Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-08-27
2004-04-13
Thanh, LoAn H. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S500000, C604S891100, C029S428000
Reexamination Certificate
active
06719739
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to implantable medication delivery devices that are implanted within the body of a patient to deliver drugs or other fluid medicaments and methods of construction of the devices. More particularly, the invention relates to techniques for sealingly attaching upper and lower outer cases to a bulkhead in such medication delivery devices.
2. Description of the Related Art
When chronic administration of a pharmaceutically active agent is required, an implantable infusion pump (“IIP”)
10
, having a reservoir
12
connected to a catheter
14
, may be the desired delivery means (FIG.
1
). For example, a IIP-catheter delivery system may be preferred when it is important to deliver the agent to a specific site or when the agent must be administered to spaced sites in tightly controlled, yet minute dosages.
Catheter
14
is connected to IIP
10
and carries fluid medicament from the reservoir
12
in IIP
10
to a desired location in a body. The IIP
10
and catheter
14
are implanted within the body.
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. 5, 1990 to Samir F. Idriss entitled “Programmable Valve Pump”; U.S. Pat. No. 4,714,462, issued Jun. 5, 1990 to Robert A. DiDomenico entitled “Positive Pressure Programmable Infusion Pump”; U.S. Pat. No. 4,714,462, issued Jun. 5, 1990 to Samir F. Idriss entitled “Passive Shuttle Metering Device For Implantable Drug Delivery System”; 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 typical IIP
10
for storing and delivering fluid medicaments to a desired location in a body according to the present invention is shown in cross-section in
FIGS. 2 and 3
. As mentioned above, IIP
10
stores and dispenses medical substances from a reservoir
12
. Reservoir
12
is formed by a reservoir structure
16
having a reservoir structure upper end
18
and a reservoir structure terminal end
20
. Reservoir structure
16
is typically a bellows
22
having pleated sides
24
and a substantially planar bottom
26
sealingly connected to the sides
24
. Pleated sides
24
are made up of a series of inwardly directed annular rings
28
and outwardly directed annular rings
30
sealingly connected at inner connection points
32
and outer connection points
34
. In the typical IIP
10
, bellows
22
terminates at its upper end
18
with an ultimate inwardly direct annular ring
36
. Ultimate inwardly direct annular ring
36
terminates in a bellows terminal end
38
so that the bellows terminal end
38
is the reservoir structure terminal end
20
for a bellows type reservoir structure
16
. Bottom
26
is usually circular so that bellows
22
is cylindrical. Because bellows
22
is cylindrical, bellows terminal end
38
is annular.
Bellows terminal end
38
is connected to an annular bracket
40
. Viewed in cross-section, bracket
40
has a horizontal leg
42
. Horizontal leg
42
has an inner terminal end
43
and an outer terminal end
44
. Bellows terminal end
38
is connected to bracket
40
at
45
near the inner terminal end
43
by means well understood in the art such as welding. Annular bracket
40
also includes a vertical leg
46
. Vertical leg
46
has an upper terminal end
47
and a lower terminal end
48
.
IIP
10
also includes a bulkhead
50
having a top surface
52
, a bottom surface
54
and an outer periphery
56
. IIP
10
includes a metering system
58
usually attached to the top surface
52
of bulkhead
50
. Metering system
58
may take the form of a peristaltic pump, a piston pump, a tubular or micro-machined capillary flow restrictor, a piezoelectric micropump or other metering means as will clear to those skilled in the art. Metering system
58
is connected to reservoir
12
through an output conduit
60
.
The bottom surface
54
of bulkhead
50
includes an annular recess
62
extending into bulkhead
50
toward top surface
52
. Recess
62
has an inner vertical wall
64
and a horizontal wall
65
connected together at
66
. Recess
62
also has an outer vertical wall
67
connected to the horizontal wall
65
at
68
. Horizontal leg
42
is about the same length as horizontal wall
66
while vertical leg
46
is about the same length as outer vertical wall
67
. Bellows
22
is attached to bulkhead
50
at recess
62
by bracket
40
as described below.
IIP
10
also typically has a primary self-sealing septum
70
through which a drug, fluid or other medicament is placed in the reservoir
12
. A hypodermic needle can be inserted through the skin and through the primary seal-sealing septum
70
into a chamber
72
that is connected to reservoir
12
through an inlet conduit
74
. Through the hypodermic needle, a quantity of a liquid agent, such as a medication, a growth factor, an antisense agent, an ionic solution, one or more antibodies, a hormone, proteins or peptides, viruses, cell suspension, a chemotherapeutic agent or toxin or some drug is inserted into the reservoir
12
. The liquid agent is then delivered from reservoir
12
through the metering system
58
and through catheter
14
that is attached to IIP
10
through a catheter connector
76
that is attached to the metering system
58
. The catheter
14
is positioned to deliver the agent to infusion sites in the patient's body.
IIP
10
may also have a catheter access port septum
78
through which a bolus injection of drug, fluid or other medicament may be administered directly to the patient through the catheter
14
, bypassing the metering system
58
. Catheter access port septum
78
may also be used to take a sample of cerebrospinal fluid (CSF) from catheter
14
or for checking the patency of catheter
14
in the event of a loss of therapeutic benefit.
As shown in detail in
FIG. 4
, IIP
10
also includes an upper case
80
and a lower case
82
that substantially defines the outer dimensions of IIP
10
and protects the inner parts, bellows
22
, bulkhead
50
and m
Philippens Frans
Verbeek Maurice T. Y.
Bauer Stephen W.
Berry Thomas G.
Kinghorn Curtis D.
Medtronic Inc.
Thanh LoAn H.
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