Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20040199262 A1
Publication typeApplication
Application numberUS 10/827,957
Publication date7 Oct 2004
Filing date20 Apr 2004
Priority date31 Aug 1998
Also published asUS6746489, US20020032487
Publication number10827957, 827957, US 2004/0199262 A1, US 2004/199262 A1, US 20040199262 A1, US 20040199262A1, US 2004199262 A1, US 2004199262A1, US-A1-20040199262, US-A1-2004199262, US2004/0199262A1, US2004/199262A1, US20040199262 A1, US20040199262A1, US2004199262 A1, US2004199262A1
InventorsKulwinder Dua, Scott Moore, John Karpiel
Original AssigneeWilson-Cook Medical Incorporated
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Prosthesis having a sleeve valve
US 20040199262 A1
Abstract
Disclosed is a pressure sensitive prosthesis (10) that includes a tubular member (11) having a passageway (12) extending therethrough and a sleeve (13) attached about one end of the tubular member. The sleeve functions as a one-way valve to permit fluid flowing through the sleeve lumen (15) in a first direction (17) and under a first pressure, while collapsing in response to fluid flowing in a second direction 18 where the pressure that exceeds that of the first direction or pressure. One aspect of the invention includes an esophageal anti-reflux expandable prosthesis wherein the sleeve is adapted to invert back through the tubular stent frame to permit belching or vomiting (fluid or materials under a third, significantly higher pressure). Another aspect of the invention includes a tubular drainage stent (60), such as a biliary or urethral stent in which the sleeve opens to permit passage of fluids, then collapses to prevent retrograde flow.
Images(10)
Previous page
Next page
Claims(37)
1. A prosthesis for placement in a patient comprising:
a tubular drainage stent having a passage extending longitudinally therethrough; and
a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
2. The prosthesis of claim 1, wherein a portion of the sleeve extends over an outer surface of the tubular drainage stent and is affixed thereto.
3. The prosthesis of claim 2, wherein the sleeve includes an attachment member that affixes the sleeve to the tubular drainage stent.
4. The prosthesis of claim 3, wherein the attachment member comprises a metal band.
5. The prosthesis of claim 1, wherein the sleeve comprises a bile-resistant polymeric material.
6. The prosthesis of claim 5, wherein the material comprises expanded polytetrafluoroethylene.
7. The prosthesis of claim 1, wherein the material comprises polyurethane.
8. The prosthesis of claim 1, wherein the sleeve has an average thickness in the range of approximately 0.001″ to 0.01″.
9. The prosthesis of claim 8, wherein the sleeve has an average thickness of approximately 0.002″ to 0.005″.
10. The prosthesis of claim 9, wherein the sleeve has a thickness of approximately 0.0025″.
11. The prosthesis of claim 1, wherein the tubular drainage stent is sized and configured for placement in the biliary system such that the sleeve is extendable into the intestine of the patient such that bile travels in the first direction thereinto.
12. The prosthesis of claim 1, wherein the prosthesis further includes a guiding catheter and pusher element having a distal end, the prosthesis being mounted over the guiding catheter such that the prosthesis is deliverable to a target site within the patient by way of the distal end of the pusher element urging the prosthesis distally and relative to the guiding catheter until the prosthesis is deployed therefrom.
13. The prosthesis of claim 1, wherein the sleeve and tubular drainage stent comprise the same polymeric material, the sleeve representing an integral extension of the one end of the tubular drainage stent.
14. The prosthesis of claim 1, wherein the sleeve is normally closed in the absence of the fluid applying a first pressure in a first direction.
15. The prosthesis of claim 1, wherein the end form which the sleeve extends includes a pigtail configuration.
16. A prosthesis for placement in a patient comprising:
a tubular drainage stent sized and configured for placement in the biliary system, the tubular drainage stent having a passage extending longitudinally therethrough; and
a sleeve comprising a polymeric material, the sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
17. The prosthesis of claim 16, wherein the sleeve is normally closed in the absence of the fluid applying a first pressure in a first direction.
18. The prosthesis of claim 16, wherein the material comprises expanded polytetrafluoroethylene.
19. The prosthesis of claim 16, wherein the sleeve has an average thickness of approximately 0.002″ to 0.005″.
20. The prosthesis of claim 14, wherein the prosthesis further includes a guiding catheter and pusher element having a distal end, the prosthesis being mounted over the guiding catheter such that the prosthesis is deliverable to a target site within the patient by way of the distal end of the pusher element urging the prosthesis distally and relative to the guiding catheter until the prosthesis is deployed therefrom.
21. A prosthesis for placement in a patient comprising:
a tubular drainage stent sized and configured for placement in a bodily passageway, the tubular drainage stent having a passage extending longitudinally therethrough, and
a sleeve comprising a thin, flexible polymeric material, the sleeve attached about the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to either a fluid applying a second pressure in a second direction or the absence of the fluid applying a first pressure in a first direction.
22. The prosthesis of claim 21, wherein the sleeve extends from an end of the tubular drainage stent.
23. The prosthesis of claim 21, wherein one end of the sleeve is affixed within the lumen of the tubular drainage stent.
24. The prosthesis of claim 21, wherein the sleeve resides completely within the lumen of the tubular drainage stent.
25. (Cancelled)
26. (Cancelled)
27. (Cancelled)
28. A prosthesis for placement in a patient comprising:
a tubular drainage stent having a passage extending longitudinally there through configured to pass only bodily matter;
a retention structure extending from an outer surface of the passage and comprising a flexible material configured to hold the tubular drainage stent within a vessel that conveys fluid without enlarging a diameter of the passage; and
a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
29. The prosthesis of claim 28, wherein the retention structure comprises a structure selected from the group consisting of a flap and a barb.
30. The prosthesis of claim 28, wherein the tubular drainage stent is sized and configured for placement within a body passage selected from the group consisting essentially of a bile duct, a pancreatic duct, and a urethra.
31. The prosthesis of claim 28, wherein the tubular drainage stent is sized and configured for placement within a body passage selected from the group consisting of a pancreatic duct and a urethra.
32. (Cancelled)
33. (Cancelled)
34. A prosthesis for placement in a patient comprising:
a tubular drainage stent having a passage sized and configured for placement within a pancreatic duct;
a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and
a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
35. A prosthesis for placement in a patient comprising:
a tubular drainage stent having a passage sized and configured for placement within a urethra;
a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and
a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
36. A prosthesis for placement in a patient comprising:
a tubular drainage stent having a passage sized and configured for conveying a glandular secretion;
a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and
a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.
37. A prosthesis for placement in a patient comprising:
a non-expanding tubular drainage stent sized and configured for placement in a bodily passageway, the tubular drainage stent having a passage extending longitudinally there through, and
a sleeve comprising a thin, flexible polymeric material, the sleeve attached about the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to either a fluid applying a second pressure in a second direction or the absence of the fluid applying a first pressure in a first direction.
Description
    CROSS-REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This application claims priority of provisional application Serial No. 60/211,753, filed Jun. 14, 2000, and is a continuation-in-part of co-pending U.S. patent application Ser. No. 09/386,173, filed Aug. 31, 1999, which claims priority to provisional application Serial No. 60/098,542, filed Aug. 31, 1998.
