WO2001012074A1 - Dispositif d'anastomose vasculaire a deploiement autonome et procede de couplage d'un conduit et d'une aorte ou autre vaisseau similaire - Google Patents

Dispositif d'anastomose vasculaire a deploiement autonome et procede de couplage d'un conduit et d'une aorte ou autre vaisseau similaire Download PDF

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Publication number
WO2001012074A1
WO2001012074A1 PCT/US2000/022627 US0022627W WO0112074A1 WO 2001012074 A1 WO2001012074 A1 WO 2001012074A1 US 0022627 W US0022627 W US 0022627W WO 0112074 A1 WO0112074 A1 WO 0112074A1
Authority
WO
WIPO (PCT)
Prior art keywords
conduit
blood vessel
sheath
filament
connector
Prior art date
Application number
PCT/US2000/022627
Other languages
English (en)
Inventor
Paulo Soltoski
Jacob Bergsland
Original Assignee
Paulo Soltoski
Jacob Bergsland
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 Paulo Soltoski, Jacob Bergsland filed Critical Paulo Soltoski
Priority to AU67826/00A priority Critical patent/AU6782600A/en
Publication of WO2001012074A1 publication Critical patent/WO2001012074A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets 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, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections

Definitions

  • the present invention relates to a device and method of coupling a conduit to a larger arterial or venous conduit or inflow source.
  • the present invention provides a means for allowing rapid establishment of the inflow anastomosis for coronary artery bypass grafting (or other vascular procedures requiring aorta-conduit anastomosis) with minimal trauma to the aortic wall and no diversion of aortic blood stream.
  • coronary artery bypass grafting or other vascular procedures requiring aorta-conduit anastomosis
  • existing surgical procedures require that a clamp be placed on the aorta. In doing so, the clamp increases the risk of stroke.
  • the present invention eliminates the need to clamp the aorta, and therefore reduces the risk of stroke.
  • a coupling device includes a conduit and a resilient filament joined to the conduit.
  • the resilient filament may be provided in the form of loops extending from the conduit and remotely resembling the frame of an umbrella when expanded.
  • a coupling device having a conduit and a resilient filament is provided.
  • the conduit is placed within a retaining sheath.
  • an incision is made in the blood vessel, and a portion of the conduit and sheath are inserted into the blood vessel.
  • the portion of the conduit inside the blood vessel is held within the blood vessel while the sheath is removed from the blood vessel and the filament is allowed to engage the blood vessel.
  • the conduit is secured to the blood vessel, for example, by threading a nut onto the conduit.
  • Figure 1 is a partially cross-sectioned view of the device according to the present invention installed in an aorta;
  • Figure 2A is a perspective view of the conduit showing some of the filaments comprising the expandable umbrella-like device in the expanded position;
  • Figure 2B is an end view of the conduit showing filaments with enlarged heads
  • Figure 2C is an end view of an alternative embodiment of the conduit showing filaments with enlarged heads
  • Figure 3 is a perspective view of the connector
  • Figure 4 is a perspective view of the connector attached to a vein
  • Figure 5A is a cross-sectioned side view of the present invention inside a retaining sheath, wherein the sheath has a beveled end;
  • Figure 5B is a cross-sectioned side view of the present invention inside a retaining sheath, wherein the sheath does not have a beveled end;
  • Figure 6A is a perspective view of the retaining sheath shown in Figure 5A;
  • Figure 6B is a perspective view of the retaining sheath shown in Figure 5B;
  • Figure 7 is a perspective view of the threaded stylet that may be used with the present invention.
  • Figure 8A is a partially cross-sectioned side view of an embodiment of the present invention being inserted into an aorta wall using the sheath depicted in Figure 6A;
  • Figure 8B is a partially cross-sectioned side view of an embodiment of the present invention being inserted into an aorta wall using the sheath depicted in Figure 6B;
  • Figure 9 is an exploded perspective view of a portion of the present invention shown in Figures 8A and 8B;
  • Figure 10 is a non-exploded cross-sectioned perspective view of the embodiment shown in Figure 9;
  • Figure 11 is a cross-sectioned top view of a portion of the embodiment shown in Figure 10 taken along the line 11—11 in Figure 10;
  • Figure 12 is an alternative embodiment of a portion of the conduit 25
