WO2010064244A2

WO2010064244A2 - Delivery system for delivering a graft from the middle thereof

Info

Publication number: WO2010064244A2
Application number: PCT/IL2009/001143
Authority: WO
Inventors: Eran Bendory; Ido Kilemnik; Ehud Bendory
Original assignee: Inverthis Ltd
Priority date: 2008-12-04
Filing date: 2009-12-03
Publication date: 2010-06-10
Also published as: WO2010064244A3

Abstract

Delivery system (100), delivering a graft (124) through a surgically created opening, including a main tube (102,104), an inner tube (108), a distal stent (120), a distal cap (118), and an externally extending tube (116), the main tube includes a proximal portion (102), and is coupled with the inner tube and the externally extending tube, the externally extending tube pulls the proximal portion proximally, thereby positioning the middle of the graft adjacent to the opening, the cap covers the stent, the inner tube pushes the cap distally, thereby exposing the stent, the stent anchors the graft onto the blood vessel, the externally extending tube pushes the main tube distally, thereby positioning the main tube distally to the opening, the externally extending tube pulls the main tube out through the expanded stent and the opening, the proximal portion is located adjacent to the externally extending tube during delivery into the blood vessel, the proximal portion detaches from the externally extending tube after delivery into the blood vessel.

Description

DELIVERY SYSTEM FOR DELIVERING A GRAFT FROM THE MIDDLE

THEREOF

Eran BENDORY, ldo KILEMNIK, Ehud BENDORY

FIELD OF THE DISCLOSED TECHNIQUE

The disclosed technique relates to stent grafts, in general, and to systems and methods for producing and deploying a bifurcated stent graft for creating an entrance into a blood vessel, in particular.

BACKGROUND OF THE DISCLOSED TECHNIQUE An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. Stent grafts are known in the art. A stent graft is employed in the treatment of a variety of conditions involving the blood vessels. For example, a stent graft is employed forming an arterial access. A bifurcated stent graft is a stent graft having three legs (e.g., T-shaped or Y-shaped), such that it forms a junction. The bifurcated stent graft is usually employed in either a vascular junction (e.g., an aortic branch or an arterial branch) or a surgically created junction (e.g., for forming an arterial access). The stent graft is deployed in the blood vessel by employing a delivery and deployment system. Following a percutaneous procedure or a minimal invasive surgery, the physician has to close the surgically created opening. An arterial access device is a device employed for closing the surgically created opening (i.e., for assisting hemostasis) in the blood vessel.

U.S. Patent No. 7,445,610 to Adams et al., entitled "Dilation and Stent Delivery System for Bifurcation Lesions" is directed at delivery system for deploying a stent at an anatomical junction (bifurcation). The delivery system includes two guide wires, a shaft, at least one stent and at least one balloon. The shaft includes a guide wire lumen and an inflation lumen. The shaft is slidable coupled with the guidewire via the guidewire lumen. The distal end of the shaft is coupled with the proximal end of the balloon (proximal being the direction closest to the opening through-which the delivery system is inserted into the blood vessel). In particular, the inflation lumen is in fluid connection with the balloon for expanding and deflating the balloon. The stent is wrapped around at least a portion of the balloon.

A physician inserts the delivery system into the blood vessel of a patient. The physician positions the delivery system at the anatomical bifurcation. The physician inflates the balloon for dilating the blood vessel and for expanding the stent. It is noted that, the bifurcated stent is deployed at an anatomical junction, and in particular the stent is not deployed at a surgically created junction for producing an entrance into the blood vessel. The stent is deployed while being mounted over the delivery system and not enfolded there within.

U.S. Patent No. 6,210,422 to Douglas, entitled "Bifurcated Vascular Graft Deployment Device" is directed at a delivery system for a bifurcated graft. The delivery system includes a graft body tube, a first limb tube and a second limb tube. The first limb tube and the second limb tube branch from the distal end of the graft body tube. The graft body, the first limb and the second limb of the graft are positioned within the graft body tube, the first limb tube and the second limb tube of the delivery system, respectively. The graft is deployed by pulling each of the first limb tube, the second limb tube and the graft body tube for exposing the first limb, the second limb and the graft body, respectively. It is noted that, the graft is deployed at an anatomical junction.

U.S. Patent No. 6,451 ,033 to Berg et al., entitled "Tubular Medical Graft Connectors" is directed at tubular medical graft connectors. This reference relates to the connection of tubular medical grafts to a patient's tubular tissue structures such as blood vessels. The system includes a connector and a delivery system. The connector includes a first section and a second section. The delivery system includes a guide wire, a dilator, and a sleeve.

First, a guide wire is inserted through an aperture into the lumen of a body conduit. Then, a dilator structure is advanced along and concentrically around the guide wire. The next step is to advance the distal portion of the sleeve into the lumen of the body conduit. The connector is inserted into and along the sleeve such that the second section is folded along the first section. When the connector has been pushed forward enough so that the second section is entirely within the lumen, the sleeve is pulled back out of the lumen. In this situation, the second section is positioned within the body conduit proximally of the aperture, while the first section is positioned partially inside the body conduit and partially extending out of the aperture of the lumen of the body conduit. Then, the first section is pulled backwards. This shifts the second section within the conduit such that the branching of first section from the second section is centered on the aperture. Thus, the connector is positioned in its designated location.

U.S. Patent No. 6,949,121 to Laguna, entitled "Apparatus and Methods for Conduits and Materials" is directed at a system for implanting a conduit in a blood vessel. The conduit includes a main member and a side-branch member. Upon initial implantation, the side-branch member is disposed within the main member and after positioning, the side-branch member is extended from the main member, and into a side-branch of the vessel. After the main member is placed in the desired location, the side- branch member may be pushed or pulled out of the main member, the entire device having been inserted into the vessel at one access site. In one of the embodiments, the main member and the side-branch may be a single continuous piece of graft material with multiple stents.

U.S. Patent No. 6,402,767 to Nash et al., entitled "Anastomosis Connection System and Method of Use" is directed at an anastomosis connection system and method of use. This reference describes a connector device and a deployment instrument that is used to carry the device to the desired position within a body vessel or organ. The method of introducing the device involves the introduction of the device through an aperture in a body lumen followed by retraction of the dilator. The dilator is retracted for positioning the device within the vessel, such that the tubular proximal portion of the device extends out of the blood vessel, in order to make possible an anastomosis or bypass. It is noted that, the bifurcated stent described in this patent is coupled between two completely resected ends of the vessel. In particular, the bifurcated stent is not deployed within a vessel such that the proximal end and the distal end thereof are positioned proximally and distally, respectively, to a surgically created opening.

U.S. Patent No. 6,663,665 to Shaolian et al., entitled "Single Puncture Bifurcation Graft Deployment System" is directed at a system for deploying a bifurcated graft within both iliac branches, as well as the aortic trunk, from a single vascular access. The deployment system includes an inner core, a middle core, an outer sheath and an actuator. The stent graft device includes a contralateral limb and an ipsilateral limb. The deployment system is advanced along a guide wire until positioned in place. The outer sheath is retracted proximally and the contralateral limb separated from the middle core. The ipsilateral limb remains sheathed by the middle core. The middle core is retracted and the ipsilateral limb is exposed and self expands. The contralateral limb is expanded by employing the actuator. The deployment system is retracted through the ipsilateral limb and withdrawn from the patient.

U.S. Patent No. 6,908,477 to McGuckin, Jr. et al., entitled "Methods of Implanting Covered Stents with Side Branch" is directed at a bifurcated stent graft device. Bifurcated covered stent includes a graft, an underlying main stent and a side stent. The graft includes a main portion and a side branch portion. The main stent underlies the main graft portion. The side stent underlies the side branch graft portion. SUMMARY OF THE PRESENT DISCLOSED TECHNIQUE

It is an object of the disclosed technique to provide a novel method and system for producing and deploying a stent graft. In accordance with an embodiment of the disclosed technique, there is thus provided a delivery system for delivering a graft into a blood vessel through a surgically created opening in the blood vessel and deploying the graft at the position of the opening. The delivery system includes a main tube, an inner tube, the graft, a distal stent, a distal cap, and an externally extending tube. The main tube includes a proximal portion. The inner tube is slidably coupled with the main tube, such that the inner tube slides proximally and distally within the main tube. The distal stent is coupled with the distal end of the graft. The distal stent expands and anchors the graft onto the blood vessel. The distal cap is coupled with the distal end of the inner tube. The distal cap covers the distal stent. The externally extending tube is coupled with the main tube. After insertion of the delivery system into the blood vessel and upon pulling of the externally extending tube, the externally extending tube pulls the proximal portion in the proximal direction, thereby positioning approximately the middle of the graft adjacent to the surgically created opening. After the distal stent is expanded and pushed, the externally extending tube pushes the main tube in the distal direction, thereby positioning the main tube including the proximal portion distally to the opening. The externally extending tube pulls the main tube out of the blood vessel through the expanded distal stent and through the surgically created opening.

The diameter of the surgically created opening is smaller than that of the delivery system. Once the graft is positioned, such that the middle thereof is adjacent to the surgically created opening, the inner tube pushes the distal cap in the distal direction, thereby removing the distal cap from the distal stent and exposing the distal stent. The proximal portion is located adjacent to the externally extending tube during insertion of the delivery system into the blood vessel through the surgically created opening. The proximal portion of the main tube detaches from the externally extending tube after insertion of the delivery system into the blood vessel. In accordance with another embodiment of the disclosed technique there is thus provided an arterial access device for enabling entry and re-entry with a dilating surgical tool into an opening within a blood vessel. The arterial access device includes a proximal portion, a distal portion, and a closable access port. The proximal portion is positioned within the blood vessel proximally to the opening. The distal portion is coupled with the distal end of the proximal portion. The distal portion is positioned within the blood vessel distally to the opening. The closable access port is coupled between the distal portion and the proximal portion. The closable access port is positioned adjacent to the opening. The closable access port is closed. Blood enters the arterial access device from the proximal portion and exits the arterial access device out of the distal portion. The closable access port enables insertion of the dilating surgical tool into the blood vessel. The closable access port re-closes upon removal of the dilating surgical tool. In accordance with a further embodiment of the disclosed technique, there is thus provided a method for delivering a graft into a blood vessel through a surgically created opening in the blood vessel and deploying the graft at the position of the opening. The method including the steps of inserting the graft into the blood vessel, detaching a proximal portion from an externally extending tube, pulling the externally extending tube, pushing a distal cap, expanding a distal stent, pushing the externally extending portion, reattaching the proximal portion, and pulling the graft out of the blood vessel.

The graft is inserted into the blood vessel through the surgically created opening. The procedure of inserting the graft is performed by employing a delivery system. The graft is positioned distally to the surgically created opening. The diameter of the surgically created opening is smaller than that of the delivery system. The procedure of pulling the externally extending tube is performed such that the proximal portion of the externally extending tube and a proximal graft portion are positioned proximally to the surgically created opening.

The procedure of pushing a distal cap of the delivery system distally is performed by pushing an inner tube of the delivery system, which is slidably coupled with the main tube, thereby exposing the distal stent. The procedure of expanding a distal stent is preformed for anchoring the graft onto the blood vessel distally to the surgically created opening. The procedure of pushing the externally extending portion is performed for pushing the delivery system and positioning the delivery system distally to the surgically created opening.

