Intraosseous access model for the humerus or tibia

Abstract

An intraosseous access model, comprises a simulated bone of a plastic material, the simulated bone having an intraosseous space. The simulated bone is sealed by a sealing material and covered in fabric. The simulated bone is incorporated in a manikin having simulated skin. The simulated skin has an opening to allow the simulated bone to be removed and replaced. A port in communication with the intraosseous space allows for introducing or draining liquids. A method of making an access model includes incorporating a simulated bone into a manikin.

Description

INTRAOSSEOUS ACCESS MODEL FOR THE HUMERUS OR TIBIATechnical Field

[0001] The technical field is of the simulation of medical procedures, intraosseous access for the introduction of medical treatments, such as pharmaceuticals, and methods related to these procedures. Background

[0002] Medication can be introduced into the circulatory system through intraosseous (“IO”) infusion, where a hole is drilled into a bone such as the humerus or tibia and medication is introduced into the intramedullary canal. Training models for this procedure have a simulated body or manikin resembling the human body or part of the human body. An artificial bone is placed in the body or manikin and medical personnel practice drilling through the bone using an intraosseous (“IO”) needle. The manikin is re-used many times during training. Leaking of artificial blood from the artificial bone is a problem that has been encountered. Leaking of liquids can lead to tire growth of mold inside the manikin. Tire IO needle punctures the artificial bone, leaving holes. If medical personnel attempt to puncture the bone at a previously used location, the feel of the needle penetrating the bone is lost and the experience is not realistic. The IO needles are used to introduce a liquid, simulating the introduction of medication. These liquids can lead to further leaking and formation of mold.Summary

[0003] In an aspect, an intraosseous access model comprises a simulated bone of a plastic or polymeric material, the simulated bone having an intraosseous space, the simulated bone being sealed by a sealing material and covered in fabric, the simulated bone being incorporated in a manikin having simulated skin, the simulated skin having an opening to allow tire simulated bone to be removed and replaced, and a port in communication with the intraosseous space for introducing or draining liquids.

[0004] In embodiments, the simulated bone includes degassed polymer. In embodiments, the fabric is stretchy, such as for example, lycra™.

[0005] In embodiments, the simulated bone is attached to a jig.

[0006] In embodiments, the manikin includes a shoulder. The opening may be adjacent the shoulder. The simulated bone can simulate at least a portion of a humerus.

[0007] The manikin can include a leg. The opening can be in the leg. In embodiments, the simulated bone simulates at least a portion of a tibia.

[0008] The opening can be closeable. For example, the opening has one of a tape and a self-sealing material.

[0009] In another aspect, a method of making an intraosseous access model, comprises forming a simulated bone in a plastic material so that the simulated bone has an intraosseous space, sealing thesimulated bone by coating it with a sealing material, filling the intraosseous space with a liquid, encapsulating the simulated bone in a polymer, covering the simulated bone in a fabric, and incorporating the simulated bone into a manikin.

[0010] The simulated bone can be printed in a polymer. In certain embodiments, the simulated bone is formed from degassed polymer.

[0011] The fabric can be stretchy fabric, such as for example, lycra.

[0012] The method can further comprise removing and replacing the simulated bone through an opening in simulated skin of the manikin. In embodiments, the opening is closeable.

[0013] In certain embodiments, tubing is added in communication with the intraosseous space.

[0014] The method can further comprise using a jig to locate the simulated bone in the manikin.

[0015] In embodiments, the intraosseous space is filled through pre-formed holes.

[0016] The sealing material can be silicone.

[0017] In embodiments, the simulated bone is incorporated in a shoulder of the manikin. For example, the simulated bone is incorporated in a leg of the manikin.

