A MEDICAL ARRANGEMENT FOR INTRODUCING AN OBJECT INTO AN ANATOMICAL TARGET POSITION

Abstract

A medical arrangement for introducing an implant into an anatomical target position comprises a first introducer and a guide wire. The guide wire is configured to be introduced before the implant into or towards the anatomical target position. The implant is configured to be delivered along the guide wire into the anatomical target position. The guide wire is configured to be retracted after the implant has been introduced into said anatomical target position so that said object essentially maintains the shape taken when introduced into said anatomical target position.

Claims

1. A medical arrangement configured to introduce an object from a distal end of the arrangement into an anatomical target position, the medical arrangement comprising a first introducer and a guide wire, wherein: said guide wire has at least a first curved shape; said at least first curved shape has a preformed shape capable of being delivered in a straightened configuration through said first introducer and is configured to be activated to said at least first curved shape within or near the anatomical target position; said guide wire is configured to be introduced before the object into or towards said anatomical target position; said object is configured to be delivered along the guide wire into said anatomical target position after the guide wire is at least partially introduced from the distal end portion of the first introducer, whereupon said object is configured to follow said guide wire and said first curved shape of the guide wire into said anatomical target position; and said guide wire is configured to be retracted after said object has been introduced into said anatomical target position so that said object maintains the shape taken when introduced into said anatomical target position.

2. The medical arrangement of claim 1, wherein said object is configured to be delivered along the guide wire into said anatomical target position after the guide wire is at least partially introduced from the distal end portion of the first introducer and when the guide wire is activated to said at least first curved shape.

3. The medical arrangement of claim 1, further comprising a second introducer, where said second introducer is arranged to be operable between the first introducer and the guide wire.

4. The medical arrangement of claim 3, wherein the second introducer is configured to be introduced from the distal end portion of the first introducer and wherein at least a distal portion of the second introducer is configured to be introduced from the distal end portion of the first introducer before the guide wire.

5. The medical arrangement claim 3, wherein the second introducer is a catheter and wherein said first introducer is a catheter.

6. The medical arrangement of claim 3, wherein said object is configured to be delivered inside the second introducer into or towards said anatomical target position after at least the distal portion of the second introducer is introduced from the distal end portion of the first introducer.

7. The medical arrangement of claim 3, wherein said second introducer is configured to be retracted after said guide wire is introduced into said anatomical target position or before said object is introduced into said anatomical target position.

8. The medical arrangement of claim 1, further comprising a guiding catheter is arranged to be operable between the first introducer and the guide wire, and between a second introducer and the guide wire.

9. The medical arrangement of claim 8, wherein the guiding catheter is configured to be introduced from the distal end portion of the first introducer and wherein at least a distal portion of the guiding catheter is configured to be introduced from the distal end portion of the first introducer after the guide wire is introduced into or towards said anatomical target position.

10. The medical arrangement of claim 9, wherein the guiding catheter is configured to be introduced inside or from the distal end portion of the second introducer when the second introducer is first delivered to its target position and wherein said second introducer is configured to be retracted before said object is introduced into said anatomical target position.

11. The medical arrangement of claim 8, wherein the guiding catheter is a flexible catheter, which is configured to be delivered along the guide wire into or towards said anatomical target position after the guide wire is at least partially introduced from the distal end portion of the first introducer.

12. The medical arrangement of claim 8, wherein said object is configured to be delivered inside the guiding catheter into or towards said anatomical target position after at least the distal portion of the guiding catheter is introduced from the distal end portion of the first introducer or the distal end portion of the second introducer into or towards said anatomical target position.

13. The medical arrangement of claim 8, wherein said guiding catheter is configured to be retracted after the object has been introduced into said anatomical target position and wherein the object is configured to be secured to the anatomical target position after the guiding catheter is retracted.

14. The medical arrangement of claim 1, wherein the distal end of the guide wire comprises a curvature tip portion in order to prevent the distal end of the guide wire from getting tangled in to tissue.

15. The medical arrangement of claim 1, wherein the object is an implant; said implant comprises a loop shaped support portion having one or more loops or coils; said implant is adapted to support said anatomical target position upon being fully delivered; and wherein said implant comprises a hollow tubular structure or loop, stich or turn structure attached to the implant, whereupon the implant is configured to be delivered into said anatomical target position so that it travels around said guide wire.

16. A method for introducing an object into an anatomical target position, said method comprising: delivering a guidewire in a straightened configuration through a first introducer; at least partially introducing said guidewire from a distal end portion of said first introducer; activating said guidewire to have at least a first curved shape within or near the anatomical target position; delivering said object along said guidewire into said anatomical target position by causing said object to follow said guide wire and said at least first curved shape into the anatomical target position; and retracting said guide wire after said object has been introduced into said anatomical target position so that said object maintains a shape taken when introduced into said anatomical target position.

17. (canceled)

18. The method of claim 16, further comprising introducing a second introducer from the distal end portion of the first introducer and wherein at least a distal portion of the second introducer is introduced from the distal end portion of the first introducer before the guide wire.

19. The method of claim 18, wherein said object is delivered inside the second introducer into or towards said anatomical target position after at least the distal portion of the second introducer is introduced from the distal end portion of the first introducer.

