WO2006056981A1 - Stent a mecanisme a encliquetage - Google Patents

Stent a mecanisme a encliquetage Download PDF

Info

Publication number
WO2006056981A1
WO2006056981A1 PCT/IL2005/001244 IL2005001244W WO2006056981A1 WO 2006056981 A1 WO2006056981 A1 WO 2006056981A1 IL 2005001244 W IL2005001244 W IL 2005001244W WO 2006056981 A1 WO2006056981 A1 WO 2006056981A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
caliber
longitudinal
cylindrical structure
longitudinal edge
Prior art date
Application number
PCT/IL2005/001244
Other languages
English (en)
Inventor
Joel Ovil
Ace Ovil
Original Assignee
Joel Ovil
Ace Ovil
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 Joel Ovil, Ace Ovil filed Critical Joel Ovil
Publication of WO2006056981A1 publication Critical patent/WO2006056981A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/92Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Definitions

  • This invention relates to medical devices and methods, and more specifically to stents and stent delivery systems.
  • Stents are expandable devices that are used to maintain the patency of a body passageway. Stents are commonly used in such passageways as blood vessels, airways, urethras and Eustachian tubes.
  • a stent in a small caliber is delivered to the passageway where it is to be deployed, and is then expanded to a larger caliber in which it applies radially outward forces on the wall of the passageway.
  • the deployed stent In order to maintain the patency of the passageway, the deployed stent must be able to resist radially inward forces applied to it by the passageway wall.
  • US patent 5,344,426 to Lau et al. discloses a stent having an open, reticulated structure.
  • the stent wall has an array of diamond-shaped apertures and fingers which project into the apertures. The fingers and apertures are engaged in a ratchet mechanism that allows the caliber of the stent to be increased while preventing the caliber of the stent from decreasing.
  • the present invention provides a stent for maintaining the patency of a body passageway such as a blood vessel, airway, urethra or Eustachian tube.
  • the stent of the invention is formed from a solid sheet-like material that is rolled into a small caliber cylindrical shape with overlapping edges. In the region of overlap of sheet edges, one or more parallel longitudinal projections on one of the surfaces mate with some of a plurality of parallel longitudinal grooves on the other surface in a ratchet mechanism.
  • the ratchet mechanism allows the stent to be expanded from its initial small caliber to a selectable larger caliber.
  • the ratchet mechanism also provides resistance to any external radially inward forces applied to the stent, so that the stent is stabilized in any selected caliber.
  • the stent of the invention is preferably made of a biocompatible material such as stainless steel or tungsten.
  • the inner surface is preferably provided with a coating that promotes formation of an endothelial layer on the inner surface of the stent.
  • the layer may be made, for example, from woven Dacron.
  • the coating also eliminates contact of the stent material with the blood circulation.
  • the invention provides a stent comprising: a solid sheet of material having a first longitudinal edge, a second longitudinal edge, a first surface and a second surface, the first surface having thereon one or more longitudinal projections adjacent to the first longitudinal edge, the second surface having therein a plurality of longitudinal grooves; whereby the sheet is rolled-up to form an elongated cylindrical structure having a first caliber with the first and second longitudinal edges overlapping and the longitudinal projections engaging some of the longitudinal grooves in a ratchet mechanism allowing the cylindrical structure.
  • the invention provides a method for maintaining the patency of a body passageway comprising:
  • a stent on a distal end of a stent delivery catheter, the stent comprising: a solid sheet of material having a first longitudinal edge, a second longitudinal edge, a first surface and a second surface, the first surface having thereon one or more longitudinal projections adjacent to the first longitudinal edge, the second longitudinal surface having therein a plurality of longitudinal grooves; whereby the sheet is rolled-up to form an elongated cylindrical structure having a first caliber with the first and second longitudinal edges overlapping and the longitudinal projections engaging some of the longitudinal grooves in a ratchet mechanism allowing the cylindrical structure to be expanded from the first caliber to a larger second caliber;
  • Fig. 1 shows a stent in accordance with one embodiment of the invention
  • Fig. 2 shows a sheet like material for forming the stent of Fig. 1;
  • Fig. 3 shows the stent of Fig. 1 mounted on a delivery catheter
  • Fig. 4 shows deployment of the stent of Fig. 1 in a body passageway.
  • Fig. 1 shows a stent 2 in accordance with one embodiment of the invention.
  • the stent 2 is formed from a sheet-like material 4 shown in Fig. 2 having an outer surface 6 and an inner surface 8.
  • the flat sheet form is shown from two different perspectives in Figs. IA and IB.
  • the flat sheet form shown in Fig. 2 is shaped on a mandrel (not shown) by rolling a longitudinal edge 10 over a longitudinal edge 12 into a small caliber cylindrical shape shown in Fig 2a.
  • the outer 6 of the sheet 4 forms the outer surface of the cylinder while the surface 8 of the sheet 4 forms the inner surface of the cylinder that defines a lumen 22.
  • the outer surface 6 is provided with one or more parallel longitudinal projections 14 adjacent to the edge 12.
  • Each projection 14 has a saw tooth profile, a first longitudinal edge 16 perpendicular to the outer surface 6 and facing the edge 22, and a second longitudinal edge 18 oblique to the outer surface 6 and facing the edge 10.
  • the projections 16 mate with some of a plurality of parallel longitudinal grooves 20 in the overlying inner surface 8 of the stent 2 and adjacent to the edge 10.
  • the longitudinal grooves 20 preferably have a saw-tooth profile formed by a surface 21 perpendicular to the surface 8 and a surface 23 oblique to the surface 8.
  • the engagement of the projections 16 and the grooves 20 forms a ratchet mechanism that allows the longitudinal projections 16 to move over the grooves 20 towards the longitudinal edge 10 while preventing the longitudinal projections 16 from moving over the grooves 20 towards the longitudinal edge 12.
  • this allows expansion of the stent from the small caliber shown in Fig. Ia to the large caliber shown in Fig. Ib when a balloon is expanded in the lumen 22 of the stent.
  • this allows the stent to be expanded to a large caliber that is selectable over a range of calibers depending on the extent of expansion of the stent, and the stent 2 in any caliber is resistant to external radially inward forces subsequently applied to the outer surface 6 of the stent, so that the stent is stabilized in any selected caliber.
  • the stent 2 is preferably made of a biocompatible material such as stainless steel or tungsten.
  • the flat sheet which forms the stent 2 may be of any suitable length and width and gauge as required in any application.
  • the length of the stent may be around 1.5 to 4 cm, the diameter of the deployed stent around 0.5 to 1.5 cm and the gauge of the sheet material 4 around 0.02 to 0.125 mm.
  • the inner surface 8 preferably has a layer 9 of woven Dacron glued onto it in order to promote formation of an endothelial layer on the inner surface.
  • the stent 2 may be used with any stent delivery catheter designed for delivering a stent in its small caliber to a body site and deploying the stent at the body site by expanding the stent to a large caliber.
  • a typical stent delivery catheter 22 comprises a slender shaft 24 having a proximal end 30 and a distal end 32, an inflatable balloon 26 located at the distal end of the shaft 24 and a port 28 located at the proximal end of the body 24.
  • the stent 2 in the small caliber shown in Fig. Ia is mounted on the distal end 32 about the balloon 26 so that the balloon 26 is located in the lumen 22 of the stent 2.
  • the shaft has an outer tube 34 and a coaxial inner tube 35 which define between them an annular inflating lumen 36 for the delivery of an inflation fluid to the interior of the balloon 26 when a source of pressurized fluid (not shown) is connected to the port 28.
