Catheter device for connecting hitches of implantable medical devices during explantation of medical devices

Abstract

A catheter device (1) is presented for connecting a hitch (65) of an implantable medical device (61) during explantation. The catheter device (1) comprises a catheter (3), a shaft (5), and a hitch gripping mechanism (7). The hitch gripping mechanism comprises a mandrel (11), a plurality of tubes (13), and a plurality of wires (15), each of which is longitudinally displaceable with respect to its associated tube, and the wires further partially extend to associated adjacent tubes (13''), with a first end (21) of each wire fixed to the shaft, and a second end (23) of each wire being displaceable with respect to the shaft and fixed to the mandrel, so that each wire, together with its associated tube and its associated adjacent tubes, forms a loop (25) which can be retracted into a closed configuration and pushed out into an open configuration.

Description

Technical Field

[0001] The present invention relates to catheter devices. Specifically, the present invention relates to an external catheter for connecting a hitch of an implantable medical device. The phrase "connecting a hitch of an implantable medical device" should be understood within the scope of this application as establishing a connection between the tether and the hitch of the medical device, and may also be referred to as capturing the medical device.

[0002] Various medical devices can be implanted into a patient's body. As an example, as will be mainly discussed below, a small implantable leadless pacemaker (ILP, sometimes called an intracardiac pacemaker) can be directly implanted into a cardiac chamber of a patient's heart.

[0003] Typically, such medical devices are implanted using a catheter device. Therein, an elongate catheter can carry the medical device at its distal end. The catheter can be introduced along with the medical device and guided along a blood vessel. In the case of an ILP, the catheter is guided towards the heart such that the ILP at its end can be introduced into one of the cardiac chambers and fixed to the inner surface of the heart wall using a fixation mechanism, for example, including tines. Therein, the ILP should be positioned at an appropriate implantation site such that its electrodes can accurately deliver electrical pacing pulses for stimulating the heart tissue.

[0004] However, in some cases, it may be necessary to explant the implanted medical device. For example, if the ILP is not implanted at an appropriate site or does not operate properly, in these situations, it may be necessary to explant the ILP and replace it with a new device. This can occur particularly in acute situations after implantation of the medical device, i.e., as long as substantial internal growth and encapsulation of the implant do not occur. Alternatively, a catheter device can be used to explant the ILP at the end of its lifespan.

[0005] Various techniques and technologies have been developed for explanting implanted medical devices.

[0006] For example, conventional implantable catheters may be used to attempt to capture an implanted medical device and remove it from its previous implantation site. In this case, a snare may be pre-loaded into the catheter, and, for example, a tine-based ILP may be recoated. However, such methods are generally complex and may not be easily, safely, and reliably applied.

[0007] Further methods are described, for example, in International Publication No. 2020 / 187666, which discloses "a catheter device for repositioning or explanting an implantable medical device," or in International Publication No. 2019 / 166230, which discloses "a recapture assembly for a catheter system, a catheter system and a method for retrieval of an implant."

[0008] An object of the present invention is to provide an alternative catheter device configured to advantageously capture and explant implantable medical devices. In particular, an object of the present invention is to provide a catheter device specifically configured to easily, safely, and / or reliably connect the hitch of an implanted medical device during explantation. Furthermore, an object of the present invention is to provide a catheter device that can assist in explanting an ILP when implanted in either the ventricle or atrium of the heart.

[0009] Such objectives may be satisfied by the subject matter of the independent claims. Advantageous embodiments are defined in the dependent claims and the corresponding specifications and drawings.

[0010] According to one aspect of the present invention, a catheter device is presented which is particularly configured to connect a hitch of an implantable medical device during explantation of the implantable medical device. The catheter device comprises an elongated inner catheter, an elongated shaft, and a hitch gripping mechanism. The elongated shaft extends throughout the entire internal volume of the inner catheter and is longitudinally displaceable relative to the inner catheter between a retracted position and an extended position. The hitch gripping mechanism is located at the distal end of the shaft, where the hitch gripping mechanism comprises a mandrel, a plurality of tubes, and a plurality of wires. The mandrel extends throughout the entire internal volume of the shaft and is longitudinally displaceable relative to the shaft between a proximal position and a distal position. The tubes extend longitudinally from the distal end of the shaft. Each of the wires has a first portion of its length that extends throughout the entire internal volume of the associated tube and is longitudinally displaceable relative to the associated tube, and a second portion of the wire that extends to the associated adjacent tube. In this configuration, the first end of each wire is fixed to the shaft, and the second end on the opposite side of each wire is displaceable relative to the shaft and fixed to the mandrel. As a result of such a configuration, each wire forms a loop with its associated tube and its associated adjacent tubes, and when the mandrel is pulled in proximal to the shaft, the loop is pulled in into a closed configuration with minimum lateral dimension, and when the mandrel is pushed out distal to the shaft, the loop is pushed out into an open configuration with maximum lateral dimension.

[0011] The proximal position should be understood as being close to the physician handling the catheter within the scope of its application. In contrast, the distal position means being further away from the physician. To summarize the invention concisely without limiting its scope, the basic concepts underlying embodiments of the invention and related possible advantages are outlined below.

[0012] The catheter devices described herein differ from conventional catheter devices primarily with respect to their particular hitch gripping mechanism. This hitch gripping mechanism includes wires and tubes that interoperate in a specific manner to enable precise opening and closing of a loop controlled by a simple longitudinal movement of a mandrel. Furthermore, the hitch gripping mechanism cooperates with the shaft of the catheter device and the inner catheter so that the loop can be initially opened while the loop is stationary relative to the inner catheter, and then the opened loop may be pushed distally away from the inner catheter to capture the hitch of the implanted medical device with the protruding loop. Subsequently, the hitch gripping mechanism may operate to first close its loop and then retract the loop toward the inner catheter together with the medical device. To ensure proper operation of the hitch gripping mechanism, the catheter device may include a specific handle including a grabber mechanism control unit specifically configured to displace the mandrel relative to the shaft and displace the shaft relative to the inner catheter, such displacement movements being performed in a particular sequence. Furthermore, the catheter device may include an outer catheter that surrounds an inner catheter and is displaceable longitudinally relative to the inner catheter, the outer catheter being particularly configured to re-cover an explanted medical device.

[0013] The possible features and related advantages of embodiments of the present invention will be described in more detail below.

[0014] The catheter device comprises an elongated catheter. This elongated catheter may be referred to as the inner catheter, as the catheter device may comprise another catheter surrounding this inner catheter, which is therefore referred to herein as the outer catheter. Alternatively, the inner catheter may be referred to as the first catheter and the outer catheter as the second catheter. The inner catheter is adapted, for example, with respect to its length, diameter, and flexibility to be introduced into the patient's blood vessels and transported to an implantation site, for example, within the cardiac chambers, particularly within the ventricles or atria. For example, the length may typically range from 20 cm to 2 m, particularly from 1.00 m to 1.60 m; the diameter may typically range from 2 mm to 2 cm, particularly from 2 mm to 8 mm; and the flexibility may allow for a bending radius of up to several centimeters.

