CA2566691A1 - Apparatus and method for delivery of therapeutic and/or diagnostic agents - Google Patents

Apparatus and method for delivery of therapeutic and/or diagnostic agents Download PDF

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Publication number
CA2566691A1
CA2566691A1 CA002566691A CA2566691A CA2566691A1 CA 2566691 A1 CA2566691 A1 CA 2566691A1 CA 002566691 A CA002566691 A CA 002566691A CA 2566691 A CA2566691 A CA 2566691A CA 2566691 A1 CA2566691 A1 CA 2566691A1
Authority
CA
Canada
Prior art keywords
port
inserter
port assembly
insertion member
cannula
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002566691A
Other languages
French (fr)
Other versions
CA2566691C (en
Inventor
April Marano-Ford
Susan Mcconnell-Montalvo
Jeffrey Field
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MEDSOLVE TECHNOLOGIES Inc
Original Assignee
Medsolve Technologies, Inc.
April Marano-Ford
Susan Mcconnell-Montalvo
Jeffrey Field
Medsolve Technologies, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medsolve Technologies, Inc., April Marano-Ford, Susan Mcconnell-Montalvo, Jeffrey Field, Medsolve Technologies, Llc filed Critical Medsolve Technologies, Inc.
Publication of CA2566691A1 publication Critical patent/CA2566691A1/en
Application granted granted Critical
Publication of CA2566691C publication Critical patent/CA2566691C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A system for delivery of agents into a living body includes a port assembly (20) having a cannula (34) extending from the mounting side (24), a port opening (26) away from the mounting side (24) and a resilient barrier (42) between the port (26) and the cannula.(34). An access hub (58) includes a connector (60) positionable at the port (26) for opening the resilient barrier (42).The access hub (58) is movable in the port assembly (20), is engaged therewith through a resilient ring coupling (76) and forms a seal with the resilient barrier (42), reducing the amount of volume to be primed. Inserters (148), both disposable and reusable, include the cannula insertion member (238) as part of the assembly. A spring loaded port driver (216) is operatively mounted within the housing (150)with movement controlled by a latch (176).

Claims (38)