  • Figure 13 is a side view of a sheath according to the present invention and a device for cutting the aorta in order to insert the sheath in the aorta;
  • Figure 14 is a partially cross-sectioned side view of an embodiment of the sheath shown in Figure 13;
  • Figure 15 is a cross-sectional side view of a holder, according to the present invention.
  • Figure 16 is a partially cross-sectioned side view of the holder installed on the conduit, according to the present invention.
  • Figure 17 shows steps of a method according to the present invention.
  • FIG. 1 shows a coupling device 10 according to the present invention installed m the aorta wall. It should be noted the present invention may be used with other blood vessels, and the scope of the present invention is not to be limited merely to use on the aorta.
  • the coupling device 10 includes an umbrella-like device 13 and a conduit 16.
  • the conduit 16 has a flexible first end section 19, a threaded middle section 22, and a second end section 25. As shown in Figure 1, when the coupling device 10 is properly installed, the second end section 25 extends through the outer aorta wall 28 and the inner aorta wall 31.
  • the coupling device 10 also includes a washer 34 and a nut 35.
  • the threaded middle section 22, second end section 25, washer 34 and nut 35 may be made from stainless steel, titanium, or other inert non-flexible materials.
  • the first end section 19 may be made from polytetrafluoroethylene and may be connected to the threaded middle section 22 by an adhesive, mechanical means or a friction fit.
  • the first end section 19 shown in Figure 1 may be connected to the threaded middle section 22 by an adhesive or a friction fit.
  • FIGS 2A, 2B and 2C show the umbrella-like device 13 and the conduit 16.
  • the umbrella-like device 13 has resilient filaments 37.
  • Each filament 37 has a first end 37A movably anchored to the second end section 25 of the conduit 16, and has a second end 37B movably attached to an adjacent filament 37.
  • the first end 37A may be movably anchored by providing an enlarged head 38 shown in Figure 2B which is larger than the holes 39.
  • the first end 37A can be looped around the second end section 25 as shown in Figure 2A.
  • the second end 37B may be movably attached by forming a loop in the second end 37B which encircles the adjacent filament 37.
  • both ends of a filament may be anchored to the conduit 25 by enlarged heads 38 on both ends of a filament 37.
  • the filaments 37 may be titanium or an alloy such as nitinol.
  • a connector 40 When assembled as shown in Figure 1, a connector 40, shown in Figures 3 and 4, is inside the conduit 16.
  • the connector 40 has a circumferential groove 43 and one or more sealing flanges 46.
  • the connector 40 may be made from polyvinylchloride.
  • a vein 49 is attached to the connector 40 by passing the connector 40 over the vein 49 and turning the vein 49 back on itself, as shown by arrows 52 in Figure 4. Then the vein 49 is secured to the connector 40 by wrapping a thread 55 around the vein 49, cinching the thread 55 so that at least part of the vein 49 resides in the groove 43, and then tying the thread 55 to form a knot 58.
  • the thread 55 may be a non-absorbable suture material, such as 5-0 ethibond.
  • the connector 40 To prepare the coupling device 10 for attachment to an aorta 61, the connector 40, with vein 49 attached thereto, is inserted into the conduit 16 so that the vein 49 extends from the first end section 19 and so that the sealing flanges 46 seat against the conduit 16, as shown in Figures 5A and 5B. Then, the threaded stylet 64 is threaded onto the threaded middle section 22 of the conduit 16. Next, the conduit 16, with threaded stylet 64 attached thereto, is placed in a sheath 67 so that the umbrella-like device 13 collapses and is held against the second end section 25, as shown in Figures 5A and 5B. Figures 6A and 6B show the sheath 67 with the conduit 16 and stylet 64 therein.
  • the sheath 67 may be made from polyvinylchloride . As shown in Figures 5A, 6A and 8A, the sheath 67 may have a beveled and hardened end 70 that may be sharpened to easily enter the aorta 61. Figure 7 shows the stylet 64.
  • the stylet 64 has internal threads 68 for threading onto the threaded middle section 22 of the conduit 16.
  • the sheath 67 is inserted through the aorta 61.
  • the sheath 67 is withdrawn from the aorta 61 while the conduit 16 is held in place by a surgeon using the threaded stylet 64.
  • the umbrella-like device 13 expands within the aorta 61.
