Angled intraosseous access system
By using a guide plate and guide block to allow the needle assembly to enter the medullary cavity at an angle, the problem of pain and dorsal wall penetration in intraosseous access devices in emergency situations is solved, enabling deeper and more accurate entry into the medullary cavity.
Patent Information
- Application Number
- CN202110977663.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-08-25
- Filing Date
- 2021-08-24
- Publication Date
- 2025-12-12
- Estimated Expiration
- 2041-08-24
AI Technical Summary
In emergency situations, existing intraosseous access devices are prone to causing increased intraosseous pressure and dorsal wall penetration during insertion, leading to patient pain and making it difficult to accurately access wider areas of the medullary cavity.
An angled intraosseous access system, including a guide plate and a guide block, is used to reduce the vertical penetration depth of the needle and increase the penetration depth by aligning the needle assembly at a predetermined angle relative to the longitudinal axis of the medullary cavity, and the design of the guide plate and guide block prevents dorsal wall penetration.
It reduces pressure within the bone marrow cavity, lowers pain levels, and improves the needle's penetration depth and accuracy, ensuring the needle does not penetrate the distal wall of the bone marrow cavity and increasing the success rate of entry in emergency situations.
Smart Images

Figure CN114098918B_ABST
Abstract
Description
[0001] Priority
[0002] This application claims priority to U.S. Provisional Application No. 63 / 069,988, filed August 25, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD
[0003] The present application relates to the field of medical devices, and more particularly to an angulated intraosseous access system. BACKGROUND
[0004] Intraosseous (IO) access devices can enhance vascular access by penetrating through surface tissue and underlying hard cortical bone layer to place an access needle and provide access to the medullary cavity of the bone. Fluids and medications can flow through the needle lumen and into the medullary cavity to infuse the vasculature. IO access events are often performed in emergency situations where immediate vascular access and / or direct intravenous access is not possible.
[0005] Patients requiring IO access report increased pain during infusion, rather than during penetration of the skin surface tissue or the bone cortex. The cause of the pain can be due to increased pressure in the medullary cavity, which is caused by the infused fluids and / or medications. Angling the needle during insertion can direct the medications toward a larger volume of the medullary cavity (e.g., the tibial tuberosity), thereby reducing the pressure within the medullary cavity, which in turn reduces discomfort. Additionally, angling the needle during penetration can reduce “backwalling,” in which the access needle penetrates through the distal wall of the bone cortex and into the medullary cavity. Disclosed herein are angulated intraosseous access systems including an angulated guide plate and an angulated guide block, and related methods that address the above issues. SUMMARY
[0006] Disclosed herein is an angulated intraosseous access system, comprising: a needle assembly including a needle defining a needle axis and configured to access a medullary cavity of a bone; a driver rotatably coupled to the needle assembly and configured to advance the needle through a bone cortex to access the medullary cavity; and one or both of a guide plate and a guide block configured to engage a skin surface and align the needle axis at a predetermined angle relative to a longitudinal axis of the medullary cavity.
[0007] In some embodiments, the predetermined angle is between 1°-90° relative to a longitudinal axis of the bone marrow cavity. In some embodiments, one of the guide plate or the guide block includes a concave or convex skin engaging surface configured to engage the skin surface. In some embodiments, the guide plate is coupled to the guide block. In some embodiments, one of the guide plate or the guide block includes a guide recess configured to engage a fiduciary body part and align the needle with the target location. In some embodiments, the guide recess is disposed on a first portion that is slidably engaged with a second portion of one of the guide plate or the guide block that is coupled to the needle.
[0008] In some embodiments, the guide block includes a first series of notches and a second series of notches each configured to receive a portion of the driver, the first series of notches configured to align the needle axis with a first predetermined angle, the second series of notches configured to align the needle axis with a second predetermined angle different from the first predetermined angle. In some embodiments, the guide plate defines a channel configured to receive the needle therethrough and maintain the needle at the predetermined angle. In some embodiments, one of the guide plate or the guide block is releasably engaged with the driver body.
[0009] In some embodiments, one or both of the guide plate and the guide block includes an adhesive disposed on a surface thereof and configured to adhere to one or both of the driver and the skin surface. In some embodiments, a portion of the guide plate is configured to abut a portion of the needle assembly to prevent a distal tip back wall of the needle from penetrating a distal wall of the bone marrow cavity.
