JP2017517345A - Tissue closure device and method - Google Patents

Abstract

When implanted in the heart, a device that closes the wound and follows wall motion (ie, expands and contracts with the myocardium).

Description

This application claims priority to US patent application Ser. No. 14 / 301,106, filed Jun. 10, 2014. U.S. Patent Application No. 14 / 301,106 is a continuation of U.S. Patent Application No. 13 / 843,930, filed March 15, 2013, with the benefit of that filing date. Insist. U.S. Patent Application No. 13 / 843,930 is a continuation of U.S. Patent Application No. 13 / 010,769, filed on January 20, 2011, with the benefit of that filing date. Insist. U.S. Patent Application No. 13 / 010,769 was filed on Jan. 20, 2010, US Provisional Patent Application No. 61 / 296,868, filed Jan. 20, 2010 United States Patent Application No. 13 / 010,766, United States Patent Application No. 13 / 010,777 filed January 20, 2011, and the United States filed January 20, 2011 Claims the benefit of patent application No. 13 / 010,774. US patent application Ser. No. 14 / 301,106 is also a continuation of, and claims priority from, international application PCT / US14 / 30868, filed March 17, 2014. International application PCT / US14 / 30868 claims priority of US patent application Ser. No. 13 / 843,930, filed Mar. 15, 2013.

  In addition, the following: U.S. Patent Application No. 14 / 301,106 filed on June 10, 2014, U.S. Patent Application No. 13/843 filed on March 15, 2013 No. 930, international application PCT / US14 / 30868 filed on March 17, 2014, US patent application No. 13 / 010,769 filed on January 20, 2011 US Provisional Patent Application No. 61 / 296,868, filed January 20, 2011, US Patent Application No. 13 / 010,766, filed January 20, 2011, US Patent Application No. 13 / 010,777 filed January 20, 2011 and US Patent Application No. 13 / 010,774 filed January 20, 2011. Saisho, the contents of each of which are incorporated entirely herein by reference.

  The present invention relates to a tissue closure device and method.

  Surgical intervention requires access to a surgical site in the viscera that is damaged and / or diseased. This involves puncturing or incising a healthy tissue layer for access to form an opening. For example, during a thoracotomy, a surgeon can open the skin between the ribs and, by extension, puncture one or more tissue layers with a trocar, scalpel, or other sharp device to create a cannula or retractor It is typically possible to allow the insertion of a to maintain an opening in the tissue. The surgical site can be accessed by inserting a surgical instrument through a cannula or retractor. For example, a surgeon and / or intervenor will have access to a diseased or damaged aortic valve by performing a thoracotomy and myotomy through the apex. This procedure requires the surgeon to access the myocardium of the patient's heart, for example by making a small intercostal incision in the patient's chest. Such a procedure further forms an access opening by incising the myocardium of the heart, and maintains the intended diameter of the access opening by inserting a sheath introducer, followed by sheathing the catheter and other devices. With protecting the heart tissue as it is inserted and / or removed through. A catheter or other device can then be inserted through the cannula into one or more heart chambers to repair a defective or damaged portion of the heart.

  In addition, some pericardial punctures involve inserting a needle through the patient's intercostal opening into the pericardium, guiding a flexible guidewire through the needle, and subsequently leaving the guidewire in place. It involves removing the needle. After removal of the needle, the opening in the pericardial tissue can be expanded by advancing a tapered dilator over the guide wire. An expanded opening, or tube, provides room for the catheter. After expansion, fluid is drained from the pericardium by guiding the catheter over the guide wire into the pericardium.

  Transpericardial or transapical access to the myocardium is generally less invasive than the more traditional surgical forms because the required entry or opening is generally relatively small. However, such small openings can be difficult to close, especially because the closed position is in the patient's body. For example, referring to the procedure above, after removing the sheath introducer and any catheter or other device extending through the sheath introducer, the opening formed in the tissue, eg, heart or pericardial tissue, is closed in the patient's body. It is done. Because these exemplary procedures involve accessing the patient's thoracic cavity through a small intercostal opening through the patient's skin and other underlying tissues (eg, fat and / or fascia), closure techniques such as suturing are traditional. More complex than using traditional open surgical procedures. Specifically, attaching a suture through a small opening to a closed position within a patient's body, such as a mini-thoracotomy, is more difficult and complex than manually operating a suture needle at an open surgical procedure site . Such difficulties can result in poor closure and / or closure requiring more time than required.

