Resorbable urethral stent and apparatus for its insertion

• US 5,160,341 A
• Filed: 11/08/1990
• Issued: 11/03/1992
• Est. Priority Date: 11/08/1990
• Status: Expired due to Term

• Current Assignee: Advanced Surgical Intervention, Inc., Coloplast A/S
• Original Assignee: Advanced Surgical Intervention, Inc.
• Inventors: Brenneman, Rodney A., Lenker, Jay A.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/610,543
• Time in Patent Office: 726 Days
• Field of Search: 606/191, 606/198, 606/192, 606/193, 606/194, 606/200, 606/108, 623/1, 623/12, 604/8, 128/6
• US Class Current: 606/198
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

A resorbable stent, particularly adapted for implantation in the penile urethra, comprises a helical coil formed from a filament of a biocompatible, biodegradable material that is resiliently deformable. The stent is compressible from a first diameter to a smaller second diameter, and restores itself substantially to its first diameter by its own resiliency when the compressing force is removed. Polymers of polylactic acid and polyglycolic acid are preferred materials. A device for inserting the stent has a first embodiment that includes a retractable sheath surrounding a rotatable rod journaled in a stationary bushing. The stent is mounted on the rod and the bushing so that relative rotation of the rod and bushing compresses the stent by coiling it more tightly. The sheath is inserted into the urethra with the stent compressed inside of it, and the retracted. The rod and bushing are then relatively rotated so as to uncoil the stent, which is restored to its first diameter. A shearing sleeve is actuated to detach the stent from the rod and the bushing. A second embodiment includes a plunger on which the stent is detachably mounted. The plunger is inserted through the sheath, thereby compressing the stent. When the stent is discharged through the distal end of the sheath into the urethra, the stent resiliently restores itself to its first diameter.

Claims

1. A device for inserting a helically-coiled stent, formed of a resiliently-deformable, biocompatible material, into a bodily lumen of a patient, comprising:

an elongate, hollow, tubular sheath adapted for insertion into the lumen, the sheath having an open distal end;

first means, engageable with the stent, for (a) carrying the stent within the sheath, and (b) discharging the stent into the lumen through the distal end of the sheath; and

second means, operatively connected to the sheath and engageable with the stent while the stent is engaged with the first means, for resiliently compressing the stent from an uncompressed first diameter to a compressed second diameter when the stent is inserted into the sheath;

whereby the stent is resiliently restored to substantially its first diameter when discharged through the distal end of the sheath into the lumen.

2. The device of claim 1, further comprising:

optical means, axially disposed within the sheath, for allowing he visualization of the lumen through the sheath when the sheath is inserted thereinto.

3. The device of claim 1, wherein the sheath is axially movable between an extended position and a retracted position, and wherein the first means comprises an elongate rod disposed axially within the interior of the sheath, the elongate rod having a distal portion on which the stent is carried, the distal portion being exposed through the distal end of the sheath when the sheath is in its retracted position.

4. The device of claim 3, wherein the elongate rod includes a head at its distal end, the head being adapted for the attachment of a first end of the stent, and wherein the second means comprises:

a tubular bushing coaxially surrounding a portion of the elongate rod extending proximally from the head, the bushing being adapted for the attachment of a second end of the stent; and

rotational means for causing relative rotation between the bushing and the elongate rod;

whereby, when the stent is attached to the head and the bushing, the relative rotation of the bushing and the elongate rod in a first direction compresses the stent from its first diameter to its second diameter, and the relative rotation of the bushing and the elongate rod in a second direction restores the stent from its second diameter substantially to its first diameter.

5. The device of claim 4, wherein the rotational means comprises means connected to an end of the elongate rod opposite the head for selectively rotating and counter-rotating the elongate rod axially relative to the bushing.

6. The device of claim 4, wherein the rotational means comprises:

a pinion gear connected to an end of the elongate rod opposite the head;

a rack operatively engaging the pinion gear and movable with respect to the pinion gear in a first direction to rotate the pinion gear, and in a second direction to counter-rotate the pinion gear; and

manually actuable means, operatively connected to the rack, for selectively moving the rack in the first and second directions.

