Suture devices and related methods

Abstract

The suturing device (100) includes a tension member (250), a suture knot (264) associated with the tension member (250), and a needle guide (210). The needle guide (210) includes a first needle (212) coupled to the tension member (250), a second needle (214), and a suture knot recess (254) configured to receive the suture knot (264). At least a portion of the suturing device (100) is configured to be guided into an opening in the tissue. The first and second needles (212, 214) are configured to be guided through the tissue adjacent to the opening in order to guide the tension member (250) through the tissue. The tension member (250) is configured to be pulled through the tissue when at least one of the first or second needles (212, 214) is retracted. The suture knot (264) is configured to unfold from the suture knot recess (254) and along the tension member (250) and to be tightened to close and seal the opening.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 541,988 filed on October 2, 2023, the disclosure of which is hereby incorporated by reference in its entirety into the present specification.

[0002] This application is also generally related to U.S. Provisional Application No. 63 / 124,400 (now lapsed) filed on December 11, 2020, U.S. Provisional Application No. 63 / 191,017 (now lapsed) filed on May 20, 2021, U.S. Patent Application No. 17 / 546,947 (now U.S. Patent No. 12,035,905 issued on July 16, 2024) filed on December 9, 2021, U.S. Patent Application No. 17 / 546,958 (now U.S. Patent No. 12,048,429 issued on July 30, 2024) filed on December 9, 2021, PCT Patent Application No. PCT / US2021 / 062667 (now lapsed) filed on December 9, 2021, PCT Patent Application No. PCT / US2021 / 062671 (now lapsed) filed on December 9, 2021, U.S. Provisional Application No. 63 / 422,345 (now lapsed) filed on November 3, 2022, U.S. Provisional Application No. 63 / 431,366 (now lapsed) filed on December 9, 2022, PCT Patent Application No. PCT / US2023 / 036651 (pending) filed on November 2, 2023, U.S. Patent Application No. 18 / 669,040 (pending) filed on May 20, 2024, and U.S. Patent Application No. 18 / 751,896 (pending) filed on June 24, 2024, the disclosures of which are hereby incorporated by reference in their entireties into the present specification.

[0003] Technical Field Embodiments relate generally to devices, systems, and associated methods for closing puncture sites or other openings in blood vessels and other tissues.

BACKGROUND ART

[0004] Vascular access for neurotherapy is traditionally performed via the femoral artery or by using radial access techniques. For vascular access to the brain using traditional techniques, neurotherapy devices must advance through long, meandering segments of anatomical structures to access the therapy site. Direct carotid artery puncture (DCP) techniques, which access the common carotid artery (CCA), allow physicians to access the brain more quickly and eliminate the need for devices that must pass through the typical femoral artery intervention route. DCP techniques involve percutaneous puncture in the skin and arterial vessels to access the CCA.

[0005] Currently, to directly close and seal a carotid artery puncture site, physicians may manually apply sutures before accessing the common carotid artery, or they may simply apply direct pressure to the site after the intervention until the canal is sealed. Applying direct pressure to the site can be ineffective because it relies on blood coagulation at the puncture site and there are no suitable anatomical structures near the common carotid artery to which pressure can be applied. The time required to close the puncture site with direct pressure can also be very long. Furthermore, the common carotid artery carries blood at high pressure (100-200 mmHg), further complicating the ability to effectively close a carotid artery puncture site using current methods.

[0006] Therefore, despite the various advances already made in this field, further improvements are needed related to devices, systems, and methods for sealing puncture sites or other openings in blood vessels and other tissues. [Overview of the Initiative]

[0007] Generally, a suturing device is provided herein. The suturing device includes a tension member, a suture knot associated with the tension member, and a needle guide. The needle guide includes a first needle coupled to the tension member, a second needle, and a suture knot recess configured to receive the suture knot. At least a portion of the suturing device is configured to be guided into an opening in tissue. The first and second needles are configured to be guided through tissue adjacent to the opening in order to guide the tension member through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture knot is configured to be deployed from the suture knot recess and along the tension member and to be tightened to close and seal the opening.

[0008] In some embodiments, the suture knot may unfold when at least one of the first or second needles retracts. A tension member may be pulled through the suture knot when at least one of the first or second needles retracts. The suturing device may include a suture knot sleeve. The suture knot may be wrapped around the suture knot sleeve. The suture knot sleeve may be at least partially inside the suture knot recess. The suture knot sleeve may hold the suture knot until it is unfolded. The needle guide may include a tension member groove configured to accommodate the tension member. The tension member may unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member groove may extend from the first needle side to the second needle side of the needle guide. The suture knot may be a sliding knot. The suture knot may be a "Tennessee slider" knot.

[0009] In an alternative embodiment, the suturing device may include a handle positioned at the proximal end of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator positioned on the handle. The needle actuator may be coupled to at least one of the first or second needles and configured to guide at least one of the first or second needles through tissue when the needle actuator is actuated. The needle actuator may include a biasing member configured to retract at least one of the first or second needles. The needle actuator biasing member may be a spring.

[0010] In alternative or additional embodiments, a needle actuator may be coupled to first and second needles. The needle actuator may be in a first needle actuator position before guiding the first and second needles through the tissue. The needle actuator may be configured to move to a second needle actuator position in order to guide the first and second needles through the tissue. The needle actuator may be configured to move to a third needle actuator position for retracting the first and second needles. The needle actuator may include a plunger and a biasing member. The needle actuator may move from a first needle actuator position to a second needle actuator position when the plunger is pressed down. The needle actuator biasing member may move the needle actuator from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring. The needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is pressed down. The sprag may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released and the sprag is in a second sprag orientation. The sprag may be configured to rotate from a first sprag orientation to a second sprag orientation. The sprag may engage with a first sprag groove when the needle actuator is in the first needle actuator position. The sprag may engage with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released.

[0011] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0012] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane.

[0013] In some embodiments, the suturing device may include a handle positioned at the proximal end of the suturing device and a suturing mechanism coupled to the distal end of a needle guide. The suturing mechanism may be associated with first and second needles. The suturing mechanism may include a pivot element that can move between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may be positioned at the distal end of the suturing device. A suturing mechanism actuator may be positioned on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing device may include an elongated shaft coupled between the handle and the needle guide. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The suturing mechanism actuator may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The biasing member of the suturing mechanism actuator may be a spring.

[0014] In some embodiments, the suture mechanism may be in an insertion and removal orientation when the suture mechanism actuator is in a first suture mechanism actuator position. The suture mechanism may be in an unfolding orientation when the suture mechanism actuator is in a second suture mechanism actuator position. The suture mechanism actuator may include a suture mechanism actuator shaft extending through an opening in a handle, the opening in the handle can restrict and guide the movement of the suture mechanism actuator shaft. The opening in the handle may be a slot. The suture mechanism actuator may be in a first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suture mechanism actuator may be in a second suture mechanism actuator position when the suture mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suture mechanism actuator may include a selector knob coupled to the suture mechanism actuator shaft and configured to allow the user to move the suture mechanism actuator between the first suture mechanism actuator position and the second suture mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0015] In alternative or additional embodiments, the suturing mechanism may include a connecting member having first and second ends, configured to pull a tension member through tissue, the first end being capable of being coupled to a first needle, and the second end being capable of being coupled to a second needle. At least one of the first or second needles may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suture mechanism.

[0016] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0017] An alternative suturing device is provided. The alternative suturing device includes a tension member, a suture knot associated with the tension member, and a needle guide. The needle guide includes a first needle coupled to the tension member, a second needle, and a tension member groove configured to accommodate the tension member. At least a portion of the suturing device is configured to be guided into an opening in the tissue. The first and second needles are configured to be guided through the tissue adjacent to the opening in order to guide the tension member through the tissue. The tension member is configured to unfold from the tension member groove when at least one of the first or second needles has been guided through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles has been retracted. The suture knot is configured to unfold from a suture knot recess and along the tension member and to be tightened to close and seal the opening.

[0018] In some embodiments, the tension member groove may extend from the first needle side to the second needle side of the needle guide. The suture knot may be unfolded when at least one of the first or second needles retracts. The tension member may be pulled through the suture knot when at least one of the first or second needles retracts. The suturing device may include a suture knot recess configured to receive the suture knot. The suturing device may include a suture knot sleeve. The suture knot sleeve may be at least partially inside the suture knot recess. The suture knot may be wrapped around the suture knot sleeve. The suture knot sleeve may hold the suture knot until it is unfolded. The suture knot may be a sliding knot. The suture knot may be a "Tennessee slider" knot.

[0019] In alternative or additional embodiments, the suturing device may include a handle positioned at the proximal end of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator positioned on the handle. The needle actuator may be coupled to at least one of a first or second needle. The needle actuator may be configured to guide at least one of the first or second needle through tissue when the needle actuator is actuated. The needle actuator may include a biasing member configured to retract at least one of the first or second needle. The needle actuator biasing member may be a spring. The needle actuator may be coupled to the first and second needles. The needle actuator may be in a first needle actuator position before guiding the first and second needles through tissue. The needle actuator may be configured to move to a second needle actuator position in order to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position in order to retract the first and second needles. A needle actuator may include a plunger and a biasing member. The needle actuator may move from a first needle actuator position to a second needle actuator position when the plunger is pressed down. The needle actuator biasing member may move the needle actuator from the second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring.

[0020] In an alternative embodiment, the needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is pressed down. The sprag may enable the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released while the sprag is in the second sprag orientation. The sprag may be configured to rotate from a first sprag orientation to a second sprag orientation when moved by the plunger. The sprag may engage with a first sprag groove when the needle actuator is in the first needle actuator position. The sprag may engage with a second sprag groove when the plunger is pressed down, thereby enabling the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released.

[0021] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0022] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member.

[0023] In some embodiments, the suturing device may include a handle positioned at the proximal end of the suturing device, a suturing mechanism coupled to the distal end of a needle guide, a suturing mechanism actuator positioned on the handle, and an elongated shaft coupled between the handle and the needle guide. The suturing mechanism may be associated with first and second needles. The suturing mechanism may include a pivot element positioned at the distal end of the suturing device and capable of moving between an insertion and removal orientation and an unfolding orientation. The suturing mechanism actuator may be coupled to the suturing mechanism and may be configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The biasing member of the suturing mechanism actuator may be a spring.

[0024] In alternative or additional embodiments, the suture mechanism may be in an insertion and removal orientation when the suture mechanism actuator is in a first suture mechanism actuator position. The suture mechanism may be in an unfolding orientation when the suture mechanism actuator is in a second suture mechanism actuator position. The suture mechanism actuator may include a suture mechanism actuator shaft extending through an opening in a handle, the opening in the handle may restrict and guide the movement of the suture mechanism actuator shaft. The opening in the handle may be a slot. The suture mechanism actuator may be in a first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suture mechanism actuator may be in a second suture mechanism actuator position when the suture mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suture mechanism actuator may include a selector knob coupled to the suture mechanism actuator shaft and configured to allow the user to move the suture mechanism actuator between the first suture mechanism actuator position and the second suture mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0025] In an alternative embodiment, the suturing mechanism may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suture mechanism.

[0026] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0027] Alternative suture devices are provided. The alternative suture device includes a tension member, a suture knot associated with the tension member, a needle guide, a handle disposed at a proximal end of the suture device, an elongate shaft coupled between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle coupled to the tension member, a second needle, and a suture knot recess configured to receive the suture knot. The needle actuator is disposed on the handle and coupled to at least one of the first needle or the second needle. At least a portion of the suture device is configured to be guided into an opening in tissue. The needle actuator is configured to guide the first and second needles through tissue adjacent to the opening to guide the tension member through the tissue when the needle actuator is actuated. The tension member is configured to be pulled through the tissue when at least one of the first needle or the second needle is retracted. The suture knot is configured to be deployed from the suture knot recess and along the tension member, and tightened to close and seal the opening.

[0028] In some embodiments, the suture knot may be deployed when at least one of the first needle or the second needle is retracted. The tension member may be pulled through the suture knot when at least one of the first needle or the second needle is retracted. The suture device may include a suture knot sleeve. The suture knot sleeve may be at least partially inside the suture knot recess. The suture knot may be wrapped around the suture knot sleeve. The suture knot sleeve may hold the suture knot until the suture knot is deployed. The suture knot may be a sliding knot. The suture knot may be a "Tennessee slider" knot. The suture device may include a tension member groove configured to receive the tension member, and the tension member may be configured to be deployed from the tension member groove when at least one of the first needle or the second needle is guided through tissue. The tension member groove may extend from a first needle side to a second needle side of the needle guide.

[0029] In an alternative embodiment, the needle actuator may include a biasing member configured to retract the first and second needles. The needle actuator biasing member may be a spring. The needle actuator may be in a first needle actuator position prior to guiding the first and second needles through tissue. The needle actuator may be configured to be moved to a second needle actuator position to guide the first and second needles through tissue. The needle actuator may be configured to be moved to a third needle actuator position to retract the first and second needles. The needle actuator may include a plunger and a biasing member. The needle actuator may move from the first needle actuator position to the second needle actuator position when the plunger is depressed. The needle actuator biasing member may move the needle actuator from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring.

[0030] In an alternative or additional aspect, the needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is depressed. The sprag may allow the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released while the sprag is in the second sprag orientation. The sprag may be configured to rotate from the first sprag orientation to the second sprag orientation when moved by the plunger. The sprag may engage with the first sprag groove when the needle actuator is in the first needle actuator position. The sprag may engage with the second sprag groove when the plunger is depressed, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0031] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0032] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane.