The proximal portion of the delivery system is reattached to the externally extending portion of the delivery system. The procedure of pulling the graft out of the blood vessel is performed through the expanded distal stent and through the surgically created opening by pulling the externally extending tube.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: Figures 1A to 1 G are schematic illustrations of a bifurcated stent graft delivery system, constructed and operative in accordance with an embodiment of the disclosed technique;

Figures 2A to 2C are schematic illustrations of a bifurcated stent graft delivery system, constructed and operative in accordance with another embodiment of the disclosed technique;

Figures 3A to 3H are schematic illustrations of a bifurcated stent graft delivery system, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figures 4A to 4C are schematic illustrations of a bifurcated stent graft delivery system, constructed and operative in accordance with another embodiment of the disclosed technique;

Figures 5A and 5B are schematic illustrations of a bifurcated stent graft delivery system, constructed and operative in accordance with a further embodiment of the disclosed technique; Figure 6 is a schematic illustration of a stent, constructed and operative in accordance with another embodiment of the disclosed technique;

Figure 7 is a schematic illustration of a stent graft device, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figure 8 is a schematic illustration of a stent graft device, constructed and operative in accordance with another embodiment of the disclosed technique;

Figure 9 is a schematic illustration of sewing coupler, constructed and operative in accordance with a further embodiment of the disclosed technique; Figure 10 is a schematic illustration of a welding coupler, constructed and operative in accordance with another embodiment of the disclosed technique;

Figure 11 is a schematic illustration of a welding coupler, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figure 12 is a schematic illustration of a sawing coupler, constructed and operative in accordance with another embodiment of the disclosed technique; Figure 13A is a schematic illustration of a graft, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figure 13B is a schematic illustration of the graft of Figure 13A including a stent; Figure 13C is a schematic illustration of the graft of Figure 13A including stent graft coating;

Figure 14 is a schematic illustration of a graft, constructed and operative in accordance with another embodiment of the disclosed technique; Figure 15 is a schematic illustration of a stent, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figure 16A is a schematic illustration of a stent design pattern, constructed and operative in accordance with another embodiment of the disclosed technique;

Figure 16B is a schematic illustration of an enlarged view of a portion of the stent design pattern of Figure 16A;

Figures 17A to 17F are schematic illustrations of a stent graft device, constructed and operative in accordance with a further embodiment of the disclosed technique; Figure 18A is a schematic illustration of stent sheaths pushing and pulling scheme for exposing the stents of a stent graft device, operative in accordance with another embodiment of the disclosed technique; Figure 18B is a schematic illustration of stent sheaths pushing and pulling scheme for exposing the stents of a stent graft device, operative in accordance with a further embodiment of the disclosed technique;

Figure 18C is a schematic illustration of stent sheaths pushing and pulling scheme for exposing the stents of a stent graft device, operative in accordance with another embodiment of the disclosed technique;

Figures 19A and 19B are schematic illustrations of an arterial access device, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figures 2OA to 2OD are schematic illustrations of an arterial access device, constructed and operative in accordance with another embodiment of the disclosed technique;

Figures 21 A and 21 B are schematic illustrations of an arterial access device, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figures 22A to 22C are schematic illustrations of an arterial access device, constructed and operative in accordance with another embodiment of the disclosed technique; Figures 23A and 23B are schematic illustrations of an arterial access device, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figures 24A and 24B are schematic illustrations of an arterial access device, constructed and operative in accordance with another embodiment of the disclosed technique; Figures 25A and 25B are schematic illustrations of an arterial access device, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figures 26A and 26B are schematic illustrations of an arterial access device, constructed and operative in accordance with another embodiment of the disclosed technique;

Figures 27A and 27B are schematic illustrations of an arterial access device, constructed and operative in accordance with a further embodiment of the disclosed technique; and Figures 28A and 28B are schematic illustrations of an arterial access device, constructed and operative in accordance with another embodiment of the disclosed technique.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The disclosed technique overcomes the disadvantages of the prior art by deploying a stent graft at a blood vessel through a surgically created opening in the blood vessel. The stent graft of the disclosed technique is delivered through the surgically created opening and is deployed around the opening such that a proximal portion and a distal portion of the stent graft are positioned proximally and distally to the opening.

The term "surgically created opening" herein below, refers to an opening of a blood vessel junction which is created by a physician, employing minimal invasive surgery (e.g., laparoscopy), or a percutaneous procedure. The size of the surgically created opening corresponds to the diameter of the delivery system. The terms distal and proximal are used throughout this application with relation to the physician deploying the stent graft. In other words, the term distal refers to the direction furthest away from the physician and the term proximal refers to the direction closer to the physician.

Reference is now made to Figures 1A to 1G, which are schematic illustrations of a bifurcated stent graft delivery system, generally referenced 100, constructed and operative in accordance with an embodiment of the disclosed technique. With reference to Figure 1A, delivery system 100 includes a main tube upper portion 102, a main tube lower portion 104, a main tube spacer 106, a secondary tube upper portion 108, a secondary tube lower portion 110, a secondary tube spacer 112, a dilator proximal cap 114, a distal tube 116, a dilator distal cap 118, a distal stent 120, a proximal stent 122, a graft 124, an introducing sleeve 128, a Guide Wire (GW) 130, a dilator extraction cap 132 and a proximal dilating stopper 138.

Main tube upper portion 102 is coupled at the distal end (i.e., the distal direction is on the left hand side of Figure 1A) thereof with the distal end of main tube lower portion 104, via main tube spacer 106. Secondary tube upper portion 108 is coupled at the distal end thereof with the distal end of secondary tube lower portion 110, via secondary tube spacer 112. Dilator proximal cap 114 is coupled with the proximal end (i.e., the proximal direction is on the right hand side of Figure 1A) of secondary tube lower portion 110. Dilator distal cap 118 is coupled with the distal end of distal tube 116. Proximal dilating stopper 138 is attached to the circumference of main tube lower portion 104, at the proximal end thereof.

Both distal stent 120 and proximal stent 122 are self expanding stents which are held at a folded configuration within delivery system 100 until they are positioned in place and are exposed. In particular, distal stent 120 is folded within dilator distal cap 118. Distal stent 120 self-expands upon removal of dilator distal cap 118 there-from. Proximal stent 122 is folded within dilator proximal cap 114. Proximal stent 122 self-expands upon removal of dilator proximal cap 114 there-from. Each of distal stent 120 and proximal stent 122 expands such that its diameter matches that of the surrounding blood vessel (e.g., blood vessel 134 of Figure 1 B). Alternatively, at least one of distal stent 120 and proximal stent 122 is a manually expanded stent, which is expanded by employing an expander (not shown - e.g., a balloon). It is noted that, Figures 1A to 1G are cross section views of delivery system 100 and therefore each of distal stent 120 and proximal stent 122 is depicted as two rows of circles.

Both dilator proximal cap 114 and dilator distal cap 118 are tapered so that they dilate a blood vessel 134 (Figure 1 B) upon entering thereto. In this manner, dilator proximal cap 114 and dilator distal cap 118 enable delivery system 100 to easily penetrate blood vessel 134 in the proximal and distal directions, respectively. The shape and tip angle of each of dilator distal cap 118 and dilator proximal cap 114 can assume a variety of forms. For example, the shape of a dilator cap is a right circular cone. Another example for the shape of a dilator cap is an oblique circular cone. It is noted that, each of dilator proximal cap 114 and dilator distal cap 118 serves the following two functions. The first function is enfolding, and keeping at a folded configuration, proximal stent 122 and distal stent 120 until they (i.e., stents 120 and 122) are positioned in the desired location within blood vessel 134 (i.e., as determined by the physician). Another function of caps 114 and 118 is dilating blood vessel 134 while penetrating there-through.

Dilator extraction cap 132 enables a smooth extraction of delivery system 100 as detailed further with reference to Figure 1 F. Dilator extraction cap 132 is positioned around the proximal end (not referenced) of main tube 102. It is noted that, dilator extraction cap 132 is a two directional dilator (i.e., tapered on both the proximal end and the distal end thereof), dilating external branch 126B (Figure 1C) of graft 124 and blood vessel 134 when extraction cap 132 is pushed and when it is pulled.

Introducing sleeve 128 envelops delivery system 100, such that dilator distal cap 118 extends from the distal end of introducing sleeve 128 for dilating blood vessel 134 during delivery of delivery system 100. In other words, the distal end of introducing sleeve and the proximal end of distal cap 118 maintain physical continuity. In particular, the distal end of introducing sleeve 128 overlaps the proximal end of dilator distal cap 118. Alternatively, the proximal end of distal cap 118 overlaps the distal end of introducing sleeve 128. Further alternatively, the distal end of introducing sleeve 128 is adjacently attached to the proximal end of distal cap 118, and the diameter of introducing sleeve 128 is substantially similar to that of distal cap 118. Introducing sleeve 128 is coated with a lubricating coating for reducing friction and enabling smoother insertion into blood vessel 134. Alternatively, introducing sleeve 128 is any introducing sleeve known in the art. GW 130 goes through distal tube 116 and through dilator distal cap 118. GW 130 is employed for guiding delivery system 100 into blood vessel 134 as known in the art.

It is noted that, a second GW 140 (Figure 3D) can go through dilator proximal cap 114. In this manner, second GW 140 is employed for guiding proximal cap 114 into blood vessel 134 proximally to a surgically created opening 136 (Figure 1 B). Alternatively, dilator proximal cap 114 includes a flexible GW tip firmly extending from the proximal tip of dilator proximal cap 114. The flexible GW tip enables dilator proximal cap 114 to easily penetrate into blood vessel 134 in the proximal direction. Further alternatively, second GW 140 is employed for deploying a second stent graft (not shown). For example, the delivery system is inserted into a bifurcated blood vessel (e.g., the iliac branches), through one of the bifurcations (i.e., one of the branches). The first stent graft is deployed in the bifurcation and one of the branches (i.e., the first branch) in a similar manner to that detailed with reference to Figures 1A to 1 F. The physician slides second GW 140 into the second branch (e.g., by employing a bender which bends second GW 140 at the bifurcation and guides second GW 140 into the second branch). The physician inserts the second stent graft, which is to be coupled with the first stent graft for forming a bifurcated stent graft for maintaining the bifurcation as well as both branches thereof open, through the first branch. The physician slides the second graft upon second GW 140 into the second branch. The physician deploys the second graft in the second branch of the bifurcated blood vessel. In this manner, the physician can deploy both the first and the second stent grafts in both the first and the second branches of the bifurcated blood vessel, through a single surgically created opening.

With reference to Figure 1 B, GW 130 is inserted into blood vessel 134 through a surgically created opening 136. Opening 136 is created by a physician (not shown) in a minimally invasive procedure, a percutaneous surgery, laparoscopy, and the like. It is noted that, the size of surgically created opening is smaller than the size of delivery system 100 (e.g., the diameter of dilating distal cap 118 and of introducing sleeve 128). In other words, delivery system 100 fits into a small opening 136 in blood vessel 134 by dilating opening 136 upon entrance. With reference to Figure 1C, the physician slides delivery system

100 over GW 130, through opening 136, and into blood vessel 134. As detailed herein above, the direction of insertion of delivery system 100 into blood vessel 134 is the distal direction (i.e., towards the left hand side of Figure 1C). The physician pushes delivery system 100 into blood vessel 134 until dilator proximal cap 114 is positioned distally to opening 136. Graft 124 includes an inner portion 126A and an external branch 126B. Inner portion 126A of graft 124 is coupled between distal stent 120 and proximal stent 122. External branch 126B is branching from the dorsal side (i.e., the top of Figure 1C) of inner portion 126A, from approximately the middle between distal stent 120 and proximal stent 122. With reference to Figure 1 D, the physician pulls out introducing sleeve 128, such that graft external branch 126B extends through opening 136 and graft inner portion 126A remains within blood vessel 134. The physician pulls main tube upper portion 102 backwards (i.e., towards himself) such that dilator proximal cap 114 is positioned proximally to opening 136. It is noted that, in order to position delivery system 100 in the deployment site (i.e., the location in which graft 124 is deployed), the physician makes a pushing movement followed by a pulling movement. In particular, the physician pushes delivery system 100 into blood vessel 134. The physician pulls main tube 102, thereby pushing proximal cap 114 proximally within blood vessel 134.

With reference to Figure 1 E, the physician pushes distal tube 116 forward, such that dilator distal cap 118 is pushed in the distal direction and is removed from distal stent 120. Distal stent 120 self-expands and is anchored to blood vessel 134 distally to opening 136. The physician pulls secondary tube upper portion 108 backwards. Secondary tube lower portion 110 is pushed in the proximal direction. Proximal dilating stopper 138 prevents proximal stent 122 from moving in the proximal direction along with proximal cap 114. Dilator proximal cap 114 is removed from proximal stent 122. Proximal stent 122 self-expands and is anchored to blood vessel 134 proximally to opening 136. Graft 124 is deployed such that inner portion 126A is anchored, via distal stent 120 and proximal stent 122, within blood vessel 134 and external branch 126B extends through opening 136. It is noted that, the physician can push distal tube 116 forward while pulling secondary tube upper portion 108 backwards, thereby exposing both distal stent 120 and proximal stent 122 substantially simultaneously. Alternatively, the physician exposes one of distal stent 120 and proximal stent 122 first, and the other one later.

