Medical device including slot with filler

Abstract

To provide a low-invasive medical device such as an operable catheter, a guide wire, a coil, or another elongated flexible member.SOLUTION: A medical device includes an elongated member having a proximal end, a distal end, and a body extending between the proximal end and the distal end. The elongated member includes a tubular portion having a plurality of slots extending in a wall of the tubular portion. The plurality of slots include a first slot. The elongated member further includes fillers arranged in the slots, respectively. The fillers include a first filler including a sponge-like material arranged in the first slot.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to minimally invasive medical devices, and more particularly to minimally invasive medical devices such as steerable catheters, guidewires, coils, and other elongated flexible members. [Background technology]

[0002] The use of intravascular catheters, pushwires, guidewires, coils, and other types of elongated delivery members to access and treat various types of conditions, such as vascular defects, is well known. For example, a suitable intravascular catheter, guidewire, or other delivery member may be inserted into a patient's vascular system. A commonly used vascular application to access a target site in a patient involves inserting a guidewire through an incision in the femoral artery near the groin and advancing the guidewire until the target site is reached. A catheter is then advanced over the guidewire until the open distal end of the catheter is positioned at the target site. Simultaneously with or after the distal end of the catheter is positioned at the target site, an intravascular implant is advanced through the catheter via the delivery wire.

[0003] Certain applications, such as neurovascular treatments, require guidewires, delivery wires, and catheters to navigate tortuous and complex vasculature. By using appropriately sized devices with the necessary performance characteristics, such as pushability, steerability, torquability, and, most importantly, distal tip flexibility, nearly any target site in the vasculature, including tortuous cerebral and peripheral vessels, can be accessed. Furthermore, forces applied to the proximal end of these wires must be transmitted to the distal end with adequate pushability (axial stiffness) and torquability (rotation). Achieving a balance of these functions is highly desirable but challenging. For example, guidewires and / or delivery wires may have variable stiffness sections (e.g., achieved by varying material ratios, including selective reinforcement, such as segmental braiding or coiling) to provide sufficient flexibility, kink resistance, pushability, and torquability to enable maneuvering through the vasculature.

[0004] In some cases, catheters, guidewires, or other delivery members may have slots along their elongate bodies or selected portions thereof. Incorporating slots into these elongate medical instruments can modify or customize the flexibility / rigidity of the devices. For example, the distal portion of a catheter, guidewire, or other delivery member may have a slot pattern (e.g., more slots per area, longer slots, and / or wider slots) that enhances its flexibility. When used as a component of a delivery system, slotted elongate tubular devices are preferably substantially sealed (e.g., using a sheath, jacket, coating, etc.) to prevent fluid exchange into (or out of) the tube lumen or to enhance lubricity. Exemplary slotted and coated medical instruments are disclosed in U.S. Patent Nos. 5,095,915, 5,443,455, 6,488,637, and 9,162,040, the entire disclosures of which are incorporated herein by reference.

[0005] Applying a sheath, jacket, or coating over a slotted, elongated tubular device increases the volume and outer diameter (OD) of the device, which can negatively impact the overall performance of the device when advancing it through narrow bends and tortuous vasculature. Summary of the Invention

[0006] The medical device comprises an elongate member having a distal end and a body extending between the proximal and distal ends, the elongate member having a tubular portion having a plurality of openings extending within its wall, the plurality of openings including a first opening, the elongate member further comprising a filler material disposed in each of the openings, the filler material including a first filler material, the first filler material including a sponge-like material disposed in the first opening.

[0007] Optionally, said sponge-like material comprises a foam material.

[0008] Optionally, said sponge-like material is compressible, stretchable, or both.

[0009] Optionally, said first filler material is adjacent two opposing surfaces that define said first opening.

[0010] Optionally, said first filler material is fixedly secured to two opposing surfaces defining said first opening.

[0011] Optionally, said plurality of openings extend through a wall of the tubular portion.

[0012] Optionally, said tubular portion comprises a lumen defined by an inner surface of a wall of said tubular portion, and said first filler material does not extend beyond said inner surface into said lumen.

[0013] Optionally, the wall of said tubular portion comprises an outer surface, and said first filler material does not extend beyond said outer surface.

[0014] Optionally, said first filler material completely fills the entire first opening.

[0015] Optionally, the first filler material fills only a portion of the first opening.

[0016] Optionally, said filler material does not extend beyond the boundaries of said opening.

