WO2005027736A2 - Devices and methods for forming magnetic anastomoses between vessels - Google Patents

Devices and methods for forming magnetic anastomoses between vessels Download PDF

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Publication number
WO2005027736A2
WO2005027736A2 PCT/US2004/031039 US2004031039W WO2005027736A2 WO 2005027736 A2 WO2005027736 A2 WO 2005027736A2 US 2004031039 W US2004031039 W US 2004031039W WO 2005027736 A2 WO2005027736 A2 WO 2005027736A2
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WO
WIPO (PCT)
Prior art keywords
delivery device
parts
tissue
carried out
releasing
Prior art date
Application number
PCT/US2004/031039
Other languages
French (fr)
Other versions
WO2005027736A3 (en
Inventor
David H. Cole
Darin C. Gittings
Dean F. Carson
Original Assignee
Ventrica, 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 Ventrica, Inc. filed Critical Ventrica, Inc.
Publication of WO2005027736A2 publication Critical patent/WO2005027736A2/en
Publication of WO2005027736A3 publication Critical patent/WO2005027736A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B60VEHICLES IN GENERAL
    • B60JWINDOWS, WINDSCREENS, NON-FIXED ROOFS, DOORS, OR SIMILAR DEVICES FOR VEHICLES; REMOVABLE EXTERNAL PROTECTIVE COVERINGS SPECIALLY ADAPTED FOR VEHICLES
    • B60J5/00Doors
    • B60J5/04Doors arranged at the vehicle sides
    • B60J5/06Doors arranged at the vehicle sides slidable; foldable
    • B60J5/062Doors arranged at the vehicle sides slidable; foldable for utility vehicles or public transport
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B61RAILWAYS
    • B61DBODY DETAILS OR KINDS OF RAILWAY VEHICLES
    • B61D19/00Door arrangements specially adapted for rail vehicles
    • B61D19/02Door arrangements specially adapted for rail vehicles for carriages
    • B61D19/026Safety devices for preventing passengers from being injured by movements of doors or variations in air pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0643Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135End-to-side connections, e.g. T- or Y-connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections

Definitions

  • This invention is directed to methods and devices for attaching one hollow body structure to another.
  • the structures may be living or dead animal or human tissue or may be a synthetic graft or a combination thereof.
  • the invention may be used in various parts of the body but is particularly suited for securing small blood vessels together.
  • a medical device such as an anastomotic connector, has a first part and a second part.
  • the second part may be split into two or more portions or may be a single part.
  • the first part is mounted on one delivery device while the second part is mounted on another delivery device.
  • the first part is introduced through an arteriotomy and the second part is positioned outside the vessel lumen although some portion may protrude into the lumen without departing from the scope of the invention.
  • the arteriotomy generally has a first side and a second side.
  • the tissue and first part are manipulated while the first part is inside the lumen so that the tissue on the first side of the arteriotomy lies over the first part in a desirable manner.
  • the first part is manipulated inside the vessel so that the desired amount of tissue over lies the first side and so that the tissue is oriented on the first part in the desired manner.
  • the first part is then held stationary and the second part is moved into a position outside the vessel to secure the tissue between the first and second parts.
  • the first part is then reoriented, if or as necessary, so that another part of the arteriotomy, such as the side opposite the first side, also lies over the first part in a desired manner.
  • a system for introducing a medical device has a first delivery device which delivers a first part and a second delivery device which delivers a second part with the first and second parts being magnetically attracted to one another.
  • the first delivery device is independently movable with respect to the second delivery device so it may be oriented independently as desired to move the two portions of the second part into position for coupling.
  • the medical devices and systems of the invention may be used for any suitable procedure to create an opening in a lumen, such as a blood vessel, or organ, such as the heart, as described below.
  • the medical device may be used for any other purpose, for example, attachment of a prosthesis, such as a valve.
  • the medical device comprises a first part, a second part and a third part with the second and third parts being magnetically attracted to the first part.
  • the second and third parts may be practiced with the second and third parts mechanically compressing or otherwise trapping or securing tissue against the first part.
  • the first part may be positioned in a vessel lumen while the second and third parts are located outside the vessel.
  • the first part is mounted to a first delivery device and the second and third parts are mounted to a second delivery device.
  • the second delivery device may include one holder for both the second and third parts so that the holder may be used to deliver the second and third parts or it may comprise two separate holders for separately delivering, respectively, the second and third parts.
  • the first delivery device may have a collapsible element that is expanded to hold the first part of the component and collapsed to release the first part.
  • the first part has a hole or opening in which the expandable part is removably positioned.
  • the expandable element is, of course, only one suitable way of releasably holding the first part, in a designated position in the vessel lumen.
  • a retainer comprising relatively movable first and second shoes which are biased apart to exert outward pressure on the sides of the opening in the component.
  • the shoes are coupled to a pair of arms which may be simply squeezed together to release the first part.
  • the arms may be compressed in any suitable manner such as with graspers, forceps or the user's fingers to release the first part.
  • the first delivery device preferably also has a stop which prevents the second part, and in particular, the two extra- vascular portions, from moving out of the desired orientation after being released. This feature is particularly helpful when the two portions of the second part are delivered independently.
  • the stop prevents each portion of the second part from rotating or otherwise displacing out of the desired orientation relative to the first part as the other portion of the second part is deployed.
  • the first delivery device may have a connecting element attached thereto which may be used to attach a shaft or the like.
  • a shaft or the like any shaft or even a conventional pair of graspers, forceps or the like may be used to grasp the delivery device.
  • the shaft may be a malleable shaft or may be a multi-link arm or any other suitable shaft. This allows the delivery device to be customized for a given procedure.
  • the arms may then be moved toward one another to release the first part.
  • robotic arms and the like could be used to actuate the delivery devices described herein.
  • the two portions of the second part also referred to as the second and third parts of the component, are held by the second delivery device.
