Occluder insertion system

Abstract

A system for inserting a self-expanding occluder (12) into a patient and for releasing the occluder (12) into the patient's left atrium (10), the system comprising an insertion unit (100) with an actuation unit (102) and an insertion catheter (104), comprising an outer tube (110) and, extending through the outer tube (110), an inner tube (108), wherein a region of the proximal end (16) of the occluder (12) is movably coupled to the outer tube (110), wherein a region of the distal end (18) of the occluder (12) is movably coupled to the inner tube (108), wherein the actuation unit (102) interacts with the inner tube (108) and the outer tube (110) to release the occluder (12), such that, upon actuation of the actuation unit (102), the inner tube (108) is movable in a distal or proximal and, on the other hand, the outer tube (110) is mobile in a proximal (27) or distal (29) direction,so that the distal end (140) and the proximal end (142) of the occluder (12) can be moved further away from or closer to each other.

Description

[0001] The invention relates to an insertion unit for introducing a self-expanding occluder into a patient and for releasing the occluder into the left auricle of the patient's ear. The invention further relates to the associated system.

[0002] The auriculae atrii, or left atrial appendages, are outpouchings of the atria of the heart in mammals. The left atrial appendage, medically known as the auricula cordis sinistra (left atrial appendage), lies next to the pulmonary artery and is a common site of blood clot formation, particularly in patients with atrial fibrillation, which can lead to a stroke. Preventing thrombi in the auricula cordis sinistra is therefore an effective stroke prophylaxis for at-risk patients. For this purpose, implants have been developed that are inserted into the appendage and close the access point, for example, with a Teflon film. In English-language literature, these implants are referred to as LAA (left atrial appendage) occluders.These implants are inserted into the protrusions and anchored there, particularly by means of anchoring elements, so that they seal the access to the protrusions fluid-tight, especially at their proximal end. Insertion is usually performed using endovascular techniques, i.e., primarily with an introducer catheter through which the implant is delivered to the insertion site. The occluders are delivered to the insertion site, particularly in a volume-reduced form, and then expand. Self-expanding materials, such as shape-memory alloys, are generally used for the occluders. Such an occluder is previously known from WO 2015 / 079023 A1.

[0003] To insert an occluder into the left auricle of a patient, it is known to use a guidewire. The guidewire is screwed onto an internal thread of the occluder, as disclosed, for example, in WO 2015 / 079023 A1. The occluder is then positioned within the left auricle. Once the occluder has expanded to its intended position, the guidewire can be removed by unscrewing it. However, this can exert undesirable torque on the occluder and, in the worst case, even cause it to detach from its position. Therefore, there is a need to address these disadvantages.

[0004] Furthermore, there is a need to be able to move an occluder as easily as possible into an insertion position, which may in particular be a compressed position, in order to bring the occluder to the left auricle of the cord in this insertion position.

[0005] Furthermore, it is known from DE 10 2009 020 012 A1 and US 5,201,757 that a stent can be brought into its self-expanding form by an opposing movement of two elements of a catheter.

[0006] EP 2 266 465 A1 discloses an occlusion instrument wherein, upon insertion, no parts protrude beyond the proximal end of the occlusion instrument.

[0007] From US 2017 / 0056222 A1, a handling unit for inserting a prosthesis is known, wherein two elements of the handling unit can be rotatably displaced relative to each other, so that an outer tube and an inner tube move translationally relative to each other and the shape expands from the gap that forms.

[0008] WO2006036837A2 discloses devices, insertion systems, and insertion techniques for a closure device for closing anatomical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects. The devices, insertion systems, and insertion techniques relate in particular, but are not limited to, a closure for a patent foramen ovale (PFO) made from a polymer tube. Specifically, a petal-shaped occluder with a locking system within an insertion sheath is provided. In certain embodiments, the insertion system comprises a first fastening system for securing a first end of the occluder and a second fastening system for securing a second end of the occluder to an insertion catheter and an introducer wire contained within the insertion system. The fastening enables the insertion (and withdrawal) of the device.