  Poor closure can expose the patient to complications such as internal bleeding and / or increased risk of infection. Even if poor closure is recognized and addressed prior to completion of the surgical procedure, correction of poor closure can increase the time required to act on the closure and expose the tissue to additional wounds. In general, it is desirable to minimize surgical procedure time in order to reduce the potential for complications and unnecessary injury to the patient.

  Accordingly, there is a need for a closure mechanism and method that is easy to operate, reliable, and requires less time to form an effective closure.

  According to a preferred embodiment of the present invention, the device comprises a plurality of anchors, at least one elastic closure element coupled to the anchors and configured to propel the anchors toward each other, And a driver configured to drive and push the anchor into the tissue while coupled to the anchor, the closure element for closing the tissue opening disposed between the anchors pushed into the tissue It is elastic enough to propel the anchors pushed into the tissue in the direction towards each other and resist the counter forces applied to the anchors propelling the anchors away from each other.

  The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  The apparatus further includes a safety release mechanism that includes a plurality of spring load members, each spring load member being independently movable between an engaged position and a disengaged position, wherein the safety release mechanism includes a spring load mechanism. It is configured to prevent the driver from driving the anchor unless all of the members are in the engaged position.

  Each anchor may include an elongated body having a distal tip configured to puncture tissue when the respective anchor is driven distally and pushed into the tissue.

  Each anchor may include an anchoring protrusion configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.

  The fixing protrusion may be a wing-like portion, and the wing-like portion may extend from the joint portion between the wing-like portion and the elongated body to the free end in the radial direction.

  The wing may include a plurality of cutting projections extending proximally at a free end of the wing.

  The wings may be formed by cuts that progress radially inward and distally into the elongated body.

  The elongate body and wing may include a plurality of longitudinally extending ridges that provide a plurality of cutting projections extending proximally at the free end of the wing.

  Each of the anchors may include first and second anchoring protrusions configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue. The second fixing protrusions are arranged at respective positions shifted from each other along the length of the elongated body.

  The first and second anchoring protrusions may be first and second wings, respectively, formed by first and second cuts that proceed radially inward and distally into the elongated body; The first and second cuts end at respective positions that are offset from each other along the length of the elongated body.

  The closure element may include at least one of a band, an elastomeric band, and a band made of silicon.

  Each anchor may include a hook-like protrusion formed to receive a band.

  The hook-like protrusion may be formed to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

  The device may include a plurality of closure elements.

  Each of the plurality of closure elements may contact two or more of the anchors.

  The closure element may form two overlapping V-shaped patterns.

  The plurality of closure elements may contact three or more of the anchors.

  The at least one closure element may include an integral V-shaped element that couples three of the anchors.

  The device may include two integral V-shaped closure elements each formed to contact three of the anchors. The two V-shaped closing elements may overlap to form a diamond shaped operating window.

  The device may further include a centering element configured to receive the guide wire. The centering element may be a tubular shaft.

  In the first configuration, the anchor may be arranged along a ring-shaped periphery.

  The closure element may be prevented from extending inside the ring-shaped perimeter by one or more tubes.

  The driver may be configured to drive a plurality of anchors simultaneously.

  The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  The apparatus may further comprise a trigger configured to release the spring load element from the preload position to drive the plurality of anchors.

  The apparatus may further include a handle, and the trigger is disposed within the handle.

  The handle, trigger, and driver may be removable from the cannula, outer working tube, the plurality of anchors, and the closure element.

  The plurality of anchors and closure elements may be formed from a bioabsorbable material.

