Intraosseous access device and method of accessing bone marrow

Abstract

The present invention discloses a puncture assembly operable to provide access to an intrabone space. The puncture assembly may include a flexible outer puncture having a longitudinal hole and a distal end operable to penetrate a bone and associated bone marrow. The puncture assembly may also include a rigid inner puncture, which includes a distal end operable to penetrate a bone and associated bone marrow. An axle with a distal end is connected to the proximal end of the flexible outer puncture. A connector with a distal end is connected to the proximal end of the rigid inner puncture. The proximal end of the connector can releasably engage a driver. The longitudinal hole of the flexible outer puncture can removably accommodate the rigid inner puncture to prevent or minimize bending of the flexible outer puncture during insertion. After the rigid inner puncture is removed from the longitudinal hole, the flexible outer puncture puncture can bend.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 670,691, filed May 11, 2018, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present application generally relates to medical instruments for accessing intraosseous spaces, and more particularly, to intraosseous devices and methods for penetrating a bone and accessing the associated bone marrow to perform a medical procedure. Background Art

[0004] An important factor in treating critically ill patients is the rapid establishment of intravenous (IV) access to administer medications and fluids directly into the circulatory system. Whether in the ambulance of a paramedic or in the emergency room of an emergency specialist, the goal is the same: to start an IV to infuse life-saving medications and fluids. The successful treatment of such critical emergencies depends largely on the skill and luck of the operator performing vascular access. While it is relatively easy to perform IV injections in some patients, for most patients, it is often very difficult for doctors, nurses and paramedics to establish IV access. To address this issue, these patients often need to be repeatedly probed with a sharp needle, and invasive procedures are required to ultimately establish IV access. Another complicating factor in achieving IV access occurs "in the field", such as at the scene of an accident or during ambulance transportation, where difficult visualization and excessive movement of the target make access to the venous system very difficult.

[0005] For chronically ill or elderly patients, easily accessible veins may not be found. Other patients have no available IV sites due to anatomical paucity of peripheral veins, obesity, severe dehydration, or prior use of IV medications. For these patients, finding an appropriate site to administer life-saving treatments often becomes a significant and frustrating task. Many critically ill patients die from subsequent complications due to delayed or impossible access to the vascular system for life-saving IV treatments.

[0006] For such patients, utilizing the intraosseous (IO) space to provide direct access to the patient's vascular system provides an attractive alternative route for administering IV medications and fluids. Medications administered intraosseously can enter the patient's bloodstream as quickly as those administered intravenously. However, it is critical to properly place the intraosseous needle at the target site. If the user inserts the needle in the wrong location, the bone may be too thick for the needle to penetrate. Or, somewhere else, the bone may be too thin and the needle may penetrate completely through the entire bone, passing through the intraosseous space. Additionally, placing the needle in the bone at an angle that is not substantially perpendicular to the patient's chest may result in the needle breaking or other complications.

[0007] In addition, conventional rigid cannulas inserted into bones may be accidentally dislodged due to impact or patient movement. For example, when the patient's arm moves, that is, when the patient raises the arm above the head, or when the patient accidentally displaces the inserted cannula to a certain position, such a rigid cannula inserted into the patient's humerus may be accidentally dislodged. Therefore, a trocar assembly with a flexible cannula is needed to prevent or reduce the possibility of it being accidentally dislodged from the patient's bone target site. Summary of the invention

[0008] Embodiments of the puncture assembly of the present invention can meet the aforementioned needs, wherein the puncture assembly is operable to provide access to the intrabone space. According to one aspect of the present invention, the puncture assembly includes a flexible outer puncture, the flexible outer puncture including a longitudinal hole and a distal end operable to penetrate the bone and associated bone marrow; a rigid inner puncture, the rigid inner puncture including a distal end operable to penetrate the bone and associated bone marrow; a hub having a distal end connected to the proximal end of the flexible outer puncture; a connector having a distal end connected to the proximal end of the rigid inner puncture and a proximal end configured to releasably engage a driver, and the longitudinal hole of the flexible outer puncture is configured to removably accommodate the rigid inner puncture to prevent or minimize bending of the flexible outer puncture during insertion, and the flexible outer puncture is configured to bend after the rigid inner puncture is removed from the longitudinal hole.

[0009] According to another aspect of the present invention, the piercer assembly further comprises a depth control ring connected to the outer piercer and adjacent to the distal end of the outer piercer, the depth control ring comprising a distal end operable to contact the bone to prevent the inner piercer and the outer piercer from further penetrating into the intrabone space.

[0010] According to another aspect of the present invention, the trocar assembly further comprises a distal cutting sleeve secured to the distal end of the outer trocar and operable to penetrate a bone and associated bone marrow.

[0011] According to another aspect of the invention, the flexible outer piercer includes a plurality of slits operable to cause the outer piercer to bend after the rigid inner piercer is removed from the longitudinal bore of the flexible outer piercer.

[0012] According to another aspect of the present invention, a plurality of slits are provided along a middle portion of the flexible outer piercing device, the middle portion being located between the distal end and the proximal end of the flexible outer piercing device.

[0013] According to another aspect of the invention, a plurality of slits are arranged in a pattern along the length of the intermediate portion of the flexible outer piercer.

[0014] According to another aspect of the present invention, the pattern of the plurality of slits includes three cutting lines per pitch.

[0015] According to another aspect of the invention, each slit in the pattern of the plurality of slits is rotationally increased by 90 degrees.

[0016] According to another aspect of the present invention, at least one of the plurality of slits is an elongated cut in a wall of the flexible outer piercer.

[0017] According to another aspect of the present invention, at least one of the plurality of slits is a perforation in the wall of the flexible outer piercer.

[0018] According to another aspect of the present invention, at least one of the plurality of slits is a notch or groove in the flexible outer piercer wall.

[0019] According to another aspect of the present invention, the plurality of slits are formed by laser.

[0020] According to another aspect of the present invention, the plurality of slits are formed by chemical etching.

[0021] According to another aspect of the present invention, the plurality of slits are formed by water seal blasting.

[0022] According to another aspect of the invention, a covering sleeve may be attached to the flexible outer piercing device, the covering sleeve being operable to prevent or minimize leakage of material from the flexible outer piercing device.

[0023] According to another aspect of the present invention, the covering sleeve is configured to cover a middle portion of the flexible outer piercer, and the covering sleeve is operable to prevent or minimize leakage of material from the plurality of slits.

[0024] According to another aspect of the present invention, the covering sleeve is operable to bend when the flexible outer piercer is bent.

[0025] According to another aspect of the invention, the covering sleeve is operable to prevent or reduce leakage of material under high pressure through the outer piercer.

[0026] According to another aspect of the present invention, the covering sleeve is a heat shrink tube.

[0027] According to another aspect of the invention, the covering sleeve comprises a polymer.

[0028] According to another aspect of the present invention, the covering sleeve comprises fluorinated ethylene propylene.

[0029] According to another aspect of the present invention, the covering sleeve is transparent.

[0030] According to another aspect of the present invention, the covering sleeve is a spiral hollow strand tube.

[0031] According to another aspect of the present invention, the outer diameter of the covering sleeve is smaller than or equal to the outer diameter of the ring.

[0032] According to another aspect of the present invention, the outer diameter of the covering sleeve is smaller than or equal to the outer diameter of the distal cutting sleeve.

[0033] According to another aspect of the invention, the distal end of the connector is configured to releasably engage the proximal end of the axle.

[0034] According to another aspect of the invention, the distal end of the connector includes a female threaded portion, and the proximal end of the axle includes a male threaded portion, and the male threaded portion and the female threaded portion are operable to threadably engage the axle to the connector.

[0035] According to another aspect of the present invention, the connector includes a socket configured to receive a drive shaft of a driver.

[0036] According to another aspect of the present invention, the socket is further configured to releasably engage a drive shaft of the driver.

[0037] According to another aspect of the invention, the socket includes a generally conical formation operable to releasably mate with a tapered portion of a drive shaft of a driver.

[0038] According to another aspect of the invention, the socket further includes a magnetic disk operable to releasably engage a magnetic drive shaft of the driver.

[0039] According to another aspect of the present invention, the flexible outer puncture device is a cannula.

[0040] According to another aspect of the present invention, the rigid inner puncture device is a stylet.

