardiac tissue.

[0005] To rotate the lead terminal pin, a fixation tool (such as a medical clamp) may be used to enable a clinician to grip the lead terminal pin and transmit torque to the lead terminal pin. This presents some difficulty in applying the desired amount of torque for the number of rotations required to ensure proper placement of the helix, especially in cases where different types of leads are provided with different lead terminal pins. Summary of the Invention

[0006] The present invention solves the above object by providing a fixture for gripping and rotating the lead terminal pin of a medical implantable cardiac lead according to claim 1.

[0007] According to one aspect of the present invention, the proposed fixation tool comprises:

[0008] The handle portion, the handle portion including a pair of arms, the pair of arms being formed by a first arm connected to a second arm at a connecting hinge portion, and

[0009] The jaw portion, the jaw portion including a pair of jaws for receiving a terminal pin between corresponding inner surfaces of the pair of jaws,

[0010] The connecting hinge portion is disposed between the jaw portion and the handle portion,

[0011] wherein, the pressure applied on the first arm and the second arm causes the pair of jaws to open through the pivotal movement of the first arm and the second arm around the connecting hinge portion; and

[0012] wherein, the opposing inner surfaces of the pair of jaws are shaped to form a cavity system between the pair of jaws, the cavity system including:

[0013] A first cavity, the first cavity being positioned adjacent to an opening located at the distal end of the jaw portion, having a first width between the opposing inner surfaces, and being shaped to grip a first lead terminal pin having a first diameter;

[0014] A second cavity, the second cavity being positioned adjacent to the first cavity, having a second width smaller than the first width between the opposing inner surfaces, and being adapted to grip, together with the first cavity, a second lead terminal pin having a second diameter greater than the first diameter; and

[0015] A third cavity, the third cavity being positioned adjacent to the second cavity and having a third width smaller than the first diameter.

[0016] Thus, the proposed cavity system having a connected first cavity and second cavity can grip lead terminal pins having various diameters and center the lead terminal pins having various diameters, thus facilitating the use of the fixing tool for various different types of lead terminal pins (such as IS1, IS4, DS1, DS4, etc.). The lead terminal pins having a larger diameter can be centered by the contact points (such as edges) obtained from the enlarged cavity formed by combining the connected first cavity and second cavity.

[0017] According to a first option combinable with the above aspects, the cavity system may include a fourth cavity, the fourth cavity being positioned adjacent to the third cavity and forming the proximal end of the cavity system, and having a width greater than the third width. Thereby, the proximal end of the cavity system can be used as a stress relief element of the jaw portion.

[0018] According to a second option that can be combined with the first option or the above aspects, each of the first arm and the second arm may include a finger pad, and the finger pad has a concave surface, a convex surface or a flat surface on the outer surface of the handle portion. Thus, specific areas of the first arm and the second arm are precisely designed to receive the pressure applied by the fingers. This clearly and intuitively indicates to the clinician a more suitable and ergonomic area of the fixing tool for pressing the medical clip to open the jaw portion. Therefore, the ergonomics can be enhanced by means of the finger pads specifically adapted to receive the fingers.

[0019] In addition, the parallel arrangement of the finger pads can further facilitate the operation of the medical clip, especially facilitating the pressing of the arms at the handle portion. For the clinician, it is indeed easier to press parallel surfaces (even just to prevent the possibility of the fingers slipping) compared to pressing surfaces that are inclined relative to each other, thus improving the operating characteristics. The parallel arrangement of the finger pads can also improve the pressure distribution applied by the clinician. Therefore, the presence of the finger pads and their parallel arrangement provide a more intuitive medical clip to the clinician.

[0020] In a specific example of the second option, the surface of each finger pad may be provided with an anti-slip surface, especially a ribbed surface and / or a rubber layer. Thus, reliable and better use of the handle portion can be supported, for example, by preventing the fingers from slipping during use.

[0021] According to a third option that can be combined with the first option, the second option or the above aspects, each of the first arm and the second arm can be bent, and the finger pads of each of the first arm and the second arm can be positioned at the inflection points of the respective arms on the handle portion. Therefore, the enlarged gap obtained between the two arms allows a wider opening and a circular shape to enable a rotational movement by the user's fingers.

[0022] According to a fourth option that can be combined with any one of the first option to the third option or the above aspects, at the handle portion, the inner surfaces of each of the first arm and the second arm opposite to the finger pads are provided with recesses, and the recesses are adapted to receive the fingers for rotating the fixing tool relative to the terminal pin. Thus, the design of the arms provides a space with a circular shape between the arms, which facilitates the rotational movement of the fixing tool by the fingers for a screwing operation.

[0023] According to a fifth option that can be combined with any one of the first option to the fourth option or the above aspects, the inner surface of the first arm may be provided with a first protrusion, and the inner surface of the second arm may be provided with a second protrusion, and the first protrusion and the second protrusion are arranged such that a predetermined pressure on the handle portion causes the protrusions to abut against each other to provide a stop function. Thus, the amount of rotational movement (opening / closing) of the jaws of the jaw portion can be restricted to prevent, for example, excessive material stress at the connecting hinge portion.

