WO2013003885A2

WO2013003885A2 - Intraosseous infusion device

Info

Publication number: WO2013003885A2
Application number: PCT/AU2012/000752
Authority: WO
Inventors: David Noble
Original assignee: David Noble
Priority date: 2011-07-01
Filing date: 2012-06-27
Publication date: 2013-01-10
Also published as: WO2013003885A3

Abstract

Described are intraosseous infusion devices that can be securely fixed for extended time periods with great sealing properties, which can be easily inserted and removed, and which have relatively small tendency to disrupt the bone materials. An example intraosseous infusion device comprises a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body. The intraosseous infusion device further comprises an elongate sealing member having a plurality of resiliently flexible ridges arranged on a side surface of the main body. The resiliently flexible ridges may have variable dimensions such as variable widths and/or variable lengths. Further, the resiliently flexible ridges may construe a left handed thread for easy insertion or removal. The intraosseous infusion device may also include a female Luer connector associated with the lumen.

Description

INTRAOSSEOUS INFUSION DEVICE

TECHNICAL FIELD

[0001] This disclosure relates generally to intraosseous infusion, and, more specifically, to intraosseous infusion devices and assemblies enabling their secure long-term fixation in bones as well as easy insertion and removal.

DESCRIPTION OF RELATED ART

[0002] The approaches described in this section could be pursued but are not necessarily approaches that have been previously conceived or pursued. Therefore, unless otherwise indicated, it should not be assumed that any of the approaches described in this section qualify as prior art merely by virtue of their inclusion in this section.

[0003] Intraosseous infusion is the process of directly infusing various fluids into the marrow of a bone. Typically, intraosseous infusion devices are injected through the skin, the bone's hard cortex and then into the soft marrow interior which allows immediate access to the vascular system. Intraosseous infusion can be used on adult or pediatric patients when traditional methods of vascular access are difficult or impossible. Often the antero-medial aspect of the tibia is used as it lies just under the skin and can easily be palpated and located. The anterior aspect of the femur, the superior iliac crest and the head of the humerus are other sites that can be used.

[0004] This route of fluid and medication administration is an alternative one to the intravascular route when the latter cannot be established in a timely manner, e.g. in emergency cases. For patients in extremis, securing vascular access is critical but peripheral intravenous catheter insertion may often be difficult, if not impossible, particularly in patients experiencing cardiac arrest, major trauma, airway compromise, severe dehydration and shock. Intraosseous infusion process is also used as an alternative route for patients who typically have poor peripheral vasculature or challenging vascular access due to diabetes, renal failure, burn victims, intravenous (IV) drug users, obese patients, the very young or elderly patients.

[0005] The use of intraosseous access has gained acceptance over the past 15 years, but the technique has been used since the 1930s. It declined in popularity due to intravenous catheters but saw a revival in the 1980s because numerous studies demonstrated the efficacy of intraosseous administration of emergency medications in patients needing resuscitation in whom establishing intravenous access was difficult. Intraosseous access requires less skill and practice than central line and has fewer serious complications than central lines. Further, intraosseous infusion can be performed faster than central lines or peripheral lines when vascular collapse is present.

[0006] However, while having many advantages over IV devices, current intraosseous infusion devices are recommended for only a period of 24- 48 hours, after which another route of access should be obtained. Therefore, intraosseous infusion has generally been viewed as a short-term, life-saving , emergency procedure. As such the current devices are designed for short term use and tend to suffer from various problems including leakage of the infusate resulting from ill-fitting devices in the bone, difficulties with easy insertion and removal of the devices, tendency to disrupt bone material during installment or removal, and so forth.

[0007] For example, currently available intraosseous infusion devices may be implemented as hollow rods or needles, which can be inserted into the bone as a single step process. However, the needle-like intraosseous infusion devices in current use are prone to leakage and have issues of device stability due to the limitations of the design of these devices. Living bone is relatively non-compliant. If a hole is made in the bone and intraosseous infusion device inserted then, unless the hole and intraosseous device are exactly matched, there is a potential for non-symmetry between the device and the hole, a reduction in the quality and quantity of device/bone interface which can creates a gap, and the potential for fluid to leak out while being infused and if there is insufficient contact between the device and the bone, the intraosseous infusion device is more prone to dislodge accidently. This is particularly an issue if the intraosseous infusion device is moved while in place. If a force is applied to the intraosseous device, such as may occur during the transfer of a patient, the device may break or deform or cause the bone to change contour or shape of the hole and create a gap. This reduces the sealing properties of intraosseous infusion devices and reduces their stability.

[0008] In another example, the currently available intraosseous infusion devices may be implemented as a threaded rod made from

biocompatible metals. If the intraosseous device has a solid thread then it will need to be screwed into the bone. Once in place removal may be difficult, if the device is left in for a period of time. Traditionally, the threaded intraosseous infusion devices are inserted with rotational and axial forces applied thereto so that it bites the material and screws into the material. Thus, the intraosseous device must be screwed into the bone and impact forces applied to enable the threads to bite into the bone facilitate the device to be screwed into the bone material. This method of inserting intraosseous infusion devices into bone materials may provide temporary security and a watertight seal. However, the intraosseous infusion devices are often inserted inappropriately in such a way as to disrupt the bone material and reduce security and sealing ability. This is more likely to happen if the bone material is soft or brittle or, if in a biological context, diseased or suffering a pathology such as osteoporosis or osteogenesis imperfecta. Accordingly, there is a high risk for undesired damage in the bone for currently existing threaded intraosseous infusion devices. It should be also appreciated that biologically active material such as bone will grow and change over time and any intraosseous infusion device inserted therein will have bone matrix grow adjacent to the devices/bone interface and can impact on the ease of removal of intraosseous devices after a period of time.

[0009] Accordingly, there is still a need to develop intraosseous infusion devices which can be inserted easily and in a controlled fashion, has reduced tendency to disrupt the bone materials, seals well without leakage of fluid, does not dislodge readily, is able to accommodate the growth of bone material and other biological materials around the intraosseous infusion devices in such a manner that their removal is easy and simple and be able to remain in the patient for an extended period of time.

