Patent Description:
The radiation exposure can cause degradation of a medicament in the device. Different elements of the device can have different capacities to attenuate or absorb the radiation. Some elements can have internal surfaces that require sterilization. X-ray beams having different source energies or electron beam of different powers can be used to sterilize the different elements and surfaces.

Different elements requiring different source energies or electron beam powers can be sterilized separately. This typically requires a sterile field in which to attach the medicament delivery assembly to the medicament-housing elements.

It would be desirable therefore to provide apparatus that may be sterilized without the need for X-ray beams having different source energies.

It would be desirable therefore to provide apparatus that may be sterilized without the need for electron beams of different powers.

It also would be desirable therefore to provide apparatus that may be sterilized without requiring separate assembly of sterile parts after sterilization of the sterile parts.

The objects and advantages of the invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:.

Apparatus and methods for delivering medicament to a patient are provided.

The apparatus includes elements, each of which has a distinct or different capacity to attenuate radiation or absorb radiation. For example, the apparatus includes a medicament delivery assembly with interactive elements for dose-setting, priming, medicament ejection, and the like. One or more elements of the medicament delivery assembly houses a radiation-sensitive medicament present in the apparatus during sterilization.

The capacity to attenuate radiation is referred to herein as "attenuation capacity. " The capacity to absorb radiation is referred to herein as "absorption capacity. " The term "radiative capacity" encompasses both "attenuation capacity" and "absorption capacity.

Quantification of radiation attenuation is discussed in<NPL>; <NPL>; <NPL>; and <NPL>: <NPL>.

Table <NUM> shows illustrative mass attenuation coefficients for different materials that may be used in the apparatus. Values are given for the mean ratio of atomic number-to-mass Z/A, the mean excitation energy I, and the density. Some density values are only nominal.

The apparatus includes chamber. The chamber contains the medicament. The chamber has a medicament delivery outlet.

The apparatus includes a delivery assembly. The delivery assembly includes an actuator chassis. The delivery assembly includes a drive mechanism. The delivery assembly may include a needle-priming mechanism. The delivery assembly includes a fluid-displacement mechanism. The fluid-displacement mechanism may include one or more hollow regions. A hollow region may reduce beam attenuation. A hollow region may reduce radiation absorption. The delivery assembly may have any other suitable elements. Delivery assembly elements may be nested. Delivery assembly elements may be nested coaxially. Delivery assembly elements may be stacked. Delivery assembly elements may be stacked axially.

The chassis is fixed to the chamber. The chassis is fixed, relative to the outlet, to the chamber. The fluid-displacement member may be engaged with the chassis. The fluid-displacement member may be slidingly engaged with the chassis. The fluid-displacement member may be threadingly engaged with the chassis. The fluid-displacement member is configured to move relative to the outlet to move the medicament through the outlet.

The chamber may be collapsible. The fluid-displacement member may collapse the chamber to deliver the medicament.

The apparatus includes an envelope. The envelope sterilely surrounds the chassis. The envelope is an envelope that encloses no residue from chemical sterilization. The sterilization may be adequate for use in a sterile field. The sterilization may be adequate for ophthalmic use. The sterilization may be adequate for use in an operating room.

"Sterile" may satisfy one or more known standards. For example, "sterile" may be defined as in ANSI/AAMI ST67. ("Generally an SAL [Sterility Assurance Level] value of <NUM>-<NUM> has been used for terminal sterilization of health care products. " "A terminally sterilized product with an SAL of greater than <NUM>-<NUM>, e.g., <NUM>-<NUM>, <NUM>-<NUM>, etc., shall not be labeled as sterile.

"Sterile" for the apparatus may correspond to "sterile" for an injector. Data for a sterile injector may demonstrate a probability of a non-sterile unit not greater than <NUM> x <NUM>-<NUM>. See, for example, <NPL>" guidance document.

The chassis is fixed to the chamber, and may support the fluid-displacement member, so that the fluid-displacement member, when moved relative to the chassis, moves relative to the chamber, and pushes the medicament out through the outlet. The chassis may support any suitable drive mechanism for driving the fluid-displacement mechanism in linear motion. The chassis may support any suitable drive mechanism for driving the fluid-displacement mechanism in rotational motion. The chassis may support any suitable drive mechanism for driving the fluid-displacement mechanism in helical motion. The mechanism may include a knob or button that an operator may push. The mechanism may include a finger flange.

The chassis may support any suitable needle-priming mechanism. The chassis may support any suitable dose-setting mechanism.

The drive mechanism may be disposed in part or in whole within the chassis. The priming mechanism may be disposed in part or in whole within the chassis. The dose-setting mechanism may be disposed in part or in whole within the chassis.

The chassis may be fixed to the chamber by virtue of the chassis's fixation to a barrel of which the chamber is part. The chassis may be disposed coaxially with the barrel. The chassis may abut the barrel. The chassis may be fixed by adhesive to the barrel.

The chamber may be in whole or in part lodged within the chassis. The barrel may be in whole or in part lodged within the chassis. The chassis may enclose, in whole or in part, one or more of the drive mechanism, the priming mechanism, the displacement member, the chamber and the barrel.

The chassis may be in whole or in part lodged within the chamber. The chassis may be in whole or in part lodged within the barrel. One or more of the drive mechanism, the priming mechanism, the displacement member, the chamber and the barrel may enclose, in whole or in part, the chassis.

The fluid-displacement member may include a shaft. The fluid-displacement member may include a plunger. The fluid-displacement member may include a flange. The flange may be configured to receive part of an operator's thumb or finger. The fluid-displacement member may include a hinge. The hinge may be a living hinge. The fluid-displacement member may include a flap. The fluid-displacement member may include an elastic energy storage device. The elastic energy storage device may include a spring. The fluid-displacement member may include a permanent magnet. The fluid-displacement member may include a ferrous member. The ferrous member may be configured to perform as an electromagnet.

The fluid-displacement member may include a membrane. The membrane may include a diaphragm. The membrane may be stretchable. The membrane may be expandable.

Models for quantifying the relative attenuation of different elements of the apparatus are discussed below.

<FIG> shows illustrative conceptual model <NUM> of "attenuation capacity" in two regions, R<NUM> and R<NUM>, of an apparatus. R<NUM> and R<NUM> are at different locations along axis z of the apparatus, and extend away from axis z along the r axis. R<NUM> may represent a portion of a medicament delivery assembly having one element with mass attenuation coefficient µ<NUM>,<NUM> and a second having mass attenuation coefficient µ<NUM>,<NUM>. R<NUM> may represent a chamber wall having mass attenuation coefficient µ<NUM>,<NUM> and a sheath having mass attenuation coefficient µ<NUM>,<NUM>. One or both of R<NUM> and R<NUM> may have a number of elements that is different from the number shown.

The "attenuation capacities" (CA) of R<NUM> and R<NUM> may be defined, respectively, as: <MAT> <MAT> wherein:.

The one-dimensional relative attenuation capacity of R<NUM> and R<NUM> may be expressed as quotient Q1D, as set forth in illustrative Equations <NUM>-<NUM>.

Q provides a comparison between the capacities of the two elements, and may characterize the relative shielding effect of the elements when the flux of energy in electron beam B has the same intensity and shape when irradiating the two elements.

