Flexible intraosseous obturator

Abstract

Apparatuses and methods for a flexible obturator for use with an access assembly of an intraosseous device are disclosed. The flexible obturator can include elastic properties and a relatively low column strength, a relatively low shear strength, and / or a relatively high compression strength. The obturator can prevent bone chips and tissue from obstructing the needle lumen when the obturator is supported in the needle. When removed from the needle, the obturator can deform under force to prevent accidental needle sticks. The flexible obturator can define a radially symmetric profile and can conform to the interior profile of the needle lumen. The flexible obturator can extend beyond the distal tip of the needle and be trimmed to be flush with the bevel of the needle. This simplifies the manufacturing process, allowing a single size of obturator to fit multiple sizes of needles.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 983,434, filed February 28, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to flexible intraosseous occluders. Summary of the Invention

[0004] Current intraosseous access devices include a rigid stainless steel occluder to prevent bone fragments and other tissue from clogging the needle lumen during placement. The occluder in the intraosseous needle prevents coring of the bone when the intraosseous (“IO”) needle drills through the bone. The occluder is positioned within the needle lumen and extends flush with the needle bevel. This blocks the internal lumen of the needle and prevents bone fragments from clogging the needle when it drills through the bone.

[0005] Although the stainless steel occluder is not intentionally designed with a distal cutting edge, the tip of the occluder is ground flush with the bevel of the needle to prevent the formation of any pockets that could accumulate bone fragments, etc. For example, as Figure 1A-1C As shown, this results in a sharp tip 146, which requires a tip safety mechanism 105 to prevent accidental needlestick injuries once removed from the needle 204. Furthermore, the stainless steel occluder requires a concentric groove or recess 150 to allow the tip safety mechanism to lock onto the tip of the occluder 104. This increases the complexity and cost of manufacturing the intraosseous access device, which includes a shield and a structure that engages the shield.

[0006] In short, the embodiments disclosed herein relate to devices and methods for using a flexible occluder with an intraosseous device to address the aforementioned problems. This document discloses an access assembly for use with an intraosseous access device, the access assembly comprising: a needle including a circular distal region communicating with a beveled distal opening; and an occluder formed of a flexible material, the occluder including a radially symmetrical elongated body designed for insertion into the lumen of the needle.

[0007] In some embodiments, when positioned within the lumen of a needle, the elongated body is deformable to conform to the internal contours of the lumen. The occluder includes a distal surface extending perpendicular to the longitudinal axis. The occluder includes a curved distal surface. In some embodiments, the elongated body further includes a beveled distal surface configured to align with the beveled distal opening of the needle. The flexible material exhibits relatively low column strength, relatively low shear strength, and relatively high compressive strength. Flexible materials include plastics, polymers, thermoplastics, polytetrafluoroethylene (“PTFE”), polyethylene (“PE”), polyurethane (“PU”), rubber, silicone, metals, alloys, or nitinol.

[0008] In some embodiments, the elongated body further includes a needle bushing and an occluder bushing, the needle bushing being configured to support the needle and defining a bushing cavity communicating with the needle lumen, and the occluder bushing being configured to support an occluder, wherein when the occluder bushing engages the needle bushing, the distal tip of the occluder extends through the needle lumen and distal to the distal tip of the needle. In some embodiments, the elongated body further includes a lumen clearing mechanism configured to advance the occluder relative to the needle lumen to remove material from a distal portion of the needle lumen. The lumen clearing mechanism is automatically triggered when the occluder is removed from the needle lumen.

[0009] A method for manufacturing an inlet assembly is also disclosed, comprising: providing a needle supported by a needle bushing and defining an inner cavity; providing an occluder supported by an occluder bushing; advancing the occluder through the inner cavity of the needle until the distal tip extends distal to the distal tip of the needle; and trimming the distal portion of the occluder to provide a distal surface flush with the beveled distal surface of the needle.