  • the second delivery device may hold only one of the parts or may hold both parts.
  • the second delivery device includes a holder having a magnet which magnetically attracts the second and third extravascular parts.
  • the holder has upper and lower flanges which, together with the magnet, form a recess in which the second and third parts are positioned.
  • the magnet may be any suitable magnetic material such as magnetic 440 c stainless steel.
  • the flanges may be made of any suitable material such as PEEK.
  • an arteriotomy may be formed by a linear cut
  • the present invention may be used to generally help to position the tissue regardless of the manner in which the tissue is cut. Thus, even a circular opening or punch may be used.
  • the two sides of the arteriotomy often extend generally in the same direction since the arteriotomy is generally a linear cut along the axis of the vessel.
  • the position of the tissue overlying the first part must be controlled to prevent tissue from extending into the throughhole which will inhibit fluid flow.
  • the position of the sides of the arteriotomy overlying the first part is particularly important.
  • the present invention provides the ability to position both sides of the arteriotomy in a desirable position before trapping tissue between the first and second parts. Although it is clearly undesirable to have tissue extending into the throughhole, it is desirable to provide enough tissue so that one placed in the lumen the first intravascular part is partially covered or not visible because it is covered by tissue. This tissue may also act like a gasket to enhance sealing at the anastomosis.
  • the first part is positioned within the blood vessel so that the first side of the arteriotomy overlies the first part in a desirable manner.
  • the second extravascular part is then moved adjacent to the first part to release the second part, thereby trapping and compressing the vessel therebetween.
  • the second part is released by rotating the second holder away from the first part in a predetermined plane or direction.
  • the first part may then be reoriented, if necessary, so that the second side of the arteriotomy is positioned and overlies the first part in a desirable manner. In this manner, the user may independently control how the tissue overlies over the first part by controlling the two sides at different times. Once the second side of the arteriotomy is in the desired position, another portion of the second extravascular part is then released, thereby compressing the second side of the arteriotomy between the first and second parts.
  • the present invention describes using magnetism to compress the tissue between the first part and the second and third parts
  • the present invention may be practiced by using simple mechanical compression or by piercing or coupling the first and second parts together in any other suitable manner.
  • using magnetism provides numerous benefits compared to some other methods of attaching the device to the vessels.
  • Another advantage of the present invention is the ability to remove and replace the second part as necessary.
  • the second delivery device is moved into engagement with the first or second portions of the second part by introducing the second part into a recess in the delivery device.
  • the second part is naturally attracted to both the first part and the holder at this time.
  • the second delivery device may be rotated in a different plane or direction to remove the second part from the first part. Moving the delivery device in this manner breaks the magnetic attraction between the first and second parts, thereby allowing the parts to be repositioned.
  • Fig. 1 shows a delivery device for delivering a first part.
  • Fig. 2 shows the distal end of the delivery device of Fig. 1 with the arms expanded to capture the first part.
  • Fig. 3 shows the arms collapsed to free the first part.
  • Fig. 4 shows another embodiment of the first delivery device.
  • Fig. 5 shows still another embodiment of the first delivery device.
  • Fig. 6 shows another view of the delivery device of Fig. 5.
  • Fig. 7A shows a second delivery device for delivering the second part.
  • Fig. 7B is an exploded view of the second delivery device.
  • Fig. 7C is a cross-sectional view of the second delivery device.
  • Fig. 8 shows the second delivery device with a first portion of the second part shown in bold lines while the second portion is shown in dotted line.
  • Fig. 8 shows the second delivery device with a first portion of the second part shown in bold lines while the second portion is shown in dotted line.
  • Fig. 8 shows the second delivery device with
  • FIG. 9 shows another embodiment of the second delivery device for delivering the two separate parts independently.
  • Fig. 10A is a side view of the second delivery device.
  • Fig. 10B is another view of the second delivery device.
  • Fig. 11 A shows the second part, formed by two separate parts or portions, separated from the first, intravascular part.
  • Fig. 1 IB shows a cross-sectional view of Fig. 11 A along line A-A.
  • Fig. 12A shows the tissue trapped between the second part on both sides of the anastomosis.
  • Fig. 12B is a cross-sectional view of Fig. 12A along line B-B.
  • Fig. 13 shows the second delivery device releasing one portion of the second part when the delivery device is rotated as shown.
  • Fig. 10A is a side view of the second delivery device.
  • Fig. 10B is another view of the second delivery device.
  • Fig. 11 A shows the second part, formed by two separate parts or portions, separated from the first, intra
  • Fig. 14 shows the manner in which the second delivery device is tilted to remove the second part.
  • Fig. 15 shows another delivery device for delivering the second part which includes a stop to prevent excessive rotation of a previously deployed portion of the second part.
  • Fig. 16A shows deployment of a first portion of the second part.
  • Fig. 16B shows deployment of the second portion of the second part.
  • Fig. 16C shows tilting and disengagement of the first portion when deploying the second portion of the second part.
  • Figs. 17A-17C show use of a stop to prevent disengagement of the previously deployed first portion of the second part.
  • Fig. 1 shows a delivery device 10 including an actuator 12, a handle 14, a shaft 16 and a distal end indicated by reference numeral 18.
  • a compression spring 20 biases the actuator 12 outward, i.e., away from the distal end 18.
  • the handle has a sleeve 22 and a slot that receives a pin 24 which is fixed to the proximal end of a rod or wire 26 that extends to distal end 18. See Figs. 2 and 3.
  • the wire 26 carries at its distal end a collar 28 which surrounds a pair of arms 30 and is configured to impart relative movement to the arms.
  • the arms 30 have notched portions 32 configured to engage the collar 28 when the latter is moved proximally with wire 26 (in the direction of the arrows in Fig. 3).