  According to a preferred embodiment of the present invention, the device comprises a plurality of anchors and at least one elastic closure element coupled to the anchors and configured to propel the anchors towards one another. The element propels the anchors pushed into the tissue in a direction away from each other and sufficient to propel the anchors pushed into the tissue in order to close the tissue openings located between the anchors pushed into the tissue It is elastic enough to resist the counter force applied to the anchor.

  The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  According to a preferred embodiment of the present invention, the method is sufficient to implant a plurality of anchors into tissue and (a) close the opening of tissue disposed between the implanted anchors and (b ) Planting by at least one elastic closure element coupled to the anchor with a force sufficient to resist the opposing forces applied to the implanted anchor that push the anchors away from each other and open the opening; Propelling the anchors in the direction towards each other.

  The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  According to a preferred embodiment of the present invention, a method is provided for implanting a plurality of anchors into tissue, at least one elastic closure element coupled to the anchors, for propelling the implanted anchors toward each other. Forming an opening in the tissue between the implanted anchors, the elastic closure element being (a) sufficient to maintain the tissue opening in the closed position, and (b) separating the anchors Propelling the implanted anchors toward each other and toward the opening with sufficient force to resist the opposing forces applied to the implanted anchor propelling in the direction of opening the opening, inserting the instrument through the opening And after removing the device from the opening, again (a) sufficient to keep the tissue opening in the closed position, and (b) the anchor is moved away to open the opening. By an elastic closure element with sufficient force to resist against forces applied to the anchor implanted promote direction, including to promote the direction toward and the implanted anchor to each other opening.

  The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  According to a preferred embodiment of the present invention, the method includes forming an opening in tissue, inserting a centering device through the opening, and using the centering device to center the anchor around the opening in the tissue. Implanting a plurality of anchors, propelling the implanted anchors toward each other and toward the opening by means of at least one elastic closure element coupled to the anchor, inserting the device through the opening, and opening After the device is removed from the device, it is again added to the implanted anchor (a) sufficient to maintain the tissue opening in the closed position, and (b) propelled away from the anchor and opening the opening. Implanted anchors are connected to each other by elastic closure elements that have sufficient force to resist the opposing forces. And comprising propulsion in a direction toward the opening.

  The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  According to a preferred embodiment of the present invention, the surgical device comprises two or more anchors, a driver configured to drive the anchors into tissue and at least one elasticity extending between the anchors. An elastic closing element, wherein the elastic closing element is spaced from the first configuration in which the anchors are located at a first distance from each other, and the anchor is at a second distance that is shorter than the first distance. The surgical device is configured to propel the anchor toward a second configuration positioned relative to each other, the surgical device maintaining the driven anchor in the first configuration, and the anchor being second by the at least one closure element. It is configured to selectively release the driven anchor to allow it to be moved toward the configuration.

  Each anchor may include an elongated body having a distal tip configured to puncture tissue when the respective anchor is driven distally and pushed into the tissue.

  Each anchor may include an anchoring protrusion configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.

  The fixing protrusion may be a wing-like portion, and the wing-like portion may extend from the joint portion between the wing-like portion and the elongated body to the free end in the radial direction.

  The wing may include a plurality of cutting projections extending proximally at a free end of the wing.

  The wings may be formed by cuts that progress radially inward and distally into the elongated body.

  The elongate body and wing may include a plurality of longitudinally extending ridges that provide a plurality of cutting projections extending proximally at the free end of the wing.

  Each of the anchors may include first and second anchoring protrusions configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue. The second fixing protrusions are arranged at respective positions shifted from each other along the length of the elongated body.

  The first and second anchoring protrusions may be first and second wings, respectively, formed by first and second cuts that proceed radially inward and distally into the elongated body; The first and second cuts end at respective positions that are offset from each other along the length of the elongated body.

  The closure element may be a band. The band may form a continuous loop. The band may be an elastomer. The band may be formed from silicon.

  Each anchor may include a hook-like protrusion formed to receive a band.

  The hook-like protrusion may be formed to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

  The device may include two or more closure elements. Each of the plurality of closure elements may contact only two of the anchors. For example, two or more closure elements may contain four closure elements, or may contain six anchors, two of the six anchors being only two of the four closure elements And four of the six anchors are connected to only one of each of the four closure elements. The closure element may form two overlapping V-shaped patterns.