SUMMARY

[0010] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter.

[0011] The present teachings relate to various intraosseous infusion devices and assemblies enabling their long-term fixation in bones, easy insertion and removal, and which prevent disruption of bone materials when used. It should be appreciated that the present teachings can be equally applicable to any medical application that requires breaching cortexes of bones and provide intraosseous infusion technology that can be inserted and later removed if required. It is also equally applicable in other biological and non-biological situations where an intraosseous infusion device requires fixation in organic or inorganic materials.

[0012] According to an aspect, there is provided an intraosseous infusion device. An example intraosseous infusion device comprises a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body. The at least one lumen can be in fluid communication with at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body. The intraosseous infusion device may further comprise an elongate sealing member having a plurality of resiliently flexible ridges arranged on a side surface of the main body. Further, the plurality of resiliently flexible ridges may have variable dimensions such as variable widths and/or variable lengths. [0013] According to various embodiments, the plurality of resiliently flexible ridges is helically wound around a core of the main body so as construe a thread. The thread can be a left handed thread or right handed thread. The resiliently flexible ridges may have an acute shape or a round shape, and can be made from a biocompatible polymer material.

[0014] The ridges can be resiliently flexible (i.e., elastomeric) such that they are deformable during use. Accordingly, the threads may be deformed, when a force is applied and restored to their original shape when the force is removed. The threads may deform as the intraosseous infusion device is inserted into a bone hole. This deformation reduces the space between the device and the bone, increases the surface contact between the device and the bone and the restorative properties of the threads increases the frictional resistance of the intraosseous infusion device to dislodgment. For example, as the main body is inserted into the bone hole, the bone surfaces defining the hole exert an inward pressure on the main body causing the ridges of the screw thread to deform. This may be particularly the case in embodiments where the device is sized such that the outermost diameter is greater than the diameter of the hole made in the bone. Forcing the device into the hole in the bone compresses the ridges of the main body and further augments sealing of the main body in the bone by increasing the surface area at the interface of the ridges and the bone.

[0015] The dimensions of the ridges may -be constant along the length of the sealing member. Alternatively, the dimensions of the ridges may vary along said length. In various embodiments, the width of resiliently flexible ridges arranged near the proximal end of the main body can be larger than the width of resiliently flexible ridges arranged near the distal end of the main body. Further, the length of resiliently flexible ridges arranged near the proximal end of the main body can be smaller than the length of resiliently flexible ridges arranged near the distal end of the main body. Accordingly, the ridges that engage the cortex are shorter and less flexible. These ridges will form a tight seal and also provide significant resistance to removal. The ridges that engage the marrow can be thus more flexible. These ridges may pass through the hole to reach the marrow space and are designed to readily deform and not restrict the ready passage of the device into the marrow space.

[0016] The intraosseous infusion device may further comprise a shoulder at or adjacent to the proximal end of the main body. In various embodiments, the main body may have a conical or cone frustum shape so that the proximal end of the main body has a wider diameter than the distal end of the main body.

[0017] The intraosseous infusion device may further comprise one or more female Luer connectors. The one or more female Luer connectors can be blind ended connectors and are not in fluid communication with one or more lumens. Alternatively, the female Luer connectors can be in fluid

communication with one or more lumens.

[0018] In general, female Luer adaptor can be used for removal of the intraosseous infusion device from the bone. It can be appreciated that if the intraosseous infusion device remains in the bone for a long period of time, then a bone matrix will attempt to grow around the intraosseous infusion device. The intraosseous infusion device has ridges and the bone matrix may grow around these ridges. Removal of the device will require it to be unscrewed from the re- grown bone matrix. The Luer system is designed to engage on a clockwise rotation and disengage on a counter-clockwise rotation. A male Luer adaptor, such as a Luer end syringe, can be engaged with the female Luer adaptor arranged on the intraosseous infusion device with a clockwise rotation. Once engaged, the Luer system can be further clockwise rotated to assist intraosseous infusion device removal.

[0019] According to various embodiments, the intraosseous infusion device can be made from bioabsorbable materials or comprise such materials. The main body and/or the plurality of resiliently flexible ridges can be impregnated or coated with a biologically active substance such as medication. Further, the main body and/or the plurality of resiliently flexible ridges can be impregnated or coated with an antimicrobial substance.

[0020] In one embodiment, the ridges may be made from a different, more resiliently flexible material to that of the remainder of the main body. Alternatively, the main body may comprise the same material as the ridges, but the thickness and/or density of the material may differ between the two. In an example, the main body may comprise a relatively harder polymer than the ridges.

[0021] The main body of the device may comprise one lumen.

Alternatively, the main body may comprise two or more lumens. In a further embodiment, three lumens are envisaged in the main body. It is also envisaged that the main body may comprise more than three lumens.

[0022] Multiple lumens allow the introduction of various different infusates and monitoring equipment. The multiple lumens may have varying diameters and thus be used for different purposes. This is particularly useful when the intraosseous access device is required in resuscitation and fluid delivery and in ongoing care including as a portal for drug delivery. [0023] In one embodiment, the main body may comprise at least one lumen having a larger diameter than the remaining lumens. The larger lumen may be used for the introduction of fluids during resuscitation of a subject when a higher flow rate is required. Being greater in diameter, the lumen enables a greater flow rate of infusate to the bone marrow.

[0024] In one embodiment, the intraosseous infusion device may comprise at least one resuscitation lumen having a diameter of approximately 3 mm. The outer diameter of the intraosseous infusion device may be greater than 6 mm and the hole drilled in the bone may be substantially 6 mm in diameter. A 6 mm entry to the bone marrow together with a 3 mm diameter lumen provides a fast flow rate and increased surface area of bone marrow for optimal fluid absorption which is critical during resuscitation.

[0025] The main body may also comprise one or more smaller lumens which may be used in the ongoing care of a patient. In one example, the smaller lumens may be used for the delivery of therapeutic agents to a patient. By having multiple smaller diametered lumens, different agents may be delivered separately. This is advantageous as many drugs are incompatible for delivery through a single line. The smaller lumens may also be used to introduce parenteral nutrition, drugs, including antibiotics or gases such as oxygen.