[0010] A method of accessing a bone marrow cavity is also disclosed, comprising: engaging a skin engaging surface of a guide plate with a skin surface, aligning a needle of an intraosseous access system with a channel of the guide plate, the channel extending at a predetermined angle relative to the skin engaging surface, and advancing the needle through the channel into the bone marrow cavity at the predetermined angle.
[0011] In some embodiments, the predetermined angle is between 1°-90° relative to a longitudinal axis of the bone marrow cavity. In some embodiments, the skin engaging surface includes a concave or convex portion configured to engage the skin surface. In some embodiments, the method further comprises coupling the guide plate with a guide block configured to engage the skin surface of the intraosseous access system and the driver and maintain an axis of the driver at the predetermined angle. In some embodiments, the method further comprises engaging a guide recess disposed on the skin engaging surface with a fiduciary body part to align the needle with the target location.
[0012] In some embodiments, the method further includes sliding a first portion of the guide plate including a guide recess disposed thereon relative to a second portion of the guide plate including a channel to align the needle with the target location. In some embodiments, the method further includes adhering a portion of the guide plate to one of the driver or the skin surface. In some embodiments, the method further includes abutting a portion of a needle hub coupled to the needle against a surface of the guide plate to prevent a distal tip back wall of the needle from penetrating a distal wall of the bone marrow cavity.
[0013] A method of accessing a bone marrow cavity is also disclosed, including engaging a portion of a driver of an intraosseous access system with a surface of a guide block, engaging a skin engaging surface of the guide block with a skin surface, aligning an axis of a needle of the intraosseous access system with a predetermined angle, and advancing the needle along the needle axis to access the bone marrow cavity at the predetermined angle.
[0014] In some embodiments, the predetermined angle is between 1°-90° relative to a longitudinal axis of the bone marrow cavity. In some embodiments, the method further includes engaging a guide recess disposed on the skin engaging surface with a fiducial body site to align the needle with the target location. In some embodiments, the method further includes sliding a first portion of the guide block including a guide recess disposed thereon relative to a second portion of the guide block to align the needle with the target location. In some embodiments, the method further includes engaging a portion of the driver with one of a first series of notches or a second series of notches to align the axis of the needle axis with one of a first predetermined angle or a second predetermined angle different from the first predetermined angle.
[0015] These and other features of the concepts provided herein will become more fully apparent from the following description, the illustrative embodiments of which are described in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS
[0016] A more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. The exemplary embodiments of the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
[0017] Figure 1A illustrates a perspective view of an angled guide plate IO access system, in accordance with some embodiments.
[0018] Figure 1B illustrates a close-up detail of a needle engaged with an angled guide plate, in accordance with some embodiments.
[0019] Figure 2 illustrates a side view of an angled guide block IO access system, in accordance with some embodiments.
[0020] Figure 3 FIG. 1 illustrates a side view of an angled combination IO access system including a guide plate and a guide block, according to some embodiments.
[0021] Figure 4 FIG. 1 illustrates a side view of an angled combination IO access system including a guide plate and a guide block, according to some embodiments.
[0022] Figures 5A-5B FIG. 1 illustrates a side view of an angled combination IO access system including a guide plate and a guide block, according to some embodiments. DETAILED DESCRIPTION
[0023] Before certain embodiments are disclosed in more detail, it is to be understood that the specific embodiments disclosed herein are illustrative of the concepts provided herein and not restrictive of the scope of the concepts provided herein. It is also to be understood that the particular embodiments disclosed herein can have features that can be readily separated from the particular embodiments disclosed herein and optionally combined with or substituted for features of any of the other embodiments disclosed herein.
