Penetration element

Abstract

A penetration element for penetrating a vessel wall (7) of a blood vessel comprises a pin (20), a first locking piece (23) and a second locking piece (24), at least the first locking piece (23) being designed as a pin securing means.

Description

[0001] Penetrating element

[0002] The invention relates to a penetrating element for penetrating a vessel wall of a blood vessel and an implant.

[0003] Dissection of the ascending aorta (type A dissection) is a life-threatening condition requiring immediate surgery. In an acute type A dissection, the primary goal of surgical treatment is to restore circulation and prevent or reverse life-threatening complications such as aortic rupture, cardiac tamponade, and myocardial ischemia. The second goal of surgical treatment, if possible, is to resect the tear in the tunica intima (the portal of entry into the false lumen) in the proximal aorta to ensure perfusion of the true lumen and thus the organs.

[0004] The classic surgical treatment of acute type A dissection involves replacing the ascending aorta with a vascular prosthesis in the form of a tubular prosthesis, with the distal anastomosis being performed using the "open" technique and in hypothermic circulatory arrest at approximately 25 °C core body temperature.

[0005] Surgical access is gained through a median sternotomy. With the help of a heart-lung machine and the patient cooled down, circulatory arrest is initiated with the patient in the head-down position, and the ascending aorta can be opened. The true lumen is identified, and the ascending aorta is resected down to its distal portion, allowing the distal ascending aorta to be viewed like an open tube. The currently standard surgical procedure involves suturing the delaminated aortic wall sections (tunica intima, tunica media, and tunica adventitia) together using the so-called "sandwich" technique.This is done by inserting an inner implant component, such as a felt strip, i.e., a strip of textile material, in a circular or radial pattern inside the aorta and applying it to the aortic wall. An outer implant component, such as a felt strip, is also applied to the vessel outside the aorta, in a circular or radial pattern. A continuous, meandering suture is then manually applied using a polypropylene suture, or individual sutures are placed, to sew these two felt strips and the aortic wall between them together (a sandwich).

[0006] This step of the operation takes approximately 25 minutes, but can be completed ten minutes faster or slower depending on surgical experience. Following this, in a second step, a tubular prosthesis is manually sewn end-to-end to this sandwich stump, the fixation site, using a polypropylene suture.

[0007] After an appropriate venting maneuver, an aortic clamp can now be placed on the now sewn-on prosthesis, and circulatory arrest is considered to be lifted. This usually concludes the most critical phase of the operation. At the proximal end closest to the heart, a supracoronary sandwich of the native aorta is then created using the same technique described above. The proximal end of the prosthesis is then sutured end-to-end to this sandwich (fixation site), as described above. It is obvious that in such a far-reaching operation, in which normal blood circulation is interrupted and the body and brain are significantly cooled, time is of the utmost importance in order to optimize the patient's chances of survival and recovery.In particular, the procedure described above for treating the dissection by applying the sandwich suture depends heavily on the individual circumstances of the respective patient, the extent of the dissection of the vessel wall and, last but not least, to a significant extent on the skill of the surgeon.

[0008] Devices have therefore already been developed to simplify and accelerate the attachment of the implant, in particular by replacing the time-consuming step of placing the polypropylene suture in the form of a continuous, meandering suture with the mechanical insertion of penetrating elements, such as staples. For this purpose, devices or applicators have been created which press the penetrating elements outwards from a carrier element and thereby drive them through the implant and the vessel wall. The implant usually consists of an inner and an outer implant part, for example in the form of felt strips or in the form of tubes made of textile material with a relatively short longitudinal extent.

[0009] For example, WO 2022 / 130274 A1 discloses a device in which a plurality of penetrating elements are mounted in radially outwardly directed guides and can be driven radially outward on supports for the penetrating elements. Theoretically, this device, or rather this applicator for the penetrating elements, offers the possibility of setting all of the penetrating elements required for securing the implant in a single step.When using this applicator, however, there is a risk that when such a large number of penetrating elements are inserted simultaneously, one or more of the penetrating elements may not be inserted properly. In view of the extremely critical situation when treating the severed aorta, this represents an unacceptable risk. In this case, at least some of the inadequately inserted penetrating elements would have to be removed. In this case, it is practically inconceivable that the operation could be brought to a successful conclusion in time. What makes this even more difficult is that the penetrating elements are basically designed like staples, and so after penetration, two ends protruding from the aortic wall and the outer part of the implant have to be properly bent over.The susceptibility to errors is therefore also increased with regard to the penetrating elements and the applicator with many individual parts and delicate structures is also to be regarded as critical if an absolutely perfect result must be achieved and a correction of the initial result does not seem feasible.

