Balloon catheter

Abstract

In some examples, the catheter (10) includes one or more balloons (28, 58, 82) positioned between an inner wall (20) and an outer wall (21) of an elongated body (12) of the catheter. The one or more balloons are configured to expand through one or more inner wall openings (30, 30A-30D) defined by the inner wall and into a lumen (26) of the catheter, and to expand through one or more outer wall openings (31, 31A-31D) defined by the outer wall, e.g., to extend radially away from an outer surface (34) of the outer wall of the catheter. In some examples, the one or more balloons are configured to expand radially inward through the one or more inner wall openings and into the lumen of the catheter to contact (e.g., directly contact) a guidewire (16) positioned within the lumen.

Description

Technical Field

[0001] The present disclosure relates to a medical catheter. Background Art

[0002] Medical catheters can be used in various medical procedures. For example, medical catheters can be used to deliver medical devices or other treatments (e.g., therapeutic agents) to a target treatment site in a patient's body. In some cases, clinicians can use a catheter in conjunction with a guidewire and an outer catheter to reach the target treatment site. For example, the catheter, together with the guidewire, can be used to penetrate and traverse a lesion within the patient's vasculature, allowing further treatment, such as with a coronary balloon or stent. Summary of the Invention

[0003] The present disclosure has described exemplary conduit, and these exemplary conduits each comprise one or more sacculus between the inner wall and the outer wall of the elongated body positioned at conduit.Described one or more sacculus are configured to expand by one or more inner wall openings limited by inner wall and enter in the lumen of conduit, and expand by one or more outer wall openings limited by outer wall, for example, to extend radially away from the outer surface of the outer wall of conduit.In some examples, described one or more sacculus are configured to expand radially inwardly by described one or more inner wall openings and enter in the lumen of conduit, to contact (for example, directly contact) the guidewire positioned in the lumen, this can contribute to guidewire providing structural support.For example, when the distal end of guidewire contacts the relatively rigid focus (for example, thrombus, calcification, dense fibrous tissue etc.) in the vascular system of patient, the contact between described one or more sacculus and the guidewire can contribute to prevent guidewire from buckling.In some examples, except radially inward expansion, described one or more sacculus are configured to expand radially outward by described one or more outer wall openings to contribute to conduit being anchored in patient's vascular system or other hollow anatomical structures.

[0004] In some examples, the catheter includes a structural support member (e.g., a coil and / or braid) positioned between the inner and outer walls of the elongated body, and the one or more balloons are configured to expand through at least one gap defined by the structural support member.

[0005] In one aspect, the present disclosure describes a catheter comprising an elongated body defining a lumen, the elongated body including an inner wall defining an inner wall opening and an outer wall defining an outer wall opening. The catheter further comprises a balloon coupled to the catheter between the inner wall and the outer wall, wherein the balloon is configured to inflate through the inner wall opening into the lumen of the elongated body and to inflate through the outer wall opening.

[0006] In another aspect, the present disclosure describes a catheter comprising an elongated body defining a lumen, the elongated body comprising an inner wall defining a plurality of inner wall openings, an outer wall defining a plurality of outer wall openings, and a structural support member positioned between the inner wall and the outer wall, wherein the structural support member defines a gap. The catheter further comprises a balloon coupled to the catheter between the inner wall and the outer wall, wherein the balloon is configured to inflate through the plurality of inner wall openings into the lumen of the elongated body and through the plurality of outer wall openings, and through the gap defined by the structural support member.

[0007] In another aspect, the present disclosure describes a method comprising introducing a catheter into a patient's vasculature, the catheter comprising an elongated body defining a lumen, the elongated body comprising an inner wall defining an inner wall opening and an outer wall defining an outer wall opening. The catheter further comprises a balloon coupled to the catheter between the inner wall and the outer wall. The method further comprises inflating the balloon so that the balloon expands through the inner wall opening into the lumen and expands through the outer wall opening.

[0008] Item 1: A catheter comprising: an elongated body defining a lumen, the elongated body including an inner wall defining an inner wall opening and an outer wall defining an outer wall opening; and a balloon connected to the catheter between the inner wall and the outer wall, wherein the balloon is configured to expand through the inner wall opening into the lumen of the elongated body and expand through the outer wall opening.

[0009] Clause 2: The catheter of Clause 1, wherein the balloon is configured to be inflated through the inner wall opening into the lumen to contact a guidewire positioned within the lumen.

[0010] Clause 3: The catheter of Clause 1 or Clause 2, further comprising a structural support member positioned between the inner wall and the outer wall, the structural support member defining a gap, wherein the balloon is configured to expand through the gap.

[0011] Clause 4: The catheter of Clause 3, wherein the structural support member comprises a coil, and wherein the gap is defined between turns of the coil.

[0012] Clause 5: A catheter according to clause 4, wherein the coil includes a proximal coil portion having a first pitch, a distal coil portion having a second pitch, and an intermediate coil portion between the proximal coil portion and the distal coil portion, the intermediate coil portion having a third pitch, the third pitch being greater than at least one of the first pitch or the second pitch.

[0013] Clause 6: The catheter of any of Clauses 3 to 5, wherein the structural support member comprises a braid, and wherein the gaps are defined by braid nodes of the braid.

[0014] Clause 7: A catheter according to Clause 6, wherein the braid includes a proximal braid portion having a first braid density, a distal braid portion having a second braid density, and an intermediate braid portion between the proximal braid portion and the distal braid portion, and the intermediate braid portion has a third braid density that is less than at least one of the first braid density or the second braid density.

[0015] Clause 8: The catheter of Clause 7, wherein the proximal braided portion, the distal braided portion, and the intermediate braided portion are of unitary construction.

[0016] Clause 9: The catheter of Clause 7 or Clause 8, wherein the inner wall opening and the outer wall opening are aligned with the intermediate braided portion along the longitudinal axis of the elongated body.

[0017] Clause 10: A catheter according to any one of clauses 1 to 9, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings including the inner wall opening, and wherein and the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings including the outer wall opening, and wherein the balloon is configured to expand through the plurality of inner wall openings into the lumen and expand through the plurality of outer wall openings.

[0018] Clause 11: A catheter according to any one of clauses 1 to 10, wherein the catheter comprises a plurality of balloons, the plurality of balloons comprising the balloons, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings comprising the inner wall openings, and wherein and the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings comprising the outer wall openings, and wherein each of the plurality of balloons is configured to expand through a corresponding inner wall opening of the plurality of inner wall openings and to expand through a corresponding outer wall opening of the plurality of outer wall openings.

[0019] Clause 12: The catheter of Clause 11, wherein the elongated body defines an inflation lumen, and wherein at least two balloons of the plurality of balloons are fluidly coupled to the inflation lumen.

[0020] Clause 13: The catheter of Clause 11 or Clause 12, wherein the elongate body defines a plurality of inflation lumens, and wherein at least two balloons of the plurality of balloons are fluidly coupled to a separate inflation lumen of the plurality of inflation lumens.

[0021] Clause 14: A system comprising: a catheter according to any one of clauses 1 to 14; and a guidewire within the lumen of the elongated body, wherein the balloon is configured to expand through the inner wall opening into the lumen to directly contact the guidewire and stabilize the guidewire relative to the catheter.

[0022] Clause 15: A catheter comprising: an elongated body defining a lumen, the elongated body comprising: an inner wall defining a plurality of inner wall openings; an outer wall defining a plurality of outer wall openings; and a structural support member positioned between the inner wall and the outer wall, wherein the structural support member defines a gap. The catheter further comprises a balloon coupled to the catheter between the inner wall and the outer wall, wherein the balloon is configured to inflate through the plurality of inner wall openings into the lumen of the elongated body and through the plurality of outer wall openings, and through the gap defined by the structural support member.

[0023] Clause 16: The catheter of Clause 15, wherein the plurality of inner wall openings and the plurality of outer wall openings are aligned with one another.

[0024] Clause 17: The catheter of Clause 15 or Clause 16, wherein at least one of the plurality of inner wall openings or the plurality of outer wall openings are distributed around the circumference of the inner wall or the outer wall, respectively.

[0025] Clause 18: A system comprising: a catheter according to any one of clauses 15 to 17; and a guidewire positioned within the lumen of the elongated body, wherein the balloon is configured to expand through the plurality of inner wall openings into the lumen to directly contact the guidewire and stabilize the guidewire relative to the catheter.

[0026] Clause 19: A method comprising: introducing a catheter into a patient's vasculature, the catheter comprising an elongated body defining a lumen, the elongated body comprising an inner wall defining an inner wall opening and an outer wall defining an outer wall opening; and a balloon coupled to the catheter between the inner wall and the outer wall. The method further comprises inflating the balloon such that the balloon expands through the inner wall opening into the lumen and expands through the outer wall opening.