[0033] In some embodiments, the suturing device may include a suturing mechanism and a suturing mechanism actuator. The suturing mechanism may be coupled to the distal end portion of a needle guide. The suturing mechanism may be associated with first and second needles. The suturing mechanism may include a pivot element located at the distal end portion of the suturing device and capable of moving between an insertion and removal orientation and an unfolding orientation. The suturing mechanism actuator may be located on a handle. The suturing mechanism actuator may be coupled to the suturing mechanism and configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The suturing mechanism actuator biasing member may be a spring.

[0034] In an alternative embodiment, the suture mechanism may be in an insertion and removal orientation when the suture mechanism actuator is in the first suture mechanism actuator position. The suture mechanism may be in an unfolding orientation when the suture mechanism actuator is in the second suture mechanism actuator position. The suture mechanism actuator may include a suture mechanism actuator shaft extending through an opening in the handle, the opening in the handle can restrict and guide the movement of the suture mechanism actuator shaft. The opening in the handle may be a slot. The suture mechanism actuator may be in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suture mechanism actuator may be in the second suture mechanism actuator position when the suture mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suture mechanism actuator may include a selector knob coupled to the suture mechanism actuator shaft and configured to allow the user to move the suture mechanism actuator between the first suture mechanism actuator position and the second suture mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0035] In alternative or additional embodiments, the suturing mechanism may include a connecting member having first and second ends, configured to pull a tension member through tissue, the first end being capable of being coupled to a first needle, and the second end being capable of being coupled to a second needle. At least one of the first or second needles may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suture mechanism.

[0036] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0037] An alternative suturing device is provided. The alternative suturing device includes a tension member, a suture knot associated with the tension member, a needle guide, a handle located at the proximal end of the suturing device, an elongated shaft coupled between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle coupled to the tension member, a second needle, and a tension member groove configured to accommodate the tension member. The needle actuator is located on the handle and coupled to at least one of the first or second needles. At least a portion of the suturing device is configured to be guided into an opening in the tissue. The needle actuator is configured to guide the first and second needles through the tissue adjacent to the opening in order to guide the tension member through the tissue when the needle actuator is actuated. The tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture knot is configured to unfold along the tension member and to be tightened to close and seal the opening.

[0038] In some embodiments, the tension member groove may extend from the first needle side to the second needle side of the needle guide. The suture knot may be unfolded when at least one of the first or second needles retracts. The tension member may be pulled through the suture knot when at least one of the first or second needles retracts. The suturing device may include a suture knot recess configured to receive the suture knot. The suturing device may include a suture knot sleeve. The suture knot sleeve may be at least partially inside the suture knot recess. The suture knot may be wrapped around the suture knot sleeve. The suture knot sleeve may hold the suture knot until it is unfolded. The suture knot may be a sliding knot. The suture knot may be a "Tennessee slider" knot.

[0039] In an alternative embodiment, the needle actuator may include a biasing member configured to retract at least one of the first or second needles. The needle actuator biasing member may be a spring. The needle actuator may be in a first needle actuator position before guiding the first and second needles through the tissue. The needle actuator may be configured to move to a second needle actuator position in order to guide the first and second needles through the tissue. The needle actuator may be configured to move to a third needle actuator position in order to retract the first and second needles.

[0040] In alternative or additional embodiments, the needle actuator may include a plunger and a biasing member. The needle actuator may move from a first needle actuator position to a second needle actuator position when the plunger is pressed down. The needle actuator biasing member may move the needle actuator from the second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring.

[0041] In alternative or additional embodiments, the needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is pressed down. The sprag may enable the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released while the sprag is in the second sprag orientation. The sprag may be configured to rotate from a first sprag orientation to a second sprag orientation when moved by the plunger. The sprag may engage with a first sprag groove when the needle actuator is in the first needle actuator position. The sprag may engage with a second sprag groove when the plunger is pressed down, thereby enabling the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released.

[0042] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0043] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane.

[0044] In some embodiments, the suturing device may include a suturing mechanism and a suturing mechanism actuator. The suturing mechanism may be coupled to the distal end portion of a needle guide. The suturing mechanism may be associated with first and second needles. The suturing mechanism may include a pivot element located at the distal end portion of the suturing device and capable of moving between an insertion and removal orientation and an unfolding orientation. The suturing mechanism actuator may be located on a handle. The suturing mechanism actuator may be coupled to the suturing mechanism and configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The suturing mechanism actuator biasing member may be a spring.

[0045] The suturing mechanism may be in an insertion and removal orientation when the suturing mechanism actuator is in the first suturing mechanism actuator position. The suturing mechanism may be in an unfolding orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position. The suture suturing mechanism actuator may include a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle can restrict and guide the movement of the suturing mechanism actuator shaft. The opening in the handle may be a slot. The suturing mechanism actuator may be in the first suturing mechanism actuator position when the suturing mechanism actuator shaft is at the first end of the slot. The suturing mechanism actuator may be in the second suturing mechanism actuator position when the suturing mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suturing mechanism actuator may include a selector knob coupled to the suturing mechanism actuator shaft and configured to allow the user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0046] In alternative or additional embodiments, the suturing mechanism may further include a connecting member having first and second ends, configured to pull a tension member through tissue, the first end being capable of being coupled to a first needle, and the second end being capable of being coupled to a second needle. At least one of the first or second needles may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes through in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

[0047] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0048] An alternative suturing device is provided. The alternative suturing device includes a tension member, a suture knot associated with the tension member, and a needle guide. The needle guide includes a first needle coupled to the tension member, a second needle, and a suture knot sleeve configured to receive the suture knot. At least a portion of the suturing device is configured to be guided into an opening in the tissue. The first and second needles are configured to be guided through the tissue adjacent to the opening in order to guide the tension member through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture knot is wrapped around the suture knot sleeve. The suture knot is configured to unfold from the suture knot sleeve and along the tension member and to be tightened to close and seal the opening.

[0049] In some embodiments, the suture knot may unfold when at least one of the first or second needles is retracted. A tension member may be pulled through the suture knot when at least one of the first or second needles is retracted. The suturing device may include a suture knot recess configured to receive the suture knot. A suture knot sleeve may be at least partially inside the suture knot recess. The needle guide may include a tension member groove configured to accommodate the tension member. The tension member may be configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member groove may extend from the first needle side to the second needle side of the needle guide. The suture knot may be a sliding knot. The suture knot may be a “Tennessee slider” knot.

[0050] In an alternative embodiment, the suturing device may include a handle positioned at the proximal end of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator positioned on the handle. The needle actuator may be coupled to at least one of the first or second needles and configured to guide at least one of the first or second needles through tissue when the needle actuator is actuated. The needle actuator may include a biasing member configured to retract at least one of the first or second needles. The needle actuator biasing member may be a spring.

[0051] In alternative or additional embodiments, needle actuators may be coupled to the first and second needles. The needle actuator may be in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator may be configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The needle actuator may be configured to move to a third needle actuator position in order to retract the first and second needles.

[0052] In alternative or additional embodiments, the needle actuator may include a plunger and a biasing member. The needle actuator may move from a first needle actuator position to a second needle actuator position when the plunger is pressed down. The needle actuator biasing member may move the needle actuator from the second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring. The needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is pressed down. The sprag may allow the needle actuator to move from the second needle actuator position to a third needle actuator position when the plunger is released and the sprag is in the second sprag orientation. The sprag may be configured to rotate from the first sprag orientation to the second sprag orientation. The sprag may engage with a first sprag groove when the needle actuator is in the first needle actuator position. The sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0053] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0054] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane.

[0055] In some embodiments, the suturing device may include a handle positioned at the proximal end of the suturing device and a suturing mechanism coupled to the distal end of a needle guide. The suturing mechanism may be associated with first and second needles. The suturing mechanism may include a pivot element that can move between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may be positioned at the distal end of the suturing device. A suturing mechanism actuator may be positioned on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing device may include an elongated shaft coupled between the handle and the needle guide. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The suturing mechanism actuator may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The biasing member of the suturing mechanism actuator may be a spring.

[0056] In some embodiments, the suture mechanism may be in an insertion and removal orientation when the suture mechanism actuator is in a first suture mechanism actuator position. The suture mechanism may be in an unfolding orientation when the suture mechanism actuator is in a second suture mechanism actuator position. The suture mechanism actuator may include a suture mechanism actuator shaft extending through an opening in a handle, the opening in the handle can restrict and guide the movement of the suture mechanism actuator shaft. The opening in the handle may be a slot. The suture mechanism actuator may be in a first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suture mechanism actuator may be in a second suture mechanism actuator position when the suture mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suture mechanism actuator may include a selector knob coupled to the suture mechanism actuator shaft and configured to allow the user to move the suture mechanism actuator between the first suture mechanism actuator position and the second suture mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0057] In alternative or additional embodiments, the suturing mechanism may further include a connecting member having first and second ends, configured to pull a tension member through tissue, the first end being capable of being coupled to a first needle, and the second end being capable of being coupled to a second needle. At least one of the first or second needles may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes through in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

[0058] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0059] An alternative suturing device is provided. The alternative suturing device includes a tension member, a suture knot associated with the tension member, a needle guide, a handle located at the proximal end of the suturing device, an elongated shaft coupled between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle coupled to the tension member, a second needle, and a suture knot sleeve configured to receive the suture knot. The needle actuator is located on the handle and coupled to at least one of the first or second needles. At least a portion of the suturing device is configured to be guided into an opening in the tissue. The needle actuator is configured to guide the first and second needles through the tissue adjacent to the opening in order to guide the tension member through the tissue when the needle actuator is actuated. The tension member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture knot is wrapped around the suture knot sleeve. The suture knot is configured to extend from the suture knot sleeve and along the tension member, and to be tightened to close and seal the opening.

[0060] In some embodiments, the suture knot may unfold when at least one of the first or second needles is retracted. A tension member may be pulled through the suture knot when at least one of the first or second needles is retracted. The suturing device may include a suture knot recess configured to receive the suture knot. A suture knot sleeve may be at least partially inside the suture knot recess. The needle guide may include a tension member groove configured to accommodate the tension member. The tension member may be configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member groove may extend from the first needle side to the second needle side of the needle guide. The suture knot may be a sliding knot. The suture knot may be a “Tennessee slider” knot.

[0061] In an alternative embodiment, the needle actuator may include a biasing member configured to retract at least one of the first or second needles. The needle actuator biasing member may be a spring. The needle actuator may be in a first needle actuator position before guiding the first and second needles through the tissue. The needle actuator may be configured to move to a second needle actuator position in order to guide the first and second needles through the tissue. The needle actuator may be configured to move to a third needle actuator position in order to retract the first and second needles.

[0062] In alternative or additional embodiments, the needle actuator may include a plunger and a biasing member. The needle actuator may move from a first needle actuator position to a second needle actuator position when the plunger is pressed down. The needle actuator biasing member may move the needle actuator from the second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator biasing member may be a spring. The needle actuator may include a sprag. The sprag may move from a first sprag orientation to a second sprag orientation when the plunger is pressed down. The sprag may allow the needle actuator to move from the second needle actuator position to a third needle actuator position when the plunger is released and the sprag is in the second sprag orientation. The sprag may be configured to rotate from the first sprag orientation to the second sprag orientation. The sprag may engage with a first sprag groove when the needle actuator is in the first needle actuator position. The sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0063] In some embodiments, the needle actuator may include a catch. When the plunger is pressed, the plunger may move the catch, and when moved, the catch may allow the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. At least a portion of the catch may be magnetic. The catch may engage with a catch groove when the needle actuator is in a first needle actuator position, and the catch may engage with a catch recess when the plunger is pressed, thereby allowing the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the catch may be magnetic, and the catch may be pulled into the catch recess by the ferromagnetic portion.

[0064] In alternative or additional embodiments, the suturing device may include a connecting member configured to pull a tension member through tissue and having first and second ends, the first end of which can be coupled to a first needle and the second end of which can be coupled to a second needle. At least one of the first or second needle may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane.

[0065] In an alternative embodiment, the suturing device may include a suturing mechanism coupled to the distal end portion of a needle guide and associated with first and second needles, and a suturing mechanism actuator positioned on a handle. The suturing mechanism may include a pivot element that can move between an insertion and removal orientation and an unfolding orientation. The pivot element may be located on the distal end portion of the suturing device. The suturing mechanism actuator may be coupled to the suturing mechanism and configured to move the suturing mechanism between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may include a biasing member configured to return the suturing mechanism to the insertion and removal orientation. The biasing member of the suturing mechanism actuator may be a spring.

[0066] In some embodiments, the suture mechanism may be in an insertion and removal orientation when the suture mechanism actuator is in a first suture mechanism actuator position. The suture mechanism may be in an unfolding orientation when the suture mechanism actuator is in a second suture mechanism actuator position. The suture mechanism actuator may include a suture mechanism actuator shaft extending through an opening in a handle, the opening in the handle can restrict and guide the movement of the suture mechanism actuator shaft. The opening in the handle may be a slot. The suture mechanism actuator may be in a first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suture mechanism actuator may be in a second suture mechanism actuator position when the suture mechanism actuator shaft is at the second end of the slot. The slot may be a "J" shaped slot. The suture mechanism actuator may include a selector knob coupled to the suture mechanism actuator shaft and configured to allow the user to move the suture mechanism actuator between the first suture mechanism actuator position and the second suture mechanism actuator position. The suture mechanism actuator may include a biasing member configured to maintain the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The suture mechanism actuator biasing member may be a spring.

