Steerable catheter with push ring assembly

Abstract

A steerable catheter (10) includes an outer sheath defining an outer sheath lumen extending from a proximal region to a distal region (16). A push ring (22) is secured within the proximal region of the outer sheath lumen. A tab (24) is secured within the distal region of the outer sheath lumen. An inner shaft member (30) extends within the outer sheath lumen between the push ring (22) and the pull ring (24). A pair of push members (26a, 26b) extend through the outer sheath lumen and are secured to the push ring (22), each of the pair defining a push member lumen extending therethrough. A pair of pull wires (28a, 28b) is secured to the pull ring (24), each of the pair of pull wires (28a, 28b) extending through one of the push member cavities.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 524,546, filed June 30, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates to medical devices and methods for manufacturing medical devices. Background Technology

[0003] Various intravascular medical devices have been developed for medical applications, such as intravascular use. Some of these devices include guidewires, catheters, etc. These devices are manufactured using a wide variety of different methods and can be used according to a wide variety of methods. Each of these medical devices and methods is known to have certain advantages and disadvantages. There is currently a need to provide alternative medical devices and alternative methods for manufacturing and using these medical devices. Summary of the Invention

[0004] This invention relates to several alternative designs, materials, and methods for manufacturing medical device structures and components, and their uses. An example can be found in a steerable catheter. The steerable catheter includes an outer sheath defining an outer sheath cavity extending from a proximal region to a distal region; a push ring fixed in the proximal region of the outer sheath cavity; a pull ring fixed in the distal region of the outer sheath cavity; and an inner shaft member extending within the outer sheath cavity located between the push ring and the pull ring. A pair of push members extend through the outer sheath cavity and are fixed to the push ring, each of the pair defining a push member cavity extending therethrough. A pair of pull wires are fixed to the pull ring, each of the pair extending through one of the push member cavities.

[0005] Alternatively or additionally, each of the pull wires may extend within the outer sheath cavity located near the pair of actuating members.

[0006] Alternatively or additionally, each of the pull wires may extend within the outer sheath cavity located distal to the pair of actuating members.

[0007] Alternatively or additionally, the push ring may include a metal cylinder, and each of the push components may be welded to the metal cylinder.

[0008] Alternatively or additionally, each of the actuating components may include a tightly wound coil.

[0009] Alternatively or additionally, each of the pull wires extending through the associated push member, together with the associated push member, can be considered a Bowden cable.

[0010] Alternatively or additionally, the push ring may define an inner diameter, and each of the pair of push members may be disposed inside the inner diameter.

[0011] Alternatively or additionally, the push ring may define an inner surface, and each of the pair of push members may be disposed radially inside the inner surface.

[0012] Alternatively or additionally, the push ring may include a plurality of holes for securing the push ring to the outer sheath.

[0013] Alternatively or additionally, the inner shaft component may include multiple hinge joints.

[0014] Alternatively or additionally, the first articulated joint immediately adjacent to the push ring may include a proximal reduced-diameter section suitable for assembly inside the push ring.

[0015] Alternatively or additionally, the push ring may include a first snap-fit ​​feature extending distally, and a first hinged joint adjacent to the push ring may include a second snap-fit ​​feature complementary to the first snap-fit ​​feature extending distally.

[0016] Another example can be found in a steering assembly suitable for a steerable catheter, the steering assembly including an outer sheath defining an outer sheath cavity extending therethrough, the steering assembly being adapted to be fitted within the outer sheath cavity. The steering assembly includes a push ring and a pair of push members welded to the push ring and adapted to extend proximally therefrom, each of the push members defining an extension through its push member cavity. The steering assembly includes a pull ring and a pair of pull wires welded to the pull ring and adapted to extend proximally therefrom. A force-transmitting member extends between the push ring and the pull ring. Each of the pull wires extends through a corresponding push member cavity located proximally to the pull ring.

[0017] Alternatively or additionally, each of the driving components includes a tightly wound coil.

[0018] Alternatively or additionally, each of the pull wires extending through the associated push member, together with the associated push member, can be considered a Bowden cable.

[0019] Alternatively or additionally, the push ring may include a plurality of holes for securing the push ring to the outer shaft.

[0020] Alternatively or additionally, the force transmission component may include multiple hinge joints.