[0027] Clause 20: The method of clause 19, wherein introducing the catheter into the vasculature comprises introducing the catheter over a guidewire, and wherein inflating the balloon comprises inflating the balloon so that the balloon expands through the inner wall opening and into the lumen to directly contact the guidewire and stabilize the guidewire relative to the catheter.

[0028] Clause 21: The method of clause 19 or clause 20, wherein the catheter further comprises a structural support member positioned between the inner wall and the outer wall, the structural support member defining a gap, and wherein inflating the balloon comprises inflating the balloon to expand the balloon through the gap.

[0029] Clause 22: The method of clause 21, wherein the structural support member comprises a coil, and wherein the gap is defined between turns of the coil.

[0030] Clause 23: The method of Clause 21 or Clause 22, wherein the structural support member comprises a braid, and wherein the gaps are defined by braid nodes of the braid.

[0031] Clause 24: The method of any one of clauses 19 to 23, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings including the inner wall opening, and wherein and the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings including the outer wall opening, and wherein inflating the balloon comprises inflating the balloon so that the balloon expands through the plurality of inner wall openings into the lumen and expands through the plurality of outer wall openings.

[0032] Clause 25: A method according to any one of clauses 19 to 24, wherein the catheter comprises a plurality of balloons, the plurality of balloons comprising the balloon, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings comprising the inner wall opening, and wherein and the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings comprising the outer wall opening, wherein inflating the balloons comprises inflating the plurality of balloons so that each of the plurality of balloons expands through a corresponding inner wall opening of the plurality of inner wall openings and expands through a corresponding outer wall opening of the plurality of outer wall openings.

[0033] Clause 26: The method of Clause 25, wherein the elongated body defines an inflation lumen fluidly coupled to at least two balloons of the plurality of balloons, and wherein inflating the plurality of balloons comprises introducing an inflation fluid into the inflation lumen.

[0034] Clause 27: The method of clause 25 or clause 26, wherein the elongated body defines a plurality of inflation lumens, wherein at least two of the plurality of balloons are fluidly coupled to a separate inflation lumen of the plurality of inflation lumens, and wherein inflating the plurality of balloons comprises independently inflating at least two of the plurality of balloons by introducing inflation fluid into at least the respective inflation lumens.

[0035] The details of one or more aspects of the disclosure are set forth in the drawings and description below.Other features, objects, and advantages of the systems and techniques described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 is a side elevation view of an exemplary catheter comprising an elongated body, a hub, and one or more balloons.

[0037] Figure 2A yes Figure 1 Schematic cross-sectional view of the catheter, cross section along Figure 1 2A-2A in FIG, and illustrates the one or more balloons in a deflated configuration and a guidewire positioned within the lumen of the elongated body.

[0038] Figure 2B yes Figure 1 Schematic cross-sectional view of the catheter, cross section along Figure 1 2A-2A in FIG, and illustrates the one or more balloons in an expanded configuration and engaged with a guidewire positioned within the lumen of the elongated body.

[0039] Figure 3A is in the patient's vascular system Figure 1 Schematic cross-sectional view of a catheter of , wherein the cross section is taken along the central longitudinal axis of the elongated body of the catheter and showing the balloon in a deflated configuration and the guidewire in the lumen of the elongated body.

[0040] Figure 3B is similar to Figure 3A A schematic cross-sectional view is shown and illustrates the balloon in an expanded configuration and engaged with a guidewire within the lumen of the elongated body.

[0041] Figure 4A is a schematic cross-sectional view of another exemplary catheter, wherein the cross section is taken along the central longitudinal axis of the elongated body of the catheter and illustrating exemplary structural support members between the inner and outer walls of the elongated body.

[0042] Figure 4B yes Figure 4A Schematic cross-sectional view of a catheter of , with the cross section taken along the central longitudinal axis of the elongated body and showing the balloon in an expanded configuration.

[0043] Figure 5A is a schematic cross-sectional view of an exemplary catheter including a liner in addition to inner and outer walls, wherein the cross section is taken along a central longitudinal axis of the elongated body of the catheter.

[0044] Figure 5B yes Figure 5AA schematic cross-sectional view of a catheter, wherein the cross section is along Figure 5A 5B-5B in FIG, and shows the balloon in a deflated configuration and the liner between the inner and outer walls of the elongated body.

[0045] Figure 5C yes Figure 5A Schematic cross-sectional view of the catheter, cross section along Figure 5A 5B-5B in FIG, and illustrates the balloon in an expanded configuration and engaged with a liner engaged with a guidewire positioned within the lumen of the elongated body.

[0046] Figure 6 is a schematic cross-sectional view of another exemplary catheter in the vasculature of a patient, with the cross section taken along the central longitudinal axis of the elongated body of the catheter and showing a balloon in a deflated configuration and another balloon in an inflated configuration.

[0047] Figure 7 is a schematic cross-sectional view of another exemplary catheter in the vasculature of a patient, wherein the cross-section is taken along the central longitudinal axis of the slender body of the catheter and showing a plurality of balloons, wherein a subset of the plurality of balloons is in a deflated configuration and another subset of the plurality of balloons is in an inflated configuration.

[0048] Figure 8 is a flow chart of an exemplary method of using a catheter including at least one balloon between an inner wall and an outer wall of the catheter.

[0049] Like reference numerals represent like elements throughout the specification and drawings. DETAILED DESCRIPTION

[0050] In example as described herein, conduit comprises elongated body and one or more sacculus, and this elongated body comprises inner wall and outer wall, and described one or more sacculus is connected to this elongated body between inner wall and outer wall.For example, described one or more sacculus can be attached (for example, bonding, adhering or otherwise connected) to inner wall, outer wall or inner wall and outer wall.Inner wall limits at least one inner wall opening, and described at least one inner wall opening is open to the inner cavity limited by elongated body, and outer wall limits at least one outer wall opening, and described at least one outer wall opening is open to the environment outside conduit.In some examples, each inner wall opening can be aligned with at least one outer wall opening completely or in part, for example, along the longitudinal axis of elongated body and the axis alignment orthogonal to the longitudinal axis.Along the axis alignment orthogonal to the longitudinal axis can refer to the circumferential alignment in the case of the conduit with circular cross section for example.In other examples, at least one inner wall opening can be offset longitudinally from at least one outer wall opening and / or offset along the axis offset orthogonal to the longitudinal axis.

[0051] The one or more balloons are configured to expand through the one or more inner wall openings and into the inner lumen, and are configured to expand through the one or more outer wall openings. For example, when the one or more balloons are in the deflated configuration, the one or more balloons may not extend through some or any of the one or more inner wall openings and / or some or any of the one or more outer wall openings, and when the one or more balloons are in the inflated configuration, the one or more balloons may extend through the one or more inner wall openings and into the inner lumen, and extend through the one or more outer wall openings and radially away from the outer surface of the outer wall.

[0052] In the expansion configuration of the one or more balloons, the one or more balloons are configured to engage (for example, directly contact or contact via the lining of a catheter) the guidewire positioned in the lumen of the elongated body to help the guidewire provide structural support. When the distal end of the guidewire contacts a relatively rigid material (for example, a lesion or other obstruction in the patient's vascular system), the structural support provided by the one or more balloons can help prevent or reduce guidewire buckling or guidewire jumping. For ease of description, relatively rigid material is primarily referred to as a lesion in this article; However, in other examples, the relatively rigid material that can cause guidewire buckling or jumping can be any relatively rigid material, such as but not limited to other obstructions (for example, thrombus, dense fibrous tissue, etc.) in the patient's blood vessel. When the distal end of the guidewire contacts the lesion while the guidewire applies distal thrust, the guidewire can be deformed (for example, buckling and / or bending away from the lesion), which can hinder the ability of the guidewire to penetrate (for example, traverse in the vascular system) lesion. In some cases, the distal end of the guidewire may be diverted from its intended path in the vasculature when the distal end contacts a lesion, which may cause the guidewire to jump subintimally into the vessel wall or completely penetrate the vessel wall.

[0053] In addition, in the expansion configuration of the one or more balloons, the one or more balloons are configured to expand through the one or more outer wall openings to engage with the wall of the blood vessel, which can help to stabilize (for example, fix) the position of the catheter relative to the blood vessel alone or in combination with other balloons of the catheter. Therefore, the one or more balloons of the exemplary catheter described herein can simultaneously engage the guide wire and the wall of the blood vessel (or other hollow anatomical structure) in the lumen of the catheter to provide support to the guide wire while the catheter is anchored in the blood vessel. In some examples, in the expansion configuration, the one or more balloons are configured to grip the guide wire to help stabilize the position of the guide wire relative to the catheter. In other examples, in the expansion configuration, the one or more balloons are configured to enable the guide wire to slide longitudinally relative to the one or more balloons while still providing structural support to the guide wire.

[0054] Although primarily reference is made herein to a patient's blood vessels, in other examples, the catheters described herein may be within other hollow anatomical structures of a patient.