[0026] Accordingly, the device may be designed to maximise flow of infusate directly to the bone marrow cavity while also conferring the advantage that different infusates may be introduced via separate lumens depending upon need of the subject.

[0027] The intraosseous infusion device may further comprise a drilling tip which can be either an integral part of the intraosseous infusion device or it can be a separate device. The drilling tip can be used to allow the intraosseous infusion device to be inserted in one step. The intraosseous infusion device may further comprise at least one reservoir for storing bioactive materials. The reservoir may be in fluid communication with one or more lumens.

[0028] According to another aspect, there is provided an intraosseous infusion device comprising a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body. The at least one lumen can be connected be in fluid communication with.at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body. The intraosseous infusion device may further comprise an elongate sealing member having a left handed thread along a length thereof. The left handed thread may comprise a plurality of resiliently flexible ridges having variable widths and/or variable lengths.

[0029] According to yet another aspect, there is provided an

intraosseous device introducer assembly. The assembly may comprise a guide member having an elongate body for introduction through a hole drilled in a bone of a subject, and an intraosseous infusion device. The intraosseous infusion device may comprise a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body. The at least one lumen can be connected to at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body. The

intraosseous infusion device may further comprise an elongate sealing member comprising a plurality of resiliently flexible ridges arranged on a side surface of the main body. The plurality of resiliently flexible ridges may have variable widths and/or variable lengths. The intraosseous infusion device can be slidable over the guide member.

[0030] In various embodiments, the guide member may further comprise a retention member positioned at or adjacent to the elongate body, the retention member comprising a plurality of flexible arms. The flexible arms can be moveable from a first extended configuration to a second reduced profile configuration.

[0031] To the accomplishment of the foregoing and related ends, the one or more aspects comprise the features hereinafter fully described and particularly pointed out in the claims. The following description, and the drawings, set forth in detail certain illustrative features of the one or more aspects. These features are indicative of just a few of the various ways in which the principles of various aspects may be employed, and this description is intended to include all such aspects and their equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] _. Embodiments are illustrated by way of example, and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:

[0033] Figure 1 is a schematic illustration of an intraosseous infusion device in position in a bone of a subject;

[0034] Figure 2A shows a schematic front view of example

intraosseous infusion device;

[0035] Figure 2B is a top plan view of example intraosseous infusion device;

[0036] Figure 3 shows another example embodiment of intraosseous infusion device having an opening at a side surface of main body;

[0037] Figure 4 shows another example embodiment of intraosseous infusion device having a shoulder.

[0038] Figure 5 shows another example embodiment of intraosseous infusion device having a shoulder and an opening at a side surface of main body;

[0039] Figure 6 shows yet another example embodiment of

intraosseous infusion device which includes multiple lumens;

[0040] Figure 7 shows yet another example embodiment of

intraosseous infusion device which includes multiple lumens and Luer connectors;

[0041] Figure 8 shows another example embodiment of intraosseous infusion device having an extended Luer connector.

[0042] Figure 9 shows yet another example embodiment of intraosseous infusion device having a drilling tip.

[0043] Figure 10A shows another embodiment of intraosseous infusion device with a shoulder.

[0044] Figure 10B shows a cross sectional view through I-I of device shown in Figure 10A;

[0045] Figure 11 shows another embodiment of shoulder.

[0046] Figure 12A is a schematic view of further embodiment of intraosseous infusion device having a blind Luer connector and multiple lumens;

[0047] Figure 12B is a cross sectional view through II-II of device shown in Figure 12 A;

[0048] Figure 12C is a schematic representation of Luer connector of the device of Figure 12 A;

[0049] Figure 13A is a schematic view of a further embodiment of intraosseous infusion device having an open Luer connector;

[0050] Figure 13B is an exploded schematic view of the open Luer connector of the device of Figure 13A;

[0051] Figure 14A is a schematic view of an embodiment of

intraosseous infusion device in situ in a bone;

[0052] Figure 14B shows schematically the compression of thread of the device of Figure 14A when inserted into a bone;

[0053] Figure 15 represents an example intraosseous infusion device in use with multiple fluid sources/monitoring sensors;

[0054] Figure 16 depicts another example embodiment of intraosseous infusion device having a blind ended female Luer connector connected to a number of different fluid infusate sources or monitoring systems;

10055] Figures 17A, 17B, 17C, 17D, and 17E are cross-sectional views of various embodiments showing multiple lumens of various intraosseous devices;

[0056] Figures 18A and 18B shows another example embodiment of intraosseous infusion device having multiple lumens;

[0057] Figure 19 is a top plan view of a further example embodiment of the intraosseous infusion device;

[0058] Figure 20 shows another example embodiment of intraosseous infusion device having extended shoulder;

[0059] Figure 21 shows use of intraosseous infusion device with a monitoring system; [0060] Figure 22 depicts an example of intraosseous infusion device having a drilling tip;

[0061] Figures 23A and 23B show the use of guide member to introduce an intraosseous infusion device into a hole in a bone;

[0062] Figure 24 shows introduction of intraosseous infusion device with the help of introducer according to an example embodiment.

DETAILED DESCRIPTION

[0063] The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show illustrations in accordance with example embodiments. These example embodiments, which are also referred to herein as "examples," are described in enough detail to enable those skilled in the art to practice the present subject matter. The embodiments can be combined, other embodiments can be utilized, or structural, logical, and electrical changes can be made, without departing from the scope of what is claimed. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined by the appended claims and their equivalents.

[0064] Figure 1 illustrates, in highly diagrammatic fashion, a portion of bone 100 of an adult human undergoing the intraosseous infusion process. The bone 100 can be a tibia bone or any other bone suitable for intraosseous infusion. As shown in the figure, the interior of the bone 100 includes a cortex 105 and a marrow 110. The marrow 110 typically includes venous venules that drain to veins leading, arterioles supplied by an arteries and a capillary network matrix connecting arterioles to venules (not shown).