[0018] In a further aspect, a method of making an intraosseous access model comprises, in certain embodiments, printing or molding a simulated bone in a plastic material so that it has an intraosseous space, sealing the bone by covering it with a protective sealing material, drilling pre-defmed holes in the bone, filling the intraosseous space with simulated blood or other fluid, encapsulating the bone in a polymer, covering the bone in fabric, and incorporating the simulated bone into a manikin. In embodiments, the simulated bone is covered with a sealing material by spraying or other means. For example, the simulated bone is covered with a silicone material. In other embodiments, the simulated bone is not filled with a liquid. In other embodiments, the simulated bone represents a bone other than tire humerus or tibia. In some embodiments, the access model is for pediatrics. In certain embodiments, the access model is for adult, animal, pediatric, or task trainers, and the size and shape of the simulated bone reflects this.Brief Description Of The Drawings

[0019] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments and together with the disclosure herein, including the detailed description of the drawings given below, served to explain principles of this disclosure.

[0020] FIG. 1 is a front perspective view of an IO model according to embodiments being filled with a liquid;

[0021] FIG. 1A is a schematic of a simulated bone, according to embodiments;

[0022] FIG. 2 is a front perspective view of an IO model filled with a liquid according to embodiment;

[0023] FIG. 3 is a front perspective view of an IO model according to embodiments;

[0024] FIG. 4 is a front perspective view of a manikin shoulder according to embodiment;

[0025] FIG. 5 is a plan view of a manikin arm according to embodiments:

[0026] FIG. 6A is a front perspective view of a simulated humorous jig according to embodiments; and

[0027] FIG. 6B is a front perspective view of a simulated tibia jig according to embodiments.Detailed Description

[0028] In embodiments, an intraosseous (“IO”) access model 110 has, in embodiments, a simulated bone 100 of a plastic or polymer material, the simulated bone 100 has an intraosseous space 112 filled with a fluid 114 (see FIGS. 1-3). In embodiments, the filled unit 104 is incorporated in a manikin 116 that represents a human body or a portion of a human body (see FIGS. 4 and 5). In embodiments, the manikin can represent an animal, a human adult, a pediatric model (human child), or be presented as a task trainer. In embodiments, the manikin has a simulated skin 118 and an opening (such as slit 120) to allow the model 110 to be removed and replaced. In embodiments, the opening is closable, such as for example, a slit 120 that is covered by a silicone tape, a sleeve, plug, or plate. For example, the opening 120 is covered with a liquid tight tape and, in certain embodiments, the model 110 has a port 122 for introducing or draining liquids. In embodiments, the model 110 has a port 122 for introducing liquids and a second port 124 for draining liquids. The liquid tight tape or other covering prevents leaking while allowing the model 110 to be replaced through the opening 120. In certain embodiments, the opening 120 is a resealable slit, having a resealable material, which may be a polymer, capable of being opened for the replacement of the model 110 in the manikin 116 and closed thereafter.

[0029] In embodiments, the manikin 116 is provided with a pod 130, or other predefined space, for receiving the IO model 110. Tire pod 130 can have a covering allowing access into an interior of the pod 130. In this way, the IO model 110 can be replaced and the manikin 116 reused.

[0030] In embodiments, the manikin 116 has an opening or slit 120 (such as. for example, at the shoulder and / or at the knee of the manikin 116), to provide access to the space where the IO model 110 is inserted (see FIG. 4). The IO model 110 can be replaced after multiple stabs by an IO needle, and, in embodiments, the opening is closed with liquid tight tape to prevent liquid from leaking out. In embodiments, the opening 120 is a resealable slit, having a resealable material, which may be a polymer, capable of being opened for the replacement of the model 110 in the manikin 116 and closed thereafter. In embodiments, there are drainage ports to drain fluids. For example, a drainage port 122 can be provided on the shoulder and / or knee of the manikin 116 to drain fluid pumped into the bone using the IO needles (see FIGS. 4 and 5). In embodiments, the manikin 116 has a port 122 for introducing fluids and a port 124 for draining fluids.

