Vascular access device chamber venting

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DESCRIPTION

Vascular Access Device Chamber Ventilation

BACKGROUND OF THE INVENTION

The present description relates to infusion therapy with vascular access devices. Infusion therapy is one of the most common healthcare procedures. Inpatients, home care patients, and other patients receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into the vascular system. Infusion therapy could be used to treat infection, provide anesthesia or analgesia, provide nutritional support, treat cancerous developments, maintain blood pressure and heart rate, or many other clinically significant uses.

Infusion therapy is facilitated by a vascular access device. The vascular access device could access a peripheral or central vasculature of the patient. The vascular access device could remain for a short term (days) a moderate term (weeks) or a long term (months or years). The vascular access device could be used for continuous infusion therapy or for intermittent therapy.

A common vascular access device is a plastic catheter that is inserted into a patient's vein. The length of the catheter could range from a few centimeters for peripheral access to many centimeters for central access. The catheter could be inserted transcutaneously or it could be surgically implanted under the patient's skin. The catheter, or any other vascular access device attached to it, could have a single lumen or multiple lumens for the infusion of many fluids simultaneously.

The vascular access device commonly includes a Luer adapter to which other medical devices could be attached. For example, an administration set could be attached to a vascular access device at one end and an intravenous bag (hereinafter IV) at the other end. The administration set is a fluid passageway for continuous infusion of fluids and pharmaceuticals. Commonly, an IV access device is a vascular access device that could be attached to another vascular access device, closes the vascular access device, and allows intermittent infusion or injection of fluids and pharmaceuticals. An IV access device could include a housing and a septum (or septum) to close the system. The septum could be opened with a blunt cannula or a male Luer from a medical device.

When the septum of a vascular access device stops working properly, certain complications can occur. Complications associated with infusion therapy could cause morbidity and even mortality. A significant complication is infection of the bloodstream in association with the catheter (hereinafter CRBSI). An estimate of 250,000-400,000 cases of central venous catheter (hereinafter CVC) in association with bloodstream infection (hereinafter BSI) occur annually in US hospitals: attributable mortality is an estimated percentage of the 12% to 25% for each infection and a cost to the healthcare system of $ 25,000 (€ 18,750) to $ 56,000 (€ 42,000) per episode.

Vascular access devices prevent complications, such as infection resulting from CRBSI, by providing a properly functioning septum during fixation and / or access of the vascular access device by other medical devices. Properly functioning septa will act, in part, as barriers against infection between the internal and external environments of the vascular access device during fixation and / or access by other medical devices. By functioning adequately as barriers against infection, the septa minimize CRBSI and other complications.

In order to function properly, a septum needs to open and close during use without difficulty. Often times, a gas chamber adjacent to a septum must be vented to allow the gas to transfer to an external environment when the septum is activated for use. If the gas chambers in the vicinity are not ventilated, a septum would be unable to open without exerting a significant force. Once opened, the septum will be reluctant to close as the neighboring gas chambers remain compressed under vacuum pressure. Therefore, what is needed are various septum vent structures and methods capable of maximizing the proper functionality of the septum.

From WO 97/21464 a medical device is known comprising a vascular access device within an external environment. The vascular access device includes a septum partially housed within a body. Additionally, a gas chamber housed between a body and a septum is described as well as a ventilation system adjacent to the body.

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BRIEF COMPENDIUM OF THE INVENTION

The present invention is defined in claims 1 and 7. It has been developed in response to problems and needs that arise in the art that have not been fully addressed by currently available vascular access systems, devices, and methods. Therefore, these systems, devices and methods have been developed to reduce complications, such as the risk and occurrence of CRBSi, between the gas chamber and the external environment.

A medical device includes a vascular access device placed within an external environment. The vascular access device includes a body, a septum housed at least partially within the body, a gas chamber housed between the body and the septum, and a ventilation system adjacent to the body. gas chamber and external environment.

The ventilation system is formed within at least part of the septum. For example, the septum could include a bottom disc and the ventilation system could be a channel formed within the upper surface of the bottom disc of the septum. As another example, the septum could include an upper disc, and the ventilation system could be a channel formed through the upper disc of the septum. Alternatively, the ventilation system could be a channel formed in the bottom surface of the upper disc of the septum.

The ventilation system could also be a non-compressible gas channel that is located between the septum and the body. The non-compressible gas channel could include a porous material. The vent system could also be a low pressure gas valve adjacent to the body, furthermore, the body could be a frame, and the vent valve could transfer gas between the frame members and the external environment.

Furthermore, the septum of the medical device has a slit, in addition to the ventilation system.

One method of ventilating a gas chamber within a medical device includes providing a vascular access device in an external environment, providing a ventilation system adjacent to the body of the vascular access device, transferring gas between a gas chamber housed within the body. device and the external environment through the ventilation system. The device also includes a septum housed within the body, and the gas chamber is housed between the body and the septum.