[0021] Alternatively or additionally, the first articulated joint immediately adjacent to the push ring may include a proximal reduced-diameter section suitable for assembly inside the push ring.

[0022] Alternatively or additionally, the push ring may include a first snap-fit ​​feature extending distally, and a first hinged joint adjacent to the push ring may include a second snap-fit ​​feature complementary to the first snap-fit ​​feature extending distally.

[0023] Another example can be found in a steerable catheter. A steerable catheter includes an outer shaft defining an outer shaft cavity extending from a proximal region to a distal region; a push ring fixed in the proximal region of the outer shaft cavity; a pull ring fixed in the distal region of the outer shaft cavity; a plurality of articulated joints extending within the outer shaft cavity located between the push ring and the pull ring; a pair of push members extending through the outer shaft cavity and welded to the push ring, each of the push members defining a push member cavity extending therethrough; and a pair of pull wires welded to the pull ring, each of the pull wires extending through one of the push member cavities, each of the pull wires extending through the outer shaft cavity both proximal and distal to the push members.

[0024] The foregoing summary is provided to facilitate understanding of some of the distinctive features of this invention and is not intended to be an exhaustive description. The invention will be fully understood by considering the entire specification, claims, drawings, and abstract as a whole. Attached Figure Description

[0025] The invention can be more fully understood by considering the following description of various examples taken in conjunction with the accompanying drawings, in which:

[0026] Figure 1 It is a schematic view of an illustrative, steerable conduit shown in a straight line.

[0027] Figure 2 It is shown in a deflection pattern. Figure 1 A schematic view of the illustrative tract that can be turned towards;

[0028] Figure 3 It is along Figure 1 A cross-sectional view taken from line 3-3;

[0029] Figure 4 yes Figure 1 An illustrative perspective view of a portion of the catheter;

[0030] Figure 5 yes Figure 4 A magnified view of a portion;

[0031] Figure 6 It is formed Figure 1 A schematic view illustrating the steerable components of a steerable conduit.

[0032] Figure 7 yes Figure 1A schematic view of a portion of the illustrative tractable catheter;

[0033] Figure 8 yes Figure 1 An illustrative perspective view of a portion of the catheter;

[0034] Figure 9 yes Figure 8 The illustration shows an end view of a portion of the rotatable catheter;

[0035] Figure 10 It is a three-dimensional view of the pushing component fixed to the push ring;

[0036] Figure 11 yes Figure 10 End view;

[0037] Figure 12 yes Figure 10 A magnified view of a portion;

[0038] Figure 13 This is a schematic partial cross-sectional view of an illustrative steerable conduit;

[0039] Figure 14 This is a schematic view illustrating the connection between the push ring and the hinged joint; and

[0040] Figure 15 This is a schematic view illustrating the connection between the push ring and the hinged joint.

[0041] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that the invention is not intended to limit its aspects to the specific examples described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0042] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered in a similar manner. The drawings, not necessarily drawn to scale, depict examples that are not intended to limit the scope of the invention. Although examples for various elements are shown, those skilled in the art will recognize that many of the provided examples have suitable alternatives that can be utilized.

[0043] All numbers are assumed to be modified by the term "about" unless otherwise expressly indicated in the text. A description of a range of numbers indicated by an endpoint includes all numbers falling into that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0044] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise expressly indicated. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless otherwise expressly indicated.

[0045] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, whether or not it is explicitly described, that feature, structure, or characteristic may also be applied to other embodiments, unless expressly stated otherwise.

[0046] Figure 1 and Figure 2 A schematic view of an illustrative steerable catheter 10 is provided. The illustrative steerable catheter 10 can generally represent a steerable catheter suitable for any of a variety of applications. The steerable catheter 10 in... Figure 1 The directional conduit 10 is shown in a straight or undeflected position. Figure 2 The steerable conduit 10 is shown in a bent or deflected configuration. In some cases, the steerable conduit 10 can be biased to... Figure 1 The straight shape shown can be manipulated to... Figure 2 The deflection pattern is shown. In some cases, the steerable conduit 10 can be biased to... Figure 2 The bending shape shown can be manipulated to... Figure 1 The straight shape is shown. The steerable conduit 10 includes an elongated shaft 12 extending from the proximal region 14 to the distal region 16. The elongated shaft 12 may include a single polymer layer, or may include two or more polymer layers. In some cases, for example, the elongated shaft 12 may include one or more reinforcing members. As will be discussed, the elongated shaft 12 may include structures that enable the steerable conduit 10 to be steered or to deflect the distal region 16, such as... Figure 2 As shown.