[0055] Exemplary catheter as herein described comprises the relatively flexible elongated body (in some examples, also referred to as catheter body or elongated member) that is configured to be navigated through the patient's vascular system.This elongated body comprises inwall and outer wall, and this inwall and outer wall are for example coaxially arranged, and in some examples, this inwall and outer wall are at corresponding proximal end and / or at corresponding distal end place co-edge.In some examples, inwall and outer wall are directly connected to each other along at least some lengths of conduit.In addition or alternatively, in some examples, inwall and outer wall can for example be separated from each other by intermediate layer, structural support member (for example, braid and / or coil) or their any combination.For example, the innermost surface of outer wall can separate any suitable distance with the outermost surface of inwall, such as but not limited to approximately 0.05 millimeter (mm) to approximately 0.5mm, wherein in the case of the elongated body with circular cross section, this distance is measured in radial direction.

[0056] The inner wall and outer wall can be formed by any suitable material, such as but not limited to polymers, for example, aliphatic polyamides, thermoplastic elastomers, thermoplastic polyurethanes or combinations thereof. In some examples, the inner wall and outer wall are formed by the same material. In other examples, the inner wall and outer wall are formed by different materials. Additionally, in some examples, the inner wall and / or outer wall can include only one material layer, while in other examples, the inner wall and / or outer wall include multiple material layers. The multiple material layers can be attached to each other (e.g., bonded) or can be separated from each other.

[0057] One or more balloons are mechanically connected to the elongated body between the inner wall and the outer wall using any suitable technology, such as but not limited to welding, adhesive, attachment mechanism (e.g., a band on the proximal portion and distal portion of the balloon) etc. or their combination. For example, the proximal end and distal end of the balloon can be mechanically connected to the outer surface of the inner wall and / or the inner surface of the outer wall. Even when the balloon is inflated, the proximal end and distal end of each balloon in the one or more balloons remain connected to the elongated body between the inner wall and the outer wall. The one or more balloons are connected between the inner wall and the outer wall of the catheter, rather than, for example, being connected in the inner cavity of the elongated body or the outer surface of the elongated body, which can help the catheter maintain a relatively low overall outer profile (e.g., diameter or other maximum cross-sectional dimensions, the cross section being intercepted in a direction orthogonal to the longitudinal axis of the elongated body).

[0058] In some examples, in addition to the inner wall and outer wall, the elongated body of the catheter may also include one or more layers. For example, the elongated body may include an inner lining that defines the lumen of the catheter. In another example, the elongated body may include a structural support member positioned between the inner wall and the outer wall of the elongated body, and at least one balloon positioned between the inner wall and the outer wall is configured to expand through the gap defined by the structural support member. For example, the structural support member may include a coil, and the balloon may be configured to expand through the turns of the coil to expand radially inward through the inner wall opening and / or radially outward through the outer wall opening. This enables the structural support member to provide force and / or torque transmission from the proximal side of the balloon to the distal side of the balloon. In contrast, if the coil or other structural support member ends at the proximal side of the balloon and then starts again at the distal side of the balloon, the force and / or torque applied to the catheter on the proximal side of the balloon will be less transmitted to the distal side of the balloon.

[0059] For another example, in addition to or in place of the coil, the structural support member may further comprise a braid, and the balloon may be configured to expand through the braided nodes of the braid to expand radially inward through the inner wall openings and / or radially outward through the outer wall openings. In some examples, the braid comprises a proximal braid portion, a distal braid portion, and an intermediate braid portion between the proximal braid portion and the distal braid portion. The braid density of the intermediate braid portion is less than the braid density of the proximal braid portion and / or the braid density of the distal braid portion. At least one inner wall opening and at least one outer wall opening are aligned with the intermediate braid portion so that the balloon expands through the braid along the intermediate braid portion.

[0060] If the structural support member includes both coils and braids, the coils and braids may have any suitable arrangement relative to each other. For example, the coils and braids may be longitudinally separated from each other or may partially or completely overlap in a radial direction.

[0061] In some examples, the catheter includes a plurality of balloons aligned longitudinally. When inflated, the plurality of balloons are configured to expand through a plurality of inner wall openings to provide support to a guidewire positioned within the lumen of the elongated body, and are configured to expand through a plurality of outer wall openings to anchor the catheter in the patient's vascular system. In some examples, each of the plurality of balloons is configured to expand away from substantially the same distance from the outer surface and / or inner surface of the elongated body in the corresponding inflated state. In other examples, at least two of the plurality of balloons are configured to expand away from different distances from the outer surface and / or inner surface of the elongated body in the corresponding inflated state.

[0062] In some examples, at least two of the multiple balloons are fluidically coupled to independent inflation lumens in the multiple inflation lumens. This can enable clinicians to independently inflate the balloons to help navigate the catheter to a target treatment site within the patient's vascular system. For example, selective expansion of a subset of the multiple balloons (e.g., only one balloon or more than one but less than all balloons) can help modify the position of the catheter in the blood vessel relative to the center of the blood vessel, for example, to re-center the catheter in the blood vessel or better position the catheter to navigate around a bend in the vascular system. For another example, when a guidewire begins to penetrate a relatively rigid vascular system, a balloon closer to the distal tip of the catheter can help reduce guidewire buckling and / or jumping, while another balloon closer to the proximal side can be advantageous when the catheter and guidewire are advanced through a relatively rigid material.

[0063] In addition to or in lieu of independent inflation lumens, in some examples, at least two of the plurality of balloons are fluidly coupled to a common inflation lumen. A catheter configuration in which at least two balloons are fluidly coupled to a common inflation lumen can help the catheter maintain a relatively low-profile configuration compared to examples in which each balloon is fluidly coupled to an independent inflation lumen.

[0064] The exemplary catheters described herein can be used for any suitable medical procedures, such as, but not limited to, procedures for treating defects in the neurovascular system, peripheral vascular system, and coronary vascular system. Exemplary defects include, but are not limited to, vascular obstruction (e.g., caused by a dense fibrous cap), aneurysms, arterial malformations, and the like. For example, in order to traverse or penetrate a lesion in a patient's blood vessel, a clinician can navigate a guidewire through the patient's vascular system to a position near the lesion, deliver a catheter to the position via the guidewire, couple the guidewire and catheter together using one or more balloons described herein, and penetrate the lesion with the coupled guidewire and catheter.

[0065] Figure 1 2 is a side elevational view of an exemplary catheter 10 configured to provide structural support to a guidewire 16 positioned within a lumen 26 of the catheter 10. The catheter 10 may be used with any suitable medical procedure. For example, the catheter 10 may be used with the guidewire 16 to penetrate (e.g., partially or completely traverse) a blockage in a patient's blood vessel.

[0066] The catheter 10 includes an elongated body 12 (also referred to as a catheter body in some examples herein) and a balloon 28. The elongated body 12 includes an inner wall 20 and an outer wall 21 and, in some examples, a structural support member 22 positioned between the inner wall 20 and the outer wall 21. Figures 2A to 3B). In addition, in some examples, the elongated body 12 may include one or more structures in addition to the inner wall 20, the outer wall 21, and the structural support member 22. For example, in some examples, the elongated body 12 and other elongated bodies described herein may include an inner lining directed radially inward relative to the inner wall 20, as shown in FIG. Figure 5A and Figure 5B The liner 84 is shown as described. The liner can define the interior cavity 26 of the elongated body 12.

[0067] The elongated body 12 extends from a proximal end 12A to a distal end 12B along a central longitudinal axis A and defines at least one lumen 26 (e.g., one lumen, two lumens, or three lumens), wherein the at least one lumen terminates at a distal opening 13 defined by the elongated body 12. In some examples, the elongated body 12 comprises a tubular body. Figure 1 In the example shown, the proximal end 12A of the elongated body 12 is housed within the hub 14 and mechanically connected to the hub 14 via adhesive, welding, or another suitable technique or combination of techniques. An opening 15 defined by the hub 14 and located at the proximal end 14A of the hub 14 is aligned with the lumen 26 of the elongated body 12 such that the lumen 26 is accessible through the opening 15.

[0068] The elongated body 12 can have any suitable dimensions, which can depend on the medical procedure for which the catheter 10 is intended to be used. For example, the elongated body 12 can have any suitable length, such as, but not limited to, about 50 centimeters (cm) to about 150 cm, such as about 75 cm, about 90 cm, or about 135 cm (e.g., exactly these lengths or approximately these lengths within manufacturing tolerances), and can be formed from any suitable material. For example, the elongated body 12 can be formed from metal, a polymer, or a combination thereof.