[0041] According to another aspect of the invention, a piercer assembly operable to provide access to an intrabone space includes a slotted drill bit operable to penetrate a bone and associated bone marrow; a flexible cannula including a longitudinal bore and a distal end connected to the slotted drill bit; a rigid stylet configured to be releasably received within the longitudinal bore of the flexible cannula, the rigid stylet being operable to prevent or minimize bending of the flexible cannula during insertion when the rigid stylet is within the longitudinal bore of the flexible cannula, and the flexible cannula being configured to bend after the rigid stylet is removed from the longitudinal bore; an axle having a distal end connected to a proximal end of the flexible cannula; and a connector having a distal end connected to the proximal end of the rigid stylet and a proximal end configured to releasably engage a driver.

[0042] According to another aspect of the present invention, the fluted drill bit includes a head, a body portion, and cutting grooves extending along the head and body portions, the cutting grooves forming a channel that can be operated to allow blood and / or bone marrow samples to be aspirated from the intrabone space or to deliver drugs to the intrabone space.

[0043] According to another aspect of the invention, the flexible sleeve includes a plurality of slits operable to cause the flexible sleeve to bend after the rigid stylet is removed from the longitudinal bore of the flexible sleeve.

[0044] According to another aspect of the present invention, the plurality of slits are disposed along a middle portion of the flexible outer sleeve, the middle portion being located between the distal end and the proximal end of the flexible sleeve.

[0045] According to another aspect of the invention, a plurality of slits are arranged in a pattern along the length of the intermediate portion of the flexible sleeve.

[0046] According to another aspect of the present invention, the pattern of the plurality of slits includes three cutting lines per pitch.

[0047] According to another aspect of the invention, each slit in the pattern of the plurality of slits is rotationally increased by 90 degrees.

[0048] According to another aspect of the invention, at least one of the plurality of slits is an elongated cutout in the wall of the flexible sleeve.

[0049] According to another aspect of the invention, at least one of the plurality of slits is a perforation in the wall of the flexible sleeve.

[0050] According to another aspect of the invention, at least one of the plurality of slits is a notch or groove in the wall of the flexible sleeve.

[0051] According to another aspect of the present invention, the plurality of slits are formed by laser.

[0052] According to another aspect of the present invention, the plurality of slits are formed by chemical etching.

[0053] According to another aspect of the present invention, the plurality of slits are formed by water-sealed blasting.

[0054] According to another aspect of the invention, a covering sleeve may be attached to the flexible sleeve, the covering sleeve being operable to prevent or minimize leakage of material from the flexible sleeve.

[0055] According to another aspect of the present invention, the covering sleeve is configured to cover a middle portion of the flexible sleeve, and the covering sleeve is operable to prevent or minimize leakage of material from the plurality of slits.

[0056] According to another aspect of the present invention, the covering sleeve is operable to bend when the flexible sleeve is bent.

[0057] According to another aspect of the invention, the cover sleeve is operable to prevent or reduce leakage of material passing through the casing under high pressure.

[0058] According to another aspect of the present invention, the covering sleeve is a heat shrink tube.

[0059] According to another aspect of the invention, the covering sleeve comprises a polymer.

[0060] According to another aspect of the present invention, the covering sleeve comprises fluorinated ethylene propylene.

[0061] According to another aspect of the present invention, the covering sleeve is transparent.

[0062] According to another aspect of the present invention, the covering sleeve is a spiral hollow strand tube.

[0063] According to another aspect of the present invention, the outer diameter of the covering sleeve is smaller than or equal to the outer diameter of the head of the fluted cutting tip.

[0064] According to another aspect of the invention, the distal end of the connector is configured to releasably engage the proximal end of the axle.

[0065] According to another aspect of the invention, the distal end of the connector includes a female threaded portion, and the proximal end of the axle includes a male threaded portion, and the male threaded portion and the female threaded portion are operable to threadably engage the axle to the connector.

[0066] According to another aspect of the invention, the connector includes a socket configured to receive a drive shaft of the driver.

[0067] According to another aspect of the present invention, the socket is further configured to releasably engage a drive shaft of the driver.

[0068] According to another aspect of the invention, the socket includes a generally conical formation operable to releasably mate with a conical portion of a drive shaft of a driver.

[0069] According to another aspect of the invention, the socket further comprises a magnetic disk operable to releasably engage a magnetic portion of a drive shaft of the driver.

[0070] According to another aspect of the present invention, a puncture assembly operable to provide access to an intrabone space includes a rigid stylet including a distal end operable to penetrate a bone and associated bone marrow; a cannula having a distal end operable to penetrate a bone and associated bone marrow; a longitudinal hole configured to receive a portion of the rigid stylet; a flexible tube attached to an outer surface of a portion of the cannula to provide fluid communication between the cannula and the axle, the flexible tube configured to receive a portion of the rigid stylet; and the rigid stylet is configured to support the flexible tube during insertion.

[0071] According to another aspect of the present invention, the sleeve further comprises a proximal end forming a female lock portion.

[0072] According to another aspect of the present invention, the rigid stylet further comprises a key section including a distal end forming a male key portion which cooperates with a female lock portion at the proximal end of the cannula to ensure that the distal end of the cannula is properly oriented relative to the distal end of the stylet to form a cutting tip that can penetrate bone and associated bone marrow.

[0073] According to another aspect of the present invention, the flexible tube is transparent.

[0074] In order that the detailed description of the invention and the contribution to the art may be better understood, the above has outlined certain aspects of the invention. Further embodiments of the invention will be described below and form the subject of the appended claims.

[0075] In the present invention, before explaining in detail at least one aspect of the piercer assembly, it should be understood that the application of the piercer assembly is not limited to the construction details and the arrangement of the components set forth in the following description or shown in the accompanying drawings. The piercer assembly can have other aspects in addition to the described aspects and can be practiced and implemented in various ways. In addition, it should be understood that the words and terms used herein and in the abstract are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0076] Those skilled in the art will appreciate that the concepts upon which the present invention is based can be readily used as the basis for other structures, methods and systems that achieve the several purposes of the piercer assembly. In addition, it is important that the claims are considered to include equivalent constructions without departing from the spirit and scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] In order that the present invention may be readily understood, various aspects of an intraosseous (IO) access device are shown by way of example in the drawings wherein like parts are designated by like reference numerals throughout.

[0078] Figure 1 It is a perspective view of the intraosseous needle assembly of the present invention.

[0079] Figure 2 for Figure 1 An exploded perspective view of an intraosseous needle set.

[0080] Figure 3 for Figure 1 Side cross-sectional view of an intraosseous needle assembly.

[0081] Figure 4 for Figure 1 A side cross-sectional view of the separation of the inner puncture device and the outer puncture device of the intrabone needle assembly.

[0082] Figure 5 Shows Figure 1 The tip part of the intraosseous needle set.

[0083] Fig. 6A for Figure 1 A top view of the inner puncture tip portion of the intraosseous needle assembly.

[0084] Figure 6B for Figure 1 A side view of the inner puncture tip portion of the intraosseous needle set.

[0085] Fig. 7A for Figure 1 Side view of the outer puncture device of the intraosseous needle set.

[0086] Figure 7B for Figure 1 A top view of the outer puncture device of the intraosseous needle assembly.

[0087] Figure 7C According to another aspect of the present invention, Figure 1 The tip part of the needle set.

[0088] Fig.7D According to another aspect of the present invention, Figure 1 The outer trocar part of the needle set.

[0089] Fig. 7E Shows Fig.7D The outer trocar is restored to its original shape.

[0090] Figure 7F According to another aspect of the present invention, Figure 1 The tip part of the needle set.

[0091] Figure 7G According to another aspect of the present invention, Figure 1 Part of the outer trocar of the needle set.

[0092] Figure 7HShows Figure 7G The outer trocar is restored to its original shape.

[0093] Fig.7I According to another aspect of the present invention, Figure 1 The tip part of the needle set.

[0094] Figure 7J According to another aspect of the present invention, Figure 1 Part of the outer trocar of the needle set.

[0095] Figure 7K Shows Figure 7J The outer trocar is restored to its original shape.

[0096] Figure 7L According to another aspect of the present invention, Figure 1 The tip part of the needle set.

[0097] Figure 7M According to another aspect of the present invention, Figure 1 Part of the outer trocar of the needle set.

[0098] Figure 7N Shows Figure 7M The outer trocar is restored to its original shape.

[0099] Fig.7O According to another aspect of the present invention, Figure 1 The tip part of the needle set.

[0100] Figure 7P According to another aspect of the present invention, Figure 1 Part of the outer trocar of the needle set.

[0101] Figure 7Q Shows Figure 7P The outer trocar is restored to its original shape.