[0010] In some embodiments, the occluder bushing engages the needle bushing as the distal tip of the occluder extends distally toward the distal tip of the needle. In some embodiments, the method further includes adhering the occluder to the occluder bushing before advancing the occluder through the needle lumen. The occluder is formed of a flexible material exhibiting relatively low columnar strength, relatively low shear strength, and relatively high compressive strength. Flexible materials include plastics, polymers, thermoplastics, polytetrafluoroethylene (“PTFE”), polyethylene (“PE”), polyurethane (“PU”), rubber, silicone, metals, alloys, or nitinol. The occluder defines a radially symmetrical, elongated body. Providing an occluder includes the occluder defining a distal surface extending perpendicular to the longitudinal axis of the occluder. Providing an occluder includes the occluder defining a radially symmetrical, curved distal surface. In some embodiments, the method further includes a lumen removal mechanism configured to advance the occluder relative to the needle lumen to remove material from the distal portion of the needle lumen. When the occluder bushing separates from the needle bushing, the internal cavity clearing mechanism is automatically triggered. Attached Figure Description

[0011] A more specific description of this disclosure will be presented with reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained in more specific and detailed manner using the accompanying drawings, in which:

[0012] Figure 1A An exploded view of an exemplary intraosseous access system according to an embodiment disclosed herein is shown, wherein the system's access component subset is shown in a slightly enlarged and front view and the actuator component is shown in a perspective view.

[0013] Figure 1B The embodiments disclosed herein are shown. Figure 1A Enter the cross-sectional view of the component;

[0014] Figure 1C The following is illustrated: from the embodiment disclosed herein Figure 1A A cross-sectional view of the dam tip and safety guard removed from the entry component;

[0015] Figure 1D-1F The embodiments disclosed herein are shown. Figure 1A Enter the detailed close-up view of the component;

[0016] Figure 2A A blocker assembly according to an embodiment disclosed herein is shown;

[0017] Figure 2B-2E A side view and a proximal view of a blocker according to an embodiment disclosed herein are shown;

[0018] Figures 3A-3C A block assembly according to an embodiment disclosed herein is shown; and

[0019] Figure 3D-3E A cross-sectional view of the occluder and needle assembly according to the embodiments disclosed herein is shown; Detailed Implementation

[0020] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the features of a particular embodiment disclosed herein may be readily separable from that particular embodiment and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0021] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide for sequential or numerical limitations. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. For convenience, labels such as “left,” “right,” “up,” “down,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0022] For example, the terms "proximal," "proximal portion," or "proximal portion" of a needle disclosed herein include the portion of the needle intended to be close to the clinician when the needle is used on a patient. Similarly, the term "proximal length" of a needle includes the length of the needle intended to be close to the clinician when the needle is used on a patient. For example, the term "proximal end" of a needle includes one end of the needle intended to be close to the clinician when the needle is used on a patient. The proximal portion, proximal portion, or proximal length of a needle may include the proximal side of the needle; however, the proximal portion, proximal portion, or proximal length of a needle does not necessarily include the proximal end of the needle. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0023] For example, the term "distal," "distal portion," or "distal part" of a needle disclosed herein includes the portion intended to be close to or within the patient when the needle is used on a patient. Similarly, the term "distal length" of a needle includes the length of the needle intended to be close to or within the patient when the needle is used on a patient. For example, the term "distal end" of a needle includes the end intended to be close to or within the patient when the needle is used on a patient. The distal portion, distal part, or distal length of a needle may include the distal end of the needle; however, the distal portion, distal part, or distal length of a needle does not necessarily include the distal side of the needle. That is, unless the context otherwise implies, the distal portion, distal part, or distal length of a needle is not the distal portion or distal length of the needle.

[0024] like Figure 1A As shown, to aid in describing the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle 204 extending from the driver 101. The lateral axis extends orthogonally to the longitudinal axis, and the transverse axis extends orthogonally to both the longitudinal and lateral axes. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0025] This disclosure generally relates to intraosseous (“IO”) access devices, systems, and methods thereof. Figure 1A An exploded view of an exemplary intraosseous access system 100 is shown, with some components shown in a front view and others in a perspective view. The intraosseous access system 100 can be used to penetrate the skin and the underlying hard bone for intraosseous access, such as via a channel through the interior of the bone to access the patient's bone marrow and / or vascular system.

[0026] In one embodiment, the system includes an actuator 101 and an entry assembly 109. The actuator 101 can be used to rotate the entry assembly 109 into the patient's bone. In one embodiment, the actuator 101 can be automatic or manual. In one embodiment, the actuator 101 is an automatic actuator 108. For example, the automatic actuator 108 can be a drill that achieves high rotational speeds. The intraosseous entry system 100 may also include an occluder assembly 102, a guard 105, and a needle assembly 202, which may be collectively referred to as the entry assembly 109. In one embodiment, the occluder assembly 102 includes an occluder 104 and an occluder bushing 103. In one embodiment, the occluder bushing 103 is attached to the occluder 104 in any suitable manner (e.g., one or more adhesives or overmolding). The occluder bushing 103 may be configured to interface with the actuator 101.

