Slotted medical instrument with filler

Abstract

The invention relates to a slotted medical device with filler. A medical device is disclosed, comprising: an elongate member having a proximal end, a distal end, and a body extending between the proximal end and the distal end; wherein the elongate member comprises a tubular section having a plurality of slots extending into a wall of the tubular section, the plurality of slots comprising a first slot; and wherein the elongated member further comprises fillers respectively located in the slots, the fillers comprising a first filler, and wherein the first filler comprises a spongy material located in the first slot.

Description

[0001] This application is a divisional application of an application with an application date of March 10, 2021, application number 202180017253.8, and invention name “Slotted medical device with filler”. Technical Field

[0002] 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 Art

[0003] It is well known that intravascular catheters, push wires, guide wires, coils and other types of elongated delivery members are used to assess and treat various types of diseases, such as vascular defects. For example, suitable intravascular catheters, guide wires or other delivery members can be inserted into the patient's vascular system. Commonly used vascular applications close to the target site in the patient's body involve inserting a guide wire through an incision in the femoral artery near the groin, and advancing the guide wire until the guide wire arrives at the target site. Then, the catheter advances on the guide wire until the open distal end of the catheter is arranged at the target site. While or after the distal end of the catheter is placed at the target site, the intravascular implant is advanced by the catheter via the delivery wire.

[0004] In certain applications, such as neurovascular treatment, guidewires, delivery wires and catheters need to travel in tortuous and complex vascular systems. By using an appropriately sized instrument with necessary performance characteristics (such as "pushability", "steerability", "torqueability" and the most important distal end flexibility), almost any target site in the vascular system can be approached, including target sites in the tortuous brain and peripheral vascular systems. In addition, the force applied to the proximal end of these wires should be transmitted to the distal end to obtain appropriate pushability (axial rigidity) and torsionability (rotation). It is very ideal to achieve a balance between these characteristics, but it is difficult. For example, a guidewire and / or delivery wire may include a variable stiffness section (for example, by changing the proportion of materials in different sections of the wire, including selective reinforcement, such as braiding, coiling, etc.), and the variable stiffness section is suitable for providing sufficient flexibility, anti-kinking, pushability and torsionability to allow travel through the vascular system.

[0005] In some cases, catheter, guide wire or other conveying member can include the groove along its elongated body or its selected part.Slot is incorporated into these elongated medical devices and can modify or customize the flexibility / rigidity of the device.For example, the distal portion of catheter, guide wire or other conveying member can have the groove pattern (for example, more grooves (unit area), longer grooves and / or wider grooves) that increases its flexibility.When used as the part of conveying system, the elongated tubular device of slotting is preferably substantially sealed (for example, using sheath, shield, coating or its analogue), to prevent fluid exchange (entering or leaving) the lumen of tube, and also enhance lubricity.Exemplary slotted and coated medical devices are disclosed in U.S. Patent Nos. 5,095,915, 5,443,455, 6,488,637 and 9,162,040, and the full disclosures of these U.S. Patents are incorporated herein by reference.

[0006] Having a sheath, shield or coating on a slotted, elongated tubular device adds bulk to the device and also increases the outer diameter (OD) of the device, which may negatively impact the overall performance of the device when traversing narrow, curved and tortuous vasculature. Summary of the invention

[0007] A medical device comprises: an elongated member having a proximal end, a distal end and a body extending between the proximal end and the distal end; wherein the elongated member comprises a tubular portion having a plurality of openings extending into a wall of the tubular portion, the plurality of openings comprising a first opening; and wherein the elongated member further comprises fillers respectively located in the openings, the fillers comprising a first filler, wherein the first filler comprises a sponge-like material located in the first opening.

[0008] Optionally, the spongy material comprises a foam material.

[0009] Optionally, the sponge-like material is compressible, stretchable, or both.

[0010] Optionally, the first filler abuts against two opposing surfaces defining the first opening.

[0011] Optionally, the first filler is securely fixed to two opposing surfaces defining the first opening.

[0012] Optionally, a plurality of openings extend through the wall of the tubular section.

[0013] Optionally, the tubular section comprises a cavity defined by an inner surface of a wall of the tubular section, and wherein the first filler does not extend beyond the inner surface into the cavity.

[0014] Optionally, the wall of the tubular section comprises an outer surface, and wherein the first filler does not extend beyond the outer surface.

[0015] Optionally, the first filler completely fills the entire first opening.