[0102] Figure 8 for Figure 1 Rear perspective view of the connector of the intraosseous needle set.

[0103] Fig. 9 is a perspective view of an intraosseous needle assembly with a depth control ring according to the present invention.

[0104] Fig.10 for Fig. 9 An exploded perspective view of an intraosseous needle set.

[0105] Fig.11 for Fig. 9 Side cross-sectional view of an intraosseous needle assembly.

[0106] Fig.12 for Fig. 9A side cross-sectional view of the separation of the inner puncture device and the outer puncture device of the intrabone needle assembly.

[0107] Fig.13 1 is a perspective view of an intraosseous needle assembly with a distal cutting sleeve according to the present invention.

[0108] Fig.14 for Fig.13 An exploded perspective view of an intraosseous needle set.

[0109] Fig.15 for Fig.13 Side cross-sectional view of an intraosseous needle assembly.

[0110] Fig.16 for Fig.13 A side cross-sectional view of the separation of the inner puncture device and the outer puncture device of the intrabone needle assembly.

[0111] Fig.17 Shows Fig.13 The tip part of the intraosseous needle set.

[0112] Fig.18A 1 is a side view of a distal cutting sleeve according to the present invention.

[0113] Fig.18B FIG. 4 is a top view of a distal cutting sleeve according to the present invention.

[0114] Fig.19 is a perspective view of an intraosseous needle assembly having a fluted cutting drill bit according to the present invention.

[0115] Fig. 20 for Fig.19 An exploded perspective view of an intraosseous needle set.

[0116] Fig.21 for Fig.19 Side cross-sectional view of an intraosseous needle assembly.

[0117] Fig. 22 FIG. 4 is a front view of a fluted cutting drill bit according to the present invention.

[0118] Fig.23 for Fig.19 A partial cross-sectional view of a portion of an intraosseous needle set.

[0119] Fig.24 1 is a side view of a fluted cutting drill bit according to the present invention.

[0120] Fig.25A An intraosseous needle set having a key system according to one aspect of the present invention is shown.

[0121] Fig.25B Shows Fig.25A The tip part of the intraosseous needle set.

[0122] Fig.25C A manual driver connected to an intraosseous needle set having a key system is shown according to one aspect of the present invention.

[0123] Fig.26 An intraosseous needle set according to one aspect of the present invention is shown, wherein the rigid inner piercing member is separated from the flexible outer piercing member.

[0124] Fig. 27 Shows Fig.26 A flexible outer puncture device in a bent state of the intraosseous needle group. DETAILED DESCRIPTION

[0125] The present invention provides an intraosseous (IO) device and method, the intraosseous device is used to penetrate the bone and enter the relevant bone marrow to perform medical procedures, such as aspiration and biopsy of the bone marrow. The term "intraosseous (IO) device" in this application includes but is not limited to any hollow needle, hollow drill, puncture assembly, bone puncture, catheter, cannula, trocar, stylet, inner puncture, outer penetrator, IO needle, biopsy needle, aspiration needle, IO needle group, biopsy needle group or aspiration needle group that can be operated to provide a passage into the intraosseous space or the interior of the bone. In addition, various other IO devices can also be formed according to one or more teachings of the present invention. The IO device can be formed at least in part by metal alloys such as 304 stainless steel and other biocompatible materials associated with needles and similar medical devices.

[0126] The term "fluid" may be used in this application to refer to any liquid, including but not limited to blood, water, saline solution, IV solution, plasma or any mixture of liquids, particulate matter, dissolved drugs and / or drugs related to bone marrow biopsy or bone marrow aspiration or infusion of bone marrow or other target sites. The term "fluid" as used in this patent application also includes any body fluid extracted from the target area and / or liquid containing particulate matter, such as bone marrow and / or cells.

[0127] The terms "harvest" and "harvesting" as used in this application include bone and / or bone marrow biopsy and bone marrow aspiration. A bone and / or bone marrow biopsy (sometimes referred to as a "needle biopsy") can generally be described as removing a relatively small piece or portion of a bone and / or bone marrow specimen from a selected target area for biopsy purposes. A bone marrow aspiration (sometimes referred to as a "bone marrow sampling") can generally be described as removing a large amount of bone marrow from a selected target area. The relatively large amount of bone marrow can be used for diagnosis, transplantation, and / or research. For example, certain stem cell research techniques may require a relatively large amount of bone marrow.

[0128] As used herein, the terms "insertion site," "penetration site," "target site," and "installation site" are used to describe locations on a bone where an intraosseous device may be inserted or drilled into the bone and associated bone marrow. The insertion site, penetration site, target site, and installation site are typically covered by skin and soft tissue. The term "target area" as used herein is used to describe a selected portion of a bone cavity or a location in a bone cavity from which associated bone marrow may be harvested in accordance with the teachings of the present invention.

[0129] According to the teachings of the present invention, an IO device can be inserted into a selected target area or target site in a few seconds using an electric driver. However, the various teachings of the present invention are not limited to use with an electric driver. According to the teachings of the present invention, manual drivers and mechanical auxiliary drivers, such as spring-driven drivers, can also be used with IO devices. When it is not possible to use an electric-driven driver for bone entry, such manual drivers can be used with the IO device of the present invention. The situation may involve military special operations, in which extreme temperatures and strict weight restrictions limit the items that can be carried in combat. The same is true for civilian emergency medical services (EMS) or first responders, in which case the long shelf life and infrequent use make the convenience of electric drivers impractical. When a manual driver is used, manual force can be applied to the handle or grip to insert the puncture or needle into the bone to enter the bone marrow. In the event that the electric-driven driver does not work properly (for example, due to power exhaustion), the manual driver can serve as a useful backup device. Therefore, using the IO device of the present invention and any driver, bones can be penetrated and the relevant bone marrow can be entered. For some applications, the IO device includes a first end operable to penetrate a bone and / or associated bone marrow, and a second end operable to releasably engage an actuator (eg, a powered actuator or a manual actuator).

[0130] According to the teachings of the present invention, the IO needle group and other IO devices include a first IO device such as a cannula, a catheter or an external puncture device and a second IO device such as a stylet, a trocar or an internal puncture device. Various types of cutting surfaces can be formed near the first end of the first IO device and the first end of the second IO device. The cutting surface of the first IO device and the cutting surface of the second IO device can cooperate with each other to penetrate the bone and / or related bone marrow. The first connector or the first axle can be used to releasably engage the first IO needle or IO device with the second IO needle or IO device. For example, the IO needle group can include a first connector or a first axle, which has a hollow cannula, a catheter or an external puncture device attached thereto and extending from the first end of the first axle. The second end of the first axle can be operated to releasably engage with the first end of the second connector or the second axle. The stylet, trocar or internal puncture device can also be connected to the first end of the second axle and extend from the first end of the second axle. The second end of the first axle may include an opening sized to allow a stylet, trocar, or internal puncture device to be inserted into the opening and into a lumen in a cannula, catheter, or external puncture device. The second end of the second axle may be operable to releasably engage a drive shaft extending from an electric drive or a manual drive.

[0131] Although various features of the present invention may be described in terms of the IO devices depicted in the drawings, the present invention is not limited to the IO devices shown in the drawings. IO devices having various sizes and / or configurations may be formed in accordance with the teachings of the present invention.

[0132] Trocar assemblies such as IO needle sets 100, 100a, 100b, and 100c represent only some examples of IO access devices formed in accordance with the teachings of the present invention. Figure 1 and Figure 2 , the puncture assembly 100 includes a flexible outer puncture or cannula 110 and a rigid inner puncture or stylet 120. The first end 111 of the cannula 110 and the first end 121 of the stylet 120 are operable to penetrate the bone and associated bone marrow. In particular, the first end 111 of the cannula and the first end 121 of the stylet 120 form corresponding cutting tips. The stylet 120 includes a rigid longitudinal body and is configured to be slidably and releasably disposed in a longitudinal bore or lumen 118 of the cannula 110. Various features of the first end 111 of the cannula 110 and the first end 121 of the stylet 120 are described in detail in detail. Figure 56. In some embodiments, the fluid port can be disposed at various locations on the cannula body, including at the first end 111 of the cannula. The first end 101 or distal end of the piercer assembly 100 can generally correspond to the first end 111 or distal end of the cannula 110 and the first end 121 or distal end of the stylet 120. The second end 102 or proximal end of the piercer assembly can generally correspond to the second end 112 or proximal end of the cannula 110 and the second end 122 or proximal end of the stylet 120. The second end 102 of the piercer assembly can be operable to releasably attach to a driver, which will be discussed in further detail below.

