Piercing element

Abstract

The invention relates to a piercing element for piercing a blood vessel wall (7) of a blood vessel, comprising a spike (20), a first locking element (23) and a second locking element (24), wherein at least the first locking element (23) is configured as a shaft holding element.

Description

Technical Field

[0001] This invention relates to a puncture element for penetrating the blood vessel wall and implants. Background Technology

[0002] Ascending aortic dissection (Type A dissection) is a life-threatening condition requiring immediate surgery. In acute Type A dissection, the primary goal of surgical treatment is to restore blood circulation and avoid or eliminate life-threatening complications such as aortic rupture, cardiac tamponade, and myocardial ischemia. A further goal of surgical treatment is, where possible, to remove the intimal tear in the proximal aorta (i.e., the entrance to the false lumen) to ensure perfusion of the true lumen and, consequently, the organs.

[0003] The classic surgical treatment for acute type A aortic dissection is to replace the ascending aorta with a tubular prosthesis, with the distal anastomosis performed using an "open" technique and hypothermic circulatory arrest at a core body temperature of approximately 25°C.

[0004] The surgical approach employed a median sternotomy. With the patient on a cardiopulmonary bypass machine and under hypothermia, circulatory arrest was initiated in a head-down position, and the ascending aorta was opened. The true lumen was identified, and the distal portion of the ascending aorta was removed, making the distal ascending aorta visible as an open tube.

[0005] In commonly used surgical methods, the so-called "sandwich" technique is employed to suture together the layered or delaminated portions of the aortic wall (intima, media, and adventitia). This is done by inserting an inner implant component (e.g., a felt strip, i.e., a strip made of textile material) circumferentially or radially into and abutting it against the aortic wall, and then placing an outer implant component (e.g., a felt strip) circumferentially or radially around the aorta and abutting it against the vessel. Then, continuous zigzag sutures or single-needle sutures are made manually using polypropylene sutures to suture the two felt strips and the aortic wall between them together (the sandwich structure).

[0006] This surgical step takes approximately 25 minutes, but depending on the surgeon's experience, it may be ten minutes faster or slower. Next, in the second step, polypropylene sutures are used to manually and continuously suture end-to-end to the sandwich remnant (i.e., the fixation site).

[0007] After the appropriate venting procedures, the aortic clamp can now be placed on the sutured prosthesis, and the circulatory arrest is released. This is typically the most critical phase of the surgery. Proximally, closer to the heart, an autologous aortic sandwich procedure above the coronary artery is then performed using the same technique described above. The proximal prosthesis end is then sutured end-to-end to this sandwich structure (fixation site), as described above.

[0008] It is evident that in such major surgeries, normal blood circulation is interrupted and the body and brain are deeply cooled, making the time factor crucial for optimizing the patient's chances of survival and recovery. In particular, the aforementioned practice of using sandwich sutures to treat dissections depends heavily on the individual patient's condition, the degree of vascular wall dissection, and ultimately, the surgeon's skill.

[0009] Therefore, devices have been developed, particularly to simplify and accelerate implant placement by replacing the time-consuming step of setting polypropylene sutures in a continuous, zigzag pattern with machine-implanted puncture elements (e.g., staples). To this end, devices or applicators have been provided that push the puncture element outward from the carrier element and thereby pass it through the implant and the vessel wall, wherein the implant typically consists of an inner implant component and an outer implant component, for example, in the form of a felt strip or a tube made of textile material with a relatively short longitudinal extension.

[0010] For example, WO 2022 / 130274 A1 discloses a device in which multiple puncture elements are supported in radially outward-oriented guides and can be radially outwardly driven on supports for the puncture elements. Theoretically, such a device or applicator for puncture elements provides the possibility of placing all the necessary puncture elements for implant fixation in a single step. However, a concern arises when using such an applicator: if one or more puncture elements are not properly placed when multiple such puncture elements are placed simultaneously, this poses a nearly unacceptable risk given the extremely critical situation when dealing with a severed aorta, as the inadequately placed puncture element must be at least partially removed in this case, and it is practically unimaginable to complete the procedure successfully in such a situation. Adding to the difficulty, the puncture elements are essentially constructed like staples and therefore, after penetration, the two ends protruding from the aortic wall and the outer implant component of the implant must be properly bent. Therefore, the error rate also increases with the puncture element, and the dispenser with its many parts and intricate structure should be considered critical when it is necessary to achieve absolutely perfect results and it seems impossible to correct the initial results. Summary of the Invention

[0011] Therefore, the objective of this invention is to provide a puncture element that can be placed more reliably than the prior art.