[0016] Optionally, the first filler fills only a portion of the first opening.

[0017] Optionally, the filler does not extend beyond the boundaries of the opening.

[0018] Optionally, the sponge-like material comprises laser drilled or laser cut openings.

[0019] Optionally, the spongy material comprises a closed cell material.

[0020] Optionally, the medical device is a guidewire.

[0021] Optionally, the medical device is a delivery wire.

[0022] Optionally, the medical device is an implant.

[0023] Optionally, the medical device is a catheter.

[0024] Optionally, one of the openings has a width of less than 0.051 cm.

[0025] A medical device comprises: an elongated member having a proximal end, a distal end and a body extending between the proximal end and the distal end; wherein the elongated member comprises a tubular portion having a plurality of openings extending into a wall of the tubular portion, the plurality of openings comprising a first opening; and wherein the elongated member further comprises fillers respectively located in the openings, the fillers comprising a first filler, the first filler portion not extending beyond any boundary of the first opening.

[0026] Optionally, the first filler comprises a sponge-like material located in the first opening.

[0027] Optionally, the spongy material comprises a closed cell material.

[0028] Optionally, the spongy material comprises a foam material.

[0029] Optionally, the sponge-like material comprises laser drilled or laser cut openings.

[0030] Optionally, the first filler is made of a compressible, stretchable or both material.

[0031] Optionally, the first filler abuts against two opposing surfaces defining the first opening.

[0032] Optionally, the first filler is securely fixed to two opposing surfaces defining the first opening.

[0033] Optionally, a plurality of openings extend through the wall of the tubular section.

[0034] Optionally, the tubular section comprises a cavity defined by an inner surface of a wall of the tubular section, and wherein the first filler does not extend beyond the inner surface into the cavity.

[0035] Optionally, the wall of the tubular section comprises an outer surface, and wherein the first filler does not extend beyond the outer surface.

[0036] Optionally, the first filler completely fills the entire first opening.

[0037] Optionally, the first filler fills only a portion of the first opening.

[0038] Optionally, the medical device is a guidewire.

[0039] Optionally, the medical device is a delivery wire.

[0040] Optionally, the medical device is an implant.

[0041] Optionally, the medical device is a catheter.

[0042] Additional and other aspects and features of the embodiments will become apparent from the following detailed description based on the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 A medical device is shown;

[0044] Figure 2A-2C Shows Figure 1 A medical device, in particular a tubular section of the medical device having a plurality of openings in the form of slots;

[0045] Figure 3 Shows Figure 2B A medical device showing a filling within a groove of a tubular portion of the medical device;

[0046] Figure 4 Shows Figure 3 A cross-sectional view of a medical device showing a filler within a slot in a neutral configuration;

[0047] Figure 5 and Figure 6 Shows Figure 3 Cross-sectional view of a medical device showing the filler within the groove in tension and compression configurations. DETAILED DESCRIPTION

[0048] Various embodiments are described below with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and in all drawings, elements of similar structure or function are represented by the same reference numerals. It should also be noted that these drawings are intended only to facilitate the description of the embodiments. They are not intended to be a comprehensive and exhaustive description of the present invention or to limit the scope of the present invention. In addition, the illustrated embodiments do not necessarily have all aspects or advantages shown. The aspects or advantages described in conjunction with a specific embodiment are not necessarily limited to that embodiment, and may also be practiced in any other embodiment, even if not illustrated as such, or if not so explicitly described.

[0049] For the following defined terms, these definitions shall prevail, unless a different definition is given in the claims or elsewhere in this specification.

[0050] Whether explicitly stated or not, all numerical values ​​are assumed herein to be modified by the term "about". The term "about" generally refers to a numerical range that a person skilled in the art would consider to be equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. In some cases, the term "about" may refer to a value within the range of + / -10% of a value. For example, a value of 2 or about 2 may refer to any value within the range of 2+ / -10% (=2+ / -0.2=1.8 to 2.2).

[0051] 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).

[0052] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0053] Figure 1 A medical device 10 is depicted according to some embodiments. The medical device 10 is configured for insertion into a blood vessel 12. The medical device 10 may be a catheter, a guidewire, a delivery wire (e.g., a pushwire), an implant (e.g., a coil), a combination of the foregoing, or any other type of elongated member for medical use, such as for treatment and / or for diagnosis of disease.