With reference to Figure 1 F, the physician pushes main tube upper portion 102 and secondary tube upper portion 108 forward, while holding distal tube 116 in place. Secondary tube lower portion 110 and dilator proximal cap 114 are pushed in the distal direction toward dilator distal cap 118 and through expanded proximal stent 122. note that, proximal dilating stopper 138 dilates proximal stent 122 and distal stent 120 while going there-through, thereby enabling proximal cap 114 to pass through proximal stent 122 and distal stent 120. It is noted that once proximal cap 114 is positioned with distal cap 118, proximal dilating stopper 138 can move into proximal cap 114 (i.e., as depicted in Figure 1 F). Furthermore, since dilator extraction cap 132 is coupled with main tube 102, the physician pushes dilator extraction cap 132, together with main tube 102, towards dilator distal cap 118 and closes dilator distal cap 118. In other words, dilator extraction cap 132 encloses main tube lower portion 104, secondary tube lower portion 110, and proximal cap 114 within dilator distal cap 118.

Note that, dilator extraction cap 132 dilates proximal stent 122 while going there-through (i.e., both in the distal and proximal directions). In this manner dilator extraction cap 132 is able to pass through distal stent 120 and close distal cap 118. Further in this manner, dilator extraction cap 132 enables distal cap 118 to pass through distal stent 120 in the proximal direction.

Alternatively, the physician pushed all of main tube upper portion 102, secondary tube upper portion 108, and distal tube 116 in the distal direction until dilator extraction cap 132 is positioned distally to distal stent 120. The physician pulls distal tube 116 in the proximal direction, such that dilator extraction cap 132 closes distal cap 118 (i.e., with proximal cap 114 within).

The physician pulls distal tube 116 backwards, such that dilator distal cap 118 is pulled in the proximal direction through expanded distal stent 120 and out of blood vessel 134 through opening 136. As detailed herein above, dilator extraction cap 132 enables a smooth extraction of delivery system 100 by dilating graft 126B, blood vessel 134 and surgically created opening 136. With reference to Figure 1G, dilator proximal cap 114, main tube lower portion 104, and secondary tube lower portion 110 (not depicted in Figure 1G) are folded within dilator distal cap 118. Dilator extraction cap 132 closes dilator distal cap 118.

It is noted that, graft 124 is deployed at the location of surgically created opening 136. That is, the physician does not have to navigate delivery system 100 within blood vessel 134 to the deployment site of graft 134. It is further noted that, in the example set forth in Figures 1A to 1G, before the deployment of graft 124, each of dilator distal cap 118 and dilator proximal cap 114 contain distal stent 120 and proximal stent 122, respectively. After deployment and at the retrieval of delivery system 100, each of dilator distal cap 118 and dilator proximal cap 114 is retrieved through the now expanded distal stent 120 and proximal stent 122, respectively. In other words, the stents are deployed within the caps at a folded configuration and the caps are retrieved through the stents when they are deployed and expanded. In the example set forth in Figures 1A to 1G, the distal stent and the proximal stent could be two portions of a single stent. Alternatively, the distal stent and the proximal stent are replaced by any other anchoring devices capable of anchoring the bifurcated graft into position. In the example set forth in Figures 1A to 1G, a bifurcated graft is deployed within blood vessel 134. Blood vessel 134 can be any blood vessel such as an artery (e.g., the coronary artery). Reference is now made to Figures 2A to 2C, which are schematic illustrations of a bifurcated stent graft delivery system, generally referenced 150, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 2A, delivery system 150 includes a main tube 152, an inner tube 154, a stent sheath 156, a distal cap 158, a stent 160, and an introducing sleeve 162. Main tube 152 includes an upper split 164, a lower split 166, a distal portion 168 a plurality of slits 170 and at least one stent stopper 172. Inner tube 154 includes a plurality of rods 174. Stent sheath 156 includes a sheath opening 176. Distal cap 158 includes a unidirectional fastener 178 and a plurality of pushing teeth 180. Stent 160 includes a stent opening 182. Introducing sleeve 162 includes a knife 184.

Distal portion 168 of main tube 152 splits on the proximal end thereof (not referenced) into upper split 164 and lower split 166. Upper split 164 and lower split 166 are produced by making a slit at the middle of main tube 152 along a horizontal plane. Lower split 164 is separated from upper split 166 by extending the slicing of main tube 152 toward the ventral side (i.e., the bottom) of main tube 152 at a location near the proximal end of main tube 152. A lower portion 186 of upper split 164 matches an upper portion 188 of lower split 166. When positioned at a folded configuration lower portion 186 of upper split 164 is attached to upper portion 188 of lower split 166 and the diameter of upper split 164 and lower split 166 attached together is similar to that of distal portion 168.

Slits 170 are positioned along a circumference of distal portion 168. In the example set forth in Figures 2A to 2C, there are four slits 170. Alternatively, there is at least one slit 170. Stent stoppers 172 are positioned on the external circumference of distal portion 168, proximally to the proximal end of slits 170. In the example set forth in Figures 2A to 2C there are two stent stoppers 172. Alternatively, there is at least one stent stopper 172. Main tube 152 envelopes inner tube 154, such that inner tube 154 goes through distal portion 168 and upper split 164. Rods 174 are positioned on the external circumference of inner tube 154, extending vertically from inner tube 154. Each of rods 174 extends outward from a respective one of slits 170 (i.e., the number of rods 174 is equal to the number of slits 170). When inner tube 154 slides along main tube 152, each of rods 174 slides along its respective one of slits 170. Rods 174 are coupled at the peripheral end thereof with the distal end of stent sheath 156. It is noted that Figures 2A and 2C are cross section views of delivery system 150 and therefore stent 160 is depicted as two rows of circles. Stent 160 envelopes upper split 164 and lower split 166. Stent opening 182 is positioned on the dorsal side of stent sheath 156, such that upper split 164 extends there-through. Stent sheath 156 envelopes stent 160. Sheath opening 176 is positioned on the dorsal side of stent sheath 156, such that upper split 164 extends there-through. Stent opening 182 coincides with sheath opening 176. It is noted that stent 160 is deployed such that both stent opening 182 and sheath opening 176 coincide with the surgically created opening (e.g., opening 136 of Figure 1 B), through which delivery system 150 is delivered into a blood vessel (e.g., blood vessel 134 of Figure 1 B).

Pushing teeth 180 are positioned on the internal circumference of the middle portion of distal cap 158 such that when main tube 152 (i.e., distal portion 168 of main tube 152) is pushed in the distal direction, main tube 152 pushes distal cap 158 in the distal direction, via pushing teeth 180. Unidirectional fastener 178 extends proximally from the internal distal end of distal cap 158. Alternatively, distal portion 168 is permanently coupled with distal cap 158, and both pushing teeth 180 and unidirectional fastener 178 are omitted. Knife 184 is coupled on the ventral side of introducing sleeve at the distal end thereof. Delivery system 150 is introduced into the blood vessel in a similar fashion to that of delivery system 100 of Figures 1A to 1G. Once inside the blood vessel, introducing sleeve 162 is pulled out of the blood vessel by the physician until the just the distal end thereof extends into the blood vessel. In this manner, knife 184 is positioned adjacent to the proximal end of stent opening 182 such that when stent sheath 156 is pushed distally, knife 184 cuts stent sheath 156 proximally to stent opening 182. When introducing sleeve 162 is pulled, lower split 166 splits from upper split 164. The physician pulls main tube 152 backwards such that lower split 166 is pulled proximally inside the blood vessel (i.e., in a substantially similar manner to main tube lower portion 104 and proximal tube lower portion 110 of Figures 1A to 1G).

With reference to Figure 2B, main tube distal portion 168, inner tube 154, rods 174, and slits 170, are depicted from a front view cross-section. Inner tube 154 is positioned within main tube 152. Rods 174 extend from the external circumference of inner tube 154 through slits 170.

With reference to Figure 2C, the physician pushes inner tube 154 forward while maintaining main tube 152 in place. Inner tube 154 moves rods 174 in the distal direction. Rods 174 move stent sheath 156 in the distal direction, such that the dorsal side of stent sheath proximally to opening 176 (Figure 2A) is pushed against knife 184. Knife 184 cuts the dorsal side of stent sheath 156 proximally of opening 176. The physician pushes inner tube 154, and thus stent sheath 156, forward until stent 160 is fully exposed (i.e., stent sheath 156 is fully removed from stent 160). Alternatively, instead of employing knife 184 for cutting the dorsal side of stent sheath 156, stent sheath 156 includes a thread (not shown) embedded in the dorsal side thereof, proximally of opening 176. Rods 174 pull stent sheath 156 in the distal direction and pull the thread, such that the dorsal side thereof, proximally of opening 176, is unstitched. Stent stoppers 172 stop stent 160 from being pushed distally with stent sheath 156, such that stent 160 is exposed when stent sheath 156 is pushed distally. Stent 160 self-expands and attaches itself to the walls of the blood vessel (i.e., Stent 160 is a self-expanding stent). Alternatively stent 160 is expanded manually by an expander (not shown - e.g., a balloon).

Inner tube 154 extends distally from main tube 152 and once inner tube 154 touches unidirectional fastener 178 it attaches itself thereto, such that when the physician pulls backward inner tube 154, distal cap 158 is pulled proximally as well. Main tube 152 and inner tube 154 are folded within distal cap 158, such that lower split 166 and upper split 164 are at the folded configuration described herein above with reference to Figure 2A. The physician pulls back inner tube 154 and delivery system 150 is pulled back through expanded stent 160 and outside of the blood vessel.

It is noted that, stent 160 is deployed at the location of the surgically created opening, through which stent 160 is delivered into the blood vessel. In this manner, the physician does not navigate delivery system 150 through the blood vessel. It is further noted that, the surgically created opening is small and corresponds in size and shape to delivery system 150. Note also that the physician positions delivery system 150 by simple movements of pushing (i.e., pushing main tube upper split 164) and then pulling (i.e., pulling upper split 164).

Reference is now made to Figures 3A to 3H, which are schematic illustrations of a bifurcated stent graft delivery system, generally referenced 200, constructed and operative in accordance with a further embodiment of the disclosed technique. System 200 includes a distal cap 202, a main tube 204, an inner tube 206, a thread 208, an extraction shaft 210, a pushing shaft 212, a handle 214 and a stent graft 222. Stent graft 222 includes a distal graft portion 226, a proximal graft portion 224, and an extending graft portion 228. Distal graft portion 226 is coupled with proximal graft portion 224 and with extending graft portion 228. Distal graft portion 226 is supported by a distal stent 230. Proximal graft portion 224 is supported by a proximal stent 232. Proximal stent 232 is delivered and deployed in an expanded stance. Distal stent 230 is a self expanding stent. Alternatively, distal stent 230 is expanded manually by an expander (not shown - e.g., a balloon). Further alternatively, proximal stent 232 is tightened around distal end 216, and is expanded by pulling proximal portion 218 distally there-through (i.e., the maximal diameter of proximal portion 218 is larger than that of distal portion 216, as detailed herein below). For simplicity reasons, distal stent 230 and proximal stent 232 are shown only in figure 3A.

Main tube 204 includes a distal end 216, a proximal end 218 and a lumen 220. Distal end 216 is coupled with proximal end 218. Lumen 220 is an elongated cavity, positioned substantially in the center of proximal end 218 along the distal-proximal axis. Distal cap 202 is coupled with main tube 204 via inner tube 206. Inner tube 206 is firmly coupled with and extends proximally from, the center of distal cap 202 along the distal-proximal axis.

Inner tube 206 is slidably coupled with main tube 204, such that inner tube 206 can slide from an open configuration of delivery system 200, as depicted in Figure 3A, to a closed configuration thereof, as depicted in Figure 3B. In particular, inner tube 206 slides through lumen 220. At the open configuration (i.e., Figure 3A) inner tube 206 extends to approximately the middle of main tube 204 such that there is a gap between distal cap 202 and main tube 204. At the closed configuration (i.e., Figure 3B) inner tube 206 extends substantially to the proximal end of main tube 204, such that distal cap 202 is positioned adjacent to main tube 204.

It is noted that, the shape of distal end 216 of main tube 204 conforms to the shape of distal cap 202. In this manner, at the closed configuration, distal cap 202 and main tube 204 form the shape of a capsule (no shown) having a similar diameter across its proximal-distal axis. Inner tube 206 includes a lump 238 at the proximal end thereof.

Lump 238 is a mechanical stopper preventing main tube 204 and distal cap 202 to move towards each other when being either pushed or pulled. Lump 238 is designed and constructed such that when put under predetermined force, lump 238 ceases from performing its function (i.e., keeping main tube 204 and distal cap 202 away from each other). For example, lump 238 is a bulge, positioned within a corresponding void 240 within main tube 204, preventing inner tube 206 from sliding through lumen 220. In case the physician applies the predetermined force, lump 238 shatters and allows inner tube 206 to slide along lumen 220.