[0012] To solve this task, the piercing element according to the invention includes a pin, a first locking member and a second locking member, and is characterized in that at least the first locking member is configured as a shaft retaining element or a shaft safety element (pin retaining element).

[0013] In this invention, a "shaft retaining element" is understood as a mechanical element configured to prevent or limit axial movement of the pin relative to the locking member against the penetration direction. The shaft retaining element may include, for example, a protrusion, an elastically deformable element, or other mechanical structure that prevents the pin from slipping back after penetration of the vessel wall and / or implant, thus ensuring reliable fixation. The shaft retaining element may, in particular, have one or more radially projecting structures that form a support for the pin. Preferably, the locking member has at least one element that can be deflected when the pin is inserted in the penetration direction. When an attempt is made to pull the pin back in the opposite direction, this element forms a form-locking and / or friction-locking engagement with the pin, thereby preventing the pin from being pulled back.

[0014] Preferably, the second locking element is also configured as an axis-retaining element. The puncture element according to the invention thus consists of three separate components. These components are the pin and two locking elements, which makes the tissue-implant connection largely independent of its thickness, since the pin can be selected independently of the locking elements to have a length corresponding to the desired thickness. The first and second locking elements can be penetrated by the pin, and at least the first locking element is configured to fix the position of the pin in the radial direction and optionally in the axial direction in the penetrated state.

[0015] The puncture element according to the invention is used to penetrate the vessel wall and the implant to install the implant as a fixation site for a vascular prosthesis on the vessel wall, or to penetrate the vessel wall and the vascular prosthesis to directly fix the vascular prosthesis to the vessel wall.

[0016] Because the pin is a separate component and therefore constructed separately from the two locking elements in the puncture element according to the invention, the pin can be fully concealed in the corresponding applicator before placement, which offers several advantages. Firstly, by completely housing the pin in the applicator, the risk of injury when the puncture element is near the surgical site is eliminated, as the pin is only removed from the applicator with its tip when the puncture element is placed. Furthermore, the pin will not be lost in the surgical area.

[0017] During placement of the puncture element, the pin is driven through two locking members, such that the pin is first optimally guided by the second locking member as it penetrates the vessel wall and implant, and therefore does not tend to bend. In this way, the pin penetrates the vessel wall and implant extremely straight and can then be reliably received and secured by the first locking member.

[0018] The invention is preferably modified such that a support portion for the ejection element is formed on the proximal end of the pin. The support portion is constructed with an increased diameter relative to the other diameters of the pin and provides reliable support for the ejection element of the corresponding applicator to drive the pin distally, thereby allowing the pin to penetrate the implant and blood vessel.

[0019] To optimize the pin entry into the second locking member of the piercing element according to the invention, according to a preferred embodiment, the invention can be improved such that the second locking member is constructed as a washer having a preferably centered hole for the pin to pass through, the hole having a frustoconical chamfer for the pin entry hole. This frustoconical chamfer guides the tip of the pin into the hole even with a small radial deviation relative to the ideal position. For the same reason and with the same effect, according to another preferred embodiment of the invention, the first locking member is constructed as a washer having a preferably centered hole for the pin to pass through, the hole having a frustoconical chamfer for the pin entry hole. Within the scope of this specification, the first locking member is the one that secures the pin at the distal end and therefore near the pin tip, and the second locking member is the one that secures the pin at the proximal end and therefore near the pin base.

[0020] According to a preferred embodiment of the invention, the support portion is preferably modified such that it corresponds to a frustoconical chamfered construction for the pin entry hole. In this way, the support portion and therefore the proximal end can be sealed into the washer, which serves as a second locking member, and thus form the smoothest possible proximal closure of the puncture element according to the invention.

