Suturing device and related methods

Abstract

The present disclosure provides a suturing device (100) including a tensile member (250), a suture knot (264) associated with the tensile member (250), and a needle guide (210). The needle guide (210) includes a first needle (212) coupled to the tensile 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 tissue. The first and second needles (212, 214) are configured to be guided through the tissue adjacent the opening to guide the tensile member (250) through the tissue. The tensile 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 be deployed from the suture knot recess (254) and along the tensile member (250) and tightened to close and seal the opening.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 541,988, filed October 2, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also relates generally to U.S. Provisional Application Serial No. 63 / 124,400, filed December 11, 2020 (expired); U.S. Provisional Application Serial No. 63 / 191,017, filed May 20, 2021 (expired); U.S. Patent Application Serial No. 17 / 546,947, filed December 9, 2021 (now U.S. Patent No. 12,035,905, issued July 16, 2024); U.S. Patent Application Serial No. 17 / 546,958, filed December 9, 2021 (now U.S. Patent No. 12,048,429, issued July 30, 2024); and PCT Patent Application No. PCT / US2021 / 062667, filed December 9, 2021 (expired). The following patent applications are included hereby cited: PCT / US2021 / 062671 (expired), filed on December 9, 2021; U.S. Provisional Application Serial No. 63 / 422,345 (expired), filed on November 3, 2022; U.S. Provisional Application Serial No. 63 / 431,366 (expired), filed on December 9, 2022; PCT / US2023 / 036651 (pending), filed on November 2, 2023; U.S. Patent Application Serial No. 18 / 669,040 (pending), filed on May 20, 2024; and U.S. Patent Application Serial No. 18 / 751,896 (pending), filed on June 24, 2024. Their disclosures are incorporated herein by reference in their entirety. Technical Field

[0004] The embodiments generally relate to devices, systems, and related methods for closing puncture sites or other openings in blood vessels and other tissues. Background Technology

[0005] Vascular access for neurotherapy has traditionally been via the femoral artery or the radial artery. For vessels accessing the brain using conventional routes, neurotherapy devices must traverse long, winding sections of the anatomy to reach the treatment site. Direct carotid artery puncture (DCP) to the common carotid artery (CCA) allows physicians to access the brain more quickly and eliminates the need for devices that must traverse the typical femoral artery approach. DCP involves percutaneous puncture of the skin and artery to access the CCA.

[0006] Currently, to close and seal a direct carotid artery puncture, physicians can either manually apply sutures before entering the common carotid artery, or simply apply direct pressure to the site after the intervention until the vessel is sealed. Applying direct pressure to the site relies on blood clotting at the puncture site and can be ineffective due to the lack of suitable anatomical structures near the common carotid artery where pressure can be applied. The time required to close the puncture site with direct pressure can also be quite long. Furthermore, the common carotid artery delivers blood under high pressure (100 to 200 mmHg), which further complicates the ability to effectively close the carotid artery puncture site using current methods.

[0007] Therefore, despite the various advances made in this field, further improvements are still needed in the devices, systems, and methods used to seal puncture sites or other openings in blood vessels and other tissues. Summary of the Invention

[0008] Generally, this document provides a suturing device. The suturing device includes a tensile member, a suture knot associated with the tensile member, and a needle guide. The needle guide includes a first needle, 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 to guide the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts. The suture structure causes it to unfold from the suture knot recess and along the tensile member, and is tightened to close and seal the opening.

[0009] In some embodiments, the suture knot may unfold when at least one of the first or second needles is retracted. When at least one of the first or second needles is retracted, a tensile member may be pulled through the suture knot. 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 unfolds. The needle guide may include a tensile member recess configured to receive the tensile member. When at least one of the first or second needles is guided through the tissue, the tensile member may unfold from the tensile member recess. The tensile member recess may extend from the first needle side of the needle guide to the second needle side. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot.

[0010] In an alternative embodiment, the suturing device may include a handle located at a proximal portion of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator located on the handle. The needle actuator may be coupled to at least one of a first or second needle and configured to guide at least one of the first or second needles through tissue when the needle actuator is activated. 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.

[0011] In an alternative or additional manner, the needle actuator may be coupled to a first needle and a second needle. 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 to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position to retract the first and second needles. The needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator may move from the first needle actuator position to the second needle actuator position. When the plunger is released, the needle actuator biasing member may move the needle actuator from the second needle actuator position to the third needle actuator position. The needle actuator biasing member may be a spring. The needle actuator may include a pawl. When the plunger is depressed, the pawl may move from a first pawl orientation to a second pawl orientation. When the plunger is released and the pawl is in the second pawl orientation, the pawl may allow the needle actuator to move from the second needle actuator position to the third needle actuator position. The pawl can be configured to rotate from a first pawl orientation to a second pawl orientation. When the needle actuator is in the first needle actuator position, the pawl can engage the first pawl groove. When the plunger is depressed, the pawl can engage the second pawl groove, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0012] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0013] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane.

[0014] In some embodiments, the suturing device may include a handle located at a proximal portion of the suturing device and a suturing mechanism coupled to a distal portion of a needle guide. The suturing mechanism may be associated with a first needle and a second needle. The suturing mechanism may include a pivoting element movable between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may be located at the distal portion of the suturing device. A suturing mechanism actuator may be located on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between the insertion and removal orientation and the 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.

[0015] In some embodiments, when the suture actuator is in a first suture actuator position, the suture mechanism may be in an insertion and removal orientation. When the suture actuator is in a second suture actuator position, the suture mechanism may be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator may be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator may be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0016] In an alternative or additional aspect, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0017] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0018] An alternative suture device is provided. The alternative suture device includes a tensile member, a suture knot associated with the tensile member, and a needle guide. The needle guide includes a first needle and a second needle coupled to the tensile member, and a tensile member groove configured to receive the tensile member. At least a portion of the suture 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 to guide the tensile member through the tissue. The tensile member is configured to unfold from the tensile member groove when at least one of the first or second needles is guided through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture structure causes it to unfold from the suture knot recess and along the tensile member, and is tightened to close and seal the opening.

[0019] In some embodiments, the tensile member groove may extend from the first needle side of the needle guide to the second needle side. The suture knot may unfold when at least one of the first or second needles is retracted. The tensile 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. 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 unfolds. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot.

[0020] In alternative or additional aspects, the suturing device may include a handle located at the proximal portion of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator located 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 needles through tissue when the needle actuator is activated. 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 coupled to both 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 to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position to retract the first and second needles. The needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator can move from the first needle actuator position to the second needle actuator position. When the plunger is released, the needle actuator biasing member can move the needle actuator from the second needle actuator position to the third needle actuator position. The needle actuator biasing member can be a spring.

[0021] In an alternative embodiment, the needle actuator may include a pawl. When the plunger is depressed, the pawl can move from a first pawl orientation to a second pawl orientation. When the pawl is in the second pawl orientation, it allows the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The pawl may be configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger. When the needle actuator is in the first needle actuator position, the pawl can engage a first pawl recess. When the plunger is depressed, the pawl can engage a second pawl recess, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0022] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0023] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member.

[0024] In some embodiments, the suturing device may include a handle located at a proximal portion of the suturing device, a suturing mechanism coupled to a distal portion of a needle guide, a suturing mechanism actuator located on the handle, and an elongated shaft coupled between the handle and the needle guide. The suturing mechanism may be associated with a first needle and a second needle. The suturing mechanism may include a pivoting element located at the distal portion of the suturing device and movable between an insertion and removal orientation and an unfolding orientation. The suturing mechanism actuator may be coupled to the suturing mechanism and configured to move the suturing mechanism between the insertion and removal orientation and the 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 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.

[0025] In an alternative or additional manner, when the suture actuator is in the first suture actuator position, the suture mechanism may be in an insertion and removal orientation. When the suture actuator is in the second suture actuator position, the suture mechanism may be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator may be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator may be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0026] In an alternative embodiment, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being engageable with a first needle and the second end being engageable with 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0027] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0028] An alternative suture device is provided. The alternative suture device includes a tensile member, a suture knot associated with the tensile member, a needle guide, a handle located proximal to the suture device, an elongated shaft connected between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle and a second needle connected to the tensile member, and a suture knot recess configured to receive the suture knot. The needle actuator is located on the handle and connected 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 tissue. The needle actuator is configured to guide the first and second needles through tissue adjacent to the opening when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts. The suture structure causes it to unfold from the suture knot recess and along the tensile member, and is tightened to close and seal the opening.

[0029] In some embodiments, the suture knot can unfold when at least one of the first or second needles is retracted. When at least one of the first or second needles is retracted, a tension member can be pulled through 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 unfolds. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot. The suturing device may include a tension member recess configured to receive a tension member, and the tension member may be configured to unfold from the tension member recess when at least one of the first or second needles is guided through the tissue. The tension member recess may extend from the first needle side of the needle guide to the second needle side.

[0030] 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 before guiding the first and second needles through tissue. The needle actuator may be configured to move to a second needle actuator position to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position to retract the first and second needles. The needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator may move from the first needle actuator position to the second needle actuator position. When the plunger is released, the needle actuator biasing member may move the needle actuator from the second needle actuator position to the third needle actuator position. The needle actuator biasing member may be a spring.

[0031] In an alternative or additional manner, the needle actuator may include a pawl. When the plunger is depressed, the pawl can move from a first pawl orientation to a second pawl orientation. When the pawl is in the second pawl orientation, it allows the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The pawl may be configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger. When the needle actuator is in the first needle actuator position, the pawl can engage a first pawl recess. When the plunger is depressed, the pawl can engage a second pawl recess, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0032] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0033] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane.

[0034] In some embodiments, the suturing apparatus may include a suturing mechanism and a suturing mechanism actuator. The suturing mechanism may be coupled to a distal portion of a needle guide. The suturing mechanism may be associated with a first needle and a second needle. The suturing mechanism may include a pivoting element located at the distal portion of the suturing apparatus and movable 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 the insertion and removal orientation and the 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 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.

[0035] In an alternative embodiment, when the suture actuator is in the first suture actuator position, the suture mechanism may be in an insertion and removal orientation. When the suture actuator is in the second suture actuator position, the suture mechanism may be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator may be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator may be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0036] In an alternative or additional aspect, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0037] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0038] An alternative suture device is provided. The alternative suture device includes a tensile member, a suture knot associated with the tensile member, a needle guide, a handle located proximal to the suture device, an elongated shaft connected between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle and a second needle coupled to the tensile member, and a tensile member groove configured to receive the tensile 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 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 when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to unfold from the tensile member groove when at least one of the first or second needles is guided through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles is retracted. The suture structure causes it to unfold along the tensile member and be tightened to close and seal the opening.

[0039] In some embodiments, the tensile member groove may extend from the first needle side of the needle guide to the second needle side. The suture knot may unfold when at least one of the first or second needles is retracted. The tensile 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. 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 unfolds. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot.

[0040] In an alternative embodiment, the needle actuator may include a biasing member configured to retract at least one of a first or second needle. 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 tissue. The needle actuator may be configured to move to a second needle actuator position to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position to retract the first and second needles.

[0041] In an alternative or additional manner, the needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator can move from a first needle actuator position to a second needle actuator position. When the plunger is released, the needle actuator biasing member can move the needle actuator from the second needle actuator position to a third needle actuator position. The needle actuator biasing member may be a spring.

