HK1176261A - Manual interosseous device - Google Patents

Description

Manual intraosseous instrument

The present invention is a divisional application that is proposed again by divisional application (divisional filing date 2009, 5/5, application number 200910138130.0) proposed by invention patent application No.200580003261.8 (PCT/US 2005/002484) entitled "manual intraosseous instrument", which was proposed on the basis of 25/1/2005.

RELATED APPLICATIONS

This application claims priority from a provisional patent application No.60/539171 entitled "manual intraosseous device" filed on 26.1.2004.

This application claims priority from a provisional patent application No.60/547868 entitled "impact actuated endosseous needle" filed on 26.2.2004.

Technical Field

The present invention relates generally to a medical device for accessing bone marrow, and more particularly to a device and method for penetrating a bone and inserting a penetrator or needle into associated bone marrow.

Background

Each year, millions of patients are treated in the united states for life-threatening emergencies. Such emergencies include shock, trauma, heart disease, drug overdose, diabetic ketoacidosis, arrhythmia, burns, and epilepsy, to name just a few. For example, according to the american heart association, more than 1,500,000 patients are threatened by heart disease (myocardial infarction) each year, with more than 500,000 of them dying from fatal complications.

A key factor in addressing all of these emergencies is the rapid establishment of Intravenous (IV) syringes to inject drugs and fluids directly into the blood circulation system. The goal is the same whether it is rescued by a caregiver in an emergency vehicle or by an emergency specialist in an emergency room — an intravenous injection is initiated to inject life-saving drugs and fluids. The ability to successfully address these critical emergencies in the procedure of accessing the blood vessel depends to a great extent on the skill and luck of the operator. While it is relatively easy to initiate an intravenous injection for some patients, physicians, nurses, and paramedics often experience great difficulty in establishing intravenous access for approximately 20% of patients. In an attempt to address this problem, these patients are repeatedly spiked with sharp needles, and may require invasive procedures to ultimately establish venous access.

Another complication occurs in the "field" when access to the vein is achieved, for example, at the scene of an accident or during transport in an ambulance, where it is difficult to find the target and excessive motion makes access to the venous system very difficult.

In the case of patients with chronic disease or older age, no easily accessible veins can be found at all. Other patients may not have an available IV site due to anatomical scarcity of the peripheral veins, obesity, extreme dehydration, or previous use of IV drugs. For these patients, finding the appropriate location for injecting life-saving drugs becomes a significant and frustrating task. While morbidity and mortality statistics are not generally available, it is known that many patients suffering from life-threatening emergencies die of complications due to delayed or simply impossible access of life-saving IV therapies to the vascular system. For these patients, alternative methods need to be found.

Many medical devices, such as syringes, hypodermic needles, catheters, IV tubing, and stopcocks, may include either pin (male) or box (female) luer type fittings. The end of the pin or the end of the sleeve may include threads that allow the associated medical device to be removably engaged with other devices having complementary luer fittings. Luer connectors are sometimes referred to as luer slips (slips) or luer locks. Luer slips require the associated collar to be threaded half a turn so that the end of the pin and the end of the sleeve are securely engaged with each other. When engaged and twisted half a turn or more, the luer lock functions by forming a water tight fit between the pin and the sleeve. Luer locks typically include a threaded locking collar on the end of the barrel that mates with ears or tabs on the end of the associated pin, providing a more positive locking connection. Luer fittings typically form a fluid tight seal. Some luer fittings may include a tapered fitting.

Disclosure of Invention

In accordance with the teachings of the present invention, an apparatus and method are provided for communicating with or accessing bone marrow of a bone. The device may include a handle having a drive shaft, a hub having first and second ends, wherein the first end is operable to be connected to the drive shaft and the second end is operable to be connected to a penetrator hub (hub). The penetrator needle hub may include a penetrator operable to access bone marrow.

In an alternative embodiment, an apparatus for manually penetrating a bone and associated bone marrow is provided. The device may include a handle having at least one drive shaft, a detachable joint having a first end and a second end, wherein the first end is operable to connect to the at least one drive shaft and the second end is operable to connect to a penetrator hub. The penetrator needle hub has an adapter operatively connected to the adapter and a penetrator operatively inserted into bone marrow.

In another embodiment, a method of accessing bone marrow of a bone is provided. The method may include inserting a penetrator into bone marrow using an instrument having a handle, a drive shaft, and a fitting with a first end operable to be coupled to the drive shaft and a second end operable to be coupled to a penetrator assembly. For some applications, a trocar may be disposed within a penetrator assembly. After inserting portions of the penetrator assembly into bone marrow, the handle and adapter may be disengaged from the penetrator assembly. The trocar may be removable from the penetrator assembly and associated penetrator during use.

In various embodiments of the instrument, the handle may be T-shaped, pistol-shaped, circular or oval, an ergonomically designed grip, or any other shape suitable for general or special use. In various embodiments, the handle may include a cavity enclosing an intraosseous needle, a penetrator and associated trocar, or any other accessory suitable for use with the instrument.

In another embodiment, a powered instrument for penetrating bone marrow of a bone is provided. The apparatus may include a housing, a motor, a gear assembly, at least one drive shaft, and a power source, and at least one drive shaft operable to couple with an auxiliary device and further operable to provide rotational energy to the auxiliary device. In various embodiments, the auxiliary device may include a ring cutter, an inhalation device, or a flashlight.

