Medical instrument for mapping and / or ablation

Abstract

A medical device includes a first shaft and an expandable tip assembly configured for mapping and / or ablation. The expandable tip assembly includes a basket with a plurality of struts. The struts of the basket are connected to a proximal coupler and a distal coupler, respectively. The expandable tip assembly can also include an expandable balloon within the basket and connected to the proximal coupler and the distal coupler. The shaft between the proximal coupler and the distal coupler can be provided with a pattern on a wall of a first shaft portion within the expandable tip assembly. The expandable tip assembly can also include a sensor configured to measure a characteristic indicative of an expansion state of the expandable balloon.

Description

Technical Field

[0001] A medical device (such as a catheter) can be used to diagnose and treat cardiac arrhythmias. The catheter may include a distal component for mapping and / or treating target sites within a body cavity. To reach the target site within the patient's body, the catheter may be advanced through a body cavity containing one or more curved sections. Summary of the Invention

[0002] This disclosure relates to a distal connector configured to be fixed to a conduit shaft, the connector comprising: a first wall having a central lumen; a plurality of protrusions extending outwardly from the first wall; a plurality of second walls, each second wall extending between two of the plurality of protrusions; and a plurality of grooves, wherein each groove is defined by the first wall, one of the second walls and two of the plurality of protrusions, and the groove is configured to receive a single rib of a basket.

[0003] Each of the plurality of protrusions may include a curved front end portion having a radius of curvature greater than that of a curved rear end portion.

[0004] The curved front end portion can bend outwards and away from the far side of the connector.

[0005] Each of the plurality of protrusions may further include a side surface that forms a first angle (A5) with the bisector of the groove.

[0006] Each second wall may define a through hole communicating with the groove, the through hole being configured to secure the reinforcing bar in the groove.

[0007] Each second wall may be recessed in the longitudinal and / or radial directions.

[0008] The first end of the second wall can be aligned with the first end of the first wall.

[0009] The distal side of the distal connector can form an opening that communicates with the central cavity.

[0010] Each slot can be set opposite to another slot.

[0011] The distal side may be symmetrical.

[0012] Adjacent slots can be arranged along the second angle (A4).

[0013] The distal connector may also include at least one rib extending from the first wall and adjacent to the plurality of protrusions and the plurality of second walls.

[0014] The sides of each rib can be oriented to form a third angle (A3).

[0015] The first wall may define at least one through hole for securing the connector to the shaft.

[0016] The through hole may include a first through hole and a second through hole, and at least one rib may be located between the first through hole and the second through hole.

[0017] The through hole can be a hole or a slit.

[0018] A through hole may be provided near the second end of the connector.

[0019] This disclosure also relates to a conduit shaft having a helical pattern engraved on its shaft wall, wherein the helical pattern includes a helical trunk and interlocking elements at an angle relative to the longitudinal axis of the shaft, the helical trunk comprising alternating first and second portions, wherein paired interlocking elements extend from opposite sides of each first portion of the helical trunk, each interlocking element comprising a post and two arms at an angle to each other, the two arms having curved edges; and the side of each second portion is complementary in shape to the interlocking element extending from an adjacent turn of the helical trunk.

[0020] This disclosure also relates to a conduit shaft having a spiral pattern engraved on its shaft wall, wherein the spiral pattern includes a spiral trunk and interlocking first and second elements arranged at an angle relative to the longitudinal axis of the shaft, and the first and second elements have different shapes.

[0021] Each second element may define a slot configured to accommodate one of the first elements.

[0022] Each first element may include a rod and a rounded end with a diameter greater than the width of the rod, and the rod extends from one side of the helical trunk.

[0023] Each second element may include a pair of components.

[0024] The paired components may define a closed end of the groove and an opening of the groove, wherein the size of the opening may be designed to retain the rounded end of one of the first elements within the groove.

[0025] Each of the paired components may include a curved portion whose radius of curvature is complementary to the radius of curvature of the rounded end of one of the first elements located within the slot.

[0026] The second element may be symmetrically distributed about the longitudinal line that bisects the groove.

[0027] Each component in the pair can be a mirror image of the other.

[0028] The shaft can be made of polymer materials.

[0029] The shaft can be made of metal.

[0030] The present invention also relates to a medical device comprising: a distal connector as described herein, wherein the connector is connected to a first shaft; and a basket connected to the first shaft via the distal connector, the basket comprising a plurality of ribs, wherein each rib is fixed to one of a plurality of slots in the distal connector.

[0031] The present invention also relates to a medical device comprising: a catheter shaft as described herein, the shaft including a first shaft; a distal connector as described herein, wherein the distal connector is connected to the first shaft; and a basket connected to the first shaft via the distal connector, the basket including a plurality of ribs, wherein each rib is fixed to one of the slots of the connector.

[0032] The present invention also relates to a medical device wherein the first axis is a catheter axis as described herein, wherein a spiral pattern may be located within a portion of the length of the wall of the first axis positioned within a basket.

[0033] The distal connector can be attached to the first shaft at the distal end of the spiral pattern.

[0034] The distal side of the distal connector can be the distal side of the medical device.

[0035] The basket may also include one or more tethers, each of which may extend between adjacent ribs of the multiple ribs.

[0036] The one or more tethers may be located in the far end region of the basket.

[0037] Each tether can be arranged in a circumferential direction.

[0038] The first end of each rope can be positioned in front of the second end.

[0039] The rope can be made of metal.

[0040] The basket may also include one or more electrodes for ablation and / or mapping.

[0041] Each rib may include at least one of the electrodes.

[0042] The medical device may further include an expandable balloon located within the basket, the expandable balloon comprising: an outer surface; a distal end connected to a distal connector; and a proximal end connected to a proximal connector; wherein the expandable balloon is selectively expandable such that when the expandable balloon is in an expanded state, the outer surface of the expandable balloon contacts the inner surface of the plurality of ribs.

[0043] A first sensor may be located between the inner surface of the first rib of the plurality of ribs and the outer surface of the balloon, wherein the first sensor may be configured to output a signal indicating the expansion state of the expandable balloon.

[0044] The first sensor may be the first electrode, and the electrical response measured between the first electrode and the second electrode may be a signal indicating the expansion state.

[0045] The first electrode may be the exposed end of the first wire fixed to the insulating portion of the first rib.

[0046] When the expandable balloon is in the expanded state, a high-impedance path can be set between the first electrode and the second electrode; when the expandable balloon is in the unexpanded state, a low-impedance path can be set between the first electrode and the second electrode.

[0047] The second electrode may be an electrode located on a second rib among a plurality of ribs, the second rib comprising: a body containing a conductive material; and an insulating material covering a portion of the body, wherein the electrode includes an exposed portion of the body.

[0048] The near end of the basket can be connected to the far end of the second axis.

[0049] The second electrode can be a ring electrode, located on the second axis near the basket.

[0050] The second electrode may be the exposed end of the second wire located on the inner surface of the second rib among the multiple ribs, wherein the exposed end of the second wire may be connected to the insulating portion of the body of the second rib among the multiple ribs.

[0051] When the expandable balloon is in the expanded state, a low-impedance path can be set between the first electrode and the second electrode; when the expandable balloon is in the unexpanded state, a high-impedance path can be set between the first electrode and the second electrode.

[0052] The second electrode can be fixed to the outer surface of the expandable balloon and aligned with the first electrode.

[0053] The present invention also relates to a medical device, wherein the sensor is a pressure sensor connected to the inner surface insulating portion of the first rib among a plurality of ribs, wherein when the inflatable balloon inflates, a gradually increasing pressure is applied between the pressure sensor and the outer surface of the balloon; and when the balloon deflates, a gradually decreasing pressure is applied between the pressure sensor and the outer surface of the balloon.

[0054] The present invention also relates to a method for detecting the expansion state of an expandable balloon in a medical device having a basket comprising multiple ribs, the balloon being located within the multiple ribs, the method comprising: measuring features indicating the expansion state of the expandable balloon using a sensor located between the inner surface of a first rib of the multiple ribs and the outer surface of the expandable balloon; determining the expansion state of the expandable balloon based on the measured features; and displaying the expansion state of the expandable balloon on a display.

[0055] The sensor may be a first electrode, wherein the measurement feature associated with the first electrode may be the impedance between the first electrode and the second electrode.

[0056] Determining the expansion state of an expandable balloon can include comparing a measured impedance with a first threshold, wherein when the impedance is greater than the first threshold, the expandable balloon is determined to be in an inflated state; when the impedance is less than the first threshold, the expandable balloon is determined to be in an uninflated state.

[0057] Determining the expansion state of an expandable balloon may also include comparing the measured impedance with a second threshold, wherein when the impedance is greater than the second threshold, the expandable balloon is determined to be in an over-inflated state.

[0058] The second electrode may be located on the outer surface of the balloon and aligned with the first electrode. Determining the expansion state of the expandable balloon may include comparing the measured impedance with a first threshold. When the impedance is less than the first threshold, the expandable balloon may be determined to be in an inflated state. When the impedance is greater than the first threshold, the expandable balloon may be determined to be in an uninflated state.

[0059] The sensor may be a pressure sensor, wherein the measured characteristic may be the pressure between the pressure sensor and the expandable balloon, wherein determining the expansion state of the expandable balloon may include comparing the measured pressure with a first threshold; wherein when the pressure is greater than the first threshold, the balloon may be determined to be in an inflated state; when the pressure is less than the first threshold, the balloon may be determined to be in an uninflated state.

[0060] This disclosure also relates to a system for detecting balloon inflation, the system comprising: a medical device including: a basket assembly fixed to a distal end of an axis, the basket assembly including a plurality of ribs; an expandable balloon having an outer surface, the balloon being located within the basket assembly and the expandable balloon being selectively expandable such that the outer surface of the expandable balloon can contact the inner surface of at least one of the plurality of ribs; and a first sensor located between the inner surface of the first rib of the plurality of ribs and the outer surface of the balloon, wherein the first sensor is configured to monitor features indicating an inflation state of the expandable balloon; an electronic control unit configured to receive feedback from the first sensor indicating the measured features, wherein the electronic control unit determines an inflation state based on the feedback and generates an output; and a display receiving the output from the electronic control unit and displaying the inflation state of the balloon.

[0061] The first sensor can be the first electrode.

[0062] The first electrode may be the exposed end of the first wire fixed to the insulating portion of the first reinforcing bar.

[0063] The measured characteristic can be the impedance between the first electrode and the second electrode. The electronic control unit can compare the measured impedance with a first threshold. When the impedance is greater than the first threshold, it can be determined that the balloon is inflated. When the impedance is less than the first threshold, it can be determined that the balloon is not inflated.

[0064] The second electrode may be an electrode located on a second rib among a plurality of ribs, the second rib comprising: a first end connected to the distal end of the outer shaft element; a second end connected to the distal end of the shaft element located within the balloon; a body comprising a conductive material; and an insulating material covering a portion of the body, wherein the second electrode includes an exposed portion of the body.

[0065] The second electrode can be a ring electrode located at the distal end of the axis near the basket assembly.

[0066] The second electrode may be the exposed end of a second wire located on the inner surface of a second rib among a plurality of ribs, wherein the exposed end of the second wire may be connected to an insulating portion of the body of the second rib.

[0067] The electronic control unit further compares the measured impedance with a second threshold. When the impedance is greater than the second threshold, it can be determined that the balloon is in an overinflated state.

[0068] The measured feature may be the impedance measured between the first electrode and the second electrode, wherein the second electrode may be fixed on the outer surface of the balloon and aligned with the first electrode, and wherein the electronic control unit may compare the measured impedance with a first threshold, wherein when the impedance is less than the first threshold, it can be determined that the balloon is inflated, and wherein when the impedance is greater than the first threshold, it can be determined that the balloon is not inflated.

[0069] The first sensor can be a pressure sensor connected to the insulating part of the inner surface of the first rib. The feature indicating the balloon's expansion state can be the measured pressure between the pressure sensor and the outer surface of the balloon. The electronic control unit can compare the measured pressure with a first threshold. When the pressure is greater than the first threshold, it can be determined that the balloon is inflated; when the pressure is less than the first threshold, it can be determined that the balloon is not inflated.

[0070] The present invention also relates to a medical device comprising: a basket; a distal connector connected to the distal end of the basket; a proximal connector connected to the proximal end of the basket and a catheter shaft, the proximal connector defining a lumen; and a support shaft comprising: a distal end fixed to the distal connector; and a proximal end freely floating within the lumen of the proximal connector.

[0071] The present invention also relates to a medical device comprising: a distal connector including: a basket fixation region; a balloon region adjacent to the basket fixation region; and at least one magnetic sensor disposed along a groove on the outer surface of the distal connector; and a proximal connector including: a balloon fixation region; a basket fixation region adjacent to the balloon fixation region; and at least one magnetic sensor fixed to the outer surface of the proximal connector; a basket connected to the basket fixation regions of the distal and proximal connectors; and a balloon located within the basket, the balloon being connected to the balloon fixation regions of the distal and proximal connectors.

[0072] The present invention also relates to a medical device comprising: a basket including a plurality of ribs; a distal connector including a distal side; and a rib fixing assembly for fixing the distal ends of the plurality of ribs; wherein the plurality of ribs located in the rib fixing assembly are tangent to the distal side.

[0073] The present invention also relates to a basket comprising a plurality of reinforcing ribs, wherein the distal end of each reinforcing rib is a barb, the barb comprising at least one protrusion.

[0074] The present invention also relates to a connector comprising: a first fixing component including a groove having a first open end and a second open end; an annular portion adjacent to the second open end, the annular portion being configured to receive a barbed end of a basket reinforcement; and an annular wall adjacent to the annular portion.

[0075] The present invention also relates to a connector comprising: a balloon fixation region including: a plurality of ribs; and at least one magnetic sensor fixed in a groove on the outer surface of the balloon fixation region, the groove extending through at least a portion of the plurality of ribs; and a basket fixation region longitudinally adjacent to the balloon fixation region.

[0076] The present invention also relates to a shaft for a medical device, comprising: a polymer tube constituting an inner layer of the shaft; a braided layer located on the polymer tube and having the same length therefrom; a coil located at a first end of the braided layer; a first polymer having a first hardness on the coil; a second polymer having a second hardness on the middle portion of the braided layer; and a third polymer having a third hardness on the second end of the braided layer.

[0077] The present invention also relates to a method for manufacturing a conduit shaft, comprising: forming a braided layer around a polymer tube; winding a metal wire around a first end of the braided layer; reflowing a first polymer having a first hardness of a first hardness tester onto the wound metal wire; reflowing a second polymer having a second hardness tester hardness to a middle portion of the braided layer; and reflowing a third polymer having a third hardness tester hardness to a proximal portion of the braided layer.

[0078] The first polymer, the second polymer, and the third polymer can form the outer layer of the shaft.

[0079] The second hardness value can be less than the first hardness value, and the first hardness value can be less than the third hardness value.

[0080] The polymer tube can be a polytetrafluoroethylene (PTFE) tube, the braided layer includes multiple metal wires, the coil can be a metal wire, the first polymer can be polyether intercalated amide (PEBA), the second polymer can be polyether intercalated amide (PEBA), and the third polymer can also be polyether intercalated amide (PEBA).

[0081] The multiple metal wires may include stainless steel, and the coil may also include stainless steel.

[0082] The first polymer, the second polymer, and the third polymer may be located within the gap defined by the braided layers and / or coils.

[0083] The first part has a first length, the second part has a second length, and the third part has a third length, wherein the second length may be greater than the first length and the third length; and / or the first length may be the minimum length.

[0084] The shaft may form part of a medical device, which further includes: an outer shaft coaxial with the shaft; a basket; a distal connector for securing the distal end of the basket to the distal end of the shaft; and a proximal connector for securing the proximal end of the basket to the outer shaft; wherein the basket is supported by a first portion of the shaft.

[0085] The basket can be supported by only the first part of the shaft located between the distal and proximal connectors.

[0086] The present invention also relates to a distal connector for connecting a basket to a guide shaft, the distal connector including a first wall, a plurality of protrusions extending outward from the first wall, and a plurality of grooves, wherein each groove is defined by the first wall and the plurality of protrusions, and wherein the groove is configured to receive a single rib of the basket.

[0087] The distal connector disclosed in this article may be capless.

[0088] The first wall may define a central cavity.

[0089] Each of the plurality of protrusions may include a curved leading edge portion having a radius of curvature greater than that of its trailing edge portion.

[0090] Each groove can be located opposite another groove.

[0091] The first wall may define at least one through hole for securing the distal connector to the shaft.

[0092] Each protrusion can define a fixing groove, which is configured to receive the rib fixing part of the basket rib.

[0093] Each groove can be located opposite another groove.

[0094] The first wall may define at least one through hole for securing the distal connector to the shaft.

[0095] Each protrusion may define a fixing groove, which is configured to receive the rib fixing part of the basket rib.

[0096] The distal connector can be attached to a shaft comprising: a polymer tube constituting an inner layer of the shaft; a braided layer located on the polymer tube and of the same length therefrom; a coil located at a first end of the braided layer; and at least one polymer constituting an outer layer of the shaft.

[0097] The at least one polymer layer may include: a first polymer covering the coil, having a first hardness; a second polymer covering the middle portion of the braided layer, having a second hardness; and a third polymer covering the second end of the braided layer, having a third hardness.

[0098] The at least one polymer may be a polymer having a hardness of a single hardness tester.

[0099] The at least one magnetic sensor may be located in a groove on the outer surface of the distal connector.

[0100] The plurality of protrusions and the plurality of grooves may be located within the basket fixing area of ​​the distal connector.

[0101] The distal connector may also include a balloon fixing area near the basket fixing area.

[0102] The balloon fixation area may include an overmolded portion for securing the balloon to the distal connector.

[0103] This disclosure also relates to a medical device comprising a distal connector, a proximal connector, a basket, and a balloon. The distal connector may include a basket fixation region; a balloon fixation region located near the basket fixation region; and at least one magnetic sensor disposed along a groove on the outer surface of the distal connector. The proximal connector may include a balloon fixation region; a basket fixation region located near the balloon fixation region; and at least one magnetic sensor fixed to the outer surface of the proximal connector. The basket may be coupled to the distal connector and the basket fixation region of the proximal connector. The balloon may be located within the basket and coupled to the balloon fixation regions of the distal connector and the proximal connector.

[0104] The basket may include one or more electrodes for ablation and / or mapping.

[0105] The basket may include multiple ribs, each rib including at least one covered portion and at least one uncovered portion, wherein the at least one uncovered portion is an electrode.

[0106] The balloon fixation area of ​​the distal connector may include an overmolded portion made of a material with a hardness similar to that of the balloon, for bonding the balloon to the distal connector.

[0107] A first shaft may be connected to a distal connector. This shaft may include a polymer tube forming its inner layer; a braided layer on the polymer tube and of the same length therefrom; and a coil located at a first end of the braided layer.

[0108] The present invention also relates to a shaft for a medical device. The shaft may include a polymer tube constituting its inner layer; a braided layer located on the polymer tube and of the same length therefrom; a coil located at a first end of the braided layer; and at least one polymer constituting its outer layer.

[0109] The polymer tube may include polytetrafluoroethylene (PTFE).

[0110] The at least one polymer may include polyether intercalated amide (PEBA).

[0111] The at least one polymer may include: a first polymer having a first hardness on the coil; a second polymer having a second hardness on the middle portion of the braid; and a third polymer having a third hardness on the second end of the braid.

[0112] The length of the second end may be greater than the length of the first end, but less than the length of the middle portion.

[0113] The shaft can be connected to a distal connector that includes the basket fixing area. Attached Figure Description

[0114] Figure 1A schematic diagram of a system including a catheter with an expandable end assembly is shown.

[0115] Figure 2 A schematic diagram of a conduit with a mesh basket is shown, which can be connected to... Figure 1 The systems shown are used together.

[0116] Figure 3A A cross-sectional view of a catheter with a basket-balloon assembly is shown, which can be used with... Figure 1 The systems shown are used together.

[0117] Figure 3B It shows that it can be used Figure 3A The net basket-balloon assembly and / or shown Figure 1 Isometric view of the basket of the system shown.

[0118] Figure 3C It shows that it can be used Figure 1 Isometric view of the basket-balloon assembly of the system shown.

[0119] Figure 4A An isometric view of a connector constructed to connect the distal end of a basket to a guide shaft is shown.

[0120] Figure 4B An isometric view of a connector constructed to connect the distal end of a basket to a guide shaft is shown.

[0121] Figure 4C It shows Figure 4B Side view of the connector shown.

[0122] Figure 4D An isometric view of a connector constructed to connect the distal end of a basket to a guide shaft is shown.

[0123] Figure 4E An isometric view of a connector constructed to connect the distal end of a basket to a guide shaft is shown.

[0124] Figure 4F An isometric view of the barb is shown.

[0125] Figure 4G An isometric view of the barb is shown.

[0126] Figure 5 It shows Figure 4A Side view of the connector shown.

[0127] Figure 6 It shows Figure 5 The connector shown is a cross-sectional view taken along line AA.

[0128] Figure 7It shows Figure 5 An enlarged view of region B of the connector shown.

[0129] Figure 8 It shows Figure 5 The view of the far end of the connector is shown.

[0130] Figure 9 It shows Figure 5 A view of the near end of the connector shown.

[0131] Figure 10 A first isometric view of the proximal connector, used to connect the proximal end of the basket to the conduit shaft, is shown.

[0132] Figure 11 It shows Figure 10 The second isometric view of the proximal connector is shown.

[0133] Figure 12 It shows Figure 10 A cross-sectional view of the proximal connector shown.

[0134] Figure 13 It shows Figure 10 End view of the proximal connector shown.

[0135] Figure 14A and 14B It shows the relationship with Figure 10 An isometric view of the mesh basket reinforcement bars connected by the proximal connector shown.

[0136] Figure 15 The construction for connecting is shown. Figure 10 Isometric view of the retaining ring of the proximal connector shown.

[0137] Figure 16 It shows Figure 10 An isometric view of the basket attached to the catheter via a proximal connector.

[0138] Figure 17 An isometric view is shown of a proximal connector constructed to connect the proximal end of a basket to a conduit shaft.

[0139] Figure 18 It shows Figure 17 A cross-sectional view of the proximal connector shown.

[0140] Figure 19 It shows Figure 17 Isometric view of the retaining ring and connector assembly of the proximal connector shown.

[0141] Figure 20A It shows Figure 17 An isometric view of the retaining ring of the proximal connector shown, and Figure 20B It shows Figure 17 End view of the retaining ring of the proximal connector shown.

[0142] Figure 21 An isometric view of a conduit shaft with a non-spiral cut pattern is shown.

[0143] Figure 22 A side view of a conduit shaft with a spiral cut pattern is shown.

[0144] Figure 23 It shows Figure 22 The image shows an axonal view of a conduit with a bend.

[0145] Figure 24 A plan view of a portion of the spiral-cut pattern, which is non-spiral oriented, is shown for illustration. Figure 22 Details of the spiral cut pattern shown.

[0146] Figure 25 An isometric view of a portion of the spiral-cut pattern, which is non-spiral oriented, is shown for illustration. Figure 22 Details of the spiral cut pattern shown.

[0147] Figure 26 A plan view of a portion of the spiral-cut pattern, which is non-spiral oriented, is shown for illustration. Figure 22 Details of the spiral cut pattern shown.

[0148] Figure 27 A plan view of a portion of the spiral-cut pattern, which is non-spiral oriented, is shown for illustration. Figure 22 Details of the spiral cut pattern shown.

[0149] Figure 28 A side view of a conduit shaft with a spiral cut pattern is shown.

[0150] Figure 29 It shows Figure 28 The image shows a side view with a curved conduit shaft.

[0151] Figure 30 An isometric view of a portion of the spiral-cut pattern is shown, which is non-spiral oriented, to illustrate... Figure 28 Details of the spiral cut pattern shown.

[0152] Figure 31 It shows Figure 28 A plan view of the component with the spiral cut pattern shown.

[0153] Figure 32 A plan view of a portion of the spiral-cut pattern is shown, which is non-spiral oriented, to illustrate... Figure 28 Details of the spiral cut pattern shown.

[0154] Figure 33 A plan view of a portion of the spiral-cut pattern is shown, which is non-spiral oriented, to illustrate... Figure 28 Details of the spiral cut pattern shown.

[0155] Figure 34 A side view of the balloon-basket assembly is shown.

[0156] Figure 35 It shows Figure 34 A view of the distal end of the balloon-basket assembly shown.

[0157] Figure 36 A side view of the balloon-basket assembly is shown.

[0158] Figure 37 It shows that it can be used Figure 1 An isometric view of one embodiment of the basket-balloon assembly of the catheter in the illustrated system, with the balloon in an inflated state.

[0159] Figure 38 It shows that it can be used Figure 1 An isometric view of another embodiment of the basket of the catheter-balloon terminal assembly of the system shown.

[0160] Figure 39A and Figure 39B A side view of a portion of the net basket-ball assembly is shown.

[0161] Figure 40A and Figure 40B A side view of a portion of the net basket-ball assembly.

[0162] Figure 41A and Figure 41B A side view of a portion of the net basket-ball assembly.

[0163] Figure 42 A flowchart illustrating a method for determining the balloon dilation status is shown.

[0164] Figure 43 An isometric view of the duct axis is shown.

[0165] Figure 44 A cross-sectional view of a portion of the duct shaft is shown.

[0166] Figure 45 A cross-sectional view of a portion of the duct shaft is shown.

[0167] Figure 46 An isometric view of a medical device including a basket-balloon assembly is shown.

[0168] Figure 47 A flowchart illustrating the manufacturing process of the conduit shaft is shown.

[0169] Figure 48 An isometric view of the features at the distal end of the basket fixed to the connector is shown.

[0170] Figure 49 An isometric view shows the features of the distal end of the basket-balloon assembly fixed to the connector.

[0171] Figure 50 A cross-sectional view of the features of a connector with an offset sensor is shown.

[0172] Figure 51 An isometric view of the distal connector is shown.

[0173] Figure 52 An isometric view of the distal connector is shown.

[0174] Figure 53 An isometric view showing the features of the proximal connector is provided.

[0175] Figure 54 An isometric view showing the features of the proximal connector is provided.

[0176] Figure 55 An isometric view showing the features of the proximal connector is provided.

[0177] Figure 56 An isometric view showing the features of the proximal connector is provided.

[0178] Figure 57 A cross-sectional view showing the features of the proximal connector is shown.

[0179] Figure 58 An isometric view showing the features of the proximal connector is provided.

[0180] Figure 59 and Figure 60 An isometric view showing the features of the proximal connector is provided.

[0181] Figure 61 An isometric view showing the features of the proximal connector is provided.

[0182] Figure 62 A cross-sectional view showing the features of the proximal connector is shown. Detailed Implementation

[0183] Figure 1 This is an isometric view of a system 100 used to perform medical procedures on a patient 138. The system 100 may include medical devices, such as catheter 102; a mapping and / or ablation system 118 compatible with catheter 102; a computer system 122 including a display 132 and input / output devices 134; and a fluid source 130.

[0184] The conduit 102 of system 100 includes a handle 104; at least one shaft (e.g., shaft 106) extending distally from the handle 104; a cable connector 114; and an expandable end assembly located at the distal end 110 of the conduit 102. The expandable end assembly may be a basket (e.g., Figure 2 (As shown). The expandable end component can be a balloon-basket assembly, which includes a balloon located within the basket (e.g., as shown). Figure 3A and 3C (As shown). As will be discussed in more detail below, the expandable end-effector can be connected to a medical device via at least one connector.

[0185] The catheter 102 may be a cardiac mapping device. The catheter 102 may be a treatment delivery device configured to deliver ablation therapy, wherein at least a portion (e.g., portion 136) of the catheter 102 is located within the patient 138. Exemplary ablation therapies include radiofrequency (RF) ablation and / or electroporation ablation.

[0186] Mapping and / or ablation system 118 can be connected to catheter 102 via cable connector 114 and cable 116 for treatment. Mapping and / or ablation system 118 may include a generator capable of supplying energy to one or more electrodes located on an expandable distal assembly via cable 116 and one or more wires included within shaft 106. These electrodes can be used for cardiac mapping and / or ablation. Mapping and / or ablation system 118 can be configured to supply radiofrequency (RF) energy to catheter 102 constructed for performing radiofrequency ablation. Mapping and / or ablation system 118 can also be configured to provide short-duration direct current (DC) pulses to perform electroporation ablation (i.e., pulsed field ablation). Mapping and / or ablation system 118 can be connected to computer system 122. For example, computer system 122 can provide instructions to mapping and / or ablation system 118 (e.g., defining electrical pulses, selecting electrodes to receive pulses, etc.).

[0187] System 100 may include a fluid source 130 connected to catheter 102 via cable 128 and cable connector 114 to deliver fluid to catheter 102. The fluid source may provide an inflation medium to the interior of the balloon to inflate the balloon. The amount of fluid delivered may be selectively adjusted according to the balloon's inflation state and the desired inflation state.

[0188] Computer system 122 can be connected to conduit 102 via cable 120 and cable connector 114. For example... Figure 1As shown, computer system 122 may include an electronic control unit (ECU) 124 and a computer-readable medium or storage unit 126. ECU 124 may include a processor configured to execute instructions stored in computer-readable medium 126 to perform one or more of the functions described herein. For example, computer system 122 may be configured to receive one or more signals generated by sensors located at the distal end 110 of catheter 102 (e.g., sensors located on expandable end assemblies, shafts, etc.). The received feedback may be used to determine the position of catheter 102 within patient 138 (e.g., positioning / navigation), assess treatment status (e.g., lesion assessment, tissue contact, etc.), map cardiac electrophysiological characteristics (e.g., cardiac mapping), and / or determine the operational status of the catheter (e.g., balloon dilation status, electrode status, etc.). Computer system 122 may generate one or more outputs directed to these functions and display them on display 132.