[0017] Optionally, said sponge-like material has laser-drilled or laser-cut openings.

[0018] Optionally, said sponge-like material comprises a closed-cell material.

[0019] Optionally, said medical device is a guidewire.

[0020] Optionally, said medical device is a delivery wire.

[0021] Optionally, said medical device is an implant.

[0022] Optionally, said medical device is a catheter.

[0023] Optionally, one of said openings has a width of less than 0.051 cm.

[0024] The medical device comprises an elongate member having a proximal end, a distal end, and a body extending between the proximal and distal ends, the elongate member having a tubular portion having a plurality of openings extending within its wall, the plurality of openings including a first opening, the elongate member further having a filler material disposed in each of the openings, the filler material including a first filler material that does not extend beyond the boundary of the first opening.

[0025] Optionally, the first filler material comprises a sponge-like material disposed in the first opening.

[0026] Optionally, said sponge-like material comprises a closed-cell material.

[0027] Optionally, said sponge-like material comprises a foam material.

[0028] Optionally, said sponge-like material has laser-drilled or laser-cut openings.

[0029] Optionally, said first filler material is made from a material that is compressible, stretchable, or both.

[0030] Optionally, said first filler material is adjacent two opposing surfaces that define said first opening.

[0031] Optionally, said first filler material is fixedly secured to two opposing surfaces defining said first opening.

[0032] Optionally, said plurality of openings extend through a wall of the tubular portion.

[0033] Optionally, said tubular portion comprises a lumen defined by an inner surface of a wall of said tubular portion, and said first filler material does not extend beyond said inner surface into the lumen.

[0034] Optionally, the wall of said tubular portion comprises an outer surface, and said first filler material does not extend beyond the outer surface.

[0035] Optionally, said first filler material completely fills the entire first opening.

[0036] Optionally, the first filler material fills only a portion of the first opening.

[0037] Optionally, said medical device is a guidewire.

[0038] Optionally, said medical device is a delivery wire.

[0039] Optionally, said medical device is an implant.

[0040] Optionally, said medical device is a catheter.

[0041] Other and further aspects and features of the embodiments will become apparent from the following detailed description when considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0042] [Figure 1] FIG. 1 shows a medical device. [Figure 2] 2A-2C show the medical device of FIG. 1, particularly showing the tubular portion of the medical device having a plurality of openings in the form of slots. [Figure 3] FIG. 3 shows the medical device of FIG. 2B, showing the filler material within the slots in the tubular portion of the medical device. [Figure 4] FIG. 4 shows a cross section of the medical device of FIG. 3, showing the filler material in the slot in a neutral state. [Figure 5] FIG. 5 shows a cross-sectional view of the medical device of FIG. 3, illustrating the tension and compression of the filler material within the slots. [Figure 6] FIG. 6 shows a cross-sectional view of the medical device of FIG. 3, illustrating the filler material in tension and compression within the slots. DETAILED DESCRIPTION OF THE INVENTION

[0043] Various embodiments will now be described with reference to the drawings. It should be noted that the drawings are not drawn to scale, and that elements of similar structure or function are represented by the same reference numerals throughout the drawings. It should also be noted that the drawings are intended only to facilitate the description of the embodiments. They are not intended to be an exhaustive description of the invention or to limit the scope of the invention. Furthermore, the illustrated embodiment need not have all of the illustrated aspects or advantages. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not so illustrated or explicitly described.

[0044] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0045] In this specification, all numerical values, whether explicitly stated or not, are assumed to be modified by the word "about." The word "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., have the same function or result). In many cases, the word "about" may include numerical values ​​rounded to the nearest significant figure. In some cases, the word "about" may refer to a range of values ​​within ±10% of the value. For example, a value of 2 or a value about 2 may refer to any value within the range of 2 ±10% (= 2 ± 0.2 = 1.8 to 2.2).

[0046] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0047] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is used broadly to include "and / or" unless the content clearly dictates otherwise.

[0048] 1 illustrates a medical device 10 according to some embodiments. The medical device 10 is configured for insertion into a blood vessel 12. The medical device 10 may be any of a catheter, a guidewire, a delivery wire (e.g., a pushwire), an implant (e.g., a coil), a combination thereof, or any other type of elongated member for medical applications such as the treatment and / or diagnosis of a medical condition.