Instruments and methods incorporating teachings of the present invention may be used for any purpose including the delivery of fluids, drugs, medicaments, chemicals, and any other biologically active substance including blood into the bone marrow of any bone of a human or animal. The teachings of the present invention may also be used to extract bone marrow and/or stem cells. The teachings of the present invention may also be used to access body tissues or cavities other than bone marrow of a human or animal.

Drawings

A more complete and thorough understanding of the present embodiments and advantages thereof may be acquired by referring to the following description taken in conjunction with the accompanying drawings, in which like reference numbers indicate like features, and wherein:

FIG. 1A is an exemplary illustration of an apparatus operable to penetrate bone marrow of a bone;

FIG. 1B is an exploded view of the instrument of FIG. 1A;

FIG. 1C is a schematic end view of the instrument of FIG. 1A;

FIG. 1D is a schematic diagram of one example of a driver and joint incorporating teachings of the present invention;

FIG. 1E is a schematic view of an example of a penetrator assembly removably engaged with a handle in accordance with the teachings of the present invention;

FIG. 1F is an exploded cross-sectional schematic view of a penetrator assembly with portions broken away having an outer penetrator and an inner penetrator and removably engaged with a handle in accordance with teachings of the present invention;

FIG. 1G is an enlarged schematic view of a tip formed on an inner penetrator in accordance with the teachings of the present invention;

FIG. 1H is an enlarged schematic view of a tip formed on an outer penetrator in accordance with the teachings of the present invention;

FIG. 1I is a schematic drawing in section and elevation with portions broken away showing one example of an instrument in communication with bone marrow of a bone according to the teachings of the present invention;

FIG. 2 is an exemplary illustration of an apparatus for penetrating bone marrow of a bone according to the teachings of the present disclosure;

FIG. 3A is an exemplary illustration of an apparatus operable to penetrate bone marrow of a bone according to the teachings of the present invention;

FIG. 3B is an exemplary illustration of an apparatus operable to penetrate bone marrow of a bone according to the teachings of the present invention;

FIG. 3C is an exemplary illustration of an apparatus operable to penetrate bone marrow of a bone in accordance with the teachings of the present invention;

FIG. 3D is a schematic perspective view of a container operable to enclose a penetrator assembly in accordance with the teachings of the present invention;

FIG. 4A is another example view of an apparatus for penetrating bone marrow of a bone according to the teachings of the present invention;

FIG. 4B is a schematic drawing in section of one example of a penetrator assembly with portions broken away in accordance with the teachings of the present invention removably engaged with a drive shaft;

FIG. 4C is a schematic drawing in section showing another example of an opening formed in a penetrator assembly with portions broken away in accordance with teachings of the present disclosure, wherein the penetrator assembly is removably engaged with a drive shaft;

FIG. 4D is a schematic drawing in section illustrating yet another example of an opening formed in a penetrator assembly with portions broken away in accordance with teachings of the present disclosure, wherein the penetrator assembly is removably engaged with a drive shaft;

FIG. 5A is an exemplary illustration of an improved assistive device used with a device operable to penetrate bone marrow of a bone in accordance with the teachings of the present invention;

FIG. 5B is an exemplary illustration of a powered apparatus operable to penetrate bone marrow of a bone and adapted to operate an auxiliary device;

FIG. 6A is an exploded schematic view of another example of an apparatus operable to penetrate bone marrow of a bone in accordance with the teachings of the present invention;

FIG. 6B is a schematic illustration of yet another example of an apparatus operable to penetrate bone marrow of a bone in accordance with the teachings of the present invention;

fig. 7 is an exploded schematic view of one example of an adapter suitable for connecting a tube to a needle hub and penetrator in accordance with the teachings of the present invention.

Detailed Description

The preferred embodiments of the present invention and its advantages are best understood by referring to figures 1A-7 of the drawings, like numerals being used for like and similar parts of the drawings.

Various aspects of the invention are described in terms of treating a human patient. However, devices and methods incorporating teachings of the present invention may also be used to treat animals.

Sometimes, battery powered drivers may not be effective or suitable for Intraosseous (IO) access. These situations may involve special military operations, as extreme temperatures and severe weight restrictions limit the portability of the object in combat. The same is true for civilian Emergency Medical Services (EMS) or first responders, as long storage and infrequent use make the convenience of battery powered drivers impractical. For this reason, manual drivers offer some advantages over battery powered drivers. Intraosseous access is sometimes performed using a manual driver for a longer period of time than is required using a powered driver. However, with either driver, the bone may be penetrated and into the associated bone marrow. When using a manual driver, manual force may be applied to a handle or knob to insert a penetrator or needle into a bone to access bone marrow. Manual drives may also be used as a useful backup in cases where the battery powered drive is unable to perform its function, for example due to a power source being depleted.

Fig. 1A, 1B, and 1C illustrate one embodiment of a manual driver 10a in which a handle 12a includes a drive shaft 16 a. The manual driver 10a may also include an alternative ratchet mechanism as shown in fig. 3A. The handle 12a may be shaped in a variety of shapes, for example, may be formed with a finger grip 20. The handle 12a may be made of a material suitable for multiple use or a material suitable for disposable or disposable use. A T-shaped handle 12e (see fig. 3 c), a generally circular or oval shaped handle 12a (see fig. 1A and 1B), a pistol grip handle 12B (see fig. 2), or any other ergonomically designed shape suitable for gripping by a human hand or finger when manually inserting a penetrator may also be used.

