WO2004096013A2 - Methods and devices for temporarily sealing a blood vessel during an anastomosis - Google Patents
Methods and devices for temporarily sealing a blood vessel during an anastomosis Download PDFInfo
- Publication number
- WO2004096013A2 WO2004096013A2 PCT/US2004/012843 US2004012843W WO2004096013A2 WO 2004096013 A2 WO2004096013 A2 WO 2004096013A2 US 2004012843 W US2004012843 W US 2004012843W WO 2004096013 A2 WO2004096013 A2 WO 2004096013A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- blood vessel
- intravascular
- extravascular
- opening
- anastomosis
- Prior art date
Links
- 238000007789 sealing Methods 0.000 title claims abstract description 32
- 230000003872 anastomosis Effects 0.000 title claims abstract description 25
- 210000004204 blood vessel Anatomy 0.000 title claims description 58
- 238000000034 method Methods 0.000 title claims description 19
- 230000000149 penetrating effect Effects 0.000 claims 2
- 238000004873 anchoring Methods 0.000 claims 1
- 230000035515 penetration Effects 0.000 claims 1
- 210000000709 aorta Anatomy 0.000 abstract description 14
- 239000012528 membrane Substances 0.000 description 5
- 210000001519 tissue Anatomy 0.000 description 3
- 210000001105 femoral artery Anatomy 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000002411 adverse Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 210000003038 endothelium Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 210000001349 mammary artery Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 210000003752 saphenous vein Anatomy 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12036—Type of occlusion partial occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00831—Material properties
- A61B2017/00876—Material properties magnetic
Definitions
- the present invention is directed to methods and devices for temporarily sealing an opening in a body cavity or lumen such as a blood vessel.
- the present invention is suited for sealing the opening in the aorta when forming an anastomosis for coronary bypass surgery.
- Clamp-type devices are disclosed in U.S. Patent No. 5,447,515 and 6,620,177.
- a drawback with these clamp-type devices is that a separate incision is required for one arm of the clamp.
- the present invention is directed to additional methods and devices for sealing an opening in a blood vessel.
- the present invention is directed to methods and device for temporarily sealing a body cavity or body lumen such as the aorta.
- a sealing device which has intravascular and extravascular elements magnetically attracted to one another.
- One or both of the elements may have magnetic components or elements to create the magnetic attraction.
- the intravascular element has a flexible body which conforms to the shape of the inner wall of the blood vessel.
- An opening is formed in the blood vessel which is sealed by the intravascular element.
- the intravascular element may be delivered endovascularly with a catheter, or through a cannula or trocar near the aorta and adjacent to the anastomosis.
- the device may also be delivered through the same opening that is created to form the anastomosis which provides the benefits described below.
- the intravascular element has a flexible body which can deform to the shape of the inner wall of the aorta and, in particular, is flexible to be deformed by magnetic forces exerted by the extravascular element in conformance with the shape of the aorta. In this manner, the extravascular element may be used to deploy and anchor the intravascular element.
- the intravascular and extravascular elements may be coupled together with a connector extending through the opening used to create the anastomosis.
- the connector may acts like a spring which clamps the device to the blood vessel.
- the spring may be created with a wire which acts like a coil spring or with any other suitable structure which provides a spring force.
- the connector may also simply be a tension element, such as a wire or filament, which is tensioned to create a clamping force between the intravascular and extravascular elements.
- Fig. 1 shows an intravascular part of a device for temporarily sealing an opening in a blood vessel when creating an anastomosis.
- Fig. 2 shows the intravascular component collapsed within a delivery element
- Fig. 3 shows the intravascular component with elements advanced into a channel in the device.
- Fig. 4 shows a cross-sectional view of the intravascular component.
- Fig. 5 shows an extravascular component of the device of Fig. 1.
- Fig. 6 shows the device' of Fig. 1 mounted to a blood vessel.
- Fig. 7 is an isometric view of another device for temporarily sealing an opening in a blood vessel.
- Fig. 8 shows a plan view of the device of Fig. 7.
- Fig. 9 shows a side view of the device of Fig. 7.
- Fig. 10 shows another device for temporarily sealing an opening in a blood vessel.
