Patent Description:
Patients who require IO access report experiencing increased pain during infusion rather than during penetration of the skin surface tissues or bone cortex. The cause of pain may be due to increased pressure in the medullary cavity due to the infused fluids and/or medication. Angling the needle during insertion may direct medication towards larger volumes of the medullary cavity, e.g. the tibial tuberosity, reducing the pressure within the medullary cavity, and in turn reducing discomfort. Further, angling the needle during penetration can mitigate "backwalling," where the access needle traverses the medullary cavity and penetrates the far wall of bone cortex. Disclosed herein are angled intraosseous access systems including an angled guide plate and an angled guide block, and associated methods thereof that address the foregoing. <CIT> relates to an access device configured for inserting an intraosseous catheter into an interior portion of a bone. <CIT> relates to an apparatus and method for introducing portals into bone. <CIT> relates to an instrument for navigating to a target area near a subchondral defect of a bone and associated methods. <CIT> relates to a guide instrument for controlling the depth and trajectory of a surgical access device into a bone.

The present invention is defined by the angled intraosseous access system according to independent claim <NUM>. Optional preferred features are recited in the dependent claims. The methods disclosed are not claimed.

In some embodiments, the predetermined angle is between <NUM>°-<NUM>° relative to the longitudinal axis of the medullary 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 a 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 which is coupled to the needle.

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.

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 against a portion of the needle assembly to prevent a distal tip of the needle from backwalling a far wall of the medullary cavity.

Also disclosed is a method, not forming part of the claimed invention, of accessing a medullary cavity including, 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 to access the medullary cavity at the predetermined angle.

In some embodiments, the predetermined angle is between <NUM>°-<NUM>° relative to a longitudinal axis of the medullary cavity. In some embodiments, the skin engaging surface includes a concave or a convex portion configured to engage the skin surface. In some embodiments, the method further includes coupling the guide plate with a guide block configured to engage the skin surface and a driver of the intraosseous access system and maintain an axis of the driver at the predetermined angle. In some embodiments, the method further includes engaging a guide recess, disposed on the skin engaging surface, with a fiduciary body part to align the needle with a target location.

In some embodiments, the method further includes sliding a first portion of the guide plate including the guide recess disposed thereon, relative to a second portion of the guide plate including the channel, to align the needle with a 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 of the needle from backwalling a far wall of the medullary cavity.

Also disclosed is a method, not forming part of the claimed invention, of accessing a medullary cavity including, engaging a portion of a driver of an intraosseous access system with a surface of the 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 medullary cavity at the predetermined angle.

In some embodiments, the predetermined angle is between <NUM>°-<NUM>° relative to a longitudinal axis of the medullary cavity. In some embodiments, the method further includes engaging a guide recess disposed on the skin engaging surface with a fiduciary body part to align the needle with a target location. In some embodiments, the method further includes sliding a first portion of the guide block including the guide recess disposed thereon, relative to a second portion of the guide block to align the needle with a target location. In some embodiments, the method further includes engaging the 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.

With respect to "proximal," a "proximal portion" or a "proximal-end portion" of, for example, a needle disclosed herein includes a portion of the needle intended to be near a clinician when the needle is used on a patient. Likewise, a "proximal length" of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient. A "proximal end" of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the needle can include the proximal end of the needle; however, the proximal portion, the proximal-end portion, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the needle is not a terminal portion or terminal length of the needle.

With respect to "distal," a "distal portion" or a "distal-end portion" of, for example, a needle disclosed herein includes a portion of the needle intended to be near or in a patient when the needle is used on the patient. Likewise, a "distal length" of, for example, the needle includes a length of the needle intended to be near or in the patient when the needle is used on the patient. A "distal end" of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient. The distal portion, the distal-end portion, or the distal length of the needle can include the distal end of the needle; however, the distal portion, the distal-end portion, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the needle is not a terminal portion or terminal length of the needle.