  • the arms 30 carry at their distal ends a pair of relatively movable shoes 34, 36 which are configured to engage the opening of an anastomotic component constructed according to the invention, thereby holding the component securely.
  • the shoes 34, 36 are positioned within the opening O of a part of a component of the invention.
  • the shoes 34, 36 respectively have ledges 40, 42 which project beyond the opening O so as to engage the underside of the component part 38 (Fig. 2).
  • Fig. 3 shows the distal end 18 of the device 10 after the actuator 12 has been moved so as to move the shoes 34, 36 toward each other and out of engagement with the component part 38. The distal end 18 of the delivery device 10 may then be removed from the now-positioned component part 38.
  • Fig. 4 shows another embodiment of the invention comprising a delivery device having a distal end 50 which includes a shaft 52, a pair of relatively movable arms 54, and a device for imparting relative movement to the arms 54, which in the illustrated embodiment is in the form of forceps or graspers 56 provided with pads 58 that engage the arms 54.
  • the arms 54 may have first and second shoes 34, 36 which engage the opening O of the component part 38 in the manner described above.
  • Figs. 5 and 6 show still another embodiment of the invention comprising a delivery device having a distal end 60 which includes a block 62, a shaft 64, a pair of relatively movable arms 66 and a device for imparting relative movement to the arms (not shown in Figs. 5 and 6).
  • Figs. 7A-7C show in part a delivery device constructed according to one embodiment of the invention for use in which is used to deliver and deploy the second extravascular part (which itself may include at least first and second portions which may also be referred to herein as second and third parts).
  • a second delivery device shown in Figs. 7A-7C is indicated by the reference numeral 70 and comprises a distal end including a body or core 72 and a pair of plates 74, 76.
  • the plates 74, 76 have respective openings 78, 80 which are configured to receive the ends of the body 72 (Figs. 7B-7C) such that the plates abut the extensions 82 of the body.
  • the body or core 72 also has a blind bore 84 and a recess 86 configured to adjustably receive a shaft 88 (Fig. 7C). As shown in Figs.
  • the extensions 82 of the body 72 cooperate with the plates 74, 76 to form a pair of channels 90 each of which is configured to removably receive one portion of the extravascular second part of the component (not shown in figs. 7a-7c).
  • This embodiment of the invention preferably uses magnetism to hold the portion(s) of the second part securely on the delivery device 70.
  • the body or core 72 may comprise magnetic material so as to magnetically attract the two portions of the extravascular part of the component thereto.
  • the plates 74, 76 may be any suitable material, for example, a strong polymer or plastic.
  • the shaft 88 is preferably malleable to allow it to be bent to any desired shape or configuration. Figs.
  • FIG. 8 and 9 show two embodiments of a delivery device 70.
  • the embodiment of Fig. 8 corresponds to that of Figs. 7A-7C and is provided with a pair of channels 90 for receiving the two portions of the extravascular part of the component.
  • a first portion 92A of the extravascular part is shown positioned within a channel 90 in Fig. 8, while a second portion 92B of the extravascular part is shown (in phantom) positioned in the other channel 90.
  • Fig. 9 shows a delivery device 70' with a channel 90' that is configured to receive only one of the extravascular portions 92' .
  • the delivery device 70' includes a body or core 72' and first and second plates 74', 76' secured thereto.
  • the delivery device 70' may be used to deploy both portions of the extravascular or second part when the parts are shaped the same as they are for the second part shown above.
  • Figs. 10A and 10B show another embodiment of a delivery device 100 which includes a body or core 102, plates 104, 106, and sections 108 configured to receive respective portions of the extravascular part of a component.
  • the body 102 has a fitting 110 that adjustably receives a malleable shaft 112.
  • the body 102 and the plates 104, 106 are integrally formed in this embodiment, as shown in Fig. 10B, to form a pair of channels 114 (only one of which holds a portion 116 of the component).
  • Fig. 11A shows a vessel V and an anastomotic component comprising a first, intravascular part 38 and a second, extravascular part that includes first and second portions 92A, 92B.
  • the first part 38 has an opening O and is positioned within the lumen L of vessel V adjacent an incision I in the wall thereof.
  • the sides of the incision I preferably overlie the first part 38 around the opening O and are either coextensive therewith or, more preferably, extend slightly beyond the inner edge that defines the opening O. See Fig. 11B (which is a sectional view taken along line A-A in Fig. 11 A).
  • Figs. 11B which is a sectional view taken along line A-A in Fig. 11 A).
  • FIG. 12A and 12B show first and second portions 92A, 92B of the second, extravascular part after they have been moved against the wall of vessel V on opposite sides of the incision I.
  • the tissue of the vessel wall is compressed between the intravascular part 38 and each extravascular portion 92A, 92B.
  • Fig. 12B shows the edges of the incision I overhanging the inner diameter of the intravascular part 38.
  • the tissue may be oriented in any suitable or desirable manner between the first and second parts.
  • the illustrated component is magnetically coupled (or otherwise coupled) to a similar component mounted on another vessel the layer of tissue lying on intravascular part 38 forms a gasket to enhance attachment and sealing.
  • any suitable securing structure such as cleats 118, may be provided to bolster attachment of the vessels, for example, by tacking the cleats to tissue with suture.
  • one of the portions 92A, 92B is deployed first while orienting the tissue in a desirable position overlying or covering the first part 38.
  • the tissue may completely or only partially cover the first part 38 depending upon the particular application and device.
  • the other portion 92B is then deployed.
  • the first part Before deploying the other portion 92B of the second part, the first part may still be manipulated with the first device holder to orient the tissue on the other side of the anastomosis in a desirable position.
  • Fig. 13 shows the delivery device 60 with the intravascular part 38 mounted on the distal end thereof.
  • a portion 92A of the extravascular part is shown magnetically coupled to the intravascular part 38 (the vessels being omitted for clarity).