[0047] The steerable conduit 10 includes a hub 18. Although schematically shown, the hub may also include any number of different connections for attaching other devices to the steerable conduit 10. As shown, the hub 18 includes a Luer connector 20, which can be used to flush the steerable conduit 10 before use. The Luer connector 20 can accommodate a guidewire (not shown) extending through the Luer connector 20, allowing the steerable conduit 10 to be advanced over the guidewire. Other hub configurations are also conceivable.

[0048] The steerable catheter 10 includes a structure that allows the steerable catheter 10 to... Figure 1 The straight shape shown is Figure 2 The steerable conduit 10 can move between the bending configurations shown. In some cases, the steerable conduit 10 may include a combination of a push member and a pull wire that enables the steerable conduit 10 to be steered. Figure 3 It is along Figure 1 A cross-sectional view of the distal region 16 of the steerable conduit 10, taken by line 3-3. (See also...) Figure 3 As can be seen, the steerable conduit 10 includes a push ring 22 and a pull ring 24. The push ring 22 is attached to a pair of push members 26a and 26b. In some cases, the push members 26a and 26b are welded to the push ring 22. A pair of pull wires 28a and 28b are attached to the pull ring 24. In some cases, the pull wires 28a and 28b are welded to the pull ring 24.

[0049] In use, tension can be applied to one or both of the pull wires 28a and 28b to deflect the distal region 16. The push ring 22 (and the push members 26a and 26b) provides resistance to the inner shaft member 30 extending between the push ring 22 and the pull ring 24. In some cases, the inner shaft member 30 can be considered a force-transmitting member. For example, the inner shaft member 30 can be a reinforced polymer sleeve. In some cases, the inner shaft member 30 can be a laser-cut thiourea tube with cut-out gaps to enhance the flexibility of the inner shaft member 30 while allowing the inner shaft member 30 to resist compressive forces applied to it by virtue of its position between the push ring 22 and the pull ring 24. In some cases, for example, the inner shaft member 30 can be or otherwise comprises multiple articulated joints.

[0050] In some cases, push member 26a may define a push member cavity 32a extending therethrough, and push member 26b may define a push member cavity 32b extending therethrough. In some cases, each of pull wires 28a and 28b may extend through a push member cavity 32, which passes through the corresponding push members 26a and 26b. For example, pull wire 28a may extend through a push member cavity 32a within push member 26a, and pull wire 28b may extend through a push member cavity 32b within push member 26b. In some cases, pull wires, such as pull wire 26a extending through push member 26a, or combinations of pull wire 26b extending through push member 26b, may be referred to as Bowden cables. In some cases, push members 26a and 26b themselves may be referred to as Bowden cables.

[0051] In some cases, each of the actuating members 26a and 26b may be formed as a tightly wound coil. In some cases, the coil may have an inner diameter ranging from 0.005 inches to 0.025 inches and an outer diameter ranging from 0.007 inches to 0.045 inches, and may be formed from wire with a diameter ranging from 0.001 inches to 0.01 inches. Although not explicitly shown, each of the actuating members 26a and 26b may be embedded in a polymer layer extending proximal to the push ring 22, thereby anchoring the actuating members 26a and 26b in a suitable position within the steerable conduit 10. In some cases, the pull wires 28a and 28b may be formed from any suitable material and may have a diameter, for example, ranging from 0.004 inches to 0.024 inches.

[0052] The steerable catheter 10 includes an outer sheath 34 extending over a push ring 22, a pull ring 24, and an inner shaft member 30 therebetween. The outer sheath 34 defines an outer sheath lumen 36 extending through it and housing the push ring 22, the pull ring 24, and the inner shaft member 30 therebetween. The outer sheath 34 can be formed of any suitable material. Illustrative materials for the outer sheath 34 include polymers such as polyurethane, PEBA (polyether block amide), and polyamides. The outer sheath 34 can have any desired thickness, such as in the range of 0.002 inches to 0.025 inches. In some cases, the material or multiple materials used to form the outer sheath 34 can vary along the length of the steerable catheter 10.