When a first attenuation capacity is greater than a second attenuation capacity, the first attenuation capacity may be expressed as being a multiple of the second attenuation capacity. The multiple may be the quotient.

When B is an X-ray beam, PRAD<NUM> and PRAD<NUM> will be the same, so <MAT>.

For I elements i of R<NUM> and J elements j of R<NUM>, <MAT>.

If B is an electron beam having power PEB, <MAT> and <MAT> wherein Z<NUM> and Z<NUM> are the atomic numbers of the material in R<NUM> and R<NUM>, respectively and VEB is the voltage of B. Therefore, for Equation <NUM>, <MAT>.

Equation <NUM> assumes that VEB is the same for R<NUM> and R<NUM>. When different beams are used for the different regions, each region may be exposed to different beam voltages, V. For example, the radiation may be attenuated inside the apparatus by one or more apparatus components, which may have different material properties, and may be disposed longitudinally with respect to each other, and may attenuate the radiation at different rates.

When the material is a complex molecule or a polymer, Z<NUM> and Z<NUM> may be determined by an empirical relationship. The empirical relationship may depend on bulk density of the material. Examples of such relationships are set forth in <NPL>.

Table <NUM> shows illustrative potential and power of energy beam B, as an electron beam.

When the energy beam is an X-ray beam, the source generates X-rays that in the aggregate have a distribution of energies, based on the source energy. Most of the energies are below the potential of the beam. Table <NUM> shows illustrative X-ray source energies.

<FIG> shows illustrative conceptual model <NUM> of absorption capacity in a volume, such as volume V, which may represent, in whole or in part, an apparatus element, such as the delivery assembly, the chamber, the envelope, the sheath or any other suitable element. Model <NUM> may represent an application of model <NUM> (shown in <FIG>) to the volume.

ϕ* represents the angular position of V, about the z-axis, relative to energy beam B. Energy beam B is shown as being collimated. Energy beam B may have any suitable cross-sectional profile. Energy beam B may include an X-ray beam. The X-ray beam may include Bremsstrahlung radiation.

V may be toroidal. V may be annular. V may be cylindrical. V may be rectilinear. V may be irregular. V may include one or more elements or element constituents. V may include void spaces between the elements or constituents. V may have spatially non-uniform mass distribution. V may have spatially non-uniform atomic number distribution. V may have spatially non-uniform mass density. V may have spatially non-uniform atomic number density.

V may absorb or scatter energy of electron beam B, which is emitted by source S through window W. The absorption capacity of an element may depend on mass density. The absorption capacity of an element may depend on atomic number density. The absorption capacity of an element may depend on the spatial distribution of mass V.

dV is a differential volume of V. Equation <NUM> gives an illustrative expression of the differential absorption capacity dC of dV. <MAT> in which p is the volumetric density of atomic number, or any other suitable unit that attenuates a beam such as B, and cylindrical coordinates r, θ and z are as shown.

Illustrative equations <NUM>-<NUM> illustrate one way in which absorption capacity can be generalized to V of arbitrary geometry.

C for any geometry may be expressed, by analogy, in rectilinear, spherical or any other suitable coordinate system.

ra greater than zero may express a hollow element. ra greater than zero may define an interior surface of an element. A different element may be disposed inside the interior surface. ra equal to zero may express an element having a solid core.

p may vary within V with one or more of r, θ and z. If there is more than one element V that contributes to absorption capacity, for an assembly of parts, for example, the total capacity may be constructed as set forth in illustrative Equations <NUM>-<NUM>: <MAT> wherein: <MAT> wherein each of the i elements has ith limits in r, z and θ, and an ith p.

Coaxially nested volumes, each having a distinct absorption capacity, may be expressed using Equation <NUM> with Equation <NUM>, in which the limits of z and θ do not change with i: <MAT>.

Ctotal for elements may be calculated, whether in cylindrical, rectilinear, spherical, or other coordinate systems.

The absorptive capacities of one or more elements may be compared to each other by calculating a ratio. The ratio may be expressed as a multiple. The ratio may be expressed as a quotient. For example, the absorptive capacity of a first element (for example, the chamber, having a volume V<NUM>) may be compared to the absorptive capacity of a second element (for example, the delivery assembly, having a volume V<NUM>).

The relative absorption capacity of two element volumes V<NUM> and V<NUM> may be expressed as quotient Q3D, such as in illustrative Equations <NUM>-<NUM>.

Ratio Q3D provides a comparison between the capacities of the two elements, and may predict the shielding effect of the elements when the flux of energy in electron beam B has the same intensity and shape when irradiating the two elements, and when ϕ* (shown in <FIG>) is the same when irradiating the two elements.

Limits of the integrals in Q3D may be set differently from those expressed in Equation <NUM>. The limits may capture features of the shapes of V<NUM> and V<NUM>. Table <NUM> lists illustrative examples of limits, one or more of which may be employed in a formulation of Q3D.

<FIG> shows conceptually a schematic cross-section of illustrative element <NUM>. Element <NUM> may contain medicament <NUM>. Electron beam B, shown incident on chamber <NUM>, may be used to sterilize outer surface <NUM> of chamber <NUM>.

<FIG> shows conceptually a schematic cross-section of illustrative element <NUM>. Element <NUM> may be, in part or in whole, offset along axis z from element <NUM> (shown in <FIG>). Element <NUM> may have inner radius ra<NUM> that may be smaller than inner radius ra<NUM> of element <NUM>. Element <NUM> may have outer radius rb<NUM> that may be greater than outer radius rb<NUM> of element <NUM>. A segment of element <NUM> is shown for reference.

<FIG> shows conceptually a schematic cross-section of illustrative element <NUM>. Element <NUM> may be, in part or in whole, offset along axis z from element <NUM> (shown in <FIG>). Element <NUM> may have inner radius ra<NUM> that may be greater than outer radius rb<NUM> of element <NUM>. Element <NUM> may have outer radius rb<NUM> that may be greater than outer radius rb<NUM> of element <NUM>. A segment of element <NUM> is shown for reference.

<FIG> shows conceptually a schematic cross-section of illustrative delivery assembly element <NUM>. Element <NUM> may be, in part or in whole, offset along axis z from element <NUM> (shown in <FIG>). Element <NUM> may have inner radius ra<NUM> that may be lesser than inner radius ra<NUM> of element <NUM>. Element <NUM> may have outer radius rb<NUM> that may be lesser than inner radius ra<NUM> of element <NUM>. A segment of element <NUM> is shown for reference.

<FIG> shows conceptually a schematic cross-section of illustrative delivery assembly element <NUM>. Element <NUM> may be, in part or in whole, offset along axis z from element <NUM> (shown in <FIG>). Element <NUM> may have inner radius ra<NUM> that may be smaller than inner radius ra<NUM> of element <NUM>. Element <NUM> may have outer radius rb<NUM> that may be greater than outer radius rb<NUM> of element <NUM>. A segment of element <NUM> is shown for reference. rb<NUM> may vary with θ (as rb<NUM>(θ)).

rb<NUM> may have one or more maximum values rb<NUM>(θ)max. rb<NUM>(θ)max may be greater than rb<NUM>. rb<NUM>(θ)max may be lesser than rb<NUM>. rb<NUM>(θ)max may be greater than ra<NUM>. rb<NUM> (θ)max may be lesser than ra<NUM>.

rb<NUM> may have one or more minimum values rb<NUM>(θ)min. rb<NUM>(θ)min may be greater than rb<NUM>. rb<NUM>(θ)min may be lesser than rb<NUM>. rb<NUM>(θ)min may be greater than ra<NUM>. rb<NUM> (θ)min may be lesser than ra<NUM>.

