Expandable medical device for use with a needle

Abstract

Disclosed herein are medical devices, assemblies, and methods for protecting the sharp tip of a medical needle. Some embodiments include an expandable device configured to be at least partially disposed within the needle cavity. The device may include an expandable distal portion designed to transition between a first configuration and a second configuration, wherein the expandable distal portion has an outer diameter that is the same as or less than the inner diameter of the needle cavity, and in the second configuration, the expandable distal portion has an outer diameter that is greater than the inner diameter of the needle cavity. An elongated inner member may be used to transition the expandable distal portion from the first configuration to the second configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 696,516, filed on July 11, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and methods for making medical devices. More particularly, the present invention relates to medical needles and devices and assemblies for protecting the sharp tip of a medical needle, and methods for making and using such devices and assemblies. Background Art

[0004] Various medical devices have been developed for medical use, for example, medical needles having sharp tips, such as biopsy needles. In some cases, it may be desirable to provide a medical device, assembly, or method for guarding and / or protecting the sharp distal tip of a medical needle. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using such medical devices. Summary of the invention

[0005] The present invention provides designs, materials, manufacturing methods, and use alternatives for medical devices, such as medical needle assemblies, expandable devices for use with medical needles, probes for use with medical needles, and the like.

[0006] One example embodiment includes a medical needle assembly including a needle having a needle body including a sharp distal tip and having a needle lumen defining an inner diameter. The assembly includes an elongated tubular member configured to be at least partially disposed within the needle lumen and including an expandable distal portion having an inner lumen defining an inner surface. The expandable distal portion is designed to transition between a first configuration and a second configuration, wherein the expandable distal portion has an outer diameter that is the same as or less than the inner diameter of the needle lumen, and wherein the expandable distal portion has an outer diameter that is greater than the inner diameter of the needle lumen. The assembly includes an elongated inner member configured to transition the expandable distal portion from the first configuration to the second configuration.

[0007] Alternatively or additionally to any of the above or following embodiments, wherein the expandable distal portion is disposed distally and adjacent to the sharp distal tip when in the second configuration such that the expandable distal portion protects the sharp distal tip of the needle.

[0008] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member engages the inner surface of the expandable distal portion to transition the expandable distal portion from the first configuration to the second configuration.

[0009] Alternatively or additionally to any of the above or following embodiments, wherein when the expandable distal portion is in the second configuration, an outer surface of the elongate inner member engages an inner surface of the expandable distal portion.

[0010] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member is disengaged from the expandable distal portion to transition the expandable distal portion from the second configuration to the first configuration.

[0011] Alternatively or additionally to any of the above or following embodiments, wherein when the expandable distal portion is in the first configuration, an outer surface of the elongate inner member is decoupled from an inner surface of the expandable distal portion.

[0012] Alternatively or additionally to any of the above or following embodiments, wherein the expandable distal portion has an inner diameter and the elongated inner member has an outer diameter, and when in the first configuration, the outer diameter of the elongated inner member is greater than the inner diameter of the expandable distal portion.

[0013] Alternatively or additionally to any of the above or following embodiments, the inner member comprises a proximal segment and a distal segment, and the distal segment comprises an outer diameter greater than the inner diameter of the expandable distal portion, and the proximal segment comprises an outer diameter less than the outer diameter of the distal segment.

[0014] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member includes a proximal body portion having a first wall thickness, and the distal expandable portion has a second wall thickness greater than the first wall thickness.

[0015] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member comprises a coil.

[0016] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a coil.

[0017] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a tubular body including an expansion relief slot formed therein.

[0018] Another example embodiment includes an expandable device for protecting a sharp distal tip of a needle defining a lumen. The expandable device includes an elongated tubular member including a body portion configured to be at least partially disposed within a needle lumen; and an expandable distal portion defining an inner lumen including an inner surface. The expandable distal portion is designed to transition between a first form and a second form, in which the expandable distal portion has an outer diameter that is the same as or less than the inner diameter of the needle lumen, and in which the expandable distal portion has an outer diameter that is greater than the inner diameter of the needle lumen and is configured to protect the sharp distal tip of the needle. The expandable device also includes an elongated inner member configured to be at least partially disposed within the inner lumen of the elongated tubular member and configured to transition the expandable distal portion between the first form and the second form.

[0019] Alternatively or additionally to any of the above or following embodiments, wherein when in the second configuration, an outer diameter of the expandable distal portion is greater than an outer diameter of the proximal body portion.

[0020] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member engages the inner surface of the expandable distal portion to transition the expandable distal portion from the first configuration to the second configuration.

[0021] Alternatively or additionally to any of the above or following embodiments, wherein when the expandable distal portion is in the second configuration, an outer surface of the elongate inner member engages an inner surface of the expandable distal portion.

[0022] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member decouples from the inner surface of the expandable distal portion to transition the expandable distal portion from the second configuration to the first configuration.

[0023] Alternatively or additionally to any of the above or following embodiments, wherein when the expandable distal portion is in the first configuration, the outer surface of the elongate inner member is decoupled from the inner surface of the expandable distal portion.

[0024] Alternatively or additionally to any of the above or following embodiments, wherein the expandable distal portion has an inner diameter and the elongated inner member has an outer diameter, and when in the first configuration, the outer diameter of the elongated inner member is greater than the inner diameter of the expandable distal portion.

[0025] Alternatively or additionally to any of the above or following embodiments, the inner member comprises a proximal segment and a distal segment, and the distal segment comprises an outer diameter greater than the inner diameter of the expandable distal portion, and the proximal segment comprises an outer diameter less than the outer diameter of the distal segment.

[0026] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member includes a proximal body portion having a first wall thickness, and the distal expandable portion has a second wall thickness greater than the first wall thickness.

[0027] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member comprises a coil.

[0028] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a coil.

[0029] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a tubular body including an expansion relief slot formed therein.

[0030] Another example embodiment includes a method of protecting a sharp tip of a needle having a needle lumen. The method includes positioning an elongated tubular member having an expandable distal portion within the needle lumen such that the expandable distal portion is distal to the sharp tip, the expandable distal portion being in a first configuration, wherein the expandable distal portion has an outer diameter that is the same as or less than an inner diameter of the needle lumen. The method also includes transitioning the expandable distal portion to a second configuration, wherein the expandable distal portion has an outer diameter that is greater than the inner diameter of the needle lumen, wherein the elongated inner member is used to transition the expandable distal portion from the first configuration to the second configuration.

[0031] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member defines an outer surface and the expandable distal portion has an inner cavity defining an inner surface, wherein converting the expandable distal portion from a first form to a second form includes joining the outer surface of the elongated inner member with the inner surface of the expandable distal portion such that the outer diameter of the expandable distal portion increases.

[0032] Alternatively or additionally to any of the above or following embodiments, it also includes converting the expandable distal portion from the second form to the first form by disengaging the outer surface of the slender inner member from the inner surface of the expandable distal portion so that the outer diameter of the expandable distal portion is reduced.

[0033] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member is used to transition the expandable distal portion from a first configuration to a second configuration by longitudinally moving the elongated inner member into the lumen of the expandable distal portion.

[0034] Alternatively or additionally to any of the above or following embodiments, wherein the elongated inner member is used to transition the expandable distal portion from the second configuration to the first configuration by longitudinally moving the elongated inner member out of the lumen of the expandable distal portion.