  • the delivery device 70 is shown as it is being manipulated in the direction of the arrow to release the extravascular portion 92A. Rotating the device 70 in the plane indicated by the arrow in Fig. 13 releases the portion 92A because the attraction between the device 70 and the portion 92A is overcome when moved in this manner, unlike the attraction between the intravascular part 38 and the portion 92A.
  • FIG. 14 shows the delivery device 60 and intravascular part 38 mounted thereon being held in position while the delivery device 70 and extravascular portion 92A are rotated in the direction or plane indicated by the arrow.
  • This movement pulls the portion 92A off of the intravascular part 38 as the magnetic attraction between the two is overcome by manipulating the device in the direction of the arrow, unlike the attraction between the portion 92A and the delivery device 70.
  • This feature allows the user to initially deploy the component, check the attachment, and remove and replace the part(s) to obtain the best connection.
  • Fig. 15 shows another embodiment comprising a delivery device 120 comprising a pair of arms 122 with ends 124 secured to respective shoes 126, 128.
  • the device 120 is provided with means 130 for maintaining one extravascular portion 92A in place until the other portion 92B is also coupled to the intravascular part 38.
  • the illustrated means which of course is only exemplary, is in the form of a pair of stops 132 which extend outwardly from arms 122. The stops 122 hold one already- coupled portion 92A relative to the intravascular part 38 while the other portion 92B is coupled thereto.
  • Figs. 16A-16C show a schematic delivery device 140 carrying an intravascular part 142 adapted to be coupled to first and second portions 144A, 144B. In Fig. 16A the delivery device 140 and intravascular part 142 carried thereby are tilted in the direction of the arrow so that the part 142 faces the portion 144A.
  • FIG. 16B shows the delivery device 140 and intravascular part 142, with the first extravascular portion 144A magnetically (or otherwise) coupled thereto, being tilted in the opposite direction, as indicated by the arrow.
  • Manipulating the delivery device 140 and intravascular part 142 as shown in Fig. 16B may facilitate easy coupling with the second extravascular portion 144B by orienting the two so as to face each other, however, this movement may adversely affect coupling between the first extravascular portion 144A and the intravascular part 142.
  • rotation of the intravascular part 142 can break the attachment between the part 142 and the already-mounted first extravascular portion 144A.
  • Figs. 17A-17C show a delivery device 150 with the ends 124 of the arms 122 serving as means 156 for preventing disengagement between the intravascular and extravascular parts of the component of the invention.
  • the means 156 comprises stops 158A, 158B which serve to prevent disengagement as shown in the sequential views of Figs. 17A-17C which may be the ends 124 of the arms 122 as described above.

Abstract

Device and method for attaching an anastomotic component to a vessel are provided. The device has a first part (38) positioned within the vessel and a second part, having two separate portions (92A, 92B), is positioned outside the vessel. The anastomosis is created by first trapping one side of the anastomosis between the first and second parts and then repositioning the device as necessary before trapping the other side of the anastomosis. In this manner, the orientation and amount of tissue trapped between the parts can be controlled in two or more independent steps.

Description

DEVICES AND METHODS FOR FORMING MAGNETIC ANASTOMOSES BETWEEN VESSELS
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit from provisional application 60/503,416 filed September 15, 2003.
BACKGROUND OF THE INVENTION
This invention is directed to methods and devices for attaching one hollow body structure to another. The structures may be living or dead animal or human tissue or may be a synthetic graft or a combination thereof. Furthermore, the invention may be used in various parts of the body but is particularly suited for securing small blood vessels together.
SUMMARY OF THE INVENTION
In one aspect of the present invention, a method of handling tissue when creating an opening in a blood vessel is provided. A medical device, such as an anastomotic connector, has a first part and a second part. The second part may be split into two or more portions or may be a single part. The first part is mounted on one delivery device while the second part is mounted on another delivery device. The first part is introduced through an arteriotomy and the second part is positioned outside the vessel lumen although some portion may protrude into the lumen without departing from the scope of the invention. The arteriotomy generally has a first side and a second side. As will be described, the tissue and first part are manipulated while the first part is inside the lumen so that the tissue on the first side of the arteriotomy lies over the first part in a desirable manner. Stated another way, the first part is manipulated inside the vessel so that the desired amount of tissue over lies the first side and so that the tissue is oriented on the first part in the desired manner. The first part is then held stationary and the second part is moved into a position outside the vessel to secure the tissue between the first and second parts. The first part is then reoriented, if or as necessary, so that another part of the arteriotomy, such as the side opposite the first side, also lies over the first part in a desired manner. The first part is again held stationary and the second part is moved into position to compress the tissue between the first and second parts. In this manner, the two sides of the arteriotomy are handled independently so that tissue overlying the first part, and lying between the first and second parts, is arranged and oriented in a desirable manner. In another aspect of the delivery device, a system for introducing a medical device is provided. The system has a first delivery device which delivers a first part and a second delivery device which delivers a second part with the first and second parts being magnetically attracted to one another. The first delivery device is independently movable with respect to the second delivery device so it may be oriented independently as desired to move the two portions of the second part into position for coupling. The medical devices and systems of the invention may be used for any suitable procedure to create an opening in a lumen, such as a blood vessel, or organ, such as the heart, as described below. Of course, the medical device may be used for any other purpose, for example, attachment of a prosthesis, such as a valve. The medical device comprises a first part, a second part and a third part with the second and third parts being magnetically attracted to the first part. Various aspects of the present invention may be practiced with the second and third parts mechanically compressing or otherwise trapping or securing tissue against the first part. For instance, the first part may be positioned in a vessel lumen while the second and third parts are located outside the