IMPLANTATION DEVICE

Description

[0001] The invention relates to an implantation device for implanting a vascular implant, which enables simple positioning and slip-free unloading of a vascular implant.

[0002] US 2013 / 158655 A1 shows a handle for use with a percutaneous delivery system for aortic valve replacement.

[0003] Implantation instruments and catheters are used to introduce and position medical implants in blood vessel systems, for example for use in human medicine. In so-called percutaneous transluminal angioplasty and percutaneous transluminal coronary angioplasty, minimally invasive implants such as stents are advanced through the vessels and applied to the affected section of the vessel using an implantation instrument (delivery system). To position the catheter in the vessel, a catheter diameter significantly smaller than the affected vessel with the constriction that the catheter must penetrate is selected. For self-expanding implants such as nitinol stents, a sheath (tube) on the catheter system is used for this purpose. As soon as the catheter system reaches the narrowed section of the vessel, the sheath is flushed and then pushed backward relative to the catheter system.The self-expanding stent unfolds above the Af temperature (shape memory alloy), whereby the Af temperature is chosen to be significantly lower than body temperature.

[0004] The relative movement of the sheath on the fixed catheter system is crucial for the implant's positioning accuracy in the vessel. While the surgeon typically secures the system with one hand and retracts the sheath with the other, slight relative movement between the sheath and the catheter system can often occur, leading to incorrect implantation and thus serious complications.

[0005] Particularly in implants that also incorporate sensor functions, the frictional force between the movable sheath and the implant is often increased due to their geometric properties. This requires the user to exert considerable force to release the sensor system. High frictional forces can lead to undesirable relative movement of the entire catheter system with respect to the sheath, causing the unloading process to either fail or be performed incorrectly.

[0006] State-of-the-art solutions are known that are also used in the cardiovascular field. Such systems are used, for example, for stent grafts or for the implantation of heart valve replacements.

[0007] The object of the present invention is to provide an implantation device for implanting a vascular implant which allows a safer implantation.

[0008] The object is achieved by the implantation device according to claim 1. The dependent claims specify advantageous developments of the implantation device according to the invention.

[0009] According to the invention, an implantation device for implanting a vascular implant is provided. The implantation device according to the invention comprises an internally toothed gear, which can advantageously be cylindrical.

[0010] The implantation device according to the invention also comprises one or more transport devices arranged side by side. Each of the transport devices comprises a spindle and an externally toothed gear arranged coaxially with the spindle. The externally toothed gear is rigidly connected to the spindle. Advantageously, an axis of rotation of the externally toothed gear is coaxial with an axis around which the spindle is wound. Advantageously, the spindles of all transport devices have the same helicity.

[0011] Particularly advantageously, the spindle and the externally toothed gear of the transport devices can each be carried by a common shaft which is coaxial to the axis of rotation of the externally toothed gear.

[0012] The implantation device according to the invention also comprises at least one adapter having a number of threads corresponding to the number of transport devices. The threads are advantageously helical internal threads. The thread axes of the threads are advantageously parallel to one another.

[0013] In the implantation device according to the invention, the gears of one or more transport devices mesh with the internally toothed gear. In this way, rotation of the internally toothed gear is transmitted to the externally toothed gears of the transport devices, which in turn cause rotation of the spindles.

[0014] According to the invention, the spindles of one or more transport devices each engage with one of the adapter's threads. Advantageously, the adapter's internal threads each have the same pitch as the spindle that engages this thread. Rotation of the spindles therefore results in a movement of the adapter in the direction of the spindle axis.

[0015] The implantation device according to the invention also has a tubular sheath connected to the adapter at one of its ends. Movement of the adapter thus results in movement of the sheath.

[0016] Furthermore, the implantation device comprises a cannula tube which is arranged next to and parallel to the spindles of the one or more transport devices over at least the length of the spindles.

[0017] The implantation device also comprises a catheter that is at least partially disposed within the cannula tube. The catheter is preferably glued to the cannula tube at one end.