[0067] In alternative or additional embodiments, the suturing mechanism may further include a connecting member having first and second ends, configured to pull a tension member through tissue, the first end being capable of being coupled to a first needle, and the second end being capable of being coupled to a second needle. At least one of the first or second needles may include a barbed needle tip, and the connecting member may include at least one tab configured to grip the barbed needle tip. The connecting member may include a plurality of notches configured to allow the connecting member to deform. The notches may be spaced along the length of the connecting member, and the spacing of the notches may at least partially define the bending radius of the connecting member. The notches may have widths, and the widths of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the widths of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow the connecting member to deform in a single plane. The connecting member may be configured so that the suturing mechanism passes through in one direction. The connecting member may include at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

[0068] In some embodiments, the first needle may include a removable needle tip coupled to a tension member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suturing device. The suture knot may be configured to unfold while the guidewire is inside the opening. The suturing device may include at least one locking tab configured to engage the suturing device with an introducer sheath when at least a portion of the suturing device is guided through the introducer sheath. The suturing device may be part of a suturing device system including an introducer sheath. The introducer sheath may be configured to be introduced into an opening in the tissue, and the introducer sheath may be configured to be withdrawn from the opening with at least a portion of the suturing device remaining inside the opening. The suturing device system may include a knot pusher configured to advance the suturing knot along the tension member.

[0069] A method is provided for applying sutures to close and seal an opening in tissue. The method for applying sutures to close and seal an opening in tissue includes guiding at least one needle through tissue adjacent to the opening; guiding a tension member through tissue adjacent to the opening; guiding at least a portion of at least one needle through a suture knot; unfolding the suture knot; and tightening the suture knot to close and seal the opening.

[0070] In some embodiments, the method may include guiding a tension member through a suture knot. The method may include unfolding a suture knot from a knot recess. The method may include unfolding a suture knot from a sleeve. The method may include guiding at least a portion of at least one needle through a sleeve. The method may include guiding at least a portion of a tension member through a sleeve. The method may include unfolding a suture knot on a tension member. The suture knot may be a pre-tied knot. The method may include guiding at least a portion of a suture mechanism having a pivot element in an insertion and removal orientation through an opening in the tissue, moving the pivot element of the suture mechanism to an unfolded orientation, returning the pivot element to an insertion and removal orientation, and withdrawing the suture mechanism from the opening.

[0071] In an alternative embodiment, the method may include guiding an introducer sheath into an opening in the tissue, guiding at least a portion of a suturing mechanism through the introducer sheath, and withdrawing the introducer sheath from the opening while at least a portion of the suturing mechanism remains inside the opening. The method may include attaching the suturing mechanism to the proximal end of the introducer sheath. The suturing mechanism may include a connecting member having first and second ends. The suturing mechanism may include a first needle and a second needle. The method may include attaching the first needle to the first end of the connecting member, attaching the second needle to the second end of the connecting member, attaching the first and second needles, and pulling a tension member to retract through the tissue using the connecting member. The method may include guiding a guidewire through the opening. The method may include unfolding a suture knot while the guidewire is inside the opening. The method may include withdrawing the guidewire from the opening.

[0072] The present invention is illustrated by the description of its particular embodiments, and while embodiments are described in considerable detail, it is not intended to limit the appended claims to such details or to restrict them in any way. The various features discussed herein may be used individually or in any combination within or between various embodiments. Additional advantages and modifications will be readily apparent to those skilled in the art. Thus, in its broader embodiments, the present invention is not limited to specific details, representative apparatus and methods, or the exemplary embodiments shown and described. Accordingly, deviations from such details may be made without departing from the scope or spirit of the general concept of the invention. [Brief explanation of the drawing]

[0073] [Figure 1] This is a perspective view of an exemplary suturing device and introducer sheath. [Figure 2] Figure 1 is a perspective view of an exemplary suturing device. [Figure 3] Figure 1 is a perspective view of an exemplary suturing device. [Figure 4]Figures 1 to 3 are exploded views of exemplary suture devices. [Figure 5A] Figures 1 to 3 are top views of a portion of an exemplary suture device. [Figure 5B] Figures 1 to 3 are top views of a portion of an exemplary suture device. [Figure 6A] Figures 1 to 3 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 6B] Figures 1 to 3 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 6C] Figures 1 to 3 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 6D] Figures 1 to 3 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 6E] Figures 1 to 3 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 6F] Figures 1 to 3 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 7A] Figures 1 to 3 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 7B] Figures 1 to 3 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 7C] Figures 1 to 3 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 8A] Figures 1 to 3 are perspective views of the suturing mechanism of exemplary suturing devices. [Figure 8B] Figures 1 to 3 are perspective views of the suturing mechanism of exemplary suturing devices. [Figure 8C] Figures 1 to 3 are perspective views of the suturing mechanism of exemplary suturing devices. [Figure 9A] Figures 1 to 3 are cross-sectional side views of the suturing mechanism of exemplary suturing devices. [Figure 9B] Figures 1 to 3 are cross-sectional side views of the suturing mechanism of exemplary suturing devices. [Figure 10A] Figures 1-3 are perspective views of the suturing mechanism of exemplary suturing devices, with the suturing mechanism hidden. [Figure 10B] Figures 1-3 are perspective views of the suturing mechanism of exemplary suturing devices, with the suturing mechanism hidden. [Figure 11A] A is a side view of an exemplary connecting member. [Figure 11B] B is an end view of an exemplary connecting member of Figure 11A. [Figure 11C] C is a side view of an alternative, exemplary connecting member. [Figure 12A] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12B] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12C] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12D] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12E] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12F] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12G] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12H] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12I] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12J] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12K] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12L] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12M] Figures 1 to 3 illustrate exemplary suturing devices, particularly the use of the suturing mechanism at the distal end of intravascular suturing devices, step by step. [Figure 12N] This is an exemplary perspective view of a knot pusher. [Figure 13] A perspective view of an alternative, exemplary suturing device. [Figure 14] A perspective view of an alternative, exemplary suturing device. [Figure 15] Figures 13 and 14 are exploded views of an exemplary suture device. [Figure 16A] Figures 13 and 14 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 16B] Figures 13 and 14 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 16C] Figures 13 and 14 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 16D] Figures 13 and 14 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 16E] Figures 13 and 14 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 16F] Figures 13 and 14 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 17A] Figures 13 and 14 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 17B] Figures 13 and 14 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 17C] Figures 13 and 14 are cross-sectional views of a portion of the handle of an exemplary suturing device. [Figure 18A] This is a perspective view of an alternative, exemplary suture mechanism. [Figure 18B] This is a perspective view of an alternative, exemplary suture mechanism. [Figure 19A] Figures 18A and 18B are cross-sectional views of exemplary suture mechanisms. [Figure 19B] Figures 18A and 18B are cross-sectional views of exemplary suture mechanisms. [Figure 20A] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20B] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20C] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20D] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20E] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20F] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20G] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20H]Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20I] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20J] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20K] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20L] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 20M] Figures 18A and 18B illustrate exemplary suturing mechanisms, particularly the use of intravascular suturing mechanisms, step by step. [Figure 21] A perspective view of an alternative, exemplary suturing device. [Figure 22] A perspective view of an alternative, exemplary suturing device. [Figure 23] Figures 21 and 22 are exploded views of an exemplary suture device. [Figure 23A] Figures 21 and 22 are exploded views of a portion of the handle of an exemplary suturing device. [Figure 23B] Figures 21 and 22 are exploded views of alternative parts of the handle of an exemplary suturing device. [Figure 24A] Figures 21 and 22 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 24B] Figures 21 and 22 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 24C] Figures 21 and 22 are cross-sectional top views showing a portion of the handle of an exemplary suture device, illustrating at least some of the components of the handle. [Figure 24D]Figures 21 and 22 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 24E] Figures 21 and 22 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 24F] Figures 21 and 22 are cross-sectional top views showing a portion of the handle of an exemplary suture device, illustrating at least some of the components of the handle. [Figure 24G] Figures 21 and 22 are side views of an exemplary suture device, showing at least some of the external features of the handle. [Figure 24H] Figures 21 and 22 are cross-sectional side views of an exemplary suture device, showing at least some of the components of the handle. [Figure 24I] Figures 21 and 22 are cross-sectional top views showing a portion of the handle of an exemplary suture device, illustrating at least some of the components of the handle. [Modes for carrying out the invention]

[0074] This disclosure generally relates to devices, systems, and methods for sealing puncture sites or other openings in blood vessels and other tissues. A specific example of this disclosure is a device and / or system that can directly access and percutaneously seal an opening in the common carotid artery created during direct access to the common carotid artery for neurovascular therapy. The devices disclosed herein generally enable single suture closure of a blood vessel, such as the common carotid artery or another canal, via a minimally invasive percutaneous technique. As used herein, the terms “canal,” “blood vessel,” “artery,” “vein,” and similar forms thereof mean any component of the circulatory system that transports blood throughout the human body. The devices, systems, and methods described herein may also be used in other therapies or surgical procedures.

[0075] Figure 1 is a perspective view of an exemplary suturing device 100 and introducer sheath 20, and Figures 2 and 3 are perspective views of the exemplary suturing device 100. The suturing device 100 includes a long shaft 110, a handle 130 coupled to the proximal end portion 112 of the shaft 110, and a suturing mechanism 200 coupled to the distal end portion 114 of the shaft 110. As used herein to describe various embodiments of the suturing device from the user's perspective, “proximal” may generally refer to the direction toward the user of the device, and “distal” may generally refer to the direction toward the user of the device. For reference, arrow 10 generally points in the proximal direction, and arrow 12 generally points in the distal direction. As used herein, “suture,” “suture,” and similar forms of these terms mean any flexible tensile member, regardless of form or material, suitable for bringing tissues together. As used herein, “tensile member” may be a monofilament suture, a multifilament suture, a metallic suture, or any other suitable tensile member.

[0076] Figure 4 is an exploded view of the suturing device 100 showing at least some of the components of an exemplary handle 130. Figures 5A and 5B are top views of a portion of the handle 130. Figures 6A, 6C, and 6E are side views of the exemplary suturing device 100 showing at least some of the external features of the handle 130. Figures 6B, 6D, and 6F are cross-sectional side views of the suturing device 100 showing at least some of the components of the handle 130. Figures 7A, 7B, and 7C are cross-sectional views of the handle 130.

[0077] Referring to Figures 2, 4, and 6A, the handle 130 includes an upper shell 130a, a lower shell 130b, a nose cone 130c, and a rear cap 130d. The lower shell 130b includes a gripping surface with finger recesses 132 configured to assist a user in grasping the handle 130. The upper and lower shells 130a, 130b include finger tabs 134 configured to assist a user in manipulating various feature parts of the suturing device 100. A suturing mechanism actuator 150, configured to operate the suturing mechanism 200, is housed within the handle 130. A needle actuator 170, located at the proximal end of the handle 130 and configured to extend and retract the suture needles 212, 214, is described below with reference to Figure 10A. The distal end of the handle 130, see Figure 1, includes an insert 136 with a locking tab 136a for engaging and coupling the suturing device 100 with another device, such as an introducer sheath 20. The handle 130 includes markings 138a, 138b, 138c, and 138d, which may include letters, numbers, and / or symbols, to assist and direct the user in operating various feature parts of the suturing device 100. The handle 130 includes a "J" shaped slot 140, a spring wall 144, a guide spacer 146, and a guide wire port 148. The shaft, see Figure 6B, is connected to the distal end of the handle 130 and is fixed and sealed to the handle 130 with a shaft seal 142.

[0078] Referring to Figures 2, 4, 6A, and 6B, the suture mechanism actuator 150 includes a selector knob 152, an actuator retainer 154, an actuator follower 156, and first and second suture mechanism actuator springs 158, 160. Other forms of biasing members may be used instead of springs 158, 160. The actuator retainer 154, see Figure 3, includes a suture mechanism actuator shaft 162 extending through a "J"-shaped slot 140. The "J"-shaped slot 140, see Figures 5A and 5B, guides the movement of the shaft 162, and thereby guides the movement of the actuator retainer 154. The first suture mechanism actuator spring 158 biases the actuator retainer 154 distally when the spring 158 is compressed between the actuator retainer 154 and the spring wall 144. The distal bias of the actuator spring 158 holds the shaft 162, which extends through the "J"-shaped slot 140, in place at the first end 140a or the second end 140b of the "J"-shaped slot 140 until the user operates the selector knob 152. The actuator follower 156, located inside the actuator retainer 154, is biased proximal by a second suture mechanism actuator spring 160. A pair of guide rods 164a, 164b guide the actuator follower 156 in the proximal and distal directions and prevent it from rotating. Although the suture mechanism actuator 150 is shown and described as being manually driven, the suture mechanism actuator 150 may be motorized, mechanically powered, or otherwise assisted.

[0079] Referring to Figures 2, 4, 6E, and 6F, the needle actuator 170 includes a plunger 172, a plunger cap 174, a sprag 176, a needle follower 180, a spring 182, and a retainer 184. Other forms of biasing members may be used instead of the spring 182. The plunger 172 includes a pair of angled guides 186 that engage with tabs 178 on the sprag 176. The sprag tabs 178 alternately engage with a first pair of sprag grooves 190a, 190b and a second pair of sprag grooves 192a, 192b, connected by a third pair of sprag grooves 194a, 194b inside the handle 130, as shown in Figures 7A, 7B, and 7C. The plunger 172 includes markings 188a, 188b, and 188c to assist the user in manipulating various feature parts of the suturing device 100 and to provide instructions to the user. Guide rods 164a and 164b guide the plunger 172 in the proximal and distal directions and prevent it from rotating. Although the needle actuator 170 is shown and described as being manually driven, the needle actuator 170 may be motorized, mechanically powered, or otherwise assisted.

