Hypodermic ampoule with skin tensioning clip

Claim 2

In a unitary hypodermic device of the contained-needle type comprising a closed medicament-containing cylindrical glass ampoule having a pierceable wall at one end thereof, a hypodermic needle having a pointed discharge end disposed in the ampoule for movement to pierce and project through said pierceable wall, and means for moving said needle through said pierceable wall while expressing medicament from the ampoule therethrough; the improvement in which said ampoule has an outer circumferentially extending bead adjacent the pierceable wall end thereof, and said pierceable wall includes a relatively rigid annular outer portion frictionally retained by said bead and having an external surface configured to provide an annular, skin-engaging rim surrounding a concavely recessed surface portion that defines a central opening thereon and a cylindrical sidewall having an internal circumferential groove for receiving said bead and locking said outer portion to said ampoule, said cylindrical sidewall also including an end portion beyond said internal groove that snugly engages said cylinder about its circumference inwardly of the bead thereon, and said bead having opposite side portions that slope differently relative to the axis of said cylinder to facilitate forcing said end portion of said outer portion over said bead when applying said outer portion to the cylinder and to render removal thereof by reverse movement more difficult; and a separate relatively flexible pierceable inner diaphragm portion for closing the end of said ampoule and held in position by said outer portion, said diaphragm portion having a central gland projecting outwardly through said central opening in said outer portion and embracing the pointed discharge end of said needle, said annular rim and projecting gland being axially related to be pressed, together, against the skin of the patient to tense the skin within the rim for increasing the resistance of the skin to pressure from the gland and more effectively sealing the gland against the skin while urging the gland inwardly against the pointed end of the needle to facilitate piercing of the gland and the skin upon actuation of said needle-moving means.

Claim 3

A hypodermic ampoule according to claim 1 in which said cylindrical sidewall of said outer portion is sufficiently resistant to elastic deformation to substantially prevent its removal without breaking said ampoule.

Claim 4

A multichamber ampoule for mixing and discharging medicaments, comprising a first cylinder, a first diaphragm sealed to and closing one end of said first cylinder, a plunger slidably disposed in the other end of said first cylinder to provide a first chamber between said plunger and first diaphragm, a hollow needle disposed in said first chamber for movement with said plunger toward said first diaphragm and having an open end adjacent said plunger and an opposite pointed discharge end adjacent said first diaphragm, and a powder medicament in said first chamber; a second cylinder axially aligned with said first cylinder and having one end closed by insertion of said first diaphragm therein with a peripheral portion of the first diaphragm in axial sliding engagement with the inner surface thereof, a second diaphragm closing the other end of said second cylinder, said first and second diaphragms and second cylinder, together, defining a second chamber, and a fluid medicament in said second chamber; whereby said fluid and solid medicaments may be mixed preparatory to discharge thereof by first moving said plunger and needle sufficiently toward said first diaphragm to project the pointed end of the needle through said first diaphragm to establish communication between the two chambers and by then moving said first cylinder, first diaphragm, plunger, and needle as a unit toward said second diaphragm to progressively reduce the volume of said second chamber substantially to zero and thereby express said liquid medicament through the needle into the first chamber while bringing said first and second diaphragms substantially into engagement and disposing the pointed end of said needle in position to project the needle through said second diaphragm upon further movement of said plunger toward said first and second diaphragms the improvement in which said second diaphragm comprises a pierceable wall having a relatively rigid, annular, outer portion having an external surface configured to provide an annular, skin-engaging rim surround a concavely recessed surface portion that defines a central opening therein and a relatively flexible, pierceable, inner diaphragm portion having a central gland projecting outwardly through said central opening and embracing the pointed discharge end of said needle.

