Needleless vial access device

Claim 2

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region and terminating with a luer flange for connection to an engaging structure, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region, an aperture at the outermost end of the cannula and in fluid communication with the internal flow channel, a piercing member in communication with the flow channel and, means for providing an interference fit between the piercing member and the cannula.

Claim 3

The cannula assembly of claim 1 wherein the piercing member comprises a tip having a spike point, a body portion and a base.

Claim 4

The cannula assembly of claim 1 wherein the piercing member comprises a tip having a spike point, a body portion, a base and at least one channel longitudinally through the body portion.

Claim 5

The cannula assembly of claim 1 wherein the piercing member comprises a tip having a spike point, a body portion, a base and at least one channel longitudinally along the body portion.

Claim 6

The cannula assembly of claim 1 wherein the means for retention comprises a friction fit between the piercing member and the blunt distal end of the blunt cannula.

Claim 7

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region and terminating with a luer flange for connection to a mating structure, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region, an aperture at the outermost end of the cannula and in fluid communication with the internal flow channel; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 8

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region and terminating with a luer flange for connection to a mating structure, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region, an aperture at the outermost end of the cannula and in fluid communication with the internal flow channel; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 9

The cannula assembly of claim 6 wherein the body of the tip comprises a generally conical shape.

Claim 10

The cannula assembly of claim 6 wherein the tip comprises a generally solid conical shape with at least one cutout.

Claim 11

The cannula assembly of claim 6 wherein the shaft includes an alignment means having a squared portion integral with the tip which includes a series of corners opposing the tip which initiate a transition region forming a generally cylindrical extension.

Claim 12

The cannula assembly of claim 6 wherein the shaft includes an alignment means having a thickened neck portion integral with the base of the tip.

Claim 13

The cannula assembly of claim 6 wherein the shaft includes an outer diameter less than the inner diameter of the flow channel so that a void is created between the shaft and the cannula permitting fluid or air flow through the flow channel.

Claim 14

The cannula assembly of claim 6 wherein the shaft includes a thickened neck portion integrally connected to the base of the tip so that a void is created between the shaft and the cannula permitting fluid or air flow through the flow channel.

Claim 15

The cannula assembly of claim 6 wherein the means for retention comprises a tapered surface of a terminal end of the shaft opposing the integral connection with the base and a detent integral with terminal end and opposing the tapered surface.

Claim 16

A cannula assembly adapted to pierce a solid closure or stopper having a blunt cannula with a blunt distal end, a proximal end and a mid-region connecting the distal and proximal ends with a stepped wall segregating the mid-region and proximal end, an interior region throughout the mid-region and terminating at each end defining a flow channel and a piercing member slidably cooperating with the flow channel, the piercing member comprising: a tip having a spike point, a generally conically shaped body and a base with at least one cutout through the body and base, a shaft having a squared portion integral with and extending from the base of the tip, terminating in a series of corners, a transition region tapering from the corners into a generally cylindrical extension to a proximal end and, means for providing an interference fit between the piercing member and the cannula.

Claim 17

A cannula assembly adapted to pierce a solid closure or stopper having a blunt cannula with a blunt distal end, a proximal end and a mid-region connecting the distal and proximal ends with a stepped wall segregating the mid-region and proximal end, an interior region throughout the mid-region and terminating at each end defining a flow channel and a piercing member slidably cooperating with the flow channel, the piercing member comprising: a tip having a spike point, a generally conically shaped body and a base with at least one cutout through the body and base, a shaft having a squared portion integral with and extending from the base of the tip, terminating in a series of corners, a transition region tapering from the corners into a generally cylindrical extension to a proximal end and, means for providing an interference fit between the piercing member and the cannula.

Claim 18

The piercing member of claim 14 wherein the piercing member cooperates with the flow channel by the shaft being slidably received within the flow channel so that the shaft extends into the proximal end of the cannula and the corners contact the distal end of the cannula.

Claim 19

The piercing member of claim 14 wherein the piercing member cooperates with the flow channel by the shaft being received within the flow channel so that the corners contact the distal end of the cannula.

Claim 20

The piercing member of claim 14 wherein the piercing member cooperates with the flow channel by the shaft being slidably received within the flow channel, thereby creating a void between the shaft and the interior surfaces of the distal end and mid-region of the cannula.

Claim 21

The piercing member of claim 14 wherein the means comprises a detent integral with the proximal end of the piercing member.

Claim 22

The piercing member of claim 14 wherein the means comprises a detent integral with the proximal end of the piercing member so that upon cooperation of the piercing member and the flow channel the detent is positioned against the stepped wall thereby preventing inadvertent disengagement of the piercing member and the cannula.