[0049] The medical device 10 includes an elongate member 11 having a proximal end 15, a distal end 16, and a body 13 extending between the proximal end 15 and the distal end 16. The elongate member 11 has a tubular portion 14 at the distal end 16 of the elongate member 11. The tubular portion 14 is configured to enhance flexibility at the distal end 16 of the elongate member 11. The tubular portion 14 can be any elongate device or component having an internal lumen, which can be formed from any material, such as any suitable biocompatible metal, polymer, or combination thereof. In some embodiments, the tubular portion 14 can be a slotted hypotube. In some embodiments, the tubular portion 14 can have a circular cross-section. In other embodiments, the tubular portion 14 of the elongate member 11 can have any cross-sectional shape, such as an oval, or any custom-designed shape. Additionally, in some embodiments, the tubular portion 14 can have different cross-sectional shapes and / or dimensions along the longitudinal axis of the elongate member 11.

[0050] 2A-2C show a portion of the tubular portion 14. FIGS. 2A and 2B are side and perspective views, respectively. FIG. 2C is an axial cross-sectional view taken along line AA in FIG. 2A. As shown in FIGS. 2A and 2B, the tubular portion 14 has a plurality of openings 20 extending within the wall of the tubular portion 14. In the illustrated example, the openings 20 are elongated slots 20 extending circumferentially around the longitudinal axis of the tubular portion 14. The tubular portion 14 has sets 26 of slots 20 at respective longitudinal positions along the longitudinal axis of the tubular portion 14 of the elongated member 11. As a result of the segmentation by the slots 20, the tubular portion 14 has a stack 22 of a plurality of annular segments (e.g., rings) connected by a plurality of beams 24. The annular segments 22 are connected in series by corresponding groups (e.g., pairs) 28 of beams 24.

[0051] As shown in FIG. 2C , the beams 24 in each group 28 are arranged in the same plane perpendicular to the longitudinal axis of the tubular portion 14. In the illustrated embodiment, each group 28 has two beams 24 arranged on opposite sides of the tubular portion 14. In other embodiments, each group 28 may have three or more beams 24, or only one beam 24. The beams 24 in each group 28 may be circumferentially spaced an equal distance apart. As shown, each beam 24 in a pair 28 has a flat wall 25 at each end of the beam 24. In some embodiments, the walls 25 of the beams 24 in a pair 28 may be formed with two cuts.

[0052] In some embodiments, the openings (e.g., slots) 20 can be formed in the tubular portion 14 by sawing with a circular blade, micro-machining, laser cutting, electrical discharge machining, plasma arc cutting, grinding, milling, casting, molding, chemical etching, or other known suitable methods. In other embodiments, the tubular portion having the openings 20 can be manufactured using "additive" manufacturing (e.g., 3D printing) rather than the various "subtractive" techniques described.

[0053] In some embodiments, the openings (e.g., slots) 20 extend entirely through the wall of the tubular portion 14. In particular, the openings 20 penetrate radially through the entire thickness of the wall of the tubular portion 14. In this case, the openings 20 formed in the tubular portion 14 have a circular cross-section perpendicular to its longitudinal axis, and are arc-shaped when viewed axially (as shown in FIG. 2C). In other embodiments, the openings 20 do not penetrate the entire thickness of the tubular portion 14, i.e., the openings 20 do not completely penetrate the wall of the tubular portion 14. Instead, the openings 20 partially penetrate the wall of the tubular portion 14. The tubular portion 14 can have a wall thickness of 0.0025 cm to 0.025 cm, or 0.0025 cm to 0.015 cm, or 0.005 cm to 0.01 cm. In other embodiments, the tubular portion 14 can have a wall thickness greater than 0.025 cm or less than 0.0025 cm.

[0054] The openings (e.g., slots) 20 are advantageous because they increase the flexibility of the tubular portion 14 of the elongate member 11, while the beams 24 and annular segments 22 provide suitable torque transmission characteristics. The openings 20 are formed such that the annular segments 22 are interconnected by one or more beams 24. Such an interconnected structure provides relatively high torsional stiffness while retaining a desired level of lateral bending flexibility.