[0069] In some examples, the outer diameter of the elongated body 12 can be about 2 French to about 12 French, such as about 3 French or about 6 French. The measurement term French (abbreviated as Fr or F) is three times the diameter of the device as measured in mm. Thus, a diameter of 6 French is about 2 mm (e.g., about 1.8 mm), a diameter of 5 French is about 1.67 mm, a diameter of 4 French is about 1.33 mm, and a diameter of 3 French is about 1 mm. As used herein with respect to dimensions, the term "about" can refer to an exact value, such as when used to describe a numerical value, while "about" or "approximately" refers to a value within a range resulting from manufacturing tolerances and / or within 1%, 5%, or 10% of a value. For example, a length of about 10 mm refers to a length of 10 mm within the range allowed by manufacturing tolerances, or a length of 10 mm + / - 0.1 mm, + / - 0.5 mm, or + / - 1 mm in various examples.

[0070] In some examples, at least a portion of the outer surface 34 of the elongated body 12 includes one or more materials, such as, but not limited to, an antithrombotic coating, an antimicrobial coating, and / or a lubricious coating, which can help reduce thrombosis in vitro. The lubricious coating can be configured to reduce static or dynamic friction between the elongated body 12 and the patient's tissue as the elongated body 12 is advanced through the vasculature. The lubricious coating can be, for example, a hydrophilic coating. In some examples, the entire working length of the elongated body 12 (from the distal portion 14B of the hub 14 (or where the strain relief member 11 separates from the hub 14) to the distal end 12B of the elongated body 12) is coated with the hydrophilic coating. In other examples, only a portion of the working length of the elongated body 12 is coated with the hydrophilic coating. This can provide a length of the elongated body 12 distal to the hub 14 that a clinician can grasp, for example, to rotate or push the elongated body 12 through the patient's vasculature or other hollow anatomical structure.

[0071] In some examples, the elongated body 12 may include one or more radiopaque markers that may assist a clinician in determining the positioning of the catheter 10 relative to the target treatment site. For example, the one or more radiopaque markers may be positioned proximal to the elongated body 12, within the elongated body 12, adjacent to the balloon 28, or a combination thereof.

[0072] The inner wall 20 of the elongated body 12 faces radially inward relative to the outer wall 21 of the elongated body 12, such that the inner wall 20 is closer to the inner cavity 26 than the outer wall 21. In some examples, the inner surface of the inner wall 20 defines the inner cavity 26, but in some examples, a coating, such as a lubricating coating, may be positioned along the inner surface of the inner wall 20. The inner wall 20 and the outer wall 21 can have any suitable configuration. For example, the inner wall 20 and the outer wall 21 can be respective layers of a multi-layer elongated body 12, and can each include one or more layers. Although a gap is shown between the inner wall 20 and the outer wall 21 in some figures, in some examples, the inner wall 20 and the outer wall 21 can be in direct contact with each other in at least some sections along the length of the elongated body 12, or can be separated from each other by another layer, such as a bonding layer or another intermediate layer. For example, the inner wall 20 and the outer wall 21 can be directly attached to each other or indirectly attached via a bonding layer. In other examples, the inner wall 20 and the outer wall 21 are not attached to each other.

[0073] The inner wall 20 and the outer wall 21 can be formed from any suitable material, such as, but not limited to, the exemplary polymers discussed above with respect to the elongated body 12. In examples where the inner wall 20 and / or the outer wall 21 comprise multiple layers, the multiple layers of the respective walls 20, 21 can be formed from the same material, or at least two of the multiple layers can be formed from different materials, which can be selected to provide the elongated body 12 with various desired structural characteristics. In some examples, the inner wall 20 and the outer wall 21 are formed from the same material, while in other examples, the inner wall 20 and the outer wall 21 are formed from different materials. Additionally, in some examples, the inner wall 20 and the outer wall 21 can have substantially the same thickness (e.g., the same except for manufacturing tolerances), where the thickness is measured in a direction perpendicular to the central longitudinal axis A. In other examples, the inner wall 20 and the outer wall 21 have different thicknesses. The thickness of each of the walls 20, 21 can depend on the intended use of the catheter 10. For example, in some examples, the thickness of each wall is approximately 0.02 mm to approximately 5 mm.

[0074] The inner wall 20 defines at least one inner wall opening 30 through which the balloon 28 is configured to expand when the balloon 28 is in its expanded state (also referred to herein as the inflated state) and into the inner lumen 26. The inner wall openings 30 can be distributed along the periphery of the inner wall (e.g., circumferentially in the case of an inner wall having a circular cross-section) and / or longitudinally along the longitudinal axis A. In some cases, for example, the inner wall openings 30 are longitudinally aligned but distributed circumferentially along the inner surface of the inner wall 20. The inner wall openings 30 can be uniformly distributed or non-uniformly distributed. In addition to or in lieu of being separated from one another along the periphery of the inner wall (e.g., circumferentially), the inner wall openings 30 can be longitudinally separated from one another along the longitudinal axis A.

[0075] The outer wall 21 defines at least one outer wall opening 31 through which the balloon 28 is configured to expand radially outwardly, when the balloon 28 is in its expanded state, away from an outer surface 34 of the elongated body 12. As with the inner wall openings 30, the outer wall openings 31 can be distributed along the circumference of the inner wall (e.g., circumferentially in the case of an outer wall having a circular cross-section) and / or longitudinally along the longitudinal axis A.

[0076] Although for ease of description, the slender body, inner wall and outer wall of the catheter are mainly described in this document as having a circular cross-section, in other examples, the slender body, inner wall and / or outer wall of the catheter may have other cross-sectional shapes, and the cross-section is cut in a direction orthogonal to the central longitudinal axis of the corresponding slender body, inner wall or outer wall.

[0077] In the expanded configuration within the vessel 38, the balloon 28 can be conformable to engage with the wall of the vessel 38 to anchor the elongated body 12 in the vessel and to engage with the guidewire 16 to provide structural support to the guidewire 16. The balloon 28 can be formed of any suitable material, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polyamide (e.g., nylon, polyamide 6 (PA 6), or polyamide 66 (PA66), polycarbonate (PC), polyethylene (e.g., high-density polyethylene (HDPE) or low-density polyethylene (LDPE)), poly(methyl methacrylate) (PMMA), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polybutylene terephthalate (PBT), styrene acrylonitrile (SAN), thermoplastic elastomers (TPE) (e.g., polyether block amide (PEBA)), polyphenylene sulfide (PPS), polyetheretherketone (PEEK), and polyetheretherketone (PEEK). ), polyurethane, polyester, or blends, copolymers, or co-extrusions thereof. Balloon 28 can be inflated to any suitable pressure via an inflation fluid (e.g., saline) delivered to balloon 28 via an inflation lumen defined by elongated body 12 (e.g., between inner wall 20 and outer wall 21). In some examples, balloon 28 can be inflated to a pressure of approximately 2 to 6 atmospheres. Balloon 28 can be configured to deflate via a vacuum or other stable source applied to the one or more inflation lumens to forcibly remove the inflation fluid from balloon 28.

[0078] Balloon 28 can have any suitable size or shape. In some examples, balloon 28 can be defined to have a cross-sectional diameter in the expanded configuration that is equal to or greater than the cross-sectional diameter of blood vessel 38 (e.g., approximately 2 mm to approximately 4 mm). In addition or alternatively, balloon 28 can present a cross-sectional diameter configured to conform to a range of blood vessel diameters when inflated to the expanded configuration. Balloon 28 can have any suitable length. In some examples, balloon 28 has a length of approximately 0.2 cm to 5 cm. In some examples, the distal-most portion of balloon 28 is separated from the distal end 12B of elongated body 12 by a distance of approximately 1 cm to approximately 10 cm, but in other examples, other balloon positions can be used.

[0079] As reference Figure 2A and Figure 2BAs discussed, the balloon 28 is configured to simultaneously expand through the at least one inner wall opening 30 and the at least one outer wall opening 31. In some examples, the outer wall opening 31 can be fully or partially longitudinally and / or circumferentially aligned with the at least one inner wall opening 30 (e.g., the spacing and shape of the outer wall openings 31). In other examples, the at least one inner wall opening 30 can be longitudinally and / or circumferentially offset from the at least one outer wall opening 31. Additionally, in some examples, there can be an equal number of inner wall openings 30 and outer wall openings 31. However, in other examples, there can be a greater or lesser number of inner wall openings 30 than outer wall openings 31.

[0080] The inner wall openings 30 and the outer wall openings 31 have any suitable size, which may depend on one or more factors, such as, but not limited to, the number of openings 30, 31, the size of the balloon, the number of balloons, and the medical procedure for which the catheter 10 is intended to be used. The inner wall openings 30 and the outer wall openings 31 may be circular, oval, or any other shape suitable for balloon 28 to expand through. In some examples, the inner wall openings 30 have an average maximum cross-sectional dimension of 0.01 mm to about 2 mm, and the outer wall openings 31 have an average maximum cross-sectional dimension of 0.01 mm to about 2 mm. The size and / or number of the inner wall openings 30 may depend on the guidewire diameter of the guidewire 16 positioned in the lumen 26 of the elongated body 12, for example, selected so that the balloon 28 can expand into the lumen 26 to an amount sufficient to engage the guidewire 16. The size and / or number of the outer wall openings 31 may depend on the size of the blood vessel (e.g., the diameter of the blood vessel to which the catheter 10 is configured to fit). For example, the size and / or number of outer wall openings 31 are selected to enable balloon 28 to expand into and through outer wall openings 31 by an amount sufficient to engage the inner wall of the blood vessel.