1. A system for delivery of therapeutic and/or diagnostic agents into a living body comprising a port assembly including a base having a mounting side, a port opening away from the mounting side, a cannula extending from the mounting side and a resilient barrier between the port and the cannula controlling communication between the port and the cannula;
an access hub including a connector positionable in the port at the resilient barrier, a fitting and a passage extending in the access hub through the fitting and the connector, the resilient barrier being open with the connector positioned in the port.
2. The system of claim 1, the resilient barrier being a valve including a resilient body with a slit therethrough, the slit being closed when unstressed.
3. The system of any of claims 1 and 2, the connector not extending through the resilient barrier with the connector positioned fully into the port.
4. The system of any of claims I through 3, the resilient barrier being in sealing contact with the connector about the passage with the connector positioned fully into the port.
5. The system of any of claims 1 through 4, the access hub being engageable with the port assembly and pivotable relative to the port assembly with the connector positioned in the port.
6. The system of further comprising a radially resilient bearing ring retained on one of the port assembly and the access hub; and an annular surface on the other of the port assembly and the access hub engageable with the radially resilient bearing ring, the bearing ring having radial stress against the annular surface with the access hub and the port assembly engaged to bias the connector to be positioned in the port.
7. The system of any of claims 1 through 6, the access hub further including a tab pivotally mounted to the access hub and including a first position against the base and a second position extending outwardly from the base.
8. The system of any of claims 1 through 7, the access hub further including a hub periphery with cut-outs diametrically opposed exposing the port assembly and having undercut sides.
9. An inserter for a port assembly, comprising a housing assembly including a housing having a bore and a latch;
a port driver slidably mounted in the bore and including a seat for receiving the port assembly and a socket;
a cannula insertion member retained in the socket;
a spring operatively between the housing and the port driver, the latch being selectively engageable with the port driver with the spring in a stressed state.
10. The inserter of claim 9, the housing further having a mount in the bore, the latch being held by the mount from moving toward the port driver, the spring being operatively between the mount and the port driver.
11. The inserter of claim 10, the latch including hooks, a first position with the hooks engaged with the port driver and a second position with the hooks disengaged from the port driver.
12. The inserter of claim 11, the first and second positions being angularly displaced.
13. The inserter of any of claims 9 through 12, the housing further including a stop at the end of the bore proximate the seat extending to limit sliding motion of the port driver and not to limit motion of the port assembly positioned on the seat.
14. The inserter of any of claims 9 through 13 further comprising a cover on the latch, the cover being removable from the latch and lockable in the end of the bore proximally the port driver, the cover including a container for the cannula insertion member.
15. The inserter of claim 14, the container having a skew side deflecting the cannula insertion member rigidly fixed in the socket with the container locked in the end of the bore.
16. The inserter of any of claims 9 through 15, the socket for rigidly fixing the cannula insertion member to the driver including a bonding agent therein.
17. The inserter of claims 9 through 16, the socket further releasably retaining the cannula insertion member, the socket having a passageway with an open end proximate the seat and a shoulder extending into the passageway at the open end.
18. The inserter of claim 17, the socket releasably retaining the cannula insertion member being split along the passageway.
19. The inserter of claims 9 through 17 further comprising a retainer on the port driver to engage the port assembly with minimal release force.
20. The inserter of claim 19, the retainer having a minimal interference fit with the port assembly.
21. The inserter of claim 20, the retainer being a circular ring on the seat.
22. A delivery system comprising a port assembly;
an inserter including a housing having a bore, a latch located in the bore and having a socket with a passageway having an open end and a stop, a port driver slidably mounted in the bore and having a seat, a resilient member operatively between the housing and the port driver, the latch being held in the housing and extendable to selectively engage the port driver with the resilient member in a stressed state, the port assembly being positioned in the seat, and a cannula insertion member having a needle extending through the port assembly and a needle hub slidable in the passageway a distance limited by the stop and fixed to the needle through the open end, the seat receiving the port assembly.
23. The port delivery system of claim 22, the socket for retaining the cannula insertion member being split along the passageway into first and second socket elements, the latch having a web extending across the bore and levers on one side of the web, the socket elements being on the other side of the web and aligned with the levers so that forcing the levers toward one another moves the socket elements apart to release the needle hub from the stop.
24 24. The port delivery system of any of claims 22 and 23, the inserter further having a retainer on the port driver engageable with the port assembly with minimal release force.
25. The port delivery system of any of claims 22 through 24, the port driver having a retainer for minimal interference fit with the port assembly.
26. The port delivery system of claim 25, the retainer being a circular ring on the seat, the port assembly having a circular channel receiving the circular ring.
27. The port delivery system of any of claims 22 through 26, the port driver being separable from the port assembly and inseparable from the cannula insertion member.
28. The port delivery system of claim 27, the port assembly including a base having a mounting side and a cannula extending from the mounting side, the port assembly being releasably retained in the seat on the port driver by the fit between the cannula insertion member and the cannula.
29. The port delivery system of claim 28, the mounting side having adhesive, the adhesive having a greater separation force when placed than the retention force of the fit between the cannula insertion member and the cannula.
30. The port delivery system of any of claims 22 through 29 further comprising an access hub including a connector, the port assembly including a base having a mounting side, a port opening away from the mounting side and a cannula extending from the base; the seat receiving the port assembly, the cannula insertion member being positionable at the port with the port assembly in the seat, the connector being positionable at the port with the port assembly separated from the seat.
31. The delivery system of claim 30 further comprising a first closure removably mounted to the housing across the bore, the seat facing the first closure;
a second closure removably mounted to the housing across the bore at the opposite end of the housing from the first closure.
32. The delivery system of claim 31, the first and second closures being peel-off sheets adhered to the housing around the bore.
33. The delivery system any of claims 22 through 32, the socket for retaining the cannula insertion member being split along the passageway into first and second socket elements, the latch having a web extending across the bore and levers on one side of the web, the socket elements being on the other side of the web and aligned with the levers so that forcing the levers toward one another moves the socket elements apart to release the needle hub from the stop.
34. A method for placing and connecting a port including a port assembly with a base having a mounting side, a cannula, a port opening away from the mounting side and a resilient barrier in communication with the cannula, using an inserter having a cannula insertion member, a socket securely receiving the cannula insertion member and a spring loaded port driver with a seat receiving the port assembly, and using a hub, the hub having a connector in communication with the port with the port assembly and the hub engaged, comprising placing the inserter with a port assembly at the site;
releasing the spring loaded port driver to advance the base to the site;
withdrawing the inserter from the site including retaining the cannula insertion member with the socket and leaving the port assembly at the site;
engaging the hub with the port assembly including movably mounting the hub with the base and opening the resilient barrier after withdrawing the inserter.
35. The method of claim 34 further comprising securely fixing the cannula insertion member in the socket;
placing the port assembly in the seat with the cannula insertion member extending through the cannula;
forcing the port driver against the spring to compress the spring;
latching the port driver in the bore with the spring compressed.
36. The method of claim 35 further comprising sealing the ends of the bore after latching the port driver, assembling the port assembly with the cannula insertion member and placing the port assembly.
37. The method of claim 35 further comprising placing the inserter at the site;
releasing the spring loaded port driver to advance the port to the site;
withdrawing the inserter from the site including retaining the cannula insertion member in the socket and leaving the port assembly at the site.
38. The method of claim 37, the inserter further having a cover, the method further comprising placing the cover over the cannula insertion member including locking it to the inserter.
CA2566691A 2003-05-09 2004-05-07 Apparatus and method for delivery of therapeutic and/or diagnostic agents Expired - Fee Related CA2566691C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/435,620 US6926694B2 (en) 2003-05-09 2003-05-09 Apparatus and method for delivery of therapeutic and/or diagnostic agents
US10/435,620 2003-05-09
PCT/US2004/014207 WO2004101071A2 (en) 2003-05-09 2004-05-07 Infusion hub assembly and inserter

Publications (2)

Publication Number Publication Date
CA2566691A1 true CA2566691A1 (en) 2004-11-25
CA2566691C CA2566691C (en) 2010-03-16

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Family Applications (1)

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CA2566691A Expired - Fee Related CA2566691C (en) 2003-05-09 2004-05-07 Apparatus and method for delivery of therapeutic and/or diagnostic agents

Country Status (4)

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US (7) US6926694B2 (en)
EP (1) EP1622663A4 (en)
CA (1) CA2566691C (en)
WO (1) WO2004101071A2 (en)

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US20050261629A1 (en) 2005-11-24
US6926694B2 (en) 2005-08-09
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US7022108B2 (en) 2006-04-04
US6991620B2 (en) 2006-01-31
US20050131347A1 (en) 2005-06-16
CA2566691C (en) 2010-03-16
US6991619B2 (en) 2006-01-31
US20050119611A1 (en) 2005-06-02
US20060229559A1 (en) 2006-10-12
EP1622663A2 (en) 2006-02-08
WO2004101071A2 (en) 2004-11-25
US7128730B2 (en) 2006-10-31
WO2004101071A3 (en) 2005-02-10
US20050256456A1 (en) 2005-11-17

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