Anatomical subclavian central line and transvenous pacer training simulator apparatus

Abstract

A simulator apparatus for training medical professionals in various procedures involving the human clavicle and heart. The apparatus includes a clavicle model and a heart model. The clavicle model simulates a partial or full human shoulder and neck. The heart model simulates the human heart. The models may be used separately or together to practice procedures, namely inserting a central line and placing a pacemaker through a central line. The purpose of the simulator is to provide a user with a cost-effective, portable training simulator to practice performing procedures involving the shoulder, neck, and heart.

Description

PCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROVANATOMICAL SUBCLAVIAN CENTRAL LINE AND TRANSVENOUS PACER TRAINING SIMULATOR APPARATUSBACKGROUND OF THE INVENTION1. Fi el d of the Inventi on

[0001] The present invention relates to the training of medical professionals in emergency medicine, lifesaving, and critical care procedures. More particularly, the present invention relates to medical procedure simulation of the subclavian and internal jugular arteries. Still more particularly, the present invention relates to a simulator apparatus designed to provide training for subclavian procedures including central line placement and intravenous pacemaker insertion.2. Description of the Prior Art

[0002] Emergency medicine, critical care, and other specialties are responsible for performing medical procedures. Many of these procedures are rare, limiting the amount of skill maintenance that can be done with patient care. Procedural skill proficiency and competence can be maintained through simulation, but most active practicing clinicians do not have ready access to a simulation center. The training of medical professionals requires access to easy-to-use simulators which allow procedural skillset maintenance, as well as the training of medical students, residents, and other learners.

[0003] Many current trainers are complex, expensive, and are, therefore, only available to1 earner s / practiti oners who have access to a simulation center. Most currently practicing clinicians do not have ready access to a simulation center, must pay significant costs for the use of simulation center space and resources, and / or do not, given the above noted obstacles, utilize such facilities for a variety of reasons. The cost and limited spectrum of use of current simulators prohibits the average practicing clinician from accessing them, at least with a frequency to allow for skill maintenance. This leads to procedural skill set decay, especially in uncommon and infrequent procedures. Access to trainers at practitioner’s homes or place of practice would help eliminate many of these barriers to procedural training, and therefore, procedural skill maintenance.

[0004] A need, therefore, exists for simulators that can be utilized outside of a simulation center. In particular, practitioners would benefit from easy assembled, simple to use simulators thatPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV maintain the necessary fidelity to practice procedures, particularly ones that are rarely seen in clinical practice. Trainers or simulators that are deliverable to the end users’ homes or places of practice would help eliminate many of these barriers to procedural training.

[0005] The present invention solves the above noted problems by creating a low-cost medical simulator that facilitates the practice of several different medical procedures, including subclavian and internal jugular vein identification via ultrasound, subclavian and internal jugular vein access, placement of central line via the subclavian vein or internal jugular vein, and temporary pacemaker placement. The inventive model may also be used to practice other procedures associated with the clavicle, neck, shoulder, and heart regions.SUMMARY OF THE INVENTION

[0006] The current invention provides a solution to the need for a simulator that aids in training users to carry out medical procedures. The invention is a medical procedure training simulator apparatus that facilitates the practice of procedures in the clavicle, shoulder, neck, and heart area. The simulator is in the form of an easy-to-ship product that can be utilized anywhere. Prior to this invention, the ability to practice these procedures in situ (where they practice medicine, an ideal location for training) or in the home environment, was not feasible to the training or practicing clinician due to lack of access, expense of materials or a combination of the above.

[0007] The anatomical clavicle and heart simulator may be used to practice a variety of procedures including but not limited to ultrasound location of the subclavian vein, ultrasound location of the internal jugular veins, access of the subclavian veins, access of the internal jugular veins, placement of a central line via the subclavian veins, placement of a central line via the internal jugular veins, temporary transvenous pacemaker placement via the subclavian vein, temporary transvenous pacemaker placement via the internal jugular vein, and other procedures. The simulator is an apparatus that has a clavicle model and a heart model. The clavicle model and heart models may be used together or may be used individually. The models may be oriented to provide simulation for access sites individually, or any combination of the venous access sites. For example, the clavicle model may simulate the right internal jugular vein. The clavicle model may also simulate the right internal jugular vein and the right subclavian vein. In another example, the clavicle model may simulate the right internal jugular vein, the left internal jugular vein, the right subclavian vein, and the left subclavian vein. The present invention provides aPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV method in which the user may utilize the simulator to train on specific models separate from the other models listed herein. Alternatively, the user may choose to utilize the simulator with both the clavicle model and heart model attached to better simulate real-life conditions.