[0024] According to a sixth option that can be combined with any one of the first to fifth options or the above aspects, the first protrusion and the second protrusion can be arranged at the free end of the handle portion. Thus, the end of the arm of the handle portion can be used to provide a stop function.

[0025] According to a seventh option that can be combined with any one of the first to fifth options or the above aspects, the first protrusion and the second protrusion can be arranged between the finger pad and the connecting hinge portion. Thus, the end of the arm can be shortened to provide a larger opening at the proximal end of the handle portion, which facilitates access to the internal space between the arms to rotate the fixing tool.

[0026] According to an eighth option that can be combined with any one of the first to seventh options or the above aspects, when no pressure is applied to the handle portion, the opening at the distal end of the jaw portion can be smaller than the second diameter. Thus, an insertion force is required to insert the lead terminal pin into the opening of the jaw portion and provide a click function during insertion.

[0027] According to a ninth option that can be combined with any one of the first to eighth options or the above aspects, when no pressure is applied to the handle portion, the first diameter can range between 0.50 mm and 1.20 mm, particularly between 1.62 mm and 1.56 mm, and the second diameter can range between 0.50 mm and 1.30 mm, particularly between 1.40 mm and 1.34 mm. Thus, the fixing tool can be adapted for combined use with, for example, IS1 and DF4 lead terminal pins or other terminal pins with similar diameters.

[0028] According to a tenth option that can be combined with any one of the first to ninth options or the above aspects, when no pressure is applied to the handle portion, at the opening at the distal end, the minimum distance between the opposing inner surfaces of the pair of jaws can range between 0.50 mm and 1.20 mm, particularly between 0.80 mm and 1.00 mm. Thus, a desired click function can be provided for combined use with, for example, IS1 and DF4 lead terminal pins or other terminal pins with similar diameters.

[0029] According to an eleventh option that can be combined with any one of the first to tenth options or the above aspects, the fixing tool can be integrally formed as a single piece, particularly integrally formed as a single piece from a plastic material. Thus, the manufacturing cost can be reduced.

[0030] According to a twelfth option that can be combined with any one of the first to eleventh options or the above aspects, the fixing tool can further include an insertion support funnel, which can be removably or non-removably fixed to the jaw portion to facilitate inserting a probe through the hole of the lead terminal pin into the heart lead. Description of the Drawings

[0031] To aid in understanding the present disclosure and to illustrate how embodiments may be implemented, reference is made, by way of example, to the accompanying drawings, in which:

[0032] Figure 1A is schematically shown how a fixation tool is clamped to the terminal pin of a lead;

[0033] Figure 1B is schematically shown how Figure 1A the fixation tool rotates to screw the distal helical portion into the heart tissue;

[0034] Figure 2 is schematically shown a side view of a fixation tool having finger pads according to an embodiment;

[0035] Figure 3A and Figure 3B is schematically shown a perspective view of two alternative examples of the handle portion of a fixation tool according to an embodiment;

[0036] Figure 4 is schematically shown a perspective view of a fixation tool having alternative stop protrusions according to an embodiment;

[0037] Figure 5 is schematically shown an enlarged portion of a fixation tool having a chamber system including four chambers according to an embodiment;

[0038] FIG. 6 schematically shows an enlarged jaw portion of a fixation tool having a third chamber of different lengths according to an embodiment;

[0039] Figure 7 is schematically shown an enlarged jaw portion of a fixation tool into which lead terminal pins of different diameters are inserted according to an embodiment;

[0040] Figure 8 is schematically shown an enlarged jaw portion of a fixation tool having an indication of the opening width at the distal end according to an embodiment;

[0041] Figure 9 is schematically shown a perspective view of the chamber system at the jaw portion of a fixation tool having inclined opposing inner jaw surfaces according to an embodiment;

[0042] Figure 10 is schematically shown a perspective view and a front view of a fixation tool having an insertion support funnel according to an embodiment; and

[0043] Figure 11 is schematically shown a perspective view and a front view of a fixation tool having an alternative design of the insertion support funnel. DETAILED DESCRIPTION

[0044] In the following, embodiments of the present invention are described in more detail based on a fixing tool (e.g., a medical clip) that enables a doctor or other user to screw the distal electrode (e.g., a helix) of a lead into a patient's heart tissue. More specifically, a doctor can clamp the fixing tool onto the terminal pins (e.g., IS1 and / or DF4 pins) of the lead / remove the fixing tool from the terminal pins (e.g., IS1 and / or DF4 pins) of the lead, and can transmit torque to the terminal pins in an intuitive manner.

[0045] Figure 1A Schematically shows how the butterfly fixing tool 40 is clamped onto the lead terminal pin 70 provided at the electrical conductor of the lead 20 (only shown in Figure 1B ).

