Catheter for administering medical therapy to a remote location in the body.

Description

1 / 34 Catheter for administering medical therapy to a remote location in the body.

[001] The present invention relates to a catheter for administering medical therapy to a remote location in the body.

[002] In the aforementioned medical therapy, such as, for example, an interventional cardiovascular or neurovascular application, such a catheter must be angled through the tortuous folds and curves of a passage (vasculature) to reach the target anatomy. Such a catheter requires sufficient flexibility, particularly near its distal end, to navigate such tortuous paths. However, other design aspects must also be considered. For example, the catheter must also be able to provide sufficient torque capacity (i.e., the ability to transmit torque applied at the proximal end all the way to the distal end), push capacity (i.e., the ability to transmit axial thrust to the distal end), and structural integrity to perform the intended medical functions.

[003] US patent 2021 / 0023339 A1 describes a torsion-resistant catheter having at least one first pair of core wires residing in the catheter body on opposite sides of the catheter lumen. The core wires have relatively stiff proximal ends but taper toward the distal ends. The tapered construction Petition 870250087495, dated 09 / 26 / 2025, p. 55 / 103 2 / 34 gives the central wires a degree of distal flexibility that helps the catheter advance along a vasculature to a site of interest without twisting. In addition, the central wires greatly improve the torsional rigidity of the catheter so that rotation of the proximal end of the catheter translates into a substantially equivalent rotation at the distal end. If desired, molding tapes are provided on the catheter body adjacent to the distal ends of the central wires. See, for example, molding tapes 160 and 162 on the right side of Fig. 5 of US document 2021 / 0023339 A1. The molding tapes can be pre-bent by a physician before a surgical procedure to help the physician advance the catheter along the vasculature. That is, the molding tapes can be pre-bent by the physician at a desired deflection angle and to maintain that angle.This is useful when the catheter is intended for use in a medical procedure where the vasculature leading to the target site has a generally known angle of approach. Finally, central wires provide the ability to push the catheter through the vasculature without the need for the catheter to pass through a guidewire already in situ within the vasculature.

[004] It is an object of the present invention to provide an alternative catheter having a 'moldable' catheter section near the distal end, which is pre-foldable by a Petition 870250087495, dated 09 / 26 / 2025, p. 56 / 103 3 / 34 medical, with well-balanced omnidirectional bending capability and high shape retention, while allowing the catheter to be made reliably and efficiently and being designed with favorable properties regarding flexibility, torque capacity, pushability and lumen structure integrity.

[005] For that purpose, the invention provides a catheter according to the independent claim in Appendix 1. Preferred embodiments of the invention are provided by the dependent claims in Appendix 2 to 9.

[006] Consequently, the invention provides a catheter for administering medical therapy to a remote location in a body, wherein: The catheter has a proximal end, a distal end, and a longitudinal direction that extends from the proximal end to the distal end; The catheter comprises a tubular catheter wall, which surrounds a catheter lumen structure, and which extends from the distal end, in a proximal manner along the longitudinal direction, to at least 100 mm proximal from the distal end; The catheter wall comprises a pre-foldable wall section, which is manually pre-folded along its length. Petition 870250087495, dated 09 / 26 / 2025, p. 57 / 103 4 / 34 the entire pre-folding strip along the longitudinal direction, wherein said pre-folding strip extends at least between 5 mm proximal from the distal end and 10 mm proximal from the distal end; The pre-folding wall section comprises: - a pre-foldable skeleton, extending at least along the entire pre-folding strip, and providing catheter wall reinforcement in the longitudinal direction, as well as in a circumferential direction around the longitudinal direction, wherein the pre-foldable skeleton is an interrupted tubular reinforcement wall obtained by microfabricating a cutting pattern in a completely uninterrupted tubular reinforcement wall made of a reinforcing material, - an inner lining, which is coaxially surrounded by said pre-foldable skeleton in relation to a central line of the catheter wall and - an outer laminate, which coaxially surrounds the aforementioned pre-foldable skeleton in relation to the centerline of the catheter wall; The pre-folding skeleton comprises: - a number N of right-hand helical supports, extending along N right-hand helical directions, respectively, where N b 2, Petition 870250087495, dated 09 / 26 / 2025, p. 58 / 103 5 / 34 - N helical supports to the left, extending along N helical directions to the left, respectively and - a plurality of ring-shaped supports, extending along circular directions, respectively; Each of the aforementioned right-hand helical supports, left-hand helical supports, and ring-shaped supports are arranged coaxially with respect to the centerline, wherein the N right-hand helical supports are angularly spaced equally from each other by 360 divided by N degrees around the centerline, wherein the N left-hand helical supports are angularly spaced equally from each other by 360 divided by N degrees around the centerline, wherein the ring-shaped supports extend mutually parallel to each other and mutually spaced in the longitudinal direction, wherein the pre-foldable skeleton comprises, for each of the aforementioned ring-shaped supports, N connecting nodes in N angularly equally spaced positions, respectively, of each ring-shaped support in question, and wherein at each connecting node,Each ring-shaped support in question is connected to one of the N helical supports on the right, as well as to one of the N helical supports on the left. Petition 870250087495, dated 09 / 26 / 2025, p. 59 / 103 6 / 34 left; A general ratio for cutting the skeleton of a longitudinal section of the catheter wall in a longitudinal strip along the longitudinal direction is defined as the percentage of: - the volume of all parts, within the aforementioned longitudinal strip, of the aforementioned reinforcing material being cut from the aforementioned completely uninterrupted tubular reinforcing wall according to the aforementioned microfabricated cutting pattern, in relation to - the volume of all parts, within the aforementioned longitudinal strip, of the aforementioned reinforcement material of the aforementioned fully uninterrupted tubular reinforcement wall; and the overall shear ratio of the skeleton of the pre-folding wall section in the aforementioned pre-folding strip is between 45% and 85%.