20. The method of claim 18, wherein said second introducer is retracted after said guide wire is introduced into said anatomical target position or before said object is introduced into said anatomical target position.

21. The method of claim 18, wherein a guiding catheter is introduced from the distal end portion of the first introducer and wherein at least a distal portion of the guiding catheter is introduced from the distal end portion of the first introducer after the guide wire is introduced into or towards said anatomical target position.

22. The method of claim 21, wherein the guiding catheter is introduced inside or from the distal end portion of the second introducer when the second introducer is first delivered to its target position and wherein said second introducer is retracted before said object is introduced into said anatomical target position.

23. The method of claim 21, wherein said guiding catheter is retracted after the object has been introduced into said anatomical target position and wherein the object is secured to the anatomical target position after the guiding catheter is retracted.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0034] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0035] FIG. 2 illustrates an exemplary tissue anchoring unit for securing the flexible leaflet to the adjacent tissue and/or annulus according to an advantageous embodiment of the invention, and

[0036] FIGS. 3-23 illustrate a medical arrangement for introducing an implant into an anatomical target position according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0037] FIGS. 1A-1B and 2 are already discussed in more details in connection with the background of the invention portion above.

[0038] In addition, it is to be noted that the implant 110 comprises advantageously a hollow structure so that it can be passed along the guide wire 103 so that the guide wire 103 is inside the hollow structured implant 110. However, the implant 110 may also have loops, stitches or turns 113 coupled with it, as can be seen in FIG. 2, whereupon the implant, even a solid implant, can be delivered to the position so that the loops or turns 113 travel around the guide wire 103.

[0039] FIGS. 3-23 illustrate a medical arrangement 100 for introducing an implant into a heart as an example of the anatomical target position 20 according to advantageous embodiments of the invention. In FIG. 3 the first introducer 101 is delivered next to the annulus 20 of the heart, and the second introducer 102 is introduced from the distal end portion 101A of the first introducer 101. It is to be noted that the second introducer is an optional introducer, but it is still illustrated in Figures as an example. The second introducer can be used for example to bypass the leaflets 22, 24 of the heart, as well as to achieve a turn to a specific direction by turning the distal end 102A of the second introducer 102 (namely turnability of the introducers are limited). In addition, it is to be noted that at least a distal portion 102A of the second introducer 102 is introduced from the distal end portion 101A of the first introducer 101 before the guide wire, and may thereby guide or instruct the guide wire 103 to bypass the leaflets, for example, as can be seen in FIG. 4.

[0040] When the second introducer has bypassed the leaflets 22, 24, the guide wire 103 can be delivered into or towards the position 20. It is to be noted that the guide wire 103 is delivered into the position before the implant 110.

[0041] The guide wire 103 has advantageously an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire 103 can be delivered in a straightened configuration 1031 through the first introducer 101, as can be seen in FIG. 4. In said activated shape the guide wire 103 takes at least a first curved shape 103B within or near the anatomical target position 20. When the guide wire 103 is activated to said at least first curved shape 103B, it is delivered to or at least towards the position. According to an example the distal end 103A of the guide wire 103 may comprise a curvature tip portion 103J, such as a J-shape, in order to allowing smooth delivery of the distal end 103A of the guide wire 103 and to prevent the distal end 103A of the guide wire 103 from getting tangled into tissue.

[0042] The arrangement may additionally comprise also a guiding catheter 104, as can be seen in FIGS. 5-11, where the guiding catheter 104 is operated between the first introducer 101 and the guide wire 103, and if the second introducer is used, also between the second introducer 102 and the guide wire 103. The guiding catheter 104 is introduced from the distal end portion 101A of the first introducer 101 (and from the distal end portion 102A of the second introducer 102, if used). It is to be noted that at least a distal portion 104A of the guiding catheter 104 is introduced from the distal end portion 101A of the first introducer 101 (and from the distal end portion 102A of the second introducer 102, if used) only after the guide wire 103 is introduced into or towards said anatomical target position 20.

[0043] The guiding catheter 104 is delivered along the guide wire 103 into or towards said anatomical target position 20 after the guide wire 103 is at least partially introduced from the distal end portion 101A of the first introducer 101, as can be seen in FIGS. 5-8. Most advantageously the guiding catheter 104 is delivered to the anatomical target position 20 when the guide wire is fully delivered to the anatomical target position, in particular when the guiding catheter 104 is flexible, whereupon the guiding catheter 104 is guided by the guide wire 103.

[0044] When the guide wire 103 and the guiding catheter 104 are delivered into the position, the second introducer 102 is retracted and it is retracted advantageously before delivering the implant 110 into the anatomical target position 20, as is the case in FIG. 9. This is not mandatory but by this more space can be arranged for the implant. It is to be noted that also the first introducer can be retracted before delivering the implant 110 or even right after the delivering of the second introducers, even if this is not shown in the Figures. By this even more space can be arranged for the implant.