[0021] To reliably secure the pin, the pin may have at least one axially oriented circumferential locking groove for the insertion of a first locking element, formed by a (preferably abrupt) reduction in the pin diameter, as in a preferred embodiment of the invention. The reduction in diameter here is relative to the actual diameter of the pin beside the locking groove. The locking groove is a recess surrounding the circumference of the pin, on which a shaft retaining element can act to optimally prevent distal slippage.

[0022] The preferred pin has multiple circumferential locking grooves acting axially, such that the pin can continue to pass through the locking member as it penetrates the implant and blood vessel, and can be held at one of the multiple locking grooves when the second locking member achieves optimal contact with the outer part of the implant.

[0023] In order to optimally secure the second locking member in the applicator before and during placement of the puncture element according to the invention, according to a preferred embodiment of the invention, the second locking member is configured as a washer having an annular groove, preferably having a continuously extending longitudinal section.

[0024] This design of the second locking member allows a retaining structure corresponding to the groove shape to be inserted into a suitable dispenser, thereby retaining the second locking member on the dispenser. The longitudinal profile of the groove is preferably designed to extend continuously, allowing for easy engagement and disengagement between the groove and the retaining structure on the dispenser, since no discontinuities need to be overcome and the retaining structure can therefore be constructed, for example, as a simple spring element or elastic wire.

[0025] Preferably, the invention can be modified such that the first and / or second locking member is at least partially encased in a plastic sheath that can be penetrated by the pin. This sheath can be suitably constructed to conceal the support or tip of the pin. The plastic sheath can be penetrated by the pin without problems during implantation, i.e., during placement of the puncture element, and subsequently cover the tip of the puncture element.

[0026] To effectively shield the tip of the pin, according to a preferred embodiment, the invention can be modified such that the first locking member is fitted with a plastic cap on one side that is permeable by the pin. The size of this plastic cap can be designed accordingly to reliably enclose the tip of the pin when it has fully passed through the implant and blood vessel.

[0027] Instead of securing the pin tip with the plastic cap just described, a preferred embodiment of the invention may include a hollow metal cap on one side for the pin to enter. The hollow metal cap can also be used to shield the tip of the piercing element and can be adapted to bend the pin tip if the pin itself is too long.

[0028] An applicator (for placing a puncture element according to the invention for mounting an implant as a fixation site of a vascular prosthesis on the wall of a blood vessel by penetrating the vessel wall and the implant with at least one puncture element according to the invention and preferably multiple puncture elements according to the invention) comprises: a channel for receiving and discharging the at least one pin; and a movable first gripper for detachably receiving a first locking member for the puncture element, wherein the channel has a discharge region oriented toward the first gripper and defining a discharge direction, the discharge region having an outlet for the pin, and the first gripper is movable in the discharge direction from an initial position to a close-fitting position closer to the outlet than the initial position. The channel preferably has a circular cross-section.

[0029] Therefore, the applicator retains a single pin, which, compared to the prior art, works in conjunction with at least one locking member as a mating element to achieve locking after penetration of the implant and the vessel wall. This locking member allows the pin to be secured without bending it for fixation, as is done with prior art puncture elements. The mating element, or locking member, is accordingly constructed to reliably secure the pin of the puncture element. Because only a single puncture element is placed through the applicator, the applicator according to the invention can be structurally simpler.

[0030] The applicator has only one channel for discharging the pin of the puncture element, which can therefore be optimally designed to allow for a favorable flow of force from the applicator's operating element to the discharge area. During implant placement, the movable first gripper, along with the first locking member held therein, moves in the discharge direction from its initial position to a closer abutment position than the initial position, securing the pre-placed implant component to the vessel wall. In the abutment position, the first gripper abuts against the outer component of the implant and thus provides resistance to the pin of the puncture element penetrating the implant and the vessel wall. After the pin penetrates or punctures the implant and the vessel wall, the pin engages with the first locking member and remains effectively locked in the movable first gripper. The applicator is then unloaded, and the locking member is released. This also allows for a visual check of the correct placement of the puncture element before placing the next one. In this way, the implant can be quickly and reliably installed onto the vessel wall.