[0035] Alternatively or additionally to any of the above or following embodiments, wherein the expandable distal portion has an inner diameter and the elongated inner member has an outer diameter, and when in the first configuration, the outer diameter of the elongated inner member is greater than the inner diameter of the expandable distal portion.

[0036] Alternatively or additionally to any of the above or following embodiments, the inner member comprises a proximal segment and a distal segment, and the distal segment comprises an outer diameter greater than the inner diameter of the expandable distal portion, and the proximal segment comprises an outer diameter less than the outer diameter of the distal segment.

[0037] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member includes a proximal body portion having a first wall thickness, and the distal expandable portion has a second wall thickness greater than the first wall thickness.

[0038] Alternatively or additionally to any of the above or following embodiments, wherein the elongated tubular member comprises a coil.

[0039] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a coil.

[0040] Alternatively or additionally to any of the above or following embodiments, wherein the distal expandable portion comprises a tubular body including an expansion relief slot formed therein.

[0041] Another example embodiment includes a medical needle assembly including a needle having a needle body including a sharp distal tip and having a needle lumen. The assembly includes an elongated probe including a proximal segment, a distal segment, and an intermediate segment, wherein the distal segment includes an elongated tapered rigidity profile, and the intermediate segment is more rigid than the distal segment. The probe is disposed within the needle lumen such that the rigid intermediate segment is within the sharp distal tip and the tapered distal segment extends distally beyond the sharp distal tip.

[0042] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0044] Figure 1is a partial cross-sectional side view of an example embodiment of a medical needle assembly, the medical needle assembly comprising a needle having a sharp distal tip, a slender tubular member at least partially disposed within a needle lumen and including an expandable distal portion in a first or unexpanded form, and an elongated inner member disposed within the slender tubular member.

[0045] Figure 2 yes Figure 1 A partial cross-sectional side view of an example embodiment of wherein the expandable distal portion is shown in a second or expanded configuration, protecting a sharp distal tip of the needle;

[0046] Figure 3 is a diagram showing a delivery device being advanced within a patient's anatomy and a device being advanced through the delivery device. Figure 2 a partial cross-sectional plan view of an example medical needle assembly of wherein the expandable distal portion is in a second or expanded configuration to protect the sharp distal tip of the needle during delivery;

[0047] Figure 4 yes Figure 3 a partially enlarged cross-sectional side view of a distal portion of a delivery device and a medical needle assembly, wherein the expandable distal portion is in a second or expanded configuration;

[0048] Figure 5 yes Figure 4 A partial cross-sectional side view of a delivery device and medical needle assembly of FIG. 1 showing the expandable distal portion being transitioned to a first or unexpanded configuration;

[0049] Figure 6 yes Figure 5 a partial cross-sectional side view of a delivery device and medical needle assembly of , showing the expandable distal portion in a first or unexpanded configuration, and the needle advanced distally on the expandable distal portion;

[0050] Figure 7 yes Figure 6 a partial cross-sectional side view of a delivery device and a medical needle, wherein the elongated tubular member including the expandable distal portion and the elongated inner member have been removed from the distal portion of the needle and the needle is advanced into tissue to obtain a sample;

[0051] Figure 8 is a partial cross-sectional side view of another example embodiment of a medical needle assembly including an alternative configuration for an expandable distal portion, shown in a first or unexpanded configuration;

[0052] Fig. 9 yes Figure 8 A partial cross-sectional side view of an example embodiment of wherein the expandable distal portion is shown in a second or expanded configuration, protecting a sharp distal tip of the needle;

[0053] Fig.10 is a partial cross-sectional side view of another example embodiment of a medical needle assembly including an alternative configuration for an expandable distal portion, shown in a first or unexpanded configuration;

[0054] Fig.11 yes Fig.10 A partial side view of an example embodiment of;

[0055] Fig.12 yes Fig.10 A partial cross-sectional side view of an example embodiment of wherein the expandable distal portion is shown in a second or expanded configuration, protecting a sharp distal tip of the needle;

[0056] Fig.13 yes Fig.12 A partial side view of an example embodiment of , wherein the expandable distal portion is shown in a second or expanded configuration, protecting a sharp distal tip of the needle;

[0057] Fig.14 is a partial cross-sectional side view of another example embodiment of a medical needle assembly including alternative configurations for an expandable distal portion and an elongated inner member, wherein the expandable distal portion is shown in a first or unexpanded configuration;

[0058] Fig.15 yes Fig.14 A partial cross-sectional side view of an example embodiment of wherein the expandable distal portion is in a second or expanded configuration protecting a sharp distal tip of the needle; and

[0059] Fig.16 is a partial cross-sectional side view of another example embodiment of a medical needle assembly including a needle having a sharp distal tip, and an elongated inner member disposed within the needle and including a rigid portion disposed adjacent the sharp distal tip and including a blunt distal tip.

[0060] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0061] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0062] All numerical values ​​are assumed herein to be modified by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the referenced value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0063] 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).

[0064] 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 generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0065] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when specific features, structures, and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0066] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0067] Medical needles, such as biopsy, aspiration or delivery needles, are widely used in medical procedures throughout the world. It may be desirable to guard and / or protect the sharp distal tip of a medical needle before use or during use or before or during delivery. For example, a needle, such as a biopsy needle, may be navigated to a target or treatment site through a delivery device and / or through the patient's anatomical structure. During such navigation, it may be desirable to guard or protect the sharp needle tip so that the tip does not accidentally scrape, scrape, pierce or become embedded or stuck in the delivery device or in the anatomical structure. Once at the desired site, it may also be desirable to expose or "unprotect" the sharp tip of the needle so that it can be used, for example, to collect a biopsy sample or to aspirate and / or deliver fluids or materials. Thus, some embodiments of the present invention may include methods and devices that can be configured and used to selectively guard or protect the sharp needle tip when desired, and may also be configured and used to selectively allow the sharp needle tip to be exposed for use as desired.

[0068] Figure 1 A partial cross-sectional view of an exemplary embodiment of a medical needle assembly 10 is shown. The medical needle assembly 10 includes a needle 12 having a needle body 14 defining a sharp distal tip 16. The needle body 14 has an outer surface 15 and an inner surface 20, and defines a needle cavity 18 having an inner diameter D1. The sharp distal tip 16 defines a distal needle opening 19 into the needle cavity 18. The needle 12 can be any of a variety of medical needles, such as: a biopsy needle; an aspiration needle, such as a needle that can be used for fine needle aspiration; a delivery needle, such as a needle for delivering therapeutic fluids and / or materials, etc. In the particular embodiment shown, the needle 12 can be a biopsy needle. The sharp distal tip 16 and / or the needle opening 19 can be configured to pierce and obtain a sample from tissue. Some example configurations for the sharp distal tip 16 include francine, lancet, beveled and / or hubers tip configurations, or any other desired needle tip configuration that may be used, for example, in biopsy and / or aspiration needles or other types of medical needles. The needle 12 may include or be made of one or more metals, polymers, and / or composites or layered structures thereof, including any of those disclosed herein.