Various techniques may be used to removably engage or connect the handle to the associated adapter and/or penetrator in accordance with the teachings of the present invention. For some applications, the handle and associated joint may be formed as a single unit. See fig. 6A and 6B. In this configuration, the handle/adapter combination is operatively connected to the hub of the tissue penetrator. The handle and the joint may or may not be detachable from each other. For other applications, the handle may be removably engaged with the hub and associated penetrator without the use of a coupling.

Fig. 1B shows the instrument 10a with separation between the components. The handle 12a includes an optional finger grip or finger rest 20. Drive shaft or coupling 16a is removably engaged with end 181 of adapter 180. Inner penetrator or trocar 220 extends from end 182 of adapter 180. Adapter 180 and associated inner penetrator 220 may be removably connected to one another by a luer-type fitting, a threaded connection, or other suitable fitting formed on first end 201 of needle hub 200. Outer penetrator 210 extends from second end 202 of hub 200.

Fig. 1C shows an end view of the instrument 10 a.

An opening 186 in fig. 1D may be formed in first end 181 to receive associated drive shaft 16 a. See fig. 1D. The openings 186 may be formed in various configurations and/or sizes. For some applications, opening 186 may include a channel or passage sized to receive a portion of drive shaft 16 a. One or more webs 136 may be formed within end 181 and extend from opening 186. An open portion or space 138 may be formed between the webs 136. Each projection 146 extending from an adjacent portion of the handle 12a removably engages the web 136 and the space 138. Opening 186 and associated web 136 can be used to removably connect joint 180 with a manual driver or a powered driver. Fig. 5B shows an example of a power driver.

Fig. 1E shows an enlarged view of penetrator assembly 160.

As shown in FIG. 1F, penetrator assembly 160 may include adapter 180, a hub and associated hub 200, an outer penetrator 210 and an inner penetrator 220. Penetrator assembly 160 may include an outer penetrator (e.g., a cannula, hollow tube or hollow drill bit) and an inner penetrator (e.g., a stylet or trocar). Various stylets and/or trocars may be disposed within the outer penetrator. For some applications outer penetrator or cannula 210 may be described as a substantially elongate tube sized to receive inner penetrator or stylet 220 therein. Portions of inner penetrator 220 may be disposed within longitudinal passage 184 extending through outer penetrator 210. The outer diameter of inner penetrator 220 and the inner diameter of longitudinal passage 184 may be selected such that inner penetrator 220 may be slidably disposed within outer penetrator 210.

A metal disk 70 may be disposed within the opening 186 for removably connecting the adapter 180 and the magnetic drive shaft. For some applications, drive shaft 16a may be magnetized. End 223 of inner penetrator 220 is preferably spaced from metal disc 70 with an insulating or non-conductive material disposed therebetween.

Tip 211 of outer penetrator 210 and/or tip 222 of inner penetrator 220 may be operable to penetrate bone and associated bone marrow. The configuration of the tips 211 and/or 222 may be selected to penetrate bone or other body cavities in a manner that produces minimal trauma. First end or tip 222 of inner penetrator 220 may be trapezoidal in shape and may include one or more cutting surfaces. In one embodiment, outer penetrator 210 and inner penetrator 220 may be ground together as a unit during an associated manufacturing process. Providing a mating fit allows each tip 211 and 222 to act as a separate drilling unit that facilitates insertion and minimizes injury when inserting portions of penetrator assembly 160 into a bone and associated bone marrow. Inner penetrator 220 may also include longitudinal grooves (not expressly shown) extending along the sides of inner penetrator 220 to allow bone chips and/or tissue to be expelled from the insertion site as penetrator assembly 160 is drilled deeper into an associated bone. Outer penetrator 210 may be formed from stainless steel, titanium, or other material having suitable strength and durability to penetrate bone.

Hub 200 may be used to stabilize penetrator assembly 160 as an associated penetrator is inserted into the skin, soft tissue and adjacent bone of a patient at a selected insertion site. First end 201 of hub 200 is operable for removable engagement or connection with an associated connector 180. Second end 202 of hub 200 may be sized and configured to accommodate an insertion location associated with outer penetrator 210. The combination of hub 200 and outer penetrator 210 may sometimes be referred to as a "penetrator device" or an intraosseous needle.

For some applications, the fitting 180 may be described as a substantially cylindrical tube defined in part by a first end 181 and a second end 182. The exterior of the fitting 180 may include an enlarged taper adjacent the end 181. A plurality of longitudinal ridges 190 may be formed on the exterior of adapter 180 to allow an operator to grasp an associated penetrator assembly 160 when coupled with a drive shaft. See fig. 1E. Longitudinal ridges 190 also allow joint 180 to be grasped to separate it from hub 200 when outer penetrator 210 has been inserted into a bone and associated bone marrow.

Second end 182 of connector 180 may include an opening 185, such opening 185 being sized to receive first end 201 of hub 200 therein. Threads 188 may be formed in opening 185 adjacent second end 182 of fitting 180. Threaded adapter 188 may be used to removably connect joint 180 with threaded adapter 208 adjacent first end 201 of hub 200.

First end 201 of hub 200 may include a threaded connection 208 formed on the exterior thereof or other suitable adapter. The first end 201 may have a generally cylindrical pin-like configuration adapted to removably engage the second or sleeve end 182 of the adapter 180.