[0008] In an embodiment, the simulator is a clavicle model formed to represent the human neck and clavicle region. Either of these components may be optional, and / or individual assemblies may include a single component or a combination of the components. For example, the clavicle model may be used individually to perform simulations to access the venous sites. The heart model may be used individually to perform simulations of the placement of the temporary transvenous pacemaker. The models may be used in conjunction to perform simulations of the combination of identification of venous access sites, access of the venous sites, and placement of the central line or temporary transvenous pacemaker.

[0009] The clavicle model may serve as the base to which the heart model is removably attached. The clavicle model is designed to receive and retain the heart model. The heart model may be removably attached to the clavicle model in a designated area located near the chest or lower clavicle portion of the clavicle model.

[0010] The clavicle model is shaped to simulate that of the human clavicle to provide an accurate simulation of the procedures when in use. The size of the clavicle model is designed to be of a similar size to that of an average human clavicle region. When in use, the clavicle model may be placed on a flat surface to utilize optional suction cups. Alternatively, the clavicle model may be placed on a surface at an angle to simulate various patient conditions or alignments. In an embodiment, the clavicle model may be adhered to a flat surface using the optional suction cups located on the back side of the clavicle model.

[0011] The heart model may be removably attached to the lower or bottom portion of the clavicle model. The heart model is designed to simulate the human heart. The heart model may be used as a standalone model for training procedures involving the heart. The model may be placed on a flat surface and utilized without the clavicle model. Alternatively, the model may be used in conjunction with the clavicle model to better simulate actual medical conditions and procedures.

[0012] The clavicle model is equipped to engage with the heart model in such a fashion that at least one of a plurality of tubes of the clavicle model connect to the heart model. The plurality of tubes are substantially shaped and oriented as the primary veins and arteries located in the human clavicle region and heart region. The plurality of tubes substantially shaped as human veins arePCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV oriented to merge together and connect to the entry site of the heart model. The entry site is substantially shaped and oriented to that of the human superior vena cava. The clavicle model and heart model are designed to be able to practice procedures simulating access to veins (typically, the subclavian veins and the jugular veins) and heart (typically, the right ventricle). The simulations may include access to the veins, access to the heart, or access to the veins, traverse through the venous system, and into the heart.

[0013] It is an object of the simulator to be easily portable such that the user may move the simulator or models of the simulator in an easy and convenient way to enable training in almost any location.BRIEF DECRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a front elevation view of an embodiment of the clavicle and heart model of the present invention.

[0015] FIG. 2 is a front view representation of an upper body and heart of a human which the clavicle model and heart model represent.

[0016] FIG. 3 is a bottom perspective view of an embodiment of the clavicle model of the present invention.

[0017] FIG. 4 is a top perspective view of the clavicle model of the present invention.

[0018] FIG. 5 is a front perspective representation of an upper body of a human which the clavicle model represents.

[0019] FIG. 6 is a front view of a representation of the heart of a human which the heart model represents.

[0020] FIG. 7 is a front perspective view of an embodiment of the heart model of the present invention.

[0021] FIG. 8 is a top perspective view of the optional basin with the bone element and blood vessel holes.DETAILED DESCRIPTION OF THE INVENTION

[0022] The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in aPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV limiting sense but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.

[0023] An anatomical clavicle and heart simulator apparatus 10 of the present invention is shown in FIGS. 1-8. The simulator apparatus 10 includes a clavicle model 30 and a heart model 50 as depicted in FIGS. 1-2. The clavicle model 30 is shown alone in FIGS. 3-5. The heart model 50 is shown alone in FIGS. 6-7. An optional basin 70 for use with the clavicle model 30 is depicted in FIG. 8.

[0024] The present invention may be used to facilitate training and practicing of a number of medical procedures involving the clavicle and heart. The procedures include, but are not limited to, subclavian vein access, jugular vein access, central line placement, and other procedures involving the clavicle and / or heart.

