Safety sterile cartride unit apparatus and methods

• US 6,036,675 A
• Filed: 02/03/1999
• Issued: 03/14/2000
• Est. Priority Date: 02/03/1999
• Status: Expired due to Fees

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L., Thorne, Gale H.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/243,761
• Time in Patent Office: 405 Days
• Field of Search: 604/110, 604/181, 604/187, 604/192, 604/198, 604/218, 604/228, 604/200, 604/201, 604/232, 604/234, 604/263, 604/221, 128/919
• US Class Current: 604/232
• CPC Class Codes: A61M 2005/2411 from the front
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
• CPC Class Codes: Y10S 128/919 Syringe, means to protect user

Abstract

A low cost safety sterile cartridge injector apparatus comprising an injector and a safety needle sheath having elements which promote facile assembly and disassembly. An embodiment is disclosed which incorporates an integral needle hub and safety sheath which is displaced to protectively cover a medical needle after use. The sheath also incorporates patterns of rachet teeth which cooperate with a holder portion of the injector to lock a sterile cartridge in place for use in a medical procedure and to release the cartridge for facile disposal when the sheath is displaced to cover and protectively shroud the needle after use. Through this process, need for rotary collars to capture and hold the cartridge in place during use is eliminated, reducing injector cost and apparatus assembly steps and time.

Claims

1. A sterile cartridge injector apparatus comprising:

a sterile cartridge assembly comprising an elongated syringe housing comprising a first end comprising a penetrable seal which, until penetrated, is impermeable to passage of liquids, a second open end disposed opposite said first end, a volume for containing a bolus of dispensable liquid disposed between the first and second ends and a slideable plunger seal disposed between the volume and the second end;

said plunger seal comprising a releasible attachment whereby a plunger rod is temporarily affixed for use in forcing displacement of the plunger seal through the housing to displace the liquid;

a sterile cartridge receptacle comprising an elongated cartridge holder wherein said sterile cartridge assembly is reolaceably disposed for use, a proximal end associated with said second open end through which said sterile cartridge assembly is linearly proximally displaceable into the receptacle, said proximal end comprising an abutment which retards proximal displacement of the sterile cartridge assembly toward a user and a distal end associated with said first end;

the abutment comprising a hole through which the plunger rod communicates with the plunger seal;

the plunger rod member comprising an elongated stem for communicating with the plunger seal through the hole, a distally disposed connector for releasibly affixing the plunger seal to the releasible attachment and a digital interface for facile displacement of the plunger rod relative to the receptacle;

the distal end of the sterile cartridge receptacle further comprising at least one distally extending arm which comprises a catch;

a needle hub assembly comprising;

a medical needle comprising a proximally disposed sharpened tip for penetrating said seal for access to the bolus of dispensable liquid and a distally disposed sharpened tip for percutaneous entry into a patient;

a needle hub comprising a latch interface which cooperates with said catch to securely, but releasibly, affix said needle hub assembly to said receptacle for the purpose of retaining the sterile cartridge assembly within the receptacle for the purposes of dispensing liquid therefrom.

2. A sterile cartridge injector and needle hub safety apparatus for a disposable sterile cartridge unit, said apparatus comprising:

an sterile cartridge injector comprising;

a sterile cartridge receptacle comprising an elongated cartridge holder wherein a disposable sterile cartridge unit is disposed for use in a medical application, a proximal end comprising an abutment which retards displacement of the sterile cartridge assembly toward a user and a distal end associated with a needle hub assembly;

a plunger rod, associated with said receptacle, which connectively interfaces with a plunger of the sterile cartridge unit to displace the plunger for the purpose of dispensing fluid from the sterile cartridge unit;

said distal end comprising a receiving connection whereby said sterile cartridge receptable is securely affixed to the needle hub assembly; and

the needle hub assembly comprising;

a medical needle;

a needle hub in which said needle is securely affixed;

a displaceable safety sheath securely affixed to said needle hub and disposed to permit access to said medical needle while the needle is used in a medical procedure and displaced and securely latched to provide a protective cover for said medical needle after the procedures;

an engaging connection comprising a selectively engageable catch which, in combination with said receiving connection, securely affixes said hub assembly to said sterile cartridge receptacle until the displaceable safety sheath is displaced and securely latched to provide the protective cover for the medical needle whereupon the selectively engageable catch is released from engagement with the receiving connection permitting the needle hub assembly to be separated from the sterile cartridge assembly.