vessel. The first part is mounted to a first delivery device and the second and third parts are mounted to a second delivery device. The second delivery device may include one holder for both the second and third parts so that the holder may be used to deliver the second and third parts or it may comprise two separate holders for separately delivering, respectively, the second and third parts. The first delivery device may have a collapsible element that is expanded to hold the first part of the component and collapsed to release the first part. The first part has a hole or opening in which the expandable part is removably positioned. The expandable element is, of course, only one suitable way of releasably holding the first part, in a designated position in the vessel lumen. Another embodiment uses a retainer comprising relatively movable first and second shoes which are biased apart to exert outward pressure on the sides of the opening in the component. The shoes are coupled to a pair of arms which may be simply squeezed together to release the first part. The arms may be compressed in any suitable manner such as with graspers, forceps or the user's fingers to release the first part. The first delivery device preferably also has a stop which prevents the second part, and in particular, the two extra- vascular portions, from moving out of the desired orientation after being released. This feature is particularly helpful when the two portions of the second part are delivered independently. The stop prevents each portion of the second part from rotating or otherwise displacing out of the desired orientation relative to the first part as the other portion of the second part is deployed. The first delivery device may have a connecting element attached thereto which may be used to attach a shaft or the like. Of course, any shaft or even a conventional pair of graspers, forceps or the like may be used to grasp the delivery device. The shaft may be a malleable shaft or may be a multi-link arm or any other suitable shaft. This allows the delivery device to be customized for a given procedure. The arms may then be moved toward one another to release the first part. Of course, robotic arms and the like could be used to actuate the delivery devices described herein. The two portions of the second part, also referred to as the second and third parts of the component, are held by the second delivery device. The second delivery device may hold only one of the parts or may hold both parts. An advantage of providing a separate delivery device is that the first part may be oriented and positioned within the vessel lumen independently of the second and third parts to provide the advantages described herein in connection with control of tissue. The second delivery device includes a holder having a magnet which magnetically attracts the second and third extravascular parts. The holder has upper and lower flanges which, together with the magnet, form a recess in which the second and third parts are positioned. The magnet may be any suitable magnetic material such as magnetic 440 c stainless steel. The flanges may be made of any suitable material such as PEEK. According to the invention an arteriotomy is created in a blood vessel and the first part is introduced into the blood vessel. The arteriotomy has a first side and a second side. Although an arteriotomy may be formed by a linear cut, the present invention may be used to generally help to position the tissue regardless of the manner in which the tissue is cut. Thus, even a circular opening or punch may be used. When the present invention is used for vascular anastomosis, the two sides of the arteriotomy often extend generally in the same direction since the arteriotomy is generally a linear cut along the axis of the vessel. As can be appreciated, the position of the tissue overlying the first part must be controlled to prevent tissue from extending into the throughhole which will inhibit fluid flow. In particular, the position of the sides of the arteriotomy overlying the first part is particularly important. The present invention provides the ability to position both sides of the arteriotomy in a desirable position before trapping tissue between the first and second parts. Although it is clearly undesirable to have tissue extending into the throughhole, it is desirable to provide enough tissue so that one placed in the lumen the first intravascular part is partially covered or not visible because it is covered by tissue. This tissue may also act like a gasket to enhance sealing at the anastomosis. The first part is positioned within the blood vessel so that the first side of the arteriotomy overlies the first part in a desirable manner. The second extravascular part is then moved adjacent to the first part to release the second part, thereby trapping and compressing the vessel therebetween. The second part is released by rotating the second holder away from the first part in a predetermined plane or direction. Rotation in this direction will cause the second part to break free from the magnetic attraction to the holder. After releasing the second part, the first part may then be reoriented, if necessary, so that the second side of the arteriotomy is positioned and overlies the first part in a desirable manner. In this manner, the user may independently control how the tissue overlies over the first part by controlling the two sides at different times. Once the second side of the arteriotomy is in the desired position, another portion of the second extravascular part is then released, thereby compressing the second side of the arteriotomy between the first and second parts. Although the present invention describes using magnetism to compress the tissue between the first part and the second and third parts, the present invention may be practiced by using simple mechanical compression or by piercing or coupling the first and second parts together in any other suitable manner. Of course, using magnetism provides numerous benefits compared to some other methods of attaching the device to the vessels. Another advantage of the present invention is the ability to remove and replace the second part as necessary. The second delivery device is moved into engagement with the first or second portions of the second part by introducing the second part into a recess in the delivery device. The second part is naturally attracted to both the first part and the holder at this time. The second delivery device may be rotated in a different plane or direction to remove the second part from the first part. Moving the delivery device in this manner breaks the magnetic attraction between the first and second parts, thereby allowing the parts to be repositioned.