WO1993013824A1 - Segmentarily expandable tubular endoluminal prosthesis - Google Patents

Segmentarily expandable tubular endoluminal prosthesis Download PDF

Info

Publication number
WO1993013824A1
WO1993013824A1 PCT/DK1993/000015 DK9300015W WO9313824A1 WO 1993013824 A1 WO1993013824 A1 WO 1993013824A1 DK 9300015 W DK9300015 W DK 9300015W WO 9313824 A1 WO9313824 A1 WO 9313824A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
diameter
stent according
coil
expansion
Prior art date
Application number
PCT/DK1993/000015
Other languages
French (fr)
Inventor
Erik Othel-Jacobsen
Henrik Harboe
Original Assignee
Engineers & Doctors A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Engineers & Doctors A/S filed Critical Engineers & Doctors A/S
Publication of WO1993013824A1 publication Critical patent/WO1993013824A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils

Definitions

  • the invention concerns a tubular endoluminal prosthesis (in the following called: A "stent”) , comprising a helically coiled, or otherwise as a tubular structur shaped, single wire of Nickel-Titanium alloy with shape memory properties (in the following called SMA for: Shape Memory Alloy) and a primary shape where one or more segments has a diameter considerably greater than the rest of the stent and a secondary shape where the segment or those segments with the greater diameter or perhaps the total coil is turned to the same lesser diameter.
  • SMA Shape Memory Alloy
  • the stent will keep the same length before and after expansion with a particularly desirable relation between the expansion and the space between the threads before and after expansion.
  • the single wire design of the stent is a particular advance when the stent is to be removed from a body cavity because the SMA becomes soft (superelastic) when it is cooled.
  • the stent can be removed by grasping any part of it and pulling it out as a thread.
  • Other stents of helically coiled metal wire such as spring steel are known for placement in the part of the male urethra passing through the prostate gland.
  • a considerable disadvantage to the known stent is that after placement it sometimes slides away from the desired position in the urethra because the stent stays with the diameter it had at placement. Space does not permit insertion of a large di noirr stent and the urethra itself does not retain the stent in the desired position.
  • the urethra and many other natural cavities (such as the ureters, the biliary tract, the airways, the intestine, the blood vessels) in the human body are compliant in the transverse plane and allows expansion of a stent or parts thereof after the stent has been placed in a desired position.
  • Stents are known which can concentrically expand or which can expand after placement in a desired position in a body cavity. These stents expand equally much in the entire length of the stent.
  • PCT/SE 2083,00131 which is a selfexpanding stent consisitng of a number of - curved and tubularly wowen wires of spring steel as well as a tubularly shaped Titanium stent developed by the American company ASI (Advanced Surgical Intervention Inc.) , San Clemente, Californien) .
  • the Titanium stent has shifting plackets which open when the stent is expanded with a luminally placed balloon which forces the stent out to a previously determined diameter. Both these stents become shorter after expansion which is a disadvantage during use because it impedes exact placement of the expanding stent. Additionally both these stents are firmly grown over with tissue after some time requiring special equipment for removal because the stents consist of many wires or a rigid tube.
  • stents with slits which can form basketlike, longitudinal bulges on one ore more segments of the stent.
  • a stent made of rubber is known from R.S. Munro og F.B. Scott, the journal “UROLOGY", November 1976, vol.8, no. 5, p. 492-494 and also a stent made of polyurethane from Nissenkorn I, 22nd Congress, Societe Internationale d'Urologie, Nov 1991. Abstract nr. 580.
  • These stents have some important disadvantages among others the above mentioned change of length. Aditionally it is inexpedient that the stents do not expand in all the circumference but only have longitudinal bulgings. In this way the fastening of these stents is poor. It is further inexpedient that the lumen of these stents is the same before and after ex ⁇ pansion.
  • the purpose of the present invention is to eliminate the majority of the disadvantages with the known stents.
  • This purpose is achieved in accordance with the invention which is characteristic in that it consists of a single helically coiled wire of SMA where one or more segments of the coil can be brought to expand after the stent has been placed in a desired position in a natural cavity.
  • the construction furthermore allows the possibility of expansion of the total length of the coil but with excessive expansion of one or more segments of the coil.
  • the or those parts of the stent which does not expand or expands considerably less, can possibly be densely coiled whereby scartissue or the like have difficulty in growing into the lumen of the stent (this is known from densely coiled stents of steel wire) .
  • the memory effect allows that one or more previously defined segments of the stent can be brought to expand when the stent is placed in a desired position in a natural cavity.
  • the memory effect additionally allows larger expansion of a coil consiting of a single wire than what can be achived with wire of known materials with spring capabilities. A particularly effective fastening of the stent in the desired position is achieved by the relatively large expansion of the stent.
  • the memory effect further means that the wire does not need to be tensed during the insertion whereby the insertion does not require equipment resistent to torsion.
  • the invention can chiefly be used in the male urethra and particularly the part of the male urethra passing through the prostate.
  • the stent according to the invention can aditionally be used in other positions in the urethra, in the biliary tract, the blood vessels and the the gatroin testinal tract and also in other natural cavities in the human body.
  • the drawing which describes a particularly suitable design of the invention.
  • the drawn stent When the drawn stent has been placed in the part of the male urethra which passes through the prostate and expansion has taken place of the segment of the stent closest to the external urethral sphincter, the stent will remain in position and allow urinary passage without obstructing the function of the sphincter.
  • the outer diameter of the stent is between 5mm and 8mm before expansion and between 9mm and 13mm after expansion.
  • the thickness of the SMA wire is between .6mm and .9mm.
  • the transition temperature (i.e. the temperature which activates the memory effect) in the utilized SMA is in the interval +38.5°C to +50°C. In case the stent shall be used in other natural cavities for example the stent length and diameter and the wire thickness can be changed accordingly.
  • fig. 1 is a preferred design of the stent according to the invention where l indicates a helically coiled wire of SMA.
  • 2 indicates a segment of the stent which can be brought to expand by ter ical treatment in the interval +38.5°C to +50°C.
  • fig. 2 3 indicates the expanding segment after expansion has taken place.
  • the stent is seen used in the part of the male urethra passing through the prostate 4.
  • 5 indicates the male urinary sphincter. 6 is the bladder.

