Central Venous Access Trainer (CVAT)

A training device for the preparation, execution and maintenance of central venous catheters comprising a central block including a cavern traversing through the block, a tube running through the cavern, a reservoir containing a liquid with a distal end of the tube engaged with the reservoir, a covering material secured over the central block, a guidewire extended through the covering material and within the tube, a hydraulic or pneumatic device operationally associated with the reservoir and allowing the reservoir and the tube to be filled and pressurized with the liquid, a scalpel or similar instrument for making a small incision in the covering material at the site where the guide wire extends through the covering material, a dilator to expand the incision opening and then remove from the incision and guidewire and a catheter to feed over the guidewire and into the incision.

FIELD OF INVENTION

The instant invention relates to medical devices which permit an individual the opportunity to practice Central Venous Catheterization.

BACKGROUND OF THE INVENTION

Central Venous Catheterization is a common procedure which is performed daily on patients throughout the world. A Central Venous Catheter (CVC), also known as a central line, central venous line, or central venous access catheter, is a catheter placed into a large vein. Catheters can be placed in veins in the: neck (internal jugular vein), chest (subclavian vein or axillary vein), groin (femoral vein), or through veins in the arms (also known as a PICC line, or peripherally inserted central catheters). A CVC is used to administer medication or fluids that are unable to be taken by mouth or would harm a smaller peripheral vein, obtain blood tests (specifically the “central venous oxygen saturation”), and measure central venous pressure.

Central venous catheters usually remain in place for a longer period than other venous access devices, especially when the reason for their use is longstanding (such as total parenteral nutrition in a chronically ill person). For such indications, a Hickman line, a PICC line, or a Port-a-Cath may be considered because of their smaller infection risk. Sterile technique is highly important here, as a line may serve as an entry point for pathogenic organisms. Additionally, the line itself may become infected with bacteria such asStaphylococcus aureusand coagulase-negativeStaphylococci.

Training medical professionals on how to properly prepare, place, secure and maintain a CVC is critical. The risks associated with central line placement include infection, hematoma, collapsed lung and damage to veins and arteries. There are anatomical models available to allow medical professionals the opportunity to practice part of the Central Venous Catheterization procedure. While manufacturers advertise that entire procedure can be performed on their central line trainers, we have found that the steps of nicking, dilating, and inserting the central line dramatically decreases the lifespan of the product and makes an already expensive trainer even more costly due to an increased tissue set replacement cycle. However, omitting these steps can lead to an incomplete skill set for the learner. Additionally, expensive anatomical training devices do not allow for the training of individuals in flushing with saline, care and maintenance.

Thus, there is clearly a need for a device which allows for thorough, yet inexpensive training in all aspects of the Central Venous Catheterization preparation, execution and maintenance. The instant invention is designed to provide such each of these elements.

SUMMARY OF THE INVENTION

A training device for the preparation, execution and maintenance of central venous catheters comprising a central block including a cavern traversing through the block, a tube running through the cavern, a reservoir containing a liquid with a distal end of the tube engaged with the reservoir, a covering material secured over the central block, a guidewire extended through the covering material and within the tube, a hydraulic or pneumatic device operationally associated with the reservoir and allowing the reservoir and the tube to be filled and pressurized with the liquid, a scalpel or similar instrument for making a small incision in the covering material at the site where the guide wire extends through the covering material, a dilator to expand the incision opening and then remove from the incision and guidewire and a catheter to feed over the guidewire and into the incision.

DETAILED DESCRIPTION OF THE INVENTION

The instant invention, referred to as the Central Venous Access Trainer (CVAT)10allows a healthcare provider to practice Central Venous Catheterization in a simulated environment as accurately and thoroughly as possible while being highly cognizant of expenses. Central Venous Catheter (CVC), also known as a central line, central venous line, or central venous access catheter, is a catheter placed into a large vein. Catheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or axillary vein), groin (femoral vein), or through veins in the arms (also known as a PICC line, or peripherally inserted central catheters), It is used to administer medication or fluids that are unable to be taken by mouth or would harm a smaller peripheral vein, obtain blood tests (specifically the “central venous oxygen saturation”), and measure central venous pressure. Reasons for the use of central lines include long-term intravenous antibiotics, long-term parenteral nutrition, especially in chronically ill persons, long-term pain medications, chemotherapy, drugs that are prone to cause phlebitis in peripheral veins (caustic), (i.e. calcium chloride, chemotherapy, hypertonic saline, potassium chloride (KCl), amiodarone, vasopressors (for example, epinephrine, dopamine), plasmapheresis, peripheral blood stem cell collections, dialysis, frequent blood draws, frequent or persistent requirement for intravenous access, need for intravenous therapy when peripheral venous access is impossible (i.e. blood, medication, rehydration). Monitoring of the central venous pressure (CVP) in acutely ill people to quantify fluid balance is also accomplished.

Central venous catheters usually remain in place for a longer period than other venous access devices, especially when the reason for their use is longstanding (such as total parenteral nutrition in a chronically ill person). For such indications, a Hickman line, a PICC line, or a Port-a-Cath may be considered because of their smaller infection risk. Sterile technique is highly important here, as a line may serve as an entry point for pathogenic organisms. Additionally, the line itself may become infected with bacteria such asStaphylococcus aureusand coagulase-negativeStaphylococci.