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 shows a delivery device for delivering a first part. Fig. 2 shows the distal end of the delivery device of Fig. 1 with the arms expanded to capture the first part. Fig. 3 shows the arms collapsed to free the first part. Fig. 4 shows another embodiment of the first delivery device. Fig. 5 shows still another embodiment of the first delivery device. Fig. 6 shows another view of the delivery device of Fig. 5. Fig. 7A shows a second delivery device for delivering the second part. Fig. 7B is an exploded view of the second delivery device. Fig. 7C is a cross-sectional view of the second delivery device. Fig. 8 shows the second delivery device with a first portion of the second part shown in bold lines while the second portion is shown in dotted line. Fig. 9 shows another embodiment of the second delivery device for delivering the two separate parts independently. Fig. 10A is a side view of the second delivery device. Fig. 10B is another view of the second delivery device. Fig. 11 A shows the second part, formed by two separate parts or portions, separated from the first, intravascular part. Fig. 1 IB shows a cross-sectional view of Fig. 11 A along line A-A. Fig. 12A shows the tissue trapped between the second part on both sides of the anastomosis. Fig. 12B is a cross-sectional view of Fig. 12A along line B-B. Fig. 13 shows the second delivery device releasing one portion of the second part when the delivery device is rotated as shown. Fig. 14 shows the manner in which the second delivery device is tilted to remove the second part. Fig. 15 shows another delivery device for delivering the second part which includes a stop to prevent excessive rotation of a previously deployed portion of the second part. Fig. 16A shows deployment of a first portion of the second part. Fig. 16B shows deployment of the second portion of the second part. Fig. 16C shows tilting and disengagement of the first portion when deploying the second portion of the second part. Figs. 17A-17C show use of a stop to prevent disengagement of the previously deployed first portion of the second part.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Fig. 1 shows a delivery device 10 including an actuator 12, a handle 14, a shaft 16 and a distal end indicated by reference numeral 18. A compression spring 20 biases the actuator 12 outward, i.e., away from the distal end 18. The handle has a sleeve 22 and a slot that receives a pin 24 which is fixed to the proximal end of a rod or wire 26 that extends to distal end 18. See Figs. 2 and 3. The wire 26 carries at its distal end a collar 28 which surrounds a pair of arms 30 and is configured to impart relative movement to the arms. The arms 30 have notched portions 32 configured to engage the collar 28 when the latter is moved proximally with wire 26 (in the direction of the arrows in Fig. 3). The arms 30 carry at their distal ends a pair of relatively movable shoes 34, 36 which are configured to engage the opening of an anastomotic component constructed according to the invention, thereby holding the component securely. Specifically, referring to Figs. 2 and 3, the shoes 34, 36 are positioned within the opening O of a part of a component of the invention. As shown, the shoes 34, 36 respectively have ledges 40, 42 which project beyond the opening O so as to engage the underside of the component part 38 (Fig. 2). Fig. 3 shows the distal end 18 of the device 10 after the actuator 12 has been moved so as to move the shoes 34, 36 toward each other and out of engagement with the component part 38. The distal end 18 of the delivery device 10 may then be removed from the now-positioned component part 38. Fig. 4 shows another embodiment of the invention comprising a delivery device having a distal end 50 which includes a shaft 52, a pair of relatively movable arms 54, and a device for imparting relative movement to the arms 54, which in the illustrated embodiment is in the form of forceps or graspers 56 provided with pads 58 that engage the arms 54. The arms 54 may have first and second shoes 34, 36 which engage the opening O of the component part 38 in the manner described above. Figs. 5 and 6 show still another embodiment of the invention comprising a delivery device having a distal end 60 which includes a block 62, a shaft 64, a pair of relatively movable arms 66 and a device for imparting relative movement to the arms (not shown in Figs. 5 and 6). It will be recognized that any suitable instrument, such as forceps or graspers, may be used to engage and squeeze the arms 66 together. The arms 66 has first and second shoes 34, 36 which engage the opening O of the component part 38 in the manner described above. It should be noted that this embodiment provides a delivery device with a reduced-sized distal end, as indicated by the length H. This permits use of the delivery device in a minimally invasive manner or any other application where access to the site is limited. Figs. 7A-7C show in part a delivery device constructed according to one embodiment of the invention for use in which is used to deliver and deploy the second extravascular part (which itself may include at least first and second portions which may also be referred to herein as second and third parts). More specifically, the exemplary configuration of a second delivery device shown in Figs. 7A-7C is indicated by the reference numeral 70 and comprises a distal end including a body or core 72 and a pair of plates 74, 76. The plates 74, 76 have respective openings 78, 80 which are configured to receive the ends of the body 72 (Figs. 7B-7C) such that the plates abut the extensions 82 of the body. The body or core 72 also has a blind bore 84 and a recess 86 configured to adjustably receive a shaft 88 (Fig. 7C). As shown in Figs. 7A and 7C, the extensions 82 of the body 72 cooperate with the plates 74, 76 to form a pair of channels 90 each of which is configured to removably receive one portion of the extravascular second part of the component (not shown in figs. 7a-7c). This embodiment of the invention preferably uses magnetism to hold the portion(s) of the second part securely on the delivery device 70. For example, the body or core 72 may comprise magnetic material so as to magnetically attract the two portions of the extravascular part of the component thereto. The plates 74, 76 may be any suitable material, for example, a strong polymer or plastic. Also, the shaft 88 is preferably malleable to allow it to be bent to any desired shape or configuration. Figs. 8 and 9 show two embodiments of a delivery device 70. The embodiment of Fig. 8 corresponds to that of Figs. 7A-7C and is provided with a pair of channels 90 for receiving the two portions of the extravascular part of the component. A first portion 92A of the extravascular part is shown positioned within a channel 90 in Fig. 8, while a second portion 92B of the extravascular part is shown (in phantom) positioned in the other channel 90. Fig. 9 shows a delivery device 70' with a channel 90' that is configured to receive only one of the extravascular portions 92' . The delivery device 70' includes a body or core 72' and first and second plates 74', 76' secured thereto. The delivery device 70' may be used to deploy both portions of the extravascular or second part when the parts are shaped the same as they are for the second part shown above. Figs. 10A and 10B show another embodiment of a delivery device 100 which includes a body or core 102, plates 104, 106, and sections 108 configured to receive respective portions of the extravascular part of a component. The body 102 has a fitting 110 that adjustably receives a malleable shaft 112. The body 102 and the plates 104, 106 are integrally formed in this embodiment, as shown in Fig. 10B, to form a pair of channels 114 (only one of which holds a portion 116 of the component).
