JP2024521191A - Vein Simulator System - Google Patents

Abstract

The venous simulator system can be used by clinicians to improve proficiency in placing a catheter, such as a PIVC, or otherwise accessing the vascular system. The venous simulator system can include a simulated portion of a body, such as a simulated human arm, that includes at least one simulated vein. The venous simulator system can also include a control system, one or more sensors, and one or more feedback components. The control system can utilize the one or more sensors to generate feedback during the clinician's attempt to place the catheter and can output the feedback via the feedback component either during or after the attempt.

Description

The present invention relates to a vein simulator system.

When clinicians, such as nursing students, graduate, they typically have minimal proficiency in placing peripheral intravenous catheters (PIVCs) and are expected to improve their proficiency on the job. The problem with this approach is that inexperienced clinicians often need to make multiple attempts to successfully place a PIVC, which is a negative experience for patients. To minimize negative experiences, many centers limit the number of failed attempts an inexperienced clinician can make. Once the inexperienced clinician reaches the maximum number of allowed failed attempts (e.g., two attempts), an experienced clinician should place the PIVC.

Several vein simulator systems have been developed to improve the proficiency of inexperienced clinicians in placing a PIVC. Such vein simulators often take the form of a fake arm that contains a tube through which red fluid is pumped. These vein simulators may be made of materials that react similarly to human skin and veins, so that the inexperienced clinician can learn how it should feel when the needle is inserted into the vein during PIVC placement. However, these vein simulators do not provide useful guidance to teach the inexperienced clinician whether they have placed the PIVC properly or improperly.

The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in the environments described above. Rather, this background is provided only to illustrate one example of a technology area in which some embodiments described herein may be practiced.

The present disclosure generally relates to a venous simulator system that can be used by a clinician to improve proficiency in placing a catheter, such as a PIVC, or otherwise accessing the vascular system. The venous simulator system can include a simulated portion of a body, such as a simulated human arm, that includes at least one simulated vein. The venous simulator system can also include a control system, one or more sensors, and one or more feedback components. The control system can utilize one or more sensors to generate feedback during the clinician's attempt to place the catheter, and can output the feedback via the feedback component either during or after the attempt.

In some embodiments, the vein simulator system may include a simulated portion of a body including a first simulated vein, a control system, at least one sensor, and at least one feedback component. The control system may be configured to employ the at least one sensor to generate feedback while a clinician is attempting to place a catheter in the first vein. The control system may be further configured to present feedback to the clinician via the at least one feedback component.

In some embodiments, the simulated portion of the body is a simulated human arm. In some embodiments, the at least one sensor includes one or more cameras. In some embodiments, the at least one feedback component includes a display device. In some embodiments, the camera is external to the simulated portion of the body. In some embodiments, the simulated portion of the body includes a simulated internal tissue into which the first simulated one extends, and the camera is positioned within the simulated internal tissue. In some embodiments, the camera is positioned inside the first simulated vein.

In some embodiments, the simulated portion of the body includes a simulated internal tissue, and the vein simulator system further includes a light source that illuminates the simulated internal tissue. In some embodiments, the at least one sensor includes a film on or forming a portion of a sidewall of the simulated vein. In some embodiments, the control system creates said feedback based on a signal created, induced, or transmitted by the film in response to proximity to or contact with a needle used to place the catheter. In some embodiments, the at least one feedback component includes an audio feedback component or a visual feedback component. In some embodiments, the at least one sensor includes multiple sensors and is configured to create an association between feedback generated by the multiple sensors.

In some embodiments, the vein simulator system may include a simulated portion of a body including simulated internal flesh, a first simulated vein extending into the simulated internal flesh, and simulated skin positioned over the simulated internal flesh and the first simulated vein. The vein simulator system may further include a control system and at least one camera positioned to capture video of the first simulated vein.

In some embodiments, the at least one camera may be located outside the simulated internal flesh, inside the simulated internal flesh, and/or inside the first simulated vein. In some embodiments, the vein simulator system may include at least one sensor located on or within a sidewall of the first simulated vein, the at least one sensor configured to provide an indication to the control system when the needle contacts or is in proximity to the sensor. In some embodiments, the vein simulator system may include at least one feedback component. In some embodiments, the at least one feedback component may be one or more of a display device, a speaker, or a light.

In some embodiments, the vein simulator system may include a simulated portion of a body including a first simulated vein, a pump for pumping fluid through the first simulated vein, a control system, at least one sensor, and at least one feedback component. In some embodiments, the control system may be configured to generate feedback using the at least one sensor while a clinician is attempting to place a catheter in the first simulated vein, and the control system may be configured to output the feedback via the at least one feedback component.