[0080] Figures 8A, 8B, and 8C are perspective views of an exemplary suturing mechanism 200, Figures 9A and 9B are cross-sectional side views of the suturing mechanism 200, and Figures 10A and 10B are perspective views of the suturing mechanism 200 with parts of the suturing mechanism 200 hidden. The suturing mechanism 200 includes a needle guide 210 and a pivot element 230. The needle guide 210, see Figures 7A and 7B, includes two needles 212, 214 which are integral with or fixedly coupled to the respective wires 216, 218. Needle 212 is a two-piece needle including a barbed needle tip 212a which is removable from the needle body 212b by, for example, friction fitting or adhesive. Needle 214 has an integral (i.e., fixed) barbed needle tip 214a. The term “integrated” here encompasses a one-piece structure and a structure in which the needle tip 214a is fixedly (i.e., “irremovably”) coupled to the rest of the integrated needle 214. The wires 216, 218 may be, for example, solid wire-like members or hollow (e.g., hypotube). The wires 216, 218 are coupled to the needle follower 180 of the needle actuator 170, see Figure 7B. The needle guide 210 also includes a guidewire lumen 220 coupled to the guidewire lumen 116a of the shaft 110, see Figure 10A, which is coupled to the guidewire port 148 in the handle 130, see Figure 2. The shaft 110 may be a multi-lumen flexible or rigid member in which the central lumen 116b carries the actuator wire 234, two of the lumens 116c and 116d carry needles 212 and 214 respectively, and a fifth lumen 116e can be used as a guidewire, flushing, and / or blood port. When used as a blood port, the lumen 116e may provide the user with an indicator that the distal end of the suturing device 100 and / or the distal end of the introducer sheath 20 has entered the blood vessel 60. In some embodiments, the needle guide 210 may be an integral part of the shaft 110.

[0081] The pivot element 230 is fixed to the distal end of the needle guide 210 by a pivot 232. The pivot 232 allows the pivot element 230 to pivot between an insertion and removal orientation shown in Figures 8A, 8B, and 9A, and a deployment orientation shown in Figures 8C and 9B. The insertion and removal orientation generally aligns the pivot element 230 with the needle guide 210 and shaft 110. The insertion and removal orientation allows, for example, the pivot element 230 to be inserted into a blood vessel and then removed therefrom. The deployment orientation orients the pivot element 230 at an angle to the longitudinal axis of the needle guide 210 and shaft 110. In some embodiments, the deployment orientation orients the pivot element 230 at an angle that is roughly or nearly perpendicular to the longitudinal axis of the needle guide 210 and shaft 110. In other embodiments, the angle of the deployed pivot element 230 with respect to the longitudinal axis of the needle guide 210 and shaft 110 may be between 30 and 90 degrees. The deployed orientation of the pivot element 230 facilitates, for example, suturing procedures performed from within a blood vessel.

[0082] Referring to Figures 6B, 9A, and 9B, in this exemplary embodiment, the suture mechanism actuator 150 is coupled to a pivot element 230 by an actuator wire 234. The actuator wire 234 is coupled to an actuator follower 156 of the suture mechanism actuator 150. The actuator wire 234 includes a retainer 236 that engages with a hole 238 in the pivot element 230 and secures the actuator wire 234 to the pivot element 230. The pivot element 230 includes an actuator wire groove 240 configured to accommodate the actuator wire 234 when the pivot element 230 is in the insertion and removal orientation, as shown in Figure 9A. The distal end of the actuator wire 234 includes a formed angle 242. The actuator wire 234 may be, for example, heat-set to create the formed angle 242. The formed angle 242 acts as a biasing member to keep the pivot element 230 aligned longitudinally with the longitudinal axis of the shaft 110 for insertion and removal of the suture mechanism 200. The pivot element 230 includes a passage 244 having a flexible connector 270 housed therein. The pivot element 230 also includes a through hole 246 used to secure the flexible connector 270. During the assembly of the flexible connector 270 to the pivot element 230, an adhesive, such as epoxy, is injected into the hole 246 to secure the flexible connector 270 to the pivot element 230. The flexible connector 270 may be secured to the pivot element 230 by other means, such as friction fitting between the flexible connector 270 and the passage 244.

[0083] As the user moves the selector knob 152, the "J"-shaped slot 140 (see Figures 5A, 5B, and 6B) restricts and guides the movement of the suture mechanism actuator shaft 162, thereby restricting and guides the movement of the actuator retainer 154. The actuator retainer 154 can be moved both proximal and distal to the handle 130 and rotated around the central axis of the handle 130 by moving the selector knob 152. Generally, moving the selector knob 152 proximal moves the actuator follower 156 proximal, which puts tension on the actuator wire 234, thereby moving the pivot element 230 to the deployed orientation shown in Figure 6B. Generally, moving the selector knob 152 distally moves the actuator follower 156 distally, which reduces the tension on the actuator wire 234 and / or compresses the actuator wire 234, thereby moving the pivot element 230 into the insertion and removal orientation shown in Figure 6A. As shown in Figure 5A, when the suture mechanism actuator 150 is in the first position and the suture mechanism actuator shaft 162 is at the first end 140a of the "J"-shaped slot 140, the pivot element 230 of the suture mechanism 200 is in the insertion and removal orientation, as shown in Figure 9A. When the suture mechanism actuator 150 is in the second position and the suture mechanism actuator shaft 162 is at the second end 140b of the "J"-shaped slot 140, as shown in Figure 5B, the pivot element 230 is in the deployment orientation, as shown in Figure 9B.

[0084] Referring to Figures 8A, 8B, 8C, 9A, and 9B, in this exemplary embodiment, the needle guide 210 includes a tension member 250 in a tension member groove 252 that wraps around the needle guide 210 from the first needle 212 side to the second needle 214 side. One end of the tension member 250 is coupled to the needle tip 212a. The needle guide 210 also includes a knot recess 254 for housing a suture knot 264. The knot recess 254 is a cavity in the needle guide that is large enough to accommodate the suture knot 264. A ring 256 wraps around the proximal end of the needle guide 210 and connects the needle guide 210 to the shaft 110. The ring 256 may partially cover the knot recess 254. The “coil” of the suture knot 264 is wound around the needle 214, and the needle 214 holds the suture knot 264 in the knot recess 254 until the suture knot 264 needs to be unfolded. The suture knot 264 can be any desired form of knot suitable for tying a suture, such as a sliding knot that slides automatically along the tension member 250 and tightens when one end of the tension member 250 is pulled. One form of knot suitable for use in this situation is the “Tennessee slider” knot.

[0085] As described herein, the length of the tension member 250 is the measured distance from the last loop or coil of the suture knot 264 to the end of the tension member 250 that is coupled to the needle tip 212a. The length of the tension member 250 determines the deployment distance of the suture knot 264, which is the distance the suture mechanism 200 must retract from the patient's percutaneous exit site before the suture knot 264 is deployed from the suture mechanism 200. A short tension member length means that the suture knot 264 is released very close to the patient's percutaneous exit site. A long tension member length means that the suture knot 264 is released away from the patient's percutaneous exit site. The length of the tension member can be between 1.0 inch and 10.0 inch.

[0086] Figure 11A is a side view of an exemplary connecting member 270, and Figure 11B is an end view of the connecting member 270. The connecting member 270 has first and second end portions 272, 274. The first and second end portions 272, 274, refer to Figures 12E and 12F, include internal tabs 276, 278 configured to grasp the needle tips 212a, 214a, respectively, and thereby connect the needle tips 212a, 214a to the connecting member 270. The connecting member 270 is configured to pull the tension member 250 through tissue during a suturing procedure to close an opening in a vascular wall as described herein. The connecting member 270 may also have an external tab 280 configured to allow the connecting member 270 to move only in one direction indicated by arrow 282 within a passage 244 of a pivot element 230, refer to Figure 9B. The tab 280 may be fixed or movable to allow the coupling member 270 to move in one direction within the passage 244 and to prevent the coupling member 270 from retracting out of the passage 244.

[0087] In this exemplary embodiment, the coupling member 270 includes a plurality of opposing notches 284 configured to allow the coupling member 270 to bend or deform within a single plane. Limiting the deformation of the coupling member 270 to a single plane can improve control of the coupling member 270. For example, as opposed to a helically wound member, positioning the notches 284 on opposite sides of the central axis of the coupling member 270 allows the coupling member 270 to deform without stretching it. The notches 284 are spaced along the length of the coupling member 270, and the spacing of the notches defines, at least partially, the bending radius of the coupling member 270. Varying the spacing of the notches 284 along the length of the coupling member 270 would create a plurality of bending radii. The notches 284 have widths 286a, 286b, and the widths 286a, 286b of the notches 284 define, at least partially, the bending radius of the coupling member 270. The notch 284 may have multiple widths 286a, 286b to create multiple bending radii. Alternatively, the notch 284 along the length of the connecting member 270 may be patterned in a spiral shape with multiple pitch distances.

[0088] Figure 11C is a side view of an alternative exemplary coupling member 270'. In general, coupling member 270' is similar in structure and operation to coupling member 270 described above, and coupling member 270' may be used in place of other coupling members or any feature portion of coupling member 270' may be used in various other exemplary embodiments according to this disclosure. Similar reference numerals refer to similar components. For brevity, the following description will minimize redundant explanations and focus on the differences between coupling member 270 and coupling member 270'. In this exemplary embodiment, coupling member 270' includes a plurality of opposing notches 284' configured to allow coupling member 270' to bend or deform in a single plane. The notches 284' are equally spaced along the length of coupling member 270', and the spacing of the notches defines, at least partially, the bending radius of coupling member 270'. The notch 284' has a uniform width 286', and the width 286' of the notch 284' defines at least partially the bending radius of the connecting member 270'.

[0089] Figures 12A to 12M illustrate step-by-step the use of a suturing device 100 for closing a puncture site or opening 62 within the vascular wall 60a of a blood vessel 60, particularly the distal end and suturing mechanism 200 within a blood vessel 60 such as the common carotid artery. The opening 62 may be a site of access to the vessel for medical procedures. Figure 12N is a perspective view of an exemplary knot pusher 300.

[0090] In preparation for the procedure, refer to Figures 2 and 8A. For example, the guidewire 30, such as a 0.018-inch OD guidewire, is inserted through the guidewire port 148 in the handle 130 and exited through the guidewire lumen 220 in the suturing mechanism 200. Alternatively, the guidewire 30 may be inserted through the guidewire lumen 220 in the suturing mechanism 200 and exited through the guidewire port 148 in the handle 130. The guidewire 30 and suturing mechanism 200 are inserted into the proximal end 22 of the introducer sheath 20 with the pivot element 230 in the insertion and removal orientation, refer to Figure 1. The introducer sheath 20 is guided through the opening 62 of the vessel 60 using the guidewire 30. The suturing mechanism 200 can be guided by inserting the guidewire 30 into the guidewire lumen 220 and bringing it out through the guidewire port 148 in the handle 130, as can be seen in Figures 2 and 8A.

[0091] The suturing device 100, as shown in Figures 1 and 2, advances until the mark 118 on the shaft 110 aligns with the proximal end 22 of the introducer sheath 20. When the mark 118 on the shaft 110 aligns with the proximal end 22 of the introducer sheath 20, the suturing mechanism 200 is fully within the introducer sheath 20. The suturing mechanism 200 and shaft 110, as shown in Figures 1 and 2, are kept stationary relative to the vessel 60, and the introducer sheath 20 is pulled proximal over the suturing mechanism 200 and shaft 110 until the locking tab 136a engages with the proximal end 22 of the introducer sheath 20. This corresponds to the marking 138a, which in this exemplary example is “1” indicating step 1 to the user. The locking tab 136a secures the suturing device 100 to the introducer sheath 20, with the suturing mechanism 200 extending into the blood vessel 60 beyond the distal end 24 of the introducer sheath 20 (see Figure 12A). Connecting the locking tab 136a to the distal end 22 of the introducer sheath 20 ensures that the suturing mechanism 200 extends beyond the distal end 24 of the introducer sheath 20. The introducer sheath 20 is withdrawn from the opening 62 inside the blood vessel 60 while the suturing mechanism 200 remains inside the blood vessel 60, thereby allowing for internal exchange of the suturing device 100 and the introducer sheath 20. This suppresses (eliminates, or at least substantially reduces) the blood loss typically experienced during a typical device exchange, for example, as a result of high blood pressure found in the common carotid artery. The introducer sheath 20 maintains a relationship surrounding the shaft 110 for the remainder of the procedure.

[0092] Alternatively, the distal end 24 of the introducer sheath 20 may be inside the blood vessel 60, for example, as part of the procedure. The distal end of the needle guide 210 is inserted into the proximal end 22 of the introducer sheath 20, with the pivot element 230 aligned to its longitudinal extension parallel and aligned with the longitudinal axis of the needle guide 210 and the shaft 110. A depth marker or indicator 118 on the shaft 110 provides the user with visual feedback on how far the suturing device 100 has been inserted into the introducer sheath 20. The suturing device 100 advances, as shown in Figure 1, until the locking tab 136a engages with the proximal end 22 of the introducer sheath 20. As described above, the locking tab 136a secures the suturing device 100 to the introducer sheath 20, with the suturing mechanism 200 extending beyond the distal end of the introducer sheath 20.