Fig. 11A shows a vessel V and an anastomotic component comprising a first, intravascular part 38 and a second, extravascular part that includes first and second portions 92A, 92B. The first part 38 has an opening O and is positioned within the lumen L of vessel V adjacent an incision I in the wall thereof. The sides of the incision I preferably overlie the first part 38 around the opening O and are either coextensive therewith or, more preferably, extend slightly beyond the inner edge that defines the opening O. See Fig. 11B (which is a sectional view taken along line A-A in Fig. 11 A). Figs. 12A and 12B show first and second portions 92A, 92B of the second, extravascular part after they have been moved against the wall of vessel V on opposite sides of the incision I. As shown in Fig. 12B, the tissue of the vessel wall is compressed between the intravascular part 38 and each extravascular portion 92A, 92B. Additionally, Fig. 12B shows the edges of the incision I overhanging the inner diameter of the intravascular part 38. Of course, the tissue may be oriented in any suitable or desirable manner between the first and second parts. When the illustrated component is magnetically coupled (or otherwise coupled) to a similar component mounted on another vessel the layer of tissue lying on intravascular part 38 forms a gasket to enhance attachment and sealing. Any suitable securing structure, such as cleats 118, may be provided to bolster attachment of the vessels, for example, by tacking the cleats to tissue with suture. As mentioned above, one of the portions 92A, 92B is deployed first while orienting the tissue in a desirable position overlying or covering the first part 38. The tissue may completely or only partially cover the first part 38 depending upon the particular application and device. After compressing the tissue around the anastomosis between 92A and part 38, the other portion 92B is then deployed. Before deploying the other portion 92B of the second part, the first part may still be manipulated with the first device holder to orient the tissue on the other side of the anastomosis in a desirable position. Once the tissue is oriented as desired, the other portion 92B is then deployed thereby compressing tissue on the other side of the anastomosis between the first and second parts. Fig. 13 shows the delivery device 60 with the intravascular part 38 mounted on the distal end thereof. A portion 92A of the extravascular part is shown magnetically coupled to the intravascular part 38 (the vessels being omitted for clarity). The delivery device 70 is shown as it is being manipulated in the direction of the arrow to release the extravascular portion 92A. Rotating the device 70 in the plane indicated by the arrow in Fig. 13 releases the portion 92A because the attraction between the device 70 and the portion 92A is overcome when moved in this manner, unlike the attraction between the intravascular part 38 and the portion 92A. Fig. 14 shows the delivery device 60 and intravascular part 38 mounted thereon being held in position while the delivery device 70 and extravascular portion 92A are rotated in the direction or plane indicated by the arrow. This movement pulls the portion 92A off of the intravascular part 38 as the magnetic attraction between the two is overcome by manipulating the device in the direction of the arrow, unlike the attraction between the portion 92A and the delivery device 70. This feature allows the user to initially deploy the component, check the attachment, and remove and replace the part(s) to obtain the best connection. Fig. 15 shows another embodiment comprising a delivery device 120 comprising a pair of arms 122 with ends 124 secured to respective shoes 126, 128. The device 120 is provided with means 130 for maintaining one extravascular portion 92A in place until the other portion 92B is also coupled to the intravascular part 38. The illustrated means, which of course is only exemplary, is in the form of a pair of stops 132 which extend outwardly from arms 122. The stops 122 hold one already- coupled portion 92A relative to the intravascular part 38 while the other portion 92B is coupled thereto. Figs. 16A-16C show a schematic delivery device 140 carrying an intravascular part 142 adapted to be coupled to first and second portions 144A, 144B. In Fig. 16A the delivery device 140 and intravascular part 142 carried thereby are tilted in the direction of the arrow so that the part 142 faces the portion 144A. Fig. 16B shows the delivery device 140 and intravascular part 142, with the first extravascular portion 144A magnetically (or otherwise) coupled thereto, being tilted in the opposite direction, as indicated by the arrow. Manipulating the delivery device 140 and intravascular part 142 as shown in Fig. 16B may facilitate easy coupling with the second extravascular portion 144B by orienting the two so as to face each other, however, this movement may adversely affect coupling between the first extravascular portion 144A and the intravascular part 142. As shown in Fig. 16C, rotation of the intravascular part 142 can break the attachment between the part 142 and the already-mounted first extravascular portion 144A. The portion 144A may be induced to flip over onto the vessel wall directly on top of the intravascular part 142, as shown in Fig. 16C. Figs. 17A-17C show a delivery device 150 with the ends 124 of the arms 122 serving as means 156 for preventing disengagement between the intravascular and extravascular parts of the component of the invention. The means 156 comprises stops 158A, 158B which serve to prevent disengagement as shown in the sequential views of Figs. 17A-17C which may be the ends 124 of the arms 122 as described above. The above description together with the drawings and claims describe various aspects of the invention. Of course, it is understood that aspects, features and advantages of the invention may be practiced using other physical embodiments from those described herein. For example, the components may be coupled together using any other suitable connecting mechanism without departing from various aspects of the invention.

Claims

What is claimed:
1. A method of securing a medical device to a blood vessel, comprising the steps of: providing a medical device having a first part, a second part and a third part, the first part being mounted on a first delivery device; introducing the first part through an opening in a blood vessel, the opening having a first side and a second side, the first part having a tliroughhole therein; orienting the first part at a first position using the first delivery device, the first position being selected so that the first side of the arteriotomy is at a desired orientation relative to the first part; securing the tissue between the first and second parts while holding the first part in the first position using the first delivery device; orienting the first part at a second position using the first delivery device, the second position being selected so that the second side of the arteriotomy is at a desired orientation relative to the first part; and securing the tissue between the first and third parts while holding the first part in the second position using the first delivery device.
2. The method of claim 1, wherein: the securing steps are carried out with the first part being magnetically attracted to the second and third parts.
3. The method of claim 1, wherein: the providing step is carried out with the first delivery device having a stop which prevents the second part from rotating out of a proper orientation with respect to the first part when orienting the first part.
4. The method of claim 1, wherein: the providing step is carried out with the second and third parts being mounted to a second delivery device, the second delivery device being magnetically attracted to the second and third parts.
5. The method of claim 1, wherein: the securing steps are carried out by compressing the tissue between the first part and the second part and between the first part and the third part.
6. The method of claim 1, further comprising the step of: moving a graft vessel having a connector toward the medical device; and coupling the graft vessel to the blood vessel with the connector being magnetically attracted to the medical device.
