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US6171298B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Intravesical infuser

Assignee: Situs Corp
•
Filing: 1998-03-11
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Granted: 2001-01-09
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Expires: 2018-03-11
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Abstract

Abstract A drug-infusing device is implanted into a body cavity such as a bladder. The device is implanted in an uninflated, low profile state. After insertion into the body cavity, the device is filled with a substance, such as a drug, and assumes an increased profile. After the device is filled, it is allowed to float freely within the body cavity. Alternatively, the device can be tethered to a wall of the body cavity. The device delivers the drug at a controlled rate over an extended period of time. In order to deliver the drug at a controlled rate, the device preferably has a pressure-responsive valving member. The flow resistance of the valving member is responsive to the pressure at which the drug is stored within the infusing device. The resistance of the valving member decreases as the pressure within the infusing device decreases, thereby providing a resultant controlled flow rate.

Inventors

  • 👤 David G. Matsuura
  • 👤 Walter Dean Gillespie
  • 👤 John Patrick Greelis
  • 👤 Charles Lowell Parsons
  • 👤 Mikxay Sirivong
  • 👤 Paul F. Zupkas

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-06 12:19
CPC Classifications
A; A61; A61M; A61M31/00; A61M31/002; A61L; A61L17/00; A61L17/14; A61L17/145; A61L27/00; A61L27/28; A61L27/34; A61L31/00; A61L31/08; A61L31/10; A61L33/00; A61L33/0005; A61L33/0011; A61L33/0094; A61L33/06; A61L33/08; A61M2210/00; A61M2210/10; A61M2210/1078; A61M2210/1085; A61M5/00; A61M5/14; A61M5/142; A61M5/145; A61M5/148; A61M5/152