[0009] WO2017157316A1 discloses a closure device for the left atrial appendage (1) and an insertion device (6). The left atrial appendage occluder (1) comprises a plurality of struts (11), wherein the struts (11) are distributed over the outside of a first hub (10) and extend outwards, the strut (11) branching at a first location (110) into a left strut (111) and a right strut (112), the left strut (111) and the right support ray (112) of adjacent support rays (11) being joined at a second location (113) and extending distally to form a distal end, and a support rod (12) being provided between adjacent support rays (11) to ensure the stability of the left atrial appendage occluder (1) and to prevent it from becoming irregularly deformed or slipping laterally.The left atrial oaccluder (1) forms a dense network with the bracing rods (12) between the adjacent support beams (11), thereby further improving the overall strength of the left atrial oaccluder (1).

[0010] US2012185031A1 discloses a stent delivery system and a method for implanting a stent. The system comprises an elongated shaft with a proximal section, a distal section, a lumen extending at least partially through the shaft, and a stent receiving section on the distal shaft section. The system further comprises a stent positioned on the stent receiving section of the elongated shaft, the stent having a compressed and an expanded configuration. Proximal and distal retention elements, which are detachably connected to the stent and have a first position and a second position, are also included. The proximal and distal retention elements jointly exert a longitudinal tensile force on at least one section of the stent, with the proximal and distal retention elements each being in the first position.A drive system is provided which is configured to move the proximal and distal limiting elements simultaneously, and which includes a threaded drive shaft that is mechanically connected to a rotatable handle.

[0011] The present invention is therefore based on the overall objective of further developing the known state of the art.

[0012] This problem is solved by a system having the features of claim 2.

[0013] The invention is defined in the attached claims.

[0014] The proposed system involves inserting a self-expanding occluder into a patient and deploying it into the patient's left auricle. The system comprises an insertion unit with a drive unit and an insertion catheter consisting of an outer tube and an inner tube extending through the outer tube. A proximal end of the occluder is coupled to the movement of the outer tube, while a distal end is coupled to the movement of the inner tube. The drive unit interacts with the inner and outer tubes of the occluder in such a way that, upon activation, both the inner tube and the outer tube are movable in a distal or proximal direction, allowing the proximal and distal ends of the occluder to move away from or towards each other.

[0015] The coupling of the proximal end of the occluder with the outer tube and the distal end with the inner tube allows the proximal and distal ends of the occluder to be moved away from or towards each other. To insert the occluder into a patient and guide it to the left auricle of the heart, the inner tube can first be moved distally while the outer tube moves proximally. This allows the proximal and distal ends of the occluder to be moved apart, thus bringing the occluder into an insertion position. In this insertion position, the occluder is compressed, resulting in increased length but a reduced diameter. This allows it to be guided through blood vessels, in particular, to the left auricle of the heart.

[0016] To release the occluder in the left auricle, the inner tube can be moved proximally while the outer tube moves distally. This causes the proximal and distal ends of the occluder to move towards each other, with the occluder primarily assuming its self-expanding shape. During this process, the length of the occluder decreases while its diameter increases. As this release occurs, the occluder comes into contact with the left auricle, thus closing it off.

[0017] Overall, a change in the position of the occluder can be brought about in a particularly simple way, in order to firstly transfer the occluder into an insertion position in which the occluder can be brought particularly easily to the auricula cordis sinistra of a patient, and secondly to be able to release the occluder, whereby it tends in particular to its self-expanding form and after release tightly closes the auricula cordis sinistra.

[0018] An advantageous embodiment of the invention provides that the outer tube terminates distally in front of the inner tube. This allows for a particularly simple coupling of movement between the proximal end region of the occluder and the outer tube, and between the distal end region of the occluder and the inner tube.

