Device and method for suturing intracardiac defects
First Claim
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1. A method for suturing a patent foramen ovale (PFO), the method comprising:
- providing a suturing device comprising;
a housing having a foot actuation handle and a needle actuation handle, the housing having a proximal end and a distal end;
a flexible shaft extending from the distal end of the housing, the flexible shaft having a proximal end and a distal end and a longitudinal axis;
a foot housing extending from the distal end of the shaft and having a foot housing proximal end and foot housing distal end, both of which are aligned with the longitudinal axis of the flexible shaft, the foot housing defining a pre-formed curve portion between the foot housing proximal end and foot housing distal end, the pre-formed curve portion being in the curved configuration in a pre-deployed and deployed configuration of the suturing device, the foot housing carrying a pivotable first foot pivotal about a pivotal axis orientated in the pre-formed curve portion, the first foot being operatively connected to a first foot actuation wire and a second foot actuation wire, the first foot actuation wire being connected to the foot actuation handle and being routed over a bearing disposed proximal to and radially offset from a pivot point of the first foot, the first foot actuation wire and the second foot actuation wire being connected to the first foot on opposite sides of the pivot point and extending from the foot toward the bearing at angular orientations transverse to one another;
a first needle extending from the needle actuation handle and through the shaft;
a length of suture having a first end and a second end; and
a distal sheath coupled to the foot housing distal end and extending distally from the foot housing distal end of the foot housing, the distal sheath defining a guidewire lumen distally the foot housing, a proximal end of the distal sheath having a longitudinal axis aligned with the longitudinal axis of the foot housing and the flexible shaft;
advancing the suturing device through an inferior vena cava, right atrium, and PFO such that the first foot is positioned in the left atrium;
deploying the first foot to a deployed position;
orienting the suturing device such that a distal portion of tissue of the PFO is received in the pre-formed curve portion of the foot housing;
advancing the first needle through tissue and further into a first needle receptacle disposed on the first foot; and
advancing the first end of the length of suture through the tissue.
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Abstract
A method for suturing a patent foramen ovale (PFO) includes providing a suturing device, advancing the suturing device through the inferior vena cava, right atrium, and PFO such that a first foot of the device is positioned in the left atrium, deploying the first foot to a deployed position, orienting the suturing device such that a distal portion of tissue of the PFO is received in a pre-formed curve portion of a foot housing of the device, advancing the first needle through tissue and further into a first needle receptacle disposed on the first foot, and advancing at least one end of the length of suture through the tissue to suture the PFO.
592 Citations
18 Claims
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1. A method for suturing a patent foramen ovale (PFO), the method comprising:
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providing a suturing device comprising; a housing having a foot actuation handle and a needle actuation handle, the housing having a proximal end and a distal end; a flexible shaft extending from the distal end of the housing, the flexible shaft having a proximal end and a distal end and a longitudinal axis; a foot housing extending from the distal end of the shaft and having a foot housing proximal end and foot housing distal end, both of which are aligned with the longitudinal axis of the flexible shaft, the foot housing defining a pre-formed curve portion between the foot housing proximal end and foot housing distal end, the pre-formed curve portion being in the curved configuration in a pre-deployed and deployed configuration of the suturing device, the foot housing carrying a pivotable first foot pivotal about a pivotal axis orientated in the pre-formed curve portion, the first foot being operatively connected to a first foot actuation wire and a second foot actuation wire, the first foot actuation wire being connected to the foot actuation handle and being routed over a bearing disposed proximal to and radially offset from a pivot point of the first foot, the first foot actuation wire and the second foot actuation wire being connected to the first foot on opposite sides of the pivot point and extending from the foot toward the bearing at angular orientations transverse to one another; a first needle extending from the needle actuation handle and through the shaft; a length of suture having a first end and a second end; and a distal sheath coupled to the foot housing distal end and extending distally from the foot housing distal end of the foot housing, the distal sheath defining a guidewire lumen distally the foot housing, a proximal end of the distal sheath having a longitudinal axis aligned with the longitudinal axis of the foot housing and the flexible shaft; advancing the suturing device through an inferior vena cava, right atrium, and PFO such that the first foot is positioned in the left atrium; deploying the first foot to a deployed position; orienting the suturing device such that a distal portion of tissue of the PFO is received in the pre-formed curve portion of the foot housing; advancing the first needle through tissue and further into a first needle receptacle disposed on the first foot; and advancing the first end of the length of suture through the tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for suturing a Patent Foramen Ovale (PFO) having a Primum tissue and a Secundum tissue, the method comprising:
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providing a suturing device comprising; a housing having a first foot actuation handle and a first needle actuation handle, the housing having a proximal end and a distal end; a flexible shaft extending from the distal end of the housing, the flexible shaft having a proximal end and a distal end and supports a distal foot housing carrying a pivotal first foot, the first foot being selectively deployable from a low profile configuration to a deployed configuration having a proximal side and a distal side, the distal foot housing having a foot housing proximal end, a foot housing distal end and a pre-formed curve portion between the foot housing proximal end and the foot housing distal end, the foot housing proximal end and the foot housing distal end being axially aligned with a longitudinal axis of the flexible shaft and the pre-formed curve portion being in a curved configuration in a pre-deployed and deployed configuration of the suturing device, the first foot being operatively connected to a first foot actuation wire and a second foot actuation wire, the first foot actuation wire being connected to the foot actuation handle and being routed over a bearing disposed proximal to and radially offset from a pivot point of the first foot, the first foot actuation wire and the second foot actuation wire being connected to the first foot on opposite sides of the pivot point and extending from the foot toward the bearing at angular orientations transverse to one another; and a distal sheath extending distally from the foot housing distal end of the foot housing, the distal sheath defining a guidewire lumen distal the foot housing distal end of the foot housing; advancing a distal portion of a suturing device through a right atrium, the PFO and into a left atrium; deploying the first foot to a deployed position such that the first foot is oriented at a selectable acute angle from the longitudinal axis to provide optimal apposition of the first foot to one of the Primum tissue and the Secundum tissue; positioning the deployed first foot adjacent to one of the Primum tissue and the Secundum tissue; orienting the suturing device such that a distal portion of one of the Primum tissue and the Secundum tissue of the PFO is received in the pre-formed curve portion of the foot housing; advancing a first needle of the suturing device through the one of the Primum tissue and Secundum tissue, and into receptive association with the deployed first foot, the first needle supporting one end of a length of suture; and drawing the one end of the length of suture through one of the Primum tissue and Secundum tissue. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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Specification