[0081] The inner wall openings 30 and the outer wall openings 31 can be formed by any suitable technique. In some examples, the openings 30, 31 are formed by mechanical techniques, such as, but not limited to, laser cutting, drilling, stamping, or a combination thereof. In other examples, the openings 30, 31 are formed by chemical techniques, such as, but not limited to, selective dissolution of one or more sections of the respective inner wall 20 and outer wall 21.

[0082] As about Figures 3A to 4B As further described in detail in some examples, the elongated body 12 includes a structural support member (e.g., a coil and / or braid) positioned between the inner wall 20 and the outer wall 21 or the inner lining ( Figures 1 to 4B2 and 3. The structural support member is configured to increase the structural integrity of the elongated body 12 while enabling the elongated body 12 to maintain relative flexibility. For example, the structural support member can be configured to help the elongated body 12 substantially maintain its cross-sectional shape, or at least help prevent the elongated body 12 from buckling or kinking as it is navigated through tortuous anatomical structures.

[0083] In some examples, the structural support member includes one or more braids each defining a plurality of braided nodes, one or more coils each defining a plurality of turns (e.g., in a helical shape), or a combination of one or more braids and one or more coils. For example, the proximal portion of the structural support member may include the braid, and the distal portion of the structural support member may include the coil, or vice versa. For another example, in some examples, the braid and coil may fully or partially overlap.

[0084] The structural support member can be formed from any suitable material, such as a metal, a polymer, or a combination thereof. In some examples, the structural support member is formed from a shape memory material, such as nickel titanium alloy (Nitinol). In some examples, the structural support member is formed from stainless steel. In some cases, nickel titanium alloy can be more resistant to crushing than stainless steel and, therefore, can be used to form a structural support member of a catheter that is more resistant to kinking and buckling than stainless steel.

[0085] As referenced below Figures 3A to 4B As discussed in further detail, the structural support member defines gaps through which the balloon 28 can expand when expanded through the inner wall openings 30 into the inner lumen 26 and / or when expanded through the outer wall openings 31 away from the outer surface 34 of the elongated body 12. For example, in examples where the structural support member comprises a coil, the gaps are defined between the turns of the coil, and the balloon 28 can be positioned and configured to expand through the turns of the coil to expand into the inner lumen 26 of the catheter 10 and / or to expand through the turns of the coil to expand radially from the outer surface 34. For another example, in examples where the structural support member comprises a braid, the gaps are defined by the braid nodes of the braid, and the balloon 28 can be positioned and configured to expand through the braid nodes of the braid to anchor the catheter in the vasculature.

[0086] As described in further detail below, balloon 28 is configured to provide structural support to the guidewire 16 positioned in lumen 26, for example, so that guidewire 16 can penetrate the lesion in the patient's blood vessel alone or in combination with elongated body 12. Guidewire 16 has a relatively flexible configuration so that the clinician can navigate guidewire 16 from an access point (for example, at the femoral artery or radial artery) through the vascular system to reach the target treatment site in the patient's body. Depending on the hardness of the lesion, guidewire 16 may be relatively difficult to penetrate the lesion without additional structural support (for example, so that it remains centered in lumen 26 or in a blood vessel). For example, when the distal end 16B of guidewire 16 contacts a relatively rigid material (for example, a lesion or other obstruction in the patient's vascular system) while applying distal thrust to the proximal portion of guidewire 16 (for example, near the nearest end of guidewire 16), the distal portion of guidewire 16 can bend or otherwise deformed, which can hinder the ability of guidewire 16 to penetrate (for example, traverse) the lesion. For example, when the distal end 16B contacts a lesion, the distal end 16B of the guidewire 16 may be diverted away from the lesion, which may cause the guidewire 16 to jump into the vessel wall beneath the intima or to completely penetrate the vessel wall.

[0087] Balloon 28 may be formed from any suitable material, such as, but not limited to, polyethylene, polyethylene terephthalate (PET), nylon, polyether block amide, polytetrafluoroethylene (PTFE), polyurethane, polyester, silicone, polyvinyl chloride, polypropylene, polyurethane, polyamide, latex, natural rubber, synthetic rubber, etc. In some examples, balloon 28 may be made of an expandable material (e.g., a stretchable material that expands under pressure).

[0088] In some examples, the balloon 28 may have a structural feature (e.g., a roughened surface) or a friction-increasing coating that is configured to increase the static friction between the balloon 28 and the guidewire 16. This may help the balloon 28 to grip the guidewire 16 when in the expanded state and help, for example, to stabilize the catheter 10 and the guidewire 16 by fixing their relative longitudinal positions. However, in other examples, the balloon 28 is configured to allow the guidewire 16 to slide longitudinally relative to the catheter, even when the balloon 28 is in the expanded configuration. In these examples, the balloon 28 can still provide structural support and the balloon 28 can help keep the guidewire 16 relatively centered in the lumen 26, which can help guide the guidewire 16 through a more central portion of the lesion and minimize the risk of the guidewire 16 inadvertently extending through the vessel wall.

[0089] In some examples, the balloon 28 can be formed separately from the elongated body 12 and connected to the elongated body 12 between the inner wall 20 and the outer wall 21 using any suitable technique. For example, the proximal and distal ends of the balloon 28 can be bonded (e.g., via an adhesive), crimped, swaged, welded, or otherwise secured to the inner wall 20 and the outer wall 21 of the elongated body 12. In other examples, the balloon 28 can be integrally formed with the elongated body 12.

[0090] The hub 14 is positioned at the proximal end of the catheter 10 and defines an opening through which the lumen 26 of the elongated body 12 is accessible and, in some examples, is closed. For example, the hub 14 may include a luer connector for connecting to another device, a hemostatic valve, or another mechanism or combination of mechanisms. In some examples, the catheter 10 includes a strain relief member 11, which may be part of the hub 14 or separate from the hub 14. In other examples, the proximal end of the catheter 10 may include another structure in addition to or in place of the hub 14.

[0091] The hub 14 can include one or more extension members 32A and 32B (collectively, "extension members 32") in fluid communication with one or more inflation lumens of the elongated body 12, which are in fluid communication with the balloon 28. For example, each of the extension members 32A, 32B can be in fluid communication with a respective inflation lumen or with the same inflation lumen. Thus, the extension members 32 can be used to deliver an inflation fluid (e.g., saline) to the one or more balloons 28.

[0092] Figure 2A yes Figure 1 A schematic cross-sectional view of the catheter 10, with a cross section along Figure 1 2A-2A in FIG, and illustrates the balloon 28 in a deflated (eg, collapsed or uninflated) configuration and the guidewire 16 positioned within the lumen 26 of the elongated body 12. FIG. Figure 2B yes Figure 1 A schematic cross-sectional view of the catheter 10, with a cross section along Figure 1 2A-2A in FIG, and illustrates the balloon 28 in an expanded configuration and engaged with the guidewire 16. In some examples, the expanded configuration is a fully expanded configuration, which is the configuration of the balloon 28 at a predetermined maximum inflation pressure.

[0093] In the bleed configuration ( Figure 2A ), the outer surface of the balloon 28 is relatively close to the inner wall 20 and the outer wall 21 of the elongated body 12. Figure 2AAs shown, in some examples, when balloon 28 is in the deflated configuration, e.g., when there is no inflation fluid within balloon 28, balloon 28 is completely contained between inner wall 20 and outer wall 21. For example, no portion of balloon 28 protrudes beyond outermost surface 18 of outer wall 21 or innermost surface 17 of inner wall 20. In other examples, when balloon 28 is in the deflated configuration, balloon 28 at least partially protrudes beyond outermost surface 18 of outer wall 21 and / or innermost surface 17 of inner wall 20.

[0094] like Figure 2B As shown, in the expanded configuration, the balloon 28 expands radially outward through the outer wall openings 31A-31D and expands radially inward through the inner wall openings 30A-30D, so that at least some portion of the outer surface of the balloon 28 expands away from the outer wall 21 and at least some portion of the outer surface of the balloon 28 engages the guidewire 16. Thus, in the deflated configuration, the balloon 28 has a relatively low profile configuration, and in the expanded configuration, the balloon 28 has a higher profile configuration than the deflated configuration. In some examples, in the expanded configuration, the balloon 28 extends a distance of about 0.5 mm to about 5 mm from the outermost surface 18 of the outer wall 21 when fully expanded.

[0095] Despite Figure 2A and Figure 2B While four inner wall openings 30A- 30D and four outer wall openings 31A- 31D are shown in the example of FIG, in other examples, the inner wall 20 may define any suitable number of inner wall openings 30 and the outer wall 21 may define any suitable number of inner wall openings 30.