[0019] A further advantageous embodiment of the invention provides that the occluder comprises a frame with a tubular proximal end section through which the introducer catheter is inserted into the occluder. In this way, the introducer catheter can be inserted into the occluder in a particularly simple manner. The distal end of the outer tube can be located immediately distal to the tubular proximal end section, so that the outer tube interacts with the tubular proximal end section of the occluder to couple movement. It is conceivable that the outer tube interacts with the tubular proximal end section in a form-fit or force-fit manner. Furthermore, the occluder tends toward its self-expanding form, so that, starting from the insertion position, the occluder can support movement of the outer tube distally by intrinsically tending toward the expanded position.

[0020] It is also advantageous if the occluder includes a cup-shaped distal end region to which the inner tube of the introducer catheter is attached. The distal end of the inner tube can therefore be inserted into and terminate within the cup-shaped distal end region of the occluder. The cup-shaped distal end region thus comprises, in particular, a cylindrical shell section and a base section. Consequently, a coupling of movement between the inner tube and the distal end region of the occluder can be provided, especially in the distal direction. It is conceivable that the inner tube is arranged in the distal cup-shaped end region in a form-fit or force-fit manner. This allows for coupling of movement between the inner tube and the distal cup-shaped end region of the occluder even when the inner tube is moved in a proximal direction.Furthermore, the occluder tends in particular towards its self-expanding form, so that, starting from the insertion position of the occluder, when the inner tube moves in a proximal direction, the movement can be supported by the intrinsic tendency to move into the expanded position.

[0021] It is particularly advantageous if the occluder can be moved into an insertion position for use in a patient by allowing a distal end of the inner tube and a distal end of the outer tube to move away from each other, so that the proximal and distal ends of the occluder can be moved apart. In this insertion position, the occluder can have a reduced diameter and thus be compressed. The occluder can also have an increased length, so that in the insertion position, compared to the release position, the occluder has a reduced diameter but a greater length. In this insertion position, the occluder can be guided particularly easily to the left auricle of the heart.

[0022] It is particularly preferred if the distal ends of the inner and outer tubes can be moved towards each other to release the occluder, such that the proximal and distal ends of the occluder can move towards each other. It is particularly conceivable that, during the release process, the occluder tends towards its self-expanding form, so that, starting from the insertion position, when the inner tube moves proximally or the outer tube distally, the occluder intrinsically tends towards the expanded position.

[0023] It may be designed that a central portion of the occluder, between the proximal and distal ends, essentially maintains its position during deployment. To deploy the occluder at its intended position within the left auricle, the distal ends of the inner and outer tubes move towards each other, causing the proximal and distal ends of the occluder to also converge. Since the occluder may be self-expanding, it may be designed to expand into its self-expanding position during deployment. In this final position, the occluder can adhere to the inner surface of the left auricle and tightly seal it, thereby reducing the risk of thrombus formation and the associated risk of stroke.In its final position, the occluder can either assume its self-expanding final shape. However, it is also conceivable that the final position of the occluder, in which it forms a sealing connection to the left auricle of the ear, is reached before the self-expanding final shape is achieved, and the occluder can then no longer deform.

[0024] It is conceivable that the occluder has a central axis extending through both the proximal and distal ends. The occluder can be shaped around this axis. In its insertion position, the occluder can have a center point located between the proximal and distal ends along this axis. When the occluder is released, it can be designed, in particular, that the proximal and distal ends of the occluder move towards each other in such a way that the center point of the occluder maintains, or essentially maintains, its position. This allows for a particularly precise positioning and release of the occluder at the left auricle of the cord. In its final position, the occluder can, in particular, have a spherical outer contour, so that the center point can also be the center of this circular outer contour.

[0025] It is particularly preferred that the drive unit comprises a first transmission element with a first transmission thread, a second transmission element with a second transmission thread, and an actuator element operable by an operator, comprising a first drive thread and a second drive thread. The first transmission element is coupled to the inner tube for movement. The second transmission element is coupled to the outer tube for movement. The first drive thread interacts with the first transmission thread, while the second drive thread interacts with the second transmission thread to move the distal ends of the outer and inner tubes toward or away from each other. This provides a particularly simple method of motion coupling between the drive unit and the outer or inner tube of the introducer catheter.The first and second drive threads can be formed in one piece. In particular, the entire actuating element can be formed in one piece. Consequently, when the actuating element is actuated, the distal ends of the outer and inner hoses can be moved towards or away from each other simultaneously. It can be provided that the first and second transmission threads, as well as the first and second drive threads, are synchronized such that when the actuating element is actuated, the inner and outer hoses are each displaced by the same distance in opposite directions.

