WO2024147095A1

WO2024147095A1 - Integrated endoscopic step-up drainage system

Info

Publication number: WO2024147095A1
Application number: PCT/IB2024/050051
Authority: WO
Inventors: Omri NAVEH; Ronny BARAK; Elad Einav
Original assignee: Endo Gi Medical Ltd.
Priority date: 2023-01-03
Filing date: 2024-01-03
Publication date: 2024-07-11

Abstract

An assembled stent delivery system comprises: a primary delivery member comprising an actuation-wire conveyance housing at least a portion of an actuation wire distally attached to the primary delivery member at a point located proximal to the electrocautery-enhanced tip, and a wire conduit housing a portion of a tip-actuation wire; and a secondary delivery member, partly constrained distally by a surface feature of the primary delivery member. In a first-stent deployment configuration, distal advancements of the first stent and/or proximal withdrawals of the primary delivery member are effective to release the constrained distal portion of the secondary delivery member to deploy the first stent. In a second-stent deployment configuration, distal advancements of the second stent and/or proximal withdrawals of the secondary delivery member are effective to deploy the second stent.

Description

INTEGRATED ENDOSCOPIC STEP-UP DRAINAGE SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of U.S. Provisional Patent Application No. 63/436,874, filed on January 3, 2023, which is incorporated herein by reference in its entirety. This patent application claims the benefit of U.S. Provisional Patent Application No. 63/523,468, filed on June 27, 2023, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

Embodiments of the present invention relate generally to medical devices and more particularly to methods and apparatus for delivering and deploying elements of an endoscopic step-up drainage system.

SUMMARY OF THE INVENTION

According to embodiments disclosed herein, a delivery system for deploying stents comprises, when in an assembled state: (a) an elongated primary delivery member comprising: (i) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and (ii) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocautery-actuation wire. The delivery system additionally comprises, in said assembled state: (b) an inflatable member in contact with the inflationfluid conveyance and in fluid communication with the lumen via the inflation-fluid port; and (c) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member. When the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the deflated inflatable member and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

In some embodiments, the electrocautery-enhanced tip can be configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated. In some embodiments, the inflatable member can be configured to (i) expand the respective diathermic holes when inflated therewithin, and (ii) allow passage therearound of a first stent when deflated subsequent to the expanding.

In some embodiments, the first-stent deployment configuration can be further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and/or by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs. In some embodiments, the second-stent deployment configuration can be further characterized by the distal end of the secondary delivery member being disposed within the distal organ.

In some embodiments, in said assembled state, the distal end of the secondary delivery member can be proximal to the inflatable member. In some embodiments, in said assembled state, the distal portion of the secondary delivery member can circumvent the inflatable member.

In some embodiments, the delivery system can additionally comprise a pusher tube, operable, when disposed to surround the secondary delivery member and the array proximal to the second stent, to effect the one or more distal-direction advancements of the first and second stents.

In some embodiments, at least one of the stents can comprise a pigtail stent. In some embodiments, the delivery system can additionally comprise the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member.

In some embodiments, it can be that the delivery system is configured for delivery of stents without the use of a guidewire.

According to embodiments disclosed herein, a delivery system for deploying one or more stents to connect between a proximal organ and a distal organ of a human subject comprises, when in an assembled state: (a) an array of one or more elongated primary delivery members, the array comprising: (i) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and (ii) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end thereof, the tip being configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto, the conduit housing at least a portion of an electrocautery-actuation wire. The delivery system additionally comprises: (b) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, the inflatable member configured to (i) expand the respective diathermic holes when inflated therewithin, and (ii) allow passage therearound of a first stent when deflated subsequent to the expanding; and (c) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of one of the one or more primary delivery members of the array at least at a proximal constraintpoint of the distal portion of the secondary delivery member. When the delivery system is in a first-stent deployment configuration characterized by (i) the first stent surrounding the array proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the array and/or one or more proximal-direction withdrawals of the array relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent.

In some embodiments, the delivery system can additionally comprise a pusher tube, operable, when disposed to surround the secondary delivery member and the array proximal to the first stent, to effect the one or more distal-direction advancements of the first stent.

In some embodiments, when the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed, (ii) the distal end of the secondary delivery member being disposed within the distal organ, and/or (iii) a second stent surrounding at least the secondary delivery member: one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent can be effective to deploy the second stent.

In some embodiments, the delivery system can comprise a pusher tube surrounding, proximal to the second stent, surrounding at least the secondary delivery member.

In some embodiments, the one or more stents can comprise at least one pigtail stent.

In some embodiments, the array can comprise exactly one primary delivery member, and said exactly one primary delivery member can comprise both the inflationfluid conveyance and the wire conduit.

In some embodiments, it can be that the delivery system can be configured for delivery of stents without the use of a guidewire. In some embodiments, the delivery system can additionally comprise the first stent and the first stent surrounds the one or more primary delivery members of the array proximal to the inflatable member and does not surround the secondary delivery member.

In some embodiments, the delivery system can additionally comprise the second stent, and the second stent surrounds at least the secondary delivery member.

A method is disclosed according to embodiments disclosed herein, for delivering one or more stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system according to any one of claims 12 to 20; (b) loading a first stent on the delivery system to surround the array proximal to the inflatable member, without surrounding the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflationfluid port, and (ii) deflating the inflatable member; and (e) releasing the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point, and deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, wherein the releasing and deploying include at least one of retracting the array relative to the first stent and pushing the first stent to advance distally relative to the array.

In some embodiments, the method can additionally comprise: (i) loading a second stent on the delivery system to surround, proximal to the first stent, the array and the secondary delivery member; and (ii) after the deploying of the first stent, deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent. According to embodiments disclosed herein, a delivery system for deploying two stents to connect between a proximal organ and a distal organ of a human subject comprises, when in an assembled state: (a) an elongated primary delivery member comprising: (i) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and (ii) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocautery-actuation wire. The delivery system further comprises, when in said assembled state: (b) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflationfluid port; and (c) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member, wherein when the delivery system is in a first- stent deployment configuration characterized by (i) the first stent surrounding the first delivery member proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed, (ii) the distal end of the secondary delivery member being disposed within the distal organ, and (iii) a second stent surrounding at least the secondary delivery member: one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent. In some embodiments, in said assembled state, the distal end of the secondary delivery member can be disposed proximal to the inflatable member.

In some embodiments, in said assembled state, the distal portion of the secondary delivery member can circumvent the inflatable member.

In some embodiments, the delivery system can additionally comprise a pusher tube, operable, when disposed to surround the primary and secondary delivery members proximal to the second stent, to effect the one or more distal-direction advancements of the first stent relative to the primary delivery member and the one or more distal-direction advancements of the second stent relative to the secondary delivery member.

In some embodiments, at least one of the first and second stents can be a pigtail stent. In some embodiments, both of the first and second stents can be pigtail stents.

In some embodiments, the delivery system can additionally comprise the first and second stents, the first stent can surround the primary delivery member proximal to the inflatable member and not surround the secondary delivery member, and the second stent can be disposed proximal to the first stent and surround at least the secondary delivery member.

In some embodiments, a method for delivering two stents to connect between a proximal organ and a distal organ of a human subject can comprise (a) providing the delivery system; (b) loading the two stents on the delivery system so that a first stent surrounds the primary delivery member proximal to the inflatable member, without surrounding the secondary delivery member, and a second stent surrounds at least the secondary delivery member proximal to the first stent; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; (e) releasing the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point, and deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, wherein the releasing and deploying include at least one of retracting the primary delivery member relative to the first stent and pushing the first stent to advance distally relative to the primary delivery member; and (f) after the deploying of the first stent, deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

A method is disclosed, according to embodiments, for delivering one or more stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an array of one or more elongated primary delivery members, the array comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflationfluid conveyance and in fluid communication with the lumen via the inflation-fluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraint-point; (b) loading a first stent on the delivery system to surround the one or more primary delivery members of the array proximal to the inflatable member, without surrounding the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocauteryactuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; and (e) deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array relative to the first stent, and (ii) pushing the first stent to advance distally relative to the one or more delivery members of the array, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point. The method additionally comprises advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the expanding, to dispose the inflatable member within both respective diathermic holes, and (iii) before the deploying, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

In some embodiments, the method can additionally comprise: (i) before the advancing of the delivery system to dispose the electrocautery-enhanced tip at the inner surface: loading a second stent on the delivery system to surround, proximal to the first stent, the one or more primary delivery members of the array and the secondary delivery member; and (ii) after the deploying of the first stent: deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

In some embodiments, the array can comprise exactly one elongated primary delivery member, said exactly one elongated primary delivery member comprising both the inflation-fluid conveyance and the wire conduit.

In some embodiments, it can be that the one or more stents are delivered without using a guide wire.

A method is disclosed, according to embodiments disclosed herein, for delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an array of one or more elongated primary delivery members, the array comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflationfluid conveyance and in fluid communication with the lumen via the inflation-fluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraint-point; (b) loading the two stents on the delivery system, such that (i) a first stent surrounds the one or more primary delivery members of the array proximal to the inflatable member, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the one or more primary delivery members of the array and the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocauteryactuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; (e) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array relative to the first stent, and (ii) pushing the first stent to advance distally relative to the one or more primary delivery members of the array, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (f) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent. The method additionally comprises advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the expanding, to dispose the inflatable member within both respective diathermic holes, and (iii) before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

A method is disclosed, according to embodiments, for delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an elongated primary delivery member comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point; (b) loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the inflatable member, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member and the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; (e) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (f) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

In some embodiments, the method can additionally comprise advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the expanding, to dispose the inflatable member within both respective diathermic holes, and (iii) before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

A method is disclosed, according to embodiments, for delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a pre-loaded delivery system comprising: (i) an elongated primary delivery member comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point, (iv) a first stent surrounding the primary delivery member proximal to the inflatable member and not surrounding the secondary delivery member, and (v) a second stent surrounding, proximal to the first stent, the primary delivery member and the secondary delivery member; (b) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery- enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (c) expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflationfluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; (d) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (e) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

A method is disclosed, according to embodiments, for of delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an elongated primary delivery member comprising: (A) an expansion-actuation conduit extending from a proximal portion of the primary delivery member to an expansion member in a distal portion thereof, the expansion-actuation conduit housing at least a portion of an expansionactuation member, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, the wire conduit housing at least a portion of an electrocautery-actuation wire, and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point; (b) loading two stents on the delivery system so that a first stent surrounds the primary delivery member proximal to the expansion member without surrounding the secondary delivery member, and a second stent surrounds at least the secondary delivery member proximal to the first stent.(c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (d) expanding the respective diathermic holes, the expanding including (i) expanding the expansion member using the expansion-actuation member, and (ii) contracting the expansion member; (e) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (f) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

In some embodiments, the method additionally comprises advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the expanding, to dispose the expansion member within both respective diathermic holes, and (iii) before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ. According to embodiments disclosed herein, a delivery system for deploying stents, the delivery system comprises, when in an assembled state: (a) an elongated primary delivery member comprising: (i) an expansion-actuation conduit extending from a proximal portion of the primary delivery member to an expansion member in a distal portion thereof, the expansion-actuation conduit housing at least a portion of an expansion-actuation member, (ii) the expansion member, and (iii) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery- enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocautery-actuation wire. The delivery system additionally comprises, when in said assembled state: (b) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the expansion member, of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member. When the delivery system is in a first-stent deployment configuration characterized by the first stent surrounding the first delivery member proximal to the contracted expansion member and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent. When the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

In some embodiments, it can be that the electrocautery-enhanced tip is configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated. In some embodiments, it can be that the expansion member is configured to (i) expand the respective diathermic holes when activated therewithin, and (ii) allow passage therearound of a first stent when contracted subsequent to the expanding. In some embodiments, the first-stent deployment configuration can be further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs.