[0054] The medical device 10 includes an elongated 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 elongated member 11 includes a tubular section 14 at the distal end 16 of the elongated member 11. The tubular section 14 is configured to increase the flexibility of the distal end 16 of the elongated member 11. The tubular section 14 can be any elongated instrument or component with a cavity, which can be formed by any material, for example, any suitable biocompatible metal, polymer or combination thereof. In some embodiments, the tubular section 14 can be a slotted hypotube. In some embodiments, the tubular section 14 can have a circular cross-section. In other embodiments, the tubular section 14 of the elongated member 11 can have any cross-sectional shape, such as an elliptical or any custom designed shape. In addition, in some embodiments, the tubular section 14 can have different cross-sectional shapes and / or cross-sectional sizes along the longitudinal axis of the elongated member 11.

[0055] Figure 2A-2C A portion of the tubular section 14 is depicted. Figure 2A and Figure 2B They are side view and perspective view respectively. Figure 2C It is along Figure 2A Axial cross-section of the line marked AA in FIG. Figure 2A and Figure 2B , the tubular section 14 includes a plurality of openings 20 extending into the wall of the tubular section 14. In the example shown, the openings 20 are elongated slots 20 extending circumferentially around the longitudinal axis of the tubular section 14. The tubular section 14 has a set 26 of slots 20 at respective longitudinal positions along the longitudinal axis of the tubular section 14 of the elongated member 11. As a result of being segmented by the slots 20, the tubular section 14 has a stack of annular segments (e.g., rings) 22 connected by a plurality of beams 24. The annular segments 22 are sequentially connected by respective sets (e.g., pairs) 28 of beams 24.

[0056] like Figure 2C As shown in the figure, the beams 24 in each group 28 are arranged in the same plane perpendicular to the longitudinal axis of the tubular section 14. In the embodiment shown, each group 28 has two beams 24 arranged on opposite sides of the tubular section 14. In other embodiments, each group 28 can have more than two beams 24, or only a single beam 24. The beams 24 in each group 28 can be spaced an equal distance from each other in the circumferential direction. As shown, each beam 24 in the pair 28 has a flat wall 25 at the opposite end of the beam 24. In some embodiments, the wall 25 of the beam 24 in the pair 28 can be formed with two cutouts.

[0057] In some embodiments, the opening (e.g., slot) 20 may be formed in the tubular section 14 by sawing the tubular section 14 with a circular blade, micromachining, laser machining, electrical discharge machining, plasma arc cutting, grinding, milling, casting, molding, chemical etching, or other known suitable methods, etc. In other embodiments, the tubular section having the opening 20 may be manufactured using "additive" manufacturing (e.g., 3D printing) rather than the various "subtractive" techniques described.

[0058] In some embodiments, the opening (e.g., slot) 20 extends through the wall of the tubular section 14. In particular, the opening 20 radially penetrates the entire thickness of the wall of the tubular section 14. In this case, when viewed from the axial direction, the opening 20 formed in the tubular section 14 (the circular cross-section of the opening 20 is perpendicular to the longitudinal axis of the tubular section) will be arc-shaped (e.g., Figure 2C 15 ). In other embodiments, the opening 20 does not penetrate the entire thickness of the tubular section 14, that is, the opening 20 does not completely penetrate the wall of the tubular section 14. Alternatively, the opening 20 only partially penetrates into the wall of the tubular section 14. The tubular section 14 may have a wall thickness that is any wall thickness between 0.0025 cm and 0.025 cm, or any wall thickness between 0.0025 cm and 0.015 cm, or any wall thickness between 0.005 cm and 0.01 cm. In other embodiments, the tubular section 14 may have a wall thickness that is greater than 0.025 cm or less than 0.0025 cm.

[0059] The openings (e.g., slots) 20 are advantageous because they enhance the flexibility of the tubular section 14 of the elongated member 11, while the beams 24 and ring segments 22 provide suitable torque transmission characteristics. The openings 20 are formed such that the ring segments 22 are interconnected by one or more beams 24. This interconnected structure provides a relatively high level of torsional stiffness while maintaining a desired level of lateral bending flexibility.

[0060] It should be noted that the tubular section 14 of the elongated member 11 is not limited to having the configurations and features described in the above examples, and in other embodiments, the tubular section 14 may have other configurations and features. For example, in other embodiments, the tubular section 14 of the elongated member 11 may have different arrangements and configurations of the openings 20, the annular segments 22, and the beams 24. In some embodiments, at least some or all of the beams 24 are arranged so that their respective longitudinal axes form the same angle or a similar angle (e.g., 0 degrees + / - 10 degrees) with the longitudinal axis of the tubular section 14 (similar to Figure 2A ). In other embodiments, the beams 24 are arranged so that their respective longitudinal axes form different angles with the longitudinal axis of the tubular section 14. It should be appreciated that the distribution and / or configuration of the openings 20, the annular segments 22, and the beams 24 may have any suitable variations and combinations thereof.