It is understood that both the general description above and the detailed description which follows are exemplary and explanatory and are not intended to limit the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so recited in the claims. Therefore, the detailed description which follows is not to be taken in a limiting sense.

Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.
FIG. 1A is an assembly diagram of a vein simulator system configured in accordance with one or more embodiments of the present disclosure. FIG. 1B is an exploded perspective view of the vein simulator system of FIG. 1A. FIG. 1C illustrates the venous simulator system of FIG. 1A with the simulated arm removed. FIG. 1D illustrates the vein simulator system of FIG. 1A with the simulated skin removed from the simulated arm. FIG. 1E illustrates the vein simulator system of FIG. 1A with the simulated skin partially removed from the simulated arm. FIG. 2A illustrates a clinician using the venous simulator system of FIG. FIG. 2B provides an example of visual feedback that may be provided during placement of a PIVC by the venous simulator system of FIG. 1A or another venous simulator system configured in accordance with one or more embodiments of the present disclosure. FIG. 3A is a block diagram illustrating how a vein simulator system configured in accordance with one or more embodiments of the present disclosure can employ a camera external to the simulated vein to provide visual feedback during placement of the PIVC. FIG. 3B is a block diagram illustrating how a vein simulator system configured in accordance with one or more embodiments of the present disclosure can employ a camera inside a simulated vein to provide visual feedback during placement of a PIVC. 4A and 4B are block diagrams illustrating how a vein simulator system configured in accordance with one or more embodiments of the present disclosure can employ sensors on or in a simulated vein to provide feedback during placement of a PIVC. 4A and 4B are block diagrams illustrating how a vein simulator system configured in accordance with one or more embodiments of the present disclosure can employ sensors on or in a simulated vein to provide feedback during placement of a PIVC.

A vein simulator system configured according to one or more embodiments of the present disclosure may employ one or more sensors to provide feedback to a clinician during the PIVC placement process. Different types of sensors may be employed to provide different types of feedback. For example, a camera may be employed to provide visual (e.g., video) feedback of the advancement of the PIVC within the simulated vein. As another example, a film of conductive or capacitive material, etc., may be included on, in, or near the simulated vein to provide visual and/or audio feedback representative of the position of the PIVC within the simulated vein.

1A-E provide an example of a vein simulator system 100 configured in accordance with one or more embodiments of the present disclosure. The vein simulator system 100 includes a base 110 having a housing 111 and a support 112. The housing 111 may be used primarily to house various computer, electrical or other components, while the support 112 may be used primarily to support a simulated arm or other simulated portion of a human body or animal.

In some embodiments, the simulated arm or other simulated portion can be formed from simulated internal tissue (e.g., medical gelatin) that may include multiple grooves (e.g., grooves 131 and 132) for receiving simulated veins (simulated veins 141 and 142, which in some embodiments may be formed from rubber latex tubing), and simulated skin 150 (e.g., a silicon-based material with a single outer layer of spandex powder mesh fabric) for covering the simulated internal tissue 130. The simulated internal tissue 130 can be positioned on top of the support 112, and the simulated skin 150 can be placed over the simulated internal tissue 130 and secured to the support 112 via the fastening members 113. For example, as best shown in FIG. 1E, the support 112 can include holes 118 for receiving screws 119 that tighten the fastening members 113 on the sides of the simulated skin 150. The screws 119 are inserted into the simulated skin 150, thereby ensuring that the simulated skin 150 is firmly supported over the simulated internal tissue 130. As another example, a spring, a loaded clamp, a snap member, or any other suitable mechanism could be used to secure the fixing member 113 to the support 112.

The simulated veins 141 and 142 can be positioned within the grooves 131 and 132 and connected together at one end and to the pump 133 at the opposite end, thereby allowing the pump 133 to simulate flow through the simulated veins 141 and 142. In some embodiments, the support 112 can be at least partially hollow to allow the ends of the simulated veins 141 and 142 to connect (e.g., via tubing extending between the hole 117 and the protruding end 115 of the support 112). In some embodiments, a single length of tubing can be used to form the simulated veins 141 and 142. In some embodiments, the grooves 131 and 132 and the simulated veins 141 and 142 can be sized and configured in an anatomically correct manner (e.g., to match the size and location of veins in an actual human arm). However, in embodiments, any configuration of grooves and simulated veins could be used.