[0015] The catheter device further comprises an elongated shaft extending through the internal volume of the inner catheter. That is, the outer diameter of the shaft is smaller than the inner diameter of the inner catheter. The shaft may be linearly displaced longitudinally within the inner catheter. In particular, the shaft may be displaced between a retracted position where the shaft (i.e., its geometric center) is closer to the proximal end of the inner catheter than the protruding position, and a protruding position where it is closer to the distal end of the inner catheter than the retracted position.

[0016] The catheter device further comprises a hitch gripping mechanism. The hitch gripping mechanism is located at the distal end of the shaft, i.e., it can be fixed. The hitch gripping mechanism comprises a mandrel and a plurality of tubes and wires that interact with each other to form a loop that can be appropriately opened and closed when the mandrel is displaced relative to the shaft. The hitch gripping mechanism may comprise at least two tubes, particularly three to five tubes, and a corresponding number of wires.

[0017] A mandrel is an elongated, preferably metallic, member such as a wire, cable, or rod, which may be bent and, when guided within a shaft, can transmit tensile forces and compressive forces along its longitudinal direction. The outer diameter of the mandrel is generally smaller than the inner diameter of the shaft so that the mandrel can be housed within the shaft and displaced longitudinally relative to the shaft. In particular, the mandrel may be drawn in to a proximal position where the mandrel (i.e., its geometric center) is closer to the proximal end of the shaft than to a distal position, and may be pushed out to a distal position where the mandrel is closer to the distal end of the shaft than to a proximal position.

[0018] The tube is positioned at the distal end of the shaft and extends from the distal end of the shaft. The tube is elongated, hollow, and bendable. However, the tube is preferably substantially incompressible along its longitudinal direction. The tube may be made of various materials such as plastic or metal. The tube may be preformed and / or pre-stressed into an intended shape, and such shape may be linear or curved.

[0019] The wire is also positioned at the distal end of the shaft and extends from the distal end of the shaft. The wire is slender and bendable. Preferably, the wire is substantially incompressible along its longitudinal direction. Generally, the wire has an outer diameter smaller than the inner diameter of the tube so that at least a first portion of each wire may extend across the entire internal volume of the relevant tube and be displaced longitudinally relative to the relevant tube. The wire may be made of a metallic material. Preferably, the wire contains or consists of a metallic material that allows for some morphogenesis. For example, the wire may contain or consist of nitinol. Nitinol wires are typically kink-resistant and superelastic. These properties, combined with the set morphology of the wire, result in a loop that is very suitable for catching the hitch of the ILP. The wire may be preformed and / or pre-stressed into an intended shape, and such shape may be linear or curved.

[0020] The wires may be made of some radiopaque material to make them more visible under fluorescence fluoroscopy. Although nitinol wires are explicitly mentioned above, the wires may be made of any fluorescence-visible or non-fluorescence-visible material that allows for morphogenesis and provides some kink resistance and / or superelasticity.

[0021] The wires, tubes, and mandrels are connected to each other and / or to the shaft, and are displaceable in a particular way with respect to each other and / or to the shaft. In particular, each wire is displaceable with respect to the associated tube, extending with its first portion throughout the entire internal volume of the associated tube, while its second portion generally extends away from the associated tube toward the associated adjacent tube. Thus, the associated tube and the associated adjacent tube are interconnected with each other via a wire connecting them. This causes the two adjacent tubes to form a loop together with the interconnecting wire.

[0022] There, the first end of each wire is fixed to the shaft, that is, the first end of such a wire is either stationary on the shaft or positioned at a predetermined distance from the shaft, insofar as the shaft is stationary and the first end of the wire can move with the shaft. The second end of the wire is fixed to the mandrel and may be displaced relative to the shaft.

[0023] Such configuration and fixing of the first and second ends allows the wire, together with the associated tube and associated adjacent tube, to form a loop that may be closed by pulling the mandrel to its proximal position relative to the shaft and opened by pushing the mandrel to its distal position relative to the shaft. Therein, in the closed configuration, the loop has a minimum lateral dimension. In particular, by pulling the mandrel to its proximal position, the wire attached thereto is pulled in such a way that it pulls the associated tube and associated adjacent tube toward each other, thereby reducing the distance between the two tubes and thus reducing the lateral dimension of the loop to its closed configuration. In the other direction, by pushing the mandrel to its distal position, the wire attached thereto is pushed in such a way that it pushes the associated tube and associated adjacent tube toward each other, thereby increasing the distance between the two tubes and accordingly increasing the lateral dimension of the loop to its open configuration.

[0024] Therefore, in such a particular hitch gripping mechanism, the loop can be precisely opened and closed by appropriately displacing the mandrel relative to the surrounding shaft, while the shaft itself may remain substantially stationary at its distal end along with the loop. In other words, as a result of a specific arrangement of multiple tubes and multiple wires extending through the tubes, one end of which is fixed to the shaft and the other end to the mandrel, the hitch gripping mechanism can precisely open and close the loop, and the opening and closing motion can be precisely controlled by a simple linear displacement of the mandrel relative to the shaft.

[0025] According to one embodiment, at least one of the wire and the tube is mechanically pre-formed to bend radially away from the longitudinal axis of the shaft.

[0026] In other words, at least one wire and / or at least one tube is mechanically pre-formed so as to bend away from the longitudinal axis of the shaft when no external force is applied to the respective wire or tube. In particular, the wire is pre-formed so as to form a circle that expands radially from the longitudinal axis of the shaft at the distal end. Thus, when the wire is no longer forced into a straight shape along the longitudinal axis of the shaft, i.e., when the mandrel is in its distal position, the wire and / or tube bend into an open (pre-formed) configuration having a maximum lateral dimension. However, when the wire is drawn in by pulling the mandrel to its proximal position, the wire draws the associated tubes and adjacent tubes towards each other and thus bends into a closed configuration having a minimum lateral dimension relative to the wire's inherent pre-formed configuration.

[0027] According to one embodiment, the first end of each wire is fixed to an associated adjacent tube. The wire may be adhered or fastened to the distal end of an adjacent tube, inserted into the lumen of an adjacent tube and fixed therein, and / or passed through the lumen of an adjacent tube and fixed somewhere proximal to the shaft.

[0028] Generally, the first end of the wire, in contrast to the second end of the wire, may be attached to any component as long as this first end of the wire is fixed relative to the shaft so that it does not displace with the mandrel. However, it has been found beneficial to fix and attach the first end of the wire to an associated adjacent tube. In other words, while a portion of the wire extends through the associated tube, another portion of the wire extends from the associated tube to an associated adjacent tube, and its distal end (first end) is fixed to the adjacent tube or within the adjacent tube, or passed through the adjacent tube and fixed to the shaft. Such fixation can be established easily and reliably.

[0029] According to one embodiment, at least one of the wire and the tube comprises a radiopaque material.

[0030] In other words, at least one of the wires and / or at least one of the tubes may comprise or consist of a radiopaque material. By providing such a radiopaque material, each wire or tube may be visible by fluoroscopy taken during the implantation procedure. This may facilitate the accurate positioning of a hitch gripping mechanism having a loop for connecting a hitch of an implanted medical device. Further, a physician may be able to observe the hitch gripping mechanism and its interaction with the medical device, thereby facilitating an attempt to capture the medical device by the gripping mechanism.

[0031] According to one embodiment, the inner catheter is operable.