<FIG> show embodiments of a guide plate angled intraosseous (IO) access system <NUM> configured to penetrate a bone cortex <NUM> and surface tissues <NUM> to access a medullary cavity <NUM>. In an embodiment, the guide plate angled IO access system <NUM> generally includes an IO access system <NUM> and an angled guide plate ("guide plate") <NUM>. The IO access system <NUM> generally includes a driver <NUM> having a body <NUM>, and a needle assembly <NUM> rotatably coupled to the driver <NUM>. In an embodiment, the driver <NUM> includes an automatic driver or a manual driver configured to rotate the needle assembly <NUM> and drill a needle <NUM> through the surface tissues <NUM> and bone cortex <NUM>, access a medullary cavity <NUM> of a bone of a patient.

In an embodiment, the driver <NUM> can include a drive spring, electric motor, or similar electrical, mechanical, electro-mechanical, or kinetic mechanism configured to rotate the needle assembly <NUM> and drill the needle assembly into a bone of a patient. In an embodiment, the needle assembly <NUM> can include a needle <NUM> defining a lumen and supported by a needle hub <NUM>. The needle assembly <NUM> can further include an obturator <NUM> disposed within the lumen of the needle <NUM> and supported by an obturator hub <NUM>. The obturator <NUM> can be configured to prevent tissue and bone fragments from entering the needle lumen during a placement event and occluding a fluid flow through the needle lumen. Once the needle <NUM> has been placed, the driver <NUM> and obturator <NUM> can be removed. Fluids and/or medications can flow through the needle lumen and into the medullary cavity <NUM> to infuse into the vasculature of the patient. Further details and embodiments of IO access systems can be found, for example in the following published applications: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

In an embodiment, the guide plate <NUM> includes a body <NUM> defining a skin engaging surface <NUM>, and a channel <NUM> extending at an angle (Θ) relative to a longitudinal axis of the body <NUM>. In an embodiment, the skin engaging surface <NUM> can be a bottom surface of the body <NUM>. However, it will be appreciated that the skin engaging surface <NUM> can include one or more surfaces of the body <NUM>. In an embodiment, the skin engaging surface <NUM> of the guide plate <NUM> can engage a skin surface <NUM> and align the channel <NUM> at an angle (Θ) relative thereto. In an embodiment, the guide plate <NUM> align the channel <NUM> at an angle (Θ) relative to a longitudinal axis <NUM> of the medullary cavity <NUM>. In an embodiment, the angle (Θ) of the channel <NUM> can be between <NUM>° and <NUM>°. In an embodiment, the angle (Θ) of the channel <NUM> can be between <NUM>°-<NUM>°. In an embodiment, the angle (Θ) of the channel <NUM> can be substantially <NUM>°, however greater or lesser angles are also contemplated.

In an embodiment, a diameter of the channel <NUM> can be equal to or slightly larger than a diameter of the needle <NUM>. As such, the needle <NUM> can slidably engage the channel <NUM> and substantially align an axis <NUM> of the needle <NUM> with an axis of the channel <NUM>. In some embodiments, the diameter of the guide plate channel <NUM> may be a consistent diameter along the length thereof. In some embodiments, the guide plate channel <NUM> or portion thereof may define a tapered shape, having a greater diameter proximate a first end relative to a second end, opposite the first end. In some embodiments, an entrance of the guide plate channel <NUM> may be tapered to facilitate aligning a needle <NUM> with the channel <NUM>.

In an exemplary method of use, a user can engage a skin engaging surface <NUM> of the guide plate <NUM> with a skin surface <NUM> and align the channel <NUM> with a target insertion site. The user can then align the needle <NUM> with the channel <NUM> and advance a distal tip <NUM> of the needle <NUM> through the channel <NUM>. Advancing the needle <NUM> through the channel <NUM> can align an axis <NUM> of the needle <NUM> with the axis of the channel <NUM>. A user can then actuate the driver <NUM> to rotate the needle assembly <NUM> and "drill" the needle <NUM> into the patient. The needle <NUM> can then penetrate the surface tissues <NUM>, hard bone cortex <NUM> and the medullary cavity <NUM> at the predetermined angle (Θ) defined by the channel <NUM>.