[0053] Figure 4 This is a perspective view showing a push ring 22, a pull ring 24, push members 26a and 26b attached to the push ring 22, and pull wires 28a and 28b attached to the pull ring 24. As can be seen, push members 26a and 26b extend proximally from the push ring 22 by a length L1. In some cases, the length L1 is chosen to be long enough to adequately anchor push members 26a and 26b within the outer sheath 34 or within an additional polymer layer (not shown). In some cases, each of the push members 26a and 26b may have a length L1 ranging from 12 inches to 72 inches. In some cases, pull cables 28a and 28b may have a length L2 sufficient to extend from the pull ring 24 located within the distal region 16 of the elongated shaft 12 to a hub or handle (not shown) located at or near the proximal end of the elongated shaft 12, such that pull cables 28a and 28b can be pulled individually or in combination to bend or deflect the distal region 16 of the elongated shaft 12. In some cases, pull cables 28a and 28b may have a length L2 ranging from, for example, 14 inches to 80 inches.

[0054] In some cases, each of the draw wires 28a and 28b may extend within the outer sheath cavity 36 located proximal to the actuating members 26a and 26b. Each of the draw wires 28a and 28b may extend within the outer sheath cavity 36 located distal to the actuating members 26a and 26b. The draw wires 28a and 28b extend through the actuating member cavities 32a and 32b, respectively. The draw wire 28a is freely translated within the actuating member cavity 32a extending through the actuating member 26a. The draw wire 28b is freely translated within the actuating member cavity 32b extending through the actuating member 26b.

[0055] Figure 5 Centered on push ring 22 Figure 4 A magnified view of a portion of the image. The push ring 22 can be viewed as having a proximal edge 38 and a distal edge 40. The push ring 22 has an inner surface 42 and an outer surface 44. The outer surface 44 is adapted to contact the corresponding inner surface of the outer sheath 34. In some cases, depending on the length L3 of the push ring 22, one or more polymer layers may be formed on the exterior of the push ring 22, including, for example, the outer sheath 34. Figure 3 (and thus, without the need for a spindle).

[0056] For example, push ring 22 can be a metal cylinder. Suitable materials for push ring 22 include stainless steel. In some cases, push ring 22 can be a cylinder having a length L3 ranging from 0.03 inches to 0.35 inches, an inner diameter ranging from 0.02 inches to 0.25 inches, and an outer diameter ranging from 0.03 inches to 0.35 inches. For example, pull ring 24 can be a metal cylinder. Suitable materials for pull ring 24 include stainless steel. In some cases, pull ring 24 can be a cylinder having a length ranging from 0.03 inches to 0.35 inches, an inner diameter ranging from 0.02 inches to 0.25 inches, and an outer diameter ranging from 0.03 inches to 0.35 inches.

[0057] In some cases, push members 26a and 26b can be welded to the inner surface 42 of the push ring 22. The welded area 46 is shown in dashed lines, indicating the location where push member 26a is welded to the push ring 22. Any of a variety of welding techniques can be contemplated. Although not shown, a similar welded area on the opposite side of the push ring 22 indicates the location where push member 26b is welded to the push ring 22.

[0058] Figure 6This is a schematic cross-sectional view of an illustrative steering assembly 50 suitable for a steerable catheter (such as steerable catheter 10), which includes an outer sheath (such as outer sheath 34) defining an outer sheath cavity (such as outer sheath cavity 36) extending therethrough, and the steering assembly 50 is adapted to be fitted within the outer sheath cavity. The steering assembly includes a push ring 22 and a pair of push members 26a and 26b welded to the push ring 22 and adapted to extend proximally from the push ring 22. Each of the push members 26a and 26b includes push member cavities 32a and 32b extending therethrough, respectively. The steering assembly 50 includes a pull ring 24 and a pair of pull wires 28a and 28b welded to the pull ring 24 and adapted to extend proximally from the pull ring 24. A force transmission member 30 extends between the push ring 22 and the pull ring 24. The pull wire 28a extends through the push member cavity 32a within the push member 26a, and the pull wire 28b extends through the push member cavity 32b within the push member 26b.