[0027] In one embodiment, the guard 105 is configured to engage with the blocker 104. When the guard 105 is in a first operating mode, the engagement allows longitudinal movement between the blocker 104 and the guard 105. In a second operating mode, longitudinal movement between the blocker 104 and the guard 105 can be prevented.

[0028] For example, in a first operating mode, the occluder 104 holds the guard 105 in the unlocked state. The occluder 104 can then be moved to a position where the guard 105 is no longer held in the unlocked state, and the guard 105 can automatically transition to a second operating mode, i.e., a locked state, in which longitudinal movement between the guard 105 and the occluder 104 is almost or completely prohibited. In the second operating mode, the guard 105 can suppress unintentional contact with the distal tip of the occluder 104 and prevent accidental needlestick injuries. In an embodiment, the guard 105 can be configured to rotate about a longitudinal axis relative to the occluder 104 in either the first or second operating mode.

[0029] The automatic actuator 108 can take any suitable form. The actuator 108 may include a handle 110 that can be held by a user with one hand. The actuator 108 may also include any suitable type of actuator 111, such as a trigger actuator, via which the user can selectively actuate the actuator 108 to rotate the coupling interface 112. For example, the actuator 111 may include a button (as shown) or a switch or other mechanical or electrical element for actuating the actuator 108. In an embodiment, the coupling interface 112 is formed as a socket 113 defining a cavity 114. The coupling interface 112 may be configured to engage with a stopper bushing 103. In an embodiment, the socket 113 includes sidewalls that substantially define a hexagonal cavity into which a hexagonal protrusion of the stopper bushing 103 can be received. Other suitable coupling interfaces may be considered.

[0030] The automatic actuator 108 may include any suitable type of energy source 115 configured to power the rotational movement of the coupling interface 112. For example, in one embodiment, the energy source 115 may include one or more batteries that provide power to the automatic actuator 108. In other embodiments, the energy source 115 may include one or more springs (e.g., coil springs) or other biasing members that may store potential mechanical energy that can be released when the actuator 111 is actuated. The energy source 115 may be coupled to the coupling interface 112 in any suitable manner. For example, in one embodiment, the automatic actuator 108 includes an electrical, mechanical, or electromechanical connection 116 to the gear assembly 117. In some embodiments, the coupling 116 may include an electric motor that generates mechanical movement from electrical energy supplied by the power source 115. In other embodiments, the coupling 116 may include a mechanical linkage that mechanically transfers rotational energy from the mechanical (e.g., spring-based) energy source 115 to the gear assembly 117. The automatic drive 108 may include any suitable type of mechanical connector 118 to engage the gear assembly 117 with the coupling interface 112. In other embodiments, the gear assembly 117 may be omitted.

[0031] In several embodiments, the automatic drive 108 can rotate the coupling interface 112, thereby causing the entry component 109 to rotate at a speed much greater than that achievable by manually rotating the entry component 109. For example, in various embodiments, the automatic drive 108 can rotate the entry component 109 at a speed between 200 and 3000 revolutions per minute (rpm). However, it should be understood that smaller or larger rotational speeds are also conceivable.

[0032] like Figure 1AAs shown, the needle assembly 202 includes a needle 204 and a needle bushing 203, the needle bushing 203 being attached to the needle 204 in any suitable manner. The needle bushing 203 can be configured to engage with the occluder bushing 103, and can thus be engaged with the driver 101. Figure 1B-1F Further details of entering component 109 are shown. Figure 1B A cross-sectional view of the entry assembly 109 is shown, in which the needle bushing 203 is held by the stopper bushing 103. The stopper 104 is disposed within the needle, and the guard 105 is in the unlocked position within the entry assembly 109. Figure 1C A cross-sectional view of the entry assembly 109 is shown, with the stopper 104 removed from the needle and the guard in a second, locked operating mode. Figure 1D An exploded view of component 109 is shown. Figure 1E An enlarged cross-sectional view of needle 204 is shown. Figure 1F An enlarged cross-sectional view of the occluder 104 is shown.