  • TECHNICAL FIELD
  • [0002]
    This invention relates generally to medical devices and, in particular, to an indwelling valved prosthesis.
  • BACKGROUND OF THE INVENTION
  • [0003]
    Anti-reflux esophageal prosthesis or stents are typically placed in the lower esophagus and through the lower esophageal sphincter to maintain the patency thereof due to the presence of a cancerous tumor commonly found in the vicinity thereof. The cancerous tumor growth typically impinges the flow of food and fluids through the esophagus. Lower esophageal cancer in the United States presently occurs at the rate of approximately 12,000 patients per year. The incidence in the United States is approximately 5.1 per 100,000 people, which is rising particularly in white male patients. Esophageal prosthesis or stents are typically utilized in these cancerous patients. However, these devices are not FDA approved for benign tumors which also cause blockage or partial stenosis of the esophagus. Esophageal prosthesis or stents are utilized in Europe and other countries for benign tumor conditions, but not in the United States at this time.
  • [0004]
    A problem with esophageal prosthesis or stents is that fluid from the stomach flows into the mouth of the patient when in a prone position. In an attempt to solve this problem, a number of esophageal prosthesis or stents utilize a one-way valve such as a duck-bill or reed-type valve in which only food or fluid from the esophagus flows into the stomach in only an antegrade or forward direction. However, these one-way anti-reflux prosthesis or stents present another problem. When the patient wants to belch or vomit, he/she is prevented from doing so, because the one-way valve prevents backward flow in the retrograde direction. Such condition is not only painful to the patient, but can also lead to more complicated medical conditions.
  • [0005]
    There are other anatomical sites, such as the biliary tree or genitourinary system in which a prosthesis may be placed to maintain an open lumen for passage of bodily fluids, thereby creating risk of undesirable retrograde flow and/or migration of pathogenic organisms which could lead to infection or other problems, such as obstruction of the stent. When a drainage stent or catheter is placed across a sphincter or natural stricture at the opening to a bodily passage, the sphincter or stricture cannot fulfill its normal function of restricting retrograde flow or migration. What is needed is a prosthesis and one-way valve that can effectively regulate antegrade and retrograde flow in response to the normal flow rates and pressures that exist across the site in which the prosthesis is placed.
  • SUMMARY OF THE INVENTION
  • [0006]
    The foregoing problems are solved and a technical advance is achieved in an illustrative prosthesis having a sleeve which permits antegrade flow under a first pressure through the sleeve, and collapses in response to a second flow or pressure that is greater than the first flow or pressure.
  • [0007]
    In one aspect of the invention, the prosthesis comprises an anti-reflux esophageal prosthesis in which a sleeve extending from a tubular frame thereof inverts through the passage of the tubular frame and allows stomach gas or vomit to flow in a retrograde direction when the pressure in the stomach exceeds a given level. In the antegrade or downward position, the sleeve collapses and prevents the reflux of stomach gas and fluid from flowing through the esophagus and into the mouth of the patient. The collapsible sleeve functions as a one-way valve and allows the patient to ingest or pass liquid and food therethrough and into the stomach. In addition, the tubular frame of this advantageous anti-reflux esophageal prosthesis maintains the patency of the lower esophagus and sphincter particularly when a cancerous tumor impedes fluid flow through the esophagus.
  • [0008]
    In another advantageous aspect of the present invention, the tubular frame of the anti-reflux esophageal prosthesis includes a plurality of self-expanding zig-zag stents. The compressed stents along with the sleeve are positioned in an delivery catheter which is orally passed through the esophagus and lower sphincter. The prosthesis is then deployed from the delivery catheter with, for example, a dilator or pusher catheter that is inserted in the lumen of the delivery catheter. The deployed, self-expanding stents readily expand to engage the esophagus and lower sphincter and maintain them in a patent condition.
  • [0009]
    The self-expanding stents of the tubular frame are also advantageously flared at each end of the tubular frame to prevent antegrade and retrograde migration of the expanded prosthesis. To further prevent migration of the zig-zag stents with respect to each other, a filament is circumferentially positioned through closed eyelets at the bends of adjacent zig-zag stents. The filaments are also utilized advantageously to control the radial expansion and the flared configuration of the stents positioned at the ends of the tubular frame.
  • [0010]
    The pressure needed to collapse or invert the one-way valvular sleeve is a function of the sleeve material, its wall thickness and length extending from the distal end of the tubular frame. Depending on the anatomical size of the human or veterinary patient, the sleeve can extend from the end of the frame for a length in a range of from 0.0 to 20 cm, preferably in a range of 5 to 15 cm; and more preferably in length of approximately 10 cm in a human patient or 8 cm in a veterinary patient as experimentally derived therefor. The sleeve material also advantageously includes a material of polyurethane, silicone, polyamides, other urethanes or any biocompatible material that is flexible and acid resistant. The sleeve material can have an advantageous thickness of 0.005″ through 0.008″.
  • [0011]
    This thickness is at the portion covering the frame itself. The sleeve extending from an end of the frame comprises a material having a thickness in a range of 0.0015″ to and including 0.004″ and preferably approximately 0.002″. Advantageously, the length of the sleeve is made long enough so that it can be readily shortened to accommodate individual anatomical situations.
  • [0012]
    In another aspect of the invention the collapsible sleeve is attached to a tubular drainage stent, such as a biliary stent, to advantageously prevent reflux of intestinal contents and the associated bacteria into the passage of the stent. These bacteria are known to promote the formation of biofilm which can lead to occlusion of the stent. With the stent placed in the biliary tree for maintaining patency of the bile or pancreatic duct and the Papilla of Vater, the sleeve extends down into the duodenum to provide a one-way valve for the flow of bile. When bile is not being secreted, the sleeve advantageously collapses to prevent backflow of material from the duodenum, a situation which might otherwise occur in a biliary stent without a closure means. Tubular drainage stents for placement in the ureters or urethra can include either a sleeve extending from one end to permit urine flow and prevent retrograde flow or pathogen migration toward the kidneys or bladder, or the sleeve may be located completely within the lumen of the drainage stent with one end of the sleeve being bonded or otherwise attached to the inner walls of the lumen.