In an embodiment, the guide plate <NUM> can be coupled to the IO access system <NUM> and the guide plate <NUM> can be slidably engaged with the needle <NUM>. As such, a user can support the skin engaging surface <NUM> against the skin surface <NUM> and the guide plate <NUM> can further support the IO access system <NUM> with the needle axis <NUM> aligned with the channel <NUM>. The user can then actuate the driver <NUM> and urge the IO access system <NUM> including the needle <NUM> along the needle axis <NUM> at the predetermined angle (Θ) defined by the channel <NUM>. The needle <NUM> can slide through the channel <NUM> to penetrate the bone at the predetermined angle (Θ), as described herein.

In an embodiment, the guide plate <NUM> can be coupled to the IO access system <NUM>, and the needle assembly <NUM> can be slidably engaged relative to the IO access system <NUM> and guide plate <NUM> assembly. As such, a user can support the skin engaging surface <NUM> against the skin surface <NUM> and the guide plate <NUM> can further support the IO access system <NUM> with the needle axis <NUM> aligned with the channel <NUM>. The user can then actuate the driver <NUM> and the IO access system <NUM> can urge the needle <NUM> along the needle axis <NUM> to penetrate the bone at the predetermined angle (Θ), as described herein.

Advantageously, the insertion angle (Θ) of the needle <NUM> can direct a fluid flow through the needle lumen towards the wider regions of the medullary cavity <NUM>, for example at a head of the bone, and can reduce the pressure within the medullary cavity <NUM> as the fluids and/or medications are transfused. Advantageously, the guide plate <NUM> can be configured to align the needle <NUM> at an angle (Θ) relative to the axis <NUM> of the medullary cavity <NUM> and can increase the penetrable depth (d) of the medullary cavity <NUM>. As shown in <FIG>, for a given location within the medullary cavity <NUM>, a perpendicular penetrable depth (d1) (i.e. when the needle is angled perpendicular to the axis <NUM> of the medullary cavity <NUM>) is less than an angled penetrable depth (d2) (i.e. when the needle is angled (Θ) relative to the medullary axis <NUM>). As such, the angled penetrable depth (d2) mitigates the needle <NUM> from "backwalling" the far side of the medullary cavity <NUM>. Further, in an embodiment, the guide plate <NUM> can be configured to align the needle <NUM> with the widest portion of the medullary cavity <NUM>, e.g. at the head of the bone, as described in more detail herein.

In an embodiment, as shown in <FIG>, the length of the needle <NUM> extending between the needle hub <NUM> at a proximal end and a distal tip <NUM> can define a first length (L1). The channel <NUM> can define a second length (L2), less than the first length (L1), and extending axially. In an embodiment, the needle <NUM> can be advanced through the channel <NUM> until the distal tip <NUM> extends through the skin engaging surface <NUM> and a portion of the hub <NUM> abuts against a portion of the guide plate body <NUM>, proximate the channel entrance <NUM>. As such, with the skin engaging surface <NUM> contacting the skin surface <NUM>, the distal tip <NUM> can extend through the channel <NUM> and penetrate the underlying tissues <NUM>, bone cortex <NUM>, etc. In an embodiment, the length (L2) of the channel <NUM> can be predetermined such that a portion of the needle <NUM> extends through the surface tissues <NUM>, bone cortex <NUM> and into the medullary cavity <NUM> by a penetration length, or third length (L3). In an embodiment, the third length (L3) is the length of the needle (L1) less the length (L2) of the channel <NUM>. Advantageously, the length (L1) of the needle <NUM> and the length (L2) of the channel <NUM> can be predetermined to ensure the penetration length (L3) of the needle <NUM> is less than a penetration length that would "backwall" the medullary cavity <NUM>. This can prevent a user from over penetrating the needle <NUM> during an emergency placement event.

