Claims for Patent: 8,869,794

Summary for Patent: 8,869,794

Title:	Aerosolization apparatus with capsule puncturing member
Abstract:	An aerosolization apparatus comprises a housing defining a chamber having one or more air inlets. The chamber is sized to receive a capsule which contains an aerosolizable pharmaceutical formulation. A puncturing mechanism is provided within the housing and comprising a puncture member. The puncture member comprises a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule. The puncture member also comprises a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end. An end section is associated with the housing. The end section is sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule.
Inventor(s):	Tuckwell; Jon David (Cambridgeshire, GB), St. Quintin; Thomas Christopher (Cambridgeshire, GB)
Assignee:	Novartis Pharma AG (Basel, CH)
Application Number:	10/821,652
Patent Claims:	1. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing and comprising a puncture member that may be urged into said capsule, wherein the puncture member comprises a round wire comprising a tip comprising a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule, the tip further comprising a trailing end which comprises an angled planar portion that is insertable into the opening created by the cutting edge and having a length sufficient that the rearward end of the angled planar portion of the trailing end remains outside of the capsule, and thereby does not cut a wall thereof when the puncture member is urged fully into said capsule; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. 2. An aerosolization apparatus according to claim 1 wherein the end section is removably connected to the housing and wherein the end section may be removed from the housing to provide access to the chamber. 3. An aerosolization apparatus according to claim 1 wherein the puncture mechanism comprises a pair of puncture members. 4. An aerosolization apparatus according to claim 1 wherein the puncture member is adapted to puncture only one end of the capsule. 5. An aerosolization apparatus according to claim 1 wherein the chamber is elongated and has a longitudinal axis, and wherein the longitudinal axis of the chamber and the longitudinal axis of the capsule form an angle of less than about 45 degrees during use. 6. An aerosolization apparatus according to claim 1 wherein the chamber is elongated and wherein the capsule is received lengthwise within the elongated chamber. 7. An aerosolization apparatus according to claim 1 wherein the width of the chamber is less than the length of the capsule. 8. An aerosolization apparatus according to claim 1 wherein the inlet is shaped to create a swirling airflow within the chamber. 9. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing and comprising a puncture member, wherein the puncture member comprises a round wire comprising a curved forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule, and wherein the puncture member comprises a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end, the puncture member trailing end comprising a straight edge generally parallel to a tangent at a midpoint of the curved forward end, the puncture member further comprising an angled planar surface intermediate to said curved forward end and to said straight surface, wherein the angled planar surface is insertable into the opening created in the capsule; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. 10. An aerosolization apparatus according to claim 9 wherein the forward end comprises a terminus of said planar portion of the round wire. 11. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing and comprising a puncture member, wherein the puncture member comprises a round wire comprising a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule and wherein the puncture member forward end is not pointed, and wherein the puncture comprises a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end wherein the puncture member trailing end comprises a straight edge opposite to the forward end cutting edge, and intermediate to the straight edge and the forward end cutting edge is a planar portion that is insertable into the opening created in the capsule; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. 12. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing and comprising a puncture member that may be urged into, and contact, said capsule, wherein the puncture member has a tip, which comprises a curved forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule, the tip further comprising a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end, and wherein the puncture member comprises a round wire having a circular cross-section and wherein the forward end and said trailing end are formed by a planar, angular cut portion of the round wire and said trailing end further comprises a flat, planar surface generally parallel to a tangent at a midpoint of the curved forward end, wherein said tip has a generally D-shaped cross section; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. 13. An aerosolization apparatus comprising: a housing defining a chamber having one or more air inlets, the chamber being sized to receive a capsule which contains an aerosolizable pharmaceutical formulation; a puncturing mechanism within the housing and comprising a generally U-shaped puncture member having a generally circular cross-section, the puncture member having a tip for urging into a capsule, wherein the tip comprises a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule, the tip further comprising a trailing end comprising a straight edge generally perpendicular to an axis bisecting said non-pointed forward end, the tip further comprising an angled planar surface intermediate to the non-pointed forward end and to the straight edge and wherein the tip comprises a D-shaped surface; and an end section associated with the housing, the end section sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule. 14. A method of aerosolizing a pharmaceutical formulation, the method comprising: providing a capsule containing an aerosolizable pharmaceutical formulation; advancing a puncture member through the wall of the capsule to create an opening in the capsule, wherein the puncture member comprises a round wire comprising a tip having a forward end shaped to form a cutting edge and a trailing end wherein said tip comprises an angled planar portion intermediate to said forward end and to said trailing end, the planar portion having a length sufficient that the trailing end remains outside of the capsule when the tip and the angled planar portion is urged fully into said capsule, and wherein an opening into the capsule is created; aerosolizing the pharmaceutical formulation by flowing air through the chamber; and administering the aerosolized pharmaceutical formulation to the respiratory tract of a user during the user's inhalation. 15. A method according to claim 14 wherein the puncture member comprises a round wire and wherein the forward end is a planar portion of the round wire. 16. A method of aerosolizing a pharmaceutical formulation, the method comprising: providing a capsule containing an aerosolizable pharmaceutical formulation; advancing a puncture member through the wall of the capsule to create an opening in the capsule, wherein the puncture member comprises a round wire comprising a curved forward end shaped to form a cutting edge, and wherein the puncture member comprises a trailing end shaped to have a straight edge so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end wherein said straight edge is generally parallel to a tangent at a midpoint of the curved forward end, wherein an opening into the capsule is created; aerosolizing the pharmaceutical formulation by flowing air through the chamber; and administering the aerosolized pharmaceutical formulation to the respiratory tract of a user during the user's inhalation. 17. A method of aerosolizing a pharmaceutical formulation, the method comprising: providing a capsule containing an aerosolizable pharmaceutical formulation; advancing a puncture member through the wall of the capsule to create an opening in the capsule, wherein the puncture member comprises a tip having a generally circular cross-section and a curved forward end shaped to form a cutting edge and a trailing end comprising a straight edge generally perpendicular to an axis bisecting the curved forward end, and shaped to have a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the curved forward end, said forward end and said trailing end formed by an angled planar portion of the tip, wherein the tip comprises a D-shaped surface, and wherein an opening into the capsule is created; aerosolizing the pharmaceutical formulation by flowing air through the chamber; and administering the aerosolized pharmaceutical formulation to the respiratory tract of a user during the user's inhalation. 18. A puncture member for puncturing a puncturable container, the puncture member comprising a generally round wire material having a tip, the tip comprising an angled planar surface comprising a curved forward end to form a cutting edge that is effective in cutting the wall of a puncturable container to create an opening into the puncturable container, the tip further comprising a trailing end dimensioned and shaped to have a straight edge comprising a non-cutting surface wherein said straight edge does not cut the wall of the puncturable container when the trailing end is inserted into the opening created by the forward end, and wherein the trailing end further comprises a flat surface generally parallel to a tangent at a midpoint of the curved forward end and wherein said tip has a generally D-shaped cross-section.