[0133] The piercer assembly 100 also includes an axle 130 and a connector 140. The second end 112 of the cannula 110 is opposite to the first end 111 of the cannula and can be securely engaged with the first end 131 or the distal end of the axle 130. In some embodiments, the second end 112 of the cannula can be bonded to a portion within the first end 131 of the axle via an adhesive, the adhesive being a UV adhesive or other types of adhesives. The second end 122 of the stylet 120 is opposite to the first end 121 of the stylet and can be securely engaged with the first end 141 or the distal end of the connector 140. In some embodiments, the second end 122 of the stylet can be bonded to a portion 145 of the connector via an adhesive, the portion 145 being disposed within the first end 141 of the connector, the adhesive being a UV adhesive or other types of adhesives.

[0134] like Figure 3 and Figure 4As shown, the cannula 110 can extend longitudinally from the first end 131 of the axle 130, and the stylet 120 can extend from the first end 141 of the connector 140. The second end 132 or proximal end of the axle 130 can include a Luer lock fitting that releasably engages with a corresponding Luer lock fitting disposed within the first end 141 of the connector 140. More specifically, the second end 132 of the axle 130 can include an externally threaded portion 133, and the first end 141 of the connector 140 can include an internally threaded portion 143. The externally threaded portion 133 of the axle 130 can be removably connected to the internally threaded portion 143 of the connector 140, thereby forming a threaded connection between the second end 132 of the axle 130 and the first end 141 of the connector 140. A Luer lock fitting 133 disposed on a second end 132 of the hub 130 is operable to releasably engage a standard syringe-type connector and / or a standard intravenous (IV) connection and associated fluid tubing to aspirate the IO space through the cannula lumen 118, deliver medication to the IO space through the cannula lumen 118, or capture a biopsy specimen of bone and associated bone marrow. When the hub 130 is attached to the connector 140, the stylet 120 is disposed within the cannula 110 such that the stylet extends longitudinally from the first end 141 of the connector 140 and the first end 131 of the hub 130.

[0135] Various types of sockets may be provided in the second end 142 or proximal end of the connector 140 for releasably engaging the connector with a drive shaft of a manual or electric driver. For example, a driver, such as a manual or electric driver, including a drive shaft having a tapered portion may be operated to releasably engage a socket 144 provided in the second end 142 of the connector 140 and having a corresponding generally tapered configuration with the driver. In some embodiments, the driver may be secured to the intraosseous device by a magnet provided on the end of a tapered shaft extending from the driver and a metal or magnetic disk corresponding to the magnet provided in a receiver 144 in the intraosseous device.

[0136] As previously referenced Figure 3 and Figure 4As discussed, the piercer assembly 100 may include an outer piercer 110 (e.g., a cannula, a hollow tube, or a hollow drill bit) and an associated axle 130. The piercer assembly 100 may also include an inner piercer 120 (e.g., a stylet or trocar) and an associated connector 140. Various types of stylets and / or trocars may be disposed within the outer piercer. For some applications, the outer piercer or cannula 110 may be described as a generally elongated tube sized to accommodate the inner piercer or stylet 120 therein. A portion of the inner piercer 120 may be disposed within a longitudinal channel 118 extending through the outer piercer 110. The outer diameter of the inner piercer 120 and the inner diameter of the longitudinal channel 118 may be selected so that the inner piercer 120 is slidably disposed within the outer piercer 110.

[0137] The metal disk can be disposed within an opening 144 in the second end 142 of the connector 140 for releasably attaching the connector 140 to a magnetic portion of a drive shaft of a manual or electric driver. In some embodiments, the drive shaft of the driver can be magnetized. The second end 122 of the inner piercer 120 is preferably spaced from the metal disk with an insulating or non-conductive material disposed therebetween.

[0138] Figure 5 An example of corresponding cutting surfaces and tips formed at first end 111 of outer piercer 110 and first end 121 of inner piercer 120 in accordance with the teachings of the present invention is shown. First end 111 of outer piercer 110 and / or first end 121 of inner piercer 120 may be operable to penetrate bone and associated bone marrow. The configuration of the tips and / or cutting surfaces at first end 111 of outer piercer 110 and first end 121 of inner piercer 120 may be selected to penetrate bone or other body cavities with minimal trauma.

[0139] In the relevant manufacturing process, the first end 111 of the outer puncture device 110 and the first end 121 of the inner puncture device 120 can be ground together as a unit so that when the hub 130 is securely fastened to the connector 140, the cannula or outer puncture device 110 and the stylet or inner puncture device 120 are arranged relative to each other, and the corresponding cutting surfaces of the outer puncture device and the inner puncture device are substantially coplanar. Therefore, the stylet 120 has a tip with an angled / beveled angle that matches the angled / beveled angle of the cannula 110.

[0140] In other words, the first end 111 of the cannula 110 and the first end 121 of the stylet 120 may be ground simultaneously to form adjacent cutting surfaces 114, 124. Grinding the respective ends 111 and 121 simultaneously may allow a single cutting unit to be formed as follows: Figure 5In other embodiments, the first end 111 of the outer puncture device 110 and the first end 121 of the inner puncture device 120 can be independently ground in the relevant manufacturing process so that when the axle 130 is firmly fastened to the connector 140, the sleeve or outer puncture device 110 and the stylet or inner puncture device 120 are arranged relative to each other, and the corresponding cutting surfaces 114, 124 of the outer puncture device and the inner puncture device are substantially coplanar. Therefore, the stylet 120 has a tip with an inclined / beveled angle that matches the inclined / beveled angle of the sleeve 110. In addition, the cross-section of the first end 111 of the outer puncture device 110 can be trapezoidal and can include one or more cutting surfaces. Similarly, the cross-section of the first end 121 of the inner puncture device 120 can be trapezoidal and can include one or more cutting surfaces.

[0141] like Fig. 6A and Figure 6B As shown, for example, the cutting surface on the first end 121 of the inner puncture device 120 includes a first face and an adjacent second face, wherein the first face is longer than the second face. Similarly, the cutting surface on the first end 111 of the outer puncture device 110 includes a first face and an adjacent second face, wherein the first face is longer than the second face. Providing a matching fit enables the corresponding tips at the first ends 111, 121 of the outer puncture device and the inner puncture device to act as a single drilling unit, thereby facilitating insertion and minimizing damage when the portion of the puncture device assembly 100 is inserted into the bone and the associated bone marrow. The inner puncture device and the outer puncture device can be formed of stainless steel, titanium, or other biocompatible materials whose strength and durability are suitable for penetrating bones. As shown in FIG. Figure 7C , 7F , 7I, 7L and 7O, in order to achieve the desired bone penetration effect and maintain the strength of the needle tip during insertion and withdrawal from the bone and associated bone marrow, the corresponding cutting surfaces of the outer puncture and the inner puncture can be set to various sizes and shapes.

[0142] The second end 132 of the axle 130 is adapted to releasably engage or attach to an associated connector 140. The first end 131 of the axle 130 is sized and configured to be compatible with an associated insertion site of the external puncture device 110. The connector 140 includes an enlarged tapered portion adjacent to the second end 142. A plurality of longitudinal ridges 149 are provided on the outer surface of the connector 140 to allow an operator to grasp the corresponding puncture device assembly 100 during attachment to the drive shaft of the driver. When the external puncture device 110 is inserted into the bone and associated bone marrow, the connector 140 is gripped by the longitudinal ridges 149 to disengage it from the axle 130, thereby retaining the external puncture device at the insertion site.

[0143] The first end 141 of the connector 140 may include an opening 147 sized to receive the second end 132 of the axle 130 therein. Threads 143 may be provided in the opening 147 adjacent the first end 141 of the connector 140. The threaded fittings 143 may be operable to releasably attach the connector 140 to a corresponding threaded fitting 133 corresponding to the second end 132 of the axle 130. The second end 132 of the axle 130 may include a threaded portion 133 or other suitable fitting formed on an exterior thereof. In addition, the second end 132 of the axle may have a generally cylindrical opening 134 configured to matingly receive a generally cylindrical protrusion 145 disposed within the first end 141 of the connector 140, i.e., forming a pin type configuration. The protrusion 145 may include a receiver configured to securely receive the second end 122 of the stylet 120, which may be bonded to the connector by a UV adhesive or other type of adhesive.

