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WO2004105643A1 - Dispositif destine a etre fixe sur une paroi de lumiere interne - Google Patents

Dispositif destine a etre fixe sur une paroi de lumiere interne Download PDF

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Publication number
WO2004105643A1
WO2004105643A1 PCT/US2003/015731 US0315731W WO2004105643A1 WO 2004105643 A1 WO2004105643 A1 WO 2004105643A1 US 0315731 W US0315731 W US 0315731W WO 2004105643 A1 WO2004105643 A1 WO 2004105643A1
Authority
WO
WIPO (PCT)
Prior art keywords
curved needle
closed position
internal wall
open position
hub
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2003/015731
Other languages
English (en)
Inventor
Norman Godin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biomedix SA Switzerland
Original Assignee
Biomedix SA Switzerland
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 Biomedix SA Switzerland filed Critical Biomedix SA Switzerland
Priority to AU2003233578A priority Critical patent/AU2003233578A1/en
Priority to PCT/US2003/015731 priority patent/WO2004105643A1/fr
Priority to PCT/US2004/001601 priority patent/WO2004103214A1/fr
Publication of WO2004105643A1 publication Critical patent/WO2004105643A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A61B2017/00827—Treatment of gastro-esophageal reflux

Definitions

  • This invention relates generally to the field of internal medical devices, and specifically to methods and apparatus for securing medical devices to the internal wall of a biological lumen into which it has been inserted.
  • Glues such as cyanacrylates
  • glues are commonly used to secure medical devices to the internal wall of the desired biological lumen by applying the glue to the exterior of the medical device and holding the device in contact with internal wall.
  • glues presents a number of problems.
  • glues dry very quickly and can result in the medical device prematurely bonding in an undesired orientation. Once adhered, glues are not easily reversible and further moving the medical device is difficult. Additionally, glues can cause problems when being handled with an endoscope. Often the endoscope or optics can end up being glued to the medical device itself or the optics of the endoscope can be opacified by the glue itself.
  • Suturing is another method of securing medical devices to the internal wall of a biological lumen. Suturing is unsatisfactory in that space can be very limited within the lumen, causing the suturing job to be very difficult. This can result in the doctor obtaining a less than optimal suture.
  • Another object is to provide a method and apparatus for insertion into a biological lumen that can remain secured to the internal wall of the biological lumen for an extended period of time.
  • Yet another object is to provide a method and apparatus for insertion into a biological lumen that remains properly positioned.
  • a further object of the present invention is to provide a method and apparatus for insertion into a biological lumen that can be easily secured to the internal wall of the biological lumen.
  • a still further object is to provide a method and apparatus for insertion into a biological lumen that can be easily removed from the internal wall of the biological lumen after it is secured thereto.
  • Still another object is to provide a method and apparatus for insertion into a biological lumen that does not interfere with an endoscope or other optics while being secured to the internal wall.
  • biological lumen as used herein is meant to include body cavities and/or orifices.
  • the biological lumen can be, for example, the stomach, colon, rectum, bladder, uterus, vagina, biliary ducts (including the common bile duct), or blood vessels.
  • the apparatus will be an anti-reflux device, such as that disclosed in United States Patent 5,861,036 or United States Application Publication 2003/0009236, both of which are incorporated by reference herein.
  • the term "esophagus" in this discussion includes the lower esophageal sphincter (LES).
  • the curved needle be pivotally mounted via a tight-fit assembly, for example, with a hub having a bottom surface with a cylindrical stub protruding therefrom, the cylindrical stub tightly fits into a corresponding cavity in the apparatus when it is inserted therein. It is also preferable to have the curved needle protrude from a side wall of the hub. While a tight fit assembly is preferred, any type of pivotal connecting means can be used, such as a bolt and nut, a screw, a rivet, a flange, or a ball bearing connection.
