Injection system with hidden needles

• US 7,618,396 B2
• Filed: 08/09/2006
• Issued: 11/17/2009
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Avant Medical Corporation
• Original Assignee: Avant Medical Corporation
• Inventors: Magers, Corey M., Barnes, Andrew C., Slate, John B.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/463,529
• Publication Number:
  US 20080039795A1
• Time in Patent Office: 1,196 Days
• Field of Search: 604/130, 604/72, 604/181, 604/68, 604/183, 604/136, 604135-139, 604/62, 604/65, 604/184, 604194-195, 604/201, 604/232, 604/187, 600/432, 206/364, 206/380, 206/382, 297/77
• US Class Current: 604/136
• CPC Class Codes: A61M 2005/004 Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An auto-injector confines all functional components inside an enclosed housing, to keep its needle out-of-sight, at all times. Within the housing, a needle holder positions a needle at a location. A drive mechanism then simultaneously engages the needle with a fluid source and accelerates it with a predetermined momentum for insertion into a patient. After fluid delivery, the withdrawn needle is moved to storage within the housing for subsequent disposal.

Claims

1. An auto-injector for injecting a fluid into a patient which comprises:

a housing formed with an interior;

a fluid reservoir mounted on said housing;

at least one needle held in the interior of said housing, wherein each needle has a sharp proximal end and a sharp distal end;

a means mounted in the interior of said housing for positioning a needle at a location therein;

a fluid transfer section formed with a fluid chamber and mounted in the interior of said housing, the fluid chamber having an input port and an output port, wherein said input port is in fluid communication with the fluid reservoir, and wherein a septum covers the output port;

a flexible hose connected to said input port and to said fluid reservoir to establish fluid communication between said fluid reservoir and the fluid chamber of said transfer section; and

a means mounted in the interior of said housing for moving the fluid transfer section from a position wherein the needle is at a distance from the fluid transfer section to the location of the needle where the septum is pierced with the sharp proximal end of the needle, and to position the proximal end of the needle in the fluid chamber to establish fluid communication between the fluid reservoir and the needle, and for thereafter moving the needle with the fluid transfer section from the location to extend the sharp distal end of the needle outside said housing for insertion into the patient to inject the fluid into the patient, wherein said fluid reservoir remains stationary while said needle moves relative to the fluid reservoir from the location into the patient.

2. An auto-injector as recited in claim 1 wherein a needle for use in the auto-injector comprises:

an elongated hypodermic needle defining an axis and having a proximal end and a distal end; and

a collar mounted on said hypodermic needle between the proximal end and the distal end thereof, with said collar extending radially outward therefrom for contact with said fluid transfer section to limit axial movement of the needle in a proximal direction relative to said transfer section during insertion of the proximal end of the needle through the septum and into the fluid chamber thereof, and for contact with said housing to limit axial movement of the needle in a distal direction relative to said housing during insertion of the distal end of the needle into the patient.

3. An auto-injector as recited in claim 1 wherein said moving means comprises:

a drive rod mounted in the interior of said housing; and

a means for accelerating said drive rod into contact with an engaging means to connect the needle with said engaging means.

4. An auto-injector as recited in claim 1 wherein said positioning means is a holder mounted in the interior of said housing for movement into an orientation with a first station positioned to retrieve a sterile needle, with a second station positioned to present a sterile needle at the location for engagement of the needle in fluid communication with said fluid reservoir, and with a third station positioned for removal of a used needle from said holder for storage.

5. An auto-injector as recited in claim 1 wherein said positioning means is a holder mounted in the interior of said housing for movement along a first path to retrieve a sterile needle for placement of the needle at the location where fluid communication is established between the needle and the fluid reservoir, and for movement along a second path to deposit the needle, after use, for storage in the interior of said housing.