[0061] In addition, the openings (e.g., grooves) 20 can be arranged in any manner along the length of the tubular section 14 or around the circumference of the tubular section 14 to achieve the desired properties. For example, adjacent openings 20 or groups of openings 20 can be arranged in a symmetrical pattern, such as being substantially equally arranged on opposite sides of the circumference around the tubular section 14. Alternatively, adjacent openings 20 or groups of openings 20 (in a plane perpendicular to the longitudinal axis of the tubular section 14) can be arranged in an asymmetrical pattern. In addition, in some embodiments, the tubular section 14 can have only one opening (e.g., groove) 20 at each plane perpendicular to the longitudinal axis of the tubular section 14. The openings 20 can extend circumferentially around the longitudinal axis of the tubular section 14 by at least 45 degrees, at least 90 degrees, at least 135 degrees, at least 180 degrees, etc. In addition, adjacent openings 20 or groups of openings 20 can be equally spaced along the length of the tubular section 14. Alternatively, adjacent openings 20 or groups of openings 20 may be arranged in a pattern of increasing or decreasing density, and / or may be arranged in an asymmetric or irregular pattern. Other characteristics (e.g., opening size, opening shape, and / or opening angle relative to the longitudinal axis of the tubular section 14) may also vary along the length of the tubular section 14 to change bending flexibility / rigidity, torsional rigidity, axial rigidity, any other structural characteristics of the tubular section 14, or any combination thereof. In other embodiments, if the opening 20 is in the form of a slot, the slot may extend circumferentially in a direction that is tilted (e.g., forming a non-90 degree angle) relative to the longitudinal axis of the tubular section 14, rather than extending circumferentially in a direction perpendicular to the longitudinal axis of the tubular section 14. In some embodiments, the openings 20 are implemented between the ends of the tubular section 14 in a distributed manner. In other embodiments, it is conceivable that only a portion (some portions) of the tubular section 14 includes an opening 20, and other portions of the tubular section 14 may not include any such openings 20.

[0062] In one or more embodiments described herein, the elongated member 11 further includes fillers respectively positioned in the openings (eg, slots) 20 . Figure 3The tubular section 14 of the elongated member 11 is depicted, and in particular, the tubular section 14 having a filler 50 in each opening 20 is shown. In the illustrated embodiment, each filler 50 comprises a spongy material. It is advantageous to implement the filler 50 using a spongy material because it facilitates the mechanical bending of the elongated member 11. In addition, the spongy material can effectively reduce the hardness of bulk materials, thereby making softness exceed the bulk characteristics of the material, or making it possible for a more solid material to be used for manufacturing or processing purposes. The spongy material can be any porous material (e.g., microporous material) that is compressible, stretchable, or both. In one embodiment, the spongy material can be a foam material. In addition, in some cases, the spongy material can be realized by laser drilling or cutting polymers to produce a similar spongy structure with an opening. If the hole in the spongy structure is small enough so that the blood viscosity can produce an effective seal in conjunction with the hole, then the hole in the spongy structure does not need to be sealed. In some embodiments, filler 50 may be made of a polymer material such as polyurethane, cellulose acetate, mixed ester cellulose, PTFE / polyester, acrylic copolymer, any other biocompatible polymer, or any combination thereof. The pore size of filler 50 may be configured to prevent viscous fluids (such as blood) outside of tubular section 14 from entering and passing through filler 50. If tubular section 14 is configured to transport a substance, the pore size of filler 50 may also prevent the substance from entering and passing through filler 50 from inside tubular section 14.

[0063] In some embodiments, the tubular section 24 of the elongated member 11 has filler 50 in all corresponding openings 20 of the tubular section 24. In other embodiments, the filler 50 may be disposed only in selective openings 20 of the tubular section 14 (ie, not all openings 20).