[0189] The expandable tip assembly located at the distal end 110 of the catheter can be inserted into a target body area, such as within a patient's blood vessel, during a medical procedure. Movement of the catheter 102 can be controlled via one or more controls located on the handle 104. Typically, the expandable tip assembly can switch between a constricted and an expanded state. In the constricted state, due to its smaller overall diameter, the expandable tip assembly can move freely within the patient's vascular system. Once the desired position is reached, the expandable tip assembly can be expanded.

[0190] Figure 2 This is an isometric view of a medical device (e.g., catheter 202) that may be used in a medical procedure for patient 138. Figure 2 As shown, the medical device, such as catheter 202, may include a handle 204, at least one shaft 206, an expandable end assembly (in the form of a basket 240 having multiple ribs 242) located at the distal end 210 of catheter 202, and at least one connector configured to secure the basket 240 to catheter 202, such as a distal connector 244.

[0191] At least one shaft 206 may include an inner shaft, an outer shaft, and / or a support shaft. For example, the conduit 202 may include an inner shaft located within the outer shaft, such as... Figure 3A As shown. For example, the conduit may include an outer shaft and a support shaft, configured to support the end assembly, such as... Figure 3B and 3C As shown. The conduit 202 may include a proximal connector and a distal connector. In this application, "proximal" refers to the position closer to the user, and "distal" refers to the position farther from the user. The connector may be a single component or an integral structure (e.g., see...). Figure 6 It can also be composed of multiple components (for example, see...). Figure 57The connector can be modular. For example, the connector may include a male end received by a female end. A connector with a male / female connector may also include a misalignment / retention section for positioning the male / female ends. The connector may include at least one fixing region. The fixing region may be configured to secure the basket and / or balloon of the expandable end assembly. The connector may include a basket fixing region longitudinally adjacent to the balloon fixing region. The distal connector 244 may be configured to secure the various components of the catheter together. For example, the distal connector may connect the ribs 242 of the basket 240 to the shaft 206 (e.g., Figure 3A (as shown in the inner shaft) or basket support shaft (such as Figure 3B and 3C (As shown). Other features of the connector will be discussed in more detail below.

[0192] As described above, the expandable end assembly (e.g., basket 240) may include at least one electrode for ablation and / or mapping. The electrode may be carried by the basket. For example, the ribs may be made of a conductive material, and the electrode may be an exposed area of ​​the ribs (e.g., as shown in the image). Figure 3B (As shown). Electrodes can be attached to the ribs. For example, the electrode can be a ring electrode. For ease of discussion, a basket with eight ribs is shown in the figure, which are approximately parallel to the longitudinal axis of the end assembly when the basket is in the expanded state (see, for example, see...). Figure 3B However, when the basket is in an expanded state, baskets with more or fewer ribs, and / or baskets with ribs not parallel to the longitudinal axis of the end component (e.g., petal-shaped), may also be used in medical devices having one or more of the features and / or components disclosed herein.

[0193] Figures 3A-3B The distal region of the exemplary medical device shown typically illustrates the available components and features. Further details of the components and features are available in... Figure 4A As shown in -41, 43-46 and 48-63.

[0194] Figure 3A This is a cross-sectional view of the distal region of a medical device (e.g., catheter 302) that may be used in a medical procedure on patient 138. Figure 3A As shown, the medical device (e.g., catheter 302) may include an outer shaft 306, an inner shaft 308 located within the outer shaft 306, and an expandable distal end assembly 339 located at the distal end 310 of the catheter 302. Figure 2Similar to the catheter 202 shown, the distal assembly 339 includes a basket 340 comprising multiple reinforcing ribs 342. The catheter 302 may include a distal connector 344 configured to secure the basket 340 to an inner shaft 308 and a proximal connector 345 configured to secure the distal assembly 339 to the inner shaft 308 and / or the outer shaft 306. Similar to basket 240, basket 340 may include at least one electrode for ablation and / or mapping.

[0195] like Figure 3A The illustrated end assembly 339 also includes an expandable balloon 346 located within the basket 340. The balloon 346 can be secured to the distal connector 344 and the proximal connector 345. The balloon 346 can be made of an insulating material. For example, the balloon material can be one or more of nylon, polyamine, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylene, highly irradiated linear low-density polyethylene (LDPE), polyurethane, cross-linked low-density polyethylene (PETs), acrylonitrile polymers and copolymers, or acrylonitrile blends and ionomer resins. As described above, fluid from the fluid source 130 can be delivered to the balloon 346 to inflate the balloon within the basket.

[0196] The medical device may also include at least one magnetic sensor. The at least one magnetic sensor can be used for navigation (e.g., determining the position and / or orientation of the medical device within the patient's body).

[0197] The magnetic sensor can be a solid magnetic sensor or a hollow magnetic sensor. The magnetic sensor can be configured to sense electromagnetic fields. At least one magnetic sensor can be located near the distal end of the expandable end assembly (distal magnetic sensor), and at least one magnetic sensor can be located near the proximal end of the expandable end assembly (proximal magnetic sensor). The longitudinal axis of the magnetic sensor can be parallel to, at an angle to, and / or offset from the longitudinal axis of the catheter (see [reference]). Figure 3A , 50 (and 51). As will be discussed in more detail below, a distal magnetic sensor may be connected to a distal connector, and a proximal magnetic sensor may be connected to a proximal connector. The sensor wire connected to the magnetic sensor may include a protective layer. For example, the sensor wire may be wrapped with a protective tube. The magnetic sensor may have a sensor wire extending from one end (hereinafter referred to as the wire end). The wire end may face towards the proximal end (e.g., see 51). Figure 50 This is called a proximal orientation magnetic sensor, or distal (e.g., see [reference]). Figure 53 This is called a remote orientation magnetic sensor.

[0198] Back Figure 3AThe conduit 302 includes a magnetic sensor 366 located near the distal end of the end assembly 339; and a plurality of magnetic sensors 367, 368 located near the proximal end of the end assembly 339. In this example, the magnetic sensor 366 is located within the distal connector 344 and is coaxial with the inner axis 308 and the longitudinal axis of the conduit 302; while the plurality of magnetic sensors 367, 368 are located outside the inner axis 308 and are offset from the longitudinal axis of the conduit 302.

[0199] Figure 3B This is an isometric view of the distal region of a medical device (e.g., catheter 370) used to perform medical procedures on a patient 138. Catheter 370 includes: a basket 372 fixed to a distal connector 380 and a proximal connector 384; a sensor (not shown) located within the distal connector 380 and connected to at least one sensor wire 386; a support shaft 382 located within the basket 372 and extending between the distal connector 380 and the proximal connector 384; a shaft 388 extending proximally from the proximal connector 384; and one or more shaft electrodes 390a, 390b (collectively referred to as electrodes 390).

[0200] One or more electrodes (e.g., electrode 390) may be used for navigation, for example, impedance tracking of a medical device (hereinafter referred to as navigation electrodes). The navigation electrodes may be connected to an axis (e.g., axis 388), a proximal connector, and / or a distal connector. A method for navigating the medical device may utilize information from at least one magnetic sensor and / or navigation electrode.

[0201] like Figure 3A As shown, the balloon can be placed within the basket 372. In this example, the plurality of ribs 374 are eight ribs. Similar to baskets 240 and 340, basket 372 may include at least one electrode for ablation and / or mapping. In this example, the ribs 374 are made of a conductive material, and the electrode 376 is the exposed area of ​​the ribs 374. Although Figure 3BEach rib 374 has only one conductive region (electrode) 376, but a rib may have multiple conductive regions (electrodes). The conductive material may be a nickel-titanium alloy. As shown, insulating regions 378a and 378b (collectively referred to as insulating regions 378) are located on both sides of the electrode. The insulating regions 378 may be encapsulated on the rib using an overmolding process. The insulating regions may be polyether intercalated amide (PEBA). The hardness of PEBA material is 72 Shore D. The hardness of the hardness tester described herein is measured by a Shore hardness tester, using either Shore A or Shore D hardness scales according to ASTM-D2240{2021}. The Shore A scale is used for softer rubbers, while the Shore D scale is used for harder rubbers. Preferably, the Shore D scale is used when selecting the hardness tester disclosed herein. Ribs with overmolded insulating regions may have variable widths. For example, the width of a rib region configured to be overmolded with insulating material may be smaller than the width of a rib region configured as a conductive region (electrode).

[0202] The connector may include at least one fixing region. The fixing region may be configured to secure the net basket and / or balloon of the expandable end assembly to the connector. The connector may include a net basket fixing region longitudinally adjacent to the balloon fixing region. Figure 3B As shown, the distal end of the basket 372 is secured to the distal connector 380, and the proximal end of the basket 372 is secured to the proximal connector 384. For a catheter containing a balloon located within the basket, the distal connector 380 may be secured to the distal end of the balloon, and the proximal connector 384 may be secured to the proximal end of the balloon, as will be discussed in more detail below.

[0203] and Figure 3A Compared to the catheter shown, the distal connector 380 is fixed to the distal end of the support shaft 382, ​​rather than to the inner shaft 308. The catheter 370 may not have an inner shaft located within shaft 388. A catheter without an inner shaft may offer better maneuverability than one with an inner shaft. The proximal end of the support shaft 382 can be fixed to the proximal connector 384. For example, as... Figure 3B As shown, the distal end of the support shaft 382 is located within the cavity defined by the distal connector 380, and the proximal end of the support shaft 382 is located within the cavity defined by the proximal connector 384. The distal end of the support shaft 382 can be fixed to the distal connector 380, while the proximal end of the support shaft 382 can float freely within the cavity of the proximal connector 384, as described below. The longitudinal length of the support shaft 382 can be less than the longitudinal length of the basket 372. The support shaft 382 can include a cutting pattern. The cutting pattern can be non-spiral (e.g., ...). Figure 21 (As shown), it can also be spiral-shaped (e.g., as shown). Figure 22 (As shown). Examples of cutting patterns that can be applied to support shaft 382 will be discussed in more detail below.

[0204] like Figure 3B As shown, a sensor wire 386 extending from a sensor located in the distal connector 380 can be soldered to the distal connector 380 and / or the proximal connector 384. For example, the sensor wire 386 can extend along the outer surface of the distal connector 380 and the outer surface of the proximal connector 384. The sensor wire 386 may include a stress-relieving mechanism. For example, the sensor wire 386 can float freely and is not fixed to the support shaft 382. Figure 3B As shown, the sensor wire 386 extends spirally around the support shaft 382 in a free-floating manner.

[0205] Figure 3C This is an isometric view of the distal region of a medical device (e.g., catheter 371) used to perform medical procedures on patient 138. Catheter 371 includes a basket 373 distally attached to a distal connector 381 and proximally attached to a proximal connector 385; a balloon 391 located within the basket 373; a sensor (not shown) located within the distal connector 381 and connected to at least one sensor lead 387; and a support shaft 383 located within the balloon 391 and extending between the distal connector 381 and the proximal connector 385. Figure 3B The catheter shown is similar, but its multiple ribs 374 consist of eight ribs. As described above, the basket 373 may include at least one electrode for ablation and / or mapping. (Similar to...) Figure 3B Similar to the basket 372 shown, the ribs 375 are made of conductive material, and the electrodes 377 are the exposed portions of the ribs 375. Insulating regions 379a and 379b (collectively referred to as insulating regions 379) are located on both sides of the electrodes. Although Figure 3C Each rib 375 has only one conductive area (electrode) 377, but a rib may have more than one electrode. The distal end of the support shaft 383 may be fixed to the distal connector 381, while the proximal end of the support shaft 383 may float freely within the lumen of the proximal connector 385, as described below. The support shaft 382 may contain a cut pattern.

[0206] The balloon 391 can be secured to the distal connector 381 and the proximal connector 385. One end of the balloon may be flipped, both ends may be flipped, or neither end may be flipped. For Figure 3C The distal end 393 of the catheter 371 and balloon 391 shown is flipped so that the outer surface of the balloon 391 is connected to the distal connector 381, while the proximal end 395 of the balloon is not flipped. Figure 3C As shown, the balloon in its expanded state has a first diameter 399 in a first longitudinal position (in this example, near the distal side of the insulating region 379b) and a second diameter 397 in a second longitudinal position (far from the first longitudinal position), and the second diameter 397 is larger than the first diameter 399.

[0207] The end assembly containing the balloon located within the basket can be configured to have different performance parameters. Different performance results can be provided by using balloons with different uninflated diameters, different inflated shapes, and / or different inflated diameters. For example, a smaller diameter balloon, if configured to inflate to the same diameter as a larger diameter balloon, requires significantly less material. Therefore, a basket-balloon end assembly containing a smaller diameter balloon can move more freely within the guide compared to a basket-balloon end assembly containing a larger diameter balloon. Another advantage of a small-diameter balloon is that less material may be required to manufacture it (e.g., by blow molding). The advantage of a large-diameter balloon is that less pressure may be required for inflation compared to a small-diameter balloon. However, a large-diameter balloon requires significantly more material, which may restrict the movement of the basket ribs if the collapsed material is located between and / or piled up beneath them.

[0208] As mentioned above, the basket may be in a collapsed state when the catheter is advanced through the guide. The structure of the distal connector can affect the operation of the medical device. For example, a typical distal connector may restrict the movement of the basket's ribs, making the ribs act like semi-rigid tubes, making it difficult to bend around corners and / or pass through deformed sheaths / guides, thus causing changes in sheath shape. Due to the restricted rib movement, advancing the catheter and / or reducing guide deformation may require greater force. Applying additional force may require the operator to use both hands, one hand holding the guide and the other hand advancing the catheter through the guide. Furthermore, applying additional force may increase the risk of damage to the guide and / or catheter.

[0209] like Figures 4A-4E and Figures 48-50 The distal connector features shown can address one or more of the aforementioned drawbacks. For example, securing the distal end of the basket to the shaft using the distal connector disclosed herein allows a user to operate the guide and conduit with one hand, freeing up the other hand for other operations. The user can hold the guide in their palm while advancing the conduit with their thumb and forefinger. As another example, securing the distal end of the basket to the shaft using the distal connector disclosed herein can improve performance. The conduit using the distal connector disclosed herein offers better maneuverability. For example, in some embodiments, the rib connected to the distal connector disclosed herein has additional degrees of freedom because the rib can extend beyond the distal tip of the conduit as it is advanced through a deflected guide, potentially increasing guide deflection. The conduit utilizing the distal connector disclosed herein can be inserted into a guide with at least one bend—in other words, the guide does not need to be straightened before insertion.

[0210] Figures 4A-4E and Figures 48-52Different features of the distal connector are shown. One advantage of the disclosed distal connector is that the ribs can extend beyond the distal side of the connector as the catheter is advanced through the guide. For example, as... Figure 4A As shown in -E, the distal connector lacks features such as a stop or cap, which could restrict or prevent the rib from extending beyond the distal side (hereinafter referred to as the capless distal connector). The rib of the capless distal connector extends beyond the distal side, providing additional degrees of freedom for the rib. Extending the rib beyond the distal side of the distal connector can improve catheter maneuverability. For example, extending the rib beyond the distal side of the connector can reduce guide deflection loss and / or reduce the force required to pass the catheter through the guide. Another advantage of the capless distal connector is its shorter end assembly. Figures 4A-4E Another advantage of the distal connector shown is that it has a one-piece structure. For example, the distal connector can be molded.

[0211] like Figure 4A As shown, the distal connector 440 includes a distal side 450 having an end opening 454 defined by a first wall 452. The first wall 452 extends proximally from the distal side 450 to the proximal end of the connector (not shown). The distal side 450 also includes a first region 470 extending proximally from the distal side 450 and a second region 472 extending proximally from the first region. The distal side 450 of the distal connector 440 may also be the distal side of a catheter. As shown, the proximal end of the first region 470 may be blunt, and the diameter of the first region 470 may be larger than that of the second region 472.

[0212] The first region 470 includes a basket fixing assembly configured to connect basket ribs 442 to a distal connector 440. The basket fixing assembly may form the proximal end of the first region 470. The basket fixing assembly includes a plurality of slots for receiving basket ribs 442, a plurality of protrusions 456 extending outwardly from a first wall 452, a plurality of second walls 458 located between adjacent protrusions 456, and at least one wall 412 extending from the first wall 452 (e.g., ...). Figure 6 As shown, this arrangement is optimal (for best results). This arrangement helps maintain the axial position of the ribs 442. Furthermore, this arrangement simplifies the connection between the basket and the distal connector 440. As shown, each slot can be formed by a first wall 452, a wall 412, a pair of protrusions 456, and a second wall 458. These slots can be blind holes (e.g., ...). Figure 6(As shown, for best results). The slots in the basket fixing assembly provide a path for the reinforcing ribs 442 across the distal side 450 of the distal connector 440. As shown, these slots are parallel to the longitudinal axis of the distal connector 440. However, these slots can also be at a non-oblique angle to the longitudinal axis of the distal connector. Furthermore, as mentioned above, by adjusting the number of slots, the connector can be configured to fix more or fewer than eight basket reinforcing ribs.

[0213] The protrusion 456 can also provide protection when the basket is inserted / removed through the guide. For example, the protrusion 456 can form a space between the inner diameter of the guide and the basket. For a basket with one or more coated areas on the ribs (e.g., rib portion 444), this space can protect the coated areas when the basket is inserted / removed through the guide.

[0214] The second wall 458 can be recessed. For example, the second wall 458 can be radially recessed relative to the protrusion 456. The recessed second wall 458 provides a suitably sized space so that when the basket is in the retracted state ( Figure 4A (Not shown) accommodates the reinforcing rib 442. For example, when the basket is in a retracted state, the inner surface of the reinforcing rib 442 may be located near and / or in contact with the second wall. As another example, the second wall 458 may be longitudinally recessed relative to the distal side 450—in other words, the distal end of the second wall 458 maintains a certain longitudinal distance from the distal side 450. The second wall 458 may include a through-hole 462 configured to secure the reinforcing rib 442 to the distal connector 440. For example, in some embodiments, an adhesive may be applied within the through-hole 462. The through-hole 462 may be circular and have a certain diameter (e.g., Figure 5 (Diameter D1 in the middle).

[0215] like Figure 4A As shown, the second region 472 may include at least one rib 460 extending from the first wall 452 and at least one through hole 464. The through hole 464 can serve as a mating part for securing the distal connector 440 to a shaft, such as the inner shaft 308 or a basket support shaft. For example, adhesive can be applied into the through hole 464. Alternatively, the through hole 464 can be used for welding. Figure 4A As shown, the distal connector 440 has three circumferentially extending ribs 460. These three ribs 460, arranged circumferentially, may be referred to as circumferential ribs. The ribs 460 are used to mechanically secure the balloon to the distal connector 440. The ribs 460 increase the contact surface area between the balloon and the distal connector 440. The increased surface area improves the adhesive strength between the balloon and the distal connector 440. The balloon can be attached to the distal connector 440 by adhesive and / or laser bonding.

[0216] The second region 472 of the distal coupler 440 can have a smooth outer surface due to the absence of ribs. For example, portions of the second region 472 may be replaced by an overmolded part instead of ribs, and the material of the overmolded part has a hardness similar to that of the balloon material used for adhering the balloon to the distal coupler. The material constituting the distal coupler may be less flexible and / or harder than the material used for the overmolded part. A laser may be used to adhere the balloon to the overmolded part of the distal coupler.

[0217] As shown in Figure 4B and 4C , the features of the distal coupler 440' are as depicted. Similar to the distal coupler 440 shown in Figure 4A , the distal coupler 440' includes a distal face 450' having an end opening (not visible in the figure). The end opening is defined by a first wall 452' extending outward from the distal face 450', a first region 470' extending proximally from the distal face 450', and a second region 472' extending proximally from the first region 470' to the proximal end 402'. The distal coupler 440' differs from the distal coupler 440 shown in Figure 4A in that the distal coupler 440' is shorter than the distal coupler 440. For example, the first region 470' is shorter (note the difference in the position of the struts of the basket relative to the distal face). In this way, the distal assembly has a shorter tip at the distal end away from the struts. As described above, the distal coupler may include a channel for receiving a sensor wire connected to a sensor located inside the distal coupler. For example, in the view shown in Figure 4B , the groove 468' in the second region 472' is configured to receive the sensor wire 386 (this groove is not visible in the view shown in Figure 4A ).

[0218] Similar to the first region 470 shown in Figure 4A , the first region 470' has a larger diameter than the second region 472', and includes a basket securing assembly configured to connect the basket struts 442' to the distal coupler 440'. The distal coupler constitutes the proximal end of the first region 470', and includes a plurality of grooves for receiving the basket struts 442', a plurality of protrusions 456' extending outward from the first wall 452', a plurality of second walls 458' (each second wall 458' being located between adjacent protrusions 456'), and at least one wall 412'. Compared with the distal end of the second wall 458 of the distal coupler 440 shown in Figure 4A , the distal end of the second wall 458' is closer to the distal face 450'. In addition, the at least one wall 412' is composed of a plurality of walls 412' located at the distal side of the proximal ends of the protrusions, rather than as in Figure 4AAs shown, it is collinear with the proximal end of the protrusion. The distal end of the second wall 458' can be located at the distal end of the wall 412'. Each slot is formed by a first wall 452', a pair of protrusions 456', a second wall 458', and a wall 412' located between adjacent protrusions and at the distal end of the proximal end of the protrusion 456'. As described above, the protrusion 456' can provide protection when the basket is inserted / removed through the guide. When the rib 442' of the basket is inserted into the slot, the rib 442' is tangent to the distal side 450', which is consistent with... Figure 4A The ribs 442 of the basket shown are different. Furthermore, the second wall 458' does not have through holes. Instead, the proximal end (rear edge) of the second wall 458' is located at the distal end of the wall 412', exposing the distal end 474' of the basket ribs 442'. One advantage of this arrangement is that the ribs 442' can be connected to the distal connector 440' via a mechanical mechanism (rather than adhesive), or adhesive can be used simultaneously. Although as... Figure 4B As shown, the proximal end of the second wall 458' is curved, but the proximal end of the second wall 458' can also be straight.

[0219] and Figure 4A Similar to the second region 472 shown, the second region 472' includes at least one rib 460' extending from the first wall 452' and a through hole 464'. As described above, the at least one rib 460' can provide a larger surface area for connecting the balloon to the distal connector 440'. (Similar to...) Figure 4A The second region 472 shown differs from the first region 472', which includes four ribs 460' and a first wall 452' that is concave rather than planar between adjacent ribs 460'. The concave curve between ribs 460' provides a larger surface area for connecting the balloon to the distal connector 440' compared to a planar surface between adjacent ribs. Another difference between the distal connector 440 and the distal connector 440' is that the through-hole 464' is not located between adjacent ribs 460'. Instead, as shown... Figure 4B As shown, at least one rib 460' is at least partially interrupted by a through hole 464'.

[0220] The second region 472' of the distal connector 440' can have a smooth outer surface because it lacks ribs. For example, a portion of the second region 472' can replace the ribs with an overmolded portion (or overlay) made of a material with a hardness similar to that of the balloon, used to bond the balloon to the distal connector. The material constituting the distal connector is less flexible and / or harder than the material used for the overmolded portion. The balloon can be bonded to the overmolded portion of the distal connector using a laser.

[0221] See Figure 4DFeatures of the distal connector 440" are shown. Similar to the distal connectors 440 and 440' discussed above, the distal connector 440" includes a distal side 450" having an end opening (not visible in the figure) defined by a first wall 452" extending outward from the distal side 450"; a first region 470" extending proximally from the distal side 450"; and a second region 472" (not visible in the figure) extending proximally from the first region 470" to the proximal side of the distal connector 440".

[0222] and Figure 4A and 4B Similar to the distal connectors 440 and 440' shown, the first region 470" includes a basket securing assembly comprising multiple slots for receiving basket ribs 442", multiple protrusions 456" extending outward from a first wall 452"", and multiple second walls 458" located between adjacent protrusions 456". Each slot has a distal opening and a proximal opening and is formed by the first wall 452", a pair of protrusions 456" and second walls 458". As described above, the protrusions 456" provide protection when the basket is inserted / removed via a guide. Figure 4D The distal connector 440" shown, the basket fixing assembly also includes an annular wall 466" extending from the first wall 452" and located near the slot. The height of the annular wall 466" can be constant (measured from the outer surface of the first wall 452" to the outer surface of the annular wall 466"). The proximal side 467" of the annular wall 466" can form a stop. The height of the annular wall 466" can vary. Figure 4D As shown, the distal end 474" of the basket reinforcement 442" lies within the annular region extending from the distal end of the annular wall 466" to the proximal end of the protrusion 456". The distal end 474" of the basket reinforcement 242" is hook-shaped, as... Figure 4F As shown, this will be discussed in more detail below. The advantage of using barbs to secure the basket reinforcement to the connector is that the interaction between the barbs and the basket reinforcement securing components effectively prevents longitudinal movement of the basket reinforcement. For example, as shown, for the distal connector 440", at least a portion of the barb can be aligned with the protrusion 456", thereby hindering and / or stopping the distal movement of the basket reinforcement 442" due to the barb abutting against at least one protrusion 456".

[0223] and Figure 4A and 4B Similar to the distal connectors 440 and 440' shown, the second region 472" includes at least one rib 460" extending from the first wall 452"; a through-hole (not visible in this view); and a slot 468" for receiving sensor wires. As described above, the at least one rib 460" provides a larger surface area for connecting the balloon to the distal connector 440". Figure 4DAs shown, the distal rib 460" is located near the annular wall 466".

[0224] Because the second region 472" of the distal connector 440" has no ribs, its outer surface can be very smooth. For example, a portion of the second region 472" may not be composed of ribs, but rather of an overmolded portion (or overlay) made of a material with a similar rigidity to the balloon, used to bond the balloon to the distal connector. The material constituting the distal connector can be less flexible and / or harder than the material used for the overmolded portion. The balloon can be bonded to the overmolded portion of the distal connector using a laser.

[0225] See Figure 4E The figure shows the features of the distal connector 440'''. Similar to the distal connector discussed above, the distal connector 440''' includes a distal side 450''' with an end opening (not visible in the figure), which is defined by a first wall 452''' extending outward from the distal side 450''', a first region 470''' extending proximally from the distal side 450''', and a second region 472''' extending proximally from the first region 470''' to the proximal end of the distal connector 440''' (not visible in the figure).

[0226] and Figure 4D Similar to the distal connector 440", the first region 470''' includes a basket securing assembly comprising a plurality of slots for receiving basket ribs 442''', a plurality of protrusions 456''' extending outward from the first wall 452''', a plurality of second walls 458''', each second wall 458''' located between adjacent protrusions 456''', and an annular wall 466'''. As described above, the protrusions 456''' provide protection when the basket is inserted / removed through the guide. Each slot has a distal opening and a proximal opening and is formed by the first wall 452''', a pair of protrusions 456''', and the second wall 458'''. Figure 4E As shown, the annular wall 466''' has a protrusion 482''' aligned with the protrusion 456''', and a groove 484''' aligned with the slot. Therefore, the height of the annular wall 466''' is variable. Figure 4D The basket fixing assembly shown is similar, with the distal end 474''' of the basket rib 442''' located within the space between the distal end of the annular wall 466''' and the proximal end of the protrusion 456'''. As shown, the distal end 474''' of the basket rib 242''' can be in the form of a barb, see details. Figure 4E .like Figure 4DAs shown, the basket reinforcement bar has a distal opening in the insertion slot, with the distal end of the basket reinforcement bar extending from the proximal opening and the distal end (barb) expanding. The advantage of using barbs to secure the basket reinforcement bar to the connector is that the interaction between the barb and the basket fixing assembly effectively prevents longitudinal movement of the basket reinforcement bar. For example, in the distal connector 440''' shown, at least a portion of the barb can be aligned with the protrusion 456''', thereby hindering and / or stopping the movement of the distal end of the basket reinforcement bar 442''' as the barb abuts against the proximal end of the protrusion 456'''.

[0227] and Figures 4A-4D The distal connector shown is similar, with the second region 472''' including at least one rib 460''' extending from the first wall 452''', a through hole (not visible in this view), and a slot 468''' for receiving sensor wires. Figure 4E As shown, the distal rib 460''' is located near the annular wall 466'''. Between adjacent ribs 460''', the first wall 452''' is flat, and... Figure 4A The first wall 452 shown is similar. As described above, at least one rib 460''' can provide a larger surface area to connect the spherical bag to the distal connector 440'''.