In some embodiments, at least one of the stents can comprise a pigtail stent. In some embodiments, both of the stents are pigtail stents.

According to embodiments, a delivery system for deploying stents comprises, when in an assembled state: (a) an elongated primary delivery member comprising: (i) an actuation- wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port in a distal portion thereof, the actuation-wire conveyance housing at least a portion of an actuation wire, and (ii) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery- enhanced tip at a distal end thereof, the conduit housing at least a portion of a tipactuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation- wire attachment point located proximal to the electrocautery- enhanced tip. The delivery system further comprises: (b) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member, wherein when the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the actuation-wire port and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and wherein when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

In some embodiments, the electrocautery-enhanced tip can be configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated. In some embodiments, the actuation wire can be configured to (i) be proximally withdrawn so as to deflect a portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point, and/or (ii) be electrically actuated while said portion of the primary delivery member is deflected so as to expand the respective diathermic holes by electrocautery.

In some embodiments, the first-stent deployment configuration can be further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs. In some embodiments, the second-stent deployment configuration can be further characterized by the distal end of the secondary delivery member being disposed within the distal organ.

In some embodiments, the delivery system can additionally comprise a pusher tube, operable, when disposed to surround the secondary delivery member and the primary delivery member proximal to the second stent, to effect the one or more distal- direction advancements of the first and second stents.

In some embodiments, at least one of the stents can comprise a pigtail stent.

In some embodiments, the delivery system can additionally comprise the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member. In some embodiments, the delivery system can be configured for delivery of stents without the use of a guide wire.

According to embodiments, a delivery system for deploying one or more stents to connect between a proximal organ and a distal organ of a human subject comprises, when in an assembled state: (a) an array of one or more elongated primary delivery members, the array comprising: (i) an activation-wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port in a distal portion thereof, the actuation-wire conveyance housing at least a portion of an actuation wire, and (ii) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end thereof, the tip being configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto, the conduit housing at least a portion of an electrocauteryactuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation- wire attachment point located proximal to the electrocautery- enhanced tip. The delivery system also comprises: (b) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraintpoint of the distal portion of the secondary delivery member, wherein, when the delivery system is in a first-stent deployment configuration characterized by (i) the first stent surrounding the array proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the array and/or one or more proximal-direction withdrawals of the array relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent.

A method is disclosed, according to embodiments, for delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an actuation-wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation- wire port in a distal portion thereof, the actuation-wire conveyance housing at least a portion of an actuation wire, and a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of a tip-actuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation-wire attachment point located proximal to the electrocautery-enhanced tip, and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member; (b) loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the proximal constraint-point, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member and the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery- enhanced tip via the tip-actuation wire; (d) proximally withdrawing the activation wire so as to deflect a portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point, and electrically actuating the actuation wire while said portion of the primary delivery member is deflected so as to expand the respective diathermic holes by electrocautery; (e) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (f) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent. In some embodiments, the method can additionally comprise advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the proximally withdrawing, to dispose the portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point within both respective diathermic holes, and (iii) before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

According to embodiments, a delivery system for deploying stents comprises, when in an assembled state: (a) an elongated primary delivery member comprising a wire conveyance housing at least a lengthwise portion of a tip-actuation wire and of a plurality of expansion wires, the wires extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the tip-actuation wire; and (b) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point, wherein, when the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the actuation-wire port and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and wherein, when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

In some embodiments, wherein the electrocautery-enhanced tip can be configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated via the tip-actuation wire. In some embodiments, the expansion wires can be configured such that respective distal portions thereof between a distal end of the primary delivery member and the electrocautery- enhanced tip are deflected when the tip-actuation wire is proximally withdrawn and (ii) be electrically actuated so as to expand the respective diathermic holes by electrocautery.

In some embodiments, the tip-actuation wire and the expansion wires can be electrically actuated from a single electrical circuit.

In some embodiments, at least one of the stents can comprise a pigtail stent.

In some embodiments, the delivery system can additionally comprise the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member.

In some embodiments, the delivery system can be configured for delivery of stents without the use of a guide wire.

A method is disclosed, according to embodiments, for delivering two stents to connect between a proximal organ and a distal organ of a human subject. The method comprises: (a) providing a delivery system comprising: (i) an elongated primary delivery member comprising a wire conveyance housing at least a lengthwise portion of an actuation wire and of a plurality of expansion wires, the wires extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the actuation wire; and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point; (b) loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the proximal constraint-point, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member, and the secondary delivery member; (c) opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery- enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; (d) proximally withdrawing the tip-activation wire so as to deflect a portion of each expansion wire so as to expand the respective diathermic holes by electrocautery; (e) deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and (f) deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

In some embodiments, the method can additionally comprise advancing the delivery system as follows: (i) before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, (ii) before the proximally withdrawing, to dispose the expansion wires within both respective diathermic holes, and (iii) before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ. In some embodiments, the tip-actuation wire and the expansion wires can be electrically actuated together from a single electrical circuit.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described further, by way of example, with reference to the accompanying drawings, in which the dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and not necessarily to scale. In the drawings:

Fig. 1 A is a schematically drawn perspective-view illustration of a portion of a single primary delivery member of a stent-delivery system, in accordance with embodiments of the present invention.

Fig. IB shows a section of the primary delivery member of Fig. 1A showing a lumen of inflation-fluid conveyance and a wire conduit, in accordance with embodiments of the present invention.

Fig. 2 is a schematically drawn perspective-view illustration of a portion of a stent-delivery system comprising a single primary delivery member and a secondary delivery member, in accordance with embodiments of the present invention.

Fig. 3A is a schematically drawn perspective-view illustration of a portion of a stent-delivery system comprising a plurality of primary delivery members, additionally showing a detail of the plurality of primary delivery members, in accordance with embodiments of the present invention.

Fig. 3B shows a section of the plurality of primary delivery members of Fig. 3A, showing a lumen of inflation-fluid conveyance and a wire conduit, in accordance with embodiments of the present invention.

Figs. 3C and 3D show examples of cross-sections of respective pluralities of primary delivery members, in accordance with embodiments of the present invention. Fig. 4 shows the delivery system of Fig. 2 with a first stent loaded thereupon so as to surround the single primary delivery member and not surround the secondary delivery member, in accordance with embodiments of the present invention.

Fig. 5 shows the delivery system of Fig. 3 A showing a first stent loaded thereupon so as to surround the plurality of primary delivery members and not surround the secondary delivery member, in accordance with embodiments of the present invention.

Fig. 6 shows the delivery system of Fig. 4, further showing a second stent loaded thereupon so as to surround both the single primary delivery member and the secondary delivery member, and a pusher member proximal to the second stent, in accordance with embodiments of the present invention.

Fig. 7 shows an alternative implementation of the delivery system of Fig. 6, wherein a distal portion of the secondary delivery member circumvents the inflatable member, in accordance with embodiments of the present invention.

Fig. 8 shows an alternative implementation of the delivery system of Fig. 6, wherein the balloon is one-sided and does not surround the primary delivery member, in accordance with embodiments of the present invention.

Figs 9A-K illustrate an exemplary use case of any one of the delivery systems illustrated in the Figs. 2-8, according to an exemplary procedure for delivering and deploying one or more stents to connect between a proximal organ and a distal organ, all in accordance with embodiments of the present invention. Specifically:

Fig. 9A illustrates advancing the delivery system so as to dispose a distal electrocautery-enhanced tip at a wall of a proximal organ;

Fig. 9B illustrates the distal portion of the delivery system advancing through respective holes formed in opposing walls of the proximal and distal organs;

Fig. 9C illustrates advancing the delivery system so as to dispose the inflatable member within both respective holes;

Fig.9D illustrates expanding the inflatable member (balloon); Fig. 9E shows deflating the inflatable member;

Fig. 9F illustrates advancing the delivery system so as to dispose the first stent within both holes;

Fig. 9G illustrates releasing the secondary delivery member from the primary delivery member;

Fig. 9H shows the secondary delivery member released, and illustrates the proximal withdrawal of the primary delivery member;

Fig. 91 illustrates the continued proximal withdrawal of the primary delivery member;

Fig. 9J illustrates advancing the second stent along the secondary delivery member so as to be disposed in the two holes in parallel to the first stent; and

Fig. 9K shows the two stents deployed in the two holes to connect the two organs.

Figs. 10A and 10B are respectively similar to Figs. 91 and 9K, with the first and second stents shown schematically as pigtail stents, in accordance with embodiments of the present invention.

Figs. 11A, 1 IB, 13A, and 13B show flowcharts of methods and method steps for delivering one or more stents to connect between a proximal organ and a distal organ of a human subject, in accordance with embodiments of the present invention.

Figs. 12, 14, 15A, 15B, 16A, 16B, 18A, 18B, 20A, 20B, 22A, and 22B show flowcharts of methods and method steps for delivering two stents to connect between a proximal organ and a distal organ of a human subject, in accordance with embodiments of the present invention.

Figs. 17A and 17B illustrate deployment of a delivery system comprising a mechanical expansion mechanism for expanding diathermic holes in tissues in accordance with embodiments of the present invention. Figs. 19A, 19B, and 18C illustrate deployment of a delivery system comprising an actuation wire for expanding diathermic holes in tissues, in accordance with embodiments of the present invention.

Figs. 21A, 21B, and 21C illustrate deployment of a delivery system comprising an actuation wire and multiple expansion wires for expanding diathermic holes in tissues, in accordance with embodiments of the present invention

DETAILED DESCRIPTION OF EMBODIMENTS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are generally used to designate like elements.

According to embodiments, a delivery system for use in deploying one or more stents, such as one stent, or two stents, or more than two stents, includes an array of one or more elongated primary delivery members, such as multiple primary delivery members each comprising a conveyance or lumen housing an actuation member (or element) or a single primary delivery member comprising multiple conveyances or lumens each housing an actuation member or element, and an elongated secondary delivery member. In an assembled state, a distal portion of the secondary delivery member is constrained from unrestrained movement by being held in or by a surface feature of the primary delivery member, or of at least one primary delivery member of the array of one or more primary delivery members. The delivery system of the disclosed embodiments is configured as an ‘all-in-one’ delivery system that does not require guidewires for introduction of the delivery system to a surgical site or stent-deployment site, and the delivery system is not configured for use with a guidewire. In exemplary procedures as disclosed herein with respect to use of the delivery system, a guidewire is neither required nor employed by any of the exemplary procedures.