[0093] The arrow and "2" in marking 138b indicate step 2 to the user. With the distal end of the needle guide 210 inside the vessel 60, the selector knob 152 is moved in the first direction indicated by the arrow and "2" in marking 138b, see Figure 5B, and moves the shaft 162 from the position of the first end 140a of the "J"-shaped slot 140 to the second end 140b, see Figures 5A and 5B, which pivots or rotates the pivot element 230 from the insertion and removal orientation to the deployment orientation, see Figure 12B. The "J" slot 140 helps to guide the movement of the selector knob 152. Moving the selector knob 152 moves the actuator retainer 154 and actuator follower 156 against the bias provided by springs 158, 160, see Figure 6B. Moving the selector knob 152 also rotates the actuator retainer 154 in the first direction. The biasing of the spring 158 holds the actuator retainer 154 in place within the "J" slot 140. The pivot element 230 can be rotated to an unfolded orientation, see Figure 12B, before the introducer sheath 20 is withdrawn from the opening 62 of the vessel 60, or see Figure 12C, after the introducer sheath 20 has been withdrawn from the opening 62 of the vessel 60. The pivot element 230 is then pulled proximal against the interior of the vessel wall 60a by a slight proximal pull on the suturing device 100 and thus the needle guide 210, as shown in Figure 12D. The unfolded orientation of the pivot element 230 ensures that the pivot element 230 remains inside the vessel 60.

[0094] The next step is indicated to the user by the marking "3" in Figure 2. While the pivot element 230 is in the deployed orientation, the suture needles 212, 214 are deployed or moved distally by pushing the plunger cap 174, and by the plunger 172, sprag 176, and needle follower 180 of the needle actuator 170, as indicated by arrow 188b, as shown in Figures 6A and 6C, and against the bias provided by spring 182, as shown in Figure 6B and 6D, as shown in Figure 12E. The needle follower 180 moves the suture needles 212, 214 distally toward the coupling member 270 attached to the pivot element 230. The needle tip 212a, as shown in Figure 12F, pulls the tension member 250 distally, exits the tension member groove 252, and then engages and connects with the first end 272 of the connecting member 270. The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0095] As the needle actuator 170 moves distally, the angled guide 186 of the plunger 172 engages with the tab 178 of the sprag 176 (see Figure 4). The plunger 172 moves the sprag 176 distally (see Figure 7B), with the first pair of sprag tabs 178 in the sprag grooves 190a, 190b inside the handle 130 guiding the sprag 176. When the sprag tabs 178 reach the distal ends of the first pair of sprag grooves 190a, 190b, the angled guide 186 rotates the sprag 176 within the sprag grooves 194a, 194b (see Figure 7A), and the sprag tabs 178 engage with the second pair of sprag grooves 192a, 192b inside the handle 130 (see Figure 7C).

[0096] Release of the plunger cap 174, and consequently the plunger 172, see Figures 6E and 6F, which allows the biasing of the spring 182 to move the needle follower 180 and sprag 176 proximal. This action, see Figure 12G, pulls the suture needles 212 and 214 proximal. The suture needle 214 pulls the coupling member 270 through the passage 244 of the pivot element 230 and through the tube wall 60a. Pulling or pushing the flexible coupling member 270 overcomes the bonding force or frictional fit of the adhesive fixing the flexible coupling member 270 to the pivot element 230. As the coupling member 270 is pulled by the suture needle 214, the needle tip 212a is separated from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270, pulling the tension member 250 through the tube wall 60a. The suture needle 214, see Figures 12H and 12I, pulls the connecting member 270, the needle tip 212a, and the tension member 250 through the suture knot 264. As the sprag 176 moves proximal, the second pair of sprag grooves 192a, 192b inside the handle 130 guide the sprag tab 178. The second pair of sprag grooves 192a, 192b, see Figure 6E, allow the plunger 172 to extend further from the proximal end of the handle 130. This provides the user with a check mark symbol indicating that the needles 212, 214 are retracting. The marking 188c in "JPEG2026533884000002.jpg22" is exposed.

[0097] Step 4 is indicated to the user by the arrow and "4" in marking 138d. Next, the pivot element 230 is moved distally away from the inside of the tube wall 60a, as shown in Figure 12H, and then rotated from the deployment orientation to the insertion and removal orientation. The rotation of the pivot element 230 is achieved by moving the selector knob 152 in the second direction indicated by the arrow and "4" in marking 138d, as shown in Figure 5A, and by moving the shaft 162 from the position of the second end 140b of the "J"-shaped slot 140 to the first end 140a, as shown in Figures 5A and 5B. Moving the selector knob 152 moves the actuator retainer 154 and actuator follower 156 against the bias provided by springs 158, 160. Moving the selector knob 152 also rotates the actuator retainer 154 in the second direction. The biasing force of the spring 158 holds the actuator retainer 154 in place within the "J" slot 140. With the pivot element 230 in the insertion and removal orientation, the suturing device 100 is pulled proximal, see Figure 12I, thereby removing the suturing mechanism 200 from the blood vessel 60 and releasing the suture knot 264 from the knot recess 254. As the suturing mechanism 200 is pulled proximal, the suture knot 264 slides along the tension member 250 toward the opening 62 of the blood vessel 60. As the suturing mechanism 200 is pulled proximal, the suture knot 264 tightens toward the outside of the blood vessel 60, bringing the opening 62 closer or closing, see Figures 12J and 12K. While the suture knot 264 is tightened against the outside of the blood vessel 60, the guidewire 30 remains inside the opening 62 and is not removed until the opening 62 is closed. During some procedures, it may be necessary to push the suture knot 264 toward the opening 62. Referring to Figures 12L and 12N, a knot pusher 300 including a handle 302, a long shaft 304, and a loop or ring 306 may be used to push the suture knot 264 toward the opening 62. Finally, the ends of the outer tension members 250 of the suture knot 264 are cut off to leave the opening 62 tightly closed and sealed, as shown in Figure 12M.The guidewire 30 acts as a safety device during the procedure, and the advantage of this method is that the user does not lose access to the tube access site or the opening 62 if the tension member 250 and the suture knot 264 fail to seal the opening 62. If the tension member 250 and the suture knot 264 fail to seal the opening 62, the introducer sheath 20 can be reinserted over the guidewire 30 and through the opening 62. The suture device 100 can be reinserted into the introducer sheath 20 to deploy the second tension member 250 and the suture knot 264 as described above to close and seal the opening 62.

[0098] Figures 13 and 14 are perspective views of an alternative exemplary suture device 100'. Figure 15 is an exploded view of suture device 100'. In general, suture device 100' is similar in structure and operation to suture device 100 described above, and suture device 100' may be used in place of other suture devices or any feature of suture device 100' may be used in various other exemplary embodiments according to this disclosure. Similar reference numerals refer to similar components. For brevity, the following description will minimize redundant explanations and focus on the differences between suture device 100 and suture device 100'.

[0099] The suturing device 100' includes a long shaft 110, a handle 130' coupled to the proximal end portion 112 of the shaft 110, and a suturing mechanism 200 coupled to the distal end portion 114 of the shaft 110. The differences between the suturing device 100' and the suturing device 100 are substantially limited to the handle 130' and the needle actuator 170', as will be described in detail below.

[0100] Figure 15 shows at least some of the components of an exemplary handle 130'. Figures 16A, 16C, and 16E are side views of an exemplary suture device 100' showing at least some of the external features of the handle 130'. Figures 16B, 16D, and 16F are cross-sectional side views of the suture device 100' showing at least some of the components of the handle 130'. Figures 17A, 17B, and 17C are cross-sectional views of the handle 130'.

[0101] Referring to Figures 13, 15, and 16A, the handle 130' includes an upper shell 130a', a lower shell 130b', a nose cone 130c, and a rear cap 130d. A suture mechanism actuator 150, configured to operate the suture mechanism 200, is housed within the handle 130'. The needle actuator 170', see Figure 9A, is located at the proximal end of the handle 130' and is configured to extend and retract the suture needles 212 and 214.

[0102] The needle actuator 170' includes a plunger 172', a plunger cap 174, a pair of magnetic catches 176', a spring 182', and a retainer 184. Other forms of biasing members may be used instead of the spring 182'. The catches 176' are movably mounted within a pair of recesses 186' in the plunger 172'. The catches 176' alternately engage with a pair of catch grooves 190a', 190b' inside the handle 130', and a pair of catch recesses 192a', 192b' connected to the catch grooves 190a', 190b', see Figures 17A, 17B, and 17C. The plunger 172' includes markings 188a, 188b, 188c to assist and guide the user in operating various feature parts of the suturing device 100'. Although the needle actuator 170' is shown and described as being manually driven, the needle actuator 170' may be motorized, mechanically powered, or otherwise assisted. Wires 216, 218 are coupled to the distal end 180' of the plunger 172', see Figure 17A.

[0103] Similar to the suture device 100 described above, Figures 12A to 12M illustrate stepwise the use of the suture device 100', particularly the distal end and the suture mechanism 200 within the blood vessel 60. Referring to Figure 12E, with the pivot element 230 in the deployed position, the suture needles 212 and 214 are deployed or moved distally by pushing the plunger cap 174, and consequently the plunger 172' of the needle actuator 170', distally in the direction indicated by arrow 188b (see Figures 16A and 16C), and against the bias provided by spring 182' (see Figures 16B and 16D). The plunger 172' moves the suture needles 212 and 214 distally toward the coupling member 270 attached to the pivot element 230. The needle tip 212a, as shown in Figure 12F, pulls the tension member 250 distally, exits the tension member groove 252, and then engages and connects with the first end 272 of the connecting member 270. The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0104] See Figures 16E and 16F. As the needle actuator 170' moves distally, the magnetic catch 176' moves distally within the catch grooves 190a' and 190b' inside the handle 130', see Figures 17A, 17B, and 17C. When the magnetic catch 176' reaches the distal end of the catch grooves 190a' and 190b', it is attracted to the ferromagnetic element 196', which pulls the magnetic catch 176' out of the recess 186' in the plunger 172' into the catch recesses 192a' and 192b' in the handle 130'. While the magnetic catch 176' is in the catch recesses 192a' and 192b' in the handle 130', the plunger 172' is free to move proximal. Some embodiments may have a single magnetic catch 176' and a ferromagnetic element 196', while other embodiments may have multiple magnetic catches 176' and ferromagnetic elements 196'.

[0105] Release of the plunger cap 174, and consequently the plunger 172', see Figures 16E and 16F, allows the biasing of the spring 182' to move the plunger 172' proximal. This action, see Figure 12G, pulls the suture needles 212 and 214 proximal. As described above, the suture needle 214 pulls the coupling member 270 through the passage 244 of the pivot element 230 and through the tube wall 60a. As the coupling member 270 is pulled by the suture needle 214, the needle tip 212a is separated from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the coupling member 270, pulling the tension member 250 through the tube wall 60a.

[0106] Figures 18A and 18B are perspective views of an alternative exemplary suture mechanism 200'. Figures 19A and 19B are cross-sectional views of the suture mechanism 200'. In general, the suture mechanism 200' is similar in structure and operation to the suture mechanism 200 described above, and the suture mechanism 200' may be used in place of other suture mechanisms in various other exemplary embodiments according to this disclosure, or any feature part of the suture mechanism 200' may be used. Similar reference numerals refer to similar components. For brevity, the following description will minimize redundant explanations and focus on the differences between the suture mechanism 200 and the suture mechanism 200'.

[0107] In this exemplary embodiment, the suturing mechanism 200' includes a needle guide 210' coupled to the distal end portion 114 of the shaft 110. The needle guide 210' includes a first needle 212, a second needle 214, and a pivot element 230. A tension member 250 winds around the needle guide 210' from the first needle 212 side to the second needle 214 side in a tension member groove 252'. The needle guide 210' also includes a knot recess 254', a suture knot sleeve 258', and a slot 260'. The “coil” of the suture knot 264 is wound around the suture knot sleeve 258' in the knot recess 254'. The second needle 214 passes through the suture knot sleeve 258'. The suture knot sleeve 258' holds the suture knot 264 within the knot recess 254' until the suture knot 264 needs to be unfolded. The slot 260' is configured to hold the free end 262 or any portion of the tension member 250. The free end 262 of the tension member 250 may extend from 0.13 inches to 1.00 inches from the suture knot 264.

[0108] Figures 20A–20M illustrate step-by-step the use of an intravascular suturing mechanism 200' for closing a puncture site or opening 62 within the vascular wall 60a of the blood vessel 60, such as the common carotid artery. The opening 62 may be a site of access for a medical procedure.

[0109] In preparation for the procedure, a guidewire 30, such as a 0.018-inch OD guidewire (see Figures 2 and 8A), is inserted into the handle 130 through the guidewire port 148 and exited through the guidewire lumen 220 in the suturing mechanism 200'. Alternatively, the guidewire 30 may be inserted into the suturing mechanism 200' through the guidewire lumen 220 and exited through the guidewire port 148 in the handle 130. The guidewire 30 and suturing mechanism 200' are inserted into the proximal end 22 of the introducer sheath 20 with the pivot element 230 in the insertion and removal orientation (see Figure 1). The introducer sheath 20 is guided through the opening 62 of the vessel 60 using the guidewire 30.

[0110] After the distal end 24 of the introducer sheath 20 is inside the vessel 60, the suturing mechanism 200' and shaft 110 are kept stationary relative to the vessel 60, and the introducer sheath 20 is pulled proximal over the suturing mechanism 200' and shaft 110 until the locking tab 136a engages with the proximal end 22 of the introducer sheath 20 (see Figures 1 and 2), and the suturing mechanism 200' extends into the vessel 60 beyond the distal end 24 of the introducer sheath 20 (see Figure 20A).

[0111] With the suturing mechanism 200' positioned inside the vessel 60, the pivot element 230 is pivoted or rotated from an insertion and removal orientation (see Figure 19A) to an unfolding orientation (see Figure 19B). The pivot element 230 may be rotated to an unfolding orientation (see Figure 20B) before the introducer sheath 20 is withdrawn from the opening 62 of the vessel 60, or (see Figure 20C) after the introducer sheath 20 has been withdrawn from the opening 62 of the vessel 60. The pivot element 230 is then pulled proximally against the inside of the vessel wall 60a, as shown in Figure 20D.