[0144] In some embodiments, the first end 131 of the axle 130 may include a flange. In addition, an angular slot or groove may be formed in the first end 131 of the axle 130, the slot or groove being configured to receive one end of a protective cover or a needle cap. In some embodiments, an angular slot or groove may be formed in the first end 141 of the connector 140, the slot or groove being configured to receive one end of a protective cover or a needle cap. The slot or groove may be used to releasably engage the protective cover with the piercer assembly 100. In some aspects, the cover may be a generally hollow tube with a rounded end. The cover may be disposed within the associated slot to protect portions of the associated outer piercer 110 and the inner piercer 120 prior to attachment to the driver. The cover may include a plurality of longitudinal ridges formed on its exterior. The longitudinal ridges cooperate with each other so that the cover or needle cap may be installed and removed without contaminating portions of the associated piercer. The cover may be formed of various plastics and / or metals.

[0145] The size and configuration of the first end 131 of the axle 130 can be varied to accommodate different insertion sites and / or patients. For example, the first end 131 of the axle 130 can further include an annular flange or other configuration suitable for contacting the patient's skin. In some embodiments, the first end 131 does not include an annular flange or other configuration suitable for contacting the patient's skin. The channel through the axle 130 extends from the first end 131 to the second end 132. The size and configuration of the inner diameter of the channel are selected so that the channel is securely engaged with the outer diameter of the second end 112 of the cannula or outer puncture device 110. In some aspects, the second end 112 of the cannula or outer puncture device 110 can be bonded to the axle by a UV adhesive or other types of adhesives.

[0146] For some applications, the threaded connection or fitting 133 of the first end 132 of the axle 130 can be attached with various types of Luer locks and / or Luer fittings, which are associated with intravenous tubes or syringes. For example, once the outer puncture device or sleeve 110 is inserted into the bone and the relevant bone marrow, various types of connections can be established by connecting the intravenous tube to the outer puncture device, and the fluid is transmitted to the bone marrow through the outer puncture device or sleeve. A right-angle connector can be used to connect the intravenous tube to the outer puncture device at an angle that will not kink or clamp the lumen. In some aspects, the right-angle connector can be engaged with the axle 130 by a locking nut. Other types of connectors can be used to transfer fluid between the outer puncture device 110 and the intravenous tube, so that the intravenous tube can be used to provide intravenous fluid and / or medicine to the relevant bone marrow. The intravenous tube can also be used to extract blood or bone marrow samples from the IO space. Other connectors or adapters can also be used to connect the puncture device to the intravenous tube, other types of tubes and / or syringes.

[0147] like Fig. 7A and 7B As shown, the outer piercer or cannula 110 includes a middle portion 113 disposed between a first end 111 and a second end 112. The cannula 110 can be formed of stainless steel or other suitable biocompatible materials. Although the first end 111 and the second end 112 of the cannula are rigid and non-flexible, the middle portion 113 is configured to deform by bending or telescoping. In particular, the middle portion 113 allows the cannula 110 to bend by a plurality of cutouts or slits 115 disposed on its exterior. In some embodiments, the cutouts are as shown in FIG. Fig. 7A The through cuts shown. In some embodiments, at least some of the cuts can be notches or other thinning portions of the casing material. Thus, the cuts can be completely through the casing wall, or can be perforations or grooves etched in the casing wall, or a combination of both. The cuts can be formed by methods such as laser, chemical etching, or water-sealed blasting. When the casing undergoes overall deformation, the cuts or slits 115 allow the middle portion 113 of the casing to be the part that plastically deforms. The configuration of the cuts or slits, including their size, shape, and pattern, is configured to facilitate a particular direction and / or degree of deformation of the casing.

[0148] The joints formed by the cutouts or slits 115 in the sleeve can support deformation outside the patient's body or near the position where the sleeve enters the human body. Therefore, because the sleeve can bend or telescope to adapt to the patient's movement, the sleeve 110 can be kept at the target area in the patient's body for a long time. For example, a standard rigid sleeve inserted into the patient's humerus may be displaced when the patient's arm moves. However, because the flexible sleeve 110 of the present invention can bend or telescope to adapt to the movement of the patient's arm, such as raising the arm above the head, it can be prevented from being displaced from the patient's humerus.

[0149] The pattern, size, and shape of the laser cuts or slits 115 can be selected to provide the desired flexibility while also taking into account the expected applied force. In addition, the pattern and / or design of the cuts or slits 115 can be selected to provide a specific insertion and extraction integrity of the cannula to control how much the shape of a bent or curved cannula can recover, i.e., whether the shape of the cannula can be partially or fully recovered.

[0150] For example, the outer puncture device 110a includes Fig.7D The laser cut design and / or pattern 115a shown provides the outer penetrator with high insertion and removal integrity and minimal or below average shape recovery. In other words, once the cannula 110a is bent, it will remain as is. Fig. 7E In another embodiment, the outer puncture device 110b includes Figure 7G The laser cut design and / or pattern 115b shown provides the outer piercer with moderate insertion and removal integrity, as well as Figure 7H In another embodiment, the outer piercer 110c comprises Figure 7J The laser cut design and / or pattern 115c shown provides the outer piercer with moderate insertion and removal integrity, as well as Figure 7K In another embodiment, the outer piercer 110d comprises Figure 7M The laser cut design and / or pattern 115d shown provides the outer piercer with moderate insertion and removal integrity, as well as Figure 7N In another embodiment, the outer piercer 110e comprises Figure 7P The laser cut design and / or pattern 115e shown provides the outer piercer with moderate insertion and removal integrity, as well as Figure 7Q Maximum or above average shape recovery shown.

[0151] The laser cut design and / or pattern of the slits shown in the figures allows the cannula to be retained at the insertion site during initial insertion so that the cannula can extend outwardly at the insertion portion while the associated hub is spaced accordingly from the patient. The laser cut design and / or pattern of the slits shown in the figures also allows the cannula to be bent downwardly and secured in a desired orientation, i.e., facing the patient, thereby keeping the cannula and associated hub close to the patient and therefore unnoticeable, making it less likely to be dislodged from the insertion site due to accidental knocking or collision.

[0152] Roughly like Fig. 7AAs shown, the deformable sleeve 110 is configured to withstand loads acting thereon during use, such as torque when inserted into and / or removed from a bone. In other words, the specific design and pattern of the laser cuts or slits on the sleeve are optimized to withstand various torques applied to the sleeve during insertion. In addition, each section formed by the slits 115 allows the sleeve to deform. The length of the sleeve that is deformed can vary with the total deformation implemented and / or the number of slits 115 set in the middle portion 113. In one example, the pattern of the laser cut slits 115 can have a total of 120 degrees of cut / uncut, which makes three cut lines on one pitch and increases by 90 degrees rotationally. Since there is an additional spine on every two pitches, the laser cut pattern enables the sleeve to withstand greater torque.

[0153] Back to Figures 1 to 4 , the rigid stylet 120 is configured to support the cannula 110 during the insertion process and further prevent the cannula from deforming when deformation is not required, that is, the stylet is removed from the cannula before deformation. During the insertion process, the axle 130 of the cannula 110 is engaged to the connector 140, and the rigid stylet 120 of the connector is located in the longitudinal hole 118 of the cannula, providing sufficient rigidity for the middle portion 113 of the cannula to withstand the force or torque applied to the cannula by the manual driver or the electric driver. Therefore, the stylet 120 is configured to add rigidity to the middle portion 113 of the cannula 110 during the insertion process, so that the cannula will not bend and deform unintentionally due to the force and / or torque applied by the manual driver or the electric driver. In other words, the rigid stylet provides stability and rigidity to offset the force and / or torque applied to the flexible cannula during the process of pushing and / or rotating (i.e., in a clockwise direction) the puncture with the driver to penetrate into the dense bone.

[0154] Once the tip of the puncture device is inserted into the IO cavity, the stylet 120 is removed so that the cannula 110 can remain in the same insertion position or bend against the patient's skin to accommodate an IV line or other IO device. This can also make the cannula have a smaller profile relative to the patient's skin, so that the cannula and associated needle are less prominent. The curved portion of the cannula can be pressed down against the patient's skin to further secure it in place. After the cannula is inserted in situ into the patient's target site, fluid will leak through the slit 115, such as when blood or bone marrow is aspirated, or when a drug is administered. Depending on the degree of bending experienced, at least some of the incisions tend to at least partially close during the bending of the cannula. For example, the slits on the inner side of the bend tend to close due to deformation of the cannula. The partial closure reduces the leakage of material through the cannula. However, when the cannula is bent, some of the slits may open to a greater extent, such as the slits on the outer side of the bend, so fluid leakage through the open slits may increase accordingly. For example, the slits formed on the outer side of the bend will remain the same size or open slightly due to deformation of the cannula.