  • BRIEF DESCRIPTION OF THE DRAWING
  • [0013]
    [0013]FIG. 1 depicts a pictorial view of an illustrative embodiment of a pressure sensitive anti-reflux esophageal prosthesis of the present invention;
  • [0014]
    [0014]FIG. 2 depicts an enlarged cross-sectional view of a sleeve about a cylindrical wire of a flared stent of the esophageal prosthesis taken along line 2-2 of FIG. 1;
  • [0015]
    [0015]FIG. 3 depicts an enlarged partially sectioned view of the adjacent ends of interconnected stents of the prosthesis of FIG. 1;
  • [0016]
    [0016]FIG. 4 depicts a two piece mandril that is used to apply the sleeve material to the prosthesis of FIG. 1;
  • [0017]
    [0017]FIG. 5 depicts the esophageal prosthesis of FIG. 1 deployed in the lower esophagus of a patient, and, in particular, through the lower esophageal sphincter and a cancerous tumor;
  • [0018]
    [0018]FIG. 6 depicts the anti-reflux esophageal prosthesis of FIG. 1 in a collapsed state in a delivery catheter;
  • [0019]
    [0019]FIG. 7 depicts the delivery catheter of FIG. 6 positioned in the lower esophagus, sphincter, and tumor of a patient;
  • [0020]
    [0020]FIG. 8 depicts an in-vitro barrier reflux curve for an anti-reflux esophageal prosthesis of the present invention;
  • [0021]
    [0021]FIGS. 9 and 10 depict the percent of fraction time of standard and anti-reflux esophageal prosthesis utilized in an evaluation of the present invention;
  • [0022]
    [0022]FIG. 11 depicts a pictorial view of an embodiment of a tubular drainage prosthesis of the present invention;
  • [0023]
    [0023]FIG. 12 depicts a cross-sectional view of a second embodiment of a tubular drainage prosthesis;
  • [0024]
    [0024]FIG. 13 depicts the prosthesis of FIG. 11 positioned in the common bile duct of a patient;
  • [0025]
    [0025]FIG. 14 depicts a side view of the prosthesis of FIG. 11 mounted on a delivery system;
  • [0026]
    [0026]FIG. 15 depicts a side view of one end of a valved prosthesis that includes a pigtail configuration; and
  • [0027]
    [0027]FIG. 16 depicts a laterally sectioned view of a valved prosthesis in which the sleeve is affixed with the lumen.
  • DETAILED DESCRIPTION
  • [0028]
    [0028]FIGS. 1-14 depict exemplary prostheses of the present invention comprising a tubular member 11 with a passage 12 therethrough, and a thin, flexible sleeve 13 extending from the tubular member 11. The sleeve 13, which also has a passage 15 therethrough, is configured to allow the flow of liquid or other materials moving under a first pressure until the flow and pressure are lessened where they are exceeded by the second, back pressure of the drainage environment, at which time the sleeve 13 collapses to prevent the ingress of fluids of materials into the tubular member.
  • [0029]
    [0029]FIG. 1 depicts a pictorial view of an illustrative, preferred embodiment of pressure sensitive anti-reflux esophageal prosthesis 10 of the present invention. The prosthesis includes a tubular frame 11 of a plurality 19 of self-expanding, zig-zag wire stents 20, 21, and 23 covered by a polyurethane sleeve 13 that is disposed around and extends along entire length 27 of the tubular frame. The sleeve also extends from distal end 14 of the self-expanding tubular frame and has a lumen 15 extending longitudinally therethrough. Lumen 15 of the sleeve also communicates with passage 12 of the tubular frame. When the prosthesis is positioned in the lower esophagus and through the lower sphincter of a patient, lumen 15 in lower portion 28 of the sleeve collapses upon itself due to wetting by gastric juices, fluid or saliva flowing therethrough from the esophagus in a first direction 17. As a result, sleeve 13 is in a collapsed position and acts as a one-way valve into the stomach, thereby preventing the reflux of gastric fluid from flowing in a retrograde manner through the prosthesis and esophagus and into the mouth of the patient, referred to herein as the second direction 18. However, fluid readily flows in the opposite (first) direction 17 from the esophagus and through the one-way valve sleeve into the patient's stomach.
  • [0030]
    Tubular frame 11 includes plurality 19 of self-expanding stents 20, 21, and 23 that are interconnected circumferentially by filament 24 about adjacent ends 25 and 26 of the stents. In this illustrative embodiment, the tubular frame includes four self-expanding, zig-zag wire metal stents of the Gianturco type as described in U.S. Pat. No. 4,580,568, which is incorporated by reference herein. Tubular frame includes first and second flared stents 20 and 21 positioned at distal and proximal ends 14 and 22 with first and second cylindrical stents 23 positioned therebetween. By way of example, first and second flared stents 20 and 21 have a minimum diameter of 18 mm and a flared diameter of approximately 25 mm. These diameters are nominal diameters for the stents and can be customized to meet the particular demands of any human or veterinary patient. The diameter of the flared end is maintained by end filament 29. The minimum diameter of the flared stents along with the nominal diameter of the cylindrical stents is maintained by interconnecting filaments 24. The interconnecting and end filaments 24 and 29 are, for example, 3/0 diameter mononylon suture material. The first and second flared stents 20 and 21 are positioned below and above the lower esophageal sphincter and prevent the migration of the prosthesis in either the antegrade or retrograde direction with respect to the esophagus. The flared proximal stent along with the cylindrical stents 23 also expand against any tumor that is in the region of the lower esophagus and maintains the patency of the lower esophageal lumen.
  • [0031]
    Flared stents 20 and 21 are, for example, formed from commercially available Series 304 stainless steel cylindrical wire having a diameter of approximately 0.015″. The wire is formed into a zig-zag pattern of which the ends are joined together using, for example, a metal sleeve and soldered together using silver/tin solder. However, other ways of forming a closed zig-zag configuration that resembles at least a partially tubular shape is contemplated. The flared or maximum diameter of the flared stents is approximately 25 mm with the minimum diameter at approximately 18 mm. Interconnecting cylindrical stents 23 are also formed from the same cylindrical wire and have a nominal diameter of approximately 18 mm matching that of the minimum diameter of the flared stents. The length of the individual stents is approximately 2 cm. The overall length of the tubular frame can range from 8 to 14 cm in 2 cm increments. These 2 cm increments are typically provided by increasing the number of interconnecting cylindrical stents 23.
  • [0032]
    Sleeve 13 preferably comprises a polyurethane material or other liquid impermeable material that does not degrade in the presence of fluids or gastric material that comes in contact therewith. The sleeve is disposed around and extends at least partially around tubular frame 11. Preferably, the sleeve extends the entire length of the frame and extends longitudinally from distal end 14 of the tubular frame. The length of the sleeve material extending from the distal end of the tubular frame can range from 0 through 20 cm, preferably 5 to 15 cm, and more preferably 10 cm. The length of the sleeve material can be individually customized by the physician depending on the anatomy of the patient. Experimental data has indicated that dogs typically utilize a 7 cm length of sleeve material. Human patients are expected to utilize a sleeve length of 8 or 9 cm. However, the length can again be modified by the physician to meet the particular anatomy of the patient. The wall thickness of the sleeve material disposed around the tubular frame is approximately 0.006″ thick. The thickness of the sleeve material along lower portion 28 of the sleeve is approximately 0.002″ thick.
  • [0033]
    The sleeve material preferably includes a medical grade polyurethane material; although silicone, nylon, polyamides such as other urethanes, or other biocompatible material that is flexible and acid resistant are also suitable materials. In particular, the polyurethane of the present invention is a medical grade polyurethane material grade EG-80A material commercially known as TECOFLEX® polyurethane material from Thermedics, Incorporated, Woburn, Mass.
  • [0034]
    [0034]FIG. 2 depicts an enlarged sectioned end view of sleeve 13 about cylindrical wire 30 of flared stent 20 of FIG. 1 along the line 2-2. As shown, the thickness of the sleeve material is approximately 0.006″, whereas the thickness of the sleeve material along lower or distal portion 28 thereof is preferably and approximately 0.002″. The thickness of sleeve material above distal portion 28 ranges from 0.005″ through 0.008″. Experimental data has indicated that the sleeve material along distal portion 28 still collapses at 0.004″ wall thickness so as to effectively form a one-way valve. Closure of the one-way valve sleeve material occurs at thicknesses above 0.004″; however, closure does not occur on a guaranteed basis each time. The thickness of the sleeve wall material below 0.0015″ presents a problem of tearing particularly when inserting the prosthesis into a delivery catheter.