[0112] While the pivot element 230 is in the deployed orientation (see Figure 20E), the suture needles 212 and 214 are deployed or moved distally. The needle tip 212a (see Figure 20F) pulls the tension member 250 distally, exiting the tension member groove 252', and then engages and connects with the first end 272 of the connecting member 270. The needle tip 214a engages and connects with the second end 274 of the connecting member 270. The suture needles 212 and 214 (see Figure 20G) are pulled proximal. The suture needle 214 pulls the connecting member 270 through the passage 244 of the pivot element 230 and through the tube wall 60a. As the connecting member 270 is pulled by the suture needle 214, the needle tip 212a is separated from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270, pulling the tension member 250 through the tube wall 60a. The suture needle 214, see Figure 20I, pulls the connecting member 270, the needle tip 212a, and the tension member 250 through the suture knot sleeve 258'.

[0113] The pivot element 230, as shown in Figure 20H, is moved distally away from the interior of the vessel wall 60a and then rotated from the deployment orientation to the insertion and removal orientation. With the pivot element 230 in the insertion and removal orientation, the suture mechanism 200', as shown in Figure 20I, is pulled proximal, thereby removing the suture mechanism 200' from the vessel 60 and releasing the suture knot 264 from the suture knot sleeve 258' and knot recess 254'. As the suture mechanism 200' is pulled proximal, the suture knot 264 slides along the tension member 250 toward the opening 62 of the vessel 60. As the suture mechanism 200' is pulled proximal, the suture knot 264 is tightened toward the outside of the vessel 60, as shown in Figures 20J and 20K, bringing the opening 62 closer or closing it. While the suture knot 264 is tightened against the outside of the vessel 60, the guidewire 30 remains inside the opening 62 and is not removed until the opening 62 is closed. During some procedures, it may be necessary to push the suture knot 264 toward the opening 62. Referring to Figures 20L and 12N, a knot pusher 300 including a handle 302, a long shaft 304, and a loop or ring 306 may be used to push the suture knot 264 toward the opening 62. Finally, the end of the tension member 250 on the outside of the suture knot 264 is cut to leave the opening 62 tightly closed and sealed, as shown in Figure 20M. The guidewire 30 acts as a safety device during the procedure, and the advantage of this technique is that the user does not lose access to the tube access site or the opening 62 if the tension member 250 and the suture knot 264 fail to seal the opening 62. If the tension member 250 and the suture knot 264 do not seal the opening 62, the introducer sheath 20 can be reinserted over the guide wire 30 and through the opening 62. The suture device 100 can be reinserted into the introducer sheath 20 to deploy the second tension member 250 and the suture knot 264 as described above, thereby closing and sealing the opening 62.

[0114] Figures 21 and 22 are perspective views of an alternative exemplary suture device 100''. Figure 23 is an exploded view of suture device 100''. In general, suture device 100'' is similar in structure and operation to suture devices 100 and 100' described above, and suture device 100' may be used in place of other suture devices in various other exemplary embodiments of this disclosure, or any feature of suture device 100' may be used. Similar reference numerals refer to similar components. For brevity, the following description will minimize redundant explanations and focus on the differences between suture devices 100 and 100'' and suture device 100'.

[0115] The suturing device 100'' includes a long shaft 110, a handle 130'' coupled to the proximal end portion 112 of the shaft 110, and a suturing mechanism 200 coupled to the distal end portion 114 of the shaft 110. The differences between the suturing device 100'' and the suturing devices 100 and 100' are substantially limited to the handle 130'' and the needle actuator 170'', as will be described in detail below.

[0116] Figure 23 is an exploded view of the suture device 100'', showing at least some of the components of the exemplary handle 130''. Figure 23A is an exploded view of a portion of the handle 130'' of the suture device 100''. Figures 24A, 24D, and 24G are side views of the exemplary suture device 100'' showing at least some of the external features of the handle 130''. Figures 24B, 24E, and 24H are cross-sectional side views of the suture device 100'' showing at least some of the components of the handle 130''. Figures 24C, 24F, and 24I are cross-sectional top views of a portion of the handle 130'' of the suture device 100'' showing at least some of the components of the handle 130''.

[0117] Referring to Figures 21, 23, and 23A, the handle 130'' includes an upper shell 130a'', a lower shell 130b'', a nose cone 130c, and a rear cap 130d''. A suture mechanism actuator 150, configured to operate the suture mechanism 200, is housed within the handle 130''. A needle actuator 170'', located at the proximal end of the handle 130'' (see Figure 9A), is configured to extend and retract suture needles 212 and 214.

[0118] The needle actuator 170'' includes a plunger 172'', a plunger cap 174, one or more magnetic catches 176'', a spring 182'', and a linear retainer 184''. Other forms of biasing members may be used instead of the spring 182''. The catches 176'' are movably mounted in a pair of recesses 186'' within the plunger 172''. The catches 176'', refer to 24C, 24F, and 24I, alternately engage with a pair of catch grooves 190a'', 190b'' inside the linear retainer 184'', and one or more catch recesses 192a'', 192b'' connected to one or more catch grooves 190a'', 190b''. The plunger 172'' includes markings 188a, 188b, 188c to assist and guide the user in operating various feature parts of the suturing device 100''. Although the needle actuator 170'' is shown and described as being manually driven, the needle actuator 170'' may be motorized, mechanically powered, or otherwise assisted. Wires 216 and 218 are coupled to the distal end 180'' of the plunger 172''.

[0119] Similar to the suture device 100 described above, Figures 12A to 12M illustrate stepwise the use of the suture device 100'', particularly the distal end and the suture mechanism 200 within the blood vessel 60. Referring to Figure 12E, with the pivot element 230 in the deployed orientation, the suture needles 212 and 214 are deployed or moved distally by pushing the plunger cap 174, and consequently the plunger 172'' of the needle actuator 170'', distally in the direction indicated by arrow 188b (see Figures 24A and 24D), and against the bias provided by spring 182'' (see Figures 24B and 24C). The plunger 172'' moves the suture needles 212 and 214 distally toward the coupling member 270 attached to the pivot element 230. The needle tip 212a, as shown in Figure 12F, pulls the tension member 250 distally, exits the tension member groove 252, and then engages and connects with the first end 272 of the connecting member 270. The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0120] As the needle actuator 170'' moves distally, the magnetic catch 176'' moves distally within the catch grooves 190a'' and 190b'' inside the linear retainer 184'' (see Figures 24B and 24C). When the magnetic catch 176'' reaches the distal end of the catch grooves 190a'' and 190b'', it is attracted to the ferromagnetic element 196'' (see Figures 24D, 24E, and 24F), which pulls the magnetic catch 176'' from the recess 186'' in the plunger 172'' into the catch recesses 192a'' and 192b'' in the linear retainer 184''. While the magnetic catch 176'' is inside the catch recesses 192a'' and 192b'' in the linear retainer 184'', the plunger 172'' is free to move proximal. Some embodiments, as shown in Figure 23B, may have a single magnetic catch 176'' and a ferromagnetic element 196'', while other embodiments may have multiple magnetic catches 176'' and ferromagnetic elements 196''.

[0121] Releasing the plunger cap 174, and consequently the plunger 172'', see Figures 24G, 24H, and 24I, allows the biasing of the spring 182'' to move the plunger 172'' proximal. This action, see Figure 12G, pulls the suture needles 212 and 214 proximal. As described above, the suture needle 214 pulls the coupling member 270 through the passage 244 of the pivot element 230 and through the tube wall 60a. As the coupling member 270 is pulled by the suture needle 214, the needle tip 212a is separated from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the coupling member 270, pulling the tension member 250 through the tube wall 60a.

[0122] The present invention is illustrated by the description of its particular embodiments, and while embodiments are described in considerable detail, it is not intended to limit the appended claims to such details or to restrict them in any way. The various features discussed herein may be used individually or in any combination within or between various embodiments. Additional advantages and modifications will be readily apparent to those skilled in the art. Thus, in its broader embodiments, the present invention is not limited to specific details, representative apparatus and methods, or the exemplary embodiments shown and described. Accordingly, deviations from such details may be made without departing from the scope or spirit of the general concept of the invention.

Claims

1. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide includes a suture knot recess configured to receive the suture knot, At least a portion of the suture device is configured to be guided into an opening in the tissue, The first and second needles are configured to be guided through the tissue adjacent to the opening in order to guide the tensile member through the tissue, The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device wherein the suture knot is configured to unfold from the suture knot recess and along the tension member, and to be tightened to close and seal the opening.

2. The suturing device according to claim 1, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

3. The suturing device according to claim 1, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

4. It also features a suture knot sleeve, The suturing device according to claim 1, wherein the suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until it is unfolded.

5. The suturing device according to claim 4, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

6. The needle guide further comprises a tension member groove configured to accommodate the tension member, The suturing device according to claim 1, wherein the tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue.

7. The suturing device according to claim 6, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

8. The suture device according to claim 1, wherein the suture knot is a sliding knot.

9. The suture device according to claim 1, wherein the suture knot is a "Tennessee slider" knot.

10. A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The suturing device according to claim 1, further comprising a needle actuator, which is positioned on the handle and coupled to at least one of the first or second needles, and is configured to guide at least one of the first or second needles through the tissue when the needle actuator is actuated.

11. The suturing device according to claim 10, wherein the needle actuator includes a biasing member configured to retract at least one of the first or second needles.

12. The suturing device according to claim 11, wherein the needle actuator biasing member is a spring.

13. The needle actuator is coupled to the first and second needles, The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 10, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

14. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 13, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

15. The suture device according to claim 14, wherein the needle actuator biasing member is a spring.

16. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 14, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

17. The suture device according to claim 16, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation.

18. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 16, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

19. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 14, wherein, when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

20. The suture device according to claim 19, wherein at least a portion of the catch is magnetic.

21. The catch engages with the catch groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 19, wherein the catch engages internally with a catch recess when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

22. The needle actuator further comprises a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 21, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

23. The suturing device according to claim 1, further comprising a connecting member configured to pull the tensile member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

24. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 23, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

25. The suture device according to claim 23, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

26. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 25, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

27. The notch has a width, The suture device according to claim 25, wherein the width of the notch defines at least partially the bending radius of the connecting member.

28. The aforementioned notch has multiple widths, The suture device according to claim 25, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

29. The suture device according to claim 25, wherein the notch is configured to allow the connecting member to deform within a single plane.

30. A handle positioned at the proximal end of the suture device, A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, A suture mechanism actuator is provided, which is positioned on the handle, coupled to the suture mechanism, and configured to move the suture mechanism between the insertion and removal orientation and the deployment orientation. The suturing device according to claim 1, further comprising an elongated shaft coupled between the handle and the needle guide.

31. The suturing device according to claim 30, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

32. The suture device according to claim 30, wherein the suture mechanism actuator includes a biasing member configured to return the suture mechanism to the insertion and removal orientation.

33. The suture device according to claim 32, wherein the biasing member of the suture mechanism actuator is a spring.

34. The suture mechanism is in the insertion and removal orientation when the suture mechanism actuator is in the first suture mechanism actuator position. The suturing device according to claim 30, wherein the suturing mechanism is in the unfolded orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

35. The suturing device according to claim 30, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

36. The opening in the handle is a slot, The suture mechanism actuator is in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suturing device according to claim 35, wherein the suturing mechanism actuator is in the position of the second suturing mechanism actuator when the suturing mechanism actuator shaft is at the second end of the slot.

37. The suture device according to claim 36, wherein the slot is a "J" shaped slot.

38. The suturing device according to claim 35, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

39. The suturing device according to claim 34, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

40. The suture device according to claim 39, wherein the biasing member of the suture mechanism actuator is a spring.

41. The suturing device according to claim 30, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

42. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 41, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

43. The suture device according to claim 41, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

44. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 43, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

45. The notch has a width, The suture device according to claim 43, wherein the width of the notch defines at least partially the bending radius of the connecting member.

46. The aforementioned notch has multiple widths, The suture device according to claim 43, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

47. The suture device according to claim 43, wherein the notch is configured to allow the connecting member to deform within a single plane.

48. The suturing device according to claim 43, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

49. The suturing device according to claim 48, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

50. The suturing device according to claim 1, wherein the first needle includes a removable needle tip coupled to the tensioning member.

51. The suture device according to claim 1, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

52. The suturing device according to claim 1, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

53. The suture device according to claim 1, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

54. A suturing device system, The suturing device according to claim 53, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

55. The suture device system according to claim 54, further comprising a knot pusher configured to advance the suture knot along the tension member.

56. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide includes a tension member groove configured to accommodate the tension member, At least a portion of the suture device is configured to be guided into an opening in the tissue, The first and second needles are configured to be guided through the tissue adjacent to the opening in order to guide the tensile member through the tissue, The tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device wherein the suture knot is configured to unfold along the tension member and to be tightened to close and seal the opening.

57. The suturing device according to claim 56, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

58. The suturing device according to claim 56, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

59. The suturing device according to claim 56, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

60. The suturing device according to claim 56, further comprising a suture knot recess configured to receive the suture knot.

61. It also features a suture knot sleeve, The suturing device according to claim 60, wherein the suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until it is unfolded.

62. The suturing device according to claim 61, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

63. It also features a suture knot sleeve, The suturing device according to claim 56, wherein the suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until it is unfolded.