[0026] Advantageously, the first drive thread is designed as the first internal thread, which interacts with the first transmission thread, designed as an external thread. Furthermore, the second drive thread is advantageously designed as the second internal thread, which interacts with the second transmission thread, designed as an external thread. The first and second drive threads can be formed integrally. Overall, this allows for a particularly simple implementation of motion coupling and synchronous movement in opposite directions.

[0027] Preferably, the outer tube has at least one, and in particular two or more, locking finger-like section at its distal end, which interacts with the proximal end of the occluder to couple movement. This allows for a particularly simple coupling of movement. The locking finger-like section can, in particular, interact with the tubular proximal end of the occluder and engage behind it to couple movement during proximal movement. The outer tube can, in particular, be formed in one piece.

[0028] A particularly preferred embodiment of the invention arises from the fact that the first transmission element interacts with the inner tube via a Luer connector arranged on the inner tube for motion coupling. Consequently, a Luer connector can be arranged on the inner tube. This connector can, for example, be located on the first transmission element for motion coupling.

[0029] A particularly preferred embodiment of the invention provides that the locking finger-like section is arranged in a form-fitting manner at the proximal end region of the occluder when the inner tube is arranged in the occluder. In particular, it can be provided that the locking finger-like section is elastically compliant and, starting from a rest position, is deflected from its rest position after the inner tube is inserted through the outer tube. Consequently, when the inner tube is guided through the outer tube, it can be provided that the locking finger-like section cannot deflect radially inwards, thus ensuring a stable form-fitting connection between the proximal end region of the occluder and the locking finger-like section.

[0030] It is particularly preferred if, to remove the insertion catheter from the occluder, the inner tube can first be pulled out of the occluder. Once the inner tube has been pulled out of the occluder through the outer tube, it can then be provided that the outer tube can be pulled out of the occluder.

[0031] Consequently, it can be provided that the positive-locking connection between the outer tube and the proximal end of the occluder can only be released once the inner tube has been pulled out of the occluder through the outer tube. As explained above, the distal and proximal ends of the occluder can therefore be moved towards each other to release it by means of the outer and inner tubes, whereby the distal ends of the outer and inner tubes are forced into their self-expanding shape.

[0032] Once the process of bringing the proximal and distal ends of the occluder together is complete, the introducer catheter can be easily removed from the occluder by first pulling the inner tube out of the occluder through the outer tube. Then, the outer tube can be pulled out of the occluder, with the locking finger-like section at the distal end of the outer tube being elastically displaced radially inwards to remove the outer tube from the proximal end of the occluder, which is primarily tubular.

[0033] This procedure effectively prevents, or even completely prevents, any unwanted torque transmission from the introducer catheter to the occluder. This minimizes or eliminates the risk of the occluder becoming dislodged from its position on the left auricle of the cord when the introducer catheter is removed. After removal of the introducer catheter, the occluder can fully expand into its self-expanding state, thereby creating a completely fluid-tight seal on the left auricle of the cord.

[0034] Advantageously, the insertion unit has a housing that can be held by an operator, with the transmission elements and the actuating element arranged in or on the housing. An operator, for example a surgeon, can therefore hold the housing in their hand, so that the housing can be designed to resemble a handle. The transmission elements and / or the actuating element can be arranged in or on the housing.

[0035] Preferably, the actuating element is rotatably mounted on the housing. The housing may have a central longitudinal axis, and the actuating element may be rotatable about this central longitudinal axis. The actuating element may, in particular, be formed in one piece and, especially, be hollow cylindrical with an internal thread.