[0024] With respect to the terms used herein, it is also to be understood that these terms are used herein to describe some particular embodiments for purposes of patency and are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps and do not necessarily impart a sequential or chronological order to those features or steps. For example, a “first” feature or step need not come before a “second” feature or step and a “third” feature or step need not come after the “first” and “second” features or steps. Also, terms such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like as can be used in this description should not be interpreted as implying absolute
[0025] For example, a “proximal,” “proximal portion,” or “proximal end portion” of a needle disclosed herein includes a portion of the needle that is intended to be proximate to a clinician when the needle is in use on a patient. Likewise, a “proximal length” of a needle, for example, includes a length of the needle that is intended to be proximate to a clinician when the needle is in use on a patient. A “proximal end” of a needle, for example, includes an end of the needle that is intended to be proximate to a clinician when the needle is in use on a patient. A proximal portion, proximal end portion, or proximal length of a needle can include a proximal end of the needle; however, a proximal portion, proximal end portion, or proximal length of a needle need not include a proximal end of the needle. That is, unless the context indicates otherwise, a proximal portion, proximal end portion, or proximal length of a needle is not a distal portion or distal length of the needle.
[0026] For example, a "distal," "distal portion," or "distal end portion" of a needle disclosed herein includes a portion of the needle that is intended to be proximate to or in a patient when the needle is in use on a patient. Likewise, for example, a "distal length" of a needle includes a length of the needle that is intended to be proximate to or in a patient when the needle is in use on a patient. For example, a "distal end" of a needle includes an end of the needle that is intended to be proximate to or in a patient when the needle is in use on a patient. A distal portion, distal end portion, or distal length of a needle can include a distal end of the needle; however, a distal portion, distal end portion, or distal length of a needle does not necessarily include a distal end of the needle. That is, unless the context otherwise suggests, a distal portion, distal end portion, or distal length of a needle is not a terminal portion or length of the needle.
[0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art.
[0028] Figures 1A-1B An embodiment of an angled guide plate intraosseous (IO) access system 100 configured to penetrate bone cortex 72 and surface tissue 74 to access a medullary cavity 70 of a bone is shown. In embodiments, the angled guide plate IO access system 100 generally includes an IO access system 110 and an angled guide plate ("guide plate") 130. The IO access system 110 generally includes a driver 112 having a body 114 and a needle assembly 120 rotatably coupled to the driver 112. In embodiments, the driver 112 includes an automated driver or a manual driver configured to rotate the needle assembly 120 and drill a bore with a needle 124 through the surface tissue 74 and the bone cortex 72 into the medullary cavity 70 of a bone of a patient.
[0029] In embodiments, the driver 112 can include a drive spring, motor, or similar electrical, mechanical, electromechanical, or powered mechanism configured to rotate and drill the needle assembly 120 into the patient’s bone. In embodiments, the needle assembly 120 can include a needle 124 defining an internal lumen and supported by a needle hub 126. The needle assembly 120 can also include an obturator 122 disposed within the internal lumen of the needle 124 and supported by an obturator hub 128. The obturator 122 can be configured to prevent tissue and bone fragments from entering the needle internal lumen during a placement event and to prevent obstruction of fluid flow through the needle internal lumen. Once the needle 124 has been placed, the driver 110 and obturator 122 can be removed. Fluid and / or medication can flow through the needle internal lumen and into the bone marrow cavity 70 for infusion into the patient’s vasculature. Further details and embodiments of the IO access system can be found, for example, in the following published applications: US 2021 / 0093354, US 2021 / 0093355, US 2021 / 0093358, US 2021 / 0093356, US 2021 / 0093357, US 2021 / 0137558, WO 2018 / 075694, WO 2018 / 165334, and WO 2018 / 165339, each of which is incorporated herein by reference in its entirety.
[0030] In embodiments, the guide plate 130 includes a body 131 defining a skin engagement surface 138 and a channel 132 extending at an angle (Q) relative to a longitudinal axis of the body 131. In embodiments, the skin engagement surface 138 can be a bottom surface of the body 131. However, it should be appreciated that the skin engagement surface 138 can include one or more surfaces of the body 131. In embodiments, the skin engagement surface 138 of the guide plate 130 can engage the skin surface 76 and align the channel 132 at an angle (Q) relative to the skin surface. In embodiments, the guide plate 130 aligns the channel 132 at an angle (Q) relative to the longitudinal axis 60 of the bone marrow cavity 70. In embodiments, the angle (Q) of the channel 132 can be between 1° and 90°. In embodiments, the angle (Q) of the channel 132 can be between 10°-75°. In embodiments, the angle (Q) of the channel 132 can be substantially 45°, however, greater or lesser angles are also contemplated.
