Dilation device for the urethra

• US 5,499,994 A
• Filed: 04/28/1994
• Issued: 03/19/1996
• Est. Priority Date: 07/30/1993
• Status: Expired due to Term

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Burton, John H., Cook, Timothy C., Tihon, Claude, Rhum, David
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/234,196
• Time in Patent Office: 691 Days
• Field of Search: 604/93, 604/96-97, 604/104, 604/8, 604/264-265, 604/278, 604/54, 604/280, 604/286, 606/191-192, 606/194, 606/197-198, 623/1, 623/12
• US Class Current: 606/192
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for dilating at least an obstructed portion of a urethra includes a hollow core member with opposed open ends permitting urination therethrough from the bladder, a confining covering disposed on the hollow member having a length of at least that of the obstructed portion and having hydrophilic means integrally associated therewith. The hydrophilic means is capable of absorbing water and gradually expanding for at least 30 minutes whereby the outer surface of the confining covering expands radially and outwardly, after insertion into the urethra, until dilation of the obstructed portion occurs to a desired diameter and configuration. Methods for dilating an obstructed portion of the urethra and for treating benign prostatic hyperplasia are also provided.

Claims

1. A dilation device for opening a portion of an obstructed urethra, which comprises,

an inner hollow tubular core defining a lumen therewithin, said lumen being a conduit of sufficient diameter to permit urine to flow freely therethrough from the bladder, said core being substantially non-collapsible and containing access means enabling body fluids to pass through said core in a radially outwardly direction;

an outer confining covering capable of expanding radially outwardly to a predetermined extent, said covering having a length, disposed on said core, of at least partially that of the obstructed portion of the urethra; and

hydrophilic material defined between said outer covering and said core capable of absorbing water and thereupon gradually swelling for a period of at least about 30 minutes, thereby to cause the outer covering to gradually expand radially outwardly until dilation of the obstructed portion of the urethra occurs to a desired diameter and configuration.

2. A dilation device according to claim 1, whereby said device is adapted to remain in the urethra with the hydrophilic means expanded, for a time sufficient that the dilated configuration of the urethra will tend to remain as such upon removal of the device, the inner core being non-collapsible under pressures that would emanate from a hypertrophied prostate gland and under the internal pressures exerted by the expanded hydrophilic material.

3. A dilation device according to claim 2, wherein the dilation device, in an undilated state, has a diameter of between about 20 and about 26 French.

4. A dilation device according to claim 1, wherein the hydrophilic material is capable of gradually swelling, at a rate of about 6 to about 10 French per 24 hour period, the upper limit of said expansion being self-limiting.

5. A dilation device according to claim 1, wherein the gradually expanding hydrophilic means is a cross-linked polymeric material which is insoluble but capable of absorbing water.

6. A dilation device according to claim 2, wherein said device is adapted to remain in the dilated portion of the urethra for a period of from about 5 days to about 30 days, and then removed from the urethra.

7. A dilation device according to claim 6, which additionally includes anchoring or fixing means which will retain the device within the urethra for the time desired without slippage or spontaneous movement therefrom.

8. A dilation device for opening a portion of a urethra obstructed as a consequence of a hypertrophied prostate gland, which comprises,

an inner hollow tubular core defining a lumen therewithin, said lumen being a conduit of sufficient diameter to permit urine to flow freely therethrough from the bladder, said core being non-collapsible under pressures that would emanate from the hypertrophied prostate gland and containing access means enabling body fluids to pass through said core in a radially outwardly direction;

an outer confining covering in the form of an envelope disposed about at least a portion of said inner core, said envelope having an outer surface capable of expanding radially outwardly to a predetermined maximum diameter, said envelope having a length, disposed on said core, of at least partially that of the obstructed portion of the urethra; and

hydrophilic material defined between said envelope and said core capable of absorbing water and thereupon gradually swelling for a period of at least about 30 minutes, thereby to cause the outer surface of the envelope to gradually expand radially outwardly and impact upon the prostate gland, until dilation of the obstructed portion of the urethra occurs to a desired diameter and configuration.

9. A dilation device according to claim 8, wherein the access means are a series of perforations having cross-sections smaller than the diameters of the hydrophilic material.

10. A dilation device according to claim 8, wherein the inner core comprises a permeable membrane.

11. A dilation device according to claim 8, wherein the device is adapted to remain in the urethra for a time sufficient that the dilated configuration of the urethra will tend to remain as such after removal of the device.

12. A dilation device according to claim 11, which includes means for removing said device from the urethra after a period of between about 5 and about 30 days.

13. A dilation device according to claim 12, which additionally includes anchoring or fixing means which will retain the device within the urethra for the time desired without slippage or spontaneous movement therefrom.