[0018] In an advantageous embodiment of the invention, the internally toothed gear, the one or more transport devices, and the adapter can be arranged in a common housing. The cannula tube can then be held at a distal end of the housing and extend at least to an opposite proximal end of the housing. The proximal end is understood to be the end that faces a patient during intended use of the implantation device. Accordingly, the distal end is the end that faces away from the patient during intended use. Advantageously, the catheter is connected to the end of the cannula tube at which the cannula tube is held to the housing.

[0019] In an advantageous embodiment of the invention, the cannula tube can be inserted into a wing element at the end where it is held on the housing. The wing element can have a cylindrical recess into which the cannula tube is inserted. Two wing surfaces opposite each other with respect to a cylinder axis can be arranged on an outer circumference of the cylindrical recess. Advantageously, the wing element can have sections extending beyond the wing elements in the direction of the cylinder axis and having a circular circumference. The wing element can be mounted in these sections in the housing.

[0020] In an advantageous embodiment of the invention, the internal toothing of the internally toothed gear can have 40 teeth, and the gear of one or more transport devices can have 10 teeth. Such a dimensioning enables good power transmission from the internally toothed gear to the externally toothed gear(s) and thus to the spindles.

[0021] In a particularly advantageous embodiment of the invention, the housing can have at least two openings through which the internally toothed gear protrudes. In this way, a user of the device can grip and rotate the internally toothed gear. The opening surfaces of these openings can advantageously be cylindrical and lie parallel to an outer surface of the internally toothed gear. In particular, it is also possible for the opening surfaces of the openings to coincide with the outer surface of the internally toothed gear in the region of the respective opening. Advantageously, the at least two openings can be located exactly opposite one another with respect to a rotational axis of the internally toothed gear.

[0022] In an advantageous embodiment of the invention, the implantation device can have a counter gear which is arranged inside the internally toothed gear and which engages with the toothings of the gears of the transport devices.

[0023] The counter gear can be an externally toothed gear. The dimensions of the counter gear are determined by the dimensions of the internally toothed gear and the gears of the transport devices. Advantageously, the counter gear can be arranged coaxially with a rotational axis of the internally toothed gear.

[0024] Preferably, the implantation device according to the invention comprises exactly two of the transport devices. Particularly preferably, the two transport devices are arranged opposite one another with respect to the cannula tube. Advantageously, the axes of the externally toothed gears and the spindles of these transport devices are parallel to one another.

[0025] In an advantageous embodiment of the invention, the spindles can each have a length of greater than or equal to 80 mm, preferably greater than or equal to 90 mm, particularly preferably greater than or equal to 100 mm and / or less than or equal to 130 mm, preferably less than or equal to 120 mm. The length of the spindles is preferably determined depending on the length of the implant to be implanted and is preferably at least as long as the length of the implant.

[0026] A pitch of the spindles can preferably be greater than or equal to 4 mm, preferably greater than or equal to 5 mm, preferably equal to 6 mm and / or less than or equal to 9 mm, preferably less than or equal to 7 mm.

[0027] Advantageously, the spindle can be designed as a trapezoidal thread.

[0028] In an advantageous embodiment of the invention, the tubular lock can be connected to the adapter via a screw cap and / or a ring with a chamfer.

[0029] In an advantageous embodiment of the invention, the housing can have a linear scale on its exterior. The adapter can then have an element that protrudes through a cutout in the housing that runs parallel to the scale. This cutout is preferably designed as an elongated slot that runs parallel to the cannula tube. The element that protrudes from the housing through the cutout then serves as an indicator of the position of the adapter on the scale. In this way, the position of the adapter can be read off the scale, and thus the extent to which the implant has been deployed can be determined.

[0030] The internally toothed gear, the one or more transport devices, the adapter and the cannula tube, as well as optionally the counter-gear, are advantageously arranged inside the housing. The housing can have a proximal section in which the spindles and the cannula tube are located, and in which the adapter is displaceable. On its distal side, this section of the housing can be delimited by a wall through which the shafts of the transport devices extend, so that the spindles are arranged on the proximal side of this wall and the externally toothed gears of the transport devices are arranged on the distal side of this wall. A region of the housing in which the internally toothed gear is arranged can then be connected to the distal side of the wall. This region of the housing can have the described openings through which the internally toothed gear can be rotated by a user.