[0042] In an alternative or additional manner, the needle actuator may include a pawl. When the plunger is depressed, the pawl can move from a first pawl orientation to a second pawl orientation. When the pawl is in the second pawl orientation, it allows the needle actuator to move from a second needle actuator position to a third needle actuator position when the plunger is released. The pawl may be configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger. When the needle actuator is in the first needle actuator position, the pawl can engage a first pawl recess. When the plunger is depressed, the pawl can engage a second pawl recess, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0043] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0044] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane.

[0045] In some embodiments, the suturing apparatus may include a suturing mechanism and a suturing mechanism actuator. The suturing mechanism may be coupled to a distal portion of a needle guide. The suturing mechanism may be associated with a first needle and a second needle. The suturing mechanism may include a pivoting element located at the distal portion of the suturing apparatus and movable 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 the insertion and removal orientation and the 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 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.

[0046] When the suture actuator is in the first suture actuator position, the suture mechanism can be in an insertion and removal orientation. When the suture actuator is in the second suture actuator position, the suture mechanism can be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator can be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator can be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0047] In an alternative or additional aspect, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0048] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0049] An alternative suture device is provided. The alternative suture device includes a tensile member, a suture knot associated with the tensile member, and a needle guide. The needle guide includes a first needle, a second needle, and 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 tissue. The first and second needles are configured to be guided through tissue adjacent to the opening to guide the tensile member through the tissue. The tensile 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 wound around the suture knot sleeve. The suture structure causes it to unfold from the suture knot sleeve and along the tensile member, and to be tightened to close and seal the opening.

[0050] In some embodiments, the suture knot may unfold when at least one of the first or second needles is retracted. When at least one of the first or second needles is retracted, a tension member may be pulled through the suture knot. The suturing device may include a suture knot recess configured to receive the suture knot. A suture knot sleeve may be at least partially within the suture knot recess. The needle guide may include a tension member groove configured to receive 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 of the needle guide to the second needle side. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot.

[0051] In an alternative embodiment, the suturing device may include a handle located at a proximal portion of the suturing device, an elongated shaft coupled between the handle and a needle guide, and a needle actuator located on the handle. The needle actuator may be coupled to at least one of a first or second needle and configured to guide at least one of the first or second needles through tissue when the needle actuator is activated. 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.

[0052] In an alternative or additional manner, the needle actuator may be coupled to a first needle and a second needle. 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 to guide the first and second needles through the tissue. The needle actuator may be configured to move to the third needle actuator position to retract the first and second needles.

[0053] In alternative or additional aspects, the needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator can move from a first needle actuator position to a second needle actuator position. When the plunger is released, the needle actuator biasing member can move the needle actuator from the second needle actuator position to a third needle actuator position. The needle actuator biasing member may be a spring. The needle actuator may include a pawl. When the plunger is depressed, the pawl can move from a first pawl orientation to a second pawl orientation. When the plunger is released and the pawl is in the second pawl orientation, the pawl allows the needle actuator to move from the second needle actuator position to the third needle actuator position. The pawl may be configured to rotate from the first pawl orientation to the second pawl orientation. When the needle actuator is in the first needle actuator position, the pawl can engage a first pawl recess. When the plunger is depressed, the pawl engages the second pawl groove, allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0054] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0055] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane.

[0056] In some embodiments, the suturing device may include a handle located at a proximal portion of the suturing device and a suturing mechanism coupled to a distal portion of a needle guide. The suturing mechanism may be associated with a first needle and a second needle. The suturing mechanism may include a pivoting element movable between an insertion and removal orientation and an unfolding orientation. The suturing mechanism may be located at the distal portion of the suturing device. A suturing mechanism actuator may be located on the handle, coupled to the suturing mechanism, and configured to move the suturing mechanism between the insertion and removal orientation and the 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.

[0057] In some embodiments, when the suture actuator is in a first suture actuator position, the suture mechanism may be in an insertion and removal orientation. When the suture actuator is in a second suture actuator position, the suture mechanism may be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator may be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator may be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0058] In an alternative or additional aspect, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0059] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0060] An alternative suture device is provided. The alternative suture device includes a tensile member, a suture knot associated with the tensile member, a needle guide, a handle located proximal to the suture device, an elongated shaft connected between the handle and the needle guide, and a needle actuator. The needle guide includes a first needle and a second needle coupled to the tensile member, 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 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 when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts. The suture knot is wound around the suture knot sleeve. The suture structure causes the suture to unfold from the suture knot sleeve and along the tensile member, and to be tightened to close and seal the opening.

[0061] In some embodiments, the suture knot may unfold when at least one of the first or second needles is retracted. When at least one of the first or second needles is retracted, a tension member may be pulled through the suture knot. The suturing device may include a suture knot recess configured to receive the suture knot. A suture knot sleeve may be at least partially within the suture knot recess. The needle guide may include a tension member groove configured to receive 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 of the needle guide to the second needle side. The suture knot may be a slip knot. The suture knot may be a "Tennessee slip" knot.

[0062] In an alternative embodiment, the needle actuator may include a biasing member configured to retract at least one of a first or second needle. 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 tissue. The needle actuator may be configured to move to a second needle actuator position to guide the first and second needles through tissue. The needle actuator may be configured to move to a third needle actuator position to retract the first and second needles.

[0063] In alternative or additional aspects, the needle actuator may include a plunger and a biasing member. When the plunger is depressed, the needle actuator can move from a first needle actuator position to a second needle actuator position. When the plunger is released, the needle actuator biasing member can move the needle actuator from the second needle actuator position to a third needle actuator position. The needle actuator biasing member may be a spring. The needle actuator may include a pawl. When the plunger is depressed, the pawl can move from a first pawl orientation to a second pawl orientation. When the plunger is released and the pawl is in the second pawl orientation, the pawl allows the needle actuator to move from the second needle actuator position to the third needle actuator position. The pawl may be configured to rotate from the first pawl orientation to the second pawl orientation. When the needle actuator is in the first needle actuator position, the pawl can engage a first pawl recess. When the plunger is depressed, the pawl engages the second pawl groove, allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

[0064] In some embodiments, the needle actuator may include a latch. When the plunger is depressed, the plunger is movable to the latch, and as it moves, the latch allows 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 latch may be magnetic. When the needle actuator is in the first needle actuator position, the latch engages a latch recess, and when the plunger is depressed, the latch engages a latch receptacle, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released. The needle actuator may include a ferromagnetic portion. At least a portion of the latch may be magnetic, and the latch may be pulled into the latch receptacle by the ferromagnetic portion.

[0065] In an alternative or additional aspect, the suture device may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane.

[0066] In an alternative embodiment, the suturing device may include a suturing mechanism coupled to a distal portion of a needle guide and associated with a first and second needle, and a suturing mechanism actuator located on a handle. The suturing mechanism may include a pivoting element movable between an insertion and removal orientation and an unfolding orientation. The pivoting element may be located at the distal portion of the suturing device. The suturing mechanism actuator may be coupled to the suturing mechanism and configured to move the suturing mechanism between the insertion and removal orientation and the 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 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.

[0067] In some embodiments, when the suture actuator is in a first suture actuator position, the suture mechanism may be in an insertion and removal orientation. When the suture actuator is in a second suture actuator position, the suture mechanism may be in an unfolding orientation. The suture actuator may include a suture actuator shaft extending through an opening in the handle, and the opening in the handle may restrict and guide movement of the suture actuator shaft. The opening in the handle may be a slot. When the suture actuator shaft is at a first end of the slot, the suture actuator may be in the first suture actuator position. When the suture actuator shaft is at a second end of the slot, the suture actuator may be in the second suture actuator position. The slot may be a "J"-shaped slot. The suture actuator may include a selector knob coupled to the suture actuator shaft and configured to allow a user to move the suture actuator between the first suture actuator position and the second suture actuator position. The suture mechanism actuator may include a biasing member configured to hold the suture mechanism actuator in at least one of a first suture mechanism actuator position or a second suture mechanism actuator position. The biasing member may be a spring.

[0068] In an alternative or additional aspect, the suturing mechanism may include a connecting member configured to pull a tensile member through tissue and having a first end and a second end, the first end being capable of engaging a first needle and the second end being capable of engaging 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 protrusion configured to clamp the barbed needle tip. The connecting member may include a plurality of notches configured to allow deformation of the connecting member. The notches may be spaced apart 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 a width, and the width of the notches may at least partially define the bending radius of the connecting member. The notches may have multiple widths, and the width of the notches may at least partially define multiple bending radii of the connecting member. The notches may be configured to allow deformation of the connecting member in a single plane. The connecting member may be configured to pass through the suturing mechanism in one direction. The connecting member may include at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

[0069] In some embodiments, the first needle may include a detachable needle tip coupled to a tensile member. The suturing device may include at least one of a guidewire lumen or a flushing lumen extending from a proximal portion of the suturing device to a distal portion. The suture knot may be configured to unfold when the guidewire is in an opening. The suturing device may include at least one locking protrusion configured to engage the suturing device with an introducer sheath as 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 tissue and to be withdrawn from the opening if at least a portion of the suturing device remains in the opening. The suturing device system may include a knot pusher configured to advance the suture knot along a tensile member.

[0070] A method is provided for applying a suture to close and seal an opening in tissue. The method includes guiding at least one needle through tissue adjacent to the opening, guiding a tensile member through tissue adjacent to the opening, guiding at least a portion of the at least one needle through a suture knot, untying the suture knot, and tightening the suture knot to close and seal the opening.

[0071] In some embodiments, the method may include guiding a tensile member through a suture knot. The method may include unfolding the suture knot from a knot recess. The method may include unfolding the suture knot from a cannula. The method may include guiding at least a portion of at least one needle through a cannula. The method may include guiding at least a portion of a tensile member through a cannula. The method may include unfolding the suture knot onto the tensile member. The suture knot may be pre-knotted. The method may include guiding at least a portion of a suture mechanism having a pivot element in insertion and removal orientations through an opening in the tissue, moving the pivot element of the suture mechanism to an unfolding orientation, returning the pivot element to the insertion and removal orientation, and withdrawing the suture mechanism from the opening.

[0072] In an alternative embodiment, the method may include guiding an introducer sheath into an opening in the tissue, guiding at least a portion of the suture mechanism through the introducer sheath, and withdrawing the introducer sheath from the opening while at least a portion of the suture mechanism remains in the opening. The method may include engaging the suture mechanism to a proximal end of the introducer sheath. The suture mechanism may include a connecting member having a first end and a second end. The suture mechanism may include a first needle and a second needle. The method may include engaging the first needle to a first end of the connecting member, engaging a second needle to a second end of the connecting member, retracting the first and second needles, and pulling a tensile member through the tissue using the connecting member. The method may include guiding a guidewire through the opening. The method may include untying a suture knot when the guidewire is in the opening. The method may include withdrawing the guidewire from the opening.

[0073] While the invention has been described by way of specific embodiments, and while these embodiments have been described in considerable detail, it is not intended to limit the scope of the appended claims or in any way to such details. The various features discussed herein may be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will be apparent to those skilled in the art. Therefore, the invention, in its broader aspects, is not limited to the specific details shown and described, representative devices and methods, and illustrative examples. Thus, deviations from these details may be made without departing from the scope or spirit of the overall inventive concept. Attached Figure Description

[0074] Figure 1 It is a perspective view of the illustrative suture device and the introductory sheath.

[0075] Figure 2 and Figure 3 yes Figure 1 A perspective view of an illustrative suture device.

[0076] Figure 4 yes Figures 1 to 3 An exploded diagram of the illustrative suturing device.

[0077] Figure 5A and Figure 5B yes Figures 1 to 3 A top view of a portion of the illustrative suture device.

[0078] Figure 6A , Figure 6C and Figure 6E yes Figures 1 to 3 A side view of the illustrative suture device, showing at least some of the external features of the handle.