[0096] The outer wall openings 31 can each have any suitable spacing relative to one another. The spacing can include, for example, a circumferential spacing in the direction of the outer wall 21 of the elongated body 12. In the case of an elongated body 12 having a non-circular cross-section, the circumferential spacing can also be referred to as a tangential spacing. In some examples, some or all of the outer wall openings 31 are evenly spaced around the outer wall 21 of the elongated body 12. Figure 2A In the example shown, the circumferential distance C1 between the outer wall openings 31A and 31C can be the same distance as the circumferential distance C2 between the outer wall openings 31A and 31D (e.g., a distance of about 0.02 mm to about 5 mm apart). In other examples, some or all of the outer wall openings 31 are unevenly spaced around the outer wall 21 of the elongated body 12. For example, the circumferential distance C1 between the outer wall openings 31A and 31C can be greater than the circumferential distance C2 between the outer wall openings 31A and 31D.

[0097] The inner wall openings 30 can each have any suitable spacing relative to one another. In some examples, some or all of the inner wall openings 30 are evenly spaced circumferentially along the inner wall 20. Figure 2A In the example shown, the circumferential distance D1 between the inner wall openings 30A and 30C can be the same distance as the circumferential distance D2 between the inner wall openings 30A and 30D (e.g., a distance of about 1 mm apart). In other examples, some or all of the inner wall openings 30 are unevenly spaced around the inner wall 20. For example, the circumferential distance D1 between the inner wall openings 30A and 30C can be greater than the circumferential distance D2 between the inner wall openings 30A and 30D. The circumferential distance between the wall openings can be measured, for example, from one side of the wall opening to the other (e.g., the closest portions of adjacent wall openings).

[0098] Figure 3A is in the patient's blood vessels 38 Figure 1 Schematic cross-sectional view of an example of a catheter 10 , wherein the cross section is taken along the central longitudinal axis A of the elongated body 12 of the catheter 10 , and showing the balloon 28 in a deflated configuration and the guidewire 16 positioned in the lumen 26 of the catheter 10 . Figure 3B The same view of the blood vessel and catheter 10 is shown, but with the balloon 28 in an expanded configuration and engaged with the guidewire 16 .

[0099] In the deflated configuration of balloon 28, elongated body 12 is in a relatively low-profile configuration to better configure elongated body 12 for navigation through blood vessel 38 to a target site within a patient's body. Additionally, in the deflated configuration of balloon 28, balloon 28 does not interfere with the ability of guidewire 16 to slide freely within lumen 26. For example, in some examples, when the balloon is in the deflated configuration, balloon 28 is configured to not contact guidewire 16 when guidewire 16 is centered along central longitudinal axis A of elongated body 12.

[0100] exist Figure 3A and Figure 3B In the illustrated example, the catheter 10 includes a structural support member 22 positioned between the inner wall 20 and the outer wall 21, wherein the structural support member 22 includes a coil defining a plurality of turns (e.g., in the shape of a helix). The structural support member 22 can be formed from any suitable material, such as a metal (e.g., nickel-titanium alloy and / or stainless steel), a polymer, or a combination thereof. As an example, the structural support member 22 can be formed from wire arranged to define a coil.

[0101] Structural support member 22 defines a gap through which balloon 28 can expand when expanded into lumen 26 through inner wall opening 30 and / or when expanded away from outer surface 34 of elongated body 12 through outer wall opening 31. Figure 3A and Figure 3BIn the example shown, gaps are defined between the turns of the coil, and the balloon 28 can be positioned and configured to expand through the turns of the coil to expand into the lumen 26 of the catheter 10 and / or through the turns of the coil to expand radially from the outer surface 34.

[0102] In some examples, structural support member 22 is an intermediate coil portion having a proximal coil portion, a distal coil portion and a portion positioned between the proximal coil portion and the distal coil portion, the proximal coil portion having a first pitch, and the distal coil portion having a second pitch. The intermediate coil portion has a third pitch greater than the first pitch and / or the second pitch to limit the relatively large gap through which balloon 28 can expand. The larger the coil pitch, the larger the distance between the adjacent windings of the coil. In some examples, the third pitch of the intermediate coil portion is greater than both the first pitch of the proximal coil portion and the second pitch of the distal coil portion, respectively. In some examples, the first pitch of the proximal coil portion and the second pitch of the distal coil portion are substantially equal (e.g., almost equal within the scope allowed by manufacturing tolerances).

[0103] like Figure 3B As shown, when inflated, balloon 28 is configured to expand radially outward through the turns of coil 22 and through outer wall openings 31A-31D to engage the wall of blood vessel 38 to anchor elongated body 12 in blood vessel 38. Simultaneously, balloon 28 is configured to expand radially inward through the turns of coil 22 and through inner wall openings 30A-30B to engage guidewire 16 to provide structural support to guidewire 16. For example, balloon 28 may directly contact guidewire 16, for example, rather than indirectly contacting guidewire 16 through another layer of elongated body 12.

[0104] In other examples, the structural support member 22 of the elongated body 12 may include another structure, such as a braid, in addition to or in lieu of a coil. Figure 4A and Figure 4B is a schematic cross-sectional view of another exemplary catheter 40, which is similar to catheter 10, but includes a braid 52 instead of coil 22. In other examples, a catheter may include both a braid 52 and a coil 22. Figure 4A and Figure 4B The illustrated catheter 40 includes an elongated body 42, a balloon 58, and a structural support member including a braid 52. The cross section is taken along the central longitudinal axis of the elongated body 42 of the catheter 40. Figure 4A The balloon 58 is shown in a deflated configuration, and Figure 4B The balloon 58 is shown in an expanded configuration. The catheter 40 is shown positioned within the blood vessel 38. Figure 4AIn the example shown, the elongated body 42 includes an inner wall 50, an outer wall 51, and a structural support member 52 positioned between the inner wall 50 and the outer wall 51. Except for the differences described herein, the catheter 40, the elongated body 42, the inner wall 50, the outer wall 51, and the balloon 58 are similar to those of FIG. Figures 1 to 3B The catheter 10, the elongated body 12, the inner wall 20, the outer wall 21 and the balloon 28, and the catheter 10.

[0105] The braid 52 comprises a structure defined by braided wires (e.g., wire filaments) such as metal wires (e.g., nickel-titanium alloy and / or stainless steel). The braid can be formed by, for example, a plurality of wires braided in any suitable pattern, such as, but not limited to, a single-wire two-on-two pattern, a double-wire two-on-two pattern, etc. The braid 52 defines a plurality of braid nodes. The points at which the materials (e.g., filaments) forming the braid 52 cross each other are referred to herein as "braid nodes (pic)", and the braid density can be measured in "braid nodes per inch" ("PPI"). The braid density can be adjusted by increasing or decreasing the braid nodes along the length of the braid 52.

[0106] Braid 52 includes a proximal braid portion 52A, an intermediate braid portion 52B, and a distal braid portion 52C, wherein intermediate braid portion 52B is positioned between proximal braid portion 52A and distal braid portion 52C. In some examples, braid 52 comprises a one-piece braid such that proximal braid portion 52A, intermediate braid portion 52B, and distal braid portion 52C are part of a seamless braid. Compared to an elongated body comprising multiple braid portions mechanically connected to one another, one-piece braid 52 can help elongated body 42 better distribute forces in the longitudinal and rotational directions.

[0107] Inner wall 50 and outer wall 51 define inner wall openings 60A and 60B (collectively referred to as "inner wall openings 60") and outer wall openings 61A and 61B (collectively referred to as "outer wall openings 61"), and balloon 58 is configured to expand through these wall openings. Middle braided portion 52B is aligned with inner wall opening 60 and outer wall opening 61 so that balloon 58 is configured to expand through braid 52 along middle braided portion 52B. To help provide space for this, middle braided portion 52B may have a braid density that is smaller than the braid density of proximal braided portion 52A and / or the braid density of distal braided portion 52C. For example, middle braided portion 52B has a braid density of 2 PPI to about 50 PPI, while proximal braided portion 52A and / or distal braided portion 52C have a braid density of 100 PPI to 250 PPI. In some examples, proximal braided portion 52A and distal braided portion 52C have the same braid density. However, in other examples, proximal braid portion 52A and distal braid portion 65C have different braid densities.

[0108] In some examples, the length of the middle braided portion 5252B can be based on the length of the balloon 58. For example, the middle braided portion 5252B can be any length suitable for the balloon 58 to expand through, such as, but not limited to, about 0.2 cm to about 5 cm, such as about 0.5 cm, about 2 cm, or about 3 cm. In some examples, for a given wire size, the braid density of the braid 52 is associated with the stiffness of the braid 52. Compared to a braided portion with a relatively high braid density, a braided portion with a relatively low braid density has fewer braid nodes (fewer intersections), which can result in the braided portion with a relatively low density having a higher stiffness relative to the braided portion with a relatively high braid density.