By analogy with rb<NUM>(θ), one or more of ra<NUM>, rb<NUM> and ra<NUM> may vary with θ. By analogy with rb<NUM>(θ), one or more of ra<NUM>, rb<NUM> and ra<NUM> may have one or more maximum. By analogy with rb<NUM>(θ), one or more of ra<NUM>, rb<NUM> and ra<NUM> may have one or more minimum.

rb<NUM> may have one or more maximum values rb<NUM>(z)max. rb<NUM>(z)max may be greater than rb<NUM>(z). rb<NUM>(z)max may be lesser than rb<NUM>(z). rb<NUM>(z)max may be greater than ra<NUM>(z). rb<NUM>(z)max may be lesser than ra<NUM>(z).

rb<NUM> may have one or more minimum values rb<NUM>(z)min. rb<NUM>(z)min may be greater than rb<NUM>(z). rb<NUM>(z)min may be lesser than rb<NUM>(z). rb<NUM>(z)min may be greater than ra<NUM>(z). rb<NUM>(z)min may be lesser than ra<NUM>(z).

By analogy with rb<NUM>(z), one or more of ra<NUM>, rb<NUM> and ra<NUM> may vary with z. By analogy with rb<NUM>(z), one or more of ra<NUM>, rb<NUM> and ra<NUM> may have one or more maximum. By analogy with rb<NUM>(z), one or more of ra<NUM>, rb<NUM> and ra<NUM> may have one or more minimum.

<FIG> shows conceptually variations of element radii with z in apparatus <NUM>. Apparatus <NUM> may include collar <NUM>. V<NUM> and V<NUM> may be elements that correspond to the conceptual V<NUM>s and V<NUM>s shown in <FIG>. They are spaced apart along z, distributed along z and r, and extend circumferentially out of the page in θ. M represents a medicament.

<FIG> shows for apparatus <NUM> illustrative extreme values ra<NUM>(z)min, rb<NUM>(z)max, rb<NUM>(z)max and ra<NUM>(z)min.

The chamber may be part of a prefilled syringe. The prefilled syringe may have a barrel that includes glass, plastic or any other suitable material. The prefilled syringe may include an integral needle. The prefilled syringe may be a prefilled syringe that does not include an integral needle. The prefilled syringe may include a needle safety shield.

The chamber may be part of prefilled syringe for an autoinjector. The chamber may be part of a cartridge for an autoinjector. The autoinjector may be used in an operating room environment. The autoinjector may be used in the vicinity of immunocompromised patients.

The chamber may be part of a patch pump. The patch pump may be a wearable infusion pump. The pump may deliver an injection up to tens of milliliters over a period of minutes. The pump may deliver an injection up to tens of milliliters over a period of days.

The chamber may be part of a drug vial. The vial may include plastic, glass, or any other suitable material. The vial may include a polymeric stopper.

The chamber may be part of a glass drug ampule.

The chamber may be part of a single-use dropper bottle.

The chamber may be part of a multi-use dropper bottle. The bottle may include plastic. The bottle may include a backflow prevention mechanism to prevent flow back into the dropper bottle.

The chamber has a first radiation capacity. The delivery assembly has a second radiation capacity. The first and second electron beam absorption capacities are different. The difference may be a difference between the first and second electron beam absorption capacities on a per-unit-length-of-device basis. The first radiation capacity is greater than the second radiation capacity. first radiation capacity may be greater, on a per-unit-length-of-device basis, than the second radiation capacity.

The chamber may be part of a barrel of a prefilled syringe.

The apparatus may include an envelope. The envelope may sterilely surround the chamber. The envelope may sterilely surround the delivery assembly. The envelope may sterilely surround the fluid-displacement member. The envelope may be an envelope that encloses no residue. The residue may be a residue from chemical sterilization.

The chamber may include glass. The glass may include a borosilicate glass. The chamber may include polymer. Table <NUM> lists selected illustrative materials that may be included in the chamber.

The outlet may have a central axis that extends away from the chamber. The delivery assembly may be a delivery assembly that is not rotationally symmetric about the axis. The delivery assembly may be arranged along an axis that is not collinear with the central axis.

The delivery assembly may include an autoinjector. The chamber may include a reservoir of the autoinjector.

The medicament may include a molecule. The molecule may have a mass. The mass may be in a range. The range may have a lower value and an upper limit. The lower and upper limits may be included in the range. Table <NUM> lists selected illustrative lower and upper limits.

The medicament may include a molecule that has a mass that is not greater than <NUM>,<NUM> Dalton.

The medicament may include a molecule that has a mass that is in the range <NUM>,<NUM> Dalton to <NUM>,<NUM> Dalton.

The medicament may include a molecule that has a mass that is not less than <NUM>,<NUM> Dalton and not more than <NUM>,<NUM> Dalton.

The medicament may include a molecule that has a mass that is not less than <NUM>,<NUM> Dalton.

The medicament may include a sugar. The sugar may include a monosaccharide. The sugar may include a disaccharide. The sugar may include sucrose (mol. weight <NUM> gram/mol). The sugar may include trehalose (mol. weight <NUM> gram/mol). The sugar may include glucose (mol. weight <NUM> gram/mol). The sugar may include mannitol (<NUM> gram/mol). The sugar may include sorbitol (<NUM> gram/mol). The sugar may include lactose (<NUM> gram/mol). The sugar may include maltose (<NUM> gram/mol).

The medicament may include an antibody. The antibody may have a mass that is about <NUM> kDa. The antibody may have a mass that is in a range from about <NUM> kDa to about <NUM> kDa. The antibody may have a mass that is no more than <NUM> kDA. The antibody may have a mass that is no less than <NUM> kDa. The antibody may include a monoclonal antibody.

The medicament may include an antibody fragment. The fragment may have a mass that is about <NUM> kDa. The fragment may have a mass that is in a range from about <NUM> kDa to about <NUM> kDa. The fragment may have a mass that is no more than <NUM> kDA. The fragment may have a mass that is no less than <NUM> kDa.

The medicament may include a peptide therapeutic. The peptide may have a mass that is about <NUM> kDa. The peptide therapeutic may have a mass that is in a range from about <NUM> kDa to about <NUM> kDa. The peptide therapeutic may have a mass that is no more than <NUM> kDA. The peptide therapeutic may have a mass that is no less than <NUM> kDa.

The medicament may include a biological product. The biological product may be alive. The biological product may be a biological product that is not alive. Table <NUM> lists selected illustrative biological products.

The medicament may include a formulation of one or more compounds. The compounds may include naturally occurring substances. The compounds may include substances derived from naturally occurring substances. The compounds may include synthetically produced substances. The compounds may include chimeric substances. The compounds may include engineered substances. The compounds may include humanized substances. The compounds may include substances produced by recombinant techniques. The compounds may include substances modified by recombinant techniques. The medicament may include material in a lyophilized state. The medicament may include material for reconstitution of a lyophilized material.