Stent graft 222 is mounted on delivery system 200. Distal graft portion 226 is enclosed within distal cap 202. Proximal graft portion 224 envelopes distal end 216 of main tube 204. Thread 208 is coupled with the proximal end of inner tube 206 via lump 238. Thread 208 extends from lump 238, through lumen 220, along the dorsal side of proximal end 218, along the dorsal side of distal end 216 beneath graft portion 224, and out of extraction shaft 210. Extraction shaft 210 is positioned within extending graft portion 228. Figure 3A illustrates delivery system 200 at an open configuration thereof. In particular, lump 238 is positioned approximately in the middle of main tube 204. Figure 1 B illustrates delivery system 200 at a closed configuration thereof, after deployment of stent graft 222. In particular, distal cap 202 encloses distal end 216 of main tube 204, such that delivery system 200 forms the shape of a capsule, which enables smooth extraction of delivery system 200 through extending graft portion 228. The capsule shape further dilates stents 230 and 232 as it passes there-through.

Figures 3C to 3H illustrate the delivery of stent graft 222 into blood vessel 236 by employing delivery system 200. As depicted in Figures 3C and 3D, the physician (not shown) pushes delivery system 200 through a surgically created opening 234 in blood vessel 236. The physician pushes delivery system 200 with a pushing shaft 212 via a handle 214. It is noted that, system 200 can further include an introducing sleeve (not shown), similar to introducing sleeve 128 of Figure 1A. The introducing sleeve envelopes extending graft portion 228, pushing shaft 212 and main tube 204 during insertion of delivery system 200 into blood vessel 236. Once delivery system 200 is positioned within blood vessel 236, the introducing sleeve is removed from delivery system 200.

As depicted in Figure 3E, after delivery system 200 is positioned within blood vessel 236, distally to opening 234, the physician removes pushing shaft 212. The physician pulls delivery system 200 proximally by pulling extending graft portion 228, until main tube 204 is positioned proximally to surgically created opening 234. In this manner, the connection point (not referenced) between proximal graft portion 224, distal graft portion 226 and extending graft portion 228 is positioned adjacent to surgically created opening 234. In other words, proximal graft portion 224 and distal graft portion 226 are positioned proximally and distally, respectively, to opening 234.

It is further noted that, proximal stent 232 is deployed whilst it is expanded. In particular, main tube proximal portion 218 dilates blood vessel 236, thereby enabling the deployment of proximal stent 232 whilst it is expanded. It is noted that, the maximal diameter of proximal portion 218 is larger than that of distal portion 216. In this manner, the diameter of proximal stent 232 positioned around distal portion 216 does not exceed that of proximal portion 218.

The physician pushes extraction shaft 210 such that the distal end thereof is positioned adjacent opening 234. In this manner when the physician pulls thread 208, thread 208 does not apply pressure on the walls of blood vessel 236, rather thread 208 applies pulling force on main tube 204 in the proximal-distal axis alone. The physician pulls thread 208 through extraction shaft 210 for moving main tube 204 in the distal direction, until main tube 204 is fully removed from proximal graft portion 224. Thus, main tube 204 is positioned distally to proximal graft portion 224. The physician pushes extraction shaft 210 until it is aligned with and is adjacent to, main tube 204, as depicted in Figure 3F. The physician pulls thread 208 through extraction shaft 210, while holding extraction shaft 210 in place for stopping main tube 204 from moving in the proximal direction. The physician applies a predetermined force on lump 238 and thereby, breaks lump 238. As detailed herein above, thread 208 applies force on main tube 204, and in particular on lump 238, in the proximal-distal axis alone. The physician pulls thread 208 until distal cap 202 envelopes distal end 216, such that delivery system 200 is at the closed configuration thereof, as depicted in Figure 3B. The physician extracts extraction shaft 210 through extending graft portion 228. The physician pulls thread 208 and extracts delivery system 200 from vessel 236 through stent graft 222 (i.e., through distal graft portion 226 and through extending graft portion 228).

It is noted that, stent graft 222 is deployed at the location of surgically created opening 234, through which stent graft 222 is delivered into blood vessel 236. In this manner, the physician does not navigate delivery system 200 through blood vessel 236. It is further noted that, the physician positions delivery system 200 by simple movements of pushing (i.e., pushing pushing shaft 212) and then pulling (i.e., pulling extending graft portion 228).

Reference is now made to Figures 4A to 4C, which are schematic illustrations of a bifurcated stent graft delivery system, generally referenced 250, constructed and operative in accordance with another embodiment of the disclosed technique. Delivery system 250 includes a distal cap 252, a proximal cap 254, a distal cap wire 264, a proximal cap wire 266, a main tube 268, an extraction thread 270, and an extraction shaft 276, a distal inner tube 278 and a proximal inner tube 280. A stent graft 284 substantially similar to stent graft 222 of Figures 3A to 3H is mounted on delivery system 250. Stent graft 284 includes a proximal graft portion 286, a distal graft portion 288, an extending graft portion 290, a distal stent (not shown) and a proximal stent (not shown). The distal stent supports distal graft portion 288. The proximal stent supports proximal graft portion 286. It is noted that for the sake of clearance of the drawings, both the distal stent and the proximal stent are not shown in figures 4A to 4C. The distal stent and the proximal stent are mounted around the distal end and the proximal end, respectively, of main tube 268. The distal stent and the proximal stent are covered by distal cap 252 and proximal cap 254, respectively.

Distal inner tube 278 extends from approximately the center of distal cap 252 in the proximal direction. Proximal inner tube 280 extends from approximately the center of proximal cap 254 in the distal direction. Distal inner tube 278 is slidably coupled with main tube 268, from the distal end of main tube 268. Proximal inner tube 280 is slidably coupled with main tube 268, from the proximal end of main tube 268. In this manner, Main tube 268 is slidably coupled between distal cap 252 and proximal cap 254, via distal inner tube 278 and proximal inner tube 280, respectively.

In case distal cap 252 and proximal cap 254 are both positioned adjacent to each other approximately in the middle of main tube 268, delivery system 250 is at a closed configuration thereof, as depicted in Figure 4A. In case distal cap 252 and proximal cap 254 are both positioned furthest from each other at opposing ends of main tube 268, delivery system 250 is at an open configuration thereof, as depicted in Figure 4B.

Distal cap 252 and proximal cap 254 are substantially a mirror image of each other. For brevity, only the structure of proximal cap 254 is detailed and depicted in Figure 4C (i.e., as the structure of distal cap 252 is substantially a similar mirror image). Proximal cap 254 is in the shape of a tapering hollow elongated tube. A proximal cap fastening point 262 is coupled with the distal end of proximal cap 254 (in a similar manner, a distal cap fastening point 260 is coupled with the proximal end of distal cap 252). Main tube 268 includes distal stopper 272, a proximal stopper

274, a distal ring 256 and a proximal ring 258. Distal ring 256 and proximal ring 258 are coupled at the distal and proximal ends of main tube 268, respectively. Distal stopper 272 is coupled at the distal end of main tube 268 such that when distal cap 252 is pulled distally by distal cap wire 264, distal stopper 272 stops the distal stent from moving distally as well. In this manner, the distal stent remains wrapped around the distal end of main tube 268 and is exposed. Distal stopper 272 is tapered at the proximal end thereof. In case delivery system 250 is at the open configuration, as depicted in Figure 4B, the tapering of distal stopper 272 enables easier movement of delivery system 250 in the proximal direction.

Proximal stopper 274 is coupled at the proximal end of main tube 268 such that when proximal cap 254 is pulled proximally by proximal cap wire 266, proximal stopper 274 stops the proximal stent from moving proximally as well. In this manner, the proximal stent remains wrapped around the proximal end of main tube 268 and is exposed. Proximal stopper 274 is tapered at the distal end thereof. In case delivery system 250 is at the open configuration, as depicted in Figure 4B, the tapering of proximal stopper 274 enables easier movement of delivery system 250 in the distal direction. Extraction thread 270 is coupled with the proximal end of proximal cap 254, passes along the dorsal side of proximal cap 254, within proximal graft portion 286, and out of extraction shaft 276.

Distal cap wire 264 is coupled with distal cap 252 at distal cap fastening point 260. Proximal cap wire 266 is coupled with proximal cap 254 at proximal cap fastening point 262. Each of distal cap wire 264 and proximal cap wire 266 passes through distal ring 256 and proximal ring 258, respectively. The configuration of distal cap wire 264 and proximal cap wire 266 with regards to distal cap fastening point 260, proximal cap fastening point 262, distal ring 256, and proximal ring 258 is depicted in detail in figure 4C. As detailed herein above, for brevity, only the configuration of proximal cap wire 266 is detailed therein. Proximal cap wire 266 is coupled with proximal cap fastening point 262. Proximal cap wire 266 goes through proximal ring 258 and through extraction shaft 276.

Stent graft 284 is mounted on delivery system 250. Distal graft portion 288 and the distal stent supporting it are enclosed within distal cap

252. Proximal graft portion 286 and the proximal stent supporting it are enclosed within proximal cap 254.

Delivery system 250 is positioned within a blood vessel (not shown - e.g., vessel 236 of Figures 3A to 3H) through surgically created opening (not shown - e.g., opening 234 of Figures 3A to 3H) in a similar manner to that of delivery system 200 of Figures 3A to 3H. Once delivery system 250 is positioned in place, a physician (not shown) pulls distal cap wire 264 and proximal cap wire 266 through extraction shaft 276. As a result, distal cap 252 and proximal cap 254 are moved away from each other (i.e., in distal direction and in proximal direction, respectively). Thus, delivery system 250 shifts to the open configuration, as depicted in figure 4B. It is noted that, the above motion (i.e., of both distal cap 252 and proximal cap 254) exposes the distal stent and the proximal stent, thereby allowing the stents to self expand.

Once delivery system 250 is at the open configuration, the tapered ends of distal stopper 272 and proximal stopper 274 are exposed. In this manner, distal stopper 272 and proximal stopper 274 enable smooth extraction of delivery system 250 through stent graft 284. The physician pulls extraction thread 270 through extraction shaft 276 to advance delivery system 250 in the distal direction until proximal cap 254 passes through proximal graft portion 286, such that it is aligned with extraction shaft 276. The physician removes extraction shaft 276 and extracts extraction thread 270 and delivery system 250 from the blood vessel through extending graft portion 288.

It is noted that, stent graft 284 is deployed at the location of the surgically created opening, through which stent graft 284 is delivered into the blood vessel. In this manner, the physician does not navigate delivery system 250 through the blood vessel. It is further noted that, the surgically created opening is smaller than delivery system 250. In this manner, delivery system 250 dilates the opening and the blood vessel when inserted thereto. Note also that the physician positions delivery system 250 by simple movements of pushing and then pulling.

Reference is now made to Figures 5A and 5B, which are schematic illustrations of a bifurcated stent graft delivery system, generally referenced 350, constructed and operative in accordance with a further embodiment of the disclosed technique. Delivery system 350 includes a distal cap 352, a proximal cap 354, a main tube 356, an extraction cord 358, a distal piston 360, a proximal piston 362 and a main tube power extension 368.

A stent graft 374, substantially similar to stent graft 284 of Figures 4A to 4C, is mounted on delivery system 350, such that a distal stent and a proximal stent thereof (both not shown) are covered by distal cap 352 and proximal cap 354, respectively. Each of distal cap 352, proximal cap 354 and extraction cord 358, is substantially similar to distal cap 252, proximal cap 254 and extraction cord 270, respectively, all of Figures 4A to 4C. Main tube 356 includes a lumen 376 formed along the proximal-axial axis thereof. Lumen 376 includes a distal opening and a proximal opening (both not referenced), tightly sealed by distal piston 360 and proximal piston 362, respectively. Central lumen 376 is coupled with main tube power extension 368 through a central opening (not referenced) therein. Main tube power extension 368 is further coupled with an external power source (not shown). Each of distal cap 352 and proximal cap 354 is slidably coupled with main tube 356, via distal piston 360 and proximal piston 362, respectively. Main tube 356 is further coupled with distal stopper 364 and proximal stopper 366, which are substantially similar to distal stopper 272 and proximal stopper 274 of Figures 4A to 4C.

Figure 5A depicts delivery system 350 at a closed configuration thereof. At the closed configuration, the distal end of distal cap 352 is adjacent to distal stopper 364, such that distal cap 352 is located at its most proximal position relative to main tube 356. At the closed configuration, the proximal end of proximal cap 354 is adjacent to proximal stopper 366, such that proximal cap 354 is located at its most distal position relative to main tube 356. In other words, the distance between distal cap 352 and proximal cap 354 is the shortest at the closed configuration, as depicted in Figure 5A. Figure 5B depicts delivery system 350 at an open configuration thereof. At the open configuration distal cap 352 is located at its most distal position relative to main tube 356. At the open configuration proximal cap 354 is located at its most proximal position relative to main tube 356. In other words, at the open configuration of delivery system 350, the distance between distal cap 352 and proximal cap 354 is the longest, as depicted in Figure 5B.