[0010] It is therefore an object of the present invention to provide a penetrating element which can be set more reliably than the prior art.

[0011] To achieve this object, the penetrating element according to the invention comprises a pin, a first locking piece and a second locking piece and is characterized according to the invention in that at least the first locking piece is designed as a shaft lock. A "shaft lock" in the sense of the present invention is understood to mean a mechanical element which is designed to prevent or limit an axial movement of the pin counter to a penetration direction relative to the locking piece. The shaft lock can, for example, comprise projections, elastically deformable elements or other mechanical structures which prevent the pin from sliding back after penetrating the vessel wall and / or the implant and thus ensure secure fixation. The shaft lock can in particular have one or more radially projecting structures which form an abutment for the pin.Preferably, the locking member has at least one element that can be deflected in the penetration direction upon insertion of the pin. Upon attempting to retract the pin in the opposite direction, the element interacts with the pin in a positive and / or frictional engagement, thereby preventing retraction of the pin.

[0012] Preferably, the second locking piece is also designed as a shaft lock. The penetrating element according to the invention thus consists of three separate parts. These are the pin and the two locking pieces, which enables a connection between tissue and implant largely independent of their thickness, since the pin can be selected with a length corresponding to the required thickness, independently of the locking pieces. The first and the second locking piece can be penetrated by the pin and at least the first locking piece is designed to secure the position of the pin in the penetrated state in the radial and, if necessary, in the axial direction.The penetrating element according to the invention serves to penetrate a vessel wall of a blood vessel and an implant for attaching the implant as a fixation point for a vascular prosthesis to the vessel wall or to penetrate a vessel wall and a vascular prosthesis for directly fixing the vascular prosthesis to the vessel wall.

[0013] Because the pin is a standalone part of the penetrating element according to the invention and is thus formed separately from the two locking pieces, the pin can be concealed in its entirety in a corresponding applicator before insertion, which offers a number of advantages. Firstly, the complete inclusion of the pin in the applicator eliminates the risk of injury when the penetrating element approaches the surgical site, since the pin only extends with its tip from the corresponding applicator when the penetrating element is inserted. Furthermore, the pin cannot be lost in the surgical field.

[0014] When inserting the penetrating element, the pin is driven through the two locking pieces, so that the pin is initially optimally guided by the second locking piece as it penetrates the vessel wall and the implant, preventing it from bending. This allows the pin to penetrate the vessel wall and the implant in a very straight line and can then be reliably picked up and secured by the first locking piece.

[0015] The invention can preferably be further developed such that the pin forms a support for an expulsion element at a proximal end. The support is designed with a larger diameter than the rest of the pin and provides a secure support for an expulsion element of a corresponding applicator for piercing the pin through the implant and the vessel in order to drive the pin distally.

[0016] In order to optimize the entry of the pin of the penetrating element according to the invention into the second locking piece, the invention can be further developed according to a preferred embodiment such that the second locking piece is designed as a disk with a preferably central hole for the passage of the pin, wherein the hole has a truncated cone-shaped chamfer for the entry of the pin into the hole. The truncated cone-shaped chamfer guides the tip of the pin into the hole even with minor radial deviations from the ideal position. For the same reason and with the same effect, according to a further preferred embodiment of the present invention, the first locking piece is designed as a disk with a preferably central hole for the passage of the pin and the hole has a truncated cone-shaped chamfer for the entry of the pin into the hole.In the context of the present description, the first locking piece is the locking piece that secures the pin distally and thus near its tip, and the second locking piece is the locking piece that secures the pin proximally and thus near its base.