[0036] The problem initially posed is also solved by an insertion unit according to claim 1. Accordingly, the insertion unit comprises a drive unit and an insertion catheter, which includes an outer tube and an inner tube extending through the outer tube. Using the insertion catheter, an occluder can be moved into an insertion position in a particularly simple manner in order to deliver it to the left auricle of the cord. The insertion unit can then be used to move the occluder into its final position to close the left auricle of the cord. Finally, the insertion catheter can be withdrawn from the occluder in a particularly simple manner, especially without transmitting any significant torque to the occluder. This allows for more reliable and secure positioning of the occluder at the left auricle of the cord.

[0037] Further details and advantageous embodiments of the invention can be found in the following description, which further describes and explains the embodiment of the invention shown in the figures. The figures show: Figure 1: Schematic top view of an occluder arranged on the left auricle of the ear according to one embodiment; Figure 2: Schematic perspective view of the occluder according to Figure 1 Figure 3: Top view of one half of the occluder according to Figure 2 Figure 4: Schematic cutaway view of a frame section of the occluder according to Figure 2 Figure 5: Perspective schematic representation of an insertion unit according to one embodiment; Figure 6: Schematic cross-sectional representation of the insertion unit according to Figure 1 with attached occluder in insertion position; Figure 7 schematic cross-section of the insertion unit according to Figure 1with the occluder attached in a configuration prior to removal of the insertion unit from the occluder. Figure 8: Schematic cross-section of an area around the proximal end of the occluder with the insertion unit attached; Figure 9: Illustration based on Figure 8 , wherein the inner tube of the insertion unit is removed from the occluder; and Figure 10 shows a proximal area of ​​the insertion unit with the Luer connector detached from the insertion unit.

[0038] Figure 1 The figure, marked with reference symbol 10, schematically shows the left auricle of the cord (auricula cordis sinistra) of a patient. To reduce the risk of stroke, an occluder 12 is inserted into the left auricle to close off access to it.

[0039] The occluder 12 initially comprises a one-piece frame 14. This frame includes a proximal tubular section 16 and a cup-shaped distal end section 18. The cup-shaped distal end section 18 comprises a circular cylindrical mantle section 20 and a base section 22 to form a cup-shaped structure. Between the two end sections 16 and 18, the occluder has a net-like frame section 24. This net-like frame section 24 is in Figure 4 This is particularly evident in the cutaway view. Starting from the proximal tubular end section 16, the net-like frame section 24 initially has a number of struts 26. These transition into a branching network of struts 25 to form the net structure. This process creates diamond-shaped structures 28. In the distal direction 29, the struts 25 merge again into individual struts 30, which terminate in the distal end section 18.

[0040] In the ordered state (cf. Figure 1 The occluder 12 has a proximal hemisphere 32 and a distal hemisphere 35. In the region of the proximal hemisphere 32, a number of first anchoring elements 34 are provided. These extend along a circular line around the circumference and are hook-shaped with end sections pointing proximally 27. In the region of the distal hemisphere 35, second anchoring elements 36 are provided. These also extend along a circular line around the circumference, have a rod-like shape, and project obliquely from the circumferential surface in a proximal direction 27. The anchoring elements 34 and 36 are also integrally formed with the frame 14.

[0041] The frame 14 of the occluder 12 consists of a self-expanding material, for example a shape-memory alloy, in particular a nitinol alloy. The expanded shape imprinted on the occluder 12 is spherical (cf. Figure 2 The occluder 12 has a longitudinal axis 38 extending proximally and distally through its center point. This longitudinal axis 38 also extends through the central longitudinal axis of the tubular proximal end section 16 and through the central longitudinal axis of the distal end section 18 (cf. Figure 2The proximal hemisphere 32 is completely covered by a biological tissue 40. This biological tissue 40 is specifically designed as a biological membrane. In particular, it may be the pericardium membrane. The tissue 40 has openings through which the first anchoring means 34 protrude. Furthermore, the tissue 40 has an insertion port for introducing an introducer catheter through the proximal tube section 16 into the occluder 12. When the introducer catheter has been removed from the occluder 12 after its release, the elastically compliant tissue 40 can contract to seal the insertion port substantially fluid-tight, so that overall the tissue 40 seals the proximal hemisphere 32 substantially fluid-tight and substantially covers the frame 14. As schematically indicated by surgical threads 42, the tissue is sewn to the frame 14 using PTFE threads.