[007] In the above-mentioned features of the present invention, the key features of the invention are that: The pre-folding wall section comprises the pre-folding skeleton obtained by microfabrication of said cutting pattern in such a way that the pre-folding skeleton comprises the specific structure recited of the N helical supports on the right, of the N supports Petition 870250087495, dated 09 / 26 / 2025, pp. 60 / 103 7 / 34 helical to the left, of the ring-shaped supports and connection nodes; and ii. the overall shear ratio of the pre-folded wall section skeleton is between 45% and 85%.

[008] The aforementioned key feature (i) refers to the specific structure of the pre-folding skeleton. In it, the parallel ring-shaped supports provide resistance to the arch without compromising the pre-bending capacity of the pre-folding wall section. At the same time, the two sets of N equally spaced and oppositely directed helical supports provide shape retention, as well as a well-balanced omnidirectional bending capacity under the action of pre-bending by a physician. The aforementioned pre-bending capacity is guided and regulated by the positions of the connecting nodes, as well as by the parallel ring-shaped supports. Once bent into a desired shape, the shape retention of the bent section of the catheter remains intact, since the pre-folding skeleton is a triangular structure formed only by triangles.In other words, all the connecting nodes of the pre-folding skeleton are vertices of multiple triangles, in which each triangle is formed by three support sections: a helical support on the left, a helical support on the right, and a ring-shaped support, respectively. This triangular structure is strong. Petition 870250087495, dated 09 / 26 / 2025, pp. 61 / 103 8 / 34

[009] The aforementioned key feature (ii) refers to the overall shear ratio of the skeleton of the pre-foldable wall section. The said shear ratio being not less than 45%, in accordance with the lower limit specified by the key feature (ii), avoids a pre-folding capacity of the wall section that is too laborious for a physician. The overall shear ratio of the skeleton of the pre-foldable wall section being not greater than 85%, in accordance with the upper limit specified by the key feature (ii), avoids problematic shape retention after bending of the wall section.

[0010] Furthermore, it will be readily observed that the pre-foldable skeleton gives the pre-foldable wall section very good torque capacity, pushing capacity, and lumen structure integrity. Other longitudinal sections of the catheter can be designed in many varied ways and can be firmly connected to or integrally with the pre-foldable wall section having the pre-foldable skeleton. Consequently, the invention allows the catheter to be reliably and efficiently made and designed with favorable properties regarding flexibility, torque capacity, pushing capacity, and lumen structure integrity.

[0011] It is observed that the manufacture of the aforementioned high Petition 870250087495, dated 09 / 26 / 2025, pp. 62 / 103 9 / 34 The overall shear ratio of the skeleton (at least 45%) of the pre-folded wall section according to the invention requires inventive measures to solve several problems. The reason is that the inner sheath of a catheter having a skeleton for many applications is typically a tube made of, for example, PTFE (polytetrafluoroethylene, e.g., Teflon®), PVDF (polyvinylidene fluoride, e.g., Kynar®) or HDPE (high-density polyethylene), which, during catheter manufacturing, is axially inserted into the skeleton and is then expanded against the skeleton by inflation and heat. For the aforementioned high shear ratios, problems arise when the tube made of, for example, PTFE, PVDF or HDPE, when inflated against the skeleton, projects out of the large cutouts in the skeleton material and / or breaks under the inflation pressure.Another problem, especially for skeletons made of weaker material, is that the skeleton can severely deform and / or crack and / or break under inflation pressure due to the fact that the skeleton is severely weakened by the large cutouts in the skeleton material.

[0012] In connection therewith, the present invention inter alia is based on the new insights, as described herein, that the aforementioned problems can be solved by introducing, temporarily during the Petition 870250087495, dated 09 / 26 / 2025, pp. 63 / 103 10 / 34 manufacturing a catheter according to the invention, of a heat-shrinkable outer tube over the outer side of the pre-foldable skeleton, such that the heat-shrinkable outer tube temporarily closes the cutouts in the skeleton material during said expansion of the inner lining by inflation and heat, while at the same time the heat-shrinkable outer tube temporarily reinforces the pre-foldable skeleton during said expansion of the inner lining by inflation and heat. After the inner lining has been successfully expanded against the skeleton and after the catheter under the construction has been cooled, the temporary heat-shrinkable outer tube can be removed from the outer side of the skeleton and can be replaced by the final outer laminate over the outer side of the skeleton.

[0013] Alternatively, another novel insight, as described in this document, is that the aforementioned problems can be solved by performing the following manufacturing steps to assemble the inner sheath and outer laminate to the skeleton in the case of the aforementioned high overall shear ratio of the skeleton (at least 45%) of the pre-folded wall section of the catheter wall of a catheter according to the invention. First, a tubular base layer of fluorinated ethylene propylene (FEP) is extruded and the inner sheath is extruded over the Petition 870250087495, dated 09 / 26 / 2025, pp. 64 / 103 11 / 34 base layer. Next, the FEP base layer, along with the inner sheath, is axially inserted into the skeleton. Then, the outer laminate is slid over the outer side of the skeleton. After that, a temporary heat-shrinkable FEP outer tube is slid over the outer laminate and the entire assembly is heated. During heating, the temporary heat-shrinkable FEP outer tube provides high compression on the inner sheath, skeleton, and outer laminate assembly. After the catheter under construction has cooled, the temporary heat-shrinkable outer tube can be removed from the outer side of the skeleton and the FEP base layer can be pulled axially out of the assembly, making use of FEP's favorable properties regarding being pulled. Thus, a very close fit of the inner sheath against the inner side of the skeleton is obtained.