The compounds may include a drug accepted for therapeutic treatment of a patient. The compounds may include a substance used in a therapeutic protocol. The compounds may include a substance used in a diagnostic protocol. The compounds may include a substance used in an experimental protocol. The compounds may include a substance compatible for use with apparatus and methods of the invention.

The medicament may include any medical agent listed herein, either alone or in combination with one or more other listed medical agents or with one or more other, non-listed, medical agents. The medical agents may include anti-glaucoma medications, other ocular agents, neuroprotective agents, antimicrobial agents, anti-inflammatory agents (including steroids and non-steroidal compounds), and biological agents including hormones, enzymes or enzyme-related components, antibodies or antibody-related components, oligonucleotides (including DNA, RNA, short-interfering RNA, and other suitable oligonucleotides, such as antisense oligonucleotides), DNA/RNA vectors, viruses or viral vectors, peptides, and proteins. The medical agents may include anti-angiogenesis agents, including angiostatin, anecortave acetate, thrombospondin, vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitors, and anti-VEGF drugs, such as ranibizumab (LUCENTIS®), bevacizumab (AVASTIN®), pegaptanib (MACUGEN®), sunitinib, and sorafenib, and any of a variety of known small-molecule and transcription inhibitors having an anti-angiogenesis effect; ophthalmic drugs, including glaucoma agents, such as adrenergic antagonists, including beta-blocker agents such as atenolol, propranolol, metipranolol, betaxolol, carteolol, levobetaxolol, levobunolol and timolol. The medical agents may include platelet-derived growth factor (PDGF) inhibitors and anti-PDGF drugs. The medical agents may include transformation growth factor (TGF) inhibitors and anti-TGF drugs. The medical agents may include anti-inflammatory agents including glucocorticoids and corticosteroids, such as betamethasone, cortisone, dexamethasone, dexamethasone <NUM>-phosphate, methylprednisolone, prednisolone <NUM>-phosphate, prednisolone acetate, prednisolone, loteprednol, medrysone, fluocinolone acetonide, triamcinolone acetonide, triamcinolone, beclomethasone, budesonide, flunisolide, fluorometholone, fluticasone, hydrocortisone, hydrocortisone acetate and rimexolone; and non-steroidal anti-inflammatory agents including diclofenac, flurbiprofen, ibuprofen, bromfenac, nepafenac, ketorolac, salicylate, indomethacin, naxopren, naproxen, piroxicam and nabumetone. The medical agents may include anti-cytokine agents; the medical agents may include anti-interleukin-<NUM> agents such as tocilizumab (ACTEMRA®). The medical agents may include anti-complement agents, including those targeting complement factor D (such as an anti-complement factor D antibody or an antigen-binding fragment thereof) such as lampalizumab, and those targeting complement factor H (such as an anti-complement factor H antibody or an antigen-binding fragment thereof). The medical agents may include angiopoietin-specific agents, such as an angiopoietin-<NUM> antibody or an antigen-binding fragment thereof. The medical agents may include human growth hormone. The medical agents may include any suitable medical agent.

The medicament may include one or more derivatives of any of the above-mentioned medical agents. The medicament may include advanced forms of any of the above-mentioned medical agents. The medicament may include mutated forms of any of the above-mentioned medical agents. The medicament may include combinations of any of the above-mentioned medical agents. The combinations may be incorporated into a multi-specific molecule. The multi-specific molecule may exhibit properties of its constituent parts. The multi-specific molecule may exhibit properties different from any if its constituent parts. The medicament may include depots, hydrogels and pegylated forms of any of the above medical agents. The medicament may include any suitable form of any of the above medical agents.

The envelope may include a radiation detector.

The envelope may include an interior atmosphere. The interior atmosphere may be enriched, relative to an exterior atmosphere exterior and adjacent to the envelope, in an inert gas. The exterior atmosphere may be that of a sterile field. The exterior atmosphere may be that of a health care facility. The exterior atmosphere may be that of a patient examination room. The inert gas may include nitrogen, N<NUM>. The inert gas may include Argon. The inert gas may include Helium. The inert gas may include a noble gas. The inert gas may include any suitable gas.

The envelope may enclose a water-absorbing compound at a concentration that is greater than a concentration of the compound exterior and adjacent to the envelope.

A concentration of gaseous oxygen, O<NUM>, enclosed in the envelope, may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous oxygen may be a concentration that is no greater than <NUM> parts per million.

A concentration of gaseous water vapor, H<NUM>O, enclosed in the envelope, may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million. The concentration of gaseous water vapor may be a concentration that is no greater than <NUM> parts per million.

The envelope may include a first impermeable member. The first impermeable member may be impermeable to mass transfer. The envelope may include a second impermeable member. The second impermeable member may be impermeable to mass transfer. The second impermeable member may be disposed opposite the first impermeable member. The first and second impermeable members may be sealed to each other. The first and second impermeable members may define a cabinet.

One or both of the impermeable members may have a permeability to H<NUM>O that is sufficiently low that the water-absorbing compound remains unsaturated for a shelf-life period. The shelf-life period may be no less than <NUM> day. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days.

One or both of the impermeable members may have a permeability to O<NUM> that is sufficiently low that the water-absorbing compound remains unsaturated for a shelf-life period. The shelf-life period may be no less than <NUM> day. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days. The shelf-life period may be no less than <NUM> days.

The first impermeable member may be recessed to accommodate the delivery assembly. The recess may be formed by molding the first impermeable member.

The first impermeable member may include a polymer. The polymer may include a molded polymer.

The second impermeable member may include a foil. The foil may be a packaging foil. The foil may be a foil such as that available under the trademark TYVEK from E. du Pont de Nemours and Company, Wilmington, Delaware, and its affiliates. The foil may be a foil such as that available under the trademark OVANTEX from Oliver-Tolas, Feasterville, Pennsylvania, and its affiliates.

The foil may include paper. The foil may include cellulose. The foil may include metal. The foil may include polyethylene, for example, high density polyethylene, which may be available under the tradename TYVEK, polyester or any other suitable plastic.

The first impermeable member may include a foil and the second impermeable member may include a foil.

The first impermeable member may be recessed to accommodate the delivery assembly. The second impermeable member may be recessed to accommodate the delivery assembly.

The first impermeable member may include a sheath. The second impermeable member may include a cap. The cap may include a foil.

The envelope may include a blister pack.

The residue may include vapor. The residue may include an adsorbed molecule. The adsorbed molecule may be disposed on the envelope. The adsorbed molecule may be disposed on the delivery assembly. The adsorbed molecule may be disposed on a surface of the chamber.

The first radiation capacity is greater than the second radiation capacity by a multiple. The numerical value of the multiple may be defined by a single-sided lower limit. The numerical value may be defined by a double-sided range having a lower limit and an upper limit. Table <NUM> shows selected illustrative single-sided lower limits and ranges having lower and upper limits.

The first attenuation capacity is greater than the second attenuation capacity by a multiple that is greater than <NUM>.

The first attenuation capacity may be greater than the second attenuation capacity by a multiple that is greater than <NUM>.