[0055] It should be noted that the tubular portion 14 of the elongate member 11 is not limited to having the configurations and features described in the examples above, and the tubular portion 14 may have other configurations and features in other embodiments. For example, in other embodiments, the tubular portion 14 of the elongate member 11 may have different arrangements and configurations of the openings 20, annular segments 22, and beams 24. In some embodiments, at least some or all of the beams 24 are arranged so that their respective major axes form the same or a similar angle (e.g., 0 degrees ± 10 degrees) with the major axis of the tubular portion 14 (as shown in FIG. 2A ). In other embodiments, the beams 24 are arranged so that their respective major axes form a different angle with the major axis of the tubular portion 14. It should be understood that the distribution and / or configuration of the openings 20, annular segments 22, and beams 24 may have any suitable variations and combinations thereof.

[0056] Furthermore, the openings (e.g., slots) 20 may be arranged in any manner along the length or circumference of the tubular portion 14 to achieve desired properties. For example, adjacent openings 20 or groups of openings 20 may be arranged in a symmetrical pattern, such as being essentially equally spaced on each side of the circumference of the tubular portion 14. Alternatively, adjacent openings 20 or groups of openings 20 (in a plane perpendicular to the long axis of the tubular portion 14) may be arranged in an asymmetrical pattern. Furthermore, in some embodiments, the tubular portion 14 may have only one opening (e.g., slot) 20 in each plane perpendicular to the long axis of the tubular portion 14. The openings 20 may extend circumferentially around the long axis of the tubular portion 14 at least 45 degrees, at least 90 degrees, at least 135 degrees, at least 180 degrees, etc. Furthermore, adjacent openings 20 or groups of openings 20 may be equally spaced along the length of the tubular portion 14. Adjacent openings 20 or groups of openings 20 may be arranged in patterns of increasing or decreasing density and / or may be arranged in asymmetric or irregular patterns. Other characteristics, such as opening size, opening shape, and / or opening angle relative to the longitudinal axis of the tubular portion 14, may also be varied along the length of the tubular portion 14 to vary any one or any combination of bending flexibility / stiffness, torsional stiffness, axial stiffness, other structural properties of the tubular portion 14. In further embodiments, if the openings 20 are in the form of slots, rather than extending circumferentially in a direction perpendicular to the longitudinal axis of the tubular portion 14, the slots may extend circumferentially in an oblique direction (e.g., forming an angle other than 90 degrees) relative to the longitudinal axis of the tubular portion 14. In some embodiments, the openings 20 are implemented in a dispersed manner between the ends of the tubular portion 14. In other embodiments, it is contemplated that only a portion of the annular portion 14 may have openings 20, while other portions of the annular portion 14 may be devoid of such openings 20.

[0057] In one or more embodiments described herein, the elongate member 11 also includes a filler material disposed within each of the openings (e.g., slots) 20. FIG. 3 illustrates the tubular portion 14 of the elongate member 11, particularly the tubular portion 14 having a filler material 50 within each of the openings 20. In the illustrated embodiment, each filler material 50 comprises a sponge-like material. Using a sponge-like material to implement the filler material 50 is advantageous because it facilitates mechanical bending of the elongate member 11. The sponge-like material also effectively reduces the hardness of the bulk material, thereby achieving flexibility beyond the material's bulk properties and allowing for more robust materials to be used for manufacturing and processing purposes. The sponge-like material can be any porous material (e.g., a microporous material) that is compressible, stretchable, or both. In one embodiment, the sponge-like material can be a foam material. In some embodiments, the sponge-like material can be achieved by laser drilling or cutting a polymer to create a sponge-like structure with openings. The holes in the sponge-like structure do not need to be sealed if they are small enough so that the viscosity of blood can cooperate with the holes to create an effective seal. In some embodiments, the filler material 50 can be made from a polymeric material such as polyurethane, cellulose acetate, mixed ester cellulose, PTFE / polyester, acrylic copolymer, other biocompatible polymers, or any combination thereof. The pore size of the filler material 50 can be configured to prevent viscous fluids, such as blood, outside the tubular portion 14 from entering and passing through the filler material 50. If the tubular member 14 is configured to deliver a substance, the pore size of the filler material 50 can also prevent substances from within the tubular portion 14 from entering and passing through the filler material 50.

[0058] In some embodiments, the tubular portion 24 of the elongate member 11 has filler material 50 in all of the respective openings 20 of the tubular portion 24. In other embodiments, the filler material 50 may be disposed in only selective openings 20 in the tubular portion 14 (i.e., not all openings 20 of the tubular portion 14).