[0017] According to a preferred embodiment of the present invention, the support can preferably be further developed such that the support is designed to correspond to the truncated cone-shaped chamfer for the pin's entry into the hole. In this way, the support and thus the proximal end can enter the disc as a second locking piece in a sealing manner, thus forming the smoothest possible proximal end of the penetrating element according to the invention.

[0018] To reliably secure the pin, the pin can have at least one circumferential locking groove acting in the axial direction for the engagement of the first locking piece, which is formed by a preferably sudden reduction in the diameter of the pin, as corresponds to a preferred embodiment of the present invention. The reduction in diameter is related to the actual diameter of the pin next to the locking groove. The locking groove is a recess running around the circumference of the pin, against which the shaft lock can engage in order to be optimally protected against slipping distally.

[0019] Preferably, the pin has a plurality of circumferential locking grooves acting in the axial direction, so that the pin can continue to pass through the locking piece when penetrating the implant and the vessel and can find hold on one of the plurality of locking grooves when an optimal position of the second locking piece on the outer part of the implant is reached.

[0020] For optimized securing of the second locking piece in an applicator before and during insertion of the penetrating element according to the invention, a preferred embodiment of the present invention provides that the second locking piece is designed as a disk with a circumferential groove, wherein the groove is preferably designed with a continuous longitudinal section. This design of the second locking piece enables the engagement of a holding structure shaped corresponding to the groove on a suitable applicator, so that the second locking element is held on the applicator. The preferred continuous design of the longitudinal section of the groove allows the groove to be easily engaged and disengaged from the holding structure on the applicator, since no discontinuities have to be overcome and the holding structure can therefore be designed, for example, as a simple spring element or as a springy wire.

[0021] The invention can preferably be further developed such that the first and / or the second locking piece is at least partially enclosed by a plastic sheath penetrable by the pin. Such a sheath can be suitably designed to shield the support or the tip of the pin. The plastic sheath can be easily penetrated by the pin during attachment of the implant, i.e., during insertion of the penetrating element, and subsequently covers the tip of the penetrating element.

[0022] For particularly effective shielding of the pin tip, the invention can be further developed according to a preferred embodiment such that the first locking piece is provided on one side with a plastic cap penetrable by the pin. The plastic cap can be dimensioned accordingly to reliably enclose the pin tip when it is fully inserted through the implant and the vessel.

[0023] An alternative or supplement to securing the tip of the pin with the plastic cap just described can, according to a preferred embodiment of the present invention, consist in the first locking piece having a hollow metal cap on one side for the pin to enter the metal cap. The hollow metal cap can also serve to shield the tip of the penetrating element and can also be suitable for bending the tip of the pin if the pin itself is too long.

[0024] An applicator for placing the penetrating element according to the invention for attaching an implant as a fixation point for a vascular prosthesis to a vessel wall of a blood vessel by penetrating the vessel wall and the implant with at least one penetrating element according to the invention, preferably with a plurality of penetrating elements according to the invention, has a channel for receiving and expelling the at least one pin from the channel and a displaceable, first jaw for releasably receiving a first locking piece for the penetrating element, wherein the channel has an exit region directed towards the first jaw, defining an exit direction and having an exit opening for the pin, and the first jaw is displaceable in the exit direction from an initial position into a contact position located closer to the exit opening compared to the initial position.The channel preferably has a circular cross-section.

[0025] The applicator thus holds a single pin which, in comparison to the prior art, interacts with at least one locking piece as a counterpart in order to be locked after penetrating the implant and the vessel wall. The locking piece allows the pin to be secured without the pin having to be bent over for securing purposes, as is the case with the penetrating elements of the prior art. The counterpart or locking piece is designed accordingly to enable reliable securing of the pin of the penetrating element. Because only a single penetrating element is set with the applicator, the applicator according to the invention can be designed more simply in terms of construction.

