Kit including side firing syringe needle for preparing a drug in an injection pen cartridge

• US 7,195,623 B2
• Filed: 03/21/2002
• Issued: 03/27/2007
• Est. Priority Date: 03/27/2001
• Status: Expired due to Term

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Chang, Shu Kun, Burroughs, Andrew Christopher, Fisher, Mark James, Rush, Benjamin L, Thorne, Richard Charles
• Primary Examiner(s): Bianco; Patricia
• Assistant Examiner(s): Deak; Leslie R.
• Application Number:
  US10/473,285
• Publication Number:
  US 20040116892A1
• Time in Patent Office: 1,832 Days
• Field of Search: 604/403, 604/411, 604/415, 604/416, 604/187, 604 86- 88, 604/200, 604/201, 604/203, 604/218, 604/232, 604/181
• US Class Current: 604/411
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61M 2039/042 Shrouds encircling the access needle preventing accidental needle-stick
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003

Abstract

A kit and needle assembly for reconstituting a quantity of a lyophilized pharmaceutical. The kit of the invention may include a reconstituting appliance having a non-transparent needle covering portion with a hollow adapted to receive the inserted stoppered end of the injection pen cartridge, which needle covering portion extends around a side-firing cannula to hide the cannula from side view. A shiftable alignment member retained within the needle covering portion at a first axial position, and shiftable to a second axial position when abutted by the injection pen cartridge during its insertion, may be included. The kit includes an injection pen cartridge including a barrel filled with a quantity of a lyophilized drug, a slidable plunger used during pen operation to eject the reconstituted drug, and a stopper penetrable by the cannula during drug reconstituting. The needle assembly of the invention may include a cannula defining an axial passage therethrough in communication with a reservoir of diluent fluid. The distal end of the cannula terminates in a closed piercing tip, and is provided with a side port, in communication with the axial passage, which is configured to direct fluid passing through it in a direction diverging from the axis of the cannula. A collar fixedly mounted around a portion of the cannula defines an axial venting passageway therebetween, and the collar has a piercing distal end. A method for reconstituting a quantity of a lyophilized drug in an injection pen cartridge is also disclosed.

Claims

1. A kit for reconstituting a quantity of a lyophilized drug in a cartridge to be used in an injection pen, comprising:

a) an injection pen cartridge including;

i) a barrel with at least one interior wall defining an internal reservoir partially filled with a quantity of a lyophilized drug and having an open proximal end and an open distal end;

ii) a needle-penetrable stopper in sealed engagement with said proximal end of said barrel and having a stopper height;

iii) a plunger slidably disposed within said distal end of said barrel and in sealed engagement with the interior wall of said barrel; and

b) a reconstituting appliance including;

i) a syringe body with at least one interior wall defining a fluid reservoir containing a diluent fluid and having an open proximal end and an open distal end;

ii) a plunger slidably disposed within said proximal end of said syringe body and in sealed engagement with the interior wall of said syringe body;

iii) an actuating member extending from said plunger beyond said proximal end of said syringe body and manually shiftable to effect movement of said plunger to force diluent fluid from said fluid reservoir through said open distal end of said syringe body;

iv) a cannula defining an axial passage therethrough and having a proximal end and a closed distal end, said cannula proximal end in communication with the fluid reservoir through said open distal end of said syringe body, wherein said cannula has a length greater than said stopper height and wherein the distal end of said cannula terminates in a piercing tip;

v) the distal end of said cannula defining a side port in communication with the axial passage, the side port being configured to direct fluid passing therethrough toward the interior wall of said barrel of said cartridge at an angle diverging from the axial direction of said cannula;

vi) a housing having a needle covering portion extending around said cannula, said needle covering portion including a distal end having an opening in communication with an interior hollow of said needle covering portion which is structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when inserted proximally within said opening, wherein said distal end of said needle covering portion is positioned distally of said cannula distal end;

vii) a cartridge alignment member retained within said needle covering portion at a first axial position and defining an interior hollow structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when said cartridge is proximally inserted through said opening of said needle covering portion distal end, said cartridge alignment member adapted to be abutted by said injection pen cartridge during proximal insertion of said cartridge and axially shifted relative to said needle covering portion to a second axial position at which said cannula extends through said stopper of said injection pen cartridge for drug reconstituting, wherein said cartridge alignment member comprises a tubular base portion with a stepped-down neck portion, wherein said neck portion fits within a tubular section of said needle covering portion in which fits the distal end of said syringe body, and wherein an intersection of said base portion and said neck portion defines an annular shoulder that directly abuts said tubular section when said cartridge alignment member is disposed in said second axial position; and

viii) wherein said cannula distal end is hidden from side view by at least one of said needle covering portion and said cartridge alignment member as said cannula is introduced through said stopper of said injection pen cartridge.