7. The device of claim 4, further comprising:

detachment means for detaching the stent from the bushing and the head to discharge the stent into the lumen.

8. The device of claim 7, wherein the detachment means comprises:

a tubular sleeve disposed coaxially around the bushing and adapted to slide axially thereon between a distal position and a proximal position;

a distal edge on the sleeve adapted for shearing the connections between the stent and the bushing and between the stent and the head when the sleeve is moved from its proximal position to its distal position; and

manually operable means for selectively moving the sleeve between its proximal and distal positions.

9. The device of claim 1, wherein the sheath has an internal diameter that is smaller than the first diameter of the stent, and wherein:

the first means comprises an elongate plunger, sized to be insertable into the interior of the sheath with a predetermined circumferential clearance, the plunger having a distal portion adapted for removably carrying the stent coaxially thereon; and

the second means comprises guide means, disposed at the proximal end of the sheath and engageable with the stent, for reducing the diameter of the stent to substantially the internal diameter of the sheath a the plunger is inserted into the sheath;

whereby the stent is passed through the interior of the sheath by the plunger and discharged from the distal end of the sheath into the lumen, where the stent is resiliently restored substantially to its first diameter.

10. The device of claim 9, wherein the plunger comprises an elongate hollow tube, and wherein the device further comprises:

Optical means that includes an optical guide adapted for passage through the interior of the plunger.

11. Apparatus for treating a stenosis in a bodily lumen, comprising:

a stent formed as a substantially helical coil of biocompatible, resiliently deformable material; and

insertion means, insertable into the lumen, for (a) resiliently compressing the stent from a first diameter to a smaller second diameter, (b) inserting the compressed stent into the lumen in the vicinity of the stenosis, and (c) releasing the stent, substantially restored to its first diameter, into the lumen at the site of the stenosis, the restoration of the stent to substantially its first diameter being at least partially the result of the resilient deformability of the stent.

12. The apparatus of claim 11, wherein the stent is formed from a biodegradable material.

13. The apparatus of claim 12, wherein the material is selected from the group consisting of polylactic acid homopolymers, polyglycolic acid homopolymers, and copolymers of polylactic acid and polyglycolic acid.

14. The apparatus of claim 13, wherein the stent is formed from a polylactic acid homopolymer.

15. The apparatus of claim 11, wherein the stent is formed from a filament of material having a diameter in the range of approximately 0.5 to 1.0 mm.

16. The apparatus of claim 11, further comprising:

optical means, disposed axially within the insertion means, for allowing the visualization of the lumen through the insertion means when the insertion means is inserted into the lumen.

17. The apparatus of claim 11, wherein the insertion means comprises:

an elongate, hollow, tubular sheath adapted for insertion into the lumen, the sheath having an open distal end;

first means, engageable with the stent, for (a) carrying the stent within the sheath, and (b) discharging the stent into the lumen through the distal end of the sheath; and

second means, operatively connected to the sheath and engageable with the stent while the stent is engaged with the first means, for resiliently compressing the stent from an uncompressed first diameter to a compressed second diameter when the stent is inserted into the sheath;

whereby the stent is resiliently restored to substantially its first diameter when discharged through the distal end of the sheath into the lumen.

18. The apparatus of claim 17, wherein the sheath is axially movable between an extended position and a retracted position, and wherein the first means comprises an elongate rod disposed axially within the interior of the sheath, the elongate rod having a distal portion on which the stent is carried, the distal portion being exposed through the distal end of the sheath when the sheath is in its retracted position.

19. The apparatus of claim 18, wherein the elongate rod includes a head at its distal end, the head being adapted for the attachment of a first end of the stent, and wherein the second means comprises:

a tubular bushing coaxially surrounding a portion of the elongate rod extending proximally from the head, the bushing being adapted for the attachment of a second end of the stent; and

rotational means for causing relative rotation between the bushing and the elongate rod;

whereby, when the stent is attached to the head and the bushing, the relative rotation of the bushing and the elongate rod in a first direction compresses the stent from its first diameter to its second diameter, and the relative rotation of the bushing and the elongate rod in a second direction restores the stent from its second diameter substantially to its first diameter.