[0033] As discussed herein, the occluder 104 is formed of a rigid material, such as stainless steel, to prevent tissue and / or bone from entering the lumen of the needle 204 during an access event. While not intentionally provided with a distal cutting edge, the rigid occluder 104 is ground flush with the beveled opening of the needle to provide a flush surface. Furthermore, the rigid material is sufficiently rigid and robust to prevent tissue and / or bone from entering the lumen of the needle 204 during an access event. Thus, the occluder tip 146 is sufficiently sharp to avoid the risk of needlestick injury and provides a guard 105 to engage the occluder 104 and prevent accidental needlestick injury. Further details and embodiments of the intraosseous access system 100 can be found in WO 2018 / 075694, WO 2018 / 165334, WO 2018 / 165339 and US 2018 / 0116693, each of which is incorporated herein by reference in its entirety.

[0034] Figure 1B An early stage of an exemplary method of using the intraosseous access system 100 is shown, and a cross-sectional view is provided of the access assembly 109 in an assembled state with an exemplary tip protection device. It should be understood that other tip protection methods are also contemplated and are within the scope of this invention. The access assembly 109 includes an occluder assembly 102, a guard 105, and a needle assembly 202. In some cases, the access assembly 109 will be pre-assembled and thus can be accessed substantially from the intraosseous access system 100. Figure 1BAny suitable aseptic packaging of the configuration depicted is removed. In the assembled state shown, the keyed coupling interfaces 137, 210 of the occluder bushing 103 and the needle bushing 203 can cooperate to ensure a predetermined relationship between the occluder 104 and the needle 204. Thus, the keyed coupling interfaces 137, 210 ensure that the occluder 104 defines a fixed angular orientation relative to the needle 204. The coupling interfaces 137, 210 can also maintain a fixed angular orientation during insertion events, during rotation into the assembly 109, for example, during rotation into the assembly 109 via the automatic actuator 108.

[0035] The distal surface 147 of the occluder 104 is slightly recessed relative to the distal surface 247 of the needle 204. Additionally, the distal surfaces 147 and 247 of the occluder 104 and the needle 204 are substantially parallel to each other. In some embodiments, the occluder 104 does not cut through the skin or bone during insertion. In other embodiments, the distal surfaces 147 and 247 may be substantially flush with each other. The occluder 104 may substantially fill or otherwise occlude the passage into the lumen 251 of the needle 204. For example, in the illustrated embodiment, the distal surface 147 of the occluder 104 is substantially the same size as the opening at the distal end of the lumen 251. In various embodiments, the area of ​​the distal surface 147 of the occluder 104 is no more than 5%, 10%, 15%, or 20% smaller than the area defined by the inner edge of the distal surface 247 of the needle 204. The occluder 104 can inhibit or prevent tissue and / or bone material from entering and / or advancing into the lumen 251 of the needle 204.

[0036] The inner surface 253 of the needle 204 and the outer surface of the occluder 104 may be complementaryly shaped and / or otherwise configured to prevent or block the entry of tissue, bone, and / or other substances. In another embodiment, the engagement between the occluder 104 and the needle 204 may allow the occluder 104 to be easily removed from the needle 204. For example, a snug fit, a loose fit, or a minimum clearance may be provided between at least a portion of the occluder 104 and the needle 204. During assembly of the insertion assembly 109, the arm or protrusion 132 of the occluder bushing 103 may advance over the skirt 228 of the needle bushing 203. A snap-fit ​​interface or inward protrusion 134 of the protrusion 132 may clamp the underside of the skirt 228 to hold the occluder bushing 103 and the needle bushing 203 in the connected state. The skirt portion 228 is substantially shaped as an outward protrusion, and the inner surface of the arm 132 substantially defines a recess into which the protrusion is received. In other embodiments, the protrusion / recess interface may be reversed. For example, the arm 132 may define a protrusion that is received into the recess defined by the skirt portion 228 to engage the occluder bushing 103 with the needle bushing 203.