[0026] The applicator has only a single channel for driving out the pin of the penetrating element, so that the channel can be optimally designed to enable a favorable flow of force from an actuating element of the applicator to the exit area. When the implant is applied in the exit direction, the movable first jaw with the first locking piece held therein moves from an initial position into a contact position which is closer to the exit opening than the initial position, thereby securing the previously inserted parts of the implant to the vessel wall. In the contact position, the first jaw rests against the outer part of the implant and therefore offers resistance to piercing the implant and the vessel wall with the pin of the penetrating element.After the pin has penetrated or punctured the implant and the vessel wall, it comes into action with the first locking piece and is effectively locked in the movable first jaw. The applicator is then relieved, releasing the locking piece. This also enables visual inspection of the correct placement of the penetrating element before a further penetrating element is placed. In this way, the implant can be attached to the vessel wall quickly and extremely reliably. The first jaw preferably has a recess for releasably receiving the first locking piece, into which the first locking piece is inserted.

[0027] The outlet opening for the pin is formed in a fixed, second jaw of the applicator, the second jaw being designed to releasably receive a second locking piece for the penetrating element. The second jaw preferably has a recess for releasably receiving the second locking piece, into which recess the second locking piece is inserted, for example as a disc with a circumferential groove, and is preferably secured by means of the groove. When the applicator is used, the implant and the vessel wall in between are clamped between the movable, first jaw and the fixed, second jaw, the two jaws holding two locking pieces for the pin of the penetrating element according to the invention. The pin is guided in a channel of the applicator with a circular cross-section.Due to the clamping effect, the locking pieces lie closely against the implant and the penetrating element therefore subsequently secures the implant in reliable contact with the vessel wall.

[0028] In order to reliably drive the pin out of the canal and to make the process of driving the pin out of the canal simple and cost-effective in terms of equipment, the applicator can be further developed in such a way that a rigid, and preferably flexible, ejection element is guided in the canal to drive the pin out of the canal, wherein the ejection element can be driven by a push rod in the direction of the outlet opening. For this purpose, the ejection element can be designed, for example, as a fully compressed tension spring. Such a tension spring has a very slight pitch of the individual coils, so that the coils touch one another in the normal state of the spring. The spring is therefore completely flexible and can also follow curved paths in the canal, but is more or less completely rigid when guided to prevent lateral deflection.This is the case in a channel such as in the present invention. The channel and the expulsion element could, however, also be designed as a Bowden cable, for example. The expulsion element can also be driven in the direction of the outlet opening by means of a push rod. Such a push rod can be driven in the conventional manner by simple mechanical means and by manual force. The push rod can also be flexible in order to enable the applicator according to the invention to be bent depending on the requirements of the surgical field. This makes it possible, under certain circumstances, to treat even more inaccessible areas with an appropriate suture.

[0029] If the ejection element can be driven in the direction of the outlet opening against the action of a first spring element, the ejection element is automatically reset when the user has set the penetrating element.

[0030] The first jaw can be driven by a gear mechanism to perform a linear displacement from the starting position to the contact position. This allows an actuating movement by the user, for example, on a handle of the applicator according to the invention, to be converted into the desired direction of displacement of the first jaw in order to displace the first jaw accordingly. The gear mechanism can also be designed to suitably select both the displacement path of the first jaw and its drive force depending on a desired force that must be applied by the surgeon.

[0031] The gearing is driven by a drive rod, which is driven counter to the action of a second spring element. The drive rod can run at any angle to the direction of displacement of the first jaw and thus allows a redirection of the drive direction, which is predetermined by the actuating movement of the surgeon or user of the applicator according to the invention and other mechanical components of the applicator, in the direction of displacement of the first jaw. As already discussed in connection with the ejection element, a spring-loaded mounting of the drive rod can be used to return the drive rod to its original position while returning the first jaw to its original position.

[0032] According to one variant, the drive rod is driven by a push rod, wherein preferably the ejection element and the drive rod are driven by the same push rod. The concept of driving the movable parts of the applicator according to the invention by means of push rods is to be regarded as advantageous in order to be able to implement limited drive paths in a controlled manner, wherein the introduction of force to the movable parts by a push rod only takes up a small space, which is naturally to be regarded as advantageous in a surgical instrument. When using a single push rod to drive both the ejection element and the first jaw by one and the same push rod, a desirable reduction in the number of parts of the applicator is achieved and the movements of the first jaw and the ejection element can be synchronized with one another via the common drive element of the common push rod.As already mentioned, the push rod can also be flexible and thus bendable to a certain extent in order to allow the applicator to be bent depending on the requirements of the surgical field.