2. The kit of claim 1 wherein said cartridge alignment member is retained within said needle covering portion at said first axial position by at least one projection from said tubular section of said needle covering portion that fits within a recess defined by axially spaced projecting portions of said stepped-down neck portion.

3. A method for reconstituting a quantity of a lyophilized drug in an injection pen cartridge, comprising the steps of:

a) providing an injection pen cartridge including a cartridge reservoir partially filled with a quantity of a lyophilized drug, wherein said cartridge is sealed with a needle penetrable stopper at one end and sealed with a plunger at the opposing end;

b) providing a reconstituting appliance which holds a quantity of diluent fluid and includes a needle and a housing, wherein said housing hides said needle from lateral view and defines an interior hollow around the needle which is shaped to accommodate said cartridge end with the stopper, and providing an alignment collar within said housing interior hollow which is axially shiftable from a first position to a second position by contact with said cartridge during insertion of said cartridge end with the stopper into said housing interior hollow to indicate a completed insertion to a user;

c) inserting said cartridge end with the stopper into said housing interior hollow such that said needle penetrates said stopper, wherein said needle terminates in a distal end within said cartridge reservoir;

d) laterally injecting said quantity of diluent fluid through a side port in the distal end of said needle into said cartridge reservoir above the level of said lyophilized drug; and

e) after fluid injection, withdrawing said cartridge end with the stopper from said housing interior hollow, whereby said needle is removed from said stopper.

4. The method of claim 3 further comprising providing a venting collar mounted around said needle and which, during said cartridge end insertion step, penetrates said stopper so as to extend therethrough, and further comprising the step of releasing gas pressure from said cartridge reservoir during said fluid injection through a passage between said venting collar and said needle, wherein said passage extends from said cartridge reservoir past said stopper.

5. The method of claim 4 wherein said needle and said venting collar penetrate said stopper at an angle substantially perpendicular to said stopper.

6. The method of claim 3 and further comprising the steps of:

a) loading said cartridge into an injector pen;

b) selecting a dosage; and

c) injecting the selected dosage of the reconstituted drug into a person who needs a dosage of the drug.

7. A kit for reconstituting a quantity of a lyophilized drug in a cartridge to be used in an injection pen, comprising:

a) an injection pen cartridge including;

i) a barrel with at least one interior wall defining an internal reservoir partially filled with a quantity of a lyophilized drug and having an open proximal end and an open distal end;

ii) a needle-penetrable stopper in sealed engagement with said proximal end of said barrel and having a stopper height;

iii) a plunger slidably disposed within said distal end of said barrel and in sealed engagement with the interior wall of said barrel; and

b) a reconstituting appliance including;

i) a syringe body with at least one interior wall defining a fluid reservoir containing a diluent fluid and having an open proximal end and an open distal end;

ii) a plunger slidably disposed within said proximal end of said syringe body and in sealed engagement with the interior wall of said syringe body;

iii) an actuating member extending from said plunger beyond said proximal end of said syringe body and manually shiftable to effect movement of said plunger to force diluent fluid from said fluid reservoir through said open distal end of said syringe body;

iv) a cannula defining an axial passage therethrough and having a proximal end and a closed distal end, said cannula proximal end in communication with the fluid reservoir through said open distal end of said syringe body, wherein said cannula has a length greater than said stopper height and wherein the distal end of said cannula terminates in a piercing tip;

v) the distal end of said cannula defining a side port in communication with the axial passage, the side port being configured to direct fluid passing therethrough toward the interior wall of said barrel of said cartridge at an angle diverging from the axial direction of said cannula;

vi) a housing having a needle covering portion extending around said cannula, said needle covering portion including a distal end having an opening in communication with an interior hollow of said needle covering portion which is structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when inserted proximally within said opening, wherein said distal end of said needle covering portion is positioned distally of said cannula distal end;

vii) a cartridge alignment member retained within said needle covering portion at a first axial position and defining an interior hollow structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when said cartridge is proximally inserted through said opening of said needle covering portion distal end, said cartridge alignment member adapted to be abutted by said injection pen cartridge during proximal insertion of said cartridge and axially shifted relative to said needle covering portion to a second axial position at which said cannula extends through said stopper of said injection pen cartridge for drug reconstituting, wherein said cartridge alignment member includes a shoulder that directly abuts a stop member of said needle covering portion when said cartridge alignment member is disposed in said second axial position; and

viii) wherein said cannula distal end is hidden from side view by at least one of said needle covering portion and said cartridge alignment member as said cannula is introduced through said stopper of said injection pen cartridge.