  • the washer 34 is placed around the conduit 16, and then the nut 35 is threaded onto the threaded middle section 22 so that the aorta 61 is compressed between the washer 34 and the umbrella 13, as shown in Figure 1.
  • the second end section 19 is preferably corrugated and thereby flexes to permit the vein 49 to curve away from the coupling device 10.
  • the flexible second end section 19 provides support for the vein 49 and prevents the vein 49 from tearing or kinking.
  • Figures 8A-11 depict an alternative embodiment of the present invention.
  • an inner ring 73 for capturing the filaments 37 within the second end section 25 while permitting the filaments 37 to rotate in order to deploy the umbrella-like device 13.
  • the filaments 37 each have a substantially perpendicularly extending first end 37C.
  • Figure 9 depicts the position of the first end 37C in the non-deployed position (solid lines) as well as in the deployed position (dashed lines) .
  • the first end 37C is permitted to move from the non-deployed position to the deployed position within a gap 75 between the inner ring 73 and second end section 25.
  • the inner ring 73 may be attached to the second end section 25 by an adhesive, friction fit or mechanical means .
  • Figure 12 shows another embodiment of the present invention. Unlike the embodiment shown in Figures 10 and 11, the embodiment shown in Figure 12 does not have the inner ring 73.
  • the second end 25 of the conduit 16 has holes 76 therethrough, each hole 76 having therein a portion of one of the filaments 37.
  • a portion of the filament 37 is inserted into a hole 76 until the filament 37 extends into the gap 75. Further pushing the filament 37 through the hole 76 will cause the filament 37 to bend as it contacts lower surface 77.
  • the lower surface 77 may be angled to facilitate bending of the filament 37.
  • the filament 37 extending into the gap 75 is then forced to reside in the gap 75 by bending the filament 37 to permanently deform the filament 37 so that the filament 37 can not be pulled back through the hole 76. It should be noted one or both of the flanges 46 may reside in the gap 75 to secure the connector 40 to the conduit 16.
  • a trochar 80 having a blade 83 may be installed in the sheath 67.
  • Figure 13 shows an embodiment of the trochar 80 with blade 83 installed in the sheath 67.
  • the trochar 80 is pushed toward the aorta 61 to cause the blade 83 to cut and enter the aorta 61.
  • the trochar 80 is pushed toward the aorta 61 until a portion of the sheath 67 resides inside the aorta 61.
  • FIG. 14 shows one embodiment of the sheath 67 that includes a valve 86 that allows the trochar 80 to be inserted through and removed from the valve 86.
  • the valve 86 reduces blood loss from the aorta 61 after the sheath 67 is in the aorta and the blade 83 is removed from the sheath 67.
  • the valve 86 may be a heimlich valve, commonly used in medical devices.
  • Figures 15 and 16 depict a holder 100 that may be used while threading the nut 35 onto the threaded middle section 22.
  • the holder includes a flexible loop 103, a first actuator 106 and a second actuator 109.
  • a first end of the loop 103 is attached to the first actuator 106, and a second end of the loop 103 is attached to the second actuator 109.
  • the first actuator 106 may be moved relative to the second actuator 109 within a slot 118 in the second actuator 109.
  • the first actuator 106 moves relative to the second actuator 109, the first end 112 of the loop 103 is moved, and the length of loop 103 extending from the second actuator 109 is changed.
  • the loop 103 may be drawn tight around the conduit 16 while the nut 35 is tightened, and then released from the conduit 16 once the nut 35 is tight against the washer 34.
  • the holder 100 reduces movement of the coupling device 10 while the nut 35 is threaded onto the threaded middle section 22.
  • Figure 17 shows steps of a method according to the present invention.
  • a coupling device is provided (step 200), the coupling device having a conduit and a resilient filament attached to the conduit.
  • the conduit and filament are placed (step 203) in a sheath, and a portion of the sheath is placed (step 206) in the blood vessel.
  • the sheath is removed (step 209) to leave the filament in the blood vessel, and the filament is allowed to engage the blood vessel (step 209) .
  • the conduit is secured to the blood vessel (step 212) .
  • the present invention is a device and method for coupling a conduit to an aorta or other blood vessel. It will be recognized that the device and method according to the present invention may be used in conjunction with other surgical devices and methods. Such other surgical devices and methods may include endoscopic means.