[0046] To ensure safe pin insertion, the wings (arms) of the proximal handle portion of the fixing tool 40 need to be pressed by the fingers 12 of one hand of the user to open the cavity system between a pair of jaws provided in the distal jaw portion, while the lead 20 can be held, for example, by the fingers 10 of the other hand for pin-cavity insertion in order to clamp the fixing tool 40 onto the terminal pin.

[0047] Examples of the cavity system will be described in more detail later with reference to the Figure 5 cavity.

[0048] Figure 1B Schematically shows how, after clamping the fixing tool 40 onto the lead terminal pin 70, the fixing tool 40 can be rotated by the user's fingers a suitable number of turns to screw the distal helix (not shown) of the lead 20 into the heart tissue.

[0049] Finally, the fixing tool 40 is removed from the terminal pin by pressing the wings of the handle portion again.

[0050] The proximal end of the lead 20 may include a terminal sheath and terminal pins. The terminal sheath may be made of an elastic polymer and may include one or more terminal sheath seals with a larger diameter to seal the terminal sheath to an implantable electrical device (not shown). The lead terminal pin 70 may be a metal cylinder with a relatively smooth surface to electrically connect the conductor of the lead 20 to the implanted medical device. The electrical conductor may be disposed within the lumen in the body of the lead 20 and extend from the lead terminal pin 70 to the helix to provide a physical connection between the lead terminal pin 70 and the helical electrode, and in some embodiments an electrical connection between the lead terminal pin 70 and the helical electrode. The conductor may be at least partially in the form of a coil within the lead 20.

[0051] The lead terminal pin 70 may rotate freely relative to the terminal sheath and the body of the lead 20 to transmit torque to the helix through the conductor. In Figure 1A and Figure 1BIn an embodiment, the lead terminal pin 70 further includes a hole that extends axially through the lead terminal pin 70. The conductor also defines an inner lumen that communicates with the hole such that the probe 30 can be inserted from the proximal end of the lead 20 toward the distal end to assist in positioning the distal end and the helix within the heart.

[0052] In some embodiments, the body of the lead 20 can be a tubular structure that includes one or more inner lumens (not shown). The distal end can include at least one electrode (not shown) and a helical electrode. The electrode can be used to electrically couple the lead 20 to a patient's heart (not shown). The helix 20 can also be used to electrically couple the lead 20 to the heart.

[0053] As mentioned above, the fixation tool 40 can be used to apply torque to the lead terminal pin 70 to rotate the helix and anchor the distal end of the lead 20 in the heart. For each type of lead 20, a specific number of rotations of the lead terminal pin 70 and a corresponding number of rotations of the helix are required to successfully anchor the distal end in the heart tissue. Thus, the fixation tool 40 is used to grasp the lead terminal pin 70 and rotate the lead terminal pin 70 while counting the number of rotations to determine when the helix has been successfully implanted.

[0054] A pacemaker or defibrillator lead connects the myocardial sites to be sensed or stimulated to a corresponding cardiac implantable electronic device (CIED) or other medical device. When the CIED is replaced, the lead can remain in place and can be independently attached to the new medical device. Sometimes, additional leads can be placed to address sensing or acquisition problems with existing leads. Since the late 1980s and early 1990s, the unified industry standards IS1 and DF1 have ensured the interchangeability of generators and leads from different manufacturers, enabling the device system to be customized to the needs of individual patients. Thus, such leads can have a double bifurcation (single coil lead; one IS1, one DF1) or a triple bifurcation (double coil lead; one IS1, two DF1) at their proximal ends.

[0055] In March 2010, when the International Organization for Standardization (ISO) issued its new standard ISO 27186.1 for active implantable medical devices with a quadripolar connector system for implantable cardiac rhythm management devices, the new standard was officially established. The specifications of the new standard apply to low-energy (IS4) leads and high-energy (DF4) leads and ensure the compatibility of IS4 / DF4 leads with future implanted devices.

[0056] Thus, different lead terminal pins (such as IS1 and DF4 pins) have different designs, resulting in a risk of error due to the use of the wrong fixing tool (for example, the lead pin breaks during insertion).

[0057] Now, various embodiments of an improved fixing tool 40 are described. The improved fixing tool 40 has a modified design to facilitate easier insertion of the pin when the fixing tool is open, more intuitive use, and compatibility with different lead pin types (such as IS1, DF4).

[0058] The opening of the jaw portion of the fixing tool 40 is configured to be wide enough to freely insert the pin with a smaller insertion force and a click function.

[0059] Figure 2 A side view of a fixing tool having a finger pad 42 according to an embodiment is schematically shown.

[0060] The fixing tool includes a handle portion, a connecting hinge portion 3, and a jaw portion. The handle portion has a first arm 43(1) and a second arm 43(2). The jaw portion has a pair of jaws, a jaw opening 2, and a cavity system 1. The pair of jaws includes a first jaw 45(1) and a second jaw 45(2). The cavity system 1 is configured to hold at least two different types of lead terminal pins. The protruding end portions 44 of the first arm 43(1) and the second arm 43(2) are used to provide a stop function (hard stop) when, for example, the first arm 43(1) and the second arm 43(2) are pressed together by a user's finger (as shown by the larger arrow in Figure 2 ). Under pressure, the connecting hinge portion 3 acts as an elastic hinge that rotates the first jaw 45(1) and the second jaw 45(2) in opposite directions to increase the opening 2 of the jaw portion (as shown by the smaller arrow in Figure 2 ).