  • [0035]
    [0035]FIG. 3 depicts an enlarged partially sectioned view of adjacent ends 25 and 26 of interconnected stents 20 and 23 of FIG. 1. Bends 31 of cylindrical wire 30 are formed into a keyhole configuration with silver solder 32 interconnecting the wire arms, thereby forming an aperture or eyelet 33. Interconnecting filament 24 is positioned through each eyelet and wound around at least once to aid in fixing the diameter of the expandable stents. One interconnecting or end filament is used at the end of each stent and tied at the loose ends with suture knot 34.
  • [0036]
    [0036]FIG. 4 depicts two piece mandril 35 that is used to apply sleeve material 13 to the prosthesis of FIG. 1. The mandril includes sleeve portion 36 and upper frame portion 37 that are interconnectable with, for example, threaded rod 38 and internally threaded channel 39. In use, the tubular frame including the plurality of self-expanding wire stents are positioned end-to-end and interconnected using interconnecting filament 24. The end filament is also positioned through the eyelets of the flared stents to control the maximum diameter thereof. The mandril has a minimum inner diameter matching that of the inside diameter of the inner stents and a flared diameter matching that of the flared stents. Extending from the ends of the flared portions, the mandril assumes the inner diameter of the one-way valve sleeve material. The assembled tubular frame is positioned between the upper frame portion of the sleeve portion of the mandril. The two portions of the mandril are then interconnected, thereby filling up the passage of the tubular frame. The tubular frame is then dipped into a slurry material of polyurethane to form an initial 0.004″ thickness over the entire length of the tubular frame. The mandril and covered tubular frame are then dipped in the slurry material at least one additional time to form the desired thickness of the sleeve material over mandril sleeve portion 36. After the slurry material cures, the two portions of the mandril are disconnected to form the anti-reflux esophageal prosthesis.
  • [0037]
    [0037]FIG. 5 depicts esophageal prosthesis 10 deployed in lower esophagus 40, and, in particular, through lower esophageal sphincter 41 and cancerous tumor 42. Distal flared stent 20 typically extends into the stomach along with sleeve 13. Flared stent 21 is positioned proximal to the sphincter and tumor, whereas the interconnected cylindrical stents are typically positioned through the sphincter and tumor. The flared stents 20 and 21, again, prevent a migration of the prosthesis in the esophagus. The lower or distal portion 28 of sleeve 13 extends into stomach 43. The lumen of the lower sleeve portion readily collapses when in contact with any external fluid applied thereto. However, any liquid or food is readily passed in an antegrade direction through the esophageal stent and into the stomach. As a result, one-way valve sleeve 13 opens to provide flow in the antegrade direction. Conversely, any fluids or food material 44 are prevented from flowing into the retrograde direction due to the collapsed lumen of sleeve 13. However, when the pressure of the gas or fluid in the stomach builds so as to cause the patient to belch or vomit, sleeve 13 will invert and extend in an antegrade direction through the lumen of the tubular frame as shown by phantom lines 45. In this position, gastric fluid and matter flows in the retrograde direction to relieve the patient. The length of distal portion 28 of the sleeve and the thickness thereof control the pressure at which the distal portion of the sleeve inverts through the tubular frame.
  • [0038]
    Self-expanding esophageal prosthesis are increasingly being used for palliation of malignant dysphagia. They can predispose to significant gastroesophageal reflux, including risk of aspiration, when deployed across the gastroesophageal junction. A study was performed to evaluate the anti-reflux efficacy of a esophageal prosthesis of the present invention to prevent reflux. A model EZS 21-8 from Wilson-Cook Inc., Salem, N.C. (16 mm diameter) was modified by extending its polyurethane covering 7 cm beyond its distal metal cage so as to form a “windsock” or collapsible sleeve. The pressure required to invert the windsock or collapsible sleeve into the tubular frame (reflux barrier) was determined by attaching the proximal end of the prosthesis to a hollow graduated tube and vertically inserting the stent under water until the windsock inverted. The pressure required to revert the windsock or collapsible lumen to its original one-way position was determined by pouring water into the lumen of the prosthesis. In-vivo evaluation was done in two esophagostomized dogs (male-18 kg, female-16 kg) and prosthesis insertion, positioning, and removal done by standard endoscopic and fluoroscopic techniques. Two site ambulatory esophageal pH monitoring (Synectics Medical) was performed at 5 cm and 10 cm above the gastroesophageal function. Each dog was studied twice using the standard model EZS 201-8 prosthesis and twice using the modified prosthesis (mean recording time per session 18.7+/−1 SE and 17+/−3 hours respectively). The results indicated that the windsock modification posed no difficulty in mounting or deploying the prosthesis using a currently available delivery system. Resistance to antegrade flow was minimal as even a drop of water put into the prosthesis easily passed through the windsock and both the dogs drank all the Ensure (4 cans per session) given to them irrespective of the type of prosthesis used. The pressure (cm of water) to overcome the reflux barrier was 15.7+/−0.3 SE and that to revert an inverted windsock or collapsible lumen was 0.4+/−0.03 SE. Results of the pH monitoring (mean +/−SE) is depicted in Table 1.
    TABLE 1
    Recording Standard Stent Anti-reflux Stent
    site (cm) above GEJ 5 10 5 10
    Number of reflux 229 ± 25″  56 ± 9@ 9.7 ± 7*   8 ± 5@
    episodes
    Fraction time pH  60 ± 5* 7.6 ± 2@ 0.7 ± 0.3* 0.2 ± 0.1@
    <4 (%)
  • [0039]
    The conclusions reached in the experiment were that a modified self-expanding metal esophageal prosthesis is highly effective in preventing reflux. The ability of the windsock or collapsible lumen sleeve 13 to invert at higher pressure gradients can allow patients to belch or vomit. Reversion to anti-reflux position requires minimal pressure and can be achieved by a water swallow. Further studies are indicated in FIGS. 8-10.
  • [0040]
    [0040]FIG. 6 depicts anti-reflux esophageal prosthesis 10 of FIG. 1 in a collapsed state in delivery catheter 46. Sleeve material 13 is positioned at the distal end of the delivery catheter. The prosthesis is drawn into the delivery catheter with a drawstring attached at the proximal end of the prosthesis. The drawstring and prosthesis are inserted through lumen 47 of the catheter by collapsing the tubular frame and then pulling the prosthesis into the distal end of the delivery catheter with the drawstring. To deploy the collapsed prosthesis from the delivery catheter, a pusher catheter 48 is positioned proximally in lumen 47 to engage the proximal end of the wire tubular frame 11.
  • [0041]
    [0041]FIG. 7 depicts delivery catheter 46 of FIG. 6 positioned in lower esophagus 40, sphincter 41, and tumor 42 of a patient. The distal end of the delivery catheter extends into stomach 43. As shown, the pusher has been placed in the lumen of the delivery catheter and engages the proximal end of prosthesis 10. As shown, sleeve 13 and flared distal stent 20 have been deployed from the distal end of the catheter. After the sleeve and distal flared stent 20 of the prosthesis have been deployed, the delivery catheter is partially withdrawn so as to engage the flared stent with the neck of the stomach about sphincter 41. Once positioned, the delivery catheter is pulled back while maintaining the position of the pusher catheter therein so as to release the central cylindrical stents and proximal flared stent against the sphincter, tumor, and lower esophagus.
