# US 6,719,719 B2 · Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same

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- Number: US 6,719,719 B2
- Document ID: US6719719B2
- Status: Granted
- Kind: B2
- Application number: 09/863,539
- Filed: 2001-05-23
- Published: 2002-01-10
- Granted: 2004-04-13
- Earliest claimed: 1998-11-13
- Assignees: Elan Pharma International Limited
- Inventors: Ehoud Carmel; Gilad Lavi; Gil Yigal; Izrail Tsals
- Web page: https://patentgrep.com/patent/US6719719B2

## CPC

- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61J 1/2089: {Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096)}
- A61M 5/19: having more than one chamber
- A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing}
- A61J 1/201: {having one piercing end}
- A61J 1/2013: {having two piercing ends}
- A61J 1/2017: {having three or more piercing ends}
- A61J 1/2051: {having tap means, e.g. tap means activated by sliding}
- A61J 1/2058: {having multiple connecting ports}
- A61J 1/2065: {having aligning and guiding means}
- A61J 1/2082: {for gas filtration}
- A61M 5/1782: {Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003)}
- A61M 5/2046: {Media being expelled from injector by gas generation, e.g. explosive charge}
- A61M 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)}
- A61M 5/2425: {by compression of deformable ampoule or carpule wall}
- A61M 5/3234: {Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user}
- A61M 5/38: using hydrophilic or hydrophobic filters
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/3128: {Incorporating one-way valves, e.g. pressure-relief or non-return valves}
- A61M 2005/3223: {Means impeding or disabling repositioning of used needles at the syringe nozzle}
- A61M 2205/215: Tilt detection, e.g. for warning or shut-off
- A61M 2205/583: by visual feedback
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

A spike for facilitating the introduction of liquid under pressure into a container containing a substance is provided which includes an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, where the distal end has a sharp, pointed tip. An introduction channel is located within the spike shaft for receiving liquid into the container where a portion of the introduction channel is angled to cause liquid to travel out of the introduction channel in a direction non-parallel to the longitudinal axis of the spike shaft. An extraction channel may be included within the spike shaft for removing liquid from the container, where the extraction channel extends through the elongate spike shaft towards the proximally located end portion.

## Claims

### Claim 1

A spike for facilitating the introduction of liquid under pressure into a container containing a substance, said spike comprising:
(a) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;
(b) an introduction channel within said spike shaft for receiving liquid into the container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; and
(c) an extraction channel within said spike shaft for removing liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion, said extraction channel not coaxial with said introduction channel said extraction channel having an inlet opening in said spike shaft for receiving liquid from said container and said introduction channel having a diluent outlet opening in said spike shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 2 (depends on 1)

The spike of claim 1, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

### Claim 3 (depends on 1)

The spike of claim 1, wherein said introduction channel has a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

### Claim 4 (depends on 3)

The spike of claim 3, wherein said exit leg extends from said main leg perpendicular to said longitudinal axis.

### Claim 5

A device for reconstituting a substance in a first liquid to provide a resulting liquid comprising the first liquid and the substance subsequent to being reconstituted, the device, comprising:
(a) a chamber containing the first liquid under pressure;
(b) a container containing the substance, said container having at least one container side wall and a capped end, said capped end having a cap having a pierceable portion;
(c) a spike extending through said pierceable portion into said container, said spike comprising:
(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip; and
(ii) an introduction channel within said spike shaft for receiving the first liquid into said container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; and
(d) an extraction channel within said spike shaft for removing the resulting liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion, said extraction channel not coaxial with said introduction channel, said extraction channel having an inlet opening in said shaft and said introduction channel having a diluent outlet opening in said shaft and wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 6 (depends on 5)

The device of claim 5, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

### Claim 7 (depends on 5)

The device of claim 5, wherein said introduction channel has a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

### Claim 8 (depends on 7)

The device of claim 7, wherein said exit leg is perpendicular to said longitudinal axis.

### Claim 9 (depends on 5)

The device of claim 5, wherein said pierceable portion is a rubber membrane.