The envelope may have a third radiation capacity.

The first radiation capacity may be greater than the third radiation capacity. The first radiation capacity may be greater, per unit length along a longitudinal axis of the apparatus, than the third radiation capacity. The first radiation capacity may be greater than the third radiation capacity by a multiple having a value such as one of those shown in Table <NUM>.

The third radiation capacity may be greater than the first radiation capacity. The third radiation capacity may be greater, per unit length along a longitudinal axis of the apparatus, than the first radiation capacity. The third radiation capacity may be greater than the first radiation capacity by a multiple having a value such as one of those shown in Table <NUM>.

The delivery assembly mass may include a toroidal element. The toroidal element may be disposed about the longitudinal axis. The delivery assembly may include a shaft element. The shaft element may be disposed along the longitudinal axis. The toroidal element may be rotatable, about the longitudinal axis, relative to the shaft. The shaft may be displaceable along the longitudinal axis. The shaft may be engaged with a plunger to move medicament within the chamber. The shaft may be engaged with the plunger to move medicament out of the chamber.

The apparatus may include a sheath. The chassis may support the sheath. The chamber may support the sheath. The sheath may be disposed about the medicament. The sheath may be disposed about the chamber. The sheath may have a fourth radiation capacity. The first radiation capacity may be greater, per unit length along a longitudinal axis of the apparatus, than the fourth radiation capacity. The first radiation capacity may be greater than the fourth radiation capacity by a multiple having a value such as one of those shown in Table <NUM>.

Methods for providing the apparatus are provided.

The method may include delivering, using an electron beam, to the outer surface of a barrel of the chamber, a predetermined dose of radiation. The sterilizing may include applying a predetermined dose to a surface of the delivery assembly. The surface may be a surface interior the delivery assembly. The surface may be a surface of an element of the delivery assembly. The surface may be a surface of the chassis. The surface may be a surface of the fluid-displacement member. The methods may deliver different doses to different parts of the delivery assembly. The methods may deliver the same doses to different parts of the delivery assembly. The methods may deliver different doses to different parts of the chamber. The methods may deliver the same doses to different parts of the chamber. The methods may deliver the same dose to a part of the delivery assembly and a part of a chamber.

Table <NUM> shows selected illustrative single-sided upper limits and ranges having lower and upper limits.

The method may include sterilizing the delivery assembly when the delivery assembly is affixed to the chamber. The sterilizing may be performed when the delivery assembly and the chamber are affixed to each other and sealed inside the envelope.

The sterilizing may be performed when the delivery assembly and the chamber are affixed to each other, the medicament is in the chamber, and the delivery assembly and the chamber are sealed inside the envelope. The sterilizing may include directing the electron beam through the envelope.

The method may include providing a radiation shield to protect the medicament from the electronic beam. The radiation shield may protect the medicament from the e-beam. The radiation shield may protect the medicament from Bremsstrahlung radiation.

The sterilizing may include magnetically steering the electron beam. The steering may include focusing the beam. The steering may include panning the beam to apply the dosage across a region of the apparatus. The steering may include tilting the beam to apply the dosage across a region of the apparatus. The steering may include rasterizing the beam to apply the dosage across a region of the apparatus. The sterilizing may include providing a magnetic radiation trap to localize radiation away from the medicament.

<FIG> shows illustrative apparatus <NUM> for delivering medicament.

Apparatus <NUM> may define longitudinal axis L. Axis L may be collinear with direction z. Apparatus <NUM> is shown in a state in which apparatus <NUM> is fully assembled. In that state, apparatus <NUM> may be ready for priming. In that state, apparatus <NUM> may be ready for transformation of medicament for delivery. In that state, apparatus <NUM> may be ready to discharge the medicament. In that state, discharge of the medicament from apparatus <NUM> may not have begun.

Apparatus <NUM> may include a fluid-displacement member such as plunger rod <NUM>. Rod <NUM> may be part of a mixing configuration (not shown), for example, for reconstituting a medicament.

Apparatus <NUM> may include medicament container <NUM>. Container <NUM> may be part of the mixing configuration (not shown). Container <NUM> may be disposed coaxial with axis L. Container <NUM> may be cylindrical, partially cylindrical or have any other suitable form. A distal portion of rod <NUM> may be disposed within container <NUM>.

Container <NUM> may contain medicament <NUM> in chamber <NUM>. Outlet <NUM> may have a central axis (illustrated collinear with L) that extends away from chamber <NUM>. Container <NUM> may be in sealed engagement with plunger <NUM>. A distal end of rod <NUM> may abut a proximal surface of plunger <NUM>. Rod <NUM> may engage plunger <NUM> such that it can push or pull plunger <NUM>. Rod <NUM> may contact plunger <NUM> such that it can push, but not pull, plunger <NUM>.

Apparatus <NUM> may include delivery assembly <NUM>. Delivery assembly <NUM> may include chassis <NUM>. Chassis <NUM> may engage container <NUM>. Chassis <NUM> may support one or more elements of delivery assembly <NUM> in a corresponding fixed position along axis L. Plunger <NUM> may be engaged with delivery assembly <NUM>. Plunger <NUM> may be movable along axis L. One or more elements of delivery assembly <NUM> may be fixed longitudinally along and rotatable about axis L.

Container <NUM> may be considered to be not part of delivery assembly <NUM>.

Delivery assembly <NUM> may include proximal knob <NUM>. Knob <NUM> may be disposed coaxial with axis L. Grip <NUM> may be provided on knob <NUM>. Knob <NUM> may be threadingly attached to rod <NUM>.

Delivery assembly <NUM> may include device housing <NUM>. Housing <NUM> may be disposed coaxial with axis L. Housing <NUM> may be cylindrical, partially cylindrical or have any other suitable form.

Delivery assembly <NUM> may include finger flange <NUM>. Finger flange <NUM> may be separate from housing <NUM>. Finger flange <NUM> may be attached to housing <NUM>. Finger flange <NUM> may be monolithic with housing <NUM>.

Delivery assembly <NUM> may include collar <NUM>. Collar <NUM> may be disposed coaxial with axis L. Collar <NUM> may be cylindrical, partially cylindrical or have any other suitable form. Collar <NUM> may be attached to finger flange <NUM>. Collar <NUM> may be monolithic with finger flange <NUM>. Collar <NUM> may be attached to housing <NUM>. Collar <NUM> may be monolithic with housing <NUM>.

<FIG> shows knob <NUM>. Knob <NUM> may include threads <NUM> (shown in phantom) internal to knob <NUM>.

Grip <NUM> may contribute to traction on knob <NUM> for effecting longitudinal translation of rod <NUM>. Grip <NUM> may contribute to ergonomic finger contact of the operator with knob <NUM> for effecting longitudinal translation of rod <NUM>. The finger contact with knob <NUM> through grip <NUM> may conduct tactile feedback to the operator of an extent of distal longitudinal translation of rod <NUM> along axis L.

Knob <NUM> may include turn ridges <NUM>. Turn ridges <NUM> may be utilized by the operator to effect rotation of knob <NUM> about axis L. Turn ridges <NUM> may contribute to traction on knob <NUM> for effecting translation of rod <NUM>. Turn ridges <NUM> may contribute to ergonomic finger contact of the operator with knob <NUM> for effecting translation of rod <NUM> through rotation of knob <NUM>. The finger contact with turn ridges <NUM> may conduct tactile feedback to the operator of an extent of translation of rod <NUM> along axis L.