[0064] Figure 4 The diagram shows the flow of the tubular section 14. Figure 3 20. As shown in the figure, the fillers 50 are respectively arranged in the openings (e.g., grooves) 20. When accommodated in the openings 20, each filler 50 abuts against two opposing surfaces 51 defining the openings 20. In the illustrated embodiment, each filler 50 is firmly fixed to the two opposing surfaces 51 defining the openings 20. The fixation can be achieved using an adhesive, glue, friction, etc. In some embodiments, each filler 50 completely fills the entirety of the corresponding opening 20. In other embodiments, each filler 50 only fills a portion of the opening 20.

[0065] like Figure 4, the filler 50 does not extend beyond the boundaries of each opening 20. In particular, the tubular section 14 includes a cavity 60 defined by an inner surface 62 of a wall 64 of the tubular section 14, and the filler 50 does not extend beyond the inner surface 62 into the cavity 60. In addition, the wall 64 of the tubular section 14 includes an outer surface 66, and the filler 50 does not extend beyond the outer surface 66. Therefore, the filler 50 is retained between the outer surface 66 and the inner surface 62 of the tubular section 14. This configuration is advantageous because it prevents fluids outside the tubular section 14 from entering the cavity 60 through the opening 20, and vice versa, without requiring a layer of sealing material to be provided on the outer surface 66 or the inner surface 62. Since the tubular section 14 does not have any outer shield, coating, lining or the like, the cavity of the tubular section 14 can have a relatively large cross-sectional size (e.g., diameter) for a given cross-sectional size of the tubular section 14 to be achieved. Furthermore, because the inner surface 62 of the tubular section 14 is devoid of any coatings, linings, etc., the lumen 60 of the tubular section 14 can have a relatively large cross-sectional dimension (e.g., diameter). Having a larger lumen 60 of the tubular section 14 of the elongated member 11 is advantageous because it can allow a larger volume or amount of material to be delivered via the lumen 60. For example, a neurovascular aspiration catheter can benefit from a larger diameter of the lumen 60 to aspirate a blood clot in the vasculature compared to a catheter that instead includes an outer shield, coating, or lining at the outer surface 66 or inner surface 62.

[0066] In some embodiments, the filler 50 can be flush with the inner surface 62 of the tubular section 14 and / or the outer surface 66 of the tubular section 14. In other embodiments, the filler 50 can be recessed relative to the inner surface 62 and / or the outer surface 66 of the tubular section 14.

[0067] In some embodiments, filler 50 disposed within opening 20 is compressible and stretchable. In some cases, filler 50 is considered "compressible" if it experiences a decrease in volume under compression. Figure 4 As shown in , when the tubular section 14 is in a straight configuration, the fillers 50 are in a neutral configuration (eg, they are not stretched or compressed). Figure 5 and Figure 6 As shown in , when the tubular section 14 is bent, the filler 50 on one side of the tubular section 14 is stretched because the side of the tubular section 14 is in tension, and the filler 50 on the opposite side of the tubular section 14 is compressed because the side of the tubular section 14 is in compression. In particular, when the tubular section 14 is bent, as shown in Figure 5 and Figure 6As shown, the tubular section 14 has a tension side 17 and a compression side 18. Due to the bending of the tubular section 14, the filler 50 on the tension side 17 of the tubular section 14 is stretched as the distance between adjacent ring segments 22 on the tension side 17 increases. At the same time, the filler 50 on the compression side 18 of the tubular section 14 is compressed as the distance between adjacent ring segments 22 on the compression side 18 decreases.

[0068] In some embodiments, each filler 50 on the tension side 17 may stretch an amount that allows the filler 50 to remain fixed to the two opposite sides of the opening 20 as the two opposite sides (or surfaces 51) of the opening 20 move away from each other due to the bending of the tubular section 14. Each filler 50 on the compression side 18 may also compress an amount that allows the filler 50 to remain within the opening 20 (e.g., the filler 50 is not squeezed out of the opening 20) as the two opposite sides (or surfaces 51) of the opening 20 move toward each other due to the bending of the tubular section 14.

[0069] In some embodiments, each filler 50 has an uncompressed (neutral) volume, and each filler 50 is compressible to achieve a compressed volume of less than 50%, 40%, 30%, 20%, 10% or 5% of the neutral volume. In addition, in some embodiments, each filler 50 has an unstretched (neutral) volume, and each filler 50 is stretchable to achieve a stretched volume greater than 105%, 110%, 120%, 130%, 140% or 150% of the neutral volume. In other embodiments, each filler 50 can be compressible and / or stretchable to achieve a strain (compressive strain or tensile strain) of at least 0.1, at least 0.2, at least 0.3, at least 0.4, at least 0.5, where strain is defined as the change in length of the filler 50 divided by the original length of the filler 50 (e.g., strain = change in length / original length).