[0031] In order to detachably accommodate the first locking member, the first gripper has a recess into which the first locking member is placed.

[0032] The outlet configuration for the pin is located in the fixed second jaw of the applicator, which is configured to detachably accommodate a second locking member for the puncture element. The second jaw preferably has a recess for detachably accommodating the second locking member, which is inserted into the recess, for example, as a washer with a circumferential groove, and is preferably secured by means of the groove. Thus, during use of the applicator, the implant and the vessel wall therebetween are clamped between the movable first jaw and the fixed second jaw, which provide two locking members for the pin of the puncture element according to the invention. The pin is guided in a channel of the applicator having a circular cross-section. Through the clamping action, the locking members are tightly pressed against the implant, and the puncture element thus subsequently secures the implant to the vessel wall in a reliably abutting manner.

[0033] To reliably and simply expel the pin from the channel, and to achieve this at low cost, the applicator can be modified such that a push-resistant, preferably flexible, ejection element is guided within the channel to eject the pin. This ejection element can be driven towards the discharge port by a push rod. For this purpose, the ejection element can be constructed, for example, as a fully compressed tension spring. The individual coils of such a spring have very small pitches, such that the coils are in contact with each other in the spring's normal state. Thus, while the spring is fully flexible to follow the curvature of the channel, it is more or less fully push-resistant when guided to prevent lateral displacement. This is the case in the channel as described in the invention. However, the channel and ejection element can also be constructed, for example, as a Bowden cable. The drive of the ejection element towards the discharge port can also be implemented by means of a push rod. This push rod can be driven in a conventional manner by simple mechanical means and manual force. Furthermore, the push rod can also be constructed to be flexible, allowing the applicator according to the invention to bend according to the requirements of the surgical area. This, in some cases, allows for the placement of sutures in hard-to-access areas.

[0034] If the discharge element can be driven toward the discharge port direction against the action of the first spring element, the discharge element will automatically reset after the user completes the placement of the puncture element.

[0035] The first gripper can be driven by a transmission mechanism to move linearly from an initial position to a contact position. This serves to convert the user's (e.g., applied on the handle of the applicator according to the invention) action into a desired direction of movement of the first gripper, so as to move the first gripper accordingly. The transmission mechanism can be additionally designed to appropriately select the travel distance and driving force of the first gripper according to the desired force that the surgeon must apply.

[0036] The transmission mechanism is driven by a drive rod that overcomes the action of the second spring element. The drive rod can extend at any angle relative to the direction of movement of the first gripper and thus allows the drive direction (which is predetermined by the surgeon's or the user's operation of the applicator according to the invention and by other mechanical components of the applicator) to be reversed to the direction of movement of the first gripper. As already discussed in conjunction with the discharge element, the elastic support of the drive rod can be used to return the drive rod to its initial position when the first gripper is reset to its initial position.

[0037] According to one variation, the drive rod is driven by a push rod, preferably the discharge element and the drive rod are driven by the same push rod. The concept of driving the movable part of the applicator according to the invention by means of a push rod is considered advantageous, as it allows for a controlled, limited drive stroke, wherein the force transmitted to the movable part via the push rod occupies only a small space, which is naturally considered advantageous in surgical instruments. By using a single push rod, i.e., by driving both the discharge element and the first gripper via the same push rod, a desired reduction in the number of applicator parts is achieved, and the movements of the first gripper and the discharge element can be synchronized with each other by a common drive element of the common push rod. As mentioned above, the push rod can also be constructed to be flexible and therefore to a certain extent bendable, so that the applicator can also be bent according to the requirements of the surgical area.