[0061] The first arm 43(1), the second arm 43(2), the connecting hinge portion 3, the first jaw 45(1), and the second jaw 45(2) may be integrally formed of a first material. In other embodiments, the connecting hinge portion 2 may be formed of a different material having greater elasticity than the first material. The first jaw 45(1) may protrude from the first arm 43(1) beyond the connecting hinge portion 3. The second jaw 45(2) may protrude from the second arm 43(2) beyond the connecting hinge portion 3.

[0062] As Figure 2As shown, the first jaw 45(1) and the second jaw 45(2) are spaced apart to form a tool slot having an opening 2 and a cavity system 1. The tool slot extends from the end of each of the first jaw 45(1) and the second jaw 45(2) to the distal end of the connecting hinge portion 3. The connecting hinge portion 3 may be part of a first material that connects the first arm 43(1) to the second arm 43(2), and may include a handle stress relief element 46 and a jaw stress relief element 54. The handle stress relief element 46 may be a curved cutout feature (such as a cavity having a circular or other shape) formed where the first arm 43(1) and the second arm 43(2) are connected to the connecting hinge portion 3 to reduce stress concentration in the connecting hinge portion 3. The jaw stress relief element 54 may also be a curved cutout feature (such as a cavity having a semi-circular or other shape) formed as a proximal portion of the cavity system 1, where the first jaw 45(1) projects from the first arm 43(1) and the second jaw 45(2) projects from the second arm 43(2) at the proximal portion of the cavity system 1 to reduce stress concentration in the connecting hinge portion 3.

[0063] The cavity system 1 may be provided at or near the opening 2 of the jaw portion, may extend to the connecting hinge portion 3, and may include the jaw stress relief element 54 as one of the cavities of the cavity system 1. The opening 2 of the jaw portion is configured to be aligned with the cavity system 1, and the cavity system 1 is shaped to grip at least two lead terminal pins having different diameters by using at least two of a plurality of communicating cavities formed by the opposing inner surfaces of the first jaw 45(1) and the second jaw 45(2).

[0064] The cavity system 1 and the opening 2 may be provided in the fixed tool by insert molding. That is, the pattern of the cavity system 1 and the opening 2 may be placed in a mold, and the remainder of the fixed tool may be injection molded around the cavity system 1 and the opening 2. Alternatively, the cavity system 1 and the opening 2 may be glued to or stamped from the first jaw 45(1) and the second jaw 45(2).

[0065] The tool slot having the cavity system 1 and the opening 2 may be configured such that pressing the first arm 43(1) toward the second arm 43(2) causes the first jaw 45(1) and the second jaw 45(2) to move relative to each other to change the width of the cavity system 1. In Figure 2In the illustrated embodiment, the tool slot is configured such that pressing the first arm 43(1) towards the second arm 43(2) causes the first jaw 45(1) and the second jaw 45(2) to move away from each other and against the restoring force of the connecting hinge portion 3. In doing so, the width of the tool slot increases, and thus the widths of the cavity system 1 and the opening 2 increase. In some embodiments, the width of the cavity system 1 can increase from a width less than the minimum diameter of at least two different grippable terminal pins to a width greater than the maximum diameter of at least two different grippable terminal pins.

[0066] As already mentioned above, the first jaw 45(1) and the second jaw 45(2) can be made of a first material. The surface area of the insertion slot having the cavity system 1 and the opening 2 can be made of a second material. The first material can be harder than the second material. For example, the first material can be a relatively high-hardness thermoplastic material, such as polycarbonate or acrylonitrile butadiene styrene (ABS) with a Shore hardness greater than 90D. The second material can be a thermoplastic, thermosetting, or casting material with a Shore hardness less than 90D. The second material can be, for example, silicone rubber with a Shore hardness less than 90D.

[0067] Figure 3A and Figure 3B Perspective views schematically show two alternative examples of the handle portion of a fixing tool for more intuitive use and simplified shape according to an embodiment.

[0068] Figure 3A Shows Figure 2 an example in which the finger pads are located at the inflection points of the first and second arms, while Figure 3B shows a modification of the tool arms in which there are no finger pads and scissor-like arms. In both cases, the enlarged gap between the two arms allows for a wider opening and a circular shape to enable rotational movement by the user's fingers.

[0069] Figure 4 Perspective views schematically show a fixing tool according to an embodiment with an alternative position of the stop projection 46. Placing the stop projection towards the connecting hinge portion enables the use of a shorter arm (now looking more like pliers), facilitating the insertion of fingers from the rear side for rotational movement.

