Surgery – Controlled release therapeutic device or system
Reexamination Certificate
2000-05-24
2003-07-15
Walberg, Teresa (Department: 3742)
Surgery
Controlled release therapeutic device or system
Reexamination Certificate
active
06592571
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to apparatus for delivering fluid drugs, medicaments or other medicinal liquids to a desired location within a human body and more particularly relates to means for securing such a device within a pocket of tissue of other similar location within a body.
2. Description of Related Art
A number of approaches have been followed in the prior art for the dispensing of medical substances in the body. One particularly effective method has been to implant a reservoir of fluid medical substances and a pump in a patient's body. The reservoir and pump are connected to a catheter that delivers the fluid medical substance to a desired location in the body.
A number of reservoirs, pumps and combinations of reservoirs and pumps have been developed. For example, U.S. Pat. No. 3,527,220 shows an implantable drug administrator that operates with a refillable bladder reservoir and a roller pump that is driven by a magnet located outside the body. U.S. Pat. No. 3,951,147 shows a reservoir formed from a bellows enclosed within a housing. The contents of the reservoir are pressurized by a fluorocarbon fluid located in the space between the housing and bellows. The unit continuously dispenses the liquid to the body site through a capillary tube.
U.S. Pat. No. 4,146,029 shows a dispenser that dispenses drugs in a predetermined manner which may be modified somewhat by means external to the body. A piston and bellows pumping device is used to dispense the drug.
Additional pumps and reservoirs are shown in U.S. Pat. No. 4,931,050, issued Jun. 5, 1990 to Samir F. Idriss entitled “Constant Pressure Variable Flow Pump”; U.S. Pat. No. 4,838,887, issued Jun. 13, 1989 to Samir F. Idriss entitled “Programmable Valve Pump”; U.S. Pat. No. 5,207,666, issued May 4, 1993 to Samir F. Idriss and Joshua Makower entitled “Passive Shuttle Metering Device For Implantable Drug Delivery System”; U.S. Pat. No. 4,714,462, issued Dec. 22, 1987 to Robert A. DiDomenico entitled “Positive Pressure Programmable Infusion Pump”; and U.S. Pat. No. 5,176,641 issued Jan. 5, 1993 to Samir F. Idriss entitled “Implantable Drug Infusion Reservoir Having Fluid Impelling Resilient Foam Member”.
Further pumps and reservoirs are shown in U.S. Pat. No. 5,575,770 issued Nov. 19, 1996 to Gerald S. Melsky and Bradley J. Enegren entitled “Implantable Drug Infusion System With Safe Bolus Capability”; U.S. Pat. No. 4,978,338 issued Dec. 18, 1990 to Gerald S. Melsky and Frank R. Prosl entitled “Implantable Infusion Apparatus”; U.S. Pat. No. 5,908,414 issued Jun. 1, 1999 to Karl-Heinz Otto, Manfred Wieland, Hans Baumann and Jorg-Roger Peters entitled “Implantable Infusion Pump”; and U.S. Pat. No. 5,769,823 issued Jun. 23, 1998 to Karl-Heinz Otto entitled “Implantable Infusion Pump”. The collective teachings of the patents listed above are incorporated herein in their entireties by reference.
A reservoir and pump system for storing and delivering fluid medicaments to a desired location in a body is shown schematically in
FIG. 1
generally labeled
10
. System
10
has a pump
12
that stores and dispenses fluid medicaments. A catheter
14
is connected to pump
12
and carries the fluid medicament from the pump
12
to a desired location in a body. The pump
12
and catheter
14
are implanted within the body.
Pump
12
typically has a primary septum
16
through which a drug, fluid or other medicament is placed in the pump
12
. Pump
12
may also have a bolus septum
18
through which a bolus injection of drug, fluid or other medicament may be administered to the patient through the catheter
14
.
Pump
12
is typically implanted in a body by creating a pocket in the tissue of the patient and placing the pump in the pocket. The pocket is often located under the skin in the abdomen below the rib cage. It is important that the pump
12
stay within the pocket so as not to migrate and maintain a desired orientation so as not to become separated from the catheter
14
. To this end, the pump
12
is often sutured in the pocket to the surrounding tissue. In this way, the pump
12
cannot move within the pocket.
To facilitate the suturing, as shown in
FIGS. 2-4
, a series of suture loops
20
are placed on the outside of the pump
12
. These suture loops
20
are typically made of wire that are fastened to the outside surface
22
of the pump
12
at each end
24
of each suture loop
20
by means such as welding. As a result, suture loops
20
are attached to the outside surface
22
of pump
12
at each end
24
of suture loop
20
and extend a small distance from the outside of pump
12
between the ends
24
of suture loop
20
. As a result, a space
26
is formed between the outside surface
22
and the suture loops
20
.
The surgeon, after placing pump
12
within the pocket “A” (FIG.
5
), places a suture through the tissue and through the space
26
formed between the outside surface
22
and the suture loop
20
and ties a knot to secure the pump in a fixed position relative to the pocket. Because the suture is placed between the outside surface
22
and the suture loop
20
, the suture is constrained to remain in the space
26
. As a result, as the surgeon snugs up the suture and ties the knot, the suture is brought into taught engagement with the suture loop
20
whereby the pump is securely positioned.
One problem with this configuration is that suture loops
20
extend away from the outside surface
22
of pump
12
. As a result, the ultimate dimensions of pump
12
with suture loops
20
are enlarged from the dimensions of the outside surface
22
of pump
12
itself. This then requires a slightly larger pocket to be created to hold the pump
12
with the suture loops
20
than would be necessary if pump
12
without the suture loops
20
were used. Further, the protruding suture loops
20
sometimes jab into and irritate the tissue of the pocket surrounding the suture loops
20
. These are problems in want of a solution.
SUMMARY OF THE INVENTION
A pump for pumping drugs, medicaments or other liquids is disclosed in one embodiment having suture loops co-extensive with the outside surface of the pump. At least one depression is formed in the outside surface of the pump. A suture loop, preferably in the form of a wire, co-extensive with the outer dimensions of the pump passes over the depression forming a space between the wire and the outside surface of the pump in the depression. In this position, the wire forms a suture loop. The surgeon, when suturing the pump of the present invention in place within a pocket of tissue or other similar location, places a suture between the wire and the outside surface of the pump in the depression to secure the pump.
In an alternate embodiment, depressions are created in a pump and a soft material is placed in and attached to the depressions. A suture may then be placed through the material of the soft material and the tissue of the patient in a pocket in the tissue of the patient to affixed the pump in the pocket.
It is therefore an object of the present invention to provide a pump that may be sutured in a pocket of tissue of other similar location in a body where the pump does not have any substantial protrusions from its outside surface to facilitate the pump being sutured in the desired location.
It is another object of the invention to provide a system to facilitate suturing the pump in place in a desired location that is relatively easy to manufacture.
These and other objects of the invention will be clear from the description of the invention contained herein and more particularly from the description in conjunction with the drawings attached hereto. Throughout this description, wherever referred to, like elements are referred to by like reference numbers.
REFERENCES:
patent: 3527220 (1970-09-01), Summers
patent: 3951147 (1976-04-01), Tucker et al.
patent: 4146029 (1979-03-01), Ellinwood, Jr.
patent: 4314562 (1982-02-01), Ware
patent: 4400169 (1983-08-01), Stephen
patent: 4548607 (1985-10-01), Harris
patent: 4714462
Philippens Frans
Verbeek Maurice Theodore Yvonne
Bauer Stephen W.
Kinghorn Curtis D.
Medtronic Inc.
Robinson Daniel
Walberg Teresa
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