Therapeutic device for the selective cytoreduction treatment of an obstruction in a natural lumen or passage of the human or animal body

• US 6,949,083 B2
• Filed: 04/05/2001
• Issued: 09/27/2005
• Est. Priority Date: 07/13/1994
• Status: Expired due to Fees

• Current Assignee: Marian Devonec
• Original Assignee: Marian Devonec
• Inventors: Devonec, Marian
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/826,207
• Publication Number:
  US 20010041883A1
• Time in Patent Office: 1,636 Days
• Field of Search: 604/93.01, 604/265, 604/48, 604/104, 604/96.01, 604/266, 604/523, 604514-517, 604/8, 604105-109, 604/101.01, 606/192, 606/194, 606/198, 606/191, 606/193, 623/1.11, 623/23.64, 623 2366- 2368, 623/23.7, 623/23.71, 623 2373- 2376, 623/1.15, 623/1.16, 623/1.42, 424422-426, 514/411
• US Class Current: 604/93.01
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, the lumen being obstructed by the effect of a local cell proliferation, the device including a tubular element, in particular of cylindrical shape, intended to be placed in the natural lumen and sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain an artificial channel in the lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect the lumen is obstructed.

Claims

1. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in the prostatic portion of a male urethra, comprising:

a non-biodegradable element that is designed to be placed and retained in a prostatic portion of the male urethra to maintain a channel, said element being sufficiently flexible to conform to the urethra, but sufficiently rigid to maintain the channel for urine flow in the prostatic portion, the channel providing for passage of urine from upstream of the obstruction to downstream of the obstruction; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the prostatic portion of the male urethra when said element is retained in the prostatic portion of the male urethra,

wherein said element comprises a bottom end and a top end, and wherein said cytoreductive agent is positioned between said bottom end and said top end of said element,

wherein said top end of said element is blind, and includes at least one perforation in order to ensure the passage of urine, and

wherein said device further comprises a withdrawal thread and is non-traumatically removable from the male urethra by said withdrawal thread following treatment of the obstruction.

2. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen,

wherein said element comprises a bottom end and a top end, and wherein said cytoreductive agent is positioned between said bottom end and said top end of said element,

wherein said top end of said element is blind, and includes at least one perforation in order to ensure the passage of the fluid, and

wherein said device further comprises a withdrawal thread and is non-traumatically removable from the natural lumen by said withdrawal thread following the obstruction.

3. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow;

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen; and

an other element attached to said non-biodegradable element by a flexible connection,

wherein said device further comprises a withdrawal thread and is non-traumatically removable from the natural lumen by said withdrawal thread following treatment of the obstruction.

4. The device of claim 3, wherein said other element does not comprise or support a cytoreductive agent.

5. The device of claim 3, wherein said other element comprises a core made of a biocompatible but non-biodegradable material.

6. The device of claim 5, wherein said biocompatible but non-biodegradable material of said other element is silicone rubber.

7. The device of claim 3, wherein at least a portion of said other element is radially expandable.

8. The device of claim 3, wherein said natural lumen is the prostatic portion of a male urethra.

9. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 3, into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing normal passage of the fluid.

10. The method of claim 9, wherein said cytoreductive agent causes a reduction in the obstruction.

11. The method of claim 10, wherein said cytoreductive agent causes the reduction in the obstruction when in direct contact with the obstruction.

12. The method of claim 11, wherein said cytoreductive agent gradually ceases to cause the reduction in the obstruction as direct contact of said device with the obstruction ceases.

13. The method of claim 10, further comprising removing said device once sufficient reduction has occurred that the natural lumen can function normally in absence of said device.

14. The method of claim 10, wherein the obstruction is a tumoral obstruction.

15. The method of claim 14, wherein said cytoreductive agent erodes the tumoral obstruction.

16. The method of claim 9, further comprising temporarily maintaining said device in the natural lumen and then removing said device from the natural lumen.

24. A method for treating an obstruction prostatic portion of a male urethra, comprising inserting said device of claim 8 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

17. A therapeutic device intended for being substantially fully located in a natural lumen through which a fluid naturally flows, said fluid flow being controlled by a sphincter through said lumen, said device comprising:

a non-biodegradable tubular bio-active element that is designed to be placed in at least an obstructed part of said natural lumen, upstream of said sphincter, said element having a substantially continuous wall and external surface and being sufficiently flexible to conform to said lumen, but sufficiently rigid to maintain a channel for flow of the fluid in the lumen, said wall being fluid-tight with respect to said natural fluid flow, and said channel providing for passage of the fluid flow from upstream of the obstruction to downstream of the obstruction with respect to said natural fluid flow;

said bio-active element being retained in the downstream direction by said sphincter, and in the upstream direction by retaining means linked to said element and to be placed in said lumen downstream of said sphincter, wherein said retaining means is not therapeutically active;

said bio-active element comprising a therapeutic agent that causes reduction of the obstruction supported by and arranged around and along said element to be delivered by contact between said external surface and said obstruction; and

said device being arranged to be inserted into and removed from said lumen in a substantially non-traumatic manner.

18. A device as claimed in claim 17, wherein the lumen is a male urethra and the obstructed part is the prostatic portion of said urethra.

19. A device according to claim 17, wherein the therapeutic agent is a cytoreductive agent.

20. The device according to claim 17, wherein said natural lumen is the prostatic portion of a male urethra.

22. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 17 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing the normal passage of the fluid.

23. A method for treating an obstruction in the prostatic portion of a male urethra, comprising inserting said device of claim 20 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

21. A therapeutic device intended for being substantially fully located in a natural lumen through which a fluid naturally flows, said fluid flow being controlled by a sphincter through said lumen, said device comprising:

a non-biodegradable tubular element that is designed to be placed in at least an obstructed part of said natural lumen, upstream of said sphincter, said clement having a substantially continuous wall and external surface and being sufficiently flexible to conform to said lumen, but sufficiently rigid to maintain a channel for flow of the fluid in the lumen, said channel providing for passage of the fluid flow from upstream of the obstruction to downstream of the obstruction with respect to said natural fluid flow;

said element being retained in the downstream direction by said sphincter, and in the upstream direction by retaining means linked to said element and to be placed in said lumen downstream of said sphincter;

said element comprising a therapeutic agent that causes reduction of the obstruction supported by and arranged around and along said element to be delivered by contact between said external surface and said obstruction; and

said device being arranged to be inserted into and removed from said lumen in a substantially non-traumatic manner, said device comprising a withdrawal thread at its downstream end, arranged for the non-traumatic removal of said device.