[0059] FIG. 4 shows a cross-sectional view of the annular portion 14 taken along line BB in FIG. 3 . As shown, fillers 50 are respectively disposed within openings (e.g., slots) 20. When placed within the openings 20, each filler 50 is biased against two opposing surfaces 51 that define the openings 20. In the illustrated embodiment, each filler 50 is firmly secured to the two opposing surfaces that define the openings 20. This securing may be achieved using adhesives, glue, friction, or the like. In some embodiments, each filler 50 completely fills the corresponding opening 20. In other embodiments, each filler 50 fills only a portion of the opening 20.

[0060] As shown in FIG. 4 , the filler material 50 does not extend beyond the boundaries of each opening 20. In particular, the tubular portion 14 includes a lumen 60 defined by an inner surface 62 of a wall 64 of the tubular portion 14, and the filler material 50 does not extend beyond this inner surface 62 into the lumen 60. The wall 64 of the tubular portion 14 also includes an outer surface 66, and the filler material 50 does not extend beyond this outer surface 66. Thus, the filler material 50 remains between the outer surface 66 and the inner surface. This configuration is advantageous because it prevents fluids outside the tubular portion 14 from entering the lumen 60 through the openings 20, or vice versa, without the need to place a layer of sealing material on the outer surface 66 or the inner surface 62. Because the tubular portion 14 is free of an outer jacket, coating, or liner, the lumen of the tubular portion 14 can have a relatively large cross-sectional dimension (e.g., diameter) to achieve a given cross-sectional dimension of the tubular portion 14. Additionally, because the inner surface 62 of the tubular portion 14 does not have a coating, liner, etc., the lumen 60 of the tubular portion 14 can have a relatively large cross-sectional dimension (e.g., diameter). Having a larger lumen 60 for the tubular portion 14 of the elongate member 11 is advantageous because it allows for a larger volume or amount of material to be transported through the lumen 60. For example, in a neurovascular aspiration catheter, a larger diameter lumen 60 is beneficial for aspirating thrombus within the vasculature than if the catheter had an outer jacket, coating, or liner on the outer surface 66 or inner surface 62.

[0061] In some embodiments, the filler material 50 may be flush with the inner surface 62 of the tubular portion 14 and / or the outer surface 66 of the tubular portion 14. In other embodiments, the filler material 50 may be recessed relative to the inner surface 62 and / or the outer surface 66 of the tubular portion 14.

[0062] In some embodiments, the filler material 50 disposed within the opening 20 is compressible and stretchable. In some cases, the filler material 50 is considered "compressible" if it decreases in volume under compression. As shown in FIG. 4 , when the tubular portion 14 is in a straight configuration, the filler materials 50 are in a neutral configuration (e.g., they are neither stretched nor compressed). As shown in FIGS. 5 and 6 , when the tubular portion 14 is bent, the filler material 50 on one side of the tubular portion 14 is stretched because that side of the tubular portion 14 is in tension, and the filler material 50 on the opposite side of the tubular portion 14 is compressed because that side of the tubular portion 14 is in compression. In particular, when the tubular portion 14 is bent, the tubular portion 14 has a stretched side 17 and a compressed side 18, as shown in FIGS. 5 and 6 . The filler material 50 on the stretched side 17 of the tubular portion 14 is stretched corresponding to the increase in the distance between adjacent annular segments 22 on the stretched side 17 due to the bending of the tubular portion 14. At the same time, the filler material 50 on the compression side 18 of the tubular portion 14 is compressed corresponding to the decrease in the distance between adjacent annular segments 22 on the compression side 18 .

[0063] In some embodiments, each filler material 50 on the tension side 17 is expandable by an amount that allows the filler material 50 to remain secured to opposite sides of the opening 20 when bending of the tubular portion 14 causes the two opposing sides (or faces 51) to move away from each other. Also, each filler material 50 on the compression side 18 is compressible by an amount that allows the filler material 50 to remain within the opening 20 (e.g., without being pushed out of the opening 20) when bending of the tubular portion 14 causes the opposite sides (or faces 51) of the opening 20 to move toward each other.

[0064] In some embodiments, each filler material 50 has an uncompressed (neutral) volume and is compressible to a compressed volume of less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, or less than 5% of its neutral volume. Also, in some embodiments, each filler material 50 has an unstretched (neutral) volume and is stretchable to a stretched volume of at least 105%, at least 110%, at least 120%, at least 130%, at least 140%, or at least 150% of its neutral volume. In other embodiments, each filler material 50 is compressible and / or stretchable to a strain (compressive or stretching) of at least 0.1, at least 0.2, at least 0.3, at least 0.4, or at least 0.5, where strain is defined as the change in length of the filler material 50 divided by its original length (e.g., strain = changed length / original length).