[0228] The second region 472''' of the distal connector 440''' may have a smooth outer surface because it does not have ribs. For example, a portion of the second region 472''' may replace the ribs with an overmolded portion (or overlay), made of a material with a hardness similar to that of the balloon, for bonding the balloon to the distal connector. The material constituting the distal connector may be less flexible and / or harder than the material used for the overmolded portion. The balloon may be bonded to the overmolded portion of the distal connector using a laser. The basket reinforcement may include one or more fixing portions. These fixing portions may be configured to secure the basket reinforcement to the connector (e.g., see...). Figure 4D , 4E (48 and 58). The rib fixing part can be used in conjunction with the rib retaining part of the connector. For example, as described above, the rib fixing part can abut against the rib retaining part of the connector (for example, see...). Figure 4F-4G and Figure 48 One advantage of the rib fixing part disclosed herein is that the axial alignment of the basket ribs can be more consistent. Furthermore, the rib fixing part, when used in conjunction with the rib retaining part of the connector, can provide effective distal stopping against longitudinal movement of the basket ribs. Another advantage of the rib fixing part disclosed herein is that, since the rib fixing part and the connector fixing part work together to secure the basket ribs, less or no adhesive may be required to fix the ribs to the connector. The rib retaining part can be located at one or both ends of the basket ribs (e.g., see...). Figure 4F-4GIt can also be located between the bend of the rib and the end of the rib (e.g., see...). Figure 48 The reinforcing ribs can extend from the side of the basket reinforcing ribs (see, for example, see...). Figure 48 (Hereinafter referred to as the laterally extending rib retaining portion). Two laterally extending rib retaining portions may be opposite each other. The laterally extending rib retaining portions may be the wider portion of the rib.

[0229] like Figure 4F-4G As shown, the reinforcing rib fixing part is located at the end of the reinforcing rib of the basket. The reinforcing rib fixing part may include barbs. Figure 4D and 4E As shown, barbs secure the basket ribs to the connector. One advantage of using barbs to secure the basket ribs to the connector is that the axial alignment between the ribs can be more consistent. This can improve the performance of the basket. Furthermore, as mentioned above, the barbs can effectively stop the longitudinal movement of the basket ribs at the distal end. Another advantage is that securing the ribs to the connector may require less or even no adhesive. Therefore, barbs can anchor the basket ribs to the distal connector.

[0230] like Figure 4F As shown, the barb 478 may include two protrusions 483a and 483b extending from the base 481. The width of the base 481 may be less than the width of the basket reinforcement 442. In this embodiment, the base 481 is centered, i.e., equidistant from both sides of the basket reinforcement 442a. Each protrusion 483 includes a head 485 (labeled 485b in the figure) configured to rotate the protrusion 483 180°. This 180° rotation causes the free end 487 (free end 487b in the figure) of the protrusion 483 to approach the base 481. Therefore, the protrusion 483 may be described as V-shaped or U-shaped. A first groove 488 is defined between the protrusion 483 and the base 481. A second groove 490 is defined by the two protrusions 483a and 483b. The second groove 490 may include a keyhole 489 (keyhole 489a in the figure). The barb 478 can switch between a contracted state and an expanded state. Figure 4F The barb 478 shown is in an expanded state. For example, the barb may be in a retracted state when the basket reinforcement is inserted into the slot of the connector; the barb may transition to an expanded state when the basket reinforcement extends out of the slot (see, for example, [link to connector]). Figure 4D In the contracted state, the first groove 488 may have a first size because a first distance is maintained between the protrusion 483 and the base 481; in the expanded state, the first groove 488 has a second size that is larger than the first size because a second distance is maintained between the protrusion 483 and the base 481, which is larger than the first distance.

[0231] like Figure 4GAs shown, the barb 479 may include a first protrusion 492 and a second protrusion 494 extending from the base 491. The width of the base 491 may be less than the width of the basket rib 442b. The base 491 may be offset, i.e., the base 491 may be closer to one side of the rib 442b than to the other side of the rib 442b. The first protrusion 492 includes a free end 493. The second protrusion 494 includes a head 495 located near the free end 493 of the first protrusion 492, and a free end 496 located near the base 491. Figure 4F Similar to the head 485 of the barb 478 shown, the head 495 is configured to rotate the protrusion 494 by 180°. This 180° rotation brings the free end 496 of the protrusion 494 closer to the base 491. Therefore, the protrusion 494 can be described as V-shaped or U-shaped. As shown in the figure, Figure 4G The longitudinal length of the head 495 shown is less than Figure 4F The head 485 is shown. A first groove 497 is defined by a first protrusion 492 and a second protrusion 494. A second groove 498 is defined by a second protrusion 494 and a base 491. The second groove 498 includes a keyhole 499. A barb 479 can switch between a contracted state and an expanded state. Figure 4G The barb 479 shown is in an expanded state. For example, the barb may be in a retracted state when the basket reinforcement is inserted into the slot of the connector; the barb may be in an expanded state when the basket reinforcement extends out of the slot (see, for example, [link to previous section]). Figure 4E In the contracted state, the second groove 498 may have a first size due to the first distance between the protrusion 494 and the base 491; while in the expanded state, the second groove 498 has a second size larger than the first size due to the second distance between the protrusion 494 and the base 491 (this distance is greater than the first distance).

[0232] The distal connector 440 can be configured to be fixed to a catheter shaft. For example, the catheter shaft can be inserted into the central lumen of the distal connector 440 (e.g., Figure 6 In the central lumen 604 shown. The distal connector 440 can be secured to the conduit shaft by friction fit. The first wall 452 may define at least one mating portion, such as a through hole, configured to secure the distal connector 440 to the conduit shaft. The mating portion may be a through hole. Adhesive may be applied into the through hole. The through hole can be used to weld the distal connector 440 to the shaft. The through hole may be a circular opening with a diameter (e.g., ...). Figure 6 A through hole with a diameter of D4 (464) can also be a slit or longitudinal opening with a width (e.g.) Figure 5 A slit 468 with a width of W1. The mating part may be located within the second region 472 of the distal connector 440. For example, as... Figure 4A As shown, a single through-hole 464 may be located between two ribs 460. Through-hole (e.g.) Figure 5 The through hole 564 shown may also be located near one end of the distal connector 440, either in addition to or alternatively.

[0233] like Figures 4A-4E As shown, the reinforcing ribs of the basket used for fixing to the distal connector may include bent portions (e.g., bent portion 448) to insert the ends of the reinforcing ribs 442 into the slots of the basket fixing assembly. For example, as Figure 4A As shown, the rib portion 446 extending from the end of rib portion 444 to the end of rib portion 442 includes a bent portion 448. At least one of rib portion 446 and rib portion 444 may have an insulating cap / coating. Rib 442 may be flexible. For example, the bent portion 448 may straighten as the rib is advanced beyond the distal side of the connector, and temporary secondary bends may be formed at different locations on the rib.

[0234] See Figure 5 The side view of the distal connector 440 shown indicates that the protrusion 456 may include a curved leading edge portion 508 and a curved trailing edge portion 510. The curved leading edge portion 508 may extend upward from the distal side of the distal connector 440 to the proximal side. The radius of curvature of the curved leading edge portion 508 is R1. The outer surface / side surface 506 of the protrusion may extend at an angle from the curved leading edge portion 508 to the curved trailing edge portion 510. The radius of curvature of the curved trailing edge portion 510 is R2. The radius of curvature R2 of the trailing edge portion 510 may be smaller than the radius of curvature R1 of the leading edge portion 508 (R1 > R2). For example, in one embodiment, the radius of curvature R1 is approximately three times the radius of curvature R2. The curved trailing edge portion 510 may terminate at a wall 412 (e.g., Figure 6 As shown, the best results are obtained.

[0235] like Figure 5As shown, the length of the distal coupler 440 (measured from the distal side 450 to the proximal end 502, hereinafter referred to as coupler length) is equal to the sum of lengths L1, L2, L3, L4, L5, L6 and L7. The length of the first region 470 is equal to the sum of the length L1 and the length L2 (L1+L2), and the length of the second region 472 is equal to the sum of L3+L4+L5+L6+L7. The length of the first region 470 may be less than the length of the second region 472. For example, the length of the first region 470 may be approximately 32%-42% of the coupler length, and the length of the second region 472 may be approximately 57%-67% of the coupler length. The length L1 represents the distance from the distal side to the center of the through hole 462 with a diameter of D1. The length L2 represents the distance from the center of the through hole 462 to the end of the first region 470 of the coupler. The length L2 is approximately 13% to 23% of the length of the first region 470. As shown in the figure, the distal coupler 440 has three ribs. The length L3 represents the distance from the end of the first region 470 to the first rib, the length L4 represents the distance between adjacent ribs with a through hole (for example, the through hole 464) therebetween, and the length L5 represents the distance between adjacent ribs without a through hole therebetween. The length L3 is measured from the proximal end of the first region 470 to the midpoint of the distal rib, and the length L4 and the length L5 are measured from the midpoints of the longitudinally adjacent ribs. The length L3, the length L4 and the length L5 may be the same or different. The length between adjacent ribs provided with a through hole therebetween may be greater than the length between adjacent ribs not provided with a through hole therebetween. As Figure 5 shown, L3<L5<L3. The length L6 is the distance from the midpoint of the rib to the wire outlet (e.g. Figure 3B the sensor wire 386 as shown in the figure) to allow the wire to pass out of the lumen of the distal coupler. The length L7 is the distance from the proximal end 502 of the coupler to the wire outlet (e.g. Figure 3B the sensor wire 386 as shown in the figure) to allow the wire to pass out of the lumen of the distal coupler 440. In some embodiments, the length L7 is greater than the length L1. The sum of the length L6 and the length L7 is the distance from the proximal end 502 of the distal coupler 440 to the proximal rib. The diameter D2 represents the diameter of the rib 460 located in the second region 472.

[0236] As Figure 6 shown in the figure, Figure 5 in the cross-sectional view taken along line A-A, the distal coupler 440 has a longitudinal axis 606 and adopts a one-piece or monolithic design, with a first wall 452 extending from the distal side 450 to the proximal end 502 and defining a central lumen 604. Compared with couplers comprising multiple components, the coupler with a one-piece design may be easier to manufacture, lower in cost, and / or better in performance. For example, in at least one embodiment, the distal coupler 440 is formed by molding. The shaft (e.g. Figure 3BThe distal end of the support shaft 382 shown can be located within the central lumen 604 and bonded to the distal connector.

[0237] The thickness of the first wall 452 can vary. For example, in the first region 470, the portion of the first wall 452 of length L8 located on the distal side 450 can be thicker to define the end opening 454. The remaining portion of the first wall 452 in the first region 470 can be thinner. The remaining portion of the first wall 452 in the first region 470 can be the thinnest part of the first wall 452. Figure 6 As shown, the first wall 452 adjacent to the first region 470 may be thicker than the rest of the first wall 452. In the second region 472, a portion 608 of the first wall 452 of length L11 may be thinner than the rest of the first wall 452.

[0238] The diameter of the central lumen 604 can be uniform. The central lumen 604 has a first diameter and a second diameter, the second diameter being smaller than the first diameter. For example, as... Figure 6 As shown, the diameter of the central lumen portion extending from the proximal end 502 to the edge 610 (e.g.) Figure 9 The diameter D8 shown is larger than the diameter of the central lumen portion extending from edge 610 to edge 614. The length L10 of the larger diameter portion of the central lumen 604 can be at least partially equal to... Figure 5 The lengths L7, L6, and / or L5 shown overlap. Length L10 can be approximately 34% to 44% of the connector length.

[0239] As described above, the central lumen 604 can be configured to receive a catheter shaft. The catheter shaft located within the central lumen can abut against the edge 610 of the first wall 452. The catheter shaft located within the central lumen can also abut against the edge 614.

[0240] The first wall 452 may include a sensor alignment portion configured to align with a sensor located within the central lumen 604. This sensor alignment portion may also restrict and / or prevent forward movement of the sensor. Edge 610 may be the distal end of the sensor alignment portion and prevent forward movement of the sensor located within the central lumen. Edge 614 may be the distal end of the sensor alignment portion and prevent forward movement of the sensor located within the central lumen. The sensor may extend beyond a portion L9 of the first region 470.

[0241] Wall 412 is perpendicular to the first wall 452. The second wall 458 extends parallel to the first wall 452 and is perpendicular to wall 412. As shown, the second wall 458 is connected to wall 412. The second wall 458 may also not be connected to wall 412. For example, as... Figure 4B As shown, the proximal end of the second wall 458 is located at the distal end of the wall 412. The distal connector may lack wall 412, as... Figure 4D and 4E As shown.

[0242] Figure 6 Other dimensions indicated include diameter D3, length L9, and width W2. Diameter D3 is the outer diameter of the first wall 452 in the second region 472 of the connector. Diameter D3 is less than... Figure 5 The diameter D2 (D2 > D3) is shown. The length L9 represents the distance from the wall 412 of the distal connector 440 to the center of the through hole 464, and is at least partially related to... Figure 5 The lengths L3 and / or L4 shown overlap. The sum of lengths L2 and L9 represents the gap / distance between mating parts (e.g., through holes 462 and 464). Figure 5 and Figure 6 As shown, length L9 is less than the sum of lengths L3 and L4 (L9 < (L3 + L4)). The width W2 of groove 602 is measured between the outer surface of the first wall 452 and the inner surface of the second wall 458. As described above, groove 504 is provided at the distal end of groove 602, configured to guide the movement of the rib across the distal side of the connector.

[0243] like Figure 7 As shown, the features of rib 460 are illustrated. Rib 460 has a central portion 702 located above the outer surface of the first wall 452, and a side portion 704 extending at an angle from the central portion 702 to the first wall 452. Figure 7 As shown, the longitudinal width of the central portion 702 is L12, and the angle of the inclined side 704 of the rib 460 is A3. Angle A3 can be 90° or an oblique angle. As described above, the rib 460 can serve as a reinforcing structure to enhance the mechanical strength of the connector.

[0244] The distal side of the connector disclosed herein can be symmetrical (e.g., in...). Figure 4A , Figure 8 and Figure 51 (This is most clearly shown in the image). For example, as shown in the image... Figure 8 shown Figure 4A The end view of the distal connector shown has a radially symmetrical distal side 450 with multiple slots 800 for receiving the basket reinforcement bars, for example... Figure 6 The groove 602 shown is hereinafter referred to as slot 800. Each slot 800 is opposite to another slot 800 (see axis 14), each second wall 458 is opposite to another second wall 458, and each protrusion 456 is opposite to another protrusion 456. Similarly, each groove is also opposite to another groove. The slot 800 may have rounded corners with a radius of curvature R3. Each protrusion 456 may include an outer surface 506 that is wider than the inner surface 804. Each protrusion 456 may also include a side surface 802 oriented at an angle A5 measured from a line 15 that bisects the groove and is perpendicular to the surface of the second wall.

[0245] As shown in the figure, the distal connector 440 has eight (8) slots 800, and the orientation between adjacent slots 800 is measured at an inclination angle A4 between the midpoints of adjacent slots 800. Width W3 represents the width of the second wall 458 and the distance between adjacent protrusions 456. Width W4 represents the distance from the center of the end opening 454 to the outer surface of the section of the first wall 452 forming the groove 504. Diameter D5 represents the diameter between the outer sides of the protrusions 456 in relative positions.

[0246] Figure 9 The diagram shows a view of the distal connector 440 as seen from the proximal end 502 toward the distal side 450. The proximal end can be symmetrical. For example, the proximal end can be bilaterally symmetrical about axis 902. Diameter D7 represents the diameter of the end opening 454. Diameter D7 can be configured to act as a hard stop for the magnetic sensor located within the central lumen 604 of the distal connector 440. In other words, diameter D7 is smaller than the diameter of the magnetic sensor. The groove 904 has a thickness W5 and a diameter D9. Thickness W5 and diameter D9 can be configured to provide clearance for the magnetic sensor terminals and sensor wires. The dimension of diameter D8 is related to the axis (e.g., Figure 3C The support shaft 383 shown is matched.

[0247] like Figure 48 As shown in the figure, the features of the basket securing assembly / region of the distal connector 4840 are illustrated. Similar to the distal connector 440 discussed above, the basket securing assembly of the distal connector 4840 may include a longitudinally extending protrusion 4856. The protrusion 4856 may extend parallel to the longitudinal axis of the distal connector 4840. Unlike the protrusions 456, 456', 456'' and 456''' discussed above, the protrusion 4856 is discontinuous and forms a retaining groove 4809 between a curved leading edge portion 4808 and a trailing edge portion 4810. The trailing edge portion 4810 may include a protrusion or rib 4812 extending from one side to the other. Figure 48 As shown, the fixing groove 4809 is configured to receive a laterally extending rib fixing portion 4830 extending from one or two adjacent ribs (collectively referred to as 4822). The rib fixing portion 4830 can be snapped into the fixing groove 4809. Although the fixing groove 4809 is configured to receive the laterally extending rib fixing portion 4830, the distal connector 4840 can also be used to fix ribs of the wire mesh basket that do not have rib fixing portions. Figure 48 The illustrated stiffener 4822 includes two laterally extending retaining portions 4830 located in the same longitudinal position along the stiffener 4822 and extending from opposite sides of the stiffener 4822. Furthermore, the illustrated stiffener retaining portions 4830 are located near the bend 4848 of the stiffener 4822, at a distance from the end 4850 of the stiffener 4822. However, the stiffener retaining portions 4830 can be located anywhere between the bend 4848 and the end 4850 of the stiffener 4822.

[0248] Figure 49 and Figure 50 These are, respectively, isometric views and sectional views of the distal connector 4940. The distal connector 4940 includes a first region 4970 and a second region 4972 extending proximally from the first region 4970. Figure 50 As shown, the first region 4970 and the second region 4972 can be an integral structure. The shaft 4980 can extend into the proximal opening of the distal connector 4940, such that a portion of the shaft 4980 is located within the central lumen 5004 of the distal connector 4940. The distal end of the shaft 4980 can abut against the stop 5074 (in... Figure 50 (As shown most clearly in the diagram). Stop 5074 may be located within the second region 4972 of the distal connector 4940.

[0249] The first region 4970 may include a basket fixing assembly for connecting the multiple reinforcing bars 4922. The basket fixing assembly is characterized by... Figure 5 The basket securing assembly in the first region 470 is similar. Unlike the first region 470 of the distal connector 440, the first region 4970 does not have a through hole 462. The basket securing assembly in the first region 4970 includes a plurality of longitudinally extending protrusions 4956 and a plurality of circumferentially extending protrusions 4912. Similar to the protrusions 456, 456', 456'' and 456''' discussed above, the protrusions 4956 are continuous. Each longitudinally extending protrusion 4956 may include a curved leading edge portion 4908 and a trailing edge portion 4910. The trailing edge portion 4910 may be curved as described above.

[0250] The second region 4972 of the connector may include a sensor and / or balloon fixation area. For example, the distal connector 4940 may include a slot 4965 for receiving a sensor 4966. The sensor 4966 may be used for navigation, for example, a magnetic or electromagnetic sensor as described above. The slot 4965 is defined on the outer surface of the second region 4972 of the distal connector 4940. Because the longitudinal axis of the slot 4965 is offset and parallel to the longitudinal axis of the catheter, the sensor 4966 located in the slot 4965 will also be offset and parallel to the longitudinal axis of the catheter. In this position, the sensor 4966 will not come into contact with any biological fluid that may enter the lumen 5004. Figure 50 As shown, sensor 4966 can be proximal oriented, that is, sensor wire 5067 extends from the proximal end of sensor 4966 to the proximal end, as described above.

[0251] like Figure 49 and Figure 50As shown, a portion of balloon 4946 (e.g., the distal waist) can be connected to a second region 4972 of the distal connector 4940, such that balloon 4946 extends over the notch 4965 and covers sensor 4966 located within the notch 4965. This structure, which secures balloon 4946 to sensor 4966, can improve catheter reach and / or enable more precise access to desired anatomical locations. The second region 4972 may include an overmolded thermoplastic region 4974 configured for thermally welding balloon 4946 to distal connector 4940.

[0252] As described above, the distal connector may include at least one electrode located at the distal end of the expandable end assembly. This electrode may complement or replace a magnetic sensor. For example, the electrode coupled to the distal connector may be used to track (e.g., impedance tracking) the distal end of the expandable end assembly. An axial electrode located proximal to the expandable end assembly may also be used for impedance tracking. Using electrodes for tracking can reduce the cost of the medical device and / or the cost of use. For example, the cost of an electrode may be lower than that of a magnetic sensor. Furthermore, when using the medical device during surgery, the position and / or orientation of the end assembly coupled to the distal connector can be determined without a magnetic field and / or hardware. Therefore, the cost to the user can be reduced. The electrode may be coupled to the distal side of the distal connector (hereinafter referred to as the tip electrode). The tip electrode may be non-invasive in shape. The tip electrode may be flush with the distal side of the distal connector (e.g., see...). Figure 51 It can also extend from the distal side of the distal connector to the distal end (e.g., see [link]). Figure 52 An electrode extending distally from the distal side can be referred to as a spherical electrode. In one example, the distal side of the distal connector may form a groove configured to accommodate a tip electrode. The outer diameter of the tip electrode may be smaller than the outer diameter of the distal side. The tip electrode may form a lumen communicating with the central lumen of the distal connector. The tip electrode lumen may provide a pathway for a guidewire to pass through the distal connector and / or for the delivery of fluids (e.g., contrast agents). Electrodes connected to the distal connector may also be used for ablation and / or mapping.

[0253] like Figure 51 As shown, the features of the distal connector 5140 are illustrated. Similar to the distal connectors discussed above, the distal connector 5140 includes a second region 5172 extending from the proximal end of the first region 5170. The first region 5170 and the second region 5172 may be an integral structure. Alternatively, one of the first region 5170 and the second region 5172 may be a female portion, while the other may be a male portion. For example, the second region 5172 may include a male connector that can be connected to the first region 5170. The connection may also include a misalignment / retention part for determining the orientation of the male / female connector.

[0254] The first region 5170 may include a basket fixing assembly comprising a plurality of slots or recesses 5148 and a plurality of protrusions 5156. The protrusions 5156 are discontinuous, including a distal protrusion 5108 and a proximal protrusion 5110, which define a retaining groove 5144 for receiving a rib fixing portion of the basket ribs, as described above. The outer diameter of the proximal protrusion 5110 may be larger than the outer diameter of the annular wall 5176. Therefore, the proximal end 5142 can serve as a stop. Figure 51 As shown, the distal connector 5140 is configured to secure a basket with eight ribs. However, as described above, the number of slots and protrusions can be modified to secure a basket with more or fewer ribs. An annular wall 5176 may be located at the proximal end of the first region 5170. The annular wall 5176 may act as a stop, restricting proximal movement of the basket ribs located in the slot 5148. The outer diameter of the annular wall 5176 may be smaller than the outer diameter of the proximal protrusion 5156.

[0255] The second region 5172 includes a distal portion 5180 and a proximal annular wall 5178. The proximal annular wall 5178 forms the proximal end of the second region 5172. The second region 5172 defines a groove 5174 configured to guide a wire 5190 connected to the electrode 5152. The groove 5174 extends distally from the proximal end of the distal connector 5140. Figure 51 As shown, the groove 5174 passes through the proximal annular wall 5178 and the distal portion 5180, and forms a recess 5177 on the annular wall 5176. The second region 5172 may include one or more annular ribs 5182 and / or one or more through holes 5184. Figure 51 The distal connector 5140 shown has two annular ribs 5182 (a distal annular rib and a proximal annular rib) and a plurality of through holes 5184 arranged in a row, wherein a first through hole is located between an annular wall 5176 and the distal annular rib, a second through hole is located between the two annular ribs, and a third through hole is located between the proximal annular rib and the proximal annular wall 5178. As described above, one or more annular ribs 5182 can be used to connect a balloon to the distal connector 5140, while the through holes 5184 can be used to connect the distal connector 5140 to a shaft located within the central lumen 5104 of the distal connector 5140.

[0256] In this example, the distal connector 5140 also includes an electrode 5152. For example... Figure 51As shown, electrode 5152 is a ring located within a groove in the distal side 5150 of the distal connector 5140. This arrangement allows the medical device to have a flat distal side, thereby improving contact between the distal side and the target site during use. Electrode 5152 can be attached to the distal side of the first region 5170 of the distal connector 5140 via bosses and grooves. For example, electrode 5152 may include at least one groove, and the groove in the distal side 5150 may include at least one boss. Electrode 5152 can be mounted into the groove by press fitting or die forging. Electrode 5152 defines a lumen 5154. The lumen 5154 of electrode 5152 may coincide with the central lumen 5104 of the distal connector 5140, for example, the inner diameters of lumens 5104 and 5154 are the same. The lumen 5154 may be sized to accommodate a guidewire and / or deliver a fluid, such as a contrast agent.

[0257] Figure 52 A distal connector 5240 is shown, with its electrode 5252 extending distally from the distal side of the distal connector 5240, but including... Figure 51 The distal connector 5140 shown has many of the same features as described above. For example, the distal connector 5240 includes a distal side 5150'; a first region 5170' including a basket fixing assembly comprising a plurality of slots or recesses 5148' and a plurality of discontinuous protrusions 5156', including a distal protrusion 5108' and a proximal protrusion 5110', defining a retaining groove 5144' for receiving a rib fixing portion of the basket ribs, and having a proximal end 5142' that can be used as a stop; defining The groove 5177' has an annular wall 5176'; a second region 5172', the second region including a distal portion 5180', a proximal annular wall 5178', one or more annular ribs 5182', one or more through holes 5184', and defining a groove 5174' for guiding a wire 5256 connected to an electrode, the electrode 5252 extending through the proximal annular wall 5178 and the distal portion 5180, and forming a groove 5177 on the annular wall 5176. As shown, the electrode 5252 forms a distal side 5150'.

[0258] As described above, the catheter may include a proximal connector. The proximal connector is characterized as follows: Figure 10-20B As shown in Figures 53-63. Figure 10 This is an isometric view of a proximal connector 1002 used to secure a basket to a catheter. The proximal connector 1002 can be a one-piece construction. For example, the proximal connector 1002 can be molded. The proximal connector 1002 includes a distal end 1004, a proximal end 1006, a distal region 1010, a first fixation region 1030 extending proximally from the distal region 1010, and a proximal region 1050 extending proximally from the first fixation region 1030.

[0259] The distal region 1010 may include a larger diameter region 1012, a smaller diameter region 1014, at least one groove for receiving a sensor, and at least one through-hole. Figure 10 In the view shown, the sensor recess 1016 is parallel to the longitudinal axis of the proximal connector 1002. As shown, the sensor recess 1016 may be located on the outer surface of the larger diameter region 1012. The sensor recess 1016 is sized to accommodate a magnetic sensor. The smaller diameter region 1014 includes at least one through-hole. The at least one through-hole may include a through-hole (e.g., through-hole 1018) for extending one or more sensor wires from the outside of the proximal connector 1002 into the lumen of the proximal connector 1002, and / or at least one hole (e.g., hole 1020a, collectively referred to as 1020) for draining fluid from the lumen of the proximal connector 1002 (hereinafter referred to as a medium hole). As shown, the proximal connector 1002 has a plurality of medium holes 1020.

[0260] The first fixation region 1030 is used to secure the proximal end of the inflatable balloon to the proximal connector 1002. The first fixation region 1030 includes a plurality of ribs, including a distal rib 1032, at least one intermediate rib 1036, and a proximal rib 1034. Similar to the ribs in the distal connector embodiments discussed above, the ribs of the proximal connector provide a larger surface area for attaching the balloon. Figure 10 As shown, the surface 1038 between adjacent ribs is curved. As mentioned above, this increases the surface area compared to a flat surface. However, the surface between adjacent ribs can also be flat. The first fixing region 1030 may be without ribs and has an overmolded portion (i.e., a covering layer), as discussed above in the distal connector embodiment. An inflation medium can be supplied to the balloon connected to the first fixing region 1030 through the medium hole 1020.

[0261] The proximal region 1050 includes a second fixation assembly 1054 configured to secure the basket reinforcement to the proximal connector 1002, and at least one groove configured to secure the proximal connector 1002 to the conduit shaft. As shown, the second fixation assembly 1054 may include a plurality of protrusions / bodies 1058 and a plurality of recesses 1056. A wall 1060 may extend outward from the body 1062 of the boss 1058. As shown, the wall 1060 is located at the distal end of the boss 1058. The proximal region 1050 may also include at least one longitudinal ridge for guiding one or more guide wires, and at least one groove configured to secure the proximal connector 1002 to the conduit shaft. The at least one longitudinal ridge includes a first ridge 1052. As shown, the first ridge 1052 is parallel to the longitudinal axis of the proximal connector 1002. The at least one groove includes a first groove 1064 passing through the wall of the proximal connector 1002. As shown in the figure, the first groove 1064 is parallel to the longitudinal axis of the proximal connector 1002.

[0262] Figure 11 An isometric view of the proximal connector 1002, relative to Figure 10 The view has been rotated 180°. For example... Figure 11 As shown, the proximal connector also includes a second groove, namely groove 1122, which is configured to accommodate a sensor. Sensor groove 1122 is 180° away from sensor groove 1016 and forms a 20° angle with the longitudinal axis of proximal connector 1002. Placing the magnetic sensor at a 20° angle improves its accuracy. Unlike groove 1016, groove 1122 has an opening 1124 between its two ends. Sensor wires extending from the proximal end of the sensor located in groove 1122 can pass through hole 1126. Figure 11 As shown, the proximal region 1050 may include a second longitudinal ridge 1152 and a second longitudinal groove 1164. The second longitudinal ridge 1152 corresponds to the groove, for example... Figure 12 The groove 1240 shown.