For some applications, end 202 of hub 200 may have a flange-like general configuration. An angled slot or groove 204 sized to receive an end of a protective cover or needle cap 234 may be formed in the end 202. Slot or groove 204 may be used to removably engage cover 234 with penetrator assembly 160. See fig. 1A, 1E and 2. For some applications, the cap 234 may be described as a generally hollow tube having a rounded end 232. A cap 234 may be positioned within associated slot 204 to protect portions of outer penetrator 210 and portions of inner penetrator 220 prior to attachment to an associated handle. The cover 234 may include a number of longitudinal ridges 236 formed on the exterior thereof. The longitudinal ridges 236 cooperate with one another to allow the cover or needle cap 234 to be installed and removed without contaminating the associated penetrator section. The cover 234 may be made of various plastics and/or metals.

The size and configuration of second end 202 of hub 200 may be varied to accommodate various insertion sites and/or patients. Hub 200 may be satisfactorily used with a variety of flanges or other configurations suitable for contacting the skin of a patient. Likewise, end 202 and associated flanges may be used with a variety of hubs. The present invention is not limited to hub 200, end 202 or related flanges.

A channel 206 may extend from the first end 201 through the second end 202. The inner diameter of passage 206 may be selected to securely engage the outer diameter of penetrator 210. The size and configuration of channel 206 may be selected to maintain an associated penetrator assembly in engagement with hub 200.

FIG. 1G shows an enlarged view of tip 222 formed on the end of inner penetrator 220 positioned within outer penetrator 210. Figure 1H shows an enlarged view of tip 211 formed on the end of outer penetrator 210.

In one embodiment of the present invention, the step of penetrating into the bone marrow may comprise: rotating or rotating the drive shaft to insert penetrator 24 (see fig. 4A), penetrator 110 (see fig. 4B) or penetrator 210 (see fig. 1A-1B) into bone and associated bone marrow via a rotational motion, disengaging the associated drive shaft from adapter 80 or 180 and disengaging adapter 80 or 180 from associated hub 100 or 200 to allow hub 100 or 200 and associated penetrator 24, penetrator 110 or penetrator 210 to be positioned within the bone marrow. The depth of penetration into the bone and associated bone marrow may be determined by the distance between second end 102 of hub 100 and the extreme ends of tip 30 or tip 111 or the distance between second end 202 of hub 200 and the extreme ends of tip 211. For some applications, the threaded connection or adapter 108 or 208 allows for connection with various types of luer locks and/or luer adapters associated with intravenous tubing or syringes associated with the first end 101 with the hub 100 or the first end 201 of the hub 200.

FIG. 1I shows outer penetrator or cannula 110 inserted into bone 130 and associated bone marrow 140. Various types of connections may be used to communicate fluids through outer penetrator 210 to bone marrow 140 and may then be used to connect intravenous tube 150 to outer penetrator 210. The advantage of right angle connector 132 is to allow tube 150 to be connected to outer penetrator 110 at an angle that does not kink or pinch the lumen of tube 150. A lock nut 133 may be used to engage the right angle fitting 132 with the hub 200.

FIG. 1I illustrates but one embodiment of a fitting that may be used to communicate fluid between outer penetrator 110 and tubing 150. Intravenous tubing may be used to provide intravenous fluids and/or medication to associated bone marrow. The tube may also be used to draw a blood sample from within the bone marrow. Other fittings or adapters may also be used to connect the penetrator to an intravenous tube, other types of tubing, and/or a syringe. See fig. 7.

Instruments formed in accordance with the teachings of the present invention may have an ergonomic design that allows insertion pressure or force (e.g., manual force) to be applied relatively easily, while at the same time allowing rotational motion of an associated handle. In fig. 3C, the drive shaft 16 with associated handle 12e may be aligned with an anatomically neutral position of the operator's hand and wrist as the operator's hand and wrist are rotated in and out. Such alignment allows for better axial positioning of the penetrator assembly as an associated penetrator is inserted into a bone and associated bone marrow, and less likely to allow excessive movement and/or misalignment that may result in undesirable widening and/or lengthening of an associated insertion hole. The insertion force is not limited to rotational forces, but may include reciprocating or direct axial forces applied by manual force.

FIG. 2 illustrates another embodiment of an instrument that may be used to insert a penetrator into bone marrow in accordance with teachings of the present disclosure. Fig. 2 shows a manual driver 10b, wherein the handle 12b includes a drive shaft 16 b. The manual driver 10b may also include an optional ratchet mechanism such as that shown by fig. 3A. Handle 12b is removably engaged with penetrator assembly 160 and may be used with any other penetrator assembly taught by the present invention.

The instrument 10c shown in FIG. 3A may also include a first drive shaft 16a and a second drive shaft 16 c. The drive shafts 16a and 16c may include respective ratchet mechanisms 14. Drive shafts 16a and 16c may be disposed at different angles relative to handle 12c to accommodate different insertion positions of an associated penetrator assembly and/or to accommodate different types of penetrator assemblies. The drive shafts 16a and 16c may have the same circular cross-section or may have different cross-sections.

For embodiments of the present invention such as that shown in FIG. 3A, instrument 10c may include a handle 12c having at least one lumen 40 disposed therein. The configuration and dimensions of lumen 40 (shown in phantom in FIG. 3A) may be selected to accommodate one or more penetrator assemblies and/or other devices. A cap 42 may be secured to one end of the handle 12c to retain a penetrator assembly or other device within the cavity 40.