Claim 5

A multichamber ampoule for mixing and discharging medicaments, comprising a first cylinder, a first diaphragm sealed to and closing one end of said first cylinder, a plunger slidably disposed in the other end of said first cylinder to provide a first chamber between said plunger and first diaphragm, a hollow needle disposed in said first chamber for movement with said plunger toward said first diaphragm and having an open end adjacent said plunger and an opposite pointed discharge end adjacent said first diaphragm, and a powder medicament in said first chamber; a second cylinder axially aligned with said first cylinder and having one end closed by insertion of said first diaphragm therein with a peripheral portion of the first diaphragm in axial sliding engagement with the inner surface thereof, a second diaphragm closing the other end of said second cylinder, said first and second diaphragms and second cylinder, together, defining a second chamber, and a fluid medicament in said second chamber; whereby said fluid and solid medicaments may be mixed preparatory to discharge thereof by first moving said plunger and needle sufficiently toward said first diaphragm to project the pointed end of the needle through said first diaphragm to establish communication between the two chambers and by then moving said first cylinder, first diaphragm, plunger, and needle as a unit toward said second diaphragm to progressively reduce the volume of said second chamber substantially to zero and thereby express said liquid medicament through the needle into the first chamber while bringing said first and second diaphragms substantially into engagement and disposing the pointed end of said needle in position to project the needle through said second diaphragm upon further movement of said plunger toward said first and second diaphragms the improvement in which said second diaphragm comprises a pierceable wall having a relatively rigid, annular, outer portion having an external surface configured to provide an annular, skin-engaging rim surround a concavely recessed surface portion that defines a central opening therein and a relatively flexible, pierceable, inner diaphragm portion having a central gland projecting outwardly through said central opening and embracing the pointed discharge end of said needle.

Claim 6

A multichamber hypodermic ampoule according to claim 3, wherein the outer diameter of said first cylinder is less than the inner diameter of said second cylinder.

Claim 7

A multichamber hypodermic ampoule according to claim 3, wherein the volume of said first chamber is substantially equal to the volume of said second chamber.

Claim 8

A multichamber hypodermic ampoule according to claim 3, wherein the volume of said first chamber sufficiently exceeds the volume of said second chamber so that the volume of the two medicaments in said first chamber after mixing the medicaments therein is substantially less than the remaining volume of said first chamber, whereby, prior to expelling the mixed contents of the first chamber, said plunger may be further advanced toward said first and second diaphragms to extend a portion of the length of said needle through and beyond said second diaphragm in an exposed condition for projection into a patient to the depth of muscle tissue to be injected, and said plunger may then be moved further toward said first and second diaphragms to progressively expel the mixed contents of said first chamber through said needle and into said muscle tissue while further advancing said needle into said muscle tissue.

Claim 9

A multichamber hypodermic ampoule according to claim 3, in which at least one additional diaphragm is disposed in said second chamber between said first and second diaphragms so as to divide said second chamber into a plurality of smaller chambers, and a corresponding plurality of different liquid medicaments respectively substantially fill said smaller chambers, whereby each of said liquid medicaments, one after another, may be caused to flow through said needle into said first chamber by progressive movement of said first diaphragm, first cylinder, plunger, and needle, as a unit, to bring all of said diaphragms substantially into engagement with one another.

Claim 10

A hypodermic ampoule comprising a cylinder; a plunger closing one end of the cylinder with a sliding seal; a pierceable diaphragm closing the other end of the cylinder to provide a medicament chamber therein; a hypodermic needle disposed in said chamber and extending axially thereof for movement with said plunger toward said diaphragm, said needle having an opening from the chamber into the needle at one end thereof adjacent said plunger and an opposite, pointed, discharge end; and a clip secured to said other end of said cylinder and having a bottom portion pressing said diaphragm into sealed engagement with that end of the cylinder; said diaphragm having an outwardly extending central gland portion embracing the pointed end of the needle, and said bottom portion of said clip having an external surface configured to provide an annular, skin-engaging rim surrounding a concavely recessed surface portion defining a central opening therein through which said diaphragm gland projects so that said clip rim and projecting gland may be pressed, together, against the skin of a patient to tension the skin within the clip rim, whereby the skin firmly engages the gland to urge it inwardly and facilitate penetration of the gland and skin by the needle upon inward movement of said plunger to injecT medicament through the needle and into the patient, a liquid medicament partially filling said chamber so as to leave an initial space between said plunger and the medicament when the ampoule is vertically disposed with the plunger end thereof uppermost, whereby the plunger may be moved inwardly to project the needle through and beyond said diaphragm gland prior to expressing liquid medicament through the needle, and wherein said plunger has a portion extending axially beyond the plunger end of said cylinder for a distance substantially corresponding to the length of said space axially of the cylinder.