The trainer10described herein is a cost-effective way for the users to practice all of these steps of the procedure that has, until now, had numerous steps omitted due to the cost of supplies and the recommendations from the manufacturer of commercial trainers. For example, the manufacturers of some commercial trainers allow for the visualization, palpation and location of the simulated vein to be accomplished along with the insertion of a needle in order to locate a guide wire within the simulated vein. This, is unfortunately as far as the manufacturer recommends for training to proceed in order to avoid damage to the commercial trainer. Other manufacturers advertise that the entire CVC placement procedure can be performed on their central line trainers, but most have found that the steps of nicking the simulated skin with a scalpel, dilating the entry point, and inserting the central line dramatically decreases the lifespan of the commercial trainer and makes an already expensive trainer (costing between $750 and $2000) even more costly due to an increased tissue set replacement cycle (costing between $500 and $1000). However, omitting those steps lead to an obvious incomplete skill set for the learner, thus opening up the likely result of substandard care for a patient.

During development, the CVAT10was designed and developed as a new innovative approach to improve education while decreasing cost. It has been utilized for a variety of levels of learners and from multiple disciplines including physicians, physician assistants, and registered nurses. The CVAT10has also illustrated its value in the Nursing Home and Nursing care settings for Central Line care and dressing change as well as for Port-a-Cath care. We were able to place the Port-a-Cath under the skin and they used it just as they would for a central line.

Referring to the drawings, wherein like numerals, indicate like elements, there is shown in the Figures an embodiment of a training device10for the preparation, execution and maintenance of central venous catheters15comprising a central block20including a cavern30or channel31traversing through the block20, wherein the cavern30has a proximal opening32and a distal opening34, a tube50running through the cavern30, the tube has a proximal end52, a distal end54and a lumen55which facilitates fluid communication where the proximal end52of the tube is sealed. The embodiment also includes a reservoir60containing a liquid62with the distal end54of the tube50engaged with the reservoir60and in fluid communication with the liquid62. A covering material70with an inner surface72and an outer surface74is secured over the central block20and a guidewire95with a proximal end96and a distal end98with the distal98end located within the lumen55tube50and the proximal end96extending through the covering material70. The embodiment also includes a hydraulic or pneumatic device65is operationally associated with the reservoir60and allows the reservoir60and the tube50to be filled and pressurized with the liquid62, a scalpel or similar instrument for making a small incision in the covering material70at the entry point76where the guide wire95extends through the covering material70, a dilator82to feed over the guidewire95and into the incision entry point76in order to expand the incision opening and then remove from the incision and guidewire95and a catheter15to feed over the guidewire95and into the incision.

In one embodiment of the instant invention, the central block20is made of a polystyrene, a reticulated foam or equivalent material. In another embodiment, the polystyrene is selected from the group including, but not limited to, extruded polystyrene (EPS), extruded polystyrene (XPS) a bioplastic foam, or a combination thereof. In one embodiment of the instant invention, the covering material70is made from a material selected from the group including an elastomeric material, a silicone, a latex, a natural rubber, or a combination thereof. The replacement cost for the covering material70is between 2-10% of the cost for the replacement skin of a commercial trainer ($20-$50 as opposed to $450-$850).

The instant invention may further include saline to flush the catheter15, suture materials85to suture the catheter15in place and a sterile dressing88to cover and protect the catheter15. In one embodiment of the instant invention, the training device10is used in conjunction with an anatomical central line training manikin100where a portion of the training of one or more individuals is accomplished using each device. In another embodiment, the catheter15is selected from the group including: a peripherally inserted central catheter, a tunneled catheter, an implanted port (i.e. Port-a-Cath for use in chemotherapy), or a combination thereof.

Another embodiment of the instant invention discloses a training device10for the preparation, execution and maintenance of central venous catheters15comprising a case40with a lid43and an opening44. The case40may have one or more compartments including a first compartment41and a second compartment42. In one embodiment, the opening44permits access to the interior of the case including at least one compartment. The embodiment includes a central block20residing in the case40, the block has two or more channels31traversing one or more surfaces of the block and a tube50running through each channel31, where each tube has a proximal end52, a distal end54and a lumen55which facilitates fluid communication where the proximal end52of each tube is sealed either permanently or through the use of a clamp90. The embodiment also includes a reservoir60containing a liquid62with the distal end54of each tube50engaging with the reservoir60and in fluid communication with the liquid. A covering material70with an inner surface72and an outer surface74is secured over the central block20and the outer surface74is accessible through the case opening44. A guidewire95is also included where the guide wire95has a proximal end96extending through the covering material70at the entry point76and a distal end98located within the lumen55each tube50. A hydraulic or pneumatic device65is operationally associated with the reservoir60and allows the reservoir60and each tube50to be filled and pressurized with the liquid in order to simulate the vasculature of a living patient. The embodiment also includes a scalpel or similar instrument for making a small incision in the covering material70at the entry point76where each guide wire95extends through the covering material70, a dilator82to feed over each guidewire95and into the incision76in order to expand each incision opening and then be removed from the incision and from the guidewire95, and a catheter15to feed over each guidewire95and into the incision, after which the guide wire95is removed.