[0065] The intraosseous infusion process is performed with the help of an intraosseous infusion device 120 that has been inserted into the bone 100. In particular, the intraosseous infusion device 120 is inserted through the cortex 105 of the bone 100 until distal end the intraosseous infusion device 120 is positioned in the bone marrow 110. The device 120 can be readily formed from elastomeric materials and have a deformable sealing member 125. In an example

embodiment, the deformable sealing member 125 includes a thread enabling screwing the intraosseous infusion device 120 into the bone 100. In another embodiment, deformable sealing member 125 may mere include a plurality of resiliently flexible ridges.

[0066] As will be described it below in greater detail, the intraosseous infusion device 120 can be provided with a lumen to enable to deliver various liquids or gasses into the marrow 110. For example, the intraosseous infusion device 120 can be coupled to a drug delivery system so that medication can be infused into the marrow 120 via the lumen. Alternatively, the lumen can be used for extracting/sampling liquids from the marrow 120 for further analysis. In various embodiments, the intraosseous infusion device 120 can coupled to various monitoring systems, sensors, detectors, analyzing systems, and so forth.

[0067] In operation, when intraosseous infusion is necessary for a patient, first, a hole is drilled through the bone cortex 105 into the marrow cavity 110. The hole is drilled either by a separate device or the intraosseous infusion device 120 when it is equipped with a corresponding drilling tip. Further, the intraosseous infusion device 120 is inserted into the hole of the bone using a pushing or push-rotate motion. For example, if the drilling tip is integral with the intraosseous infusion device 120 it may be necessary to have the device 120 still in rotation while it was, being pushed into place. The deformable sealing member 125, which consists of multiple resiliently flexible ridges, deforms on insertion. The function, and therefore dimensions, of the ridges that

approximate the bone cortex, when the intraosseous infusion device 120 is in the hole, may be different. It is proposed that the ridges that engage the bone cortex 105 are shorter and less flexible so as to create a tight seal and also provide significant resistance to removal. The ridges that engage the bone marrow 110 are longer, narrower, and more flexible so that they may be easily passed through the hole to reach the marrow 110 and not restrict the ready passage of the device into the marrow space.

[0068] Accordingly, when the intraosseous infusion device 120 is inserted into a bone, the sealing member 125 is deformed. The deformable ridges of the sealing member 125 squash and collapse into the spaces between the ridges to produce a secure seal and eliminate the potential gap between the device 120 and the bone.

[0069] Figure 2A shows a schematic front view of an example intraosseous infusion device 120. Figure 2B shows its a top plan view. As shown in the figures, the intraosseous infusion device 120 comprises a main body 210 and the deformable sealing member 125, which is implemented as a plurality of ridges 220. The ridges 220 can be made of resiliently flexible materials, e.g.

polymer-based materials. The main body 210 may also be flexible and be made from the same or similar polymer-based materials.

[0070] The intraosseous infusion device 120 comprises a lumen extending from a proximal end 240 of the main body 210 to a distal end 250 of the main body 210. Accordingly, there can be openings at the proximal end 240 and the distal end 250 so that fluids or gasses can travel through the lumen 230 to or from the marrow 110.

[0071] With continuing reference to Figures 2A and 2B, the main body

210 may have a cylindrical shape, conical shape, cone frustum shape, or other cone-like shape. In the shown example, the main body 210 has a cone frustum shape, whereas the diameter of the main body 210 is increasing from the distal end 250 to the proximal end 240.

[0072] The ridges 220 can be resiliently flexible so that they will deform, when a force is applied, and restore to their original shape, when the force is removed. The ridges 220 will deform as the intraosseous infusion device 120 is inserted into the hole in the bone 100. This deformation may reduce the space between the intraosseous infusion device 120 and the bone 100, increases the surface contact between the intraosseous infusion device 120 and the bone 100 and the restorative properties of the ridges 220 increases the frictional resistance of the intraosseous infusion device 120 to dislodgment. The ridges 220 will form a tight seal and also provide significant resistance to removal.

Accordingly, the ridges 220 that engage the cortex 105 may be shorter and less flexible. The ridges 220 that engage the marrow 110 may need to be more flexible.

10073] According to various embodiments, the ridges 220 may have variable dimensions. For example, the width of ridges 220 arranged near the proximal end 240 is larger than the width of ridges 220 arranged near the distal end 250. The length or diameter of ridges 220 can also be different. In an example, the length of ridges 220 arranged near the proximal end 240 is smaller than the length of ridges 220 arranged near the distal end 250.

[0074] According to various embodiments, the ridges 220 may construe a thread, for example, a left handed thread. The thread may facilitate insertion and removal of the intraosseous infusion device 120. In an alternative embodiment, the ridges 220 may construe a right handed thread.

[0075] With continuing reference to Figures 2A and 2B, the

intraosseous infusion device 120 may further comprise a Luer connector 260 or a plurality of Luer connectors (further described below). The Luer connector 260 can be a blind ended connector and is not in fluid communication with the lumen 230. Alternatively, the Luer connector 260 is in fluid communication with the lumen 230. [0076] In an example, the Luer connector 260 is a female Luer connector 260, which can be used for removal of intraosseous infusion device 120. Removal of the device 120 will require it to be unscrewed from the bone 1 0. In general, the Luer system is designed to engage on a clockwise rotation and disengage on a counter-clockwise rotation. A male Luer connector (not shown), such as a Luer end syringe, can be engaged with the female Luer connector 260 with a clockwise rotation. Once engaged, the Luer system can be further clockwise rotated to assist removal of intraosseous infusion device 120.

[0077] Figure 3 shows another example embodiment of intraosseous infusion device 120. In the shown example, an opening 300 at the distal end 250 connected to the lumen 230 is arranged on the side surface of the main body 210. Accordingly, it should be appreciated that the lumen 230 may have various liner and non-liner forms. In the shown example, the lumen 230 may have L-shaped design. The lumen 230 may also be inclined, have variable diameter, different or variable cross-section, and so forth. In an alternative embodiment, the lumen 230 may be straight and axial.

[0078] According to various embodiments, the lumen 230 may include a reservoir (not shown) which can be arranged within the main body 210. The reservoir can be used for storing medication or other liquids or gasses. In addition, the reservoir may be in fluid communication with one or more lumens 230.