In embodiments, a distal portion of a primary delivery member has an electrocautery-enhanced tip, which, when activated by powering an electrocauteryactuation wire at least partly residing in one of the conveyances or lumens of the array of one or more primary delivery members, can be used to electro-cauterize a tissue, e.g., for making a hole in a wall of an organ for subsequent passage therethrough of a distal portion of a delivery member or of the delivery system.

In embodiments, the delivery system includes an expandible portion for widening holes in organ walls made by the electrocautery-enhanced tip of the primary delivery member. The expandible portion can include an inflatable member such as a balloon. The inflatable member can be inflated, for example, by an inflation fluid caused to pass through one of the multiple conveyances or lumens in a primary delivery member of the array of one or more primary delivery members. The inflation fluid passes through an inflation-fluid port in the primary delivery member that comprises the inflation-fluid conveyance and into (and out of) the inflatable member. In some embodiments, the delivery system uses a mechanical expansion system, in which a mechanical actuator, e.g., a threaded rod or an elongated gear, mechanically opens (and closes) an expansion member.

The delivery system disclosed herein is particularly suited for delivering one or stents to connect between two organs of a human subject. A ‘stent’, as the term is used herein, means a hollow tube with predominantly or completely solid (or covered) walls comprising a plastic and/or a metal (or metal alloy), suitable for conveying a liquid therethrough. A stent can be flexible, at least to the extent required for unconstrained passage through pathways in the body. Regardless of how stents are illustrated schematically herein, examples of stents suitable for use with and deployment by the delivery systems disclosed herein can include, without limitation and not exhaustively: simple hollow tubes, tubes with anchor tabs for inhibiting migration of the stents after implantation, or pigtail stents.

In an exemplary use case, the delivery system is used to open, e.g., by cauterization, opposing holes in respective walls of a proximal organ and a distal organ, wherein the terms ‘proximal’ and ‘distal’ are used as follows: ‘distal’ means further into the body (along an insertion or advancement path) from a point of entry into the body, while ‘proximal’ means closer to the point of entry into the body. Where the terms are used in reference to apparatus outside of a patient’s body, a distal portion or distal end is that portion or end of the apparatus configured to be inserted into the body first, while a proximal end or proximal portion is either inserted last or may never be inserted (as in the case of a delivery system according to the instant embodiments, for example). Additionally, when used relatively, e.g. ‘distally displaced from’ or ‘proximal of’, the meaning is, respectively, closer to the distal end than’ or ‘closer to the proximal end than’. In light of the foregoing, the terms ‘proximal organ’ and ‘distal organ’ mean, respectively, a first organ and a second organ according to the order in which the delivery system of any of its components physically encounter the organs to be connected by the stents to be deployed by the delivery system.

An ‘organ,’ as the term is used herein, means any collection of tissue(s) and/or (according to the context) a part of the body that performs a specific function.

According to embodiments, the delivery systems disclosed herein are suitable for drainage of a fluid from a first organ to a second organ. The direction of drainage does not necessarily correspond with the proximal-distal differentiation of the two organs.

In embodiments, the delivery systems disclosed herein and the associated methods are suitable for any one of a wide range of clinical and surgical procedures. A non-exhaustive listing of relevant clinical indications for use of the delivery systems according to the embodiments and/or surgical procedures facilitated by the embodiments includes: tracheoesophageal fistula - between the esophagus and the trachea; Gastro-gastric fistula - between the gastric remnant and the gastric pouch, e.g., after a gastric bypass/sleeve procedure

Stenting of the common bile duct, e.g., laparoscopic or percutaneous, for drainage from the bile duct to the stomach or to the duodenum

Nephroureteral stenting between the ureter and kidney

Cyst drainage from a pancreatic cyst to the stomach

Cyst drainage from a pancreatic cyst to the small intestine

Gall bladder drainage to the stomach

In each specific case, the place of incision or insertion of the delivery system, the direction and nature of the delivery pathway, and the selection of proximal vs. distal organ are selected in accordance with accepted medical practice and standard of care. Procedures can be aided by any of the imaging technologies in use, such as, and not exhaustively: fluoroscopy, ultrasound, direct (e.g., endoscopic) video.

We now refer to the figures, and in particular to Figs. 1A and IB, which show a schematic illustration of a distal portion of a primary delivery member 50 according to embodiments. The primary delivery member 50 includes a shaft 51 comprising an inflation-fluid conveyance 52 and a wire conduit 53, shown schematically in crosssection in Fig. IB. The primary delivery member 50 can be flexible enough to navigate internal body passages, and can comprise a polymer. The primary delivery member 50 further includes a surface feature 55 shown in Fig. 1A as a groove. The primary delivery member 50 further includes an inflation-fluid port 56 in fluid communication with the inflation-fluid conveyance 52. The primary delivery member 50 further includes a needle section 80 comprising an electrocautery-enhanced tip 59 in electrical communication with an electrical wire (not shown) at least partly resident in the wire conduit 53. In some designs, the shaft 51 and the needle section 80 are formed or otherwise manufactured as a single unit, and in other designs, the shaft 51 and the needle section 80 are assembled to form the unit. The electrocautery-enhanced tip 59 can be attached to the end of the needle section 80 by normal means such as, and not exhaustively: gluing, heat-welding, laserwelding, or coating.

The representation of the wire conduit 53 as a lumen in the primary delivery member 50 is intended only for illustration, and the wire conduit can have a different configuration, e.g., a lengthwise groove or trench. In another embodiment (not shown), an electrically conductive path can be attached or formed on the outside of the primary delivery member 50, disposed to be in electrical communication with the electrocautery- enhanced tip 59. Referring again to Fig. IB, inflation-fluid conveyance 52 and a wire conduit 53 can be understood to extend proximally at least to a proximal portion (not shown) of the primary delivery member 50. In embodiments, the inflation-fluid conveyance 52 extends proximally to a proximal inflation-fluid port, in or proximally beyond the inflation-fluid conveyance 52, the proximal port configured for introduction and/or removal of the inflation fluid to/from the inflation-fluid conveyance 52. In embodiments, the wire conduit extends proximally to a source of electrical current in or proximally beyond the wire conduit 53, and a wire resident in the wire conduit 53 can be placed in contact the electrical current source at least during any part of a surgical procedure that requires activation of the electrocautery-enhanced tip 59 at the distal end of the primary delivery member 50.

Fig. 2 schematically illustrates an exemplary delivery system 100 according to embodiments, comprising a single primary delivery member 50, i.e., the primary delivery member 50 of Figs. 1A and IB. The single primary delivery member 50 is paired with a single secondary delivery member 60. The secondary delivery member 60 is an elongated tube or rod, and can have a smaller diameter than the primary delivery member 50 but this is not obligatory. When the delivery system 100 is assembled, a distal portion of the secondary delivery member 60 is constrained by the surface feature 55 of the primary delivery member 50, shown as a groove configured to ‘trap’ all or part of the distal portion of the secondary delivery member 60, at least at a proximal constraint-point 54 of said distal portion. The surface feature 55 is configured, i.e., sized and shaped, to constrain part of the secondary delivery member 60 to the extent that the assembled delivery system 100 can be advanced through a surgical path in the body without the secondary delivery member 60 being accidentally dislodged from the surface feature 55. In the non-limiting example of Fig. 2, the delivery system 100 of Fig. 2 includes an inflatable member 70, e.g., a balloon, surrounding the primary delivery member 50, and the distal portion of the secondary delivery member 60 ends proximal to the inflatable member 70.

The proximal portion of the delivery system 100 is not shown, and can include one or more handles for manipulation of the primary and secondary delivery members 50, 60. The proximal portion can also include an electrical connection between the electrical activation wire (for activation of the electrocautery tip 59) and a power source, and a proximal inflation-fluid port in communication with a fluid source. The proximal portion can also include mechanical and/or electronic controls for activating the electrocautery tip 59 and/or inflating and deflating the inflatable member 70. s

Figs. 3A and 3B illustrate an exemplary delivery system 100 according to embodiments, comprising two primary delivery members 52, 53. A delivery system comprising a single primary delivery member, e.g., as shown in Fig. 2, and the delivery system comprising multiple primary delivery members of Figs. 3A and 3B are functionally equivalent, and a selection of the number of primary delivery members is a design choice. The underlying concept of an array 150 of one or more primary delivery members (50 or 52, 53) includes the inflation-fluid conveyance 52 and the wire conduit 53 as discussed hereinabove, and the arrangement of the fluid conveyance and wire conduit within the array is not material. Figs. 3C and 3D show additional examples of arrangements of multiple primary delivery members 52, 53, in which the individual primary delivery members 52, 53, are attached to each other or formed, extruded or printed, etc., to be attached to each other.

With reference to Fig. 4, the delivery system 100 according to embodiments is configured to bear and deliver one or more stents, e.g., one stent, two stents or more, to a deployment location. In exemplary surgical procedures, the deployment location spans opposing holes in the walls of two organs so as to bridge or connect between the organs, e.g., for draining a fluid from one organ to the other. A first stent 41 is shown loaded on the delivery system 100, in a position suitable for advancement of the delivery system 100 through a pathway in the human body while bearing the stent 41. In some embodiments, the delivery system 100 further comprises the stent 41. The delivery system 100 can be provided in a pre-loaded state, i.e., with the stent 41 preloaded on the delivery system, e.g., as shown in Fig. 4. In either a loaded or pre-loaded state, the stent 41 surrounds the primary delivery member 50 but does not surround the secondary delivery member 60. The constraining of the distal portion of the secondary delivery member 60 by the surface feature 55 at the proximal constraint-point 54 of the distal portion is configured to facilitate the advancement of the delivery system 100 through its pathway without the stent 41 being inadvertently dislodged distally, for example so as not to block the later inflation of the inflatable member 70 before it is appropriately disposed at an intended inflation site, or so as not to be prematurely deployed off the distal end of the delivery system 100. In embodiments, a pusher tube (not shown) is provided for (i) maintaining the position, i.e., constraining the relative movement, of the stent 41 on the delivery system during advancement through the delivery pathway and/or (ii) advancing the stent(s) relative to the primary delivery member 50. In some embodiments, the delivery system further comprises the pusher tube.

In embodiments, dimensions of the various components of the system are selected in according with clinical requirements. According to an illustrative non-limiting example, a common diameter for a stent according to embodiments is 3.3mm. In other illustrative examples, a stent has a diameter between 2.5mm and 4mm. The dimensions of the primary and secondary delivery members are selected in accordance with the functionalities described herein and within the constraints associated with passing through the stents as disclosed herein.