- the present invention is directed to devices and methods for temporarily sealing an opening in a body cavity or lumen such as a blood vessel.
- the present invention may be useful for temporarily sealing an opening in the aorta when creating an anastomosis during bypass surgery.
- the descriptions below related to the aorta are equally applicable to use in any body lumen or cavity.
- the term graft vessel may mean any type of vessel including any biological or synthetic graft including, but not limited to, the internal mammary artery, saphenous vein, foreign tissue grafts and synthetic grafts such as PTFE grafts.
- a device 2 for temporarily sealing an opening in a blood vessel in accordance with the present invention is shown.
- the device 2 includes an extravascular component 4 and an intravascular component 6.
- the components 4, 6 are magnetically attracted to one another to provide a clamping force to temporarily secure the device 2 to the vessel or organ. Either one or both of the components 4, 6 may be magnetic.
- the extravascular component 6 may be split to facilitate placement and removal.
- the component 6 may have a number of poles as shown in Fig. 5 or may have fewer poles without departing from the invention.
- the intravascular component 6 may be delivered through a trocar or cannula 8 near the desired anastomosis site, through a catheter from a peripheral vessel such as the femoral artery, or through the same opening used to form the anastomosis.
- the intravascular component 6 has a flexible body 14 which is collapsed in a delivery element 15 such as a catheter, cannula or trocar.
- the component 6 may have one or more elements 10 which are magnetically attracted to the extravascular component 4.
- the elements 10 may be spherical although any other shape may be used.
- the elements 10 may be fixed to the flexible body 14 or may be movable within a channel or lumen 12 in a flexible body 14 so that the device 2 may be more easily collapsed into a relatively small shape.
- the flexible body 14 may be delivered first followed by advancement of the element 10 into the flexible body when it is desired to expand the intravascular component 6. Removal of the element 10 from the flexible body 14 may facilitate advancement, positioning and removal of the device. This feature may be particularly advantageous when the delivery element 15 is a catheter for endovascular delivery or when the delivery element 15 is delivered through the same opening used to form the anastomosis.
- the element 10 is advanced into a channel or pocket 22 in the body. Advancement of the element 10 provides a more defined shape to the intravascular component 6. Even with the element 10 in place, however, the intravascular component 6 is still flexible enough to be deformed by magnetic forces exerted by the extravascular component 4 so that the intravascular component 6 conforms to the shape of the aorta.
- the element 10 may be advanced into the flexible body 14 using fluid pressure, a string 17 coupled to the elements 10 or by simply manipulating the element 10 itself.
- the channel or lumen 12 may extend essentially radially from an outer edge of the device or may extend longitudinally from near the middle of the device when the device is introduced through the opening used to create the anastomosis as shown in Fig. 6.
- the flexible body 14 is made of a soft, conformable material, such as silicone, polyurethane or other suitable biocompatible material, to conform to the shape of the vessel.
- the flexible body 14 may include a thin membrane 20 which seals the opening in the vessel and is surrounded by the channel, lumen or pocket 22.
- the intravascular component 6 is advanced to a position adjacent the inner wall of the aorta using the delivery element 15.
- the component 6 may be delivered with a catheter through a peripheral vessel such as the femoral artery, through a cannula or trocar in the aorta; or directly through the opening used to form the anastomosis as shown in Fig. 6.
- the component 6 is initially delivered out of the delivery element 15 in a collapsed position.
- the element(s) 10 are then moved into the channel or lumen 22 in the body 14 to provide a generally circular shape to the component 6.
- the extravascular component 4 is then moved against the outer wall of the aorta so that the magnetic forces exerted on the intravascular component 6 cause the component 6 to conform to the shape of the aorta and to clamp the aorta between the components 4, 6.
- the sealing device 30 has a membrane 32 which seals against the inner wall of the blood vessel.
- the device 30 also includes an intravascular part 32 and an extravascular part 34 which contact the inner and outer walls of the blood vessel, respectively.
- a connector 36 extends between the intravascular and extravascular parts 32, 34.
- the connector 36 extends through the opening in the blood vessel and provides a spring force which clamps the device 30 to the blood vessel.