[0033] In order to transmit the force applied to the push rod for driving the first jaw to the drive rod, it can be provided that the drive rod is coupled to the push rod via a drive sleeve coupled for joint displacement with the push rod, wherein the drive sleeve is driven by the push rod against the action of a spring sleeve. The drive sleeve enables the drive force to be coupled 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. In this embodiment, the push rod can thus act axially on the ejection element and create a further force path to the drive rod via the drive sleeve.If a spring sleeve, which is in particular firmly connected to the push rod, acts resiliently on the drive sleeve, offset drive movements with different drive path lengths of the first jaw and the drive element can be achieved with simultaneous actuation of the expulsion element and the first jaw by a common push rod. In this way, with a single movement of the push rod, the first jaw can be brought into contact with a retaining ring for the implant or with the implant itself and the expulsion element can then be moved further in order to drive out the pin and set the penetrating element according to the invention. In this case, there is no further movement of the first jaw because when the first jaw and thus the first locking piece are fully in contact with the outer part of the implant, the spring sleeve compresses and the drive sleeve is therefore not positively guided by the push rod.

[0034] It can be provided that the push rod is driven by an actuating element that interacts with the push rod via a further gear. The actuating element can, for example, be designed as an actuating lever on a handle element of the applicator, so that the user only has to press the lever to insert the penetrating element in order to actuate the applicator.

[0035] Preferably, the push rod, the spring sleeve and the drive sleeve are arranged in a distal housing region of the applicator and can in this way be designed as a drive unit and preferably the first and second jaws, the gear and the drive rod as well as the channel and the expulsion element are arranged in a head of the applicator which can be detachably connected to the distal housing region. Overall, this results in a modular design of the applicator which, under certain circumstances, makes it possible to design parts of the applicator as disposable items and other parts as reusable. For example, the head could be disposable and the rest of the applicator reusable. If the push rod is designed to be flexible in order to allow the applicator to be bent, at least the distal housing region of the applicator is also designed to be flexible.According to one variant, the penetrating element is arranged as a straight pin, preferably a metal pin, in the exit area of ​​the channel distal to the expulsion element, with the pin forming a support for the expulsion element at a proximal end facing the expulsion element. The penetrating element can thus be expelled from the exit area of ​​the channel along a defined axis and driven through the locking piece(s).

[0036] According to a preferred embodiment of the present invention, the first locking piece, and preferably the second locking piece, are designed as clamping discs. Clamping discs are known in the art as shaft locks and allow a single penetration of the pin. Retraction is then impossible without considerable force, since a frictional connection and possibly also a positive connection occurs between the clamping disc and the pin in the withdrawal direction. After the pin is driven out, the penetration element according to the invention is therefore immediately secured.

[0037] The present application discloses an applicator for the penetrating element according to the invention according to the following aspects:

[0038] 1. Applicator (10) for attaching an implant (6) as a fixation point for a vascular prosthesis to a vessel wall of a blood vessel (7) by penetrating the vessel wall and the implant (6) with at least one penetrating element (20), preferably with a plurality of penetrating elements (20), wherein the applicator (1) has a channel (19) for receiving and expelling the at least one penetrating element (20) from the channel (19) and a displaceable, first jaw (9) for releasably receiving a first locking piece (23) for the penetrating element (20), wherein the channel (19) has a

[0039] Exit direction (A) defining an exit region with an exit opening (19a) for the penetrating element (20) and the first jaw (9) is displaceable in the exit direction (A) from an initial position into a contact position located closer to the exit opening (19a) compared to the initial position.

[0040] 2. Applicator according to aspect 1, wherein the outlet opening (19a) is formed in a fixed, second jaw (25), wherein the second jaw (25) is designed to releasably receive a second locking piece (24) for the penetrating element (20).