[0070] Figure 5 Schematically shows an enlarged cut-away portion of an example of the cavity system of a fixing tool according to an embodiment, where Figure 5 the proximal end of the cavity system on the horizontal axis is located at the connecting hinge portion, and the distal end of the cavity system is located at the opening of the jaw portion. The cavity system is formed by the opposing inner surfaces of the first and second jaws of the jaw portion and includes four consecutive communicating cavities 51 to 54 (in Figure 5which is indicated by the imaginary dividing line), the four consecutive communicating cavities 51 to 54 are configured to clamp two or more different types of lead terminal pins having different diameters.

[0071] The first cavity 51 is positioned adjacent to the opening of the jaw portion and has a first width b between opposite inner surfaces, and is adapted to clamp a first type of lead terminal pin having a first diameter. In addition, the second cavity 52 is positioned adjacent to the first cavity 51 and has a second width c that is less than the first width b between opposite inner surfaces, and is adapted to clamp, together with the first cavity 51, a second type of lead terminal pin having a second diameter that is greater than the first diameter. Thus, the combined shape of the adjacent and communicating first cavity 51 and second cavity 52 can be used to clamp the larger lead terminal pin, wherein four edge portions 521 (shown in the Figure 5 enlarged portion) created by the distal shape of the first cavity 51 and the combination of the first cavity 51 and the second cavity 52 at the proximal end of the first cavity 51 are used to automatically center the larger second type of terminal lead together with the contact points created at the distal end of the first cavity 51. Thus, in the Figure 5 example, the larger lead terminal pin is centered by the four contact points 521.

[0072] In addition, an additional third cavity 53 is positioned adjacent to the second cavity 52 and has a third width that is less than the second diameter to prevent the smaller first type of lead terminal from being inserted beyond the second cavity 53.

[0073] Finally, the fourth cavity 54 (which may correspond to the Figure 2 jaw stress relief element) can be positioned adjacent to the third cavity 53, forming the proximal end of the cavity system (1), and has a width greater than the third width. The fourth cavity 54 facilitates the opening and closing of the jaw portion during the clamping operation. Various other shapes of the fourth cavity 54 can be implemented (such as a complete circular shape), but a non-circular shape (such as the D-shaped or semi-circular shape as Figure 5 shown) prevents a doctor or other user from accidentally inserting a lead terminal pin into the fourth cavity 54.

[0074] The opening of the jaw portion may have a third width a, and the third width a may be less than the first width b of the first cavity 51 and the second width c of the second cavity 52 to ensure that neither of the two lead terminal pins is accidentally inserted in the non-compressed state of the arms of the fixing tool. The second width c may be equal to the third width a to facilitate the structure at the opposite inner surfaces of the first jaw and the second jaw.

[0075] Thus, the cavity system is formed by a plurality of structures protruding from the inner surfaces of the first and second jaws to define the above-mentioned cavities 51 to 54, so that the fixing tool can be fixed to a corresponding one of two or more types of terminal pins with different diameters by providing a suitable surface contact area and contact points between the selected terminal pin and the fixing tool. Additionally or alternatively, the inner surface can be configured to provide a click function during the insertion of the selected lead terminal pin by pushing the lead terminal pin from the second cavity 52 towards the first cavity 51 via the contact point 521.

[0076] In an example of a fixing tool suitable for use in combination with IS1 and DF4 lead terminal pins or other terminal pins with similar diameters, when no pressure is applied to the handle portion, the range of the width (distance) of the opening of the jaw portion can be selected to be between 1.20 mm and 0.50 mm, particularly between 1.00 mm and 0.80 mm. Here, the diameter of the larger terminal pin (e.g., IS1 pin) ranges between 1.50 mm and 1.65 mm, particularly between 1.56 mm and 1.62 mm, while the diameter of the smaller terminal pin (e.g., DF4 pin) ranges between 1.30 mm and 1.50 mm, particularly between 1.34 mm and 1.40 mm. Then, the range of the maximum width b of the first cavity 51 can be selected to be between 1.30 mm and 1.00 mm, particularly between 1.25 mm and 1.05 mm, to achieve the desired clamping force and insertion force.

[0077] In Figure 5 FIG. 6, the first cavity 51 is shown as having a circular shape. However, it should be understood that in other embodiments, the first cavity 51 or other cavities 52 to 54 or additional cavities for additional lead terminal pins may have a square, triangular or other polygonal shape.

[0078] FIG. 6 schematically shows an enlarged jaw portion of a fixing tool according to an embodiment, in which the third cavity 53 has different lengths along the pin insertion direction to control the pressing and clamping behavior of the fixing tool. In the above example of the IS1 / DF4 fixing tool, the ranges of these different lengths of the third cavity 53 can be, for example, from 1 mm to 1.5 mm or from 1.5 mm to 2 mm, depending on the desired opening characteristics and clamping force characteristics of the jaw portion.