Abstract

The invention concerns a segmentarily expandable tubular endoluminal prosthesis (a stent) comprising a helically coiled, or otherwise as a tubular structure shaped, wire of Nickel-Titanium alloy with shape memory effect (SMA). In its primary shape the diameter of one or more segments of the stent is considerably greater than the rest of the diameter of the stent. In its secondary shape the segments and possibly the total stent diameter is reduced to an extent allowing insertion of the stent into a body cavity. Once in the desired position in the body cavity the stent can return to its primary shape by exposing the stent to heat.

Description

SEGMENTARILY EXPANDABLE TUBULAR ENDOLUMINAL PROSTHESIS
The invention concerns a tubular endoluminal prosthesis (in the following called: A "stent") , comprising a helically coiled, or otherwise as a tubular structur shaped, single wire of Nickel-Titanium alloy with shape memory properties (in the following called SMA for: Shape Memory Alloy) and a primary shape where one or more segments has a diameter considerably greater than the rest of the stent and a secondary shape where the segment or those segments with the greater diameter or perhaps the total coil is turned to the same lesser diameter. On activation of the shape memory effect of the material the stent will expand because it is tranformed from the secondary shape back to the primary shape.
The stent will keep the same length before and after expansion with a particularly desirable relation between the expansion and the space between the threads before and after expansion.
The single wire design of the stent is a particular advance when the stent is to be removed from a body cavity because the SMA becomes soft (superelastic) when it is cooled. The stent can be removed by grasping any part of it and pulling it out as a thread. Other stents of helically coiled metal wire such as spring steel are known for placement in the part of the male urethra passing through the prostate gland. German patent number DE 28 27908 C2 and German patent application number 25 28 273. A considerable disadvantage to the known stent is that after placement it sometimes slides away from the desired position in the urethra because the stent stays with the diameter it had at placement. Space does not permit insertion of a large diamenter stent and the urethra itself does not retain the stent in the desired position.
The urethra and many other natural cavities (such as the ureters, the biliary tract, the airways, the intestine, the blood vessels) in the human body are compliant in the transverse plane and allows expansion of a stent or parts thereof after the stent has been placed in a desired position. Stents are known which can concentrically expand or which can expand after placement in a desired position in a body cavity. These stents expand equally much in the entire length of the stent. Examples are PCT/SE 2083,00131 which is a selfexpanding stent consisitng of a number of - curved and tubularly wowen wires of spring steel as well as a tubularly shaped Titanium stent developed by the American company ASI (Advanced Surgical Intervention Inc.) , San Clemente, Californien) . The Titanium stent has shifting plackets which open when the stent is expanded with a luminally placed balloon which forces the stent out to a previously determined diameter. Both these stents become shorter after expansion which is a disadvantage during use because it impedes exact placement of the expanding stent. Additionally both these stents are firmly grown over with tissue after some time requiring special equipment for removal because the stents consist of many wires or a rigid tube.
Furthermore there is a known expanding stent of helically coiled SMA wire, US patent 4.503.569. This stent expands equally much in its entire length and it becomes shorter during the expansion. Aditionally the stent is descibed as made of a variation of SMA with an unfavourable high transition temperature (the temperature required for activation of the shape memory effect) .