[0025] The clavicle model 30 is designed to simulate the human clavicle and neck in a simplified, representative way. The clavicle model 30 has a ultrasound phantom structure 48, a heart model connector tube 40 a connector 42, and a plurality of vein tubes 32, 34, 36, 38. The ultrasound phantom structure 48 is designed to be formed like that of the human clavicle region, which include areas corresponding to the upper arm, shoulder, clavicle, upper back, or upper chest portions of the human body. The connector tube 40 is designed to simulate the upper superior vena cava of a human. The clavicle model 30 may be equipped with one or more of the vein tubes, a first vein tube 32, a second vein tube 34, a third vein tube 36, or a fourth vein tube 38. The first vein tube 32 is designed to simulate that of the human right subclavian vein. The second vein tube 34 is designed to simulate that of the human right internal jugular vein. The third vein tube 36 is designed to simulate that of the human left internal jugular vein. The fourth vein tube 38 is designed to simulate that of the human left subclavian vein. The clavicle model 30 may have a plurality of optional artery components 82 and 84 to simulate that of the human clavicle. A first artery component 82 is designed to simulate that of the human right subclavian vein. The second artery component 84 is designed to simulate that of the carotid artery.

[0026] The clavicle model 30 may be equipped with one or more of the vein tubes 32, 34, 36, 38, depending on the desired procedure. For example, if the simulated procedure is designed to practice right subclavian vein access, an embodiment of the clavicle model 30 may have only the first vein tube 32. If the desired procedure involves the right clavicle, an embodiment of the clavicle model 30 may have only the first vein tube 32 and the second vein tube 34. In anotherPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV embodiment, the clavicle model 30 may include the four vein tubes 32, 34, 36, 38, allowing practice for any of the vein access sites.

[0027] The heart model 50 is designed to simulate the human heart in a simple, representative way. The heart model 50 has an entry tube 52, a first proximal compartment 54, a first value 55, a second proximal compartment 56, a second valve 57, a first distal compartment 58, a third valve 59, a second distal compartment 60, a placement site 62, and an opening 64. The entry tube 52 is designed to simulate the lower superior vena cava of a human. The first proximal compartment 54 is designed to simulate the human right atrium. The second proximal compartment 56 is designed to simulate the human right ventricle. The first distal compartment 58 is designed to simulate the human left atrium. The second distal compartment 60 is designed to simulate the human left ventricle. The first valve 55 is designed to simulate the tricuspid valve of the human heart. The second valve 57 is designed to simulate the pulmonary valve of the human heart. The third valve 59 is designed to simulate the mitral valve of the human heart. The placement site 62 is designed to simulate the desired location in the human heart to place a temporary pacemaker. The opening 64 is designed to simulate the opening between the superior vena cava and right atrium of the human heart.

[0028] The clavicle model 30 and the heart model 50 of the present invention 10 may be used individually, or in conjunction with each other. For example, if the desired procedure is to practice only accessing subclavian or jugular veins, the clavicle model 30 may be used independently. If the desired procedure involves that of the human heart, the heart model 50 may be used independently. Alternatively, utilizing both the clavicle model 30 and the heart model 50 together allows a user to simulate all aspects of procedures. In another example, a user may desire to simulate the entire procedure of placing a temporary pacemaker. Utilizing both the clavicle model 30 and the heart model 50, a user would first utilize a catheter to obtain access to any of the vein tubes 32, 34, 36, 38 through the ultrasound phantom structure 48. The user will guide the catheter through the selected one or more of the vein tubes 32, 34, 36, 38 into and through the connector tube 40, into and through the entry tube 52 and through the opening 64 into the first proximal compartment 54, past the first valve 55, into the second proximal compartment 56, and to the placement site 62.

[0029] The clavicle model 30 and heart model 50 may be removably connected by the connector 42. The connector 42 allows for the connector tube 40 of the clavicle model 30 and the entryPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV tube 52 of the heart model 50 to be continuously connected. The simulator 10 may also have a an optional method to allow the user to secure the clavicle model 30 and the heart model 50 together such that neither model moves independently during a procedure. Still further, the clavicle model 30 or the heart model 50 may have a plurality of optional suction cups. The optional suction cups may allow for the user to secure either or both models to a surface during use.

[0030] The clavicle model 30 is removably connected to the heart model 50. The clavicle model 30 has a ultrasound phantom structure 48 designed to simulate that of the human clavicle region. The ultrasound phantom structure 48 may be formed of a shape and material designed to simulate the structure and feel of the human clavicle region. In one embodiment, the clavicle model 30 has a first vein tube 32 and a second vein tube 34, designed to simulate the right subclavian vein and the right internal jugular vein, respectively. The heart model 50 may be connected to the clavicle model 30 with the connector 42. In an embodiment, the entry tube 52 may be connected to one of the vein tubes 32, 34, 36, 38 directly. In other embodiments, the plurality of vein tubes 32, 34, 36, 38 may merge into the connector tube 40, wherein the entry tube 52 of the heart model 50 may connect to the connector tube 40.