As will be described in greater detail later, the penetrator assembly is preferably disposed within a sealed container prior to use. Figure 3D illustrates an example of a container according to the teachings of the present invention. Penetrator assembly 160 is shown in phantom within chamber 40 to indicate that various other components in addition to container 43 may be satisfactorily disposed within the handle in accordance with the teachings of the present invention. Chamber 40 may be configured to house one or more containers 43 and/or a plurality of devices.

The instrument 10d shown in fig. 3B may include a handle 12d having an improved configuration as compared to the previously described handles 12 d. The drive shaft 16b may have 4 sides that define a generally square or rectangular cross-section. The drive shaft 16b may also have 5 sides, 6 sides, or be keyed. The handle 12d also includes a chamber 40 within which a container 43 is disposed. As previously mentioned, the instrument 10e shown in FIG. 3C may include a generally T-shaped handle 12 e.

As shown in fig. 3D, the container 43 includes a lid 44 attached thereto. The cover 44 includes a tab 46 configured to be opened by one or more fingers of a hand. The lid 44 of the container 43 can be opened by one hand of the operator. When the cover 44 is open, the operator may engage the penetrator assembly with the drive shaft of a manual or powered driver held on the other hand of the operator. A flexible band 48 may be used to removably engage the lid 44 with the container 43. The container taught by the present invention allows the penetrator assembly to be maintained in a sterile environment. When it is desired to use a penetrator assembly, a manual or powered driver may be coupled to a penetrator assembly in accordance with the teachings of the present invention without contaminating the penetrator assembly. As will be described in greater detail below, various mechanisms, such as magnets, O-rings, and/or ball detents, may be satisfactorily used to allow the drive shaft to removably engage the penetrator assembly.

Ratchet mechanism 14 (see fig. 3A, 3B and 3C) is an optional component that may be included in some embodiments to provide additional leverage for inserting an associated penetrator. For example, when rotational power is applied in a clockwise direction, the ratchet works by engaging with a hub attached to the needle assembly hub. The ratchet mechanism 14 may be reversed so that the associated handle may be rotated in either a clockwise or counterclockwise direction. Instruments taught by the present invention may include a rotatable collar (not expressly shown) configured to lock and unlock a reversible ratchet mechanism to change the direction of rotation. The drive shaft taught by the present invention may be connected to the ratchet mechanism 14 to apply a rotational force in only one direction. Ratchet mechanism 14 may be of the "silent" type, comprising three ball bearings (not expressly shown) configured to produce the desired effect, without the noise associated with conventional ratchets. The drive shaft may also be connected to the handle taught by the present invention without the use of a ratchet mechanism 14.

Various types of penetrators and penetrators assemblies may be satisfactorily used with a handle in accordance with the teachings of the present invention. Examples of such penetrators and penetrator assemblies include, but are not limited to, penetrator assembly 22 as shown in FIG. 1A, penetrator assembly 22 as shown in FIG. 4A, and penetrator assembly 60 as shown in FIG. 4B. For some applications penetrator assembly 22 may include connector 80, hub 100 and penetrator 24 as shown in fig. 4A. For some applications penetrator assembly 60 may include coupling 80, hub 100, cannula 110 and trocar 120 as shown in fig. 4B. For some applications penetrator assembly 160 may include adapter 180, hub 200, cannula 210, and trocar or stylet 220 shown in fig. 1A. The instruments and methods taught by the present invention may be used with a variety of handles, connectors, needle hubs, and penetrators. The present invention is not limited to the handles, joints, flanges, penetrators, and/or penetrator assemblies shown in fig. 1A-6B. For some applications, the handle or driver may be attached directly to the penetrator hub without the use of a coupling.

For some applications, a penetrator assembly may include only a single hollow penetrator. For other applications, however, the penetrator assembly may include an outer penetrator (e.g., a cannula, a hollow needle, or a hollow drill bit) and an inner penetrator (e.g., a stylet, a trocar, or other removable device disposed within the outer penetrator). Penetrator 24 is exemplary of a single hollow penetrator. See fig. 4A. Penetrator 24 may include one or more side apertures (not expressly shown). Cannulae 110 and 210 are examples of outer penetrators. Trocar 120 and stylet 220 are examples of inner penetrators. See fig. 1B and 1E.

The dimensions of the penetrator may vary depending on the application of the associated penetrator assembly. Penetrators are relatively small for pediatric patients, medium sized penetrators for adults and large sized penetrators for large sized patients. For example, the length of the penetrator may be in the range of 5mm to 30 mm. The penetrator may have a diameter in the range of 18 gauge (gauge) to 10 gauge (gauge). The length and diameter of the penetrator used in a particular application may depend on the size of the bone for which the instrument is intended to be used. The penetrator may have various configurations depending on the clinical needs of the associated penetrator insertion. For example, there may be a configuration for administering drugs and/or fluids to the bone marrow of a patient, and an alternative configuration for sampling the bone marrow and/or blood of a patient. Other configurations are also suitable for bone and/or biopsy. Some penetrators may be suitable for more than one use. The configuration and size of the penetrators may also vary depending on the selected insertion site for each penetrator.