[0031] In embodiments, the diameter of the channel 132 can be equal to or slightly larger than the diameter of the needle 124. As such, the needle 124 can slidably engage the channel 132 and substantially align the axis 62 of the needle 124 with the axis of the channel 132. In some embodiments, the diameter of the guide plate channel 132 can be a consistent diameter along its length. In some embodiments, the guide plate channel 132 or portions thereof can define a tapered shape having a larger diameter near a first end relative to a second end opposite the first end. In some embodiments, the entrance of the guide plate channel 132 can be tapered to facilitate alignment of the needle 124 with the channel 132.
[0032] In an exemplary method of use, a user can engage the skin engaging surface 138 of the guide plate 130 with the skin surface 76 and align the channel 132 with a target insertion site. The user can then align the needle 124 with the channel 132 and advance the distal tip 129 of the needle 124 through the channel 132. Advancing the needle 124 through the channel 132 can align the axis 62 of the needle 124 with the axis of the channel 132. The user can then actuate the driver 112 to rotate the needle assembly 120 and "drill" the needle 124 into the patient. The needle 124 can then penetrate the surface tissue 74, the hard cortical bone 72, and the bone marrow cavity 70 at the predetermined angle (Q) defined by the channel 132.
[0033] In embodiments, the guide plate 130 can be coupled to the IO access system 110 and the guide plate 130 can be slidably engaged with the needle 124. As such, a user can support the skin engaging surface 138 against the skin surface 76 and the guide plate 130 can further support the IO access system 110 while the needle axis 62 is aligned with the channel 132. The user can then actuate the driver 112 and push the IO access system 110 including the needle 124 along the needle axis 62 at the predetermined angle (Q) defined by the channel 132. As described herein, the needle 124 can slide through the channel 132 to penetrate the bone at the predetermined angle (Q).
[0034] In embodiments, the guide plate 130 can be coupled to the IO access system 110 and the needle assembly 120 can be slidably engaged relative to the IO access system 110 and the guide plate 130 assembly. As such, a user can support the skin engaging surface 138 against the skin surface 76 and the guide plate 130 can further support the IO access system 110 while the needle axis 62 is aligned with the channel 132. The user can then actuate the driver 112 and the IO access system 110 can push the needle 124 along the needle axis 62 to penetrate the bone at the predetermined angle (Q) as described herein.
[0035] Advantageously, the insertion angle (Q) of the needle 124 can direct fluid flow through the needle lumen towards a wider region of the marrow cavity 70, for example at the head of the bone, and can reduce pressure within the marrow cavity 70 during fluid and / or drug infusion. Advantageously, the guide plate 130 can be configured to align the needle 124 at an angle (Q) relative to the axis 60 of the marrow cavity 70, and can increase the penetrable depth (d) of the marrow cavity 70. As shown in Figure 1A the vertical penetrable depth (dl) (i.e., when the needle is angled perpendicular to the axis 60 of the marrow cavity 70) is less than the angled penetrable depth (d2) (i.e., when the needle is angled relative to the marrow axis 60) for a given location within the marrow cavity 70. As such, the angled penetrable depth (d2) mitigates distal “backwall penetration” of the needle 124 into the marrow cavity 70. Further, in embodiments, the guide plate 130 can be configured to align the needle 124 with the widest portion of the marrow cavity 70, for example at the head of the bone, as described in greater detail herein.
[0036] In embodiments, as shown in Figure 1B the length of the needle 124 extending between the needle hub 126 at the proximal end and the distal end 129 can define a first length (LI). The channel 132 can define a second length (L2) that is less than the first length (LI) and that extends axially. In embodiments, the needle 124 can be advanced through the channel 132 until the distal tip 129 extends through the skin engaging surface 138 and a portion of the hub 126 abuts a portion of the guide plate body 131 proximate the channel entrance 132. As such, with the skin engaging surface 138 contacting the skin surface 76, the distal tip 129 can extend through the channel 132 and penetrate the underlying tissue 74, bone cortex 72, etc. In embodiments, the length (L2) of the channel 132 can be predetermined such that a portion of the needle 124 extends through the surface tissue 74, bone cortex 72 and into the marrow cavity 70 to a penetration length or third length (L3). In embodiments, the third length (L3) is the length (LI) of the needle less the length (L2) of the channel 132. Advantageously, the length (LI) of the needle 124 and the length (L2) of the channel 132 can be predetermined to ensure that the penetration length (L3) of the needle 124 is less than the penetration length that would “backwall penetrate” the marrow cavity 70. This can prevent the user from overpenetrating the needle 124 during an emergency placement event.