[0031] In the embodiment of FIG. 2, the simulator 10 has the first vein tube 32, second vein tube 34, third vein tube 36, and fourth vein tube 38 located within the ultrasound phantom structure 48. The vein tubes 32, 34, 36, 38 merge into the connector tube 40. The connector tube 40 of the clavicle model 30 is connected to the entry tube 52 of the heart model 50 via the connector 42. The heart model 50 has the opening 64, the first proximal compartment 54, the first valve 55, the second proximal compartment 56, the second valve 57, the first distal compartment 58, the third valve 59, and the second distal compartment 60. The heart model 50 of the embodiment of FIG. 2 has the placement site 62. The combined simulator 10 allows the user to perform a number of procedures involving the clavicle and heart. The clavicle model 30 and the heart model 50 may be disconnected at the connector 42 to perform procedures on the clavicle model 30 or the heart model 50 individually.

[0032] The orientation of the clavicle model 30 shown in FIG. 3 depicts the right clavicle of the human body. The clavicle model 30 of the present embodiment has the ultrasound phantom structure 48 which contains the first vein tube 32 and the second vein tube 34. The first vein tube 32 is designed to simulate the right subclavian vein. The second vein tube 34 is designed toPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV simulate the right internal jugular vein. The ultrasound phantom structure 48 is designed to simulate the human clavicle portion surrounding the veins. In a typical medical procedure when attempting to access the veins, the user would utilize ultrasound or x-ray technology to locate the veins. The present invention 10 is designed to simulate the conditions of the human body such that ultrasound or x-ray technology may be used on the simulator 10 the same way it would be used on a human body.

[0033] FIG. 4 depicts a top perspective view of an embodiment of the clavicle model 30. The clavicle model 30 may be placed on a table or other type of workstation to simulate a patient lying in a bed. The user may utilize the simulator 10 to perform procedures involving vein access. The user would first identify the location of the veins (typically utilizing ultrasound or x- ray). The user would then insert a needle through the skin at the desired location on the ultrasound phantom structure 30 through the material and into the desired vein tube 32, 34, 36, 38. The user may then utilize medical equipment (typically a guidewire and other related equipment) to practice traversing the veins to simulate the insertion of a central line or temporary pacemaker. The ultrasound phantom structure 48 is designed to be able to practice the procedure multiple times at various vein access sites. The vein tubes 32, 34, 36, 38 are designed to be able to practice the procedure multiple times at various access sites. Performing the simulated procedures to obtain vein access may leave needle tracts in the ultrasound phantom structure 48 and punctures in the vein tubes 32, 34, 36, 38. It is a design of the present invention 10 to be able to be reused. In an embodiment, the ultrasound phantom structure 48 or the vein tubes 32, 34, 36, 38 are made of a material that may be reused while still simulating that of the human body. For example, in some embodiments, the ultrasound phantom structure 48 may be made of a ballistic gelatin or other similar material. The material may be heated at a specific temperature, typically around 260 degrees Fahrenheit, to melt and close the tracts made by previous procedures, allowing the simulator 10 to be reused. The vein components may be made of a silicone or other such material wherein the vein components are heat-tolerant as to prevent distortion of the vein components when exposed to heat to reform the ultrasound phantom structure.

[0034] The clavicle model 30 may be used as a standalone model to practice various medical procedures such as ultrasound location of veins, access of various veins through various locations, insertion of guidewires, and other medical procedures involving the human clavicle. In the invention representation of FIG. 5, the clavicle model 30 may be used to locate and performPCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV medical procedures on the first vein tube 32, second vein tube 34, third vein tube 36, or fourth vein tube 38. The ultrasound phantom structure 48 retains the vein tubes 32, 34, 36, 38 to simulate the location of veins in the human body. The vein tubes 32, 34, 36, 38 of the present embodiment merge into the connector tube 40. The connector tube 40 is designed to simulate that of the upper portion of the human superior vena cava.

[0035] FIGS. 6-7 depict the heart model 50 of the simulator 10. The heart model 50 has the entry tube 52, first proximal compartment 54, second proximal compartment 56, first distal compartment 58, and second distal compartment 60. The heart model 50 also has the first valve 55, second valve 57, and third valve 59. The heart model 50 is designed to simulate that of the human heart. A user may utilize the heart model 50 to simulate procedures such as placement of a central line, placement of a temporary pacemaker, or other medical procedures involving the human heart. For example, the user may utilize medical equipment, such as a catheter, to be inserted into the entry tube 52, through the opening 64 into the first proximal compartment 54, past the first valve 55, and into the second proximal compartment 56 to the placement site 62.