As shown in FIG. 4A, penetrator assembly 22 may include a hub 80, a hub and associated flange 100, and penetrator 24. For some applications penetrator 24 may be generally described as a hollow needle adapted to communicate fluids with bone marrow. Penetrator 24 may be configured to penetrate bone, bone marrow, or other bodily tissue or cavity. Various types of intraosseous needles and/or cannulated drill bits may be used as penetrator 24. Tip 30 of penetrator 24 may be adapted to drill a hole in bone in response to rotation of handle 22. An opening (not expressly shown) may be formed in penetrator 24 proximate tip 30 to allow fluid communication between a fluid flow passage (not expressly shown) formed within penetrator 24 and adjacent bone marrow.

As shown in fig. 4A and 4B, the needle hub 100 may be used to stabilize a penetrator assembly during insertion of an associated penetrator through skin, soft tissue and adjacent bone of a patient at a selected insertion site. The first end 101 of the needle hub 100 is operable to removably engage or connect with an associated adapter 80. Second end 102 of hub 100 and the associated flange are sized and configured to accommodate the associated insertion position of penetrator 24. The combination of hub 100 and penetrator 24 is sometimes referred to as a "penetrator instrument or assembly". Various techniques may be suitable for removably engaging the hub 80 with the hub 100 and penetrator 24. Various types of mechanical fasteners, including, for example, but not limited to, mechanical adapters and threaded connections and/or luer lock nuts, are suitable for removably engaging the handle with the penetrator in accordance with the teachings of the present invention.

For some applications, the joint 80 may be described as a generally cylindrical rod defined in part by a first end 81 and a second end 82. A longitudinal passage 84 may extend from the first end 81 through a portion of the joint 80. For some embodiments, such as that shown in FIG. 4B, the channel 84 preferably terminates before the disk 70. For some applications, the longitudinal passage 84 may be sized to accommodate a stylet or trocar. See fig. 4B. For other applications, the fitting 80 may be satisfactorily used without the longitudinal passage 84.

An enlarged opening may be formed in first end 81 to receive drive shaft 16. A threaded adapter 88 may be formed adjacent the second end 82 of the connector 80 for removably connecting the connector 80 with the first end 101 of the needle hub 100. For some applications, a number of ridges or notches 90 may be formed on the exterior of adapter 80 to allow an operator to grasp penetrator assembly 22 when connecting penetrator assembly 22 with drive shaft 16. Ridge or notch 90 also allows joint 80 to be grasped when penetrator 24 has been inserted into a bone and associated bone marrow to separate it from hub 100.

For some applications, the end 102 of the needle hub 100 may include an annular slot or groove 104 sized to receive an end of the protective cap 32. Slot or groove 104 may be used to removably engage cap 32 with penetrator assembly 22 and/or penetrator assembly 60. See fig. 4B. For some applications, the cap 32 may be described as a generally hollow tube having a rounded end 34. A cap 32 may be provided in associated slot 104 to protect the penetrator portion prior to connection of the penetrator to a manual or powered driver. Cover 32 may be made of various plastics and/or metals and may be used in alternative embodiments of penetrator assemblies.

The size and configuration of the second end 102 of the needle hub 100 may be varied to accommodate various insertion sites and/or patients. The channel 106 may extend through the needle hub 100 from the first end 101 to the second end 102. The inner diameter of passage 106 may be selected to securely engage the outer diameter of penetrator 24 and/or the outer diameter of casing 110. The dimensions and configuration of the channel 106 may be selected to securely engage the associated penetrator with the needle hub 100. Several techniques and methods may be used to secure the penetrator to the needle hub including, but not limited to, knurling, shot peening, flanges (not expressly shown), bonding, and/or indenting.

The first end 101 of the needle hub 100 may include a threaded connection 108 or other suitable adapter on the exterior thereof. The first end 101 may have a generally cylindrical pin-type configuration adapted to removably engage the second or sleeve end 82 of the adapter 80. The threaded connection 88 removably engages the threads 108.

Joints 80, 80B, 80C and 80D may have similar external configurations and dimensions as shown in fig. 4A, 4B, 4C and 4D, respectively. However, the size and configuration of the joints taught by the present invention can be greatly improved as compared to joints 80, 80b, 80c, and 80 d.

The opening 86 in each adapter 80 may have various configurations and dimensions to removably engage an associated drive shaft. For some applications, the drive shaft may have 4, 5, 6, or 8 faces. The drive shaft may also have a "D-shaped" cross-section. The drive shaft may also be of circular or any other keyed configuration. The associated openings in the drive shaft and the coupling may be tapered relative to each other (not expressly shown).

The drive shaft 16 as shown in fig. 4A may have 5 faces. The corresponding opening 86B shown in fig. 4B may also include 5 faces adapted to removably receive the drive shaft 16. For some applications, metal disk 70 may be disposed within opening 86b opposite end 81. Metal disk 70 is adapted to removably engage penetrator assembly 60 with a drive shaft formed of a magnetized material as shown in figure 4B. Drive shaft 16 may include or contain a magnet configured to removably engage a metal disk 70 disposed within penetrator assembly 60. The cooperation between the metal disc 70 and the magnetized drive shaft 16 allows for removal of the penetrator assembly from a container, such as the container 43.

For other applications, one or more magnets 72 and 74 may be disposed within the sides of the opening 86 to removably engage the associated drive shaft with the fitting 80 b. Magnets 72 and 74 are shown in phantom in FIG. 1B. Magnets 72 and/or 74 may be used to removably engage the adapter with a drive shaft made of a suitable metal alloy or other material.