[0032] An operable catheter may generally be bent laterally into a curved shape. With such bending ability, an operable catheter may be accurately steered and moved, for example, throughout a blood vessel and may follow the path of the blood vessel. In particular, upon reaching a cardiac chamber, the distal end of the operable catheter may be accurately positioned relative to the heart wall defining the cardiac chamber. Thus, since the catheter can be accurately steered, a shaft extending through the catheter, particularly a hitch gripping mechanism disposed at the distal end of this shaft, can be accurately steered and positioned relative to, for example, an implanted medical device to be implanted.

[0033] According to one embodiment, the inner catheter comprises at its distal end an alignment cone for receiving and / or aligning at least the end portion of an implantable medical device when drawn towards the inner catheter.

[0034] An alignment cone is generally formed by a portion of the inner catheter at or near its distal end, such a portion having a wider inner diameter compared to the inner diameter of the rest of the inner catheter. Due to this wider inner diameter and its conical shape, the alignment cone may have a shape substantially complementary to the shape of the end (i.e., the hitch) of the implanted medical device. Thus, during explantation, the medical device may be grasped at its end by a hitch gripping mechanism, and the inner catheter may be advanced toward the medical device so that it is ultimately aligned with and / or at least partially housed within the alignment cone. In such a configuration, the removed medical device is securely retained at the distal end of the inner catheter.

[0035] According to one embodiment, the alignment cone includes a radiopaque material.

[0036] By providing such radiopaque material, at least a portion of the alignment cone may be visible by fluoroscopy during the explantation procedure. Thus, the accurate explantation of the medical device and its placement within the alignment cone may be monitored.

[0037] According to one embodiment, the catheter device further comprises a handle coupled to the proximal end of an inner catheter. There, the handle comprises a housing coupled to the inner catheter and a grabber mechanism control unit. The grabber mechanism control unit includes an actuator displaceable relative to the housing. The actuator is mechanically coupled to a mandrel and a shaft such that initial operation of the actuator induces a change in the loop between its closed configuration and its open configuration, while subsequent operation of the actuator induces a displacement of the shaft between its retracted position and its protruding position.

[0038] The handle may be used to displace the internal catheter, along with its shaft and its hitch grasping mechanism, to the intended explantation site. After reaching such a site, an actuator for the grabber mechanism control unit may be used to adjust the loop of the hitch grasping mechanism to its open configuration, and then displace the shaft, along with the open loop, toward its protruding position to approach the hitch of the implanted medical device.

[0039] In this configuration, the actuator is coupled to the mandrel and shaft in a specific manner, and as a result, when the actuator is activated, the loop first enters its open configuration, and only afterward the shaft and the open loop are displaced toward the medical device. Such continuous loop opening and displacement can substantially simplify the capture of the hitch of the medical device. Furthermore, a specific mechanical coupling between the actuator and the mandrel and shaft ensures that when the hitch is captured, the loop first enters its closed configuration, and only afterward the shaft is pulled back to the retracted position along with the loop. Again, such continuous loop closing and displacement can substantially simplify the explantation procedure.

[0040] According to a further specific embodiment, the grabber mechanism control unit is configured such that when the actuator is first actuated in a first operating direction, the mandrel is displaced from its proximal position to its distal position and the shaft is held stationary relative to the internal catheter, and when the actuator is subsequently actuated in the first operating direction, the shaft is displaced from its retracted position to its protruding position.

[0041] In other words, the grabber mechanism control unit may be functionally adapted such that, when the actuator is actuated, as a first action, the mandrel is displaced from its proximal position to its distal position, and only after such a first action, as a second action, the shaft is displaced from its retracted position to its protruding position. There, the direction of operation may be linear, i.e., the actuator may be pushed linearly from the initial position to the final position, and during such linear operation, the mandrel is displaced first, followed by the shaft. Alternatively, the direction of operation may be nonlinear. For example, the grabber mechanism control unit may be configured such that its actuator is displaced along a curved path and / or rotated. In such alternative methods, when the actuator is actuated, the mandrel is displaced first, followed only by the shaft. In such functional embodiments, the loop is opened by the first displaced mandrel and then displaced toward the medical device to be explanted together with the displaced shaft.

[0042] Similarly, according to another further specific embodiment, the grabber mechanism control unit is configured such that when the actuator is first actuated in a second operating direction, the mandrel is displaced from its distal position to its proximal position and the shaft is held stationary relative to the internal catheter, and when the actuator is subsequently actuated in a second operating direction, the shaft is displaced from its protruding position to its retracted position.

[0043] In this case, the actuator is actuated in a second operating direction that is nearly opposite to the first operating direction. There, too, the mandrel is first displaced, thereby moving it to its proximal position, which in turn closes the loop of the hitch gripping mechanism, and then the loop is pulled back toward the retracted position together with the shaft, thereby pulling back and explanting the medical device that has been captured in the loop.

[0044] According to one embodiment, the grabber mechanism control unit comprises a mandrel carriage and a shaft carriage. There, the mandrel carriage is fixedly coupled to an actuator and a mandrel, and the mandrel carriage is displaceable relative to the shaft carriage between a first position and a second position. The shaft carriage is fixedly coupled to a shaft, and the shaft carriage is displaceable relative to the housing between a third position and a fourth position. The mandrel carriage interacts with the shaft carriage, and when the mandrel is pushed in a first direction from the first position to the second position, the displacement force is not transmitted from the mandrel carriage to the shaft carriage, thereby causing the shaft carriage to remain stationary relative to the housing. When the mandrel carriage is pushed further in the first direction from the second position, the displacement force is transmitted from the mandrel carriage to the shaft carriage, thereby pushing the shaft carriage from its third position to its fourth position. Alternatively or additionally, the mandrel carriage interacts with the shaft carriage, and when the mandrel is pulled in a second direction from a second position to a first position, the displacement force is not transmitted from the mandrel carriage to the shaft carriage, thereby causing the shaft carriage to remain stationary relative to the housing; when the mandrel carriage is pulled further in a second direction from the first position, the displacement force is transmitted from the mandrel carriage to the shaft carriage, thereby pulling the shaft carriage from its fourth position to its third position.

[0045] According to such a structural embodiment, the grabber mechanism control unit comprises at least two components, namely a mandrel carriage and a shaft carriage. These components interact with each other and are displaceable relative to each other. Furthermore, the components interact with the actuator on one hand and with the mandrel and shaft on the other, respectively. Such a structural embodiment can realize the functional characteristics described in the previous paragraph. In such an embodiment, loop opening and closing and loop displacement (distal or proximal) can be controlled by the same actuator, which simplifies the extraction procedure for the physician. The actuator, in particular the slider, can be used by the physician with one hand. Possible details of such a structural embodiment are described further below with reference to the accompanying drawings.

[0046] According to one embodiment, the catheter device further comprises an elongated outer catheter, in which the inner catheter extends throughout the entire internal volume of the outer catheter and is displaceable longitudinally relative to the outer catheter.

[0047] In other words, in addition to the inner catheter, a catheter device generally includes an outer catheter that surrounds the inner catheter. The outer catheter generally has a substantially larger diameter than the inner catheter and can be adapted to accommodate a medical device when explanted.

[0048] According to one embodiment, the external catheter is uncontrollable.