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  • 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)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif de couplage (10) et un procédé associé. Ce dispositif (10) comprend un conduit (16) ainsi qu'un filament élastique (37) relié au conduit (16). Le filament (37) peut se présenter sous la forme de boucles (103).
PCT/US2000/022627 1999-08-17 2000-08-17 Dispositif d'anastomose vasculaire a deploiement autonome et procede de couplage d'un conduit et d'une aorte ou autre vaisseau similaire WO2001012074A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU67826/00A AU6782600A (en) 1999-08-17 2000-08-17 Self-expandable vascular anastomotic device and method of coupling a conduit to an aorta or other similar vessel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14930199P 1999-08-17 1999-08-17
US60/149,301 1999-08-17

Publications (1)

Publication Number Publication Date
WO2001012074A1 true WO2001012074A1 (fr) 2001-02-22

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PCT/US2000/022627 WO2001012074A1 (fr) 1999-08-17 2000-08-17 Dispositif d'anastomose vasculaire a deploiement autonome et procede de couplage d'un conduit et d'une aorte ou autre vaisseau similaire

Country Status (2)

Country Link
AU (1) AU6782600A (fr)
WO (1) WO2001012074A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002094108A2 (fr) * 2001-05-18 2002-11-28 University College London Dispositif flexible pour transfixer et joindre des tissus
DE10205997A1 (de) * 2002-02-14 2003-09-04 Hm Medical Engineering Gmbh Vorrichtung zum Verbinden von strangartigem Gewebe
WO2010071676A3 (fr) * 2008-12-19 2010-08-19 St. Jude Medical, Inc. Systèmes, appareils et procédés pour conduits et raccords cardiovasculaires
US9055946B2 (en) 2008-11-26 2015-06-16 Phraxis Inc. Anastomotic connector
US9308311B2 (en) 2011-06-15 2016-04-12 Phraxis, Inc. Arterial venous spool anchor
US10456239B2 (en) 2011-06-15 2019-10-29 Phraxis Inc. Anastomotic connector and system for delivery
US10786346B2 (en) 2012-06-15 2020-09-29 Phraxis Inc. Arterial anchor devices forming an anastomotic connector

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5397345A (en) * 1983-12-09 1995-03-14 Endovascular Technologies, Inc. Artificial graft and implantation method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5397345A (en) * 1983-12-09 1995-03-14 Endovascular Technologies, Inc. Artificial graft and implantation method

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002094108A3 (fr) * 2001-05-18 2003-03-13 Univ London Dispositif flexible pour transfixer et joindre des tissus
WO2002094108A2 (fr) * 2001-05-18 2002-11-28 University College London Dispositif flexible pour transfixer et joindre des tissus
US7879051B2 (en) 2001-05-18 2011-02-01 Christopher Paul Swain Flexible device for transfixing and joining tissue
DE10205997A1 (de) * 2002-02-14 2003-09-04 Hm Medical Engineering Gmbh Vorrichtung zum Verbinden von strangartigem Gewebe
US9055946B2 (en) 2008-11-26 2015-06-16 Phraxis Inc. Anastomotic connector
WO2010071676A3 (fr) * 2008-12-19 2010-08-19 St. Jude Medical, Inc. Systèmes, appareils et procédés pour conduits et raccords cardiovasculaires
US8905961B2 (en) 2008-12-19 2014-12-09 St. Jude Medical, Inc. Systems, apparatuses, and methods for cardiovascular conduits and connectors
US9308311B2 (en) 2011-06-15 2016-04-12 Phraxis, Inc. Arterial venous spool anchor
US9597443B2 (en) 2011-06-15 2017-03-21 Phraxis, Inc. Anastomotic connector
US10456239B2 (en) 2011-06-15 2019-10-29 Phraxis Inc. Anastomotic connector and system for delivery
US10786346B2 (en) 2012-06-15 2020-09-29 Phraxis Inc. Arterial anchor devices forming an anastomotic connector
US11020215B2 (en) 2012-06-15 2021-06-01 Phraxis, Inc. Venous anchor devices forming an anastomotic connector
US10835366B2 (en) 2012-08-16 2020-11-17 Phraxis Inc. Arterial and venous anchor devices forming an anastomotic connector and system for delivery

Also Published As

Publication number Publication date
AU6782600A (en) 2001-03-13

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