Draining bodily fluids with a stent

• US 7,691,078 B2
• Filed: 07/11/2005
• Issued: 04/06/2010
• Est. Priority Date: 05/22/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Rioux, Robert, O'Keefe, Christopher R.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/179,110
• Publication Number:
  US 20050273158A1
• Time in Patent Office: 1,730 Days
• Field of Search: 604/96.01, 604/104, 604/105, 604/160, 604/107, 604/108, 606191-194, 606/198
• US Class Current: 604/19
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95

Abstract

A stent for assisting urinary release in a male patient includes a first segment, a second segment, and a connecting member disposed between the first and second segments. The first segment includes a multi-winged malecot. When the stent is properly positioned within the patient'"'"'s urinary system, the first segment is located on one side of the external sphincter with the multi-winged malecot located within the bladder to inhibit migration of the stent, and the second segment is located on the other side of the external sphincter and also tends to inhibit migration of the stent. The connecting segment is sized to extend through the external sphincter to couple the first and second segments together while not interfering with the normal operation of the external sphincter.

Claims

1. A stent for use in the body of a patient, comprising:

(a) a first segment locatable on the proximal side of the external sphincter of the patient and including a proximal portion, a distal end, and a lumen extending within the first segment, the proximal portion including at least one opening in communication with the lumen and an inflatable balloon, the inflatable balloon in communication with an inflation channel for conveying fluids to fill the balloon, the inflation channel extending between the inflatable balloon and a valve located on the distal end of the first segment, the valve controlling flow of fluid in and out of the inflation channel, the distal end terminating on the proximal side of the external sphincter when the stent is placed in the body of the patient;

(b) a second segment locatable on the distal side of the external sphincter of the patient and including a proximal end, a distal end, and a lumen extending within the second segment, the proximal end terminating on the distal side of the external sphincter when the stent is placed in the body of the patient; and

(c) a connecting member disposed between the first and second segments and coupling together the first and second segments, the connecting member extending from the distal end of the first segment to the proximal end of the second segment with a smooth transition at the distal and proximal ends, the connecting member being sized to extend through the external sphincter and to allow normal operation of the external sphincter by the patient when the stent is placed in the body of the patient.

2. The stent of claim 1 wherein the connecting member comprises a wire with a first end and a second end.

3. The stent according to claim 2 wherein the first and second ends of the wire are embedded in the first and second segments, respectively.

4. The stent of claim 1 wherein the connecting member is integrally connected to the first segment and the second segment.

5. The stent of claim 1 wherein a proximal end of the proximal portion of the first segment is curved.

6. The stent of claim 1 wherein the proximal portion of the first segment includes an additional opening for receiving a guide wire.

7. The stent of claim 1 wherein the first segment farther includes a reinforcing element.

8. The stent of claim 7 wherein the reinforcing element comprises a wire coil.

9. The stent of claim 7 wherein the reinforcing element comprises a wire mesh tube.

10. The stent of claim 1 wherein the second segment further comprises an elongated member extending therefrom and for extension through the urethra and out of the meatus to allow removal of the stent from the body of the patient by pulling on a part of the elongated member external to the body.

11. The stent of claim 10 wherein at least a portion of the elongated member is embedded within the second segment.

12. A stent for use in the body of a patient, comprising:

(a) a first segment locatable on the proximal side of the external sphincter of the patient and including a proximal portion, a distal end, a reinforcing element, and a lumen extending within the first segment, the proximal portion including at least one opening in communication with the lumen and an inflatable balloon, the distal end of the first segment terminating on the proximal side of the external sphincter when the stent is placed in the body of the patient;

(b) a second segment locatable on the distal side of the external sphincter of the patient and including a proximal end, a distal end, and a lumen extending within the second segment, the proximal end terminating on the distal side of the external sphincter when the stent is placed in the body of the patient;

(c) a connecting member disposed between the first and second segments and coupling together the first and second segments, the connecting member extending from the distal end of the first segment to the proximal end of the second segment with a smooth transition at the distal and proximal ends, the connecting member being sized to extend through the external sphincter and to allow normal operation of the external sphincter by the patient when the stent is placed in the body of the patient; and

(d) an inflation channel for conveying fluid to the inflatable balloon, the inflation channel extending between the inflatable balloon and a valve located on the distal end of the second segment, the valve for controlling the flow of a fluid in and out of the inflation channel.

13. The stent of claim 12 wherein the first segment, the connecting member and the second segment define the inflation channel.

14. The stent of claim 12 wherein the connecting member is integrally connected to the first segment and the second segment.

15. The stent of claim 12 wherein a proximal end of the proximal portion of the first segment is curved.

16. The stent of claim 12 wherein the proximal portion of the first segment includes an additional opening for receiving a guide wire.

17. The stent of claim 12 wherein the reinforcing element comprises a wire coil.

18. The stent of claim 12 wherein the reinforcing element comprises a wire mesh tube.

19. The stent of claim 12 wherein the second segment further comprises an elongated member extending therefrom and for extension through the urethra and out of the meatus to allow removal of the stent from the body of the patient by pulling on a part of the elongated member external to the body.