The ventilation system is formed within at least a part of the septum, and the septum has a slit. For example, the septum could include a bottom disc, and the venting system could be a channel formed within the upper surface of the bottom disc, and the method could also include transferring gas through the septum channel. As another example, the septum could include an upper disc and the ventilation system could be a channel formed through the upper disc of the septum, and the method could include transferring gas through the septum. As yet another example, the septum could include an upper disc and the ventilation system could be a channel formed on the upper surface of the upper disc of the septum, and the method could include transferring gas through the septum channel.

The ventilation system could also be a non-compressible gas channel located between the septum and the body. The ventilation system could also be a low pressure gas valve adjacent to the body. The body could also be a frame that includes multiple windows between the gas chamber housed within the body and the external environment.

The foregoing and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more apparent from the following description and appended claims, or may be learned by practice of the invention that is hereinafter specified.

BRIEF DESCRIPTION OF THE VARIOUS VIEWS OF THE DRAWINGS

In order that the manner in which the above-specified and other characteristics and advantages of the invention have been obtained may be easily understood, a more particular description of the invention is set forth below by reference to specific embodiments thereof which have been illustrated. in the drawings attached as an appendix.

Figure 1 is a perspective view of an extravascular system connected to the vascular system of a patient.

Figure 2 is a cross-sectional view of a vascular access device having at least one ventilation system.

Figure 3 is a complete cross-sectional view of the vascular access device taken along lines A-A of Figure 2.

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Figure 4 is a complete cross-sectional view of the vascular access device taken along lines BB of Figure 2.

Figure 5 is a detailed, partial cross-sectional view of a vascular access device having a ventilation system within a septum.

Figure 6 is a detailed, partial, cross-sectional view of a vascular access device having a non-compressible gas channel.

Figure 7 is a partial cross-sectional view of the non-compressible gas channel taken along lines AA of Figure 6.

Figure 8 is a cross-sectional view of a vascular access device with a gas valve.

Figure 8A is a cross-sectional view of the gas valve of Figure 8.

Figure 8B is a cross-sectional view of the gas valve of Figure 8.

Figure 8C is a cross-sectional view of the gas valve of Figure 8.

Figure 9 is a cross-sectional view of a vascular access device with a frame body.

DETAILED DESCRIPTION OF THE INVENTION

Currently preferred embodiments of the present invention will be better understood by reference to the drawings, in which like reference numerals indicate identical or functionally similar elements.

Referring now to Figure 1, a vascular access device 10 (also referred to as an extravascular device, an intravenous access device, an access port, and / or any device attached to - or that operates with - a extravascular system), is used to introduce a substance through a catheter 12 through the skin 14 and into a blood vessel 16 of a patient 18. The vascular access device 10 includes a body 20 with a lumen and a septum 22 positioned within the lumen. The septum 22 has a slit 24 through which a separate extravascular device 26, such as a syringe, could introduce a substance into the vascular access device 10.

Device 10 and all structures used in combination with it can form a larger extravascular system 28. As part of system 28, a tip 30 of separate system 26 could be inserted into device 10 through the slit in septum 22. Tip 30 serves to communicate fluid through device 10 and end 32 of catheter 12 when the device 10 is in use. . In one embodiment of the invention, when tip 30 penetrates device 10, the two opposing surfaces of groove 24 separate in opposite lateral directions and stretch the surfaces of groove 24 in an axial direction thereby increasing the overall height of the septum 22. In this particular embodiment, as the height of septum 22 has increased, the seal between device 10 and tip 30 becomes more effective.

Referring now to Figure 2, a vascular access device 10 is used within an external environment and includes a body 20 and a septum 22 at least partially housed within the body 20. A gas chamber 34 is also housed within the body 20 , between body 20 and septum 22. At least one vent system is adjacent to body 20, and the at least one vent system facilitates gas transfer between gas chamber 34 and the external environment 36 of device 10.

The ventilation system has been formed within at least a portion of the septum 22. The ventilation system could be formed at any point and along any part of the septum 22. For example, the septum 22 includes a bottom disc 38, and the ventilation system is a channel 40 formed between the upper and outer surfaces of bottom disc 38 of septum 22. As another example, the septum 22 includes an upper disc 42, and the ventilation system is a channel 44 formed through the upper disc 42 of the septum 22. As a third example, the ventilation system is a channel 46 formed on the surface. bottom of upper disk 42 of septum 22. Any number of vents, channels, grooves, or other structures capable of transferring gas or facilitating gas transfer between gas chamber 34 and external environment 36 through septum 22 are within the scope of the described embodiments. with reference to figure 2.

Referring now to Figure 3, a complete cross-sectional view taken along lines AA of septum 22 shows upper disk 42. As shown in Figure 3, channels 44 and 46 are capable of transferring gas between the gas chamber 34 and external environment 36 of device 10 through septum 22.