[0042] Near the dividing line 44 between the proximal hemisphere 32 and the distal hemisphere 35, a number of radiographic markers 38 are placed around the circumference of the proximal hemisphere 32. These enable precise positioning of the occluder 12 in the left auricle of the cord. A surgeon can therefore perform particularly accurate placement of the occluder 12.

[0043] Overall, the provision of biological tissue 40 allows for the creation of an occluder 12 with comparatively high biocompatibility. Following the placement of the occluder 12 on the left auricle of the cord, the biological tissue 40 can be overgrown by the patient's own tissue. Due to the use of biological tissue 40, there is a high degree of biocompatibility and thus an increased probability of success for surgical closure of the left auricle of the cord.

[0044] The following describes a system for introducing the occluder 12 into a patient and for releasing the occluder 12 into the left auricle of the patient according to one embodiment: Figure 5 Figure 1 shows an insertion unit 100. This unit comprises a drive unit 102 and an insertion catheter 104. The insertion catheter 104 includes an inner tube 108 and an outer tube 110. The inner tube 108 extends through the outer tube 110. Furthermore, the outer tube 110 terminates distally 29 before the inner tube 108. The drive unit 102 comprises a housing 114, which can be held in the hand by an operator, particularly a surgeon, and has an overall elongated shape.

[0045] Furthermore, the drive unit 102 comprises an actuating element 116, which is rotatably arranged in the housing 114. The actuating element 116 is hollow and has a first drive thread 118 and a second drive thread 120, wherein the first drive thread 118 is proximal to the second drive thread 120 (see Figure 1). Figure 6 and 7 The actuating element 116 is in particular designed as a single piece.

[0046] The housing 114 also contains a first transmission element 122 and a second transmission element 124. Both transmission elements 122 and 124 have a screw-like shape. The first transmission element 122 has a threaded section 126 and a head section 128. Similarly, the second transmission element 124 has a threaded section 130 and a head section 132. Both transmission elements 122 and 124 can, in particular, be formed in one piece. The first transmission element 122 is motionally coupled to the inner tube 108, while the second transmission element 124 is motionally coupled to the outer tube 110. The head section 128 of the first transmission element 122 interacts with a Luer connector 134, which is attached to the inner tube 108. The Luer connector 134 is detachably arranged on the head section 128 of the first transmission element 122.

[0047] The head section 132 of the second transmission element 124 interacts with the outer hose 110 for motion coupling. The outer hose 110 is detachably arranged on the head section 132.

[0048] At the distal end of the outer tube 110, it has two in Figure 9 Particularly clearly recognizable, finger-like end sections 136 are present. These are formed integrally with the outer tube 110 and are elastically deformable. The overall function of the insertion unit 100 is then as follows: To insert the occluder 12 into the left auricle 10, the insertion catheter 104 is first attached to the occluder 12, thus forming a system of insertion unit 100 and occluder 12, in order to bring the occluder 12 into contact with the left auricle 10 and then release the occluder 12.

[0049] The occluder 12 is initially in its self-expanding form and thus has a spherical outer contour (cf. Figure 2 The outer tube 110 is inserted into the occluder 12 through an insertion opening (not shown) in the biological tissue 40 and through the tubular proximal tube section 16. The inner tube 108 is then passed through the occluder 12 and the outer tube 110 and positioned at the distal cup-shaped end section 18 of the occluder 12. The locking finger-like sections 136 of the inner tube 108 are secured against elastic deformation radially inward, so that the locking fingers 136 come into positive contact with the proximal tubular section 16.