6. A system for injecting a fluid into a patient which comprises:

a housing formed with an interior;

a fluid reservoir mounted on said housing;

a magazine mounted on said housing for holding at least one needle;

a means mounted in the interior of said housing for moving a needle of said magazine to a location for fluid communication engagement with said fluid reservoir, with said needle having a sharp proximal end and a sharp distal end;

a fluid transfer section formed with a fluid chamber and mounted in the interior of said housing for movement relative to the needle, the fluid chamber having an input port and an output port, wherein said input port is in fluid communication with the fluid reservoir, and wherein a septum covers the output port;

a flexible hose connected to said input port and to said fluid reservoir to establish fluid communication between said fluid reservoir and the fluid chamber of said transfer section; and

a drive mechanism mounted inside said housing to drive the fluid transfer section from a position wherein the needle is at a distance from the fluid transfer section to the location of the needle and into contact with the needle to pierce the septum with the sharp proximal end of the needle, to position the proximal end of the needle in the fluid chamber of the fluid transfer section to establish fluid communication between the needle and the fluid reservoir, and to thereafter accelerate the needle with the fluid transfer section from the location for insertion of the sharp distal end of the needle into the patient, wherein said fluid reservoir remains stationary while said needle moves relative to the fluid reservoir from the location into the patient; and

a plunger mounted inside said housing for ejecting fluid from said fluid reservoir and through said needle into the patient after said needle is moved into the patient.

7. A system as recited in claim 6 wherein said moving means is a cassette formed to hold a plurality of said needles, said cassette being moveable in the interior of said housing to sequentially present a needle at the location.

8. A system as recited in claim 6 further comprising a vacuum system for stabilizing the skin of the patient at an injection site during an injection.

9. A system as recited in claim 6 wherein a needle for use in the system comprises:

an elongated hypodermic needle defining an axis; and

a collar mounted on said hypodermic needle between the proximal end and the distal end thereof, with said collar extending radially outward therefrom for contact with said transfer section to limit proximal movement of the needle relative to said transfer section during insertion of the proximal end of the needle through the septum and into the fluid chamber thereof, and for contact with said housing to limit distal movement of the needle relative to said housing during insertion of the distal end of the needle into the patient.

10. A system for injecting a fluid into a patient which comprises:

a housing formed with an interior;

a fluid reservoir mounted on said housing;

a magazine mounted on said housing for holding at least one needle;

a means for moving a needle of said magazine to a location, wherein the needle has a mass (m_needle) and a sharp proximal end and a sharp distal end;

a fluid transfer section formed with a fluid chamber and mounted in the interior of said housing for movement relative to the needle, the fluid chamber having an input port and an output port, wherein said input port is in fluid communication with the fluid reservoir, and wherein a septum covers the output port;

a flexible hose connected to said input port and to said fluid reservoir to establish fluid communication between said fluid reservoir and the fluid chamber of said transfer section and to mechanically isolate the fluid transfer section and the septum from the fluid reservoir;

a drive means mounted in the interior of said housing for accelerating a drive rod with a mass (m_rod) to a velocity (v_rod) to push the fluid transfer section from a position wherein the needle is at a distance from the fluid transfer section to the location of the needle and into contact with the needle with a predetermined momentum (m_rodv_rod), to pierce the septum with the sharp proximal end of the needle, to position the proximal end of the needle in the fluid chamber of the fluid transfer section to establish fluid communication between the fluid reservoir and the needle, and to transfer momentum from the drive rod to the needle and fluid transfer section for insertion of the sharp distal end of the needle into the patient, wherein said fluid reservoir remains stationary relative to the fluid reservoir while said needle is inserted into the patient; and

a plunger mounted in the interior of said housing for ejecting fluid from said fluid reservoir and through said needle into the patient after said needle is inserted into the patient.

11. A system as recited in claim 10 wherein the mass of the drive rod is much greater than the mass of the needle (m_rod>

>

m_needle).

12. A system as recited in claim 11 wherein the needle, the fluid transfer section, and the septum have a combined mass (m_combined).

13. A system as recited in claim 12 wherein the predetermined momentum results in a final velocity (v_f) for the needle wherein (m_rodv_rod) is substantially equal to m_combinedv_f.

