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

Abstract

A medical arrangement for introducing an object, such as an implant into an anatomical target position comprises a first introducer, a guide wire and a guiding catheter). The guide wire is configured to be introduced before the guiding catheter and object into or towards the anatomical target position. The guiding catheter is configured to be delivered into the position along the guide wire, after which the guide wire is configured to be retracted. The object is configured to be delivered inside the guiding catheter after the guide wire is retracted.

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, a guiding catheter, 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; said guide wire is configured to be activated to said at least first curved shape within or near the anatomical target position; at least a distal portion of the guide wire is configured to be introduced from the distal end portion of the first introducer before the object into or towards said anatomical target position; said guiding catheter is arranged to be operable between the first introducer and the guide wire; at least a distal portion of the guiding catheter is configured to be introduced from the distal end portion of the first introducer into or towards said anatomical target position, and along and guided by the guide wire; and 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 into or towards said anatomical target position and after the guide wire is retracted away from said anatomical target position.

2. The medical arrangement of claim 1, wherein the guiding catheter 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 guiding catheter is configured to follow said guide wire and said first curved shape of the guide wire into said anatomical target position.

3. The medical arrangement of claim 2, wherein said guiding catheter is configured to take the shape of the at least first curved shape of the guide wire and remain said first curved shape after the guide wire is retracted away from said anatomical target position.

4. The medical arrangement of claim 2, wherein said object is configured to follow said guiding catheter and said first curved shape into said anatomical target position during introduction.

5. The medical arrangement of claim 1, further comprising a cooling device for cooling the guide wire during retracting the guide wire.

6. The medical arrangement of claim 1, wherein at least the 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 at least partially introduced into or towards said anatomical target position.

7. The medical arrangement of claim 1, wherein said guiding catheter 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.

8. The medical arrangement of claim 1, wherein the object is configured to be secured to the anatomical target position after the guiding catheter is retracted at least partly.

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

10. The medical arrangement of claim 0, 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 or the guiding catheter.

11. The medical arrangement of claim 1, wherein said first introducer is a catheter or wherein the guiding catheter is a flexible catheter, and wherein a second introducer arranged to be operable between the first introducer and the guiding catheter or guide wire is a catheter.

12. The medical arrangement of claim 0, 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.

13. The medical arrangement of claim 0, wherein said second introducer is configured to be retracted after said guide wire or guiding catheter is introduced into said anatomical target position or before said implant is introduced into said anatomical target position.

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 to get tangled in to tissue.

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

16. A method for introducing an object into an anatomical target position, said method comprising: introducing a guide wire having a straightened configuration through a first introducer and from a distal end portion of the first introducer into or towards said anatomical target position; activating said guide wire to take adopt an at least first curved shape within or near the anatomical target position; introducing at least a distal portion of the guiding catheter from the distal end portion of the first introducer into or towards said anatomical target position, and along and guided by the guide wire; and delivering said object 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 into or towards said anatomical target position and after the guide wire is retracted away from said anatomical target position.

17. The method of claim 16, wherein the guiding catheter is 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 guiding catheter follows said guide wire and said first curved shape of the guide wire into said anatomical target position.

18. The method of claim 17, wherein said guiding catheter takes the shape of the at least first curved shape of the guide wire and remains said first curved shape after the guide wire is retracted away from said anatomical target position.

19. The method of claim 17, wherein said object follows said guiding catheter and said first curved shape into said anatomical target position during introduction.

20. The method of claim 16, further comprising introducing at least the distal portion of the guiding catheter from the distal end portion of the first introducer after the guide wire is at least partially introduced into or towards said anatomical target position.

21. The method of claim 16, further comprising retracting said guiding catheter 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.

22. The method of claim 16, further comprising securing the object to the anatomical target position after the guiding catheter is retracted at least partly.

23. The method of claim 16, wherein a second introducer is operated between the first introducer and the guiding catheter or guide wire, and said method further comprises introducing said second introducer from the distal end portion of the first introducer and introducing at least a distal portion of the second introducer from the distal end portion of the first introducer before the guide wire or the guiding catheter.

24. The method of claim 23, 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.

25. The method of claim 23, further comprising retracting said second introducer after said guide wire or said guiding catheter is introduced into said anatomical target position or before said implant is introduced into said anatomical target position.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0033] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0034] 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

[0035] FIGS. 3-27 illustrate a medical arrangement for introducing an implant into an anatomical target position according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0036] FIGS. 1A-1B and 2 are already discussed in more details in connection with the background of the invention portion above.

[0037] FIGS. 3-27 illustrate a medical arrangement for introducing an implant into a heart as an example of the anatomical target position according to advantageous embodiments of the invention. It is to be noted that also other kinds of object in addition to the implant can be delivered in the similar manner, such as medicines, for example. 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, or other anatomical portion, 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 thereby guide or instruct the guide wire 103 to bypass the leaflets, for example, as can be seen in FIG. 4.

[0038] 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 and guiding catheter 104.

[0039] 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 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. The arrangement advantageously comprises 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 of the second introducer, 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.

[0040] 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.

[0041] 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 a more space can be arranged for the implant.

[0042] In addition, after the guiding catheter 104 has been delivered into the anatomical target position, the guide wire 103 can be retracted, as can be seen in FIGS. 10-12. After removing the guide wire 103, the implant 110 is delivered inside the guiding catheter 104 into or towards said anatomical target position, as can be seen in FIGS. 13-15.

[0043] The guiding catheter 104 can be retracted after the implant 110 has been introduced into the anatomical target position 20. After removing the guiding catheter 104, the implant can be secured to the tissue by securing members 114, as can be seen in FIGS. 19-22. The securing can be done for example by suturing or stabling or by other securing methods known by the skilled person.

[0044] It is to be noted that the guiding catheter 104 can be retracted at once, as is the case in FIGS. 16-18, or sequentially, as is the case in FIGS. 19-22. When the guiding catheter 104 is retracted sequentially, only a part of the implant is uncovered by one move for securing. After securing said uncovered part the guiding catheter 104 can be retracted more, thereby uncovering an additional portion of the implant for securing.

[0045] 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 in other embodiments and arrangements 100 illustrated in other Figures.

[0046] FIGS. 23-27 illustrate a further example of the medical arrangement 100 to introduce the object into the anatomical target position, and especially the implant 110 into a mitral valve 20 (as an example of the anatomical target position). When introducing the implant, at least one loop-shaped structure 111 of the implant 110 abuts a first side of the heart valve and at least 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. 23-27 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. 25, 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.

[0047] 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. FIGS. 26 and 27 illustrate the arrangement 100, where the guiding catheter 104 and also the guide wire 103 are introducer into or at least towards the position for delivering the implant. As can be seen in FIG. 27, 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, as well as retracting the guide wire 103 before delivering the implant, are not shown, but the fundamental principles are the same as described elsewhere in this document.

[0048] 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, 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 particular when the guiding catheter 104 in an expandable introducer 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.

[0049] 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 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.

[0050] 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.