3. A sterile cartridge injector and needle hub safety apparatus according to claim 2 wherein said needle hub and said displaceable sheath are formed as a single integrally molded part.

4. A sterile cartridge injector and needle hub safety apparatus according to claim 2 wherein said medical needle comprises a permanent attachment to said needle hub.

5. A sterile cartridge injector and needle hub safety apparatus according to claim 2 wherein said safety sheath comprises a member which pivots about an axis to engage and provide the protective cover for the medical needle.

6. A sterile cartridge injector and needle hub safety apparatus for a disposable sterile cartridge unit, said apparatus comprising:

a sterile cartridge injector comprising;

a sterile cartridge receptacle comprising an elongated cartridge holder wherein a disposable sterile cartridge unit is disposed for use in a medical application, a proximal end comprising an abutment which retards displacement of the sterile cartridge unit toward a user and a distal end associated with a needle hub assembly;

a plunger rod, associated with said receptacle, which connectively interfaces with a plunger of the sterile cartridge unit to displace the plunger for the purpose of dispensing fluid from the sterile cartridge unit;

the needle hub safety assembly comprising;

a medical needle;

a needle hub in which said needle is securely affixed;

a displaceable safety sheath securely affixed to said needle hub and disposed to permit access to said medical needle while the needle is used in a medical procedure and displaced and securely latched to provide a protective cover for said medical needle after the procedure, said safety sheath comprising a member which pivots about an axis to engage and provide the protective cover for the medical needle;

said member comprising at least one exterior face which comprises a circular pattern of raised ratchet teeth having a radius of curvature which extends to each tooth from the center of the pivotal axis.

7. A sterile cartridge injector and needle hub safety apparatus according to claim 6 wherein said distal end of said holder comprises at least one distally extending arm comprising a series of ratchet teeth, each series of ratchet teeth cooperating with one of said circular patterns of ratchet teeth to provide a ratchet connector when said sheath is disposed to permit use of said medical needle with a sterile cartridge in a medical procedure, thereby securely, but releasibly, affixing said safety sheath and the medical needle and a sterile cartridge unit, disposed in said holder, to said holder.

8. A sterile cartridge injector and needle hub safety apparatus according to claim 7 wherein said at least one exterior face comprises an area which is void of said pattern and which juxtaposes said series of teeth when said sheath is pivoted to shroud said needle and, thereby, disengaging the ratchet connector.

9. A method for assembling a sterile cartridge into a sterile cartridge injector and needle hub apparatus for use in a medical procedure comprising the steps of:

providing a sterile cartridge unit comprising a bolus of dispensable liquid;

providing the sterile cartridge injector and needle hub apparatus, said apparatus comprising;

a sterile cartridge injector comprising;

a plunger rod which connectively interfaces with a plunger of the sterile cartridge unit plunger;

a sterile cartridge receptacle comprising a cartridge holder having an elongated channel along the long axis of the elongated channel along which said sterile cartridge unit is disposed for use in a medical application, a proximal end comprising an abutment which retards displacement of the sterile cartridge unit toward a user and a distal end associated with a needle hub assembly, said distal end comprising an open channel and a slideably engageable catch;

the needle hub assembly comprising;

a medical needle;

a needle hub in which said needle is securely affixed; and

a slideably engageable latch apparatus which securely, but releasibly, engages said catch apparatus when said needle hub assembly is displaced to be used with said injector, thereby securely affixing the needle hub assembly to the sterile cartridge;

slideably displacing a sterile cartridge in a linear proximal direction into the open channel in parallel with the long axis into said receptacle;

linearly displacing said needle hub assembly latch into contact with said slidably engageable catch to securely affix said cartridge and medical needle in a stable liquid communicating state for use in a medical procedure.