Distal piston 360 and proximal piston 362 are hydraulic pistons, slidably coupled with main tube 356. Main tube power extension 368 provides hydraulic pressure into central lumen 376, from the external power source. Thereby, the physician can control the sliding movement of distal piston 360 and proximal piston 362 (i.e., switch between the closed configuration and the open configuration of delivery system 350). Alternatively, distal piston 360, proximal piston 362, and main tube power extension 368 are associated with a different power source, such as electric, pneumatic, mechanical (e.g., gears and shafts), and the like. A physician (not shown) delivers delivery system 350 into a blood vessel (not shown), in a substantially similar manner to that of delivery system 250 of Figures 4A to 4C. The physician delivers delivery system 350 at the closed configuration thereof. Once delivery system 350 is at its designated position, the physician operates the external power source and slides distal cap 352 and proximal cap 354 in the distal and proximal directions, respectively. Thereby, the physician exposes the distal stent and the proximal stent (both not shown) of stent graft 374. The distal stent and the proximal stent self expand and stent graft 374 is deployed. The physician extracts delivery system 350 in a similar manner to that of delivery system 250 of Figures 4A to 4C.

It is noted that, stent graft 374 is deployed at the location of the surgically created opening, through which stent graft 374 is delivered into the blood vessel. In this manner, the physician does not navigate delivery system 350 through the blood vessel. It is further noted that, the diameter of the surgically created opening is smaller than that of delivery system 350, such that delivery system 350 dilates the opening. Note also that the physician positions delivery system 350 by simple movements of pushing and then pulling. A delivery system (e.g., delivery system 100 of Figure 1A or delivery system 150 of figure 2A) includes a stent graft device. Stent graft devices are produced in a variety of methods, such as those detailed herein below. It is noted that, the stent graft device can be produced in any other method known in the art. Reference is now made to Figure 6, which is a schematic illustration of a stent, generally referenced 400, constructed and operative in accordance with another embodiment of the disclosed technique. Stent 400 includes a plurality of rings 402A, 402B, 402C, 402D, 402E, 402F, 402G, 402H, 402I, and 402J. Rings 402A to 402J are wound around a graft (not shown - e.g., graft 124 of Figure 1A). Alternatively, stent rings 402A to 402J are sewn into the graft. Further alternatively, the graft is wrapped around rings 402A to 402J. Rings 402A to 402J are separate from each other and are wound at regular intervals around the graft. Alternatively, rings 402A to 402J are wound around the graft at predetermined irregular intervals. Irregular interval winding of stent rings 402A to 402J is employed, for example, for reinforcing at least one portion of the graft (e.g., the branching of a bi-furcated stent graft).

Rings 402A to 402J are made of a selected one of a plurality of materials such as, stainless steel, Cobalt alloys, Titanium alloys, Nitinol, Poly-Tetra-Fluoro-Ethylene (PTFE), and the like. The material rings 402A to 402J are made of is chosen so as to provide stent rings 402A to 402J attributes such as corrosion resistance, fatigue resistance, visibility by standard medical imaging systems (e.g., X-ray, MRI), and the like. Alternatively, at least a first portion of rings 402A to 402J are made of a first material and at least a second portion of rings 402A to 402J are made of a second material (e.g., rings 402D, 402E, 402F are made of a more flexible material than the rest of rings 402A to 402J for enabling the branching of the graft).

Reference is now made to Figure 7, which is a schematic illustration of a stent graft device, generally referenced 440, constructed and operative in accordance with a further embodiment of the disclosed technique. Stent 440 includes a bundle of strings 442 wrapped around a graft 444. Graft 444 is substantially similar to graft 124 of Figure 1A. Bundle of strings 442 includes a main bundle 446A a first branch bundle 446B and a second branch bundle 446C. Graft 444 includes a main portion 448A, a first branch portion 448B and a second branch portion 448C. The strings (not shown) of bundle of strings 442 are substantially similar to stent rings 202A to 202J of Figure 3 (i.e., similar materials and functions).

Main bundle 446A is wound around main portion 448A at a helix configuration. At the distal end of main portion 448A (i.e., at the branching of graft 444), main bundle 446A is divided into first branch bundle 446B and second branch bundle 446C. Each of first branch bundle 446B and second branch bundle 446C is wound around each of first branch portion 448B and second branch portion 448C, respectively, at a helix configuration. It is noted that, each of first branch bundle 446B and second branch bundle 446C includes half the number of strings of main bundle 446A.

Reference is now made to Figure 8, which is a schematic illustration of a stent graft device, generally referenced 470, constructed and operative in accordance with another embodiment of the disclosed technique. Stent graft 470 includes a stent 472 and a graft 474. Graft 474 is substantially similar to graft 124 of figure 1A. Graft 474 includes a main portion 478A, a first branch portion 478B and a second branch portion 478C. Stent 472 includes a double cord main portion 476A, a single cord first branch 476B and a single cord second branch 476C. Double cord main branch is braided around main portion 478A at a warp and weft configuration. At the distal end of main branch 478A double cord main portion 476A splits into single cord first branch 476B and single cord second branch 476C. Each of single cord first branch 476B and single cord second branch 476C is wrapped around each of first branch portion 478B and second branch portion 478C, in a similar fashion to double cord main portion 476A. The cords (not shown) of stent 472 are substantially similar to stent rings 402A to 402J of Figure 6 (i.e., similar in materials and functions).

Different portions of the stents, as detailed herein above, can be coupled together (e.g., for closing each of rings 402A to 402J of Figure 6) by employing a variety of couplers. In other words each of the following couplers is directed at coupling two wires of a stent, each of the wires is of a different portion of the stent. Thus, the couplers couple different portions of the stent. Several examples of such couplers are detailed herein below. Reference is now made to Figure 9, which is a schematic illustration of sewing coupler, generally referenced 500, constructed and operative in accordance with a further embodiment of the disclosed technique. Coupler 500 includes a left extension 502L, a right extension 502R, a left arm 504L, a right arm 504R, a first stitch 506A and a second stitch 506B. Left extension 502L is extending from a first stent portion (i.e., a wire of the first stent potion, for example a first end of ring 202A of Figure 3). Right extension 502R is extending from a second stent portion (e.g., a second end of ring 202A of Figure 3). Left arm 504L is coupled with the right end of left extension 502L. Right arm 504R is coupled with the left end of right extension 502R. Left arm 504L is attached to right arm 504R via first stitch 506A and second stitch 506B such that left extension 502L is securely coupled with right extension 502R. For example, left extension 502L is positioned at a first end of a string and right extension is positioned at the opposite end of the string, such that be employing coupler 500, the string is securely closed in the shape of a ring (e.g., ring 402A of figure 6). It is noted that, any number of stitches can be employed for securing left arm 504L to right arm 504R.

Reference is now made to Figure 10, which is a schematic illustration of a welding coupler, generally referenced 520, constructed and operative in accordance with another embodiment of the disclosed technique. Welding coupler 520 includes a left extension 522L, a right extension 522R, a top left arm 524T, a bottom left arm 524B, a right arm 526 and a welding seam 528. Left extension 522L is extending from a first stent portion (e.g., a first end of ring 402A of Figure 6), in a substantially similar manner to left extension 502L of Figure 9. Right extension 522R is extending from a second stent portion (e.g., a second end of ring 402A of Figure 6), in a substantially similar manner to right extension 502R of Figure 9 Top left arm 524T and bottom left arm 524B are coupled with the right end of left extension 522L. Right arm 526 is coupled with the left end of right extension 522R. Right arm 526 is welded between top left arm 524T and bottom left arm 524B via welding seam 528. Reference is now made to Figure 11 , which is a schematic illustration of a welding coupler, generally referenced 540, constructed and operative in accordance with a further embodiment of the disclosed technique. Welding coupler 540 includes a right extension 542L, a left extension 542R, a right C arm 544, a left ball arm 546, and a welding seam 548. Left extension 542L is extending from a first stent portion (e.g., a first end of ring 402A of Figure 6), in a substantially similar manner to left extension 502L of Figure 9. Right extension 542R is extending from a second stent portion (e.g., a second end of ring 402A of Figure 6), in a substantially similar manner to right extension 502R of Figure 9. Left C arm 544 is coupled with the right end of left extension 542L. Right ball arm 546 is coupled with the left end of right extension 542R. The ball end of right ball arm 546 is welded within the C shaped end of left C arm 544 via welding seam 548. Reference is now made to Figure 12, which is a schematic illustration of a sawing coupler, generally referenced 570, constructed and operative in accordance with another embodiment of the disclosed technique. Sewing coupler 570 includes a left extension 572L, a right extension 572R, a left C shaped arm 574, a right circular arm 576 and a plurality of stitches 578A, 578B, 578C and 578D. Left extension 572L is extending from a first stent portion (e.g., a first end of ring 402A of Figure 6), in a substantially similar manner to left extension 502L of Figure 9. Right extension 572R is extending from a second stent portion (e.g., a second end of ring 402A of Figure 6), in a substantially similar manner to right extension 502R of Figure 9. Left C shaped arm 574 is coupled with the right end of left extension 572L. Right circular arm 576 is coupled with the left end of right extension 572R. Right circular arm 576 is coupled with left C shaped arm 574 via stitches 578A, 578B, 578C and 578D.

There are a variety of methods for producing a graft (e.g., graft 124 of Figure 1A). Some examples of such methods are detailed herein below. Reference is now made to Figures 13A, 13B and 13C. Figure 13A is a schematic illustration of a graft, generally referenced 600, constructed and operative in accordance with a further embodiment of the disclosed technique. Figure 13B is a schematic illustration of the graft of Figure 13A including a stent, generally referenced 608. Figure 13C is a schematic illustration of the graft of Figure 13A including stent graft coating, generally referenced 610.

With reference to Figure 13A, graft 600 includes a proximal portion 602, a distal portion 604 and a branching portion 606. Proximal portion 602 is coupled at the distal end thereof with the proximal end of distal portion 604 and with branching portion 606. Graft 600 can be produced in a variety of methods. A first example of a method for producing graft 600 is by wrapping PTFE films around a graft model (not shown) in the shape of graft 600. A second example of a method for producing graft 600 is by spraying PTFE on the graft model. A third example of a method for producing graft 600 is by knitting together two cylinders of PTFE as detailed further with reference to Figure 11. A fourth example is by producing graft 600 from animal pericardium. A fifth example is by employing materials such as ceramic materials or polymers for producing graft 600. With reference to Figure 13B, a stent 608 is wrapped around graft 600. Stent 608 is produced in a variety of methods, such as detailed with reference to Figures 6, 7 and 8. With reference to Figure 13C, graft 600 and stent 608 is coated with stent graft coating 610. Stent graft coating 610 is employed for various reasons, such as improving the bio-compatibility of graft 600, drug delivery over time, and the like. In the example set forth in Figure 13C, coating 610 is depicted as a sheet coating (i.e., full coating substantially similar to the graft). Alternatively coating 610 is deposited on the wires of the stent (e.g., rings 402A to 402J of Figure 6) and is not a solid sheet but rather is in the shape of the stent. Reference is now made to Figure 14, which is a schematic illustration of a graft, generally referenced 630, constructed and operative in accordance with another embodiment of the disclosed technique. Graft 630 includes a main portion 632 and a branching portion 634. Main portion 632 includes an opening 636 in the middle of the dorsal side thereof. Branching portion 634 is coupled with opening 636 in the middle of main portion 632. Branching portion 634 is coupled with main portion 632 by employing a coupler as detailed further herein below. Each of main portion 632 and branching portion 634 is cylinder shaped.

Reference is now made to Figure 15, which is a schematic illustration of a stent, generally referenced 650, constructed and operative in accordance with a further embodiment of the disclosed technique. Stent 650 includes a main portion 652 and a proximal portion 656. Main portion 652 includes an opening 654 at the middle of the ventral side thereof. The distal end of proximal portion 656 is coupled with opening 654 of main branch 652. Reference is now made to Figures 16A and 16B. Figure 16A is a schematic illustration of a stent design pattern, generally referenced 680, constructed and operative in accordance with another embodiment of the disclosed technique. Figure 16B is a schematic illustration of an enlarged view of a portion of the stent design pattern of Figure 16A. With reference to Figure 16A, stent design 680 includes a plurality of links 682 and a gap 684. Stent design pattern 680 is an example of a design pattern of a stent (e.g., distal stent 120 of Figure 1A).