Fig. 5 shows a delivery system 100 according to the design shown in Fig. 3 A, i.e., wherein the delivery system 100 comprises two primary delivery members 52, 53, and the delivery system is shown loaded or preloaded with a first stent 41. The delivery system 100 as shown in Fig. 5 is otherwise the same as the delivery system of Fig. 4, which comprises the single primary delivery member 50, and the stent 41 surrounds the array of primary delivery members 150 (comprising the individual primary delivery members 52, 53) but does not surround the secondary delivery member 60. With reference now being made to Fig. 6, a delivery system 100 according to embodiments is configured to bear and deliver two stents to a stent-deployment location. In exemplary surgical procedures, the deployment location spans opposing holes in the walls of two organs so as to bridge or connect between the organs, e.g., for draining a fluid from one organ to the other. A first stent 41 is shown loaded on the delivery system 100, in a position suitable for advancement of the delivery system 100 through a pathway in the human body while bearing the stent 41. A second stent 42 is shown loaded on the delivery system 100, proximal to the first stent 41, in a position suitable for advancement of the delivery system 100 through a pathway in the human body while bearing both the first stent 41 and second stent 42. In some embodiments, the delivery system 100 further comprises the first and second stents 41, 42. The delivery system 100 can be provided in a pre-loaded state, i.e., with the first and second stents 41, 42 preloaded on the delivery system, e.g., as shown in Fig. 6. In either a loaded or pre-loaded state, the stent 41 surrounds the primary delivery member 50 but does not surround the secondary delivery member 60, whilst the second stent 42 surrounds both the primary delivery member 50 (or, alternatively, the array 150 of primary delivery members), and the secondary delivery member 60. A pusher tube 35 is provided for (i) maintaining the position i.e., constraining the relative movement, of the stents 41, 42 on the delivery system during advancement through the delivery pathway and/or (ii) advancing the stent(s) relative to the respective delivery members 50, 60. In some embodiments, the delivery system further comprises the pusher tube 35.

Examples of alternative designs of the disclosed embodiments are shown in Figs. 7 and 8. Fig. 7 shows a delivery system 100 in which the distal portion of the secondary delivery member 60 circumvents the inflatable member 70 rather than ending proximal to the inflatable member 70. Fig. 8 shows an inflatable member 70 that, rather than surrounding the primary delivery member 50, comprises a one-sided balloon 70. In some implementations, either one of these design approaches may be beneficial, although they are functionally equivalent to the designs shown in the preceding figures.

Exemplary procedure An exemplary procedure is disclosed for delivering and deploying one or more stents to connect between a proximal organ and a distal organ, in accordance with embodiments of the present disclosure. Principles of the procedure are disclosed in the following discussion as schematically illustrated in Figs. 9A-9K. In every one of Figs. 9A-K, the proximal organ 20i is on the left side of the drawing and distal organ 2(h is on the right side of the drawings, such that a left-to-right movement is in the distal direction, and a right-to-left movement is in the proximal direction.

According to the exemplary procedure, first and second stents 41, 42 are loaded or pre-loaded on the delivery system 100. The delivery system 100 is advanced distally to traverse at least a portion of the proximal organ 20i, as indicated by arrow 1201 in Fig. 9A, until the distal electrocautery-enhanced tip 59 is disposed at a wall 25i of the proximal organ 20i, that is opposite, e.g., close to or closest to, a wall 252 of the distal organ 202, as illustrated in Fig. 9A.

After the delivery system 100 is disposed as in Fig. 9A, the electrocautery- enhanced tip 59 at the distal end of the primary delivery member 50 is actuated and opens a hole 27i in the wall 25i. The delivery system 100 is then advanced to dispose the electrocautery-enhanced tip 59 at the opposing wall 252, i.e., of the distal organ 202, i.e., to the extent that the two walls 25i, 252 are not contiguous. The electrocautery-enhanced tip 59 is then actuated a second time (or, alternatively, continuously between the two openings) to open an opposing second hole 272 in the second wall 252. The delivery system 100 is then further advanced through the holes 27i, 272, as indicated in Fig. 9B by arrow 1202, so that the distal end of the primary delivery member 50 is disposed within the distal organ 202, as illustrated in Fig.9B. The further advancing of the delivery system 100, indicated by arrow 1203 in Fig. 9C, brings the inflatable member 70 to be disposed within both cauterized holes 27i, 272, as illustrated in Fig. 9C. Once the inflatable member 70 is disposed within both holes 27i, 272, it is inflated with the inflation fluid delivered through the lumen of the inflation-fluid conveyance 52, as illustrated in Fig. 9D and indicated therein by arrow 1204. After the expansion of the cauterized holes 27i, 272, the inflatable member 70 is deflated, as indicated in Fig. 9E by arrows 1205, e.g., by allowing the inflation fluid to flow back through the inflation-fluid conveyance 52 and be drained from a proximal inflation-fluid port (not shown). In some embodiments, the inflatable member 70 is biased to deflate when pressure therein is reduced, e.g., pressure applied and optionally maintained through the inflation-fluid conveyance 52.

Once the holes 27i, 272 are expanded and the inflatable member 70 is deflated, the delivery system 100 is advanced, as indicated by arrow 1206 in Fig. 9F, to place the first stent 41 - still in the same first-stent deployment configuration surrounding the primary delivery member 50 and not surrounding the secondary delivery member 60 - so that the first stent 41 resides in both expanded holes 27i, 272, as illustrated in Fig. 9F. When the first stent 41 is in a target location within the expanded holes 27i, 272, the first stent 41 is ready to be deployed. The deployment is accomplished with any combination of distal- direction advancements of the first stent 41 relative to the primary delivery member 50 and/or one or more proximal-direction withdrawals of the primary delivery member 50 relative to the first stent 41. The manipulation of the primary delivery member 50 can be carried out by using, for example, a handle (not shown) at the proximal end of the primary delivery member 50. Manipulation of the stent 41, can be carried out, for example, by using a pusher 35 from its proximal end. Together, the manipulations are effective (i) to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point, as illustrated in Figs. 9G and 9H, and (ii) to deploy the first stent 41. Fig. 9G illustrates the manipulation as follows: the advancement of the stent 41, e.g., using the pusher 35, is indicated by arrow 1207. The proximal withdrawal of the first delivery member 50, e.g., using the proximal handle, is indicated by arrow 1208. The forces applied by the relative advancement and relative withdrawal at the proximal constraint-point 54 of the distal portion of the secondary delivery member 60 cause the distal portion of the secondary delivery member 60 to be released from the surface feature 55, as indicated in Fig. 9G by arrow 1209. Following the release of the secondary delivery member 60, the primary delivery member 50 can be withdrawn further, as indicated by arrow 1210 in Fig. 9H and as illustrated in Fig. 9H. In this manner, the first stent 41 is deployed by fully withdrawing the primary delivery member 50 from within the stent 41, while the stent 41 is either advanced slightly if necessary, or at least held in place, by using the pusher tube 35 (not shown in Fig. 9H). The result of the foregoing manipulation, as illustrated in Fig. 91, is that the first 41 stent is deployed in the expanded holes 27i, 272 of the opposing walls 25i, 252, connecting the two organs 20i, 202, and the primary delivery member 50 is proximally withdrawn, at least into the second stent 42. According to the exemplary procedure, the primary delivery member 50 plays no further part in the procedure and can be completely withdrawn at this point, or can be withdrawn later, e.g., together with the secondary delivery member 60. The distal end of the secondary delivery member 60, as shown in Fig. 91, has remained at this point in the distal organ 202.

According to the exemplary procedure, the second stent 42 is then deployed alongside the first stent 41, e.g., parallel to the first stent 41, within the two expanded holes 27i, 272 of the opposing walls 25i, 252, to connect between and form a fluid path between, the two organs 20i, 202. The second stent 42, which at this point still surrounds the secondary delivery member 60 and optionally the primary delivery member 50 if the latter has not yet been completely withdrawn from within the second stent 42, is advanced, e.g., pushed using the pusher tube 35, to the target deployment location, as illustrated in Fig. 9J. The advancing/pushing is indicated in Fig. 9J by arrow 1211. The deployment of the stent 42 is accomplished by any combination of one or more distal- direction advancements (arrow 1211) of the second stent 42 relative to the secondary delivery member 60 and/or one or more proximal-direction withdrawals (arrow 1212) of the secondary delivery member 60 relative to the second stent 42. The pusher tube 35 and secondary delivery member 60 are withdrawn, as indicated by arrow 1213 in Fig. 9K, and the two stents 41, 42 are left in place to provide a fluid passage between the two organs 20i, 202, as illustrated in Fig. 9K.

We now refer to Figs. 10A and 10B. As described above, an example of a stent according to embodiments is a ‘pigtail’ stent. Fig. 10A is similar to Fig. 91 but illustrates a step of the exemplary procedure in which the stent 41 is a double-ended pigtail stent. In another example, not illustrated, the stent can be a single-ended pigtail stent. Fig. 10A, it can be seen that the first 41 stent, a pigtail stent, is deployed in the expanded holes 27i, 272 of the opposing walls 25i, 252, connecting the two organs 20i, 202 with the pigtails of the stent 41 in respective organs; and the primary delivery member 50 is proximally withdrawn, at least into the second stent 42. Fig. 10B is similar to Fig. 91 but illustrates the case where both stents 41, 42 are double-ended pigtail stents. The pusher tube 35 and secondary delivery member 60 are withdrawn, as indicated by arrow 1214 in Fig. 10B, and the two pigtail stents 41, 42 are left in place to provide a fluid passage between the two organs 20i, 202, as illustrated in Fig. 10B.

Referring now to Fig. 11 A, a method is disclosed for delivering one or more stents to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 11 A, the method comprises at least the five method steps SOI, S02, S03, S04, and S05.

Step SOI includes providing a delivery system 100 according to embodiments disclosed herein, the delivery system 100 comprising an array 150 of one or more elongated primary delivery members including an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the conveyance 52 at least to an inflation-fluid port 56 in a distal portion thereof, and a wire conduit 53 extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof. The conduit 53 houses at least a portion of an electrocautery-actuation wire. The delivery system 100 further comprises an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 54, and an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55, disposed proximal to the inflatable member 70, of one of the one or more primary delivery members at least at a proximal constraint-point 54 of the distal portion of the secondary delivery member 60. In some embodiments, the delivery system 100 also includes a pusher tube 35.

Step S02 includes loading a first stent 41 on the delivery system 100 to surround the array 150 proximal to the inflatable member 70, without surrounding the secondary delivery member 60.

Step S03 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53. Step S04 includes expanding the respective diathermic holes 27, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70.

Step S05 includes releasing the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54, and deploying the first stent 41 such that a proximal portion of the first stent 41 is disposed within the proximal organ 20i and a distal portion of the first stent 41 is disposed within the distal organ 202, wherein the releasing and deploying include at least one of retracting the array 150 relative to the first stent and pushing the first stent 41 to advance distally relative to the array 150. Step S05 is carried out when the at least partly constrained distal portion of the secondary delivery member 60 is disposed within the distal organ 202, and proximal and distal portions of the first stent 41 are respectively disposed within the proximal and distal organs 20i, 202.