[0037] In embodiments, as shown in Figure 1BAs shown, the guide plate 130 can also include a needle bushing slot 144 configured to receive a portion of the needle bushing 144 therein. Advantageously, the needle bushing slot 144 can be configured to facilitate alignment of the axis 62 of the needle 124 with the axis of the channel 132. In embodiments, the needle bushing 126 can abut against a portion of the needle bushing slot 144 to prevent the distal tip 129 of the needle 124 from extending beyond a predetermined penetrable length (L3), thereby mitigating penetration of the posterior wall into the bone marrow cavity 70.
[0038] In embodiments, as shown in FIG. 2, the angled IO access system 200 can include a guide block 230 configured to engage one or both of the IO access system 110 and the skin surface 76 and to align the needle 124 at an angle (0) relative to the axis 60 of the skin surface 76 and / or the bone marrow cavity 70. In embodiments, the guide block 230 includes a body 231 having a skin engaging surface 238. In embodiments, the skin engaging surface 238 can be a bottom surface of the body 231. However, it should be appreciated that the skin engaging surface 138 can include one or more surfaces of the body 231. Advantageously, the guide block 230 provides a stable surface upon which the IO access system 110 can be placed. Figure 2
[0039] In embodiments, the guide block 230 can be integrally formed with the driver body 114. In embodiments, the guide block 230 can be coupled to a portion of the driver body 114 using adhesive, bonding, welding, bolts, screws, or similar fasteners or similar suitable means. In embodiments, the guide block 230 can be releasably coupled with the driver body 114 using a clip, a latch, an interference fit, a press fit, a snap fit engagement, or similar suitable mechanism.
[0040] In embodiments, a user can grasp the driver body 114 coupled to the guide block 230 thereof and engage the skin engaging surface 238 with the skin surface 76 of a patient. In this manner, the axis 62 of the needle 124 can be positioned at the predetermined angle (0) relative to the axis 60 of the bone marrow cavity 70, as described herein.
[0041] In embodiments, the IO access system 110 can be slidably engaged with the guide block 230 along the axis 62 of the needle 124. In embodiments, the needle assembly 120 or portions thereof can slide along the axis 62 of the needle 124 relative to one or both of the driver 112 and the guide block 230. In this manner, the skin engaging surface 238 of the guide block 230 can engage the skin surface 76 and angle the axis 62 of the needle 124 relative to the axis 60 of the bone marrow cavity 70, as described herein. The needle 124 can then be slid along the needle axis 62 through the surface tissue 74, the bone cortex 72, and into the bone marrow cavity 70, as described herein.
[0042] In the implementation plan, such as Figures 1A-2 As shown, one of the skin engagement surface 138 of the guide plate 130 or the skin engagement surface 238 of the guide block 230 may define a substantially flat surface. Figure 3 As shown, in an embodiment, the skin engagement surface 138 of the guide plate 130 or the skin engagement surface 238 of the guide block 230 may include a regular or irregular concave or convex surface configured to substantially match the curved shape of the skin surface 76.
[0043] In the implementation plan, such as Figure 3 As shown, the angled I / O entry system 300 may include both a guide plate 130 and a guide block 230 to support and guide the I / O entry system 110 at a predetermined angle (θ) relative to the skin surface 76. In some embodiments, the guide plate 130 may be coupled to the guide block 230 to provide a stable surface for the user to hold a portion of the body 114 of the actuator 112 and to provide guidance for entry into the medullary cavity 70 at a predetermined angle (θ), as described herein.
[0044] In one embodiment, the guide plate 130 may be integrally formed with the guide block 230. In another embodiment, the guide plate 130 may be attached to a portion of the guide block 230 using adhesives, bonding agents, solder, bolts, screws, or similar fasteners or similar suitable means. In yet another embodiment, the guide plate 130 may be releasably attached to the guide block 230 using clips, latches, interference fits, press-fit fits, snap-fit fits, hooks, tabs, slots, or similar suitable mechanisms or combinations thereof. Advantageously, attaching the guide plate 130 and the guide block 230 together can provide increased stability during bone marrow access events to ensure accurate placement of the access needle 124.