[0155] A flexible sleeve 150 can be provided on the outer surface of the middle portion 113 of the sleeve to prevent or minimize fluid leakage. Or in other words, a flexible sleeve 150 can be provided at the incision or slit 115. In this way, the middle portion 113 of the sleeve and the deformable sleeve 150 can be bent and can be retained inside and / or outside the insertion site on the patient's body. Therefore, the sleeve 150 is configured to cover the incision 115 to reduce the leakage of the material injected or withdrawn through the sleeve 110. The covering sleeve 150 can be transparent. The covering sleeve 150 can be a heat shrink tube including a polymer, such as fluorinated ethylene propylene. The sleeve 150 is heat-shrunk on the outside of the middle portion 113 of the sleeve 110 to ensure that a suitable fluid seal is formed above the laser cutting area of ​​the sleeve, so that the fluid will not leak through the relevant slit 115. Before use, heat shrinking the sleeve on the slit on the sleeve can also ensure that the sleeve is adhered to the sleeve with sufficient strength to prevent or reduce the leakage of the material passing through the sleeve under high pressure. The sleeve may be heat shrunk during manufacture (eg, with a heat gun) so that it adheres adequately to the cannula during insertion.

[0156] In some embodiments, the sleeve 150 can extend beyond the middle portion 113 of the sleeve having the slit 115. In some embodiments, the sleeve 150 is non-compliant so that it can maintain the same diameter when the material flows through the sleeve at high pressure. In addition, the sleeve 150 has a sufficient wall thickness to ensure the stability of the sleeve when the material flows through the sleeve 110 at high pressure.

[0157] Figure 8A second end 142 of the connector 140 is shown. As previously described, a drive shaft or accessory can be releasably engaged with the second end 142 of the connector 140, and an inner piercer or stylet 120 extends from the first end 141 of the connector. The connector 140 and the axle 130 can be releasably engaged via a Luer-type fitting, a threaded connection, or other suitable fitting on the first end 141 of the connector and the second end 132 of the axle.

[0158] An opening or recess 144 may be provided in the second end 142 of the connector to accommodate a drive shaft of a manual or electric driver. The opening 144 may be provided in various configurations and / or sizes. In some embodiments, the opening 144 may include a passageway or channel sized to accommodate a drive shaft portion. One or more webs 146 may be formed in the second end 142 of the connector, the webs extending radially from the opening 144. An open section or gap 148 may be formed between the webs. Each protrusion of the drive shaft may be releasably engaged with the webs 146 and the gap 148. The opening 144 and associated webs 146 may be used to releasably couple the connector 140 to a manual driver or an electric driver.

[0159] Figure 9-12 Another embodiment of a puncture assembly, such as an IO needle set 100a, is shown. The IO needle set 100a is substantially similar to the IO needle set 100 described in detail above, and further includes a depth control ring 160 fixed to the first end 111 of the outer puncture or cannula 110. The depth control ring 160 is configured to limit the insertion depth of the inner and outer punctures during insertion. The control ring 160 has a generally elongated, hollow configuration adapted to engage with the outer diameter of the outer puncture 110. The control ring 160 can be welded to the first end 111 of the outer puncture 110 to form an integral unit therewith. The distal end of the control ring is spaced apart from the tip portion of the inner and outer punctures by a predetermined distance corresponding to the depth to which the first ends of the inner and outer punctures are inserted into the IO space. Thus, the depth of penetration into the bone and associated bone marrow can be determined by the distance between the distal end of the control ring 160 and the distal end or distal end of the needle tip at the first end 111, 121 of the cannula and stylet.

[0160] During the insertion process, the distal end of the control ring 160 is configured to contact the bone, thereby preventing the inner and outer puncture devices from further inserting into the IO space. Therefore, the control ring 160 is configured to limit the depth of the inner and outer puncture devices inserted into the bone and the associated bone marrow. The control ring 160 can be formed by various materials including stainless steel, titanium or other materials, such as those used to form the outer puncture device 110. Since the control ring 160 is usually firmly engaged with the outer surface of the outer puncture device 110, the outer puncture device 110 and the control ring 160 can rotate simultaneously with the rotation of the operator. For example, when using a manual driver, the user can insert the needle group 100a through the tissue and bone until the distal end of the collar 160 contacts the bone, thereby preventing further insertion of the needle group.

[0161] In addition, a control ring 160 is provided on the outside of the outer puncture device 110 to selectively limit the penetration depth, so that the puncture devices 110 and 120 can be satisfactorily used to enter the bone marrow in the IO space. The outer diameter of the sleeve 150 used to cover the laser cut slit in the cannula 110 is less than or equal to the outer diameter of the control ring 160 to protect the sleeve from damage during the insertion process.

[0162] Figure 13-1 8 shows another embodiment of a puncture assembly such as an IO needle set 100b. The IO needle set 100b is substantially similar to the IO needle set 100 described in detail above, and further includes a distal cutting sleeve 170 secured to the first end 111 of the outer puncture or cannula 110. The distal cutting sleeve 170 can be welded to the first end 111 of the outer puncture to form an integral unit therewith.

[0163] Fig.17 An example of cutting surfaces and tips is shown, which are formed on the first ends 111, 121 of the outer and inner piercing devices 110, 120 and the distal cutting sleeve 170. The cutting surfaces 114, 124 of the outer and inner piercing devices 110, 120 and the cutting surface 174 of the distal cutting sleeve can be ground together as a unit during the corresponding manufacturing process so that when the axle 130 is securely fastened to the connector 140, the cannula 110, the stylet 120 and the distal cutting sleeve 170 are arranged relative to each other with their respective cutting surfaces coplanar. In other words, the angled / inclined cutting surfaces at the tips of the inner piercing device, the outer piercing device and the distal cutting sleeve are configured to match each other.

[0164] In other embodiments, the respective first ends 111, 121 of the outer puncture device 110 and the inner puncture device 120 and the distal cutting sleeve 170 can be ground separately during the relevant manufacturing process so that when the axle 130 is securely fastened to the connector 140, the respective cutting surfaces 114, 124, 174 of the outer puncture device 110, the inner puncture device 120 and the distal cutting sleeve 170 are substantially coplanar. Thus, the stylet 120 has a beveled / beveled tip that matches the beveled / beveled tip of the cannula 110 and also matches the beveled / beveled tip of the distal cutting sleeve 170. In addition, the cross-section of the first end 111 of the outer puncture device 110 can be trapezoidal and can include one or more cutting surfaces. Similarly, the cross-section of the first end 121 of the inner puncture device 120 can be trapezoidal and can include one or more cutting surfaces. Similarly, the cross-section of the first end of the distal cutting sleeve 170 can also be trapezoidal and can include one or more cutting surfaces.

[0165] Provide matching fit for each cutting surface of the puncture device 110,120 and the distal cutting sleeve 170, so that the corresponding tip portion can be used as a single drilling unit, which is convenient for insertion into the bone and the associated bone marrow, and minimizes damage to the patient. Similar to the outer puncture device and the inner puncture device 110,120, the distal cutting sleeve 170 can be formed of stainless steel, titanium or other biocompatible materials with strength and durability suitable for penetrating bones. In addition, the outer diameter of the flexible sleeve 150 used to cover the laser cutting slit 115 in the sleeve is less than or equal to the outer diameter of the distal cutting sleeve 170 to protect the sleeve from damage during insertion.

[0166] Figure 19-24Another embodiment of a puncture assembly such as IO needle set 100c is shown. Except for the differences described below, IO needle set 100c is substantially similar to IO needle set 100 described in detail above. In particular, IO needle set 100c includes a slotted drill bit 180, which is fixed to the first end of flexible sleeve 110c. The slotted drill bit 180 can be welded to the first end of flexible sleeve 100c to form an integral unit therewith. Similar to the outer puncture and the inner puncture, the slotted drill bit 180 can be formed of stainless steel, titanium or other biocompatible materials with strength and durability suitable for penetrating bones. Rigid stylet 120c is used to provide structural rigidity to support flexible sleeve 110c and prevent it from bending or deforming during insertion. After needle set 100c is inserted into the IO space, stylet 120c is removed from sleeve 110c to allow sleeve to bend and deform to the desired direction. As previously described in detail above, the bending and deformation of the cannula 110c is due to the cutout or slit 115 formed in the middle portion of the cannula 110c. In some embodiments, the first end or tip of the stylet is blunt, so that there is no sharp distal tip. This blunt tip provides a high level of safety for the user when the stylet is withdrawn from the cannula.