  • [0042]
    An in-vitro and in-vivo evaluation of a modified self-expandable metal esophageal stent with an anti-reflux mechanism of the present invention was performed on a number of dogs. The evaluation included four dogs, two of which were males at 14 and 18 kg and two females at 14 and 16 kg. An esophagostomy was utilized with the use of upper gastro-intestinal endoscopy. The evaluation included the methods of ambulatory pH monitoring with the use of Synectics medical equipment at 5 and 10 cm with Gastrograph Inc. software. A liquid diet of Ensure at a pH of 6.5 was administered. The results of the employed methods are included in Table 2.
    TABLE 2
    Standard Stent Anti-Reflux Stent P
    Duration of pH 20.30 ± 1.6 21.38 ± 0.9 ns
    Monitoring (hrs · mins)
    Oral Intake Ensure (ml)  1007 ± 0.5   978 ± 0.4 ns
  • [0043]
    [0043]FIG. 8 depicts in-vitro reflux barrier curve 48 which illustrates the water column height in centimeters necessary to invert a given sleeve length extending from the distal end of the prosthesis. Rectangular median value boxes 49 indicate the median value of the water column height at the indicated sleeve lengths. The vertical bar 50 positioned on curve 48 with rectangular median value boxes 49 represent a standard deviation above and below the indicated median value. In addition, the number of reflux episodes was monitored at the distal and proximal ends of the prosthesis. With a standard prosthesis without a one way valve, 197 episodes of reflux were encountered in 250 attempts. At the proximal end of the standard tubular esphageal prosthesis, a total of 33 reflux episodes were noted with 50 attempts. Correspondently, only 16 reflux episodes were noted out of 250 attempts at the distal end of an anti-reflux esophageal prosthesis of the present invention. At the proximal end of the anti-reflux esophageal stent only 8 episodes out of 50 attempts were noted. The number of reflux episodes longer than five minutes was also noted. In the standard prosthesis, 19.8 episodes were recorded for 25 attempts. This is in contrast to 0.3 episodes for an anti-reflux esophageal stent of the present invention. At the proximal end of the prosthesis, 2.3 episodes lasting longer than five minutes were noted with three attempts; whereas none were noted with the anti-reflux prosthesis. The longest reflux episodes were also noted at the distal and proximal ends of the standard and anti-reflux prosthesis. For the standard prosthesis, 107 episodes were noted out of approximately 130 attempts; whereas only 3.8 were noted for the anti-reflux prosthesis at the distal end thereof. At the proximal end of the prosthesis, 39 episodes were noted out of 45 for the standard prosthesis; whereas only 1.8 for the anti-reflux prosthesis were noted.
  • [0044]
    [0044]FIG. 9 depicts the fraction time percentages of which the esophagus was exposed to gastric juice with a pH less than 4. At the distal end of the prosthesis, the percentage of fraction time is indicated by boxes 51 for the four dogs at the distal end of the standard prosthesis. These percentage fraction times range from 20-80% with a median value of 49%.
  • [0045]
    For the anti-reflux prosthesis, the percentage of fraction time ranges from 0.0 to approximately 1.5% with a median value of 1% as indicated by boxes 52. The p-values for these fractions times is 0.026.
  • [0046]
    [0046]FIG. 10 depicts the fraction time percentages at the proximal ends of the standard and anti-reflux prosthesis. Boxes 53 represent the percent fraction time for the standard prosthesis which ranges from approximately 4-14% with a median of 6.6%. Rectangular boxes 54 represent the percent fraction time for the anti-reflux prosthesis which range from approximately 0.0 to 1.0%. These have a p-value of approximately 0.055.
  • [0047]
    The conclusions resulting from this in-vitro and in-vivo evaluation are as follows. The modified self-expanding metal esophageal stent of the present invention is highly effective in preventing gastro-esophageal reflux. The ability of the modification to invert at higher pressure gradients allows for belching and vomiting. Once inverted, reversion to the anti-reflux position of the prosthesis requires minimal pressure that can be achieved by a water swallow.
  • [0048]
    In a second embodiment of the present invention depicted in FIGS. 11-14, the prosthesis 10 and tubular member 11 comprise a tubular drainage stent 60 having a first end 62 for drainage into a duct, vessel, organ, etc., 30 and a second end 63 that receives the fluid or other material that is moving under a first, antegrade pressure and direction 17. As defined, a tubular drainage stent (or tubular drainage catheter) is typically an elongate, closed tubular conduit (typically plastic or metal) that is placed within a bodily passage, such as the bile duct, pancreatic duct, urethra, etc. to facilitate the flow of fluids therethrough. It is typically non-expanding, unlike a the wire or open-frame stents of FIGS. 1-10. It is commonly placed either to establish or maintain patency of the bodily passage or to drain an organ or fluid source, such as the gall bladder or urinary bladder. The tubular drainage stent may also include a retention means 64,65 at one or more ends 62,63, such as flaps, barbs, pigtail loops, etc. The tubular drainage stent 60 is attached to the collapsible sleeve 13, which acts as a one-way valve to prevent retrograde flow 18 therethrough. The first end 67 of the sleeve is maintained open when the fluid or material passing through the sleeve is exhibiting a pressure associated with normal antegrade flow 17. The first end 67 collapses shut when the antegrade flow 17 has ceased or lessened such that the second fluid pressure 18 occurring in the environment into which the fluid is drained becomes higher than the first pressure of the antegrade flow 17. In the illustrative biliary stent embodiment, bile is able to flow into the duodenum 71, but the sleeve 13 closes in the absence of measurable flow 17, thus preventing the contents of the intestinal tract, which now have a second, higher pressure 18, from entering the passageway of the stent. The sleeve 13 is made of a biocompatible material that will not degrade when placed in the particular environment of the human body into which it is to be placed. Possible materials include expanded polytetrafluoroethylene (ePTFE), polyurethane, silicone, nylon, polyamides such as other urethanes, or other biocompatible materials. It is important that the sleeve material be selected appropriately. For example, in the illustrative embodiment, the sleeve is typically made of a 2-3 cm section of ePTFE which is much more resistant to the caustic bile than would a sleeve of polyurethane. The ePTFE tube is extruded into a thin wall tube having sufficient flexibility to collapse and seal against the ingress of fluid, while having sufficient integrity to resist tearing. The normal range of sleeve thickness for the illustrative embodiment is 0.001 to 0.01 in., with a more preferred thickness of 0.002 to 0.005 in (e.g., 0.0025). The second end 68 of the sleeve is attached about the first end 62 of a biliary stent 60, such as a ST-2 SOEHENDRA TANNENBAUM® stent, a COTTON-LEUNG® stent or a COTTON-HUIBREGTSE® stent (Wilson-Cook Medical Inc., Winston-Salem, N.C.), by an attachment means 66, such as an illustrative crimped metal band. This band 66 can be made radiopaque to also serve as a fluoroscopic marker. Other methods of attachment could include, suture binding, selected medical grade adhesives, or thermal bonding, if appropriate for both the sleeve and stent polymers.