  • the pressurized fluid flows in the lumen 36 into the balloon 26 via openings 27 in the outer tube 34 so as to expand the balloon 26.
  • the volume of the pressurized fluid delivered to the balloon 26 is determined so as to achieve a predetermined inflation of the balloon 26 so as to cause the stent 2 to expand from its initial small caliber shown in Fig. Ia to a predetermined large caliber, such as the large caliber shown in Fig. Ib.
  • the catheter 22 is mountable on a guidewire 38 that is slidably disposed within an inner lumen 40 of inner tube 34.
  • the catheter 22 is provided with a blunt flexible tip 42 at its distal end.
  • a knob 44 attached to the proximal end of the guidewire 38 is used to apply a torque to the proximal end of the guidewire 38 that is transmitted to the tip 42 of the guidewire 38 so that the guidewire can be navigated to a desired body site such as a site within an individual's vascular system or other body passageway.
  • Fig. 4 shows deployment of the stent 2 in a body passageway such as a stenotic region 44 of an artery 46.
  • the artery 46 has an endothelial layer 47 containing atheromatous plaque 49 in the stenotic region 44.
  • the distal end of the guidewire 38 was navigated through the vascular system to the artery 46.
  • the catheter 22 was then mounted on the guidewire 38, and the distal end 32 of the catheter 22 was guided along the guidewire 38 until the stent 2 in its small caliber and the underlying balloon 26 were positioned in the stenotic region 44.
  • Fig. 4 shows deployment of the stent 2 in a body passageway such as a stenotic region 44 of an artery 46.
  • the artery 46 has an endothelial layer 47 containing atheromatous plaque 49 in the stenotic region 44.
  • the distal end of the guidewire 38 was navigated through the vascular system to the artery 46.
  • the catheter 22 was then mounted on the guidewire 38, and
  • the balloon 26 has been inflated to a predetermined diameter by delivering a predetermined amount of a pressurized fluid to the balloon 26 to bring the stent 2 to a predetermined large caliber so as to expand the stenotic region 44 into a dilated state and to maintain the stenotic region 44 in the dilated state.
  • the balloon 26 is then deflated and the deflated catheter 22 is removed from the artery 46 leaving the expanded stent 2 in the artery 46 pressing against the arterial lining, as shown in Fig. 2c.
  • the stent 2 is preferably deployed in a large caliber in which the inner surface 8 of the stent 2 is flush with the endothelium 47 as shown in Figs.
  • the inner surface 8 of the stent 2 has a layer 9 of woven Dacron glued onto it, it can serve as a matrix for the adherence of cells from the blood circulation in order promote the formation of an endothelial layer on the inner surface 8. If, in the future, it should become necessary, the stent can be expanded further by reinserting the balloon 26 into the lumen 22 of the stent and inflating the balloon in order to achieve a still larger caliber of the stent.
  • a stent having a solid wall prevents penetration of old endothelial cells through the stent wall into the lumen of the stent, and the coating 9 eliminates contact of the stent material from the blood circulation. Overdilation of the stent promotes alignment of the endothelial layer 51 that forms on the stent wall and the previously existing endothelial layer 47 of the blood vessel 46.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un stent (2) comprenant une feuille rigide de matériau qui est enroulée de manière à former une structure cylindrique allongée. La feuille de matériau présente une première surface (6) comportant une ou plusieurs saillies longitudinales (14), et une seconde surface (8) comportant une pluralité de rainures longitudinales (20). Dans la structure cylindrique, les saillies longitudinales (14) sont en prise avec plusieurs rainures longitudinales (20) dans un mécanisme d'encliquetage, entraînant ainsi l'expansion d'un premier calibre à un second calibre supérieur. Le stent selon l'invention peut être utilisé dans un procédé destiné à maintenir la perméabilité d'un passage corporel.
PCT/IL2005/001244 2004-11-24 2005-11-23 Stent a mecanisme a encliquetage WO2006056981A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US63019404P 2004-11-24 2004-11-24
US60/630,194 2004-11-24