### Claim 10

A hand-held drug reconstitution and injection device, comprising:
(a) a diluent vial containing a diluent and having an elongate diluent vial spike extending through a diluent vial cap on said diluent vial, said diluent vial spike comprising:
(i) a distal end located inside said diluent vial, a diluent vial spike side wall, and a proximally located lower portion located outside said diluent vial;
(ii) a diluent vial spike air inlet conduit extending between an air inlet conduit opening in said proximally located lower portion and a diluent vial spike side wall opening adjacent said distal end; and
(iii) a diluent exit conduit extending between an entrance opening on said diluent vial spike side wall adjacent said distal end and an exit opening on said proximally located lower portion of said diluent vial spike;
(b) a drug vial containing a substance to be reconstituted, said drug vial having at least one drug vial side wall and a capped end, said capped end having a cap having a pierceable membrane, said drug vial having a drug vial spike extending through said drug vial cap on said drug vial, said drug vial spike comprising:
(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end located inside said drug vial, and a proximally located end portion located outside said drug vial, said distal end having a sharp, pointed tip;
(ii) an introduction channel within said spike shaft for receiving the diluent into said drug vial, a portion of said introduction channel angled to cause the diluent to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; said introduction channel having a diluent inlet opening on said proximally located end portion and a diluent outlet opening in said spike side wall adjacent said distal end; and
(iii) an extraction channel within said spike shaft for removing a reconstituted drug from said drug vial, said extraction channel extending from an extraction channel inlet opening in said spike side wall adjacent said distal end to an extraction channel outlet opening in the proximally located end portion;
(c) an air conduit extending between an air pressurizer and said air inlet conduit opening;
(d) a diluent conduit extending between said exit opening and said diluent inlet opening, for transfer of said diluent through said diluent conduit from said diluent vial to said drug vial; and
(e) a reconstituted drug conduit extending between said extraction channel outlet opening and a needle having an orifice therein for injection into a patient.

### Claim 11 (depends on 10)

The spike of claim 10, wherein said portion of said introduction channel is perpendicular to said longitudinal axis.

### Claim 12 (depends on 10)

The spike of claim 10, wherein said introduction channel has a main leg extending from said diluent inlet opening towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to said diluent outlet opening in said spike side wall.

### Claim 13 (depends on 10)

The device of claim 10, wherein said exit leg is perpendicular to said longitudinal axis.

### Claim 14 (depends on 10)

The device of claim 10, wherein said extraction channel inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 15 (depends on 10)

The device of claim 10, wherein said reconstituted drug conduit includes an air separator to separate air from the reconstituted drug prior to injection.

### Claim 16 (depends on 15)

The device of claim 15, wherein the air separator is a hydrophilic membrane.

### Claim 17 (depends on 10)

The device of claim 10, wherein the air pressurizer is a cylinder and plunger.

### Claim 18

A spike for the introduction of liquid under pressure into a container and for the withdrawing of liquid from the container, said spike comprising:
(a) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;
(b) an introduction channel within said spike shaft for receiving liquid into said container, said introduction channel including a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and an exit leg extending from said main leg to a diluent outlet opening in said spike side wall;
(c) an extraction channel within said spike shaft for removing liquid from said container, and
(d) said extraction channel having an inlet opening on said spike shaft inside the container for receiving liquid from the container and said introduction channel having a diluent outlet opening on said spike shaft for delivering liquid into said container, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 19

A method for introducing liquid under pressure into a container containing a substance, comprising the steps of:
(a) providing an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;
(b) providing an introduction channel within said spike shaft, a portion of said introduction channel angled to cause the liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;
(c) providing the liquid under pressure into said container through said introduction channel such that the liquid travels out of said spike shaft in a direction non-parallel to said longitudinal axis of said spike shaft; and
(d) providing an extraction channel within said spike shaft, said extraction channel extending through said elongate spike shaft towards said proximally located end portion and including the step of removing liquid from said container through said extraction channel.

### Claim 20 (depends on 19)

The method of claim 19, wherein the step of providing said introduction channel includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

### Claim 21 (depends on 19)

The method of claim 19, wherein said step of providing said introduction channel includes providing a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

### Claim 22 (depends on 21)

The method of claim 21, wherein said step including providing said exit leg includes providing said exit leg extending from said main leg perpendicular to said longitudinal axis.

### Claim 23 (depends on 19)

The method of claim 19, wherein said step of providing said extraction channel includes providing an inlet opening in said spike shaft for receiving liquid from said container and wherein said step of providing said introduction channel includes providing a diluent outlet opening in said spike shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 24

A method for reconstituting a substance in a first liquid to provide a resulting liquid comprising the first liquid and the substance subsequent to being reconstituted, said method comprising:
(a) providing a chamber containing the first liquid;
(b) providing a container containing the substance, said container having at least one container side wall and a capped end, said capped end having a cap having a pierceable portion; and
(c) providing a spike comprising:
(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip; and
(ii) an introduction channel within said spike shaft for receiving the first liquid into said container, a portion of said introduction channel angled to cause liquid to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft;
(d) providing a diluent conduit extending between chamber and said introduction channel of said spike, for transfer of said diluent through said diluent conduit from said chamber to said container;
(e) piercing said spike through said pierceable portion into said container; and
(f) pressurizing said first liquid in said chamber to cause said first liquid to flow from said chamber, through said diluent conduit and into said container through said introduction channel.

### Claim 25 (depends on 24)

The method of claim 24, the step of providing an extraction channel within said spike shaft for removing the resulting liquid from said container, said extraction channel extending through said elongate spike shaft towards said proximally located end portion.

### Claim 26 (depends on 24)

The method of claim 24, wherein the step of providing the introduction channel includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

### Claim 27 (depends on 24)

The method of claim 24, wherein the step of providing said introduction channel includes providing a main leg extending from said proximally located end portion towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to a diluent outlet opening in said spike side wall.