[0069] The medical needle assembly 10 also includes an expandable medical device for use with the needle 12. The expandable medical device can be designed to have a first or unexpanded configuration, wherein the medical device is configured to selectively allow the needle 12 to be moved thereon, for example, to allow exposure of the sharp distal tip 16 when desired. The expandable medical device can be designed to have a second or expanded configuration, wherein the expandable portion of the medical device is designed to guard and / or protect the sharp distal tip 16 when so desired. This embodiment includes a slender tubular member 22 that is configured to be at least partially disposed within the needle cavity 18. The slender tubular member 22 includes a proximal body portion 24 and an expandable distal portion 26 that is configured to transition between a first radially unexpanded configuration and a second radially expanded configuration, for example, by using a slender inner member 34.

[0070] The proximal body portion 24 has an outer surface 27 and an inner surface 29 defining an inner cavity 31. The proximal body portion 24 has a wall 25 having a first wall thickness, the first wall thickness being defined between the outer surface 27 and the inner surface 29. The proximal body portion 24 may have an outer diameter D5. The outer diameter D5 may be sized and / or configured such that the proximal body portion 24 may fit within the needle cavity 18 and / or may move longitudinally therein. For example, the proximal body portion 24 may have an outer diameter D5 that is less than the inner diameter D1 of the needle cavity 18, such that the proximal body portion 24 may be disposed within the needle cavity 18. The proximal body portion 24 may have an inner diameter D4 defined by the inner cavity 31, which may be configured to receive another device therein, such as an elongated inner member 34, as discussed in more detail below and herein. The proximal body portion 24 may include any structure as desired, such as a solid tubular member, an extrusion, a coil, a braid, a mesh, etc. In the illustrated embodiment, the proximal body portion 24 comprises a solid tubular member.The proximal body portion 24 may include or be made of one or more metals, polymers, and / or composites or layered structures thereof, including any of those disclosed herein.

[0071] The expandable distal portion 26 has an inner surface 28 and an outer surface 32 defining an inner cavity 30. The inner cavity 30 can be connected to the inner cavity 31 of the body portion 24 and / or be in fluid communication therewith. The inner cavities 30 and 31 can be coaxial with each other and can be configured so that the device (such as, the elongated inner member 34) can extend and / or move longitudinally from one cavity (e.g., cavity 31) to another cavity (e.g., cavity 30) when so desired. The expandable distal portion 26 has a wall 33 having a second wall thickness, which is defined between the inner surface 28 and the outer surface 32. In the illustrated embodiment, the second wall thickness (the wall thickness of the expandable distal portion 26) is greater than the first wall thickness (the wall thickness of the proximal body portion 24). The expandable distal portion 26 can have an outer diameter D2 and an inner diameter D3. The expandable distal portion 26 can be configured to expand and / or contract radially so that it can be converted between a first radially unexpanded configuration and a second radially expanded configuration, as discussed in more detail below and herein. The expandable distal portion 26 can include any structure as desired, such as a tubular member, an extrusion, a coil, a braid, a mesh, etc. In the illustrated embodiment, the expandable distal portion 26 includes a coil member. The expandable distal portion 26 can include or be made of one or more metals, polymers, and / or composites or layered structures thereof, including any of those disclosed herein.

[0072] In the particular embodiment shown, the proximal body portion 24 and the expandable distal portion 26 are separate components that are connected together, for example, via bonding, such as welding, brazing, brazing, adhesive bonding, mechanical bonding, or interlocking, to create the elongated tubular member 22. However, in other embodiments, the body portion 24 and the expandable distal portion 26 can be a single component and / or a single and / or unitary structure. For example, the elongated tubular member 22 including the body portion 24 and the expandable distal portion 26 can be a full-length single and / or unitary structure, such as a tubular member, an extrusion, a coil, a braid, a mesh, etc.

[0073] The elongated inner member 34 includes a proximal section 38 and a distal section 40 and has an outer surface 36 and an outer diameter D6. The outer diameter D6 can be sized and / or configured so that the elongated inner member 34 can be assembled in the inner cavity 31 of the proximal body portion 24 and / or can be longitudinally moved therein. For example, the elongated inner member 34 can have an outer diameter D6 that is smaller than the inner diameter D4 of the proximal body portion 24, so that the elongated inner member 34 can be arranged in the inner cavity 31 and / or can be longitudinally moved therein. In this embodiment, the proximal section 38 and the distal section 40 include the same outer diameter D6. However, in other embodiments, the outer diameter of the elongated inner member 34 can vary along its length between the proximal section and the distal section, for example, as will be seen in other embodiments herein. The elongated inner member 34 can be configured and / or arranged to convert the expandable distal portion 26 between a first or radially unexpanded configuration and a second or radially expanded configuration. For example, the elongated inner member 34, when in the first or radially unexpanded configuration, can include an outer diameter D6 that is greater than the inner diameter D3 of the expandable distal portion 26. The elongated inner member 34 can be a solid or tubular structural member, and can take the form of a device such as a core member, a guidewire, a dilator, a trocar, an obturator, or any other such structural member or device.

[0074] As noted herein, expandable distal portion 26 is designed to transition between a first radially unexpanded configuration and a second radially expanded configuration. Figure 1The expandable distal portion 26 is shown in a first configuration, wherein the expandable distal portion 26 has an outer diameter D2 that is the same as or less than the inner diameter D1 of the needle cavity 18. In this configuration, an elongated inner member 34 including an outer diameter D6 is disposed within the inner cavity 31 of the proximal body portion 24 and disposed proximal to the distal expandable portion 26. Thus, the outer surface of the elongated inner member 34 does not engage and / or disengage from the inner surface 28 of the expandable distal portion 26. The expandable distal portion 26 in the first configuration can have an outer diameter D2 that is configured to fit within the needle cavity 18 and / or be longitudinally movable therein. Thus, when in this first configuration, the needle 12 including the sharp distal tip 16 can be longitudinally movable over and / or around the expandable distal portion 26, and / or the expandable distal portion 26 can be movable within the needle 12 so that it is disposed within and / or movable therein the needle cavity 18. In this first configuration, the sharpened needle tip may be considered to be less radially protected and / or guarded by the expandable distal portion 26 than when in the second, expanded configuration.

[0075] In this embodiment, when in the first form, the inner diameter D3 of the expandable distal portion 26 can be smaller than the inner diameter D4 of the proximal body portion 24. Additionally, the outer diameter D2 of the expandable distal portion 26 can be the same as the outer diameter D5 of the proximal body portion 24. As can be appreciated, the change in wall thickness between the distal expandable portion 26 and the body portion 24 can allow this to be achieved. However, other embodiments can have different configurations. For example, it is contemplated that in some embodiments, when in the first form, the outer diameter D2 of the expandable distal portion 26 can be smaller than the outer diameter D5 of the proximal body portion 24, as long as the expandable distal portion 26 has sufficient wall thickness to allow sufficient radial expansion of the outer diameter D2 when transitioning to the second form (as discussed in more detail below).