Publications (1)

Publication Number Publication Date
WO2006056981A1 true WO2006056981A1 (fr) 2006-06-01

Family

ID=35708460

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2005/001244 WO2006056981A1 (fr) 2004-11-24 2005-11-23 Stent a mecanisme a encliquetage

Country Status (1)

Country Link
WO (1) WO2006056981A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007031796A1 (de) * 2007-07-07 2009-01-08 WRW Consulting GbR (Vertretungsberechtigter Gesellschafter: Dr. Walter Reith, 66424 Homburg) Radial expandierbares System für den Einsatz in Körperröhren
WO2010048671A1 (fr) * 2008-10-30 2010-05-06 Macquarie University Support de vaisceau et sa méthode d’utilisation
DE102009003890A1 (de) * 2009-01-02 2010-07-08 Bioregeneration Gmbh Vorrichtung mit einer in ein Gefäß des Körpers eines Patienten implantierbaren Einrichtung und einer Auskleidung sowie Verfahren zum Herstellen derselben
WO2011100870A1 (fr) * 2010-02-22 2011-08-25 上海交通大学医学院附属新华医院 Système de mise en place d'un nouveau stent bioabsorbable à coulissement et verrouillage
CN107708612A (zh) * 2015-06-02 2018-02-16 株式会社Adeka 源自生物体的组织的片材、由该片材得到的管状结构体以及包含该管状结构体的人工血管
CN112386372A (zh) * 2020-11-26 2021-02-23 北京爱康宜诚医疗器材有限公司 髓内融合件及具有其的股骨假体组件
WO2021165432A1 (fr) * 2020-02-18 2021-08-26 Lau Ernest Échafaudage pour tube

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5192307A (en) * 1987-12-08 1993-03-09 Wall W Henry Angioplasty stent
GB2270264A (en) * 1992-09-02 1994-03-09 Ellis Dev Ltd Palliative stent and insertion device therefor
US5618299A (en) * 1993-04-23 1997-04-08 Advanced Cardiovascular Systems, Inc. Ratcheting stent
US5797951A (en) * 1995-08-09 1998-08-25 Mueller; Edward Gene Expandable support member
WO1999048441A1 (fr) * 1998-03-25 1999-09-30 Endotex Interventional Systems, Inc. Greffon en feuille enroulee convenant pour des lumieres simples ou en y, et modes de realisation et d'utilisation
US20020007222A1 (en) * 2000-04-11 2002-01-17 Ashvin Desai Method and apparatus for supporting a body organ

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5192307A (en) * 1987-12-08 1993-03-09 Wall W Henry Angioplasty stent
GB2270264A (en) * 1992-09-02 1994-03-09 Ellis Dev Ltd Palliative stent and insertion device therefor
US5618299A (en) * 1993-04-23 1997-04-08 Advanced Cardiovascular Systems, Inc. Ratcheting stent
US5797951A (en) * 1995-08-09 1998-08-25 Mueller; Edward Gene Expandable support member
WO1999048441A1 (fr) * 1998-03-25 1999-09-30 Endotex Interventional Systems, Inc. Greffon en feuille enroulee convenant pour des lumieres simples ou en y, et modes de realisation et d'utilisation
US20020007222A1 (en) * 2000-04-11 2002-01-17 Ashvin Desai Method and apparatus for supporting a body organ

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007031796A1 (de) * 2007-07-07 2009-01-08 WRW Consulting GbR (Vertretungsberechtigter Gesellschafter: Dr. Walter Reith, 66424 Homburg) Radial expandierbares System für den Einsatz in Körperröhren
US8696734B2 (en) 2007-07-07 2014-04-15 Wrw Consulting Gbr Radially expandable system for use in body tubes
WO2010048671A1 (fr) * 2008-10-30 2010-05-06 Macquarie University Support de vaisceau et sa méthode d’utilisation
DE102009003890A1 (de) * 2009-01-02 2010-07-08 Bioregeneration Gmbh Vorrichtung mit einer in ein Gefäß des Körpers eines Patienten implantierbaren Einrichtung und einer Auskleidung sowie Verfahren zum Herstellen derselben
WO2011100870A1 (fr) * 2010-02-22 2011-08-25 上海交通大学医学院附属新华医院 Système de mise en place d'un nouveau stent bioabsorbable à coulissement et verrouillage
JP2013520250A (ja) * 2010-02-22 2013-06-06 上海交通大学医学院附属新薬医院 新型スライドファスナー式生体吸收性ステントの輸送システム
CN107708612A (zh) * 2015-06-02 2018-02-16 株式会社Adeka 源自生物体的组织的片材、由该片材得到的管状结构体以及包含该管状结构体的人工血管
WO2021165432A1 (fr) * 2020-02-18 2021-08-26 Lau Ernest Échafaudage pour tube
CN112386372A (zh) * 2020-11-26 2021-02-23 北京爱康宜诚医疗器材有限公司 髓内融合件及具有其的股骨假体组件
CN112386372B (zh) * 2020-11-26 2022-05-03 北京爱康宜诚医疗器材有限公司 髓内融合件及具有其的股骨假体组件

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