[0079] Figure 7 FIG. 6 schematically shows an enlarged jaw portion of a fixing tool according to an embodiment, in which the indicated positions of different inserted lead terminal pins 70, 72 with different diameters are shown. Figure 7The dashed-line shape of the cavity system shown indicates the position (distance) of the opposing surfaces of the first and second jaws of the jaw portion when no pressure is applied to the handle portion. It should be noted that only one of the two lead terminal pins 70, 72 can be inserted at a time. In Figure 7 the case shown, the larger lead terminal pin 72 is held by the jaw portion, while the smaller lead terminal pin 70 is shown only for comparison purposes.

[0080] The smaller terminal pin 70 can be individually accommodated in the first cavity, where the outer shape of the smaller terminal pin 70 matches the upper and lower shapes of the first cavity created by the opposing inner surfaces of the first and second jaws. In contrast, the larger terminal pin 72 is accommodated in the combined space of the first and second cavities because the outer shape of the larger terminal pin 72 does not match the upper and lower shapes of the first cavity (i.e., is larger than the upper and lower shapes of the first cavity). However, the four contact points created by the communicating cavities of the cavity system at the proximal and distal ends of the first cavity ( Figure 5 the contact points 521 in) cause the larger terminal pin 72 to be automatically centered. The contact points at the surface of the lower jaw are indicated by the corresponding arrows in Figure 7 .

[0081] As already mentioned above, the combined setting of the first and second cavities enables the use of a fixing tool to apply torque to two or more different types of terminal pins with different diameters (such as IS1, DF4, etc.).

[0082] Referring again to Figure 2 , the first arm 43(1) and the second arm 43(2) can be pressed towards each other such that the movement of the first arm 43(1) and the second arm 43(2) acts against the restoring force of the resiliently connected hinge portion 3, causing the first jaw 45(1) and the second jaw 45(2) to move separately, thereby increasing the width of the tool slot with opening 2 and the cavity system 1 from a width smaller than the minimum diameter of all the clippable terminal pins 70, 72 to a width larger than the maximum diameter of all the clippable terminal pins 70, 72. Once the width of the tool slot with opening 2 and the cavity system 1 approaches or is larger than the diameter of the currently intended selected terminal pin to be grasped, the terminal pin can be pressed or slid through opening 2 and clamped into the corresponding cavity space of the cavity system 1 with a matching width.

[0083] As Figure 7 shown, the larger terminal pin 72 can be clamped in the combined cavity space created by the first and second cavities (such as Figure 5 the first cavity 51 and the second cavity 52) by the clamping function achieved by the smaller diameter of opening 2, where the contact points center the diameter of the larger terminal pin 72. Alternatively, the smaller terminal pin 70 can be inserted and clamped into the first cavity (such as Figure 5In the first cavity 51), the first cavity has a smaller width and upper and lower boundary shapes adapted to the diameter of the smaller terminal pin 70.

[0084] Release the first arm 43(1) and the second arm 43(2) so that the restoring force of the connecting hinge member 3 can move the first jaw 45(1) and the second jaw 45(2) closer together, thereby reducing the width of the corresponding cavity of the cavity system 1 to approximately the diameter of the selected terminal pin 70 or 72. Due to the presence of the selected terminal pin 70 or 72, the width of the corresponding cavity of the cavity system 1 cannot be restored to its original width less than the diameter of the selected terminal pin 70 or 72. Therefore, a sufficiently large restoring force of the connecting hinge portion 3 remains to fix the fixing tool to the selected terminal pin 70 or 72. Once fixed to the selected terminal pin, the fixing tool can be used to apply torque to the selected terminal pin 70 or 72, for example as Figure 1B shown.

[0085] By providing a lower hardness of the second material at the opposing inner surfaces of the first jaw 45(1) and the second jaw 45(2), the fixing of the fixing tool to the selected terminal pin 70 or 72 can be enhanced. Compared to, for example, a harder first material, the second material can grip the terminal pin 70 or 72 more effectively because the second material can deform to a greater extent against the terminal pin 70 or 72, thereby increasing the surface contact area between the terminal pin 70 or 72 and the fixing tool. The second material may also have a higher coefficient of friction than the first material. These features can provide a more secure mechanical connection between the fixing tool and the terminal pin 70 or 72.

[0086] In an example of a fixing tool adapted for use with IS1 and DF4 terminal pins, the maximum force selectable for opening the jaw portion can be about 15 N, while the maximum insertion force for inserting a lead terminal pin (click function) through the opening 2 of the jaw portion can be obtained as about 30 N. Then, a clamping force of about 30 N can be applied to the inserted terminal pin.

[0087] Figure 8 A magnified jaw portion of a fixing tool with an indication of the opening width 80 of the jaw portion is schematically shown according to an embodiment.

[0088] In the above example of a fixing tool adapted for use with IS1 and DS4 terminal pins, the width 80 (i.e., the distance between the opposing inner surfaces of the first jaw and the second jaw) can range between 1 mm and 0.8 mm, for example to obtain the desired click function.

[0089] Figure 9 A perspective view of a cavity system at the jaw portion of a fixing tool with inclined opposing inner jaw surfaces is schematically shown according to an embodiment.

[0090] As Figure 9 shown, the opposing inner surfaces of the first and second jaws are inclined such that the distance between the surfaces linearly increases from the side edges of the surfaces to the middle. Thereby, insertion of the lead terminal pin can be facilitated.