[0041] 3. Applicator according to aspect 1 or 2, wherein a shear-resistant, and preferably flexible, expulsion element (18) is guided in the channel (19) for expelling the penetrating element (20) from the channel (19), wherein preferably the expulsion element (18) is driven by a push rod (15) in the direction of

[0042] Outlet opening (19a) can be driven.

[0043] 4. Applicator according to aspect 3, wherein the expulsion element (18) can be driven against the action of a first spring element (17) in the direction of the outlet opening (19a).

[0044] 5. The applicator according to any one of aspects 1 to 4, wherein the first jaw (9) can be driven by a gear (10) to perform a linear displacement from the starting position into the contact position. 6. The applicator according to aspect 5, wherein the gear (10) is driven by a drive rod (11), wherein the drive rod (11) is preferably driven counter to the action of a second spring element (22).

[0045] 7. Applicator according to aspect 6, wherein the drive rod (11) is driven by a push rod (15), wherein preferably the expulsion element (18) and the drive rod (11) are driven by the same push rod (15).

[0046] 8. Applicator according to aspect 6 or 7, wherein the drive rod (11) is coupled to the push rod (15) by means of a drive sleeve (13) coupled to the push rod (15) for joint displacement, wherein the drive sleeve (13) is preferably driven by the push rod (15) against the action of a spring sleeve (14).

[0047] 9. Applicator according to aspect 6, 7 or 8, wherein the push rod (15) is driven by an actuating element (4) which interacts with the push rod (15) via a further gear.

[0048] 10. Applicator according to aspect 8 or 9, wherein the push rod (15), the spring sleeve (14) and the drive sleeve (13) are arranged in a distal housing region (2a) of the applicator (1).

[0049] 11. Applicator according to aspect 10, wherein the first and second jaws (9, 25), the gear (10) and the drive rod (11), as well as the channel (19) and the expulsion element (18) are arranged in a head (3) of the applicator (1) that is detachably connectable to the distal housing region (2a). 12. Applicator according to one of aspects 3 to 11, wherein the penetrating element (20) is arranged as a straight pin (20), preferably a metal pin (20), in the exit region of the channel (19) distal to the expulsion element (18), wherein the pin (20) forms a support (20a) for the expulsion element (18) at a proximal end facing the expulsion element (18).

[0050] 13. Applicator according to one of aspects 2 to 12, wherein the first locking piece (23) and preferably the second locking piece (24) are designed as clamping discs.

[0051] 14. Applicator according to one of aspects 1 to 13, wherein a locking piece (23) is surrounded by a plastic sheath (27) penetrable by the penetrating element.

[0052] 15. Applicator according to one of aspects 1 to 14, wherein a locking element (23) has a hollow metal cap (28) for the penetration of the penetrating element (20).

[0053] 16. Set for attaching an implant (6) as a fixation point for a vascular prosthesis to a vessel wall of a blood vessel (7), comprising at least one applicator (1) according to one of claims 11 to 15, the head (3) of which is connected to or separated from the distal housing region (2a) of the applicator (1), a first retaining ring (5a) for holding an inner implant part (6a), and a second retaining ring (5b) for holding an outer implant part (6b).

[0054] 17. Set according to aspect 16 comprising the implant (6) in the form of a first implant part (6a) which is arranged externally on the first retaining ring (5a) and a second implant part (6b) which is arranged internally on the second retaining ring (5b), wherein preferably the first and the second implant part (6a, 6b) are designed as a tube made of textile material.

[0055] 18. Set according to aspect 16 or 17 comprising at least one further head (3) for attachment to the distal housing region (2a) of the applicator (1).

[0056] The invention is explained in more detail below with reference to an exemplary embodiment shown in the drawing. In this drawing, Figures 1 and 2 show perspective views of the applicator, Figures 3 to 5 show an overall view of the applicator in section at various stages of setting a penetrating element, Figures 6 to 9 show detailed views of the applicator in section at various stages of setting a penetrating element according to the invention, Figures 10a and 10b show detailed views of a penetrating element according to the invention, Figure 11 shows a perspective view of the individual parts of the penetrating element according to the invention in an unsecured state, Figure 12 shows a perspective view of the penetrating element according to the invention in a secured state and Figure 13 shows a side view of the pin of the penetrating element according to the invention.