[0070] It is noted that the fillers 50 are advantageous because they block the openings 20 to prevent fluid from passing through the wall of the tubular section 14, while also allowing the tubular section 14 to be more flexible (compared to solutions that apply a shield or coating to cover the openings 20). Thus, the tubular section 14 can travel through relatively steep bends without breaking or permanently deforming the tubular section 14. Figure 5 As shown in , when the tubular section 14 moves through a blood vessel having a first bend, the tubular section 14 may bend to form a first curvature. Figure 6As shown in , when the tubular section 14 moves through a blood vessel with a steeper or more acute turn, the tubular section 14 can bend further to form a second curvature greater than the first curvature. Regardless of the curvature formed by the tubular section 14, the filler 50 on both the tension side 17 and the compression side 18 remains within the opening (e.g., groove) 20 and allows the ring segments 22 to remain aligned with each other. Thus, the ring segments (e.g., rings) are prevented from overlapping with adjacent ring segments (e.g., rings), and / or any ring segments are prevented from moving into the lumen 60 of the tubular section 14.

[0071] In addition, using a compressible material to implement the filler 50 is advantageous over using an incompressible material (i.e., a material that displaces in response to compression without undergoing a volume change). This is because the opening of the slotted tube filled with an incompressible material may result in a tube that is stiffer than desired, or may result in a tube with undesirable bending properties. In some cases, this may be compensated by attempting to cut more material from the tube. However, this technique may adversely affect other desired properties, such as hoop strength, torque transmission capabilities, etc.

[0072] Various techniques can be used to place and fix the filler 50 in the corresponding opening 20. In some embodiments, the filler 50 can be placed in the groove 20 of the tubular section 14 by spraying the tubular section 14 with a suitable polymer solution or dipping the tubular section 14 in a suitable polymer solution, thereby allowing the solution to fill the groove. After the solution dries or solidifies, it becomes the filler 50 in the groove 20. Any excess solution (in wet or dry form) can be removed from the tubular section 14. In other embodiments, the filler 50 can be a separately formed component that is separately inserted into the groove 20 and is separately fixed to the corresponding groove 20 after the filler 50 is formed.

[0073] As described, the elongated member 11 with the tubular section 14 is not limited to the described examples. For example, in other embodiments, instead of configuring the tubular section 14 as a part of a delivery tube (e.g., a catheter), the tubular section 14 can be any implant, such as a coil. In this case, the opening 20 can be the interval between adjacent turns of the coil. The coil can be adjacent to a push wire or a delivery wire, or can be detachably connected to a push wire or a delivery wire. The coil can be constructed (e.g., set the size and / or shape) to be placed in a blood vessel, and can be used to treat diseases in the vascular system. For example, the coil can be used to fill an aneurysm cavity. In some embodiments, (one or more) fillers 50 are configured to be arranged in the space between adjacent turns of the coil. (One or more) fillers 50 allow the coil to travel through sharp bends while allowing the turns of the coil to remain aligned when the coil undergoes bending. Since the turns of the coil do not move laterally relative to each other during the coil bending process, the outer surface of the coil remains substantially smooth. Exemplary coils for medical use are disclosed and described in US Patent Application No. 16 / 676,338, the entire disclosure of which is incorporated herein by reference.

[0074] In addition, as described in some embodiments, the filler 50 does not extend beyond the boundaries of the corresponding opening 20. However, in other embodiments, the filler 50 can extend beyond the boundaries of the opening 20. For example, in other embodiments, (one or more) fillers 50 can extend beyond the inner surface of the wall of the tubular section 14 into the cavity 60, and / or can extend beyond the outer surface of the wall of the tubular section 14. In addition, in some embodiments, the portion of the filler 50 that extends beyond the boundary of the opening 20 can be a protrusion, an elongated protrusion, a block, or can have a random shape (for example, in some cases, the portion of the filler 50 that extends beyond the boundary of the opening 20 may be a manufacturing artifact). In other embodiments, the portion of the filler 50 that extends beyond the inner surface of the tubular section 14 can extend to an inner layer disposed on the inner surface of the tubular section 14, wherein the portion of the filler 50 can be separately attached to the inner layer, or can be formed integrally with the inner layer. In other embodiments, the portion of the filler 50 extending beyond the outer surface of the tubular section 14 may extend to an outer layer disposed on the outer surface of the tubular section 14, wherein the portion of the filler 50 may be separately attached to the outer layer, or may be formed integrally with the outer layer. In other embodiments, the filler 50 may have a first portion extending beyond the outer surface of the tubular section 14, and a second portion extending beyond the inner surface of the tubular section 14. In this case, the first portion of the filler 50 may be separately attached to the outer layer disposed on the outer surface of the tubular section 14, and the second portion of the filler 50 may be separately attached to the inner layer disposed on the inner surface of the tubular section 14.