Turn ridges <NUM> may be spaced circumferentially around knob <NUM>. Turn ridges <NUM> may be spaced regularly around a circumference of grip <NUM>. Turn ridges <NUM> being spaced regularly about the circumference of grip <NUM> may provide the operator a measure of an extent of rotation performed.

Knob <NUM> may include turn direction signage <NUM>. In the operational state, apparatus <NUM> may effect distal displacement of rod <NUM> within container <NUM> in response to rotation of knob <NUM> about axis L in only one of two rotational directions. Turn direction signage <NUM> may provide the operator with cues as to an effective rotational direction. The cues may serve as reminders before and/or during the operational state. The cues may be visual. The cues may be tactile.

As depicted, the effective rotational direction for distal displacement of rod <NUM> within container <NUM> in response to rotation of knob <NUM> about axis L may be clockwise for apparatus <NUM>. (For some embodiments, not shown, counter-clockwise rotation may the effective rotational direction. For some embodiments, turn direction signage may provide cues for counter-clockwise rotation.

Distal rod end <NUM> may define a distal end of anti-rotation slot <NUM>. Anti-rotation slot <NUM> may be parallel to axis L. Distal rod end <NUM> may include one or more additional anti-rotation slots or features (not shown) distributed about the circumference of rod <NUM> in a regular or irregular manner. Anti-rotation slot <NUM> may extend all or some of the way proximally to threads <NUM>. Threads <NUM> may extend proximally some or all of the way to proximal rod end <NUM>. Threads <NUM> may engage threads <NUM> of knob <NUM>.

Rod <NUM> may include flat face <NUM>. Flat face <NUM> may be parallel to axis L. Rod <NUM> may include one or more additional flat faces (not shown) distributed about the circumference of rod <NUM> in a regular or irregular manner. Flat face <NUM> may extend all or some of the way from near anti-rotation slot <NUM> to proximal end <NUM>. Flat face <NUM> may be longitudinally coextensive with threads <NUM>. Flat face <NUM> may be circumferentially displaced from slot <NUM>. The circumferential displacement may be <NUM>°of arc from slot <NUM>.

Container <NUM> may be disposed in device <NUM> distal to finger flange <NUM>. Container <NUM> may be disposed in housing <NUM> distal to finger flange <NUM>. Proximal rim <NUM> of container <NUM> surrounding a proximal opening of container <NUM> may be recessed in device <NUM> distal to finger flange <NUM>. Proximal rim <NUM> of container <NUM> may be recessed in housing <NUM>.

Knob <NUM> may be disposed coaxially within collar <NUM>. Collar <NUM> may include viewing window <NUM>. A portion of signage <NUM> may be visible through window <NUM>.

Rod <NUM> may be contained in container <NUM> with distal end <NUM> abutting plunger proximal face <NUM>. Proximal rod end <NUM> may extend proximally into collar <NUM>. Knob <NUM> may extend distally into collar <NUM> to threadingly engage rod <NUM>.

<FIG> shows illustrative apparatus <NUM> for delivering medicament. Apparatus <NUM> may include delivery assembly <NUM>. Apparatus <NUM> may include container <NUM>. Container <NUM> may be considered to not be part of delivery assembly <NUM>. Apparatus <NUM> may include hub <NUM>. Hub <NUM> may be affixed to container <NUM>. Hub <NUM> may be a needle hub.

<FIG> shows illustrative apparatus <NUM> from a perspective that is different from that shown in <FIG>.

<FIG> shows a cross-sectional view of apparatus <NUM> taken along lines <NUM>-<NUM> (shown in <FIG>).

Apparatus <NUM> may define longitudinal axis L. Axis L may be collinear with direction z. Apparatus <NUM> is shown in a state in which apparatus <NUM> is fully assembled. In that state, apparatus <NUM> may be ready for priming. In that state, apparatus <NUM> may be ready for transformation of the medicament for delivery. In that state, apparatus <NUM> may be ready to discharge the medicament. In that state, discharge of the medicament from apparatus <NUM> may not have begun.

Container <NUM> may be part of the mixing configuration (not shown). Container <NUM> may be disposed coaxial with axis L. Container <NUM> may be cylindrical, partially cylindrical or have any other suitable form. A distal portion of rod <NUM> may be disposed within container <NUM>.

Container <NUM> may contain medicament <NUM> in chamber <NUM>. Outlet <NUM> may have a central axis (illustrated as collinear with L) that extends away from chamber <NUM>. Container <NUM> may be in sealed engagement with plunger <NUM>. A distal end of rod <NUM> may abut a proximal surface of plunger <NUM>. A distal end of rod <NUM> may engage a proximal surface of plunger <NUM>. Rod <NUM> may engage plunger <NUM> such that it can push or pull plunger <NUM>. Rod <NUM> may contact plunger <NUM> such that it can push, but not pull, plunger <NUM>.

Delivery assembly <NUM> may include chassis <NUM>. Chassis <NUM> may engage container <NUM>. Chassis <NUM> may support one or more elements of delivery assembly <NUM> in a corresponding fixed position along axis L. Plunger <NUM> may be engaged with delivery assembly <NUM>. Plunger <NUM> may be movable along axis L. One or more elements of delivery assembly <NUM> may be fixed longitudinally along and rotatable about axis L.

Delivery assembly <NUM> may include finger flange <NUM>. Finger flange <NUM> may be separate from housing <NUM>. Finger flange <NUM> may be attached to housing <NUM>. Finger flange <NUM> may be monolithic with housing <NUM>. Finger flange <NUM> may be monolithic with chassis <NUM>.

Delivery assembly <NUM> may include collar <NUM>. Collar <NUM> may be disposed coaxial with axis L. Collar <NUM> may be cylindrical, partially cylindrical or have any other suitable form. Collar <NUM> may be attached to finger flange <NUM>. Collar <NUM> may be monolithic with finger flange <NUM>. Collar <NUM> may be attached to housing <NUM>. Collar <NUM> may be monolithic with housing <NUM>. Collar <NUM> may be attached to chassis <NUM>. Collar <NUM> may be monolithic with chassis <NUM>.

<FIG> shows illustrative envelope <NUM>. Envelope <NUM> may enclose some or all of an apparatus such as an apparatus having one or more features of the illustrative concepts shown in one or more of <FIG> or an apparatus having one or more features in common with the illustrative apparatus show in one or more of <FIG>. Envelope <NUM> may enclose an atmosphere.

Envelope <NUM> may include sleeve <NUM>. Sleeve <NUM> may be hollow. Sleeve <NUM> may include first section <NUM>. Sleeve <NUM> may include second section <NUM>. First section <NUM> may have a diameter that is greater than that of second section <NUM>. First section <NUM> may accommodate a large-diameter portion of the apparatus. Second section <NUM> may accommodate a relatively smaller-diameter portion of the apparatus.

Envelope <NUM> may include foil or cap <NUM>. Foil or cap <NUM> may be sealed to sleeve <NUM>. Envelope <NUM>, with the enclosed apparatus, may be sterilized after foil or cap <NUM> is sealed to sleeve <NUM>.