64. The suture device according to claim 56, wherein the suture knot is a sliding knot.

65. The suture device according to claim 56, wherein the suture knot is a "Tennessee slider" knot.

66. A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The suturing device according to claim 56, further comprising a needle actuator, which is positioned on the handle and coupled to at least one of the first or second needles, and is configured to guide at least one of the first or second needles through the tissue when the needle actuator is actuated.

67. The suturing device according to claim 66, wherein the needle actuator includes a biasing member configured to retract at least one of the first or second needles.

68. The suture device according to claim 67, wherein the needle actuator biasing member is a spring.

69. The needle actuator is coupled to the first and second needles, The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 66, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

70. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 69, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

71. The suture device according to claim 70, wherein the needle actuator biasing member is a spring.

72. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 70, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

73. The suturing device according to claim 72, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation when moved by the plunger.

74. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 72, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

75. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 70, wherein when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

76. The suture device according to claim 75, wherein at least a portion of the catch is magnetic.

77. The catch engages with the catch groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 75, wherein the catch engages with a catch recess when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

78. The needle actuator further comprises a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 75, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

79. The suturing device according to claim 56, further comprising a connecting member configured to pull the tensile member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

80. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 79, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

81. The suture device according to claim 79, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

82. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 81, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

83. The notch has a width, The suture device according to claim 81, wherein the width of the notch defines at least partially the bending radius of the connecting member.

84. The aforementioned notch has multiple widths, The suture device according to claim 81, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

85. The suture device according to claim 81, wherein the notch is configured to allow the connecting member to deform within a single plane.

86. A handle positioned at the proximal end of the suture device, A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, A suture mechanism actuator is provided, which is positioned on the handle, coupled to the suture mechanism, and configured to move the suture mechanism between the insertion and removal orientation and the deployment orientation. The suturing device according to claim 56, further comprising an elongated shaft coupled between the handle and the needle guide.

87. The suturing device according to claim 86, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

88. The suturing device according to claim 86, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

89. The suture device according to claim 88, wherein the biasing member of the suture mechanism actuator is a spring.

90. When the suture mechanism actuator is in the first suture mechanism actuator position, the suture mechanism is in the insertion and removal orientation. The suturing device according to claim 86, wherein the suturing mechanism is in the unfolded orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

91. The suturing device according to claim 86, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

92. The opening in the handle is a slot, When the suture mechanism actuator shaft is at the first end of the slot, the suture mechanism actuator is in the first suture mechanism actuator position. The suturing device according to claim 91, wherein the suturing mechanism actuator is in the second suturing mechanism actuator position when the suturing mechanism actuator shaft is at the second end of the slot.

93. The suture device according to claim 92, wherein the slot is a "J" shaped slot.

94. The suturing device according to claim 92, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

95. The suturing device according to claim 92, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

96. The suture device according to claim 95, wherein the biasing member of the suture mechanism actuator is a spring.

97. The suturing device according to claim 56, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

98. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 97, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

99. The suture device according to claim 97, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

100. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 99, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

101. The notch has a width, The suture device according to claim 99, wherein the width of the notch defines at least partially the bending radius of the connecting member.

102. The aforementioned notch has multiple widths, The suture device according to claim 99, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

103. The suture device according to claim 99, wherein the notch is configured to allow the connecting member to deform within a single plane.

104. The suturing device according to claim 97, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

105. The suturing device according to claim 104, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

106. The suturing device according to claim 56, wherein the first needle includes a removable needle tip coupled to the tensioning member.

107. The suture device according to claim 56, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

108. The suturing device according to claim 56, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

109. The suture device according to claim 56, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

110. A suturing device system, The suturing device according to claim 109, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

111. The suture device system according to claim 110, further comprising a knot pusher configured to advance the suture knot along the tension member.

112. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide including a suture knot recess configured to receive the suture knot, A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The device comprises a needle actuator positioned on the handle and coupled to at least one of the first or second needles, At least a portion of the suture device is configured to be guided into an opening in the tissue, The needle actuator is configured to guide the first and second needles through the tissue adjacent to the opening in order to guide the tension member through the tissue when the needle actuator is activated. The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device wherein the suture knot is configured to unfold from the suture knot recess and along the tension member, and to be tightened to close and seal the opening.

113. The suturing device according to claim 112, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

114. The suturing device according to claim 112, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

115. It also features a suture knot sleeve, The suturing device according to claim 112, wherein the suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until it is unfolded.

116. The suturing device according to claim 115, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

117. The needle guide further comprises a tension member groove configured to accommodate the tension member, The suturing device according to claim 112, wherein the tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue.

118. The suturing device according to claim 117, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

119. The suture device according to claim 112, wherein the suture knot is a sliding knot.

120. The suture device according to claim 112, wherein the suture knot is a "Tennessee slider" knot.

121. The suturing device according to claim 112, wherein the needle actuator includes a biasing member configured to retract the first and second needles.

122. The suture device according to claim 121, wherein the needle actuator biasing member is a spring.

123. The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 112, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

124. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 123, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

125. The suture device according to claim 124, wherein the needle actuator biasing member is a spring.

126. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 124, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

127. The suturing device according to claim 126, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation when moved by the plunger.

128. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 126, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

129. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 124, wherein, when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

130. The suture device according to claim 129, wherein at least a portion of the catch is magnetic.

131. The catch engages with the catch groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 130, wherein the catch engages with a catch recess when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

132. The needle actuator further comprises a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 131, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

133. The suturing device according to claim 112, further comprising a connecting member configured to pull the tensioning member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

134. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 133, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

135. The suture device according to claim 133, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

136. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 135, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

137. The notch has a width, The suture device according to claim 135, wherein the width of the notch defines at least partially the bending radius of the connecting member.

138. The aforementioned notch has multiple widths, The suture device according to claim 135, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

139. The suture device according to claim 135, wherein the notch is configured to allow the connecting member to deform within a single plane.

140. A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, The suturing device according to claim 112, further comprising a suturing mechanism actuator, which is disposed on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between the insertion and removal orientation and the deployment orientation.

141. The suturing device according to claim 140, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

142. The suture device according to claim 140, wherein the suture mechanism actuator includes a biasing member configured to return the suture mechanism to the insertion and removal orientation.

143. The suture device according to claim 142, wherein the biasing member of the suture mechanism actuator is a spring.

144. The suture mechanism is in the insertion and removal orientation when the suture mechanism actuator is in the first suture mechanism actuator position. The suturing device according to claim 140, wherein the suturing mechanism is in the unfolding orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

145. The suturing device according to claim 140, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

146. The opening in the handle is a slot, The suture mechanism actuator is in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suturing device according to claim 145, wherein the suturing mechanism actuator is in the position of the second suturing mechanism actuator when the suturing mechanism actuator shaft is at the second end of the slot.

147. The suture device according to claim 146, wherein the slot is a "J" shaped slot.

148. The suturing device according to claim 145, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

149. The suturing device according to claim 148, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

150. The suture device according to claim 149, wherein the biasing member of the suture mechanism actuator is a spring.

151. The suturing device according to claim 140, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

152. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 151, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

153. The suture device according to claim 151, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

154. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 153, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

155. The notch has a width, The suture device according to claim 153, wherein the width of the notch defines at least partially the bending radius of the connecting member.

156. The aforementioned notch has multiple widths, The suture device according to claim 153, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

157. The suture device according to claim 153, wherein the notch is configured to allow the connecting member to deform within a single plane.

158. The suturing device according to claim 153, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

159. The suturing device according to claim 158, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

160. The suturing device according to claim 112, wherein the first needle includes a removable needle tip coupled to the tensioning member.

161. The suture device according to claim 112, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

162. The suturing device according to claim 112, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

163. The suture device according to claim 112, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

164. A suturing device system, The suturing device according to claim 163, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

165. The suture device system according to claim 164, further comprising a knot pusher configured to advance the suture knot along the tension member.

166. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide including a tension member groove configured to accommodate the tension member, A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The device comprises a needle actuator positioned on the handle and coupled to at least one of the first or second needles, At least a portion of the suture device is configured to be guided into an opening in the tissue, The needle actuator is configured to guide the first and second needles through the tissue adjacent to the opening in order to guide the tension member through the tissue when the needle actuator is activated. The tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue. The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device wherein the suture knot is configured to unfold along the tension member and to be tightened to close and seal the opening.

167. The suturing device according to claim 166, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

168. The suturing device according to claim 166, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

169. The suturing device according to claim 166, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

170. The suturing device according to claim 166, further comprising a suture knot recess configured to receive the suture knot.

171. It also features a suture knot sleeve, The suturing device according to claim 170, wherein the suturing knot is wrapped around the suturing knot sleeve, and the suturing knot sleeve holds the suturing knot until it is unfolded.

172. The suturing device according to claim 171, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

173. It also features a suture knot sleeve, The suturing device according to claim 166, wherein the suturing knot is wrapped around the suturing knot sleeve, and the suturing knot sleeve holds the suturing knot until it is unfolded.

174. The suture device according to claim 166, wherein the suture knot is a sliding knot.

175. The suture device according to claim 166, wherein the suture knot is a "Tennessee slider" knot.

176. The suturing device according to claim 166, wherein the needle actuator includes a biasing member configured to retract at least one of the first or second needles.

177. The suture device according to claim 176, wherein the needle actuator biasing member is a spring.

178. The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 166, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

179. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 178, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

180. The suture device according to claim 179, wherein the needle actuator biasing member is a spring.

181. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 179, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

182. The suturing device according to claim 181, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation when moved by the plunger.

183. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 181, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

184. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 179, wherein, when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

185. The suture device according to claim 184, wherein at least a portion of the catch is magnetic.

186. The catch engages with the catch groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 184, wherein the catch engages with a catch recess when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

187. The needle actuator further comprises a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 186, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

188. The suturing device according to claim 166, further comprising a connecting member configured to pull the tensioning member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

189. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 188, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

190. The suture device according to claim 188, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

191. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 190, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

192. The notch has a width, The suture device according to claim 190, wherein the width of the notch defines at least partially the bending radius of the connecting member.

193. The aforementioned notch has multiple widths, The suture device according to claim 190, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

194. The suture device according to claim 190, wherein the notch is configured to allow the connecting member to deform within a single plane.

195. A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, The suturing device according to claim 166, further comprising a suturing mechanism actuator, which is positioned on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between the insertion and removal orientation and the deployment orientation.

196. The suturing device according to claim 195, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

197. The suturing device according to claim 195, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

198. The suture device according to claim 197, wherein the biasing member of the suture mechanism actuator is a spring.

199. When the suture mechanism actuator is in the first suture mechanism actuator position, the suture mechanism is in the insertion and removal orientation. The suturing device according to claim 195, wherein the suturing mechanism is in the unfolded orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

200. The suturing device according to claim 195, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

201. The opening in the handle is a slot, The suture mechanism actuator is in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suturing device according to claim 200, wherein the suturing mechanism actuator is in the position of the second suturing mechanism actuator when the suturing mechanism actuator shaft is at the second end of the slot.

202. The suture device according to claim 201, wherein the slot is a "J" shaped slot.

203. The suturing device according to claim 200, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

204. The suturing device according to claim 199, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

205. The suture device according to claim 204, wherein the biasing member of the suture mechanism actuator is a spring.

206. The suturing device according to claim 166, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

207. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 206, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

208. The suture device according to claim 206, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

209. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 208, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

210. The notch has a width, The suture device according to claim 208, wherein the width of the notch defines at least partially the bending radius of the connecting member.

211. The aforementioned notch has multiple widths, The suture device according to claim 208, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

212. The suture device according to claim 211, wherein the notch is configured to allow the connecting member to deform within a single plane.

213. The suturing device according to claim 206, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

214. The suturing device according to claim 213, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

215. The suturing device according to claim 166, wherein the first needle includes a removable needle tip coupled to the tensioning member.

216. The suture device according to claim 166, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

217. The suturing device according to claim 166, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

218. The suture device according to claim 166, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

219. A suturing device system, The suturing device according to claim 218, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

220. The suture device system according to claim 219, further comprising a knot pusher configured to advance the suture knot along the tension member.

221. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide is provided, which includes a suture knot sleeve configured to receive the suture knot, At least a portion of the suture device is configured to be guided into an opening in the tissue, The first and second needles are configured to be guided through the tissue adjacent to the opening in order to guide the tensile member through the tissue, The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device in which the suture knot is wrapped around the suture knot sleeve, and the suture knot is configured to unfold from the suture knot sleeve along the tension member and tighten to close and seal the opening.

222. The suturing device according to claim 221, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

223. The suturing device according to claim 221, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

224. The suturing device according to claim 221, further comprising a suture knot recess configured to receive the suture knot.

225. The suturing device according to claim 224, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

226. The needle guide further comprises a tension member groove configured to accommodate the tension member, The suturing device according to claim 221, wherein the tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue.

227. The suturing device according to claim 225, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

228. The suture device according to claim 221, wherein the suture knot is a sliding knot.

229. The suture device according to claim 221, wherein the suture knot is a "Tennessee slider" knot.

230. A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The suturing device according to claim 221, further comprising a needle actuator, which is positioned on the handle and coupled to at least one of the first or second needles, and is configured to guide at least one of the first or second needles through the tissue when the needle actuator is actuated.

231. The suturing device according to claim 230, wherein the needle actuator includes a biasing member configured to retract at least one of the first or second needles.