20. The apparatus of claim 19, wherein the rotational means comprises means connected to an end of the elongate rod opposite the head for selectively rotating and counter-rotating the elongate rod axially relative to the bushing.

21. The apparatus of claim 19, wherein the rotational means comprises:

a pinion gear connected to an end of the elongate rod opposite the head;

a rack operatively engaging the pinion gear and movable with respect to the pinion gear in a first direction to rotate the pinion gear, and in a second direction to counter-rotate the pinion gear; and

manually actuable means, operatively connected to the rack, for selectively moving the rack in the first and second directions.

22. The apparatus of claim 19, further comprising:

detachment means for detaching the stent from the bushing and the head to discharge the stent into the lumen.

23. The apparatus of claim 22, wherein the detachment means comprises:

a tubular sleeve disposed coaxially around the bushing and adapted to slide axially thereon between a distal position and a proximal position;

a distal edge on the sleeve adapted for shearing the connections between the stent and the bushing and between the stent and the head when the sleeve is moved from its proximal position to its distal position; and

manually operable mean for selectively moving the sleeve between its proximal and distal positions.

24. The apparatus of claim 17, wherein the sheath has an internal diameter that is smaller than the first diameter of the stent, and wherein:

the first means comprises an elongate plunger, sized to be insertable into the interior of the sheath with a predetermined circumferential clearance, the plunger having a distal portion adapted for removably carrying the stent coaxially thereon; and

the second means comprises guide means, disposed at the proximal end of the sheath and engageable with the stent, for reducing the diameter of the stent to substantially the internal diameter of the sheath as the plunger is inserted into the sheath;

whereby the stent is passed through the interior of the sheath by the plunger and discharged from the distal end of the sheath into the lumen, where the stent is resiliently restored substantially to its first diameter.

25. The apparatus of claim 24, wherein the plunger comprises an elongate tube, and wherein the apparatus further comprises an optical guide adapted for passage through the interior of the plunger.

26. A method for treating a stenosis in a bodily lumen, comprising the steps of:

(1) inserting at least a portion of a sheath, including a distal end thereof, into the lumen, while the lumen is under direct visualization through the sheath;

(2) providing a helically coiled stent of resiliently deformable, biocompatible material;

(3) resiliently compressing the stent from an uncompressed first diameter to a smaller compressed diameter;

(4) while the stent is compressed to its smaller diameter, and while the lumen is under direct visualization through the sheath, passing the stent through the sheath into the lumen to the vicinity of the stenosis; and

(5) while the lumen is under direct visualization through the sheath, discharging the stent, from the distal end of the sheath, into the lumen at the site of the stenosis, thereby allowing the stent to restore itself substantially to its uncompressed diameter, at least substantially as a result of its inherent resiliency.

27. The method of claim 26, wherein the stent is formed from a biodegradable material selected from the group consisting of homopolymers of polylactic acid, homopolymers of polyglycolic acid, and copolymers of polylactic acid and polyglycolic acid.

28. A method for treating a stenosis in a bodily lumen, comprising the steps of:

(1) providing a helically-coiled stent of resiliently deformable, biocompatible material, the stent being provided in an uncompressed first diameter, and removably attached to manually actuable coiling means for selectively coiling the stent more or less tightly;

(2) actuating the coiling means to coil the stent more tightly, thereby resiliently compressing the stent from the uncompressed first diameter to a compressed second diameter smaller than the first diameter;

(3) enclosing the stent within a sheath, near the distal end thereof, while maintaining the stent in its second diameter;

(4) inserting at least that portion of the sheath enclosing the stent into the lumen so as to locate the stent substantially at the site of the stenosis;

(5) withdrawing the sheath; and

(6) restoring the stent substantially to its uncompressed first diameter at the site of the stenosis.