Referring now to Figure 4, a complete cross-sectional view taken along lines BB of septum 22 shows bottom disc 38. As shown in Figure 4, the upper surface of bottom disc 38 of septum 22 includes at least one channel 40 capable of facilitating gas transfer between gas chamber 34 and external environment 36 through septum 22.

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When the septum 22 of the embodiments described with reference to Figures 2 to 4 is activated, the gas could be transferred between the gas chamber 34 and the external environment through any chamber or ventilation system. For example, when the tip 30 of a separate access device is inserted into the groove 24 of the septum 22, the two opposing surfaces 48 of the groove 24 will separate in two opposite directions toward the body 20 of the device 10, causing a or more gas chambers 34 decrease in size. As the gas chamber 34 decreases in size, the gas will be transferred through a ventilation system to the external environment 36. When the tip 30 is removed from the groove 24, the elastic properties of the septum 22 will cause the two opposite surfaces 48 of the groove 24 to return to their original position. Resulting in at least one gas chamber 34 increasing in size and volume to its original level, When the volume of chamber 34 returns to its original level, the gas will travel from the external environment through a ventilation system or a channel into gas chamber 34, thereby preventing any vacuum within gas chamber 34 from preventing or inhibiting the two opposing surfaces 48 of slit 24 from returning to their original closed position. Any ventilation system or gas chamber within the septum 22 of the device 10 described with reference to Figures 2 to 4 could be realized by means of any part of the septum 22, such as the bottom disc 38, directly to the external environment 36 as described with reference to Figure 5.

Referring now to Figure 5, a detailed view of a vascular access device includes a view of the bottom disc 38 of a septum 22. The bottom disc 38 extends its arm 50 from inside the body 20 of the device 10 to the environment. external 36 that surrounds the device 10. The septum 22 is formed of an elastomeric and elastic material and is housed between parts of the body 20 where the arm 50 approaches the external environment 36. A gas chamber 34 housed between septum 22 and body 20 communicates with the external environment 36 in a manner that facilitates gas transfer through a continuous channel or vent system 52 formed within the upper surface of bottom disc 38 . The ventilation system or continuous channel 52 provides a continuous supply of air from the gas chamber 34 to the external environment 36 during the use of the device 10, thereby, in a manner similar to the embodiments described with reference to FIGS. 2 through 4, the embodiment described with reference to Figure 5 enables and facilitates gas transfer between gas chamber 34 and external environment 36 during activation of septum 22.

Referring now to FIG. 6, a detailed partial cross-sectional view of a vascular access device 10 includes a non-compressible gas channel 54 housed or otherwise positioned between the bottom disc 38 of the septum 22 and the body 20 of the device. 10. The non-compressible gas channel 54 could be formed of any material that is non-deformable and incompressible and capable of transferring gas from its porous structure or material The non-compressible gas channel 54 could be located between any point between any part of the septum 22 and the body 20 in order to provide a gas transfer path from gas chamber 34 and any other chamber within device 10 and / or external environment 36..

Referring now to Figure 7, a partial cross-sectional view of a portion of device 10 taken along lines BB shows the non-compressible gas channel 54. As shown in Figure 7, the non-compressible gas channel 54 is located between the septum 22 and the rigid housing of the body 20. The non-compressible gas channel 54 could extend to the external environment 36 as shown, for example, by the arm 50 of FIG. 5.

Referring now to Figure 8, a vascular access device 10 may include a low pressure gas valve 56 located adjacent to the body 20 of the device 10. The low pressure bi-directional gas valve 56 remains closed when the device is not in use. 10, not leaving an open channel for gas transfer between the gas chamber 34 of the device 10 and the external environment 36. When device 10 is used and septum 22 is activated, gas valve 56 opens allowing gas to escape from gas chamber 54 to the external environment 36. When septum 22 returns to its original position after activation, for example, upon removal of tip 30 from a separate access device 26, gas directional valve 56 will allow gas to enter gas chamber 34 from external environment 36. Gas valve 56 remains closed between ports of device 10 as shown in Figure 8A. Gas valve 56 allows gas to escape from chamber 34 during insertion of a device into septum 22 as shown in Figure 8B. And, gas valve 56 allows gas to enter gas chamber 34 upon removal of a device that accesses septum 22 as shown in Figure 8C.

Referring now to Figure 9, a vascular access device 10 includes a body 20 which is a frame that provides the structure with only the support necessary to provide adequate functionality to septum 22 and adequate fixation to a separate access device 26 by means of threads 58 that are fixed to the frame of the body 20. Thus, large windows 60 appear in the body frame 20 where the gas chamber 34 would normally have appeared in the embodiments described above. Thus, the windows 60 function as vents that transfer gas between the frame members of the body 20, providing means by which gas can be exchanged between any internal gas chamber and the external environment 36.

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The present invention could be carried out in other specific ways without departing from the structures, methods, or other essential features as widely described herein and claimed hereinafter. The described embodiments are to be considered in all respects illustrative, not restrictive. Accordingly, the scope of the invention is indicated by the appended claims, rather than by the foregoing description.