Pressure equalizing device for vial access
First Claim
1. A pressure-equalizing vial access device for retaining aerosols when accessing a vial having a pierceable seal located over an opening of the vial, the vial access device comprising:
- a cannula having a medicament lumen and a vent lumen separate from the medicament lumen, the cannula having a relatively sharp tip to pierce the seal of the vial and a length selected so that the tip can be located within the vial;
a body portion having;
a medicament port in fluid communication with the medicament lumen of the cannula, the medicament port configured to receive a connector from a second container to allow liquid to be introduced into and removed from the vial; and
a vent port in fluid communication with the vent lumen of the cannula, the vent port being separate from the medicament port and configured to allow passage of fluid to and from the vent lumen; and
a rigid chamber located in fluid communication with the vent port and the vent lumen without being in fluid communication with the medicament port or medicament lumen, the rigid chamber having a pressure relief port open to atmosphere and an equalizing port connecting to the vent port and vent lumen, the rigid chamber having rigid walls and a fixed internal volume, the rigid chamber comprising;
a filter disposed at the equalizing port of the rigid chamber so that any fluid passing between the rigid chamber and the vent port must pass through the filter; and
a volume control device located within and entirely confined by the rigid chamber providing a sealed barrier between the equalizing port and the pressure relief port and freely movable between the equalizing port and the pressure relief port to vary the internal volume of the rigid chamber available to the equalizing port in response to pressure changes occurring in the vent lumen;
whereby increases in pressure in the vial resulting from the introduction of liquid for reconstitution of vial contents are equalized by the volume control device moving away from the equalizing port to create a greater volume in the vent lumen/rigid chamber combination and decreases in pressure in the vial resulting from aspiration of reconstituted liquid from the vial contents are equalized by the volume control device moving toward the equalizing port to create a lesser volume in the vent lumen/rigid chamber combination.
3 Assignments
0 Petitions
Accused Products
Abstract
A pressure-equalizing vial access device and method providing closed and sealed reconstitution of vial contents. A rigid container with a fixed internal volume is connected with a vent lumen extending into the vial. As pressure in the vial increases, the pressure is equalized with atmospheric pressure by varying the volume of a compartment within the rigid container. The compartment is formed with a volume control device that automatically varies the volume of the compartment in the rigid container to accommodate and equalize the pressure in the vial by increasing or decreasing the volume of the compartment. In one case the volume control device comprises a sliding disk and in another, a bladder that compresses with an increase in volume in the container and expands with a decrease.
197 Citations
29 Claims
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1. A pressure-equalizing vial access device for retaining aerosols when accessing a vial having a pierceable seal located over an opening of the vial, the vial access device comprising:
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a cannula having a medicament lumen and a vent lumen separate from the medicament lumen, the cannula having a relatively sharp tip to pierce the seal of the vial and a length selected so that the tip can be located within the vial; a body portion having; a medicament port in fluid communication with the medicament lumen of the cannula, the medicament port configured to receive a connector from a second container to allow liquid to be introduced into and removed from the vial; and a vent port in fluid communication with the vent lumen of the cannula, the vent port being separate from the medicament port and configured to allow passage of fluid to and from the vent lumen; and a rigid chamber located in fluid communication with the vent port and the vent lumen without being in fluid communication with the medicament port or medicament lumen, the rigid chamber having a pressure relief port open to atmosphere and an equalizing port connecting to the vent port and vent lumen, the rigid chamber having rigid walls and a fixed internal volume, the rigid chamber comprising; a filter disposed at the equalizing port of the rigid chamber so that any fluid passing between the rigid chamber and the vent port must pass through the filter; and a volume control device located within and entirely confined by the rigid chamber providing a sealed barrier between the equalizing port and the pressure relief port and freely movable between the equalizing port and the pressure relief port to vary the internal volume of the rigid chamber available to the equalizing port in response to pressure changes occurring in the vent lumen; whereby increases in pressure in the vial resulting from the introduction of liquid for reconstitution of vial contents are equalized by the volume control device moving away from the equalizing port to create a greater volume in the vent lumen/rigid chamber combination and decreases in pressure in the vial resulting from aspiration of reconstituted liquid from the vial contents are equalized by the volume control device moving toward the equalizing port to create a lesser volume in the vent lumen/rigid chamber combination. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A pressure-equalizing vial access device for retaining aerosols when accessing a vial having a pierceable seal located over an opening of the vial and a vial volume, the vial access device comprising:
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a flexible attachment device configured to engage the vial for secure mounting of the vial access device to the vial; a cannula on the attachment device, the cannula having a sharpened tip configured to pierce the seal of the vial, a vent opening adjacent the sharpened tip, and a medicament opening, the vent opening leading to a vent lumen extending through the cannula, the medicament opening leading to a medicament lumen extending through the cannula; a body portion having; a medicament port in fluid communication with the medicament lumen of the cannula, the medicament port configured to receive a connector from a second container to allow liquid to be introduced into and removed from the vial; and a vent port in fluid communication with the vent lumen of the cannula, the vent port being separate from the medicament port and configured to allow passage of gas to and from the vial; and a rigid chamber located in fluid communication with the vent port without being in fluid communication with the medicament port or medicament lumen, the rigid chamber having a pressure relief port open to atmosphere and an equalizing port connecting to the vent port, the rigid chamber having rigid walls with a fixed internal volume, that internal volume being at least as great as the vial volume, the rigid chamber comprising; a hydrophobic filter disposed at the equalizing port of the rigid chamber so that any fluid passing between the rigid chamber and the vent port must pass through the hydrophobic filter; and a freely-movable volume control device located within and entirely confined by the rigid chamber providing a sealed barrier between the equalizing port and the pressure relief port and freely movable within the rigid chamber to vary the volume within the rigid chamber between the equalizing port and the volume control device in response to pressure changes occurring at the equalizing port; whereby increases in pressure in the vial resulting from the introduction of liquid for reconstitution of vial contents are equalized by the volume control device moving away from the equalizing port to create a greater volume in the vent lumen/rigid chamber combination and decreases in pressure in the vial resulting from aspiration of reconstituted liquid from the vial contents are equalized by the volume control device moving toward the equalizing port to create a lesser volume in the vent lumen/rigid chamber combination. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method for retaining aerosols when accessing a vial having a pierceable seal located over an opening of the vial, the method comprising:
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piercing the vial seal to establish fluid communication with vial contents; conducting liquid into the vial through a medicament lumen; when pressure in the vial increases above atmospheric pressure, conducting gas out of the vial through a vent lumen which is separate from the medicament lumen; filtering the gas conducted out of the vial; confining the filtered gas conducted out of the vial in a sealed container having rigid walls and a fixed volume; dividing the sealed container into two compartments; varying the volume of a first compartment of the sealed container to receive the filtered gas conducted out of the vial and equalize the received filtered gas to atmospheric pressure thereby equalizing the pressure in the vial to atmospheric pressure;
returning the received filtered gas to the vial when pressure in the vial decreases below atmospheric pressure thereby equalizing the pressure in the vial to atmospheric pressure;
whereby increases in pressure in the vial resulting from the introduction of liquid for reconstitution of vial contents are equalized by increasing the volume in the first compartment of the rigid chamber combination and decreases in pressure in the vial resulting from aspiration of reconstituted liquid from the vial contents are equalized by decreasing the volume of the first compartment;
wherein the step of varying the volume of the first compartment comprises automatically moving a sealed barrier located within the rigid container in response to pressure changes in the vial to vary the volume of the first compartment;
wherein the step of moving a sealed barrier further comprises automatically moving a freely-movable sliding disk within the rigid container in response to pressure changes in the vial to vary the volume of the first compartment, the sliding disk sealing the first compartment from the atmosphere. - View Dependent Claims (25, 27, 28, 29)
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26. A method for retaining aerosols when accessing a vial having a pierceable seal located over an opening of the vial, the method comprising:
- piercing the vial seal to establish fluid communication with vial contents;
conducting liquid into the vial through a medicament lumen;
when pressure in the vial increases above atmospheric pressure, conducting gas out of the vial through a vent lumen which is separate from the medicament lumen;
filtering the gas conducted out of the vial;
confining the filtered gas conducted out of the vial in a sealed container having rigid walls and a fixed volume;
dividing the sealed container into two compartments;
varying the volume of a first compartment of the sealed container to receive the filtered gas conducted out of the vial and equalize the received filtered gas to atmospheric pressure thereby equalizing the pressure in the vial to atmospheric pressure;
returning the received filtered gas to the vial when pressure in the vial decreases below atmospheric pressure thereby equalizing the pressure in the vial to atmospheric pressure;
whereby increases in pressure in the vial resulting from the introduction of liquid for reconstitution of vial contents are equalized by increasing the volume in the first compartment of the rigid chamber combination and decreases in pressure in the vial resulting from aspiration of reconstituted liquid from the vial contents are equalized by decreasing the volume of the first compartment;
wherein the step of varying the volume of the first compartment comprises automatically moving a sealed barrier located within the rigid container in response to pressure changes in the vial to vary the volume of the first compartment;
wherein the step of moving a sealed barrier further comprises automatically moving a freely-movable flexible bladder within the rigid container in response to pressure changes in the vial to vary the volume of the first compartment, the flexible bladder sealing the first compartment from the atmosphere;
wherein the step of varying the volume further comprises mounting the flexible bladder within the rigid-walled container such that the bladder compressed to receive gas from the vial and expands to provide gas to the vial, the bladder contained within the rigid container such that the bladder in its expanded and compressed states is contained entirely within the rigid container.
- piercing the vial seal to establish fluid communication with vial contents;
Specification