A Medical Arrangement for Introducing an Object into an Anatomical Target Position

Abstract

A medical arrangement is configured to introduce an object, such as an implant or medicament, from a distal end of the arrangement into an anatomical target position. The medical arrangement comprises a first and second introducer, both having distal and proximal ends. The first introducer is an outer introducer and the second introducer is configured to be operated inside and guided by the first introducer. In addition, at least a portion of the first introducer is configured to take a first curved shape, and at least a portion of the second introducer is configured to take a second curved shape so that the first and second curved shapes are concentric curved shapes so all curves are in the same hand direction and thereby form a helical loop structure.

Claims

1-17. (canceled)

18. A medical arrangement configured to introduce an object from a distal end of the arrangement into an anatomical target position, said anatomical target position being in a left atrium or a left ventricle or an annulus area of a mitral valve, said medical arrangement comprising: a first introducer having distal and proximal ends; and a second introducer having distal and proximal ends; wherein: said first introducer is an outer introducer and said second introducer is configured to be operated inside and guided by said first introducer; at least a portion of said first introducer is configured to take a first curved shape, and at least a portion of the second introducer is configured to take a second curved shape, wherein said first and second curved shapes are concentric curved shapes; and said first introducer is configured to be delivered into a first side of the annulus of the mitral valve essentially in a mitral plane at an angle less than 45° in relation to the mitral plane.

19. The medical arrangement of claim 18, wherein said first introducer is configured to take said first curved shape when said first introducer is delivered towards or into said anatomical target position, and said second introducer is configured to take said second curved shape to the same hand direction as said first curved shape of said first introducer when said second introducer is introduced from the distal end portion of said first introducer.

20. The medical arrangement of claim 18, further comprising a third introducer having distal and proximal ends, and wherein: said third introducer is an inner introducer and said second introducer is configured to be operated between said first introducer and said third introducer, and said third introducer is configured to take a third curved shape to the same hand direction as the first and second curved shapes of said first and second introducers when said third introducer is introduced from the distal end portion of said second introducer.

21. The medical arrangement of claim 18, wherein said portion of the introducer taking said curved shape is a distal portion of said introducer, said distal portion being located between the distal end and proximal end of the introducer.

22. The medical arrangement of claim 21, wherein the introducer comprises a third portion between the distal end and said distal portion taking said curved shape, wherein said third portion has a different curvature radius than said portion taking said curved shape, or wherein said third portion is a straight portion.

23. The medical arrangement of claim 1, wherein said second introducer is configured to take at least one additional curved shape, where said additional curved shape is configured to be located between said second curved shape and the proximal end of the second introducer.

24. The medical arrangement of claim 1, wherein said portion of the first or second introducer taking said curved shape is also configured to form an angle essentially perpendicular to said first and second curved shape directions or to the mitral plane and into direction to form a helix form.

25. The medical arrangement of claim 20, wherein said first introducer is an outer steerable catheter, said second introducer is a steerable catheter, and said third introducer is an inner steerable catheter.

26. The medical arrangement of claim 20, wherein said first introducer is configured to be delivered first, said second introducer is configured to be delivered second, and said third introducer is configured to be delivered third.

27. The medical arrangement of claim 20, wherein the distal portion of said first introducer is configured to be retracted before said object is introduced into said anatomical target position via the second introducer or after said second introducer is introduced into said anatomical target position; or wherein the distal portion of said second introducer is configured to be retracted before said object is introduced into said anatomical target position or after said third introducer is introduced into said anatomical target position.

28. The medical arrangement of claim 1, wherein a cross-section of said second introducer is expandable and at least a portion of a housing of the introducer is expansible.

29. The medical arrangement of claim 20, wherein a cross-section of said third introducer is expandable and at least portion of a housing of the introducer is expansible.

30. The medical arrangement of claim 20, whereupon said second introducer or said third introducer is configured to be delivered to a second side of the annulus of the mitral valve between leaflets, said second side of the annulus being opposite to said first side.

31. The medical arrangement of claim 20, wherein the second introducer is configured to be introduced from the distal end of the first introducer and wherein at least a distal end of the second introducer is configured to be introduced from the distal end of the first introducer before the third introducer when the third introducer used.

32. The medical arrangement of claim 20, wherein the third introducer is configured to be introduced from the distal end of the second introducer before introducing said implant or medicament.

33. The medical arrangement of claim 18, wherein said second curved shape of said second introducer has a first shape capable of being delivered in a straightened configuration through said first introducer and configured to be activated to said at least second curved shape within or near the anatomical target position; or wherein said third curved shape of said third introducer has a first shape capable of being delivered in a straightened configuration through said first introducer and configured to be activated to said at least third curved shape within or near the anatomical target position.