[0049] In particular, the outer catheter does not necessarily have to be maneuverable and may therefore be relatively simple. Alternatively, during the explantation procedure, the maneuverable inner catheter may first be guided toward the explantation site, and then the non-maneuverable outer catheter may be displaced along the inner catheter and made to follow the path of the inner catheter.

[0050] According to one embodiment, the external catheter is provided with a protector cup at its distal end, the protector cup having a widened inner diameter for accommodating at least a portion of an implantable medical device.

[0051] According to one embodiment, the external catheter includes a fluoroscopic marker at its distal end and / or a visible marker at a position away from its distal end.

[0052] Possible details of the above-described embodiments and the features of the external catheter are described below with reference to the attached drawings.

[0053] It should be noted that possible features and advantages of embodiments of the present invention are described herein in part with respect to catheter devices and in part with respect to methods of using such catheter devices. Those skilled in the art will recognize that features can be appropriately moved from one embodiment to another, and that features can be modified, adapted, combined, and / or replaced to arrive at further embodiments of the present invention.

[0054] Advantageous embodiments of the present invention will be described below with reference to the attached drawings. However, neither the drawings nor the description should be construed as limiting the present invention. [Brief explanation of the drawing]

[0055] [Figure 1] This shows an overall diagram of a catheter device according to one embodiment of the present invention. [Figure 2] Figure 1 shows a partial view of the distal portion of the catheter device. [Figure 3] Figure 1 shows a partial view of the proximal portion of the catheter device. [Figure 4A] Figure 1 shows an enlarged view of the hitch gripping mechanism of the catheter device, where the loop is in an open configuration. [Figure 4B] Figure 1 shows an enlarged view of the hitch gripping mechanism of the catheter device, where the loop is in a closed configuration. [Figure 5]Figure 1 shows cross-sectional views of some of the main components of the hitch gripping device located at the distal end of the catheter. [Figure 5a] Figure 1 shows a more detailed schematic diagram of some selected components of the hitch gripping device. [Figure 6A] This visualizes the series of operations of the catheter device shown in Figure 1 during the explantation procedure. [Figure 6B] This visualizes the series of operations of the catheter device shown in Figure 1 during the explantation procedure. [Figure 6C] This visualizes the series of operations of the catheter device shown in Figure 1 during the explantation procedure. [Figure 6D] This visualizes the series of operations of the catheter device shown in Figure 1 during the explantation procedure. [Figure 6E] This visualizes the series of operations of the catheter device shown in Figure 1 during the explantation procedure. [Figure 7] Visualize another operational step during the explantation procedure.

[0056] The drawings are only schematic and do not represent the actual size. The same reference numerals indicate the same or similar features.

[0057] Figure 1 shows the entire catheter device 1. Figures 2 and 3 show enlarged views of the distal and proximal portions of the catheter device 1, respectively. Figures 4A and 4B show enlarged views of the hitch gripping mechanism 7 of the catheter device 1. Figure 5 shows a cross-sectional view representing several hitch gripping devices located at the distal end of the catheter 1.

[0058] The catheter device 1 is configured to connect the hitch 65 of an implantable medical device 61 (see Figure 6D), such as an implantable leadless space maker 63, during the procedure for explanting the medical device 61.

[0059] The catheter device 1 comprises an elongated inner catheter 3, an elongated shaft 5, and a hitch gripping mechanism 7. Furthermore, the catheter device 1 comprises an outer catheter 51 and a handle 33. The shaft 5 extends along the internal volume of the inner catheter 3 and may be displaced longitudinally relative to the inner catheter 3. The inner catheter 3 is maneuverable. The movement of the inner catheter 3 may be controlled using a steering knob 71 provided on the handle 33. The inner catheter 3 has an alignment cone 29 at its distal end 31, and when retracted toward the inner catheter 3, the implantable medical device 61 can be housed in and / or aligned with the alignment cone 29. The alignment cone 29 contains a radiopaque material. The inner catheter 3 may be flushed with fluid via a catheter flushing port 73. The inner catheter 3 extends through the internal volume of the outer catheter 51 and is displaceable longitudinally relative to the outer catheter 51. The outer catheter 51 is not maneuverable. The outer catheter 51 is equipped with a protector cup 53 at its distal end 55. Due to its locally enlarged inner diameter, such a protector cup 53 may accommodate at least part, or preferably all, of the implantable medical device 61. The distal end 55 of the outer catheter 51 is provided with a fluoroscopic marker 57. Furthermore, a visible marker 59 may be provided at a distance from the distal end 55 and function as a visual introducer cover band.

[0060] In another embodiment (not shown), the lavage port may be attached to the grabber mechanism shaft 5 and then have several holes through the shaft so that when the grabber mechanism is lavaged, the holes are interconnected with the inner catheter, thereby allowing both shafts to be lavaged simultaneously. Another embodiment (not shown) is a lavage port attached to all three shafts (shaft, inner catheter, and outer catheter), so that each of the three shafts can be lavaged independently.

[0061] The hitch gripping mechanism 7 is located at the distal end 9 of the shaft 5. The hitch gripping mechanism 7 comprises a mandrel 11, a plurality of tubes 13, and a plurality of wires 15. The mandrel 11 extends throughout the entire internal volume of the shaft 5 and is displaceable longitudinally relative to the shaft 5. In particular, the mandrel 11 can be displaced longitudinally between a proximal and distal position via interaction with the handle 33, as will be further described below. The plurality of tubes 13 extend longitudinally from the distal end 9 of the shaft 5. Each of the wires 15 partially extends across the entire internal volume of the associated tube 13' toward the associated adjacent tube 13''. In particular, a first portion 17 of each wire 15 extends throughout the entire associated tube 13', while a second portion 19 of the wire is exposed from the associated tube 13' and extends toward the associated adjacent tube 13'', where the first end 21 of each wire 15 is fixed to the shaft 5. In the example shown in Figure 5, such a first end 21 is fixedly attached to the distal end 27 of the associated adjacent pipe 13'' and is therefore held at a predetermined distance from the shaft 5, such predetermined distance corresponding to the length of the associated adjacent pipe 13''. The opposite second end 23 of each wire 15 is fixed to the mandrel 11 and is displaceable relative to the shaft 5.

[0062] Figure 5a provides a more detailed schematic representation of two exemplary tubes 13' and 13'' of the grabber mechanism in the transition from a closed configuration (left) to an open configuration (right). Both tubes 13' and 13'' contain two lumens 50a and 50b. The first end 21 of the wire 15 is fixedly attached (e.g., glued) to one lumen 50b of tube 13'' and connected to the mandrel 11 via the corresponding lumen 50a of the adjacent tube 13'. The wire 15 is secured to the mandrel 11 via a crimp connection 11a.

[0063] As a result of this structural configuration, each wire 15 forms a loop 25 with its associated tube 13' and its associated adjacent tube 13''. This loop 25 can be opened and closed by appropriately displacing the mandrel 11. Specifically, when the mandrel 11 is retracted to its proximal position relative to the shaft 5, the loop 25 is retracted into a closed configuration with minimum lateral dimension, as shown in Figure 4B. When the mandrel 11 is pushed out in the other direction to its distal position relative to the shaft 5, the loop 25 is pushed out into an open configuration with maximum lateral dimension, as shown in Figure 4A.

