Hypodermically implantable genitourinary prosthesis

• US 4,773,393 A
• Filed: 07/03/1986
• Issued: 09/27/1988
• Est. Priority Date: 07/03/1986
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Malizia, Anthony A. Jr., Haber, Terry M.
• Primary Examiner(s): Truluck, Dalton L.
• Assistant Examiner(s): Wilkens, Frank
• Application Number:
  US06/881,830
• Time in Patent Office: 817 Days
• Field of Search: 128/1 R, 128/DIG. 25, 128/325, 128/343, 128/344, 128/1.3, 128/129, 604/57, 604/59, 604/60, 604/49, 604/51, 604/96, 604/274, 623/6
• US Class Current: 600/30
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

Apparatus for hypodermically implanting a genitourinary prosthesis comprising an extensible, inflatable tissue expanding containment membrane to be located in the proximal periurethral tissues to add bulk to these tissues and thereby overcome urinary incontinence by means of localized, controlled tissue volume increase. Hypodermic positioning, injecting and inflating instruments are also disclosed for implanting the containment membrane and for percutaneously infusing the membrane with biocompatible fluid or suspended particulate matter. The containment membrane functions as an envelope for retaining the fluid or particulate matter therewith in while controllably and advantageously increasing localized tissue volume and simultaneously preventing the migration of such fluid or particles. Accordingly, an increased passive occlusive pressure may be applied to the patient'"'"'s urethra to achieve continence.

Claims

1. An injectable system for hypodermically implanting an inflatable containment membrane for increasing local tissue volume at the injection site, said system comprising:

an inflatable containment membrane being in a normally uninflated condition;

outer tube means having a cutting end for penetrating the tissue of a patient undergoing treatment, said uninflated containment membrane being located within said outer tube means;

inner tube means extending through said outer tube means and communicating between the interior of said containment membrane and a source of material, said containment membrane being percutaneously infused with and inflated by material from said source via said inner tube means for simultaneously increasing local tissue volume while preventing the migration of the material contained within said membrane;

said inner tube means and said outer tube means being concentrically aligned with and spaced from one another such that a first portion of said containment membrane is retained in the space between said inner and outer tube means and a second portion of said containment membrane is extended across the cutting end of said outer tube means to form a non-coring cutting end for preventing the patient'"'"'s tissue from entering the outer tube means when the tissue is penetrated; and

means for detaching said inflated membrane from the space between said inner and outer tube means so that said membrane remains implanted within the tissue of the patient.

2. The system recited in claim 1, wherein said containment membrane has an orifice biased toward a normally closed condition, said inner tube means extending through said orifice and holding said orifice open for percutaneously infusing and thereby inflating said containment membrane with material from said source.

3. An injectable system for hypodermically implanting an inflatable containment membrane for increasing local tissue volume at the injection site, said system comprising:

an inflatable containment membrane being is a normally uninflated condition;

outer tube means having a cutting end for penetrating the tissue of a patient undergoing treatment, said uninflated containment membrane being located within said outer tube means;

inner tube means extending through said outer tube means and being concentrically aligned with and spaced from said inner tube means, a portion of the containment membrane being retained in the space between said inner and outer tube means, said inner tube means extending between the interior of said containment membrane and a source of material, said containment membrane being percutaneously infused with and inflated by material from said source via said inner tube means for simultaneously increasing local tissue volume while preventing the migration of the material contained within said membrane; and

means connected to apply a force through the space between said inner and outer tube means for dispensing said containment membrane from said space after said membrane is inflated.

4. A hypodermic system for treating urinary incontinence by means of applying increased occlusive pressure to the urethra by producing a proportional increase of localized tissue volume proximal to the urethra, said system comprising:

an inflatable containment membrane being in a normally uninflated condition and having an orifice biased in a normally closed condition;

outer tube means having a cutting end for piercing a channel through the patient'"'"'s urethral tissue, said uninflated containment membrane located within said outer tube means behind the cutting end thereof; and

inner tube means located within said outer tube means and extending at a first end thereof through said orifice and into the interior of said containment membrane and communicating at the other end with a source of material, so that said membrane may be percutaneously infused with a supply of material from said source for inflating said membrane and thereby increasing both the local tissue volume proximal to the urethra and the occlusive pressure applied to the urethra,

said outer tube means and said inner tube means being concentrically aligned with and spaced from one another to retain a portion of said containment membrane in the space therebetween, said containment membrane removably receiving said inner tube means through the orifice thereof for holding said orifice open, such that said containment membrane is detachably connected to said inner tube means and said containment membrane is inflated with material from said source.

5. The system recited in claim 4, further comprising means connected to apply a force through the space between said inner and outer tube means for detaching said containment membrane from said inner tube means and for dispensing said containment membrane from said space after said membrane is inflated.

6. A non-surgical method of implanting prosthesis comprising an inflatable containment membrane for treating urinary incontinence by increasing localized tissue volume and the occlusive pressure applied to a patient'"'"'s urethra for holding the patient continent, said method comprising the steps of:

locating an inner filling tube within a hollow outer trocar tube having a cutting end, such that said inner filling tube and said outer trocar tube are arranged in coaxial alignment and spaced from one another;

locating a portion of an uninflated membrane within said outer trocar tube, such that said portion is retained in the space between said outer trocar tube and said inner filling tube and said inner filling tube communicates with the interior of said containment membrane for inflating said membrane;

piercing a small tunnel through the patient'"'"'s urethral tissues with the cutting end of said outer trocar tube;

infusing said containment membrane with a supply of material from a source thereof by way of said inner filling tube to inflate said membrane;

detaching said inflated containment membrane from the space between said outer and inner tubes; and

removing said outer trocar tube from the patient'"'"'s urethral tissues.

7. The non-surgical method recited in claim 6, including the additional step of applying a force through the space between said outer trocar tube and said inner filling tube for detaching said inflated containment membrane therefrom.