[0263] Figure 12 Given Figure 10 A longitudinal cross-sectional view. A groove 1240 on the inner surface of the connector wall extends proximally from the hole 1126 to the second longitudinal groove 1164. The groove 1240 can be used to guide sensor wires through the proximal connector 1002. Two other grooves 1240 on the inner surface of the connector wall can be used to guide wires of the distal sensor and another sensor connected to the proximal connector 1002. The diameter of the proximal region 1050 is variable. For example, the diameter of the portion 1254 extending from the proximal end 1006 to the proximal end of the second fixing assembly 1054 is smaller than the diameter of the portion 1252 extending from the proximal end of the second fixing assembly 1054 to the proximal end of the first fixing region 1030. As will be discussed in more detail below, the smaller diameter portion can be inserted into the guide shaft.

[0264] Figure 13 This is an end view of the proximal connector 1002, showing a lumen 1308, a second fixing region with a boss 1058 and a groove 1056, and an opening 1302 for receiving one or more wires extending from a sensor located in the distal connector (e.g., groove 1013).

[0265] Figure 14A and 14B An isometric view is shown of the basket reinforcement 1442 connected to the second fixing member 1054 and the sensor wire 1486 located in the groove 1013. Figure 14A In the view, the basket reinforcement 1442 extending above the proximal connector 1002 is transparent. The view also shows a magnetic sensor 1408 located in a recess 1016, and two sensor leads 1410a and 1410b extending from the proximal end of the magnetic sensor 1408. The magnetic sensor 1408 can be encapsulated in the recess 1016. When the balloon is connected to the proximal connector 1002, the magnetic sensor 1408 will be located within the balloon cavity and exposed to the inflation medium. The magnetic sensor 1408 can be covered with a layer of material.

[0266] like Figure 14B As shown, to secure the basket reinforcement 1442 to the second fixing member 1054, the basket reinforcement 1442 is located in the groove 1013 between adjacent bosses 1058. The proximal end 1474 of the basket reinforcement 1442 is located on the proximal side of the proximal end of the second fixing member 1054. A gap is left between the proximal end 1474 and the outer surface of the proximal connector 1002.

[0267] The catheter may include a retaining ring (e.g., see...). Figure 15 20, 52-55). The retaining ring may be an integral retaining ring (e.g., see...). Figure 15 and 20) or multi-component retaining rings (e.g., see [reference]). Figures 54-55The retaining ring secures the basket reinforcement to the connector. One or more annular electrodes can be arranged around and / or secured to the retaining ring. Arranging one or more annular electrodes around the retaining ring offers several advantages. For example, arranging the annular electrodes around the retaining ring reduces the distance between the annular electrodes and the proximal end of the basket. As another example, arranging multiple annular electrodes around the retaining ring reduces the inter-ring electrode spacing (i.e., the distance between adjacent annular electrodes). For example, the inter-ring electrode spacing can be reduced by 67% to 77%. Another advantage is that the length between the basket and the bend of the flexible shaft (the flexible pouch length) can be shortened. For example, the length between the basket and the bend of the flexible shaft can be shortened by 35% to 43%. Furthermore, using the retaining ring disclosed herein can shorten the length from the distal end of the shaft to the flexible portion of the shaft. For example, the length from the distal end of the shaft to the flexible portion of the shaft can be shortened by 66% to 76%. Shortening one or more of the above lengths can shorten the flexible pouch length of the catheter. Shortening the flexible pouch length can improve venous accessibility.

[0268] like Figure 15 As shown, the figure provides an isometric view of an integral retaining ring 1502 configured to surround the proximal connector 1002 and / or the basket reinforcement (e.g., Figure 16The mesh basket ribs 1442 shown are arranged as follows. The retaining ring 1502 may include multiple annular portions defining a lumen sized to surround a portion of the proximal connector 1002. As shown, the retaining ring 1502 includes: a first annular portion 1510 forming a first end of the retaining ring 1502; a second annular portion 1512 extending from the first annular portion 1510; a third annular portion 1514 extending from the second annular portion 1512; a fourth annular portion 1516 extending from the third annular portion 1514; a fifth annular portion 1518 extending from the fourth annular portion 1516; and a sixth annular portion 1520 extending from the fifth annular portion 1518 and forming a second end of the retaining ring 1502. The first annular portion 1510 may form the distal end of the retaining ring 1502, while the sixth annular portion 1520 may form the proximal end of the retaining ring 1502. The outer diameter and / or inner diameter of the retaining ring 1502 may be variable. For example, in this embodiment, the outer diameter (od1) of the second annular portion 1512 is larger than the outer diameter (od3) of the third annular portion 1514, while the outer diameter (od5) of the fifth annular portion 1518 is smaller than the outer diameter (od3) of the third annular portion 1514. The inner diameter of the retaining ring 1502 can also be variable. For example, as will be discussed in more detail below, the distal end of the second annular portion 1512 can have a first inner diameter, and the second inner diameter is smaller than the first inner diameter. Furthermore, some annular portions can be at an angle. For example, in this embodiment, the first annular portion 1510, the fourth annular portion 1516, and the sixth annular portion 1520 are at an angle to the longitudinal axis of the retaining ring 1502. As shown, the first annular portion 1510 extends downward from the second annular portion 1512, the fourth annular portion extends downward from the third annular portion 1514, and the sixth annular portion 1520 extends downward from the fifth annular portion 1518. The inclined surface of the first annular portion 1510 can abut against the distal end of the wall 1060 of the boss 1058. This arrangement can serve as a hard stop for the retaining ring 1502, restricting proximal movement of the retaining ring 1502 (e.g., Figure 16 (As shown). The retaining ring may also include at least one hole 1522. The hole 1522 may be a blind hole or a through hole for securing the shaft electrode to the retaining ring 1502.

[0269] Figure 16 For the purpose of illustrating an isometric view, the retaining ring 1502 is positioned around a basket rib 1442 connected to a second fixing member 1054, and a shaft 1606 with one or more electrodes 1610 is positioned above the retaining ring 1502. The proximal connector 1602 may be a multi-component assembly including a proximal connector 1002 and the retaining ring 1502.

[0270] like Figure 16As shown, the retaining ring 1502 may include one or more rigid stop structures to restrict distal and / or proximal movement of the retaining ring 1502. For example, the distal end of the retaining ring 1502 may be located at the distal end of the wall 1060 of the boss 1058. The smaller second inner diameter of the second annular portion 1512 may form a surface that contacts the proximal end face of the wall 1060 of the boss 1058. This structure can serve as a rigid stop structure for the retaining ring 1502 to restrict distal movement of the retaining ring 1502. Similarly, the inner diameter of the first annular portion 1510 may extend downward so that the first annular portion 1510 is located near the distal end surface of the wall 1060 of the boss 1058. The proximal end of the third annular portion 1514 may be aligned with the proximal end of the second retaining member 1054. The inner diameter of the third annular portion 1514 may be the same as the second inner diameter of the second annular portion 1512. The distal end of the fourth annular portion 1516 may be aligned with the proximal end of the second retaining member 1054. The fifth annular portion 1518 may be located above the proximal end 1474 of the net basket reinforcement 1442. The proximal end of the sixth annular portion 1520 is located near the end of the net basket reinforcement 1442.

[0271] The distal end of shaft 1606 may extend to the proximal end of the second annular portion 1512 of retaining ring 1502. The distal end of shaft 1606 may abut against the distal shaft electrode 1610a or the second annular portion 1512 of retaining ring 1502. Shaft 1606 may be secured to retaining ring 1502 by adhesive and / or welding. The advantage of this arrangement is that retaining ring 1502 and shaft 1606 overlap, which may improve catheter performance.

[0272] The electrode connected to the fixing ring can be a ring electrode. For example... Figure 16 As shown, the distal shaft electrode 1610a is located above the third annular portion 1514. The blunt end of the second annular portion 1512 can serve as a hard stop for the distal shaft electrode 1610a. The distal shaft electrode 1610a can be overmolded onto the retaining ring 1502. The advantage of using the retaining ring 1502 is that, since the distal shaft electrode 1610a abuts against the blunt end of the second annular portion 1512 (which can also serve as a hard stop), there is no need to press-fit the distal shaft electrode 1610a. Figure 16 As shown, the second axial electrode 1610b is located near the end of the retaining ring 1502. Figure 16 As shown, one of its advantages is that the axial electrode 1610 can be narrower than a typical axial electrode. This allows for a smaller gap between the distal axial electrode 1610a and the adjacent axial electrode 1610b.

[0273] like Figure 16As shown, one advantage of the connector 1002 is that, since the sensor 1408 is located within the balloon cavity connected to the proximal connector 1002, the distal axial electrode 1610 can be closer to the distal assembly (where the sensor is typically located). With this arrangement, the position and / or orientation information of the distal assembly determined by the signal from the distal axial electrode 1610a can be acquired more quickly than with a distal axial electrode closer to the proximal end. Furthermore, the distal assembly with this proximal connector 1002 is shorter, which may improve catheter function, for example, making passage through the guide easier.

[0274] Figure 17 This is an isometric view of another embodiment of the proximal connector 1702. The proximal connector 1702 has the same advantages as the proximal connector 1002. The proximal connector 1702 includes a connecting member 1718 having a distal end 1704 and a proximal end 1706, and a retaining ring 1710 surrounding the connecting member 1718. The connecting member 1718 includes a retaining region 1720 for attaching a balloon to the proximal connector 1702, an intermediate portion 1740 extending from the retaining region 1720 to the distal end of the retaining ring 1710, and a proximal region 1750 extending from the distal end of the retaining ring 1710 to the proximal end 1706. The connecting member 1718 also includes at least one recess 1724 and / or at least one slot 1742. Similar to the proximal connectors discussed above, at least one slot 1742 may be configured to receive a sensor (e.g., a magnetic sensor). Figure 17 As shown, the groove 1724 is parallel to the longitudinal axis of the connecting member 1718. Similar to the proximal connector 1002, the proximal connector 1702 may include a second groove at a 180° angle to the groove 1724 and at an inclined angle to the longitudinal axis of the proximal connector 1702. A first opening 1722 may extend from the distal end of the groove 1724. A second opening 1744 extends from the proximal end of the groove 1724. The connecting member 1718 may also include a third opening, such as a slot 1742. In at least one embodiment, the second opening 1744, the third opening 1742, and the... Figure 17 The additional opening, not visible in the view shown, is configured to route wires (e.g., magnetic sensor wires) from the outer surface of the connector to the inner surface of the proximal connector, through below the retaining ring 1710, and then back to the outer surface of the proximal connector near the retaining ring 1710.

[0275] Figure 18This is a longitudinal cross-sectional view of the proximal connector 1702, showing the lumen 1808 defined by the connector member 1718. Similar to the first fixation region 1030 of the proximal connector 1002 discussed above, the fixation region 1720 includes a plurality of ribs, including a distal rib 1832, at least one intermediate rib 1836a (collectively referred to as 1836), and a proximal rib 1834. As mentioned above, these ribs provide a larger surface area for balloon attachment. Figure 18 As shown, the surface 1838 between adjacent ribs is curved. As mentioned above, this increases the surface area compared to a flat surface. In other embodiments, the surface between adjacent ribs is flat. In other embodiments, the first fixing region 1030 may be without ribs and has an overmolded portion as described in the distal connector embodiment above.

[0276] The inner surface of the proximal connector 1702 defines at least one hole. Figure 18 In the illustrated embodiment, the proximal connector 1702 includes a distal bore 1810 (whose first diameter is for receiving a basket support shaft), an intermediate bore 1814 (whose second diameter is smaller than the first diameter), and a proximal bore 1816 (whose third diameter is larger than the second diameter and is sized to receive a catheter shaft). In some embodiments, the support shaft floats freely within the lumen of the proximal connector 1702, thus allowing the support shaft to translate within the distal bore 1810 (↔ in the figure). As described above, the support shaft can be bonded to the distal connector, therefore, the relative positions of the distal and proximal connectors may change during use—becoming farther or closer (e.g., during catheter insertion and / or withdrawal through the guide, or during balloon inflation). The catheter shaft inserted into the proximal bore 1816 may abut against edge 1820. The catheter shaft inserted into the proximal bore 1816 forms an expansion cavity for delivering balloon inflation media. In some embodiments, the expansion cavity extends from one or more holes in a support tube extending distal to the proximal connector. In other embodiments, the proximal connector 1702 includes one or more orifices (not shown) in fluid communication with the expansion chamber.

[0277] Figure 19 This is an exploded view of the connecting member 1718 and the retaining ring 1710. In at least one embodiment, the connecting member 1718 and the retaining ring 1710 are connected together. For example, the connecting member 1718 and the retaining ring 1710 are connected by a groove 1910 formed on the outer surface of the connecting member 1718. The groove 1910 can serve as a rib groove.

[0278] Figure 20A and 20BThese are isometric views and end views of the retaining ring 1710. The retaining ring 1710 includes a wall 2008 defining a lumen 2002, a first annular portion 2012 having a first outer diameter, and a second annular portion 2014 having a second outer diameter. In this embodiment, the first outer diameter is larger than the second outer diameter. The wall 2008 defines a plurality of channels 2016 for receiving the basket reinforcement bars. The inner surface of the wall 2008 may define a groove 2018 for connecting the retaining ring 1710 and the connecting member 1718 together. The groove 2018 may serve as a keyway.

[0279] like Figures 53-59 As shown in the figure, other features of the proximal connector are illustrated. Figure 53 A proximal connector 5302 is shown connected to at least one shaft, which is an inner shaft 5308 extending from the proximal end of the proximal connector 5302. The proximal connector 5302 includes a connector body 5306, which may be integral or composed of multiple parts. Similar to the proximal connector 1702, the proximal connector 5302 includes a distal portion 5310, an intermediate portion 5340, and a proximal portion 5350. The distal portion 5310 may be separable from the intermediate portion 5340. For example, the distal portion 5310 may include a male connector configured to be received within the central lumen of the intermediate portion 5340. The distal portion 5310 and the intermediate portion 5340 may include complementary structures configured to prevent rotation of one portion 5310 or 5340 relative to the other portion 5340 or 5310. For example, these complementary structures may be grooves and protrusions. The distal portion 5310 may include a balloon fixation region. The balloon fixation area may be an overmolded area of ​​the distal portion 5310. The intermediate portion 5340 may include a basket fixation assembly comprising a plurality of alternately arranged protrusions 5312 and grooves / slots 5318. Each protrusion 5312 may include a distal end 5314 and a proximal end 5316. As described above, the protrusions 5312 and grooves 5318 may be configured to secure the ribs to the proximal connector 5302 and may include alignment and / or retention portions. The proximal end / edge of the proximal connector 5302 may define at least one groove, such as groove 5354. Groove 5354 may contain adhesive for securing the proximal connector 5302 to another component of the catheter, such as the catheter shaft.

[0280] The proximal connector may define at least one sensor channel. The sensor channel may be configured to accommodate an electromagnetic sensor. For example... Figure 53As shown, the proximal portion 5350 defines a sensor channel 5352. A sensor wire 5332 may extend from the distal end of the sensor 5330. The polarity of the sensor 5330 is opposite to that of the sensor 4966 coupled to the distal connector 4840. Therefore, the sensor 5330 can be described as having reverse polarity. Navigation and / or imaging protocols (e.g., software) can be adjusted to accommodate the reverse polarity sensor. The pin connections of the sensor wire 5332 of the reverse polarity sensor can also be adjusted to accommodate the reverse polarity sensor. The reverse polarity sensor can provide stress relief for the sensor wire 5332. Reversing the polarity provides sufficient space for the wiring of the sensor wire, thereby reducing wear. Utilizing the sensor channel to secure the sensor and wiring can shorten the required length of the sensor wire. This may reduce the size of the flexible pouch.

[0281] like Figure 54 As shown, the proximal connector 5402 may include a retaining ring 5419 disposed around the connector body. The retaining ring 5419 may be disposed around the ribs of the basket fixing assembly connected to the proximal connector 5402. Thus, the retaining ring 5419 may secure multiple ribs 5422 to the proximal connector 5402. At least one electrode (collectively referred to as 5490) may be connected to the retaining ring 5419. The outer surface of the electrode may be flush with the outer surface of the retaining ring 5419. Figure 53 A first annular electrode 5490a and a second annular electrode 5490b are shown connected to a retaining ring 5419. The annular electrode 5490 can be fixed to the retaining ring 5419 without press-fitting. For example, the annular electrode 5490 can be press-fitted into the retaining ring 5419. As described above, the retaining ring can be composed of multiple components. For example, the first retaining ring component 5432 and the second retaining ring component 5442 can be separate components, rather than a single component for housing the annular electrode 5490.

[0282] An outer shaft 5488 may extend from the proximal end of a retaining ring 5419. The outer shaft 5488 may surround the proximal portion of the proximal connector 5302 and the inner shaft (e.g., shaft 5308). A shaft 5480 may extend from the distal end of the distal portion 5410 of the proximal connector 5402. Shaft 5480 may be the inner shaft (e.g., shaft 5308) or a separate support shaft (e.g., support shaft 383 discussed above).

[0283] As described above, the proximal connector can define one or more channels or slots. The channels / slots can be configured to accommodate one or more wires. For example, such as... Figure 54 As shown, the proximal connector 5402 defines a channel 5560 through which a wire 5554 passes. One or more channels may be defined by the proximal portion 5550. The channels / slots may be arranged longitudinally. Figure 55The channel / groove shown has straight sidewalls, thus giving the channel a constant circumferential width. However, the sidewalls can also be stepped, thus giving the channel a variable circumferential width (e.g., see...). Figure 56 (See channel 5560'). The stepped sidewalls may have a wider width on the first surface of the connector and a narrower width on the second surface. For example, a channel with a variable circumferential width may be funnel-shaped, wider at the distal end of the channel and narrower at the proximal end (see, for example, see...). Figure 56 (See channel 5560' shown). This structure can significantly reduce the soldering of wires extending from the proximal end of the expandable end assembly.

[0284] One or more wires may also extend along the outer surface of the proximal connector 5402. For example, Figure 55 The wire 5556 is shown extending below the retaining ring 5419 and along the outer surface of the proximal portion 5550. The wire 5556 can be connected to a sensor or electrode that is connected to a component of the end assembly (e.g., a basket connector, a distal connector).

[0285] As described above, the proximal connector may include one or more alignment and / or retaining parts. For example, such as Figure 55 As shown, the proximal connector 5402 may include an alignment portion for joining first and second retaining ring assemblies 5432, 5442 together. The alignment portion is a key assembly 5538. The first retaining ring assembly 5432 includes a key 5539, and the second retaining ring assembly 5442 defines a groove / recess 5540 for receiving the key 5539. Alternatively, the alignment / retention portion may be an edge. For example, as... Figure 55 As shown, the retaining ring 5419 includes multiple edges 5534, 5536, and 5544, configured to retain / position multiple annular electrodes. The annular electrodes can be positioned between and / or retained within a groove / slot by one or two edges. The groove / slot may be formed by a portion of the retaining ring components 5432 and 5442 with a reduced outer diameter. For example, the outer diameter of the proximal portion 5543 of the second retaining ring component 5442 may be reduced. As shown in the figure. Figure 55As shown, the first annular electrode 5490a is secured and abuts against a first edge 5534 and a second edge 5536. The first edge 5534 may be defined by a first retaining ring member 5432. The second edge 5536 may be the distal edge of the second retaining ring member 5442. The distal edge of the second annular electrode 5490b may be secured and abuts against a third edge 5544. The proximal edge of the second annular electrode 5490b may abut against a shaft (e.g., outer shaft 5488) connected to the proximal connector 5302. A stop may be provided along the outer surface of the proximal connector 5302. For example, edge 5552 extends along the outer surface of the proximal portion 5350 of the proximal connector 5302. Edge 5552 may provide a hard stop for the second retaining ring assembly 5442. The inner surface of the proximal connector may also be provided with an alignment / holding function (e.g., see...). Figure 57 ).

[0286] like Figure 57 As shown, the figure presents a cross-sectional view of the proximal connector 5402. The proximal connector 5402 may include an inner surface 5702 defining a central lumen 5709. As described above, the proximal connector may be composed of multiple components. The various components of the proximal connector may overlap. For example, as... Figure 57 As shown, the distal side 5738 of the second retaining ring member 5442 overlaps with the proximal side 5734 of the first retaining ring member 5432. The overlapping members can have complementary shapes or surfaces. For example, the shape of the overlapping portion of the proximal portion 5543 of the second retaining ring member 5442 is complementary to the shape of the proximal portion 5350 extending distally from the edge 5752. In this example, the complementary shape is a curved surface. However, any complementary shape can be used.

[0287] like Figure 57 As shown, the basket reinforcement 5422 may be located between the retaining ring 5419 of the proximal connector 5402 and the intermediate region 5740. Each reinforcement 5422 may include an electrical connector 5724 connected to the end of the reinforcement 5422. A space 5716 may exist near the electrical connector 5724. Flexible circuitry connected to the electrical connector 5724 may be located within the space 5716. The space 5716 may be defined by the inner surface of the second retaining ring assembly 5442 and the intermediate region 5740 of the proximal connector 5402.

[0288] As described above, the inner surface of the connector may include a retaining / aligning portion. For example, the proximal connector 5402 includes an annular protrusion / edge 5712 disposed along the inner surface of its intermediate portion 5340. The protrusion 5712 can act as a hard stop for the inner shaft 5708, which can abut against the protrusion 5712. Therefore, the protrusion 5712 can restrict distal movement of the inner shaft 5708.

[0289] The wires can be routed along the inner surface 5702 of the central lumen 5709. For example, as... Figure 57 As shown, conductor 5764 can be located inside sheath 5762.

[0290] like Figure 58 As shown in the figure, the retaining / aligning portion of the connector is illustrated. Similar to the connectors discussed above, connector 5402 includes a basket retaining assembly with a protrusion 5812 and a groove for receiving the basket ribs 5422. Figure 58 As shown, the reinforcing rib 5422 may include a first set of reinforcing rib retaining portions 5830a and a second set of reinforcing rib retaining portions 5830b. The first set of reinforcing rib retaining portions 5830a is configured to abut against the distal end 5814 of the protrusion 5812, and the second set of reinforcing rib retaining portions 5830b is configured to abut against the proximal end of the protrusion 5812. The basket fixing assembly may also include a retaining / aligning portion configured to connect the intermediate region 5740 of the connector 5402 to the retaining ring 5419. For example, the distal end 5814 of the protrusion 5812 may include a protrusion configured as a hard stop at the distal end of the retaining ring 5419. The distal end of the first retaining ring assembly 5432 may define a retaining portion that engages with the protrusion to retain the position of the retaining ring 5419. For example, the distal end of the first retaining ring assembly 5432 may extend downward to abut against the distal end of the protrusion. This may restrict proximal movement of the retaining ring 5419. The distal end of the first retaining ring member 5432 may be further formed with an edge that abuts against the proximal side of the protrusion 5812. Therefore, the retaining ring structure may be a channel / groove, for example, defined by the downwardly extending distal end and the edge. The retaining ring 5419 can also be connected to the connector body 5306 using an alignment portion. This alignment portion may include a snap-fit ​​connector comprising a protrusion configured to engage in a recess or groove. For example, the proximal end 5816 of the protrusion 5812 may be configured to engage in a groove 5892 defined by the inner surface of the first retaining ring member 5432.

[0291] like Figures 59-61 As shown, the conduit may include a deflection assembly comprising at least one pull wire for deflecting the conduit shaft. This deflection assembly can be connected to a proximal connector. The advantage of securing the deflection assembly to the proximal connector compared to connecting it to the conduit shaft is that the connector provides support for the pulling force used to deflect the conduit. Another advantage of this arrangement is improved electrical isolation between the deflection assembly and the conductor / wire. Furthermore, this arrangement provides more space for wiring. Moreover, integrating the deflection assembly may be more cost-effective than using a separate connector and deflection assembly. The at least one pull wire may also “float” within the lumen defined by the inner and outer shafts of the conduit. The pull wire can be connected to the proximal connector in any suitable manner. For example, the pull wire can be secured to the proximal connector using anchors. Anchors can secure at least one pull wire to the proximal connector. Examples of anchoring devices include pull wire loops (e.g., see...). Figure 59 ) or crimp sleeve (e.g., see Figure 61 ).

[0292] The proximal connector 5402 may also include at least one fixing portion for securing at least one guy wire anchor to the proximal connector 5402. Therefore, these retaining portions can be described as deflection assembly retaining portions. Figure 59 and Figure 61 A proximal connector 5402 is shown, which has two annular retaining portions, a distal retaining portion 5952, and a proximal retaining portion 5954 (in Figures 54-55 and Figures 57-58 (Not visible in the middle). A groove for accommodating the guy wire anchor may be located between retaining parts 5952 and 5954. (As shown) Figure 59 and 61 As shown, retaining portions 5952 and 5954 are discontinuous. For example, channel 5560 passes through retaining structures 5952 and 5954. However, the retaining portions can also be continuous. The proximal retaining portion 5954 may include a downwardly extending inclined proximal surface, for example, extending toward the longitudinal axis of the proximal connector 5402.

[0293] Figures 59-60 Different views of the proximal connector 5402 are shown, in which a pull ring 5910 is located between retainers 5952 and 5954. The pull ring 5910 can be secured to the proximal connector 5402 by crimping, interference fit, or adhesive. When the pull ring 5910 is located between retainers 5952 and 5954, its outer surface can be flush with the outer surfaces of retainers 5952 and 5954. At least one pull wire (not visible in the figure) can extend proximally from the pull ring 5910. An outer shaft (e.g., outer shaft 5488) can be arranged around the pull ring 5910 and abut against an annular electrode (second annular electrode 5490b). The pull ring 5910 may extend one or more grooves (hereinafter referred to as pull ring grooves) on its proximal distal side. The pull ring grooves may coincide with the grooves / channels defined by the proximal connector 5402. For example, as Figure 59 As shown, pull ring 5910 includes a pull ring groove 5912 that coincides with channel 5560. The width of the pull ring groove should be at least the same as the width of the overlapping groove / channel defined by the proximal connector. For example, the widths of pull ring groove 5912 and channel 5560 are the same. Providing a pull ring groove with a width at least equal to the width of the groove / channel defined by the proximal connector allows space for wire and / or cable routing within the groove / channel. The distal edge of pull ring 5910 may not extend beyond the proximal groove.

[0294] Figure 60 The position and orientation of the magnetic sensor are shown. The magnetic sensor 6030 is located within the sensor channel 6052 relative to the pull ring 5910. The magnetic sensor 6030 can be tilted relative to the longitudinal axis of the proximal connector 5402. The magnetic sensor 6030 has a distal-facing end 6032 and a proximal-facing end 6034. (As shown...) Figure 60 As shown, sensor channel 6052 can pass through distal retaining portion 5952. Proximal facing end 6034 of magnetic sensor 6030 can abut against pull ring 5910. As described above, sensor 6030 can have reverse polarity, with its sensor wire extending from distal facing end 6032. Distal facing end 6032 can be located below a portion of retaining ring 5419. Figure 60 As shown, sensor channel 6052 can pass through distal retaining portion 5952. The proximal facing end 6034 of magnetic sensor 6030 can abut against pull ring 5910. As described above, the polarity of sensor 6030 can be reversed, and sensor wires extend from distal facing end 6032. Distal facing end 6032 can be located below a portion of retaining ring 5419. Figure 60 As shown, the second fixing ring component 5442 of the fixing ring 5419 can be located on the distal facing end 6032.

[0295] Figure 61 A crimped sleeve (collectively referred to as 6104) is shown located between fixing portions 5952 and 5954. The crimped sleeve 6104 may abut against one or both of the fixing portions 5952 and 5954. A first pull wire 6102a extends from the proximal end of the first crimped sleeve 6104a, and a second pull wire 6102b extends from the proximal end of the second crimped sleeve 6004b. The second pull wire 6102b may form a 180° angle with the first pull wire 6102a.

[0296] like Figure 62 As shown in the figure, other features of the distal portion 5410 of the proximal connector 5402 are illustrated. As described above, the distal portion 5410 of the connector 5402 may include a balloon fixation region for securing the balloon 6246 to the proximal connector 5402. This balloon fixation region may include at least one through-hole 6204 extending from the outer surface of the distal portion 5410 to the intermediate region 5740 of the proximal connector 5402. The balloon may be attached to the proximal connector using thermal bonding rather than adhesive bonding. The overlay 6202 may be configured to thermally bond the balloon to the proximal connector and / or bond the distal sensor wire 6267 to the proximal connector. For example, when the overlay 6202 is heated, the overlay 6202 may flow back into one or more through-holes 6204, causing at least a portion of the overlay 6202 to extend to the inner surface 5702 of the proximal connector 5402. The hardness of the overlay 6202 can be similar to that of the balloon used to bond the balloon to the proximal connector. The material constituting the proximal connector 5402 can be harder than the material used for the overlay 6202. The overlay 6202 can be heated using a laser.

[0297] As described above, the basket reinforcement bars can be parallel to or not parallel to the longitudinal axis of the end assembly when the basket is in the expanded state. The proximal and distal connectors described above can be used to connect the basket, regardless of whether the basket reinforcement bars are parallel to the longitudinal axis of the end assembly when the basket is in the expanded state.

[0298] Medical devices such as catheters 102, 202, and 302 can be designed to bend as they are advanced through guides and / or body cavities. A challenge with maneuverable catheters is predicting their degree of bending—which can be too great or too small. Therefore, controlling the degree of bending is crucial. For catheters used in complex anatomy, pre-programmed bending shapes can also be helpful. Furthermore, during catheter advancement, the forces acting on the distal end of the catheter may be greater than on other parts of the catheter. This can affect catheter performance; for example, the catheter shaft may become kinked. Therefore, improving the catheter's response speed to applied forces is essential.