[0079] Figure 6B , Figure 6D and Figure 6F yes Figures 1 to 3 A cross-sectional side view of the illustrative stitching device, showing at least some of the components of the handle.

[0080] Figure 7A , Figure 7B and Figure 7C yes Figures 1 to 3 A cross-sectional view of a portion of the handle of an illustrative suture device.

[0081] Figure 8A , Figure 8B and Figure 8C yes Figures 1 to 3 A perspective view of the suturing mechanism of an illustrative suturing device.

[0082] Figure 9A and Figure 9B yes Figures 1 to 3 A cross-sectional side view of the suturing mechanism of an illustrative suturing device.

[0083] Figure 10A and Figure 10B yes Figures 1 to 3 A perspective view of the suturing mechanism of an illustrative suturing device, in which a portion of the suturing mechanism is hidden.

[0084] Figure 11A This is a side view illustrating the connecting components.

[0085] Figure 11B yes Figure 11A An end view of the illustrative connecting component.

[0086] Figure 11C This is a side view of an alternative illustrative connecting component.

[0087] Figures 12A to 12M Step by step, it was shown Figures 1 to 3 Illustrative suturing devices, particularly the use of suturing mechanisms at the distal end of suturing devices within blood vessels.

[0088] Figure 12N It is a perspective view of the illustrative structural actuator.

[0089] Figure 13 and Figure 14 This is a perspective view of an alternative illustrative suture device.

[0090] Figure 15 yes Figure 13 and Figure 14 An exploded diagram of the illustrative suturing device.

[0091] Figure 16A , Figure 16C and Figure 16E yes Figure 13 and Figure 14 A side view of the illustrative suture device, showing at least some of the external features of the handle.

[0092] Figure 16B , Figure 16D and Figure 16F yes Figure 13 and Figure 14 A cross-sectional side view of the illustrative stitching device, showing at least some of the components of the handle.

[0093] Figure 17A , Figure 17B and Figure 17C yes Figure 13 and Figure 14 A cross-sectional view of a portion of the handle of an illustrative suture device.

[0094] Figure 18A and Figure 18B This is a perspective view of an alternative illustrative suture mechanism.

[0095] Figure 19A and 19B yes Figure 18A and Figure 18B A cross-sectional view illustrating the suture mechanism.

[0096] Figures 20A to 20M Step by step, it was shown Figure 18A and Figure 18B The illustrative suturing mechanism, and especially the use of suturing mechanisms within blood vessels.

[0097] Figure 21 and Figure 22 This is a perspective view of an alternative illustrative suture device.

[0098] Figure 23 yes Figure 21 and Figure 22 An exploded diagram of the illustrative suturing device.

[0099] Figure 23A yes Figure 21 and Figure 22 An exploded view of a portion of the handle of an illustrative suture device.

[0100] Figure 23B yes Figure 21 and Figure 22 An exploded view of the alternative part of the handle of the illustrative suture device.

[0101] Figure 24A , Figure 24D and Figure 24G yes Figure 21 and Figure 22 A side view of the illustrative suture device, showing at least some of the external features of the handle.

[0102] Figure 24B , Figure 24E and Figure 24H yes Figure 21 and Figure 22 A cross-sectional side view of the illustrative stitching device, showing at least some of the components of the handle.

[0103] Figure 24C , Figure 24F and Figure 24I yes Figure 21 and Figure 22 A cross-sectional top view of a portion of the handle of an illustrative sewing device, showing at least some of the components of the handle. Detailed Implementation

[0104] This disclosure generally relates to devices, systems, and methods for sealing puncture sites or other openings in blood vessels and other tissues. Specific examples of this disclosure include devices and / or systems that can directly access and percutaneously seal openings in the common carotid artery formed during direct access to the common carotid artery for neurovascular treatment. The devices disclosed herein typically allow for single-suture closure of blood vessels, such as the common carotid artery or another vessel, via a minimally invasive percutaneous approach. As used herein, the terms “vessel,” “artery,” “vein,” and similar forms of these terms refer to any component of the circulatory system that delivers blood throughout the body. The devices, systems, and methods described herein may also be used during other therapies or surgical procedures.

[0105] Figure 1 It is a perspective view of the illustrative suture device 100 and the insertion sheath 20, and Figure 2 and Figure 3This is a perspective view of an illustrative suture device 100. The suture device 100 includes an elongated shaft 110, a handle 130 coupled to a proximal portion 112 of the shaft 110, and a suture mechanism 200 coupled to a distal portion 114 of the shaft 110. As used herein, various embodiments of the suture device are described from the user's perspective; "proximal" may refer to a direction generally toward the user of the device, while "distal" may refer to a direction generally away from 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," "stitch," and similar forms of these terms refer to any flexible tensile member, regardless of its form or material, and suitable for access to tissue. As used herein, a "tensile member" may be a monofilament suture, a multifilament suture, a metallic suture, or any other suitable tensile member.

[0106] Figure 4 This is an exploded view of the sewing device 100, showing at least some of the components of the illustrative handle 130. Figure 5A and Figure 5B This is a top view of a part of the handle 130. Figure 6A , Figure 6C and Figure 6E This is a side view of the illustrative suture device 100, showing at least some of the external features of the handle 130. Figure 6B , Figure 6D and Figure 6F This is a cross-sectional side view of the sewing device 100, showing at least some of the components of the handle 130. Figure 7A , Figure 7B and Figure 7C This is a cross-sectional view of handle 130.

[0107] Reference Figure 2 , Figure 4 and Figure 6A The handle 130 includes an upper shell 130a, a lower shell 130b, a nose cone 130c, and a rear cover 130d. The lower shell 130b includes a gripping surface with finger-like recesses 132 configured to assist the user in gripping the handle 130. The upper shell 130a and lower shell 130b include finger-like protrusions 134 configured to assist the user in operating the suture device 100. A suture mechanism actuator 150 configured to operate the suture mechanism 200 is mounted in the handle 130. A needle actuator 170 is located proximal to the handle 130 and configured to deploy and retract suture needles 212, 214, see [link to details]. Figure 10A And described below. The distal end of the handle 130 includes an insert 136 with a locking protrusion 136a for engaging and connecting the suture device 100 to another device (such as, for example, an introducer sheath 20), see below. Figure 1The handle 130 includes markings 138a, 138b, 138c, and 138d, which may include letters, numbers, and / or symbols to assist and guide the user in operating various features of the suture 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. A shaft is connected to the distal end of the handle 130 and secured and sealed to the handle 130 by a shaft seal 142, see [link to shaft seal]. Figure 6B .

[0108] Reference Figure 2 , Figure 4 , Figure 6A and Figure 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 and 160. Other forms of biasing members may be used instead of springs 158 and 160. The actuator retainer 154 includes a suture mechanism actuator shaft 162 extending through a "J"-shaped slot 140, see [link to relevant documentation]. Figure 3 The "J"-shaped slot 140 guides the movement of the shaft 162, thereby causing the actuator retainer 154 to move. See [reference needed]. Figure 5A and Figure 5B When spring 158 is compressed between actuator retainer 154 and spring wall 144, the first stitching mechanism actuator spring 158 biases actuator retainer 154 in the distal direction. This distal bias of actuator spring 158 holds shaft 162, extending through the "J"-shaped slot 140, in place at either the first end 140a or the second end 140b of the "J"-shaped slot 140 until the user actuates selector knob 152. Actuator follower 156, located within actuator retainer 154, is biased in the proximal direction by second stitching mechanism actuator spring 160. A pair of guide rods 164a, 164b guide and prevent rotation of actuator follower 156 during proximal and distal movement. Although stitching mechanism actuator 150 is shown and described as manually actuated, it can be motorized, mechanically leveraged, or otherwise assisted.

[0109] Reference Figure 2 , Figure 4 , Figure 6E and Figure 6FThe needle actuator 170 includes a plunger 172, a plunger cap 174, a pawl 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 protrusions 178 on the pawl 176. The pawl protrusions 178 alternately engage a first pair of pawl recesses 190a, 190b and a second pair of pawl recesses 192a, 192b, which are connected by a third pair of pawl recesses 194a, 194b inside the handle 130, see [link to handle 130]. Figure 7A , 7B And 7C. The plunger 172 includes markings 188a, 188b, 188c to assist and guide the user in operating various features of the suture device 100. Guide rods 164a, 164b guide and prevent rotation of the plunger 172 as it moves in the proximal and distal directions. Although the needle actuator 170 is shown and described as manually actuated, the needle actuator 170 may be motorized, mechanically leveraged, or otherwise assisted.

[0110] Figure 8A , Figure 8B and Figure 8C This is a perspective view of the illustrative suture mechanism 200. Figure 9A and Figure 9B This is a cross-sectional side view of the sewing mechanism 200, and Figure 10A and Figure 10B This is a perspective view of the suture mechanism 200 with a portion of it concealed. The suture mechanism 200 includes a needle guide 210 and a pivot element 230. The needle guide 210 includes two needles 212, 214, which are integrally formed with or fixedly connected to corresponding threads 216, 218, see [reference needed]. Figure 7A and Figure 7B Needle 212 is a two-piece needle including a barbed needle tip 212a, which can be detached from needle body 212b by, for example, friction fit or adhesive. Needle 214 has an integral (i.e., fixed) barbed needle tip 214a. The term "integral" here encompasses both the integral construction and the construction in which the needle tip 214a is fixedly (i.e., not "removably") attached to the rest of the integral needle 214. Wires 216, 218 can be, for example, solid wire members or hollow (e.g., a hypo tube). Wires 216, 218 are attached to needle follower 180 of needle actuator 170, see [link to details]. Figure 7B The needle guide 210 also includes a guidewire lumen 220, which is connected to the guidewire lumen 116a of the shaft 110, see [link to documentation]. Figure 10A The guidewire lumen 116a is connected to the guidewire port 148 in the handle 130, see [link / reference]. Figure 2The shaft 110 can be a multi-lumen flexible or rigid member, wherein the central lumen 116b carries the actuator wire 234, two of the lumens 116c and 116d respectively carry needles 212 and 214, and a fifth lumen 116e can be used for guidewire, for flushing, and / or as a blood port. When used as a blood port, lumen 116e can provide the user with an indication that the distal end of the suture 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 can be an integral part of the shaft 110.

[0111] Pivoting element 230 is secured to the distal end of needle guide 210 via pivot 232. Pivoting 232 allows pivot element 230 to... Figure 8A , Figure 8B and Figure 9A The insertion and removal orientations shown are consistent with Figure 8C and Figure 9B The pivoting orientations shown are pivoting. Insertion and removal orientations typically align the pivoting element 230 with the needle guide 210 and shaft 110. For example, the insertion and removal orientation allows the pivoting element 230 to be inserted into and removed from a blood vessel. The deployment orientation orients the pivoting element 230 at an angle to the longitudinal axes of the needle guide 210 and shaft 110. In some embodiments, the deployment orientation orients the pivoting element 230 at an angle generally or almost perpendicular to the longitudinal axes of the needle guide 210 and shaft 110. In other embodiments, the angle between the deployed pivoting element 230 and the longitudinal axes of the needle guide 210 and shaft 110 can be between 30 degrees and 90 degrees. For example, the deployment orientation of the pivoting element 230 facilitates suturing from within a blood vessel.