[0057] In Figure 1, a handle of the applicator 1 is provided with the reference number 2. The handle 2 has a distal housing region 2a and a head 3 is placed on the distal housing region 2a, wherein the head 3 can be secured to the distal housing region 2a or the handle 2, for example, by a bayonet lock. The handle 2 also has an actuating element, the lever 4, which can be actuated by a user. A second, outer retaining ring is provided with the reference number 5b and it can be seen that an outer, second implant part 6b made of a textile material is inserted inside the retaining ring 5b and is brought into contact with the vessel wall 7 by means of the second or outer retaining ring 5b.

[0058] In Figure 2 and the other figures, identical or corresponding elements are provided with the same reference numerals. It can be seen that the lever 4 was actuated in the direction of arrow 8 and that, accordingly, a displaceable first jaw 9 was displaced in the direction of arrow 12 toward the outer retaining ring 5b. The first jaw 9 rests against the second retaining ring 5b and holds it and the outer implant part 6b.

[0059] In the sectional view according to Figure 3, a corresponding first or inner retaining ring 5a and a first, inner implant part 6a can be seen, which are placed against the wall of the vessel 7. Furthermore, in Figure 3 the displaceable first jaw 9 can be seen in an initial position and thus spaced from the vessel 7 or from the outer retaining ring 5b. The first jaw 9 can be displaced in the direction of the arrow 12 by means of a gear 10, which in turn is driven by a drive rod 11, by actuating the lever 4, whereby the first jaw 9 is lowered onto the outer, second implant part 6b. The drive rod 11 is coupled to a push rod 15 via a drive sleeve 13 and a spring sleeve 14. The spring sleeve 14 contains a spring 16.The push rod 15 acts axially and through the mediation of a first spring element 17 on an expulsion element 18, which can be driven through the channel 19 by the push rod. A pin 20 of the penetrating element according to the invention is mounted in the channel 19 and is expelled from the channel 19 by the expulsion element 18.

[0060] Figure 4 shows that when the lever 4 is actuated, the push rod 15 is moved in the direction of the arrow 21, so that the push rod 15 drives the first spring element 17 and thus the ejector element 18 through the channel 19. At the same time, the drive rod 11 was moved in the direction of the arrow 21 by the action of the spring sleeve 14 and the drive sleeve 13, so that the first jaw 9 was moved into the contact position in contact with the second retaining ring 5b by the action of the gear 10. The movement phases of the ejector element 18 and the displaceable first jaw 9 are decoupled from one another by the action of the spring sleeve 14, so that the ejector element 18 can be moved further by the action of the push rod 15 when the first jaw 9 is already in the contact position.

[0061] In Figure 5, it can be seen that upon further actuation of the lever 4 in the direction of arrow 8, the pin 20 is pushed out of the channel 19 and through the vessel 7 and the implant parts 6a and 6b, whereby the implant parts 6a and 6b are fixed to the vessel 7. Due to the action of the first spring element 17 and the second spring element 22, the applicator 1 according to the invention is reset when the lever 4 is released.

[0062] In Figure 6, the initial position of the first jaw 9 can be seen more clearly, and it can be seen that a first locking piece 23 for the pin 20 is releasably received in a recess of the first, movable jaw 9. A second locking piece 24 for the pin 20 is releasably received in a recess of the second, fixed jaw 25. A plastic cap for the locking piece 23 is designated by the reference numeral 27.

[0063] In Figure 7, the first jaw 9 is in the contact position, with the first locking piece 23 for the pin 20 also being in contact with the outer implant part 6b.

[0064] Figure 8 shows a state in which the pin 20 has penetrated the implant parts 6a and 6b as well as the vessel 7, wherein the second locking piece 24 for the pin 20 has been lifted out of the second, fixed jaw 25. The pin 20 also penetrates the first locking piece 23, whereby an irreversible anchoring of the pin 20 in the locking pieces 23 and 24 takes place. A support on the pin 20 for the expulsion element 18 is designated by the reference symbol 20a.