### Claim 28 (depends on 27)

The method of claim 27, wherein said step including providing said exit leg includes providing said exit leg perpendicular to said longitudinal axis.

### Claim 29 (depends on 25)

The method of claim 25, wherein said step of providing said extraction channel includes providing an inlet opening in said shaft and said step of providing said introduction channel includes providing a diluent outlet opening in said shaft, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening.

### Claim 30 (depends on 24)

The method of claim 24, wherein said step including providing said pierceable portion includes providing a rubber membrane.

### Claim 31

A method for reconstituting a drug, comprising:
(a) providing a diluent vial spike comprising:
(i) a distal end, a diluent vial spike side wall, and a proximally located lower portion;
(ii) a diluent vial spike air inlet conduit extending between an air inlet conduit opening in said proximally located lower portion and a diluent vial spike side wall opening adjacent said distal end; and
(iii) a diluent exit conduit extending between an entrance opening on said diluent vial spike side wall adjacent said distal end and an exit opening on said proximally located lower portion of said diluent vial spike;
(b) providing a diluent vial having a diluent vial cap and containing a diluent;
(c) extending said distal end of said elongate diluent vial spike through said diluent vial cap;
(d) providing a drug vial containing a substance to be reconstituted, said drug vial having at least one drug vial side wall and a capped end, said capped end having a cap having a pierceable membrane;
(e) providing a drug vial spike comprising:
(i) an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end, and a proximally located end portion, said distal end having a sharp, pointed tip;
(ii) an introduction channel within said spike shaft for receiving the diluent into said drug vial, a portion of said introduction channel angled to cause the diluent to travel out of the introduction channel in a direction non-parallel to said longitudinal axis of said spike shaft; said introduction channel having a diluent inlet opening on said proximally located end portion and a diluent outlet opening in said spike side wall adjacent said distal end; and
(iii) an extraction channel within said spike shaft for removing a reconstituted drug from said drug vial, said extraction channel extending from an extraction channel inlet opening in said spike side wall adjacent said distal end to an extraction channel outlet opening in the proximally located end portion;
(f) piercing said drug vial spike through said drug vial cap such that said distal end of said drug vial spike is located inside said drug vial and said proximally located end portion is located outside said drug vial;
(g) providing an air conduit extending between an air pressurizer and said air inlet conduit opening;
(h) providing a diluent conduit extending between said exit opening and said diluent inlet opening, for transfer of said diluent through said diluent conduit from said diluent vial to said drug vial;
(i) providing a reconstituted drug conduit extending between said extraction channel outlet opening and a needle having an orifice therein for injection into a patient; and
(j) pressurizing said diluent vial using said air pressurizer to cause air to flow through said air conduit to said air inlet conduit opening, to cause diluent to flow out of said diluent exit conduit, through said diluent conduit, and through said introduction channel to mix with said substance and to cause said reconstituted drug to flow through said extraction channel and through said orifice in said needle.

### Claim 32 (depends on 31)

The method of claim 31, wherein said step including providing said introduction channel is includes providing said portion of said introduction channel perpendicular to said longitudinal axis.

### Claim 33 (depends on 31)

The method of claim 31, wherein said step of providing said introduction channel includes providing a main leg extending from said diluent inlet opening towards said distal end, at or substantially parallel to said longitudinal axis, and providing an exit leg extending from said main leg to said diluent outlet opening in said spike side wall.

### Claim 34 (depends on 31)

The method of claim 31, wherein said step including providing said introduction channel includes providing said exit leg perpendicular to said longitudinal axis.

### Claim 35 (depends on 31)

The method of claim 31, wherein the step of providing said extraction channel includes providing said extraction channel inlet opening closer to said proximally located end portion than said diluent outlet opening.

### Claim 36 (depends on 31)

The method of claim 31, wherein said step including providing said reconstituted drug conduit includes providing an air separator to separate air from the reconstituted drug prior to injection.

### Claim 37 (depends on 36)

The method claim 36, wherein step of providing the air separator includes providing a hydrophilic membrane.

### Claim 38 (depends on 31)

The method of claim 31, wherein the step including providing an air pressurizer includes providing a cylinder and plunger.

### Claim 39

A method for introducing liquid under pressure into a container and for withdrawing liquid from the container, said method comprising:
(a) providing an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, said distal end having a sharp, pointed tip;
(b) providing an introduction channel within said spike shaft for receiving liquid into said container, said introduction channel having a diluent outlet opening on said spike shaft for delivering liquid into said container, a portion of said introduction channel being non-parallel to said longitudinal axis of said spike shaft;
(c) providing an extraction channel within said spike shaft for removing liquid from said container, said extraction channel having an inlet opening on said spike shaft inside the container for receiving liquid from the container, wherein said inlet opening is closer to said proximally located end portion than said diluent outlet opening;
(d) receiving liquid into said container through said introduction channel; and
(e) withdrawing liquid from said container through said extraction channel.