In some embodiments, the method additionally comprises method steps S06 and S07, as illustrated by the flow chart in Fig. 1 IB.

Step S06 includes loading a second stent 42 on the delivery system 100 to surround, proximal to the first stent 41, the array 150 and the secondary delivery member 60. Step S06 can be carried out consecutively to Step S02, include before or after Step S02.

Step S07 includes deploying the second stent 42 after the deploying of the first stent 41, such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60, and retracting the secondary delivery member 60 relative to the second stent 42. Step S07 is carried out when the distal end of the secondary delivery member 60 is disposed within the distal organ 202.

Referring now to Fig. 12, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 12, the method comprises at least the six method steps Sil, S12, S13, S14, S15, and S16.

Step Sil includes providing a delivery system 100 according to embodiments disclosed herein, the delivery system 100 includes an elongated primary delivery member 50 comprising an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the conveyance 52 at least to an inflation-fluid port 56 in a distal portion thereof, and a wire conduit 53 extending from a proximal portion of the primary delivery member 50 to an electrocautery-enhanced tip 59 at a distal end thereof, the conduit 53 housing at least a portion of an electrocautery-actuation wire. The delivery system 100 further comprises an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 56, and an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55, disposed proximal to the inflatable member 70, of the primary delivery member 50 at least at a proximal constraint-point 54 of the distal portion of the secondary delivery member 60. In some embodiments, the delivery system 100 also includes a pusher tube 35.

Step S12 includes loading the two stents 41, 42 on the delivery system 100 so that a first stent 41 surrounds the primary delivery member 50 proximal to the inflatable member 70, without surrounding the secondary delivery member 60, and a second stent 42 surrounds at least the secondary delivery member 60 proximal to the first stent 41.

Step S13 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53.

Step S14 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70. Step S15 includes releasing the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54, and deploying the first stent 41 such that a proximal portion of the first stent 41 is disposed within the proximal organ 20i and a distal portion of the first stent 41 is disposed within the distal organ 202, wherein the releasing and deploying include at least one of retracting the primary delivery member 50 relative to the first stent 41 and pushing the first stent 41 to advance distally relative to the primary delivery member 50. Step S15 is carried out when the at least partly constrained distal portion of the secondary delivery member 60 is disposed within the distal organ 202, and proximal and distal portions of the first stent 41 are respectively disposed within the proximal and distal organs 20i, 202.

Step S16 includes deploying the second stent 42 after the deploying of the first stent 41 such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent. Step S16 is carried out when the distal end of the secondary delivery member 60 is disposed within the distal organ 202.

Referring now to Fig. 13 A, a method is disclosed for delivering one or more stents to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 13 A, the method comprises at least the eight method steps S21, S22, S23, S24, S25, S26A, S26B, and S26C.

Step S21 includes providing a delivery system 100 comprising: (i) an array 150 of one or more elongated primary delivery members, the array 150 comprising: (A) an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the inflation-fluid conveyance 52 at least to an inflation-fluid port 56 in a distal portion thereof, and (B) a wire conduit 53 extending from a proximal portion of the array 150 to an electrocautery-enhanced tip 59 at a distal end of the wire conduit 53, (ii) an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 56, and (iii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of one of the one or more primary delivery members of the array 150 at least at a proximal constraint-point 54. In some embodiments, the array 150 comprises exactly one elongated primary delivery member 50, said exactly one elongated primary delivery member 50 comprising both the inflation-fluid conveyance 52 and the wire conduit 53.

Step S22 includes loading a first stent 41 on the delivery system 100 to surround the one or more primary delivery members of the array 150 proximal to the inflatable member 70, without surrounding the secondary delivery member 60.

Step S23 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53.

Step S24 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70.

Step S25 includes deploying the first stent 41 such that a proximal portion of the first stent 41 is disposed within the proximal organ 201 and a distal portion of the first stent 41 is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array 150 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the one or more delivery members of the array 150, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S26A includes advancing the delivery system 100 before Step S23, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 201.

Step S26B includes advancing the delivery system 100 before Step S24, to dispose the inflatable member 70 within both respective diathermic holes 27i, 272. Step S26C includes advancing the delivery system 100 before Step S25, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202.

In some embodiments, the method additionally comprises method steps S27 and S28, as illustrated by the flow chart in Fig. 13B.

Step S27 includes loading a second stent 42 on the delivery system 100 before Step S26A, to surround, proximal to the first stent 41, the one or more primary delivery members of the array 150 and the secondary delivery member 60.

Step S28 includes deploying the second stent 42 after Step S25 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

Referring now to Fig. 14, a method is disclosed for delivering two stents to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 14, the method comprises at least the nine method steps S31, S32, S33, S34, S35, S36, S37A, S37B, and S37C.

Step S31 includes providing a delivery system 100 comprising: (i) an array 150 of one or more elongated primary delivery members, the array 150 comprising: (A) an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the inflation-fluid conveyance 52 at least to an inflation-fluid port 56 in a distal portion thereof, and (B) a wire conduit 53 extending from a proximal portion of the array 150 to an electrocautery-enhanced tip 59 at a distal end of the wire conduit 53, (ii) an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 56, and (iii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of one of the one or more primary delivery members of the array 150 at least at a proximal constraint-point 54. Step S32 includes loading the two stents 41, 42 on the delivery system 100, such that (i) a first stent 41 surrounds the one or more primary delivery members of the array 150 proximal to the inflatable member 70, without surrounding the secondary delivery member 60, and (ii) a second stent 42 surrounds, proximal to the first stent 41, the one or more primary delivery members of the array 150 and the secondary delivery member 60.

Step S33 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53.

Step S34 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70.

Step S35 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array 150 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the one or more primary delivery members of the array 150, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S36 includes deploying the second stent 42 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

Step S37A includes advancing the delivery system 100 before Step S33, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i. Step S37B includes advancing the delivery system 100 before Step S34, to dispose the inflatable member 70 within both respective diathermic holes 27i, 272.

Step S37C includes advancing the delivery system 100 before Step S35, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202.

Referring now to Fig. 15 A, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 15 A, the method comprises at least the six method steps S41, S42, S43, S44, S45, and S46.

Step S41 includes providing a delivery system 100 comprising: (i) an elongated primary delivery member 50 comprising: (A) an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the inflation-fluid conveyance

52 at least to an inflation-fluid port 56 in a distal portion thereof, and (B) a wire conduit

53 extending from a proximal portion of the primary delivery member 50 to an electrocautery-enhanced tip 59 at a distal end of the wire conduit 53, (ii) an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 56, and (iii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of the primary delivery member 50 at least at a proximal constraint-point.

Step S42 includes loading the two stents 41, 42 on the delivery system, such that (i) a first stent 41 surrounds the primary delivery member 50 proximal to the inflatable member 70, without surrounding the secondary delivery member 60, and (ii) a second stent 42 surrounds, proximal to the first stent 41, the primary delivery member 50 and the secondary delivery member 60.

Step S43 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 201, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53. Step S44 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70.

Step S45 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the primary delivery member 50 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the primary delivery member 50, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S46 includes deploying the second stent 42 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

In some embodiments, the method additionally comprises method steps S47A, S47B, and S47C, as illustrated by the flow chart in Fig. 15B.

Step S47A includes advancing the delivery system 100 before Step S43, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i.

Step S47B includes advancing the delivery system 100 before Step S44, to dispose the inflatable member 70 within both respective diathermic holes 27i, 272.

Step S47C includes advancing the delivery system 100 before Step S45, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202. Referring now to Fig. 16A, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 2(h of a human subject. As illustrated by the flow chart in Fig. 15 A, the method comprises at least the six method steps S51, S52, S53, S54, and S55.

Step S51 includes providing a pre-loaded delivery system 100 comprising: (i) an elongated primary delivery member 50 comprising: (A) an inflation-fluid conveyance 52 comprising a lumen extending from a proximal portion of the inflation-fluid conveyance

53 extending from a proximal portion of the primary delivery member 50 to an electrocautery-enhanced tip 59 at a distal end of the wire conduit 53, (ii) an inflatable member 70 in contact with the inflation-fluid conveyance 52 and in fluid communication with the lumen via the inflation-fluid port 56, (iii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of the primary delivery member 50 at least at a proximal constraint-point 54, (iv) a first stent 41 surrounding the primary delivery member 50 proximal to the inflatable member 70 and not surrounding the secondary delivery member 60, and (v) a second stent 42 surrounding, proximal to the first stent 41, the primary delivery member 50 and the secondary delivery member 60.

Step S52 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53.

Step S53 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) inflating the inflatable member 70 with an inflation fluid delivered through the inflation-fluid conveyance 52 and the inflation-fluid port 56, and (ii) deflating the inflatable member 70.

Step S54 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the primary delivery member 50 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the primary delivery member 50, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S55 includes deploying the second stent 42 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

In some embodiments, the method additionally comprises method steps S56A, S56B, and S56C, as illustrated by the flow chart in Fig. 16B.

Step S56A includes advancing the delivery system 100 before Step S53, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i.

Step S56B includes advancing the delivery system 100 before Step S54, to dispose the inflatable member 70 within both respective diathermic holes 27i, 272.

Step S56C includes advancing the delivery system 100 before Step S55, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202.

Reference is now made to Figs. 17A and 17B. An alternative primary delivery member 250 comprises an expansion-actuation conduit 252 extending from a proximal portion of the primary delivery member 250 to a mechanical expansion member 270 in a distal portion thereof. The expansion- actuation conduit 252 houses at least a portion of an expansion-actuation member 275. The expansion-actuation member is effective, when actuated, to cause the expansion of the mechanical expansion member 270, As well as the subsequent contraction of the mechanical expansion member 270. The primary delivery member 250 also comprises the wire conduit 53 for housing a wire configured to activate an electrocautery-enhanced tip 59 (not shown) at the distal end of the wire conduit 53. Fig. 17A shows the mechanical expansion member 270 in a contracted state, whilst Fig. 18A shows the mechanical expansion member 270 in an expanded state.

In the non-limiting example of Figs. 17A and 17B the mechanical expansion member 270 is represented as a jack for expanding a portion of the wall of the primary delivery device 250; in other examples, other suitable mechanical expansion solutions are used.

Referring now to Fig. 18 A, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 18A, the method comprises at least the six method steps S61, S62, S63, S64, S65, and S66.

Step S61 includes providing a delivery system 100 comprising: (i) an elongated primary delivery member 250 comprising: (A) an expansion-actuation conduit 252 extending from a proximal portion of the primary delivery member 250 to an expansion member 270 in a distal portion thereof, the expansion-actuation conduit 252 housing at least a portion of an expansion-actuation member 275, and (B) a wire conduit 53 extending from a proximal portion of the primary delivery member 50 to an electrocautery-enhanced tip 59 at a distal end of the wire conduit 53, the wire conduit 53 housing at least a portion of an electrocautery-actuation wire, and (ii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of the primary delivery member at least at a proximal constraint-point 54.