[0045] In some embodiments, one or more surfaces of the guide plate body 131 or the guide block body 231 may include an adhesive or the like. For example, an adhesive surface may be disposed on skin engagement surfaces 138, 238 to facilitate securing the guide plate 130 or the guide block 230 to the skin surface 76. In some embodiments, the adhesive surface may be configured to secure one or both of the guide plate 130 and the guide block 230 relative to the IO entry system 110. In some embodiments, one or more surfaces of the guide plate 131 or the guide block body 231 may include a material with a high coefficient of friction, such as silicone rubber, to facilitate securing the guide plate 130 or the guide block 230 relative to the skin surface 76 or the IO entry system 110 or a combination thereof.
[0046] like Figure 4As shown, in embodiments, one of the guide plates 130 or guide blocks 230 can include a guide recess 290 configured to engage the reference point body site 78 and facilitate alignment of the needle 124 with the target region of the bone. For example, the skin engaging surface 238 of the guide block 230 can include a guide recess 290 configured to receive the reference point body site 78, such as the malleolus, carpal bone, or the like, and facilitate alignment of the needle 124 with the target region of the bone. The driver 112 can be coupled to the guide block 230 by the needle assembly 120 disposed proximate the first end 242. The guide recess 290 can be disposed on the skin engaging surface 238 proximate the second end 244, which is disposed opposite the first end 242 along an axis of the guide block 230 that extends substantially parallel to the axis 60 of the skin surface 76 or the medullary cavity 70. In embodiments, the guide recess 290 can be a regular or irregular concave shape and can be configured to engage the reference point body site 78, such as the malleolus, or the like. When the guide block 230 is aligned with the reference point body site 78, the needle 124 of the IO access system 110 will be aligned at an angle (Θ) with the target region of the bone, such as the tibial tuberosity, or the like.
[0047] Advantageously, the guide block 230 including the guide recess 290 can quickly and intuitively align the needle 124 with the target region of the bone, such as the widest portion of the medullary cavity 70, during an emergency placement event where time and the presence of trained personnel can be limited. Furthermore, the guide block 230 can angle the needle 124 relative to the axis 60 of the medullary cavity 70 to further increase the penetrable depth of the needle 124.
[0048] In embodiments, a portion of the guide plate 130 or guide block 230 can be slidably engaged therewith to allow a user to adjust the position of the guide recess 290 relative to the needle 124. For example, as shown, a first portion 130A of the guide plate 130 including the guide recess 290 can be slidably engaged with a second portion 130B of the guide plate 130 supporting the guide plate 130. In this manner, the distance between the guide recess 290 and the needle 124 of the IO access system 110 can be modified to suit different sizes of bones of different patients. For example, the distance between the malleolus and the tibial tuberosity of taller patients can be greater than that of shorter patients. Figure 4
[0049] In an exemplary method of use, the guide plate 130 and guide block 230 assembly can engage the patient's skin surface 76. In an embodiment, concave or convex skin engagement surfaces 138, 238 can engage the patient's curved skin surface 76. In an embodiment, the guide recess 290 can engage the reference point body portion 78 to align the needle 124 with a target area. In an embodiment, the user can adjust the first portion 230A of the guide block 230 relative to the second portion 230B and engage the guide recess 290 with the reference point body portion 78. In an embodiment, the user can align the needle 124 with the channel 132. In an embodiment, the needle 124 can be "preloaded" within the channel 132 before the system 300 engages the skin surface 76. The user can then actuate the driver 112 to rotate the needle assembly 120. In an embodiment, the IO entry system 100 can slide relative to one of the guide plate 130 or guide block 230 to allow the needle 124 to travel through the channel 132. In an embodiment, the needle assembly 120 can be advanced relative to the driver 112 through the channel 132. Then, as described in this article, the needle can penetrate the bone at a predetermined angle (θ) to enter the medullary cavity 70.
[0050] Figures 5A-5B An embodiment of an adjustable-angle I / O access system 400 is shown. The system 400 includes a guide block 430 having a skin engagement surface 438 and one or more notches 432 disposed on one or more surfaces of the guide block 430. The one or more notches 432 can be configured to receive a portion of a actuator body 114 and to position the actuator 112 at one or more predetermined angles relative to the axis 60 of the medullary cavity 70 when the skin engagement surface 438 engages with the skin surface 76.