[0079] Figure 4 shows another example embodiment of intraosseous infusion device 120 having a shoulder 400. The shoulder 400 arranged at or adjacent to the proximal end 240 of the main body 210 so as to abut with the skin of the patient to prevent the intraosseous infusion device 120 slipping too far into the bone. In other words, the shoulder 400 can be used to limit insertion of the intraosseous infusion device 120. According to various embodiments, the shoulder 400 may also assist in sealing the hole in the bone to prevent any leakages. The shoulder 400 may have various designs which are further described below with reference to Figures 10A, 10B and 11.

[0080] Figure 5 shows yet another example embodiment of

intraosseous infusion device 120 having the shoulder 400. In the shown example embodiment, one of the opening 300 associated with the lumen 230 is arranged at the side surface of the main body 210. This embodiment is similar to the one shown in Figure 3.

[0081] Figure 6 shows an example embodiment of intraosseous infusion device 120 which includes multiple lumens 230. In particular, in the shown example there are two lumens 230 and 610. The additional lumen 610 may be inclined relative to the central (rotation) axis of the main body 210.

However, it should be appreciated that any suitable shape and any suitable placement of the additional lumen 610 can be implemented depending on an application.

[0082] In the shown example embodiment, there is a tube 620 attached to the additional lumen 610, which can be used to deliver or extract various liquids or gasses. In an example, the tube 620 attached to the additional lumen 610 via the shoulder 400. In other words, the lumens 230 and 610 may be embedded into the shoulder 400.

[0083] Figure 7 shows yet another example embodiment of

intraosseous infusion device 120 which includes multiple lumens 230 and also multiple Luer connectors 260. In particular, there can be a female Luer connector 260A being in fluid communication with the lumen 230, and further there can be an additional Luer connector 260B which can be also arranged on or adjacent to the proximal end 240 of the main body 210 or the shoulder 400. The additional Luer connector 260B can be coupled to the additional lumen 610 to deliver or extract various liquids or gasses. In should be also mentioned that the additional Luer connector 260B can be either a female Luer connector or male Luer connector.

[0084] Figure 8 shows another example embodiment of intraosseous infusion device 120 having an extended Luer connector 260. As shown in this figure, the female Luer connector 260 has an extended base (tubing) so that its proximal end may be arranged above the skin of the patient. In other words, the length of Luer connector 260 is greater than the subcutaneous tissue thickness so as it can exit the skin at some distance and make it easy to access the lumen 230. In further embodiments, there can be provided various other attachments to the intraosseous infusion device 120 to permit exiting the skin.

[0085] Figure 9 shows another example embodiment of intraosseous infusion device 120 having a drilling (cutting) tip 900. The drilling tip 900 is positioned at or adjacent to the distal end 250 of the main body 210 and configured to assist making a hole in the bone 100. In operation, the intraosseous infusion device 120 may be screwed into the bone 100 so that the drilling tip 900 creates a hole of a suitable diameter.

[0086] In example embodiments, the drilling tip 900 may be collapsible to facilitate its removal through the intraosseous infusion device 120 after the drill bid was used to create a hole. Furthermore, in the embodiments, when the drilling tip 900 is used, the Luer connector 260 and/or the shoulder 400 can be modified to assist clockwise rotation of the intraosseous infusion device 120. In particular, the Luer connector 260 can be of a male type or the shoulder 400 may have one or more excesses or support elements (not shown) for an adapter configured to screw the intraosseous infusion device 120. In general, it should be understood that the drilling tip 900 may be either an integral part of the intraosseous infusion device 120 or can be a separate detachable device.

[0087] Figures Ϊ0Α, 10B and 11 show various embodiments of intraosseous infusion device 120 having a shoulder. Shoulder 400 as shown in Figures 10A and 10B comprises a flange-like member spaced from the proximal end 240. In this example, the shoulder 400 has a complanate shape.

[0088] Shoulder 400, as shown in Figure 11, has a hemispheric design or similar thickened design. The thickened shape of the shoulder 400 may have the advantage that it may accommodate a number of Luer connectors 260 or a number of lumens 230 or their openings therein.

[0089] In an alternative embodiment depicted in Figure 20, the proximal end 240 of the main body 210 is segmented to provide multiple flanges 2010, which may facilitate securing the device 120 to the skin.

[0090] Turning back to Figure 11, the intraosseous infusion device 120 comprises a female Luer connector 1120 for engagement with a male Luer connector of a separate device (e.g;, an adapter). As shown in Figure 11, the female Luer connector 1120 is blind ended and comprises a solid base 1130 from which a female hollow receptacle 1140 extends. The receptacle 1140 comprises a collar 1150 extending outwardly at the proximal end. However, it should be appreciated that the collar may be replaced by any suitable shape to allow it to engage a male luer connector.

[0091] Figures 12A, 12B and 12C show further embodiments of the intraosseous infusion device 120 having a blind Luer connector 1120 and multiple lumens 230A and 230B, and further show a separate device (adapter) 1210 to be connected to the intraosseous infusion device 120. In an example, the separate device 1210 may refer to a syringe having a male Luer connector. The male Luer connector comprises an outer barrel 1220 having an inner thread 1230 and a tapered nose portion 1240 extending through the barrel 1220. The tapered nose 1240 can be received in the receptacle 1140. As the male Luer connector is rotated clockwise, the inner thread 1230 is thread over the collar 1150 until the two connectors are locked together or an outer rim 1250 of barrel 1220 engages the solid base 1130.

[0092] Because thread 220 of the main body 210 is a left handed thread, it will be appreciated that further rotation of the male Luer connector will cause the device 120 to start to unscrew from the bone 100. The present embodiment, therefore, provides a convenient mechanism for removal of the device 120 from the bone 100, using medical equipment that is close at hand.

[0093] Furthermore, the Luer connection need not be blind ended to simply provide a removal mechanism. Figure 13 depicts an embodiment where the base 1130 comprises an aperture 1300 therein. The aperture 1300 comprises an opening of lumen 230. The Luer connection is achieved as described above with reference to Figures 12A, 12B and 12C. When connected in this manner, tapered nose portion 1240 sits in friction fit engagement within the receptacle 1140 to create fluid line A. This embodiment provides both a removal mechanism as described above and a fluid path for the delivery or extraction of various liquids or gasses. The male Luer connector may be part of any type of suitable infusate delivery device, such as a Luer syringe as shown in the drawings by way of one example only.