29. The method of claim 28, wherein the step of restoring comprises the steps of:

(a) actuating the coiling means to coil the stent less tightly to restore the stent substantially to its first diameter; and

(b) removing the stent from the coiling means.

30. The method of claim 28, wherein the stent is formed from a biodegradable material selected from the group consisting of homopolymers of polylactic acid, homopolymers of polyglycolic acid, and copolymers of polylactic acid and polyglycolic acid.

31. The method of claim 28, wherein the step of inserting is performed under direct visualization of the lumen through the sheath.

32. The method of claim 31, wherein the steps of withdrawing and restoring are performed under direct visualization of the lumen through the sheath.

33. A device for inserting a helically-coiled stent, formed of a resiliently-deformable, biocompatible material, into a bodily lumen of a patient, comprising:

an elongate, hollow, tubular sheath adapted for insertion into the lumen, the sheath having an open distal end, the sheath being axially-movable between an extended position and a retracted position;

an elongate rod, disposed axially within the interior of the sheath, and having a distal portion that is exposed through the distal end of the sheath when the sheath is in its retracted position, the distal portion terminating in a head adapted for the removable attachment thereto of one end of the stent;

a tubular bushing coaxially surrounding a portion of the removable attachment thereto of a second end of the stent; and

rotational means for causing relative rotation between the bushing and the rod;

whereby, when the stent is attached to the head and the bushing, the relative rotation of the bushing and the elongate rod in a first direction compresses the stent from a first diameter to a smaller second diameter, and the relative rotation of the bushing and the elongate rod in a second direction restores the stent from its second diameter substantially to its first diameter.

34. The device of claim 33, wherein the rotational means comprises means connected to an end of the elongate rod opposite the head for selectively rotating and counter-rotating the elongate rod axially relative to the bushing.

35. The device of claim 33, wherein the rotational means comprises:

a pinion gear connected to an end of the elongate rod opposite the head;

a rack operatively engaging the pinion gear and movable with respect to the pinion gear in a first direction to rotate the pinion gear, and in a second direction to counter-rotate the pinion gear; and

manually actuable means, operatively connected to the rack, for selectively moving the rack in the first and second directions.

36. The device of claim 33, further comprising:

detachment means for detaching the stent from the bushing and the head to discharge the stent into the lumen

37. The device of claim 36, wherein the detachment means comprises:

a tubular sleeve disposed coaxially around the bushing and adapted to slide axially thereon between a distal position and a proximal position;

a distal edge on the sleeve adapted for shearing the connections between the stent and the bushing and between the stent and the head when the sleeve is moved from its proximal position to its distal position; and

manually operable means for selectively moving the sleeve between its proximal and distal positions.

38. The device of claim 33, further comprising:

optical means, disposed axially within the sheath, for allowing the visualization of the lumen through the sheath when the sheath is inserted into the lumen.

39. A device for inserting a helically-coiled stent, formed of a resiliently-deformable, biocompatible material, into a bodily lumen of a patient, comprising:

an elongate, hollow, tubular sheath adapted for insertion into the lumen, the sheath having an open distal end;

an elongate plunger, sized to be insertable into the interior of the sheath with a predetermined circumferential clearance, the plunger having a distal portion adapted for removably carrying the stent coaxially thereon; and

guide means, disposed at the proximal end of the sheath and engageable with the stent, for reducing the diameter of the stent from an uncompressed first diameter to substantially the internal diameter of the sheath as the plunger is inserted into the sheath;

whereby the stent is passed through the interior of the sheath by the plunger and discharged from the distal end of the sheath into the lumen, where the stent is resiliently restored substantially to its first diameter.

40. The device of claim 39, further comprising:

optical means, extending axially through the sheath, for allowing the visualization of the lumen through the sheath when the sheath is inserted into the lumen.

41. The device of claim 40, wherein the plunger comprises an elongate hollow tube, and wherein the optical means includes an optical guide adapted for passage through the interior of the plunger.