[0076] Figure 2The expandable distal portion 26 is shown in a second configuration, wherein the expandable distal portion 26 has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. The elongated inner member 34 has been longitudinally moved in a distal direction and has been forced into the lumen 30 of the expandable distal portion 26 with a predetermined amount of force, such that the outer surface 36 of the elongated inner member 34 engages and / or engages with the inner surface 28 of the expandable distal portion 26. Because the outer diameter D6 of the elongated inner member 34 is greater than the initial (e.g., unexpanded) inner diameter D3 of the expandable distal member 26, when the elongated inner member 34 is inserted therein, it forces the expandable distal member 26 to radially expand. When in the second configuration, the radial expansion thus increases both the inner diameter D3 and the outer diameter D2 of the expandable distal member 26 relative to these diameters in the first configuration. Thus, when in the second configuration, the inner diameter D3 of the expandable distal member 26 is approximately the same as (or slightly smaller than) the outer diameter D6 of the elongated inner member 34, and the outer diameter D2 is greater than the inner diameter D1 of the needle lumen 18. Thus, the expandable distal portion 26 when in the second configuration can have an outer diameter D2 that is configured such that it cannot fit within the needle lumen 18 and / or cannot move longitudinally therein. The expandable distal portion 26 is disposed adjacent to the sharp distal tip 16 and has a larger diameter D2, and thus can function to guard and / or protect the sharp distal tip 16. Thus, in this configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded by the expandable distal portion 26.

[0077] In this embodiment, when in the second form, the inner diameter D2 of the expandable distal portion 26 can be greater than the outer diameter D5 of the proximal body portion 24. Additionally, when in the second form, the inner diameter D3 of the expandable distal portion 26 can be the same as the inner diameter D4 of the proximal body portion 24. As can be appreciated, the variation in wall thickness between the distal expandable portion 26 and the body portion 24 can allow this to be achieved. However, other embodiments can have different configurations. For example, it is contemplated that in some embodiments, when in the second form, the inner diameter D3 of the expandable distal portion 26 can be less than the inner diameter D4 of the proximal body portion 24, as long as the expandable distal portion 26 has sufficient wall thickness to allow sufficient radial expansion to be greater than the inner diameter D1 of the needle cavity 18 when in the second form.

[0078] The expandable medical device as disclosed herein can therefore be used in a method of protecting the sharp tip of the needle 12. Figure 1 As shown, the elongated tubular member 22 having the expandable distal portion 26 in the first configuration can be disposed within the needle lumen 18 such that the expandable distal portion 26 is distal to the sharp distal tip 16. Subsequently, the expandable distal portion 26 can be converted to the second configuration using the elongated inner member 34, as shown in FIG. Figure 2 As shown, the expandable distal portion 26 is converted from the first configuration to the second configuration.

[0079] The expandable distal portion 26 can be configured to be biased toward a first and / or unexpanded configuration. For example, when relaxed (e.g., without applying a predetermined transition force), the expandable distal portion 26 can be configured to be in an unexpanded configuration, e.g., Figure 1 As shown. The expandable distal portion 26 may include structure and / or be made of materials that can help achieve this. For example, the expandable distal portion 26 may include such structure and / or be made of flexible and / or elastic materials that can allow the expandable distal portion 26 to be mechanically and / or elastically biased to a first or unexpanded configuration. The expandable distal portion 26 can be transformed from a first configuration to a second configuration by applying a predetermined transformation force (e.g., applied by the slender inner member 34), and then can be mechanically and / or elastically restored and / or recovered to the first configuration once the predetermined transformation force is removed (e.g., the slender inner member 34 is removed therefrom). The expandable distal portion 26 may include and / or be made of a tube, such as a slotted or cut tube, a winding, a braid, a coil, a mesh, etc., and the tube may be structurally configured to allow such elastic expansion and / or contraction. In Figure 1 and Figure 2 In the illustrated embodiment, the expandable distal portion 26 includes a coiled member that may include a spring force that may allow for radial expansion and contraction as desired.

[0080] In this regard, by removing the predetermined expansion force applied by the elongated inner member 34, the expandable distal portion 26 can be extended from the distal end of the elongated inner member 34 to the distal end of the elongated inner member 34. Figure 2 The second expansion state shown is transformed into Figure 1 For example, by moving the elongated inner member 34 out of the lumen 30 of the expandable distal portion 26 in a proximal direction, the outer surface 36 of the elongated inner member 34 will be disengaged from the inner surface 28 of the expandable distal portion 26. In this way, the expandable distal portion 26 can be restored and / or relaxed back to the first configuration, wherein the expandable distal portion 26 has an outer diameter D2 that is the same as or smaller than the inner diameter D1 of the needle lumen 18, as shown in FIG. Figure 1 shown.

[0081] As indicated herein, it may be desirable to guard and / or protect the sharp distal tip 16 of the needle 12 as the needle 12 is navigated to a target or treatment site via a delivery device and / or through the patient's anatomy so that the tip does not undesirably scrape, scrape, pierce, or become embedded or stuck in the delivery device or in the anatomy. Subsequently, it may also be desirable to expose or "unprotect" the sharp distal tip 16 of the needle 12 for use at the target or treatment site. Reference will now be made to Figures 3 to 7The above references are shown and described using Figure 1 and Figure 2 An example method of using the medical needle assembly 10 is described.

[0082] Figure 3 is a partial cross-sectional plan view showing a delivery device 8 being advanced within the anatomy of a patient. In this example, the delivery device 8 is advanced through the trachea T ​​and the bronchial tree BT to a position adjacent to a peripheral node PN in a lung L of the patient. A medical needle assembly 10 is shown as being advanced through the delivery device 8 and can be used to obtain a biopsy sample of a peripheral node. The delivery device 8 can be any suitable device configured to deliver the needle assembly 10. Some examples of suitable delivery devices can include an endoscope, a delivery sheath, a guide catheter, a delivery tube, etc. In other embodiments, a delivery device may not be required, and the needle assembly 10 can be delivered and / or navigated directly through the anatomy of the patient.

[0083] Figure 4 FIG. 8 is an enlarged cross-sectional side view of the distal portion of the delivery device 8 and the medical needle assembly 10 advanced therein. As can be appreciated, the expandable distal portion 26 is as described above with reference to FIG. Figure 2 The second expanded configuration is shown and described wherein the expandable distal portion 26 has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. In this configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded by the expandable distal portion 26. This can aid in navigating the delivery device 8 to a target or treatment site so that the sharp distal tip 16 does not undesirably scrape, scrape, pierce, or become lodged or stuck in the delivery device 8.

[0084] like Figure 5 As shown, once the medical needle assembly 10 is navigated to the vicinity of the target and / or treatment site as desired, the expandable distal portion 26 can be converted from the second expanded configuration to the first unexpanded configuration, as described above with reference to Figure 1 and Figure 2 As shown and described above, in the first configuration, the expandable distal portion 26 has an outer diameter D2 that is the same as or less than the inner diameter D1 of the needle lumen 18. In the first configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded relative to when in the second expanded configuration, not being expanded by the distal portion 26. Additionally, in the first configuration, the needle 12 including the sharp distal tip 16 can be longitudinally moved over and / or around the expandable distal portion 26 and / or longitudinally moved distally beyond the expandable distal portion 26.

[0085] For example, Figure 6Needle 12 is shown advanced distally over expandable distal portion 26 (in a first, unexpanded configuration) such that sharpened distal tip 16 is distal to expandable distal portion 26 and exposed for use, for example, in taking a biopsy sample.