[0037] The protrusion 132 and the skirt 228 can be collectively referred to as the releasable engagement mechanism 262. The releasable engagement mechanism 262 can be configured to hold the occluder bushing 103 and the needle bushing 203 engaged together during normal operation of the assembly 109, such as during removal from the package and / or engagement with the automatic actuator 108. However, the releasable engagement mechanism 262 can provide a relatively weak engagement that can be released when a sufficient removal force is applied to the occluder bushing 103 proximally relative to the needle bushing 203. For example, the releasable engagement mechanism 262 can provide an engagement force that tends to maintain engagement between the occluder bushing 103 and the needle bushing 203. When the proximally force on the occluder bushing 103 exceeds the engagement force of the releasable engagement mechanism 262, the releasable engagement mechanism 262 can disengage and allow the occluder bushing 103 to be withdrawn from the needle bushing 203. In various implementations, the coupling force (i.e., the force that counteracts the force on the occluder bushing 103 toward the proximal side) may not exceed approximately 0.25, 0.5, 0.75, 1.0, 1.5, or 2.0 pounds.

[0038] In some embodiments, the releasable engagement mechanism 262 provides a engagement force significantly lower than the embedding force between the needle 204 and the bone into which it is inserted. The releasable engagement mechanism 262 can be configured to allow the occluder bushing 103 to disengage from the needle bushing 203 after the needle bushing 203 has been introduced into the bone by applying a proximal force to the occluder bushing 103, this proximal force being on the order of magnitude less than the force exerted by the bone on the cannula 204 (which holds the cannula 204 in place within the bone). Therefore, in some embodiments, after the access component 109 has been introduced into the bone, the user can simply pull posteriorly or proximally on the occluder bushing 103 with any amount of force exceeding the engagement force of the releasable engagement mechanism 262, and the occluder bushing 103 will automatically disengage from the needle bushing 203. Furthermore, the occluder bushing 103 can be withdrawn from the needle bushing 203 and the patient, and the needle 204 can remain in the bone. In some cases, after the access component 109 has been introduced into the bone, the user can remove the occluder bushing 103 from the needle bushing 203 with one hand. Other suitable arrangements of the releasable engagement mechanism 262 are also contemplated.

[0039] When the entry assembly 109 is in the assembled state, the guard 105 can be engaged with each of the plug 104 and needle bushing 204 in an unlocked state, in which arms 162, 163 are deflected outward away from the longitudinal axis. Specifically, the proximal end 140 of the plug 104 can extend through the entire guard 105, and this proximal end 140 can define a larger diameter than the recess 150. The proximal end 140 of the plug 104 extends through the lateral extensions 172, 173 and the collar 160. The larger diameter region of the plug 104 can hold the guard 105 in the unlocked state to allow the plug 104 to translate proximally relative to the guard 105 when the user wishes to remove the plug bushing 103 from the needle bushing 204.

[0040] When the guard 105 is in the unlocked state, the arms deflect outward, which allows the outward protrusions 178, 179 of the arms 162, 163 to be positioned or otherwise located within the grooves 227 of the needle bushing 203. Therefore, during the initial phase of the retraction of the stopper 104 through the guard 105, the outward protrusions 178, 179 can engage with the grooves 227 to hold the guard 105 in a fixed longitudinal position relative to the needle bushing 203. In other embodiments, the grooves 227 and the outward protrusions 178, 179 can be reversed. For example, in some embodiments, the inner surface of the needle bushing 203 can define one or more inward protrusions, and the arms 162, 163 can define inward recesses into which the inward protrusions are engaged when the guard 105 is in the unlocked state (relative to the stopper 104) and in the engaged state relative to the needle bushing 203.

[0041] Figure 1C This is another enlarged cross-sectional view of assembly 109 when the occluder 104 has been fully withdrawn from needle bushing 203. Before the depicted stage, the occluder 104 is withdrawn proximally a sufficient amount to bring the recess 150 into the vicinity of the openings 174, 175. Due to the reduced diameter of the recess 150, the constricted portions of the openings 174, 175 fit into the recess 150, and thus allow the arms 162, 163 to automatically transition to their unbiased, undeflected, or undeformed states; that is, the arms 162, 163 can elastically return to a less bent or unbent state to automatically lock the guard 105 to the occluder 104.