[0112] Reference Figure 6B , Figure 9A and Figure 9B In this illustrative embodiment, the suture mechanism actuator 150 is coupled to the pivot element 230 via an actuator wire 234. The actuator wire 234 is coupled to the actuator follower 156 of the suture mechanism actuator 150. The actuator wire 234 includes a retainer 236 that engages 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 recess 240 configured such that when the pivot element 230 is in a position as described above... Figure 9AThe actuator line 234 is accommodated in the insertion and removal orientation shown. The distal end of the actuator line 234 includes a forming angle 242. For example, the actuator line 234 may be heat-set to create the forming angle 242. The forming angle 242 acts as a biasing member to keep the pivot element 230 longitudinally aligned with the longitudinal axis of the shaft 110 for insertion and removal of the stitching mechanism 200. The pivot element 230 includes a channel 244 in which a flexible connecting member 270 is accommodated. The pivot element 230 also includes a through hole 246 for securing the flexible connecting member 270. During the assembly of the flexible connecting member 270 to the pivot element 230, an adhesive such as epoxy resin is injected into the hole 246, thereby securing the flexible connecting member 270 to the pivot element 230. The flexible connecting member 270 may also be secured to the pivot element 230 by other means, such as a frictional engagement between the flexible connecting member 270 and the channel 244.

[0113] When the user moves the selector knob 152, the "J"-shaped slot 140 restricts and guides the movement of the sewing mechanism actuator shaft 162, thereby restricting and guiding the movement of the actuator retainer 154, see [link to relevant documentation]. Figure 5A , Figure 5B and Figure 6B The actuator retainer 154 is movable relative to the handle 130 in both proximal and distal directions and rotates about the central axis of the handle 130 by moving the selector knob 152. Generally, moving the selector knob 152 in the proximal direction moves the actuator follower 156 in the proximal direction, which tightens the actuator line 234, thereby moving the pivot element 230 to the deployment orientation. Figure 6B As shown. Generally, moving the selector knob 152 in the distal direction moves the actuator follower 156 in the distal direction, which reduces tension and / or compresses the actuator wire 234, thereby moving the pivot element 230 to the insertion and removal orientation. Figure 6A As shown. When the suture mechanism actuator 150 is in the first position, the suture mechanism actuator shaft 162 is located in the first end 140a of the "J"-shaped slot 140, as... Figure 5A As shown, the pivot element 230 of the suture mechanism 200 is positioned as follows: Figure 9A The insertion and removal orientations are shown. When the suture mechanism actuator 150 is in the second position, the suture mechanism actuator shaft 162 is located in the second end 140b of the "J"-shaped slot 140, as shown. Figure 5B As shown, the pivot element 230 is in the position as Figure 9B The unfolding orientation is shown.

[0114] Reference Figure 8A , Figure 8B , Figure 8C , Figure 9A and Figure 9BIn this illustrative embodiment, the needle guide 210 includes a tensile member 250 in a tensile member groove 252, which is wound around the needle guide 210 from the first needle 212 side to the second needle 214 side. One end of the tensile member 250 is coupled to the needle tip 212a. The needle guide 210 also includes a knot recess 254 for receiving a suture knot 264. The knot recess 254 is a cavity in the needle guide large enough to accommodate the suture knot 264. A loop 256 is wound around the proximal end of the needle guide 210, connecting the needle guide 210 to the shaft 110. The loop 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 unwound. The knot 264 can be any desired form of knot suitable for tying the thread, such as a slip knot, which will slide automatically along the tensile member 250 and tighten as one end of the tensile member 250 is pulled. One suitable knot for use in this case is the "Tennessee slip" knot.

[0115] As described herein, the length of the tensile member 250 is the measured distance from the last loop or coil of the suture knot 264 to the end of the tensile member 250 connected to the needle tip 212a. The length of the tensile member 250 determines the unfolding 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 unfolds from the patient's percutaneous exit site. A short tensile member length means that the suture knot 264 is released very close to the patient's percutaneous exit site. A long tensile member length means that the suture knot 264 is further released from the patient's percutaneous exit site. The tensile member length can be from 1.0'' to 10.0''.

[0116] Figure 11A This is a side view of the illustrative connecting member 270 and Figure 11B This is an end view of the connecting member 270. The connecting member 270 has a first end portion 272 and a second end portion 274. The first end portion 272 and the second end portion 274 include internal protrusions 276 and 278 configured to clamp the needle tips 212a and 214a respectively, thereby connecting the needle tips 212a and 214a to the connecting member 270. See [link to documentation]. Figure 12E and 12F The connecting member 270 is configured to pull the tensile member 250 through the tissue during suturing to close an opening in the vessel wall described herein. The connecting member 270 may also have an external protrusion 280 configured such that the connecting member 270 can only move in one direction indicated by arrow 282 within the channel 244 of the pivot element 230, see [link to relevant documentation]. Figure 9BThe protrusion 280 may be fixed or movable to allow the connecting member 270 to move unidirectionally in the channel 244 and to prevent the connecting member 270 from exiting the channel 244.

[0117] In this illustrative embodiment, the connecting member 270 includes a plurality of opposing notches 284 configured to allow the connecting member 270 to bend or deform in a single plane. Limiting the deformation of the connecting member 270 to a single plane improves the control of the connecting member 270. Unlike, for example, a helical winding member, positioning the notches 284 on opposite sides of the central axis of the connecting member 270 allows the connecting member 270 to deform without elongating. The notches 284 are spaced apart along the length of the connecting member 270, and the spacing of the notches at least partially defines the bending radius of the connecting member 270. Varying the spacing of the notches 284 along the length of the connecting member 270 will produce a plurality of bending radii. The notches 284 have widths 286a, 286b, and the widths 286a, 286b of the notches 284 at least partially define the bending radius of the connecting member 270. The notches 284 may have multiple widths 286a, 286b, thereby producing multiple bending radii. Alternatively, the notch 284 along the length of the connecting member 270 can be patterned in a spiral manner with multiple pitch distances.

[0118] Figure 11C This is a side view of the alternative illustrative connecting member 270'. Generally, in various other exemplary embodiments according to this disclosure, the connecting member 270' is similar in construction and operation to the connecting member 270 described above, and the connecting member 270' may replace other connecting members, or may use any features of the connecting member 270'. Similar reference numerals refer to similar parts. For brevity, the following description minimizes redundant description and focuses on the differences between the connecting member 270 and the connecting member 270'. In this illustrative embodiment, the connecting member 270' includes a plurality of opposing recesses 284' configured to allow the connecting member 270' to bend or deform in a single plane. The recesses 284' are equally spaced along the length of the connecting member 270', and the spacing of the recesses at least partially defines the bending radius of the connecting member 270'. The recesses 284' have a uniform width 286', and the width 286' of the recesses 284' at least partially defines the bending radius of the connecting member 270'.

[0119] Figures 12A to 12M The use of the suturing device 100, and particularly the suturing mechanism 200 within the distal portion and within the blood vessel 60 (such as the common carotid artery), is illustrated step by step for closing the puncture site or opening 62 in the vessel wall 60a of the blood vessel 60. The opening 62 may be a vascular access site for medical procedures. Figure 12N This is a perspective view of the illustrative junction actuator 300.

[0120] During surgical preparation, guidewire 30, such as, for example, a 0.018'' OD guidewire, is inserted through guidewire port 148 in handle 130 and exited through guidewire lumen 220 in suture mechanism 200, see [link to suture mechanism 200]. Figure 2 and Figure 8A Alternatively, the guidewire 30 can be inserted through the guidewire lumen 220 in the suture mechanism 200 and exited through the guidewire port 148 in the handle 130. The guidewire 30 and the suture 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 [link to relevant documentation]. Figure 1 The guidewire 30 guides the introducer sheath 20 through the opening 62 in the blood vessel 60. The suture mechanism 200 can be guided above the guidewire 30 by inserting the guidewire 30 into the guidewire lumen 220 and withdrawing it through the guidewire port 148 in the handle 130, see [link to suture mechanism 200]. Figure 2 and Figure 8A .

[0121] The suture device 100 advances until the mark 118 on the shaft 110 is aligned with the proximal end 22 of the introducer sheath 20, see [reference]. Figure 1 and Figure 2 When the mark 118 on the shaft 110 is aligned with the proximal end 22 of the introducer sheath 20, the suture mechanism 200 is completely within the introducer sheath 20. The suture mechanism 200 and the shaft 110 remain fixed relative to the blood vessel 60, and the introducer sheath 20 is pulled proximally past the suture mechanism 200 and the shaft 110 until the locking protrusion 136a engages the proximal end 22 of the introducer sheath 20, see [link to relevant documentation]. Figure 1 and Figure 2 This corresponds to mark 138a, which is “1” in this illustrative example, indicating step 1 to the user. Locking protrusion 136a secures the suture device 100 to the introducer sheath 20, wherein the suture mechanism 200 extends through the distal end 24 of the introducer sheath 20 and into the blood vessel 60, see [link to relevant documentation]. Figure 12A The locking protrusion 136a is attached to the distal end 22 of the introducer sheath 20, ensuring that the suture mechanism 200 extends past the distal end 24 of the introducer sheath 20. The introducer sheath 20 is withdrawn from the opening 62 in the vessel 60 while the suture mechanism 200 remains inside the vessel 60, thereby allowing for internal replacement of the suture device 100 and the introducer sheath 20. This will suppress (eliminate or at least significantly reduce) blood loss typically experienced during typical device replacement due to, for example, hypertension found in the common carotid artery. The introducer sheath 20 maintains a circumferential relationship with the axis 110 for the remainder of the procedure.

[0122] Alternatively, for example as part of the procedure, the distal end 24 of the introducer sheath 20 may be positioned within the blood vessel 60. 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 and its longitudinal extension parallel and aligned with the longitudinal axes 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 suture device 100 has been inserted into the introducer sheath 20. The suture device 100 advances until the locking protrusion 136a engages the proximal end 22 of the introducer sheath 20, see [link to relevant documentation]. Figure 1 As described above, the locking protrusion 136a secures the suture device 100 to the introducer sheath 20, wherein the suture mechanism 200 extends through the distal end of the introducer sheath 20.

[0123] The arrow and the "2" marked 138b indicate step 2 to the user. With the distal end of the needle guide 210 inside the blood vessel 60, the selector knob 152 moves in the first direction indicated by the arrow and the "2" marked 138b, see [link to relevant documentation]. Figure 5B Move shaft 162 from the first end 140a of the "J"-shaped slot 140 to the second end 140b, see [reference]. Figure 5A and Figure 5B This causes the pivot element 230 to pivot or rotate from the insertion and removal orientation to the unfolding orientation, see [link to relevant documentation]. Figure 12B The J-shaped slot 140 helps guide the movement of the selector knob 152. Moving the selector knob 152 causes the actuator retainer 154 and the actuator follower 156 to move against the bias provided by the springs 158 and 160, see [reference needed]. Figure 6B The selector knob 152 also rotates the actuator retainer 154 in the first direction. The bias of the spring 158 holds the actuator retainer 154 in the proper position within the "J"-shaped slot 140. The pivot element 230 can be rotated to the unfolding orientation before the inserter sheath 20 is withdrawn from the opening 62 in the vessel 60, see [link to relevant documentation]. Figure 12B Or, after withdrawing the insertion sheath 20 from the opening 62 in the blood vessel 60, see Figure 12C Then, by slightly pulling the suture device 100 proximally and thus pulling the needle guide 210, the pivot element 230 is pulled proximally against the interior of the vessel wall 60a, as... Figure 12D As shown. The deployment orientation of the pivot element 230 ensures that the pivot element 230 remains inside the blood vessel 60.