[0064] To enable the hitch gripping mechanism 7 to operate properly, the handle 33 comprises a housing 37 and a grabber mechanism control unit 39 including an actuator 41. The handle 33 is coupled to the proximal end 35 of the inner catheter 3. In particular, the housing 37 is coupled to the inner catheter 3. The grabber mechanism control unit 39 comprises a mandrel carrier 47 and a shaft carriage 49. The mandrel carrier 47 is fixedly coupled to the actuator 41 such that any operation of the actuator 41 results in a direct displacement of the mandrel carrier 47. The mandrel carrier 47 is further fixedly coupled to the mandrel 11 such that any displacement of the mandrel carriage 47 results in a corresponding displacement of the mandrel 11. Furthermore, the mandrel carriage 47 is displaceable relative to the shaft carriage 49 between a first position and a second position. The shaft carriage 49 is fixedly coupled to the shaft 5 such that any displacement of the shaft carriage 47 results in a corresponding displacement of the shaft 5. Furthermore, the shaft carriage 49 is displaceable relative to the housing 37 between a third position and a fourth position.

[0065] The operation of the handle 33 and its cooperation with other components of the catheter device 1 are shown in Figures 6A to 6E, where a series of processing steps are represented for the process by which the implanted medical device 61 is grasped and explanted using the hitch gripping mechanism 7 of the catheter device. Figure 7 shows the final stage of the process in which the tethered medical device 61 is housed in the protector cup 53 of the outer catheter 51.

[0066] The actuator 41 of the handle 33 may be actuated by the physician during the explantation process. The actuator 41 is displaceable relative to the housing 37 in a linear first operating direction 43 and a contralinear second operating direction 45. The actuator 41 is mechanically coupled to the mandrel 11 and shaft 5 in a specific manner, so that the first actuation of the actuator 41 acts the hitch gripping mechanism 7 to change the loop 25 from its closed configuration to its open configuration or vice versa, and subsequent actsuation of the actuator 41 induces the displacement of the shaft 5 between its retracted position and its protruding position or vice versa. The various displacement actions in the actuator 41 and the resulting reactions in the hitch gripping mechanism 7 are visualized in a series of Figures 6A to 6E, further highlighted by arrows included in each subfigure.

[0067] Specifically, the sequence begins when the internal catheter 3 is correctly positioned with its distal end close to the explantation site (see Figure 6A). In this situation, the actuator 41 is in its initial position, the mandrel carriage 47 is in its first position, and the shaft carriage 49 is in its third position.

[0068] Starting from such an initial configuration, the actuator 41 is first pushed in a first operating direction 43 (see Figure 6B). During such initial operation, the mandrel carriage 47 is pushed from its first position to its second position relative to the shaft carriage 49, and the mandrel 11 is pushed distally in the direction corresponding to the first operating direction 43, thereby changing the configuration of the hitch gripping mechanism 7 from its closed loop configuration as shown in Figure 6A to its open loop configuration as shown in Figure 6B. There, the mandrel carriage 47 interacts with the shaft carriage 49 in such a way that no substantial displacement force is transmitted from the mandrel carriage 47 to the shaft carriage 49. Thus, the shaft carriage 49 is stationary relative to the housing 37.

[0069] When the actuator 41 is further pushed in the first operating direction 43 (see Figure 6C), the mandrel carriage 47 not only further displaces the mandrel 11 distally, but the displacement force is also transmitted from the mandrel carriage 47 to the shaft carriage 49, thereby pushing the shaft carriage 49 from its third position to its fourth position. Such displacement of the shaft carriage 49 displaces the shaft 5 distally toward the medical device 61. In particular, the hitch gripping mechanism 7 may be pushed toward the medical device 61 together with the shaft 5 so that its open loop 25 approaches the hitch 65 of the medical device 61.

[0070] Next, the actuator 41 is retracted in the second operating direction 45 (see Figure 6D). As a result of this retraction, the mandrel carriage 47 is displaced from its second position back to its first position relative to the shaft carriage 49, initially only displacing the mandrel 11 proximal, while no substantial displacement force is transmitted from the mandrel carriage 47 to the shaft carriage 49, thereby causing the shaft carriage 49 to become stationary in its fourth position. Thus, the mandrel 11 is displaced relative to the shaft 5 in the second operating direction 45. As a result of this displacement, the mandrel 11 retracts the hitch gripping mechanism 7 to close the previously open loop 25. The closed loop 25 is then able to connect to and grip the hitch 65 of the medical device 61.

[0071] As the actuator 41 is further retracted in the second operating direction 45 (see Figure 6E), the mandrel carriage 47 begins to transmit the displacement force to the shaft carriage 49. Thus, both carriages 47 and 49 are displaced together, and the shaft carriage 49 returns from its previous fourth position to its third position. This displacement motion displaces the shaft 5, together with the hitch gripping mechanism 7 and the medical device 61 it grips, toward the inner catheter 3. When it is close enough to the inner catheter 3, the rear surface of the medical device 61 contacts the alignment cone 29 and is aligned with the inner catheter 3.

[0072] Finally, by appropriately displacing the outer catheter control hub 67, the outer catheter 51 is pushed toward the distal end of the inner catheter 3 (see Figure 7). This pushes the protector cup 53 of the distal end 55 of the outer catheter 51 so that it covers the medical device 61. Thus, the medical device 61, housed within the protector cup 53, may then be explanted from the patient.

[0073] Next, some further background information and some further descriptions and details relating to embodiments of the catheter devices disclosed herein are given, in slightly alternative terms.

[0074] As an introduction, I will briefly summarize it as follows. An invention for designing a novel catheter that facilitates the explantation of a leadless pacemaker is disclosed.

[0075] This design provides an excellent means of steering and re-acquiring a leadless pacemaker acutely placed in either the interventricular septum or apex, or within the atrial appendage. It should be noted that acute implantation refers to the days, weeks, and potentially months (not exceeding 6 months) following the initial implantation of a leadless pacemaker. Once encapsulated, the leadless pacemaker is no longer recognized as acutely implanted.

[0076] Furthermore, this leadless pacemaker explantation catheter design provides an excellent means of establishing a connection between the catheter and the leadless pacemaker by using a custom gripping mechanism mechanically incorporated into the catheter handle design in a novel manner. This gripping mechanism and its incorporation into the catheter handle design can be interpreted as being central to the concepts presented herein.

[0077] In summary, the disclosed method provides the user with a means to steer a leadless pacemaker, either positioned in the apex, septum, or appendage of the right ventricle, to establish a secure connection to the leadless pacemaker, to re-cover the leadless pacemaker once implanted, and to safely and reliably remove the device and catheter from the patient's anatomical structure.

[0078] Here, some background information is provided as follows: The implantation of a leadless pacemaker requires the proper positioning and delivery of the implant to a specific location in the heart. During this procedure, the device is implanted in the heart and secured there by an appropriate fixation mechanism (e.g., multiple flexible metal tines). Electrical and fixation measurements are performed by the user to ensure that the implantation site is appropriate before the implant is removed.

[0079] However, in some cases, even after assessing the suitability of the implantation site and releasing the implant, the implant's position may be deemed unacceptable for the implant to function properly. This assessment can be performed hours, days, weeks, and potentially months after implantation of a leadless space maker. In these situations, the physician must remove the implant from the patient because tissue ingrowth and encapsulation into the implant have not yet occurred.