[0059] Figure 7 This is a schematic view illustrating how the combination of push ring 22 (and push member 26) and pull ring 24 (and pull cord 28a) influences the transmission of force. As can be seen, the combination of push ring 22 and pull ring 24 results in a compression zone 52, which exists between push ring 22 and pull ring 24. Pulling one or both of pull cords 28a and 28b proximally (only pull cord 28a is visible in this view), as shown by arrow 52a, pushes pull ring 24 proximally, and this compressive force is resisted by push ring 22, which remains stationary and in place (as shown by arrow 52b), at least in part due to its embedding within outer sheath 34. Figure 3 Furthermore, the push members 26a and 26b (only push member 26a is visible in this view) are embedded within the polymer layer and therefore resist movement. The Bowden cable shielding area 54 embedded in the polymer by the push members 26a and 26b helps to anchor the push ring 22 and thus helps to form and maintain the compression area 52.

[0060] Figure 8 This is a perspective view showing the pushing members 26a and 26b welded to the inner surface 42 of the push ring 22. The view clearly shows the pushing member cavities 32a and 32b extending through the pushing members 26a and 26b, respectively. Figure 8 In the middle, the pushing members 26a and 26b are completely located within the circle defined by the inner surface of the pushing ring 22. This is in the end view. Figure 9As shown in the diagram. In some cases, the push members 26a and 26b may not be fully disposed within the circle defined by the inner surface 42 of the push ring 22. In some cases, the push ring 22 may have notches or be otherwise cut to allow the push members 26a and 26b to be welded to the push ring 22, but in a position where the push members 26a and 26b are radially outwardly moved, in order to reduce the volume loss that would otherwise be occupied by the push members 26a and 26b inside the push ring 22.

[0061] Figure 10 This is a schematic view of illustrative component 60, in which push member 62, representing push member 26a or push member 26b, is fixed to push ring 64 (representing push ring 22). Figure 11 It is its end view, and Figure 12 This is a side view. The pull wire 66, representing pull wire 28a or pull wire 28b, extends through the push member cavity 68, which in turn extends through the push member 62. In some cases, the push ring 64 may include a notch 70 cut into the push ring 64, which allows the push member 62 to be positioned only on the inner surface 42 (e.g., Figure 5 (As shown) it moves radially outward. Conversely, the notch 70 allows the push member 62 to be positioned at least partially within the wall of the push ring 64. The push ring 64 can be considered to include an inner surface 72 and an outer surface 74. The push member 62 can extend radially inward beyond the inner surface 72, but not as far as it would extend without the notch 70. Figure 11 As shown, the pushing member 62 extends radially inward beyond the inner surface 72 and radially outward to the outer surface 74. In some cases, the pushing member 62 may be positioned relative to the push ring 64 such that the pushing member 62 extends radially outward beyond the outer surface 74.

[0062] The push member 62 is secured to the push ring 62 via one or more welds 76. In some cases, the push ring 62 may include one or more holes 78 extending from the inner surface 72 to the outer surface 74. In some cases, the one or more holes 78 may be adapted to allow polymer backflow into the one or more holes 78 during the formation of a steerable conduit, such as when forming an outer sheath extending on the push ring 62. In some cases, polymer backflow into the one or more holes 78 may help anchor the push ring 62. The push ring 62 may include any number of holes 78.

[0063] Figure 13This is a schematic partial cross-sectional view of an illustrative steerable catheter 80. The illustrative steerable catheter 80 includes a proximal outer sheath 82 and a distal outer sheath 84. In some cases, the proximal outer sheath 82 and the distal outer sheath 84 may be formed of separate polymers. In some cases, the proximal outer sheath 82 and the distal outer sheath 84 may be formed of the same polymer. The proximal outer sheath 82 and the distal outer sheath 84 together define an outer sheath cavity 86 extending therethrough. A push ring 88 is disposed within the outer sheath cavity 86. A first push member 90a and a second push member 90b extend distally into the push ring 88 and are secured thereto via a weld 92. A first pull wire 94a and a second pull wire 94b extend through the push members 90a and 90b, respectively, and extend distally therefrom.