In the above embodiment, the central block20is made of a polystyrene, a reticulated foam or equivalent material. In another embodiment, the polystyrene is selected from the group including, but not limited to, extruded polystyrene (EPS), extruded polystyrene (XPS) a bioplastic foam, or a combination thereof. In one embodiment of the instant invention, the covering material70is made from a material selected from the group including an elastomeric material, a silicone, a latex, a natural rubber, or a combination thereof. The instant invention may further include saline to flush the catheter15, suture materials85to suture the catheter15in place and a sterile dressing88to cover and protect the catheter15. In one embodiment of the instant invention, the training device10is used in conjunction with an anatomical central line training manikin100where a portion of the training of one or more individuals is accomplished using each device. In another embodiment, the catheter15is selected from the group including: a peripherally inserted central catheter, a tunneled catheter, an implanted port (i.e. Port-a-Cath for use in chemotherapy), or a combination thereof.

The instant invention also includes a method of training a person in the preparation, execution and maintenance of a catheter15comprising the steps of:(a) providing an anatomical central line training manikin100;(b) cleaning/sterilizing the area proximal to a vein/tube into which the CVC15will be inserted;(c) palpating the vein/tube within the training manikin100;(d) inserting a syringe91and needle into the training manikin100and locating the vein/tube;(e) removing the syringe91from the needle;(f) inserting a guide wire95into the needle;(g) feeding the guide wire95into the vein/tube;(h) providing a training device10for the preparation, execution and maintenance of catheters15comprising:a case40with a lid43and an opening44;central block20residing in the case40, the block has two or more channels31traversing one or more surfaces of the block;a tube50running through each channel31, where each tube has a proximal end52, a distal end54and a lumen55which facilitates fluid communication where the proximal end52of each tube is sealed either permanently or through the use of a clamp90;a reservoir60containing a liquid62with the distal end54of each tube50engaging with the reservoir60and in fluid communication with the liquid;a covering material70with an inner surface72and an outer surface74is secured over the central block20and the outer surface74is accessible through the case opening44;a guidewire95is also included where the guide wire95has a proximal end96extending through the covering material70at the entry point76and a distal end98located within the lumen55each tube50;a hydraulic or pneumatic device65is operationally associated with the reservoir60and allows the reservoir60and each tube50to be filled and pressurized with the liquid in order to simulate the vasculature of a living patient;(i) incising the covering material70with a scalpel or similar instrument at the entry point76where each guide wire95extends through the covering material70;(j) feeding a dilator82over each guidewire95and into the entry point76in order to expand each entry point76;(k) removing the dilator82from the entry point76and guidewire95, leaving the guide wire95in place;(l) feeding a catheter15over each guidewire95;(m) inserting the catheter into the incision until it is in its desired location;(n) removing the guidewire95; and(o) flushing the catheter out with saline.

In one embodiment of the above method, the central block20is made of a polystyrene, a reticulated foam or equivalent material. The polystyrene is selected from the group consisting of: extruded polystyrene (EPS), extruded polystyrene (XPS) a bioplastic foam, or a combination thereof. In another embodiment, the covering material70is made from a material including an elastomeric material, a silicone, a latex, a natural rubber, or a combination thereof. In another embodiment, the catheter15is selected from the group including: a peripherally inserted central catheter, a tunneled catheter, an implanted port (i.e. Port-a-Cath for use in chemotherapy), or a combination thereof.

In one embodiment, the above method further includes the steps of:(p) suturing the catheter15in place on the outer surface74of the covering material70;(q) placement of an antimicrobial material or device on the patient's skin around the catheter15and the entry point76; and(r) covering the catheter15with a sterile dressing88to protect the catheter15.

In another embodiment, the above method(s) further includes the steps of:(s) removing the sterile dressing88from the catheter15;(t) removing the antimicrobial material or device from the patient's skin and cleaning the patient's skin around the catheter15and entry point76into the patient;(u) observing the patient's skin around the catheter15and entry point76and noting any signs of discoloration and/or infection;(v) flushing the catheter15out with saline to ensure that the catheter is functioning properly;(w) placement of a new antimicrobial material or device on the patient's skin around the catheter15and the entry point76; and(x) covering the catheter15with a sterile dressing88to protect the catheter.

In one embodiment, the above method includes the use of sonogram technology (including color Doppler duplex sonography) to aid in the placement of the catheter15during any of the steps described above. In any of the above embodiments, the case40may have one or more compartments including a first compartment41and a second compartment42. The opening44permits access to the interior of the case including at least one compartment41,42and the covering material70.

Any method described herein may incorporate any design element contained within this application and any other document/application incorporated by reference herein. Any design element contained within this application may be incorporated into any embodiment contained within this application.

The present invention may be embodied in other forms without departing from the spirit and the essential attributes thereof, and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicating the scope of the invention. The invention illustratively discloses herein suitably may be practiced in the absence of any element which is not specifically disclosed herein.