[0299] To control catheter bending and / or prevent kinking, a specific pattern can be cut into at least a portion of the catheter shaft (hereinafter referred to as the cut portion). The pattern can be helical or non-helical. Typically, the pattern is cut into the wall of the catheter shaft, with the cut line extending from the outer surface of the catheter shaft to the inner surface.

[0300] At least one axis of the catheter may include at least one trimmed axis pattern. The trimmed axis pattern may be located within the end-effector, such as basket 240 or end-effector 339. For example, as discussed above, the inner axis of support axis 382 may include a trimmed axis pattern. Another example is an inner axis (e.g., inner axis 308) that includes a trimmed axis pattern. The trimmed axis pattern may be located within the end-effector, and at least one trimmed axis pattern may be located proximally to the end-effector. A controllable catheter with two controllable trimmed axis patterns may also have advantages. For example, the catheter may have a first portion configured to bend at a predetermined angle (e.g., 90°); a second portion being a straight portion extending from the first portion; and a third portion being a curved portion extending from the second portion. Different portions may employ different trimmed axis patterns. For example, the spiral trimmed axis patterns of the first and third portions may be the same but different sizes, or they may be different spiral trimmed axis patterns. A catheter with at least one trimmed axis portion can be used for a variety of procedures. For example, electrophysiological procedures, dilation procedures, and device delivery / implantation procedures (e.g., implantation of a left atrial appendage occluder or stent).

[0301] The bending axis experiences compressive stress on the inside of the bend and tensile stress on the outside. It is advantageous to distribute the stress / force away from the inside / outside of the bend. In at least one embodiment, a cutting pattern as described herein can distribute the force / stress circumferentially.

[0302] like Figure 21As shown, the figure illustrates an isometric view of a non-spiral pattern 2104 cut out from the basket support shaft 2102. This non-spiral pattern 2104 includes multiple slots 2106 perpendicular to the longitudinal axis of the basket support shaft 2102 and multiple support members 2110 parallel to the longitudinal axis of the basket support shaft 2102. As shown, the slots 2106 and support members 2110 can be arranged alternately in a circumferential direction, with longitudinally adjacent slots offset from each other in the circumferential direction. For example, slot 2106a is longitudinally adjacent to slot 2106b, but offset from slot 2106b in the circumferential direction. This arrangement of the slots 2106 divides the support members 2110 into several groups, each group of members arranged along a straight line parallel to the longitudinal axis of the basket support shaft 2102. For example, support members 2110a and 2110b belong to the first group of support members 2110 arranged along a straight line parallel to the longitudinal axis. Similarly, support members 2110c and 2110d belong to the second support member group 2110, which is arranged along a second straight line parallel to the longitudinal axis.

[0303] As mentioned above, the cutting pattern can be helical. The column strength of a shaft portion with a helical cutting pattern may be reduced compared to a shaft portion without a helical pattern. The helical pattern can reduce bending deformation of the shaft portion. The helical pattern can influence or control the bending angle of the shaft portion. For example, a helical pattern with a larger maximum bending angle will result in a larger bending angle than a helical pattern with a smaller maximum bending angle. The bending angle can be measured as the change in angle per unit length. For example, a 180° bend might have a bending angle of 18° / inch, while a 90° bend might have a bending angle of 9° / inch.

[0304] Unlike typical cut patterns, the bending characteristics of the cut shaft portion are determined and predicted by the cut dimensions of the spiral pattern. Therefore, the advantage of the spiral cut method disclosed herein is that it can be cut into conduit shafts made of a variety of materials, including metallic and / or polymeric materials. Some non-limiting examples of conduit shaft materials include nickel-titanium alloys, stainless steel, polyether intercalated amide (PEBA), polyethylene terephthalate (PET), polyetheretherketone (PEEK), and / or polyetherimide (PEI).

[0305] Because the cutting dimensions of the helical pattern determine the bending characteristics of the cut shaft portion, shafts cut with the same helical pattern exhibit consistent performance characteristics. For example, nickel-titanium alloy shafts and stainless steel shafts cut with the same helical pattern have the same bending characteristics. Conversely, nickel-titanium alloy shafts and stainless steel shafts cut with the same typical cutting pattern exhibit different bending characteristics. Applying the same helical pattern to shafts of different materials provides design flexibility. For example, the helical pattern described herein can be used for catheter shafts required for different surgeries. Furthermore, the choice of shaft material can be independent of the choice of helical pattern. The selection of shaft material can be based on other factors such as intended use, strength, cost, etc. The helical pattern can be processed by laser cutting or milling. For example, the pattern can be cut on the shaft using a Swiss-type milling machine. In some embodiments, the outer and / or inner surfaces of the cut shaft portion are exposed—in other words, there is no coating or layer on the surface.

[0306] Table 1 provides some equations describing certain characteristics of the spiral pattern disclosed herein. References will follow below. Figure 22-33 Exemplary spiral patterns with these properties will be discussed in more detail.

[0307] Table 1

[0308]

[0309] Wherein, the helix length SL represents the length of the expanding pattern, the pitch P is the longitudinal distance between adjacent turns of the helix pattern, and the helix angle θ is the angle between one turn of the helix pattern and an axis parallel to the longitudinal axis (see [reference]). Figure 22 Angle A7 is shown in the figure.

[0310] The pitch P affects the bending characteristics, longitudinal characteristics, and / or the ratio of cutting space to material of the cutting shaft portion. For example, in some embodiments, a cutting shaft portion with a smaller pitch requires less force to bend than a cutting shaft portion with a larger pitch. The pitch P of the helical pattern can vary. For example, the pitch P of one helical pattern can be seven times (7x) the pitch P of another helical pattern. As shown in Table 1, the selected pitch P affects the number of turns about the longitudinal axis of the shaft, the helical length SL of the cutting pattern, and the helix angle. For example, the number of turns n of the helical pattern is inversely proportional to the pitch P. Therefore, as the pitch increases, the number of turns n decreases. As another example, the helix angle θ is inversely proportional to the pitch P. As the helix angle θ increases, the pitch P may decrease—in other words, for a given length, a helical pattern with a larger helix angle θ (a tighter pitch P) has more turns than a helical length with a smaller helix angle θ (a looser pitch P). The helical pattern can be a left-handed helix with a tilted helix angle θ. The helix angle θ can control the bending shape of the cutting shaft portion when bending. The tilted helix angle θ can be equal to or greater than 45° and / or less than 90° (90° > θ ≥ 45°). When the axis is straight, the helix angle θ of each turn (e.g., Figure 22 The helix angle A7 of the circle 2213 shown can remain constant—each circle is oriented with the same helix angle θ. The helix angle θ used in the helical pattern may vary. For example, the first part of the helical pattern may be oriented with a first helix angle θ1, while the second part may be oriented with a second helix angle θ2. This gives the cut shaft portion two different bending characteristics.

[0311] The spiral pattern comprises a trunk oriented at a helical angle θ. This helically oriented trunk extends in multiple turns around the longitudinal axis of the axis, from one end of the pattern to the other. As used herein, a single turn extends a maximum of 360° around the longitudinal axis of the axis. The trunk width may vary between different spiral patterns. For example, the trunk of one spiral pattern may be wider than the trunk of another spiral pattern (for comparison). Figure 22 The main trunk 2212 and Figure 28 (The main stem 2812). A spiral pattern with a wider main stem may be easier to bend (e.g., less force is required to bend it).

[0312] Each loop of the trunk can contain multiple elements. These trunk elements can have the same shape or different shapes. Elements in one loop of the spiral trunk at the end of the spiral pattern extend from one side of the trunk, while elements in other loops extend from both sides. The trunk can consist of alternating first and second sections, where each first section has extending elements, while each second section has no extending elements. Elements extending from both sides of the first section of the trunk can be arranged along the axis. This arrangement allows trunk elements in adjacent loops to be aligned in rows. Furthermore, when the axis is loaded, these elements can respond to the load like a beam. In contrast, elements in a typical cut pattern that are offset or staggered along the circumference do not respond to the load like a beam. Multiple elements extending from both sides of each loop of the trunk can also improve the bending characteristics of the cut section. For example, the cut section can bend in multiple directions. Without being bound by theory, a trunk with multiple elements can more easily transition between tighter patterns (closer loops) and looser patterns (looser loops), thus allowing for different bending angles along the length of the cut axis section. For example, the cut portion can exhibit different bending angles along the length of the cut axis portion.

[0313] Multiple components can be interlocked. For example, these components may include a component base (having a first width) extending from the main body and a component head (having a second width greater than the first width) located at one end of the component base. One component or two circumferentially adjacent components extending from the first ring of the main body can define a slot, the opening end of which is defined by the component head, and the sides (width) by the component base. The slot is sized to accommodate components extending from a second ring. Components can translate within the slot. For example, components can translate when the cut shaft portion is straight and / or curved. Because the direction of the slot includes a longitudinal component, the cut shaft portion can longitudinally expand and contract as the component translates within the slot, thus providing another degree of freedom for the cut shaft portion. In other words, the cut shaft portion does not resist stretching or compression. This contrasts with typical cutting methods that restrict the longitudinal movement (stretching or compression) of the cut shaft portion. The amount of longitudinal expansion / contraction can be calibrated. For example, the longitudinal expansion / contraction of the helical pattern can be adjusted to the desired value by adjusting the size / length of the component base, the size / length of the component head, the helix angle θ, and / or the pitch P. Furthermore, as mentioned above, the pitch affects the number of turns for a given length, thus affecting the longitudinal characteristics of the cut-axis portion. For example, a larger pitch may produce greater longitudinal expansion / contraction than a smaller pitch.

[0314] The spiral pattern can be customized to meet the required strength. For example, for the same wall thickness and pipe diameter, a first spiral pattern (e.g.) can be used. Figure 22 The cutting axis portion of pattern 2210 shown may be larger than that of a pattern with a second spiral pattern (e.g., Figure 28The cutting shaft portion of pattern 2810 shown has higher strength.

[0315] Figure 22-27 A first embodiment of a spiral pattern having at least one of the above-described features / properties is shown. See also Figure 22 The figure shows a left-handed spiral pattern 2210 passing through the wall of axis 2208. This pattern 2210 includes a trunk 2212 that extends spirally around the longitudinal axis of axis 2208 at least one turn, with nine turns 2213a-2213i (collectively referred to as turns 2213) shown in the figure. The number of turns 2213 may depend on the spiral length SL and / or spiral angle θ of the spiral pattern, as discussed previously. As shown, the trunk 2212 can be symmetrical about the major axis 12. The major axis 12 can divide the trunk 2212 into two mirror-symmetrical parts. When axis 2208 is a straight axis, as... Figure 22 As shown, each turn 2213 is oriented with a tilted helix angle A7, which is measured between the axis 12 of the main trunk 2212 (provided as turn 2213i in this figure) and the axis 10 parallel to the longitudinal axis of axis 2208. Multiple elements (discussed in more detail below) extend from the side of the main trunk 2212.

[0316] The gap or groove 2230 located between rings 2213c and 2213d can define the geometry of the main shaft 2212 and its extensions. The width of the gap 2230 can be uniform. For example, in some embodiments, when the shaft is straight, the width of the gap 2230 can be uniform, such as... Figure 22 As shown. The width of the gap 2230 can also be non-uniform. For example, when the shaft is bent, the width of the gap 2230 can be non-uniform, such as... Figure 23 As shown. The width of the gap 2230 can also be non-uniform, for example, when the shaft is straight, such as... Figure 24 As shown. Pattern 2210 may include rounded corners, which can provide higher strength and / or durability compared to right angles.

[0317] As mentioned above, the cutting shaft section can control the bending of the conduit. Figure 23 This illustrates how the spiral pattern 2210 adapts to the bending of the shaft 2208. The advantage of the spiral pattern 2210 is that it can adapt to a wider variety of bends compared to typical cut patterns. The spiral pattern 2210 may experience compressive stress at the inner side 2304 of the bend and tensile stress at the outer side 2302 of the bend. Features of the spiral pattern 2210, such as... Figure 25 The element 2518 shown may translate longitudinally and / or rotate circumferentially as the cutting axis portion bends. For example... Figure 23As shown, compared to the outer bend 2302, adjacent spiral coils 2213 along the inner bend 2304 are compressed (closer to each other). This performance characteristic is achieved through the alignment of element 2518, as described below. In other words, on the inner bend, element 2518 can fit tightly against adjacent coils 2213 of the main stem 2212; while on the outer bend 2302, a gap can exist between element 2518 and adjacent coils 2213 of the main stem 2212. Along the outer bend 2302, the pitch P between adjacent coils can be greater than the pitch P along the inner bend 2304. When shaft 2208 bends, element 2518 can always remain within the shaft wall. This gives shaft 2208 a smooth outer surface.

[0318] like Figure 24 As shown in the figure, half of two adjacent rings 2213a and 2213b in pattern 2210 are displayed. In this embodiment, the main trunk 2212 is composed of alternating main trunk sections of different shapes. Figure 24 In circle 2213b, the two first main branches 2414a and 2414b are identified by a first diagonal line pattern, and the two second main branches 2416a and 2416b are identified by a second diagonal line pattern. In this example, the first main branch 2414a is shorter than the second main branch 2416a. Figure 24 As shown, the spiral pattern elements extend only from the first main section 2414. The first main section 2414 and / or the second main section 2416 may be symmetrical about an axis perpendicular to the long axis of the main section 2212 (e.g., axis 15). The width of the first main section 2414 may be constant, while the width of the second main section 2416 may vary.

[0319] Components (e.g.) Figure 25 Component 2518 shown may be connected to or extend from the side of the first trunk portion 2414, while no component is connected to or extends from the side of the second trunk portion 2416. In this application, a side refers to a portion extending from the outer surface of the shaft to the inner surface of the shaft. Each second trunk portion 2416 may include a first trunk side 2450, a second trunk side 2452, a third trunk side 2454, and a fourth trunk side 2456. The first trunk side 2450 is located between the first trunk portion 2414a and the second trunk side 2452. The second trunk side 2452 is located between the first trunk side 2450 and the third trunk side 2454, and the third trunk side 2454 is located between the second trunk side 2452 and the fourth trunk side 2456. The fourth trunk side 2456 is located between the third trunk side 2454 and another first trunk portion 2414b. The second main trunk side 2452 and the third main trunk side 2454 form an obtuse angle with each other (e.g., Figure 26 (See angle A8). The first main side 2450 and / or the fourth main side 2456 can be straight or curved.

[0320] In spiral pattern 2210, the elements extending from the main stem have the same shape. Figure 25 Two elements 2518a and 2518b (collectively referred to as elements 2518) extending from adjacent spiral coils 2213a and 2213b of the main stem are shown. Circumferentially adjacent elements 2518 extending from adjacent spiral coils 2213 extend in opposite directions. For example, element 2518a extends in a first longitudinal direction, while element 2518b extends in a second longitudinal direction opposite to the first longitudinal direction. Each element 2518 extends from the first main stem portion 2414 (one of which is marked with a slash) and is located near the second main stem portion 2416 of the adjacent coil 2213 of the main stem 2212. Elements 2518a and 2518b are a pair of elements 2518, extending from opposite sides of the first main stem portion 2414 (e.g., ...). Figure 22-23 (As shown), and no element 2518 extends from either side of the second main section 2416. (As shown) Figure 22 As shown, when shaft 2208 is not bent, elements 2518 are arranged in a row and at a certain angle to axis 10, which is parallel to the longitudinal axis of shaft 2208. The arrangement of elements 2518 can prevent beam bending and / or reduce torsion when shaft bends.

[0321] Figure 26 Other features of element 2518 are indicated. For example, as shown, element 2518 may be located in groove 2230, with uneven gaps 2640 and 2642 between element 2518 in groove 2230 and the ring 2213a of the main stem, as well as between adjacent elements 2518 constituting groove 2230. The width of gap 2642 between circumferentially adjacent elements 2518 is smaller than the width of gap 2640 between element 2518 in groove 2230 and adjacent ring 2213 of the main stem 2212. The narrow groove 2230 between circumferentially adjacent elements 2518 can reduce the amount of bending in the cutting pattern 2210.

[0322] Component 2518 can be symmetrical about the major axis 17. Component 2518 includes a column 2620, a first arm 2626a, and a second arm 2626b (collectively referred to as arms 2626), wherein the column 2620 forms the bottom of component 2518, and the arms 2626 form the top of component 2518. As described above, components 2518 are interconnected. As shown, the circumferential width of the component head (arm 2626) is greater than the circumferential width of the component bottom (column 2620), therefore, from a loop of the main body 2212 ( Figure 26 The element head (arm 2626) of the circumferentially adjacent element 2518 extending from the ring 2213b defines the opening of the slot 2230, the slot being large enough to accommodate the opening from the adjacent ring ( Figure 26The bottom of the element (post 2620) extending from the main stem 2212 (circle 2213a) is defined by the bottom of the circumferentially adjacent element 2518 (post 2620). Furthermore, the width of the slot 2230 is equal to the length of the second main stem portion 2416 (in...). Figure 26 In the view shown, both width and length are measured along the vertical direction.

[0323] The column 2620 extends from the main trunk 2212 and includes opposing first column sides 2622 and second column sides 2624 parallel to the long axis 17. The length of the column 2620 may affect the curvature angle of the spiral pattern, as will be discussed in detail below. Figure 26 As shown, the side surface 2622 of the first column and the side surface 2624 of the second column are straight lines.

[0324] Arm 2626 is located at one end of column 2620 and includes multiple sides. For example, arm 2626d includes a first arm side 2630, a second arm side 2632, a third arm side 2634, and a fourth arm side 2636. The first arm side 2630 is located between the column side and the second arm side 2632. The first arm side 2630 extends at an angle to the column sides 2622 and 2624. The first arm sides 2630 of longitudinally adjacent arms 2626 may have complementary shapes so that they can fit / butt together when they contact each other. In this embodiment, the first arm side 2630 includes at least one bend.

[0325] The second arm side 2632 extends between the first arm side 2630 and the third arm side 2634. In this embodiment, the second arm side 2632 is parallel to the major axis 17 of the element 2518. An element with a second arm side (e.g., element 2518) may be more robust than an element with a corner between the first and third arm sides (in other words, an element lacking a second arm side, not shown).

[0326] The third arm side 2634 is located between the second arm side 2632 and the fourth arm side 2636. The third arm side 2634 can be approximately orthogonal to the second arm side 2632. The third arm side 2634 can be as follows: Figure 25 The extended fillet formed by multiple straight lines shown can also be as follows: Figure 26 The single straight line portion shown.

[0327] The fourth arm side 2636 extends between the third arm side 2634 and the fourth arm side 2626c. The fourth arm side 2636 of the two arms of element 2518 can be at an obtuse angle (e.g., Figure 27Angle A8 (as shown) extends. The shape of the fourth arm side 2636 may be inverted with the shape of one or more sides of the second main body 2416 so that these sides can mate / butt when in contact with each other. The interaction between the fourth arm side 2636 of element 2518 and the second and third main body sides 2452, 2454 can improve the performance of pattern 2210, making it superior to typical cut patterns. For example, this interaction can maintain the position of element 2518 relative to the main body 2212 and / or the slot 2230.

[0328] Figure 27 The relationships between the features in pattern 2210 are shown, such as angle A7, angle A8, length L13, length L14, length L15, length L16, width W6, width W7, width W8, width W9, and width W10. Angle A7 is relative to the major axis of element 2518 (e.g., Figure 26 The included angle between the second or third main trunk sides 2452 and 2454 (shown on shaft 17) represents the orientation of sides 2452 and 2454 of the second main trunk portion 2416. Angle A7 can be an inclination angle. For example, angle A7 can be approximately 65° to 75°. Angle A8 measures the included angle between the fourth arm sides 2636 of the arm 2626 of element 2518, which is also the included angle between sides 2452 and 2454 of the second main trunk portion 2416. Angle A8 can be an obtuse angle. For example, angle A8 is approximately 135° to 145°. Width W8 measures the included angle between the first column side 2622 and the second column side 2624, which is the width of column 2620 (element base). Angle A8 and width W8 can be calibrated to determine the location of the load applied to the cut shaft portion during bending. For example, selecting appropriate angle A8 and width W8 can cause different magnitudes of stress to be applied to the inner / outer sides of the bent cut shaft portion. For example, reducing the width W8 can improve the ability of the column 2620 to resist lateral loads applied along its long axis. As another example, increasing the angle A8 can increase the circumferential distribution of the load. Distributing the load so that it is not concentrated on the inner / outer side of the bend can improve the strength of the cut shaft portion. A more distributed load also provides design flexibility. For example, the spiral cut pattern 2210 can be applied to catheter shafts used in different surgical procedures.

[0329] The length L13, measured from the side of the first arm 1530 to the side of the third arm 1534, is the length of the side of the second arm 2632. The length L14, measured from the side of the trunk 2212 to the arm 2626, is the length of the side of the column 2622 and 2624. Length L14 can be greater than length L13 (L14 > L13). As mentioned above, the length L14 of the column 2620 affects the maximum bending angle of the spiral pattern 2210. For example, a larger length L14 will result in a larger maximum bending angle for the cut shaft portion. Furthermore, adjusting the length L13 or the length L14 can make the spiral pattern 2210 looser or tighter. For example, decreasing the length L13 and / or L14 can make the spiral tighter (more turns per unit shaft length). Modifying the length L13 or the length L14 can also change the bending angle of the cut shaft portion along its length. For example, the length L14 can be decreased or the length L13 increased to create a gentler bend when bending the cut shaft portion. Lengths L13 and / or L14 may remain constant. In other embodiments, lengths L13 and / or L14 may be variable. For example, an element extending from one loop of the trunk may have a first length L13 and a first length L14, while an element extending from another loop of the trunk may have a second length L13 and a second length L14.

[0330] Element 2518 extending from the adjacent ring 2213 of the main shaft 2212 can be translated relative to each other in a generally longitudinal direction. For example, in this embodiment, element 2518 can move within a groove 2230 defined by two circumferentially adjacent elements 2518. When the cutting shaft portion is compressed and shortened, element 2518 can abut against the main shaft 2212 of the adjacent ring 2213, thereby forming a gap between the head of element 2518 in the groove 2230 and the head of element 2518 defining the opening of the groove 2230 (e.g., the gap between arms 2626b and arms 2626c). The amount of longitudinal translation can be represented by the difference between length L13 and length L14 (L14-L13). The lengths L14-L13 represent two scenarios: first, the maximum gap length between arms 2626b and 2626c when the element 2518 in slot 2230 abuts against the main stem 2212 under compression; and second, the maximum gap length between the head (e.g., arm 2626) of the element 2518 in slot 2230 and the adjacent loop 2213 of the main stem 2212. Modifying lengths L14 and / or L13 may affect the longitudinal expansion / contraction of the cutting axis pattern. For example, increasing length L14 and / or decreasing length L13 can increase longitudinal expansion / contraction.

[0331] Length L15 is measured between the first and fourth trunk sides 2450 and 2454 of the second trunk portion 2416 of the adjacent ring 2213 of the trunk 2212. Length L15 represents the maximum length of the pitch P between adjacent rings of the trunk.

[0332] Length L16 is the longitudinal width of the gap 2230 between the ring 2213 of the main stem 2212 and the element 2518 extending from the adjacent ring 2213 of the main stem 2212, at which point the element 2518 is located in the middle of the slot. Length L17 is the longitudinal width of the gap between the elements 2518 extending from the adjacent ring 2213 of the main stem 2212. When the element 2518 is in this position, both length L16 and length L17 can be equal to (L14-L13) / 2. Lengths L16 and L17 are reciprocals of each other. When the arm of the element 2518 abuts against the main stem 2212, length L16 approaches zero, and length L17 reaches its maximum value. Similarly, when the arms of adjacent circumferential elements 2518 abut against each other, length L17 approaches zero, and length L16 reaches its maximum value. The maximum values ​​of lengths L16 and L17 depend on the magnitudes of lengths L13, L14, and / or L15. In some embodiments, the maximum value of length L16 and length L17 can be equal to the difference between length L14 and length L13 (L14-L13).

[0333] The distance between the longitudinal line extending from the end of the fourth arm side 2636 and the longitudinal line extending from the beginning of the third arm side 2634 represents the perimeter / range of the fourth arm side 2636. Width W7 is the distance from the fourth arm side 2636 of the adjacent arm of element 2518 to the third arm side 2634, representing the length of the fourth arm side 2636. Width W7 may be greater than width W6. Width W9 is the distance between the two second arm sides 2632 of element 2518, representing the cumulative width of arms 2626a and 2626b, and representing the width of the head of element 2518. As mentioned above, width W9 is greater than width W8 (W9 > W8; i.e., element head width > element bottom width). Width W9 can be 2-3 times or 2.5 times width W8. Width W10 refers to the circumferential gap between the column sides 2622 and 2624 of circumferentially adjacent columns 2620 extending from the same ring 2213 of the main trunk 2212, which is located between circumferentially adjacent elements along the same longitudinal direction. The relative lengths of widths W9 and W10 can be configured according to the translation and / or rotation of element 2518 during shaft bending. Width W9 can be at most 98% of width W10, or at least 60% of width W10. In at least one embodiment, A8 > A7, W10 > W9 > L15 > W8 > L14 > W7 > W6 > L13, and L16 and L17 are variable.

[0334] Figure 28-33 A second embodiment of a spiral pattern having one or more of the features / constructions described above is shown. Unlike spiral pattern 2210, spiral pattern 2810 has different element shapes. Figures 30-33An enlarged view is provided of a portion of pattern 2810 cut out from the wall of axis 2808, and in Figure 33 Some dimensions of pattern 2810 are marked. As mentioned above, the advantage of spiral pattern 2810 is that the performance of the shaft during use is independent of the material properties of the tubing.

[0335] like Figure 28 and Figure 29 As shown, the spiral pattern 2810 is a left-handed spiral pattern cut out from a portion of the shaft 2808. The spiral pattern 2810 includes a main stem 2812 extending around the longitudinal axis of the shaft with multiple turns 2813a-e (collectively referred to as turns 2813), a plurality of first elements 2818 having a first shape, a plurality of second elements 2819 having a second shape, and a plurality of grooves 2830. The main stem 2812 includes alternating first main stem portions 2814 (in... Figure 28 The first engraved line marking pattern) and the second main section 2816 (in Figure 28 (Identified by the second engraved line pattern). Similar to the spiral pattern 2210, the second main branch 2816 is shorter than the first main branch 2814, and elements 2818 and 2819 extend only from the first main branch 2814. In this example, the main branch 2812 is symmetrical about the major axis 19, and its width measured perpendicular to the major axis 19 is consistent. The main branch 2812 forms an angle with the longitudinal axis of the axis 2808, for example, the angle between the major axis 19 and the line 2820.

[0336] Similar to element 2518 of spiral pattern 2210, the first element 2818 and second element 2819 of spiral pattern 2810 are also configured to interlock, wherein the first element 2818 is located within a slot 2830 defined by the second element 2819. In this embodiment, the first element 2818 and second element 2819 are arranged alternately on both sides of the main trunk 2812. The first element 2818 and second element 2819 extend from opposite sides of the same portion of the main trunk 2812. This arrangement forms rows of alternating longitudinally arranged first elements 2818 and second elements 2819, wherein elements 2818 and 2819 in circumferentially adjacent rows are oriented in opposite directions. For example, for a row along line 2820, the first element 2818 and second element 2819 are arranged alternately, wherein the first element 2818 is arranged in a first direction (right side in the figure), and the second element 2819 is arranged in the opposite second direction (left side in the figure). Similarly, for a row along line 2822, the first element 2818 and the second element 2819 are also arranged alternately, with the first element 2818 arranged along the second direction and the second element 2819 arranged along the first direction. For example... Figure 28 As shown, when the cutting axis portion is not bent (is straight), the long axis of the first element 2818 can be aligned with the long axis of the groove 2830.

[0337] As mentioned above, the cutting shaft section can control the bending of the conduit. Figure 29 The diagram illustrates how the spiral pattern 2810 adapts to the curvature of the shaft 2808. The advantage of the spiral pattern 2810 is that it can accommodate a wider variety of bends compared to typical cutting patterns. In at least one embodiment, the first element 2818 and the second element 2819 can translate and / or rotate as the shaft bends. For example, the position of element 2818 within the groove 2830 can differ. For instance, because the first element 2818 can translate within the groove 2830, at the outer side 2902 of the curve / bend, the first element 2818 is located near the opening of the groove 2830; while at the inner side 2904 of the turn / bend, the first element 2818 is located away from the opening of the groove 2830. Furthermore, because the first element 2818 is rotatable, its orientation may change as the shaft bends. For example, 2818 may be closer to one side of the groove than the other. Therefore, the pattern 2810 can adapt to stretching and compression when the cut shaft portion is a straight and / or curved portion.

[0338] In addition to the groove 2830, the spiral pattern 2810 may form one or more additional gaps or openings. Translation and / or rotation of the elements may affect the gaps between adjacent elements 2818, 2819. The gap between adjacent elements along the outer side of the bend 2902 may be smaller than the gap along the inner side of the bend 2904. For example, gap 2906 is smaller than gap 2908. The gap between adjacent elements along the outer side of the bend 2902 may also be larger than the gap along the inner side of the bend 2904. For example, gap 2910 is larger than gap 2912. The gap size may gradually decrease from the outer side of the bend 2902 to the inner side of the bend 2904. For example, gaps 2914, 2916, and 2918 gradually decrease. When the shaft 2808 bends, elements 2818, 2819 may remain within the wall of the shaft 2808. This allows the shaft 2208 to have a smooth outer surface.