  • the curved needle is preferably substantially semi-circular shaped, which improves the ability of the needle to pierce and reliably engage the internal wall of the biological lumen.
  • the hub preferably comprises a female socket or a bolt head to be engaged by a rotational tool.
  • the rotational tool can be supplied via an endoscope.
  • the curved needle is pivotably mounted on a clip body.
  • the apparatus preferably has a stopper to prevent the curved needle from pivoting beyond the closed position when pivoted from the open position.
  • the clip body can comprise a cavity into which the cylindrical stub can be inserted to form a tight pivotal fit.
  • the clip body can be a rigid structure comprising a front plate, back plate, and top plate. The top plate can have a hole and either or both of the front and back plates can have one or more teeth to secure the clip body to another element of the apparatus.
  • a sleeve forming a cavity can be positioned between the front and back plates so that the hole and the sleeve cavity are substantially aligned.
  • the curved needle can be pivotally connected to the clip body by extending the cylindrical stub through the hole in the top plate and into the sleeve cavity to form a tight fit.
  • the invention comprises a method of securing an apparatus to an internal wall of a biological lumen with a pivotable curved needle having an open position and a closed position; inserting the apparatus into the lumen; and pivoting the curved needle about an axis to the closed position, thereby causing the curved needle to pierce and engage the internal wall.
  • the curved needle can be in either the open or the closed position during the insertion of the apparatus.
  • the apparatus can be removed or adjusted by pivoting the curved needle about the axis from the closed position back to the open position, thereby causing the curved needle to disengage the internal wall.
  • Figure 1 is a side view of a balloon catheter positioned in an esophagus.
  • Figure 2 is a top perspective view of an embodiment of a clip assembly having a pivotable curved needle according to the present invention.
  • Figure 3 is an exploded view of the clip assembly embodiment of FIG. 2.
  • Figure 4 is a perspective view an endoscopic rotational tool about to engage the clip assembly connected to a section of a wall an anti-reflux prosthesis.
  • Figure 5 is a side, partially cut-away view of an anti-reflux prosthesis, partially in section, according to an embodiment of the present invention inserted within an esophagus, illustrated in cross-section
  • Figure 6 is a perspective view of an embodiment of a clip assembly according to the present invention with a female socket.
  • a balloon catheter is inserted into esophagus 30 to determine the size of esophagus 30 and thereby the proper size of the ring of the anti-reflux prosthesis 400 (FIG. 5) for insertion.
  • Balloon catheter 10 comprises balloon 11, syringe 12 and pressure monitor 13 (illustrated as a generic box).
  • balloon 11 is inserted into esophagus 30 until it reaches the location to be sized. Once in position, balloon 11 is inflated by depressing plunger 14 of syringe 12 which is filled air, oxygen, or some other gas.
  • Balloon 11 is inflated by syringe 12 until balloon 11 contacts internal wall 31 of esophagus 30. Upon contacting internal wall 31 of esophagus 30, an increase in pressure is detected by pressure monitor 13. The volume of air supplied to balloon 11 by syringe 12 is recorded and correlated to a specific balloon diameter. This diameter is used to choose an appropriately sized anti-reflux prosthesis for insertion into esophagus 30. Balloon 11 is deflated and removed from esophagus 30.
  • an embodiment of a clip assembly 200 comprises clip body 210, curved needle 220, stopper 230, hub 240, and sleeve 250.
  • Clip body 210 is a rigid structure and comprises top plate 211, front plate 212, and back plate 213. Front plate 212 and back plate 213 have teeth 215. Teeth 215 are adapted to secured clip assembly 200 to wall 610 (FIG. 4) of anti- reflux device 400 (FIG. 5) by either biting into wall 610 or fitting into corresponding indentations.