These types of expanding or expandable stents assumes that the whole of the actual natural cavity take on or will tolerate to be forced to adopt the expanded diameter of all of the stent. This is possible in natural cavities of relatively uniform diameter and continuity. But many natural cavities does not have such uniform diameter and many natural cavities have anatomically conditioned widenings and orifices. In such natural cavities it is more suitable with a stent which exclusively expands in one or more segments or a stent which expands considerably more in one or more segments of the stent. This is particularly suitable because a segmentary expansion will better fasten the stent in a desired position in a natural cavity and particularly if such position is in or near a change of dimension or an orifice in the natural cavity.
There are known stents with slits which can form basketlike, longitudinal bulges on one ore more segments of the stent. Such a stent made of rubber is known from R.S. Munro og F.B. Scott, the journal "UROLOGY", November 1976, vol.8, no. 5, p. 492-494 and also a stent made of polyurethane from Nissenkorn I, 22nd Congress, Societe Internationale d'Urologie, Nov 1991. Abstract nr. 580. These stents have some important disadvantages among others the above mentioned change of length. Aditionally it is inexpedient that the stents do not expand in all the circumference but only have longitudinal bulgings. In this way the fastening of these stents is poor. It is further inexpedient that the lumen of these stents is the same before and after ex¬ pansion.
The purpose of the present invention is to eliminate the majority of the disadvantages with the known stents.
This purpose is achieved in accordance with the invention which is characteristic in that it consists of a single helically coiled wire of SMA where one or more segments of the coil can be brought to expand after the stent has been placed in a desired position in a natural cavity. The construction furthermore allows the possibility of expansion of the total length of the coil but with excessive expansion of one or more segments of the coil. The or those parts of the stent which does not expand or expands considerably less, can possibly be densely coiled whereby scartissue or the like have difficulty in growing into the lumen of the stent (this is known from densely coiled stents of steel wire) . The memory effect allows that one or more previously defined segments of the stent can be brought to expand when the stent is placed in a desired position in a natural cavity. The memory effect additionally allows larger expansion of a coil consiting of a single wire than what can be achived with wire of known materials with spring capabilities. A particularly effective fastening of the stent in the desired position is achieved by the relatively large expansion of the stent. The memory effect further means that the wire does not need to be tensed during the insertion whereby the insertion does not require equipment resistent to torsion.
The invention can chiefly be used in the male urethra and particularly the part of the male urethra passing through the prostate. The stent according to the invention can aditionally be used in other positions in the urethra, in the biliary tract, the blood vessels and the the gatroin testinal tract and also in other natural cavities in the human body.
The following will refer to the drawing which describes a particularly suitable design of the invention. When the drawn stent has been placed in the part of the male urethra which passes through the prostate and expansion has taken place of the segment of the stent closest to the external urethral sphincter, the stent will remain in position and allow urinary passage without obstructing the function of the sphincter. With this particular design the outer diameter of the stent is between 5mm and 8mm before expansion and between 9mm and 13mm after expansion. The thickness of the SMA wire is between .6mm and .9mm. The transition temperature (i.e. the temperature which activates the memory effect) in the utilized SMA is in the interval +38.5°C to +50°C. In case the stent shall be used in other natural cavities for example the stent length and diameter and the wire thickness can be changed accordingly.
Referring to the drawing, fig. 1 is a preferred design of the stent according to the invention where l indicates a helically coiled wire of SMA. 2 indicates a segment of the stent which can be brought to expand by ter ical treatment in the interval +38.5°C to +50°C. In fig. 2 3 indicates the expanding segment after expansion has taken place. In fig. 3 the stent is seen used in the part of the male urethra passing through the prostate 4. 5 indicates the male urinary sphincter. 6 is the bladder.