[0031] In certain embodiments, an intraosseous access model 110 comprises a simulated bone 100 of a plastic or polymer material, the simulated bone having an intraosseous space 112 filled with a liquid or gel, the simulated bone being sealed by a silicone material and covered in fabric, the simulated bone being incorporated in a manikin 116 having simulated skin, the skin having an opening to allow' tire simulatedbone to be removed and replaced. In embodiments, the opening 119 is a slit covered by liquid tight tape 121 (see FIG. 5) and the simulated bone, in certain embodiments, has a port 122 for introducing or draining liquids.

[0032] In embodiments, a manikin 116 has an IO model 110 comprising a simulated bone 100 of a plastic material, the simulated bone having an intraosseous space 112 filled with fluid 114, the simulated bone 100 being sealed and covered in fabric 118. the model 110 being incorporated in a manikin 116. the manikin having a simulated skin. In embodiments, the manikin has an opening 119 ( a slit, resealable slit, or pod), which may be for example, at the shoulder and / or at tire knee of the manikin 116), to provide access to the space where the IO model 110 is inserted. The IO model 110, for example, is replaceable through the opening 119, the opening can be closed with a liquid tight closure, which may be a polymer, liquid type tape, or a resealable material, capable of being opened for the replacement of the model 110 in the manikin 116 and closed thereafter. In embodiments, the manikin has a resealable opening that is incorporated into the opening, such as for example, hook and loop fasteners, zip fasteners, interlocking plastic strips, or the like, that are closable by sliding a slider or pinching with the fingers, inn certain embodiments. In embodiments, a resealable opening can include pressure sensitive adhesive or other material that adheres to itself.

[0033] In embodiments, the manikin 116 includes ports for the introduction or drainage of fluids. In embodiments, the manikin 116 has a port 122 for introducing fluids and a port 124 for draining fluids. In embodiments, the manikin 116 has an IO model 110 that is pre-filled with fluid during manufacturing. The manikin 116 can have an opening 119 for replacement of the IO model. In embodiments, tire replacement IO model is prcfillcd with liquid for simulating blood, while in other embodiments, the IO model 110 is filled with fluid in place in the manikin 116.

[0034] In embodiments, a manikin 116 has a valve 132 for introducing fluid into the IO model 110 continuously during use (see FIG. 5). In embodiments, the manikin 116 has a valve for introducing fluid while the model 110 is in place in the manikin 116.

[0035] Certain sensors, electronic modules, and other devices, may be connected to the manikin to indicate the penetration of an IO needle, in use. Alternatively, mechanical monitors can be used to provide a visual indication to the user of the depth of penetration of an IO needle. Such mechanical monitors can be incorporated in the manikin. In embodiments, a go / no-go indicator informs the user whether the IO needle has penetrated the intramedullary space. For example, an indication to the user that the IO needle has passed the intramedullary space and is located in the simulated bone is incorporated into the manikin. For example, sensors and light indicators can be connected to tire manikin to indicate that the IO needle penetrated into the intramedullary space (such as a light flashing green), and / or indicate that the IO needle penetrated into the material of tire simulated bone (such as a light flashing red) can be incorporated into the manikin. Inembodiments, the manikin 116 has one or more sensors 142 connected to a monitor 140 such as, for example, depicted in FIG. 5. Tire monitor 140 has a red light 144 and a green light 146 to indicate to the user whether the IO needle is located in the intramedullary' space 112.

[0036] In embodiments, mechanical monitors are used, visual monitors and / or visual aids are used. For example, a window is provided in the side of the access model, making a cross section of the bone and the needle going into it visible. In embodiments, the bone is composed in such a way that the flash / feedback is different depending on the depth of the needle.

[0037] In embodiments, the simulated bone 100 is made for a space in a manikin 116 including a jig 136 for attaching the simulated bone 100 to tire manikin 116 and locating it in the manikin using the jig 136. In embodiments, the simulated bone 100 is attached to the jig 136. The simulated bone 100 can be filled with a gel or liquid when inserted into the manikin 116 using the jig 136. In embodiments, the simulated bone 100 is unfilled when inserted into the manikin 1 16 using the jig 136.