Each of links 682 is coupled with other links 682 on at least a selected one of the left side, the right side, the top, and the bottom thereof. It is noted that, by not coupling each of links 682 with other links 682 on all sides (i.e., left, right, top bottom) the elasticity of stent design 680 is increased and stent design 680 can be stretched and deformed into a wider variety of frames. Gap 684 is positioned at the center of stent design pattern 680. Gap 684 is filled with stent links 682 ordered as detailed further herein below with reference to Figure 16B. It is noted that, stent design pattern 680 depicts a portion of the stent and therefore is rectangular (i.e., the full stent is cylindrical).

With reference to Figure 16B, links 682 filling the gap of Figure 16A are depicted in an enlarged view. The surface area of gap 684 would be covered with three links 682 anywhere else on stent design pattern 680, other than gap 684. Gap 684 is filled with fifteen links 682 ordered in three rows of increasing number of links 682. First row 686 of links 682 includes three links 682. Second row 688 of links 682 includes five links 682. Third row 690 of links 682 includes seven links 682. Gap 684 filled with an increased number of links 682 enables stent design 680 to spread to a bigger perimeter than any other surface of stent design 680 (i.e., gap 684 includes a larger number of links 682). The bigger perimeter of the portion of gap 684 within stent design 680 is employed for example in the branching portion of stent 650 of Figure 15, which is of a bigger perimeter than the rest of stent 650 of Figure 15. Each of links 682 is substantially similar in terms of materials to rings 402A to 402J of Figure 6.

Reference is now made to Figures 17A to 17E, which are schematic illustrations of a stent graft device, generally referenced 720, constructed and operative in accordance with a further embodiment of the disclosed technique. Stent graft 720 includes a proximal graft portion 722, a distal graft portion 724, an extending graft portion 726, a graft opening 736, an elongated stent 734, and an outer layer 740. Elongated stent 734 includes a distal stent portion 728, a proximal stent portion 730 and a stent opening 732. Outer layer 740 includes an outer opening 738. Proximal graft portion 722 is coupled with distal graft portion 724 for forming an elongated graft 744. Proximal stent portion 730 is coupled with distal stent portion 728 for forming elongated stent 734. Elongated stent is constructed of rows of links 746, 748 and 750. Each of the links (not referenced) of rows of links 746, 748 and 750 is substantially similar to links 682 of Figure 16A. Graft opening 736 is positioned on the dorsal side of elongated graft 744, approximately at the middle thereof. Stent opening 732 is positioned on the dorsal side of elongated stent 734, approximately at the middle thereof. Outer opening 738 is positioned on the dorsal side of outer layer 740, approximately at the middle thereof. Alternatively all of graft opening 736, stent opening 732 and outer opening 738 is positioned either distally or proximally to the middle of elongated graft 744, elongated stent 734 and outer layer 740, respectively.

Elongated graft 744 is coupled with extending graft portion 726 via graft opening 736. Elongated stent 734 is enveloping elongated graft 744, such that stent opening 732 coincides with graft opening 736. Outer layer 740 envelopes elongated graft 744 and elongated stent 734, such that outer opening coincides with graft opening 736 and with stent opening 732. In this manner, extending graft portion 726 extends through stent opening 732, graft opening 736 and outer opening 738. It is noted that, all of graft opening 736, stent opening 732 and outer opening 738 coincide with each other for defining a closable access port (not referenced) in stent graft 720.

Extending graft portion 726 is coupled with elongated graft 744 at a coupling angle 742. Stent opening 732 is a double strut closed link which functions as double strut keel connecting all rows of links 746, 748 and 750 of elongated stent 734. In other words, stent opening 732 is a stent link which couples row of links 748 with rows of links 746 and 750. In this manner stent 734 is flexible. In an alternative case, where elongated stent includes more than three rows of links (e.g., five rows of links), stent opening 732 couples all rows of links of elongated stent 734. Further alternatively, stent opening 732 couples three rows of links, and other longitudinally elongated couplers (not shown - e.g., coupling rods, coupling rings, coupling threads) couple at least one of the three rows with other rows of links either above or below. Outer layer 740 is substantially similar to stent graft coating 610 of Figure 13C. Outer layer 740 is employed for various reasons, such as improving the bio-compatibility of stent graft 720, lubricating stent graft 720, drug delivery over time, and the like. Outer layer 740 is optional and can be omitted from stent graft 720.

As depicted in Figure 17E, stent opening 732 is at a closed configuration thereof. The closed configuration is the default configuration of stent opening 732. Stent opening 732 switches to an open configuration upon appliance of an external force thereon, such as an object (i.e., a dilator) pushed into elongated graft 744 through extending graft portion 726. This is useful for applications in which it is important to discontinue fluid communication between elongated graft 744 and extending graft portion 726, upon removal of such external object, it is noted that, at the closed configuration of stent opening 732, graft opening 736 and outer opening 738 are closed as well, thereby discontinuing fluid connection. It is further noted that, upon removal of the pushed object (e.g., the dilator), stent opening 732 returns to the closed configuration.

Alternatively, as depicted in Figure 17F the default configuration of stent opening 732 is the open configuration. Stent opening 732 is employed in case it is important to maintain fluid communication between elongated graft 744 and extending graft portion 726, through graft opening 736, stent opening 732 and outer opening 738.

Reference is now made to Figures 18A to 18C. Figure 18A is a schematic illustration of stent sheaths pushing and pulling scheme, generally referenced 800, for exposing the stents of a stent graft device, constructed and operative in accordance with another embodiment of the disclosed technique. Figure 18B is a schematic illustration of stent sheaths pushing and pulling scheme, generally referenced 820, for exposing the stents of a stent graft device, operative in accordance with a further embodiment of the disclosed technique. Figure 18C is a schematic illustration of stent sheaths pushing and pulling scheme, generally referenced 840, for exposing the stents of a stent graft device, operative in accordance with another embodiment of the disclosed technique.

With reference to Figure 18A, stent sheath pushing and pulling scheme 800 includes a graft 802, a distal stent sheath 804, a proximal stent sheath 806, an external stent sheath 808, a distal stent sheath over arrow 810, a distal stent sheath through arrow 812, a proximal stent sheath over arrow 814, a proximal stent sheath through arrow 816, and an external stent sheath over arrow 818. Each of distal stent sheath 804, proximal stent sheath 806, and external stent sheath 808, covers a respective stent (e.g., distal stent 120 of Figure 1A). Stent sheath pushing and pulling scheme 800 depicts the pushing and pulling scheme of each of distal stent sheath 804, proximal stent sheath 806, and external stent sheath 808, employed for exposing each of the stents and for retracting a delivery system (e.g., delivery system 100 of Figure 1A). Each of arrows 810, 814, and 818 is depicted as a continuous arrow (i.e., as opposed to a dashed arrow) meaning the movement a respective stent sheath makes is over its respective folded stent. Each of arrows 812 and 816 is depicted as a dashed arrow meaning the movement a respective stent sheath makes is through its respective expanded stent. External stent sheath 808 is pulled in the direction of external stent sheath over arrow 818, such that it moves over its respective stent and exposes the stent. Distal stent sheath 804 is first pushed in the direction of distal stent sheath over arrow 810 such that it moves over its respective stent and exposes it. After the stent expands, distal stent sheath 804 is pulled in the direction of distal stent sheath through arrow 812 such that it moves through its respective expanded stent and through the expanded stent respective of external stent sheath 808, and is pulled out.

Proximal stent sheath 806 is first pushed in the direction of proximal stent sheath over arrow 814 such that it moves over its respective stent and exposes it. After the stent expands, proximal stent sheath 806 is first pulled in the direction of the lower portion of proximal stent sheath through arrow 816 such that it moves through the expanded stent. Than, proximal stent sheath 806 is pulled in the direction of the upper portion of arrow 816 such that it moves through the expanded stent respective of external stent sheath 808 and is pulled out. It is noted that, each of distal stent sheath 804 and proximal stent sheath 806 is pushed over its respective stent for exposing the stent and through its expanded respective stent for retraction of the delivery system.

With reference to Figure 18B, stent sheath pushing and pulling scheme 820 includes a graft 822, a main stent sheath 826, a branching stent sheath 824, a branching stent sheath over arrow 828, a branching stent sheath through arrow 830, and a main stent sheath over arrow 832. Each of main stent sheath 826 and branching stent sheath 824, covers a respective stent (not shown - e.g., distal stent 120 of Figure 1A). Main stent sheath 826 is pulled in the direction of main stent sheath over arrow 832 such that it moves over its respective stent and exposes it. Branching stent sheath 824 is first pushed in the direction of branching stent sheath over arrow 828 such that it moves over its respective stent and exposes it. Than, branching stent sheath 824 is pulled in the direction of the lower portion of branching stent sheath through arrow 830 such that is moves through its expanded respective stent. Last, branching stent sheath 824 is pulled in the direction of the upper portion of branching stent sheath through arrow 830 such that it moves through the stent respective of main stent sheath 826 and is pulled out. With reference to Figure 18C, stent sheath pushing and pulling scheme 840 includes a graft 842, a main stent sheath 844, a branching stent sheath 846, a main stent sheath over arrow 848, a main stent sheath through arrow 470, and a branching stent sheath over arrow 472. Each of main stent sheath 844 and branching stent sheath 846 covers a respective stent (not shown - e.g., distal stent 120 of Figure 1A). Branching stent sheath 846 is pulled in the direction of branching stent sheath over arrow 852 such that it moves over its respective stent and exposes it. Main stent 844 is first pushed in the direction of main stent sheath over arrow 848 such that it moves over its respective stent and exposes it. Than, main stent sheath 844 is pulled in the direction of main stent sheath through arrow 850 such that it moves through its respective expanded stent and is pulled out.

An arterial access device is a device deployed in an artery of a patient and enables access to that artery. A physician opens the arterial access device by pushing a dilating surgical tool (e.g., a dilating element of a large diameter delivery system, such as abdominal aortic aneurysm system or a percutaneous aortic valve system, or a hemo-dialysis needle) there-through. The arterial access device either re-closes autonomously or is closed by the physician, once the dilating surgical tool is removed there-from, thereby decreasing blood loss. Reference is now made to Figures 19A and 19B, which are schematic illustrations of an arterial access device, generally referenced 880, constructed and operative in accordance with a further embodiment of the disclosed technique. With reference to Figure 19A, arterial access device 880 includes a bifurcated graft 882 and a closing ring 884. Bifurcated graft 882 is made of substantially similar materials to stent graft 720 of Figures 17A to 17E (e.g., PTFE, Nitinol, pericardium, Dacron and stainless steal alloy). Alternatively, bifurcated graft 882 is made of biodegradable materials (i.e., arterial access device 880 is biodegradable). In this manner, Arterial access device 880 is configured to degrade and be disposed of, after a predetermined time. Closing ring 884 is made of either non-degradable or degradable materials. Some examples of materials closing ring 884 can be made of are Nitinol, elastic polymers, and the like.

Bifurcated graft 882 includes a main portion 888 and a branching portion 886. Bifurcated graft 882 is deployed at a blood vessel (not shown - e.g., blood vessel 134 of Figure 1A) in a substantially similar manner to graft 124 of Figure 1A. Main portion 888 is positioned within the blood vessel, and branching portion 886 extends out of the surgically created opening (not shown - e.g., surgically created opening 136 of Figure 1 B). The physician installs closing ring 884 on the proximal end of branching portion 886 (i.e., on the end of branching portion 886 extending out of the blood vessel).

The physician tightens closing ring 884 around branching portion 886 until branching portion 886 is sealed and blood from the blood vessel can not go there-through. The physician can tighten closing ring 884 in a variety of ways, such as employing a plier, and the like. Figure 19B depicts closing ring 884 from a top view perspective. Alternatively, closing ring 884 is installed on branching portion 886 prior to the delivery of arterial access device 880. Once arterial access device 880 is delivered and the delivery system is extracted and removed from branching portion 886, closing ring 884 self-tightens around branching portion 886. Branching portion 886 and closing ring 884 define a closable access port (not referenced) of arterial access device 880.

After deployment of arterial access device 880, the physician can re-access the blood vessel by pushing a dilating surgical tool into branching portion 886, thereby dilating closing ring 884. Once the physician removes the dilating surgical tool from the blood vessel and from arterial access device 880, the physician re-tightens closing ring 884 for closing arterial access device 880.

