Catheter system for implantation of prosthetic heart valves

Abstract

A catheter is described for the transvascular implantation of prosthetic heart valves, e.g., including self-expanding anchorage supports, to reduce the risk to the patient during the implantation. Accordingly, a prosthetic heart valve with anchorage supports is temporarily housed in a folded form in a cartridge-type unit during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system, which includes a flexible region that can be guided through the aorta. Actuating elements run through the interior of the hollow guide system, permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

Claims

1. A catheter system comprising: a prosthetic heart valve comprising a heart valve prosthesis attached to a support, wherein the support extends from a first end to a second end, and the second end of the support comprises retaining elements; and a catheter for transvascular delivery of the prosthetic heart valve, the catheter comprising: a guide system comprising a cartridge that includes a tip, an outer sleeve, and an inner sleeve, wherein the outer sleeve and the inner sleeve are configured to retain the prosthetic heart valve in a collapsed state radially therebetween, the inner sleeve including anchoring elements for engaging the retaining elements of the prosthetic heart valve, and wherein the outer sleeve and the inner sleeve are movable relative to each other along a longitudinal axis of the guide system for uncovering the prosthetic heart valve; and a manipulating part coupled to the guide system for controlling movement of the guide system, the manipulating part comprising: a handle; a tube comprising outer threads; a first actuator coupled to the handle, wherein a first movement of the manipulating part, including rotation of the first actuator relative to the handle, causes relative axial movement between the outer sleeve and the inner sleeve to uncover the prosthetic heart valve; and a second actuator coupled to the handle, wherein a second movement of the manipulating part, including movement of the second actuator in a proximal-distal direction of the catheter, causes relative movement between the tip and the outer sleeve.

2. The system of claim 1, wherein rotation of the first actuator relative to the handle engages the threads of the tube to cause movement of the tube along a longitudinal axis of the tube.

3. The system of claim 1, wherein movement of the second actuator in the proximal-distal direction is independent of rotation of the first actuator.

4. The system of claim 1, wherein the manipulating part includes a stop to limit movement of the tube relative to the handle.

5. The system of claim 1, wherein the retaining elements of the support define holes for receiving the anchoring elements of the inner sleeve.

6. The system of claim 1, wherein the outer sleeve is configured to completely cover the inner sleeve and the prosthetic heart valve to retain the prosthetic heart valve in the collapsed state.

7. The system of claim 1, wherein the manipulating part is configured to retract the prosthetic heart valve within the outer sleeve when the first end of the support is uncovered and the second end is covered by the outer sleeve.

8. The system of claim 1, wherein the support is self-expanding.

9. The system of claim 1, wherein the heart valve prosthesis is attached to the support by stitching.

10. A catheter system comprising: a prosthetic heart valve comprising a heart valve prosthesis attached to a self-expanding support, wherein the support extends from a first end to a second end, and the second end of the support comprises two retaining elements; and a catheter for transvascular delivery of the prosthetic heart valve, the catheter comprising: a guide system comprising a cartridge that includes a tip, an outer sleeve, and an inner sleeve, wherein the outer sleeve and the inner sleeve are configured to retain the prosthetic heart valve in a collapsed state radially therebetween, the inner sleeve including anchoring elements for engaging the retaining elements of the prosthetic heart valve, and wherein the outer sleeve and the inner sleeve are movable relative to each other along a longitudinal axis of the guide system for uncovering the prosthetic heart valve; and a manipulating part coupled to the guide system for controlling movement of the guide system, the manipulating part comprising: a handle; a tube comprising outer threads; a first actuator coupled to the handle, wherein a first movement of the manipulating part, including rotation of the first actuator relative to the handle to engage the threads of the tube, causes relative axial movement between the outer sleeve and the inner sleeve to uncover the prosthetic heart valve in a direction from the first end of the support to the second end of the support; and a second actuator coupled to the handle, wherein a second movement of the manipulating part, including movement of the second actuator in a proximal-distal direction of the catheter, causes relative movement between the tip and the outer sleeve, independent of rotation of the first actuator.

11. The system of claim 10, wherein the first actuator controls movement of the tube along a longitudinal axis of the tube.

12. The system of claim 10, wherein when the prosthetic heart valve is retained radially between the inner sleeve and the outer sleeve in the collapsed state, the first end of the support is adjacent to the tip.

13. The system of claim 10, wherein each retaining element of the support defines a hole for receiving a corresponding anchoring element of the inner sleeve in order to anchor the prosthetic heart valve to the catheter.