[0124] The next step is indicated to the user by the "3" marked 138c, see [link / reference]. Figure 2 When the pivot element 230 is in the unfolded orientation, the plunger cap 174 is pushed in the distal direction indicated by arrow 188b, thereby actuating the plunger 172, pawl 176, and needle follower 180 of the needle actuator 170 (see...). Figure 6A and 6C and resists the bias provided by spring 182 (see) Figure 6B and Figure 6D ), suture needles 212 and 214 spread or move in the distal direction, see Figure 12E The needle follower 180 moves the suture needles 212, 214 distally toward the connecting member 270 attached to the pivot element 230. The needle tip 212a pulls the tensile member 250 distally and out of the tensile member groove 252, and then engages and connects with the first end 272 of the connecting member 270, see [link to details]. Figure 12F The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0125] When the needle actuator 170 moves in the distal direction, the angled guide 186 of the plunger 172 engages the protrusion 178 of the pawl 176, see Figure 4 The plunger 172 moves the pawl 176 in a distal direction, wherein the pawl protrusion 178 in the first pair of pawl grooves 190a, 190b inside the handle 130 guides the pawl 176, see [reference]. Figure 7B When the pawl protrusion 178 reaches the distal end of the first pair of pawl grooves 190a, 190b, the angled guide 186 causes the pawl 176 to rotate within the pawl grooves 194a, 194b, see [reference]. Figure 7A And the pawl protrusion 178 engages with the second pair of pawl grooves 192a, 192b inside the handle 130, see [reference]. Figure 7C .

[0126] Release the plunger cap 174, and thereby release the plunger 172, allowing the spring 182 to be biased so that the needle follower 180 and the pawl 176 can move in the proximal direction, see [link to previous section]. Figure 6E and Figure 6F This action pulls the suture needles 212 and 214 in the proximal direction, see [reference needed]. Figure 12G The suture needle 214 pulls the connecting member 270 through the channel 244 of the pivot element 230 and through the vessel wall 60a. Pulling or pushing the flexible connecting member 270 overcomes the bonding force or frictional fit of the adhesive securing the flexible connecting member 270 to the pivot element 230. When the connecting member 270 is pulled by the suture needle 214, the needle tip 212a separates from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270 and pulls the tensile member 250 through the vessel wall 60a. The suture needle 214 pulls the connecting member 270, the needle tip 212a, and the tensile member 250 through the suture knot 264, see [link to suture knot]. Figure 12H and Figure 12IAs the pawl 176 moves in the proximal direction, a second pair of pawl grooves 192a, 192b inside the handle 130 guides the pawl protrusion 178. The second pair of pawl grooves 192a, 192b allows the plunger 172 to extend further from the proximal end of the handle 130, see [link to previous section]. Figure 6E This reveals the check mark “√” 188c, which retracts towards the user indicator pins 212, 214.

[0127] Step 4 is indicated to the user by an arrow and the "4" marked 138d. Next, the pivot element 230 moves distally away from the interior of the vessel wall 60a and then rotates from the unfolding orientation to the insertion and removal orientation, see [link to relevant documentation]. Figure 12H Rotation of pivot element 230 is achieved by moving selector knob 152 in the second direction indicated by the arrow and the "4" marked 138d (see...). Figure 5A ), moving shaft 162 from the position at the second end 140b of the "J"-shaped slot 140 to the first end 140a (see Figure 5A and Figure 5B This is achieved by moving the selector knob 152, which moves the actuator retainer 154 and the actuator follower 156 against the bias provided by the springs 158 and 160. The selector knob 152 also rotates the actuator retainer 154 in a second direction. The bias of the spring 158 holds the actuator retainer 154 in the proper position in the "J"-shaped slot 140. With the pivot element 230 in the insertion and removal orientation, the suture device 100 is pulled in the proximal direction, thereby removing the suture mechanism 200 from the blood vessel 60 and releasing the suture knot 264 from the knot recess 254, see [link to relevant documentation]. Figure 12I When the suture mechanism 200 is pulled proximally, the suture knot 264 slides along the tensile member 250 toward the opening 62 in the blood vessel 60. When the suture mechanism 200 is pulled proximally, the suture knot 264 is tightened against the outside of the blood vessel 60, see [link to suture mechanism 200]. Figure 12J and 12K The guidewire 30 is brought close to or closes the opening 62. The guidewire 30 remains in the opening 62 while the suture knot 264 is pulled taut against the outside of the blood vessel 60, and the guidewire 30 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. (See reference...) Figure 12L and Figure 12N A knot pusher 300, including a handle 302, an elongated shaft 304, and a ring or loop 306, can be used to push the suture knot 264 toward the opening 62. Finally, the end of the tensile member 250 on the outside of the suture knot 264 is cut off, leaving the opening 62 securely closed and sealed, as... Figure 12MAs shown. The guidewire 30 acts as a safety device during the procedure, and the advantage of this method is that the user will not lose access to the vascular access site or opening 62 if the tensile member 250 and suture knot 264 do not seal the opening 62. If the tensile member 250 and suture knot 264 do not seal the opening 62, the introducer sheath 20 can be reinserted onto the guidewire 30 and through the opening 62. The suture device 100 can be reinserted into the introducer sheath 20 to unfold the second tensile member 250 and suture knot 264 to close and seal the opening 62, as described above.

[0128] Figure 13 and Figure 14 This is a perspective view of the alternative illustrative suture device 100'. Figure 15 This is an exploded view of the suture device 100'. Generally, the suture device 100' is similar in construction and operation to the suture device 100 described above, and in various other exemplary embodiments according to this disclosure, the suture device 100' may replace other suture devices, or any feature of the suture device 100' may be used. Similar reference numerals refer to similar parts. For the sake of brevity, the following description minimizes redundant description and focuses on the differences between the suture device 100 and the suture device 100'.

[0129] The suture device 100' includes an elongated shaft 110, a handle 130' connected to a proximal portion 112 of the shaft 110, and a suture mechanism 200 connected to a distal portion 114 of the shaft 110. The difference between the suture device 100' and the suture device 100 is substantially limited to the handle 130' and the needle actuator 170', as described in detail below.

[0130] Figure 15 At least some of the components of the illustrative handle 130' are shown. Figure 16A , Figure 16C and Figure 16E This is a side view of the illustrative suture device 100', showing at least some of the external features of the handle 130'. Figure 16B , Figure 16D and Figure 16F This is a cross-sectional side view of the sewing device 100', showing at least some of the components of the handle 130'. Figure 17A , Figure 17B and Figure 17C This is a cross-sectional view of handle 130'.

[0131] Reference Figure 13 , Figure 15 and Figure 16AThe handle 130' includes an upper shell 130a', a lower shell 130b', a nose cone 130c, and a rear cover 130d. A suture mechanism actuator 150, configured to operate the suture mechanism 200, is mounted in the handle 130'. A needle actuator 170' is located at the proximal end of the handle 130' and is configured to deploy and retract suture needles 212, 214, see [link to documentation]. Figure 9A .

[0132] The needle actuator 170' includes a plunger 172', a plunger cap 174, a pair of magnetic latches 176', a spring 182', and a retainer 184. Other forms of biasing members may be used instead of the spring 182'. The latches 176' are movably mounted in a pair of recesses 186' within the plunger 172'. The latches 176' alternately engage a pair of latch recesses 190a', 190b' and a pair of latch recesses 192a', 192b' that connect to the latch recesses 190a', 190b' inside the handle 130', see [link to details]. Figure 17A , Figure 17B and Figure 17C The plunger 172' includes markings 188a, 188b, and 188c to assist and guide the user in operating the suture device 100'. Although the needle actuator 170' is shown and described as manually actuated, it can be motorized, mechanically leveraged, or otherwise assisted. Lines 216 and 218 are coupled to the distal end 180' of the plunger 172', see [link to details]. Figure 17A .

[0133] Similar to the suture device 100 described above, Figures 12A to 12M The suturing device 100' is shown step by step, and particularly the distal end and suturing mechanism 200 are used within the blood vessel 60. (See reference...) Figure 12E With the pivot element 230 in the deployed orientation, the plunger cap 174 is pushed in the distal direction indicated by arrow 188b, thereby actuating the plunger 172' of the needle actuator 170' (see...). Figure 16A and Figure 16C and resists the bias provided by spring 182' (see Figure 16B and Figure 16D The suture needles 212 and 214 extend or move in the distal direction. The plunger 172' moves the suture needles 212 and 214 distally toward the connecting member 270 attached to the pivot element 230. The needle tip 212a pulls the tensile member 250 distally and out of the tensile member groove 252, and then engages and connects with the first end 272 of the connecting member 270, see [link to relevant documentation]. Figure 12F The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0134] When the needle actuator 170' moves in the distal direction, see Figure 16E and Figure 16F The magnetic latch 176' moves in the distal direction within the latching grooves 190a' and 190b' inside the handle 130', see [reference]. Figure 17A , Figure 17B and Figure 17C When the magnetic latch 176' reaches the distal end of the latch recesses 190a' and 190b', the magnetic latch 176' is attracted to the ferromagnetic element 196'. The ferromagnetic element pulls the magnetic latch 176' out of the recess 186' in the plunger 172' and into the latch recesses 192a' and 192b' in the handle 130'. When the magnetic latch 176' is in the latch recesses 192a' and 192b' in the handle 130', the plunger 172' moves freely in the proximal direction. Some embodiments may have a single magnetic latch 176' and ferromagnetic element 196', while other embodiments may have multiple magnetic latches 176' and ferromagnetic elements 196'.

[0135] Release the plunger cap 174, thereby releasing the plunger 172', allowing the spring 182' to be biased so that the plunger 172' moves in the proximal direction, see [link to previous section]. Figure 16E and 16F This action pulls the suture needles 212 and 214 in the proximal direction, see [reference needed]. Figure 12G As described above, the suture needle 214 pulls the connecting member 270 through the channel 244 of the pivot element 230 and through the blood vessel wall 60a. When the connecting member 270 is pulled by the suture needle 214, the needle tip 212a separates from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270 and pulls the tensile member 250 through the blood vessel wall 60a.

[0136] Figure 18A and Figure 18B This is a perspective view of the alternative illustrative suture mechanism 200'. Figure 19A and Figure 19B This is a cross-sectional view of the stitching mechanism 200'. Generally, the stitching mechanism 200' is similar in construction and operation to the stitching mechanism 200 described above, and in various other exemplary embodiments according to this disclosure, the stitching mechanism 200' may replace other stitching mechanisms, or any features of the stitching mechanism 200' may be used. Similar reference numerals refer to similar parts. For the sake of brevity, the following description minimizes redundant description and focuses on the differences between the stitching mechanism 200 and the stitching mechanism 200'.

[0137] In this illustrative embodiment, the suture mechanism 200' includes a needle guide 210' coupled to the distal 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 tensile member 250 is wound around the needle guide 210' in a tensile member groove 252' from the first needle 212 side to the second needle 214 side. 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 in the knot recess 254' until the suture knot 264 needs to be unwound. The slot 260' is configured to hold any portion of the free end 262 or the tensile member 250. The free end 262 of the tensile member 250 may extend 0.13'' to 1.00'' from the suture knot 264.

[0138] Figures 20A to 20M The use of the suturing mechanism 200' within a blood vessel 60 (such as the common carotid artery) is illustrated step by step, for closing a puncture or opening 62 in the vessel wall 60a of the blood vessel 60. The opening 62 may be a vascular access site for medical procedures.

[0139] During surgical preparation, guidewire 30, such as a 0.018'' OD guidewire, is inserted through guidewire port 148 in handle 130 and exits through guidewire lumen 220 in suture mechanism 200', see [link to suture mechanism 200]. Figure 2 and Figure 8A Alternatively, the guidewire 30 can be inserted through the guidewire lumen 220 in the suture mechanism 200' and withdrawn through the guidewire port 148 in the handle 130. The guidewire 30 and the suture 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 [link to relevant documentation]. Figure 1 Guide the introducer sheath 20 through the opening 62 in the blood vessel 60 using the guidewire 30.