It is noted that in case branching portion 886 is kept within the body of the patient while arterial access device 880 is close (i.e., closing ring 884 is tightened), blood can coagulate within branching portion 886 and prevent re-entry into arterial access device 880. The physician can insert an anti coagulation bar (not shown - e.g., a Teflon bar) into branching portion 886 for preventing blood coagulation there-within. In this manner, when re-accessing the blood vessel through arterial access device 880, the physician first removes the anti coagulation bar and than pushes the dilating surgical tool through branching portion 886. Reference is now made to Figures 2OA to 2OD, which are schematic illustrations of an arterial access device, generally referenced 900, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 2OA, arterial access device 900 includes a bifurcated graft 902 and a tightening coil 904. Bifurcated graft 902 is substantially similar to bifurcated stent graft 720 of Figure 17A to 17E (i.e., similar both in form and in materials which it is made from). Tightening coil 904 is made of materials similar to that of closing ring 884 of Figures 19A and 19B. Alternatively, bifurcated graft 902 is made of biodegradable material. Bifurcated graft 902 includes a main portion 908 and a branching portion 906.

Bifurcated graft 902 is deployed in a substantially similar manner to that of graft 124 of Figure 1A. The physician tightens tightening coil 904 around the proximal end of branching portion 906, until branching portion 906 is sealed and blood from the blood vessel can not pass there-through. Alternatively, tightening coil 904 is spring like and self tightens around branching portion 906 once the delivery system is removed from branching portion 906 (i.e., tightening coil 904 is a stretched spring, wound around branching portion 906). Branching portion 906 and closing ring 884 define a closable access port (not referenced) of arterial access device 900. After deployment of arterial access device 900, the physician can re-access the blood vessel by pushing a dilating surgical tool into branching portion 906, thereby dilating closing ring 904. Once the physician removes the dilating surgical tool from the blood vessel and from arterial access device 900, the physician re-tightens closing ring 904 for closing arterial access device 900.

With reference to Figure 2OB, tightening coil 904 is depicted from a side view perspective. With reference to Figure 2OC, a tightening ring 910 is depicted from a top view perspective. Tightening ring 910 is substantially similar to closing ring 882 of Figure 19A, except for the shape thereof. The shape of tightening ring 910 is five petals flower shape. Alternatively, tightening ring 910 can be of a different shape, such as a three petals flower shape, a four petals flower shape, and the like. With reference to Figure 2OD, a tightening ring 912 is depicted from a top view perspective. Tightening ring 912 is substantially similar to closing ring 882 of Figure 19A, except for the shape thereof. The shape of tightening ring 912 is that of an open mouth.

Reference is now made to Figures 21 A and 21 B, which are schematic illustrations of an arterial access device, generally referenced 930, constructed and operative in accordance with a further embodiment of the disclosed technique. With reference to Figure 21A, arterial access device 930 includes a bifurcated graft 932, a closing ring 934 and a blood absorbing cushion 940. Bifurcated graft 932 includes a main portion 938 and a branching portion 936. Each of bifurcated graft 932 and closing ring 934 is substantially similar to bifurcated graft 882 and closing ring 884 of Figure 19A, respectively. Blood absorbing cushion 940 is positioned within branching portion 936 at the proximal end thereof. With reference to Figure 21 B, blood absorbing cushion 940 is exposed from a respective sheath (not shown) and comes into contact with the blood within the blood vessel. Blood absorbing cushion 940 is made of a blood absorbing material for enabling a rapid hemostasis of the surgically created opening. One example of blood absorbing cushion 940 is a collagen scaffold which expands when coming into contact with blood and seals branching portion 936. Branching portion 936 and closing ring 884 define a closable access port (not referenced) of arterial access device 880. When the physician tries to re-access the blood vessel through arterial access device 930, the physician first removes blood absorbing cushion from branching portion 936, and then pushes the dilating surgical tool into arterial access device 930. After the physician removes the dilating surgical tool from arterial access device 930, closing ring 934 autonomously re-tightens around branching portion 936 and re-closes arterial access device 930. The physician replaces blood absorbing cushion 940 with a new blood absorbing cushion 940.

Reference is now made to Figures 22A to 22C, which are schematic illustrations of an arterial access device, generally referenced 960, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 22A, arterial access device 960 includes a graft 964 and an U-shaped slit 966. U-shaped slit 966 is positioned on the dorsal side of graft 964, approximately in the middle thereof. U-shaped Flap 968 is a portion of graft 964 which is defined by U-shaped slit 966 and is slightly larger than U-shaped slit 966, such that when closed, U-shaped flap 968 fully covers U-shaped slit 966. U-shaped flap 968 can swing open into graft 964. U-shaped flap 968 and U-shaped slit 966 define a closable access port (not referenced) which allows re-access of a catheter into the blood vessel, and closes the blood vessel as soon as the catheter is removed.

Graft 964 is substantially cylindrical. Arterial access device 960 is positioned within a blood vessel (not shown - e.g., blood vessel 134 of Figure 1 B), such that U-shaped slit 966 is positioned adjacent to a surgically created opening (not shown - e.g., opening 136 of Figure 1 B). U-shaped Flap 968 can swing from a closed stance (i.e., closing over U-shaped slit 966) to an open stance (i.e., swinging open into graft 964) for allowing a catheter 962 to enter into the blood vessel. The physician deploys arterial access device 960 into the blood vessel prior to a percutaneous procedure. Alternatively, the physician deploys arterial access device 960 after the percutaneous procedure, possibly utilizing the guide wire (e.g., GW 136 of Figure 1 B) of the percutaneous procedure. Further, alternatively, catheter 962 represents the delivery system employed for delivering arterial access device 960 into the blood vessel. Once delivery catheter 962 is removed from arterial access device 960, arterial access device 960 closes the blood vessel and prevents blood spilling out of the surgically created opening. Graft 964 is made of substantially similar materials to graft 124 of Figure 1A (e.g., PTFE, Nitinol, pericardium, Dacron and stainless steal alloy). Alternatively, Arterial access device 960 is made of biodegradable materials such that an extraction thereof is unnecessary. Arterial access device 960 is configured to degrade and be disposed of, after a predetermined period of time. In the example set forth in Figure 22, U- shaped slit 966 is U-shaped. Alternatively slit 966 and accordingly flap 968 are of any shape having a flat base (i.e., the base of slit 966 and of flap 968 is the end of flap 968 which is coupled with graft 964), such as a triangle, a rectangle, and the like. It is noted that, arterial access device 960 starts functioning (i.e., closes the blood vessel and inhibits blood spill) as soon as it is delivered and the delivery system is extracted. With reference to Figure 22B, arterial access device 960 is depicted from a top view perspective. With reference to Figure 22C, arterial access device 960 is depicted from a side view perspective.

Reference is now made to Figures 23A and 23B, which are schematic illustrations of an arterial access device, generally referenced 990, constructed and operative in accordance with a further embodiment of the disclosed technique. With reference to Figure 23A, arterial access device 990 is depicted from a top view perspective. Arterial access device 990 includes a graft 992, a U-shaped slit 994 and a closing stent 996. U-shaped slit 994 is positioned on the dorsal side of graft 992, approximately in the middle thereof. U-shaped Flap 998 is a portion of graft 992 which is defined by U-shaped slit 994 and is slightly larger than U-shaped slit 994, such that when closed, U-shaped flap 998 fully covers U-shaped slit 994. U-shaped flap 998 can swing open into graft 992. Graft 992 is substantially cylindrical. U-shaped flap 998 and U-shaped slit 994 define a closable access port (not referenced) which allows re-access of a catheter into the blood vessel, and closes the blood vessel as soon as the catheter is removed. Closing stent 996 is positioned approximately in the middle of graft 992. Closing stent 996 is enveloped by graft 992. Alternatively, closing stent 996 is embedded between two layers of graft 992 or is external to graft 992.

Closing stent 996 pushes U-shaped flap 998 in the dorsal direction against U-shaped slit 994, such that U-shaped flap 998 covers U-shaped slit 994 and closes it. Arterial access device 990 is positioned within a blood vessel (not shown - e.g., blood vessel 134 of Figure 1 B) such that U-shaped slit 994 is positioned adjacent to the surgically created opening (not shown - e.g., surgically created opening 136 of Figure 1 B). When the physician inserts a dilating surgical tool (e.g., a catheter or a hemo-dialysis machine) into the surgically created opening, the dilating surgical tool pushes U-shaped flap 998 in the ventral direction and opens U-shaped slit 994. When the physician extracts the dilating surgical tool and pulls it out of the surgically created opening, closing stent 996 re-closes U-shaped slit 994 by pushing U-shaped flap 998 there-against. With reference to Figure 23B, arterial access device 990 is depicted from a side cross section view. Arterial access device 990 further includes a structural stent 1000 enveloped by graft 992. Structural stent 1000 maintains the structural stability of graft 992. Arterial access device 990 remains in the body of the patient. Alternatively, Arterial access device 990 is configured to degrade and be disposed of, after a pre-determined period of time. Arterial access device 990 can be coated by a variety of materials, such as procoagulants, medical drugs (i.e., drug eluting coated graft), and the like. It is noted that, arterial access device 990 starts functioning (i.e., closes the blood vessel and inhibits blood spill) as soon as it is delivered and the delivery system is extracted.

Reference is now made to Figures 24A and 24B, which are schematic illustrations of an arterial access device, generally referenced 1020, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 24A, Arterial access device 1020 includes a graft 1022, and a stent 1034. Graft 1022 includes a front portion 1024, a back portion 1026 and a slit 1028. The dorsal side of front portion 1024 overlaps the dorsal side of back portion 1026 defining a front portion overlapping end 1030 and a back portion overlapped end 1032. Slit 1028 is positioned at the front end of back portion overlapped end 1032, such that back portion overlapped end 1032 can be pushed down into graft 1022 and allow re-access into graft 1022. in other words, slit 1028 front portion overlapping end 1030 and back portion overlapped end 1032 define a closable access port (not referenced) which allows re-access of a catheter into the blood vessel, and closes the blood vessel as soon as the catheter is removed. Arterial access device 1020 is positioned within a blood vessel

(not shown) such that blood flows in the direction from front portion 1024 to back portion 1026. The inner diameter of front portion 1024 is slightly smaller than the inner diameter of back portion 1026. When back portion overlapped end 1032 is closed against front portion overlapping end 1030, back portion overlapped end 1032 does not extend beyond the inner diameter of front portion 1024. In this manner, when blood flows through arterial access device 1020, the blood does not push against back portion overlapped end 1032 and accidentally forces the access port open.

Stent 1034 is enveloped by graft 1022 and maintains the structural stability of graft 1022. Stent 1034 further maintains back portion overlapped end 1032 closed against front portion overlapping end 1030. In this manner, blood flowing through arterial access device 1020 does not spill in the gap between overlapped end 1032 and overlapping end 1030. Arterial access device 1020 is positioned within the blood vessel such that overlapping end 1030 is aligned with a surgically created opening (not shown). The physician inserts a catheter through the surgically created opening and pushes the catheter between overlapping end 1030 and overlapped end 1032, and into the blood vessel. When the physician pulls the catheter out, stent 1034 pushes overlapped end 1032 in the dorsal direction and attaches overlapped end 1032 to overlapping end 1030, effectively closing the surgically created opening. It is noted that, arterial access device 1020 starts functioning (i.e., closes the blood vessel and inhibits blood spill) as soon as it is delivered and the delivery system is extracted. With reference to Figure 24B, arterial access device 1020 is depicted from a top view perspective. Some further examples of arterial access device configurations are detailed herein below. Reference is now made to Figures 25A and 25B, which are schematic illustrations of an arterial access device, generally reverenced 1050, constructed and operative in accordance with a further embodiment of the disclosed technique. With reference to Figure 25A, arterial access device 1050 includes a graft 1052 and an overlapping tube 1056. Graft 1052 and overlapping tube 1056 are substantially cylindrical. The diameter of graft 1052 is slightly smaller than that of overlapping tube 1056. Graft 1052 includes a slit 1054 positioned at the middle of the dorsal side thereof. With reference to Figure 25B, overlapping portion is positioned around the middle of graft 1052 and over slit 1054. The front end of overlapping tube 1056 is sewn to graft 1052 by sew 1058. Overlapping tube 1056, sew 1058 and slit 1054 define an access port into graft 1052. Arterial access device 1050 is positioned within a blood vessel (not shown) for enabling re-entry into a blood vessel through a surgically created opening (not shown).