[0050] Then, an operator, in particular a surgeon, can take hold of the housing 114 and rotate the actuating element 116. As in Figure 6As shown, the actuating element 116 is first rotated such that the head-like sections 128, 132 of the two transmission elements 122, 124 are moved towards each other. This moves the distal end 137 of the outer tube 110 and the distal end 138 of the inner tube 108 away from each other. As a result, the distal end 140 of the occluder 12 is displaced distally 29, while the proximal end 142 of the occluder is displaced proximally 27. Overall, the occluder 12 is thereby transferred into an insertion position, so that the occluder 12 assumes a compressed form in which, compared to its self-expanding form, it has an elongated outer contour with a reduced diameter d (cf. Figure 6In this compressed insertion position, the occluder 12, together with the introducer catheter 104, can be inserted into a blood vessel and then advanced to its target position at the left auricle of the cord. The position of the occluder 12 can be determined using the radiographic markers 38. The occluder 12 should be positioned at the left auricle of the cord, particularly in the central region, i.e., in the area of ​​the radiographic markers 38.

[0051] To release occluder 12, as described in Figure 7As shown, the actuating element 116 rotates such that the head-like sections 128, 132 are moved away from each other. This moves the inner tube 108 in a proximal direction 27, while the outer tube 110 moves in a distal direction 29. During this relative movement, the proximal end 142 and the distal end 140 of the occluder 12 are moved towards each other. This increases the diameter d of the occluder 12. The occluder 12 expands into its self-expanding shape, so that the proximal end 142 and the distal end 140 of the occluder press towards each other.

[0052] The position of the central part of occluder 12 remains unchanged, which is reflected in the Figure 6 and 7 as illustrated by the midline 144. The midline 144 runs through the center of the occluder 12 between the proximal end 142 and the distal end 140, when the latter is positioned as shown in Figure 6shown, having reached the determination position. The center of the occluder 12 therefore remains in its original position and thus unchanged when the occluder, as shown in Figure 7 depicted, released.

[0053] In the Figure 6 In the position shown, the inner tube 108 is held force-fit in the proximal direction 27 at the cup-shaped distal end section 18 of the occluder 12. Consequently, when the inner tube 108 moves proximally, the distal end section 18 of the occluder 12 also moves proximally 27. If the occluder 12 is thereby moved into a position as shown in Figure 7 As shown, the force of the frictional connection is reduced, so that, as in Figure 10 shown that the Luer connector 134 can be detached from the head-like section 128 with comparatively little effort, so that the Luer connector 134 and thus the inner hose 108 can be pulled off the occluder 12 through the outer hose 110.

[0054] Then, as in Figure 10 As shown, the outer hose 110 can be pulled away from the occluder 12, since the locking finger-like sections 136 can now move elastically radially inwards. The occluder 12 can then assume its release position, in which it takes on its self-expanding shape, as shown in Figure 1shown, can assume, or at least force itself into its self-expanding final form and thus tightly close the left auricle of the cord. Once the introducer catheter has been removed from the occluder 12 after its release, the elastically compliant tissue 40 can contract in such a way that the introducer opening (not shown) in the tissue 40 is essentially fluid-tight, so that overall the tissue 40 essentially or completely seals the proximal hemisphere 32 fluid-tight and substantially or completely covers the frame 14. Subsequently, the patient's skin can grow over the biological tissue 40, so that the left auricle of the cord can be permanently and stably closed.

[0055] Due to the proposed configuration, the introducer catheter 104 can be removed from the occluder 12 particularly easily. This is achieved especially without, or almost without, any torque being applied to the occluder 12. Thus, the risk of the introducer catheter 104 being unintentionally displaced from its designated position when removed from the occluder 12 is reduced.