[0065] Note that the filler material 50 advantageously blocks the openings 20, preventing fluid movement across the wall of the tubular portion 14, while also making the tubular portion 14 more flexible (compared to solutions in which a jacket or coating is applied to cover the openings 20). As a result, the tubular portion 14 can navigate relatively tight bends without damaging or permanently deforming the tubular portion 14. As shown in FIG. 5, the tubular portion 14 can bend to form a first curvature as the tubular portion 14 is advanced through a blood vessel having a first bend. As shown in FIG. 6, as the tubular portion 14 navigates through a blood vessel through a tighter or sharper bend, the tubular portion 14 can further bend to form a second curvature that is greater than the first curvature. Regardless of the curvature formed by the tubular portion 14, the filler material 50 on both the tension side 17 and the compression side 18 remains within the openings (e.g., slots) 20, allowing the annular segments 22 to remain aligned with one another. As a result, annular segments (e.g., rings) are prevented from overlapping with adjacent annular segments (e.g., rings) and / or any annular segment is prevented from moving into lumen 60 of tubular portion 14.

[0066] Additionally, using a compressible material to implement the filler 50 has advantages over using an incompressible material (i.e., a material that displaces without undergoing a volumetric change in response to compression). This is because the opening of the slotted tube filled with an incompressible material can make the tube unnecessarily stiff or result in undesirable bending characteristics. In some cases, this can be compensated for by cutting out more material from the tube. However, such techniques can adversely affect other desirable properties, such as hoop strength and torque transmission capability.

[0067] Various techniques can be employed to position and secure the filler material 50 in each opening 20. In some embodiments, the filler material 50 can be placed within the slots 20 of the tubular portion 14 by spraying or dipping the tubular portion 14 in a suitable polymer solution, causing the solution to fill the slots. Once the solution dries or hardens, it becomes the filler material 50 within the slots 20. Excess solution (wet or dry) can be removed from the tubular portion 14. In other embodiments, the filler materials 50 can be formed separately and then inserted into the slots 20 individually and secured to their respective slots 20.

[0068] As mentioned above, the elongate member 11 having the tubular portion 14 is not limited to the described examples. For example, in other embodiments, instead of the tubular portion 14 being configured as part of a delivery tube (e.g., a catheter), the tubular portion 14 may be any implant, such as a coil. In such cases, the opening 20 may be the space between adjacent loops of the coil. The coil may abut against a push wire or delivery wire or may be removably coupled to the push wire or delivery wire. The coil may be configured (e.g., sized and / or shaped) to be placed within a blood vessel and utilized to treat conditions within the vasculature. For example, the coil may be used to occlude aneurysm cavities. In some embodiments, the filler material 50 is configured to be placed within the space between adjacent loops of the coil. The filler material 50 keeps the coil loops aligned as the coil bends, allowing the coil to pass through sharp bends. Because the coil loops do not move laterally relative to each other during bending, the outer surface of the coil remains substantially flat. An exemplary coil for medical use is disclosed and described in US patent application Ser. No. 16 / 676,338, the entire disclosure of which is incorporated herein by reference.

[0069] Also, as described in some embodiments, the filler material 50 does not extend beyond the boundaries of the respective openings 20. However, in other embodiments, the filler material 50 may extend beyond the boundaries of the openings 20. For example, in other embodiments, the filler material 50 may extend beyond the inner surface of the wall of the tubular portion 14 into the lumen 60 and / or beyond the outer surface of the wall of the tubular portion 14. In some embodiments, the portion of the filler material 50 that extends beyond the boundaries of the openings 20 may be a ridge, a strip, a block, or have a random shape (e.g., in some cases, the portion of the filler material 50 that extends beyond the boundaries of the openings 20 may be a manufacturing artifact). In further embodiments, the portion of the filler material 50 that extends beyond the inner surface of the tubular portion 14 may extend into an inner layer disposed on the inner surface of the tubular portion 14, and the portion of the filler material 50 may be separately attached to the inner layer or may be integrally formed with the inner layer. In further embodiments, the portion of filler material 50 that extends beyond the outer surface of tubular portion 14 can extend to an outer layer disposed on the outer surface of tubular portion 14, and this portion of filler material 50 can be separately attached to or integrally formed with the outer layer. In other embodiments, filler material 50 can have a first portion that extends beyond the outer surface of tubular portion 14 and a second portion that extends beyond the inner surface of tubular portion 14. In such cases, the first portion of filler material 50 can be separately attached to an outer layer disposed on the outer surface of tubular portion 14, and the second portion of filler material 50 can be separately attached to an inner layer disposed on the inner surface of tubular portion 14.