[0038] To transmit the force applied to the push rod for driving the first gripper to the drive rod, the drive rod can be configured to be coupled to the push rod via a drive sleeve that is coupled to the push rod for common movement, the drive sleeve being driven by the push rod against the action of the spring sleeve. The drive sleeve allows for the coupling of driving force from the axis of the push rod to the drive rod, which is particularly advantageous when the push rod drives both the drive rod and the ejection element. Thus, in this embodiment, the push rod can act axially on the ejection element and form another force path to the drive rod via the drive sleeve. If a spring sleeve, particularly fixedly connected to the push rod, acts elastically on the drive sleeve, then misaligned drive movements with different drive stroke lengths for the first gripper and the ejection element can be achieved when the ejection element and the first gripper are operated simultaneously via the common push rod. Therefore, with a single movement of the push rod, the first gripper can be brought into contact with the retaining ring for the implant or the implant itself, and the ejection element can then continue to move to eject the pin and place the puncture element according to the invention. In this situation, the first gripper no longer moves because when the first gripper and therefore the first locking member are fully against the outer implant component, the spring sleeve is compressed and the drive sleeve is no longer forcibly linked with the push rod.

[0039] It can be specified that the push rod is driven by an operating element, which works in conjunction with the push rod via another transmission mechanism. The operating element can be configured, for example, as an operating lever on the dispenser handle element, so that the user only needs to press the lever to operate the dispenser in order to set the puncture element.

[0040] Preferably, the push rod, spring sleeve, and drive sleeve are located in the distal housing region of the dispenser and can be designed as a drive unit in this manner. Preferably, the first and second grippers, transmission mechanism, drive rod, channel, and discharge element are located in the head assembly of the dispenser, which is detachably connectable to the distal housing region. Overall, this results in a modular structure for the dispenser, which in some cases allows some parts of the dispenser to be designed as disposable items, while others are designed to be reusable. Thus, for example, the head assembly can be disposable, while the rest of the dispenser is reusable. If the push rod is constructed to be flexible to allow bending of the dispenser, then at least the distal housing region of the dispenser is also constructed to be flexible.

[0041] According to one variation, the piercing element, as a pin, preferably a metal pin, is disposed at the distal end of the discharge element in the discharge region of the channel, the pin forming a support portion for the discharge element at its proximal end toward the discharge element. Therefore, the piercing element can be discharged from the discharge region of the channel along a defined axis and driven through the one or more locking elements.

[0042] According to a preferred embodiment of the invention, the first locking member, and preferably the second locking member, is constructed as a clamping washer. Clamping washers are known in the prior art as shaft retaining elements and allow the pin to be inserted in one go, and cannot be pulled back without applying a large force because a force lock and, if necessary, a form lock are formed between the clamping washer and the pin in the pull-back direction. Therefore, the piercing element according to the invention is immediately secured after the pin is ejected.

[0043] This application discloses an applicator for a puncture element according to the present invention, based on the following aspects:

[0044] 1. An applicator (10) for mounting an implant (6) as a fixation site of a vascular prosthesis on the wall of a blood vessel (7) by penetrating the blood vessel wall and the implant (6) with at least one puncture element (20), preferably multiple puncture elements (20), wherein the applicator (1) has a channel (19) for receiving at least one puncture element (20) and discharging it from a channel (19) and a movable first gripper (9) for detachably receiving a first locking member (23) for the puncture element (20), wherein the channel (19) has a discharge area facing the first gripper (9) defining a discharge direction (A), the discharge area having an outlet (19a) for the puncture element (20), and the first gripper (9) is movable in the discharge direction (A) from an initial position to a close-fitting position closer to the outlet (19a) than the initial position.

[0045] 2. The applicator according to aspect 1, wherein the outlet (19a) is configured in a fixed second gripper (25) configured to detachably accommodate a second locking member (24) for the piercing element (20).

[0046] 3. The applicator according to aspect 1 or 2, wherein a push-resistant and preferably flexible discharge element (18) is guided in the channel (19) for pushing the puncture element (20) out of the channel (19), preferably the discharge element (18) can be driven by a push rod (15) toward the discharge port (19a).

[0047] 4. The dispenser according to aspect 3, wherein the discharge element (18) can be driven toward the discharge port (19a) against the action of the first spring element (17).

[0048] 5. The dispenser according to any one of aspects 1 to 4, wherein the first gripper (9) can be driven by means of a transmission mechanism (10) to move linearly from an initial position to an abutment position.