[0065] In the state shown in Figure 9, the first jaw 9 is raised by the action of the second spring element 22 in the opposite direction to the arrow 12 and the expulsion element is retracted into the channel 19 by the action of the first spring element 14. The head 3 can thus be retracted in the direction of the arrow 26 and replaced in order to insert a further penetrating element. The outlet opening of the channel is provided with the reference symbol 19a and an exit direction parallel to the exit region 19b is defined by the axis A. In Figure 10a, the pin 20 of the penetrating element according to the invention can be clearly seen. The pin 20 has a support 20a for an expulsion element 18 at its proximal end facing away from the tip 20b. The first locking piece is designated by 23 and is designed as a shaft lock.A plastic cap 27 occupies one side of the locking piece 23 and, as shown in Figure 10b, is penetrated by the pin 20, so that the tip 20b of the pin 20 is enclosed. The plastic sleeve 27 can have a cap 28, or the cap 28 can completely replace the plastic sleeve 27 in order to shield the tip of the pin 20. The second locking piece 24 is provided with the reference numeral 24 and has on its underside a recess in the form of a truncated conical chamfer 29 for the support 20a.

[0066] In Figure 10b, the penetration element is shown in the locked state, with the pin 20 being clamped by the shaft lock in the first penetration element 23. The support 20a is received in the recess 29.

[0067] Figure 11 shows the just-described parts of the penetrating element according to the invention in a perspective view obliquely from below. It can be seen that the second locking piece 24 can have a groove 30 with a rising profile. A corresponding holding structure, for example, a resilient wire, can engage in the groove.

[0068] In Figure 12 it can be seen that in the secured state of the penetrating element according to the invention the base 20c of the pin 20 is received in a recess 31 of the second locking piece 24, so that overall a smoother silhouette of the penetrating element results.

[0069] In Figure 13, the pin 20 is shown in a preferred variant, wherein several circumferential locking grooves 32 acting in the axial direction are provided for the engagement of the first locking piece 23.

Claims

Patent claims:

1. Penetrating element for penetrating a vessel wall (7) of a blood vessel and an implant, comprising a pin (20), a first locking piece (23) and a second locking piece (24), characterized in that at least the first locking piece (23) is designed as a shaft lock, wherein preferably the second locking piece (24) is also designed as a shaft lock.

2. Penetrating element according to claim 1, characterized in that the pin (20) forms a support (20a) for an expulsion element (18) at a proximal end.

3. Penetrating element according to claim 1 or 2, characterized in that the second locking piece (24) is designed as a disc with a preferably central hole (24a) for the passage of the pin (20), wherein the hole (24a) has a truncated conical chamfer (29) for the entry of the pin (20) into the hole (24a).

4. Penetrating element according to claim 1, 2 or 3, characterized in that the first locking piece (23) is designed as a disc with a preferably central hole (23a) for the passage of the pin, wherein the hole has a truncated cone-shaped chamfer (33) for the entry of the pin (20) into the hole (23a).

5. Penetrating element according to claim 2, 3 or 4, characterized in that the support (20a) is designed corresponding to the truncated conical chamfer (29) for the entry of the pin (20) into the hole (24a).

6. Penetrating element according to one of claims 1 to 5, characterized in that the pin (20) for the engagement of the first locking piece (23) has at least one circumferential locking groove (32) acting in the axial direction, which is formed by a, preferably abrupt, reduction in the diameter of the pin (20).

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

8. Penetrating element according to one of claims 1 to 7, characterized in that the second locking piece (24) is designed as a disc with a circumferential groove (30), wherein the groove (30) is preferably designed with a continuously extending longitudinal section.

9. Penetrating element according to one of claims 1 to 8, characterized in that the first and / or the second locking piece (23, 24) is at least partially enclosed by a plastic sleeve (27) penetrable by the pin (20).

10. Penetrating element according to one of claims 3 to 9, characterized in that the first locking piece (23) is provided on one side with a plastic cap (27) which can be penetrated by the pin (20).

11. Penetrating element according to one of claims 3 to 10, characterized in that the first locking piece (23) has on one side a hollow metal cap (28) for the Entry of the pin (20) into the metal cap (28) and the Bending the pin on an inside of the metal cap (28) .

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