  • [0049]
    An alternative method of forming the sleeve for a tubular drainage stent 60 is depicted in FIG. 12. Rather than attaching a separately extruded or preformed sleeve 13 to the tubular member 11, the wall of the tubular member, which is made of polyethylene in this embodiment, is thinned out distally from the first end 62 of the tubular drainage stent 60, such that the sleeve 13 is integral with the tubular member 11. A transition zone 77 exists between the first end tubular drainage stent 60 and the second end 68 of the sleeve 13, beyond which the sleeve 13 becomes sufficiently thin to collapse into a closed position in the absence of antegrade flow 17, such as bile.
  • [0050]
    [0050]FIG. 13 depicts how the illustrative embodiment is used within the common bile duct 69 to permit the drainage of bile across the Papilla of Vater 70 and into the duodenum 71. The biliary stent 60 is positioned in the normal manner inside the common bile duct 69 with the first end 62 of the stent extending outside of the duct and Papilla of Vater 70. The first retention means 64 abuts the opening of the sphincter to prevent ingress of the stent 60 into the duct while the second retention means 65, located about the second end 63, is positioned well inside the duct to prevent the stent 60 from migrating outward. The sleeve 13 lies completely within the duodenum where it acts as a one-way valve to prevent intestinal contents from entering the biliary stent 60. Unlike the embodiment of FIG. 1, the sleeve 13 is not designed to invert back through the tubular member 13 in the presence of a third, significantly higher pressure, a situation which is normally not found inside the duodenum, or even clinically necessary as with the esophageal embodiment where belching or vomiting make such a capability desirous. Placement of the embodiments of FIGS. 11-12 can be accomplished by a system such as that depicted in FIG. 14. The biliary stent 60 is mounted on a guiding catheter 73 which is fed over an standard biliary exchange wire guide 74 into the bile duct. To deploy the stent from over the guiding catheter 73, a pusher element 72 is used with the distal end 75 of the pusher contacting the first end 62 of stent 60 and urging it forward until deployment occurs. The sleeve 13 is normally folded in accordion fashion prior to deployment, whereby it resumes its elongate configuration once the prosthesis 10 has been properly positioned.
  • [0051]
    [0051]FIG. 15 depicts a prosthesis 10 comprising a tubular drainage stent 60 that is configured for placement in the urinary system, such as within the ureter between the kidney and the bladder. The sleeve 13 is attached to the first end 62 of the tubular drainage stent 60, which includes a first retention means 64 that comprises a pigtail configuration 79. In a ureteral stent, the pigtail 79 would be placed within the bladder to prevent migration of the stent. Optionally, a pigtail configuration 79 can be used to anchor the second end of the stent (not shown), typically within the ureteropelvic junction. The pigtail configuration is exemplary of a large variety of well know pigtail ureteral and urethral stents.
  • [0052]
    [0052]FIG. 16 depicts a tubular drainage stent 60 in which the first end 68 of the sleeve 13 is affixed completely within the lumen 12 of the stent 60, the attachment 66 comprising a well-known means such as thermal bonding, adhesive, or a ring of material that can affix the sleeve 13 material to the inner walls 78 of the stent 60. In the illustrative embodiment, the sleeve 13 resides completely within the lumen 12, such that it doesn't not extend beyond the end of the tubular drainage stent 12. This could have particular utility in a urethral stent to prevent migration of pathogenic organism though the stent and into the bladder, while still allowing antegrade flow of urine 17. Having a sleeve 13 extending out of the urethra would normally be less acceptable from a clinical and patient's point of view.
  • [0053]
    As with each of the embodiments of FIGS. 11-16, it is important that the sleeve be made highly flexible and readily collapsible such that normally exists it a closed state, either by a fluid (air or bodily fluids) applying second pressure in a second direction 18 to at least substantially close the sleeve lumen 15 to greatly reduce retrograde migration of fluids, materials, or pathogens, or merely by the absence of fluid applying a first pressure in a first direction 17. In the preferred embodiments, the sleeve 13 does not maintain its regular tubular configuration (unless perhaps, it is hanging straight down) due to the inability of the thin polymeric material to support such a configuration against gravitational forces. Rather, it collapses into a closed configuration or self-closes to form a one-way valve due to the material adhering to itself, particularly if wet, the atmospheric pressure or fluid pressure in the second direction 18, typically facilitating its closure.
  • [0054]
    It is to be understood that the above described anti-reflux esophageal, biliary, an urological prostheses 10 are merely illustrative embodiments of this invention. The present invention can also include other devices and methods for manufacturing and using them may be devised by those skilled in the art without departing from the spirit and scope of the invention. It is also to be understood that the invention is directed to embodiments both comprising and consisting of disclosed parts. For example, in the esophageal embodiments, it is contemplated that only a portion of the tubular frame need be coated with the sleeve material. Furthermore, the sleeve material extending from the distal end of the tubular member can be formed with different material from that covering the tubular frame. It is also contemplated that the material of the self-expanding stents can be formed of other materials such as nickel titanium alloys commercially known as nitinol, spring steel, and any other spring-like material formed to assume the flexible self-expanding zig-zag stent configuration.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3868956 *5 Jun 19724 Mar 1975Ralph J AlfidiVessel implantable appliance and method of implanting it
US3890977 *1 Mar 197424 Jun 1975Bruce C WilsonKinetic memory electrodes, catheters and cannulae
US4149911 *17 Jan 197817 Apr 1979Raychem LimitedMemory metal article
US4271827 *13 Sep 19799 Jun 1981Angelchik Jean PMethod for prevention of gastro esophageal reflux
US4425908 *22 Oct 198117 Jan 1984Beth Israel HospitalBlood clot filter