For embodiments of the present invention, such as that shown in fig. 4C, the opening 86C may have a generally circular cross-section. An O-ring 96 may be disposed within the opening 86c of the fitting 80 c. The O-ring 96 can form a satisfactory engagement with an associated drive shaft having a corresponding generally circular cross-section. The drive shafts 16a and 16c shown in fig. 3A may have a substantially circular cross-section.

The joint 80D as shown in fig. 4D may include a ball 96 and a spring 98, wherein the ball 96 and spring 98 are shown to engage corresponding detents or grooves (not expressly shown) in the drive shaft. Ball detent mechanism 96 and spring 98 may cooperate with one another to removably engage adapter 80d and the associated penetrator assembly with the drive shaft. Other mechanisms may be suitable for removably engaging the drive shaft with the adapter in accordance with the teachings of the present invention. These mechanisms include, but are not limited to, snap-ring type joints (not expressly shown), keyed joints (not expressly shown), and similar removable connections.

For the embodiment shown in fig. 4B, various types of threaded connections or other suitable fittings may be employed. The end 82 of the hub 80 preferably includes an enlarged opening or passageway sized to receive the first end 101 of the needle hub 100. Threads 88 formed in end 82 removably engage threads 108 formed on the exterior of end 101.

For embodiments of the present invention such as that shown in fig. 4B, penetrator assembly 60 may include an outer penetrator (e.g., a cannula, a hollow needle, or a hollow drill bit) and an inner penetrator (e.g., a stylet or trocar). Various types of stylets or trocars may be disposed within the outer penetrator. For some applications outer penetrator or cannula 110 may be described as having a generally elongated, hollow tube sized to receive inner penetrator or trocar 120 therein. Portions of the trocar 120 may be disposed within the longitudinal passage 84 extending through the connector 80. The outer diameter of the trocar 120 and the inner diameter of the longitudinal passage 84 may be selected so that the trocar 120 may be securely engaged with the connector 80. For some applications, the metal disk 70 may be disposed within the opening 86 adjacent the trocar 120.

Tip 111 of outer penetrator 110 and/or tip 112 of inner penetrator 120 may be operable to penetrate bone and associated bone marrow. The configuration of tips 111 and/or 121 may be selected to penetrate bone or other body cavities with minimal trauma. The first end or tip 121 of the trocar 120 may include one or more cutting surfaces. In one embodiment, outer penetrator 110 and inner penetrator 120 may be separately ground during manufacture and then aligned to ensure a precise fit to allow respective tips 111 and 121 to act as a single drilling unit to facilitate insertion and minimize injury when portions of penetrator assembly 60 are inserted into a bone and associated bone marrow. The resulting structure of tips 111 and 121 can penetrate bone or other body cavities with minimal injury.

Inner penetrator 120 may also include longitudinal grooves (not expressly shown) extending along sides of inner penetrator 120 to allow bone chips and/or tissue to be expelled from an insertion site as penetrator assembly 60 is drilled deeper into an associated bone. The cannula 110 may be made of stainless steel, titanium, or other material having suitable strength and durability to penetrate bone.

Various auxiliary tools and devices are often carried by emergency medical service personnel and/or first responders. A ring cutter 50 shown in fig. 5A may be representative of such an auxiliary tool. The ring cutter 50 may include a thumb grip 52 and a finger protector 54. The annular cutting blade 56 is rotatably mounted on an arm 58 extending from the handle 12 f.

For some applications, annular cutting blade 56 may engage a hub incorporating teachings of the present invention. For example, as shown in fig. 5B, the annular cutting blade 56 may be securely engaged with the hub 100B. The first end 101 of the needle hub 110b may be modified to have an opening 86b similar to the opening 86b described with respect to the fitting 80 b. For some applications, the handle 12, 12a, 12b, 12c, 12d and/or 12e may be removably engaged with the hub or hub 100b to rotate the annular cutting blade 56. For other applications, a powered driver 312 may be coupled to the needle hub or needle hub 100 b. The drive 312 may include a motor 314 coupled to the drive shaft 300. A battery or power source 318 may be provided within the powered driver 312. A trigger 320 may be used to activate the motor 314.

Examples of powered drivers that may employ needle hubs or flanges are shown in U.S. patent 6183442 entitled "tissue penetrating device and method of use thereof" and U.S. patent 5554154 entitled "intraosseous needle drill". Powered drivers are also shown in U.S. patent application No.10/449503 entitled "apparatus and method for emergency access to bone marrow" filed on 30/5/2003 and in U.S. patent application No. 10/449476 filed on 30/5/2003.

In other situations where rotational force or power is required, it is advantageous for the operator to have a reliable power drive. For example, the drive shaft 300 may be compatible with various auxiliary devices that are driven in a rotational or reciprocating manner. Other examples of auxiliary or additional devices (not expressly shown) that may be coupled to the handle of the present teachings include, but are not limited to, orthopedic fixation devices, portable inhalation devices, flashlights, or any other medical or field device that uses an electrical power source. The flashlight connected to the manual or powered driver may include a red light or a white light for night vision (not expressly shown). These lamps may be of the LED type.

Fig. 1A, 2, 3A-3C, 6A and 6B and 1B illustrate an embodiment of the present invention that includes a manual driver that is removably engageable with a hub in accordance with the teachings of the present invention. The instrument 10f shown in fig. 6A may include a handle 12f with a joint 280 formed as a single piece. Various types of threaded connections and/or other adapters may be satisfactorily used to removably engage the driver 10f with the needle hub 200. For some applications threaded connection 188 may be formed within connector 280 for removable engagement with threaded connection 208 formed on hub 200. In fig. 6A, instrument 10f may include a penetrator or trocar 220 extending from handle 12 f.