[0080] Accordingly, the disclosures detailed herein are specific to the design of catheter tools that enable a user to easily and reliably steer, re-cover, and remove an implant and catheter from the patient's anatomical structure to a leadless pacemaker implanted in either the apex or septum of the right ventricle or within the atrial appendage.

[0081] Currently, there is one known solution in the field that features catheters specifically used for explantation of leadless pacemakers. In this solution, a dedicated explantation catheter is used to remove a screw-based fixed leadless pacemaker from the right ventricle. This design solution involves the catheter using a handle mechanism to unscrew the implant from the anatomical structure, re-cover it, and grasp the implant using either a triple-loop or single-loop snare within the catheter before removing it from the anatomical structure.

[0082] Another approach involves using an implantable catheter with a pre-loaded snare instead of a dedicated explantation catheter to re-cover the tine-based leadless pacemaker. However, implantable catheters with snares cannot easily, safely, or reliably explant the leadless pacemaker, and as a result, the majority of users have abandoned this explantation technique, opting instead to steer to the implant using a ready-made, maneuverable sheath. This involves using a ready-made snare with a diameter of approximately 10-20 mm to establish connection to the implant, and then pulling the implant out of the heart wall, from the right ventricle, across the tricuspid valve, and through the introducer to explant it from the anatomical structure.

[0083] Finally, since there are currently no known atrial appendage leadless pacemaker implants available in the field, there is no known solution for atrial appendage explantation catheters.

[0084] Some of the known drawbacks of the solutions are as follows: One known technique requires the use of a considerable number of control units and actuators on the catheter's handle to manipulate the snare to establish a tethered connection to a screw-based fixed implant. This technique then requires the use of additional control to unscrew the implant from the fixed anatomical structure before it can finally be re-covered within the catheter and removed from the anatomical structure. The considerable number of control units and actuators required to perform these steps and procedures gives the catheter a high degree of complexity and low utility. It is also used only for explantation from the right ventricle.

[0085] Another approach involves using an implantable catheter with a pre-loaded snare instead of a dedicated explantation catheter to re-cover a tine-based leadless pacemaker in acute situations. However, implantable catheters with snares cannot easily, safely, or reliably explant leadless pacemakers. Due to the length of the implant catheter, only microloop snares can be used with the implant catheter, and the use of microsnare loops makes establishing a connection to the implant extremely difficult. This is because the loop's diameter is so small that it requires the user to be extremely precise while attempting to establish a connection between the loop and the implant. Furthermore, maneuvering and steering the implant catheter makes the explantation purpose extremely difficult due to the long, rigid, non-flexible cup at the distal end of those implant catheters. Due to these usability issues, the majority of users have abandoned this explantation technique, opting instead to steer to the implant using a ready-made, maneuverable sheath. Instead, they now use a ready-made snare approximately 10-20 mm in diameter to establish connection to the implant and then pull the implant out of the heart wall, from the right ventricle, across the tricuspid valve, and down through the introducer to explant it from the anatomical structure. This leaves the implant's fixation mechanism exposed throughout the entire removal process, potentially allowing excessive force to be applied to the heart wall during the removal process (potentially tearing and opening the wall) and allowing the fixation mechanism to catch on structures within the heart while being pulled out from the anatomical structure (potentially leading to damage to anatomical structures).

[0086] Therefore, the objective is to design a catheter tool that allows the user to easily and reliably steer a leadless pacemaker implanted in the apex or septum of the right ventricle or within the atrial appendage, to easily and reliably establish a connection between the implant and the catheter, to re-cover the implant within the catheter, and to provide a means for removing the implant and catheter from the patient's anatomical structure.

[0087] As shown in Figures 1-4, the design solution consists of a non-maneuverable, linear but flexible outer catheter connected to a protector cup used to re-cover the implant and its fixation mechanism, allowing the implant to be safely removed from anatomical structures. The outer catheter is connected to a control hub used to advance and retract the outer catheter on a maneuverable inner catheter. The OC control hub also has a flush port / tube for flushing air out of the outer catheter.

[0088] The design solution also consists of a maneuverable catheter used to steer to an implant positioned either in the apex or septum of the right ventricle or within the atrial appendage. The maneuverable catheter has a fluoroscopic alignment cone at its distal tip, used to protect the implant hitch from damage during interaction with the protector cup on the outer catheter during the recoating process. The handle also has a steering control knob for steering the maneuverable catheter. The handle is mechanically designed so that when the user releases their hand from the handle or handle steering actuator, the steering position remains fixed and does not loosen or return to its nominal / starting position. The non-maneuverable outer catheter has a hub used to advance the outer maneuverable catheter distally on the maneuverable catheter to recoat the implant. The maneuverable catheter has no pre-shape curve and is perfectly linear with respect to its zero position to facilitate steering to the atrial appendage and across the tricuspid valve to the right ventricle.

[0089] In a second embodiment, the maneuverable catheter may have a pre-shaped curve to facilitate steering across the tricuspid valve to the right ventricle only. In this second embodiment, the explantation catheter is used only to explant a leadless pacemaker from the right ventricle, and not from both the right ventricle and the atrial appendage.

[0090] Additionally, there is a non-maneuverable catheter-based hitch gripping mechanism that extends longitudinally from the main handle of the catheter through the maneuverable catheter and terminates at the distal end of the maneuverable catheter. This hitch gripping mechanism is used to establish a connection between the catheter and the implant so that it can be detached from anatomical structures.

[0091] The hitch grasping mechanism is controlled via a single actuator on the catheter handle. The distal end of the hitch grasping mechanism consists of three or more tubes into which nitinol wires are interwoven to form loops (see, in particular, Figures 4 and 5). One end of each nitinol wire is fixed to the shaft of the mechanism, and the other end of each nitinol wire is connected to a mandrel. The mandrel is used to push the wire distally to open the loop and to pull the wire proximal to close the loop. The mandrel is connected to an actuator on the handle used to control the grabber mechanism.

[0092] The hitch gripping mechanism is operated via a single actuator on the handle. The actuator has two independent functions. The first function is to open and close the loop. The second function is to advance and retract the mechanism distally and proximal in a nested manner. To advance the slider distally, the loop is always opened first, and then the slider can be advanced distally in a nested manner by continuing to advance it distally. To retract the slider proximal, the loop is always closed first, and then the slider can be retracted proximally in a nested manner by continuing to retract it proximal. This can be seen in Figures 6A to 6E.

[0093] The design of this mechanism ensures that the loop is always open when advancing outward from the maneuverable catheter and always closed when retracting inward from the maneuverable catheter. This is a key design element of this novel design solution. Another key design element of this design is that the loop can be closed on the hitch before being retracted. This prevents the problem of having to advance or retract the entire catheter assembly while attempting to perform an action to establish a connection between the catheter and the implant.

[0094] Once the implant's hitch gripping mechanism successfully establishes a connection between the catheter and the implant, and the slider is fully retracted so that the implant's hitch seats inside the alignment cone (see Figure 6D), the outer catheter hub can be advanced distally, thereby pushing the outer catheter and protector cup onto the maneuverable catheter (as if the catheter were a guide rail) and onto the implant, allowing the implant to be re-covered inside. This can be seen in Figure 7.