[0070] Additionally, in some embodiments, any of the filler materials 50 described herein can be made from a closed-cell material. In some applications, it may be desirable to use a closed-cell material for the filler material 50. For example, a catheter may be required to have a certain pressure resistance to withstand suction pressure (negative pressure) and / or infusion pressure (positive pressure). Closed-cell materials are advantageous for implementing the filler material 50 because they do not create a fluid leakage path under pressure differentials. In other embodiments, the filler material 50 may be made from an open-cell material (e.g., open-cell foam). In such cases, if fluid leakage prevention is desired, an inner liner and / or an outer liner (jacket) can be added to the tubular structure along with the filler material 50. The inner liner can be a polymer inner liner in some embodiments. Also, in some embodiments, the outer liner (jacket) can be made from a polymer. Alternatively or additionally, the open-cell material has a small amount of open cells (e.g., cells or cavities within the material) so that the cells (e.g., cavities) do not connect to form paths through the thickness of the filler material. In some embodiments, gassing and / or degassing processes may be performed during manufacturing to affect how open the cell structure of the open-cell material is, thereby achieving a degree of celling and / or cell collapse. In other embodiments, mechanical processes such as laser cutting may be used to create the open cell structure.

[0071] Additionally, in embodiments in which the device 10 is a catheter, the elongate member 11 may be implemented using a tube (e.g., a hypotube) having a cut pattern. In some embodiments, such a cut pattern may be a laser cut pattern. Also, in some embodiments, the tube having a cut pattern may provide one or more mechanical requirements (e.g., axial stiffness, hoop strength, bending stiffness, bend radius, torsional stiffness, etc., or any combination thereof) without relying on the mechanical properties of the filler material 50. In some embodiments, the filler material 50 may be made from a material having an elastic modulus that is less than 10%, or less than 5%, or less than 1%, or less than 0.1%, or less than 0.05%, or less than 0.01%, or less than 0.001% of the elastic modulus of the material of the tube (implementing the elongate member 11). This allows the filler material 50 to be significantly more compressible than the material of the tube.

[0072] Implementing the filler material 50 using a compressible material is advantageous because it prevents the filler material 50 from interfering with the mechanical properties of the tube. In some cases, when designing a catheter, it may be desirable to provide high stiffness in the proximal section of the catheter. This can be achieved by using tubing without slots in the proximal section. However, such a design may not meet the bend radius requirements. Therefore, it may be desirable to add several slots to enable the proximal section of the tubing to achieve the desired stiffness and bend radius requirements. In such a design, using an incompressible filler material to fill the slots may adversely affect the bending stiffness of a catheter formed with this tubing, as the incompressible filler material may increase the bending stiffness of the catheter. To compensate, wider slots can be implemented in the tubing, but widening the slots may decrease the stiffness of the proximal section of the tubing and increase manufacturing costs. Using a compressible filler material 50 advantageously avoids the need to use a "wider slot" solution while still achieving the desired stiffness and bend radius in the proximal section of the tubing (using the filler material 50).

[0073] Additionally, in some cases, when designing a catheter, it may be desirable to reduce the stiffness of the distal section of the catheter (relative to the proximal section) so that it can be easily bent. This can be achieved by using tubing made from soft polymers. However, such designs may not meet buckling resistance requirements and may result in low hoop strength in the distal section of the tubing. Therefore, it may be desirable to implement the distal section of the tubing using rigid hoop elements, such as metal rings / coils, metal braids, or metal sections cut from metal tubing (to achieve the desired hoop strength). These hoop elements may be spaced far enough apart to allow the distal section of the tubing to bend at a tight bend radius (e.g., to achieve a 90-degree bend, a 180-degree bend, or a 360-degree bend). In such designs, the tubing wall can be thickened to meet column strength and tensile property requirements. However, thicker tubing walls can increase bending stiffness, negatively impacting bend radius requirements, increasing the overall device size, and / or reducing the catheter lumen size. Additionally, in such designs, using an incompressible filler material to fill the slots can adversely affect the bending stiffness and bend radius of the catheter, as the incompressible filler material can increase the bending stiffness of the catheter and make it more resistant to bending. Advantageously, using a compressible filler material 50 can achieve the desired bending stiffness, column strength, and bend radius of the tubing (using the filler material 50) while eliminating the need to thicken the tubing wall.