34. The medical arrangement of claim 20, wherein said arrangement is configured to deliver said object inside the second introducer or third introducer into or towards said anatomical target position after at least the distal end of the second introducer or third introducer is introduced from the distal end of the first or second introducer.

35. The medical arrangement of claim 20, wherein at least one introducer comprises a flexible portion arranged in an area of the curve and into a casing of the introducer so that said introducer is configured to take said curved shape at the point of said flexible portion and to said direction said flexible portion enables.

36. The medical arrangement of claim 35, wherein the flexible portion is a cutting, a laser cutting, or a material weakening.

37. The medical arrangement of claim 18, wherein the object is an implant or medicament.

38. The medical arrangement of claim 18, wherein said first introducer is configured to be delivered at an angle less than 30° in relation to the mitral plane.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0031] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0032] FIG. 2 illustrates an exemplary implant,

[0033] FIGS. 3-13 illustrate a medical arrangement for introducing an implant or medicament into an anatomical target position according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0034] FIGS. 1A-1B and 2 are already discussed in more details in connection with the background of the invention portion above.

[0035] FIGS. 3-13 illustrate a medical arrangement 100 for introducing an implant 110 into an anatomical target position according to advantageous embodiments of the invention, where the medical arrangement 100 comprises a first introducer 101 having distal and proximal ends 101A, 101B. The introducer is advantageously configured to be delivered into the mitral valve area in a mitral plane 105 or in an angle 101E advantageously less than 45° and more advantageously less than less than 30° in relation to the mitral plane 105. In addition, the arrangement comprises also second introducer 102 having distal and proximal ends 102A, 102B.

[0036] The first introducer 101 is delivered first in a straightened configuration 101F until the distal end 101B of the first introducer 101 reaches the anatomical target position, whereupon the distal portion is configured to take the first curved shape 101C, advantageously following the anatomical shapes of the anatomical target position. It is to be noted that the first introducer 101 does not typically go further, but after this the second introducer 102 is delivered inside the first introducer 101 in a straightened configuration 102F. The second introducer 102 follows the shapes of the first introducer 101 until it comes out from the distal end 101B of the first introducer 101, after which the second introducer 102 is still delivered further until the distal portion of the second introducer 102 is configured to take the second curved shape 102C, as can be seen in FIG. 3.

[0037] According to an example the second introducer 102 can still be delivered further until the distal portion of the second introducer 102 is configured to take the additional curved shape 102G, as can be seen in FIG. 4. The additional curved shape 102G locates to the direction of the proximal end 102B from the second curved shape 102C. However, it is to be noted that the additional curved shape 102G is optional, for example if third or more introducers are used, as is illustrated in FIGS. 8-12.

[0038] Advantageously the second introducer 102 (possibly also the first introducer 101) comprises a flexible portion 106 so that said introducer 101, 102 takes said curved shape 101C, 102C at the point of said flexible portion 106 to the direction where the flexible portion 106 locates. The flexible portion 106 can be a cutting, in particularly a laser cutting, for example or achieved by material weakening. The flexible portion 106 is arranged into a casing of the introducer 101, 102 and so that it is left inside the curve when the introducer takes said curve shape.

[0039] It is to be noted that the first and second curved shapes turn the first and second introducers 101, 102 concentrically essentially in the mitral plane 105. However, as can be seen in FIGS. 3, 4 and 7, for example, the first and second introducers 101, 102 are also configured to tilt or bank downwards 108 and thereby form an angle 109A, 109B also downwards 108. Therefore, when the introducers are delivered for example to the left ventricle, the introducers take a helical loop form due to said first and second and additional curved shapes 101C, 102C, 102G, but in addition to this the distal end portion of the first introducer 101, and advantageously also the second introducer 102 takes the angle downwards 108, whereupon at least the second (or third, if used) introducer 102 can be delivered to the opposite side of the annulus and so that the introducers still follow smoothly the shapes of the anatomical target position.

[0040] As can be seen in FIGS. 5-6, at least the distal portion 101A (or even the whole introducer) of the first introducer 101 is retracted before the implant 110 is introduced into the anatomical target position 20 via the second introducer 102, whereupon more space can be arranged for delivering of the implant, especially if the second introducer is expandable 107. The distal portion 101A of the first introducer 101 is retracted however advantageously after the second introducer 102 is delivered into the anatomical target position 20. If the third introducer 103 is used, as is the case in FIGS. 8-12, then at least the distal portion 102A of the second introducer 102 is advantageously retracted before the implant 110 is introduced into the anatomical target position 20 and also advantageously after said third introducer 103 is delivered into said anatomical target position 20. In this case also at least the first introducer is retracted.