[0064] The steerable catheter 80 includes a plurality of articulated joints 96 disposed within an outer sheath lumen 86. In some cases, the plurality of articulated joints 96 extend between a push ring 88 and a pull ring (not shown in this view), the pull ring being positioned distal to the plurality of articulated joints 96. In some cases, the plurality of articulated joints 96 may be considered as replacing the inner shaft member 30, and the plurality of articulated joints 96 together may be considered as forming a force-transmitting member extending between the push ring 88 and the pull ring (not shown). Each of the articulated joints 96 may include internal structures that allow pull wires 94a and 94b to extend through the articulated joint 96 while constraining the relative radial position of the pull wires 94a and 94b relative to the articulated joint 96. In some cases, the steerable catheter 80 may include a marking band 98. In some cases, the marking band 98 may indicate the location where the proximal outer sheath 82 ends and the distal outer sheath 84 begins, but this is not required.

[0065] Figure 14 This is a schematic view of a possible junction between the push ring 88 and the first articulated joint 96. In some cases, the push ring 88 has an inner surface 100 defining an annular opening 102 within the push ring 88. The first articulated joint 96 can be considered to include a proximal segment 104 and a distal segment 106. The proximal segment 104 may have a diameter that is reduced relative to the diameter of the distal segment 106. In some cases, the proximal segment 104 may have a diameter that allows the proximal segment 104 to fit into the annular opening 102, which opens into the push ring 88. In some cases, the first articulated joint 96 (and each subsequent articulated joint 96) may include an internal structure 108 that helps to constrain and position a draw wire (not shown) extending through the articulated joint 96. In some cases, the internal structure 108 may include a pair of holes 110 through which the draw wire can extend.

[0066] Figure 15A schematic view is provided of a possible junction between the push ring 88 and the first hinge joint 96. In some cases, the push ring 88 has an outer surface 112 extending from a proximal edge 114 to a distal edge 116 of the push ring 88. In some cases, the push ring 88 may include a retaining feature 118 extending proximally from the distal edge 116. In some cases, the retaining feature 118 includes an elongated hole 120 adapted to engage a complementary structure on the first hinge joint 96.

[0067] In some cases, the first articulated joint 96 includes an outer surface 122 extending distally from the proximal edge 124 of the first articulated joint 96. The outer surface 122 includes a recessed region 126. An angled lug 128 extends radially outward from the recessed region 126 (only one is visible in this view), but in some cases, it does not extend radially outward from the outer surface of the first articulated joint 96. It should be understood that when the push ring 88 is moved toward the first articulated joint 96, a retaining feature 118 extending distally from the distal edge 116 of the push ring 88 will engage in the recessed region 126. The retaining feature 118 will extend over the angled lug 128 until the push ring 88 and the first articulated joint 96 are sufficiently close to each other so that the angled lug 128 engages in the elongated hole 120, thereby securing the push ring 88 to the first articulated joint 96. The fixing feature 118 can be regarded as a first snap-fit ​​feature extending distally, and the recessed area 120 and the angled lug 128 can each be regarded as a complementary second snap-fit ​​feature adapted to form a snap-fit ​​with the snap-fit ​​feature extending distally.

[0068] Materials that can be used in the various components and elements of the medical stents, spindles, and other devices disclosed herein may include those commonly associated with medical devices and spindles. For simplicity, the following discussion refers to devices. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, medical stents, spindles, filaments, anti-migration rings, coverings, and / or their elements or parts.

[0069] In some embodiments, the device and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or other suitable materials.

[0070] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., DELRIN® available from DuPont), polyether block copolymers, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether copolymers (e.g., ARNITEL® available from DSM EngineeringPlastics), ether- or ester-based copolymers (e.g., phthalate / poly(hydrocarbon ether) and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, Linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID®, commercially available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., Aortech) Biomaterials' ElastEon® or AdvanSource Biomaterials' ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.

[0071] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linear elastic and / or hyperelastic nickel-titanium; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®, other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0072] In at least some embodiments, part or all of the device and / or its components may also be doped with, made of, or otherwise included in a radiopaque material. A radiopaque material should be understood as one capable of producing a relatively bright image on a fluorescent screen or using another imaging technique during medical procedures. This relatively bright image helps the user of the device determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the device to achieve the same result.

[0073] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is endowed to the devices and / or other elements disclosed herein. For example, the devices and / or parts thereof may be made of materials that substantially do not distort images and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The devices or parts thereof may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), nickel-titanium, etc.