[0074] Additionally, in some embodiments, the width of the opening (e.g., slot) in elongate member 11 for receiving filler material 50 may be anywhere from 0.0013 cm to 0.05 cm, or anywhere from 0.0038 cm to 0.038 cm, or anywhere from 0.0025 cm to 0.025 cm. Also, in some embodiments, the width of the opening (e.g., slot) at the distal end of elongate member 11 may be different (e.g., smaller) than the width of the opening proximal to the distal end. For example, in some embodiments, the width of the opening that accommodates the filler material 50 may be between 0.005 cm and 0.05 cm, or between 0.005 cm and 0.038 cm, or between 0.007 cm and 0.025 cm, or between 0.01 cm and 0.025 cm at the distal end of the elongate member 11, and at other portions proximal to the distal end of the elongate member 11 (e.g., the proximal end), the width of the opening may be between 0.0013 cm and 0.005 cm, or between 0.005 cm and 0.0038 cm, or between 0.002 cm and 0.003 cm (e.g., 0.0025 cm).

Claims

1. an elongate member having a proximal end, a distal end, and a body extending between the proximal and distal ends; the elongated member has a tubular portion having a plurality of openings extending through a wall thereof, the plurality of openings including a first opening; The medical device, wherein the elongated member further includes a filler material disposed in each of the openings, the filler material including a first filler material, the first filler material including a sponge-like material disposed in the first openings.

2. The medical device of claim 1 , wherein the sponge-like material comprises a foam material.

3. The medical device of claim 1 , wherein the sponge-like material comprises a closed-cell material.

4. The medical device of any one of claims 1 to 3, wherein the plurality of openings extend through the wall of the tubular portion.

5. 5. The medical device of claim 1, wherein the tubular portion comprises a lumen defined by an inner surface of a wall of the tubular portion, and the first filler material does not extend beyond the inner surface into the lumen.

6. The medical device of any one of claims 1 to 5, wherein the wall of the tubular portion comprises an outer surface, and the first filler material does not extend beyond the outer surface.

7. The medical device according to any one of claims 1 to 6, wherein the first filling material completely fills the entire first opening.

8. The medical device according to any one of claims 1 to 6, wherein the first filler material fills only a portion of the first opening.

9. The medical device of any one of claims 1 to 7, wherein the filler material does not extend beyond the boundaries of the opening.

10. The medical device of any one of claims 1 to 9, wherein the medical device is a guidewire, a delivery wire, a catheter, or an implant.

11. The medical device according to any one of claims 1 to 10, wherein the width of one of the openings is less than 0.05 cm.

12. an elongate member having a proximal end, a distal end, and a body extending between the proximal and distal ends; the elongated member has a tubular portion having a plurality of openings extending through a wall thereof, the plurality of openings including a first opening; The medical device, wherein the elongated member further has a filler material disposed in each of the openings, the filler material including a first filler material that does not extend beyond the boundary of the first opening.

13. The medical device of claim 12 , wherein the first filler material comprises a sponge-like material disposed in the first opening.

14. The medical device of claim 13 , wherein the sponge-like material comprises a closed-cell material.

15. The medical device of any one of claims 12 to 14, wherein the plurality of openings extend through the wall of the tubular portion.

16. 16. The medical device of claim 12, wherein the tubular portion comprises a lumen defined by an inner surface of a wall of the tubular portion, and the first filler material does not extend beyond the inner surface into the lumen.

17. The medical device of any one of claims 12 to 16, wherein the wall of the tubular portion comprises an outer surface, and the first filler material does not extend beyond the outer surface.

18. The medical device according to any one of claims 12 to 17, wherein the first filling material completely fills the entire first opening.

19. The medical device according to any one of claims 12 to 17, wherein the first filling material fills only a portion of the first opening.

20. The medical device of any of claims 12 to 19, wherein the medical device is a guidewire, a delivery wire, an implant, or a catheter.

Images