Reference is now made to Figures 26A and 26B, which are schematic illustrations of an arterial access device, generally referenced 1070, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 26A, arterial access device 1070 includes a front portion 1072 and a back portion 1074. Front portion 1072 and back portion 1074 are substantially cylindrical. The diameter of back portion 1074 is slightly smaller than that of front portion 1072. With reference to Figure 26B, front portion 1072 overlaps back portion 1074 and is sewn to back portion 1074 with sew 1076. Sew 1076 does not fully circumvent front portion 1072, such that a slit (not shown) is remained between front portion 1072 and back portion 1074 allowing access into arterial access device 1070. Arterial access device 1070 is positioned within a blood vessel (not shown) for enabling re-entry into a blood vessel through a surgically created opening (not shown).

Reference is now made to Figures 27A and 27B, which are schematic illustrations of an arterial access device, generally referenced 1090, constructed and operative in accordance with a further embodiment of the disclosed technique. With reference to Figure 27A, arterial access device 1090 includes a front portion 1092 and a back portion 1094. Front portion 1092 is in the shape of a narrow cylinder (not referenced) widening into a wide cylinder (not referenced), resembling a funnel. Back portion 1094 is substantially similar shape to front portion 1092. The diameter of back portion 1094 is slightly larger than that of front portion 1092. With reference to Figure 27B, back portion 1094 overlaps front portion 1092, such that the wider end of back portion 1094 surrounds the wider portion of front portion 1092. Front portion 1092 is attached to back portion by employing an attachment method, such as sewing (e.g., sew 1076 of Figure 26B), gluing, and the like. It is noted that front portion 1092 and back portion 1094 are not attached there-between across the entire circumference thereof, rather a slit similar to slit 1054 (Figure 25B) is left unattached.

Reference is now made to Figures 28A and 28B, which are schematic illustrations of an arterial access device, generally referenced 1110, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to Figure 28A, arterial access device 1110 is depicted from a top view perspective. Arterial access device 1110 includes a tube 1112 and a sleeve 1114. The distal end of sleeve 1114 is coupled with the proximal end of tube 1112 across a portion of the circumference thereof (not referenced). The uncoupled portion of the circumference of the distal end of sleeve 1114 enables a catheter to enter arterial access device 1110 and is defined as a closable access port 1116. Closable access port 1116 is positioned on the dorsal side of the circumference of the distal end of sleeve 1114 (i.e., and on the dorsal side of the circumference of the proximal end of tube 1112). Arterial access device 1110 is made of substantially similar materials as those of arterial access device 880 of Figure 19A. Arterial access device 1110 is delivered and deployed within a blood vessel (not shown) in a substantially similar manner to that of graft 124 of Figure 1A. With reference to Figure 28B, arterial access device 1110 is depicted from an isometric view perspective.

In the examples set forth in Figures 19A, 19B, 2OA, 2OB, 2OC, 2OD, 21 A, 21 B, 22A, 22B, 22C, 23A, 23B, 24A, 24B, 25A, 25B, 26A, 26B, 27A, 27B, 28A and 28B, the arterial access devices are all delivered in a substantially similar manner to that of graft 124 of Figure 1A (i.e., delivered from the middle thereof). The arterial access devices are either made of non-biodegrading materials (e.g., PTFE, Nitinol, pericardium, Dacron and stainless steal alloys) and remain within the body of the patient, or of biodegradable materials and are removed from the body of the patient after a predetermined period of time. In the example set forth in Figures 22A, 22B, 22C, 23A, 23B, 24A, 24B, 25A, 25B, 26A, 26B, 27A, 27B, 28A and 28B (i.e., arterial access devices having no branching portion), the arterial access devices start functioning as soon as the delivery system is extracted.

It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.

Claims

1. Delivery system for delivering a graft into a blood vessel through a surgically created opening in the blood vessel and deploying the graft at the position of the opening, the delivery system comprising: a main tube including a proximal portion; an inner tube slidably coupled with said main tube, such that said inner tube slides proximally and distally within said main tube; said graft; a distal stent, coupled with the distal end of said graft, said distal stent expands and anchors said graft onto said blood vessel; a distal cap coupled with the distal end of said inner tube, said distal cap covering said distal stent; and an externally extending tube, coupled with said main tube, after insertion of said delivery system into said blood vessel and upon pulling of said externally extending tube, said externally extending tube pulling said proximal portion in the proximal direction, thereby positioning approximately the middle of said graft adjacent to said surgically created opening, after said distal stent expands and upon being pushed, said externally extending tube pushing said main tube in the distal direction, thereby positioning said main tube including said proximal portion distally to said opening, said externally extending tube pulling said main tube out of said blood vessel through said expanded distal stent and through said surgically created opening; wherein the diameter of said surgically created opening is smaller than that of said delivery system, and wherein once said graft is positioned, such that the middle thereof is adjacent to said surgically created opening, said inner tube pushing said distal cap in the distal direction, thereby removing said distal cap from said distal stent and exposing said distal stent, said proximal portion is located adjacent to said externally extending tube during insertion of said delivery system into said blood vessel through said surgically created opening, said proximal portion of said main tube detaches from said externally extending tube after insertion of said delivery system into said blood vessel.

2. The delivery system of claim 1 , further comprising a proximal stent, said proximal stent being coupled with the proximal end of said graft, said proximal stent expands and anchors said graft onto said blood vessel.

3. The delivery system of claim 2, further comprising a proximal cap, said proximal cap covers said proximal stent during delivery of said graft into said blood vessel, said proximal cap exposes said proximal stent once said graft is positioned, such that the middle thereof is adjacent to said surgically created opening.

4. The delivery system of claim 2, wherein at least one of said distal stent and said proximal stent being a self-expanding stent.

5. The delivery system of claim 3, wherein said distal cap and said proximal cap having a tapered shape.

6. The delivery system of claim 2, wherein said proximal stent replaces said distal stent such that said delivery system includes said proximal stent as a single stent.

7. The delivery system of claim 3, further comprising, a proximal guidewire slidably coupled with said proximal cap; and a second graft, said second graft is delivered into said blood vessel through said surgically created opening, said second graft is guided onto said proximal guidewire and is deployed proximally to said graft.

8. The delivery system of claim 7, wherein said blood vessel being a bifurcated blood vessel including a bifurcation a first branch and a second branch, said delivery system is inserted into said bifurcated blood vessel through said first branch, said surgically created opening is positioned on said first branch, said proximal guidewire is inserted into said bifurcated blood vessel through said first branch and slides through said proximal cap into said second branch, said second graft is inserted into said bifurcated blood vessel through said first branch and slides upon said proximal guidewire into said second branch.

9. Arterial access device for enabling entry and re-entry with a dilating surgical tool into an opening within a blood vessel, the arterial access device comprising: a proximal portion positioned within said blood vessel proximally to said opening; a distal portion, coupled with the distal end of said proximal portion, said distal portion being positioned within said blood vessel distally to said opening; and a closable access port, coupled between said distal portion and said proximal portion, said closable access port being positioned adjacent to said opening, said closable access port being closed; wherein blood enters said arterial access device from said proximal portion and exits said arterial access device out of said distal portion, and wherein said closable access port enables insertion of said dilating surgical tool into said blood vessel, said closable access port re-closing upon removal of said dilating surgical tool.

10. The arterial access device of claim 9, further comprising an elongated stent enveloping said proximal portion and said distal portion, said elongated stent includes a stent opening coinciding with said closable access port, wherein said stent opening is closed, said stent opening enables insertion of a surgical tool into said blood vessel, said stent opening re-closing upon removal of said surgical tool, thereby re-closing said closable access port.

11. The arterial access device of claim 9, wherein said closable access port being an extending portion and an closing ring, said extending portion being coupled with said distal portion and with said proximal portion, said extending portion extending out through said opening, said closing ring being wrapped around said extending portion, said closing ring being tightened around said extending portion for closing said closable access port.

12. The arterial access device of claim 11 , wherein said closing ring being tightened around said extending portion manually.

13. The arterial access device of claim 11 , wherein said closing ring self tightening around said extending portion.

14. The arterial access device of claim 9, wherein said arterial access device being made of biodegradable materials, such that said arterial access device biodegrades within said blood vessel after a predetermined period of time.

15. The arterial access device of claim 11 , further comprising a blood absorbing cushion, located within said extending portion, such that said closing ring being wrapped around said blood absorbing cushion, wherein said blood absorbing cushion decreases blood loss through said opening, and wherein a physician removes said blood absorbing cushion prior to insertion of said dilating surgical tool into said arterial access device, and said physician replacing said blood absorbing cushion with a new blood absorbing cushion after removing said dilating surgical tool from said arterial access device.

16. the arterial access device of claim 11 , wherein in case said arterial access device is kept close within said blood vessel such that said extending portion extends through said opening, a physician inserts a anti coagulation bar into said extending portion for preventing blood coagulation within said extending portion.

17. The arterial access device of claim 9, wherein closable access port includes a slit and a covering flap, said covering flap covering said slit for closing said closable access port.

18. The arterial access device of claim 17, further comprising a closing stent positioned within said arterial access device adjacent to said slit, wherein said closing stent closing said closable access port.

19. The arterial access device of claim 9, wherein said distal portion overlaps said proximal portion, such that a an overlapping proximal end of said distal portion is enveloping an overlapped distal end of said proximal portion, said arterial access device further comprising a slit located on the proximal end of said overlapped distal end of said proximal portion, said slit, said overlapping portion and said overlapped portion defining said closable access port.

20. The arterial access device of claim 19, wherein the diameter of said distal portion being slightly smaller than the diameter of said proximal portion.

21. The arterial access device of claim 9, further comprising a slit and an overlapping tube, said slit positioned between said distal portion and said proximal portion, said overlapping tube enveloping said slit, the diameter of said overlapping tube is slightly bigger than the diameter of said distal tube and of said proximal tube, the distal end of said overlapping tube being sewn to said distal portion, said slit and said overlapping tube defining said closable access port.

22. The arterial access device of claim 9, wherein the diameter of said distal portion being slightly larger than that of said proximal portion, said distal portion overlapping said proximal portion, the proximal end of said distal portion being sewn to said proximal portion, such that at least some of the circumference of the proximal end of said distal portion remains un-sewn, therefore defining a slit, said slit and the overlapping portion of said distal portion defining said closable access port.

23. The arterial access device of claim 22, wherein said distal portion having the shape of a cylinder widening into a wider cylinder towards the proximal end thereof, said proximal portion having the shape of a cylinder widening into a wider cylinder towards the distal end thereof.

24. The arterial access device of claim 22, wherein said distal portion is coupled with said proximal portion at end thereof, such that there is no overlap between said distal portion and said proximal portion.

25. Method for delivering a graft into a blood vessel through a surgically created opening in the blood vessel and deploying the graft at the position of the opening, the method comprising the procedures of: inserting said graft into said blood vessel through said surgically created opening by employing a delivery system, said graft being positioned distally to said surgically created opening, the diameter of said surgically created opening is smaller than that of said delivery system; detaching a proximal portion of a main tube of said delivery system from an externally extending tube of said delivery system; pulling said externally extending tube such that said proximal portion and a proximal graft portion of said graft being positioned proximally to said surgically created opening; pushing a distal cap of said delivery system distally by pushing an inner tube of said delivery system, slidably coupled with said main tube, thereby exposing said distal stent; expanding a distal stent and anchoring said graft onto said blood vessel distally to said surgically created opening; pushing said externally extending portion, thereby pushing said delivery system and positioning said delivery system distally to said surgically created opening; reattaching said proximal portion of said delivery system to said externally extending portion of said delivery system; and pulling said graft out of said blood vessel through said expanded distal stent and through said surgically created opening by pulling said externally extending tube.

26. The method of claim 25, further comprising the procedure of expanding a proximal stent of said graft and anchoring said graft onto said blood vessel proximally to said surgically created opening.

27. The method of claim 26, where said procedure of expanding said proximal stent including a sub procedure of pushing a proximal cap of said delivery system in the proximal direction for exposing said proximal stent.

28. The method of claim 25, further comprising the pre-procedure of creating said surgically created opening at a desired deployment site for said graft and having a diameter corresponding to the diameter of said delivery system.

29. The method of claim 25, wherein said blood vessel is a bifurcated blood vessel having a bifurcation, a first branch, and a second branch, said surgically created opening is positioned on said first branch such that said procedure of inserting said graft into said blood vessel is performed through said first branch.

30. The method of claim 29, further comprising the procedures of, inserting a proximal guidewire through said surgically created opening; sliding said proximal guidewire into said second branch; guiding a second graft by said proximal guidewire into said second branch; and deploying said second graft in said second branch.