Hand-held instrument for implanting, dispensing, and inflating an inflatable membrane

• US 4,802,479 A
• Filed: 10/31/1986
• Issued: 02/07/1989
• Est. Priority Date: 10/31/1986
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Smedley, William H., Haber, Terry M.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/925,163
• Time in Patent Office: 830 Days
• Field of Search: 128/1 R, 128/305, 128/305.3, 128/311, 128/325, 128/328, 128/341, 128/343, 128/344, 128/348.1, 128/330, 128/DIG. 25, 128/329, 128/345, 604/61, 604/97-99, 604/158, 604/223, 604/272-274, 604/162, 604/104-109, 604/51
• US Class Current: 606/192
• 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

A compact, hand-held instrument by which to permit a physician to accurately and controllably implant, dispense, and inflate an inflatable membrane at a predetermined target area within the tissues of a patient. In a preferred embodiment of the invention, the inflatable membrane is a genitourinary prosthesis, and the targeted area lies within the corpus spongiousum surrounding the urethra to enable a patient to overcome urinary incontinence by means of increasing both localized tissue volume and passive occlusive pressure upon the urethral mucosa. The instrument includes a trocar assembly having a plurality of telescoping trocar members which may be either retracted for dilating a tunnel through the urethral tissues of the patient or expanded for placing, dispensing and inflating the membrane at the end of the tunnel. The membrane is percutaneously infused with and inflated by material (e.g. biocompatible fluid) supplied from a vernier hypodermic syringe to a hollow, non-coring needle, which needle carries the membrane and communicates with the syringe.

Claims

1. An instrument for implanting an inflatable genitourinary prosthesis within the urethral tissues of a patient to increase local tissue density and the application of occlusive pressure at the periurethral tissues of the corpus spongiousum for treating urinary incontinence, said instrument including an inflatable genitourinary prosthesis, means for inflating said prosthesis with material, and trocar assembly means comprising:

an infusion tube extending between said inflating means and said prosthesis to deliver material for inflating said prosthesis;

a pair of normally open tunneling members for dilating a tunnel through the urethral tissues, said tunneling members movable to either a closed position to surround and protect an uninflated prosthesis and thereby form a tissue dilating nose or to an open position to permit said prosthesis to be inflated and positioned within the urethral tissues; and

an outer trocar sleeve movable to a first position to surround and engage said tunneling members to retain said members in the closed position to form said dilating nose or to a second position retracted from said tunneling members to release said members for movement to the open position to permit inflation of said prosthesis.

2. The instrument recited in claim 1, said trocar assembly further comprising an inner trocar tube concentrically arranged with respect to each of said infusion tube and said outer trocar sleeve, such that said infusion tube is slideable through said inner trocar tube and said inner trocar tube is slideable through said outer trocar sleeve;

said prosthesis removably supported at one end of and being detachable from said infusion tube after inflation of said prosthesis so as to be positioned within the urethral tissues of the patient when said infusion tube is slideably withdrawn through said inner trocar tube.

3. The instrument recited in claim 2, wherein said inner trocar tube and said outer trocar sleeve are provided with a plurality of perforations through which a sterilizing fluid or gas may pass for sterilizing said inner trocar tube, said outer trocar sleeve, and said infusion tube.

4. An instrument for implanting, dispensing and inflating an inflatable membrane within subcutaneous tissue of a patient, said instrument comprising:

carrying means to which said membrane is removably attached;

a source of material communicating with said membrane to inflate said membrane after said membrane is implanted within the patient'"'"'s tissue;

dilating means for cutting a tunnel through the patient'"'"'s tissue, said dilating means disposed in either a closed condition to surround and protect an uninflated membrane whereby to form a dilating nose for penetrating the patient'"'"'s tissue or an open condition whereby to permit said membrane to be dispensed and inflated; and

an outer sleeve surrounding said dilating means and slidable axially thereon, said outer sleeve moveable to either an axially extended position at which to close said dilating means around said membrane to form said dilating nose or to an axially retracted position at which to release said dilating means to the open condition for dispensing said membrane.

5. The instrument recited in claim 4, wherein said dilating means includes a pair of articulating members adapted to be disposed in either of said closed or open conditions depending upon the position of said outer sleeve relative thereto.

6. The instrument recited in claim 4, wherein said means for carrying said membrane includes a hollow needle, said membrane communicating with said source of material by way of said needle so that an uninflated membrane may be inflated when said dilating means is disposed in the open condition.