[0095] The proposed design solution may incorporate one of the following features: 1.) A visual marker on the outer catheter to indicate when the catheter has been fully inserted into its introducer and when it is time to begin using fluoroscopy. This can be seen as the “introducer catheter band” or visible marker in Figure 1 above.

[0096] 2.) A maneuverable internal catheter that can be fully flexed along its distal end, improving control and maneuverability, allowing the user to easily steer it across the tricuspid valve from the atrium to the right ventricle, steer it to the implantation site within the right ventricle, and steer it to the implant placed in the atrial appendage.

[0097] 3.) A fluoroscopic-visible alignment cone attached to the distal end of a maneuverable internal catheter, used to seat the implant hitch and protect the hitch from damage due to interaction with the protector cup during the re-covering process.

[0098] 4.) A non-maneuverable external catheter having a shape-setting curve that allows it to be advanced distally and proximal on a maneuverable internal catheter, even when the maneuverable internal catheter is bent along a steep angle or complex shape.

[0099] 5.) A novel, unmaneuverable internal catheter-based implant hitch grasping mechanism having a loop at its distal end controlled by a single actuator on the catheter handle.

[0100] 6.) The hitch gripping mechanism includes three or more "finger" components used to form a loop by advancing and retracting a nitinol wire that extends inside the fingers, which are attached to a mandrel mounted on the catheter's handle / actuator.

[0101] 7.) A hitch gripping mechanism that is fluorescently visible by including a fluorescently visible wire and / or tube having loops and fingers.

[0102] 8.) When operated on the handle, distal advancement of the actuator for the gripping mechanism always opens the loop before advancing the loop distally.

[0103] 9.) When operated on the handle, the proximal retraction of the actuator for the gripping mechanism always closes the loop before retracting the loop proximal.

[0104] 10.) The loop is always fully open or closed during each process, remaining stationary in its position before the hitch gripping mechanism moves forward in a nested manner distally or retracts proximal.

[0105] 11.) A hitch gripping mechanism having a loop that is always open when advancing outward from the maneuverable catheter and always closed when retracting inward from the maneuverable catheter.

[0106] 12.) The open loop diameter of the hitch gripping mechanism is in the range of 10 to 25 mm in diameter.

[0107] 13.) A hitch gripping handle mechanism comprising two components (shown in Figures 6A to 6E) having the following functions. a. A mandrel carriage connected to a wire at the distal end of the hitch gripping mechanism. When it moves forward, the wire pushes the loop open. When it moves backward, the wire pulls the loop closed. When the actuator is moved distally, the mandrel carriage (directly connected to the actuator) moves forward with the actuator until the loop is open. b. A shaft carriage that can only move forward or backward after the loop has opened or closed following the movement of the mandrel carriage. For example, after the loop opens, the mandrel carriage makes contact with the shaft carriage and begins to push both the shaft wire and the loop wire distally, thereby moving the entire assembly distally in a nested manner (see Figures 6A-6C). When the actuator is moved proximal, the mandrel carriage moves proximal independently of the shaft carriage until the loop is closed. At that point, the mandrel carriage makes contact with the shaft carriage again and begins to pull both the shaft wire and the loop wire proximal, moving the entire assembly backward in a nested manner (see Figures 6D-6E).

[0108] 14.) A steering mechanism or actuator that enables advanced user control over a maneuverable internal catheter. The steering mechanism or actuator maintains the fixed steering position of the catheter even when the user releases their hands from the mechanism or actuator.

[0109] 15.) The user's ability to safely and reliably re-cover the implant within the implant protector cup of the external catheter.

[0110] 16.) The ability to safely remove implants and catheter tooling from anatomical structures.

[0111] This technique presents a specialized tool specifically designed to safely and reliably steer the implant to a leadless pacemaker located either in the interventricular septum or apex of the right ventricle, or to a leadless pacemaker located in the atrial appendage, establish a connection to the implant hitch via a novel grasping mechanism, and explant the implant by re-capturing it in a protector cup located at the distal end of the lateral catheter of the explantation catheter, and to safely remove the implant and catheter from the patient's anatomical structure.

[0112] Embodiments of the present invention provide at least one of the following advantages. 1.) A maneuverable internal catheter used as a means of safely, reliably, and easily navigating to the implantation site. This is achieved by not having an implant protector cup attached to the maneuverable internal catheter. The implant protector cup acts as a long, straight, non-bending component that can hinder movement through paths with narrow geometric shapes and small radii of curvature. When a leadless pacemaker is implanted, it is important to allow the user as much control as possible to navigate the catheter to the implant.

[0113] 2.) A hitch gripping mechanism used to easily, safely, and reliably establish a connection between the catheter and the implant, so that the implant can be re-covered within the catheter and removed from the anatomical structure. The main advantages of the hitch gripping mechanism are as follows: a. When activated on the handle, distal advancement of the actuator for the gripping mechanism always opens the loop before advancing the loop distally. b. When operated on the handle, the proximal retraction of the actuator for the gripping mechanism always closes the loop before retracting it proximal. c. All operations are controlled via a single actuator (a slider in this embodiment). d. The action of gripping the hitch with the implant does not require very precise maneuvering because it allows the loop to move forward over the hitch with the loop open, increasing the survival area into which the hitch can enter to engage the hitch. If the loop reaches the hitch with the loop closed, the action of opening the loop will open the loop without the hitch being within the inner radius of the loop, and therefore may fail to engage the hitch, potentially requiring additional action and maneuvering. The action of opening the loop does not affect the implant position by pushing a hitch from the intended path, as the loop always exits the maneuverable inner catheter when in the open position. f. Since the loop closes completely before retracting, the user does not need to advance any part of the gripping mechanism distally toward the implant while closing the loop on the implant. Typically, when a user is attempting to grasp an object while using a snare, the snare is simultaneously moving forward or backward, while the scintillator is moving forward or backward on the snare to precisely control the snare during the snaring process. The advantage of the currently disclosed hitch gripping mechanism is that the user does not need to advance / retract multiple objects simultaneously to establish a connection to an object (such as a hitch on an implant).

[0114] 3.) An external catheter (unmaneuverable) having a protector cup at its distal end, which is used to steer the catheter to the implant once connection to the implant is established, and to safely and securely re-cover the implant and its fixation mechanism before returning it to the external catheter. a. The external (uncontrollable) catheter can be easily advanced along the OD of the controllable internal catheter to the implant without affecting the implant's position. b. Because the connection to the implant is already established, the long linear length of the implant protector cup is easily tracked on the OD of the maneuverable inner catheter as if it were a guide rail, and no additional maneuvering is required to perform this action. c. Once the implant protector cup reaches the implant, the implant is easily re-covered within the cup.

[0115] At this point, the user can remove the implant and tooling from the patient's anatomical structure. No other tools yet exist that would enable the user to perform the procedure of explanting an implanted leadless pacemaker with a tine-based fixation mechanism from either the right ventricle or the atrial appendage in such an easy, safe, and reliable manner.