[0042] When the guard 105 is in the locked state, portions of the contracted portions of the defining openings 174, 175 of the lateral extensions 172, 173 enter the recess 150 to secure the guard 105 to the stopper 104. When the guard 105 is locked to the stopper 104, movement of the guard 105 relative to the stopper 104 in one or more directions (e.g., longitudinal and / or rotational directions) can be prevented or limited. In some embodiments, interference between the lateral extensions 172, 173 and the proximal and distal sides of the recess 150 can respectively limit longitudinal movement of the guard 105 relative to the stopper 104. When the arms 162, 163 automatically transition to the locked state relative to the stopper 104, the arms 162, 163 substantially simultaneously disengage the guard from the needle bushing 203. Specifically, the inward movement of the arms 162, 163 causes outward protrusions to exit the groove 227 of the needle bushing 203. This frees the guard 105 to move relative to the needle bushing 203, for example, by moving proximally in the longitudinal direction to exit the lumen 224. The guard 105 is naturally held in a locked state relative to the occluder 104 and restricts access to the distal tip 146 of the occluder 104.

[0043] like Figure 1E As shown is an enlarged view of the occluder 104 within the needle 204. The distal portion of the needle cavity 251 defines an asymmetrical shape including a circular portion 248 and a bevel 247, the bevel 247 including an opening 260 communicating with the needle cavity 251. Thus, in Figure 1F The occluder 104, shown separately and made of rigid material, includes a distal portion 142 shaped to mate with the distal portion of the needle lumen 251. Furthermore, the occluder 104 includes a longitudinal length matching the longitudinal length of the needle lumen 251 to align the shaped portion with the needle lumen 251. Thus, rigid occluders 104 of varying lengths must be produced to match the different longitudinal lengths of the needle 204, and a high degree of engineering precision is required to correctly position the distal portion when assembled into assembly 109.

[0044] Figures 2A-2E An exemplary embodiment of a closure assembly 102 including a closure member 304 formed of a flexible material is shown. The closure member 304 may define a substantially circular cross-section and include a diameter sized to fit snugly within the inner diameter of a needle cavity 251. In this embodiment, the longitudinal length of the closure member 304 may be longer than the length of the closure member 104 used with the needle 204. Thus, when the closure member bushing 103 engages the needle bushing 203, for example as... Figure 1B As shown, the distal tip 346 of the occluder 304 extends distally toward the distal tip 246 of the needle 204.

[0045] In the implementation plan, such as Figure 2BAs shown, the distal tip 346A of the occluder 304A can define a rounded tip. In an embodiment, as... Figure 2D As shown, the distal tip 346B of the occluder 304B can define a square tip, which includes a distal surface extending perpendicular to the longitudinal axis. Optionally, the edges of the distal surface 346B can be rounded or chamfered. Figure 2C and 2E As shown, in the embodiment, the blockers 304A and 304B define a radially symmetrical cross section extending from the longitudinal axis.

[0046] In one embodiment, the occluder 304 may be formed of a flexible plastic exhibiting elastic properties and capable of easily deforming or bending when a force is applied and returning to its undeformed shape when the force is removed. In another embodiment, the occluder 304 may be formed of a material exhibiting a combination of mechanical properties including relatively high flexibility, high elasticity, and high compressive strength. In yet another embodiment, the occluder 304 may be formed of plastics, polymers, thermoplastics, polytetrafluoroethylene (“PTFE”), polyethylene (“PE”), polyurethane (“PU”), rubber, silicone, metals, alloys, nitinol, or similar materials.

[0047] For example, such as Figure 2A As shown, the elongated occluder 304 extending from the occluder bushing 103 is self-supporting. However, as Figure 3A As shown, when a longitudinal force is applied, the occluder 304 can bend and deform, thus exhibiting relatively low columnar strength. When the force is removed, the occluder 304 exhibits elastic properties and returns to its original shape. Furthermore, as... Figure 3B As shown, when a lateral force is applied, the occluder 304 can bend and deform, thus exhibiting relatively low shear strength. When the force is removed, the occluder 304 exhibits elastic properties and returns to its original shape. However, as... Figure 3C As shown, the occluder 304 can exhibit relatively high compressive strength, such that the occluder 304 resists equal and opposite forces applied to the material with only relatively small deformation or no deformation.

[0048] like Figure 3D-3E As shown, the flexible occluder 304 can advantageously conform to the shape of the distal portion of the needle lumen 251. Furthermore, the distal portion 342 of the occluder 304 can be bent to fit through the angled opening 260, allowing the distal tip of the occluder 346 to extend distally to the distal tip 246 of the needle 204. Figure 3EAs shown, the excess portion of the closure 304 extending through the opening 260 can be trimmed to provide a bevel 347 flush with the bevel 247 of the needle 204. It should be understood that this provides a distal tip 346, which is then positioned proximal to the distal tip 246 of the needle.