Step S62 includes loading the two stents 41, 42 on the delivery system, such that (i) a first stent 41 surrounds the primary delivery member 50 proximal to the expansion member 270, without surrounding the secondary delivery member 60, and (ii) a second stent 42 surrounds, proximal to the first stent 41, the primary delivery member 50 and the secondary delivery member 60.

Step S63 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit 53.

Step S64 includes expanding the respective diathermic holes 27i, 272, the expanding including (i) expanding the expansion member 70 using the expansionactuation member 275, and (ii) contracting the expansion member 270.

Step S65 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the primary delivery member 50 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the primary delivery member 50, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S66 includes deploying the second stent 42 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

In some embodiments, the method additionally comprises method steps S67A, S67B, and S67C, as illustrated by the flow chart in Fig. 18B.

Step S67A includes advancing the delivery system 100 before Step S63, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i.

Step S67B includes advancing the delivery system 100 before Step S64, to dispose the expansion member 270 within both respective diathermic holes 27i, 272.

Step S67C includes advancing the delivery system 100 before Step S65, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202. Reference is now made to Figs. 19A, 19B and 19C. A delivery system 100 comprises an alternative primary delivery member 350 which includes an actuation-wire conveyance 352 extending from a proximal portion of the primary delivery member 350 and through the primary delivery member 350, at least to an actuation- wire port 64. An actuation wire 65, at least a lengthwise part of which is housed in the actuation-wire conveyance 352, exits the primary delivery member 350 at the actuation-wire port 64 and extends distally, parallel to and alongside the primary delivery member 350. The actuation wire 65 is distally anchored, at a distal actuation-wire attachment point 62 proximal to an electrocautery-enhanced tip 59 of a needle element 380 at the distal end of the primary delivery member 350 and of the delivery system 100. The distal anchoring can be by any technique robust enough to sustain the forces of actuating the actuation wire as described hereinbelow, for example and not exhaustively: tying, clamping, welding, or threading through holes. An optional element for guiding the actuation wire 65, e.g., a ring 63 through which the actuation wire 65 may pass, can be provided distal of the actuation- wire port 64. Other labeled elements associated with the delivery system, including the secondary delivery member 60, and first and second stents 41, 42, have the same functions and, optionally, the same structures, as disclosed in connection with other exemplary delivery systems illustrated, inter alia, in Figs. 2, 3A, 4-8, and 9A-9K. Similar to the role of the needle 80 or needle 180 in the delivery systems of the present disclosure, the needle element 380 is configured to open opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, by actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire (not shown) at least partly housed in an actuation-wire conduit, e.g., the wire conduit 53 of Figs. IB or 3A-D. Fig. 19A schematically shows the position of the delivery system 100 after being advanced, as indicated by arrow 1221, to bring the electrocautery-enhanced tip 59 to the wall 25i of the proximal organ 20i.

Fig. 19B is similar to, e.g., Fig. 9C, in that it illustrates the delivery system 100 of Fig. 19A after the diathermic holes 27i, 272 have been opened by the electrocautery- enhanced tip 59 in respective walls 25i, 252 of the proximal and distal organs 20i, 202. Also, the delivery system 100 has been further advanced, as indicated by arrow 1222 of Fig. 19B, such that the distal end of the delivery member 350 is disposed within the distal organ 202 and a portion of the actuation wire 65 resides within the two diathermic holes 27i, 27₂.

Fig. 19C schematically illustrates the operation and function of the actuation wire 65 to expand the diathermic holes 27i, 272 in the walls 25i, 252. The actuation wire 65 is proximally withdrawn, i.e., pulled backwards from its proximal end, as indicated by arrow 1223 in Fig. 19C, causing a distal portion of the primary delivery member 350 to be bent or deflected between the actuation-wire port 64 (shown in Fig. 19 A) and the distal actuation-wire attachment point 62. The primary delivery device 350 is deflected away from the taut actuation wire 65 as a result of the pulling, but the primary delivery device 350 is constrained by its presence in the diathermic holes 27i, 272, and so the resistance of the tissue against movement of the primary delivery device 350 tends to force the actuation wire 65 in the direction opposite the deflection of the primary delivery device 350, as indicated in Fig. 19C by arrow 1224. The actuation wire 65 is electrified, either before, during or after the pulling and deflection, and so when the actuation wire is forced against the tissue of the diathermic holes 27i, 272, the tissue is electrocauterized by the actuation wire 65 and the diathermic holes 27i, 272 are thus expanded.

Referring now to Fig. 20A, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 20A, the method comprises at least the six method steps S71, S72, S73, S74, S75, and S76.

Step S71 includes providing a delivery system comprising: an actuation- wire conveyance 352 comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port 64 in a distal portion thereof, the actuationwire conveyance 352 housing at least a lengthwise portion of an actuation wire 65, and a wire conduit 53 extending from a proximal portion of the primary delivery member 350 to an electrocautery-enhanced tip 59 at a distal end thereof, the conduit housing at least a portion of a tip-actuation wire. According to the method, the actuation wire 65 is distally attached to the primary delivery member 350 at an actuation-wire attachment point 62 located proximal to the electrocautery-enhanced tip. The delivery system further comprises an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of the primary delivery member at least at a proximal constraint-point 54 (as illustrated, e.g., in Fig. 9G).

Step S72 includes loading the two stents 41, 42 on the delivery system 100, such that (i) a first stent 41 surrounds the primary delivery member 50 proximal to the proximal constraint-point 54, without surrounding the secondary delivery member 60, and (ii) a second stent 42 surrounds, proximal to the first stent 41, the primary delivery member 50 and the secondary delivery member 60.

Step S73 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit.

Step S74 includes proximally withdrawing the activation wire 65 so as to deflect a portion of the primary delivery member 350 between the actuation-wire port 64 and the actuation- wire attachment point 62, and electrically actuating the actuation wire 65 while said portion of the primary delivery member 350 is deflected so as to expand the respective diathermic holes 27i, 272 by electrocautery.

Step S75 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the primary delivery member 50 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the primary delivery member 50, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

In some embodiments, the method additionally comprises method steps S77A, S77B, and S77C, as illustrated by the flow chart in Fig. 20B. Step S77A includes advancing the delivery system 100 before Step S73, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i.

Step S77B includes advancing the delivery system 100 before Step S74, to dispose the actuation wire 65 within both respective diathermic holes 27i, 272.

Step S77C includes advancing the delivery system 100 before Step S75, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202.

In some embodiments, the delivery system 100 includes an array 150 of one or more primary delivery members similar to the array 150 shown in Figs. 3A-D, rather than a single primary delivery member 50.

Reference is now made to Figs. 21A, 21B and 21C. A delivery system 100 comprises an alternative primary delivery member 450 which includes a wire conveyance 452 housing at least a lengthwise portion of a tip-actuation wire 75 and of a plurality of expansion wires 76, the wires 75, 76 extending from a proximal portion of the primary delivery member 450 to an electrocautery-enhanced tip 59 at a distal end of the tipactuation wire 75. Other labeled elements associated with the delivery system, including the secondary delivery member 60, and first and second stents 41, 42, have the same functions and, optionally, the same structures, as disclosed in connection with other exemplary delivery systems illustrated, inter alia, in Figs. 2, 3A, 4-8, and 9A-9K. Similar to the role of the needle 80 or needle 180 in the delivery systems of the present disclosure, the needle element 480 is configured to open opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, by actuating the electrocautery-enhanced tip 59 via the tip-actuation wire 75 at least partly housed in the wire conveyance 452. Fig. 21 A schematically shows the position of the delivery system 100 after being advanced, as indicated by arrow 1231, to bring the electrocautery- enhanced tip 59 to the wall 25i of the proximal organ 20i.

Fig. 21B is similar to, e.g., Figs. 9C and 19B, in that it illustrates the delivery system 100 of Fig. 19A after the diathermic holes 27i, 272 have been opened by the electrocautery-enhanced tip 59 in respective walls 25i, 252 of the proximal and distal organs 20i, 202. Also, the delivery system 100 has been further advanced, as indicated by arrow 1232 of Fig. 21B, such that the distal end of the delivery member 450 is disposed within the distal organ 202 and a respective portion of the each of the expansion wires 76 resides within the two diathermic holes 27i, 272.

Fig. 21C schematically illustrates the operation and function of the expansion wires 76 to expand the diathermic holes 27i, 272 in the walls 25i, 252. The tip-actuation wire 75 is proximally withdrawn, i.e., pulled backwards from its proximal end, as indicated by arrow 1233 in Fig. 21C, causing the expansion wires 76 to be deflected, e.g., bent or arched, away from the tip-actuation wire 75. In the non-limiting of Fig. 21C,

The expansion wires 76 are electrified to activate their ability to electrocauterize tissue. In some implementations, the tip-actuation wire 75 and the expansion wires 76 commonly powered on a single electrical circuit. In some implementations, the expansion wires are activated on a separate circuit, e.g., to activate after the diathermic holes 27i, 272 have been opened. In any implementation, the expansion wires 76 are electrified before, during or after the proximal withdrawing and deflection of the expansion wires 76 away from the tip-actuation wire 75, such that in the deflected state of Fig. 21C the activated expansion wire 76 are effective to electrocauterize tissue surrounding the initial diathermic holes 27i, 272 and expand the holes, as indicated by arrows 1234 in Fig. 21C.

In Figs. 21A-C, two expansion wires 761, 762 are shown, but there can be any number of expansion wires, for example, 3, 4, 5, 6, or more.

Referring now to Fig. 22A, a method is disclosed for delivering two stents 41, 42 to connect between a proximal organ 20i and a distal organ 202 of a human subject. As illustrated by the flow chart in Fig. 22A, the method comprises at least the six method steps S81, S82, S83, S84, S85, and S86.

Step S81 includes providing a delivery system comprising: (i) an elongated primary delivery member 450 comprising a wire conveyance housing at least a lengthwise portion of a tip-actuation wire 75 and of a plurality of expansion wires 76, the wires 75, 76 extending from a proximal portion of the primary delivery member 450 to an electrocautery-enhanced tip 59 at a distal end of the tip-actuation wire 75; and (ii) an elongated secondary delivery member 60, a distal portion thereof at least partly constrained by a surface feature 55 of the primary delivery member at least at a proximal constraint-point 54 (as illustrated, e.g., in Fig. 9G). Step S82 includes loading the two stents 41, 42 on the delivery system 100, such that (i) a first stent 41 surrounds the primary delivery member 50 proximal to the proximal constraint-point 54, without surrounding the secondary delivery member 60, and (ii) a second stent 42 surrounds, proximal to the first stent 41, the primary delivery member 50 and the secondary delivery member 60.

Step S83 includes opening opposing diathermic holes 27i, 272 in respective walls 25i, 252 of the proximal and distal organs 20i, 202, the opening including actuating the electrocautery-enhanced tip 59 via an electrocautery-actuation wire at least partly housed in the wire conduit.

Step S84 includes proximally withdrawing the tip-activation wire 65 so as to deflect a portion of each expansion wire 76 so as to expand the respective diathermic holes 27i, 272 by electrocautery.