[0094] A slightly different embodiment is depicted in Figures 14A and

14B. Here, the Luer connection is simply used for insertion and removal of the IO device 120 rather than providing an access fluid path. Instead, a proximal opening 1410 of lumen 230 is positioned on a radial surface of head 1110 and spaced from the Luer connection. The lumen 230 of this embodiment therefore extends at first radially before bending to travel in an axial direction through the main body 210 and a distal opening 1420 in the bone marrow 110.

[0095] Figures 14A and 14B schematically represent the embodiment described above wherein the ridges 220 construing a screw thread are

deformable. In particular, there is shown placement of the intraosseous infusion device 120 into the bone 100 such that the main body 210 accesses the marrow 110 through the skin 1430 and cortex 105. Figure 14B shows schematically the compression of the thread when inserted into the bone 100. While exaggerated, it will be appreciated that deformation of the ridges 220 increases the surface-to- surface contact between the device 120 and the cortex 105 to prevent leakage.

[0096] Figure 15 depicts an example embodiment of intraosseous infusion device 120 connected to a number of different fluid infusate sources or monitoring systems. In this embodiment, the lumen 230 may be brought into fluid communication with, for example, a resuscitation fluid source 1510, drug source 1520 or nutrition source 1530. The choice of fluid to be administered through the intraosseous infusion device 120 may be regulated through clamping of the individual lines 1540. A hub 1550 receives the lines 1540 and comprises a single administration line 1560 which is brought into fluid communication with lumen 230.

[0097] According to other embodiments, the intraosseous infusion device 120 may be connected in a similar manner to a number of different monitoring devices, systems or sensors. For example, the intraosseous infusion device 120 may be in fluid communication with blood chemistry sensors or systems, blood pressure monitoring systems, and so forth.

[0098] Figure 16 depicts another example embodiment of intraosseous infusion device 120 having a blind ended female Luer connector 1120 connected to a number of different fluid infusate sources or monitoring systems. Here, the Luer connection is simply used for insertion and removal of the device 120 rather than providing an access fluid path. Instead, proximal opening 1410 of lumen 230 is positioned on a radial surface of head 1110 and spaced from the Luer connector 1120. The lumen 230 of this embodiment therefore extends at first radially before bending to travel in an axial direction through the main body 210 and opening at distal opening 1420.

[0099] A number of different fluid infusate sources may be connected to the lumen 230. In this embodiment, the lumen 230 may be brought into fluid communication with the resuscitation fluid source 1510, drug source 1520 or nutrition source 1530. As mentioned above, the choice of fluid to be

administered through the intraosseous device 120 may be regulated through clamping of the individual lines 1540. There also can be used the hub 1550 which receives the lines 1540 and comprises a single administration line 1560 which is brought into fluid communication with the lumen 230.

[00100] It should be also mentioned that the device 120 may comprise multiple lumens 230 such that every single lumen is in fluid communication with a particular infusion or monitoring system.

[00101] Figures 17A, 17B, 17C, 17D, and 17E depict cross-sectional views of various embodiments showing multiple lumens of various intraosseous devices 120. While lumen 230 may comprise a single lumen, it may also comprise a lumen housing 1710 with several distinct lumens 1720 and 1730 housed therein. Typically, each individual lumens 1720 or 1730 may be connected to an individual fluid source or monitoring system such as depicted in Figures 19 or 20. It will be appreciated that the lumens 1720 and 1730 may be of varying diameters depending upon the liquids/gasses to be delivered/extracted and the state of the patient. In an example, the wider diameter of lumen 1720 is designed to deliver life saving fluids during resuscitation as the wide diameter may allow for a higher flow rate. In such instances it is critical that fluid is administered quickly and directly.

[00102] The smaller diameter of lumens 1730 may be used to deliver drugs, such as antibiotics, bone marrow priming agents and probes, oxygen, and so forth. Still further, the smaller diametered lumens 1730 may be used to introduce monitoring equipment (e.g., sensors, detectors) to provide information on the state of the patient including the cardiovascular performance.

[00103] Figure 17E depicts a further embodiment of the device 120 having a central relatively wide lumen 1720 and three peripheral lumens 1730A, 1730B and 1730C. In this embodiment, the outer wall 1740 of the device 120 is made from a relatively rigid material to form a relatively hard outer shell. While three lumens 1730A, 1730B and 1730C are depicted there may be more or less lumens present around the periphery.

[00104] Figures 18 A and 18B shows another example embodiment of intraosseous infusion device 120 having multiple lumens 230. In Figure 18A, the device 120 comprises a main resuscitation axial lumen 1810 and several radial, smaller lumens 1820. A similar embodiment is shown in Figure 19 with a wide bore resuscitation lumen 1910 and several smaller lumens 1920 provided. As shown, the lumens 1810, 1820, 1910, and 1920 may have different and/or variable shapes, dimensions, and cross-sections depending on current application. Each lumens may be in a fluid communication with infusion and/or monitoring systems.

100105] In any of these embodiments, regardless of the number, size and orientation of the lumens, the intraosseous infusion device 120 may have a Luer connector, which can be either a blind ended for insertion and removal purposes only or an open Luer connector for creating an additional lumen through the intraosseous infusion device 120.

[00106] Figure 20 shows another example embodiment of intraosseous infusion device 120 which has an "extended" shoulder. In particular, the proximal end 240 of the main body 210 is segmented to provide three flanges 2010. The flanges 2010 is configured to secure the of intraosseous infusion device 120 to the skin 1430 and/or the bone cortex 105 and prevent it slipping into the bone. There are also gaps 2020 arranged for easy access ports as shown in the . figure.