[0038] In embodiments, a simulated bone 100, which may be a portion of the tibia or humerus, as well as any long bone in tire body, is made from a polymer using molding, sculpting, and / or additive manufacturing techniques. In embodiments, the polymer is polylactic acid (“PLA”) or a similar material. For example, the simulated bone 100 is 3D printed in polylactic acid or other polymer by a filament extruder printer. In an example, the printer unit is movable to eject a polymer in a certain shape. In an example, the simulated bone 100 part is moved or rotated as polymer is ejected in a desired shape. The density of the material of the simulated bone 100 can be varied during its formation. For example, manufacturing of the material of the simulated bone to have variable density, such as simulation of a solid cortical layer, varying densities of bone, and simulation of a cavity having bone marrow is included in certain embodiments. In embodiments, different materials are incorporated to simulate different aspects of the simulated bone. For example, the simulated bone 100 can be formed including a mesh, different densities of polymer, hollow spaces, and / or or a matrix of polymer material. Tire simulated bone 100 may be provided in various sizes.

[0039] In embodiments, the simulated bone 100 is a molded plastic part. In embodiments, the simulated bone 100 may be injection molded. The shape of the bone can be reproduced using computer data, hand sculpting, or other means. In embodiments, the shape of the bone that is produced includes tire shape of an intramedullary’ canal 112. In embodiments, the simulated bone 100 is coated in a protective sealing material, such as for example, a silicone material. This seals the unit to prevent leaking, allow for repeated use, and resist the growth of mold. In an example, the coating is a silicone material, such as a coating resin, where the simulated bone part 100 is coated by or immersed in a resin to encapsulate it. In embodiments, the sealing material is applied to the simulated bone by other means. For example, the sealing material may be sprayed on. This seals the unit, helping to prevent any leaking and also resists the growthof mold. In embodiments, during the formation of the simulated bone 100, preset holes are formed. The preset holes, in embodiments, are opened with a drill (see FIG. 1). A liquid or gel material, (which can be simulated blood or theatrical blood), is introduced into the simulated bone 100 such as for example, being injected into the simulated bone (see FIGS. 2 and 3). The simulated bone 100 can be filled with any liquid or gel. In embodiments, the simulated bone 100 is injected with a liquid or gel using an apparatus, such as for example, a syringe 102.

[0040] The filled unit 104 is closed. For example, the holes in the unit 104 are covered or filled. For example, molded caps can be glued into the holes to seal the unit 104. In embodiments, the unit 104 is coated in a sealing material, such as silicone, to further encapsulate it. In embodiments, the unit 104 is immersed in water to cure the sealing material. Once ready for production, the unit is further sealed by covering it in a sealing material and reinforcing it with fabric. For example, tire unit 104 can be encapsulated in silicone and reinforced with a fabric material. The unit 104 can be covered with a simulated skin material. It can be incorporated into a manikin or a portion of manikin. The manikin, in embodiments, has a simulated skin, which can be made of silicone.

[0041] In certain embodiments, the polymer material of the unit 104 can be degassed to remove air pockets in the material and reduce the chance of leaking. For example, the unit 104 can be made of degassed silicone. The unit 104 can be covered in a stretchy fabric, such as for example, lycra™ . The fabric is coated with a protective material. For example, the fabric is coated or brushed with a silicone material and cured. This seals the unit 104, helping to prevent any leaking and resisting the growth of mold.

[0042] In a method of assembling the IO model 110, in embodiments, the simulated bone 100 is formed including forming a jig 136 for attaching the simulated bone to the manikin and locating it in the manikin (see FIGS. 6Aand 6B). In embodiments, layers of polymer material are applied to a mold. In embodiments, a first layer of silicone is applied to a mold, such as by stippling the silicone, or other polymer, into the mold. A second layer of polymer is applied to the mold, such as by stippling silicone into the mold, and a stretchy fabric (such as lycra fabric) is added. The fabric is coated with a sealing material (which may be silicone) to encapsulate it. At this time, the jig 136 is added to the mold. In embodiments, nylon fabric (or other resilient material) is added in the comers, for reinforcement. A polymer material is introduced into the mold, covering the jig 136. For example, a degassed polymer is poured into the mold, covering the jig. Fabric is applied, which is coated with silicone to encapsulate it. in embodiments. In certain embodiments, tubing 137 is added into the mold, which will be used for introducing or draining liquids. In certain embodiments, the tubing is connected to one or more valves for introducing liquids, draining liquids, and controlling the flow of those materials. Tire simulated bone is demolded after the polymer has cured.