[0045] The implant 110 is then delivered around (and guided by) the guide wire 103 and inside the guiding catheter 104 into or towards said anatomical target position, as can be seen in FIGS. 10-12. This can be done after at least the distal portion 104A of the guiding catheter 104 is introduced from the distal end portion 101A of the first and second introducers 101, 102 into or towards said anatomical target position, but most advantageously when the distal end of the guiding catheter 104 is delivered into the anatomical target position.

[0046] The guiding catheter 104 is then retracted after the implant 110 is introduced into the anatomical target position 20 after which the implant can be secured to the tissue by securing members 114, as can be seen in FIG. 14. The securing can be done for example by suturing or stabling or by other securing methods known by the skilled person. In addition, the guiding catheter 104 can be retracted sequentially, uncovering only a part of the implant for securing, and after securing said uncovered part the guiding catheter 104 can be retracted more, thereby uncovering an additional portion of the implant for securing.

[0047] When the implant 110 is introduced and secured into the position 20 (and also the guiding catheter is retracted), as is the case in FIG. 10, the guide wire 103 can be retracted and the implant 110 essentially maintains the shape taken when introduced into said anatomical target position 20, corresponding to the shape of the guide wire in the anatomical target position, as can be seen in FIGS. 15-18.

[0048] FIG. 13 illustrates the order of the introducers 101 and 102, guiding catheter 104, guide wire 103 and the implant 110.

[0049] In addition, FIG. 8 illustrates also a cooling arrangement 115 for supplying a cooling agent (arrow) and thereby cooling the guide wire 103. It is to be noted that the arrangement may comprise one or more cooling arrangements 115 and arranged in connection with the first introducer, second introducer and/or guiding catheter. In addition, even if the cooling arrangement 115 is illustrated only in connection with FIG. 8, it should be understood, that it may also be comprised by other embodiments and arrangements 100 illustrated in other Figures.

[0050] FIGS. 19-23 illustrate a further example of the medical arrangement 100 to introduce the implant 110 into a mitral valve 20 (as an example of the anatomical target position) so that at least one loop-shaped structure 111 of the implant 110 abuts a first side of the heart valve and one second loop-shaped structure 112 abuts a second, opposite, side of the valve to thereby trap a portion of the valve tissue 20 between the second and the first support structures 111, 112. In FIGS. 19-23 the first introducer 110 has a first curve shape and the second introducer 102 has a second curve shape to the same curvature direction as the first curve shape of the first introducer 101 so to form a concentric system 100. As can be seen in FIG. 21, the arrangement may also have an additional second introducer 102x, which again has third curve shape but still to the same curvature direction as the first and second curve shapes of the first and second introducers, wherein said first, second and third curved shapes are concentric curved shapes. In addition, the additional second introducer 102x may also be a steerable catheter or having pre-curved structure so that it has ability to seek said third curve shape at least and advantageously when delivered into or towards the anatomical target position.

[0051] It is to be noted that the first introducer is introduced next to the annulus and the second as well as additional second introducers 102, 102x are used to bypass the leaflets 22, 24 and to be introduced to the opposite side of the annulus as the first introducer is delivered.

[0052] FIGS. 22 and 23 illustrate the arrangement 100, where the guiding catheter 104 and also the guide wire 103 are introduced into or at least towards the position for delivering the implant. As can be seen in FIG. 23, the second as well as additional second introducers 102, 102x can be retracted before introducing the implant. The implant and the steps for delivering it are not shown, but the fundamental principles are the same as described elsewhere in this document.

[0053] It is to be noted that according to an embodiment the first introducer 101 can be retracted already after the second introducer 102 is delivered and before the delivery of the additional second introducer 102x and guiding catheter 104 and implant, and the second introducer 102 can be retracted after the additional second introducer 102x is delivered and before the delivery of the guiding catheter 104 and implant, and that the additional second introducer 102x can be retracted after the guiding catheter 104 is delivered toward or into the anatomical target position and before the delivery of the implant 110. In this way a maximum space can be provided for the delivering catheter 104, or the guiding catheter 104, and in particularly when the guiding catheter 104 in an expandable catheter 104, whereupon a relatively big implant can be delivered into the anatomical target position. Previously, the diameter of the all additional introducers or catheters must have been smaller and smaller, whereupon the diameter of the last delivering catheter is particularly small, which remarkably limits also the size of the object, such as the implant, to be delivered.

[0054] The invention has been explained above with reference to the aforementioned embodiments, and several advantages of the invention have been demonstrated. It is clear that the invention is not only restricted to these embodiments, but comprises all possible embodiments within the spirit and scope of the inventive thought and the following patent claims. For example the guide wire is at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire is configured to be delivered in a straightened configuration through said first introducer and in said activated shape the guide wire is configured to take said at least a first curved shape within or near the anatomical target position. The guide wire is advantageously configured to be introduced before the implant into or towards the anatomical target position. However, it is to be noted that the guide wire should at least reach the target position before the implant.

[0055] In addition, it is to be noted that even if the implant is described in this document as an example to be delivered, also other kinds of object can be delivered according to the invention, such as medicaments, for example. Furthermore, even if the heart is described in many embodiments, it is to be understood that the heart is only an example of the anatomical target. Still, in addition it is to be noted that the implant can be rigid or flexible.