[0041] By this a bigger implant can be delivered without any needs for bigger introducers, namely because when the first introducer 101 is retracted and the second introducer is expandable, the cross-section 107 of the second introducer 102 can expand and take the space needed for the implant. The second introducer can be manufactured for example of flexible or stretchable material. It is to be understood that also the third introducer 103 can be expandable in the cases where the third introducer 103 is used.

[0042] FIGS. 8-12 illustrate the medical arrangement 100 with third introducer having distal and proximal ends 103A, 103B, where in FIG. 8 the first introducer 101 is delivered so that it takes the first curve shape 101C and the first angle 109A to the downward 108. Next the second introducer 102 is delivered inside the first introducer 101 and from the distal end 101A of the first introducer 101 so that it takes the second curve shape 102C and the second angle 109B to the downward direction 108, as is the case in FIG. 9. Then the third introducer 103 is delivered inside the first and second introducers 101, 102 and from the distal end 102A of the second introducer 102, as can be seen in FIG. 10. It is to be noted that the third introducer 103 does not advantageously take any angle 109B to the downward direction 108, because advantageously the third introducer is already delivered to the opposite side of the annulus (between the leaflets) and there is no need to go downwards anymore. Thus, it is advantageous that the third (or any additional) introducer 103, 104 will follow the anatomical target environment, such as the annulus essentially in the mitral plane 105.

[0043] However, the third introducer 103 is configured to take the third curved shape 103C to the same hand direction as the first and second curved shapes 101C, 102C of the first and second introducers 101, 102 when the third introducer 103 is introduced from the distal end portion 102A of the second introducer 102 so that said first, second and third curved shapes 101C, 102C, 103C are concentric curved shapes.

[0044] As is the case also with two introducers in FIGS. 3-7, the first introducer 101 is delivered first and said second introducer 102 is delivered secondly and then the third introducer 103 last. As can be seen in FIG. 11, there might be also still additional introducers 104, where the operational principle is analogous with three introducers. In addition, also in this embodiment at least the distal portion 102A of the second introducer 102 is retracted before the implant 110 is introduced into the anatomical target position 20, but anyway after the third introducer 103 is introduced into the anatomical target position. This is for protecting the tissue of the anatomical target position and environment, when the third introducer can be delivered inside the second introducer as far as possible. Same naturally applies to other situations, where for example at least the distal end 101A of the first introducer 101 is retracted after introduction of the third introducer 103 and so on. FIG. 12 illustrates an example with four introducers 101-104, where the second and third introducers 102, 103 are retracted and the additional introducer 104 is left to protect the tissue about the delivering of the implant 110. It is to be understood that the additional introducer 104 is illustrated in FIG. 12 so that it is already retracted a certain length towards the proximal end so that the implant delivered can be seen better. In addition, it is to be noted that also the first introducer could have been retracted.

[0045] The introducers 101, 102, 103 comprises advantageously also third portions 101D, 102D, 103D between the distal ends 101C, 102C, 103C and said distal portions taking said curved shapes 101C, 102C, 103C. The third portions 101D, 102D, 103D have different curvature radius than the portions taking said curved shapes 101C, 102C, 103C. In some case the third portion 101D, 102D, 103D may be even essentially a direct portion. This will guide the next inner introducer 102, 103 or the implant 110 to take better orientation and direction in relation to the surrounding anatomical environment, because in this way the distal end 102A, 103B, 110B of the outcoming inner introducer 102, 103 or the implant 110 will follow better the shapes of the anatomical target position, i.e. otherwise it will easily hit the tissue of the anatomical environment, such as the annulus.

[0046] FIG. 13 illustrates an example of the first and second introducers 101,102 how to control the formation of the curved shapes 101C, 102C. The introducer may for example comprise an operating wire 113 (or the like) arranged to elongate between the proximal and distal ends of the introducer and along a side to which said curved shape is to be provided so advantageously the same side where the flexible portion 106 is provided.

[0047] The distal ends 101A, 102A of the first and second introducers 101, 102 comprise advantageously a reinforcement ring 114 to which said the operating wire 113 is coupled with. Thus, when the operating wire 113 is tightened advantageously from the proximal end of the introducer 101B, 102B, it will cause the introducer 101, 102 in question to bend to that direction. There flexible portion is arranged inside the curve and into a casing of the introducer so that when the operating wire is tightened, said introducer is caused to take said curved shape at the point of said flexible portion and to said direction said flexible portion locates. The flexible portion can be for example a cutting, such as for example a laser cutting, but also other techniques can be used, such as material weakening, like thinning the wall of the introducer inside the curve. According to embodiment also memory materials can be used.

[0048] In addition, it is to be noted that when the operating wire 113 is coupled to the reinforcement ring 114 in an angle 115, the tightening of the operating wire 113 will also tilt or bank the distal end 101A, 102A of the introducer in question to the downward direction 108, as depicted in FIGS. 3, 4 and 7, for example.

[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.

[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.