Claims

PATENT CLAIMS
1. Tubular endoluminal protshesis (a stent) c h a r a c- t e r i s e in consisting of a single helically coiled, or in other ways as a tubular structure shaped, wire of Nickel-Titanium alloy with memory capability and a primary shape where one or more segments has a diameter which is considerably greater than the rest of the stent and a secondary shape where the or those segments with the greater diameter or possibly the total coil has been reduced to the same or a smaller diameter, whereby the release of the memory capability of the material will bring the stent to expand as it returns to the primary shape.
2. Stent according to claim 1, c h a r a c t e r i s e d in that the Nickel-Titanium SMA has a transition temperature between +38,5°C and +50°C.
3. Stent according to claims 1 and 2, c h a r a c t e r i¬ s e d in that the diameter of the wire is between .3mm and 1.0mm.
4. Stent according to claim 1, c h a r a c t e r i s e d in that the stent is equally long before and after expansion.
5. Stent according to claims 1, 2, 3 and 4, c h a r a c- t e r i s e d in that the coil has an outer diameter of 2mm to 9mm before expansion and up to 4mm to 15mm after expansion.
6. Stent according to claims 1, 4 and 5, c h a r a c t e¬ r i s e d in that an expanding segment is situated in one end of the coil.
7. Stent according to claims 1, 4 and 5, c h a r-a c t e- r i s e d in that there is an expanding segment in each end of the coil.
8. Stent according to claims 1, 4 and 5, c h a r a c t e¬ r i s e d in that the part of the coil which does not expand or which expands considerably less is densely coiled.
9. Stent according to claims 1 and 2, c h a r a c t e r i¬ s e d in that the Nickel-Titanium SMA becomes soft at a temperature of between +8,5°C and 20°C.
10. Stent according to claim 1, 3, 4, 5, 6 and 8 c h a- r a c t e r i s e d by that a smaller number of threads in one end of the stent is not densely coiled.
PCT/DK1993/000015 1992-01-20 1993-01-19 Segmentarily expandable tubular endoluminal prosthesis WO1993013824A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK6192A DK6192A (en) 1992-01-20 1992-01-20 SEGMENTALLY EXPANDABLE TUBULAR ENDOLUMINAL PROSTHESIS
DK0061/92 1992-01-20