[0049] It should be understood that the needle 204, formed of a rigid material such as stainless steel, provides the necessary columnar strength and shear strength to resist deformation of the needle 204 / occluder 304 assembly. Furthermore, the occluder 304, constrained within the needle lumen 251, exhibits sufficient compressive strength to resist longitudinal forces, e.g., to resist any bone fragments being forced proximally into the needle lumen 251 during an insertion event. In an embodiment, the occluder 304 exhibits minimal compressive deformation, allowing the distal tip 346 to retract to some extent into the needle lumen 251. In an embodiment, the elasticity of the occluder 304 then restores its original, undeformed shape upon removal of the force (i.e., when the needle penetrates the cortical layer of bone), and repels any bone fragments or other material from the needle lumen 251.

[0050] Advantageously, due to the compressive strength of the occluder 304, the occluder 304 prevents bone material from entering the needle lumen during insertion. Furthermore, when the occluder 304 is removed from the needle 204, the risk of needlestick injury is reduced due to the flexibility of the occluder 304. For example, when the flexible occluder 304 is subjected to longitudinal or lateral forces, its mechanical properties are configured to allow the occluder 304 to bend, thereby preventing skin abrasion. Similarly, although the tip 346 of the occluder presents a sharp point, its mechanical properties are configured to allow the occluder 304 to deform, thereby preventing skin abrasion.

[0051] An exemplary method for manufacturing an access assembly 109 using a flexible occluder 304 is provided. An elongated cylinder of flexible material is provided to form the body 343 of the occluder 304 and defines a circular cross-sectional shape. The outer diameter of the body 343 of the occluder 304 is configured to fit snugly within the inner diameter of the needle lumen 251. The proximal end of the occluder body 343 can be attached to the occluder bushing 103 using welding, bonding, adhesive, or the like. The longitudinal length of the occluder 304 can be equal to or longer than the longitudinal length of the needle lumen 251. Therefore, when the occluder bushing 103 engages the needle bushing 203, the distal tip of the occluder 304 can extend distally to the lumen opening 260. In an embodiment, the distal tip 346 can be cut or ground to provide a bevel 347 of the occluder 304 flush with the bevel 247, such as... Figure 3E As shown.

[0052] Advantageously, the occluder 304 also provides a simplified manufacturing process. Initially, the guard 105 is unnecessary because the flexibility of the occluder 304 prevents needlestick injuries. This simplifies the manufacturing process and provides a smaller entry assembly 109. The manufacturing of the occluder 304 is further simplified because neither the recess 150 for engaging the guard 105 needs to be formed in the occluder 304, nor the annular groove 227 for retaining the guard within the needle bushing 203 is required. Figure 1B These are either finely detailed structures or similar features. Due to the required size and precision, these finely detailed structures cannot be molded into place. Instead, additional steps are needed to machine these features into place, which increases cost and complexity.

[0053] The manufacture of the stopper 304 is also simplified by requiring only a single-base length, which can be easily trimmed to fit needles of any length. For example, the flexible stopper 304 can bypass the circular region 248 and angled opening 260 of the needle 204 to advance distally to its distal tip 246. The flexible stopper 304 can then be trimmed to a specific size and provide an angled tip flush with the distal side 247 of the needle 204. This eliminates the need to form different stoppers of different sizes to fit different needles and simplifies the manufacturing process. Figure 2B As shown, axis 50 indicates the inner diameter (x) of the needle cavity 251. The circular region 248 and the angled opening 260 prevent the rigid stopper from advancing distally to the distal tip 246 of the needle 204. Thus, before assembly with the needle 204, the rigid stopper can be pre-formed with a circular portion 146 and a beveled distal surface 147 to match the circular portion 246 and bevel 247 of the needle cavity. Therefore, rigid stoppers of different lengths are required to accommodate needles of different lengths.