Claims Analysis

Total Claims: 63
Claim 1
Independent Claim 87 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second arcuate shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.
Claim 2
Dependent Claim 87 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second arcuate shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.
Claim 3
Dependent Claim 22 words
The device of claim 1 , further comprising a tethering means for tethering said device to a wall of the body cavity.
Claim 4
Dependent Claim 21 words
The device of claim 1 , wherein said reservoir resumes substantially said first shape as said pressurized fluid substance is dispensed.
Claim 5
Dependent Claim 23 words
The device of claim 1 , wherein said reservoir is coated so as to inhibit deposition of materials present in the urinary tract.
Claim 6
Dependent Claim 19 words
The device of claim 1 , wherein said reservoir is coated so as increase the lubricity of the device.
Claim 7
Dependent Claim 23 words
The device of claim 1 , wherein said flow-restricted exit port provides a means of rapidly purging said pressurized substance from said reservoir.
Claim 8
Dependent Claim 19 words
The device of claim 6 , wherein said reservoir resumes substantially said first shape upon purging said pressurized substance.
Claim 9
Dependent Claim 43 words
The device of claim 1 , wherein said reservoir is elongated, said valve assembly is disposed at a first end of said elongated reservoir and said flow-restricted exit port is disposed at a second end of said elongated reservoir opposite said first end.
Claim 10
Dependent Claim 21 words
The device of claim 8 , wherein said second end has greater buoyancy than the overall buoyancy of said elongated reservoir.
Claim 11
Dependent Claim 19 words
The device of claim 8 , wherein said second end is at least partially covered by a compliant bumper.
Claim 12
Dependent Claim 11 words
The device of claim 8 , further comprising a capture member.
Claim 13
Dependent Claim 34 words
The device of claim 11 , wherein said capture member is incorporated into a release mechanism which is configured to allow said flow-restricted exit port to purge said pressurized substance from said elongated reservoir.
Claim 14
Dependent Claim 19 words
The device of claim 8 , further comprising a capture member protruding from the center of said second end.
Claim 15
Dependent Claim 54 words
The device of claim 1 , further comprising a capture member coupled to said flow-restricted exit port, wherein if force is exerted upon said capture member while opposite pressure is maintained against said flow-restricted exit port, the flow restriction of said flow-restricted exit port is reduced such that said pressurized fluid substance is purged.
Claim 16
Dependent Claim 44 words
The device of claim 14 , wherein said flow-restricted exit port is configured to mate with a sheath that is introduced into said body cavity such that said pressurized substance is purged through a channel of said sheath rather than into said body cavity.
Claim 17
Dependent Claim 25 words
The device of claim 1 , wherein said flow-restricted exit port provides delivery of said pressurized substance over a period of at least 5 days.
Claim 18
Dependent Claim 26 words
The device of claim 1 , wherein said flow-restricted exit port provides delivery of said pressurized fluid substance over a period of at least 15 days.
Claim 19
Dependent Claim 32 words
The device of claim 1 , wherein said pressurized substance is in a liquid form and the device delivers said pressurized fluid substance at a rate of less than about 400 μl/hour.
Claim 20
Dependent Claim 20 words
The device of claim 1 , wherein said second shape facilitates retention of said elongated reservoir in said body cavity.
Claim 21
Dependent Claim 29 words
The device of claim 1 , wherein said second shape has a cross sectional shape of sufficient diameter to deter voiding of said elongated reservoir through a mammalian urethra.
Claim 22
Dependent Claim 26 words
The device of claim 1 , wherein said second shape deters obstruction of mammalian bladder neck so as to allow urine to pass around the device.
Claim 23
Dependent Claim 11 words
The device of claim 1 , wherein said reservoir is elastomeric.
Claim 24
Dependent Claim 13 words
The device of claim 1 , wherein said pressured substance is a drug.
Claim 25
Dependent Claim 14 words
The device of claim 1 , wherein said pressured substance is a diagnostic tool.
Claim 26
Dependent Claim 28 words
The device of claim 1 , wherein said reservoir is elongated and a first end of said reservoir has greater buoyancy than the overall buoyancy of said reservoir.
Claim 27
Dependent Claim 19 words
The device of claim 1 , wherein said first end is at least partially covered by a compliant bumper.
Claim 28
Dependent Claim 26 words
The device of claim 1 , wherein said valve assembly comprises an opening for accepting a secure coupling fitting through which said pressurized substance is dispensed.
Claim 29
Dependent Claim 29 words
The device of claim 27 , wherein said opening is further for securing the device to an introducer which is used to disposed the device within said body cavity.
Claim 30
Dependent Claim 22 words
The device of claim 1 , wherein said valve assembly comprises a floating disc which is biased to occlude an input channel.
Claim 31
Dependent Claim 40 words
The device of claim 1 , wherein a resistance of said flow-restricted exit port varies in proportion to a pressure level of said pressurized substance such that said flow-restricted exit port dispenses said pressurized fluid substance at a controlled rate.
Claim 32
Dependent Claim 39 words
The device of claim 30 , wherein said flow-restricted exit port varies said resistance by varying an area of a flow channel of said flow-restricted exit port in inverse proportion to said pressure level of said pressurized fluid substance.
Claim 33
Dependent Claim 62 words
The device of claim 1 , wherein said flow-restricted exit port comprises a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow-restricted exit port in a manner inversely related to a pressure level of said pressurized substance.
Claim 34
Dependent Claim 16 words
The device of claim 1 , wherein said flow-restricted exit port is comprised of sintered metal.
Claim 35
Dependent Claim 49 words