The vein simulator system 100 may also include a control system 120 (e.g., a computer) that may be housed within the housing 111. In some embodiments, the control system 120 may power the pump 133 to ensure that the fluid pressure and flow rate within the simulated veins 141 and 142 match the desired blood pressure and blood flow rates. In some embodiments, the control system 120 may power/control the light source 122, which may be located under or within the simulated internal tissue 130. For example, the support 112 may include a groove 116 within which the light source 122 may be housed. In some embodiments, the light source 122 may be in the form of an LED strip. In some embodiments, the light source 122 may extend along the entire length of the simulated internal tissue 130 or along a portion of the length of the simulated internal tissue 130 (e.g., below the intended insertion site).

As best shown in FIG. 1D, in some embodiments, the simulated internal tissue 130 may be transparent, allowing the light source 122 to illuminate it and the camera 121 (one type of sensor that may be employed in embodiments of the present disclosure) to capture an image of the simulated internal tissue 130 (one of the visual types of feedback that may be provided in embodiments of the present disclosure). For example, the housing 111 may include a wall 114 and an opening 114a that faces the simulated internal tissue 130. The camera 121 may be positioned in the opening 114a and directed toward the simulated internal tissue 130. The control system 120 may then use the camera 121 to capture an image of the simulated internal tissue 130 and the simulated veins 141 and 142 while the clinician performs the placement of the PIVC. In some embodiments, the vein simulator system 100 may include a display device 160 that may be coupled to the control system 120, thereby enabling the control system 120 to output an image to the display device 160. Thus, the clinician can view the image on the display device 160 as they attempt to place the PIVC.

The simulated internal tissue 130, the simulated veins 141 and 142, and the simulated skin 150 can be designed to have mechanical properties that match those of a human arm. For example, by constructing the simulated skin 150 from a silicon-based material with an outer layer of spandex powder mesh fabric, and the simulated veins 141 and 142 from rubber latex tubing, the penetration force and stiffness can be substantially matched to that of human skin and veins. Also, the simulated veins 141 and 142 can be sized and positioned to match the size and position of human veins. The pump 133 can be configured to create a fluid pressure in the simulated veins 141 and 142 that matches human blood pressure, thereby causing realistic flashbacks when the simulated veins 141 and 142 are punctured. Furthermore, by forming the simulated internal tissue 130 of medical gelatin, it can provide support and consistency similar to that of human subcutaneous tissue while being transparent to facilitate observation of the insertion site, as described below. In some embodiments, a heat gun can be used on the simulated internal tissue 130 after it has been molded into a shape that increases its transparency. In some embodiments, a uniform piece of glass or clear plastic can be pressed against the simulated internal tissue 130 to flatten its surface and remove any optical distortions that cause surface irregularities.

2A and 2B provide an example of how the vein simulator system 100 allows the clinician to view an image of an attempt to place a PIVC. FIG. 2A shows a clinician 200 attempting to place a PIVC in a simulated vein 141. FIG. 2B provides an example of an image that may be captured by the camera 121 and displayed on the display device 160 during this attempt. As shown, the light source 122 in the channel 116 illuminates the simulated internal tissue 130, including the channels 131 and 132 and the simulated veins 141 and 142 contained therein. This illumination allows the needle 210 and the distal end 211 of the needle 210 to be seen. In particular, the image allows the clinician to view the location of the distal end 211 in relation to the side wall 141a of the simulated vein 141. In this context, the side wall may be viewed as the side wall of the simulated vein 141 opposite the point of insertion, and typically may be the bottom wall of the simulated vein 141.

By observing the video, during or even after placement of the PIVC, the clinician can learn whether or not the PIVC has been successfully placed. For example, the visual feedback provided by the camera 121 can help the clinician learn when the distal end 211 of the needle 210 has reached the proper location within the simulated vein 141. This can assist the clinician not only in initially penetrating the simulated vein 141, but also in avoiding contacting or penetrating the sidewall 141a once the needle 210 is within the simulated vein 141.

In the above-described embodiment, the camera 121 is housed within the housing 111 and positioned at the end of the simulated internal tissue 130. Various other positions and/or configurations of the camera 121 may be employed in embodiments of the present disclosure. For example, FIG. 3A represents how the camera 121 may be positioned within the simulated internal tissue 130. In such embodiments, the camera 121 may be positioned at any suitable location within the simulated internal tissue 130 and oriented toward the intended insertion area. For example, in FIG. 3A, the camera 121 is positioned to the side of the simulated vein 141 and captures a picture perpendicular to the length of the simulated vein. In other examples, the camera 121 may be positioned above or below the simulated vein 141 and capture a picture that is aligned with the length of the simulated vein 141. In such cases, the camera 121 may be positioned upstream or downstream of the intended insertion area. In some embodiments, multiple cameras 121 may be used and positioned and/or oriented in various ways, whereby various views of the insertion area may be captured.