[0014] It is observed that the last mentioned use of such an extruded FEP base layer is a more effective and much more economical alternative when compared to the traditional use of a temporary silvered copper wire, which at the end of a manufacturing subprocess is pulled axially out of an inner lining of a catheter under construction.

[0015] Another advantage of the present invention is that, thanks to the high overall shear ratio of the skeleton (at least Petition 870250087495, dated 09 / 26 / 2025, pp. 65 / 103 12 / 34 45%) of the pre-folded wall section of a catheter wall according to the invention, and thanks to the findings mentioned above, as described in this document, the invention allows for the efficient embedding of a radiopaque element (for example, a radiopaque marker) in the catheter wall, since the radiopaque element can be perfectly located in a space of the cutting pattern, said space being delimited by the pre-folded skeleton, the inner layer, and the outer laminate.

[0016] In a preferred embodiment of a catheter according to the invention, said pre-folding strip extends at least between 0.5 mm proximal from the distal end and 15 mm proximal from the distal end. Thus, the pre-folding skeleton extends distally even closer to the distal end, which increases the physician's options for shaping the catheter closer to the distal end.

[0017] More preferably, the aforementioned pre-folding strip extends at least between the distal end and 20 mm proximal from the distal end, which increases the physician's options for further shaping the catheter.

[0018] In another preferred embodiment of a catheter according to the invention, the general cutting ratio of the skeleton of the pre-foldable wall section in said pre-folding range Petition 870250087495, dated 09 / 26 / 2025, pp. 66 / 103 13 / 34 folding is between 60% and 80%. This further facilitates the moldability of the wall section for a physician and additionally improves shape retention after molding.

[0019] More than one preferred method, the overall shear ratio of the skeleton of the pre-folded wall section in the said pre-folding range is between 70% and 78%. This further facilitates the moldability of the wall section for a physician and further improves shape retention after molding.

[0020] In another preferred embodiment of a catheter according to the invention, the radio-opaque element is embedded in the catheter wall by the fact that the radio-opaque element is located in a space of the cutting pattern, said space being delimited by the pre-foldable skeleton, the inner layer and the outer laminate.

[0021] The catheter according to the invention can be incorporated as a quick-change catheter having the tubular catheter wall as a distal quick-change tubular segment that is spaced from the proximal end of the quick-change catheter.

[0022] Such a quick-change catheter has a proximal catheter segment, proximally from the distal quick-change tubular segment, which may, for example, be an impeller rod connected to the distal quick-change tubular segment. Such an impeller rod may advantageously have Petition 870250087495, dated 09 / 26 / 2025, pp. 67 / 103 14 / 34 is a round design with a diameter d of 0.40 mm to support a 1:1 torque capability from the proximal end to the distal end. Such a 1:1 torque capability is highly desirable for this type of device since the physician needs to be able to precisely direct the catheter toward a target location, such as a bend or a side branch of a vascular passage.

[0023] Alternatively, the catheter according to the invention may be incorporated as an over-the-wire (OTW) catheter, wherein the tubular catheter wall and catheter lumen structure extend along the entire longitudinal direction from the proximal end to the distal end.

[0024] Such a catheter over wire may advantageously have a catheter skeleton that extends along the entire longitudinal direction from the proximal end to the distal end and that provides reinforcement of the catheter wall in the longitudinal direction as well as in the circumferential direction around the longitudinal direction, wherein the catheter skeleton over wire is an interrupted tubular reinforcement wall obtained by microfabricating a cut pattern in a completely uninterrupted tubular reinforcement wall made of a reinforcing material. Consequently, in this case, the pre-folding skeleton of the pre-folding wall section is Petition 870250087495, dated 09 / 26 / 2025, pp. 68 / 103 15 / 34 a section of the catheter skeleton over the wire. Preferably, the catheter skeleton over the wire is designed to support 1:1 torque capability from the proximal end to the distal end of the catheter over the wire. Alternatively to said skeleton over the wire, the catheter over the wire, in longitudinal sections outside the pre-bending range of the pre-bending skeleton, may also be designed with, for example, wire braids or coil structures to support 1:1 torque capability.

[0025] In another preferred embodiment of a catheter according to the invention, the N helical supports on the right and the N helical supports on the left each have the same pitch compared to each other, said pitch being defined as the distance, measured along the longitudinal direction, of a helical winding of a helical support in question, and wherein the pre-folding strip has at least one continuous sub-strip having a length equal to said pitch, and wherein the pre-folding skeleton has several N multiplied by 2 of said ring-shaped supports in said continuous sub-strip.

[0026] The invention is further elucidated herein with reference to a non-limiting embodiment and with reference to the schematic figures in the accompanying drawing, in which the following is shown. Petition 870250087495, dated 09 / 26 / 2025, pp. 69 / 103 16 / 34

[0027] Fig. 1 shows, in a longitudinal side view, an example of an embodiment of a catheter according to the invention, wherein in Fig. 1 the pre-folding range of the pre-folding wall section of the catheter wall is indicated by a brace mark and wherein, in the embodiment of the catheter of Fig. 1, the number mentioned above N is equal to two (N = 2).