- the device 30 may include a wire 38, such as a superelastic wire, which forms a loop 37 at the intravascular part, a loop 39 at the extravascular part and length of wire which at the connector 36 which acts like a spring coil.
- the intravascular part 32 having the membrane 32 is deflected in direction of arrow 38 so that the connector 36 creates a spring force to clamp the device to the vessel.
- Two advantages of the device 30 are that no part of the device 30 extends through the lumen of the blood vessel or graft vessel and that the blood vessel and graft vessel are not penetrated or pierced to deliver or mount the device 30.
- a tear-away member 33 such as a suture, may be used to partially or completely detach the membrane 22 or to simply segment or cut the membrane to facilitate removal.
- the device 40 also includes an intravascular part 42 and an extravascular part 44 which contact the inner and outer walls of the blood vessel, respectively.
- a tensioning element 46 extends through the opening in the vessel which is used to form the anastomosis.
- the tensioning element 46 is held by the extravascular part 44 and may have a number of discrete positions provided by beads 48. Of course, any other suitable mechanism may be used to apply and maintain tension on the element 46 with or without discrete positions.
- the intravascular part 42 as has an expandable frame 50 which opens and closes a cover 52.
- the frame 50 is collapsed during introduction and removal in any suitable manner as is known in the art.
- the frame may be collapsed with a ring (not shown) which is simply moved over the frame 50 to collapse the frame 50.
- the frame 50 is expanded to seal around the opening.
- Tension is then applied to the tensioning element 46 to form a seal around the opening.
- the device 40 also shares the same advantages as some of the other devices described herein such as minimal disturbance and trauma to the blood vessel and graft.
- a suture 54 may be used to tear away part or all of the cover when removing the device.
- the device 40 is preferably removed directly through the same opening used to create the anastomosis.
- the extravascular part 34 may be advantageously rotated relative to the intravascular part 32 to so that the device 30 or parts thereof may be moved to reduce interference with creation of the anastomosis.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (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
Description
Claims
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US46564303P | 2003-04-26 | 2003-04-26 | |
US60/465,643 | 2003-04-26 | ||
US47255603P | 2003-05-22 | 2003-05-22 | |
US60/472,556 | 2003-05-22 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004096013A2 true WO2004096013A2 (en) | 2004-11-11 |
WO2004096013A3 WO2004096013A3 (en) | 2007-03-29 |
Family
ID=33423568
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/012843 WO2004096013A2 (en) | 2003-04-26 | 2004-04-26 | Methods and devices for temporarily sealing a blood vessel during an anastomosis |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2004096013A2 (en) |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016007917A3 (en) * | 2014-07-11 | 2016-03-10 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to-side anastomosis |
CN107468300A (en) * | 2011-07-12 | 2017-12-15 | 消化道肿瘤治疗研究中心 | Modularization magnetic stapling apparatus |
US10182802B2 (en) | 2007-03-29 | 2019-01-22 | Nobles Medical Technologies, Inc. | Suturing devices and methods for closing a patent foramen ovale |
US10285687B2 (en) | 2008-05-09 | 2019-05-14 | Nobles Medical Technologies Inc. | Suturing devices and methods for suturing an anatomic valve |
US10420545B2 (en) | 2012-05-11 | 2019-09-24 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic structure |
US10512458B2 (en) | 2013-12-06 | 2019-12-24 | Med-Venture Investments, Llc | Suturing methods and apparatuses |
US10610216B2 (en) | 2011-04-15 | 2020-04-07 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic valve |
US10687801B2 (en) | 2016-04-11 | 2020-06-23 | Nobles Medical Technologies Ii, Inc. | Suture spools for tissue suturing device |