[0031] On the distal side of the internally toothed gear, there may be a further section of the housing that holds the cannula tube and catheter. This section may be tapered compared to the other proximal sections of the housing.

[0032] The invention will be explained below by way of example with reference to several figures. Like reference numerals denote like or corresponding features. The features described in the examples can also be implemented independently of the specific example and can be combined between different examples.

[0033] It shows Figure 1 an exploded view of an implantation device according to the invention, Figure 2 a section through an internally toothed gear with externally toothed gears and a counter gear, and Figures 3 and 4an example of a sensor implant that can be implanted with the implantation device according to the invention.

[0034] Figure 1 shows an example of an implantation device according to the invention as an exploded view. In the example shown, the implantation device has a housing 1, which here is designed in two parts with an upper shell 1a and a lower shell 1b. In the following, the left side of the housing will be referred to as the proximal side and the right side as the distal side. Two transport devices 2a and 2b are arranged inside the housing, each having a spindle 3a, 3b and an externally toothed gear 4a, 4b. The spindles 3a, 3b and the externally toothed gears 4a, 4b of the transport devices 2a and 2b are each carried by a common shaft 5a and 5b, respectively.

[0035] Also located inside the housing 1 is an adapter 6, which has two internal threads 7a and 7b, into which the spindles 3a and 3b of the transport directions engage. The spindles 3a and 3b can be fixedly mounted in the proximal area of ​​the housing and loosely mounted in the distal area.

[0036] The adapter 6 has an element 8 that protrudes through a notch 9 in the upper shell 1a of the housing, making it visible from the outside on the upper shell 1a. The upper shell 1a has a scale 10 along the notch 9. If the adapter 6 moves inside the housing, the element 8 moves along the scale 10, so that the position of the adapter 6 can be read off the scale 10.

[0037] The housing has a wall 11 inside it, which delimits a proximal section of the housing toward the distal side. The shafts 5a and 5b of the transport devices 2a, 2b pass through the wall 11. The externally toothed gears 4a, 4b of the transport devices 2a, 2b are then located on the distal side of the wall 11.

[0038] The spindles 3a, 3b are arranged in the proximal area of ​​the housing. By rotating the spindles 3a, 3b, the adapter 6 can be moved in this area of ​​the housing between the proximal end of the housing and the wall 11.

[0039] An internally toothed gear 12 is arranged in a region of the housing distal to the wall 11. In this region, the housing has two openings 13a and 13b through which the internally toothed gear 12 protrudes. The internally toothed gear 12 can be rotated from the outside through the openings 13a and 13b.

[0040] The externally toothed gears 4a and 4b of the transport devices 2a and 2b mesh with the internal toothing of the internally toothed gear 12. Also arranged inside the internally toothed gear 12 is a counter gear 14 that meshes with both externally toothed gears 4a, 4b of the transport devices 2a, 2b. The counter gear 14 is coaxial with a cylinder axis of the internally toothed gear 12. A cannula tube 15 runs inside the housing and is positioned so that it lies exactly midway between the transport devices 2a and 2b. The adapter 6 has a through-opening 17 centered between the internal threads 7a, 7b, through which the cannula tube 15 extends, allowing the adapter 6 to slide along the cannula tube 15.

[0041] The Figure 1The device shown has an inner catheter 16 that extends partially inside the cannula tube 15. The catheter 16 is glued to the cannula tube 15 at its distal end.

[0042] The adapter 6 is connected to a sheath 18 on its proximal side. The connection between the sheath 18 and the adapter 6 can be established, for example, via a screw cap 20 and a stainless steel ring with a chamfer 19. A grommet 21 can be provided around the screw cap 20 and the stainless steel ring 19 to provide protection against bending and kinking, as well as to precisely guide the sheath 18 during removal.

[0043] To prevent rotation and transport of the housing, a stopper 22 may be provided, which can be inserted, for example, through the notch 9 and, when inserted, blocks the movement of the adapter 6. For this purpose, the stopper 22 may, for example, have pins that engage in corresponding openings on the top side of the upper shell 1a.