[0086] Figure 7 The sharp distal tip 16 is then shown being advanced into tissue to obtain a biopsy sample. Figure 7 , the entire expandable medical device including the elongated tubular member 22 (which includes a proximal body portion 24 and an expandable distal portion 26) and the elongated inner member 34 has been removed from the needle 12, for example, by withdrawing it proximally through the needle 12. After the needle 12 has been used to obtain a biopsy sample, the needle 12 (including the tissue sample) and the delivery device 8 can be removed from the anatomical structure.

[0087] Figures 8 to 15 Some additional example embodiments of needle assemblies and / or expandable medical devices according to the present invention are shown, which may be identical or similar in form and function to the needle assembly 10 and / or expandable medical device described above. Each of these example needle assemblies and / or expandable medical devices includes a slender tubular member that is configured to be at least partially disposed within a needle cavity. Each of the slender tubular members includes a proximal body portion and an expandable distal portion that is configured to convert between a first radially unexpanded form and a second radially expanded form, for example, by using a slender inner member. The structures shown, named and numbered in these embodiments may include structures, materials and / or uses that are identical or similar to those of any similarly named and numbered structures shown and described herein, for example, in the embodiments above. The features, structures, materials and uses of the various embodiments may be combined and / or used in other embodiments. For example, any of the needle assembly and / or expandable medical device and / or needle and / or elongated tubular member and / or expandable distal portion and / or proximal body portion and / or elongated inner member and / or features, components or components thereof and any of the above referenced Figures 1 to 7 The discussion of any relevant structure in the embodiments of the present invention can be equally applicable to any and all of the other embodiments described herein, and vice versa. In particular, the expandable distal portion and the slender inner member in each of these embodiments (although possibly including some structural differences described) can still allow for transition between a first radially unexpanded configuration and a second radially expanded configuration and can be used to protect the sharp distal tip of the needle in a manner similar to and according to the methods described herein.

[0088] Figure 8 shows a structure similar in form and function to that of the reference Figure 1 and Figure 2A partial cross-sectional view of another exemplary embodiment of the needle assembly 110 of the needle assembly 10 shown and described, wherein similarly named structures and / or similarly numbered structures may be similar in form and function to those discussed elsewhere herein. However, in this embodiment, the elongated tubular member 122 includes an expandable distal portion 126, the wall thickness of which may vary along at least a portion of its length. In the particular embodiment shown, the expandable distal portion 126 includes a tapered coil structure, wherein the diameter of the coil winding decreases as the winding extends distally. However, other embodiments may not include the coil, but rather some other tubular structures that may taper distally. This configuration may provide the expandable distal portion 126 with a rigid profile that tapers when it extends distally, wherein the more proximal portion including a greater wall thickness is more rigid, and the more distal portion including a smaller wall thickness is less rigid.

[0089] The expandable distal portion 126 has an inner surface 128 and an outer surface 132 defining an inner cavity 130. The expandable distal portion 126 has a wall 133 having a wall thickness defined between the inner surface 128 and the outer surface 132. As can be appreciated, due to the tapered structure, the wall thickness can vary and / or taper along the length of the expandable distal portion 126, wherein the wall thickness is greatest near the proximal end and smallest near the distal end. The expandable distal portion 126 can have an outer diameter D2 and an inner diameter D3. Similar to and / or due to the tapering of the wall thickness, the inner diameter D3, the outer diameter D2, or both can also taper along the length of the expandable distal portion 126.

[0090] Similar to other embodiments described herein, the expandable distal portion 126 is designed to transition between a first radially unexpanded configuration and a second radially expanded configuration. Figure 8 The expandable distal portion 126 is shown in a first configuration, wherein the expandable distal portion 126 has an outer diameter D2 that is the same as or less than the inner diameter D1 of the needle lumen 18. Thus, when in this first configuration, the needle 12 including the sharpened distal tip 16 can be longitudinally moved over and / or around the expandable distal portion 126, and / or the expandable distal portion 26 can be moved within the needle 12 such that it is disposed within and / or movable within the needle lumen 18. In this first configuration, the sharpened needle tip 16 can be considered to be radially unprotected and / or unguarded by the expandable distal portion 126 than when in the second expanded configuration.

[0091] Fig. 9The expandable distal portion 126 is shown in a second configuration, wherein the expandable distal portion 126 has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. At least a portion of the expandable distal portion 126, such as the proximal portion, has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. The elongated inner member 34 has been longitudinally moved in a distal direction and has been forced into the lumen 130 of the expandable distal portion 126 with a predetermined amount of force, such that the outer surface 36 of the elongated inner member 34 engages and / or engages with the inner surface 128 of the expandable distal portion 126. Because the outer diameter D6 of the elongated inner member 34 is greater than the initial (e.g., unexpanded) inner diameter D3 of the expandable distal member 126, when the elongated inner member 34 is inserted therein, it forces the expandable distal member 126 to radially expand. When in the second configuration, the radial expansion thus increases both the inner diameter D3 and the outer diameter D2 of the expandable distal portion 126 relative to these diameters in the first configuration. Thus, the expandable distal portion 126 when in the second configuration can have an outer diameter D2 that is configured such that it cannot fit within the needle lumen 18 and / or cannot move longitudinally therein. The expandable distal portion 126 is disposed adjacent the sharp distal tip 16 and has a larger diameter D2, and thus can function to guard and / or protect the sharp distal tip 16. Thus, in this configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded by the expandable distal portion 126.

[0092] Fig.10 A partial cross-sectional view of another exemplary embodiment of a needle assembly 210 similar in form and function to the needle assemblies 10 and 110 shown and described herein is shown, wherein similarly named structures and / or similarly numbered structures may be similar in form and function to those discussed elsewhere herein. However, in this embodiment, the expandable distal portion 226 may be a non-coiled tubular member. Additionally, the entire elongated tubular member 222 may be an integral and / or one-piece construction. In other words, the elongated tubular member 222 including the proximal body portion 24 and the expandable distal portion 226 may be a full-length single and / or integral structure, such as a tubular member, an extrusion, a coil, a braid, a mesh, etc. In this particular embodiment shown, the elongated tubular member 222 may be an integral and / or single tubular member and / or an extrusion.

[0093] The expandable distal portion 226 has an inner surface 228 and an outer surface 232 defining an inner cavity 230. The expandable distal portion 226 has a wall 233 having a wall thickness defined between the inner surface 228 and the outer surface 232. The wall thickness of the expandable distal portion 226 is greater than the wall thickness of the proximal body portion 24. The expandable distal portion 226 can have an outer diameter D2 and an inner diameter D3. The expandable distal portion 26 can be configured to expand and / or contract radially so that it can be converted between a first radially unexpanded configuration and a second radially expanded configuration, as discussed in more detail below and herein.

[0094] Fig.11 A side view of the needle assembly 210 is shown. In the side view, it can be seen that the expandable distal portion 226 can include one or more expansion release structures 250, such as one or more channels, slots, folds, cuts, material changes, hardness changes, etc., which are formed, cut, constructed and / or otherwise disposed in the wall 233 and extend longitudinally along and / or in the wall 233. Such expansion release structures 250 can allow for controlled and / or easier expansion of the entire and / or integral expandable distal portion 226. For example, the expansion release structure 250 can be designed and / or configured to expand preferentially and / or more than the rest of the wall 233. The expandable distal portion 226 can include a single expansion release structure 250 or can include multiple such expansion release structures 250. If multiple expansion release structures are used, they can be radially spaced apart from each other in any manner as desired. For example, multiple expansion release structures 250 can be equally spaced radially around the expandable distal portion 226 (e.g., two expansion release structures are radially spaced 180 degrees apart, three expansion release structures are radially spaced 120 degrees apart, four expansion release structures are radially spaced 90 degrees apart, etc.), or can be unequally spaced radially around the expandable distal portion 226 (e.g., three expansion release structures, the first two of which are radially spaced 40 degrees apart from each other, and the third is spaced 160 degrees apart from the first two, etc.).