US10758223B2 (en) | 2005-06-20 | 2020-09-01 | Scarab Technology Services, Llc | Method and apparatus for applying a knot to a suture |
US11202624B2 (en) | 2017-08-18 | 2021-12-21 | Nobles Medical Technologies Ii, Inc. | Apparatus for applying a knot to a suture |
US11839370B2 (en) | 2017-06-19 | 2023-12-12 | Heartstitch, Inc. | Suturing devices and methods for suturing an opening in the apex of the heart |
US11957331B2 (en) | 2017-06-19 | 2024-04-16 | Heartstitch, Inc. | Suturing systems and methods for suturing body tissue |
US12161339B2 (en) | 2012-12-21 | 2024-12-10 | Ircad | Applicators for modular magnetic anastomosis device |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5626601A (en) * | 1995-10-27 | 1997-05-06 | Gary Gershony | Vascular sealing apparatus and method |
-
2004
- 2004-04-26 WO PCT/US2004/012843 patent/WO2004096013A2/en active Application Filing
Cited By (25)
Publication number | Priority date | Publication date | Assignee | Title |
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US11744576B2 (en) | 2005-06-20 | 2023-09-05 | Scarab Technology Services, Llc | Method and apparatus for applying a knot to a suture |
US10758223B2 (en) | 2005-06-20 | 2020-09-01 | Scarab Technology Services, Llc | Method and apparatus for applying a knot to a suture |
US11197661B2 (en) | 2007-03-29 | 2021-12-14 | Scarab Technology Services, Llc | Device for applying a knot to a suture |
US10182802B2 (en) | 2007-03-29 | 2019-01-22 | Nobles Medical Technologies, Inc. | Suturing devices and methods for closing a patent foramen ovale |
US10285687B2 (en) | 2008-05-09 | 2019-05-14 | Nobles Medical Technologies Inc. | Suturing devices and methods for suturing an anatomic valve |
US11166712B2 (en) | 2008-05-09 | 2021-11-09 | Scarab Technology Services, Llc | Suturing devices and methods for suturing an anatomic valve |
US10624629B2 (en) | 2011-04-15 | 2020-04-21 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic valve |
US10610216B2 (en) | 2011-04-15 | 2020-04-07 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic valve |
US11974749B2 (en) | 2011-07-12 | 2024-05-07 | Ircad | Modular magnetic devices for use in creating tissue anastomosis |
US11344308B2 (en) | 2011-07-12 | 2022-05-31 | Ircad | Modular magnetic devices for use in creating tissue anastomosis |
US12251108B2 (en) | 2011-07-12 | 2025-03-18 | Ircad | Modular magnetic devices for use in creating tissue anastomosis |
CN107468300A (en) * | 2011-07-12 | 2017-12-15 | 消化道肿瘤治疗研究中心 | Modularization magnetic stapling apparatus |
US11051802B2 (en) | 2012-05-11 | 2021-07-06 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic structure |
US10420545B2 (en) | 2012-05-11 | 2019-09-24 | Heartstitch, Inc. | Suturing devices and methods for suturing an anatomic structure |
US12161339B2 (en) | 2012-12-21 | 2024-12-10 | Ircad | Applicators for modular magnetic anastomosis device |
US10512458B2 (en) | 2013-12-06 | 2019-12-24 | Med-Venture Investments, Llc | Suturing methods and apparatuses |
US11779324B2 (en) | 2013-12-06 | 2023-10-10 | Med-Venture Investments, Llc | Suturing methods and apparatuses |
US11395658B2 (en) | 2014-07-11 | 2022-07-26 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to-side anastomosis |
EP3166507B1 (en) * | 2014-07-11 | 2023-10-25 | Cardio Medical Solutions, Inc. | Device for assisting end-to-side anastomosis |
WO2016007917A3 (en) * | 2014-07-11 | 2016-03-10 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to-side anastomosis |
US10178993B2 (en) | 2014-07-11 | 2019-01-15 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to-side anastomosis |
US10687801B2 (en) | 2016-04-11 | 2020-06-23 | Nobles Medical Technologies Ii, Inc. | Suture spools for tissue suturing device |
US11839370B2 (en) | 2017-06-19 | 2023-12-12 | Heartstitch, Inc. | Suturing devices and methods for suturing an opening in the apex of the heart |
US11957331B2 (en) | 2017-06-19 | 2024-04-16 | Heartstitch, Inc. | Suturing systems and methods for suturing body tissue |
US11202624B2 (en) | 2017-08-18 | 2021-12-21 | Nobles Medical Technologies Ii, Inc. | Apparatus for applying a knot to a suture |
Also Published As
Publication number | Publication date |
---|---|
WO2004096013A3 (en) | 2007-03-29 |
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