Fig. 6B shows instrument 10g including handle 12g and hub 200. For embodiments of the invention such as that shown in fig. 6B, instrument 10g does not include a penetrator or trocar. Hub 200 may include penetrator 24 having side port or opening 26 formed therein as previously described.

Fig. 7 is a schematic view of one example of a luer or luer fitting that may be satisfactorily formed between hub 200 and iv tube 150. The male fitting 144 may be inserted into one end of a tube 150. Male fitting 144 preferably includes a tapered surface 62 designed to form a fluid tight seal with tapered surface 64, wherein tapered surface 64 is formed with a needle hub 200 adjacent end 210. Tapered surfaces 62 and 64 cooperate with one another to form portions of a fluid tight luer fitting or fitting. A luer lock nut or luer clip 133 may be used to securely engage tapered surfaces 62 and 64 to one another. Luer lock nut 133 may securely engage threads 208 formed on the exterior of hub 200 adjacent end 201. After hub 200 and associated penetrator 210 have been placed at the selected insertion location, male luer fitting 36 may be slidably disposed within female luer fitting 38. Luer fittings 36 and 38 preferably have tapered surfaces that engage one another to form a substantially fluid tight seal therebetween. Luer lock 133 may be used to securely engage to maintain secure engagement between luer fittings 36 and 38.

Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the following claims.

Claims (8)

1. An apparatus for penetrating a bone and associated bone marrow, the apparatus comprising:

a handle (12 f) having a joint (280) formed as an integral part of the handle;

a hub (200) having a first end (201) and a second end (202), an outer penetrator (210) extending from the second end (202) of the hub (200); and

the adapter (280) has an adapter (188), the adapter (188) being adapted to be removably engaged with the first end (201) of the needle hub (200) so that a force can be applied to the handle (12 f) to insert the outer penetrator (210) into bone marrow.

2. The apparatus of claim 1, further comprising:

an inner penetrator (220) extending from the handle (12 f); and

inner penetrator (220) may be operable to be slidably disposed within a longitudinal passageway of outer penetrator (210) during releasable engagement of hub (200) with coupling (280).

3. The apparatus of claim 1, further comprising:

the outer penetrator (210) has a tip (211); and

an opening (26) is formed in the outer penetrator (210) adjacent the tip (211).

4. The instrument according to any one of claims 1 to 3, wherein the adapter (188) is a threaded connection.

5. An apparatus for penetrating a bone and associated bone marrow, the apparatus comprising:

a handle (12 f) having a joint (280) formed as an integral part of the handle;

a hub (200) having a first end (201) and a second end (202), an outer penetrator (210) extending from the second end (202) of the hub (200);

a connector (280) for removably engaging the handle (12 f) with the first end (201) of the hub (200);

connector (280) has a threaded connection (188), which threaded connection (188) is intended to be detachably engaged with a related threaded connection (208) formed on first end (201) of hub (200), so that a force can be applied to handle (12 f) to insert outer penetrator (210) into bone marrow;

an inner penetrator (220) extending from the handle (12 f);

inner penetrator (220) may be operable to be slidably disposed within a longitudinal passage of outer penetrator (210) during removable engagement of outer penetrator (210) with adapter (280).

6. The apparatus of claim 5, further comprising:

the first end (201) of the needle seat (200) is provided with an opening, and a conical surface (64) is arranged in the opening;

a right angle fitting (132), the right angle fitting (132) connected to the adapter (144) and extending from the adapter (144);

the adapter (144) having a tapered surface (62) formed on an exterior of the adapter (144);

the tapered surface (62) of the adapter (144) is adapted to form a fluid seal with a tapered surface (64) provided in the first end (201) of the needle hub (200);

the right-angle connector (132) is connected to a pipe (150);

an adapter (144) and a right angle fitting (132) operable to be in fluid communication with the lumen of the tube;

a clamp (133), the clamp (133) slidably disposed on the right angle joint (132) adjacent the adapter (144);

the penetrator hub (200) comprises a threaded connection (208) arranged adjacent to the first end (201) of the penetrator hub (200); and

the threaded connection (208) of the penetrator hub (200) is adapted to removably engage an associated threaded connection (188) of the collar (133) when the adapter (144) is disposed in the first end (201) of the penetrator hub (200).

7. The apparatus of claim 5, further comprising:

the first end (201) of the penetrator hub (200) is provided with an opening, and a conical surface (64) is arranged in the opening;

a right angle fitting (132), the right angle fitting (132) being connected to and extending from one end of the pipe;

an adapter (144) disposed on the other end of the right angle connector (132);

a tapered surface (62) is formed on the exterior of the adapter (144);

a tapered surface (62) of the adapter (144) for forming a fluid seal with a tapered surface (64) provided in the first end (201) of the penetrator hub (200);

the right angle fitting (132) being operable to be in fluid communication with the lumen of the tube;

the penetrator hub (200) comprises a threaded connection (208) arranged adjacent to the first end (201) of the penetrator hub (200); and

the threaded connection (208) of the penetrator hub (200) is used for detachably engaging the related threaded connection (188) of the clamp (133), and the clamp (133) is slidably arranged on the right-angle connector (132).

8. The device according to claim 6 or 7, wherein the right angle joint (132) prevents kinking or pinching of the lumen of the tube (150).