[0140] After the distal end 24 of the introducer sheath 20 is inside the blood vessel 60, the suture mechanism 200' and shaft 110 remain fixed relative to the blood vessel 60, and the introducer sheath 20 is pulled proximally past the suture mechanism 200' and shaft 110 until the locking protrusion 136a engages the proximal end 22 of the introducer sheath 20. See [link to relevant documentation]. Figure 1 and Figure 2 Furthermore, the suture mechanism 200' extends through the distal end 24 of the introducer sheath 20 and enters the blood vessel 60, see [reference]. Figure 20A .

[0141] With the suture mechanism 200' inside the blood vessel 60, the pivot element 230 is oriented from insertion and removal (see [reference]). Figure 19APivot or rotate to unfolding orientation (see...) Figure 19B Before the sheath 20 is withdrawn from the opening 62 in the vessel 60, the pivot element 230 can be rotated to the unfolding orientation, see [link to relevant documentation]. Figure 20B Or, after withdrawing the insertion sheath 20 from the opening 62 in the blood vessel 60, see Figure 20C Then the pivot element 230 is pulled proximally against the interior of the vessel wall 60a, as... Figure 20D As shown.

[0142] When the pivot element 230 is in the unfolded orientation, the suture needles 212 and 214 unfold or move in the distal direction. See Figure 20E The needle tip 212a pulls the tensile member 250 distally and out of the tensile member groove 252', and then engages and connects with the first end 272 of the connecting member 270, see [link to details]. Figure 20F The needle tip 214a engages and connects with the second end 274 of the connecting member 270. The suture needles 212 and 214 are pulled in the proximal direction, see [reference needed]. Figure 20G The suture needle 214 pulls the connecting member 270 through the channel 244 of the pivot element 230 and through the vessel wall 60a. When the connecting member 270 is pulled by the suture needle 214, the needle tip 212a separates from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270 and pulls the tensile member 250 through the vessel wall 60a. The suture needle 214 pulls the connecting member 270, the needle tip 212a, and the tensile member 250 through the suture knot sleeve 258', see [reference needed]. Figure 20I .

[0143] The pivot element 230 moves distally from the interior of the vessel wall 60a and then rotates from the unfolding orientation to the insertion and removal orientation, see [link to relevant documentation]. Figure 20H With the pivot element 230 in the insertion and removal orientation, the suture mechanism 200' is pulled in the proximal direction, thereby removing the suture mechanism 200' from the blood vessel 60 and releasing the suture knot 264 from the knot sleeve 258' and the knot recess 254', see [link to previous section]. Figure 20I When the suture mechanism 200' is pulled in the proximal direction, the suture knot 264 slides along the tensile member 250 toward the opening 62 in the blood vessel 60. When the suture mechanism 200' is pulled proximally, the suture knot 264 is tightened against the outer side of the blood vessel 60, see [link to relevant documentation]. Figure 20J and Figure 20K The guidewire 30 is brought close to or closes the opening 62. The guidewire 30 remains in the opening 62 while the suture knot 264 is pulled taut against the outside of the blood vessel 60, and the guidewire 30 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. (See reference...) Figure 20L and Figure 12NA knot pusher 300, including a handle 302, an elongated shaft 304, and a ring or loop 306, can be used to push the suture knot 264 toward the opening 62. Finally, the end of the tensile member 250 on the outside of the suture knot 264 is cut off, leaving the opening 62 securely closed and sealed, as... Figure 20M As shown. The guidewire 30 acts as a safety device during the procedure, and the advantage of this method is that the user will not lose access to the vascular access site or opening 62 if the tensile member 250 and suture knot 264 do not seal the opening 62. If the tensile member 250 and suture knot 264 do not seal the opening 62, the introducer sheath 20 can be reinserted onto the guidewire 30 and through the opening 62. The suture device 100 can be reinserted into the introducer sheath 20 to unfold the second tensile member 250 and suture knot 264 to close and seal the opening 62, as described above.

[0144] Figure 21 and Figure 22 This is a perspective view of the alternative illustrative suture device 100''. Figure 23 This is an exploded view of the suture device 100''. Generally, the suture device 100'' is similar in construction and operation to the suture devices 100 and 100' described above, and in various other exemplary embodiments according to this disclosure, the suture device 100' may replace other suture devices, or any feature of the suture device 100' may be used. Similar reference numerals refer to similar parts. For the sake of brevity, the following description minimizes redundant description and focuses on the differences between the suture devices 100 and 100'' and the suture device 100'.

[0145] The suture device 100'' includes an elongated shaft 110, a handle 130'' connected to a proximal portion 112 of the shaft 110, and a suture mechanism 200 connected to a distal portion 114 of the shaft 110. The difference between the suture device 100'' and the suture devices 100 and 100' is substantially limited to the handle 130'' and the needle actuator 170'', as described in detail below.

[0146] Figure 23 It is an exploded view of the sewing device 100'' and shows at least some of the components of the illustrative handle 130''. Figure 23A This is an exploded view of a portion of the handle 130'' of the suture device 100''. Figure 24A , Figure 24D and Figure 24G This is a side view of the illustrative suture device 100'', showing at least some of the external features of the handle 130''. Figure 24B , Figure 24E and Figure 24H This is a cross-sectional side view of the sewing device 100'', showing at least some of the components of the handle 130''. Figure 24C , Figure 24F and Figure 24I This is a cross-sectional top view of a portion of the handle 130'' of the sewing device 100'', showing at least some of the components of the handle 130''.

[0147] Reference Figure 21 , Figure 23 and Figure 23A The handle 130'' includes an upper shell 130a'', a lower shell 130b'', a nose cone 130c, and a rear cover 130d''. A suture mechanism actuator 150, configured to operate the suture mechanism 200, is mounted in the handle 130''. A needle actuator 170'' is located at the proximal end of the handle 130'' and is configured to deploy and retract suture needles 212, 214, see [reference needed]. Figure 9A .

[0148] The needle actuator 170'' includes a plunger 172'', a plunger cap 174, one or more magnetic latches 176'', a spring 182'', and a linear retainer 184''. Other forms of biasing members may be used instead of the spring 182''. The latches 176'' are movably mounted in a pair of recesses 186'' of the plunger 172''. The latches 176'' alternately engage a pair of latch recesses 190a'', 190b'' and one or more latch recesses 192a', 192b' connected to one or more latch recesses 190a', 190b' inside the linear retainer 184'', see [link to documentation]. Figure 24C , Figure 24F and Figure 24I The plunger 172'' includes markings 188a, 188b, and 188c to assist and guide the user in operating the suture device 100''. Although the needle actuator 170'' is shown and described as manually actuated, the needle actuator 170'' can be motorized, mechanically leveraged, or otherwise assisted. Wires 216 and 218 are coupled to the distal end 180'' of the plunger 172''.

[0149] Similar to the suture device 100 described above, Figures 12A to 12M The suturing device 100'' is shown step by step, and in particular the use of the distal end within the blood vessel 60 and the suturing mechanism 200. (See reference...) Figure 12E With the pivot element 230 in the unfolded orientation, the plunger cap 174 is pushed in the distal direction indicated by arrow 188b, thereby actuating the plunger 172'' of the needle actuator 170'' (see...). Figure 24A and Figure 24D and resists the bias provided by spring 182'' (see) Figure 24B and Figure 24CThe suture needles 212 and 214 extend or move in the distal direction. The plunger 172'' moves the suture needles 212 and 214 distally toward the connecting member 270 attached to the pivot element 230. The needle tip 212a pulls the tensile member 250 distally and out of the tensile member groove 252, and then engages and connects with the first end 272 of the connecting member 270, see [link to relevant documentation]. Figure 12F The needle tip 214a engages and connects with the second end 274 of the connecting member 270.

[0150] When the needle actuator 170'' moves in the distal direction, the magnetic latch 176'' moves in the distal direction within the latching grooves 190a'' and 190b'' inside the linear retainer 184''. See Figure 24B and Figure 24C When the magnetic latch 176' reaches the far end of the latch recesses 190a' and 190b', the magnetic latch 176' is attracted to the ferromagnetic element 196''. The ferromagnetic element pulls the magnetic latch 176'' out of the recess 186'' in the plunger 172'' and into the latch recesses 192a'' and 192b'' in the linear retainer 184''. See [link / reference] Figure 24D , Figure 24E and Figure 24F When the magnetic latch 176'' is in the latch recesses 192a'' and 192b'' in the linear retainer 184'', the plunger 172'' moves freely in the proximal direction. Some embodiments may have a single magnetic latch 176'' and ferromagnetic element 196'', while other embodiments may have multiple magnetic latches 176'' and ferromagnetic elements 196'', see [link to relevant documentation]. Figure 23B .

[0151] Release plunger cap 174, thereby releasing plunger 172'', allowing the bias of spring 182'' to move plunger 172'' in the proximal direction, see [link to relevant documentation]. Figure 24G , 24H And 24I. This action pulls the suture needles 212 and 214 in the proximal direction, see 24I. Figure 12G As described above, the suture needle 214 pulls the connecting member 270 through the channel 244 of the pivot element 230 and through the blood vessel wall 60a. When the connecting member 270 is pulled by the suture needle 214, the needle tip 212a separates from the needle body 212b of the suture needle 212. The needle tip 212a is pulled by the connecting member 270 and pulls the tensile member 250 through the blood vessel wall 60a.

[0152] While the invention has been described by way of specific embodiments, and while these embodiments have been described in considerable detail, it is not intended to limit the scope of the appended claims or in any way to such details. The various features discussed herein may be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will be apparent to those skilled in the art. Therefore, the invention, in its broader aspects, is not limited to the specific details shown and described, representative devices and methods, and illustrative examples. Thus, deviations from these details may be made without departing from the scope or spirit of the overall inventive concept.

Claims

1. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; as well as Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, and A suture knot recess is 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 to guide the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The suture structure therein causes the suture to extend from the suture knot recess and along the tensile member, and is pulled tight to close and seal the opening.

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

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

4. The suturing device according to claim 1, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

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

6. The suturing apparatus of claim 1, wherein the needle guide further comprises a tensile member groove configured to receive the tensile member; The tensile member is configured to unfold from the groove of the tensile member when at least one of the first needle or the second needle is guided through the tissue.

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

8. The suturing apparatus according to claim 1, wherein the suture knot is a slip knot.

9. The suturing apparatus of claim 1, wherein the suture knot is a "Tennessee slip" knot.

10. The suturing device according to claim 1, further comprising: The handle is located at the proximal portion of the suture device; An elongated shaft connecting the handle and the needle guide; as well as A needle actuator located on the handle, the needle actuator being coupled to at least one of the first needle or the second needle, and configured to guide at least one of the first needle or the second needle through the tissue when the needle actuator is activated.

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

12. The suturing apparatus of claim 11, wherein the needle actuator biasing member is a spring.

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

14. The suturing apparatus of claim 13, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 14, wherein the needle actuator biasing member is a spring.

16. The suturing apparatus of claim 14, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 of claim 16, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation.

18. The suture device of claim 16, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 14, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 19, wherein at least a portion of the snap fastener is magnetic.

21. The suture device of claim 19, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, 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 suturing apparatus of claim 21, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

23. The suturing apparatus of claim 1, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

24. The suturing apparatus of claim 23, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

25. The suturing apparatus of claim 23, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

28. The suturing device of claim 25, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

29. The suturing device of claim 25, wherein the notch is configured to allow the connecting member to deform in a single plane.