  • curved needle 220 is substantially semi-circular shaped and protrudes from side wall 243 of hub 240.
  • Hub 240 also comprises cylindrical stub 241 protruding from its bottom.
  • Sleeve 250 forms sleeve cavity 251.
  • hub 240 also comprises bolt head 242. As illustrated in FIG. 1,
  • bolt head 242 is adapted to be engaged by rotational tool 350 so that curved needle 220 can be rotated about axis A-B (FIG 3) in both a clockwise and counterclockwise direction.
  • Curved needle 220 is illustrated in a closed position. If curved needle 220 is rotated 180 degrees counter-clockwise, it would be an open position. When in the open position (NOT illustrated), no portion of curved needle 220 extends beyond outer surface 611 of wall 610.
  • curved needle 220 When curved needle 220 is in the open position and bolt head 242 is rotated in a clockwise direction, curved needle 220 will rotate in a clockwise direction until it contacts stopper 230. Once curved needle contacts stopper 230, stopper 230 prevents curved needle from rotating any further in the clockwise direction.
  • stopper 230 can be adapted so as to not interfere with the rotation of curved needle of 220 about axis A-B.
  • sleeve 250 can be adapted to act as a stopper if desired. Additionally, sleeve 250 can be sized so that the tight fit between cylindrical stub 241 and sleeve cavity
  • Clip assembly 200 is secured to wall 610 of anti-reflux prosthesis 400 through the use of teeth 215, as is illustrated in FIG. 4.
  • Anti-reflux prosthesis 400 is inserted into an esophagus 30 with all of the curved needles 220 in an open position.
  • the curved needle 220 illustrated on the left is shown in the open position.
  • curved needle 220 does not engage internal wall 31 and does not interfere with the insertion placement of anti-reflux prosthesis 400 in esophagus 30.
  • the anti-reflux prosthesis 400 is first positioned in the desired location within esophagus 30, and then each curved needle 220 is pivoted about axis A-B from the open position to a closed position.
  • the curved needle 220 illustrated on the right is shown in the closed position. As curved needle 220 is pivoted from the open position to the closed position, curved needle 220 pierces and engages internal wall 31, securing anti-reflux prosthesis in place. Once secured to internal wall 31, anti-reflux prosthesis 400 can be removed by pivoting all of the curved needles 220 back into the open position. All pivoting of curved needle 220 within esophagus 30 can be accomplished with rotational tool 350
  • FIG. 4 through the use of an endoscope.
  • each curved needle 220 will be rotated 360 degrees in the appropriate direction instead of 180 degrees.
  • hub 240 can be modified to be compatible with any type of rotational device. As illustrated, hub 240 can have a female socket
  • the female socket 245 instead of a bolt head for facilitating pivoting of curved needle 220.
  • the female socket 245 can receive a male-ended rotational device rather than a female-ended device 350.
  • the clip body can be adapted to comprise a cavity formed within the clip body itself.
  • a sleeve is not necessary and the cylindrical stub of the hub will fit directly into this cavity to form a tight fit.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un appareil et un procédé de fixation de dispositifs médicaux sur une paroi interne (31) d'une lumière biologique. Dans un mode de réalisation, l'invention concerne un appareil (400) destiné à être inséré dans une lumière biologique présentant une paroi interne (31), ledit appareil (400) comprenant une aiguille incurvée (220) pouvant pivoter autour d'un axe entre une position ouverte et une position fermée et conçue pour percer et s'engager dans ladite paroi interne (31) lorsqu'elle pivote de ladite position ouverte à ladite position fermée.
PCT/US2003/015731 2003-05-20 2003-05-20 Dispositif destine a etre fixe sur une paroi de lumiere interne Ceased WO2004105643A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2003233578A AU2003233578A1 (en) 2003-05-20 2003-05-20 Device for securing to wall of internal lumen
PCT/US2003/015731 WO2004105643A1 (fr) 2003-05-20 2003-05-20 Dispositif destine a etre fixe sur une paroi de lumiere interne
PCT/US2004/001601 WO2004103214A1 (fr) 2003-05-20 2004-01-21 Dispositif pour fixation a la paroi d'une lumiere interne