Step S85 includes deploying the first stent 41 such that a proximal portion thereof is disposed within the proximal organ 20i and a distal portion thereof is disposed within the distal organ 202, the deploying including at least one of: (i) retracting the primary delivery member 50 relative to the first stent 41, and (ii) pushing the first stent 41 to advance distally relative to the primary delivery member 50, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member 60 from the surface feature 55 at least at the proximal constrained point 54.

Step S86 includes deploying the second stent 42 such that a distal portion thereof is disposed within the distal organ 202 and a proximal portion thereof is disposed within the proximal organ 20i, the deploying of the second stent 42 including pushing the second stent 42 to advance distally relative to the secondary delivery member 60 and retracting the secondary delivery member 60 relative to the second stent 42.

In some embodiments, the method additionally comprises method steps S87A, S87B, and S87C, as illustrated by the flow chart in Fig. 22B.

Step S87A includes advancing the delivery system 100 before Step S83, to dispose the electrocautery-enhanced tip 59 at an inner surface of the respective wall 25i of the proximal organ 20i. Step S87B includes advancing the delivery system 100 before Step S84, to dispose the the expansion wires 76 within both respective diathermic holes 27i, 272.

Step S87C includes advancing the delivery system 100 before Step S85, to dispose the at least partly constrained distal portion of the secondary delivery member 60 and the distal portion of the first stent 41 within the distal organ 202.

Any of the methods and method steps disclosed herein can be combined in any combination. Any of the methods and method steps disclosed herein may be carried out without the use of a guidewire.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description. The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons skilled in the art to which the invention pertains.

Claims

1. A delivery system for deploying stents, the delivery system comprising, when in an assembled state: a. an elongated primary delivery member comprising: i. an actuation-wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port in a distal portion thereof, the actuation-wire conveyance housing at least a portion of an actuation wire, and ii. a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of a tip-actuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation-wire attachment point located proximal to the electrocautery-enhanced tip; and b. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member, wherein: when the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the actuation-wire port and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal- direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

2. The delivery system of claim 1 , wherein the electrocautery-enhanced tip is configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated.

3. The delivery system of either one of claims 1 or 2, wherein the actuation wire is configured to (i) be proximally withdrawn so as to deflect a portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point, and (ii) be electrically actuated while said portion of the primary delivery member is deflected so as to expand the respective diathermic holes by electrocautery.

4. The delivery system of any one of claims 1 to 3, wherein the first-stent deployment configuration is further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs.

5. The delivery system of any one of claims 1 to 4, wherein the second-stent deployment configuration is further characterized by the distal end of the secondary delivery member being disposed within the distal organ.

6. The delivery system of any one of claims 1 to 5, additionally comprising a pusher tube, operable, when disposed to surround the secondary delivery member and the primary delivery member proximal to the second stent, to effect the one or more distal-direction advancements of the first and second stents.

7. The delivery system of any one of claims 1 to 6, wherein at least one of the stents comprises a pigtail stent.

8. The delivery system of any one of claims 1 to 7, additionally comprising the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member.

9. The delivery system of any one of claims 1 to 8, wherein the delivery system is configured for delivery of stents without the use of a guidewire.

10. A delivery system for deploying one or more stents to connect between a proximal organ and a distal organ of a human subject, the delivery system comprising, when in an assembled state: a. an array of one or more elongated primary delivery members, the array comprising: i. an activation-wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port in a distal portion thereof, the actuation-wire conveyance housing at least a portion of an actuation wire, and ii. a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end thereof, the tip being configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto, the conduit housing at least a portion of an electrocautery- enabled actuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation-wire attachment point located proximal to the electrocautery-enhanced tip; and b. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraint-point of the distal portion of the secondary delivery member, wherein, when the delivery system is in a first-stent deployment configuration characterized by (i) the first stent surrounding the array proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the array and/or one or more proximal-direction withdrawals of the array relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent.

11. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. Providing a delivery system comprising: (i) an actuation-wire conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an actuation-wire port in a distal portion thereof, the actuationwire conveyance housing at least a lengthwise portion of an actuation wire, and a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of a tip-actuation wire, wherein the actuation wire is distally attached to the primary delivery member at an actuation-wire attachment point located proximal to the electrocautery- enhanced tip, and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member; b. loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the proximal constraint-point, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member and the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via the tip-actuation wire; d. proximally withdrawing the activation wire so as to deflect a portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point, and electrically actuating the actuation wire while said portion of the primary delivery member is deflected so as to expand the respective diathermic holes by electrocautery; e. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and f. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

12. The method of claim 11, additionally comprising advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the proximally withdrawing, to dispose the portion of the primary delivery member between the actuation-wire port and the actuation-wire attachment point within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

13. A delivery system for deploying stents, the delivery system comprising, when in an assembled state: a. an elongated primary delivery member comprising a wire conveyance housing at least a lengthwise portion of a tip-actuation wire and of a plurality of expansion wires, the wires extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the tip- actuation wire; and b. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point, wherein: when the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the actuation-wire port and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal- direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

14. The delivery system of claim 13, wherein the electrocautery-enhanced tip is configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated via the tipactuation wire.

15. The delivery system of either one of claims 13 or 14, wherein the expansion wires are configured such that respective distal portions thereof between a distal end of the primary delivery member and the electrocautery-enhanced tip are deflected when the tip-actuation wire is proximally withdrawn and (ii) be electrically actuated so as to expand the respective diathermic holes by electrocautery.

16. The delivery system of any one of claims 13 to 15, wherein the tip-actuation wire and the expansion wires are electrically actuated from a single electrical circuit.

17. The delivery system of any one of claims 13 to 16, wherein the first-stent deployment configuration is further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs.

18. The delivery system of any one of claims 13 to 17, wherein the second-stent deployment configuration is further characterized by the distal end of the secondary delivery member being disposed within the distal organ.

19. The delivery system of any one of claims 13 to 18, additionally comprising a pusher tube, operable, when disposed to surround the secondary delivery member and the primary delivery member proximal to the second stent, to effect the one or more distal-direction advancements of the first and second stents.

20. The delivery system of any one of claims 13 to 19, wherein at least one of the stents comprises a pigtail stent.

21. The delivery system of any one of claims 13 to 20, additionally comprising the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member.

22. The delivery system of any one of claims 13 to 20, wherein the delivery system is configured for delivery of stents without the use of a guidewire.

23. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system comprising: (i) an elongated primary delivery member comprising a wire conveyance housing at least a lengthwise portion of an actuation wire and of a plurality of expansion wires, the wires extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the tip-actuation wire; and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point of the distal portion of the secondary delivery member; b. loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the proximal constraint-point, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member, and the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. proximally withdrawing the tip-activation wire so as to deflect a portion of each expansion wire so as to expand the respective diathermic holes by electrocautery; e. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and f. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

24. The method of claim 23, additionally comprising advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the proximally withdrawing, to dispose the expansion wires within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

25. The method of either one of claims 23 or 24, wherein the tip-actuation wire and the expansion wires are electrically actuated together from a single electrical circuit.

26. A delivery system for deploying stents, the delivery system comprising, when in an assembled state: a. an elongated primary delivery member comprising: i. an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and ii. a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocauteryactuation wire; b. an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port; and c. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of the primary delivery member at least at a proximal constraintpoint of the distal portion of the secondary delivery member, wherein: when the delivery system is in a first-stent deployment configuration characterized by a first stent surrounding the first delivery member proximal to the deflated inflatable member and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal- direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

27. The delivery system of claim 26, wherein the electrocautery-enhanced tip is configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated.

28. The delivery system of either one of claims 26 or 27, wherein the inflatable member is configured to (i) expand the respective diathermic holes when inflated therewithin, and (ii) allow passage therearound of a first stent when deflated subsequent to the expanding.

29. The delivery system of any one of claims 26 to 28, wherein the first-stent deployment configuration is further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs.

30. The delivery system of any one of claims 26 to 29, wherein the second-stent deployment configuration is further characterized by the distal end of the secondary delivery member being disposed within the distal organ.

31. The delivery system of any one of claims 26 to 29, wherein, in said assembled state, the distal end of the secondary delivery member is proximal to the inflatable member.

32. The delivery system of any one of claims 26 to 29, wherein, in said assembled state, the distal portion of the secondary delivery member circumvents the inflatable member.

33. The delivery system of any one of claims 26 to 32, additionally comprising a pusher tube, operable, when disposed to surround the secondary delivery member and the primary delivery member proximal to the second stent, to effect the one or more distal-direction advancements of the first and second stents.

34. The delivery system of any one of claims 26 to 33, wherein at least one of the stents comprises a pigtail stent.

35. The delivery system of any one of claims 26 to 34, additionally comprising the first and second stents, the first stent surrounding the primary delivery member and not surrounding the secondary delivery member, the second stent surrounding at least the secondary delivery member.

36. The delivery system of any one of claims 26 to 35, wherein the delivery system is configured for delivery of stents without the use of a guidewire.

37. A delivery system for deploying one or more stents to connect between a proximal organ and a distal organ of a human subject, the delivery system comprising, when in an assembled state: a. an array of one or more elongated primary delivery members, the array comprising: i. an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and ii. a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end thereof, the tip being configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto, the conduit housing at least a portion of an electrocauteryactuation wire; b. an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, the inflatable member configured to (i) expand the respective diathermic holes when inflated therewithin, and (ii) allow passage therearound of a first stent when deflated subsequent to the expanding; and c. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of one of the one or more primary delivery members of the array at least at a proximal constraint-point of the distal portion of the secondary delivery member, wherein, when the delivery system is in a first-stent deployment configuration characterized by (i) the first stent surrounding the array proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the array and/or one or more proximal-direction withdrawals of the array relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent.

38. The delivery system of claim 37, wherein, in said assembled state, the distal end of the secondary delivery member is proximal to the inflatable member.

39. The delivery system of claim 37, wherein, in said assembled state, the distal portion of the secondary delivery member circumvents the inflatable member.

40. The delivery system of any one of claims 37 to 39, additionally comprising a pusher tube, operable, when disposed to surround the secondary delivery member and the array proximal to the first stent, to effect the one or more distal-direction advancements of the first stent.

41. The delivery system of any one claims 37 to 40, wherein, when the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed, (ii) the distal end of the secondary delivery member being disposed within the distal organ, and (iii) a second stent surrounding at least the secondary delivery member: one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

42. The delivery system of claim 41, comprising a pusher tube surrounding, proximal to the second stent, surrounding at least the secondary delivery member.

43. The delivery system of any one of claims 37 to 42, wherein the one or more stents comprise at least one pigtail stent.

44. The delivery system of any one of claims 37 to 43, wherein the array comprises exactly one primary delivery member, said exactly one primary delivery member comprising both the inflation-fluid conveyance and the wire conduit.

45. The delivery system of any one of claims 37 to 44, wherein the delivery system is configured for delivery of stents without the use of a guidewire.