100107] Figure 21 shows the use of intraosseous infusion device 120 with a monitoring system 2100 such as a cardiovascular monitoring system. As shown, the intraosseous infusion device 120 is placed within the bone cortex 105. There are nutrient arteries 2110 that feed the marrow 110. The mean pressure within the marrow cavity is about 50mmHg. Pressure waves within the arteries 2110 are pulsatile and these pulse waves are transited in a form to the marrow 110. Various sensors or detectors may sense these waves to determine characteristics of patient's cardiovascular system.

[00108] As depicted in Figure 21, a pressure transducer 2120 is operatively coupled to the intraosseous infusion device 120. The pressure transducer 2120 may provide intraosseous pressure data that can be further processed by a processor 2130 or computer. The processed data may then be displayed via a monitor 2140. [00109] The intraosseous infusion device 120 in Figure 21 is shown to have three distinct lumens 230. Accordingly, each lumen 230 may be in fluid communication with a specific sensor, detector, monitoring system, infusion system, and so forth. In an example embodiment, one of the lumens 230 may be used for monitoring purposes whereas the other two lumens are free should the patient requires fluids or drugs based on the results of the monitoring.

[00110] In addition, LED monitors 2150 such as modified pulse oxymeters can be fitted to the intraosseous infusion device 120 as shown in Figure 21 and can detect capillary pulsation arid oxymetry. The resultant data can be interpreted to give an estimate of cardiac preload and or arterial blood pressure and or oxygen saturation. In this regard, anaesthetists may use the variation in peak and mean arterial pressure with respiration "swing" or the profile or other data from the pressure wave curve to provide a guide to cardiac preload.

[00111] Figure 22 depicts an example isometric view of intraosseous infusion device 120 having a drilling tip 900 positioned and configured to extend through the device 120. In an example, the drilling tip 900 may be collapsible to facilitate its removal through the of intraosseous infusion device 120. In another example, a part or the entire drilling tip 900 can be incorporated into the intraosseous infusion device 120.

[00112] Figures 23A and 23B show the use of guide member 2300 to introduce the intraosseous infusion device 120. Specifically, the guide member 2300 can be used to introduce the intraosseous infusion device 120 into the bone cortex 105 of a patient. The guide member 2300 may have an elongate core member 2310 which can be inserted through a pre-drilled hole in the bone cortex 105. The core member 2310 can include a retention member 2320 which is made from a plurality of flexible arms or bristles 2330.

[00113] The flexible arms or bristles 2330 can be connected to the elongate core member 2310 and typically extend from the core member 2310, for example, between an angle of 45° and 90° in their extended configuration such that they provide an area of increased diameter. The arms or bristles 2330 may flex upon exertion of pressure thereon. For example, the arms or bristles 2330 may be caused to bend from a substantially right angled configuration relative to the elongate core to the reduced profile configuration whereupon the arms or bristles 2330 are pushed against and abut with the elongate core member 2310. Figure 23A which shows the arms or bristles 2330 bending as the guide member 2300 is pushed through the hole drilled in the bone.

[00114] As shown in Figure 23A, the elongate core member 2310 is relatively straight to allow for intraosseous infusion device 120 to slide over it. The retention member 2320 is positioned within the hole in the bone and the intraosseous infusion device 120 pushed down over the elongate core member until it abuts with the retention member. With the intraosseous infusion device 120 loaded onto the guide member 2300 it may then be "toggled" into position. Manual force to push the intraosseous infusion device 120 fully into the hole such that it provide an intraosseous access port may be required whereupon the healthcare professional pulls the elongate core member 2310 in a proximal direction to cause the arms 2330 of the retention member 2320 to abut with the distal end of the intraosseous infusion device 120 which causes the arms to flex inwardly towards the core member 2310. In this reduced profile, the entire guide member 2300 may be withdrawn through a central lumen 230 of the intraosseous infusion device 120.

[00115] Figure 24 shows the introduction of intraosseous infusion device 120 into a bone with the help of an introducer 2400. In an example embodiment, the introducer 2400 comprises a lumen 2410 configured to receive a guidewire 2420. The introducer 2400 is further sized such that a medical device, e.g., the intraosseous infusion device 120, is slidable over at least a length thereof. The example provided in Figure 24 shows the intraosseous infusion device 120 being introduced into a patent's bone by the introducer 2400.

[00116] In operation, the guidewire 2420 can be introduced through a drilled hole in the bone. The introducer 2400 then slides over the guidewire 2420 and the device slides over the introducer 2400 until it is positioned within the hole in the bone. The guidewire 2420 and introducer 2400 are then removed through central lumen 2430 of the intraosseous infusion device 120.

Examples

Example 1: Resuscitation Device

[00117] The aim of this experiment was to provide a prototype of resuscitation intraosseous infusion device 120 for use in paediatric and adult populations and which achieved a 95% success rate for insertion and optimal infusion rates.

[00118] The functioning prototype was developed in line with the above description and in a bovine cadaver model achieved a rate of successful insertion of 100%. Flow rates in the bovine cadaver model were roughly 40% greater than the "EZ-IO" intraosseous device by (Vidacare Corporation Shavano Park, Texas, US). This suggests that flow rates of about 200 ml/minutes may be achieved in the adult humerus and possibly the adult tibia.

[00119] Specifically, a bovine cadaver bone was cleaned and access to the marrow achieved by drilling using a 6 mm medical grade metal drill. The drill was then withdrawn. The prototype device was then inserted manually with a simple push motion. It should be appreciated that drill size, hole size and insertion method may vary.

[00120] In this experiment, the prototype device was made from a polymeric material with a deformable thread as described above. As such the device could be easily pushed into the hole created in the bone, with the thread deforming upon entry into the hole.

[00121] The aim was to establish a superior flow rate into the bone marrow. Pressure in excess of 1200 mmHg were achieved for the prototype device and tested to establish the optimal pressure/flow ratio to optimise the flow rate.

[00122] The prototype device was also designed with an internal diameter of approximately 3 mm. The internal diameter of intravenous tubing is about 2.5 mm. The results showed negligible additional resistance in the prototype device. This contrasts to other intraosseous infusion devices currently available on the market that have needle sizes of about 15 G.