[0044] The cannula tube 15 can be inserted at its distal end into a wing component 23 which is located in an area delimiting the housing in the distal direction.

[0045] Figure 2 shows a section through the implantation device according to the invention according to Figure 1 in the area of ​​the internally toothed gear 12. The cutting plane is perpendicular to the longitudinal directions of the shafts 5a, 5b of the transport devices 2a, 2b.

[0046] If the internally toothed gear 12 is rotated clockwise by a user as shown, the externally toothed gears 4a, 4b of the transport devices 2a, 2b also rotate clockwise. The centrally arranged countergear 4 meshes with the gears 4a, 4b and rotates counterclockwise in this case. The countergear 14 allows the torque to be transmitted between the gears 4a, 4b.

[0047] In the example shown, the internally toothed gear 12 has 40 teeth, and the two externally toothed gears 4a and 4b each have 10 teeth. The gear ratio of the gear train in the example shown is therefore 4, and all teeth have a pressure angle of 20°.

[0048] If the implant is 100 mm long, it is advantageous if the distance traveled through the sheath 18 during implantation is at least 100 mm. In the example shown, the pitch of the thread flanks of the spindles 3a, 3b was set to 6 mm to cover this distance. In combination with the selected gear ratio, complete release of the implant is possible with 4.16 revolutions of the internally toothed gear 12. The thread of the spindle can be designed as a trapezoidal thread, which is particularly well suited for transmitting movements and forces.

[0049] The scale 10 on the visible surface of the upper shell 1a in centimeters serves to read the traveled path.

[0050] The implantation device of the invention can be used, for example, for the deployment of peripheral stents, for the deployment of multiple peripheral stents with defined intervals, and for the deployment of stent grafts. In particular, it can be used for the deployment of vascular and cardiovascular implants.

[0051] The implantation device according to the invention enables simple positioning and slip-free unloading of an implant with greater force and torque transmission than is possible with prior art systems. By reducing the force required, the risk of relative movement of the catheter to the sheath during the implantation procedure is reduced.

[0052] Flushing of the catheter system can be performed through a Luer-Lock connector in adapter 6. A guide wire, however, can be inserted through the wing element 23.

[0053] Figure 3 shows an example of a sensor implant that can be implanted with the implantation device according to the invention. The sensor implant comprises a printed circuit 33 with a first conductor loop structure 31 and a second conductor loop structure 32. The conductor loop structure 31 is on a front side, in the Figure 3 facing the viewer, of a substrate 34 and the second conductor loop structure 32 on a back side of the substrate 34 facing away from the viewer. The substrate 34 thus electrically insulates the first conductor loop structure 31 and the second conductor loop structure 32 from one another.

[0054] In the example shown, the conductor loop structures 31 and 32 each have three turns. Each of the conductor loop structures 31 and 32 has two straight regions that are parallel to one another and are connected to one another via two circularly curved regions. In the straight regions, the conductor tracks run parallel to one another and straight, and in the circularly curved regions, the conductor tracks run along a circular line and parallel to one another for all turns of the same conductor loop structure. A first capacitive pressure sensor 35 is coupled to the first conductor loop structure 31. The capacitive pressure sensor 35 is coupled between the two ends of the conductor loop structure 31. Accordingly, the conductor loop structure 32 has a second capacitive pressure sensor 36, which in turn is arranged between the two ends of the conductor loop structure 32.The first capacitive pressure sensor 35 forms a first resonant circuit with a first resonant frequency with the first conductor loop structure 31. The second capacitive pressure sensor 36 forms a second resonant circuit with a second resonant frequency with the second conductor loop structure 32.

[0055] The first conductor loop structure 31 is wound around a winding axis, wherein the winding axis here passes through the center of the conductor tracks of the conductor loop structure 31 and is perpendicular to the substrate 34. Similarly, the conductor tracks of the second conductor loop structure 32 are wound around a second coil axis, which in turn passes through the center of the conductor track of the second conductor loop structure 32 and is perpendicular to the substrate 34.