US4445896 *18 Mar 19821 May 1984Cook, Inc.Catheter plug
US4494531 *6 Dec 198222 Jan 1985Cook, IncorporatedExpandable blood clot filter
US4503569 *3 Mar 198312 Mar 1985Dotter Charles TTransluminally placed expandable graft prosthesis
US4512338 *25 Jan 198323 Apr 1985Balko Alexander BProcess for restoring patency to body vessels
US4572186 *7 Dec 198325 Feb 1986Cordis CorporationVessel dilation
US4580568 *1 Oct 19848 Apr 1986Cook, IncorporatedPercutaneous endovascular stent and method for insertion thereof
US4636313 *3 Feb 198413 Jan 1987Vaillancourt Vincent LFlexible filter disposed within flexible conductor
US4649922 *23 Jan 198617 Mar 1987Wiktor Donimik MCatheter arrangement having a variable diameter tip and spring prosthesis
US4655771 *11 Apr 19837 Apr 1987Shepherd Patents S.A.Prosthesis comprising an expansible or contractile tubular body
US4657530 *9 Apr 198414 Apr 1987Henry BuchwaldCompression pump-catheter
US4665918 *6 Jan 198619 May 1987Garza Gilbert AProsthesis system and method
US4681110 *2 Dec 198521 Jul 1987Wiktor Dominik MCatheter arrangement having a blood vessel liner, and method of using it
US4687468 *25 Jul 198618 Aug 1987Cook, IncorporatedImplantable insulin administration device
US4716900 *9 May 19865 Jan 1988Pfizer Hospital Products Group, Inc.Intraintestinal bypass graft
US4719916 *19 Sep 198619 Jan 1988Biagio RavoIntraintestinal bypass tube
US4723549 *18 Sep 19869 Feb 1988Wholey Mark HMethod and apparatus for dilating blood vessels
US4729766 *22 Apr 19858 Mar 1988Astra Meditec AktiebolagVascular prosthesis and method in producing it
US4732152 *5 Dec 198522 Mar 1988Medinvent S.A.Device for implantation and a method of implantation in a vessel using such device
US4733665 *7 Nov 198529 Mar 1988Expandable Grafts PartnershipExpandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4739762 *3 Nov 198626 Apr 1988Expandable Grafts PartnershipExpandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4762128 *9 Dec 19869 Aug 1988Advanced Surgical Intervention, Inc.Method and apparatus for treating hypertrophy of the prostate gland
US4768507 *31 Aug 19876 Sep 1988Medinnovations, Inc.Intravascular stent and percutaneous insertion catheter system for the dilation of an arterial stenosis and the prevention of arterial restenosis
US4794928 *10 Jun 19873 Jan 1989Kletschka Harold DAngioplasty device and method of using the same
US4800882 *13 Mar 198731 Jan 1989Cook IncorporatedEndovascular stent and delivery system
US4820298 *20 Nov 198711 Apr 1989Leveen Eric GInternal vascular prosthesis
US4825861 *2 May 19862 May 1989Walter Koss Of IndustriestrasseEndotube
US4830003 *17 Jun 198816 May 1989Wolff Rodney GCompressive stent and delivery system
US4846836 *3 Oct 198811 Jul 1989Reich Jonathan DArtificial lower gastrointestinal valve
US4848343 *30 Oct 198718 Jul 1989Medinvent S.A.Device for transluminal implantation
US4856516 *9 Jan 198915 Aug 1989Cordis CorporationEndovascular stent apparatus and method
US4907336 *9 Sep 198813 Mar 1990Cook IncorporatedMethod of making an endovascular stent and delivery system
US4913141 *25 Oct 19883 Apr 1990Cordis CorporationApparatus and method for placement of a stent within a subject vessel
US4921484 *25 Jul 19881 May 1990Cordis CorporationMesh balloon catheter device
US4922905 *28 May 19878 May 1990Strecker Ernst PDilatation catheter
US4955899 *26 May 198911 Sep 1990Impra, Inc.Longitudinally compliant vascular graft
US4957508 *30 Oct 198718 Sep 1990Ube Industries, Ltd.Medical tubes
US5015253 *15 Jun 198914 May 1991Cordis CorporationNon-woven endoprosthesis
US5019090 *1 Sep 198828 May 1991Corvita CorporationRadially expandable endoprosthesis and the like
US5019102 *7 Dec 198828 May 1991Eberhard HoeneAnti-refluxive internal ureteral stent with a dynamic hood-valve at the vesical end for prevention of urinary reflux into the upper urinary tract upon increase of vesical pressure
US5026377 *17 Aug 199025 Jun 1991American Medical Systems, Inc.Stent placement instrument and method
US5035706 *17 Oct 198930 Jul 1991Cook IncorporatedPercutaneous stent and method for retrieval thereof
US5041126 *14 Sep 198820 Aug 1991Cook IncorporatedEndovascular stent and delivery system
US5078736 *4 May 19907 Jan 1992Interventional Thermodynamics, Inc.Method and apparatus for maintaining patency in the body passages
US5089006 *29 Nov 198918 Feb 1992Stiles Frank BBiological duct liner and installation catheter
US5108416 *13 Feb 199028 Apr 1992C. R. Bard, Inc.Stent introducer system
US5112900 *28 Nov 199012 May 1992Tactyl Technologies, Inc.Elastomeric triblock copolymer compositions and articles made therewith
US5123917 *27 Apr 199023 Jun 1992Lee Peter YExpandable intraluminal vascular graft
US5133732 *22 Mar 198928 Jul 1992Medtronic, Inc.Intravascular stent
US5135536 *5 Feb 19914 Aug 1992Cordis CorporationEndovascular stent and method
US5176626 *15 Jan 19925 Jan 1993Wilson-Cook Medical, Inc.Indwelling stent
US5221261 *10 Aug 199222 Jun 1993Schneider (Usa) Inc.Radially expandable fixation member
US5282823 *19 Mar 19921 Feb 1994Medtronic, Inc.Intravascular radially expandable stent
US5282824 *15 Jun 19921 Feb 1994Cook, IncorporatedPercutaneous stent assembly
US5306300 *22 Sep 199226 Apr 1994Berry H LeeTubular digestive screen
US5314444 *2 Apr 199324 May 1994Cook IncorporatedEndovascular stent and delivery system
US5314473 *5 Jan 199324 May 1994Godin Norman JProsthesis for preventing gastric reflux into the esophagus
US5316023 *8 Jan 199231 May 1994Expandable Grafts PartnershipMethod for bilateral intra-aortic bypass
US5316543 *27 Nov 199031 May 1994Cook IncorporatedMedical apparatus and methods for treating sliding hiatal hernias
US5330500 *17 Oct 199119 Jul 1994Song Ho YSelf-expanding endovascular stent with silicone coating
US5334210 *9 Apr 19932 Aug 1994Cook IncorporatedVascular occlusion assembly
US5378239 *22 Jun 19933 Jan 1995Schneider (Usa) Inc.Radially expandable fixation member constructed of recovery metal
US5405316 *17 Nov 199311 Apr 1995Magram; GaryCerebrospinal fluid shunt
US5405377 *21 Feb 199211 Apr 1995Endotech Ltd.Intraluminal stent
US5411552 *14 Jun 19942 May 1995Andersen; Henning R.Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US5413601 *30 Sep 19939 May 1995Keshelava; Viktor V.Tubular organ prosthesis
US5443499 *8 Mar 199422 Aug 1995Meadox Medicals, Inc.Radially expandable tubular prosthesis
US5496277 *22 Nov 19945 Mar 1996Schneider (Usa) Inc.Radially expandable body implantable device
US5500014 *9 May 199419 Mar 1996Baxter International Inc.Biological valvular prothesis
US5507771 *24 Apr 199516 Apr 1996Cook IncorporatedStent assembly