[0091] In the above example of the fixing tool adapted to be used in combination with the IS1 and DS4 terminal pins, at a handle compression force of about 15 N, the distance M at the middle can range between 1.39 mm and 1.60 mm, and the distance S at the side edges can range between 1.61 mm and 1.82 mm.

[0092] Alternatively, other non-linear inclinations (quadratic inclination, circular inclination, etc.) can be used to facilitate insertion of the terminal pin.

[0093] Figure 10 An example of a fixing tool is shown having an insertion support funnel 100 associated with the probe mentioned above (e.g., Figure 1A probe 30 therein), which is inserted from the proximal end to the distal end of the lead to assist in positioning the distal end and the helical portion within the heart. The insertion support funnel 100 facilitates insertion of the probe into the corresponding hole of the lead terminal pin after the lead terminal pin is clamped in the cavity system (e.g., clamped at the first cavity).

[0094] Thus, doctors or other users who are not yet familiar with the fixing tool and its pin insertion area can be supported by the insertion support funnel 100 to guide the distal end (e.g., the mandrel) of the probe into the hole of the lead terminal pin clamped by the cavity system of the jaw portion. In the case of a small design of the cavity system for the IS1 and DF4 lead terminal pins, the area dedicated to clamping the IS1 or DF4 pin (e.g., the first cavity) is hardly visible to the doctor or other user and can be confused, for example, with the distal stress relief element 54 (the fourth cavity). The insertion support funnel prevents visual confusion, such that the doctor or other user will not hesitate to insert the distal end of the probe into the hole of the clamped lead terminal pin by a forced axial movement, as the risk of breakage of the terminal pin and / or the internal pin connection is reduced.

[0095] The insertion support funnel 100 can be provided as a one-piece element molded or removably fixed (e.g., clamped) to the first jaw or the second jaw, or as a two-piece element having a first part molded or removably fixed to the first jaw and a second part molded or removably fixed to the second jaw. The insertion support funnel 100 can be fixed to the fixing tool during the manufacturing / assembly of the fixing tool or during use by the doctor or other user to increase the flexibility of use (e.g., optional use, pin-dependent use, etc.).

[0096] In one example, a "dual-purpose" insertion support funnel 100 can be provided that can be used in a first mode (inserted directly onto a lead terminal pin) or in a second mode ("plugged" onto a fixing tool).

[0097] Figure 11 Perspective and front views of a fixing tool with an alternative design of the insertion support funnel 100 are schematically shown.

[0098] Figure 11 The illustrated insertion support funnel 100 consists of two separate molded plastic parts, namely the funnel 100 and the retaining element 102, which can be permanently assembled during manufacturing (e.g., by molding) or plugged together by a doctor or other user in a sterile area. This option enables an uninterrupted 360° profile of the insertion support funnel 100. Additionally, the geometric design enables the axis of the insertion support funnel 100 to be aligned with the clamping axis of the jaw portion.

[0099] As an additional or alternative measure, a visual arrow-type marking specifying a suitable clamping area (e.g., a first cavity) can also provide support for the correct insertion of the probe.

[0100] Figure 10 and Figure 11 The proposed design of the insertion support funnel 100 of and is very flexible in its use and, compared to other embodiments discussed herein, does not result in any ergonomic deficiencies. In addition to facilitating the insertion of the lead terminal pin, it also clearly indicates to the user the clamping area where the probe is to be inserted.

[0101] By Figure 10 and Figure 11 The asymmetry introduced by the insertion support funnel 100 of and may introduce a risk of manufacturing or assembly errors. Therefore, in an alternative embodiment, the insertion support funnel 100 can be provided on both sides to obtain a symmetric overall structure.

[0102] It should be noted that Figure 10 and Figure 11 The above-mentioned insertion support funnel 100 of and can also be provided for a fixing tool having a jaw portion adapted to clamp a single type of lead terminal pin, i.e., a jaw portion having a single cavity shaped to accommodate and clamp a terminal pin of a single diameter.

[0103] In summary, a fixing tool for clamping and rotating a lead terminal pin of a medical implantable cardiac lead has been described. The fixing tool includes a handle portion and a jaw portion. The opposing inner surfaces of a pair of jaws of the jaw portion are shaped to form a cavity system between the pair of jaws. The cavity system includes a first cavity and a second cavity. The first cavity is positioned adjacent to an opening located at the distal end of the jaw portion and has a first width between the opposing inner surfaces, and is shaped to clamp a first lead terminal pin having a first diameter. The second cavity is positioned adjacent to the first cavity and has a second width less than the first width between the opposing inner surfaces, and is adapted to clamp, together with the first cavity, a second lead terminal pin having a second diameter greater than the first diameter.

[0104] The embodiments and examples described herein should be understood as illustrative examples of embodiments of the present invention. Further embodiments and examples are contemplated. As already mentioned, the shape and number of cavities for different terminal pins having different diameters and / or shapes can vary to enable clamping of more or other terminal pins by using the same single fixing tool.