In an embodiment, as shown in <FIG>, the guide plate <NUM> can further include a needle hub slot <NUM> configured to receive a portion of the needle hub <NUM> therein. Advantageously, the needle hub slot <NUM> can be configured to facilitate aligning the axis <NUM> of the needle with axis of the channel <NUM>. In an embodiment, the needle hub <NUM> can abut against a portion of the needle hub slot <NUM> to prevent the distal tip <NUM> of the needle <NUM> from extending beyond the predetermined penetrable length (L3), mitigating backwalling of the medullary cavity <NUM>.

In an embodiment, as shown in <FIG>, an angled IO access system <NUM> can include a guide block <NUM>, configured to engage one or both of the IO access system <NUM> and the skin surface <NUM> and align the needle <NUM> at an angle (Θ) relative to the skin surface <NUM> and/or an axis <NUM> of the medullary cavity <NUM>. In an embodiment, the guide block <NUM> includes a body <NUM> having a skin engaging surface <NUM>. In an embodiment, the skin engaging surface <NUM> can be a bottom surface of the body <NUM>. However, it will be appreciated that the skin engaging surface <NUM> can include one or more surfaces of the body <NUM>. Advantageously, the guide block <NUM> provides a stable surface for IO access system <NUM> to rest on.

In an embodiment, the guide block <NUM> can be integrally formed with the driver body <NUM>. In an embodiment, the guide block <NUM> can be coupled to a portion of the driver body <NUM> using adhesive, bonding, welding, bolts, screws, or similar fasteners, or similar suitable means. In an embodiment, the guide block <NUM> can be releasably coupled with the driver body <NUM> using a clip, latch, interference fit, press-fit, or snap-fit engagement, or similar suitable mechanism.

In an embodiment, a user can grasp the driver body <NUM> with the guide block <NUM> coupled thereto, and engage the skin engaging surface <NUM> with the skin surface <NUM> of the patient. As such, an axis <NUM> of the needle <NUM> can be positioned at a predetermined angle (Θ) relative to the axis <NUM> of the medullary cavity <NUM>, as described herein.

In an embodiment, the IO access system <NUM> can be slidably engaged with the guide block <NUM> along the axis <NUM> of the needle <NUM>. In an embodiment, the needle assembly <NUM> or portions thereof can be slidable relative to one or both of the driver <NUM> and the guide block <NUM>, along the axis <NUM> of the needle <NUM>. As such, the skin engaging surface <NUM> of the guide block <NUM> can engage the skin surface <NUM> and angle the axis <NUM> of the needle <NUM> relative to the axis <NUM> of the medullary cavity <NUM>, as described herein. The needle <NUM> can then slide along the needle axis <NUM> through the surface tissues <NUM>, bone cortex <NUM>, and access the medullary cavity <NUM>, as described herein.

In an embodiment, as shown in <FIG>, one of the skin engaging surface <NUM> of the guide plate <NUM>, or the skin engaging surface <NUM> of the guide block <NUM> can define a substantially flat surface. As shown in <FIG>, in an embodiment, the skin engaging surface <NUM> of the guide plate <NUM>, or the skin engaging surface <NUM> of the guide block <NUM> can include a regular or irregular concave or convex surface configured to substantially match a curved shape of a skin surface <NUM>.

In an embodiment, as shown in <FIG>, an angled IO access system <NUM> can include both the guide plate <NUM>, and the guide block <NUM> to support and guide the IO access system <NUM> at a predetermined angle (Θ) relative to the skin surface <NUM>. In some embodiments, the guide plate <NUM> can be coupled to the guide block <NUM> to provide the user with a stable surface to rest a portion of the body <NUM> of the driver <NUM> and provide a guide for accessing the medullary cavity <NUM> at a predetermined angle (Θ), as described herein.