[0056] From the Figure 3 shown structure can be as in Figure 4The implant shown can be produced by bending the substrate 34 about an axis that runs parallel to the long sides of the substrate 34, which are parallel to the straight sections of the conductor loop structures 31 and 32. This direction will be referred to below as the Z-direction.

[0057] Figure 4A shows this embodiment of the transponder in a first direction, which is perpendicular to the Z-direction and at an angle of 45° to the X-axis and the Y-axis. Partial Figure 4B shows the transponder viewed in the X-axis direction.

[0058] The conductor loop structures 31 and 32 can advantageously be dimensioned such that, when the substrate 34 is bent in the manner described, the straight regions of the conductor loop structures are diametrically opposed to each other with respect to the axis around which the substrate 34 was bent. The substrate 34 is preferably bent into a circular shape such that the coil axes of the first conductor loop structure and the second conductor loop structure 32 are at the desired angle to each other, preferably perpendicular to each other. The implantation device according to the invention is suitable for implanting such an implant.

Claims

1. Implantation device for implanting a vascular implant, comprising an internally toothed gear (12), one or more transport devices (2a, 2b) arranged adjacent to one another, each with a spindle (3a, 3b) and an externally toothed gear (4a, 4b) arranged coaxially to the spindle (3a, 3b), which is firmly connected to the spindle (3a, 3b), at least one adapter (6) with a number of threads (7a, 7b) corresponding to the number of transport devices, wherein the gears (4a, 4b) of the one or more transport devices (2a, 2b) are in engagement with the internal thread of the internally toothed gear (12), and wherein the spindles (3a, 3b) of the one or more transport devices (2a, 2b) are each in engagement with one of the threads (7a, 7b) of the adapter (6), further comprising a tubular sheath (18) which is connected at one of its ends to the adapter (6), a hypotube (15) which is arranged over at least the length of the spindles (3a, 3b), adjacent to the spindles (3a, 3b) of the one or more transport devices (2a, 2b) and parallel to them, and a catheter (16) which is at least partially arranged within the hypotube (15).

2. Implantation device according to the preceding claim, wherein the internally toothed gear (12), the one or more transport devices (2a, 2b) and the adapter (6) are arranged in a common housing (1), wherein the hypotube (15) is held at a distal end of the housing (1) and extends at least to an opposite proximal end of the housing (1) and wherein the catheter (16) is connected to the end of the hypotube (15) at which the hypotube is (15) held on the housing (1).

3. Implantation device according to any of the preceding claims, wherein the hypotube (15) is inserted into a wing element (23) at the end at which it is held on the housing (1).

4. Implantation device according to any of the preceding claims, wherein the internal toothing of the internally toothed gear (12) has 40 teeth, and wherein the gear(s) (4a, 4b) of the one or more transport devices (2a, 2b) each have 10 teeth.

5. Implantation device according to any of claims 2 to 4, wherein the housing (1) has at least two openings through which the internally toothed gear (12) protrudes and can be rotated.

6. Implantation device according to any of the preceding claims, further comprising a counter gear (4) which is arranged inside the internally toothed gear (12) and in engagement with the teeth of the gears (4a, 4b) of the transport devices (2a, 2b), wherein the counter gear (4) is preferably arranged coaxially to an axis of rotation of the internally toothed gear (12).

7. Implantation device according to any of the preceding claims, comprising exactly two transport devices (2a, 2b) which are arranged opposite one another with respect to the hypotube (15).

8. Implantation device according to any of the preceding claims, wherein the length of the spindles (3a, 3b) is in each case equal to or greater than 100 mm.

9. Implantation device according to any of the preceding claims, wherein the pitch of the spindles (3, 3b) is 6 mm.

10. Implantation device according to any of the preceding claims, wherein the spindle (3a, 3b) is designed as a trapezoidal thread.

11. Implantation device according to any of claims 2 to 11, wherein the housing (1) has a linear scale (10) on an outer face, and wherein the adapter (6) has an element (8) which protrudes through an incision (9) in the housing (1), which extends parallel to the scale (10), adjacent to the scale.