Claim 11

A hypodermic ampoule comprising a cylinder; a plunger closing one end of the cylinder with a sliding seal; a pierceable diaphragm closing the other end of the cylinder to provide a medicament chamber therein; a hypodermic needle disposed in said chamber and extending axially thereof for movement with said plunger toward said diaphragm, said needle having an opening from the chamber into the needle at one end thereof adjacent said plunger and an opposite, pointed, discharge end; and a clip secured to said other end of said cylinder and having a bottom portion pressing said diaphragm into sealed engagement with that end of the cylinder; said diaphragm having an outwardly extending central gland portion embracing the pointed end of the needle, and said bottom portion of said clip having an external surface configured to provide an annular, skin-engaging rim surrounding a concavely recessed surface portion defining a central opening therein through which said diaphragm gland projects so that said clip rim and projecting gland may be pressed, together, against the skin of a patient to tension the skin within the clip rim, whereby the skin firmly engages the gland to urge it inwardly and facilitate penetration of the gland and skin by the needle upon inward movement of said plunger to injecT medicament through the needle and into the patient, a liquid medicament partially filling said chamber so as to leave an initial space between said plunger and the medicament when the ampoule is vertically disposed with the plunger end thereof uppermost, whereby the plunger may be moved inwardly to project the needle through and beyond said diaphragm gland prior to expressing liquid medicament through the needle, and wherein said plunger has a portion extending axially beyond the plunger end of said cylinder for a distance substantially corresponding to the length of said space axially of the cylinder.

Claim 12

A hypodermic ampoule according to claim 8, including a cup-shaped needle guard removably secured to said clip and having a bottom portion spaced from said gland an axial distance substantially corresponding to the axial length of said initial space between said plunger and medicament.

Claim 13

A hypodermic ampoule according to claim 8, wherein said plunger and diaphragm are rubber and said cylinder is rigid and substantially transparent.

Claim 14

A hypodermic ampoule according to claim 8 in which said cylinder has an outer, circumferentially extending bead adjacent the diaphragm end thereof, and said clip is cup-shaped with a cylindrical sidewall embracing said bead and the adjacent end portion of the cylinder for securing the clip and said diaphragm to the cylinder.

Claim 15

A hypodermic ampoule according to claim 8 in which said cylinder is formed of glass and has an outer, circumferentially extending bead adjacent the diaphragm end thereof, said clip being cup-shaped with a generally cylindrical sidewall embracing said bead and the adjacent end portion of the cylinder, and said cylindrical sidewall of the clip having an internal, circumferential groove receiving said bead of said cylinder and locking the clip against removal.