46. The delivery system of any one of claims 37 to 45, additionally comprising the first stent, the first stent surrounding the one or more primary delivery members of the array proximal to the inflatable member and not surrounding the secondary delivery member.

47. The delivery system of any one of claims 37 to 46, additionally comprising the second stent, the second stent surrounding at least the secondary delivery member.

48. A method of delivering one or more stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system according to any one of claims 37 to 46; b. loading a first stent on the delivery system to surround the array proximal to the inflatable member, without surrounding the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; and e. releasing the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point, and deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, wherein the releasing and deploying include at least one of retracting the array relative to the first stent and pushing the first stent to advance distally relative to the array.

49. The method of claim 48, additionally comprising: i. loading a second stent on the delivery system to surround, proximal to the first stent, the array and the secondary delivery member; and ii. after the deploying of the first stent, deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

50. A delivery system for deploying two stents to connect between a proximal organ and a distal organ of a human subject, the delivery system comprising, when in an assembled state: a. an elongated primary delivery member comprising: i. an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the conveyance at least to an inflation-fluid port in a distal portion thereof, and ii. a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocauteryactuation wire; b. an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port; and c. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the inflatable member, of the primary delivery member at least at a proximal constraintpoint of the distal portion of the secondary delivery member, wherein: when the delivery system is in a first-stent deployment configuration characterized by (i) the first stent surrounding the first delivery member proximal to the deflated inflatable member and not surrounding the secondary delivery member, (ii) the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and (iii) proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs: one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed, (ii) the distal end of the secondary delivery member being disposed within the distal organ, and (iii) a second stent surrounding at least the secondary delivery member: one or more distal-direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

51. The delivery system of claim 50, wherein, in said assembled state, the distal end of the secondary delivery member is proximal to the inflatable member.

52. The delivery system of claim 51 , wherein, in said assembled state, the distal portion of the secondary delivery member circumvents the inflatable member.

53. The delivery system of any one of claims 50 to 52, additionally comprising a pusher tube, operable, when disposed to surround the primary and secondary delivery members proximal to the second stent, to effect the one or more distal- direction advancements of the first stent relative to the primary delivery member and the one or more distal-direction advancements of the second stent relative to the secondary delivery member.

54. The delivery system of any one of claims 50 to 53, wherein the first and second stents are pigtail stents.

55. The delivery system of any one of claims 50 to 54, wherein the delivery system is configured for delivery of stents without the use of a guidewire.

56. The delivery system of any one of claims 50 to 55, additionally comprising the first and second stents, the first stent surrounding the primary delivery member proximal to the inflatable member and not surrounding the secondary delivery member, the second stent being disposed proximal to the first stent surrounding at least the secondary delivery member.

57. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system according to any one of claims 50 to 56; b. loading the two stents on the delivery system so that a first stent surrounds the primary delivery member proximal to the inflatable member, without surrounding the secondary delivery member, and a second stent surrounds at least the secondary delivery member proximal to the first stent; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; e. releasing the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point, and deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, wherein the releasing and deploying include at least one of retracting the primary delivery member relative to the first stent and pushing the first stent to advance distally relative to the primary delivery member; and f. after the deploying of the first stent, deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

58. A method of delivering one or more stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system comprising: (i) an array of one or more elongated primary delivery members, the array comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraint-point; b. loading a first stent on the delivery system to surround the one or more primary delivery members of the array proximal to the inflatable member, without surrounding the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; and e. deploying the first stent such that a proximal portion of the first stent is disposed within the proximal organ and a distal portion of the first stent is disposed within the distal organ, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array relative to the first stent, and (ii) pushing the first stent to advance distally relative to the one or more delivery members of the array, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point, wherein the method additionally comprises advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the expanding, to dispose the inflatable member within both respective diathermic holes, and iii. before the deploying, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

59. The method of claim 58, additionally comprising: i. before the advancing of the delivery system to dispose the electrocautery-enhanced tip at the inner surface: loading a second stent on the delivery system to surround, proximal to the first stent, the one or more primary delivery members of the array and the secondary delivery member; and ii. after the deploying of the first stent: deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

60. The method of either one of claims 58 or 59, wherein the array comprises exactly one elongated primary delivery member, said exactly one elongated primary delivery member comprising both the inflation-fluid conveyance and the wire conduit.

61. The method of any one of claims 58 to 60, wherein the one or more stents are delivered without using a guidewire.

62. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system comprising: (i) an array of one or more elongated primary delivery members, the array comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the array to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflation-fluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of one of the one or more primary delivery members of the array at least at a proximal constraint-point; b. loading the two stents on the delivery system, such that (i) a first stent surrounds the one or more primary delivery members of the array proximal to the inflatable member, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the one or more primary delivery members of the array and the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; e. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the one or more primary delivery members of the array relative to the first stent, and (ii) pushing the first stent to advance distally relative to the one or more primary delivery members of the array, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and f. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent, wherein the method additionally comprises advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the expanding, to dispose the inflatable member within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

63. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system comprising: (i) an elongated primary delivery member comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflation-fluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflation-fluid conveyance and in fluid communication with the lumen via the inflationfluid port, and (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point; b. loading the two stents on the delivery system, such that (i) a first stent surrounds the primary delivery member proximal to the inflatable member, without surrounding the secondary delivery member, and (ii) a second stent surrounds, proximal to the first stent, the primary delivery member and the secondary delivery member; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; e. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and f. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

64. The method of claim 63, additionally comprising advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the expanding, to dispose the inflatable member within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

65. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a pre-loaded delivery system comprising: (i) an elongated primary delivery member comprising: (A) an inflation-fluid conveyance comprising a lumen extending from a proximal portion of the inflationfluid conveyance at least to an inflation-fluid port in a distal portion thereof, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, (ii) an inflatable member in contact with the inflationfluid conveyance and in fluid communication with the lumen via the inflation-fluid port, (iii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point, (iv) a first stent surrounding the primary delivery member proximal to the inflatable member and not surrounding the secondary delivery member, and (v) a second stent surrounding, proximal to the first stent, the primary delivery member and the secondary delivery member; b. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; c. expanding the respective diathermic holes, the expanding including (i) inflating the inflatable member with an inflation fluid delivered through the inflation-fluid conveyance and the inflation-fluid port, and (ii) deflating the inflatable member; d. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and e. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

66. The method of claim 65, additionally comprising advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the expanding, to dispose the inflatable member within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

67. A method of delivering two stents to connect between a proximal organ and a distal organ of a human subject, the method comprising: a. providing a delivery system comprising: (i) an elongated primary delivery member comprising: (A) an expansion- actuation conduit extending from a proximal portion of the primary delivery member to an expansion member in a distal portion thereof, the expansion-actuation conduit housing at least a portion of an expansion-actuation member, and (B) a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end of the wire conduit, the wire conduit housing at least a portion of an electrocautery-actuation wire, and (ii) an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature of the primary delivery member at least at a proximal constraint-point; b. loading two stents on the delivery system so that a first stent surrounds the primary delivery member proximal to the expansion member without surrounding the secondary delivery member, and a second stent surrounds at least the secondary delivery member proximal to the first stent; c. opening opposing diathermic holes in respective walls of the proximal and distal organs, the opening including actuating the electrocautery-enhanced tip via an electrocautery-actuation wire at least partly housed in the wire conduit; d. expanding the respective diathermic holes, the expanding including (i) expanding the expansion member using the expansion-actuation member, and (ii) contracting the expansion member; e. deploying the first stent such that a proximal portion thereof is disposed within the proximal organ and a distal portion thereof is disposed within the distal organ, the deploying including at least one of: (i) retracting the primary delivery member relative to the first stent, and (ii) pushing the first stent to advance distally relative to the primary delivery member, the at least one of retracting and pushing being effective to release the constrained distal portion of the secondary delivery member from the surface feature at least at the proximal constrained point; and f. deploying the second stent such that a distal portion thereof is disposed within the distal organ and a proximal portion thereof is disposed within the proximal organ, the deploying of the second stent including pushing the second stent to advance distally relative to the secondary delivery member and retracting the secondary delivery member relative to the second stent.

68. The method of claim 67, additionally comprising advancing the delivery system as follows: i. before the opening, to dispose the electrocautery-enhanced tip at an inner surface of the respective wall of the proximal organ, ii. before the expanding, to dispose the expansion member within both respective diathermic holes, and iii. before the deploying of the first stent, to dispose the at least partly constrained distal portion of the secondary delivery member and the distal portion of the first stent within the distal organ.

69. A delivery system for deploying stents, the delivery system comprising, when in an assembled state: a. an elongated primary delivery member comprising: i. an expansion-actuation conduit extending from a proximal portion of the primary delivery member to an expansion member in a distal portion thereof, the expansion-actuation conduit housing at least a portion of an expansion-actuation member, ii. the expansion member, and iii. a wire conduit extending from a proximal portion of the primary delivery member to an electrocautery-enhanced tip at a distal end thereof, the conduit housing at least a portion of an electrocauteryactuation wire; b. an elongated secondary delivery member, a distal portion thereof at least partly constrained by a surface feature, disposed proximal to the expansion member, of the primary delivery member at least at a proximal constraintpoint of the distal portion of the secondary delivery member, wherein: when the delivery system is in a first-stent deployment configuration characterized by the first stent surrounding the first delivery member proximal to the contracted expansion member and not surrounding the secondary delivery member, one or more distal-direction advancements of the first stent relative to the primary delivery member and/or one or more proximal-direction withdrawals of the primary delivery member relative to the first stent are effective to release the constrained distal portion of the secondary delivery member at least at the proximal constrained point and to deploy the first stent, and when the delivery system is in a second-stent deployment configuration characterized by (i) the first stent being deployed and a second stent surrounding at least the secondary delivery member, one or more distal- direction advancements of the second stent relative to the secondary delivery member and/or one or more proximal-direction withdrawals of the secondary delivery member relative to the second stent are effective to deploy the second stent.

70. The delivery system of claim 69, wherein the electrocautery-enhanced tip is configured to open respective diathermic holes in respective opposing walls of the proximal and distal organs when advanced thereto and actuated.

71. The delivery system of either one of claims 69 or 70, wherein the expansion member is configured to (i) expand the respective diathermic holes when activated therewithin, and (ii) allow passage therearound of a first stent when contracted subsequent to the expanding.

72. The delivery system of any one of claims 69 to 71, wherein the first-stent deployment configuration is further characterized by the at least partly constrained distal portion of the secondary delivery member being disposed within the distal organ, and by proximal and distal portions of the first stent being respectively disposed within the proximal and distal organs.

73. The delivery system of any one of claims 69 to 72, additionally comprising a pusher tube, operable, when disposed to surround the secondary delivery member and the array proximal to the second stent, to effect the one or more distal- direction advancements of the first and second stents.

74. The delivery system of any one of claims 69 to 73, wherein at least one of the stents comprises a pigtail stent.

75. The delivery system of any one of claims 69 to 74, wherein the delivery system is configured for delivery of stents without the use of a guidewire.