20. The stent of claim 19 wherein at least a portion of the elongated member is embedded within the second segment.

21. A method of positioning a stent within the urinary system of a patient, the method comprising:

(a) providing a stent comprising;

a first segment locatable on the proximal side of the external sphincter of the patient and including a proximal portion, a distal end, and a lumen extending within the first segment, the proximal portion including at least one opening in communication with the lumen and an inflatable balloon, the inflatable balloon in communication with an inflation channel for conveying fluids to fill the balloon, the inflation channel extending between the inflatable balloon and a valve located on the distal end of the first segment, the valve controlling flow of fluid in and out of the inflation channel, the distal end terminating on the proximal side of the external sphincter when the stent is placed in the body of the patient;

a second segment locatable on the distal side of the external sphincter of the patient and including a proximal end, a distal end, and a lumen extending within the second segment, the proximal end terminating on the distal side of the external sphincter when the stent is placed in the body of the patient; and

a connecting member disposed between the first and second segments and coupling together the first and second segments, the connecting member extending from the distal end of the first segment to the proximal end of the second segment with a smooth transition at the distal and proximal ends, the connecting member being sized to extend through the external sphincter and to allow normal operation of the external sphincter by the patient when the stent is placed in the body of the patient;

(b) providing a stylet for pushing the stent through the patient'"'"'s urethra, the stylet comprising a proximal end and a distal end, and sized to be received within the lumens of the second and first segments;

(c) providing a syringe and an inflation segment for filling the inflatable balloon with fluid, the inflation segment comprising a first end, a second end, and a lumen extending within the inflation segment;

(d) connecting the first end of the inflation segment to the syringe and the second end to the valve located on the distal end of the first segment;

(e) passing the stylet through the lumens of the second and first segments of the stent;

(f) inserting the stent, stylet, and inflation segment into the patient'"'"'s urethra;

(g) positioning the stent within the urinary system such that the first segment is located substantially within the prostatic urethra with the proximal portion located within the bladder and the distal end terminating prior to the proximal side of the external sphincter, the second segment located on the distal side of the external sphincter, and the connecting member extending through the external sphincter;

(h) filling the inflatable balloon located within the bladder with the fluid by activating the syringe to force the fluid from the syringe, through the lumen of the inflation segment, through the inflation channel, and into the inflatable balloon;

(i) disconnecting the second end of the inflation segment from the valve located on the distal end of the first segment;

(j) removing the stylet from the first and second segments; and

(k) removing the stylet and inflation segment completely from the patient'"'"'s urethra, thereby leaving the stent positioned within the patient'"'"'s urinary system.

22. A method of positioning a stent within the urinary system of a patient, the method comprising:

(a) providing a stent comprising;

a first segment locatable on the proximal side of the external sphincter of the patient and including a proximal portion, a distal end, a reinforcing element, and a lumen extending within the first segment, the proximal portion including at least one opening in communication with the lumen and an inflatable balloon, the distal end of the first segment terminating on the proximal side of the external sphincter when the stent is placed in the body of the patient;

the second segment locatable on the distal side of the external sphincter of the patient and including a proximal end, the distal end, and a lumen extending within the second segment, the proximal end terminating on the distal side of the external sphincter when the stent is placed in the body of the patient;

a connecting member disposed between the first and second segments and coupling together the first and second segments, the connecting member extending from the distal end of the first segment to the proximal end of the second segment with a smooth transition at the distal and proximal ends, the connecting member being sized to extend through the external sphincter and to allow normal operation of the external sphincter by the patient when the stent is placed in the body of the patient; and

an inflation channel for conveying fluid to the inflatable balloon, the inflation channel extending between the inflatable balloon and a valve located on the distal end of the second segment, the valve for controlling the flow of a fluid in and out of the inflation channel;

(b) providing a stylet for pushing the stent through the patient'"'"'s urethra, the stylet comprising a proximal end and a distal end, and sized to be received within the lumens of the second and first segments;

(c) providing a syringe and an inflation segment for filling the inflatable balloon with fluid, the inflation segment comprising a first end, a second end, and a lumen extending within the inflation segment;

(d) connecting the first end of the inflation segment to the syringe and the second end to the valve located on the distal end of the second segment;

(e) passing the stylet through the lumens of the second and first segments of the stent;

(f) inserting the stent, stylet, and inflation segment into the patient'"'"'s urethra;

(g) positioning the stent within the urinary system such that the first segment is located substantially within the prostatic urethra with the proximal portion located within the bladder and the distal end terminating prior to the proximal side of the external sphincter, the second segment located on the distal side of the external sphincter, and the connecting member extending through the external sphincter;

(h) filling the inflatable balloon located within the bladder with the fluid by activating the syringe to force the fluid from the syringe, through the lumen of the inflation segment, through the inflation channel, and into the inflatable balloon;

(i) disconnecting the second end of the inflation segment from the valve located on the distal end of the second segment;

(j) removing the stylet from the first and second segments; and

(k) removing the stylet and inflation segment completely from the patient'"'"'s urethra, thereby leaving the stent positioned within the patient'"'"'s urinary system.