[0028] Fig. 2 shows, in a perspective view, a longitudinal section of the pre-foldable skeleton of the pre-foldable wall section of the catheter of Fig. 1.

[0029] Fig. 3A shows a small longitudinal section of the pre-folded wall section of the catheter of Fig. 1, wherein the longitudinal section shown comprises a part of the pre-folded skeleton, and wherein the view shown is a longitudinal sectional view, which contains the centerline of the catheter wall.

[0030] Fig. 3B shows a cross-section through the longitudinal section of the pre-folded wall section of Fig. 3A, wherein the cross-section shown is perpendicular to the centerline of the catheter wall.

[0031] Fig. 4 shows a small longitudinal section of the pre-foldable skeleton of the pre-foldable wall section of the catheter of Fig. 1, wherein the view shown is a top view of the longitudinal section in an imaginary state of “unrolled tube of the longitudinal section. Petition 870250087495, dated 09 / 26 / 2025, pp. 70 / 103 17 / 34

[0032] Fig. 5A again shows a small longitudinal section of the pre-foldable skeleton of the pre-foldable wall section of the catheter from Fig. 1, however, this time, the view shown is a longitudinal side view.

[0033] Fig. 5B shows the longitudinal side view of Fig. 5A again, however, this time in a folded state of the longitudinal section as a result of a physician having pre-folded the pre-foldable wall section of the catheter of Fig. 1.

[0034] Fig. 6 shows, in a side view similar to the side view of Fig. 5A, an example of a distal skeleton of a distal section of a tubular catheter according to the invention, wherein the distal skeleton of Fig. 6 is an end-to-end interconnection of the pre-foldable skeleton of Figs. 1-5 with a second skeleton and a third skeleton.

[0035] Figs. 7A-7E show details of the second skeleton in Fig. 6.

[0036] Figs. 8A-8C show details of the third skeleton in Fig. 6.

[0037] Fig. 9 shows, in a view similar to the view in Fig. 4, a small longitudinal section of an example of an alternative embodiment of a pre-foldable skeleton of a catheter according to the invention, wherein in the alternative embodiment of the pre-foldable skeleton of Fig. 9 the number Petition 870250087495, dated 09 / 26 / 2025, pp. 71-103 18 / 34 mentioned above N equals three (N = 3).

[0038] The reference signs used in the embodiment of Figs. 1-8 refer to the parts and aspects of the invention mentioned above, as well as to related parts and aspects, as follows: catheter tubular catheter wall 3--------------lumen structure proximal end distal end distal skeleton pre-folding skeleton A------------cutting pattern interior lining -------------- outer laminate longitudinal direction circumferential direction center line ------------ pre-folding wall section ------------ pre-folding range second track third track 21L, 22L --- two helical supports on the left 21R, 22R --- two helical supports on the right

[0039] 23-26 -------- four supports in the shape of Petition 870250087495, dated 09 / 26 / 2025, pp. 72 / 103 19 / 34 ring second skeleton third skeleton 51-54 ------- helical parts 61-66 ------- helical slits 90-99 --------ten connection nodes

[0040] The reference signs used in the alternative embodiment of Fig. 9 refer to the parts and aspects of the invention mentioned above, as well as to related parts and aspects, as follows: 107 ---------------------- pre-folding skeleton 107A -------------------- cutting pattern 110 ---------------------- longitudinal direction 111 ---------------------- circumferential direction 121L, 122L, 123L --- three helical supports on the left 121R, 122R, 123R --- three right-hand helical supports 123-128 ----------------- six ring-shaped supports 140-160 ----------------- twenty-one connection nodes

[0041] Based on the introductory description above, including the brief description of the figures in the drawing and based on the reference signs listed above used in Petition 870250087495, dated 09 / 26 / 2025, pp. 73 / 103 20 / 34 Figs. 1-9, the modality of Figs. 1-8, and the alternative modality of Fig. 9 are, for the most part, readily self-explanatory. The following additional explanations are given.

[0042] Fig. 1 shows catheter 1 having longitudinal direction 10, proximal end 4 and distal end 5. Fig. 1 additionally shows the pre-folding strip 15 of the pre-folding wall section 14 of the catheter wall 2.

[0043] In the embodiment of Figs. 1-8, the number mentioned above N is equal to two (N = 2). This means that, in the embodiment of Figs. 1-8, the pre-folding skeleton 7 comprises two helical supports on the right that are angularly spaced equally from each other by 180 degrees and two helical supports on the left that are angularly spaced equally from each other by 180 degrees.

[0044] The perspective view of Fig. 2 shows that the pre-foldable skeleton 7 of the pre-foldable wall section 14 of catheter 1 in Fig. 1 has the two helical supports on the left 21L, 22L, the two helical supports on the right 21R, 22R and at least the mutually parallel ring-shaped supports 23-26.

[0045] Figs. 3A-3B show that the pre-folding wall section 14 does not only have the skeleton 7, which Petition 870250087495, dated 09 / 26 / 2025, pp. 74 / 103 21 / 34 comprises the cutting pattern 7A, but also has an inner coating 8 and an outer laminate 9. In the example of Figs. 3A-3B, the lumen structure 3 of catheter 1 is a single-lumen structure. Alternatively, a catheter according to the invention may have a multi-lumen structure.