[0075] In addition, in some embodiments, any one of the (one or more) fillers 50 described herein can be made of closed-cell material. In some applications, it may be desirable to use closed-cell material for (one or more) fillers 50. For example, the catheter may need to have a certain pressure resistance, for example, for resisting suction (negative) pressure, and / or for injection (positive) pressure. Closed-cell material is advantageous for implementing (one or more) fillers 50 because it does not allow fluid leakage paths under pressure differentials. In other embodiments, (one or more) fillers 50 can be made of open-cell material (e.g., open-cell foam). In this case, if fluid leakage needs to be prevented, the inner liner and / or outer liner (shield) can be added to the tubular structure together with the filler 50. In some embodiments, the inner liner can be a polymer inner liner. In addition, in some embodiments, the outer liner (shield) can also be made of polymer. Alternatively or additionally, the open-cell material can have a small amount of open pores (e.g., bubbles or cavities in the material) so that the holes (e.g., cavities) are not connected to form a path through the thickness of the filler 50. In some embodiments, a deflation and / or degassing process may be performed during manufacturing to achieve a certain degree of bubbles and / or bubble collapse, which affects the degree of openness of the pore structure of the open-cell material. In other embodiments, the open-cell structure may be manufactured using a mechanical process such as laser cutting.

[0076] In addition, in the embodiment where the instrument 10 is a catheter, the elongated member 11 can be implemented using a tube (e.g., a hypotube) with a cutting pattern. In some embodiments, such a cutting pattern can be a laser cutting pattern. In addition, in some embodiments, the tube with a cutting pattern can provide one or more mechanical requirements (e.g., axial stiffness, hoop strength, bending stiffness, bending radius, torsional stiffness, etc., or any combination of the foregoing) without relying on the mechanical properties of the filler 50. In some embodiments, the filler 50 can be made of a material having an elastic modulus less than 10%, or 5%, or 1%, or 0.1%, or 0.05%, or 0.01%, or 0.001% of the elastic modulus of the material of the tube (implementing the elongated member 11). This allows the filler 50 to have significantly greater compressibility than the material of the tube.

[0077] It is advantageous to implement filler 50 using compressible material because it allows filler 50 not to interfere with the mechanical properties of the tube. In some cases, when designing a catheter, it may be desirable to provide a higher rigidity to the proximal portion of the catheter. This can be achieved using a tube without grooves in the proximal portion. However, such a design may not meet the requirements of the bending radius. Therefore, it may be desirable to add some grooves to allow the proximal portion of the tube to achieve the desired rigidity and bending radius requirements. In such a design, if an incompressible filler is used to fill the groove, the bending rigidity of the catheter formed by the tube may be adversely affected because the incompressible filler may increase the bending rigidity of the catheter. In order to compensate for this, a wider groove can be implemented at the tube, but widening the groove may reduce the rigidity at the proximal portion of the tube, and may also increase manufacturing costs. It is advantageous to use a compressible filler 50 because it can avoid the need to use a "wider groove" solution while still allowing the proximal portion of the tube (with filler 50) to achieve the required rigidity and bending radius.

[0078] In addition, in some cases, when designing catheter, it may be desirable to provide less rigidity to realize easier bending (compared with proximal part) for the distal part of catheter. This can be realized using the pipe made of soft polymer. However, such design may not meet the anti-kink requirement, and the distal part of pipe may have low hoop strength. Therefore, it may be desirable to use rigid hoop element to realize the distal part of pipe, such as metal ring / coil, metal braid or the metal section of the metal pipe from cutting (to realize the hoop strength of expectation). Hoop element can be spaced enough distances to allow the distal part of pipe to bend with steep bending radius (for example, realize 90 degree bending, 180 degree bending or even 360 degree bending). In this design, tube wall can be thickened, to meet column strength and tensile performance requirements. However, thickening tube wall may increase bending rigidity, may negatively affect bending radius requirement, may increase the overall size of instrument, and / or may reduce the cavity size of catheter. Furthermore, in such a design, if an incompressible filler is used to fill the slot, the bending stiffness and bend radius of the conduit may be adversely affected because the incompressible filler may increase the bending stiffness of the conduit, making the conduit more resistant to bending. The use of a compressible filler 50 is advantageous because it may allow the desired bending stiffness, column strength, and bend radius of the tube (with the filler 50) to be achieved while avoiding the need to thicken the tube wall.