7. The method of claim 6, wherein: the moving and coupling steps are carried out with the graft vessel also being a blood vessel and the connector being the same as the medical device attached to the blood vessel.
8. The method of claim 1 , further comprising the step of: removing the second part after the securing step; reorienting the first part after the removing step; and replacing the second part after the reorienting step.
9. A system for attaching a medical device to a tissue structure using magnetism, comprising: a medical device having a first part and a second part, the first and second parts being magnetically attracted to one another; a first delivery device which releasably holds the first part; a second delivery device which releasably holds the second part; wherein the first delivery device is independently positionable relative to the second delivery device so that the first delivery device may be oriented as desired and the second part released to cause the first and second parts to compress a tissue structure therebetween.
10. The system of claim 9, wherein: the first delivery device holds the first part with a mechanical connection; and the second delivery device holds the second part by magnetic attraction.
11. The system of claim 9, further comprising: a third part which is magnetically attracted to the first part; a third delivery device which releasably holds the third part, the third part being magnetically attracted to the first part.
12. The system of claim 9, wherein: the second delivery device also releasably holds a third part, the third part being magnetically attracted to the first part.
13. The system of claim 12, wherein: the second delivery device is configured to release the second and third parts independently.
14. The system of claim 9, wherein: the second delivery device has a recess which receives the second part.
15. The system of claim 9, wherein: the second delivery device has at least two recesses which receive the second and third parts.
16. The system of claim 9, wherein: the second delivery device holds the second part using magnetic attraction.
17. The system of claim 16, wherein: the second delivery device is configured to remove the second part after the second part has been released.
18. The system of claim 9, wherein: the first delivery device has a malleable handle.
19. A method of attaching a medical device using magnetism, comprising the steps of: providing a medical device having a first part, a second part and a third part, the second and third parts being magnetically attracted to the first part; positioning the first part in contact with a tissue structure; positioning the second part adjacent a first side of an opening in the tissue structure; releasing the second part so that the first side of the opening in the tissue structure is held between the first and second parts, the first and second parts being magnetically attracted to one another thereby trapping the tissue structure therebetween; and releasing the third part after releasing the second part, the third part being magnetically attracted to the first part to compress the tissue structure therebetween.
20. The method of claim 19, wherein: the releasing step is carried out with the second part being coupled to a delivery device prior to releasing, the first part being held by the first delivery device with magnetic attraction.
21. The method of claim 19, wherein: the releasing steps are carried out with a delivery device carrying the second and third parts prior to releasing.
22. The method of claim 19, wherein: the releasing step is carried out with the first delivery device carrying one of the second and third parts prior to each of the releasing steps.
23. The method of claim 19, wherein: the positioning step is carried out with the tissue structure being a blood vessel.
24. The method of claim 23, wherein: the positioning steps are carried out with the first part being introduced into the blood vessel and into contact with an internal surface of the blood vessel and the second part being positioned in contact with an external surface of the blood vessel.
25. The method of claim 19, further comprising the step of: reorienting the first part after releasing the second part and before releasing the third part.
26. The method of claim 19, further comprising the steps of: removing at least one of the second and third parts; and positioning and releasing the at least one of the second and third parts again.
27. The method of claim 26, wherein: the removing step is carried out with a delivery device which releases at least one of the fkst and second parts from the magnetic attraction to the first part after the releasing step; the positioning step also being carried out with the at least one of the first and second parts being coupled to the first delivery device. *
28. The method of claim 26, wherein: the releasing and removing steps are carried out with the first delivery device being rotated in different planes.
29. The method of claim 19, wherein: the providing step is carried out with the first part being carried by a first delivery device and the second part being carried by a second delivery device, the first and second delivery devices being independently positionable.
30. The method of claim 29, wherein: the providing step is carried out with the first and second delivery devices being separate delivery devices which are positioned independently of one another.
31. The method of claim 29, wherein: the providing step is carried out with the first part being held by a delivery device having a malleable shaft.
32. A method of handling tissue when attaching a medical device to a tissue structure, comprising the steps of: providing a first medical device for forming an opening in a body structure, the medical device having a first part, a second part and a third part; positioning the first part on a side of the body structure, wherein the first part has a throughhole; orienting the first part so that tissue overlying the first part is at a first desired position; trapping tissue between the first and second parts when the tissue overlying the first part is in the first desired position; orienting the first part so that tissue overlying the first part is at a second desired position; and trapping tissue between the first and third parts when the tissue overlying the first part is in a second desired position.
33. The method of claim 32, wherein: the providing step is carried out with the second and third parts being magnetically attracted to the first part.
34. The method of claim 32, wherein: the positioning step is carried out with the body structure being a blood vessel.
35. The method of claim 32, further comprising: providing a second medical device coupled to a graft vessel.
36. An anastomotic connector, comprising: a fkst, intravascular part having an opening therein; a second, extravascular part configured, wherein the second extravascular part is configured to cooperate with the fkst part to compress tissue on a side of an anastomosis; and a third, extravascular part which is independently movable with respect to the second extravascular part so that the thkd extravascular part may be positioned independently of the second extravascular part, wherein the third extravascular part is configured to cooperate with the first part to compress tissue on another side of the anastomosis.
37. The anastomotic connector of claim 36, wherein: the second and third parts are magnetically attracted to the first part.
38. The anastomotic connector of claim 36, wherein: the second and third parts are independently positionable with respect to the first part.
PCT/US2004/031039 2003-09-15 2004-09-15 Devices and methods for forming magnetic anastomoses between vessels WO2005027736A2 (en)

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US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
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DE102009009925A1 (en) 2009-02-20 2010-09-02 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Device for executing anastomosis with connection of two hollow containers, has retaining arrangement for fixing sections of hollow containers
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US10154844B2 (en) 2016-07-25 2018-12-18 Virender K. Sharma Magnetic anastomosis device and delivery system
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system

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