[0046] Fig. 4 shows a small longitudinal section of the pre-folding skeleton 7 of the pre-folding wall section 14 of catheter 1. In Fig. 4, the view shown is a top view of the longitudinal section in an imaginary “unrolled tube” state of the longitudinal section. To explain the term “unrolled tube,” it is noted that the pre-folding skeleton is a tubular wall (more particularly, an interrupted tubular reinforcement wall) and that such a tubular wall can be imaginarily unrolled in a completely straight state by imaginarily unrolling it in a completely straight plane after an imaginary straight cut, parallel to the catheter centerline, has been made along the entire length of the tubular wall. In Fig. 4, the aforementioned imaginary straight cut is a straight line passing through the connecting nodes 90, 91, and 92 of the pre-folding skeleton 7. In Fig. 4, the reference numbers 90, 91, and 92 are shown both at the bottom of Fig. 4 and at the top of Fig. 4.4, given that the locations to which these reference numbers 90, 91 and 92 are pointing are... Petition 870250087495, dated 09 / 26 / 2025, pp. 75 / 103 22 / 34 will join when the completely straight state of Fig. 4 is “rolled up” again to form the tubular state of the pre-folding skeleton 7 as shown in the perspective view of Fig. 2.

[0047] From Fig. 4 it can be seen that:

[0048] - the left-hand helical support 22L extends successively from connection node 90 to connection node 93, to connection node 96, to connection node 99, to connection node 92; and

[0049] - the left-hand helical support 21L extends successively from connection node 95 to connection node 98, to connection node 91, to connection node 94, to connection node 97;

[0050] - the right-hand helical support 21R extends successively from connection node 95 to connection node 93, to connection node 91, to connection node 99, to connection node 97; and

[0051] - the right-hand helical support 22R extends successively from connection node 90 to connection node 98, to connection node 96, to connection node 94, to connection node 92.

[0052] From Fig. 4, it can be inferred that the two helical supports on the right 21R and 22R are angularly spaced 180 degrees apart from each other around the center line 12, that the two helical supports on Petition 870250087495, dated 09 / 26 / 2025, pp. 76 / 103 23 / 34 left 21L and 22L are angularly spaced relative to each other by 180 degrees around the center line 12 and that the ring-shaped supports 23, 24, 25, 26 extend mutually parallel relative to each other and mutually spaced in the longitudinal direction 10.

[0053] From Fig. 4, it can be further inferred that the pre-folding skeleton 7 comprises, for each of the ring-shaped supports shown 23, 24, 25, 26, two connection nodes in two diametrically opposite positions, respectively, of each ring-shaped support in question and that, at each connection node, each ring-shaped support in question is connected to one of the two helical supports on the right 21R, 22R as well as to one of the two helical supports on the left 21L, 22L.

[0054] Fig. 4 clearly illustrates that the pre-folding skeleton 7 is a triangular structure formed only by triangles. That is, all the connecting nodes 90-99 of the pre-folding skeleton 7 are vertices of multiple triangles, in which each triangle is formed by three support sections: a helical support on the left, a helical support on the right, and a ring-shaped support, respectively. Such a triangular structure is strong and allows for the retention of its favorable shape.

[0055] Figs. 5A and 5B illustrate that the triangular structure of the pre-folding skeleton 7 will only Petition 870250087495, dated 09 / 26 / 2025, pp. 77 / 103 24 / 34 slightly deformed when a physician has pre-bent the pre-bent wall section 14 of catheter 1. The parallel ring-shaped supports (including ring-shaped supports 23-26 shown) provide arch resistance without impairing the pre-bendability of the pre-bent wall section. At the same time, said pre-bendability is guided and regulated by the positions of the connecting nodes (including connecting nodes 90-99 shown), as well as by the parallel ring-shaped supports. Clearly, the multitriangular character of the pre-bent skeleton 7 remains intact after pre-bendling, as does the good retention of the skeleton's shape.

[0056] In the example shown, the pre-folding skeleton 7 has the following dimensions. The pre-folding strip 15 extends between the distal end 5 and 20.0 mm proximal from the distal end 5. Therefore, the pre-folding skeleton 7 has a length of 20.0 mm in the longitudinal direction 10. The pre-folding skeleton 7 has an outer diameter of 0.635 mm and an inner diameter of 0.510 mm. The pitch of each of the two helical supports on the right 21R, 22R and the two helical supports on the left 21L, 22L is 1.00 mm, where pitch is defined as the distance, measured along the longitudinal direction 10, of a helical winding of a helical support in question. Petition 870250087495, dated 09 / 26 / 2025, pp. 78 / 103 25 / 34 Therefore, in Fig. 4, the pitch of each of the helical supports is equal to the distance, measured along the longitudinal direction 10, between the two centers of the two connecting nodes 90 and 92, respectively. The mutually parallel ring-shaped supports are spaced 0.250 mm apart as measured along the longitudinal direction 10. The width of each of the helical supports and ring-shaped supports is 0.030 mm as measured in the “unrolled tube” state of the pre-folding skeleton 7 shown in Fig. 4. The overall shear ratio of the pre-folding wall section skeleton 14 in the pre-folding strip 15 is approximately 76%.

[0057] Note that in the example shown, the pre-foldable skeleton 7 terminates at the distal end 5 of the catheter 1. Alternatively, however, the inner sheath 8 and / or the outer laminate 9 may extend slightly distally beyond the pre-foldable skeleton 7 to make the distal end 5 atraumatic.

