WO2010011530A2 - Device to close openings in body tissue - Google Patents

Device to close openings in body tissue Download PDF

Info

Publication number
WO2010011530A2
WO2010011530A2 PCT/US2009/050507 US2009050507W WO2010011530A2 WO 2010011530 A2 WO2010011530 A2 WO 2010011530A2 US 2009050507 W US2009050507 W US 2009050507W WO 2010011530 A2 WO2010011530 A2 WO 2010011530A2
Authority
WO
WIPO (PCT)
Prior art keywords
midsection
configuration
end section
catheter
anchoring members
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/US2009/050507
Other languages
English (en)
French (fr)
Other versions
WO2010011530A3 (en
Inventor
Tracee E.J. Eidenschink
Jan Weber
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.)
Boston Scientific Scimed Inc
Original Assignee
Scimed Life Systems Inc
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 Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Priority to CA2731223A priority Critical patent/CA2731223A1/en
Priority to EP09790387A priority patent/EP2317930A2/en
Priority to JP2011520092A priority patent/JP5816551B2/ja
Publication of WO2010011530A2 publication Critical patent/WO2010011530A2/en
Publication of WO2010011530A3 publication Critical patent/WO2010011530A3/en
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
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3132—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00597—Implements comprising a membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00668—Type of implements the implement being a tack or a staple
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49908—Joining by deforming

Definitions

  • transluminal endoscopic surgical procedures More recently, there has been interest in transluminal endoscopic surgical procedures.
  • an endoscope In transluminal endoscopic surgery, an endoscope is used to deliberately breach (puncture) the wall of the stomach or other organ to work within the peritoneal cavity.
  • a flexible endoscope (along with the required surgical tools) is inserted into the stomach through a natural anatomic opening. Once the endoscope reaches the stomach, the wall of the stomach is punctured and the endoscope advanced into the abdominal cavity where the remotely controlled surgical tools can be used to perform delicate surgical procedures.
  • the endoscope and the tools are withdrawn through the hole in the stomach and the puncture is closed.
  • the constrained configuration may correspond to a collapsed shape of the end sections; the unconstrained configuration may correspond to an expanded shape of the end sections; the end sections may be configured to transform from the constrained configuration to the unconstrained configuration when released from a catheter; the one or more anchoring members may be connected together by a base; the base of both end sections may abut the midsection; at least one of the end sections may include a covering material; the covering material may be a fabric; the midsection may be configured to transform from a first configuration to the at least one configuration, wherein the first configuration may correspond to a shape of the midsection when the device is constrained and the at least one configuration may correspond to a shape of the midsection when unconstrained; the midsection may be configured to transform from the first configuration to the at least one configuration by twisting; the midsection may be configured to transform from the first configuration to the at least one configuration when the device is released from a catheter; the end sections may be made of one of an
  • the unconstrained configuration may be a shape in which the device is substantially planar transverse to the longitudinal axis; deploying the device may include forcing the device out of catheter.
  • FIG. 1 is a schematic view of an endoscope performing an exemplary transluminal endoscopic surgical procedure.
  • FIG. 6 is a schematic view of the kinked midsection of the device of FIG. 2 after being deployed at a work site.
  • FIG. 7 is a schematic illustration of the catheter of FIG. 4A being withdrawn after the device is deployed at the work site.
  • FIG. 12 is a schematic illustration of a further embodiment of a closure device.
  • FIG. 13A is schematic view of another exemplary closure device of the current invention for closing a puncture created during the endoscopic surgical procedure of FIG. 1.
  • FIG. 13C is a schematic illustration of the transformed shape of the device of FIG. 13A closing the puncture.
  • the irrigation lumen may be configured to facilitate fluid flow from the proximal end 60 to the distal end 90.
  • the proximal end 60 of the irrigation lumen may be attached to a source of fluid, and the distal end 90 may be attached to a nozzle to alter fluid flow.
  • the aspiration lumen may be configured to facilitate suction and/or fluid flow through it.
  • fluid may flow from the proximal end 60 to the work site 55 through the irrigation lumen. The fluid may then be removed from the work site 55 through the aspiration lumen.
  • the aspiration lumen may also be configured to remove biological material along with fluid from the work site 55. For instance, a tissue sample along with fluid (delivered to the work site 55 via the irrigation lumen) may be extracted out of the body through the aspiration lumen or any other lumen configured for this purpose.
  • an endoscopic instrument 30 may also include a mechanism to operate the end effector 32 from outside the body.
  • This mechanism may include linkage that connects the end effector 32 to an actuation device (not shown) at the proximal end.
  • this linkage may operate the end effector in response to actuation of the actuation device.
  • the end effector 32 may include forceps with a pair of jaws rotatably coupled to each other.
  • the linkage in this embodiment, may include a pair of cables, each coupled to a jaw of the forceps at the distal end and to the actuation device at the proximal end. Actuation of the actuation device may move one of the cables relative to the other, causing the jaws of the forceps to open and close.
  • polystyrene resins polycaprolactams and polyacrylamides
  • resins including alkyd resins, phenolic resins, urea resins, melamine resins, epoxy resins, allyl resins and epoxide resins
  • polycarbonates polyacrylonitriles
  • polyvinylpyrrolidones cross-linked and otherwise
  • Withdrawing the catheter 35 from puncture 80 may include gently pulling the catheter 35 out of the body through the working lumen of the endoscope 10.
  • FIG. 7 shows a schematic illustrating withdrawing of catheter 35. Withdrawing the catheter 35 (depicted by arrow 95) may drag the midsection 44 (any part still retained within the catheter 35) along with the second end section 43 out of catheter 35. Once out of the catheter 35, the second end section 43 may also unfold on the inner side 70b of the organ wall 70. As with the first end section 41 , the second end section 43 may also unfold to the unconstrained configuration.
  • FIG. 11 illustrates another embodiment of device 4Od.
  • the end section outer circumference 58 may be threaded. It is contemplated that the inner surface of the catheter 35 may also be threaded to mate with the threads on the end section outer circumference 58.
  • ejecting the second end section 43d may involve rotating the catheter 35 around the longitudinal axis 54. Rotation of the catheter 35 around the longitudinal axis 54 may advance second end section 43d out of the catheter 35. The ejected device 4Od may then close puncture 80 as described previously. Rotating the catheter 35 around the longitudinal axis 54 may also simultaneously kink and close midsection 44 and eject the second end section 43d. The threads on second end section 43d may also enhance gripping of the organ wall.
  • slots 144 and the strands 142 in the embodiment illustrated in FIGS. 13A-13C are depicted as substantially straight, any configuration of slots 144 and strands 142 may be used with device 140.
  • the strands 142 may be curved, tapered, curvilinear, or helically shaped.
  • the folds 150 on different strands 142 may be located such that, after transforming to the unconstrained configuration, the folded strands form an interweaving pattern closing the puncture 80.
  • the interweaving pattern of the folded strands may make the covering material 146 redundant, and therefore, be eliminated.
  • the anchoring members 246 in the constrained configuration, substantially resemble a frustum of a cone. In some embodiments, the multiple anchoring members 246 may retain the constrained configuration when the deforming force is released. In other embodiments, a constraining force may be applied to the device 240 to keep the anchoring members 246 in the constrained configuration.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)
  • Devices For Medical Bathing And Washing (AREA)
PCT/US2009/050507 2008-07-21 2009-07-14 Device to close openings in body tissue Ceased WO2010011530A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA2731223A CA2731223A1 (en) 2008-07-21 2009-07-14 Device to close openings in body tissue
EP09790387A EP2317930A2 (en) 2008-07-21 2009-07-14 Device to close openings in body tissue
JP2011520092A JP5816551B2 (ja) 2008-07-21 2009-07-14 身体組織内の開口部を閉鎖するためのデバイス