8. A kit for reconstituting a quantity of a lyophilized drug in a cartridge to be used in an injection pen, comprising:

a) an injection pen cartridge including;

i) a barrel with at least one interior wall defining an internal reservoir partially filled with a quantity of a lyophilized drug and having an open proximal end and an open distal end;

ii) a needle-penetrable stopper in sealed engagement with said proximal end of said barrel and having a stopper height;

iii) a plunger slidably disposed within said distal end of said barrel and in sealed engagement with the interior wall of said barrel; and

b) a reconstituting appliance including;

i) a syringe body with at least one interior wall defining a fluid reservoir containing a diluent fluid and having an open proximal end and an open distal end;

ii) a plunger slidably disposed within said proximal end of said syringe body and in sealed engagement with the interior wall of said syringe body;

iii) an actuating member extending from said plunger beyond said proximal end of said syringe body and manually shiftable to effect movement of said plunger to force diluent fluid from said fluid reservoir through said open distal end of said syringe body;

iv) a cannula defining an axial passage therethrough and having a proximal end and a closed distal end, said cannula proximal end in communication with the fluid reservoir through said open distal end of said syringe body, wherein said cannula has a length greater than said stopper height and wherein the distal end of said cannula terminates in a piercing tip;

v) the distal end of said cannula defining a side port in communication with the axial passage, the side port being configured to direct fluid passing therethrough toward the interior wall of said barrel of said cartridge at an angle diverging from the axial direction of said cannula;

vi) a housing having a needle covering portion extending around said cannula, said needle covering portion including a distal end having an opening in communication with an interior hollow of said needle covering portion which is structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when inserted proximally within said opening, wherein said distal end of said needle covering portion is positioned distally of said cannula distal end;

vii) a cartridge alignment member retained within said needle covering portion at a first axial position and defining an interior hollow structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when said cartridge is proximally inserted through said opening of said needle covering portion distal end, said cartridge alignment member adapted to be abutted by said injection pen cartridge during proximal insertion of said cartridge and axially shifted relative to said needle covering portion to a second axial position at which said cannula extends through said stopper of said injection pen cartridge for drug reconstituting, wherein said cartridge alignment member is retained within said needle covering portion at said first axial position by at least one projection of said needle covering portion that fits within a recess defined by axially spaced projecting portions of said alignment member; and

viii) wherein said cannula distal end is hidden from side view by at least one of said needle covering portion and said cartridge alignment member as said cannula is introduced through said stopper of said injection pen cartridge.

9. A kit for reconstituting a quantity of a lyophilized drug in a cartridge to be used in an injection pen, comprising:

a) an injection pen cartridge including;

i) a barrel with at least one interior wall defining an internal reservoir partially filled with a quantity of a lyophilized drug and having an open proximal end and an open distal end;

ii) a needle-penetrable stopper in sealed engagement with said proximal end of said barrel and having a stopper height;

iii) a plunger slidably disposed within said distal end of said barrel and in sealed engagement with the interior wall of said barrel; and

b) a reconstituting appliance including;

i) a syringe body with at least one interior wall defining a fluid reservoir containing a diluent fluid and having an open proximal end and an open distal end;

ii) a plunger slidably disposed within said proximal end of said syringe body and in sealed engagement with the interior wall of said syringe body;

iii) an actuating member extending from said plunger beyond said proximal end of said syringe body and manually shiftable to effect movement of said plunger to force diluent fluid from said fluid reservoir through said open distal end of said syringe body;

iv) a cannula defining an axial passage therethrough and having a proximal end and a closed distal end, said cannula proximal end in communication with the fluid reservoir through said open distal end of said syringe body, wherein said cannula has a length greater than said stopper height and wherein the distal end of said cannula terminates in a piercing tip;

v) the distal end of said cannula defining a side port in communication with the axial passage, the side port being configured to direct fluid passing therethrough toward the interior wall of said barrel of said cartridge at an angle diverging from the axial direction of said cannula;

vi) a housing having a needle covering portion extending around said cannula, said needle covering portion including a distal end having an opening in communication with an interior hollow of said needle covering portion which is structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when inserted proximally within said opening, wherein said distal end of said needle covering portion is positioned distally of said cannula distal end;

vii) a cartridge alignment member retained within said needle covering portion at a first axial position and defining an interior hollow structured and arranged to receive the proximal end of said barrel of said injection pen cartridge when said cartridge is proximally inserted through said opening of said needle covering portion distal end, said cartridge alignment member adapted to be abutted by said injection pen cartridge during proximal insertion of said cartridge and axially shifted relative to said needle covering portion to a second axial position at which said cannula extends through said stopper of said injection pen cartridge for drug reconstituting;

viii) wherein said cannula distal end is hidden from side view by at least one of said needle covering portion and said cartridge alignment member as said cannula is introduced through said stopper of said injection pen cartridge; and

ix) a collar fixedly mounted around a portion of said cannula and defining an axial venting passage between said cannula and said collar, wherein said collar extends through said stopper for venting said injection pen cartridge when said alignment member has been axially shifted within said needle covering portion to said second axial position by abutting contact with said injection pen cartridge during proximal insertion of said cartridge.