4A and 4B provide an example in which the vein simulator system 100 includes a sensor 400 in, on, or adjacent to the simulated vein 141. In FIG. 4A, the sensor 400 may be in the form of a film along, embedded in, or sufficiently close to the sidewall 141a to detect a change in an electrical property (e.g., capacitance) that may evoke when a PIVC needle approaches or contacts the film. For example, the sensor 400 may be a capacitive film that generates a signal indicative of the proximity of the needle (e.g., by changing capacitance in relation to proximity). The sensor 400 may provide such a signal to a circuit 401 of the control system 120. The circuit 401 may process the signal to determine the proximity of the needle and/or when the needle contacts the sensor 400.

The control system 120 may include a feedback component 402 by which the control system 120 outputs feedback. For example, the feedback component 402 may be a speaker that outputs audio feedback. In such a case, the circuit 401 may cause the feedback component 402 to output a sound when the signal from the sensor 400 indicates that the needle is contacting the sensor 400. Similarly, the circuit 401 may cause the feedback component 402 to output a sound when the signal from the sensor 400 indicates that the needle is approaching the sensor 400, and may change this sound (e.g., its pitch or volume) as the needle approaches the sensor 400. The clinician may rely on such a sound to learn when the needle has reached the correct position for proper placement of the PIVC and/or to avoid contacting the sidewall 141a.

In another example, the feedback component may be a visual feedback component, such as one or more LEDs or display device 160. In such a case, circuit 401 may cause visual feedback output to feedback component 402 to indicate when the needle contacts sensor 400 and/or to indicate the ongoing proximity of the needle to sensor 400. For example, if feedback component 402 is an LED, circuit 401 may cause the LED to blink at a faster rate as the needle approaches sensor 400. In another example, circuit 401 may generate and update a visual representation of the needle's position relative to sidewall 141a based on signals received from sensor 400, and may also provide the visual representation to feedback component 402 for display to the clinician (e.g., as part of a display integrated into housing 111 or on display device 160). Any other reasonable type of feedback component may also be used.

FIG. 4B is a variation in which the sensor 400 forms part of a circuit that is completed when the needle contacts the sensor 400. In particular, the needle and sensor 400 may be connected to a circuit 401 that is capable of detecting when the needle contacts the sensor 400 due to the change in current and/or voltage that this contact causes. In such an embodiment, the circuit 401 may provide feedback to the clinician using feedback component 402, as described above.

In some embodiments of the present disclosure, the vein simulator system may employ any one or more sensors and feedback of the types described above to assist the clinician in learning to properly place the PIVC. For example, in addition to the camera 121, the vein simulator system 100 may include a sensor 400 to better inform the clinician when contacting the side wall 141a.

In some embodiments, the control system 120 may be configured to store the feedback it generates so that it can be later reviewed and/or scored. For example, the control system 120 may maintain a log of the clinician's attempts to place a PIVC using the vein simulator system 100. In such a case, the control system 120 (or an external system) may use the log to generate a score for the clinician. Such a score may represent whether each particular attempt was successful, the degree to which each particular attempt was successful, an average success rate, a trend for success, or any other measure of success.

In some embodiments, when multiple sensors are employed, the control system 120 may be configured to create an association between the feedback from the different sensors. For example, the control system 120 may employ a video time code to associate the feedback from the sensor 400 with the video. Such an association may allow the clinician to accurately determine when the needle touches the sidewall while viewing the video.

Although this disclosure provides an example in which a vein simulator system resembles a human arm, the same techniques may be employed to create a vein simulator system that resembles another part of the human body, such as an entire arm, a leg, or a torso.

The simulated skin 150 can be opaque, so that it resembles human skin in that it prevents the clinician from seeing the PIVC while inserting it into the simulated vein 141 or 142. Meanwhile, the simulated internal tissue 130 can be transparent, so that the clinician can still rely on the camera 121 to ensure that he or she is performing the PIVC placement correctly. Once the clinician is confident that he or she can place the PIVC correctly, he or she can turn off the camera 121 or avoid viewing the captured footage for a series of runs. In this way, the vein simulator system 100 can help the clinician develop skills quickly without relying on footage to perform proper PIVC placement.