Claim 25

The method of claim 20 including the step of drawing a volume of air into the receiver after connecting the cannula assembly to the receiver without dislodging the assembly from the receiver.

Claim 26

The method of claim 20 including the step of expelling a volume of air from the receiver into the drug vial after insertion of the cannula assembly through the stopper without dislodging the assembly from the receiver.

Claim 27

The method of claim 20 wherein the disengaging piercing member remains contained in the drug vial.

Claim 28

The method of claim 20 wherein the disengaged piercing member is imbedded in the stopper.

Claim 29

A cannula assembly adapted to pierce a solid closure comprising: a blunt cannula having a proximal end and a distal end, an interior and exterior surface, an aperture at the distal end, and a central channel through the cannula in fluid communication with the aperture, the cannula has a generally cylindrical mid-region, the exterior surface of the cannula tapers inwardly from the mid-region of the cannula toward the aperture; a piercing member having opposed first and second ends, the first end extends through the aperture inside the central channel to define a void to allow for the flow of liquid or air, the second end of the piercing member being adjacent the cannula distal end; and, means for providing an interference fit between the piercing member and the cannula.

Claim 30

A cannula assembly adapted to pierce a solid closure comprising: a blunt cannula having a proximal end and a distal end, an interior and exterior surface, an aperture at the distal end, and a central channel through the cannula in fluid communication with the aperture, the cannula has a generally cylindrical mid-region, the exterior surface of the cannula tapers inwardly from the mid-region of the cannula toward the aperture; a piercing member having opposed first and second ends, the first end extends through the aperture inside the central channel to define a void to allow for the flow of liquid or air, the second end of the piercing member being adjacent the cannula distal end; and, means for providing an interference fit between the piercing member and the cannula.

Claim 31

The cannula assembly of claim 25 wherein the means for attaching the piercing member to the cannula includes: means at the first end of the piercing member for applying a first force against the cannula to prevent movement of the piercing member away from the cannula; and, means at the second end of the piercing member adapted for applying a second force greater than the first force against the closure to prevent retrograde motion of the piercing member toward the cannula.

Claim 32

The assembly of claim 26 wherein the piercing member first end extends inside the cannula channel and attaches to the interior surface of the cannula.

Claim 33

The assembly of claim 27 wherein the means for applying the first force is a detent at the first piercing member end.

Claim 34

The assembly of claim 28 wherein the detent has a trapezoidal shape having a flat apex and two opposed downwardly and outwardly sloping legs.

Claim 35

The assembly of claim 26 wherein the piercing member has an elongate shaft having first and second opposed ends, wherein the means for applying the second force includes an enlarged tip at the second shaft end.

Claim 36

The assembly of claim 30 wherein the tip is generally conically shaped.

Claim 37

The assembly of claim 31 wherein the tip has a portion removed to define a cut-out.

Claim 38

The assembly of claim 30 wherein an intermediate portion of the shaft has a square shaped cross section.

Claim 39

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having a squared portion integral with the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 40

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having a squared portion integral with the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 41

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having a thickened neck portion integral with the base of the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 42

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having a thickened neck portion integral with the base of the tip; and, means for providing an interference fit between the piercing member and the cannula.

Claim 43

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, the piercing member having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having an outer diameter less than an inner diameter of the flow channel to define a void between the shaft and the channel to permit the flow of fluid or air through the void in the flow channel; and, means for providing an interference fit between the piercing member and the cannula.

Claim 44

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal end with an interior region, a generally cylindrical mid-region extending from the proximal end, an end region extending from the mid-region terminating in a blunt distal end and having a tapered outer surface, an internal flow channel extending through the end region and mid-region to communicate with the interior region of the proximal end region; a piercing member slidably cooperating with the flow channel, the piercing member having a tip having a spike point, a body portion and a base, a shaft integral with and extending from the base of the tip, the shaft having an outer diameter less than an inner diameter of the flow channel to define a void between the shaft and the channel to permit the flow of fluid or air through the void in the flow channel; and, means for providing an interference fit between the piercing member and the cannula.

Claim 45

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal and distal end, a flow channel extending therewithin, and an aperture in fluid communication with the flow channel; a piercing member having a tip and a shaft extending from the tip, the shaft extends inside the flow channel to define a void to allow for the passage of fluid or air through the flow channel; and, means for providing an interference fit between the piercing member and the cannula.

Claim 46

A cannula assembly adapted to pierce a solid closure or stopper comprising: a blunt cannula having a proximal and distal end, a flow channel extending therewithin, and an aperture in fluid communication with the flow channel; a piercing member having a tip and a shaft extending from the tip, the shaft extends inside the flow channel to define a void to allow for the passage of fluid or air through the flow channel; and, means for providing an interference fit between the piercing member and the cannula.