[0109] In some examples, the middle braided portion 52B, which has a relatively low braid density, can be aligned with the inner and outer wall openings 60, 61. The inner and outer wall openings 60, 61 can define relatively weak points along the elongated body 42, and therefore, the elongated body 42 can be more likely to kink along the region with the inner and outer wall openings 60, 61. Aligning the middle braided portion 52B, which has a relatively low braid density and correspondingly high stiffness, with the inner and outer wall openings 60, 61 can help compensate for such weaknesses along the elongated body 42 and, therefore, help minimize the likelihood of kinking at the region with the inner and outer wall openings 60, 61. The middle braided portion 52B, which has a relatively low braid density and correspondingly high stiffness, can also maintain the propulsion capability of the elongated body 42 and the torque transfer from the proximal end to the distal end of the catheter 40 by compensating the elongated body 42 for any weakness caused by the presence of the inner and outer wall openings 60, 61.

[0110] like Figure 4BAs shown, balloon 58 is configured to expand through the braided nodes of middle portion 52B of braid 52. Balloon 58 is configured to expand radially outward through the braided nodes of braid 52 and through outer wall openings 61 to engage the vessel wall of blood vessel 38. Simultaneously, balloon 58 is configured to expand radially inward through the braided nodes of braid 52 and through inner wall openings 60 to engage guidewire 16 positioned within lumen 46 of elongated body 42. Thus, when inflated, balloon 58 can simultaneously engage guidewire 16 and the wall of blood vessel 38 to provide support to guidewire 16 while anchoring catheter 40 within blood vessel 38. Without balloon 58, when the distal end of guidewire 16 contacts a lesion within blood vessel 38, guidewire 16 may be more likely to buckle or jump, and elongated body 42 may tend to move, for example, outside of the artery, which may result in poor penetration of the lesion. Thus, the catheter 40 described herein can provide support to the guidewire 16 to avoid or reduce guidewire buckling or guidewire jumping, and help free up the clinician's hands during medical procedures by inflating a balloon 58 that is part of the catheter 40.

[0111] In some examples, in addition to or in place of a structural support member 52 (such as a coil or braid), the catheter 40 or any of the other catheters described herein includes one or more axial wires 53 extending along at least a portion of the length of the catheter (measured from the proximal end to the distal end of the catheter). The axial wires 53 are configured to add structural support, such as column strength, to the elongated body 42 as it is navigated through tortuous anatomical structures. The axial wires 53 are substantially straight (e.g., straight or nearly straight within the range permitted by manufacturing tolerances) and can extend along the longitudinal axis of the elongated body 42. The axial wires 53 can be positioned between the inner wall 50 and the outer wall 51. In examples where the catheter 42 also includes a braid 52 (or another structural support member), the axial wires 53 can be positioned between the outer wall 51 and the braid 52 and / or between the inner wall 50 and the braid 52. The axial wires 53 help distribute the flexibility provided by the braid 52 (or other structural support member) along the length of the braid 52. For example, by eliminating gaps between the braided nodes of the structural support member 52 , the axial wires may transmit flexural motion from the structural support member 52 along the length of the catheter 40 .

[0112] In some exemplary catheters described herein, such as reference Figures 2A to 4B In the described catheters 10, 40, the catheters are configured such that the respective balloons 28, 58 are configured to directly contact the guidewire 16 positioned within the respective lumens 26, 46. In other examples of the catheters described herein, the catheters include a liner positioned between the balloon and the guidewire 16 such that the balloon indirectly contacts the guidewire 16 when the balloon is in the inflated configuration. Figures 5A to 5CAn exemplary catheter 70 is shown including an elongated body 72 including an inner wall 74 defining a plurality of inner wall openings 76A-76D, an outer wall 78 defining a plurality of outer wall openings 80A-80D, and a liner 84 facing radially inward relative to the inner wall 74 . Figure 5B and Figure 5C yes Figure 5A A schematic cross-sectional view of a catheter, wherein the cross section is along Figure 5A The line 5B-5B in FIG. 5B is taken and is orthogonal to the central longitudinal axis of the elongated body 72. The balloon 82 is Figure 5B is in a bleed configuration and is Figure 5C In the expanded (inflated) configuration.

[0113] The liner 84 defines an interior lumen 86 of the elongated body 72. In some examples, at least the interior surface of the liner 84 can be lubricious to facilitate the introduction and passage of a medical device, such as a guidewire 16. For example, the material forming the entire liner 84 can be lubricious, or the liner 59 can be formed from two or more materials, wherein the material defining the interior surface of the liner 84 can be more lubricious than the material interfacing with the inner wall 74. In some examples, in addition to or instead of being formed from a lubricious material, the interior surface of the liner 84 is coated with a lubricious coating.

[0114] Exemplary materials from which the liner 84 may be formed include, but are not limited to, polytetrafluoroethylene (PTFE), fluoropolymers, perfluoroalkoxyalkanes (PFA), fluorinated ethylene propylene (FEP), or any combination thereof. For example, the liner 59 may be formed from, for example, may consist essentially of, unetched PTFE.

[0115] In some examples, at least a portion of the liner 84 may be attached to the inner wall 74 of the elongated body 72. For example, the inner wall 74 and the liner 84 may be attached or bonded together along their respective lengths, except for the area where the inner wall 74 defines the inner wall openings 76A-76D. As another example, the inner wall 74 and the liner 84 may be attached or bonded together along only a portion of their respective lengths.

[0116] like Figure 5B As shown, when balloon 82 is in the deflated configuration, e.g., when there is no inflation fluid within balloon 82, balloon 82 may be contained between inner wall 74 and outer wall 78 and may not extend through inner wall openings 76A-76D or outer wall openings 80A-80D. Figure 5CAs shown, in the expanded configuration, the balloon 82 extends radially outward through the outer wall openings 80A-80D and expands radially inward through the inner wall openings 76A-76D, such that at least some portion of the outer surface of the balloon 28 engages the liner 84 and pushes the liner 84 toward the guidewire 16 into engagement with the guidewire 16. In some examples, to help increase the ability of the balloon 82 to secure the position of the guidewire 16 and the catheter 70, the liner 84 can include a surface treatment (e.g., etching) to increase static friction between the liner 84 and the guidewire 16 when the balloon 82 is expanded through the inner wall openings 76A-76D and engages the liner 84 with the guidewire 16.

[0117] Despite Figures 5A to 5C Not shown, but in some examples, the catheter 70 includes a structural support member, such as the coil 22 ( Figure 3A and Figure 3B ) or braid 52( Figure 4A and Figure 4B ), and the balloon 82 can be configured to expand through the gap defined by the structural support member.

[0118] As shown in Figures 5 and Figure 6 As discussed, instead of a single balloon 28, in some examples, the catheter may include multiple balloons. The balloon may be in fluid communication with one or more inflation lumens defined by the elongated body of the catheter and configured to receive inflation fluid via the one or more inflation lumens to expand from a corresponding deflated configuration to a corresponding inflated configuration. The multiple balloons may also each be deflated via the one or more inflation lumens. In some examples, at least two of the multiple balloons may be fluidly coupled to independent inflation lumens. Instead of or in addition to this configuration, as described with reference to Figure 6 As discussed, in some examples, at least two balloons of the plurality of balloons can be fluidly coupled to the same inflation lumen.

[0119] Although Figures 1 to 5C A catheter with a single balloon is shown, but in some examples, more than one balloon may be connected to the elongated body of the catheter between the inner and outer walls of the catheter. Figure 6 is a schematic cross-sectional view of another exemplary catheter 90 in a patient's blood vessel 38, wherein the cross section is taken along the central longitudinal axis of the elongated body 92 of the catheter 90. The catheter 90 includes a plurality of balloons, including balloons 94A and 94B (collectively referred to as "balloons 94"), positioned between an inner wall 91 and an outer wall 93 and configured to extend through openings defined in the inner wall 91 and the outer wall 93. Although Figure 6 90 may further include an inner liner (e.g., Figures 4A to 5CAside from the differences described herein, catheter 90, including elongated body 92 and balloon 94, is similar to catheters 10, 40. Thus, the description of elongated bodies 12, 42 and balloons 28, 58 also applies to elongated body 92 and balloon 94.

[0120] At least two of the plurality of balloons 94 are fluidly coupled to independent inflation lumens, which enables the at least two balloons to be independently inflated by inflation fluid 96 (e.g., saline) delivered through the respective inflation lumens. Figure 6 In the illustrated example, the elongated body 92 defines at least two independent inflation lumens 98A and 98B (collectively referred to as "inflation lumens 98") that are fluidly coupled to respective balloons 94A, 94B and respective extension members 32A, 32B ( Figure 1 ). Balloon 94A is fluidly coupled to inflation lumen 98A but not to inflation lumen 98B, and balloon 94B is fluidly coupled to inflation lumen 98B but not to inflation lumen 98A. That is, inflation lumen 98B is fluidly isolated from and not fluidly coupled to balloon 94A, and inflation lumen 98A is fluidly isolated from and not fluidly coupled to balloon 94B. Thus, catheter 90 is configured such that a clinician can selectively inflate a subset of the plurality of balloons 94 (e.g., one balloon or more than one but less than all of the balloons 94) during a medical procedure. For example, in Figure 6 , balloon 94A is shown in a deflated configuration and balloon 94B is shown in an inflated configuration.