7. The instrument recited in claim 6, further comprising an inner tube coaxially aligned with and slidable axially through said outer sleeve;

and

an infusion tube coaxially aligned with and slidable axially through said inner tube, said infusion tube extending between said source of material and said hollow needle for supplying material to said membrane, said needle being attached to and supported from one end of said infusion tube.

8. The instrument recited in claim 7, wherein said inner tube and said outer sleeve are provided with a plurality of perforations through which a sterilizing fluid or gas may pass for sterilizing said inner tube, said outer sleeve, and said infusion tube.

9. The instrument recited in claim 7, further comprising means for moving said infusion tube axially through said inner tube from an axially extended position at which to inflate said membrane to an axially retracted position by which to detach said inflated membrane from said needle when said infusion tube is moved through said inner tube.

10. The instrument recited in claim 9, further comprising first, second, and third positin control means respectively coupled to said outer sleeve, said inner tube, and said infusion tube, said position control means being slidable axially along said instrument to correspondingly control the movements of said outer sleeve, inner tube, and infusion tube relative to one another.

11. The instrument recited in claim 10, further comprising a plurality of guide slots extending axially along said instrument, said position control means being received in and slidable through respective ones of said guide slots to control the movements of said outer sleeve, said inner tube, and said infusion tube relative to one another.

12. The instrument recited in claims 4, wherein said inflatable membrane is an elastic genitourinary prosthesis and the subcutaneous tissue is the periurethral tissues of the corpus spongiousum, said prosthesis being implanted and inflated for the treatment of urinary incontinence.

13. The instrument recited in claims 4, wherein said source of material for inflating said membrane is a hypodermic syringe.

14. A hand-held instrument comprising a plurality of telescoping tubular members by which to implant, dispense and inflate an inflatable membrane within the subcutaneous tissues of a patient, said instrument comprising:

an elastic, inflatable membrane;

a source of material communicating with said membrane to inflate said membrane after said membrane has been implanted within the patient'"'"'s tissue,

dilating means for cutting a tunnel through the patient'"'"'s tissue, said dilating means disposed in either a closed condition to surround and protect an uninflated membrane, whereby to form a dilating nose for penetrating the patient'"'"'s tissue or an open condition, whereby to permit said membrane to be dispensed and inflated;

an outer sleeve surrounding said dilating means and slidable axially thereover, said outer sleeve movable to either an axially extended position at which to close said dilating means around said membrane to form said dilating nose or to an axially retracted position at which to release said dilating means to the open condition for dispensing said membrane;

an inner tube coaxially aligned with and slidable axially through said outer sleeve; and

an infusion tube coaxially aligned with and slidable axially through said inner tube and extending between said source of material and said membrane for supplying material from said source to inflate said membrane.

15. The instrument recited in claim 14, further comprising a hollow hypodermic needle attached to and supported from one end of said infusion tube, said membrane being detachably connected to said needle, such that material for inflating said membrane is supplied from said source thereof to said membrane by way of said infusion tube and said needle.

16. The instrument recited in claim 14, wherein said dilating means includes a pair of articulating members adapted to be disposed in either of the closed or open conditions depending upon the position of said outer sleeve relative thereto.

17. The instrument recited in claim 14, wherein said membrane is detachably connected to one end of said infusion tube.

18. The instrument recited in claim 17, further comprising:

means to retract said outer sleeve from said dilating means to release said dilating means to the open condition;

means to withdraw said infusion tube through said inner tube after said membrane is inflated, said inner tube forming a shoulder against which said membrane is moved for detaching said membrane from said infusion tube; and

means to withdraw said inner tube through said outer sleeve after said infusion tube is withdrawn through said inner tube.

19. The instrument recited in claim 18, wherein said means to retract said outer sleeve, said means to withdraw said infusion tube, and said means to withdraw said inner tube are respectively coupled to said outer sleeve, said infusion tube, and said inner tube and are adapted for axial movement along said instrument to control the movement of said outer sleeve, said infusion tube, and said inner tube relative to one another.

20. The instrument recited in claim 19, further comprising a plurality of guide slots extending axially along said instrument, said means to retract said outer sleeve, said means to withdraw said infusion tube, and said means to withdraw said inner tube being received in and slidable through respective ones of said slots to control the movements of said outer sleeve, said infusion tube, and said inner tube relative to one another.