14. The system of claim 10, wherein the guide system comprises a bendable region configured to navigate a bend in an aorta during transvascular delivery of the prosthetic heart valve.

15. The system of claim 10, wherein the manipulating part comprises a fluid port in communication with the cartridge.

16. A catheter system comprising: a prosthetic heart valve comprising a heart valve prosthesis stitched to a support, wherein the support extends from a first end to a second end, and the second end of the support comprises retaining elements; and a catheter for transvascular delivery of the prosthetic heart valve, the catheter comprising: a guide system comprising a cartridge that includes a tip, an outer sleeve, and an inner sleeve, wherein the outer sleeve and the inner sleeve are configured to retain the prosthetic heart valve in a collapsed state radially therebetween, the inner sleeve including anchoring elements for engaging the retaining elements of the prosthetic heart valve, and wherein the outer sleeve and the inner sleeve are movable relative to each other along a longitudinal axis of the guide system for uncovering the prosthetic heart valve; and a manipulating part coupled to the guide system by a bendable region configured to navigate a bend in an aorta during delivery of the prosthetic heart valve, the manipulating part comprising: a handle; a tube comprising outer threads; a first actuator coupled to the handle, wherein a first movement of the manipulating part, including rotation of the first actuator relative to the handle to engage the threads of the tube, causes relative axial movement between the outer sleeve and the inner sleeve to uncover the prosthetic heart valve in a direction from the first end of the support to the second end of the support; and a second actuator coupled to the handle, wherein a second movement of the manipulating part, including movement of the second actuator in a proximal-distal direction of the catheter, causes relative movement between the tip and the outer sleeve; wherein the manipulating part is configured to retract the prosthetic heart valve within the outer sleeve when the first end of the support is uncovered and the second end is covered by the outer sleeve.

17. The system of claim 16, wherein the manipulating part further comprises: a stop to limit movement of the tube relative to the handle; and a fluid port in communication with the cartridge.

18. The system of claim 16, wherein the support includes exactly two retaining elements, each retaining element defining a hole.

19. The system of claim 16, wherein the first actuator engages the threads by rotating about a longitudinal axis of the tube.

20. The system of claim 19, wherein rotation of the first actuator is independent of movement of the second actuator in the proximal-distal direction.

Description

(1) The invention will be explained in more detail on the basis of examples.

(2) Of the drawings:

(3) FIGS. 1 to 4 are schematic diagrams illustrating an example of a catheter proposed by the invention during different possible phases of an implantation procedure;

(4) FIG. 5 shows an example of a catheter with a manipulating part and

(5) FIG. 6 is an exploded diagram illustrating the manipulating part illustrated in FIG. 5.

(6) FIGS. 1 to 4 are intended to illustrate and provide a clearer understanding of an example of a catheter proposed by the invention. The individual diagrams illustrate different phases which take place during implantation of an anchoring support 10 incorporating a heart valve prosthesis.

(7) The example of a catheter proposed by the invention illustrated in FIG. 1 is shown with the cartridge unit 4, which is still completely closed, containing an anchoring support 10 incorporating a heart valve prosthesis in the non-expanded state and thus collapsed, so that it can be fed by means of the internally hollow guide system 1 through an appropriate access into the aorta and through it to the respective implantation site on the patient's heart.

(8) Proximally disposed on the cartridge unit 4 is a flexible tip made from silicone, which facilitates the introduction procedure and reduces the risk of damage.

(9) Part 5 of the cartridge unit is releasably connected to the other parts of the guide system 1, for example by means of a screw connection.

(10) Adjoining the cartridge unit 4 is a bendable region 9, which is designed and dimensioned so that it is guaranteed to be able to move through the bend of a patient's aorta without causing problems.

(11) Possible designs of such a bendable region 9 will be explained below.

(12) Other parts of the internally hollow guide system 1 are also illustrated and FIGS. 1 to 4 show two operating elements 2 and 3 running through the guide system 1 as far as the cartridge unit 4, and in this instance the operating element 2 likewise runs through the internally hollow operating element 3 as far as the cartridge unit 4.

(13) The operating elements 2 and 3 in this instance are provided in the form of lengths of compression spring, which are preferably reinforced by means of tension wire. Such tension wires make the catheter safer as it is being removed from the patient's body once the operation is complete.

(14) Other parts 11 of the guide system 1 are illustrated on the left-hand side, which may be provided in the form of more or fewer sleeve-shaped parts, although these must be secured so that they are sufficiently pressure- and tension-resistant to withstand introduction into the aorta and extraction from the aorta again. Appropriately stiff plastic hoses may be used for this purpose, for example PTFE hoses or hoses with a PTFE base, because they are sufficiently compatible with the organism and can also be sterilised.