[0167] The slotted cutting tip 180 includes an integrally formed head 182 and a longitudinal body portion 184. The cutting slot extends continuously through the head and the body portion. The proximal end of the head is securely fixed to the distal end of the cannula 100c so that the longitudinal body portion 184 is received within the first end of the cannula. After the needle assembly 100c is inserted into the IO space and the stylet 120c is withdrawn from the cannula 110c, the slotted cutting tip 180 remains attached to the first end of the cannula so that the grooved cutting tip remains anchored in the IO space.

[0168] The cut grooves form corresponding channels along both the head and body portions 182, 184 of the slotted tip 180, which allow blood and / or bone marrow samples to be drawn from the IO space or drugs to be delivered to the IO space (i.e., the material can flow along the channels defined by the head and body portions of the grooves and the inner surface of the cannula). In addition, the outer diameter of the flexible sleeve 150 used to cover the laser cut slit 115 in the cannula 110c is less than or equal to the slotted cutting tip 180 to protect the sleeve from damage during insertion.

[0169] Fig.25AAnother embodiment of a puncture assembly such as an IO needle set 100d is shown. The puncture assembly 100d includes an outer puncture or cannula 110d and a rigid inner puncture or stylet 120d. The first end 111d of the cannula 110d and the first end 121d of the stylet 120d can be operated to penetrate the bone and the associated bone marrow. In particular, the first ends 111d, 121d of the cannula and the stylet form corresponding cutting tips, and similar to the IO needle sets 100, 100a, 100b and 100c described above, the stylet 120d can be slidably and releasably configured in the longitudinal bore or lumen of the cannula 110d.

[0170] The puncture assembly 100d also includes an axle 130d and a connector 140d, which includes all the features of the axle 130 and the connector 140 described above. A portion of a flexible sleeve or tube 150d may be adhered or bonded to the outer surface of the sleeve 110d portion to provide fluid communication between the sleeve and the axle 130d. The flexible sleeve 150d is adapted to bend and may be retained inside and / or outside of an insertion site on the patient's body. The sleeve or tube 150 may include a transparent polymer to facilitate viewing of materials such as bone marrow or medicine passing therethrough.

[0171] The second end 112d of the sleeve 110d is located opposite to the first end 111d of the sleeve and forms a female lock portion. Fig.25B As shown, the stylet 120d includes a key portion 125d having a first end 126d, the first end 126d forming a male key portion, which cooperates with a female lock portion at the second end 112d of the cannula 110d. Therefore, the male key portion 126d is configured to cooperate with the female lock portion 112d when the stylet 120d is fully inserted into the cannula 110d, thereby ensuring that the first end 111d of the cannula is properly oriented relative to the first end 121d of the stylet to form a cutting tip that can be operated to penetrate the bone and associated bone marrow. In addition, the rigid stylet 120d is configured to support the flexible tube 150d during insertion, preventing the cannula from deforming when deformation is not required, that is, removing the stylet from the tube before deformation occurs.

[0172] For example, during insertion, axle 130d engages connector 140d such that rigid stylet 120d is received within cannula 110d and flexible tube 150d, providing the cannula with sufficient rigidity to withstand forces or torques applied to the cannula by a manual or electric driver. Fig.25CAn example of a manual driver 200 connected to an IO needle set 100d is shown in FIG. Thus, the stylet 120d is configured to increase the rigidity of the flexible tube 150d during insertion so that the cannula is not unintentionally bent and deformed by the force and / or torque applied by the driver. In other words, the rigid stylet provides stability and rigidity to offset the force and / or torque applied to the flexible cannula during the process of pushing and / or rotating the puncture with the driver to penetrate into dense bone.

[0173] Fig.26 Another embodiment of a puncture assembly, such as an IO needle set 100e, is depicted. In particular, the IO needle set 100e includes a flexible outer puncture or cannula 110e configured to receive a rigid inner puncture or stylet 120e. The cannula 110e includes a hypotube that is capable of bending or flexing similar to the other embodiments of the flexible cannula described above. A flexible sleeve 150e, such as a spiral hollow strand, is attached to the middle portion of the hypotube 110e by welding to prevent or reduce leakage of material passing through the hypotube. Fig. 27 As shown, when the rigid stylet is removed from the cannula, the hypotube 110e and corresponding flexible sleeve 150e can be bent into a curved configuration.

[0174] Although the puncture assembly with a flexible outer puncture and a rigid inner puncture is described in specific aspects, the present invention is not limited to the disclosed aspects. In addition, many features and advantages of the present invention are apparent from the detailed description, and therefore, the appended claims are intended to cover all of these features and advantages of the present invention that fall within the spirit and scope of the present invention. In addition, the present invention is not limited to the exact configuration and operation shown and described, and therefore, all appropriate modifications and equivalent forms that can be adopted fall within the scope of the present invention. Therefore, the present invention should be considered illustrative rather than restrictive. Thus, the present invention is intended to cover various modifications and similar configurations included within the spirit and scope of the claims, and should be interpreted in the broadest sense to cover all such modifications and similar configurations.

Claims

1. A trocar assembly operable to provide access to an intraosseous space, the trocar assembly comprising: a flexible outer piercer including a longitudinal bore and a distal end operable to penetrate the bone and associated bone marrow; a rigid endopenter including a distal end operable to penetrate a bone and associated bone marrow; an axle having a distal end connected to the proximal end of the flexible outer piercing device; a connector having a distal end connected to a proximal end of the rigid inner piercer and a proximal end configured to releasably engage a drive shaft of a driver operable to insert the piercer assembly into the intraosseous space; and The longitudinal bore of the flexible outer piercer is configured to removably receive the rigid inner piercer to prevent or minimize bending of the flexible outer piercer during insertion, and the flexible outer piercer is configured to deform into a curved shape upon application of force after the longitudinal bore removes the rigid inner piercer.

2. The piercer assembly of claim 1 , further comprising a depth control ring connected to the outer piercer and adjacent to the distal end of the outer piercer, the depth control ring comprising a distal end operable to contact bone to prevent further penetration of the inner and outer piercers into the intrabone space.

3. The trocar assembly of claim 1 , further comprising a distal cutting sleeve secured to a distal end of the outer trocar, the distal cutting sleeve operable to penetrate a bone and associated bone marrow.

4. The trocar assembly according to claim 1, characterized in that: The flexible outer piercer includes a plurality of slits operable to cause the outer piercer to flex after the rigid inner piercer is removed from the longitudinal bore of the flexible outer piercer.

5. The trocar assembly according to claim 4, characterized in that: The plurality of slits are disposed along a middle portion of the flexible outer piercing device, the middle portion being located between the distal end and the proximal end of the flexible outer piercing device.

6. The trocar assembly according to claim 5, characterized in that: The plurality of slits are arranged in a pattern along the length of the flexible outer piercing device intermediate portion.

7. The trocar assembly according to claim 6, characterized in that: The pattern of the plurality of slits includes three cut lines per pitch.

8. The trocar assembly according to claim 7, characterized in that: Each slit in the pattern of the plurality of slits is rotationally incremented by 90 degrees.

9. The trocar assembly according to claim 4, characterized in that: At least one of the plurality of slits is an elongated cut in the wall of the flexible outer piercer.

10. The trocar assembly according to claim 4, characterized in that: At least one of the plurality of slits is a perforation in the wall of the flexible outer piercer.

11. The trocar assembly according to claim 4, characterized in that: At least one of the plurality of slits is a notch or groove in the wall of the flexible outer piercer.

12. The trocar assembly according to claim 4, characterized in that: The plurality of slits are formed by laser.

13. The trocar assembly according to claim 4, characterized in that: The plurality of slits are formed by chemical etching.

14. The trocar assembly according to claim 4, characterized in that: The plurality of slits are formed by water-sealed blasting.

15. The piercer assembly of claim 4, further comprising a covering sleeve attached to the flexible outer piercer, the covering sleeve being operable to prevent or minimize leakage of material from the flexible outer piercer.

16. The trocar assembly according to claim 15, characterized in that: The covering sleeve is configured to cover a middle portion of the flexible outer piercer, and the covering sleeve is operable to prevent or minimize leakage of material from the plurality of slits.