[0105] Any feature described in relation to any example or embodiment can be used alone or in combination with other features. In addition, any feature described in relation to any example or embodiment can also be used in combination with one or more features of any other example or embodiment or any combination of any other example or embodiment. Furthermore, equivalents and modifications not described herein can also be used within the scope of the present invention as defined by the claims.

Claims

1. A fixing tool (40) for clamping terminal pins (70, 72) of a medical implantable cardiac lead (20), the fixing tool (40) comprising: A handle portion including a pair of arms formed by a first arm (43(1)) connected to a second arm (43(2)) at a connecting hinge portion (3), and A jaw portion including a pair of jaws (45(1), 45(2)) for receiving the terminal pins (70, 72) between corresponding inner surfaces of the pair of jaws (45(1), 45(2)), The connecting hinge portion (3) being arranged between the jaw portion and the handle portion, Wherein pressure applied to the first arm and the second arm (43(1), 43(2)) causes the pair of jaws (45(1), 45(2)) to open by a pivoting movement of the first arm (43(1)) and the second arm (43(2)) about the connecting hinge portion (3); and Wherein opposite inner surfaces of the pair of jaws (43(1), 43(2)) are shaped to form a cavity system (1) between the pair of jaws (43(1), 43(2)), the cavity system (1) comprising: A first cavity (51) positioned adjacent an opening (2) at a distal end of the jaw portion, having a first width between the opposite inner surfaces, and shaped to clamp a first lead terminal pin (72) having a first diameter; A second cavity (52) positioned adjacent the first cavity (51), having a second width less than the first width between the opposite inner surfaces, and adapted to clamp, together with the first cavity (51), a second lead terminal pin (70) having a second diameter greater than the first diameter; and A third cavity (53) positioned adjacent the second cavity (52), having a third width less than the first diameter.

2. The fixing tool (40) according to claim 1, wherein, The cavity system (1) includes a fourth cavity (54) positioned adjacent the third cavity (53), forming a proximal end of the cavity system (1), and having a width greater than the third width.

3. The fixing tool (40) according to any one of the preceding claims, wherein, Each of the first arm and the second arm (43(1), 43(2)) includes a finger pad (42), the finger pad having a concave, convex or flat surface on an outer surface of the handle portion.

4. The fixing tool (40) according to claim 3, wherein, The surface of each finger pad (42) is provided with an anti-slip surface, in particular a ribbed surface and / or a rubber layer.

5. The fixing tool (40) according to any one of the preceding claims, wherein, Each of the first arm and the second arm (43(1), 43(2)) is bent, and the finger pad (42) of each of the first arm and the second arm (43(1), 43(2)) is positioned at an inflection point of the corresponding arm on the handle portion.

6. The fixing tool (40) according to claim 5, wherein, At the handle portion, the inner surface of each of the first arm and the second arm (43(1), 43(2)), which is opposite to the finger pad (42), is provided with a recess adapted to receive a finger (12) for rotating the fixing tool (40) relative to the terminal pins (70, 72).

7. The fixing tool (40) according to any one of the preceding claims, wherein, The inner surface of the first arm (43(1)) is provided with a first protrusion (44; 46), and the inner surface of the second arm (43(2)) is provided with a second protrusion (44; 46). The first protrusion (44; 46) and the second protrusion (44; 46) are arranged such that a predetermined pressure on the handle portion causes the protrusions (44; 46) to abut against each other to provide a stop function.

8. The fixing tool (40) according to claim 7, wherein, The first protrusion (44) and the second protrusion (44) are arranged at the free end of the handle portion.

9. The fixing tool (40) according to claim 7, wherein, The first protrusion (46) and the second protrusion (46) are arranged between the finger pad (42) and the connecting hinge portion (3).

10. The fixing tool (40) according to any one of the preceding claims, wherein, When no pressure is applied to the handle portion, the opening (2) at the distal end of the jaw portion is smaller than the second diameter.

11. The fixing tool (40) according to any one of the preceding claims, wherein, When no pressure is applied to the handle portion, the first diameter ranges from 1.65 mm to 1.50 mm, particularly from 1.62 mm to 1.56 mm, and the second diameter ranges from 1.50 mm to 1.30 mm, particularly from 1.40 mm to 1.34 mm.

12. The fixing tool (40) according to claim 11, wherein, When no pressure is applied to the handle portion, at the opening (2) at the distal end, the minimum distance between the opposing inner surfaces of the pair of jaws (45(1), 45(2)) ranges from 0.50 mm to 1.20 mm, particularly from 0.80 mm to 1.00 mm.

13. The fixing tool (40) according to any one of the preceding claims, being integrally formed as a single piece, particularly integrally formed as a single piece from a plastic material.

14. The fixing tool (40) according to any one of the preceding claims, further comprising an insertion support funnel (100) removably or non-removably fixed to the jaw portion to facilitate insertion of a probe through the holes of the lead terminal pins (70, 72) into the cardiac lead (20).

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