21 July, 2025
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Decision
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ORD_598566/2023
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Nordic Baltic Region…
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Claims according to Auxiliary Request 1'
1 An apparatus for indicating flex of a distal end of a catheter comprising: an elongated shaft (152);
at least one wire (174) connected to a distal end portion (188) of the elongated shaft (152); pull handle portion (158) comprising a flex activating member (154), the flex activating member (154) being coupled to the at least one wire (174) such that adjustment of the flex activating member (154) causes the distal end portion (188) of the elongated shaft (152) to flex; pull
a slide member (192) connected to the at least one wire (174); and a flex indicating member (156); pull wherein adjustment of the flex activating member (154) causes the flex indicating member (156) to move relative to the handle portion (158), and
wherein the flex activating member (154) comprises a rotatable member (155, which includes an internally threaded surface portion (160) characterised in that the rotatable member (155, 157) of the flex activating member also has an externally threaded surface portion (162), wherein the internally threaded surface portion (160) is configured to receive the slide member (192) connected to the at least one pull wire (174), and the externally threaded surface portion (162) is configured to receive an extending portion (166) of the flex indicating member (156) . 157)
The apparatus of claim 1, wherein indicia (168) indicating the amount of flex of the distal end portion of the elongated shaft (152) are provided at the handle portion (158), preferably wherein the indicia (168) depict the amount of flex using a triangular marking system or numbers.
The apparatus of one of claims 1 or 2, wherein the flex activating member (154) and the flex indicating member (156) are separate members. any
4 The apparatus of one of claims 1 to 3, wherein the handle portion (158) comprises a slot (164) for receiving at least a portion of the flex indicating member (156), preferably wherein the slot (164) is a longitudinal slot.
The apparatus of claim 1 wherein rotating the rotatable member (155, 157) is configured to cause the slide member (192) to move along the internally threaded
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surface portion (160) and the movement of the slide member (192) along the internally threaded surface portion (160) changes the amount of flex of the distal end portion of the elongated shaft (152), wherein the rotation of the rotatable member (155, 157) causes the flex indicating member (156) to move longitudinally and change its position within the slot (164) of the handle portion (158) and the position of the flex indicating member (156) within the slot (164) indicates the amount of flex of the distal end portion of the elongated shaft (152).
6 The apparatus of one of the preceding claims; wherein the handle portion (158) includes a main body (159) formed with a central lumen (161) that receives a proximal end portion of the elongated shaft (152), preferably wherein the handle portion (158) includes a side arm (62) defining an internal passage which fluidly communicates with the central lumen (161) at the main body (159) of the handle portion (158), more preferably wherein a stopcock is mounted on the upper end of side arm (62).
The apparatus of claim 1, wherein the slide member (192) is formed with external threads that mate with the internally threaded surface portion (160) of the rotatable member (155, 157)
The apparatus of claim 7, wherein a proximal end portion of the pull wire (174) extends into and is secured to a retaining pin (180), wherein the retaining pin (180) is disposed in a slot in the slide member (192).
9 The apparatus of one of the preceding claims; wherein the apparatus for indicating flex is a flex catheter for implantation of a prosthetic heart valve.
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