14. A dilation device according to claim 13, wherein the outer surface of the envelope expands at a rate of between 6 to 10 French per 24 hour period, the upper limit of such expansion being self-limiting.

15. A dilation device for opening a portion of a urethra obstructed as a consequence of a hypertrophied prostate gland, which comprises,

an inner hollow tubular core defining a lumen therewithin, said lumen being a conduit of sufficient diameter to permit urine to flow freely therethrough from the bladder, said core being non-collapsible under pressures that would emanate from the hypertrophied prostate gland and containing access means enabling body fluids to pass through said core in a radially outwardly direction;

an outer confining covering in the form of a collapsible and expandable bag disposed about at least a portion of said core, said bag having on outer elastic surface capable of expanding radially outwardly, said bag having a length, disposed on said core, of at least partially that of the obstructed portion of the urethra; and

hydrophilic material defined between said outer surface of said bag and said core capable of absorbing water and thereupon gradually swelling for a period of at least about 30 minutes, thereby to cause the outer surface of the bag to gradually expand radially outwardly until equilibrium is obtained between the radial pressures of the expanded hydrophilic material and the prostatic tissue, and until dilation of the obstructed portion of the urethra occurs to a desired diameter and configuration.

16. A dilation device according to claim 15, wherein the device is adapted to remain in the urethra for a time sufficient that the dilated configuration of the urethra will tend to remain as such after removal of the device.

17. A dilation device according to claim 16, which includes means for removing said device from the urethra after a period of between about 5 and about 30 days.

18. A dilation device according to claim 17, which additionally includes anchoring or fixing means which will retain the device within the urethra for the time desired without slippage or spontaneous movement therefrom.

19. A dilation device according to claim 18, wherein the outer surface of the bag expands at a rate of between 6 and 10 French per 24 hour period.

20. A dilation device according to claim 18, wherein said anchoring or fixing means comprise a filament attached at one end to said core and traversing through at least a portion of said core, said filament further extending out of said core and having a portion thereof capable of being reversibly coiled or straightened when positioned in the area of the external sphincter, which when in a coiled mode will provide an anchoring or fixing mechanism for the device.

21. A dilation device according to claim 15 whereby to effect removal thereof, the collapsible bag is initially torn and collapsed by externally applied means.

22. A method of dilating a portion of a urethra obstructed as a consequence of a hypertrophied prostate gland, by inserting a device into the urethra comprising,

an inner hollow tubular core defining a lumen therewithin, said lumen being a conduit of sufficient diameter to permit urine to flow freely therethrough from the bladder, said core being non-collapsible under pressures that would emanate from the hypertrophied prostate gland and containing access means enabling body fluids to pass through said core in a radially outwardly direction;

and having

an outer confining covering capable of expanding radially outwardly to a predetermined extent, said covering having a length, disposed on said core, of at least partially that of the obstructed portion of the urethra; and

having

hydrophilic material defined between said outer covering and said core capable of absorbing water and thereupon gradually swelling for a period of at least about 30 minutes;

disposing the device within at least the length of the obstructed portion; and

leaving said device within the urethra for at least 30 minutes until the hydrophilic means swell due to the uptake of body fluids, whereby the outer covering expands to the extent dilation of the obstructed portion of the urethra occurs to a desired diameter and configuration.

23. A method according to claim 22, wherein the device remains in the urethra for a time sufficient so that the dilated configuration will tend to remain in such configuration after the device is removed.

24. A method according to claim 22 wherein the hydrophilic means expands at a rate of between 6 and 10 French per 24 hour period, the expansion being self-limiting.

25. A method according to claim 23, Wherein the device remains in the urethra for a period of from about 5 days to about 30 days before being removed from the urethra.

26. A method according to claim 22, wherein the outer confining covering is in the form of an envelope having an outer surface capable of expanding to a predetermined diameter.

27. A method according to claim 22, wherein the outer confining covering is in a form of a collapsible and expandable bag, having an elastic outer surface capable of expanding to the extent where equilibrium is obtained between the radial pressures of the expanded hydrophilic material and the prostatic tissue.

28. A method of treating benign prostatic hyperplasia which comprises,

inserting a dilation device into a urethra obstructed as a consequence of the prostatic hyperplasia, said device having hydrophilic means integrally associated therewith which are adapted to gradually swell and then expand radially outwardly when water is absorbed by said means,

retaining said device within at least the obstructed portion of the urethra for a period of at least about 30 minutes whereby the hydrophilic means swell due to the uptake of body fluids and gradually expand radially and outwardly to effect a desired dilation of the obstructed portion,

leaving the device in the urethra for a period of between about 5 and about 30 days, and removing the device from the urethra, the dilated portion of the urethra thereby tending to remain in such dilated configuration.