[0036] FIG. 8 depicts the optional basin 70. The optional basin 70 provides a structure in which the gel of the ultrasound phantom structure 48 may be molded into while being reheated for reuse. The basin 70 is shaped as the clavicle model 30, allowing the gel to be heated to the desired temperature to become a liquid or gelatin form and solidify as the ultrasound phantom structure 48 once removed from the heat. The vein tubes 32, 34, 36, and 38, and optional artery tubes 82, 84 will remain in the desired location during the heating process. The basin 70 may have a plurality of blood vessel holes 72 designed to hold the vein tubes or artery tubes in place during reheating. The basin 70 may also have an optional clavicle bone element 74. The clavicle bone element 74 is designed to simulate that of the human clavicle.

[0037] The present invention has been described with reference to specific examples and configurations. It is only intended to be limited to the description set out in the claims and equivalents.

Claims

PCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROVWhat is claimed is:

1. A clavicle and heart anatomical simulator apparatus for training medical professionals involving the clavicle and heart, the apparatus comprising: a clavicle model, substantially shaped like that of the human clavicle; a heart model, substantially shaped like that of the human heart; a plurality of vein tubes, substantially shaped like that of human veins; and and a connector; wherein the clavicle model has a ultrasound phantom structure; wherein the heart model has a first proximal compartment, a second proximal compartment, a first distal compartment, and a second distal compartment; wherein the plurality of vein tubes are located within the ultrasound phantom structure, wherein the connector forms a removably retained connection between a connector tube of the clavicle model and an entry tube of the heart model; and wherein the clavicle model and the heart model are made of one or more materials that permit insertions into the vein tubes to pass therethrough for simulating a medical procedure.

2. The simulator apparatus of Claim 1 wherein the ultrasound phantom structure is made of a nonmetallic material.

3. The simulator apparatus of Claim 1 wherein the ultrasound phantom structure is made of a material which may be heated to reform the structure such that the simulator apparatus may be reused after procedures have been performed.

4. The simulator apparatus of Claim 1 wherein the clavicle model and heart model are configured to be removably engaged with the connector.

5. The simulator apparatus of Claim 1 wherein the clavicle model and heart model are made of one continuous structure.PCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV6. The simulator apparatus of Claim 1 wherein the clavicle model or the heart model is removably engaged with a surface to secure the apparatus to the surface while in use.

7. The simulator apparatus of Claim 1 wherein the clavicle model has an optional basin in which the basin provides the structure of the clavicle model during reheating.

8. A clavicle model anatomical simulator apparatus to assist in training medical professionals in procedures involving the human clavicle, the apparatus comprising: a clavicle model, substantially shaped like that of the human clavicle; a plurality of vein tubes, substantially shaped like that of human veins; wherein the clavicle model has a ultrasound phantom structure; and the plurality of vein tubes are located within the ultrasound phantom structure.

9. The simulator apparatus of Claim 8 wherein the ultrasound phantom structure is made of a nonmetallic material.

10. The simulator apparatus of Claim 8 wherein the ultrasound phantom structure is made of a material which may be heated to reform the structure such that the simulator apparatus may be reused.

11. The simulator apparatus of Claim 8 wherein the clavicle model is removably engaged with a surface to secure the apparatus to the surface while in use.

12. The simulator apparatus of Claim 8 wherein the clavicle model has an optional basin in which the basin provides the structure of the clavicle model during reheating.

13. A heart model anatomical simulator apparatus to assist in training medical professionals in procedures involving the human heart, the apparatus comprising a heart model, substantially shaped like that of the human heart, wherein the heart model has: a first proximal compartment; a second proximal compartment;PCT / US25 / 41697 12 August 2025 (12.08.2025)Atty Docket No. HALO-003PROV a first distal compartment; a second distal compartment; and an entry tube; wherein the first proximal compartment is substantially oriented like that of the right atrium of the human heart; wherein the second proximal compartment is substantially oriented like that of the right ventricle of the human heart; wherein the first distal compartment is substantially oriented like that of the left atrium of the human heart; wherein the second distal compartment is substantially oriented like that of the left ventricle of the human heart; and wherein the entry tube is substantially oriented like that of the human superior vena cava.

14. The simulator apparatus of Claim 13 wherein the heart model is made of a nonmetallic material.

15. The simulator apparatus of Claim 13 wherein the heart model is removably engaged with a surface to secure the apparatus while in use.

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