[0058] Fig. 6 shows the pre-folding skeleton 7 in the pre-folding strip 15, together with a second skeleton 44 and a third skeleton 45. The three skeletons 7, 44 and 45 are successively interconnected end-to-end along the longitudinal direction 10 to form a distal skeleton 6 of a distal section of the tubular catheter wall 2. The second skeleton 44 extends into a second Petition 870250087495, dated 09 / 26 / 2025, pp. 79 / 103 26 / 34 band 16, which extends in the longitudinal direction 10 from 20.0 mm proximal from the distal end 5 to 100.0 mm proximal from the distal end 5. The third skeleton 45 extends in a third band 17, which extends in the longitudinal direction 10 from 100.0 mm proximal from the distal end 5 to 150.0 mm proximal from the distal end 5. The second skeleton 44 and the third skeleton 45 are shown in more detail in Figs. 7-8, respectively.

[0059] Reference is now made to Figs. 7A-7E, which illustrate the second skeleton 44. The second skeleton 44 extends in the second band 16 (see Fig. 6) along the longitudinal direction 10 for a length of 80.0 mm. Each of Figs. 7A-7E shows the second skeleton 44 only along a portion of the latter length mentioned. Fig. 7A shows a portion of the second skeleton 44 in longitudinal lateral view. Figs. 7B and 7C show two other portions of the second skeleton 44 in longitudinal lateral view, wherein the portion of Fig. 7B is located distally from the portion of Fig. 7A and the portion of Fig. 7C is located proximally from the portion of Fig. 7A. Fig. 7D is a perspective view of the second skeleton 44. Fig. 7E shows a top view of a longitudinal section of the second skeleton 44 in an imaginary uncoiled tube state of the longitudinal section (the Petition 870250087495, dated 09 / 26 / 2025, pp. 80 / 103 27 / 34 The term “unwound tube” was explained above with reference to Fig. 4). Figs. 7D-7E show that the second skeleton 44 consists of four helical parts, two of which are right-hand helical parts 51, 52 and two of which are left-hand helical parts 53, 54, wherein the two right-hand helical parts 51, 52 are crossing the two left-hand helical parts 53, 54 at multiple nodes of the second skeleton 44.

[0060] In Figs. 7B-7C, some dimensions have been indicated by numerical values, which should be interpreted in millimeters (mm). Figs. 7B-7C serve to illustrate the aspect in which the thickness of the helical parts of the second skeleton 44 gradually decreases distally along the longitudinal direction. Thus, the flexibility of the second skeleton 44 of the catheter wall 2 gradually increases distally along the longitudinal direction 10.

[0061] Reference is now made to Figs. 8A-8C, which show the third skeleton 45 in longitudinal side view. The third skeleton 45 extends in the third band 17 (see Fig. 6) along the longitudinal direction 10 for a length of 50.0 mm. Each of Figs. 8A-8C shows the third skeleton 45 only along a portion of the latter length mentioned. The portion in Fig. 8C is located distally away from the portion in Fig. Petition 870250087495, dated 09 / 26 / 2025, pp. 81-103 28 / 34 8A. The part in Fig. 8B is located distally away from the part in Fig. 8C. The third skeleton 45 has several helical slots that are interconnected end-to-end along the longitudinal direction 10. Each helical slot has only a few helical windings. For example, Fig. 8A shows helical slots 61 and 62, Fig. 8C shows helical slots 63 and 64, and Fig. 8B shows helical slots 65 and 66. Two mutually connected helical slots each have winding directions opposite to each other. Such mutual connections of two helical slots with opposite directions are shown in the longitudinal middle of each of Figs. 8A-8C. Figures 8A-8C further serve to illustrate that the pitch of the helical slits gradually decreases for distally subsequent helical slits along the longitudinal direction 10.Due to the aforementioned decrease in pitch, the overall shear ratio of the catheter wall skeleton 2 in the third band 17 gradually increases distally, with the effect that the flexibility of the catheter wall 2 in the third band 17 gradually increases distally along the longitudinal direction.

[0062] The three interconnected skeletons 7, 44 and 45 of the distal skeleton 6 of Fig. 6 can be manufactured integrally by microfabricating a cutting pattern in a completely uninterrupted tubular reinforcement wall made Petition 870250087495, dated 09 / 26 / 2025, pp. 82 / 103 29 / 34 of a reinforcing material.

[0063] A tubular catheter wall comprising the pre-foldable skeleton 7 or the larger distal skeleton 6, for example, may be part of a quick-change catheter having the tubular catheter wall as a distal quick-change tubular segment that is spaced from the proximal end of the quick-change catheter. Alternatively, such a tubular catheter wall, for example, may be part of an over-the-wire (OTW) catheter, wherein the tubular catheter wall extends along the entire longitudinal direction from the proximal end to the distal end.

[0064] As mentioned, the embodiment in Figs. 1-8 is an embodiment in which N = 2. It is further noted that the embodiment in Figs. 1-8 is more specifically an example of the aforementioned preferred embodiment of a catheter according to the invention, wherein the N (i.e., two) right-hand helical supports (21R, 22R) and the N (i.e., two) left-hand helical supports (21L, 22L) each have the same pitch compared to each other, said pitch being defined as the distance, measured along the longitudinal direction, of a helical winding of a helical support in question, and wherein the pre-folding strip has at least one continuous sub-strip having a length equal to said pitch, and wherein the pre-folding skeleton has several N multiplied by 2 Petition 870250087495, dated 09 / 26 / 2025, pp. 83-103 30 / 34 (i.e., four) of said ring-shaped supports (23, 24, 25, 26) in said continuous sub-strip. This is clear from Fig. 4, which is a small longitudinal section of the pre-folding skeleton 7, wherein said small longitudinal section corresponds to said continuous sub-strip having a length equal to said pitch. In Fig. 4, it is seen that the pre-folding skeleton 7 has ten connecting nodes (90-99) in said continuous sub-strip.