[0049] 6. The applicator according to aspect 5, wherein the transmission mechanism (10) is driven by a drive rod (11), preferably the drive rod (11) being driven against the action of the second spring element (22).

[0050] 7. The dispenser according to aspect 6, wherein the drive rod (11) is driven by a push rod (15), preferably the discharge element (18) and the drive rod (11) are driven by the same push rod (15).

[0051] 8. The dispenser according to aspect 6 or 7, wherein the drive rod (11) is coupled to the push rod (15) via a drive sleeve (13) coupled to the push rod (15) to achieve co-movement, preferably the drive sleeve (13) is driven by the push rod (15) overcoming the action of the spring sleeve (14).

[0052] 9. The applicator according to aspect 6, 7 or 8, wherein the push rod (15) is driven by an operating element (4) which works in conjunction with the push rod (15) through another transmission mechanism.

[0053] 10. The dispenser according to aspect 8 or 9, wherein the push rod (15), spring sleeve (14) and drive sleeve (13) are disposed in the distal housing region (2a) of the dispenser (1).

[0054] 11. The dispenser according to aspect 10, wherein the first and second grippers (9, 25), the transmission mechanism (10) and the drive rod (11), as well as the channel (19) and the discharge element (18) are disposed in a head part (3) of the dispenser (1) that is detachably connected to the distal housing region (2a).

[0055] 12. The applicator according to any one of aspects 3 to 11, wherein the piercing element (20) is provided as a pin (20), preferably a metal pin (20), in the discharge area of ​​the channel (19) at the distal end of the discharge element (18), the pin (20) forming a support (20a) for the discharge element (18) at its proximal end toward the discharge element (18).

[0056] 13. The dispenser according to any one of aspects 2 to 12, wherein the first locking member (23) and preferably the second locking member (24) are configured as clamping washers.

[0057] 14. The dispenser according to any one of aspects 1 to 13, wherein a locking element (23) is surrounded by a plastic sheath (27) that can be penetrated by a piercing element.

[0058] 15. The applicator according to any one of aspects 1 to 14, wherein a locking member (23) has a hollow metal cap (28) for the insertion of the piercing element (20).

[0059] 16. A kit for mounting an implant (6) as a fixation site for a vascular prosthesis onto the vessel wall (7) of a blood vessel, comprising: at least one applicator (1) according to any one of aspects 11 to 15, the head part (3) of which is connected to or separated from the distal housing region (2a) of the applicator (1); a first retaining ring (5a) for retaining the inner implant part (6a); and a second retaining ring (5b) for retaining the outer implant part (6b).

[0060] 17. The kit according to aspect 16 includes: an implant (6) in the form of a first implant component (6a) and a second implant component (6b), the first implant component being disposed outside a first retaining ring (5a) and the second implant component being disposed inside a second retaining ring (5b), preferably the first implant component and the second implant component (6a, 6b) being constructed as tubes made of textile material.

[0061] 18. The kit according to aspect 16 or 17 includes at least one additional head component (3) for mounting on the distal housing region (2a) of the dispenser (1). Attached Figure Description

[0062] The invention will now be described in more detail with reference to the embodiments shown in the accompanying drawings. In the drawings, Figure 1 and 2 A perspective view of the dispenser is shown. Figures 3 to 5 This shows an overall cross-sectional view of the dispenser at different stages of puncture element placement. Figures 6 to 9 Detailed cross-sectional views of the dispenser at different stages of placement of the puncture element according to the invention are shown. Figure 10a and 10b A detailed diagram of the puncture element according to the present invention is shown. Figure 11 A perspective view of the puncture element component according to the invention in its unlocked state is shown. Figure 12 A perspective view of the puncture element according to the invention in its locked state is shown. Figure 13 A side view of the pin of the puncture element according to the present invention is shown. Detailed Implementation

[0063] exist Figure 1 In this design, the handle of the applicator 1 is marked with reference numeral 2. The handle 2 has a distal housing region 2a, and a head component 3 is fitted onto the distal housing region 2a. The head component 3 is secured to the distal housing region 2a or the handle 2, for example, by a bayonet connection. Furthermore, the handle 2 has an operating lever 4 as an operating element, which can be operated by the user. The second outer retaining ring is marked with reference numeral 5b, and it can be seen that a second outer implant component 6b made of textile material is inserted into the inner side of the retaining ring 5b and is thus secured to the vessel wall 7 by means of the second or outer retaining ring 5b.