[0116] Finally, note that the term “comprising” does not exclude other elements or steps, and “a” or “an” does not exclude plurals. Also, elements described in relation to different embodiments may be combined. Note that reference numerals in the claims should not be construed as limiting the claims. [Explanation of symbols]

[0117] 1. Catheter device 3. Internal catheter 5 shafts 7. Hitch gripping mechanism 9. Distal end of the shaft 11 Mandrels 13 tube 13' Related tubes 13'' Related adjacent pipes 15 wires 17. First part of the wire 19. Second part of the wire 21 First end of the wire 23 The second end of the wire 25 loops 27 Distal end of related adjacent pipe 29 Alignment Cones 31 Distal end of the internal catheter 33 Handle 35 Proximal end of the internal catheter 37 Housing 39 Grab mechanism control unit 41 Actuator 43 First operating direction 45 Second operating direction 47 Mandrel Carriage 49 Shaft Carriage 51 External catheter 53 Protector Cup 55 Distal end of the external catheter 57 X-ray fluoroscopy markers 59 Visible markers 61 Medical devices 63. Implantable Leadless Spacer 65 Hitch 67 External Catheter Control Hub 69 External catheter irrigation port 71 Steering knob 73 Catheter irrigation port

Claims

1. A catheter device (1) for connecting the hitch (65) of an implantable medical device (61) during explantation of the implantable medical device (61), The catheter device (1) is A long, slender internal catheter (3), An elongated shaft (5) extends throughout the entire internal volume of the inner catheter (3) and is displaceable longitudinally relative to the inner catheter (3) between a retracted position and a protruding position, The system includes a hitch gripping mechanism (7) located at the distal end (9) of the shaft (5), The hitch gripping mechanism (7) is A mandrel (11) extends throughout the entire internal volume of the shaft (5) and is displaceable longitudinally relative to the shaft (5) between a proximal position and a distal position, A plurality of tubes (13) extending longitudinally from the distal end (9) of the shaft (5), A plurality of wires (15), each of which extends together with a first portion (17) of its length over the entire internal volume of a related tube (13') of the tube (13) and is displaceable longitudinally with respect to the related tube (13'), a second portion (19) of the wire (15) extends to a related adjacent tube (13'') of the tube (13), a first end (21) of each wire (15) is fixed to the shaft (5), and a second end (23) on the opposite side of each wire (15) is displaceable with respect to the shaft (5). A catheter device (1) comprising: a plurality of wires (15) fixed to the mandrel (11), each wire (15) forming a loop (25) with its associated tube (13') and its associated adjacent tube (13''), wherein when the mandrel (11) is retracted proximal to the shaft (5), the loop (25) is retracted into a closed configuration having a minimum lateral dimension, and when the mandrel (11) is pushed distal to the shaft (5), the loop (25) is pushed into an open configuration having a maximum lateral dimension.

2. The catheter device (1) according to claim 1, wherein at least one of the wire (15) and the tube (13) is mechanically pre-formed to bend radially away from the longitudinal axis of the shaft (5).

3. The catheter device (1) according to claim 1, wherein the first end (21) of each wire (15) is fixed to the distal end (27) of the associated adjacent tube (13'').

4. The catheter device (1) according to claim 1, wherein at least one of the wire (15) and the tube (13) is made of a radiopaque material.

5. The catheter device (1) according to claim 1, wherein the internal catheter (3) is maneuverable.

6. The catheter device (1) according to claim 1, wherein the internal catheter (3) is provided with an alignment cone (29) at its distal end (31) for at least one of receiving and aligning at least one of the ends of the implantable medical device (61) when the internal catheter (3) is drawn toward the internal catheter (3).

7. The catheter device (1) according to claim 6, wherein the alignment cone (29) comprises a radiopaque material.

8. The inner catheter (3) is further provided with a handle (33) connected to its proximal end (35), The handle (33) is The housing (37) is connected to the inner catheter (3), A grabber mechanism control unit (39) including an actuator (41) displaceable relative to the housing (37), wherein the actuator (41) is mechanically coupled to the mandrel (11) and the shaft (5) such that the initial operation of the actuator (41) induces a change in the loop (25) between its closed and open configurations, while the subsequent operation of the actuator (41) induces a displacement of the shaft (5) between its retracted position and its protruding position. A catheter device (1) according to claim 1, comprising:

9. The catheter device (1) according to claim 8, wherein the grabber mechanism control unit (39) is configured such that when the actuator (41) is first actuated in a first operating direction (43), the mandrel (11) is displaced from its proximal position to its distal position, and the shaft (5) is held stationary relative to the internal catheter (3), and when the actuator (41) is subsequently actuated in the first operating direction (43), the shaft (5) is displaced from its retracted position to its protruding position.

10. The catheter device (1) according to claim 8, wherein the grabber mechanism control unit (39) is configured such that when the actuator (41) is first actuated in a second operating direction (45), the mandrel (11) is displaced from its distal position to its proximal position, and the shaft (5) is held stationary relative to the internal catheter (3), and when the actuator (41) is subsequently actuated in the second operating direction (45), the shaft (5) is displaced from its protruding position to its retracted position.

11. The grabber mechanism control unit (39) comprises a mandrel carriage (47) and a shaft carriage (49), The mandrel carriage (47) is fixedly coupled to the actuator (41) and the mandrel (11), and the mandrel carriage (47) is displaceable relative to the shaft carriage (49) between a first position and a second position. The shaft carriage (49) is fixedly coupled to the shaft (5), and the shaft carriage (49) is displaceable relative to the housing (37) between a third position and a fourth position. When the mandrel carriage (47) interacts with the shaft carriage (49) and the mandrel (11) is pushed from the first position to the second position in the first operating direction (43), the displacement force is not transmitted from the mandrel carriage (47) to the shaft carriage (49), thereby causing the shaft carriage (49) to remain stationary relative to the housing (37). When the mandrel carriage (47) is further pushed from the second position in the first direction, the displacement force is transmitted from the mandrel carriage (47) to the shaft carriage (49), thereby pushing the shaft carriage (49) from its third position to its fourth position, and / or The catheter device (1) according to claim 8, wherein the mandrel carriage (47) interacts with the shaft carriage (49), and when the mandrel (11) is pulled from the second position to the first position in the second operating direction (45), the displacement force is not transmitted from the mandrel carriage (47) to the shaft carriage (49), thereby causing the shaft carriage (49) to become stationary relative to the housing (37), and when the mandrel carriage (47) is pulled further from the first position in the second direction, the displacement force is transmitted from the mandrel carriage (47) to the shaft carriage (49), thereby pulling the shaft carriage (49) from its fourth position to its third position.

12. It is further equipped with a long, slender outer catheter (51), The catheter device (1) according to claim 1, wherein the inner catheter (3) extends over the entire internal volume of the outer catheter (51) and is displaceable longitudinally relative to the outer catheter (51).

13. The catheter device (1) according to claim 12, wherein the external catheter (51) is uncontrollable.

14. The catheter device (1) according to claim 12, wherein the outer catheter (51) is provided with a protector cup (53) at its distal end (55), and the protector cup (53) has an enlarged inner diameter for accommodating at least a portion of the implantable medical device (61).

15. The aforementioned external catheter (51) is An X-ray fluoroscopy marker (57) is attached to its distal end (55), The catheter device (1) according to claim 12, comprising at least one of the following: a visible marker (59) located away from its distal end (55).

Images