[0065] Reference is now made to Fig. 9, which shows the pre-folding skeleton 107 as an alternative embodiment to the pre-folding skeleton 7 in Fig. 4. In the alternative pre-folding skeleton 107 of Fig. 9, the number mentioned above N is equal to three (N = 3). This means that in the embodiment of Fig. 9 the pre-folding skeleton 107 comprises N (i.e., three) right-hand helical supports (121R, 122R, 123R) which are angularly spaced equally with respect to each other by 120 degrees and N (i.e., three) left-hand helical supports (121L, 122L, 123L) which are angularly spaced equally with respect to each other by 120 degrees.

[0066] It is further observed that when the alternative pre-foldable skeleton 107 is used in the catheter embodiment of Figs. 1-8 to replace the pre-foldable skeleton 7, an example of the preferred embodiment mentioned above of a Petition 870250087495, dated 09 / 26 / 2025, pp. 84 / 103 31 / 34 catheter according to the invention, wherein the N (i.e., three) helical supports on the right and the N (i.e., three) helical supports on the left each have the same pitch compared to each other, said pitch being defined as the distance, measured along the longitudinal direction, of a helical winding of a helical support in question, and wherein the pre-folding strip has at least one continuous sub-strip having a length equal to said pitch and in which the pre-folding skeleton has several N multiplied by 2 (i.e., six) of said ring-shaped supports (123, 124, 125, 126, 127, 128) in said continuous sub-strip. This is clear from Fig. 9, which is a small longitudinal section of the pre-folding skeleton 107, wherein said small longitudinal section corresponds to such continuous sub-strip having a length equal to said pitch. In Fig.9, it is seen that the pre-foldable skeleton 107 has twenty-one connection nodes (140-160) in the said continuous sub-strip.

[0067] From the example embodiments of a catheter according to the invention explained above for N = 2 and N = 3, respectively, it will be sufficiently clear to the reader of the present description how examples of embodiments of a catheter according to the invention for N to 4 can be designed analogously.

[0068] The invention can be practiced with structures Petition 870250087495, dated 09 / 26 / 2025, pp. 85 / 103 32 / 34 very varied, very varied materials, very varied shapes and very varied dimensions of the pre-folding skeleton, inner lining and outer laminate of the catheter and with very varied additional features and very varied accessories of the catheter, such as the very varied structures, very varied materials, very varied shapes and very varied dimensions of the skeletons, inner linings and outer laminates and such very varied additional features and very varied accessories that are used in known catheters to administer medical therapy to a remote location in a body, provided that the catheter is within the scope of the appended claims.

[0069] Regardless of the overall shear ratio of the skeleton, the following general observation is made. If, throughout the longitudinally continuous section of a catheter wall, the catheter wall has a completely uninterrupted metallic tubular reinforcement wall, for example, in the form of a completely uninterrupted metallic hypotube, then the said longitudinal section has an overall shear ratio of 0%.

[0070] It is further noted that according to the invention, typical dimensions of some parts and aspects of the invention and the applicable practical ranges of such dimensions could be as follows in the case of the catheter being a Petition 870250087495, dated 09 / 26 / 2025, pp. 86 / 103 33 / 34 microcatheter for cardiovascular or neurovascular interventional application. The effective catheter length (as measured from the distal end of a catheter connector) may range from 130 cm to 160 cm and typically may be 135 cm. The maximum outer diameter of the pre-fold wall section of the tubular catheter may range from 0.60 mm to 1.20 mm and typically may be 0.75 mm, although noting that the word "maximum" in the term "maximum outer diameter" refers to the maximum value considered along the entire length of the pre-fold wall section. The minimum inner diameter of the pre-fold wall section of the tubular catheter may range from 0.36 mm to 0.55 mm and typically may be 0.45 mm, although noting that the word "minimum" in the term "minimum inner diameter" refers to the minimum value considered along the entire length of the pre-fold wall section.For example, the following typical combinations of maximum outside diameter and minimum inside diameter of the pre-folded wall section are possible: a maximum outside diameter of 0.75 mm in combination with a minimum inside diameter of 0.45 mm, a maximum outside diameter of 1.20 mm in combination with a minimum inside diameter of 0.55 mm, or a maximum outside diameter of 0.60 mm in combination with a minimum inside diameter of 0.36 mm. Petition 870250087495, dated 09 / 26 / 2025, pp. 87 / 103 34 / 34

[0071] However, the present invention can be incorporated into various other catheters for administering medical therapy to a remote location in a body, which may be non-vascular catheters and / or non-microcatheters, such as, for example, catheters for administering medical therapy to renal vessels, fallopian tubes and other such vessels and locations. In such cases, typical dimensions of some parts and aspects of the invention and applicable practical ranges of such dimensions may differ from those mentioned above for microcatheters for interventional cardiovascular or neurovascular applications. Petition 870250087495, dated 09 / 26 / 2025, pp. 88 / 103