30. The suturing device according to claim 1, further comprising: The handle is located at the proximal portion of the suture device; A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; A suture mechanism actuator located on the handle, the suture mechanism actuator being coupled to the suture mechanism and configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation; as well as An elongated shaft connecting the handle and the needle guide.

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

32. The suturing apparatus of claim 30, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

33. The suturing apparatus of claim 32, wherein the suturing mechanism actuator biasing member is a spring.

34. The suturing apparatus of claim 30, wherein when the suturing mechanism actuator is in the first suturing mechanism actuator position, the suturing mechanism is in the insertion and removal orientation, and When the suture mechanism actuator is in the second suture mechanism actuator position, the suture mechanism is in the unfolding orientation.

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

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

37. The suturing apparatus of claim 36, wherein the slot is a "J"-shaped slot.

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

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

40. The suturing apparatus of claim 39, wherein the suturing mechanism actuator biasing member is a spring.

41. The suturing apparatus of claim 30, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

42. The suturing apparatus of claim 41, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

43. The suturing device of claim 41, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

46. ​​The suturing device of claim 43, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

47. The stitching device of claim 43, wherein the notch is configured to allow the connecting member to deform in a single plane.

48. The suturing apparatus of claim 43, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

49. The suturing apparatus of claim 48, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from retracting from the suturing mechanism.

50. The suturing apparatus of claim 1, wherein the first needle includes a detachable needle tip coupled to the tensile member.

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

52. The suture device of claim 1, wherein the suture structure causes the guide wire to unfold when it is in the opening.

53. The suturing device of claim 1, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

54. A suture device system comprising: The suturing apparatus according to claim 53; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

56. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; as well as Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, and A tensile member groove is configured to accommodate the tensile 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 to guide the tensile member through the tissue. The tensile member is configured to unfold from a groove in the tensile member when at least one of the first or second needles is guided through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The stitch structure therein causes the opening to unfold and be tightened along the tensile member to close and seal it.

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

58. The suturing apparatus of claim 56, wherein the suture knot unfolds when at least one of the first needle or the second needle is retracted.

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

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

61. The suturing apparatus according to claim 60, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

62. The suturing apparatus of claim 61, wherein the suture knot sleeve is at least partially inside the suture knot recess.

63. The suturing apparatus according to claim 56, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

64. The suturing apparatus of claim 56, wherein the suture knot is a slip knot.

65. The suturing apparatus of claim 56, wherein the suture knot is a "Tennessee slip" knot.

66. The suturing apparatus of claim 56, further comprising: The handle is located at the proximal portion of the suture device; An elongated shaft connecting the handle and the needle guide; as well as A needle actuator located on the handle, the needle actuator being coupled to at least one of the first needle or the second needle, and configured to guide at least one of the first needle or the second needle through the tissue when the needle actuator is activated.

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

68. The suturing apparatus of claim 67, wherein the needle actuator biasing member is a spring.

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

70. The suturing apparatus of claim 69, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 70, wherein the needle actuator biasing member is a spring.

72. The suturing apparatus of claim 70, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 suture device of claim 72, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger.

74. The suture device of claim 72, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 70, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 75, wherein at least a portion of the snap fastener is magnetic.

77. The suture device of claim 75, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, 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 suturing apparatus of claim 75, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

79. The suturing apparatus of claim 56, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

80. The suturing apparatus of claim 79, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

81. The suturing apparatus of claim 79, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

84. The suturing device of claim 81, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

85. The stitching device of claim 81, wherein the notch is configured to allow the connecting member to deform in a single plane.

86. The suturing apparatus of claim 56, further comprising: The handle is located at the proximal portion of the suture device; A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; A suture mechanism actuator located on the handle, the suture mechanism actuator being coupled to the suture mechanism and configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation; as well as An elongated shaft connecting the handle and the needle guide.

87. The suturing apparatus of 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 apparatus of 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 suturing apparatus of claim 88, wherein the suturing mechanism actuator biasing member is a spring.

90. The suturing apparatus of claim 86, wherein when the suturing mechanism actuator is in the first suturing mechanism actuator position, the suturing mechanism is in the insertion and removal orientation, and When the suture mechanism actuator is in the second suture mechanism actuator position, the suture mechanism is in the unfolding orientation.

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

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

93. The suturing apparatus of claim 92, wherein the slot is a "J"-shaped slot.

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

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

96. The suturing apparatus of claim 95, wherein the suturing mechanism actuator biasing member is a spring.

97. The suturing apparatus of claim 56, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

98. The suturing apparatus of claim 97, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

99. The suturing apparatus of claim 97, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

102. The suturing device of claim 99, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

103. The suturing device of claim 99, wherein the notch is configured to allow the connecting member to deform in a single plane.

104. The suturing apparatus of claim 97, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

105. The suturing apparatus of claim 104, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

106. The suturing apparatus of claim 56, wherein the first needle includes a detachable needle tip coupled to the tensile member.

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

108. The suture device of claim 56, wherein the suture structure causes the guide wire to unfold when it is in the opening.

109. The suturing device of claim 56, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

110. A suture device system comprising: The suturing apparatus according to claim 109; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

112. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, and A suture knot recess is configured to receive the suture knot; The handle is located at the proximal end of the suture device; An elongated shaft connecting the handle and the needle guide; and A needle actuator located on the handle and connected to at least one of the first needle or the second needle; 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 when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The suture structure therein causes the suture to extend from the suture knot recess and along the tensile member, and is pulled tight to close and seal the opening.

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

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

115. The suturing apparatus according to claim 112, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

116. The suturing apparatus of claim 115, wherein the suture knot sleeve is at least partially inside the suture knot recess.

117. The suturing apparatus of claim 112, wherein the needle guide further comprises a tensile member groove configured to receive the tensile member; The tensile member is configured to unfold from the groove of the tensile member when at least one of the first needle or the second needle is guided through the tissue.

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

119. The suturing apparatus according to claim 112, wherein the suture knot is a slip knot.

120. The suturing apparatus of claim 112, wherein the suture knot is a "Tennessee slip" knot.

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

122. The suturing apparatus of claim 121, wherein the needle actuator biasing member is a spring.

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

124. The suturing apparatus of claim 123, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 124, wherein the needle actuator biasing member is a spring.

126. The suturing apparatus of claim 124, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 suture device of claim 126, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger.

128. The suture device of claim 126, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 124, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 129, wherein at least a portion of the snap fastener is magnetic.

131. The suture device according to claim 130, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, 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 suturing apparatus of claim 131, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

133. The suturing apparatus of claim 112, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

134. The suturing apparatus of claim 133, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

135. The suturing apparatus of claim 133, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

138. The suturing device of claim 135, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

139. The suturing device of claim 135, wherein the notch is configured to allow the connecting member to deform in a single plane.

140. The suturing device according to claim 112, further comprising: A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; as well as A suture mechanism actuator is located on the handle, the suture mechanism actuator is coupled to the suture mechanism, and is configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation.

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

142. The suturing apparatus of claim 140, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

143. The suturing apparatus of claim 142, wherein the suturing mechanism actuator biasing member is a spring.

144. The suturing apparatus of claim 140, wherein when the suturing mechanism actuator is in the first suturing mechanism actuator position, the suturing mechanism is in the insertion and removal orientation, and When the suture mechanism actuator is in the second suture mechanism actuator position, the suture mechanism is in the unfolding orientation.

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

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

147. The suturing apparatus of claim 146, wherein the slot is a "J"-shaped slot.

148. The suturing apparatus of claim 145, wherein the suturing mechanism actuator further includes a selector knob coupled to the suturing mechanism actuator shaft and configured such that a user can move the suturing mechanism actuator between a first suturing mechanism actuator position and a second suturing mechanism actuator position.

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

150. The suturing apparatus of claim 149, wherein the suturing mechanism actuator biasing member is a spring.

151. The suturing apparatus of claim 140, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

152. The suturing apparatus of claim 151, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

153. The suturing apparatus of claim 151, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

156. The suturing device of claim 153, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

157. The suturing device of claim 153, wherein the notch is configured to allow the connecting member to deform in a single plane.

158. The suturing apparatus of claim 153, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

159. The suturing apparatus of claim 158, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

160. The suturing apparatus of claim 112, wherein the first needle includes a detachable needle tip coupled to the tensile member.

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

162. The suturing apparatus of claim 112, wherein the suture structure causes the guide wire to unfold when it is in the opening.

163. The suturing device of claim 112, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

164. A suture device system comprising: The suturing apparatus according to claim 163; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

166. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, and A tensile member groove is configured to accommodate the tensile member; The handle is located at the proximal end of the suture device; An elongated shaft connecting the handle and the needle guide; and A needle actuator located on the handle and connected to at least one of the first needle or the second needle; 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 when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to unfold from a groove in the tensile member when at least one of the first or second needles is guided through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The stitch structure therein causes the opening to unfold and be tightened along the tensile member to close and seal it.

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

168. The suturing apparatus of claim 166, wherein the suture knot unfolds when at least one of the first needle or the second needle is retracted.

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

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

171. The suturing apparatus of claim 170, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

172. The suturing apparatus of claim 171, wherein the suture knot sleeve is at least partially inside the suture knot recess.

173. The suturing apparatus of claim 166, further comprising a suture knot sleeve; The suture knot is wrapped around the suture knot sleeve, and the suture knot sleeve holds the suture knot until the suture knot is unwound.

174. The suturing apparatus of claim 166, wherein the suture knot is a slip knot.

175. The suturing apparatus of claim 166, wherein the suture knot is a "Tennessee slip" knot.

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

177. The suturing apparatus of claim 176, wherein the needle actuator biasing member is a spring.

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

179. The suturing apparatus of claim 178, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 179, wherein the needle actuator biasing member is a spring.

181. The suturing apparatus of claim 179, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 suture device of claim 181, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger.

183. The suture device according to claim 181, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 179, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 184, wherein at least a portion of the snap fastener is magnetic.

186. The suture device according to claim 184, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, 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 suturing apparatus of claim 186, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

188. The suturing apparatus of claim 166, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

189. The suturing apparatus of claim 188, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

190. The suturing apparatus of claim 188, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

193. The suturing device of claim 190, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

194. The suturing device of claim 190, wherein the notch is configured to allow the connecting member to deform in a single plane.

195. The suturing apparatus of claim 166, further comprising: A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; as well as A suture mechanism actuator is located on the handle, the suture mechanism actuator is coupled to the suture mechanism, and is configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation.

196. The suturing apparatus of 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 apparatus of 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 suturing apparatus of claim 197, wherein the suturing mechanism actuator biasing member is a spring.

199. The suturing apparatus of claim 195, wherein when the suturing mechanism actuator is in the first suturing mechanism actuator position, the suturing mechanism is in the insertion and removal orientation, and When the suture mechanism actuator is in the second suture mechanism actuator position, the suture mechanism is in the unfolding orientation.

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

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

202. The suturing apparatus of claim 201, wherein the slot is a "J"-shaped slot.

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

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

205. The suturing apparatus of claim 204, wherein the suturing mechanism actuator biasing member is a spring.

206. The suturing apparatus of claim 166, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

207. The suturing apparatus of claim 206, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

208. The suturing apparatus of claim 206, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

211. The suturing device of claim 208, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

212. The suturing device of claim 211, wherein the notch is configured to allow the connecting member to deform in a single plane.

213. The suturing apparatus of claim 206, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

214. The suturing apparatus of claim 213, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from retracting from the suturing mechanism.

215. The suturing apparatus of claim 166, wherein the first needle includes a detachable needle tip coupled to the tensile member.