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Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2706764A1 (en) * 1993-06-24 1994-12-30 Synthelabo
EP0666065A1 (en) * 1994-02-02 1995-08-09 Katsushi Mori Stent for biliary, urinary or vascular system
WO1996035395A1 (en) * 1995-05-12 1996-11-14 Lund Instruments Ab A device for maintaining a passage for urine through the prostate
US5630829A (en) * 1994-12-09 1997-05-20 Intervascular, Inc. High hoop strength intraluminal stent
US5667522A (en) * 1994-03-03 1997-09-16 Medinol Ltd. Urological stent and deployment device therefor
EP0909199A1 (en) * 1996-04-09 1999-04-21 Endocare, Inc. Urological stent therapy system and method
US6146403A (en) * 1997-05-22 2000-11-14 Scimed Life Systems, Inc. Variable expansion force stent
US6413269B1 (en) 2000-07-06 2002-07-02 Endocare, Inc. Stent delivery system
EP0944369B1 (en) * 1995-05-05 2002-10-02 Christian Prof. Dr. Chaussy Endosphincter and set for releasably closing the urethra
WO2003079934A1 (en) * 2002-03-19 2003-10-02 Scimed Life Systems, Inc. Stent retention element and related methods
US6629981B2 (en) 2000-07-06 2003-10-07 Endocare, Inc. Stent delivery system
US6702846B2 (en) 1996-04-09 2004-03-09 Endocare, Inc. Urological stent therapy system and method
US7125419B2 (en) 2000-05-30 2006-10-24 Devax, Inc. Noncylindrical stent deployment for treating vascular bifurcations
US7169175B2 (en) 2000-05-22 2007-01-30 Orbusneich Medical, Inc. Self-expanding stent
WO2007062661A2 (en) * 2005-12-02 2007-06-07 Pnn Medical A/S A stent
EP2243507A1 (en) 2005-10-29 2010-10-27 PNN Medical SA Stent with anchoring portion
US8391570B2 (en) 2005-07-08 2013-03-05 Pnn Medical A/S Method of guiding an irradiation equipment
US8728143B2 (en) 1996-06-06 2014-05-20 Biosensors International Group, Ltd. Endoprosthesis deployment system for treating vascular bifurcations
US8864817B2 (en) 2002-11-08 2014-10-21 Jacques Séguin Endoprosthesis for vascular bifurcation
US8992595B2 (en) 2012-04-04 2015-03-31 Trivascular, Inc. Durable stent graft with tapered struts and stable delivery methods and devices
US9101501B2 (en) 1996-06-06 2015-08-11 Biosensors International Group, Ltd. Bifurcation stent and method of positioning in a body lumen
US9498363B2 (en) 2012-04-06 2016-11-22 Trivascular, Inc. Delivery catheter for endovascular device
JP2017507752A (en) * 2014-03-14 2017-03-23 ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー Indwelling body lumen dilator
US9867727B2 (en) 1998-02-09 2018-01-16 Trivascular, Inc. Endovascular graft
US10159557B2 (en) 2007-10-04 2018-12-25 Trivascular, Inc. Modular vascular graft for low profile percutaneous delivery
CN109906100A (en) * 2016-11-04 2019-06-18 波士顿科学医学有限公司 Controlled extending bracket