[0339] like Figures 30-33 As shown in the figure, more details of the spiral pattern 2810 cut from the wall of shaft 2808 are shown, in which Figure 33 Some dimensions of the first element 2818 and the second element 2819 are indicated. Figure 30Two adjacent turns 2813a and 2813b of a spiral pattern 2810 cut on the wall 3002 of shaft 2808 are shown. Each first element 2818 includes a rod 3020 with an end 3022. As shown, the diameter of the end 3022 may be greater than the width of the rod 3020. The end 3022 is located in a groove 2830. Although the end 3022 is circular in this embodiment, it may also have other shapes. As mentioned above, the pattern 2810 may include gaps in addition to the grooves 2830. For example, a gap 3032 may exist between the second element 2819 and the main stem 2812 of the adjacent turn 2813 (see also). Figure 29 (See gaps 2914, 2916, and 2918 shown). Furthermore, a second element 2819 extending from adjacent rings 2813a and 2813b may define gap 3034 (see also...). Figure 29 (Gap 2906 and 2908 shown). Rotation and / or translation of the main trunk 2812 and / or one or more elements 2818 or 2819 may affect the size of gap 3032 and / or gap 3034.

[0340] like Figure 31 As shown in the figure, other features of the second element 2819 and the main stem 2812 are illustrated. The main stem 2812 has a first side 3114 and a second side 3116. The head width of the second element 2819 is W15. Figure 28 As shown, the bottom width of the second element 2819 is substantially equal to the length of the first main trunk portion 2814. Each second element 2819 may include two components 3124a and 3124b (collectively referred to as components 3124). The components 3124a and 3124b of the second element 2819 may be arranged in opposite directions and / or be mirror images of each other about the major axis 3102 of the second element 2819. Components 3124 may be asymmetrical about their major axis 3104 and / or asymmetrical about an axis 3106 perpendicular to the major axis 3104.

[0341] Figure 32 Other features of the first element 2818 and the second element 2819 are shown. The length of the rod 3020 is the distance from the side 2360 of the main stem 2812 to the rounded end 3022. The rod 3020 of the first element 2818 includes rod sides 2322 and 2324 extending from the side 3260 of the main stem 2812. At least the rounded end 3022 is located within the groove 2830.

[0342] Figure 32One of the two components 3124 is identified by a slash. Each component 3124 may include multiple sides (collectively referred to as component sides): first component side 3230, second component side 3236, third component side 3238, fourth component side 3240, fifth component side 3242, and sixth component side 3244. Figure 32 As shown, the first component side surface 3230 includes a straight portion 3233 located between the first curved portion 3232 and the second curved portion 3234. However, the straight portion 3233 may be curved. The first component side surface 3230 maintains a certain distance from the main body 2812. The first curved portion 3232 of the components 3124a and 3124b of the second element 2819 may form the closed end of the groove 2830.

[0343] The second component side surface 3236 extends from the second curved surface 3234 of the first component side surface 3230 to the third component side surface 3238. The edge 3235 between the first component side surface 3230 and the second component side surface 3236 may be rounded. The edge 3235 of the component 3124 of the second element 2819 defines the opening of the slot 2830. The distance between the edges 3235 defining the opening of the slot 2830 can be selected so that the first element can be in different orientations. For example, the first element 2819 may be aligned with the slot 2830 or may be at an angle to the slot 2830. Figure 28 and Figure 32 As shown, the major axis of the first element 2819 is aligned with the major axis of the slot 2830. Figure 28 and Figure 32 As shown, the major axis of the first element 2819 is aligned with the major axis of the slot 2830.

[0344] The shape of the third component side surface 3238 is inverted compared to the shape of the main trunk 2812 side surface. For example, in this embodiment, both the third component side surface 3238 and the main trunk 2812 side surface are straight lines. When the shaft bends, the azimuth angle of the third component side surface 3238 relative to the main trunk may change. For example, for Figure 29 As shown in the diagram, the third member side 3238 can be at an angle to the main trunk 2812. The fourth member side 3240 extends from the third member side to the fifth member side 3242. The fifth member side 3242 extends from the fourth member side 3240. The sixth member side 3244 extends from the fifth member side 3242 to the main trunk 2812. Figure 32 As shown, the sixth component side 3244 is curved. However, the sixth component side 3244 can also be straight. A gap may exist between the sixth component side 3244 and the fourth component side 3240. This gap may allow the component 3124 of the adjacent element 2819 to translate during use as the shaft is manipulated (forward, bent). Figure 32The view shown indicates right ↔ left.

[0345] The component 3124 of the second element 2819 may include a narrower portion connecting a first wider portion 3250 extending from the side (side 3114 or 3116) of the main trunk 2812 and a second wider portion 3252 located at the other end of the component 3124. The first wider portion 3250 may be referred to as the bottom of the component, and the second wider portion 3252 may be referred to as the head of the component. Figure 32 As shown, the length of the component head (upwards ↔ downwards in the figure) is greater than the length of the component bottom. As shown, the first wider portion 3250 includes a portion of the first component side 3230 and a portion of the sixth side 3244, and the second wider portion 3252 includes a portion of the first component side 3230, a second component side, a third component side 3238, a portion of the fourth component side 3240, a portion of the fifth component side 3242, and a portion of the sixth component side 3244.

[0346] Figure 33 The relationship between features (e.g., angles and lengths) of the spiral pattern 2810 is shown, such as angles A9 and A10, radii of curvature R4, R5, R6 and R7, widths W11, W12, W13 and W14; and lengths L18, L19, L20, L21 and L22. The length L18 between the sides of adjacent turns of the trunk 2812 represents the pitch P between adjacent turns 2813 of the trunk 2812. It can be seen that the pitch P of the spiral pattern 2810 is greater than that of the spiral pattern 2210. As mentioned above, the bending force required for a spiral pattern with a smaller pitch P may be less than that for a spiral pattern with a larger pitch P. Therefore, bending the spiral pattern 2810 may require a greater force than bending the spiral pattern 2210.

[0347] The length of the second component side 3236 is W14, and it forms an angle A9 with the radially adjacent column side (column side 3222 or column side 3224). Angle A9 is approximately 45° to 55°. The straight portion 3233 forms an angle A10 with the fifth component side 3242. Angle A10 is approximately 63° to 73°. The first curved portion 3232 forms the curved closed end of the groove 2830, and its radius of curvature is R7. The radius of curvature of the second curved portion 3234 may be complementary to the radius of curvature R6 of the rounded end 3022 of the first component 2818. The radius of curvature R6 may be smaller than the radius of curvature R7. For example, the radius of curvature R6 may be 0.8 to 0.95 times the radius of curvature R7. The length of the third component side 3238 is W11. The third component side 3238 forms a gap of length L21 with the main body 2812. The radius of curvature of the fourth component side 3240 is R5. The fifth member side 3242 of the longitudinally adjacent member 3124 forms a gap of length L22. As described above, the size of the gap depends on the amount of translation, and the lengths L21 and L22 are inversely proportional. For example, when the length L21 decreases, the length L22 increases. The radius of curvature R4 of the sixth side 3244 can be greater than the radius of curvature R5 of the fourth side 3240. In at least one embodiment, A9>A10, L18>L19>L20>W11>W12>W13>W14, and L21 and L22 are variable. Figure 33 As shown, L18>L19>L20>W11>L22>L21>W12>W13>W14.

[0348] As shown, slot 2830 is entirely defined by a single (1) second element 2819. However, slot 2830 can also be defined by a second element 2819 and a portion of a main stem 2812. For example, a portion of a first portion 2814 of the main stem 2812 can be placed between the two second elements 2819 to define slot 2830 (not shown). As described above, slot 2830 is sized to accommodate a first element 2818. Slot 2830 includes an opening with a width W12 at one end that is just large enough to accommodate the first element 2818. Width W12 can be obtained by measuring the distance between the edges 3235 of members 3124a and 3124b of the second element 2819. As shown, the width W12 of the opening is greater than the width W13 of the rod 3020, but less than the width / diameter 2R6 of the rounded end 3022—in other words, 2R6 > W12 > W13. Furthermore, unlike the groove 2230 of the spiral pattern 2210, the width of the groove 2230 is smaller than the length of the first portion 2814, such as... Figure 28 and Figure 31 As shown.

[0349] The first element 2818 can translate L20 within the slot 2830 by a distance (in Figures 32-33In the view, move right ↔ left. Figure 32 A spiral pattern 2810 in a stretched state is shown. Length L20 is the maximum distance (translation distance) that the first element 2818 can translate within the groove 2830. Length L20 can be measured from the center of the rounded end 3022 located at the opening to the point where the center of the rounded end 3022 is located when the rounded end 3022 abuts against the other end of the groove 2830. The translation distance of the first element 2818 can be affected by changing the length of the rod 3020, length L18, length L20, length L21, and / or the radius of curvature R6 of the rounded end 3022. For example, in this embodiment, length L21 limits the translation of the spiral pattern 2810 because L21 is less than the length of the rod 3020, which in turn is less than length L20. Increasing length L21 will increase the translation distance. As another example, a smaller rounded end 3022 may have a greater translation distance than a larger rounded end 3022.

[0350] As described above, when the spiral pattern 2810 bends, the partially rounded end 3022 of the first element 2818 may be located at the opening of the groove 2830, while the other rounded ends 2111 are located away from the opening of the groove 2830. The rounded end 3022 located at the opening of the groove 2830 can transmit force to the member 3124 constituting the opening of the groove 2830. In other words, the applied force can be distributed in the circumferential direction. Compared with a cutting pattern that does not distribute the load in the circumferential direction, distributing the load in the circumferential direction can improve the strength of the cutting shaft portion.

[0351] The basket device at the distal end of a medical device (such as the basket device discussed above) may be subjected to forces during use, causing changes or displacements in the relative positions of the basket ribs, resulting in the ribs being too close or too far apart than intended. For example, the expansion and / or collapse of the balloon located within the basket (e.g., distal assembly 339) may cause relative displacement of the ribs, adversely affecting the performance of the device. Furthermore, an increase in the spacing between adjacent ribs may reduce therapeutic efficacy. Therefore, providing a method to maintain consistent rib spacing would be highly beneficial.

[0352] like Figures 34-36 As shown, the basket may include tethers 3408 and 3608 connecting adjacent reinforcing bars. Although Figures 34-36 The end components shown include balloons 346' and 346'' located within baskets 340' and 340'', but not baskets without balloons (e.g., Figure 2 The end assembly shown may also include a tether. The tether can be configured to maintain consistent spacing between the ribs of the net basket during balloon expansion and / or collapse, such as... Figure 35As shown. A tether can extend between each pair of adjacent reinforcing bars. The tether can be located between the midpoint and the distal end of the basket so that tether 3408 is visible when viewing the guide tube from the distal end, as shown. Figure 35 As shown. The area between the midpoint and the far end of the basket can be called the far side of the basket.

[0353] Each netting rib may include a tether securing device for attaching one end of a tether. For example, the tether securing device may be a groove, eyelet, or post. The tether may be attached to the tether securing device. The tether securing device may be located on the outer surface, inner surface, or extend from the side of the rib.

[0354] like Figures 34-35 As shown, the ends 3410 and 3412 of the tether can be connected to adjacent reinforcing bars, such that when the net basket is in the expanded state, the tether is perpendicular to the reinforcing bars. As shown, when the net basket is in the expanded and unexpanded states, the ends 3410 and 3412 are in the same longitudinal position along the reinforcing bars. The ends 3610 and 3612 of the tether 3608 can be connected to adjacent reinforcing bars 242''a and 242''b, such that when the net basket 240'' is in the expanded state, the tether 3608 forms an angle A6 with reinforcing bar 242''a. Figure 36 As shown in the figure, the longitudinal positions of ends 3610 and 3612 along the ribs differ when the basket is in the expanded and unexpanded states. Arranging the tethers at an angle can reduce the profile of the end components when they are introduced into or removed from the guide.

[0355] The tether can be made of a low-elasticity material or an elastic material with a minimum Young's modulus. For example, the minimum Young's modulus of the tether can be 0.4 GPa. The tether can be made of highly crystalline polymers. Examples of highly crystalline polymers that can be used for tethers include polytetrafluoroethylene (PTFE), high-density polyethylene (HDPE), polyethylene terephthalate (PET), and nylon 66.

[0356] As described above, the end-effector assembly may include a balloon located within the basket, such as the end-effector assembly shown in Figure 3. Placing the balloon within the basket serves one or more purposes. For example, inflating the balloon to contact the basket provides mechanical support. Furthermore, when the end-effector assembly is used for ablation, the balloon, made of insulating material, reduces energy loss from the electrodes located on the basket. Reduced energy loss improves the therapeutic effect of the ablation protocol. For example, by reducing energy loss, a larger lesion can be created. Therefore, it is important to be able to assess the balloon's expansion relative to the basket.

[0357] For reference Figure 37The figure illustrates a conduit 3700, which includes an end assembly 3702 connected to a shaft 3708. The shaft 3708 may include at least one shaft electrode 3720. The shaft electrode 3720 may be an annular electrode. Figure 37 As shown, the conduit 3700 includes an annular electrode 3720 arranged along the outer surface of axis 3708, which is close to the end assembly 3702. However, multiple axial electrodes may also be arranged along axis 3708.

[0358] and Figure 3A and Figure 3C The end components shown are similar. Figure 37 The illustrated end assembly 3702 includes a basket 3740 and an expandable balloon 3746 located within the space defined by the basket 3740. As described above, the basket 3740 includes multiple ribs 3742, with proximal ends 3712 and distal ends 3714. The proximal ends of the ribs can be connected to an outer shaft, and their distal ends can be connected to another shaft, such as an inner shaft (e.g., an inner shaft). Figure 3A (as shown), or the basket support axis (such as...) Figure 3B-3C (As shown). The distal end of the basket 3740 can be connected to a distal connector, such as the distal connector shown and described in Figures 4-9 above; the proximal end of the basket 3740 is connected to a proximal connector, such as the one shown above. Figure 10-2 The proximal connector shown and described in Figure 0; the basket 3740 includes tethers, such as those described above. Figures 34-36 The tethers shown and described. And / or one or more conduit shafts 3706, 3708 include cut shaft patterns, such as those described above. Figure 21-33 Patterns 2104, 2210, and 2810 are shown and described.

[0359] As described above, the two ends of the balloon 3746 can be connected to the shaft 3708, or to a proximal and distal connector. The expandable balloon 3746, located within the defined space of the basket 3740, spans the length of the rib. In some embodiments, the balloon 3746 is located between the distal end of the outer shaft and the distal end of the inner shaft. As described above, the balloon 3746 can be supplied with fluid via a fluid source (such as... Figure 1 The balloon 3746 is selectively expanded by the fluid or other medium provided (as shown). The balloon 3746 can have multiple expanded / unexpanded states (e.g., uninflated / unexpanded, inflated / expanded, over-inflated / over-expanded). When the balloon 3746 is in the unexpanded state, its outer surface may maintain a certain distance (non-contact) from the inner surface of the basket 3740. The balloon 3746 may be in the unexpanded state before the expansion medium is injected into it and after the expansion medium is withdrawn from it. In the expanded state, the outer surface of the balloon 3746 may contact the inner surface of at least one of the multiple ribs, but will not extend between the sides of adjacent ribs, such as... Figure 37 As shown. Figure 3AThe cross-sectional view also shows the balloon in its expanded state. The contact between the balloon 3746 and the basket provides mechanical support for the end-cap assembly 3702. This mechanical support in the expanded state allows the basket-balloon end-cap assembly 3702 to remain expanded. In some embodiments, when the balloon is made of insulating material and the electrodes 3716 are positioned on the flanges of the basket, the expanded state can reduce energy loss, thereby enhancing the therapeutic effect of the ablation force delivered by the electrodes 3716 located on the plurality of flanges 3742. In other words, more ablation energy can be directed to the target tissue. This reduction in energy loss may be attributed to the balloon's position relative to the electrodes and adjacent tissue. The therapeutic effect of the ablation force is enhanced due to the creation of a larger lesion.

[0360] The inner shaft 3708 can be slidably positioned within the outer shaft 3706. This allows the basket 3740 to switch between a contracted and an expanded state. When the inner shaft 3708 slides distally relative to the outer shaft 3706, the basket 3740 can be axially compressed to a contracted state. The basket 3740 can be in a contracted state during catheter guidance to the target site within the body cavity. When the inner shaft 3708 slides proximally relative to the outer shaft 3706, the basket 3740 can radially expand to an expanded state. The basket 3740 can selectively expand to optimize surface contact with the target tissue. The baskets 240 and / or 340 described above can also expand and contract in a similar manner.

[0361] Providing excessive expansion medium to the balloon may cause it to become overinflated. In an overinflated state, the outer surface of the balloon may contact the inner surface of at least one of the ribs 3742, and / or extend between one or more adjacent ribs 3742. The overinflated balloon 3746 may extend radially beyond the outer surface of the basket 3740.

[0362] The end assembly 3702 may also include at least one electrode 3716 for mapping and / or ablation. The at least one electrode 3716 may be located on and / or connected to the basket 3740 and / or balloon 3746. For example, similar to baskets 240 and 340, basket 3740 has one or more electrodes 3716. Although in Figure 37In the illustrated embodiment, each rib 3742 includes an electrode 3716, but the rib may have no electrode or multiple electrodes. The electrodes may be mounted or otherwise fixed to the outer surface of at least one rib. The electrode may be an exposed portion of the rib, made of a conductive material. The exposed portion may be located on the outer surface of the rib, while the inner surface of the rib is insulated. The electrode may be located in the middle region of the rib (e.g., in the portion of the rib 3742 furthest from the longitudinal centerline of the conduit during basket expansion). The proximal end of the electrode may be located near the middle position of the rib, while the distal end of the electrode is closer to the distal end of the rib than the middle position. For example, as... Figure 37 As shown, each rib 3742 includes an electrode 3716 and an exposed portion, the proximal end of which is located near the middle of the rib 3742 (e.g., during basket expansion, at or near the portion of the rib 3742 furthest from the longitudinal centerline of the conduit), while the distal end is closer to the distal end 3714 of the rib rather than the middle position. Insulating portions 3718a and 3718b are located on either side of the exposed portion and the electrode 3716. As described above, the electrode can receive electrical signals from the mapping and / or ablation system 118 via one or more wires within the cable 116 and the outer shaft 3706.

[0363] Nickinol is a non-limiting example of a conductive material that can be used to manufacture ribs. Insulating materials can be applied to portions of the rib that do not serve as electrodes. The insulating coating on the rib can be selectively removed to expose portions of the conductive rib. The insulating material can be one or more of the following: heat-shrinkable materials (e.g., PET), polymer tubing, or polymer coatings. Polymer coatings can be applied to the rib by spraying or dipping. Exemplary polymer materials that can be used as insulating materials include PET, polyimide, and / or polyether intercalated amide (PEBA).

[0364] The catheter may also include at least one sensor configured to measure characteristics indicating the balloon's inflation / expansion status (such as...). Figure 38(As shown). This sensor is a conductive sensor, configured to measure the impedance between the sensor (first electrode) and a second electrode indicating the balloon's expansion state. For example, in some embodiments, the ECU 124 of the computer system 122 executes instructions to establish a circuit between the sensor (first electrode) and the second electrode. The conductive sensor can be an electrode or an exposed end of a wire. The second electrode can be an electrode connected to a basket, an electrode connected to the balloon, and / or an electrode connected to the conduit shaft (e.g., inner and / or outer shaft). The sensor can also be a pressure sensor, configured to measure pressure. For example, the sensor can measure the pressure between the sensor and the balloon, which indicates the balloon's expansion state. The pressure sensor can be a mechanical pressure sensor or a voltage force sensor. Mechanical measurements can be converted into electrical signals. For example, a microelectromechanical system (MEMS) sensor can convert mechanical pressure into an electrical signal.

[0365] The sensor can be connected to the end assembly and / or the distal end of the outer shaft. For example, Figure 38 An embodiment of catheter 3800 is shown, wherein sensor 3844 is connected to basket 3840 (balloon not shown) of end assembly 3802. Similar to basket 3740, basket 3840 includes multiple ribs 3842 and at least one electrode 3816 (two electrode regions are identified in the figure). Basket 3840 also includes a support shaft 3808, as... Figure 3B As shown. Sensor 3844 is connected to wire 3826 passing through the outer shaft (not shown). Wire 3826 can be configured to transmit signals and / or information about measurement characteristics to computer system 122.

[0366] Embodiments with multiple sensors may include one or more sensors located in the proximal region of the end component (near the midpoint of the end component), one or more sensors located in the distal region of the end component (far from the midpoint of the end component), or one or more sensors located in both the proximal and distal regions of the end component. For example, Figure 38 The sensor 3844 shown is connected to the proximal region of the basket. Although Figure 38 The sensor 3844 shown is connected to the rib 3842b via a single electrode 3816, but the sensor can also be connected to ribs without electrodes or with multiple electrodes. Figure 38 As shown, sensor 3844 can be connected to the inner surface of rib 3842b.

[0367] Figures 39-41 show characteristic views of the sensors connected to the basket-ball end assembly. Figure 39A , 40A In the 41A, the balloon is in an uninflated state; while Figure 39B , 40BIn 41B, the balloon is in an inflated state. As described above, the sensor can be connected to an electrodeless rib. For example, as... Figure 39A As shown, end assembly 3902 includes sensor 3944, which is connected to the inner surface 3952 of the electrodeless rib 3942. Sensor 3944 is connected to wire 3926, which is configured to transmit signals and / or transmit information about measurement characteristics to computer system 122. As described above, balloon 3946 may be made of insulating material. Flange 3942 has an outer surface 3950 and an inner surface 3952, and balloon 3946 has an outer surface 3960 and an inner surface 3962. When balloon 3946 is in an uninflated state, its outer surface 3960 does not contact the inner surface 3952 of the flange and / or sensor 3944, as... Figure 39A As shown. When the balloon 3946 is in the inflated state, its outer surface 3960 contacts the inner surface 3952 of the flange and / or the sensor 3944, as... Figure 39B As shown.

[0368] As described above, sensor 3944 can be a pressure sensor, where pressure is a measurement characteristic indicating the balloon's inflation state. Measuring pressure can indicate contact (e.g., Figure 39B (as shown) or non-contact (such as) Figure 39A (As shown). This relationship can be used to distinguish between a balloon in an uninflated (non-contact) state and a balloon in an inflated (contact) state. The sensor can measure pressure values ​​and / or pressure changes. As the balloon inflates / contracts, the measured pressure may increase / decrease. Continued inflation of the balloon after initial contact with sensor 3944 may result in an increase in measured pressure. In this way, an uninflated state can be distinguished from an inflated state (related to a first pressure) or an over-inflated state (related to a second pressure greater than the first pressure). Assessment of pressure changes can be used to determine whether the balloon is inflating or deflating.

[0369] As described above, the impedance measured between the two electrodes / conductors can serve as a characteristic indicator of the balloon's inflation state as measured by the sensor. Sensor 3944 can be a conductor (first electrode). For example, the sensor can be an electrode or an exposed wire. The second electrode can be an electrode located on another axis, an electrode connected to the outer surface of the balloon, or an axial electrode, such as electrode 3720. The ECU 124 of computer system 122 can execute instructions to establish a circuit between the sensor (first electrode) and the second electrode. The impedance measured when the balloon is not inflated may be lower than the impedance measured when the balloon is inflated. When the catheter is used in a blood-containing body cavity, the measured impedance may be lower because the blood contains electrolytes, which can conduct electricity after ionization. Balloon inflation may cause the balloon to contact and / or cover the sensor (first electrode), thereby increasing the measured impedance. When the balloon is made of insulating material, the change in measured impedance between the uninflated and inflated states may be even greater.

[0370] Figures 40A-40B An embodiment of the end-effector 4002 is shown, which includes a sensor 4044 connected to a rib 4042 via an electrode 4016. The sensor 4044 is connected to an inner surface 4052 of the rib 4042, which has no electrodes. The sensor 4044 is connected to a wire 4026. Similar to wire 3826, wire 4026 can be configured to transmit signals to a computer system 122 and / or transmit information about measurement characteristics. Rib 4042 includes insulating regions 4018a, 4018b and an outer surface 4050. The balloon 4046 has an outer surface 4060 and an inner surface 4062. As described above, the balloon 4046 can be made of an insulating material. Figure 40A As shown, when the balloon 4046 is in the uninflated state, the outer surface 4060 of the balloon does not contact the inner rib surface 4052 and / or the sensor 4044. Figure 40B As shown, when the balloon 4046 is in the inflated state, the outer surface 4060 of the balloon is in contact with the inner rib surface 4052 and / or the sensor 4044.

[0371] As described above, sensor 4044 can be a pressure sensor, and the measured pressure is a characteristic value indicating the balloon's inflation state. The measured pressure can indicate the contact state (e.g., ...). Figure 40B (as shown) or non-contact state (such as) Figure 40A (As shown). This relationship can be used to distinguish between an uninflated (non-contact) balloon and an inflated (contact) balloon. The sensor can measure pressure values ​​and / or pressure changes. As the balloon inflates / contracts, the measured pressure may increase / decrease. Continued inflation of the balloon after initial contact with sensor 4044 may cause an increase in the measured pressure. In this way, an uninflated state can be distinguished from an inflated state (related to a first pressure) or an over-inflated state (related to a second pressure greater than the first pressure). Assessment of pressure changes can be used to determine whether the balloon is inflating or deflating.

[0372] As described above, the impedance measured between the two electrodes / conductors can serve as a characteristic indicator of the balloon dilation state measured by the sensor. In these embodiments, sensor 4044 is a conductor (first electrode). For example, the sensor can be an electrode or a bare wire. Figure 40AAs shown in -B, the second electrode is the rib electrode 4016. However, the second electrode can also be an electrode located on another rib, an electrode connected to the outer surface of the balloon, or an axial electrode, such as electrode 3720. The ECU 124 of the computer system 122 can execute instructions to establish a circuit between the sensor (first electrode) and the second electrode. The impedance measured when the balloon is in the uninflated state may be lower than the impedance measured when the balloon is in the inflated state. When the catheter is used in a body cavity containing blood, the measured impedance may be lower because blood is a conductor. Inflation of the balloon may cause the balloon to contact and / or cover the sensor (first electrode), which may increase the measured impedance. When the balloon is made of insulating material, the change in measured impedance between the uninflated and inflated states is greater.

[0373] Figure 41A -B illustrates the features of end assembly 4102, which includes a sensor 4144 connected to rib 4142. While sensor 4144 is connected to the inner surface 4152 of rib 4142 via electrode 4116 as shown, the sensor can also be connected to the inner surface of the rib without electrodes. Sensor 4144 is connected to wire 4126. Similar to wire 4126, wire 4126 can also be configured to transmit signals to computer system 122 and / or convey information about the measured characteristic. Rib 4142 includes insulating regions 4118a, 4118b and an outer surface 4150. Figure 41B As shown, balloon 4146 includes an outer surface 4160, an inner surface 4162, and a plate 4174. When the balloon is inflated, the plate 4174 contacts the sensor 4144. As shown, the plate 4174 is connected to the outer surface 4160 and is an electrode connected to the wire 4176. The plate 4174 can be a material harder than the balloon material. For example, a portion of the polymer constituting the balloon wall can be cross-linked. As described above, balloon 4146 can be made of an insulating material. When balloon 4146 is in an uninflated state, its outer surface 4160 does not contact the inner surface 4152 and / or the sensor 4144, as... Figure 41A As shown. When the balloon 4146 is in the inflated state, its outer surface 4160 contacts the inner surface 4152 and / or the sensor 4144, for example as... Figure 41B As shown.

[0374] As described above, sensor 4144 can be a pressure sensor, and the measured pressure is a characteristic value indicating the balloon's inflation state. Figure 41B As shown, the measured pressure can indicate the contact condition with the plate 4174, or it can be as follows: Figure 41AAs shown, this indicates the non-contact state with plate 4174. This relationship can be used to distinguish between a balloon in an uninflated state (non-contact) and a balloon in an inflated state (contact). The sensor can measure pressure values ​​and / or pressure changes. As the balloon inflates / contracts, the measured pressure may increase / decrease. Continued inflation of the balloon after initial contact with sensor 4144 may cause an increase in the measured pressure. In this way, an uninflated state can be distinguished from an inflated state (related to a first pressure) or an overinflated state (related to a second pressure greater than the first pressure). Assessment of pressure changes can be used to determine whether the balloon is inflating or deflating.

[0375] As described above, the impedance measured between the two electrodes / conductors can serve as a characteristic indicator of the balloon's inflation state as measured by the sensor. Sensor 4144 can be a conductor (first electrode). For example, the sensor can be an electrode or an exposed wire. The second electrode can be plate 4174 (balloon electrode), rib electrode 4116, an electrode on another rib, or an axial electrode, such as electrode 3720. ECU 124 of computer system 122 can execute instructions to establish a circuit between the sensor (first electrode) and the second electrode. The measured impedance may be higher when the balloon is inflated; the measured impedance may be lower when the balloon is not inflated. For example, as described above, referring to Figures 39-40, when the balloon is inflated or over-inflated (in contact with the sensor), the impedance between the sensor and the second electrode is greater than the impedance when the balloon is not inflated (not in contact with the sensor). The measured impedance may be lower when the balloon is inflated (in contact with the sensor); while the measured impedance may be higher when the balloon is not inflated (not in contact with the sensor). For example, when the balloon 4146 inflates, causing the balloon electrode 4174 to contact the sensor 4144 (first electrode) (as... Figure 41B As shown), a short circuit is formed between sensor 4144 and balloon electrode 4174, causing the measured impedance to be lower than when balloon electrode 4174 is separated from sensor 4144 (e.g.). Figure 41A The impedance measured (as shown in the figure).