[00123] Drilling the hole in accordance with the abovementioned procedure develops a sinus of 6 mm diameter and width of marrow within the marrow cavity. This significantly increases surface area for fluid absorption. It was also found that the surface area could be further increased by physical manipulation of the marrow cavity using manipulation equipment such as wires, brushes or tubes inserted through the intraosseous infusion device.

[00124] In a further experiment with a bovine tibia, the marrow was chemically manipulated with exposure to room temperature for four days. This resulted in flow rates that were substantially greater than experiments in bovine tibia that had not been treated this way. It is further possible to chemically manipulate the marrow with chemicals, such as hyaluronidase or the like enzymes, so as to reduce resistance and significantly improve fluid flow.

[00125] The experimentation found that an excellent seal was produced when the intraosseous infusion device was inserted and the thread deformed to increase the surface area of contact with the surrounding bone. Particularly, it was found that the intraosseous infusion device resisted axial or shear dislodgment and could only be easily removed by rotation and gentle traction. It was further shown that^" the prototype device may stay within the bone for a period of time much greater than 48 hours without unwanted damaging of the bone or leakages.

[00126] However, even if a device was dislodged it was easily replaced with another device since the hole was large enough to be felt with a finger. The prototype device was non-ferrous and so was compatible with Magnetic

Resonance Imaging (MRI) technology.

Example 2: Central Line Substitution

[00127] A prototype device suitable as a substitute for central line insertion was developed. The prototype including the features as described herein and having multiple lumens to allow for continuous intravascular access for therapeutic support such as antibiotics, inotropic support and total parenteral nutrition. For this use, the lumen was sized between 1 mm to 2 mm since the flows are not required to be as high as for resuscitation. The device was found to have a 95% success fate for insertion and provided a convenient multi-lumen access portal for therapeutic support.

[00128] Thus, various intraosseous infusion devices and corresponding assemblies are described. Comparing to known prior art devices, the

intraosseous infusion devices described herein can be securely installed in a bone for an extended period of time (usually, much greater than 48 hours, e.g. weeks or months) and with excellent sealing conditions preventing leakage and also any unwanted damages to the bone. The described intraosseous infusion devices may also be easy inserted and removed regardless of how long they were in use.

[00129] Although embodiments have been described with reference to specific example embodiments, it will be evident that various modifications and changes can be made to these example embodiments without departing from the broader spirit and scope of the present application. Accordingly, the

specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

Claims

1. An intraosseous infusion device comprising: a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body, the at least one lumen is in fluid communication with at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body; and an elongate sealing member comprising a plurality of resiliently flexible ridges arranged on a side surface of the main body, wherein the plurality of resiliently flexible ridges having variable widths and/or variable lengths.

2. The intraosseous infusion device of claim 1, wherein the plurality of resiliently flexible ridges is helically wound around a core of the main body so as construe a thread.

3. The intraosseous infusion device of claim 2, wherein the thread is a left handed thread.

4. The intraosseous infusion device of claim 1, further comprising a shoulder at or adjacent to the proximal end of the main body.

5. The intraosseous infusion device of claim 1, wherein the plurality of resiliently flexible ridges is made from a polymer material.

6. The intraosseous infusion device of claim 1, further comprising one or more female Luer connectors.

7. The intraosseous infusion device of claim 6, wherein the one or more female Luer connectors are blind ended connectors and are not in fluid communication with the at least one lumen.

8. The intraosseous infusion device of claim 6, wherein the one or more female Luer connectors are in fluid communication with the at least one lumen.

9. The intraosseous infusion device of claim 1, wherein the main body has a cone frustum shape, wherein the proximal end of the main body has a wider diameter than the distal end of the main body.

10. The intraosseous infusion device of claim 1, wherein the plurality of resiliently flexible ridges has an acute shape or a round shape.

11. The intraosseous infusion device of claim 1, wherein the width of resiliently flexible ridges arranged near the proximal end of the main body is larger than the width of resiliently flexible ridges arranged near the distal end of the main body.

12; The intraosseous infusion device of claim 1, wherein the length of resiliently flexible ridges arranged near the proximal end of the main body is smaller than the length of resiliently flexible ridges arranged near the distal end of the main body.

13. The intraosseous infusion device of claim 1, wherein the intraosseous infusion device is made from or comprises bioabsorbable materials.

14. The intraosseous infusion device of claim 1, wherein the main body and/or the plurality of resiliently flexible ridges is/are impregnated or coated with a biologically active substance.

15. The intraosseous infusion device of claim 1, wherein the main body and/or the plurality of resiliently flexible ridges is/are impregnated or coated with an antimicrobial substance.

16. The intraosseous infusion device of claim 1, wherein the at least one opening at the distal end of the main body is arranged on the side surface of main body.

17. The intraosseous infusion device of claim 1, wherein the at least one lumen comprising at least one axial lumen.

18. The intraosseous infusion device of claim 1, further comprising a drilling tip.

19. The intraosseous infusion device of claim 1, further comprising at least one reservoir for storing bioactive materials.

20. The intraosseous infusion device of claim 1, wherein the main body having at least two lumens, wherein one of the lumens having a greater diameter than the remaining one or more lumens.

21. An intraosseous infusion device comprising: a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body, the at least one lumen is in fluid communication with at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body; and an elongate sealing member comprising a left handed thread along a length thereof, wherein the left handed thread comprising a plurality of resiliency flexible ridges having variable widths and/or variable lengths.

22. An intraosseous device introducer assembly comprising: a guide member comprising an elongate body for introduction through a hole drilled in a bone of a subject; and an intraosseous infusion device comprising: i) a main body having at least one lumen extending from a proximal end of the main body to a distal end of the main body, the at least one lumen is connected to at least one opening at the proximal end of the main body and at least one opening at the distal end of the main body; and

ii) an elongate sealing member comprising a plurality of resiliency flexible ridges arranged on a side surface of the main body, wherein the plurality of resiliently flexible ridges having variable widths and/or variable lengths;

wherein said intraosseous infusion device is slid able over the guide member.

23. The intraosseous device introducer assembly of claim 22, wherein the guide member further comprising a retention member positioned at or adjacent to the elongate body, the retention member comprising a plurality of flexible arms, wherein the flexible arms moveable from a first extended configuration to a second reduced profile configuration.