(15) FIG. 2 illustrates the procedure which takes place during a first stage of the operation on reaching the implantation site on the respective patient's heart. The part/sleeve-shaped element 7 of the cartridge unit 4 can be pulled back in the distal direction by a distal movement of one of the operating elements 2 and/or 3 so that some hoops of the anchoring support 10, for example and preferably the support hoops provided on the known-heart valve prosthesis disclosed in WO 2004/019825 A1, expand and are biased radially outwards.

(16) The entire catheter with the guide system 1 and the cartridge unit 4 can therefore be pushed proximally and these hoops (support hoops) introduced into the pockets of the patient's old heart valve. When the surgeon feels a perceptible resistance, the process of introducing the support hoops of the anchoring support 10 into the pockets of the old heart valve is complete.

(17) The part/sleeve-shaped element 5 of the cartridge unit 4 can then be moved proximally forwards, so that other hoops of the anchoring support can then also be released so that they can self-expand and open up the heart valve prosthesis.

(18) A preliminary stage of this is illustrated in FIG. 3, where a heart valve prosthesis has not yet been fully unfolded and the anchoring support 10 can also not yet be fully anchored.

(19) As also illustrated in FIG. 3, a distal part of the anchoring support 10 is still accommodated inside the cartridge unit 4, underneath the part/sleeve-shaped element 7 in the cartridge unit 4. This remains the case until the process of unfolding and positioning the heart valve prosthesis has reached the stage where its functionality can be checked.

(20) If the check reveals incorrect functioning or faulty positioning, the part/sleeve-shaped element 7 can be pushed proximally again by one of the two operating elements 2 or 3 so that the anchoring support 10 with the heart valve prosthesis is at east partially accommodated in the cartridge unit 4 again and then the entire catheter can be removed from the patient by pulling it out of the aorta without causing damage to the vessel wall.

(21) If the function test reveals that the heart valve prosthesis is able to fulfil its function to at least a sufficient capacity, the part/sleeve-shaped element 7 may be moved distally back, as illustrated in FIG. 4, or another part/sleeve-shaped element 6 of the cartridge unit 4 may be pushed in the proximal direction so that the distal part of the anchoring support 10 can also be released and expand fully.

(22) As also illustrated in FIG. 4, eyes or other appropriate elements are provided at distal end regions of the anchoring support 10, which were previously engaged in anchoring elements 8 provided on the part/sleeve-shaped element 6. These eyes and the anchoring elements 8 ensure reliable retraction or extraction if it is established that an anchoring support 10 incorporating a heart valve prosthesis has been incorrectly or badly implanted, enabling the anchoring support 10 and heart valve prosthesis to be removed from the patient's body.

(23) By means of the anchoring elements 8 as well as other guide elements 16 which may optionally be provided on the part/sleeve-shaped element 6 of the cartridge unit 4, it is also possible to effect a radial turning movement to enable the hoops of an anchoring support 10 to be introduced into the pockets of an old heart valve prosthesis in an exactly correct angular position, for example, in which case the entire catheter can be turned slightly about its longitudinal axis by the surgeon during the implantation.

(24) Detail A of FIG. 4 also specifically illustrates a cannula 12, which is fed through the cartridge unit 4 along its longitudinal axis. By mans of the cannula 4, the guide wire described in the general part of the description can be fed through cartridge unit 4.

(25) FIG. 5 illustrates an example of a catheter with an additional manipulating part 13, on which other control elements are provided in order to permit manipulation.

(26) The guide system 1 together with the cartridge unit 4 described above with reference to FIGS. 1 to 4 are also used in this example.

(27) However, detail A illustrates one possible design of the bendable region 9 in the form of a link chain.

(28) The individual links 9.1 are generally of the same shape and dimension.

(29) In this respect, the oppositely lying end faces of the individual links 9.1 are shaped so as to form individual joints 9.2, each of which positively engages in adjacent individual links 9.1 and as a result of gaps with a sufficient gap width between the individual links 9.1 respectively ensure that the bendable region bends about at least 180 as mentioned above, with a radius of approximately 50 mm.

(30) The individual joints 9.2 are formed by a cut-out in the respective oppositely lying end faces of the individual links 9.1, whereby a co-operating cut-out on one end face and a co-operating rounded, complementary protruding area on the diametrically opposite end face of the individual links 9.1 form the individual joints 9.2 on respective adjacent individual links 9.1.