<FIG> shows that sleeve <NUM> may include illustrative flange <NUM>. Foil or cap <NUM> may be sealed to flange <NUM>. <FIG> shows that sleeve <NUM> may include base <NUM>.

<FIG> shows another view of envelope <NUM>.

<FIG> shows a cross-sectional view of envelope <NUM> taken along lines <NUM>-<NUM> (shown in <FIG>). Foil or cap <NUM> is shown abutting flange <NUM>.

<FIG> shows envelope <NUM> without a foil or a cap. An upper surface of flange <NUM> is exposed.

<FIG> shows illustrative manipulator arm <NUM> (shown in part) delivering apparatus <NUM> (shown in <FIG>) to envelope <NUM>. The manipulator arm may deliver an apparatus such as apparatus <NUM> (shown in <FIG>), or any other suitable apparatus, to envelope <NUM>, or any other suitable envelope. The apparatus may be in a non-sterile state. The apparatus may include a medicament (not shown) such as medicament <NUM> (shown in <FIG>), or any other suitable medicament. The apparatus may include a chamber. The chamber may contain the medicament may be in a sterile state. The chamber may be in a sterile state. The medicament may be in a sterile state.

<FIG> shows illustrative envelope <NUM> and illustrative apparatus <NUM>. Envelope <NUM> may have one or more features in common with envelope <NUM> (shown in <FIG>). Apparatus <NUM> may have one or more features in common with one or both of apparatus <NUM> (shown in <FIG>) and apparatus <NUM> (shown in <FIG>).

Apparatus <NUM> may be sealed within envelope <NUM>.

Envelope <NUM> may include energy detector <NUM>. Energy detector <NUM> may detect an energy beam such as beam B. Energy detector <NUM> may indicate that it has been subjected to an energy beam such as beam B. The indicator may be a visual indicator, such as a color change. The indicator may include a radiochromic dye. The indicator may include a X-ray film. The indicator may be a radio-frequency indicator, such as a radio frequency identification antenna. Energy detector <NUM> is shown affixed to inner wall <NUM> of envelope <NUM>. Energy detector <NUM> may be disposed on inner surface <NUM> of foil or cap <NUM>, on inner surface <NUM> of base <NUM>, or in any other suitable location in or on envelope <NUM>, within the structure of the wall of envelope <NUM>, or within foil or cap <NUM>.

Apparatus <NUM> may include energy detector <NUM>. Energy detector <NUM> may have one or more features in common with energy detector <NUM>. Energy detector <NUM> is shown on outer surface <NUM> of chamber <NUM>, interior to housing <NUM>. Energy detector <NUM> may be disposed on any surface of apparatus <NUM>, or within the any element of apparatus <NUM>.

An apparatus such as apparatus <NUM> (shown in <FIG>), or any other suitable apparatus, may be sealed within an envelope such as <NUM> (shown in <FIG>) or any other suitable envelope.

<FIG> shows envelope <NUM>, with apparatus <NUM> (shown in <FIG>) sealed inside, disposed within illustrative sterilization system <NUM>. Sterilization system <NUM> may include an enclosure, such as shielded cabinet <NUM>. System <NUM> may include source <NUM> of energy beam B. Source <NUM> and envelope <NUM> may be arranged such that energy beam B is oriented, relative to apparatus <NUM>, at an angle to the orientation shown. For example, energy beam B may be oriented parallel to axis L of apparatus <NUM>. Energy beam B may be oriented obliquely to axis L of apparatus <NUM>. When energy beam B is oriented parallel to axis L, apparatus <NUM> may be arranged such that energy beam B is incident at an end of apparatus <NUM> at which the delivery assembly is disposed. When energy beam B is oriented parallel to axis L, apparatus <NUM> may be arranged such that energy beam B is incident at an end of apparatus <NUM> opposite the end at which the delivery assembly is disposed. System <NUM> may include one or more coils <NUM> and <NUM> for electromagnetically steering focusing beam B. System <NUM> may include one or more coils for electromagnetically focusing beam B. Shielded cabinet <NUM> may include materials and may be dimensioned to contain beam B, and radiation caused thereby.

System <NUM> may include handling robot <NUM>. Envelope <NUM> is shown supported on platen or turret <NUM> of robot <NUM>. Transmission box <NUM> may include appropriate power supply and drive mechanisms to rotate shaft <NUM>. Transmission box <NUM> may include appropriate power supply and drive mechanisms to rotate shaft <NUM> continuously about axis L. Transmission box <NUM> may include appropriate power supply, control and drive mechanisms to rotate shaft <NUM> to one or more set values of angle ϕ about axis L. Platen or turret <NUM> may rotate with rotation of shaft <NUM>. Envelope <NUM> may rotate with rotation of platen or turret <NUM>.

Transmission box <NUM> may include appropriate power supply, control and drive mechanisms to drive wheels <NUM>. Wheels <NUM> may run along a track (not shown). Wheels <NUM> may be steerable and independent of a track.

Shielded cabinet <NUM> may include access door <NUM>.

Shielded cabinet <NUM> may include radiation shield <NUM>. Shield <NUM> may shield a portion of envelope <NUM>. The portion may be less than the entirety of envelope <NUM>. Shield <NUM> may shield a portion of apparatus <NUM> (shown in <FIG>). The portion may be less than the entirety of apparatus <NUM>. Shield <NUM> may be positioned to attenuate energy from beam B that would otherwise impinge on the medicament. Shield <NUM> may include slot <NUM>.

Robot <NUM> may move package <NUM> into slot <NUM> Robot <NUM> may move package <NUM> into slot <NUM> from a side of shield <NUM> opposite source <NUM>. Robot <NUM> may move envelope <NUM> along slot <NUM>. Shield <NUM> may be lowered about all or part of envelope <NUM> after robot <NUM> positions envelope <NUM> in a path that beam B will follow.

System <NUM> may include control hardware <NUM>. System <NUM> may include one or more antennae such as antennae <NUM>, <NUM>, <NUM> and <NUM> for transmission and receipt of signals between the components of system <NUM>.

<FIG> shows illustrative hardware <NUM>. Hardware <NUM> may be a computing machine. Hardware <NUM> may include chip module <NUM>, which may include one or more integrated circuits, and which may include logic configured to control a robotic sterilization system or to perform any other suitable logical operations.

Hardware <NUM> may include one or more of the following components: I/O circuitry <NUM>, which may include the transmitter device and the receiver device and may interface with fiber optic cable, coaxial cable, telephone lines, wireless devices, PHY layer hardware, a keypad/display control device or any other suitable media or devices; peripheral devices <NUM>, which may include counter timers, real-time timers, power-on reset generators or any other suitable peripheral devices; logical processing device <NUM>; and machine-readable memory <NUM>.

Machine-readable memory <NUM> may be configured to store information in machine-readable data-structures.

Components <NUM>, <NUM>, <NUM>, <NUM> and <NUM> may be coupled together by a system bus or other interconnections <NUM> and may be present on one or more circuit boards such as <NUM>. In some embodiments, the components may be integrated into a single silicon-based chip.