[0121] Configuring at least one balloon 94 to be fluidly coupled to an inflation lumen independent of another balloon enables a clinician to customize the anchoring mechanism of the catheter 90 to a target anchoring site by selecting a balloon 94 to be inflated based on the length of the vessel 38 in which the elongated body 92 of the catheter 90 is to be anchored. Additionally, the ability to selectively inflate a subset of the balloons 94 can enable a clinician to use the balloons 94 to, for example, facilitate navigation of the elongated body 92 to a target site within a patient. For example, a clinician can selectively inflate balloon 94B to its expanded configuration while fully deflated or only partially inflating balloon 94A to better center the elongated body 92 in the vessel 38 (e.g., when navigating the elongated body 92 around a curve) or to push the guidewire 16 to one side of the lumen 95 (e.g., when navigating the elongated body 92 around a curve). Figure 6 ). Simultaneously, when inflated, balloon 94B can exert a radially inwardly directed force to engage and re-center guidewire 16 in vessel 38.

[0122] In other examples, at least two of the balloons 94 are fluidly coupled to a common inflation lumen. For example, the elongated body 92 may define only one inflation lumen that is fluidly coupled to all of the balloons 94 and is used to deliver inflation fluid 96 to all of the balloons 94. As another example, the elongated body 92 may define multiple inflation lumens, but at least one of the inflation lumens is fluidly coupled to at least two of the balloons 94. Figure 7 An example of such a configuration is shown in FIG, which shows an exemplary catheter 100 including an elongated body 102, similar to Figure 6 The present invention relates to a catheter 90 and an elongated body 92, except that an inflation lumen 98A is in fluid communication with at least two balloons 94A, 94C, and an inflation lumen 98B is in fluid communication with at least two balloons 94B, 94D. In some examples, inflation lumens 98A, 98B are fluidly coupled, such as by an annular ring-shaped inflation lumen defined by the space between inner wall 91 and outer wall 93 of elongated body 92.

[0123] exist Figure 6 、 Figure 7 In the example of , or any other example in which the catheter includes multiple balloons, the balloons can be configured to expand to the same diameter or to different diameters. Configuring balloons such as balloons 94B, 94D to expand to different diameters can provide clinicians with different options to customize a given catheter for use with different blood vessel sizes.

[0124] Balloon 28 may be inflated to any suitable pressure via an inflation fluid (eg, saline) delivered to balloon 28 via an inflation lumen defined by elongate body 12 (eg, between inner wall 20 and outer wall 21 ).

[0125] Figure 8 is a flow chart of an exemplary method of using a catheter including at least one balloon between the inner and outer walls of the catheter. Figures 1 to 3B The catheter 10 is described Figure 8 However, in other examples, the exemplary techniques may be used with other catheters described herein.

[0126] exist Figure 8 In the method shown, a clinician may guide a guidewire 16 from a suitable access point (e.g., the femoral or radial artery) to a target site within the patient's vasculature (110) and introduce a catheter 10 into the vasculature (112) using the positioned guidewire 16. In some examples, the clinician may guide the guidewire 16 and catheter 10 to the target site via a guide catheter.

[0127] The clinician may inflate the one or more balloons 28 of the catheter 10 to an expanded configuration (114). For example, the clinician may deliver inflation fluid via separate inflation lumens (e.g., 98A, 98B) to independently inflate the balloons (e.g., balloons 94A and 94B) or deliver inflation fluid to at least two balloons (e.g., balloons 94B, 98D) via a single inflation lumen (e.g., inflation lumen 98) to inflate the balloons to an expanded configuration (114). Figure 6 and Figure 7 As described above, when the one or more balloons 28 are in the expanded configuration (e.g., Figure 2B ), the one or more balloons 28 are configured to expand radially outward through the one or more outer wall openings 31 to anchor the elongated body 12 of the catheter 10 within the blood vessel 38. At the same time, the one or more balloons 28 are configured to expand radially inward through the one or more inner wall openings 30 to provide structural support to the guidewire 16 positioned in the lumen 26 of the elongated body 12 to prevent and reduce guidewire buckling or guidewire jumping when the distal end of the guidewire 16 contacts a relatively rigid material (e.g., a lesion or other obstruction within the patient's blood vessel 38), which provides better treatment results.

[0128] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. A catheter, comprising: an elongated body defining a lumen, the elongated body comprising: an inner wall defining an inner wall opening; and an outer wall defining an outer wall opening; and A balloon is connected to the elongated body between the inner wall and the outer wall, wherein the balloon is configured to expand through the inner wall opening into the lumen of the elongated body, and wherein the balloon is configured to expand through the outer wall opening to engage a wall of a blood vessel. 2 . The catheter of claim 1 , wherein the balloon is configured to be inflated through the inner wall opening into the lumen to contact a guidewire positioned within the lumen.

3. The catheter of claim 1, further comprising a structural support member positioned between the inner wall and the outer wall, the structural support member defining a gap, wherein the balloon is configured to expand through the gap.

4. The catheter of claim 3, wherein the structural support member comprises a coil, and wherein the gap is defined between turns of the coil.

5. A catheter according to claim 4, wherein the coil includes a proximal coil portion having a first pitch, a distal coil portion having a second pitch, and an intermediate coil portion between the proximal coil portion and the distal coil portion, the intermediate coil portion having a third pitch, the third pitch being greater than at least one of the first pitch or the second pitch.

6. The catheter of claim 3, wherein the structural support member comprises a braid, and wherein the gaps are defined by braid nodes of the braid.

7. A catheter according to claim 6, wherein the braid includes a proximal braid portion having a first braiding density, a distal braid portion having a second braiding density, and an intermediate braid portion between the proximal braid portion and the distal braid portion, and the intermediate braid portion has a third braiding density, which is less than at least one of the first braiding density or the second braiding density.

8. The catheter of claim 7, wherein the proximal braided portion, the distal braided portion, and the intermediate braided portion have a unitary construction.

9. The catheter of claim 7, wherein the inner wall opening and the outer wall opening are aligned with the intermediate braided portion along a longitudinal axis of the elongated body.

10. A catheter according to claim 1, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings including the inner wall opening, and wherein and the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings including the outer wall opening, and wherein the balloon is configured to expand through the plurality of inner wall openings into the lumen and expand through the plurality of outer wall openings.

11. The catheter of claim 1 , wherein the catheter comprises a plurality of balloons, the plurality of balloons comprising the balloon, wherein the inner wall defines a plurality of inner wall openings, the plurality of inner wall openings comprising the inner wall opening, and wherein the outer wall defines a plurality of outer wall openings, the plurality of outer wall openings comprising the outer wall opening, and Wherein each balloon of the plurality of balloons is configured to expand through a corresponding inner wall opening of the plurality of inner wall openings and to expand through a corresponding outer wall opening of the plurality of outer wall openings.

12. The catheter of claim 11, wherein the elongated body defines an inflation lumen, and wherein at least two balloons of the plurality of balloons are fluidly coupled to the inflation lumen.

13. The catheter of claim 11, wherein the elongated body defines a plurality of inflation lumens, and wherein at least two balloons of the plurality of balloons are fluidly coupled to a separate inflation lumen of the plurality of inflation lumens.

14. A medical system comprising: The catheter according to claim 1; as well as A guidewire is disposed within the lumen of the elongated body, wherein the balloon is configured to be inflated through the inner wall opening into the lumen to directly contact the guidewire and stabilize the guidewire relative to the catheter.

15. A catheter comprising: an elongated body defining a lumen, the elongated body comprising: an inner wall defining a plurality of inner wall openings; an outer wall defining a plurality of outer wall openings; and a structural support member positioned between the inner wall and the outer wall, wherein the structural support member defines a gap; and A balloon is connected to the slender body between the inner wall and the outer wall, wherein the balloon is configured to expand through the plurality of inner wall openings into the tubular cavity of the slender body and expand through the plurality of outer wall openings, and expand through the gap defined by the structural support member. The catheter of claim 15 , wherein the plurality of inner wall openings and the plurality of outer wall openings are aligned with each other.

17. The catheter of claim 15, wherein at least one of the plurality of inner wall openings or the plurality of outer wall openings are distributed around a circumference of the inner wall or the outer wall, respectively.

18. A medical system comprising: The catheter according to claim 15; as well as A guidewire is positioned within the lumen of the elongated body, wherein the balloon is configured to be inflated through the plurality of inner wall openings into the lumen to directly contact the guidewire and stabilize the guidewire relative to the catheter.

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