Claims

1. Insertion unit (100) for inserting a self-expanding occluder (12) into a patient and for releasing the occluder (12) in the left atrial appendage (10) of the patient, comprising a drive unit (102) and an insertion catheter (104) which has an outer tube (110) and an inner tube (108) extending through the outer tube (110), the drive unit (102) interacting with the inner tube (108) and the outer tube (110) in order to release the occluder (12) such that, when the drive unit is actuated, the inner tube (108) is movable in a distal (29) or proximal direction (27) and the outer tube (110) is movable in a proximal direction (27) or distal direction (29) such that the distal end (140) and the proximal end (142) of the occluder (12) can be moved away from each other or towards each other, characterized in that the drive unit (102) comprises a first transmission element (122) having a first transmission thread (126) in the form of an external thread, a second transmission element (124) having a second transmission thread (130) in the form of an external thread, and an actuating element (116), which can be actuated by an operator and has a first drive thread (118), in the form of an internal thread, that interacts with the first transmission thread (126), and a second drive thread (120), in the form of an internal thread, that interacts with the second transmission thread (130), the first transmission element (122) being movement-coupled to the inner hose (108), and the second transmission element being movement-coupled to the outer hose (110), and in that the first transmission thread and the second transmission thread, as well as the first and the second drive thread (118, 120), are designed such that, when the actuating element (116) is actuated, the inner hose (108) and the outer hose (110) are each synchronously displaced by the same distance in opposite distal (29) and proximal (27) directions.

2. System for inserting a self-expanding occluder (12) into a patient and for releasing the occluder (12) in the left atrial appendage (10) of the patient, the system comprising the occluder (12) and the insertion unit (100) according to claim 1, wherein a proximal end region (16) of the occluder (12) is movement-coupled to the outer tube (110), wherein a distal end region (18) of the occluder (12) is movement-coupled to the inner tube (108).

3. System according to claim 2, wherein the outer tube (110) ends in front of the inner tube (108) in the distal direction (29).

4. System according to claim 2 or 3, wherein the occluder (12) comprises a frame (14) having a tubular proximal end region (16) through which the insertion catheter (104) is inserted into the occluder (12).

5. System according to any of the preceding claims 2 to 4, wherein the occluder (12) comprises a pot-shaped distal end region (18) on which the inner tube (108) of the insertion catheter (104) is arranged.

6. System according to any of the preceding claims 2 to 5, wherein, in order to be inserted into a patient, the occluder (12) can be transferred into an insertion position by moving a distal end (138) of the inner tube (108) and a distal end (137) of the outer tube (110) relative to each other and away from each other such that the proximal end (142) and the distal end (140) of the occluder (12) can be moved away from each other.

7. System according to claim 6, wherein, in order to release the occluder (12), the distal ends (137, 138) of the inner tube (108) and the outer tube (110) can be moved toward each other such that the proximal end (142) and the distal end (140) of the occluder (12) can be moved toward each other, preferably wherein a central part (144) of the occluder (12) between the proximal end (142) and the distal end (140) maintains its position substantially unchanged during the release of the occluder (12).

8. System according to any of the preceding claims 2 to 7, wherein the outer tube (110) has, at its distal end region, at least one, in particular two or more, latching finger-like portion (136) which interacts with the proximal end region of the occluder (12) for the purpose of movement coupling.

9. System according to claim 8, wherein the first transmission element interacts with a Luer connector (134) arranged on the inner tube (108) for the purpose of movement coupling to the inner tube (108).

10. System according to claim 8 or 9, wherein the latching finger-like portion (136) form-fittingly interacts with the proximal end region (16) of the occluder (12) when the inner tube (108) is arranged in the occluder (12).

11. System according to claim 10, wherein, in order to remove the insertion catheter (104) from the occluder (12), firstly the inner tube (108) can be pulled out of the occluder (12), and then the outer tube (110) can be pulled out of the occluder (12) as soon as the inner tube (108) has been pulled out of the occluder (12) through the outer tube (110).

12. System according to any of the preceding claims 2 to 11, wherein the drive unit (102) has a housing (114) which can be held by an operator, and wherein the transmission elements and the actuating element (116) are arranged in or on the housing (114).

13. System according to claim 12, wherein the actuating element (116) is rotatably arranged on the housing (114).

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