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10/12/06 - USPTO Class 604 |  54 views | #20060229560 | Prev - Next | About this Page  604 rss/xml feed  monitor keywords

Apparatus for delivery of therapeutic and/or diagnostic agents

USPTO Application #: 20060229560
Title: Apparatus for delivery of therapeutic and/or diagnostic agents
Abstract: A system for delivery of therapeutic and/or diagnostic agents into a living body includes a port assembly having a cannula extending from the mounting side, a port opening away from the mounting side and a resilient barrier between the port and the cannula. An access hub includes a connector positionable at the port for opening the resilient barrier. The access hub is movable in the port assembly, is engaged therewith through a resilient ring coupling and forms a seal with the resilient barrier, reducing the amount of volume to be primed. Inserters, both disposable and reusable, include the cannula insertion member as part of the assembly. A spring loaded port driver is operatively mounted within the housing with movement controlled by a latch. The driver includes a seat for receipt of a port assembly. The cannula insertion member is nonremovably fixed in a socket in the port driver in the disposable assembly. In the reusable inserter, the cannula insertion member is slidably mounted within a socket associated with the latch. Slidable movement is limited by locking shoulders. The socket is split and may be splayed to release the cannula insertion member following use.
(end of abstract)
Agent: Connolly Bove Lodge & Hutz LLP - Wilmington, DE, US
Inventors: April Marano-Ford, Susan McConnell-Montalvo, Jeffrey F. Field
USPTO Applicaton #: 20060229560 - Class: 604156000 (USPTO)

Related Patent Categories: Surgery, Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.), Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin, Material Introduced Or Removed Through Conduit, Holder, Or Implantable Reservoir Inserted In Body, Conduit Forced Into Body By Self-acting Fluid Pressure, Motor-driven, Or Mechanical Energy Storing Means
The Patent Description & Claims data below is from USPTO Patent Application 20060229560.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords



[0001] This is a divisional of U.S. patent application Ser. No. 11/300,005 filed Dec. 13, 2005; which is a divisional of U.S. patent application Ser. No. 11/040,544 filed Jan. 20, 2005, now U.S. Pat. Nos. 6,991,619; 11/040,590 filed Jan. 20, 2005 now U.S. Pat. Nos. 6,991,620; and 11/040,550 filed Jan. 20, 2005 now U.S. Pat. No. 7,022,108, which are divisional applications of U.S. Ser. No. 10/435,620, filed May 9, 2003, now U.S. Pat. No. 6,926,694, issued Aug. 9, 2005, all to the same inventors, the disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] The field of the present invention is devices for the delivery or placement of therapeutic or diagnostic agents into a living body.

[0003] Some medical procedures employ the infusion of therapeutic agents into living bodies over periods of time, making a syringe inconvenient and/or inappropriate. Such procedures have been used for the infusion of insulin, for example. In other cases, monitoring of internal body conditions with small sensors or other devices also makes syringes and like devices inappropriate for continuing access to subcutaneous tissue. To provide access in either circumstance, ports have been devised which provide support for a flexible cannula implanted in the body. Ports typically provide a housing which has a mounting side that is held by tape, dressings or direct adhesive against the body. A flexible cannula extends from the housing into the body.

[0004] Ports used for infusion may be employed in combination with a delivery tube extending to the housing of the port and in communication with the cannula as a complete infusion set. The delivery tube of such an infusion set is in communication with the flexible cannula through an infusion fluid chamber in the port to deliver therapeutic agents. Diagnostic agents such as biosensors may be delivered in like manner.

[0005] To place such ports or infusion sets including such ports, insertion sets have been used. An insertion set typically includes the port and necessarily includes a rigid sharp such as a needle which is placed through the flexible cannula for insertion into the body. The needle typically extends through a resilient barrier such as a resealable resilient mass, through a chamber and then axially through the cannula. Once the cannula has been positioned in the body, the port is positioned and the needle can be withdrawn. The resealing of the mass as the needle is withdrawn prevents fluid from leaking from the port while remaining in position at the site. Once the port has been placed with the flexible cannula extending into the body, the agent or agents can be delivered.

[0006] A first type of insertion set includes an infusion set having the port and a delivery tube in communication with the cannula. The insertion set needle accesses the housing through a different path than the delivery tube. The seal is typically bypassed by the delivery tube in this instance. Alternatively, the insertion set is used with a port rather than a complete infusion set. The delivery tube is placed after insertion of the port to complete an infusion set. The same path is used for the insertion needle as part of the insertion set as is used for communicating the tube of the infusion set with the cannula. In this latter case, the delivery tube is associated with a hub which includes a member able to pierce a resealable resilient mass for communication between the delivery tube and the cannula once the insertion set has been disassembled through retraction of the needle.

[0007] Mechanisms referred to as inserters have been devised to rapidly insert the needle and cannula into the body at the site. For the infusion of insulin in particular, diabetics self medicate. Consequently, they, a family member or other care provider places the port for infusion. This can be emotionally and physically difficult when repeated infusions are required over long periods of time. Inserters alleviate this burden somewhat by making the placement of the needle automatic and quick. Further, pressure by the inserter about the targeted site reduces the sensation of pain.

[0008] Inserters typically include a housing with a driver slidable in the housing. The driver includes a socket to receive the insertion set. A spring is operatively placed between the housing and the driver to advance rapidly an insertion set positioned in the socket. A latch then controls the advancement of the driver. One complete system including an infusion port, an insertion set having the infusion port and an insertion needle, and an inserter is illustrated in U.S. Pat. No. 6,293,925.

SUMMARY OF THE INVENTION

[0009] The present invention is directed to a system for the delivery of therapeutic and/or diagnostic agents and components therefore. A port assembly includes a base having a mounting side with a port opening away from the mounting side and a cannula extending from the mounting side. A resilient barrier with a hole therethrough is located between the port and the cannula to control communication therebetween. An access hub includes a connector which can be positioned in the port such that the hole in the resilient barrier is closed with the connector displaced from being positioned in the port and open with the connector fully positioned in the port. An inserter for the port assembly includes a housing, a latch movably positioned in the housing, a port driver slidably mounted in a housing and a spring operatively between the housing and the port driver. The latch selectively engages the port driver in a first position with the spring in a stressed state and is disengaged with the port driver in a second position.

[0010] Accordingly, it is an object of the present invention to provide an improved system for delivery of therapeutic and/or diagnostic agents into a living body. Other and further objects and advantages will appear hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a plan view of a port assembly.

[0012] FIG. 2 is a side view of the port assembly of FIG. 1.

[0013] FIG. 3 is a cross-sectional view of the port assembly of FIG. 1 taken through the axis thereof along line 3-3 of FIG. 2.

[0014] FIG. 4 is a cross-sectional view of the port assembly taken at 900 to the cross-sectional view of FIG. 3.

[0015] FIG. 5 is a detail view as seen in FIG. 3.

[0016] FIG. 6 is a perspective view of a resilient barrier.

[0017] FIG. 7 is a cross-sectional view of the resilient barrier.

[0018] FIG. 8 is a perspective view of a second port assembly.

[0019] FIG. 9 is a cross-sectional view of the port assembly of FIG. 8 taken through the axis.

[0020] FIG. 10 is a cross-sectional view of a third port assembly also taken through the axis of the assembly.

[0021] FIG. 11 is a perspective view of a port inserter.

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