All examples and conditional language described herein are intended for educational purposes to aid in understanding the concepts provided by the inventor to promote the invention and technology, and should be construed as not being limited to the specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations may be made to the present specification without departing from the spirit and scope of the present invention.

In some embodiments, the simulated portion of the body is a simulated human arm. In some embodiments, the at least one sensor includes one or more cameras. In some embodiments, the at least one feedback component includes a display device. In some embodiments, the camera is external to the simulated portion of the body. In some embodiments, the simulated portion of the body includes a simulated internal tissue into which a first simulated vein extends, and the camera is located within the simulated internal tissue. In some embodiments, the camera is located inside the first simulated vein.

In some embodiments, the simulated portion of the body includes a simulated internal tissue, and the vein simulator system further includes a light source that illuminates the simulated internal tissue. In some embodiments, the at least one sensor includes a film on or forming a portion of a sidewall of the first simulated vein. In some embodiments, the control system creates said feedback based on a signal created, induced, or transmitted by the film in response to proximity to or contact with a needle used to place the catheter. In some embodiments, the at least one feedback component includes an audio feedback component or a visual feedback component. In some embodiments, the at least one sensor comprises a plurality of sensors and is configured to create an association between feedback generated by the plurality of sensors.

Claims (20)

1. A vein simulator system, comprising:
a simulated portion of a body, the simulated portion including a first simulated vein; and
A control system;
At least one sensor;
at least one feedback component;
the control system is configured to employ at least one sensor to generate feedback while a clinician is attempting to place a catheter in the first simulated vein, and the control system is configured to present the feedback to the clinician via the at least one feedback component.
Venous simulator system. the simulated part of the body is a simulated human arm;
The vein simulator system according to claim 1 . the at least one sensor includes a camera;
The vein simulator system according to claim 1 . the at least one feedback component includes a display device;
The vein simulator system according to claim 3 . the camera is external to the simulated part of the body;
The vein simulator system according to claim 3 . the simulated portion of the body includes a simulated internal tissue into which the first simulated object extends, and the camera is positioned within the simulated internal tissue.
The vein simulator system according to claim 3 . The camera is positioned inside the first simulated vein.
The vein simulator system according to claim 3 . the simulated portion of the body includes simulated internal tissue, the vein simulator system further comprising a light source that illuminates the simulated internal tissue.
The vein simulator system according to claim 3 . the at least one sensor includes a plurality of cameras;
The vein simulator system according to claim 1 . the at least one sensor includes a film on or forming a portion of a sidewall of the simulated vein;
The vein simulator system according to claim 1 . the control system generates the feedback based on a signal generated, induced, or transmitted by the film in response to proximity to or contact with a needle used to place the catheter.
The vein simulator system of claim 10. the at least one feedback component includes an audio feedback component or a visual feedback component;
The vein simulator system of claim 11. the at least one sensor comprises a plurality of sensors, and the control system is configured to create an association between feedback generated by the plurality of sensors.
The vein simulator system according to claim 1 . 1. A vein simulator system, comprising:
a simulated portion of a body, the simulated portion including simulated interior flesh, a first simulated vein extending into the simulated interior flesh, and simulated skin overlying the simulated interior flesh and the first simulated vein;
A control system;
at least one camera positioned to capture an image of the first simulated vein;
A vein simulator system comprising: The at least one camera includes:
located outside the simulated internal meat;
or located inside the simulated internal meat;
positioned inside the first simulated vein;
one or more of
The vein simulator system of claim 14. at least one sensor positioned on or within a sidewall of the first simulated vein, the at least one sensor configured to provide an indication to the control system when a needle contacts or is in proximity to the sensor.
Further,
The vein simulator system of claim 14. further comprising at least one feedback component;
17. The vein simulator system of claim 16. The at least one feedback component:
Display device,
Speaker, or
Light,
[0033]
20. The vein simulator system of claim 17. 1. A vein simulator system, comprising:
a simulated portion of a body, the simulated portion including a first simulated vein;
a pump for pumping fluid through the first simulated vein;
A control system;
At least one sensor;
At least one feedback component;
A vein simulator system comprising: the control system is configured to generate feedback using at least one sensor while a clinician is attempting to place a catheter in the first simulated vein, and the control system is configured to output the feedback via the at least one feedback component.
20. The vein simulator system of claim 19.

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