[0064] exist Figure 2 In the accompanying drawings and subsequent figures, identical or corresponding elements are given the same reference numerals. It can be seen that the operating lever 4 has been operated in the direction of arrow 8, and the correspondingly movable first gripper 9 has moved outward toward the retaining ring 5b in the direction of arrow 12. The first gripper 9 abuts against the second retaining ring 5b and secures it, along with the outer implant component 6b.

[0065] According to Figure 3 In the cross-sectional view, the corresponding first or medial retaining ring 5a and the first medial implant component 6a can now be seen, which abut against the wall of the blood vessel 7. Furthermore, in Figure 3 As can be seen, the movable first gripper 9 is in its initial position and thus spaced apart from the blood vessel 7 or the outer retaining ring 5b. The first gripper 9 can be moved in the direction of arrow 12 by means of a transmission mechanism 10 (which is in turn driven by a drive rod 11) via an operating lever 4, thereby lowering the first gripper 9 onto the outer second implanted component 6b. The drive rod 11 is coupled to the push rod 15 by means of a drive sleeve 13 and a spring sleeve 14. The spring sleeve 14 contains a spring 16.

[0066] The push rod 15 acts axially and by means of a first spring element 17 on the discharge element 18, which can be driven by the push rod through the channel 19. A pin 20 of the piercing element according to the invention is supported in the channel 19, and the pin is discharged from the channel 19 through the discharge element 18.

[0067] exist Figure 4 As can be seen, when the operating lever 4 is operated, the push rod 15 moves in the direction of arrow 21, thereby driving the first spring element 17 and thus the discharge element 18 through the channel 19. Simultaneously, the drive rod 11 also moves in the direction of arrow 21 through the action of the spring sleeve 14 and the drive sleeve 13, thereby causing the first gripper 9 to move to the contact position against the second retaining ring 5b through the action of the transmission mechanism 10. The various movement stages of the discharge element 18 and the movable first gripper 9 are decoupled from each other through the action of the spring sleeve 14, so that when the first gripper 9 is already in the contact position, the discharge element 18 can still continue to move through the action of the push rod 15.

[0068] exist Figure 5 As can be seen, when the operating lever 4 is further operated in the direction of arrow 8, the pin 20 is pushed out from the channel 19 and passes through the blood vessel 7 and the implant components 6a and 6b, thereby fixing the implant components 6a and 6b to the blood vessel 7. When the operating lever 4 is released, the applicator 1 according to the invention is reset by the action of the first spring element 17 and the second spring element 22.

[0069] exist Figure 6 The initial position of the first jaw 9 can be seen more clearly, and it can be seen that the first locking member 23 for the pin 20 is detachably accommodated in the recess of the first movable jaw 9. The second locking member 24 for the pin 20 is detachably accommodated in the recess of the second fixed jaw 25. The plastic cap for the locking member 23 is provided with reference numeral 27.

[0070] exist Figure 7 In the middle, the first gripper 9 is in the abutting position, and the first locking member 23 for the pin 20 is also abutting against the outer implant component 6b.

[0071] exist Figure 8 The diagram shows a state in which the pin 20 has penetrated the implant components 6a and 6b and the blood vessel 7, and the second locking member 24 for the pin 20 has been lifted from the second retaining jaw 25. The pin 20 has also penetrated the first locking member 23, and the pin 20 is irreversibly anchored in the locking members 23 and 24. Reference numeral 20a is provided on the support portion of the pin 20 for the discharge element 18.

[0072] exist Figure 9In the illustrated state, the first gripper 9 is lifted against the direction of arrow 12 by the action of the second spring element 22, and the discharge element is pulled back into the channel 19 by the action of the first spring element 14. The head component 3 can therefore be pulled back in the direction of arrow 26 and replaced to accommodate another puncture element. The discharge outlet of the channel is marked with reference numeral 19a, and the discharge direction is parallel to the discharge area 19b defined by axis A.