232. The suture device according to claim 231, wherein the needle actuator biasing member is a spring.

233. The needle actuator is coupled to the first and second needles, The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 230, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

234. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 233, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

235. The suture device according to claim 234, wherein the needle actuator biasing member is a spring.

236. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 234, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

237. The suture device according to claim 236, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation.

238. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 236, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

239. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 234, wherein, when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

240. The suture device according to claim 239, wherein at least a portion of the catch is magnetic.

241. The catch engages with the catch groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 239, wherein the catch engages internally with a catch recess when the plunger is pressed down, thereby enabling the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

242. The needle actuator further comprises a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 241, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

243. The suturing device according to claim 221, further comprising a connecting member configured to pull the tensioning member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

244. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 243, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

245. The suture device according to claim 243, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

246. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 245, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

247. The notch has a width, The suture device according to claim 245, wherein the width of the notch defines at least partially the bending radius of the connecting member.

248. The aforementioned notch has multiple widths, The suture device according to claim 245, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

249. The suture device according to claim 245, wherein the notch is configured to allow the connecting member to deform within a single plane.

250. A handle positioned at the proximal end of the suture device, A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, A suture mechanism actuator is provided, which is positioned on the handle, coupled to the suture mechanism, and configured to move the suture mechanism between the insertion and removal orientation and the deployment orientation. The suturing device according to claim 221, further comprising an elongated shaft coupled between the handle and the needle guide.

251. The suturing device according to claim 250, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

252. The suture device according to claim 250, wherein the suture mechanism actuator includes a biasing member configured to return the suture mechanism to the insertion and removal orientation.

253. The suture device according to claim 252, wherein the biasing member of the suture mechanism actuator is a spring.

254. When the suture mechanism actuator is in the first suture mechanism actuator position, the suture mechanism is in the insertion and removal orientation. The suturing device according to claim 250, wherein the suturing mechanism is in the unfolding orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

255. The suturing device according to claim 250, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

256. The opening in the handle is a slot, The suture mechanism actuator is in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suturing device according to claim 255, wherein the suturing mechanism actuator is in the position of the second suturing mechanism actuator when the suturing mechanism actuator shaft is at the second end of the slot.

257. The suture device according to claim 256, wherein the slot is a "J" shaped slot.

258. The suturing device according to claim 255, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

259. The suturing device according to claim 254, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

260. The suture device according to claim 259, wherein the biasing member of the suture mechanism actuator is a spring.

261. The suturing device according to claim 250, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

262. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 261, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

263. The suture device according to claim 261, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

264. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 263, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

265. The notch has a width, The suture device according to claim 263, wherein the width of the notch defines at least partially the bending radius of the connecting member.

266. The aforementioned notch has multiple widths, The suture device according to claim 263, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

267. The suture device according to claim 263, wherein the notch is configured to allow the connecting member to deform within a single plane.

268. The suturing device according to claim 263, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

269. The suturing device according to claim 268, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

270. The suturing device according to claim 221, wherein the first needle includes a removable needle tip coupled to the tensioning member.

271. The suture device according to claim 221, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

272. The suturing device according to claim 221, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

273. The suture device according to claim 221, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

274. A suturing device system, The suturing device according to claim 273, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

275. The suture device system according to claim 274, further comprising a knot pusher configured to advance the suture knot along the tension member.

276. A suturing device, A tension member and A suture knot associated with the tension member, It is a needle guide, A first needle connected to the tension member, The second needle, A needle guide, including a suture knot sleeve configured to receive the suture knot, A handle positioned at the proximal end of the suture device, A long shaft connected between the handle and the needle guide, The device comprises a needle actuator positioned on the handle and coupled to at least one of the first or second needles, At least a portion of the suture device is configured to be guided into an opening in the tissue, The needle actuator is configured to guide the first and second needles through the tissue adjacent to the opening in order to guide the tension member through the tissue when the needle actuator is activated. The tension member is configured to be pulled through the tissue when at least one of the first or second needles retracts. A suturing device in which the suture knot is wrapped around the suture knot sleeve, and the suture knot is configured to unfold from the suture knot sleeve along the tension member and tighten to close and seal the opening.

277. The suturing device according to claim 276, wherein the suture knot is deployed when at least one of the first or second needles is retracted.

278. The suturing device according to claim 276, wherein the tensioning member is pulled through the suture knot when at least one of the first or second needles is retracted.

279. The suturing device according to claim 276, further comprising a suture knot recess configured to receive the suture knot.

280. The suturing device according to claim 279, wherein the suture knot sleeve is at least partially located inside the suture knot recess.

281. The needle guide further comprises a tension member groove configured to accommodate the tension member, The suturing device according to claim 276, wherein the tension member is configured to unfold from the tension member groove when at least one of the first or second needles is guided through the tissue.

282. The suturing device according to claim 281, wherein the tension member groove extends from the first needle side to the second needle side of the needle guide.

283. The suture device according to claim 276, wherein the suture knot is a sliding knot.

284. The suture device according to claim 283, wherein the suture knot is a "Tennessee slider" knot.

285. The suturing device according to claim 276, wherein the needle actuator includes a biasing member configured to retract the first and second needles.

286. The suture device according to claim 285, wherein the needle actuator biasing member is a spring.

287. The needle actuator is in the first needle actuator position before guiding the first and second needles through the tissue. The needle actuator is configured to move to the second needle actuator position in order to guide the first and second needles through the tissue. The suturing device according to claim 276, wherein the needle actuator is configured to move to the position of a third needle actuator in order to retract the first and second needles.

288. The aforementioned needle actuator is Plunger and, A biasing member is provided, When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position. The suturing device according to claim 287, wherein when the plunger is released, the biasing member moves the needle actuator from the second needle actuator position to the third needle actuator position.

289. The suture device according to claim 288, wherein the needle actuator biasing member is a spring.

290. The needle actuator further comprises a sprag, When the plunger is pressed, the sprag moves from a first sprag orientation to a second sprag orientation. The suturing device according to claim 288, wherein, when in the second sprag orientation, the sprag allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

291. The suturing device according to claim 290, wherein the sprag is configured to rotate from the first sprag orientation to the second sprag orientation when moved by the plunger.

292. The sprag engages with the first sprag groove when the needle actuator is in the first needle actuator position. The suturing device according to claim 290, wherein the sprag engages with a second sprag groove when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

293. The needle actuator further includes a catch, When pressed, the plunger moves the catch, The suturing device according to claim 288, wherein, when moved, the catch allows the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

294. The suture device according to claim 293, wherein at least a portion of the catch is magnetic.

295. The catch engages with the catch groove when the needle actuator is in the first needle actuator position, The suturing device according to claim 293, wherein the catch engages with a catch recess when the plunger is pressed down, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

296. The needle actuator further includes a ferromagnetic portion, At least a portion of the catch is magnetic, The suture device according to claim 295, wherein the catch is pulled into the catch recess by the ferromagnetic portion.

297. The suturing device according to claim 276, further comprising a connecting member configured to pull the tensioning member through the tissue and having first and second ends, wherein the first end can be coupled to the first needle and the second end can be coupled to the second needle.

298. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 297, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

299. The suture device according to claim 297, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

300. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 299, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

301. The notch has a width, The suture device according to claim 299, wherein the width of the notch defines at least partially the bending radius of the connecting member.

302. The aforementioned notch has multiple widths, The suture device according to claim 299, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

303. The suture device according to claim 299, wherein the notch is configured to allow the connecting member to deform within a single plane.

304. A suturing mechanism coupled to the distal end portion of the needle guide and associated with the first and second needles, which is movable between an insertion and removal orientation and an unfolding orientation and includes a pivot element located at the distal end portion of the suturing device, The suturing device according to claim 276, further comprising a suturing mechanism actuator, which is positioned on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between the insertion and removal orientation and the deployment orientation.

305. The suturing device according to claim 304, wherein the suturing mechanism includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

306. The suture device according to claim 304, wherein the suture mechanism actuator includes a biasing member configured to return the suture mechanism to the insertion and removal orientation.

307. The suture device according to claim 306, wherein the biasing member of the suture mechanism actuator is a spring.

308. The suture mechanism is in the insertion and removal orientation when the suture mechanism actuator is in the first suture mechanism actuator position. The suturing device according to claim 304, wherein the suturing mechanism is in the unfolding orientation when the suturing mechanism actuator is in the second suturing mechanism actuator position.

309. The suturing device according to claim 304, wherein the suturing mechanism actuator comprises a suturing mechanism actuator shaft extending through an opening in the handle, the opening in the handle restricts and guides the movement of the suturing mechanism actuator shaft.

310. The opening in the handle is a slot, The suture mechanism actuator is in the first suture mechanism actuator position when the suture mechanism actuator shaft is at the first end of the slot. The suturing device according to claim 309, wherein the suturing mechanism actuator is in the second suturing mechanism actuator position when the suturing mechanism actuator shaft is at the second end of the slot.

311. The suture device according to claim 310, wherein the slot is a "J" shaped slot.

312. The suturing device according to claim 309, wherein the suturing mechanism actuator further comprises a selector knob coupled to the suturing mechanism actuator shaft and configured to allow a user to move the suturing mechanism actuator between the first suturing mechanism actuator position and the second suturing mechanism actuator position.

313. The suturing device according to claim 312, wherein the suturing mechanism actuator includes a biasing member configured to maintain the suturing mechanism actuator in at least one of the first suturing mechanism actuator position or the second suturing mechanism actuator position.

314. The suture device according to claim 313, wherein the biasing member of the suture mechanism actuator is a spring.

315. The suturing device according to claim 304, wherein the suturing mechanism further comprises a connecting member configured to pull the tension member through the tissue and having first and second ends, the first end being capable of being coupled to a first needle and the second end being capable of being coupled to a second needle.

316. At least one of the first or second needles includes a barbed needle tip, The suturing device according to claim 315, wherein the connecting member includes at least one tab configured to grip the tip of the barbed needle.

317. The suture device according to claim 315, wherein the connecting member includes a plurality of notches configured to allow the connecting member to deform.

318. The notches are spaced apart along the length of the connecting member, The suturing device according to claim 317, wherein the spacing of the notches defines at least partially the bending radius of the connecting member.

319. The notch has a width, The suture device according to claim 317, wherein the width of the notch defines at least partially the bending radius of the connecting member.

320. The aforementioned notch has multiple widths, The suture device according to claim 317, wherein the width of the notch defines at least partially a plurality of bending radii of the connecting member.

321. The suture device according to claim 317, wherein the notch is configured to allow the connecting member to deform within a single plane.

322. The suturing device according to claim 315, wherein the connecting member is configured such that the suturing mechanism passes through in one direction.

323. The suturing device according to claim 322, wherein the connecting member includes at least one tab configured to prevent the connecting member from retracting from the suturing mechanism.

324. The suturing device according to claim 276, wherein the first needle includes a removable needle tip coupled to the tensioning member.

325. The suture device according to claim 276, further comprising at least one of a guidewire lumen or a flushing lumen extending from the proximal end portion to the distal end portion of the suture device.

326. The suturing device according to claim 276, wherein the suture knot is configured to unfold while the guide wire is inside the opening.

327. The suture device according to claim 276, further comprising at least one locking tab configured to engage with the introducer sheath when at least a portion of the suture device is guided through the introducer sheath.

328. A suturing device system, The suturing device according to claim 327, Equipped with an introducer sheath, The introducer sheath is configured to be introduced into the opening in the tissue, A suture device system wherein the introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains inside the opening.

329. The suture device system according to claim 328, further comprising a knot pusher configured to advance the suture knot along the tension member.

330. A method of applying sutures to close and seal an opening in tissue, To guide at least one needle through the tissue adjacent to the opening, To guide the tensile member through the tissue adjacent to the opening, Guiding at least a portion of the at least one needle through the suture knot, To unfold the aforementioned suture knot, A method comprising tightening the suture knot to close and seal the opening.

331. The method according to claim 330, further comprising guiding at least a portion of the tension member through the suture knot.

332. The method according to claim 330, wherein unfolding the suture knot includes unfolding the suture knot from the knot recess.

333. The method according to claim 330, wherein unfolding the suture knot includes unfolding the suture knot from the sleeve.

334. The method according to claim 333, further comprising guiding at least a portion of the at least one needle through the sleeve.

335. The method according to claim 333, further comprising guiding at least a portion of the tension member through the sleeve.

336. The method according to claim 330, wherein unfolding the suture knot includes unfolding the suture knot on the tension member.

337. The method according to claim 330, wherein the suture knot is a pre-tied knot.

338. To guide at least a portion of a suture mechanism having a pivot element oriented for insertion and removal through the opening in the tissue, Moving the pivot element of the suture mechanism to an unfolded orientation, Returning the pivot element to the insertion and removal orientation, The method according to claim 330, further comprising withdrawing the suture mechanism from the opening.

339. To guide the introducer sheath into the opening in the aforementioned tissue, To guide at least a portion of the suture mechanism through the introducer sheath, The method according to claim 338, further comprising withdrawing the introducer sheath from the opening while at least a portion of the suture mechanism remains inside the opening.

340. The method according to claim 339, further comprising connecting the suture mechanism to the proximal end of the introducer sheath.

341. The suture mechanism includes a connecting member having first and second ends, The at least one needle comprises a first needle and a second needle, The aforementioned method, The first needle is attached to the first end of the connecting member, The second needle is attached to the second end of the connecting member, Retracting the first and second needles, The method according to claim 338, further comprising pulling the tensile member through the tissue using the connecting member.

342. The method according to claim 330, further comprising guiding a guide wire through the opening.

343. The method according to claim 342, further comprising unfolding the suture knot while the guide wire is inside the opening.

344. The method according to claim 342, further comprising withdrawing the guide wire from the opening.

345. Any apparatus, method, or combination thereof disclosed herein.

346. Any two or more of the aforementioned claims in any combination.

347. Any combination of elements from one or more of the aforementioned claims.

348. An apparatus comprising any combination of elements as disclosed herein.

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