It will be appreciated that software components including programs and data may, if desired, be implemented in ROM (read only memory) form, including CD-ROMs, EPROMs and EEPROMs, or may be stored in any other suitable computer-readable medium such as but not limited to discs of various kinds, cards of various kinds and RAMs. Components described herein as software may, alternatively and/or additionally, be implemented wholly or partly in hardware, if desired, using conventional techniques.

Various signals representing information described herein may be transferred between a source and a destination in the form of electromagnetic waves traveling through signal-conducting media such as metal wires, optical fibers, and/or wireless transmission media (e.g., air and/or space).

Hardware <NUM> may operate in a networked environment supporting connections to one or more remote computers via a local area network (LAN), a wide area network (WAN), or other suitable networks. When used in a LAN networking environment, hardware <NUM> may be connected to the LAN through a network interface or adapter in I/O circuitry <NUM>. When used in a WAN networking environment, hardware <NUM> may include a modem or other means for establishing communications over the WAN. It will be appreciated that the network connections shown are illustrative and other means of establishing a communications link between the computers may be used. The existence of any of various well-known protocols such as TCP/IP, Ethernet, FTP, HTTP and the like is presumed, and the system may be operated in a client-server configuration to permit a user to operate logical processing device <NUM>, for example over the Internet.

Hardware <NUM> may be included in numerous general purpose or special purpose computing system environments or configurations. Examples of well-known computing systems, environments, and/or configurations that may be suitable for use with the invention include, but are not limited to, personal computers, server computers, hand-held or laptop devices, mobile phones and/or other personal digital assistants ("PDAs"), multiprocessor systems, microprocessor-based systems, tablets, programmable consumer electronics, network personal computers, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like.

Processes in accordance with the principles of the invention may include one or more features of processes illustrated in <FIG>. The processes may operate on all or some of one or more apparatus such as one or more of the apparatus shown and described above. The processes may operate on all or some of one or more envelope such as one or more of the envelopes shown and described above. For the purpose of illustrating the processes, an apparatus, in whole or in part, in an envelope, in whole or in part, will be referred to as a "package. " The system may be implemented using the system of <FIG>. Operation of the system may be governed by control hardware, such as control hardware <NUM> (shown in <FIG>), which may include the hardware shown in <FIG>, along with appropriate software.

The steps of the processes may be performed in an order other than the order shown and described herein. Some embodiments of the invention may omit steps shown and described in connection with the illustrative methods. Some embodiments of the invention may include steps that are not shown and described in connection with the illustrative methods.

<FIG> shows illustrative process <NUM>. Process <NUM> may begin at step <NUM>. At step <NUM>, the system may load a package onto a robot such as robot <NUM> (shown in <FIG>).

At step <NUM>, the system may confirm that an enclosure, such as cabinet <NUM> (shown in <FIG>) is ready to receive the package.

At step <NUM>, the system may transmit to the robot an instruction to move into the cabinet.

At step <NUM>, the system may prepare the package for exposure to an energy beam, such as beam B (shown in <FIG>).

At step <NUM>, the system may set beam parameters. The parameters may include one or more of beam width, source current, source voltage, beam pulse duration, beam pulse frequency, beam pulse train duration, beam rasterization width, beam rasterization rate or any other suitable parameters.

At step <NUM>, the system may emit the beam.

At step <NUM>, the system may query a radiation detector, such as detector <NUM> (shown in <FIG>). The query may include an optical probe of a radiochromic dye. The system may determine whether the radiation impinged on the detector. The system may determine to what extent the radiation impinged on the detector. The system may compare the extent of impingement to a target dose that is required to satisfy a sterilization requirement.

If at step <NUM>, the system determines that sterilization is incomplete, process <NUM> may continue at step <NUM>.

If at step <NUM>, the system determines that sterilization is complete, process <NUM> may proceed to step <NUM>. At step <NUM>, the system may open a cabinet door, such as door <NUM> (shown in FIG.

At step <NUM>, the system may instruct the robot to move to an output pallet station.

At step <NUM>, the system may transfer the package from the robot to a pallet or other container.

At step <NUM>, the system may instruct the robot to move from the output pallet station to an input pallet station. There, the system may load a different package onto the robot. The different package may be an unsterilized package. The different package may be a partially sterilized package.

<FIG> shows illustrative process <NUM>. The system may execute one or more of the steps of process <NUM> in connection with the execution of step <NUM> of process <NUM> (shown in <FIG>).

Process <NUM> may begin at step <NUM>. At step <NUM>, the system may turn off a source, such as source <NUM> (shown in <FIG>).

At step <NUM>, the system may open an access door, such as access door <NUM> (shown in <FIG>).

At step <NUM>, the system may confirm that the cabinet is unoccupied.

Process <NUM> may begin at step <NUM>. At step <NUM>, the system may confirm the position, relative to beam B, of the package. The position may be confirmed using one or more sensors, such as an optical sensor or any other suitable sensor. The robot may adjust the package position horizontally or vertically.

At step <NUM>, the system may position one or more radiation shields to shield some or all of the package from beam B or other radiation, such as Bremsstrahlung radiation, that may be present in the cabinet.

At step <NUM>, the system may close the access door.

Process <NUM> may begin at step <NUM>. At step <NUM>, the system may instruct the robot to sweep the package relative to beam B through angle ϕ (shown in <FIG>). The system may instruct the robot to rotate the package between two different values of ϕ.

At step <NUM>, the system may raster beam B along longitudinal axis L (shown in <FIG>) of the package. The rasterizing may be synchronized with sweeping so that the region of the package that is exposed to beam B moves longitudinally, circumferentially, or both.

At step <NUM>, the system may turn off the source.

All ranges and parameters disclosed herein are understood to encompass any and all subranges subsumed therein, and every number between the endpoints. For example, a stated range of "<NUM> to <NUM>" should be considered to include any and all subranges between (and inclusive of) the minimum value of <NUM> and the maximum value of <NUM>; that is, all subranges beginning with a minimum value of <NUM> or more (e.g., <NUM> to <NUM>), and ending with a maximum value of <NUM> or less (e.g., <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>), and to each number <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> contained within the range.

Claim 1:
A medicament delivery apparatus comprising:
a chamber (<NUM>; <NUM>) containing a medicament (<NUM>; <NUM>), and having a medicament delivery outlet (<NUM>; <NUM>);
a delivery assembly (<NUM>; <NUM>) including:
a chassis (<NUM>; <NUM>) that is fixed, relative to the outlet (<NUM>; <NUM>), to the chamber; and
a fluid-displacement member (<NUM>; <NUM>) that is configured to move relative to the outlet (<NUM>; <NUM>) to move the medicament (<NUM>; <NUM>) through the outlet (<NUM>; <NUM>); and
an envelope (<NUM>; <NUM>) that:
sterilely surrounds the chassis (<NUM>; <NUM>); and
encloses no residue from chemical sterilization, wherein:
the chamber (<NUM>; <NUM>) has a first electron beam or X-ray beam attenuation capacity;
the delivery assembly (<NUM>; <NUM>) has a second electron beam or X-ray beam attenuation capacity; and,
the first and second electron beam or X-ray beam attenuation capacities are different, the first electron beam or X-ray beam attenuation capacity being greater than the second electron or X-ray beam attenuation capacity by a multiple that is greater than <NUM>.