[0095] Similar to other embodiments described herein, the expandable distal portion 226 is designed to transition between a first radially unexpanded configuration and a second radially expanded configuration. Fig.10 and Fig.11 The expandable distal portion 226 is shown in a first, unexpanded configuration, wherein the expandable distal portion 226 has an outer diameter D2 that is the same as or smaller than the inner diameter D1 of the needle lumen 18, (eg, Fig.10Thus, when in this first configuration, the needle 12 including the sharp distal tip 16 can be moved longitudinally on and / or about the expandable distal portion 226, and / or the expandable distal portion 226 can be moved within the needle 12 such that it is disposed within and / or movable within the needle lumen 18. In this first configuration, the sharp needle tip 16 can be considered to be not radially protected and / or guarded by the expandable distal portion 226 relative to when in the second expanded configuration.

[0096] In this particular embodiment, when in the first unexpanded configuration, the elongated tubular member 222 can have a constant outer diameter along its length. Additionally, the outer diameter D2 of the expandable distal portion 26 can be equal to the outer diameter D5 of the proximal body portion 24. Additionally, in this embodiment, when in the first unexpanded configuration, the inner diameter of the elongated tubular member 222 can vary along its length. For example, the inner diameter D3 of the expandable distal portion 26 can be less than the inner diameter D4 of the proximal body portion 24. Between the proximal body portion 24 and the expandable distal portion 26, the inner diameter and / or wall thickness of the elongated tubular member 222 can have a tapered transition.

[0097] Fig.12 The expandable distal portion 226 is shown in a second configuration, wherein the expandable distal portion 226 has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. The elongated inner member 34 has been longitudinally moved in a distal direction and has been forced into the lumen 230 of the expandable distal portion 226 with a predetermined amount of force, such that the outer surface 36 of the elongated inner member 34 engages and / or engages with the inner surface 228 of the expandable distal portion 226. Because the outer diameter D6 of the elongated inner member 34 is greater than the initial (e.g., unexpanded) inner diameter D3 of the expandable distal member 226, when the elongated inner member 34 is inserted therein, it forces the expandable distal member 226 to radially expand. Fig.13 A side view of the needle assembly 210 in the second expanded configuration is shown. As can be appreciated, the one or more expansion relief structures 250 can expand and / or open in response to the expansion force, thereby allowing for better and / or more controlled and / or easier expansion of the integral and / or unitary expandable distal portion 226. The expansion relief structure 250 can be designed and / or configured to expand preferentially and / or more than the rest of the wall 233.

[0098] Return to reference Fig.12, when in the second configuration, the radial expansion thus increases both the inner diameter D3 and the outer diameter D2 of the expandable distal portion 226 relative to these diameters in the first, unexpanded configuration. Thus, the expandable distal portion 226 when in the second expanded configuration can have an outer diameter D2 that is configured such that it cannot fit within the needle lumen 18 and / or cannot move longitudinally therein. The expandable distal portion 226 is disposed adjacent to the sharp distal tip 16 and has a larger diameter D2, and thus can function to guard and / or protect the sharp distal tip 16. Thus, in this configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded by the expandable distal portion 226.

[0099] Fig.14 A partial cross-sectional view of another exemplary embodiment of a needle assembly 310 similar in form and function to the needle assemblies 10, 110, and 210 shown and described herein is shown, wherein similarly named structures and / or similarly numbered structures may be similar in form and function to those discussed elsewhere herein. In this embodiment, an elongated tubular member 322 may include a constant wall thickness along its length. The elongated tubular member 322 includes a proximal body portion 24 and an expandable distal portion 326. The proximal body portion 24 has an outer surface 27 and an inner surface 29 defining an inner cavity 31. The proximal body portion 24 has a wall 25 having a first wall thickness defined between the outer surface 27 and the inner surface 29. The expandable distal portion 326 has an inner surface 328 and an outer surface 332 defining an inner cavity 330. The expandable distal portion 326 has a wall 333 having a wall thickness defined between the inner surface 328 and the outer surface 332. The wall thickness of the expandable distal portion 326 is the same as the wall thickness of the proximal body portion 24. As in other embodiments herein, the expandable distal portion 26 can be configured to expand and / or contract radially so that it can be converted between a first radially unexpanded configuration and a second radially expanded configuration. The proximal body portion 24 can have an outer diameter D5 and an inner diameter D4. The expandable distal portion 326 can have an outer diameter D2 and an inner diameter D3. As can be appreciated, due to the constant wall thickness along the length of the elongated tubular member 322, when the expandable distal portion 326 is in the first unexpanded configuration, the outer diameter D2 can be equal to the outer diameter D5, and the inner diameter D3 can be equal to the inner diameter D4.

[0100] In this embodiment, the elongated inner member 334 includes different and / or varying outer diameters along its length. The elongated inner member 334 includes a proximal section 338 and a distal section 340. The proximal section 338 has an outer surface 336 and an outer diameter D6, and the distal section 340 has an outer surface 350 and an outer diameter D7 greater than the outer diameter D6 of the proximal section 338. The outer diameter D6 of the proximal section 338 can be sized and / or configured so that the proximal section 338 of the elongated inner member 334 can be fitted in the elongated tubular member 322 and / or can be longitudinally moved therein. For example, the proximal section 338 of the elongated inner member 334 can be sized and / or configured to be fitted in the inner cavity 31 of the proximal body portion 24 and the inner cavity 330 of the expandable distal portion 326 and / or can be longitudinally moved therein. For example, the elongated inner member 334 may have an outer diameter D6 that is smaller than the inner diameter D4 of the proximal body portion 24 and smaller than the inner diameter D3 of the distal expandable portion 336, so that the proximal segment 338 of the elongated inner member 334 may be disposed within and / or longitudinally movable within the lumens 31 and 330. However, the outer diameter D7 of the distal segment 340 may be larger than the inner diameter D3 of the expandable distal portion 326, and may also be larger than the inner diameter D4 of the proximal body portion 24.

[0101] like Fig.14 As shown, the elongated inner member 334 can be at least partially disposed within the elongated tubular member 322 such that the proximal segment 338 is disposed within the lumens 31 and 330 and the distal segment 340 extends distally beyond the expandable distal portion 326. The elongated inner member 334 can be configured and / or arranged to convert the expandable distal portion 326 between a first or radially unexpanded configuration and a second or radially expanded configuration. For example, the distal segment 340 including an outer diameter D7 can be used to expand the expandable distal portion 326, the outer diameter D7 being greater than the inner diameter D3 of the expandable distal portion 326 when in the first or radially unexpanded configuration.