Claim 16

In a hypodermic injection assembly: a. a contained-needle type of hypodermic ampoule comprising a cylinder, a puncturable diaphragm closing and sealing one end of said cylinder, a slidable plunger in the opposite end of said cylinder and spaced from said diaphragm to provide a chamber therebetween, a liquid medicament in said chamber, and a hypodermic needle disposed in said chamber for movement by said plunger to a preinjection position in which a discharge end portion of the needle has pierced and extends beyond said diaphragm in an exposed condition and thereafter to transmit medicament from said chamber into a patient receiving an injection while moving further through said diaphragm, the volume of medicament in said chamber being substantially less than the initial volume of said chamber to permit movement of the plunger to project the needle to said preinjection position before expressing medicament from the chamber through the needle, said diaphragm comprising a pierceable wall having a relatively rigid, annular, outer portion having an external surface configured to provide an annular, skin-engaging rim surrounding a concavely recessed surface portion that defines a central opening therein and a relatively flexible, pierceable, inner diaphragm portion having a central gland projecting outwardly through said central opening and embracing the discharge end of said needle; and said ampoule including radially projecting abutments spaced about its periphery; b. an applicator for actuating said ampoule to perform an injection after the needle has been projected to its preinjection position, said applicator comprising a housing having an open end for insertion of said ampoule into the housing with the needle directed axially outwardly relative to said opening until the pointed end of the needle in its preinjection position is within the housing, detent means for coacting with said abutments on said ampoule for yieldably restraining said ampoule against reverse movement toward said opening, and ampoule moving means operative first to move said ampoule past said detent means and toward said housing opening for projecting the needle frOm the housing substantially for its exposed length in its preinjection position and then for moving said ampoule plunger and needle toward said ampoule diaphragm with a continuing force sufficient to express the medicament from said chamber through said needle and into a patient; whereby operation of said ampoule moving means of the applicator while the open end of the applicator is held against the skin of a patient first moves said ampoule and needle to cause the needle to penetrate into the patient for substantially the exposed length of the needle in said preinjection position and then moves said ampoule plunger toward said ampoule diaphragm for further advancing the needle into the patient while expressing medicament from said ampoule chamber through said needle and into the patient, said housing including stop means for subsequent positive restraining engagement with said abutments on said ampoule, said detent means and said stop means being discontinuous circumferentially of said applicator housing to permit passage of said ampoule abutments thereby during insertion of the ampoule, and engagement of said abutments thereby after relative rotation of the inserted ampoule about a common axis of said housing and ampoule.

Claim 17

In a hypodermic injection assembly: a. a contained-needle type of hypodermic ampoule comprising a cylinder, a puncturable diaphragm closing and sealing one end of said cylinder, a slidable plunger in the opposite end of said cylinder and spaced from said diaphragm to provide a chamber therebetween, a liquid medicament in said chamber, and a hypodermic needle disposed in said chamber for movement by said plunger to a preinjection position in which a discharge end portion of the needle has pierced and extends beyond said diaphragm in an exposed condition and thereafter to transmit medicament from said chamber into a patient receiving an injection while moving further through said diaphragm, the volume of medicament in said chamber being substantially less than the initial volume of said chamber to permit movement of the plunger to project the needle to said preinjection position before expressing medicament from the chamber through the needle, said diaphragm comprising a pierceable wall having a relatively rigid, annular, outer portion having an external surface configured to provide an annular, skin-engaging rim surrounding a concavely recessed surface portion that defines a central opening therein and a relatively flexible, pierceable, inner diaphragm portion having a central gland projecting outwardly through said central opening and embracing the discharge end of said needle; and said ampoule including radially projecting abutments spaced about its periphery; b. an applicator for actuating said ampoule to perform an injection after the needle has been projected to its preinjection position, said applicator comprising a housing having an open end for insertion of said ampoule into the housing with the needle directed axially outwardly relative to said opening until the pointed end of the needle in its preinjection position is within the housing, detent means for coacting with said abutments on said ampoule for yieldably restraining said ampoule against reverse movement toward said opening, and ampoule moving means operative first to move said ampoule past said detent means and toward said housing opening for projecting the needle frOm the housing substantially for its exposed length in its preinjection position and then for moving said ampoule plunger and needle toward said ampoule diaphragm with a continuing force sufficient to express the medicament from said chamber through said needle and into a patient; whereby operation of said ampoule moving means of the applicator while the open end of the applicator is held against the skin of a patient first moves said ampoule and needle to cause the needle to penetrate into the patient for substantially the exposed length of the needle in said preinjection position and then moves said ampoule plunger toward said ampoule diaphragm for further advancing the needle into the patient while expressing medicament from said ampoule chamber through said needle and into the patient, said housing including stop means for subsequent positive restraining engagement with said abutments on said ampoule, said detent means and said stop means being discontinuous circumferentially of said applicator housing to permit passage of said ampoule abutments thereby during insertion of the ampoule, and engagement of said abutments thereby after relative rotation of the inserted ampoule about a common axis of said housing and ampoule.

Claim 18

A hypodermic injection assembly according to claim 13 including a cup-shaped needle guard removably secured to the diaphragm end of said ampoule, said guard having a bottom wall spaced from said diaphragm by a distance exceeding the length of said end portion of the needle in its preinjection position.