(31) Although not illustrated, the bendable region 9 may be enclosed by a plastic hose to render it fluid-tight.

(32) FIG. 5 also illustrates how a manipulating part 13 may be provided to enable a catheter proposed by the invention to be introduced and manipulated.

(33) A handle 13.1 is provided for introducing and extracting the catheter with the guide system 1 and cartridge unit 4.

(34) A fluid-tight closure in the form of a plate 17 is provided in the proximal part of the manipulating part 13, enabling the guide system 1 to be flange-mounted by means of a locking nut 23, and seal elements are provided, although these are not illustrated here.

(35) A standard Luer connection 30 is also provided, by means of which the coolant liquid can be circulated.

(36) The respective curvature of the bendable region 9 can be obtained using the handle 19, which can be turned about an axis by means of tension cables (not illustrated) and this will be further explained with the description of FIG. 6.

(37) The entire manipulating part 13 should be sealed with respect to the surrounding environment and with respect to the guide system 1 so that it is as far as possible fluid-tight and also gas-tight if necessary.

(38) The tube 28 can be moved laterally in the proximal direction by means of the lever 20 acting on the handle 13.1, and the corresponding movement and resultant traction or compression force transmitted to one of the two operating elements 2 and/or 3, thereby enabling a manipulation of the individual parts/sleeve-shaped elements 5, 6 and/or 7 of the cartridge unit 4 in the manner described above, for example in finely measured doses via the pumping movements of the lever 20.

(39) The pushing handle 25 enables the position of part 5 of the cartridge unit 4 to be manipulated relative to the sleeve-shaped part 6 of the cartridge unit 4 in the extension beyond the length of spring by means of the fixing hooks, serving as anchoring elements 8. The pushing handle 25 is latched in a thread-shaped toothing 28.1 of a tube 28 by means of a compression spring. As a result, the pushing handle 25 follows the proximal movement of the tube 28, which is connected to part 6 of the cartridge via the length of spring serving as an operating element 3.

(40) On reaching an end stop marking the first discharge stage, the pushing handle 25 can be turned in order to effect a finely measured axial displacement of part 5 of the cartridge unit 4 relative to part 6 of the cartridge unit 4 in the direction of the pitch of the thread 28.1.

(41) With respect to operating the pushing handle 25, the latter is able to move the part 5 of the cartridge unit 4 illustrated here without an additional fine adjustment.

(42) Such a manipulation enables the anchoring support 10 to be released (see FIG. 3) and in this position, the anchoring support 10 can still be retracted.

(43) When the stop 29 is released by means of an actuator member 31 provided in the form of an adjusting screw for example, the cartridge unit 4 may be extracted farther by operating the lever system 20 in the manner described above until the retaining eyes of the anchoring support 10 have moved away from the cartridge unit 4 and the anchoring support 10 is able to spring away from the anchoring elements 8 due to its expansion forces.

(44) The elements of the cartridge unit 4 may be pulled back in stages. This being the case, part 5 of the cartridge unit 4 may be retracted by pulling back the pushing handle 25 (pushing element latched) beyond part 6 of the cartridge unit 4.

(45) By operating a releasing bolt 32, part 6 of the cartridge unit 4 connected to the tube 28 can also be returned to its initial position by pulling the pushing handle 25 farther back so that the cartridge unit 4 is then completely closed again. In this state, the catheter can be removed from the patient's body again.

(46) FIG. 6 is an exploded diagram providing a more detailed illustration of the manipulating part 13 used in this example.

(47) As illustrated, when the handwheel 19 is turned via the shaft 14, two toothed racks 24 oriented parallel with one another can be displaced. Accordingly, one toothed rack 24 is moved in the proximal direction as the toothed rack 24 oriented parallel with it is moved in the distal direction.

(48) Although these are not illustrated here, tension cables may be secured to clamping jaws 21 acting on the co-operating toothed racks 24, which are fed through the internally hollow guide system 1 as far as the bendable region 9 and are preferably secured in its proximal region.

(49) By turning the handwheel 19 accordingly, a traction force can be applied to at least one of the two tension cables, causing the bendable region 9 to assume the appropriate curvature in measured doses so that the guide system 1 can be fed through the bend of the aorta in a defined manner together with the cartridge unit 4.

(50) As also illustrated in FIG. 6, the lever 20 connected to the handle 13.1 acts via fine toothing 28.1 on the tube 28, enabling it to be manipulated via the operating elements 2 and/or 3 to permit the sequential release of the anchoring support 10.