[0054] Advantageously, the manufacturing process is further simplified because the flexible stopper 304 can be attached to the stopper bushing 103 before assembly with the needle 204 and before being trimmed. When the stopper (e.g., stopper 104) is assembled to the needle 204 and then attached to the stopper bushing 103, the stopper may unintentionally adhere to additional structures (e.g., guard 105, needle bushing 203), leading to malfunction of the access assembly during use. Alternatively, the flexible stopper 304 can also be attached to the stopper bushing 103 after assembly with the needle 204. In an embodiment, the stopper tip 304 is trimmed before assembly with the needle 204. Advantageously, this prevents the needle tip from being damaged or blunted during the trimming of the stopper after assembly with the needle.

[0055] In one embodiment, the access component 109 may further include a lumen clearing mechanism (not shown) that allows the occluder 304 to move slightly relative to the needle 204 along a longitudinal axis. Advantageously, this allows the user to actuate the lumen clearing mechanism after the needle 204 has been placed to advance the occluder 304 relative to the needle 204 and remove any material disposed within the needle lumen 251. As discussed herein, the flexible nature of the occluder 304 allows the distal portion to be advanced through the distal opening 260. In one embodiment, the lumen clearing mechanism is automatically triggered as part of the process of removing the occluder 304 from the needle 204. For example, the lumen clearing mechanism may be actuated when the occluder 103 is separated from the needle bushing 203.

[0056] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. An access assembly for use with an intraosseous access device, comprising: The needle includes a circular distal region communicating with a distal opening with a bevel. An occluder, formed of a flexible material, comprising a radially symmetrical elongated body designed for insertion into the lumen of the needle; A needle bushing configured to support the needle and define a bushing cavity communicating with the needle's inner cavity; and An occluder bushing configured to support the occluder, wherein when the occluder bushing engages the needle bushing, the distal tip of the occluder extends through the needle lumen and distal to the distal tip of the needle. The elongated body is deformable when arranged within the cavity of the needle to conform to the shape of the distal portion of the cavity.

2. The entry assembly of claim 1, wherein the occluder includes a distal surface extending perpendicular to the longitudinal axis.

3. The entry assembly of claim 1, wherein the occluder includes a curved distal surface.

4. The entry component of claim 1, further comprising a beveled distal surface configured to align with the beveled distal opening of the needle.

5. The entry component of claim 1, wherein the flexible material exhibits relatively low columnar strength, relatively low shear strength, and relatively high compressive strength.

6. The entry component of claim 1, wherein the flexible material comprises one of plastic, polymer, thermoplastic, polytetrafluoroethylene, polyethylene, polyurethane, rubber, silicone, metal, alloy or nitinol.

7. The entry assembly of claim 1, further comprising an end-of-cavity clearance mechanism configured to advance the occluder relative to the needle end-of-cavity to remove material from a distal portion of the needle end-of-cavity.

8. The entry assembly of claim 7, wherein the lumen clearing mechanism is automatically triggered when the occluder is removed from the needle lumen.

9. A method of manufacturing an in-component component, comprising: A needle is provided, which is supported by a needle bushing and defines an inner cavity; A stopper is provided, which is supported by a stopper bushing, the stopper including a radially symmetrical elongated body designed for insertion into the lumen of the needle, wherein the elongated body is deformable when arranged in the lumen of the needle to conform to the shape of the distal portion of the lumen. When the occluder bushing engages the needle bushing, the occluder is advanced through the needle lumen until the distal tip extends distal to the distal tip of the needle. Trim the distal portion of the occluder to provide a distal surface flush with the beveled distal surface of the needle.

10. The method of claim 9, further comprising attaching the occluder to the occluder bushing before advancing the occluder through the needle lumen.

11. The method of claim 9, wherein the occluder is formed of a flexible material exhibiting relatively low columnar strength, relatively low shear strength, and relatively high compressive strength.

12. The method of claim 11, wherein the flexible material comprises one of plastic, polymer, thermoplastic, polytetrafluoroethylene, polyethylene, polyurethane, rubber, silicone, metal, alloy or nitinol.

13. The method of claim 9, wherein providing the occluder includes the occluder defining a distal surface extending perpendicular to the longitudinal axis of the occluder.

14. The method of claim 9, wherein providing the occluder includes the occluder defining a radially symmetrical curved distal surface.

15. The method of claim 9, further comprising an end-of-needle removal mechanism configured to advance the occluder relative to the needle end-of-needle lumen to remove material from a distal portion of the needle end-of-needle lumen.

16. The method of claim 15, wherein the lumen clearing mechanism is automatically triggered when the occluder bushing separates from the needle bushing.

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