[0051] For example, such as Figure 5A As shown, a first series of notches 432A of one or more notches 432 can receive one or more portions of the actuator body 114 and position the axis 62 of the needle 124 at a first angle (θ1) relative to the skin surface 76 and / or the bone marrow cavity axis 60. Figure 5B As shown, a second series of notches 432B of one or more notches 432 can accommodate one or more portions of the actuator body 114 and position the axis 62 of the needle 124 relative to the skin surface 76 and / or the bone marrow cavity axis 60 at a second angle (θ2) different from the first angle (θ1). In an embodiment, one of the first angle (θ1) or the second angle (θ2) can be between 1° and 90° relative to the axis 60 of the bone marrow cavity 70. In an embodiment, the guide block 430 may include one or more symbols, alphanumeric symbols, color codes, textures, etc., to indicate which series of notches 432 corresponds to which predetermined angle (θ1, θ2).
[0052] In an example method of use, the skin engaging surface 438 of the guide block 430 can engage the skin surface 76 of the patient. The user can align a portion of the driver body 114 with one of the first series of notches 432A or the second series of notches 432B to selectively align the axis 62 of the needle 124 with one of the first angle (θ1) or the second angle (θ2). The user can then actuate the driver 112 to rotate the needle assembly 120 and cause the needle 124 to be advanced into the bone marrow cavity 70 at one of the first angle (θ1) or the second angle (θ2) as described herein.
[0053] While certain specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in some detail, it is understood that additional adaptations and / or modifications can be made within the scope of the concepts provided herein. It is intended that the concepts provided herein can be practiced otherwise than as specifically disclosed.
Claims
1. An angled intraosseous access system, comprising: comprising: a needle assembly comprising a needle defining a needle axis and configured to enter a medullary cavity of a bone; a driver rotatably coupled to the needle assembly and configured to advance the needle through cortical bone to enter the medullary cavity; and a guide block or both a guide block and a guide plate configured to engage a skin surface and align the needle axis at a predetermined angle relative to a longitudinal axis of the medullary cavity, wherein the guide block comprises a first series of notches and a second series of notches each configured to receive a portion of the driver, the first series of notches configured to align the needle axis at a first predetermined angle and the second series of notches configured to align the needle axis at a second predetermined angle different from the first predetermined angle. The predetermined angle is between 1°-90° relative to the longitudinal axis of the medullary cavity.
2. The angled intraosseous access system of claim 1, wherein, One of the guide plate or the guide block comprises a concave or convex skin engagement surface configured to engage the skin surface.
3. The angled intraosseous access system of claim 1, wherein, The guide plate is coupled to the guide block.
4. The angled intraosseous access system of claim 1, wherein, One of the guide plate or the guide block comprises a guide recess configured to engage a reference point body site and align the needle with a target location.
5. The angled intraosseous access system of claim 1, wherein, The guide recess is disposed on a first portion that is slidably engaged with a second portion of one of the guide plate or the guide block, the second portion being coupled to the needle.
6. The angled intraosseous access system of claim 5, wherein, The guide plate defines a channel configured to receive the needle therethrough and maintain the needle at the predetermined angle.
7. The angled intraosseous access system of claim 1, wherein, One of the guide plate or the guide block is releasably engaged with the driver body.
8. The angled intraosseous access system of claim 1, wherein, One or both of the guide plate and the guide block comprises an adhesive disposed on a surface thereof configured to adhere to one or both of the driver and the skin surface.
9. The angled intraosseous access system of claim 1, wherein, A portion of the guide plate is configured to abut a portion of the needle assembly to prevent a distal tip back wall of the needle from penetrating a distal wall of the medullary cavity.
10. The angled intraosseous access system of claim 1, wherein,
Citation Information
Patent Citations
Autovance Feature of an Intraosseous Device
US20210093354A1
Intraosseous Sterile Barrier and Packaging
US20210093355A1
Constant-Torque Intraosseous Access Devices and Methods Thereof
US20210093356A1
Various Operating Mechanisms for Intraosseous Access Medical Devices and Methods Thereof
US20210093357A1
Step Needle for Intraosseous Access Device
US20210093358A1