216. The suturing apparatus of claim 166, further comprising at least one of a guidewire lumen or an irrigation lumen extending from the proximal portion of the suturing apparatus to the distal portion.

217. The suture device of claim 166, wherein the suture structure causes the guide wire to unfold when it is in the opening.

218. The suturing device of claim 166, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

219. A suture device system comprising: The suturing apparatus according to claim 218; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

221. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; as well as Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, 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 to guide the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The suture knot is wrapped around the suture knot sleeve, and the suture structure causes it to unfold from the suture knot sleeve and along the tensile member, and is tightened to close and seal the opening.

222. The suturing apparatus of claim 221, wherein the suture knot unfolds when at least one of the first needle or the second needle is retracted.

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

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

225. The suturing apparatus of claim 224, wherein the suture knot sleeve is at least partially inside the suture knot recess.

226. The suturing apparatus of claim 221, wherein the needle guide further comprises a tensile member groove configured to receive the tensile member; The tensile member is configured to unfold from the groove of the tensile member when at least one of the first needle or the second needle is guided through the tissue.

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

228. The suturing apparatus of claim 221, wherein the suture knot is a slip knot.

229. The suturing apparatus of claim 221, wherein the suture knot is a "Tennessee slip" knot.

230. The suturing device according to claim 221, further comprising: The handle is located at the proximal portion of the suture device; An elongated shaft connecting the handle and the needle guide; as well as A needle actuator located on the handle, the needle actuator being coupled to at least one of the first needle or the second needle, and configured to guide at least one of the first needle or the second needle through the tissue when the needle actuator is activated.

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

232. The suturing apparatus of claim 231, wherein the needle actuator biasing member is a spring.

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

234. The suturing apparatus of claim 233, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 234, wherein the needle actuator biasing member is a spring.

236. The suturing apparatus of claim 234, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 of claim 236, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation.

238. The suture device of claim 236, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 234, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 239, wherein at least a portion of the snap fastener is magnetic.

241. The suture device according to claim 239, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, thereby allowing the needle actuator to move from the second needle actuator position to the third needle actuator position when the plunger is released.

242. The suturing apparatus of claim 241, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

243. The suturing apparatus of claim 221, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

244. The suturing apparatus of claim 243, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

245. The suturing apparatus of claim 243, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

248. The suturing device of claim 245, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

249. The suturing device of claim 245, wherein the notch is configured to allow the connecting member to deform in a single plane.

250. The suturing apparatus of claim 221, further comprising: The handle is located at the proximal portion of the suture device; A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; A suture mechanism actuator located on the handle, the suture mechanism actuator being coupled to the suture mechanism and configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation; as well as An elongated shaft connecting the handle and the needle guide.

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

252. The suturing apparatus of claim 250, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

253. The suturing apparatus of claim 252, wherein the suturing mechanism actuator biasing member is a spring.

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

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

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

257. The suturing apparatus of claim 256, wherein the slot is a "J"-shaped slot.

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

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

260. The suturing apparatus of claim 259, wherein the suturing mechanism actuator biasing member is a spring.

261. The suturing apparatus of claim 250, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

262. The suturing apparatus of claim 261, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

263. The suturing apparatus of claim 261, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

266. The suturing device of claim 263, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

267. The suturing device of claim 263, wherein the notch is configured to allow the connecting member to deform in a single plane.

268. The suturing apparatus of claim 263, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

269. The suturing apparatus of claim 268, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from retracting from the suturing mechanism.

270. The suturing apparatus of claim 221, wherein the first needle includes a detachable needle tip coupled to the tensile member.

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

272. The suture device of claim 221, wherein the suture structure causes the guide wire to unfold when it is in the opening.

273. The suturing device of claim 221, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

274. A suture device system comprising: The suturing apparatus according to claim 273; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

276. A suturing device comprising: Tensile members; The seam knot associated with the tensile member; Needle guide, the needle guide comprising: The first pin connected to the tensile member The second injection, and A suture knot sleeve configured to receive the suture knot; The handle is located at the proximal end of the suture device; An elongated shaft connecting the handle and the needle guide; and A needle actuator located on the handle and connected to at least one of the first needle or the second needle; 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 when the needle actuator is activated, thereby guiding the tensile member through the tissue. The tensile member is configured to be pulled through the tissue when at least one of the first or second needles retracts, and The suture knot is wrapped around the suture knot sleeve, and the suture structure causes it to unfold from the suture knot sleeve and along the tensile member, and is tightened to close and seal the opening.

277. The suturing apparatus of claim 276, wherein the suture knot unfolds when at least one of the first needle or the second needle is retracted.

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

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

280. The suturing apparatus of claim 279, wherein the suture knot sleeve is at least partially inside the suture knot recess.

281. The suturing apparatus of claim 276, wherein the needle guide further comprises a tensile member groove configured to receive the tensile member; The tensile member is configured to unfold from the groove of the tensile member when at least one of the first needle or the second needle is guided through the tissue.

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

283. The suturing apparatus of claim 276, wherein the suture knot is a slip knot.

284. The suturing apparatus of claim 283, wherein the suture knot is a "Tennessee slip" knot.

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

286. The suturing apparatus of claim 285, wherein the needle actuator biasing member is a spring.

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

288. The suturing apparatus of claim 287, wherein the needle actuator comprises: plunger; as well as Offset component; When the plunger is pressed down, the needle actuator moves from the first needle actuator position to the second needle actuator position, and 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 suturing apparatus of claim 288, wherein the needle actuator biasing member is a spring.

290. The suturing apparatus of claim 288, wherein the needle actuator further comprises a pawl; When the plunger is depressed, the pawl moves from the first pawl orientation to the second pawl orientation, and When in the second pawl orientation, the pawl 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 suture device of claim 290, wherein the pawl is configured to rotate from the first pawl orientation to the second pawl orientation when moved by the plunger.

292. The suture device according to claim 290, wherein when the needle actuator is in the first needle actuator position, the pawl engages the first pawl groove, and When the plunger is depressed, the pawl engages the second pawl groove, 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 suturing apparatus of claim 288, wherein the needle actuator further comprises a snap fastener; When pressed down, the plunger moves the latch, and When moved, the latch 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 sewing device of claim 293, wherein at least a portion of the snap fastener is magnetic.

295. The suture device according to claim 293, wherein when the needle actuator is in the first needle actuator position, the latch engages the latch groove, and When the plunger is depressed, the latch engages the latch recess, 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 suturing apparatus of claim 295, wherein the needle actuator further comprises a ferromagnetic portion; At least a portion of the latch is magnetic, and The buckle is pulled into the buckle recess by the ferromagnetic portion.

297. The suturing apparatus of claim 276, further comprising a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

298. The suturing apparatus of claim 297, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

299. The suturing apparatus of claim 297, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

302. The suturing device of claim 299, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

303. The suturing device of claim 299, wherein the notch is configured to allow the connecting member to deform in a single plane.

304. The suturing apparatus of claim 276, further comprising: A suturing mechanism coupled to the distal portion of the needle guide and associated with the first needle and the second needle, the suturing mechanism including a pivoting element movable between an insertion and removal orientation and an unfolding orientation and located at the distal portion of the suturing device; as well as A suture mechanism actuator is located on the handle, the suture mechanism actuator is coupled to the suture mechanism, and is configured to move the suture mechanism between the insertion and removal orientation and the unfolding orientation.

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

306. The suturing apparatus of claim 304, wherein the suturing mechanism actuator includes a biasing member configured to return the suturing mechanism to the insertion and removal orientation.

307. The suturing apparatus of claim 306, wherein the suturing mechanism actuator biasing member is a spring.

308. The suturing apparatus of claim 304, wherein when the suturing mechanism actuator is in the first suturing mechanism actuator position, the suturing mechanism is in the insertion and removal orientation, and When the suture mechanism actuator is in the second suture mechanism actuator position, the suture mechanism is in the unfolding orientation.

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

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

311. The suturing apparatus of claim 310, wherein the slot is a "J"-shaped slot.

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

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

314. The suturing apparatus of claim 313, wherein the suturing mechanism actuator biasing member is a spring.

315. The suturing apparatus of claim 304, wherein the suturing mechanism further includes a connecting member configured to pull the tensile member through the tissue and having a first end and a second end, the first end being connectable to the first needle and the second end being connectable to the second needle.

316. The suturing apparatus of claim 315, wherein at least one of the first needle or the second needle comprises a barbed needle tip; and The connecting member includes at least one protrusion configured to clamp the barbed needle tip.

317. The suturing apparatus of claim 315, wherein the connecting member includes a plurality of notches configured to allow deformation of the connecting member.

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

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

320. The suturing device of claim 317, wherein the notch has a plurality of widths, and The width of the notch at least partially defines a plurality of bending radii of the connecting member.

321. The suturing device of claim 317, wherein the notch is configured to allow the connecting member to deform in a single plane.

322. The suturing apparatus of claim 315, wherein the connecting member is configured to pass through the suturing mechanism in one direction.

323. The suturing apparatus of claim 322, wherein the connecting member includes at least one protrusion configured to prevent the connecting member from exiting the suturing mechanism.

324. The suturing apparatus of claim 276, wherein the first needle includes a detachable needle tip coupled to the tensile member.

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

326. The suture device of claim 276, wherein the suture structure causes the guide wire to unfold when it is in the opening.

327. The suturing device of claim 276, further comprising at least one locking protrusion configured to engage the suturing device with the introducing sheath when at least a portion of the suturing device is guided through the introducing sheath.

328. A suture device system comprising: The suturing apparatus according to claim 327; as well as Introducing the sheath; The introducer sheath is configured to be introduced into the opening in the tissue, and The introducer sheath is configured to be withdrawn from the opening while at least a portion of the suture device remains in the opening.

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

330. A method of applying sutures to close and seal openings in tissue, the method comprising: Guide at least one needle through the tissue adjacent to the opening; Guide the tensile member through the tissue adjacent to the opening; Guide at least a portion of the at least one needle through the suture knot; Untie the stitch knot; as well as Tighten the suture knot to close and seal the opening.

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

332. The method of claim 330, wherein unfolding the suture knot comprises unfolding the suture knot from the knot recess.

333. The method of claim 330, wherein untying the suture knot comprises untying the suture knot from the sleeve.

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

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

336. The method of claim 330, wherein unfolding the suture knot comprises unfolding the suture knot onto the tensile member.

337. The method of claim 330, wherein the suture knot is pre-knotted.

338. The method of claim 330, further comprising: Guide at least a portion of the suture mechanism having a pivoting element in an insertion and removal orientation through the opening in the tissue; Move the pivot element of the suture mechanism to the unfolding orientation; Return the pivot element to the insertion and removal orientation; as well as The suture mechanism is withdrawn from the opening.

339. The method of claim 338, further comprising guiding an insertion sheath into the opening in the tissue; Guide at least a portion of the suture mechanism through the introducer sheath; and With at least a portion of the suture mechanism remaining in the opening, the introducer sheath is withdrawn from the opening.

340. The method of claim 339, further comprising attaching the suturing mechanism to the proximal end of the introducer sheath.

341. The method of claim 338, wherein the suturing mechanism comprises a connecting member having a first end and a second end; and The at least one needle includes a first needle and a second needle; The method further includes: Connect the first pin to the first end of the connecting member; Connect the second pin to the second end of the connecting member; Retract the first and second stitches; and The connecting member is used to pull the tensile member through the tissue.

342. The method of claim 330, further comprising guiding a guidewire through the opening.

343. The method of claim 342, further comprising unfolding the suture knot when the guide wire is in the opening.

344. The method of claim 342, further comprising withdrawing the guidewire from the opening.

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

346. Any combination of any two or more of the preceding claims.

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

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

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