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12981208P 2008-07-21 2008-07-21
US61/129,812 2008-07-21
US12/453,693 2009-05-19
US12/453,693 US20100016885A1 (en) 2008-07-21 2009-05-19 Device to close openings in body tissue

Publications (2)

Publication Number Publication Date
WO2010011530A2 true WO2010011530A2 (en) 2010-01-28
WO2010011530A3 WO2010011530A3 (en) 2010-03-11

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ID=41530972

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/050507 Ceased WO2010011530A2 (en) 2008-07-21 2009-07-14 Device to close openings in body tissue

Country Status (6)

Country Link
US (1) US20100016885A1 (enExample)
EP (3) EP2647338B1 (enExample)
JP (2) JP5816551B2 (enExample)
CA (1) CA2731223A1 (enExample)
ES (1) ES2624216T3 (enExample)
WO (1) WO2010011530A2 (enExample)

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Also Published As

Publication number Publication date
EP2647338A1 (en) 2013-10-09
JP5878155B2 (ja) 2016-03-08
EP2647338B1 (en) 2017-03-01
CA2731223A1 (en) 2010-01-28
ES2624216T3 (es) 2017-07-13
JP2014054561A (ja) 2014-03-27
JP5816551B2 (ja) 2015-11-18
JP2011528604A (ja) 2011-11-24
WO2010011530A3 (en) 2010-03-11
EP3187118A1 (en) 2017-07-05
US20100016885A1 (en) 2010-01-21
EP2317930A2 (en) 2011-05-11

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