14. A housing with a system mounted thereon for injecting a fluid medicament into a patient, said system comprising:

an elongated hypodermic needle defining an axis and having a sharp proximal end and a sharp distal end;

a fluid reservoir mounted on the housing;

a fluid transfer section formed with a fluid chamber and positioned for movement along a pathway inside the housing, said fluid chamber having an input port and an output port, wherein a septum covers the output port;

a flexible hose interconnecting the input port of the transfer section with the fluid reservoir to establish fluid communication between the fluid reservoir and the needle;

a collar mounted on the hypodermic needle between the proximal end and the distal end thereof with the collar extending radially outward from the needle, wherein the collar limits travel of the needle along the pathway inside the housing between a first position wherein the proximal end of the needle is at a distance from the fluid transfer section and a second position wherein the sharp proximal end of the needle is engaged in fluid communication with the fluid reservoir and the sharp distal end of the needle is inserted into the patient for infusion of the fluid medicament from the reservoir to the patient while said fluid reservoir remains stationary relative to movement of the fluid transfer section; and

a means for driving the fluid transfer section into contact with the needle at the first position to pierce the septum with the needle and to position the sharp proximal end of the needle in the chamber of the fluid transfer section when the collar abuts against the fluid transfer section to establish fluid communication between the needle and the fluid source, and for moving the needle from the first position to the second position.

15. A system as recited in claim 14 wherein the proximal end of the needle is sharp and the distal end of the needle is sharp.

16. A system as recited in claim 14 further comprising an abutment formed on the housing for contact with the collar to limit axial movement of the needle in a distal direction relative to the housing during insertion of the distal end of the needle into the patient.

17. A system as recited in claim 16 further comprising a recoil mechanism mounted on the abutment for engagement with the collar to bias the needle in a proximal direction relative to the housing for subsequent withdrawal of the needle from the patient when the needle is in its second position.

18. A system as recited in claim 17 wherein the recoil mechanism is a spring.

19. A system as recited in claim 14 wherein the needle and the collar, in combination, establish a needle unit, and wherein the system incorporates a plurality of needle units and the system further comprises a holder mounted on the housing to sequentially present each needle unit for individual travel along the pathway and to subsequently remove the needle unit from the pathway.

20. An injector which comprises:

a fluid source fixed on the injector;

an elongated hypodermic needle defining an axis and having a sharp proximal end and a sharp distal end;

a disk-shaped collar mounted on said hypodermic needle between the proximal end and the distal end thereof with the collar extending radially outward from the needle;

a fluid transfer section formed with a fluid chamber and mounted on the injector for movement relative to the needle from a position wherein the needle is at a distance from the fluid transfer section to the location of the needle to a location wherein the needle is in fluid communication with the fluid chamber, the fluid chamber having an input port and an output port, wherein said input port is in fluid communication with the fluid source, and wherein a septum covers the output port; and

a means operable with the collar for simultaneously connecting the sharp proximal end of the needle in fluid communication with the fluid source by piercing the septum with the needle and positioning the proximal end of the needle in the fluid chamber of the fluid transfer section and for inserting the sharp distal end of the needle into a body for injecting fluid from the fluid source through the needle and into the body while said fluid source remains stationary relative to movement of the fluid transfer section, wherein the connecting and inserting means comprises a flexible hose interconnecting the input port of the transfer section with the fluid source to establish fluid communication between the fluid source and the needle.

21. An injector as recited in claim 20 wherein the needle and collar, in combination, are mounted on a housing and wherein the connecting and inserting means comprises:

an abutment formed on the housing for engagement with the collar to limit axial movement of the needle in a distal direction relative to the housing during insertion of the distal end of the needle into the body; and

a recoil means mounted on the abutment for engagement with the collar to bias the needle in a proximal direction relative to the housing for subsequent withdrawal of the needle from the body.

22. An injector as recited in claim 21 wherein the body is a patient and the housing prevents visual contact by the patient with the needle.