US5534287 *29 Nov 19949 Jul 1996Schneider (Europe) A.G.Methods for applying an elastic coating layer on stents
US5545211 *22 Sep 199413 Aug 1996Sooho Medi-Tech Co., Ltd.Stent for expanding a lumen
US5645559 *21 Dec 19938 Jul 1997Schneider (Usa) IncMultiple layer stent
US5647843 *24 May 199615 Jul 1997Vance Products IncorporatedAnti-reflux ureteral stent
US5653727 *18 Jan 19965 Aug 1997Medtronic, Inc.Intravascular stent
US5662713 *14 Sep 19952 Sep 1997Boston Scientific CorporationMedical stents for body lumens exhibiting peristaltic motion
US5665115 *7 Jun 19959 Sep 1997Boston Scientific Technology, Inc.Intraluminal stent
US5716393 *20 May 199510 Feb 1998Angiomed Gmbh & Co. Medizintechnik KgStent with an end of greater diameter than its main body
US5733325 *6 May 199631 Mar 1998C. R. Bard, Inc.Non-migrating vascular prosthesis and minimally invasive placement system
US5733330 *13 Jan 199731 Mar 1998Advanced Cardiovascular Systems, Inc.Balloon-expandable, crush-resistant locking stent
US5741333 *3 Apr 199621 Apr 1998Corvita CorporationSelf-expanding stent for a medical device to be introduced into a cavity of a body
US5746766 *2 Apr 19975 May 1998Edoga; John K.Surgical stent
US5755769 *11 Mar 199326 May 1998Laboratoire Perouse ImplantExpansible endoprosthesis for a human or animal tubular organ, and fitting tool for use thereof
US5782904 *29 Sep 199421 Jul 1998Endogad Research Pty LimitedIntraluminal graft
US5788626 *18 Nov 19964 Aug 1998Schneider (Usa) IncMethod of making a stent-graft covered with expanded polytetrafluoroethylene
US5861036 *28 Feb 199619 Jan 1999Biomedix S.A. SwitzerlandMedical prosthesis for preventing gastric reflux in the esophagus
US5876445 *26 Nov 19962 Mar 1999Boston Scientific CorporationMedical stents for body lumens exhibiting peristaltic motion
US5876448 *13 Mar 19962 Mar 1999Schneider (Usa) Inc.Esophageal stent
US5876450 *9 May 19972 Mar 1999Johlin, Jr.; Frederick C.Stent for draining the pancreatic and biliary ducts and instrumentation for the placement thereof
US5879382 *30 Apr 19979 Mar 1999Boneau; Michael D.Endovascular support device and method
US5922019 *29 Dec 199513 Jul 1999Schneider (Europe) A.G.Conical stent
US6010529 *3 Dec 19964 Jan 2000Atrium Medical CorporationExpandable shielded vessel support
US6027525 *23 May 199722 Feb 2000Samsung Electronics., Ltd.Flexible self-expandable stent and method for making the same
US6264700 *27 Aug 199824 Jul 2001Endonetics, Inc.Prosthetic gastroesophageal valve
USRE35849 *30 Dec 199414 Jul 1998Wilson-Cook Medical, Inc.Indwelling stent
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7922684 *30 May 200612 Apr 2011Boston Scientific Scimed, Inc.Anti-obesity dual stent
US802955719 Jun 20094 Oct 2011Vysera Biomedical LimitedEsophageal valve
US82111861 Apr 20103 Jul 2012Metamodix, Inc.Modular gastrointestinal prostheses
US8221505 *22 Feb 200717 Jul 2012Cook Medical Technologies LlcProsthesis having a sleeve valve
US82825989 Jul 20109 Oct 2012Metamodix, Inc.External anchoring configurations for modular gastrointestinal prostheses
US850082119 Jun 20096 Aug 2013Vysera Biomedical LimitedEsophageal valve device for placing in the cardia
US860318815 Jul 201010 Dec 2013Vysera Biomedical LimitedMedical device suitable for treating reflux from a stomach to an oesophagus
US860318915 Jul 201010 Dec 2013Vysera Biomedical LimitedMedical device suitable for treating reflux from a stomach to an oesophagus
US867302020 Jul 201218 Mar 2014Vysera Biomedical LimitedEsophageal valve device for placing in the cardia
US87026417 Jan 201122 Apr 2014Metamodix, Inc.Gastrointestinal prostheses having partial bypass configurations
US87026426 Aug 201222 Apr 2014Metamodix, Inc.External anchoring configurations for modular gastrointestinal prostheses
US887680017 Dec 20104 Nov 2014Vysera Biomedical LimitedUrological device
US89924103 Nov 201131 Mar 2015Vysera Biomedical LimitedUrological device
US90443003 Apr 20142 Jun 2015Metamodix, Inc.Gastrointestinal prostheses
US917376030 Sep 20123 Nov 2015Metamodix, Inc.Delivery devices and methods for gastrointestinal implants
US927801928 Jan 20128 Mar 2016Metamodix, IncAnchors and methods for intestinal bypass sleeves
US928296822 Nov 201015 Mar 2016Treus Medical, Inc.Applicator for endoscopic treatment of biliary disease
US930807722 Dec 200612 Apr 2016Vysera Biomedical LimitedMedical device suitable for treating reflux from a stomach to an oesophagus
US94862194 Apr 20128 Nov 2016Treus Medical, Inc.Biliary shunts, delivery systems, methods of using the same and kits therefor
US949831422 Sep 201422 Nov 2016Coloplast A/SUrological device
US958574024 Sep 20157 Mar 2017Coloplast A/SUrological device
US9585742 *28 Dec 20157 Mar 2017Olympus CorporationStent
US959717323 Mar 201121 Mar 2017Boston Scientific Scimed, Inc.Anti-obesity dual stent
US96228973 Mar 201618 Apr 2017Metamodix, Inc.Pyloric anchors and methods for intestinal bypass sleeves
US20070198048 *22 Dec 200623 Aug 2007Niall BehanMedical device suitable for treating reflux from a stomach to an oesophagus
US20070282452 *30 May 20066 Dec 2007Boston Scientific Scimed, Inc.Anti-obesity dual stent
US20090143713 *25 Nov 20084 Jun 2009Jacques Van DamBiliary Shunts, Delivery Systems, Methods of Using the Same and Kits Therefor
US20090143759 *25 Nov 20084 Jun 2009Jacques Van DamMethods, Devices, Kits and Systems for Defunctionalizing the Cystic Duct
US20090143760 *25 Nov 20084 Jun 2009Jacques Van DamMethods, Devices, Kits and Systems for Defunctionalizing the Gallbladder
US20100036504 *18 Jun 200911 Feb 2010Vysera Biomedical LimitedValve
US20100114327 *19 Jun 20096 May 2010Vysera Biomedical LimitedValve
US20100280613 *15 Jul 20104 Nov 2010Vysera Biomedical LimitedMedical device suitable for treating reflux from a stomach to an oesophagus
US20100298951 *15 Jul 201025 Nov 2010Vysera Biomedical LimitedMedical device suitable for treating reflux from a stomach to an oesophagus
US20110054381 *1 Jun 20103 Mar 2011Jacques Van DamBiliary shunts, delivery systems, and methods of using the same
US20110160836 *17 Dec 201030 Jun 2011Vysera Biomedical LimitedValve device
US20110172585 *23 Mar 201114 Jul 2011Boston Scientific Scimed, Inc.Anti-obesity dual stent
US20160128824 *28 Dec 201512 May 2016Olympus CorporationStent
WO2006083763A1 *27 Jan 200610 Aug 2006Wilson-Cook Medical Inc.Prosthesis having a sleeve valve
WO2008103572A1 *12 Feb 200828 Aug 2008Wilson-Cook Medical Inc.Prosthesis having a sleeve valve
Classifications
U.S. Classification623/23.7, 623/23.66
International ClassificationA61F2/04, A61F2/86
Cooperative ClassificationA61F2002/044, A61F2/86, A61F2/04
European ClassificationA61F2/04