Claims

1 / 6 CLAIMS 1. Catheter (1) for administering medical therapy to a remote location in a body, characterized in that: the catheter has a proximal end (4), a distal end (5) and a longitudinal direction (10) extending from the proximal end to the distal end; the catheter comprises a tubular catheter wall (2), which is surrounding a catheter lumen structure (3) and extending from the distal end (5), in a proximal manner along the longitudinal direction, to at least 100 mm proximal from the distal end; the catheter wall (2) comprises a pre-foldable wall section (14), which is manually pre-foldable along the entire pre-folding range (15) along the longitudinal direction,wherein the said pre-folding strip extends at least between 5 mm proximal from the distal end and 10 mm proximal from the distal end (5); the pre-folding wall section (14) comprises: - a pre-folding skeleton (7), which extends at least along the entire said pre-folding strip and which provides reinforcement of the catheter wall (2) in the longitudinal direction (10), as well as in a direction Petition 870250087495, dated 09 / 26 / 2025, page. 89 / 103 2 / 6 circumferential (11) around the longitudinal direction (10), wherein the pre-foldable skeleton (7) is an interrupted tubular reinforcement wall obtained by microfabrication of a cutting pattern (7A) in a fully uninterrupted tubular reinforcement wall made of a reinforcing material, - an inner lining (8), which is coaxially surrounded by said pre-foldable skeleton (7) in relation to a centerline (12) of the catheter wall (2), and - an outer laminate (9),which is coaxially encircling said pre-folding skeleton (7) in relation to the centerline (12) of the catheter wall; the pre-folding skeleton comprises: - a number N of right-hand helical supports (21R, 22R), extending along N right-hand helical directions, respectively, where N > 2, - N left-hand helical supports (21L, 22L), extending along N left-hand helical directions, respectively and - a plurality of ring-shaped supports (23-26), extending along circular directions, respectively; each of said right-hand helical supports (21R, 22R), left-hand helical supports (21L, 22L) and Petition 870250087495, dated 26 / 09 / 2025, p. 90 / 103 3 / 6 ring-shaped supports (23-26) are arranged coaxially with respect to the centerline (12), wherein the N helical supports on the right are angularly spaced equally with respect to each other in 360 divided by N degrees around the centerline (12),wherein the N helical supports on the left are angularly spaced equally from each other by 360 divided by N degrees around the centerline, wherein the ring-shaped supports extend mutually parallel to each other and mutually spaced in the longitudinal direction, wherein the pre-folding skeleton (7) comprises, for each of said ring-shaped supports, N connecting nodes (90-99) in N angularly spaced equally positions, respectively, of each ring-shaped support in question and wherein, at each connecting node (90-99), each ring-shaped support (23-26) in question is connected to one of the N helical supports on the right (21R, 22R) as well as to one of the N helical supports on the left (21L, 22L); a general cut ratio of the skeleton of a longitudinal section of the catheter wall (2) in a longitudinal strip along the longitudinal direction (10) is defined as the percentage of: - the volume of all parts,within the said longitudinal strip, of the said reinforcement material being cut from the said tubular reinforcement wall Petition 870250087495, dated 09 / 26 / 2025, page 91 / 103 4 / 6 totally uninterrupted according to the microfabricated cutting pattern (7A), in relation to — the volume of all parts, within the said longitudinal strip, of the said reinforcement material of the said totally uninterrupted tubular reinforcement wall; and the cutting ratio of the overall skeleton of the pre-folding wall section (14) in the said pre-folding strip (15) is between 45% and 85%., 2. Catheter (1), according to claim 1, characterized in that said pre-folding band (15) extends at least between 0.5 mm proximal from the distal end (5) and 15 mm proximal from the distal end (5).

3. Catheter (1), according to claim 2, characterized in that said pre-folding band extends at least between the distal end (5) and 20 mm proximal from the distal end (5).

4. Catheter (1), according to any of the preceding claims, characterized in that the overall shear ratio of the skeleton of the pre-foldable wall section (14) in said pre-folding range (15) is between 60% and 80%.

5. Catheter (1), according to claim 4, Petition 870250087495, dated 09 / 26 / 2025, page 92 / 103 5 / 6 characterized in that the overall shear ratio of the skeleton of the pre-folding wall section (14) in said pre-folding range (15) is between 70% and 78%.

6. Catheter (1), according to any of the preceding claims, characterized in that the radio-opaque element is embedded in the catheter wall (2) in that the radio-opaque element is located in a cut pattern space (7A), said space being delimited by the pre-foldable skeleton (7), the inner layer (8) and the outer laminate (9).

7. Catheter (1), according to any of the preceding claims, characterized in that the catheter is a quick-change catheter having the tubular catheter wall (2) as a distal quick-change tubular segment that is spaced from the proximal end (4) of the quick-change catheter.

8. Catheter (1), according to any one of claims 1 to 6, characterized in that the catheter is an over-the-wire (OTW) catheter, wherein the tubular catheter wall (2) and the catheter lumen structure (3) extend along the entire longitudinal direction (10) from the proximal end (4) to the distal end (5).

9. Catheter (1), according to any of the preceding claims, characterized in that Petition 870250087495, dated 09 / 26 / 2025, p. 93 / 103 6 / 6 the N right-hand helical supports (21R, 22R) and the N left-hand helical supports (21L, 22L) each have the same pitch compared to each other, said pitch being defined as the distance, measured along the longitudinal direction (10), of a helical winding of a helical support in question, and wherein the pre-folding strip (15) has at least one continuous sub-strip having a length equal to said pitch, and wherein the pre-folding skeleton (7) has several N multiplied by 2 of said ring-shaped supports in said continuous sub-strip. Petition 870250087495, dated 09 / 26 / 2025, pp. 94-103

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