[0074] In some embodiments, the devices and / or other elements disclosed herein may include suitable therapeutic agents and / or be used for treatment. Some examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone); antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone). Ketones, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0075] Having described several illustrative embodiments of the invention, those skilled in the art will readily understand that other embodiments may be made and used within the scope of the appended claims. However, it should be understood that the invention is merely illustrative in many respects. Changes may be made in details, particularly in terms of shape, size, arrangement of components, and exclusion and order of steps, without departing from the scope of the invention. The scope of the invention is, of course, defined by the language of the appended claims.

Claims

1. A steerable catheter, comprising: An outer sheath that defines an outer sheath cavity extending from a proximal region to a distal region; A push ring fixed in the proximal region of the outer sheath cavity; A pull ring fixed in the distal region of the outer sheath cavity; An inner shaft member extending within the outer sheath cavity located between the push ring and the pull ring; A pair of actuating members, the pair of actuating members extending through the outer sheath cavity and fixed to the actuating ring, each of the pair of actuating members defining an actuating member cavity extending through it; as well as A pair of pull wires, the pair of pull wires being fixed to the pull ring, each of the pair of pull wires extending through one of the actuating member cavities.

2. The steerable conduit of claim 1, wherein the push ring comprises a metal cylinder, and each of the push members is welded to the metal cylinder.

3. The steerable conduit according to any one of claims 1 or 2, wherein each of the actuating members comprises a tightly wound coil.

4. The steerable conduit according to any one of claims 1 to 3, wherein the push ring defines an inner diameter, and each of the pair of push members is disposed inside the inner diameter.

5. The steerable conduit according to any one of claims 1 to 4, wherein the push ring defines an inner surface, and each of the pair of push members is disposed radially inside the inner surface.

6. The steerable conduit according to any one of claims 1 to 5, wherein the push ring includes a plurality of holes for securing the push ring to the outer sheath.

7. The steerable conduit according to any one of claims 1 to 6, wherein the inner shaft member comprises a plurality of hinge joints.

8. The steerable conduit of claim 7, wherein the first articulated joint adjacent to the push ring includes a proximal reduced diameter section adapted to be fitted inside the push ring.

9. The steerable conduit of claim 7, wherein the push ring includes a first snap-fit ​​feature extending distally, and a first hinged joint adjacent to the push ring includes a complementary second snap-fit ​​feature adapted to snap-fit ​​with the first snap-fit ​​feature extending distally.

10. A steering assembly suitable for use in a steerable catheter includes an outer sheath defining an outer sheath lumen extending therethrough, the steering assembly being adapted to be fitted within the outer sheath lumen, the steering assembly comprising: Push ring; A pair of actuating members, the pair of actuating members being welded to the actuating ring and adapted to extend therefrom proximally, each of the pair of actuating members defining an extension through its actuating member cavity; Pull ring; A pair of pull wires, said pair of pull wires being welded to the pull ring and adapted to extend proximally from the pull ring; as well as A force-transmitting member extending between the push ring and the pull ring; The pair of pull wires each extend through a corresponding push member cavity located near the pull ring.

11. The steering assembly of claim 10, wherein the push ring includes a plurality of holes for securing the push ring to the outer shaft.

12. The steering assembly according to any one of claims 10 or 11, wherein the force transmission member comprises a plurality of hinge joints.

13. The steering assembly of claim 12, wherein the first articulated joint immediately adjacent to the push ring includes a proximal reduced-diameter section adapted for mounting inside the push ring.

14. The steering assembly of claim 12, wherein the push ring includes a first snap-fit ​​feature extending distally, and a first hinge joint adjacent to the push ring includes a complementary second snap-fit ​​feature adapted to form a snap-fit ​​with the first snap-fit ​​feature extending distally.

15. A steerable catheter comprising: An outer shaft, the outer shaft defining an outer shaft cavity extending from a proximal region to a distal region; A push ring fixed in the proximal region of the outer shaft cavity; A pull ring fixed in the distal region of the outer shaft cavity; Multiple hinge joints extending within the outer shaft cavity located between the push ring and the pull ring; A pair of push members, the pair of push members extending through the outer shaft cavity and welded to the push ring, each of the pair of push members defining a push member cavity extending therethrough; as well as A pair of pull wires, the pair of pull wires being welded to the pull ring, each of the pair of pull wires extending through one of the cavity of the push member, and each of the pair of pull wires extending through the outer shaft cavity on both the proximal and distal sides of the pair of push members.

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