[0043] In embodiments, a method of making the simulated bone 100 includes forming a jig 136 for attaching the simulated bone to the manikin and locating it in tire manikin. FIG. 6A shows a jig 136 andsimulated bone 100 for simulating the humerus (or a portion thereof), whereas FIG. 6B shows a jig and simulated bone 100 for simulating a tibia (or a portion thereof). The jig may have metal pegs. Layers of polymer material are applied to the mold, in embodiments. For example, a first layer of silicone is stippled into a mold. A second layer of silicone is stippled into the mold and lycra fabric is added. Tire lycra fabric is coated with silicone to encapsulate it. Tire jig 136 is added to the mold and fabric such as nylon is added in the comers, for reinforcement. Degassed polymer is poured into the mold, covering the jig. Fabric such as lycra is applied, which is coated with polymer such as silicone to encapsulate it. Tubing is added, which will be used for introducing or draining liquids. The simulated bone is demolded and fabric is added. For example, the lycra fabric is brushed with silicone to encapsulate it.

Claims

What is claimed is:1.An intraosseous access model, comprising: a simulated bone of a plastic material, the simulated bone having an intraosseous space; the simulated bone being sealed by a sealing material and covered in fabric, the simulated bone being incorporated in a manikin having simulated skin; the simulated skin having an opening to allow the simulated bone to be removed and replaced; and a port in communication with the intraosseous space for introducing or draining liquids.

2. The intraosseous access model of claim 1. wherein the simulated bone includes degassed polymer.

3. The intraosseous access model of claim 1, wherein the fabric is lycra™.

4. Tire intraosseous access model of claim 1, wherein the simulated bone is attached to a jig.

5. The intraosseous access model of claim 1, wherein the manikin includes a shoulder.

6. The intraosseous access model of claim 5. wherein the opening is adjacent the shoulder.

7. The intraosseous access model of claim 6, wherein the simulated bone simulates at least a portion of a humerus.

8. The intraosseous access model of claim 1, wherein the manikin includes a leg.

9. The intraosseous access model of claim 8. wherein the opening is in the leg.

10. The intraosseous access model of claim 9, wherein the simulated bone simulates at least a portion of a tibia.

12. The intraosseous access model of claim 1, wherein the opening is closeable.

13. The intraosseous access model of claim 12, wherein the opening has one of a tape and a self-sealing material.14.A method of making an intraosseous access model, comprising: forming a simulated bone in a plastic material so that the simulated bone has an intraosseous space; sealing the simulated bone by coating it with a sealing material; filling the intraosseous space with a liquid; encapsulating the simulated bone in a polymer; covering the simulated bone in a fabric; and incorporating the simulated bone into a manikin.

15. Tire method of claim 14, wherein the simulated bone is printed in a polymer material.

16. The method of claim 14, wherein the simulated bone is formed from degassed polymer.

17. The method of claim 14, further comprising removing and replacing the simulated bone through an opening in simulated skin of the manikin.

18. The method of claim 17, wherein the opening is closeable.

19. Tire method of claim 14, further comprising adding tubing in communication with the intraosseous space.

20. Tire method of claim 14, further comprising using a jig to locate the simulated bone in the manikin.21 .The method of claim 14, wherein the intraosseous space is filled through pre-formed holes.

22. The method of claim 14, wherein the sealing material is silicone.

23. The method of claim 14, wherein the simulated bone is incorporated in a shoulder of the manikin.

24. The method of claim 14, wherein the simulated bone is incorporated in a leg of the manikin.

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