[0102] Fig.14The expandable distal portion 326 is shown in a first, unexpanded configuration, wherein the expandable distal portion 326 has an outer diameter D2 that is the same as or less than the inner diameter D1 of the needle lumen 18. Thus, when in this first configuration, the needle 12 including the sharpened distal tip 16 can be moved longitudinally on and / or about the expandable distal portion 326, and / or the expandable distal portion 326 can be moved within the needle 12 such that it is disposed within and / or movable within the needle lumen 18. Similarly, the outer diameter D7 of the distal segment 340 of the elongated inner member 334 can be less than the inner diameter D1 of the needle lumen 18. Thus, the needle 12 can similarly be moved longitudinally on and / or about the distal segment 340 of the elongated inner member 334, and / or the distal segment 340 of the elongated inner member 334 can be moved within the needle 12 such that it is disposed within and / or movable within the needle lumen 18. In this first configuration, the sharpened needle tip 16 can be considered to be radially unprotected and / or guarded by the expandable distal portion 326 as compared to when in the second, expanded configuration.

[0103] Fig.15 The expandable distal portion 326 is shown in a second configuration, wherein the expandable distal portion 326 has an outer diameter D2 that is greater than the inner diameter D1 of the needle lumen 18. The elongated inner member 334 has been longitudinally moved in a proximal direction and has been forced into the lumen 330 of the expandable distal portion 326 with a predetermined amount of force, such that the outer surface 350 of the distal portion 340 of the elongated inner member 334 engages and / or engages with the inner surface 328 of the expandable distal portion 326. Because the outer diameter D7 of the elongated inner member 334 is greater than the initial (e.g., unexpanded) inner diameter D3 of the expandable distal member 326, when the elongated inner member 334 is inserted therein, it forces the expandable distal portion 326 to radially expand. As can be appreciated, the expandable distal member 326 can include one or more expansion release structures, as discussed elsewhere herein, which can expand and / or open in response to an expansion force, thereby allowing for better and / or more controlled and / or easier expansion of the expandable distal portion 326. Additionally or alternatively, the expandable distal member 326 can include structures and / or materials that allow it to expand.

[0104] When in the second configuration, the radial expansion thus increases both the inner diameter D3 and the outer diameter D2 of the expandable distal portion 326 relative to these diameters in the first, unexpanded configuration. Thus, the expandable distal portion 326 when in the second expanded configuration can have an outer diameter D2 that is configured such that it cannot fit within the needle lumen 18 and / or cannot move longitudinally therein. The expandable distal portion 326 is disposed adjacent to the sharp distal tip 16 and has a larger diameter D2, and thus can function to guard and / or protect the sharp distal tip 16. Thus, in this configuration, the sharp distal tip 16 can be considered to be radially protected and / or guarded by the expandable distal portion 326.

[0105] Fig.16 A partial cross-sectional view of an alternative exemplary embodiment for a medical needle assembly 410 is shown. Similar to the above embodiments, the medical needle assembly 410 includes a needle 12 having a needle body 14 defining a sharp distal tip 16. The needle body 14 has an outer surface 15 and an inner surface 20, and defines a needle lumen 18 having an inner diameter. The sharp distal tip 16 defines a distal needle opening 19 into the needle lumen 18. The needle 12 can be any of a variety of medical needles, such as any of those already discussed herein.

[0106] In this embodiment, the needle assembly 410 includes an elongated stylet 434. The stylet includes a proximal section 438, a distal section 440, and an intermediate section 460 disposed between the proximal and distal sections. The distal section 440 includes a rounded blunt tip 442.

[0107] The probe 443 may include a rigidity profile that varies along at least a portion of the length of the probe 434. For example, the distal segment 440 includes an elongated tapered profile, wherein the diameter of the distal segment 440 decreases as it extends distally. Thus, the distal segment 440 is less rigid (e.g., more flexible) adjacent the tip 442, and gradually becomes harder (e.g., less flexible) as it extends proximally, with the hardest portion being disposed adjacent the middle segment 460. For example, due to its larger diameter, the middle segment 460 may be harder (e.g., less flexible) than the distal segment 440. For example, due to its larger diameter, the proximal segment 438 may also be harder (e.g., less flexible) than the distal segment 440. For example, due to their common diameter, the proximal segment 438 and the middle segment 440 may have substantially the same rigidity. Additionally or alternatively, the probe 443 may include using different materials, such as different metals or polymers, having different rigidities or hardnesses along their lengths to achieve a rigidity profile variation. For example, the middle segment 460 may include a metal or polymer having a higher rigidity or hardness, while the distal segment 440 may include a metal or polymer having a lower rigidity or hardness. Similarly, the proximal segment 438 may include a metal or polymer having a higher rigidity or hardness relative to the material used in the distal segment 440. The proximal segment 438 and the middle segment 440 may have substantially the same rigidity by using similar rigid materials, or their rigidities may differ from each other, for example by using materials having varying rigidities. In some embodiments, the proximal segment 438 may be more rigid than the middle segment 440, as desired, while in other embodiments, the proximal segment 438 may have less rigidity than the middle segment 440, or they may have the same rigidity.

[0108] In addition, if Fig.16 As shown, the tapered distal segment 440 can extend distally beyond the significant length of the intermediate segment. The very long length of the distal segment 440 provides a longer taper and a more gradual change in the stiffness distribution. Additionally, the very long distal segment 440 can aid in navigation and / or help guard or protect the sharp needle tip 16 from accidentally contacting the delivery device and / or anatomical structure during navigation, as discussed in more detail below. In some embodiments, the tapered distal segment 440 has a length in the range of about 1 to about 10 cm.

[0109] As can also be appreciated, there is a close tolerance between the outer surface 436 of the probe and the inner surface 20 of the needle 12. There is little or no clearance between the inner surface 20 of the needle 12 and the outer surface 436 of the probe.

[0110] The stylet 434 is disposed within the needle 12 such that the rigid intermediate section 460 is disposed below and / or within the sharp distal tip 16 of the needle 12, and the tapered distal section 440 extends distally beyond the sharp distal tip 16 and the rigid intermediate section 460. In other words, the sharp distal tip 16 of the needle is disposed around and / or around the rigid intermediate section 460, and / or surrounds the rigid intermediate section 460. In this way, the rigid intermediate section 460 rigidly supports the sharp distal tip 16 of the needle, and thus reduces the likelihood that the needle will buckle and / or bend away from the stylet 434 when force is applied, for example, during navigation. In this way, it is less likely that a gap will be created between the stylet 434 and the sharp distal tip 16, and thus the sharp needle tip 16 is less likely to accidentally scrape, scrape, pierce, or become embedded or stuck in a delivery device or in an anatomical structure during navigation.

[0111] Additionally, the very long distal segment 440 can assist in navigation and / or help guard or protect the sharp needle tip 16 from accidentally contacting the delivery device and / or anatomical structure during such navigation. Due to the very long length of the tapered distal segment 440, the blunt tip 442 is spaced a significant distance distally from the sharp needle tip 16. During navigation, particularly through tight and / or tortuous bends, the blunt tip 442 will be the leading, and will typically be the first structure of the assembly 410 to contact the delivery device and / or anatomical structure. The long tapered distal segment 440 can help space the sharp needle tip 16 from contacting the delivery device and / or tissue, and can help dissipate any bending forces applied to the probe 434. For example, a long distal segment 440 with tapered rigidity can guide a needle during navigation, for example, through a sharp bend. Thus, the long tapered distal section 440 in combination with the rigid middle section 460 can help reduce and / or prevent separation of the needle 12 from the stylet 434, thereby making it less likely that a gap will be created between the stylet 434 and the sharp needle tip 16, and thus the sharp needle tip 16 is less likely to accidentally scrape, scrape, pierce, or become embedded or stuck in the delivery device or in the anatomical structure during navigation.