17. The trocar assembly according to claim 15, characterized in that: The covering sleeve is operable to bend when the flexible outer piercer is bent.

18. The trocar assembly according to claim 15, characterized in that: The covering sleeve is operable to prevent or reduce leakage of material passing through the outer piercer at high pressure.

19. The trocar assembly according to claim 15, characterized in that: The covering sleeve is a heat shrink tube.

20. The trocar assembly according to claim 15, wherein: The covering sleeve comprises a polymer.

21. The trocar assembly according to claim 15, wherein: The cover sleeve comprises fluorinated ethylene propylene.

22. The trocar assembly according to claim 15, wherein: The covering sleeve is transparent.

23. The trocar assembly according to claim 15, characterized in that: The covering sleeve is a spiral hollow strand tube.

24. The trocar assembly according to claim 15, characterized in that: The piercer assembly also includes a depth control ring, which is connected to the outer piercer and adjacent to the distal end of the outer piercer, and the depth control ring includes a distal end that can be operated to contact the bone to prevent the inner piercer and the outer piercer from further penetrating into the bone space; the outer diameter of the covering sleeve is less than or equal to the outer diameter of the depth control ring.

25. The trocar assembly according to claim 15, wherein: The piercer assembly also includes a distal cutting sleeve fixed to the distal end of the outer piercer, the distal cutting sleeve being operable to penetrate the bone and associated bone marrow; the outer diameter of the cover sleeve is less than or equal to the outer diameter of the distal cutting sleeve.

26. The trocar assembly according to claim 1, wherein: The distal end of the connector is configured to releasably engage the proximal end of the axle.

27. The trocar assembly according to claim 26, wherein: The distal end of the connector includes a female threaded portion, and the proximal end of the axle includes a male threaded portion, and the male and female threaded portions are operable to threadably engage the axle to the connector.

28. The trocar assembly according to claim 1, wherein: The connector includes a socket configured to receive a drive shaft of a driver.

29. The trocar assembly according to claim 28, characterized in that: The socket is also configured to releasably engage a drive shaft of the driver.

30. The trocar assembly according to claim 29, wherein: The socket includes a generally conical formation operable to releasably mate with a tapered portion of a drive shaft of a driver.

31. The trocar assembly according to claim 29, wherein: The socket also includes a magnetic disk operable to releasably engage a magnetic portion of a drive shaft of the driver.

32. The trocar assembly according to claim 1, wherein: The flexible outer puncture device is a sleeve.

33. The trocar assembly according to claim 1, wherein: The rigid inner puncture device is a stylet.

34. A trocar assembly operable to provide access to an intraosseous space, the trocar assembly comprising: a fluted drill bit operable to penetrate bone and associated marrow; a flexible sleeve including a longitudinal bore and a distal end connected to the fluted drill bit; a rigid stylet configured to be releasably received within the longitudinal bore of the flexible cannula, the rigid stylet being operable to prevent or minimize bending of the flexible cannula during insertion when the rigid stylet is within the longitudinal bore of the flexible cannula, and the flexible cannula being configured to bend after the rigid stylet is removed from the longitudinal bore; an axle having a distal end connected to the proximal end of the flexible sleeve; a connector having a distal end connected to a proximal end of the rigid stylet and a proximal end configured to releasably engage a drive shaft of a driver operable to insert the piercer assembly into the intraosseous space; Wherein the fluted drill bit comprises a head portion and a body portion, and wherein the body portion of the fluted drill bit is received within the distal end of the flexible sleeve.

35. The trocar assembly according to claim 34, wherein: The fluted drill bit includes a head, a body portion, and cutting grooves extending along the head and body portions, the cutting grooves forming a channel operable to allow aspiration of blood and / or bone marrow samples from the intrabone space or delivery of drugs to the intrabone space.

36. The trocar assembly according to claim 34, wherein: The flexible sleeve includes a plurality of slits operable to cause the flexible sleeve to bend upon removal of a rigid stylet from the longitudinal bore of the flexible sleeve.

37. The trocar assembly according to claim 36, wherein: The plurality of slits are disposed along a middle portion of the flexible sleeve, the middle portion being located between the distal end and the proximal end of the flexible sleeve.

38. The trocar assembly according to claim 37, characterized in that: The plurality of slits are arranged in a pattern along the length of the intermediate portion of the flexible sleeve.

39. The trocar assembly according to claim 38, characterized in that: The pattern of the plurality of slits includes three cut lines per pitch.

40. The trocar assembly according to claim 39, wherein: Each slit in the pattern of the plurality of slits is rotationally incremented by 90 degrees.

41. The trocar assembly according to claim 36, wherein: At least one of the plurality of slits is an elongated cutout in the wall of the flexible sleeve.

42. The trocar assembly according to claim 36, wherein: At least one of the plurality of slits is a perforation in the wall of the flexible sleeve.

43. The trocar assembly according to claim 36, wherein: At least one of the plurality of slits is a notch or groove in the wall of the flexible sleeve.

44. The trocar assembly according to claim 36, wherein: The plurality of slits are formed by laser.

45. The trocar assembly according to claim 36, wherein: The plurality of slits are formed by chemical etching.

46. ​​The trocar assembly according to claim 36, wherein: The plurality of slits are formed by water-sealed blasting.

47. The piercer assembly of claim 36, further comprising a covering sleeve attached to the flexible sleeve, the covering sleeve being operable to prevent or minimize leakage of material from the flexible sleeve.

48. The trocar assembly according to claim 47, wherein: The covering sleeve is configured to cover a middle portion of the flexible sleeve, and the covering sleeve is operable to prevent or minimize leakage of material from the plurality of slits.

49. The trocar assembly according to claim 47, wherein: The cover sleeve is operable to bend when the flexible sleeve is bent.

50. The trocar assembly according to claim 47, wherein: The cover sleeve may be operable to prevent or reduce leakage of material passing through the casing under high pressure.

51. The trocar assembly according to claim 47, wherein: The covering sleeve is a heat shrink tube.

52. The trocar assembly according to claim 47, wherein: The covering sleeve comprises a polymer.

53. The trocar assembly according to claim 47, wherein: The cover sleeve comprises fluorinated ethylene propylene.

54. The trocar assembly according to claim 47, wherein: The covering sleeve is transparent.

55. The trocar assembly according to claim 47, wherein: The covering sleeve is a spiral hollow strand tube.

56. The trocar assembly according to claim 47, wherein: The outer diameter of the covering sleeve is smaller than or equal to the outer diameter of the head of the fluted cutting tip.

57. The trocar assembly according to claim 34, wherein: The distal end of the connector is configured to releasably engage the proximal end of the axle.

58. The trocar assembly according to claim 57, wherein: The distal end of the connector includes a female threaded portion, and the proximal end of the axle includes a male threaded portion, and the male and female threaded portions are operable to threadably engage the axle to the connector.

59. The trocar assembly according to claim 34, wherein: The connector includes a socket configured to receive the drive shaft of the driver.

60. The trocar assembly according to claim 59, wherein: The socket is further configured to releasably engage a drive shaft of the driver.

61. The trocar assembly according to claim 60, wherein: The socket includes a generally conical formation operable to releasably mate with a conical portion of a drive shaft of the driver.

62. The trocar assembly according to claim 59, wherein: The socket also includes a magnetic disk operable to releasably engage a magnetic portion of a drive shaft of the driver.

63. A trocar assembly operable to provide access to an intraosseous space, the trocar assembly comprising: a rigid stylet having a distal end operable to penetrate the bone and associated bone marrow; a cannula having a distal end operable to penetrate a bone and associated bone marrow and a longitudinal bore configured to receive a portion of the rigid stylet; a flexible tube having a proximal end attached to the hub and a distal end attached to an outer surface of a portion of the cannula to provide fluid communication between the cannula and the hub, the flexible tube being configured to receive a portion of the rigid stylet; The rigid stylet is configured to support the flexible tube during insertion.

64. The trocar assembly according to claim 63, wherein: The sleeve also includes a proximal end forming a female locking portion.

65. The trocar assembly according to claim 64, characterized in that The rigid stylet also includes a key portion including a distal end forming a male key portion, the male key portion cooperating with a female lock portion at the proximal end of the cannula to ensure that the distal end of the cannula is properly oriented relative to the distal end of the stylet to form a cutting tip that can be operated to penetrate bone and associated bone marrow.

66. The trocar assembly according to any one of claims 63-65, characterized in that: The flexible tube is transparent.

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