[0376] As mentioned above, the balloon's inflation state can affect the performance of the end effector components. Characteristics measured by sensors can be used to determine the balloon's inflation state. Figure 42 A flowchart of a method 4200 for determining the balloon inflation state is shown. A computer system 122 is configured to execute method 4200. The inflation state determined by method 4200 can be used to modify the balloon inflation state, for example, by adding / removing inflation media into the balloon.

[0377] like Figure 42As shown in the flowchart, in step 4202, method 4200 includes receiving at least one measurement value from a sensor indicating balloon inflation characteristics. Computer system 122 can receive this measurement value from the sensor. As mentioned above, the sensor may be a pressure sensor used to measure the pressure between the sensor and the balloon. (Refer to the above...) Figure 39B and 40B The measured pressure can be the pressure exerted by the outer surface of the balloon on the sensor when the balloon is inflated. The polymer material constituting the portion of the balloon that contacts the sensor is cross-linked. (See above reference.) Figure 41B The measured pressure can also be the pressure exerted on the sensor by a plate connected to the outer surface of the balloon when the balloon is inflated. This sensor can be conductive and configured to measure the impedance between the sensor and the second electrode. (See above reference.) Figure 39A The sensor (first electrode) and the second electrode can be connected to different ribs. Alternatively, the sensor and the second electrode can be connected to the same rib, for example... Figure 40A As shown. The sensor can be attached to the rib, while the second electrode is attached to the balloon, as referenced above. Figure 41A The sensor can be connected to an end assembly (basket or bladder), while the second electrode is connected to a shaft, such as shaft electrode 3720.

[0378] In step 4204, method 4200 includes: determining the balloon's inflation state by comparing measured values ​​to one or more thresholds; and / or monitoring balloon inflation / contraction by determining changes in measured values. The one or more thresholds may include a first threshold (e.g., a first threshold value) for distinguishing between an uninflated state and an inflated state. For example, a measured pressure value less than a threshold pressure value indicates the balloon is in an uninflated state (not in contact), while a measured pressure value greater than the threshold pressure value indicates the balloon is in an inflated state (in contact). The one or more thresholds may also include a second threshold greater than the first threshold value for distinguishing between an inflated state and an overinflated state. For example, a measured value greater than both the first and second thresholds indicates the balloon is overinflated, while a measured value greater than the first threshold but less than the second threshold indicates the balloon is in an inflated state. Table 2 summarizes methods for determining balloon inflation state using one or more thresholds.

[0379] Table 2

[0380]

[0381] As shown in Table 2, some measurement features can only distinguish between the unexpanded state and the expanded state, while other measurement features can distinguish between the unexpanded state, the expanded state, and the overexpanded state.

[0382] Changes in measurement characteristics can be used to monitor balloon expansion / contraction. For example, a positive change in a measurement characteristic may indicate that the balloon is expanding, while a negative change indicates that the balloon is contracting. Continued balloon expansion may cause the values ​​of the measurement characteristics to increase. Figure 41A As shown in -B, a negative change in the measured characteristic may indicate that the balloon is expanding, while a positive change indicates that the balloon is contracting.

[0383] In step 4206, method 4200 includes displaying the expansion state and / or changes in at least one measurement. The expansion state may be displayed on a monitor of computer system 122. Based on the displayed expansion state, a user can maintain the amount of expansion medium within the balloon or adjust the degree of balloon expansion by adding or removing expansion medium. Changes in the displayed at least one measurement can be used to monitor balloon expansion. For example, monitoring changes in measurement characteristics can be used to maintain the balloon's expansion state.

[0384] A medical device may include at least one shaft and a basket. The distal end of the basket may be connected to a distal connector, such as those shown in Figures 4-9 above. Figures 48-52 One of the distal connectors shown and described. The proximal end of the basket can be connected to a proximal connector, such as the one described above. Figure 10-2 0 and Figure 53-62 One of the proximal connectors shown and described. The basket may also include multiple tethers, such as those mentioned above. Figures 34-36 The tether shown and described. The medical device may also include a balloon located within the basket, such as... Figure 3A , 3C , Figures 49-50 and Figure 62 The balloon shown and described. The balloon can be connected to a distal connector and a proximal connector. At least one end of the balloon is foldable. The medical device may also include at least one sensor configured to measure characteristics indicating the balloon's inflation / expansion state, as described above. Figure 37 -41. The at least one axis may include a basket support axis. The basket support axis may be fixed to the proximal connector and float freely in the distal connector. The at least one axis may also include a cut axis pattern, such as those described above. Figure 21-33 Patterns 2104, 2210 and 2810 are shown and described.

[0385] Figure 43 Features of the catheter shaft 4300 are shown. Shaft 4300 can be used in one or more of the aforementioned medical devices. For example, shaft 4300 can be used to include expandable components (e.g. Figure 2The catheter 202 shown in Figure 2 or the catheter 302 shown in Figure 3 is, for example, the inner shaft of a medical device for an inner shaft (308). As will be discussed in more detail below, shaft 4300 may include one or more features that improve performance compared to a typical shaft. For example, shaft 4300 includes features for reducing kinking of the central lumen. In some applications, the kinking-reducing features are located in a portion of shaft 4300 configured to be within the expandable assembly, and shaft 4300 does not require additional components (e.g., support tubes) to reduce kinking of the central lumen while maintaining the tracking ability of shaft 4300 on a guidewire located within the central lumen. As another example, the outer diameter of shaft 4300 is smaller than that of a typical support tube passing through the expandable assembly. The reduction in the outer diameter of shaft 4300 may facilitate its insertion and passage through bent sheaths / shafts. Furthermore, when the catheter shaft 4300 described herein is used with a catheter with a basket, it provides a more “flexible” basket compared to conventional catheters with baskets due to its lower bending force. On the one hand, the reduction in bending force may make it easier for shaft 4300 to be inserted and / or advanced through the curved sheath / shaft. In addition, the structure of shaft 4300 can reduce or prevent the formation of leakage paths through the shaft wall, such as leakage from the central lumen to the outer surface of shaft 4300.

[0386] Back Figure 43 The shaft 4300 has an outer diameter of OD6 and a length of L23, measured from the first end 4302 to the second end 4304. The outer diameter OD6 can remain substantially constant. The value of the outer diameter OD6 ranges from approximately 0.061 inches to 0.064 inches. The shaft 4300 may comprise at least two parts. Figure 43 As shown, shaft 4300 includes: a first portion 4306 extending from a first end 4302 to a second end 4304, with a length of L24; a second portion 4308 extending from the first portion 4306 to the second end 4304, with a length of L25; and a third portion 4310 extending from the second portion 4308 to the second end 4304, with a length of L26. The second portion 4308 has the longest length L25. The length L24 of the first portion 4306 may be less than the length L25 of the second portion 4308 and / or the length L26 of the third portion 4310. Figure 43As shown, the length L24 of the first portion 4306 is less than the length L26 of the third portion 4310, and the length L26 of the third portion 4310 is further less than the length L25 of the second portion 4308 (L24<L26<L25). The length L24 of the first portion 4306 is approximately 2-4% of the length L23 of the shaft 4300, the length L25 of the second portion 4308 is approximately 74-78% of the length L23 of the shaft 4300, and the length L26 of the third portion 4310 is approximately 19-23% of the length L23 of the shaft 4300. As will be discussed in more detail below, the first portion 4306 of the shaft 4300 may be positioned within an expandable distal assembly (e.g., a basket and / or a balloon), and the structural design of the first portion 4306 is intended to prevent kinking of the central lumen. Accordingly, the length L24 of the first portion 4306 of the shaft 4300 may be designed to span the lumen of the expandable assembly.

[0387] As Figure 44 and Figure 45 shown, the wall 4400 of the shaft 4300 includes multiple layers (4412-4418), has a certain thickness (e.g., T1), and defines a central lumen 4402 having a diameter ID. The multiple layers include an inner layer 4412, an outer layer 4418, and one or more intermediate layers 4414, 4416. As Figure 44 shown, the first portion 4306 of the shaft 4300 may include two intermediate layers 4414, 4416, while as Figure 45 shown, the second portion and the third portion 4308, 4310 include one intermediate layer 4414. The inner layer 4412 and the first intermediate layer 4414 may extend along the length of the shaft 4300. The multiple layers 4412-4418 may include at least one polymer layer and at least one metal layer. The inner layer 4412 may be a polymer layer, the intermediate layers 4414 and 4416 may be metal layers, and the outer layer 4418 may be a polymer layer. The metal layer may be a reinforcing layer. For example, the metal reinforcing layer may be a braided layer or a coil. The first portion 4306 may include a first intermediate layer 4414 (metal braided layer) and a second intermediate layer 4416 (metal coil). As described above, the first intermediate layer 4414 may extend along the length of the shaft 4300, while the second intermediate layer 4416 may extend along the length of the first portion 4306. In one aspect, the braided first intermediate layer 4414 extending along the length of the shaft 4300 can provide crush resistance or kink resistance along the entire length of the shaft, while the coiled second intermediate layer 4416 provides enhanced pushability and kink resistance in the first portion 4306 of the shaft 4300 compared to a braided layer alone.

[0388] Flat wire can be used for at least one metallic reinforcement layer. On the one hand, using flat wire provides the necessary mechanical properties, such as critical axial strength and thrust, along the major axis without significantly increasing wall thickness, whereas using round wire would increase wall thickness. The wire dimensions constituting the braided layer can be smaller than the wire dimensions constituting the coil. The wire dimensions for the braided reinforcement layer can be 0.001 inches x 0.003 inches, and the wire dimensions for the coil can be 0.002 inches x 0.006 inches. Other wire sizes can also be used for the braided reinforcement layer and / or the coil reinforcement layer.

[0389] Polymer and metallic materials that can be used in shaft 4300 include, but are not limited to, thermoplastic polymers, elastomeric polymers, fluoropolymers, polyether intercalated amides (PEBA), polytetrafluoroethylene (PTFE), stainless steel, and nickel-titanium alloys. Shaft 4300 may include one or more regions, strip structures, coatings, components, etc., that can be detected by imaging methods such as X-rays, MRI, and ultrasound.

[0390] The outer layer 4418 can be made of different materials. The outer layer 4418 of one or more portions 4306, 4308, and 4310 of shaft 4300 can be made of polymers with different hardnesses. For example, the outer layer 4418 of the second portion 4308 can be made of a polymer with higher hardness, while the outer layers 4418 of the first portion 4306 and the second portion 4310 can be made of polymers with lower hardness. In one example, the outer layer 4418 of the first portion 4306 uses a first polymer with a first hardness of a first hardness tester, the outer layer 4418 of the second portion 4308 uses a second polymer with a second hardness of a second hardness tester, and the outer layer 4418 of the third portion 4310 uses a third polymer with a third hardness of a third hardness tester, wherein the second hardness is lower than the first hardness, and the first hardness is lower than the third hardness. For example, the first hardness could be 55 Shore D, the second hardness could be 35 Shore D, and the third hardness could be 72 Shore D.

[0391] The hardness of the outer layer 4418, the type of reinforcing layer, and / or the number of reinforcing layers can affect its flexibility. Incorporating a more flexible portion between two harder portions can improve the performance of the shaft 4300. For example, the harder first portion 4306 can provide support for the basket, reduce / prevent kinking of the central lumen 4402 in the first portion 4306, and / or reduce / prevent the formation of leakage paths, as described above. As another example, the more flexible second portion 4308 can improve the tracking performance of the shaft 4300. The flexible second portion 4308 can also make the shaft 4300 stretchable. On the one hand, this characteristic allows the basket to extend (stretch) and contract (shrink) when the shaft 4300 is used to support a medical device basket. Furthermore, the harder third portion 4310 extending from the handle can improve the pushability of the shaft 4300.

[0392] The diameter ID of the central lumen 4402 ranges from approximately 0.035 inches to approximately 0.050 inches. The diameter ID of the central lumen 4402 can be configured to accommodate a guidewire. The diameter ID of the central lumen 4402 can be configured to deliver fluid to the first end 4302 while the guidewire is located within the central lumen 4402. The diameter ID of the central lumen 4402 can remain substantially constant. As a non-limiting example, the diameter ID of the central lumen 4402 can be approximately 0.044 inches. The diameter ID of the central lumen 4402 can vary. For example, the diameter ID of the central lumen 4402 can be tapered. The central lumen 4402 passing through the first portion 4306 can have a first diameter, for example, ID1, while the central lumen 4402 passing through the second and third portions 4308, 4310 can have a second diameter, for example, ID2, which is smaller than the first diameter ID1. For example, the first diameter ID1 of the central lumen 4402 passing through the first section 4306 is approximately 0.044 inches, while the second diameter ID2 of the central lumen 4402 passing through the second and third sections 4308, 4310 is approximately 0.05 inches.

[0393] On the one hand, by defining a central lumen 4402 with a smaller diameter ID, the wall thickness T1 is sufficient to accommodate two intermediate reinforcing layers, while optimizing the cross-sectional area of ​​the central lumen 4402 to allow fluid flow when the guidewire is located within the central lumen 4402. The wall thickness T1 can remain substantially constant along the length of the axis 4300. For example, as Figure 44 and Figure 45 As shown, the outer layer 4418 in the second and third portions 4308, 4310 can be thicker than the outer layer 4418 in the first portion 4306, thus giving the shaft 4300 a substantially constant wall thickness T1. As mentioned above, the outer diameter OD6 of the shaft 4300 is smaller than that of a typical support tube that may pass through the cavity of the expandable component. On the one hand, reducing the wall thickness T1 can make the outer diameter OD6 of the shaft 4300 even smaller. The wall thickness T1 can be approximately 0.008 inches to 0.11 inches. In contrast, a braided shaft plus a typical support tube has a wall thickness of 0.023 inches.

[0394] As described above, an exemplary embodiment of shaft 4300 defines a central lumen 4402 having a diameter ID, the central lumen comprising: a distal first portion 4306 extending from a distal first end 4302; a second portion 4308 extending from the first portion 4306; a third portion 4310 extending from the second portion 4308; a PTFE inner layer 4412 extending from the distal first end 4302 to the second end 4304; a stainless steel braided layer covering the PTFE inner layer 4412 and extending from the first end 4302 to the second end 4304; wherein the first portion 4306 further comprises a stainless steel coil covering the stainless steel braided layer; and a PEBA outer layer 4418 with a hardness of 55 Shore D covering the stainless steel coil; the second portion 4308 further comprises a PEBA outer layer 4418 with a hardness of 35 Shore D covering the stainless steel braided layer; and the third portion 4310 further comprises a PEBA outer layer 4418 with a hardness of 72 Shore D covering the stainless steel braided layer. The PEBA outer layer 4418 can be reflow soldered onto the stainless steel coil and / or stainless steel braid. The wires constituting the stainless steel braid can be 0.001 inch x 0.003 inch wires, and the wires constituting the stainless steel coil can be 0.002 inch x 0.006 inch wires. The pitch of the stainless steel coil can be 0.015 inches. The diameter ID of the central lumen 4402 ranges from approximately 0.035 inches to approximately 0.050 inches.

[0395] Figure 46 A medical device 4600 is shown, with its shaft 4300 passing through a coaxial outer shaft 4604 and extending into the lumen of an expandable end assembly 4602. As described above, the shaft 4300 and the outer shaft 4604 can slide relative to each other. For example, the medical device 4600 may include a handle (not shown) configured to allow the shaft 4300 and the outer shaft 4604 to slide relative to each other. Figure 46 The expandable end assembly 4602 shown includes a balloon 4620 located within a basket 4610. The expandable end assembly 4602 may have a blunt end and / or a non-invasive distal end 4603. At least one end of the balloon 4620 may be inverted. The basket 4610 may include a plurality of ribs 4614 connected to distal and proximal connectors 4630, 4640. Each rib 4614 may include at least one electrode 4612 and a plurality of insulating regions (collectively referred to as 4616, wherein insulating regions 4616a and 4616b are identified). As described above, in some embodiments, the basket 4610 is configured for ablation and / or mapping. The basket 4610 may also include a plurality of tethers, such as those described above. Figures 34-36 The rope shown and described.

[0396] like Figure 46As shown, the basket 4610 and the balloon 4620 are connected to the distal connector 4630 and the proximal connector 4640, respectively. The expandable end assembly 4602 can be connected to the shaft 4300 via the distal connector 4630 and to the outer shaft 4604 via the proximal connector 4640. As described above, the proximal connector 4640 may include a retaining ring 4606. The relative movement of the shaft 4300 and the outer shaft 4604 can be used to expand / contract the expandable end assembly 4602. Figure 46 As shown, the distal connector 4630 can be configured to receive the first end 4302 of the shaft 4300, and the proximal connector 4640 can be configured to surround the shaft 4300. The distal connector 4630 can be as shown in Figure 4-9 and... Figures 48-52 The distal connector shown and described above. The proximal connector 4640 can be as follows: Figure 10-2 0 and Figure 53-62 The proximal connector shown and described above. As mentioned above, the inflation medium for inflating the balloon 4620 can be delivered via the proximal connector 4640 or via the shaft 4300.

[0397] The first portion 4306 may span the lumen of the basket 4610, providing support for the basket 4610. For example, the proximal end of the first portion 4306 of the shaft 4300 may coincide with the proximal end of the basket 4610. The first portion 4306 may also extend beyond the proximal end of the basket lumen. For example, the first portion 4306 may extend up to the proximal end of the proximal connector 4640. As described above, the first portion 4306 includes a spiral reinforcement layer (e.g., a second intermediate layer 4416) on a braided reinforcement layer (e.g., a first intermediate layer 4414) to prevent kinking of the central lumen of the shaft portion spanning the basket 4610.

[0398] The length of the distal first portion 4306 is approximately 2-4% of the length of the shaft 4300, the length of the second portion 4308 is approximately 74-78% of the length of the shaft 4300, and the length of the third portion 4310 is approximately 19-23% of the length of the shaft 4300. The length of the distal first portion 4306 is 1.6 inches ± 0.2 inches, the length of the second portion 4308 is 42.9 inches ± 0.5 inches, and the length of the third portion 4310 is 12.0 inches ± 0.5 inches, wherein the second portion 4308 extends proximally from the distal first portion 4306, and the third portion 4310 extends proximally from the second portion 4308. A handle of the medical device 4600 can be attached to the third portion 4310 (not shown). As described above, the handle can be configured to allow the shaft 4300 and the outer shaft 4604 to slide relative to each other.

[0399] Medical device 4600 may also include at least one sensor configured to measure characteristics indicating the inflation / expansion state of balloon 4620, as described above. Figure 37 As described in -41.

[0400] Figure 47 This is a flowchart of a method 4700 for forming a shaft 4300, which defines a central cavity 4402 and includes a first end 4302, a second end 4304, a first portion 4306 extending from the first end 4302 and having a first length L24, a second portion 4308 extending from the first portion 4306 and having a second length L25, and a third portion 4310 extending from the second portion 4308 and having a third length L26, as shown. Figure 43 and Figure 44 As shown. The first length L24 can be less than the third length L26, and the third length L26 can be less than the second length L25. The diameter ID of the central cavity 4402 can be substantially constant. The inner diameter of the central cavity 4402 in the first part 4306 can be less than the diameter of the central cavity 4402 in the second and third parts 4308 and 4310. Method 4700 can manufacture the shaft 4300 from the inside out.

[0401] In step 4702, a braided layer is formed on the outer surface of the polymer tube. The polymer tube may constitute the inner layer 4412 of the shaft 4300, while the braided layer may constitute the first intermediate layer 4414 of the shaft 4300. The polymer tube may be formed on or connected to a mandrel. The outer surface of the polymer tube may be etched. As described below, etching the polymer tube can enhance its adhesion to the mandrel. Forming the braided layer on the polymer tube may include braiding metal wires around the polymer tube. The metal wires may be braided in any manner. The braided layer may be composed of flat and / or metallic wires. The braided layer may include 0.001 inch x 0.003 inch metal wires. The polymer tube may include polytetrafluoroethylene (PTFE), while the braided layer may include stainless steel wires.

[0402] In step 4704, a winding layer is formed on the braided layer. This winding layer may form a second intermediate layer 4416 in the first portion 4306 of the shaft 4300. In one aspect, the braided layer is less prone to shifting when the coil is added compared to when the braided layer is added. This may help simplify the manufacturing process and / or obtain a more uniform shaft 4300. Forming a winding layer on the braided layer may include winding a conductor at a predetermined pitch around a first end of the braided layer. This winding layer may form a second intermediate layer 4416 in the first portion 4306 of the shaft 4300. The combination of the winding layer and the braided layer can improve the performance of the shaft 4300. For example, the wound conductor and the braided reinforcement layer can prevent kinking of the shaft 4300. The first end may be located on the distal portion of the shaft 4300. The conductor constituting the coil may be a metal conductor. The conductor may be made of stainless steel. The conductor may be a 0.002 inch x 0.006 inch conductor wound with a pitch of 0.015 inches.

[0403] In step 4706, a first polymer having a first hardness tester hardness is applied to the winding layer. The first polymer may form the outer layer 4418 of the first portion 4306 of the shaft 4300. The first polymer may be heated to allow it to flow back into the gaps or voids between the braided wires and / or adjacent coil windings. The flowing-back first polymer can bond to the polymer tube through these gaps or voids. Furthermore, etched outer surfaces of the polymer tube can enhance the adhesion between the first polymer and the polymer tube. If kinks form in the first portion 4306 of the shaft 4300, filling the gaps or voids between the braided wires and / or adjacent coil windings with the first polymer can minimize and / or eliminate leakage paths from the central lumen 4402 through the shaft wall.

[0404] In step 4708, a second polymer having a second hardness tester hardness is coated onto the middle portion of the braided layer. This second polymer can form the outer layer 4418 of the second portion 4308 of the shaft 4300. The second polymer can be heated to allow it to flow back into the gaps or voids between the braided threads. The reflowed second polymer can then bond to the polymer tube through these gaps or voids. Furthermore, etching the outer surface of the polymer tube can enhance the adhesion between the second polymer and the polymer tube. The hardness of the second hardness tester can be greater than that of the first hardness tester.

[0405] In step 4710, a third polymer having the hardness of a third hardness tester is coated onto the second end of the braided layer. This third polymer can form the outer layer 4418 of the third portion 4310 of the shaft 4300. The third polymer can be heated to allow it to flow back into the gaps or voids between the braided threads. The reflowed third polymer can then bond to the polymer tube through these gaps or voids. Furthermore, etching the outer surface of the polymer tube can enhance the adhesion between the third polymer and the polymer tube. The hardness of the third hardness tester can be greater than that of the first hardness tester but less than that of the second hardness tester.

[0406] The embodiments described in this disclosure are as follows:

[0407] A connector configured for attachment to a conduit shaft and an expandable end assembly. The expandable end assembly may include a basket. The connector includes a first wall and a basket securing assembly.

[0408] The connector can be a remote connector or a proximal connector.

[0409] The basket fixing assembly may include a plurality of protrusions extending outward from a first wall; a plurality of second walls, each second wall extending between two of the plurality of protrusions; and a plurality of grooves.

[0410] Each slot in the basket fixing assembly may be a blind hole defined by two of a first wall, one of a plurality of second walls, and a plurality of protrusions, wherein the slot is configured to receive a single rib of the basket.

[0411] The first wall can define the central lumen.

[0412] Each of the multiple protrusions in the basket fixing assembly may include a curved leading edge portion with a radius of curvature greater than that of a curved trailing edge portion.

[0413] Multiple protrusions can be consecutive.

[0414] Multiple protrusions may include retaining grooves configured to retain the rib retaining portion of the basket ribs.

[0415] The curved leading edge may bend outwards and away from the far side of the connector.

[0416] Each of the plurality of protrusions may also include a side of a line extending at a first angle (A5) into the bisector of the groove.

[0417] Each second wall may define a through hole communicating with the groove, the through hole being used to secure the reinforcing bar in the groove.

[0418] Each second wall may be recessed longitudinally and / or radially.

[0419] The proximal end of the second wall can be located distal to the proximal end of the protrusion of the defining groove.

[0420] The first end of the second wall can be aligned with the first end of the first wall.

[0421] The distal side of the connector can define an opening that communicates with the central lumen.

[0422] Each slot can be radially opposite to another slot.

[0423] The far side of the first region can be symmetrical.

[0424] Adjacent slots can be set at a second angle (A4).

[0425] The connector may include at least one rib extending from a first wall adjacent to the plurality of protrusions and the plurality of second walls.

[0426] The side of at least one rib can be oriented to form a third angle (A3).

[0427] Ribs can be arranged circumferentially.

[0428] The first wall defines at least one through hole for securing the connector to the shaft.

[0429] The at least one through hole may include a first through hole and a second through hole, and one or more of the at least one rib are located between the first through hole and the second through hole.

[0430] At least one through hole can be a hole or a slit.

[0431] At least one through hole may be located near the second end of the connector.

[0432] The slot can be a blind hole.

[0433] The annular wall may be located proximal to the protrusion and / or distal to at least one rib.

[0434] The electrode can be connected to the distal side of the distal connector.

[0435] The electrodes can be ring-shaped or spherical.

[0436] The ring electrode can be flush with the distal side.

[0437] The electrode can define a cavity that communicates with the central cavity of the connector.

[0438] The basket can expand to resemble a petal shape.

[0439] The reinforcing bar retainer can be located at the end of the reinforcing bar or extend from the side of the reinforcing bar.

[0440] The basket reinforcement connected to the distal connector may include a curved portion, wherein the reinforcement extends distally from the end of the first reinforcement and proximally from the curved portion.

[0441] The connector may include a balloon fixation area that is longitudinally adjacent to the basket fixation area.

[0442] The balloon fixation area may include multiple ribs or covered molding sections.

[0443] The connector may include at least one magnetic sensor fixed in a groove on the outer surface of the connector.

[0444] The groove may be located in the balloon fixation area, wherein the groove extends through at least a portion of a plurality of ribs.

[0445] The balloon may be an inverted balloon.

[0446] Magnetic sensors can be either near-side or far-side magnetic sensors.

[0447] The proximal magnetic sensor can be connected to the distal connector.

[0448] The distal magnetic sensor can be connected to the proximal connector.

[0449] The magnetic sensor can be offset in a ring shape relative to the longitudinal axis of the connector.

[0450] The magnetic sensor connected to the remote connector can be oriented parallel to the longitudinal axis of the connector and in a ring-shaped offset position.

[0451] The connector can be modularly designed. The balloon fixing area and the basket fixing assembly can be respectively set on different connector components, which can be connected by male / female connectors.

[0452] The guy wire anchor can be fixed to the near-side connector.

[0453] The guy wire anchor may include a pull ring or a sleeve.

[0454] The proximal connector may include at least one retainer configured to anchor a single guy wire to the proximal connector.

[0455] The retaining part may include at least one annular wall.

[0456] At least one annular wall may include a proximal annular wall and a distal annular wall.

[0457] The basket fixing assembly may include a groove, the groove including a first open end and a second open end; an annular portion adjacent to the second open end, the annular portion being configured to receive the barbed ends of the basket ribs; and an annular wall adjacent to the annular portion.

[0458] The shaft may contain a helical pattern etched onto its walls. The helical pattern consists of a helical trunk and interlocking elements angled relative to the shaft's longitudinal axis. The helical trunk is composed of alternating first and second sections. A pair of interlocking elements extends from opposite sides of each first section of the helical trunk. Each interlocking element includes a post and two arms angled relative to each other, the arms having curved edges; and the side surfaces of each second section are complementary in shape to the interlocking elements extending from adjacent turns of the helical trunk.

[0459] The shaft may include a helical pattern cut into the shaft wall. The helical pattern may include a helical trunk and interlocking first and second elements, the first and second elements being at an angle to the longitudinal axis of the shaft, wherein the first and second elements have different shapes.

[0460] Each second element may define a slot, the slot being configured to receive one of a plurality of first elements.

[0461] Each first element may include a rod and a rounded end with a diameter greater than the width of the rod, the rod extending from the side of the helical trunk.

[0462] Each second element can consist of a pair of components.

[0463] The pair of components can define the closed end of the groove and the opening of the groove, wherein the size of the opening can be designed to retain the rounded end of one of the first elements in the groove.

[0464] Each component in each pair may include a curved portion whose radius of curvature is complementary to the radius of curvature of the rounded end of one of the first elements in the groove.

[0465] The second element can be symmetrical about the longitudinal line of the bisecting groove.

[0466] The components of this pair of components can be mirror images of each other.

[0467] The shaft can be made of polymer material.

[0468] The shaft can be made of metallic material.

[0469] The shaft can be a support shaft located inside the basket.

[0470] The shaft may be a support shaft located inside the balloon.

[0471] According to another aspect, a medical device includes: a distal connector as described in one or more of the statements above, connected to a first axis; and a basket connected to the first axis via the distal connector. The basket includes a plurality of ribs, each rib being fixed to one of a plurality of slots in the distal connector.