[0112] Materials that can be used in the various devices, components, and assemblies disclosed herein may include those commonly associated with medical devices. For example, any of the needles, expandable medical devices, elongated tubular members, expandable distal portions, proximal body portions, elongated inner members, probes, and / or components thereof, or any of the medical needle assemblies disclosed herein may be made of metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials or composites of materials. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, 316LV, and 17-7 stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as UNS:

[0113] N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g. UNS: N04400, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc. or any other suitable material.

[0114] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), polyether block esters, polyurethanes (e.g., polyurethane 85A), thermoplastic polyurethanes (e.g., ), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those commercially available from DuPont ), polyamide (e.g., available from Bayer Or available from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, available under the trade name commercially available), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS)), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc., thereof. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0115] Any one of the needle, expandable medical device, elongated tubular member, expandable distal portion, proximal body portion, elongated inner member, probe and / or its assembly or any one of the medical needle assembly disclosed herein may include the use of different metals or polymers with different rigidity or hardness along its length. For example, the more proximal portion of any one of the parts, devices or assemblies disclosed herein may include a metal or polymer with higher rigidity or hardness, and the more distal portion may include a metal or polymer with lower rigidity or hardness. Any one of the assemblies, devices or assemblies disclosed herein may include one or more layers of material or be made thereof. For example, multiple layers of different materials may be used to form all or part of any one of the parts, devices or assemblies disclosed herein. Any one of the assemblies, devices or assemblies disclosed herein may also include a reinforcing member, such as a braid, a coil, a mesh, etc. and / or be made entirely of it.

[0116] In at least some embodiments, any one of the needle, expandable medical device, elongated tubular member, expandable distal portion, proximal body portion, elongated inner member, probe and / or its components or any part or all of the medical needle assembly disclosed herein can be doped with, made of or otherwise include a radiopaque material. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopic screen or with another imaging technique during a medical procedure. This relatively bright image helps the user of the guide extension catheter to determine its position. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design to achieve the same result.

[0117] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted into the design. For example, any of the needles, expandable medical devices, elongated tubular members, expandable distal portions, proximal body portions, elongated inner members, probes, and / or components thereof, or any of the medical needle assemblies disclosed herein, or portions thereof, can be made of a material that does not substantially distort the image and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in MRI images. Any of the components, devices, or assemblies disclosed herein, or portions thereof, can also be made of a material that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc.

[0118] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly matters of shape, size, and arrangement of steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A medical needle assembly, comprising: a needle having a needle body including a sharp distal tip and defining a needle lumen having an inner diameter; an elongated tubular member configured to be at least partially disposed within the needle lumen and comprising an expandable distal portion having an inner surface defining an inner lumen, wherein the expandable distal portion is designed to transition between a first configuration in which the expandable distal portion has an outer diameter that is the same as or less than the inner diameter of the needle lumen and a second configuration in which the expandable distal portion has an outer diameter that is greater than the inner diameter of the needle lumen; and an elongated inner member configured to transition the expandable distal portion from the first configuration to the second configuration; and The elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member is disengaged from an inner surface of the expandable distal portion to transition the expandable distal portion from the second configuration to the first configuration.

2. A medical needle assembly according to claim 1, wherein the expandable distal portion is disposed distally and adjacent to the sharp distal tip when in the second form, so that the expandable distal portion protects the sharp distal tip of the needle.

3. A medical needle assembly according to claim 1, wherein the expandable distal portion has an inner diameter and the slender inner member has an outer diameter, and when in the first form, the outer diameter of the slender inner member is greater than the inner diameter of the expandable distal portion.

4. A medical needle assembly according to claim 3, wherein the slender inner member includes a proximal segment and a distal segment, and the distal segment includes an outer diameter that is larger than the inner diameter of the expandable distal portion, and the proximal segment includes an outer diameter that is smaller than the outer diameter of the distal segment.

5. The medical needle assembly of claim 1, wherein the elongated tubular member includes a proximal body portion having a first wall thickness, and the expandable distal portion has a second wall thickness greater than the first wall thickness.

6. An expandable device for protecting a sharp distal tip of a needle, the needle defining a needle lumen having an inner diameter, the expandable device comprising: an elongated tubular member including a proximal body portion configured to be disposed at least partially within the needle lumen; and an expandable distal portion defining an inner lumen including an inner surface, wherein the expandable distal portion is configured to transition between a first configuration in which the expandable distal portion has an outer diameter that is the same as or smaller than the inner diameter of the needle lumen, and a second configuration in which the expandable distal portion has an outer diameter that is larger than the inner diameter of the needle lumen and is configured to protect the sharp distal tip of the needle; as well as an elongated inner member configured to be disposed at least partially within the lumen of the elongated tubular member and configured to transition the expandable distal portion between the first configuration and the second configuration; and The elongated inner member defines an outer surface, wherein the outer surface of the elongated inner member is disengaged from an inner surface of the expandable distal portion to transition the expandable distal portion from the second configuration to the first configuration.

7. An expandable device according to claim 6, wherein when in the second configuration, the outer diameter of the expandable distal portion is greater than the outer diameter of the proximal body portion.

8. The expandable device of claim 6 or 7, wherein the outer surface of the elongated inner member engages the inner surface of the expandable distal portion to transform the expandable distal portion from the first configuration to the second configuration.

9. The expandable device of claim 6, wherein the expandable distal portion has an inner diameter and the elongated inner member has an outer diameter, and when in the first configuration, the outer diameter of the elongated inner member is greater than the inner diameter of the expandable distal portion.

10. The expandable device of claim 9, wherein the inner member comprises a proximal segment and a distal segment, and the distal segment comprises the outer diameter greater than the inner diameter of the expandable distal portion, and the proximal segment comprises an outer diameter less than the outer diameter of the distal segment.

11. The expandable device of claim 6, wherein the elongated tubular member includes a proximal body portion having a first wall thickness, and the distal expandable portion has a second wall thickness greater than the first wall thickness.

12. The expandable device of claim 6, wherein the distal expandable portion comprises a coil or a tubular body including an expansion-releasing slot formed therein, or both.

13. A method for protecting a sharp tip of a needle having a needle lumen, the method comprising: disposing an elongated tubular member having an expandable distal portion within the needle lumen such that the expandable distal portion is distal to the sharpened tip, the expandable distal portion having an inner surface and being in a first configuration in which the expandable distal portion has an outer diameter that is the same as or less than the inner diameter of the needle lumen; and The expandable distal portion is transformed into a second form, in which the expandable distal portion has an outer diameter greater than the inner diameter of the needle cavity, wherein a slender inner member is used to transform the expandable distal portion from the first form to the second form, wherein the slender inner member defines an outer surface, wherein the outer surface of the slender inner member is disengaged from the inner surface of the expandable distal portion to transform the expandable distal portion from the second form to the first form.

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