10. A method for assembling a sterile cartridge into a sterile cartridge injector and needle hub apparatus for use in a medical procedure according to claim 9 wherein the sterile cartridge and needle hub apparatus providing step further comprises a step for providing a safety shroud hingeably affixed to said needle hub.

11. A method for assembling a sterile cartridge into a sterile cartridge injector and needle hub apparatus for use in a medical procedure according to claim 10 further comprising pivoting said safety shroud to enclose and protect said needle at the end of a medical procedure.

12. A method for assembling a sterile cartridge into a sterile cartridge injector and needle hub apparatus for use in a medical procedure according to claim 11 wherein said pivoting step includes a step of disengaging said latch from said catch.

13. A combination injector and medical needle hub assembly for a unit-dose sterile cartridge, said combination comprising:

an injector consisting of;

a container tray and holder for a unit-dose sterile cartridge, said container tray and holder comprising a distally disposed open end through which the unit-dose sterile cartridge can be linearly inserted and a similarly disposed, linearly engageable connector whereby a medical needle hub assembly is securely, but releasibly, affixed to the container tray and holder;

a plunger rod disposed to operate in cooperation with said container tray and holder to displace a plunger disposed within the unit-dose sterile cartridge for the purpose of dispensing liquid contents from the unit-dose sterile cartridge;

the medical needle hub assembly comprising;

a medical needle hub;

a medical needle securely affixed to said hub;

a connecting member associated with said medical needle hub which is linearly displaced relative to said container tray and holder to securely, but releasibly, engage said linearly engageable connector for the purpose of affixing the unit-dose sterile cartridge within the combination for use in a medical procedure.

14. A combination injector and medical needle hub assembly for a unit-dose sterile cartridge according to claim 13 wherein said medical needle hub assembly further comprises a safety needle sheath.

15. A combination injector and medical needle hub assembly for a unit-dose sterile cartridge according to claim 14 wherein said safety needle sheath and the connecting member are integrally formed as a single injection molded part.

16. A combination injector and medical needle hub assembly for a unit-dose sterile cartridge according to claim 14 wherein said safety needle sheath comprises a hinged attachment to said medical needle hub by which the sheath is pivoted relative to said medical needle hub assembly, first, to provide a safety sheath for said needle and, second, to disengage and release said member from said linearly engageable connector.

17. A combination injector and medical needle hub assembly for a unit-dose sterile cartridge according to claim 16 further comprising a unit-dose sterile cartridge having a distally disposed coupling and said safety needle sheath comprises a catch for the coupling whereby the safety needle sheath is securely affixed to the unit-dose sterile cartridge when the sheath is pivoted to provide the safety sheath for the medical needle.

18. A combination injector and medical needle hub assembly for a unit-does sterile cartridge according to claim 13 wherein said linearly engageable connector comprises ratchet teeth.

19. An injector for a unit-dose sterile cartridge consisting of:

a container tray and holder for a unit-dose cartridge, said tray and holder comprising a distally disposed open end through which the unit-dose cartridge can be proximally, linearly inserted into the holder and further comprising a linearly engageable connector at said open end whereby a needle hub assembly and a cartridge are securely affixed in the tray for use in a medical procedure;

a plunger rod disposed to operate in cooperation with said container tray to displace a plunger disposed within the so affixed unit-dose sterile cartridge for the purpose of dispensing liquid contents from said cartridge.

20. A needle hub assembly for an associated unit-dose sterile cartridge and a cartridge injector, said needle hub assembly comprising:

a medical needle hub;

a medical needle securely affixed to said hub;

a connecting member integrally affixed to said medical needle hub, said connecting member being linearly displaceable into a receiving connector of an associated cartridge injector to securely, but releasibly, engage and affix said connecting member with the receiving connector to thereby affix the needle hub assembly, an associated but otherwise unsrestrained, liquid containing unit-dose sterile cartridge and the further associated cartridge injector in seriatim for the purpose of dispensing liquid from the unit-dose cartridge through the medical needle.