[0079] In addition, in some embodiments, the width of the opening (e.g., slot) at the elongated member 11 for accommodating the filler 50 can have any width from 0.0013 cm to 0.05 cm, or any width from 0.0038 cm to 0.038 cm, or any width from 0.0025 cm to 0.025 cm. In addition, in some embodiments, the width of the opening (e.g., slot) at the distal end of the elongated member 11 can be different from (e.g., smaller than) the width of the opening proximal to the distal end. For example, in some embodiments, the width of the opening for accommodating the filler 50 at the distal end of the elongated member 11 can be any width from 0.005 cm to 0.05 cm, or any width from 0.005 cm to 0.038 cm, or any width from 0.007 cm to 0.025 cm, or any width from 0.01 cm to 0.025 cm, and the opening at another part of the elongated member 11 (e.g., the proximal end) (which is located proximal to the distal end of the elongated member 11) can be any width from 0.0013 cm to 0.005 cm, or any width from 0.005 cm to 0.0038 cm, or any width from 0.002 cm to 0.003 cm (e.g., 0.0025 cm).

Claims

1. A medical device comprising: an elongated member having a proximal end, a distal end, and a body extending between the proximal end and the distal end; wherein the elongated member includes a tubular portion having a first plurality of openings extending through the entire thickness of a wall of the tubular portion, the first plurality of openings including a first opening; The elongated member further comprises fillers respectively located in the openings of the first plurality of openings, the fillers comprising a first filler, Wherein the first filler is compressible and can be compressed to a compressed volume that is less than 50% of an uncompressed volume of the first filler, and / or wherein the first filler is stretchable and can be stretched to a stretched volume that is greater than 120% of an unstretched volume of the first filler.

2. The medical device according to claim 1, wherein: The first filler includes a closed-cell material.

3. The medical device according to claim 1, wherein: The first filler includes a porous material.

4. The medical device according to claim 3, wherein: The elastic modulus of the porous material is less than 10% of the elastic modulus of the material of the tubular section.

5. The medical device according to claim 1, wherein: The medical device is a guide wire, a delivery wire, a catheter or an implant.

6. The medical device according to claim 1, wherein: The first opening has a width less than 0.02 inches.

7. The medical device of claim 1, further comprising an inner layer coupled to an inner surface of the tubular section, wherein: The first filler is integral with the inner layer.

8. The medical device of claim 1, further comprising an outer layer coupled to an outer surface of the tubular section.

9. The medical device according to claim 8, wherein: The first filler is integral with the outer layer.

10. The medical device according to claim 1, wherein: The first filler includes a sponge-like material located in the first opening.

11. The medical device of claim 1 , further comprising an outer layer coupled to an outer surface of the tubular portion and an inner layer coupled to an inner surface of the tubular portion, wherein: The first filler is integral with the inner layer and / or the outer layer.

12. The medical device according to claim 1, wherein: The first filler is compressible and / or stretchable to a strain of at least 0.

5.

13. The medical device according to claim 1, wherein: The openings in the first plurality of openings are in an asymmetric pattern.

14. The medical device according to claim 1, wherein: The first plurality of openings extend at least partially circumferentially in a direction oblique to a longitudinal axis of the tubular section.

15. The medical device according to claim 1, wherein: The first plurality of openings includes a first slot that is non-perpendicular to a longitudinal axis of the tubular section.

16. The medical device according to claim 1, wherein: The tubular portion also includes a second plurality of openings extending through the entire thickness of the wall of the tubular portion, wherein the second plurality of openings are located proximal to the first plurality of openings, and wherein a width of an opening in the second plurality of openings is less than a width of a first opening in the first plurality of openings.

17. The medical device according to claim 1, wherein: The first filler has an outer boundary that defines a compressed volume of the first filler when the first filler is compressed.

18. The medical device of claim 1, wherein the first filler has an outer boundary that defines a stretched volume of the first filler when the first filler is stretched.

Images