In an embodiment, the guide plate <NUM> can be integrally formed with the guide block <NUM>. In an embodiment, the guide plate <NUM> can be coupled to a portion of the guide block <NUM> using adhesive, bonding, welding, bolts, screws, or similar fasteners, or similar suitable means. In an embodiment, the guide plate <NUM> can be releasably coupled with the guide block <NUM> using a clip, latch, interference fit engagement, press-fit engagement, snap-fit engagement, hook, tab, slot, or similar suitable mechanism, or combinations thereof. Advantageously, the guide plate <NUM> and the guide block <NUM> being coupled together can offer increased stability during a medullary access event to ensure accurate placement of the access needle <NUM>.

In an embodiment, one or more surfaces of the guide plate body <NUM> or the guide block body <NUM> can include an adhesive or the like. For example, the adhesive surface can be disposed on a skin engaging surface <NUM>, <NUM> to facilitate securing the guide plate <NUM> or guide block <NUM> to the skin surface <NUM>. In an embodiment, the adhesive surface can be configured to secure one or both of the guide plate <NUM> and the guide block <NUM> relative to the IO access system <NUM>. In an embodiment, one or more surfaces of the guide plate <NUM> or the guide block body <NUM> can include a material, e.g. silicone rubber, or the like, having a high frictional coefficient to facilitate securing the guide plate <NUM> or guide block <NUM> relative to the skin surface <NUM>, or to the IO access system <NUM>, or combinations thereof.

As shown in <FIG>, in an embodiment, one of the guide plate <NUM> or the guide block <NUM> can include a guide recess <NUM> configured to engage a fiduciary body part <NUM> and to facilitate alignment of the needle <NUM> with a target area of bone. For example, a skin engaging surface <NUM> of the guide block <NUM> can include a guide recess <NUM> configured to receive the fiduciary body part <NUM>, e.g. ankle bone, wrist bone, or the like, and to facilitate alignment of the needle <NUM> with a target area of bone. The driver <NUM> can be coupled to the guide block <NUM> with a needle assembly <NUM> disposed proximate a first end <NUM>. The guide recess <NUM> can be disposed on a skin engaging surface <NUM> proximate a second end <NUM>, disposed opposite the first end <NUM> along an axis of the guide block <NUM> extending substantially parallel to the skin surface <NUM> or the axis <NUM> of the medullary cavity <NUM>. In an embodiment, the guide recess <NUM> can be a regular or irregular concave shape and can be configured to engage a fiduciary body part <NUM>, e.g. an ankle bone or the like. When the guide block <NUM> is aligned with the fiduciary body part <NUM>, the needle <NUM> of the IO access system <NUM> will be aligned at an angle (Θ) with a target area of bone, e.g. a tibial tuberosity, or the like.

Advantageously, the guide block <NUM> including the guide recess <NUM> can quickly and intuitively align the needle <NUM> with a target area of the bone, e.g. the widest portion of the medullary cavity <NUM>, during an emergency placement event where time and availability of trained personnel may be limited. Further, the guide block <NUM> can angle the needle <NUM> relative to the axis <NUM> of the medullary cavity <NUM> to further increase a penetrable depth for the needle <NUM>.

In an embodiment, a portion of the guide plate <NUM> or the guide block <NUM> can be slidably engaged therewith, to allow a user to adjust the position of the guide recess <NUM> relative to the needle <NUM>. For example, as shown in <FIG>, a first portion 230A of the guide block <NUM> that includes the guide recess <NUM> can be slidably engaged with a second portion 230B of the guide block <NUM> that supports the IO access system <NUM>. As such, the distance between the guide recess <NUM> and the needle <NUM> of the IO access system <NUM> can be modified to suit different size bones of different patients. For example, taller patients may have a greater distance between the ankle body and the tibial tuberosity than shorter patients.