An implantable infusion device, comprising: a reservoir containing a drug; a flow-restricted exit port in fluid communication with the drug in said reservoir; and wherein said device assumes a first generally elongated shape when empty during implantation and a second arcuate shape when filled after implantation into a mammal.
Claim 36
Dependent Claim 49 words
An implantable infusion device, comprising: a reservoir containing a drug; a flow-restricted exit port in fluid communication with the drug in said reservoir; and wherein said device assumes a first generally elongated shape when empty during implantation and a second arcuate shape when filled after implantation into a mammal.
Claim 37
Dependent Claim 35 words
The device of claim 34 , further comprising: a coating on said device adapted to provide lubricity or to inhibit deposition of material on said device when implanted in a body cavity of a mammal.
Claim 38
Dependent Claim 18 words
The device of claim 35 , wherein said coating inhibits deposition of materials present in the urinary tract.
Claim 39
Dependent Claim 24 words
The device of claim 35 , wherein said coating is a surface coating on surfaces of said device exposed to the body upon implantation.
Claim 40
Dependent Claim 16 words
The device of claim 35 , wherein said coating covers only a portion of said device.
Claim 41
Dependent Claim 24 words
The device of claim 35 , wherein said flow-restricted exit port provides delivery of said drug over a period of at least 5 days.
Claim 42
Dependent Claim 23 words
The device of claim 39 herein said flow-restricted exit port provides delivery of said drug over a period of at least 15 days.
Claim 43
Dependent Claim 29 words
The device of claim 39 , wherein said drug is in a liquid form and said device delivers said drug at a rate of less than about 400 μl/hour.
Claim 44
Dependent Claim 13 words
The device of claim 35 , wherein said drug is an incontinence-treating drug.
Claim 45
Dependent Claim 15 words
The device of claim 35 , wherein said drug is used to treat urge incontinence.
Claim 46
Dependent Claim 14 words
The device of claim 35 , wherein said drug is an anesthetic or analgesic.
Claim 47
Dependent Claim 12 words
The device of claim 35 , wherein said drug is an antibiotic.
Claim 48
Dependent Claim 14 words
The device of claim 35 , wherein said drug is used to treat cystitis.
Claim 49
Dependent Claim 13 words
The device of claim 35 , wherein said drug is an anti-cancer drug.
Claim 50
Dependent Claim 11 words
The device of claim 35 , wherein said drug is oxybutynin.
Claim 51
Dependent Claim 26 words
The device of claim 35 , wherein said device has a first end and a second end, wherein at least one of said ends is buoyant.
Claim 52
Dependent Claim 16 words
The device of claim 49 , wherein said first end and said second end are buoyant.
Claim 53
Dependent Claim 20 words
The device of claim 35 , wherein said device is sized to fit through a urethra into a mammalian bladder.
Claim 54
Dependent Claim 75 words
An infusion device, comprising: a housing; a drug inside the housing; a flow controller comprising a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow path in a manner inversely related to the pressure of said drug to control the rate at which said drug is released from the housing.
Claim 55
Dependent Claim 75 words
An infusion device, comprising: a housing; a drug inside the housing; a flow controller comprising a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow path in a manner inversely related to the pressure of said drug to control the rate at which said drug is released from the housing.
Claim 56
Dependent Claim 17 words
The device of claim 52 , wherein said drug is pressurized and said flow controller is pressure-responsive.
Claim 57
Dependent Claim 26 words
The device of claim 52 , wherein said flow controller further comprises a third pressure reducing element downstream of said first and second pressure reducing elements.
Claim 58
Dependent Claim 101 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly comprising a floating disc which is biased to occlude an input channel, said valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.
Claim 59
Dependent Claim 101 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly comprising a floating disc which is biased to occlude an input channel, said valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.
Claim 60
Dependent Claim 145 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein a resistance of said flow-restricted exit port varies in proportion to a pressure level of said pressurized substance by varying an area of a flow channel of said flow-restricted exit port in inverse proportion to said pressure level of said pressurized fluid substance, such that said flow-restricted exit port dispenses said pressurized fluid substance at a controlled rate.
Claim 61
Dependent Claim 145 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein a resistance of said flow-restricted exit port varies in proportion to a pressure level of said pressurized substance by varying an area of a flow channel of said flow-restricted exit port in inverse proportion to said pressure level of said pressurized fluid substance, such that said flow-restricted exit port dispenses said pressurized fluid substance at a controlled rate.
Claim 62
Dependent Claim 142 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein said flow-restricted exit port comprises a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow-restricted exit port in a manner inversely related to a pressure level of said pressurized substance.
Claim 63
Dependent Claim 142 words
An implantable infusion device, comprising: a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance; a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein said flow-restricted exit port comprises a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow-restricted exit port in a manner inversely related to a pressure level of said pressurized substance.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2004-01-09 2004-07-10 2005-01-09 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2008-01-09 2008-07-10 2009-01-09 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2012-01-09 2012-07-10 2013-01-09 $7700.00 Window Closed / Lapsed

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