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Cited By (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0631762A1 (en) * 1993-06-24 1995-01-04 Synthelabo Prosthesis for body duct
FR2706764A1 (en) * 1993-06-24 1994-12-30 Synthelabo
EP0666065A1 (en) * 1994-02-02 1995-08-09 Katsushi Mori Stent for biliary, urinary or vascular system
US5667522A (en) * 1994-03-03 1997-09-16 Medinol Ltd. Urological stent and deployment device therefor
US5630829A (en) * 1994-12-09 1997-05-20 Intervascular, Inc. High hoop strength intraluminal stent
US5707388A (en) * 1994-12-09 1998-01-13 Intervascular, Inc. High hoop strength intraluminal stent
EP0944369B1 (en) * 1995-05-05 2002-10-02 Christian Prof. Dr. Chaussy Endosphincter and set for releasably closing the urethra
WO1996035395A1 (en) * 1995-05-12 1996-11-14 Lund Instruments Ab A device for maintaining a passage for urine through the prostate
US6119045A (en) * 1995-05-12 2000-09-12 Prostalund Operations Ab Device for maintaining a passage for urine through the prostate
EP0909199A4 (en) * 1996-04-09 2001-02-21 Endocare Inc Urological stent therapy system and method
US6416545B1 (en) 1996-04-09 2002-07-09 Endocare, Inc. Urological stent therapy system and method
US6702846B2 (en) 1996-04-09 2004-03-09 Endocare, Inc. Urological stent therapy system and method
EP0909199A1 (en) * 1996-04-09 1999-04-21 Endocare, Inc. Urological stent therapy system and method
US9101501B2 (en) 1996-06-06 2015-08-11 Biosensors International Group, Ltd. Bifurcation stent and method of positioning in a body lumen
US8728143B2 (en) 1996-06-06 2014-05-20 Biosensors International Group, Ltd. Endoprosthesis deployment system for treating vascular bifurcations
US7485130B2 (en) 1997-05-22 2009-02-03 Boston Scientific Scimed, Inc. Variable expansion force stent
US6423084B1 (en) 1997-05-22 2002-07-23 Scimed Life Systems, Inc Variable expansion force stent
US6146403A (en) * 1997-05-22 2000-11-14 Scimed Life Systems, Inc. Variable expansion force stent
US6997945B2 (en) 1997-05-22 2006-02-14 Boston Scientific Scimed, Inc. Variable expansion force stent
US10548750B2 (en) 1998-02-09 2020-02-04 Trivascular, Inc. Endovascular graft
US9867727B2 (en) 1998-02-09 2018-01-16 Trivascular, Inc. Endovascular graft
US7169175B2 (en) 2000-05-22 2007-01-30 Orbusneich Medical, Inc. Self-expanding stent
US8419786B2 (en) 2000-05-22 2013-04-16 Orbusneich Medical, Inc. Self-expanding stent
US7125419B2 (en) 2000-05-30 2006-10-24 Devax, Inc. Noncylindrical stent deployment for treating vascular bifurcations
US7686845B2 (en) 2000-05-30 2010-03-30 Devax, Inc. Noncylindrical stent deployment system for treating vascular bifurcations
US6413269B1 (en) 2000-07-06 2002-07-02 Endocare, Inc. Stent delivery system
US6629981B2 (en) 2000-07-06 2003-10-07 Endocare, Inc. Stent delivery system
WO2003079934A1 (en) * 2002-03-19 2003-10-02 Scimed Life Systems, Inc. Stent retention element and related methods
US8864817B2 (en) 2002-11-08 2014-10-21 Jacques Séguin Endoprosthesis for vascular bifurcation
US8391570B2 (en) 2005-07-08 2013-03-05 Pnn Medical A/S Method of guiding an irradiation equipment
EP2243507A1 (en) 2005-10-29 2010-10-27 PNN Medical SA Stent with anchoring portion
WO2007062661A3 (en) * 2005-12-02 2007-08-30 Engineers & Doctors Wallsten M A stent
JP2009517145A (en) * 2005-12-02 2009-04-30 ピーエヌエヌ メディカル エイ／エス Stent
WO2007062661A2 (en) * 2005-12-02 2007-06-07 Pnn Medical A/S A stent
US10159557B2 (en) 2007-10-04 2018-12-25 Trivascular, Inc. Modular vascular graft for low profile percutaneous delivery
US10682222B2 (en) 2007-10-04 2020-06-16 Trivascular, Inc. Modular vascular graft for low profile percutaneous delivery
US8992595B2 (en) 2012-04-04 2015-03-31 Trivascular, Inc. Durable stent graft with tapered struts and stable delivery methods and devices
US9498363B2 (en) 2012-04-06 2016-11-22 Trivascular, Inc. Delivery catheter for endovascular device
JP2017507752A (en) * 2014-03-14 2017-03-23 ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー Indwelling body lumen dilator
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DK6192A (en) 1993-07-21
AU3448993A (en) 1993-08-03

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