[0073] exist Figure 10a In the diagram, the pin 20 of the piercing element according to the invention can be clearly seen. The pin 20 has a support portion 20a for discharging the element 18 on its proximal end opposite to the tip 20b. The first locking member is provided with reference numeral 23 and is constructed as a shaft retaining element. A plastic cap 27 occupies one side of the locking member 23 and is as shown in the diagram. Figure 10b The pin 20 is shown to penetrate the pin 20, thus surrounding the tip 20b of the pin 20. The plastic sheath 27 may have a cap 28, or the cap 28 may completely replace the plastic sheath 27, to cover the tip of the pin 20. The second locking member 24 is provided with reference numeral 24 and has a notch on its bottom side in the form of a frustoconical chamfer 29 for the support portion 20a.

[0074] exist Figure 10b The image shows the piercing element in its locked state, with the pin 20 clamped by the shaft retaining element in the first piercing element 23. The support portion 20a is received in the recess 29.

[0075] exist Figure 11 The components of the puncture element according to the invention, as described above, are shown in a perspective view from a lower oblique angle, and it can be seen that the second locking member 24 may have a groove 30 with an upward orientation. A corresponding retaining structure (e.g., an elastic metal wire) may be embedded in this groove.

[0076] exist Figure 12 As can be seen, in the fixed state of the piercing element according to the present invention, the base 20c of the pin 20 is accommodated in the recess 31 of the second locking member 24, thereby obtaining a smoother profile of the piercing element as a whole.

[0077] exist Figure 13 The diagram shows a preferred variant of the pin 20, wherein a plurality of axially oriented, circumferential locking grooves 32 are provided for the insertion of the first locking member 23.

Claims

1. A puncture element for penetrating the vessel wall (7) and an implant, the puncture element comprising a pin (20), a first locking member (23), and a second locking member (24), characterized in that, At least the first locking element (23) is configured as a shaft retaining element, and preferably the second locking element (24) is also configured as a shaft retaining element.

2. The puncture element according to claim 1, characterized in that, The pin (20) has a support (20a) formed on its proximal end for discharging the element (18).

3. The puncture element according to claim 1 or 2, characterized in that, The second locking member (24) is constructed as a washer having a preferably centrally located hole (24a) through which a pin (20) passes, the hole (24a) having a frustoconical chamfer (29) for the pin (20) to enter the hole (24a).

4. The puncture element according to claim 1, 2, or 3, characterized in that, The first locking member (23) is constructed as a washer having a preferably centrally located hole (23a) through which a pin (20) passes, the hole having a truncated cone chamfer (33) for the pin (20) to enter the hole (23a).

5. The puncture element according to claim 2, 3 or 4, characterized in that, The support portion (20a) corresponds to the truncated chamfer (29) structure for the pin (20) entry hole (24a).

6. The puncture element according to any one of claims 1 to 5, characterized in that, For the first locking element (23) to be inserted, the pin (20) has at least one circumferential locking groove (32) acting in the axial direction, which is formed by a preferred abrupt reduction in the diameter of the pin (20).

7. The puncture element according to claim 6, characterized in that, The pin (20) has a plurality of circumferential locking grooves (32) that act in the axial direction.

8. The puncture element according to any one of claims 1 to 7, characterized in that, The second locking member (24) is constructed as a washer having a surrounding groove (30), preferably the groove (30) having a continuously extending longitudinal section.

9. The puncture element according to any one of claims 1 to 8, characterized in that, The first and / or second locking elements (23, 24) are at least partially encased in a plastic sheath (27) that can be penetrated by the pin (20).

10. The puncture element according to any one of claims 3 to 9, characterized in that, The first locking member (23) is fitted with a plastic cap (27) on one side that can be penetrated by the pin (20).

11. The puncture element according to any one of claims 3 to 10, characterized in that, The first locking member (23) has a hollow metal cap (28) on one side for the pin (20) to enter the metal cap (28) and for bending the pin on the inside of the metal cap (28).

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