[0472] According to another aspect, a medical device includes: a first shaft as described in one or more of the statements above; a distal connector as described in one or more of the statements above, wherein the distal connector is connected to the first shaft; and a basket connected to the first shaft via the distal connector, the basket including a plurality of ribs, wherein each of the plurality of ribs is fixed to one of a plurality of slots in the connector.

[0473] 66. The spiral pattern may be located on a portion of the length of the first axis wall inside the basket.

[0474] 67. The distal connector can be connected to the first shaft at the distal end of the spiral pattern.

[0475] 68. The distal side of the distal connector can be the distal side of the medical device.

[0476] 69. The medical device may further include one or more tethers, each tether extending between adjacent ribs of the plurality of ribs.

[0477] 70. One or more tethers may be located in the far end of the basket.

[0478] 71. Each tether can be arranged circumferentially.

[0479] 72. Each tether can be oriented with the first end in front of the second end.

[0480] 73. The rope can be made of metal.

[0481] 74. The basket may also include one or more electrodes for ablation and / or mapping.

[0482] 75. Each rib may have at least one of one or more electrodes.

[0483] 76. The medical device may further include an expandable balloon located within a basket. The expandable balloon may include an outer surface, a distal end connected to a distal connector, and a proximal end connected to a proximal connector. The expandable balloon is selectively expandable such that, when the expandable balloon is in the expanded state, the outer surface of the expandable balloon contacts the inner surface of the plurality of ribs.

[0484] 77. The medical device may further include a first sensor located between the inner surface of the first rib of the plurality of ribs and the outer surface of the balloon, wherein the first sensor may be configured to output a signal indicating the expansion state of the expandable balloon.

[0485] 78. The medical device may further include a first electrode and a second electrode, wherein the first sensor is the first electrode, and the electrical response measured between the first electrode and the second electrode can indicate a signal of an expansion state.

[0486] 79. The first electrode may be the exposed end of the first wire fixed to the insulating portion of the first rib.

[0487] 80. When the expandable balloon is inflated, a high-impedance path can be provided between the first and second electrodes; when the expandable balloon is not inflated, a low-impedance path can be provided between the first and second electrodes.

[0488] 81. The second electrode may be an electrode located on a second rib among a plurality of ribs, the second rib comprising a body made of conductive material; and an insulating material covering a portion of the body, wherein the electrode comprises an exposed portion of the body.

[0489] 82. The near end of the basket can be connected to the far end of the second axis.

[0490] 83. The second electrode may be a ring electrode, located on the second axis near the basket.

[0491] 84. The second electrode may be the exposed end of the second wire located on the inner surface of the second rib of the plurality of ribs, wherein the exposed end of the second wire may be connected to the insulating portion of the body of the second rib of the plurality of ribs.

[0492] 85. When the expandable balloon is inflated, a low-impedance path can be provided between the first and second electrodes; when the expandable balloon is not inflated, a high-impedance path can be provided between the first and second electrodes.

[0493] 86. The second electrode can be fixed on the outer surface of the expandable balloon and aligned with the first electrode.

[0494] 87. The sensor may be a pressure sensor connected to an insulating portion of the inner surface of the first rib among a plurality of ribs, wherein the gradually increasing pressure may be applied between the pressure sensor and the outer surface of the expandable balloon when the balloon inflates, and applied between the pressure sensor and the outer surface of the balloon when the balloon deflates.

[0495] According to another aspect, a method for detecting balloon expansion of an expandable balloon having a net basket containing multiple ribs, the balloon being located within the multiple ribs, the method comprising: measuring features indicating the expansion state of the expandable balloon using a sensor located between the inner surface of a first rib of the multiple ribs and the outer surface of the expandable balloon; determining the expansion state of the expandable balloon based on the measured features; and displaying the expansion state of the expandable balloon on a display.

[0496] The sensor may be a first electrode, wherein the measurement feature associated with the first electrode may be the impedance between the first electrode and the second electrode.

[0497] Determining the expansion state of an expandable balloon can include comparing a measured impedance with a first threshold, wherein when the impedance is greater than the first threshold, the expandable balloon is determined to be in an inflated state; when the impedance is less than the first threshold, the expandable balloon is determined to be in an uninflated state.

[0498] Determining the expansion state of an expandable balloon may also include comparing a measured impedance to a second threshold, wherein when the impedance is greater than the second threshold, the expandable balloon is determined to be in an over-inflated state.

[0499] The second electrode may be located on the outer surface of the balloon and aligned with the first electrode. Determining the expansion state of the expandable balloon includes comparing a measured impedance with a first threshold. When the impedance is less than the first threshold, the expandable balloon is determined to be in an inflated state, and when the impedance is greater than the first threshold, the expandable balloon is determined to be in an uninflated state.

[0500] The sensor can be a pressure sensor, wherein the measured characteristic can be the pressure between the pressure sensor and the expandable balloon, wherein determining the expansion state of the expandable balloon can include comparing the measured pressure with a first threshold; wherein when the pressure is greater than the first threshold, it can be determined that the balloon is inflated; and wherein when the pressure is lower than the first threshold, it can be determined that the balloon is inflated.

[0501] According to another aspect, a system for detecting balloon inflation includes a medical device, an electronic control unit, and a display. The medical device includes a basket assembly fixed to a distal end of an axis, the basket assembly comprising multiple ribs; an expandable balloon having an outer surface and located within the basket assembly, wherein the expandable balloon is selectively expandable such that the outer surface of the expandable balloon can contact the inner surface of at least one of the multiple ribs; and a first sensor located between the inner surface of the first rib of the multiple ribs and the outer surface of the balloon, wherein the first sensor is configured to monitor features indicating the inflation state of the expandable balloon. The electronic control unit is configured to receive feedback from the first sensor indicating the measured features, wherein the electronic control unit determines the inflation state based on the feedback and generates an output. The display receives output from a computer system and displays the inflation state of the balloon.

[0502] The first sensor can be the first electrode.

[0503] The first electrode may be the exposed end of the first wire fixed to the insulating portion of the first rib.

[0504] The measured characteristic can be the impedance measured between the first electrode and the second electrode. The electronic control unit can compare the measured impedance with a first threshold. When the impedance is greater than the first threshold, it can be determined that the balloon is inflated, and when the impedance is less than the first threshold, it can be determined that the balloon is not inflated.

[0505] The second electrode may be an electrode located on a second rib among a plurality of ribs. The second rib may include a first end connected to the distal end of an outer shaft element, a second end connected to the distal end of an inner shaft element, a body containing conductive material, and an insulating material covering a portion of the body, wherein the exposed portion of the body may be the second electrode.

[0506] The second electrode can be a ring electrode located at the far end of the axis near the basket assembly.

[0507] The second electrode may be the exposed end of a second wire located on the inner surface of a second rib among a plurality of ribs, wherein the exposed end of the second wire may be connected to an insulating portion of the body of the second rib.

[0508] The electronic control unit can also compare the measured impedance with a second threshold. When the impedance is greater than the second threshold, it can be determined that the balloon is in an overinflated state.

[0509] The measured characteristic can be the impedance measured between the first electrode and the second electrode, wherein the second electrode can be fixed on the outer surface of the balloon and aligned with the first electrode. The electronic control unit can compare the measured impedance with a first threshold, and when the impedance is less than the first threshold, it can be determined that the balloon is inflated, and when the impedance is greater than the first threshold, it can be determined that the balloon is not inflated.

[0510] The first sensor is a pressure sensor, which is connected to the insulating part of the inner surface of the first rib. The characteristic indicating the balloon's expansion state can be the measured pressure between the pressure sensor and the outer surface of the balloon. The electronic control unit compares the measured pressure with a first threshold. When the pressure is greater than the first threshold, it can be determined that the balloon is inflated; when the pressure is less than the first threshold, it can be determined that the balloon is not inflated.

[0511] According to another aspect, a medical device includes: a basket; a distal connector connected to the distal end of the basket; a proximal connector connected to the proximal end of the basket and a catheter shaft, the proximal connector defining a lumen; and a support shaft, the distal end of which is fixed to the distal connector, the proximal end of which floats freely within the lumen of the proximal connector.

[0512] According to another aspect, a medical device includes a distal connector, a proximal connector, at least one magnetic sensor fixed to the outer surface of the proximal connector, a basket, and a balloon, wherein the at least one magnetic sensor is located inside the balloon. The distal connector may include a first fixation region and a second fixation region adjacent to the first fixation region. The proximal connector may include a third fixation region and a fourth fixation region adjacent to the second fixation region. The basket may be connected to the first fixation region and the second fixation region. The balloon may be located within the basket. The balloon may be connected to the second fixation region and the third fixation region.

[0513] According to another aspect, a medical device includes a basket comprising a plurality of ribs and a distal connector, the distal connector including a distal side and a rib fixing assembly for fixing the distal ends of the plurality of ribs, wherein the plurality of ribs located in the rib fixing assembly are tangent to the distal side.

[0514] On the other hand, the net basket includes multiple reinforcing bars.

[0515] The reinforcing bars may contain nickel-titanium alloys.

[0516] Each reinforcing bar may contain at least one reinforcing bar retainer.

[0517] The reinforcing bar retainer may extend from the end of the reinforcing bar and / or the side of the reinforcing bar.

[0518] The reinforcing bar can be a barb, which includes at least one protrusion.

[0519] Each rib may contain at least one covered molding portion.

[0520] At least one overmolded portion may include a proximal overmolded portion, an unovermolded intermediate portion, and a distal overmolded portion.

[0521] The overmolded portion can have a polymer coated on the ribs. The ribs of the overmolded portion can be narrower than the ribs of the unovermolded portion.

[0522] The overmolded portion may include a polymer. This polymer may be a polyether-intercalated amide. The polymer has a Shore D hardness of 72.

[0523] According to another aspect, a shaft of a medical device includes: a polymer tube constituting an inner layer of the shaft; a braided layer located on and extending therefrom the polymer tube; a coil located at a first end of the braided layer; a first polymer having a first hardness on the coil; a second polymer having a second hardness on a middle portion of the braided layer; and a third polymer having a third hardness on a second end of the braided layer.

[0524] According to another aspect, a method of manufacturing a conduit shaft includes: forming a braided layer around a polymer tube; winding a metal wire around a first end of the braided layer; reflowing a first polymer having a first hardness of a ...

[0525] The first polymer, the second polymer, and the third polymer can form the outer layer of the shaft.

[0526] The hardness of the second hardness tester can be less than that of the first hardness tester, and the hardness of the first hardness tester can be less than that of the third hardness tester.

[0527] The polymer tube can be a polytetrafluoroethylene (PTFE) tube, the braided layer can include multiple metal wires, the coil can be a metal wire, the first polymer can be polyether intercalated amide (PEBA), the second polymer can be polyether intercalated amide (PEBA), and the third polymer can be polyether intercalated amide (PEBA).

[0528] Multiple metal wires can be made of stainless steel, and coils can also be made of stainless steel.

[0529] The first polymer, the second polymer, and the third polymer may be located within the gap defined by the braided layers and / or coils.

[0530] The first part has a first length, the second part has a second length, and the third part has a third length, wherein the second length may be greater than the first length and the third length; and / or the first length may be the minimum length.

[0531] The shaft may be part of a medical device, which also includes an outer shaft coaxial with the shaft; a basket; a distal connector for securing the distal end of the basket to the distal end of the shaft; and a proximal connector for securing the proximal end of the basket to the outer shaft; wherein the basket is supported by a first portion of the shaft.

[0532] The basket can be supported by only the first part of the shaft extending between the distal and proximal connectors.

[0533] The invention is defined in the appended claims. The non-exhaustive enumeration of aspects of the invention listed in the numbered clauses aids in understanding the invention.

Claims

1. A distal connector configured for attachment to a catheter shaft, the connector comprising: The first wall defines a central lumen; Multiple protrusions extending outward from the first wall; Multiple second walls, each second wall being located between two of the multiple protrusions; as well as Multiple slots, each slot being defined by a first wall, one of a plurality of second walls and two of a plurality of protrusions, wherein the slots are configured to receive a single rib of the basket.

2. The distal connector according to claim 1, wherein, Each of the plurality of protrusions includes a curved leading edge portion having a radius of curvature greater than that of a curved trailing edge portion.

3. The distal connector according to claim 2, wherein, The curved leading edge portion bends outward and away from the far side of the connector.

4. The distal connector according to any one of claims 1 to 3, wherein, Each of the plurality of protrusions also includes a side surface extending at a first angle (A5) relative to the bisector of the groove.

5. The distal connector according to any one of claims 1 to 4, wherein, Each second wall defines a through hole communicating with the groove, the through hole being configured to secure the reinforcing bar within the groove.

6. The distal connector according to any one of claims 1 to 5, wherein, Each second wall is recessed along the longitudinal and / or radial direction.

7. The distal connector according to any one of claims 1 to 6, wherein, The first end of the second wall is aligned with the first end of the first wall.

8. The distal connector according to any one of claims 1 to 7, wherein, The distal side of the distal connector is defined with an opening communicating with the central lumen.

9. The distal connector according to any one of claims 1 to 8, wherein, Each slot is arranged relative to another slot.

10. The distal connector according to claim 8 or 9, wherein, The far side is symmetrical.

11. The distal connector according to any one of claims 1 to 10, wherein two adjacent slots are arranged at a second angle (A4).

12. The distal connector according to any one of claims 1 to 11, wherein, The distal connector also includes at least one rib extending from a first wall adjacent to a plurality of protrusions to a plurality of second walls.

13. The distal connector according to claim 12, wherein, The orientation of the two sides of each rib forms a third angle (A3).

14. The distal connector according to any one of claims 1 to 13, wherein, The first wall defines at least one through hole for securing the connector to the guide shaft.

15. The distal connector according to claim 14, wherein, The at least one through hole includes a first through hole and a second through hole, and one or more of the at least one rib is located between the first through hole and the second through hole.

16. The distal connector according to claim 14 or 15, wherein, The at least one through hole is a hole or a slit.

17. The distal connector according to any one of claims 14 to 16, wherein, The at least one through hole is located near the second end of the connector.

18. A catheter shaft comprising a helical pattern cut into the wall of the shaft, wherein the helical pattern includes a helical backbone and two interlocking elements oriented at an angle relative to the longitudinal axis of the shaft, wherein the helical backbone comprises alternating first and second portions, wherein: A pair of interlocking elements extend from opposite sides of each first section of the helical trunk, each interlocking element comprising a post and two arms oriented at an angle to each other, the two arms comprising curved edges; and the side of each second section is complementary in shape to the interlocking element extending from the adjacent rotation of the helical trunk.

19. A conduit shaft comprising a helical pattern cut into the wall of the shaft, wherein the helical pattern comprises a helical trunk and interlocking first and second elements oriented at an angle relative to the longitudinal axis of the shaft, wherein the first and second elements have different shapes.

20. The catheter shaft according to claim 19, wherein, Each second element is defined with a slot constructed to receive one of the plurality of first elements.

21. The conduit shaft according to claim 19 or 20, each first element comprising a rod having a rounded end, wherein the diameter of the rounded end is greater than the width of the rod, and the rod extends from the side of the helical trunk.

22. The catheter shaft according to any one of claims 19 to 21, wherein, Each second element comprises a pair of components.

23. The catheter shaft according to claim 22, wherein, The pair of members defines a closed end of the groove and an opening of the groove, wherein the opening is sized such that the rounded end of one of the plurality of first elements is retained within the groove.

24. The catheter shaft according to claim 23, wherein, Each of the pair of components includes a curved portion whose radius of curvature is complementary to the radius of curvature of the rounded end of one of the plurality of first elements within the groove.

25. The catheter shaft according to any one of claims 20 to 24, wherein, The second element is symmetrical about the longitudinal line that bisects the groove.

26. The catheter shaft according to any one of claims 22 to 25, wherein, The pair of elements are mirror images of each other.

27. The catheter shaft according to any one of claims 18 to 26, wherein, The conduit shaft is made of polymer material.

28. The catheter shaft according to any one of claims 18 to 26, wherein, The conduit shaft is made of metal.

29. A medical device comprising: The distal connector according to any one of claims 1 to 17, wherein the connector is connected to the first shaft; as well as A basket connected to the first shaft via the distal connector, the basket comprising multiple ribs, each of the multiple ribs being fixed to one of the multiple slots of the distal connector.

30. A medical device comprising: The catheter shaft according to any one of claims 18, 27, and 28, or the catheter shaft according to any one of claims 19 to 28, wherein the catheter shaft includes a first shaft; The distal connector of any one of claims 1 to 17, wherein the distal connector is connected to the first shaft; as well as A basket connected to a first axis via a distal connector, the basket comprising multiple reinforcing ribs, each rib being fixed to one of multiple slots in the connector.

31. The medical device according to claim 30, wherein, The first axis is the conduit axis of any one of claims 19 to 28, wherein the spiral pattern is positioned along a certain length of the wall of the first axis located within the basket.

32. The medical device according to claim 31, wherein, The distal connector is connected to the first shaft and is located on the distal side of the spiral pattern.

33. The medical device according to any one of claims 30 to 32, wherein, The distal side of the distal connector is the distal side of the medical device.

34. The medical device according to any one of claims 30 to 33, further comprising one or more tethers, each tether extending between two adjacent ribs of the plurality of ribs.

35. The medical device according to claim 34, wherein, The one or more tethers are located in the far side of the basket.

36. The medical device according to claim 34 or 35, wherein, Each rope is oriented circumferentially.

37. The medical device according to claim 34 or 35, wherein, Each tether is oriented so that the first end is in front of the second end.

38. The medical device according to any one of claims 34 to 37, wherein, The tether is made of metal.

39. The medical device according to any one of claims 30 to 38, wherein the basket further comprises one or more electrodes for ablation and / or mapping.

40. The medical device according to claim 39, wherein, Each rib includes at least one of the one or more electrodes.

41. The medical device according to any one of claims 30 to 40, further comprising an expandable balloon located within the basket, the expandable balloon comprising: Outer surface; Connected to the far end of the remote connector; as well as The proximal end is connected to the proximal connector; The expandable balloon can be selectively expanded such that when the expandable balloon is in an expanded state, the outer surface of the expandable balloon contacts the inner surface of the plurality of ribs.

42. The medical device of claim 41, further comprising a first sensor located between the inner surface of the first rib of the plurality of ribs and the outer surface of the balloon, wherein the first sensor is configured to output a signal indicating the expansion state of the expandable balloon.

43. The medical device of claim 42, further comprising a first electrode and a second electrode, wherein the first sensor is the first electrode, and the electrical response measured between the first electrode and the second electrode is a signal indicating the expansion state.

44. The medical device according to claim 43, wherein, The first electrode is the exposed end of the first conductor fixed to the insulating portion of the first rib.

45. The medical device according to any one of claims 43 to 44, wherein, When the expandable balloon is in the expanded state, a high-impedance path is formed between the first and second electrodes; and when the expandable balloon is in the unexpanded state, a low-impedance path is formed between the first and second electrodes.

46. ​​The medical device according to claim 45, wherein, The second electrode is an electrode located on a second rib among multiple ribs, the second rib comprising: The body containing conductive material; and Insulating material covering the body portion, wherein the electrodes include the exposed portion of the body.

47. The medical device according to any one of claims 41 to 46, wherein, The near end of the basket is connected to the far end of the second axis.

48. The medical device according to claim 43, wherein, The second electrode is a ring electrode, located on the second axis near the basket.

49. The medical device according to claim 43, wherein, The second electrode is the exposed end of the second wire located on the inner surface of the second rib among the plurality of ribs, wherein the exposed end of the second wire is connected to the insulating portion of the body of the second rib among the plurality of ribs.

50. The medical device according to claim 43, wherein, When the expandable balloon is in the expanded state, a low-impedance path is formed between the first and second electrodes; when the expandable balloon is in the unexpanded state, a high-impedance path is formed between the first and second electrodes.

51. The medical device according to claim 50, wherein, The second electrode is fixed to the outer surface of the expandable balloon and aligned with the first electrode.

52. The medical device of claim 41, wherein the sensor is a pressure sensor connected to an insulating portion of the inner surface of a first rib of a plurality of ribs, wherein a gradually increasing pressure is formed between the pressure sensor and the outer surface of the balloon when the expandable balloon is inflated; and a gradually decreasing pressure is formed between the pressure sensor and the outer surface of the balloon when the balloon is deflated.

53. A method for detecting the expansion state of an expandable balloon in a medical device, said medical device having a basket comprising multiple ribs, the balloon being located within said multiple ribs, the method comprising: The characteristics indicating the expansion state of the expandable balloon are measured by a sensor located between the inner surface of the first rib of the multiple ribs and the outer surface of the expandable balloon. The expansion state of the expandable balloon is determined based on the measured characteristics; as well as The expansion state of the expandable balloon is shown on the display.

54. The method of claim 53, wherein the sensor is a first electrode, and wherein the measured characteristic associated with the first electrode is the impedance between the first electrode and the second electrode.

55. The method of claim 54, wherein determining the expansion state of the expandable balloon includes comparing a measured impedance with a first threshold, wherein when the impedance is greater than the first threshold, the expandable balloon is determined to be in an inflated state; wherein when the impedance is less than the first threshold, the expandable balloon is determined to be in an uninflated state.

56. The method of claim 55, wherein determining the expansion state of the expandable balloon further comprises comparing a measured impedance with a second threshold, wherein when the impedance is greater than the second threshold, the expandable balloon is determined to be in an over-inflated state.

57. The method according to claim 54, wherein, The second electrode is located on the outer surface of the balloon and is aligned with the first electrode. Determining the expansion state of the expandable balloon includes comparing the measured impedance with a first threshold. When the impedance is less than a first threshold, the expandable balloon is determined to be inflated. When the impedance is greater than the first threshold, the expandable balloon is determined to be in an uninflated state.

58. The method according to claim 53, wherein, The sensor is a pressure sensor, and the characteristic measured is the pressure between the pressure sensor and the inflatable balloon. Determining the expansion state of the expandable balloon includes comparing the measured pressure with a first threshold. When the pressure exceeds a first threshold, the balloon is determined to be inflated. When the pressure is less than the first threshold, the balloon is determined to be in an uninflated state.

59. A system for detecting balloon inflation, the system comprising: Medical devices, including: A basket assembly fixed to the distal end of an axis, the basket assembly including multiple ribs; An expandable balloon having an outer surface, wherein the balloon is located within the basket assembly, and wherein the expandable balloon is selectively expandable such that the outer surface of the expandable balloon can contact the inner surface of at least one of the plurality of ribs; and A first sensor is located between the inner surface of the first rib of the plurality of ribs and the outer surface of the balloon, wherein the first sensor is configured to monitor characteristics indicating the expansion state of the expandable balloon; An electronic control unit configured to receive feedback from the first sensor indicating a measured characteristic, wherein the electronic control unit determines an expansion state and generates an output based on the feedback; and A display receives output from the electronic control unit and shows the inflation status of the balloon.

60. The system for detecting balloon dilation according to claim 59, wherein the first sensor is a first electrode.

61. The system for detecting balloon dilation according to claim 60, wherein the first electrode is the exposed end of a first wire fixed to the insulating portion of the first rib.

62. The system for detecting balloon dilation according to claim 60, wherein the measured characteristic is an impedance measured between the first electrode and the second electrode. The electronic control unit compares the measured impedance with a first threshold, and When the impedance is greater than the first threshold, the balloon is determined to be in an inflated state; and when the impedance is less than the first threshold, the balloon is determined to be in an uninflated state.

63. The system for detecting balloon dilation according to claim 62, wherein the second electrode is an electrode located on a second rib of a plurality of ribs, the second rib comprising: The first end connected to the distal end of the external shaft element; The second end is connected to the distal end of the shaft element located inside the balloon; The body contains conductive material; as well as An insulating material covering a portion of the body, wherein the second electrode includes the exposed portion of the body.

64. The system for detecting balloon dilation according to claim 62, wherein the second electrode is an annular electrode located at the distal end of the axis proximal to the basket assembly.

65. The system for detecting balloon dilation according to claim 62, wherein the second electrode is an exposed end of a second wire located on the inner surface of a second rib of a plurality of ribs, wherein the exposed end of the second wire is connected to an insulating portion of the body of the second rib.

66. The system for detecting balloon dilation according to claim 62, wherein the electronic control unit further compares the measured impedance with a second threshold, and When the impedance is greater than the second threshold, the balloon is determined to be in an overinflated state.

67. The system for detecting balloon dilation according to claim 60, wherein the measured characteristic is an impedance measured between a first electrode and a second electrode, wherein the second electrode is fixed to the outer surface of the balloon and aligned with the first electrode, and in, The electronic control unit compares the measured impedance with a first threshold, and determines that the balloon is inflated when the impedance is less than the first threshold. When the impedance is greater than the first threshold, the balloon is determined to be in an uninflated state.

68. The system for detecting balloon dilation according to claim 59, wherein, The first sensor is a pressure sensor connected to an insulating portion of the inner surface of the first rib, and the characteristic indicating the balloon's expansion state is the measured pressure between the pressure sensor and the outer surface of the balloon, wherein the electronic control unit compares the measured pressure with a first threshold. When the pressure exceeds a first threshold, the balloon is determined to be inflated. When the pressure is less than the first threshold, the balloon is determined to be in an uninflated state.

69. A medical device comprising: Net basket; A distal connector that connects to the far end of the basket; A proximal connector is attached to the proximal end of the basket and the conduit shaft, the proximal connector defining a lumen; as well as Support shaft, comprising: Secured to the distal end of the distal connector; as well as The proximal end floats freely within the lumen of the proximal connector.

70. A medical device comprising: The distal connector includes: Fixed area for the net basket; The balloon fixation area near the net basket fixation area; and At least one magnetic sensor is disposed in a groove along the outer surface of the distal connector; Proximal connector, comprising: The balloon fixation area; and The basket fixation area proximal to the balloon fixation area; and At least one magnetic sensor is fixed to the outer surface of the proximal connector; The net basket connecting to the basket fixing area of ​​the distal connector and the proximal connector; and A balloon located inside the basket, the balloon being connected to the balloon fixation areas of the distal connector and the proximal connector.

71. A medical device comprising: A basketball hoop, which consists of multiple reinforcing ribs; The distal connector includes: Far side; and Rib retaining components, constructed to secure the distal ends of multiple ribs; Among them, the multiple ribs located in the rib retaining component are tangent to the distal side.

72. A basket comprising a plurality of reinforcing ribs, wherein the distal end of each of the plurality of reinforcing ribs is a barb including at least one protrusion.

73. A connector comprising: A first fixing component includes a groove, wherein the groove includes a first open end and a second open end; An annular portion adjacent to the second open end, the annular portion being configured to receive the barbed end of the basket reinforcement; and The annular wall adjacent to the annular portion.

74. A connector comprising: The balloon fixation area includes: Multiple ribs; and At least one magnetic sensor, said magnetic sensor being fixed within a groove on the outer surface of the balloon fixation region, said groove extending through at least some of the plurality of ribs; and The basket fixing area is adjacent to the balloon fixing area along its longitudinal direction.

75. A shaft for use in a medical device, comprising: The polymer tube constituting the inner layer of the shaft; A braided layer located on and extending together with the polymer tube; The coil located at the first end of the braided layer; A first polymer having the hardness of a first hardness tester is coated on the coil; A second polymer having a second hardness as a second hardness tester is applied to the middle portion of the braided layer; as well as A third polymer having a third hardness (as measured by a third hardness tester) is applied to the second end of the braided layer.

76. A method for manufacturing a conduit shaft, comprising: A braided layer is formed around the polymer tube; Wrap the wire around the first end of the braid; The first polymer, having the hardness of a first hardness tester, is recirculated back to the wound wire; The second polymer, which has the hardness of the second hardness tester, is reflowed to the middle part of the woven fabric; as well as The third polymer, which has the hardness of a third hardness tester, is refluxed to the near end portion of the woven fabric.

77. The conduit shaft according to claim 75 or 76, wherein the first polymer, the second polymer, and the third polymer form the outer layer of the shaft.

78. The guide shaft according to any one of claims 75 to 77, wherein the hardness of the second hardness tester is less than the hardness of the first hardness tester, and the hardness of the first hardness tester is less than the hardness of the second hardness tester.

79. The conduit shaft according to any one of claims 76 to 78, wherein, The polymer tube is a polytetrafluoroethylene (PTFE) tube, the braided layer contains multiple metal wires, the coil is a metal wire, the first polymer is polyether intercalated amide (PEBA), the second polymer is polyether intercalated amide (PEBA), and the third polymer is polyether intercalated amide (PEBA).

80. The catheter shaft according to claim 79, wherein, The multiple metal wires are made of stainless steel and the coil is also made of stainless steel.

81. The conduit shaft according to any one of claims 75 to 80, wherein, The first polymer, the second polymer, and the third polymer are located within the gap defined by the braided layer and / or the coil of the conductor.

82. The catheter shaft according to any one of claims 75 to 81, wherein, The first part has a first length, the second part has a second length, and the third part has a third length, wherein The second length is greater than the first length and the third length; and / or The first length is the minimum length.

83. The catheter shaft according to any one of claims 75 to 82, wherein the shaft constitutes part of a medical device, the medical device further comprising: An outer shaft coaxial with the aforementioned shaft; Net basket; Secure the far end of the basket to the far end of the shaft via a distal connector. as well as Secure the proximal end of the basket to the proximal connector of the outer shaft; The basket is supported by the first part of the shaft.

84. The conduit shaft of claim 83, wherein the basket is supported only by a first portion of the shaft extending between the distal connector and the proximal connector.

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