In an exemplary method of use, the guide plate <NUM> and guide block <NUM> assembly can engage a skin surface <NUM> of a patient. In an embodiment, a concave or convex skin engaging surface <NUM>, <NUM> can engage a curved skin surface <NUM> of the patient. In an embodiment, a guide recess <NUM> can engage a fiduciary body part <NUM> to align the needle <NUM> with a target area. In an embodiment, the user can adjust a first portion 230A of the guide block <NUM> relative to a second portion 230B and engage the guide recess <NUM> with the fiduciary body part <NUM>. In an embodiment, the user can align the needle <NUM> with the channel <NUM>. In an embodiment, the needle <NUM> can be "preloaded" within the channel <NUM> prior to the system <NUM> engaging the skin surface <NUM>. The user can then actuate the driver <NUM> to rotate the needle assembly <NUM>. In an embodiment, the IO access system <NUM> can slide relative to one of the guide plate <NUM> or the guide block <NUM> to advance the needle <NUM> through the channel <NUM>. In an embodiment, the needle assembly <NUM> can advance through the channel <NUM> relative to the driver <NUM>. The needle can then penetrate the bone at the predetermined angle (Θ) to access the medullary cavity <NUM>, as described herein.

<FIG> show an embodiment of an adjustable angle IO access system <NUM> including a guide block <NUM> having a skin engaging surface <NUM> and one or more notches <NUM> disposed on one or more surfaces of the guide block <NUM>. The one or more notches <NUM> can be configured to receive a portion of the driver body <NUM> and position the driver <NUM> at one or more predetermined angles relative to the axis <NUM> of the medullary cavity <NUM> when the skin engaging surface <NUM> engages a skin surface <NUM>.

For example, as shown in <FIG>, a first series of notches 432A of the one or more notches <NUM> can receive one or more portions of the driver body <NUM> and position an axis <NUM> of the needle <NUM> at a first angle (Θ1) relative to the skin surface <NUM> and/or medullary cavity axis <NUM>. As shown in <FIG>, a second series of notches 432B of the one or more notches <NUM> can receive one or more portions of the driver body <NUM> and position an axis <NUM> of the needle <NUM> at a second angle (Θ2) relative to the skin surface <NUM> and/or medullary cavity axis <NUM> different from the first angle (Θ1). In an embodiment, one of the first angle (Θ1) or the second angle (Θ2) can be between <NUM>°-<NUM>° relative to the axis <NUM> of the medullary cavity <NUM>. In an embodiment, the guide block <NUM> can include one or more symbols, alphanumeric symbols, color codes, textures, or the like to indicate which series of notches <NUM> corresponds with which predetermined angles (Θ1, Θ2).

In an exemplary method of use, a skin engaging surface <NUM> of the guide block <NUM> can engage a skin surface <NUM> of the patient. The user can align a portion of the driver body <NUM> with one of the first series of notches 432A or the second series of notches 432B to selectively align an axis <NUM> of the needle <NUM> with one of the first angle (Θ1) or the second angle (Θ2). The user can then actuate the driver <NUM> to rotate the needle assembly <NUM> and advance the needle <NUM> into the medullary cavity <NUM>, as described herein, at one of the first angle (Θ1) or the second angle (Θ2).

Claim 1:
An angled intraosseous access system, comprising:
a needle assembly (<NUM>) including a needle (<NUM>) defining a needle axis (<NUM>) and configured to access a medullary cavity (<NUM>) of a bone;
a driver (<NUM>) rotatably coupled to the needle assembly (<NUM>) and configured to advance the needle (<NUM>) through a bone cortex (<NUM>) to access the medullary cavity (<NUM>); and
a guide block (<NUM>) configured to engage a skin surface (<NUM>) and align the needle axis (<NUM>) at a predetermined angle relative to a longitudinal axis (<NUM>) of the medullary cavity (<NUM>),
wherein the guide block (<NUM>) includes a first series of notches (432A) and a second series of notches (432B) each configured to receive a portion of the driver (<NUM>), the first series of notches (432A) configured to align the needle axis (<NUM>) with a first predetermined angle, the second series of notches (432B) configured to align the needle axis (<NUM>) with a second predetermined angle different from the first predetermined angle.