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/015731 WO2004105643A1 (fr) 2003-05-20 2003-05-20 Dispositif destine a etre fixe sur une paroi de lumiere interne

Publications (1)

Publication Number Publication Date
WO2004105643A1 true WO2004105643A1 (fr) 2004-12-09

Family

ID=33476220

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2003/015731 Ceased WO2004105643A1 (fr) 2003-05-20 2003-05-20 Dispositif destine a etre fixe sur une paroi de lumiere interne
PCT/US2004/001601 Ceased WO2004103214A1 (fr) 2003-05-20 2004-01-21 Dispositif pour fixation a la paroi d'une lumiere interne

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2004/001601 Ceased WO2004103214A1 (fr) 2003-05-20 2004-01-21 Dispositif pour fixation a la paroi d'une lumiere interne

Country Status (2)

Country Link
AU (1) AU2003233578A1 (fr)
WO (2) WO2004105643A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7220284B2 (en) 2002-11-01 2007-05-22 Valentx, Inc. Gastrointestinal sleeve device and methods for treatment of morbid obesity
US7837669B2 (en) 2002-11-01 2010-11-23 Valentx, Inc. Devices and methods for endolumenal gastrointestinal bypass
US7846138B2 (en) 2002-11-01 2010-12-07 Valentx, Inc. Cuff and sleeve system for gastrointestinal bypass
US8956318B2 (en) 2012-05-31 2015-02-17 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9060844B2 (en) 2002-11-01 2015-06-23 Valentx, Inc. Apparatus and methods for treatment of morbid obesity
US9451960B2 (en) 2012-05-31 2016-09-27 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9675489B2 (en) 2012-05-31 2017-06-13 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9757264B2 (en) 2013-03-13 2017-09-12 Valentx, Inc. Devices and methods for gastrointestinal bypass

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012136249A1 (fr) * 2011-04-05 2012-10-11 Ethicon Endo-Surgery, Inc. Système de revêtement endoluminal et procédé de revêtement endoluminal d'un organe creux

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5314473A (en) * 1989-07-20 1994-05-24 Godin Norman J Prosthesis for preventing gastric reflux into the esophagus
US6004347A (en) * 1993-04-22 1999-12-21 C. R. Bard, Inc. Non-migrating vascular prosthesis and minimally invasive placement system therefor
US6254642B1 (en) * 1997-12-09 2001-07-03 Thomas V. Taylor Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5314473A (en) * 1989-07-20 1994-05-24 Godin Norman J Prosthesis for preventing gastric reflux into the esophagus
US6004347A (en) * 1993-04-22 1999-12-21 C. R. Bard, Inc. Non-migrating vascular prosthesis and minimally invasive placement system therefor
US6254642B1 (en) * 1997-12-09 2001-07-03 Thomas V. Taylor Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9561127B2 (en) 2002-11-01 2017-02-07 Valentx, Inc. Apparatus and methods for treatment of morbid obesity
US7220284B2 (en) 2002-11-01 2007-05-22 Valentx, Inc. Gastrointestinal sleeve device and methods for treatment of morbid obesity
US7846138B2 (en) 2002-11-01 2010-12-07 Valentx, Inc. Cuff and sleeve system for gastrointestinal bypass
US7892214B2 (en) 2002-11-01 2011-02-22 Valentx, Inc. Attachment system for transmural attachment at the gastroesophageal junction
US8012135B2 (en) 2002-11-01 2011-09-06 Valentx, Inc. Attachment cuff for gastrointestinal implant
US8012140B1 (en) 2002-11-01 2011-09-06 Valentx, Inc. Methods of transmural attachment in the gastrointestinal system
US8070743B2 (en) 2002-11-01 2011-12-06 Valentx, Inc. Devices and methods for attaching an endolumenal gastrointestinal implant
US8182459B2 (en) 2002-11-01 2012-05-22 Valentx, Inc. Devices and methods for endolumenal gastrointestinal bypass
US10350101B2 (en) 2002-11-01 2019-07-16 Valentx, Inc. Devices and methods for endolumenal gastrointestinal bypass
US9060844B2 (en) 2002-11-01 2015-06-23 Valentx, Inc. Apparatus and methods for treatment of morbid obesity
US7837669B2 (en) 2002-11-01 2010-11-23 Valentx, Inc. Devices and methods for endolumenal gastrointestinal bypass
US9839546B2 (en) 2002-11-01 2017-12-12 Valentx, Inc. Apparatus and methods for treatment of morbid obesity
US8968270B2 (en) 2002-11-01 2015-03-03 Valentx, Inc. Methods of replacing a gastrointestinal bypass sleeve for therapy adjustment
US9050168B2 (en) 2012-05-31 2015-06-09 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9451960B2 (en) 2012-05-31 2016-09-27 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9173759B2 (en) 2012-05-31 2015-11-03 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9566181B2 (en) 2012-05-31 2017-02-14 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9675489B2 (en) 2012-05-31 2017-06-13 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9681975B2 (en) 2012-05-31 2017-06-20 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9039649B2 (en) 2012-05-31 2015-05-26 Valentx, Inc. Devices and methods for gastrointestinal bypass
US8956318B2 (en) 2012-05-31 2015-02-17 Valentx, Inc. Devices and methods for gastrointestinal bypass
US9757264B2 (en) 2013-03-13 2017-09-12 Valentx, Inc. Devices and methods for gastrointestinal bypass

Also Published As

Publication number Publication date
WO2004103214A1 (fr) 2004-12-02
AU2003233578A1 (en) 2005-01-21

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