  The plurality of surgical closure elements may contact three or more of the anchors.

  The at least one closure element may include an integral V-shaped element configured to contact three of the anchors.

  The at least one closure element may include two or more integral V-shaped closure elements each formed to contact three of the anchors. For example, the V-shaped elements may overlap so as to form a diamond shaped operating window.

  The device may further include a centering element configured to receive the guide wire. 26. The apparatus of claim 25, wherein the centering element is a tubular shaft. The centering element may have a proximal portion that is configured to allow the centering mechanism to be retracted from the remainder of the surgical device.

  The device may further include at least one pressure sensor configured to indicate whether the device is in sufficient contact with tissue prior to driving the anchor.

  The at least one pressure sensor may include at least one contact element that extends distally from the distal end of the device. The at least one contact element may be adapted to be depressed when the distal end of the device is pressed against the tissue.

  The apparatus may further include a key plate and at least one key member, the at least one key member including a first position where the at least one key member is engaged with the key plate, and at least one key member. Has a second position that is disengaged from the key plate, and depressing the contact element moves the at least one key member from the first position to the second position.

  The key plate may prevent the anchor from being driven when at least one key member is engaged with the key plate.

  The at least one key member includes a plurality of key members, and each key member can be independently moved by a respective contact element. When any one of the key members is engaged with the key plate, the key plate can prevent the anchor from being driven.

  In the first configuration, the anchor may be arranged along a ring-shaped periphery.

  When the anchor is maintained in the first configuration, the closure element may be prevented from extending within the ring-shaped perimeter.

  The surgical device may further comprise a cannula configured to provide access to a surgical treatment site disposed between the anchors when the anchors are maintained in the first configuration.

  The cannula may be configured to maintain the anchor in the first configuration.

  The anchor and closure element may be located at a radially outer position relative to the cannula.

  The surgical device may further comprise an outer working tube with a cannula extending within the outer working tube.

  At least one of the cannula and the outer working tube may have an outer surface configured to prevent the anchor and closure element from extending to any radial position corresponding to the interior of the cannula.

  The surgical device may include a plurality of closure elements that are prevented from extending to any radial position corresponding to the internal channel of the cannula.

  The cannula may include a distal portion having a flanged orientation in which the distal portion is configured to prevent the closure element from moving distally beyond the distal end of the cannula. Forming a radially extending flange. The flange may extend radially beyond the outer surface of the outer working tube.

  The distal portion of the cannula may be actuated to a second orientation, in which the distal portion of the inner working channel is distal to the closure element beyond the distal end of the cannula. It doesn't stop moving.

  The flange may extend distally when the cannula distal portion is in the second orientation.

  The distal portion of the cannula may be actuated from the flanged orientation to the second orientation by sliding the cannula proximally relative to the outer working tube.

  The depth at which the anchor is driven by the driver may be limited by contact between the closure element and the radially extending flange.

  The driver may be configured to drive a plurality of anchors simultaneously.

  The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  The surgical device may further comprise a trigger configured to release the spring load element from the preload position to drive the plurality of anchors.

  The surgical device may further include a handle, and a trigger is disposed within the handle.

  The surgical device may further comprise a safety element that is configured to prevent the trigger from releasing the spring loaded element when in the safe position.

  The handle, trigger, and driver may be removable from the cannula, outer working tube, the plurality of anchors, and the closure element.

  The plurality of anchors and closure elements may be formed from a bioabsorbable material.

  According to a preferred embodiment of the present invention, the method implants two or more anchors into a tissue, the implanted anchors in a first configuration in which the anchors are located at a first distance from each other. Maintaining, propelling the anchor from the first configuration toward a second configuration where the anchors are located at a second distance that is less than the first distance, between two or more anchors Forming an opening in the tissue in the region and constricting the opening by allowing the anchor to move from the first configuration to the second configuration.

  The opening may be formed while the embedded anchor is maintained in the first configuration.

  The opening may be formed using a trocar, scalpel, or other sharp device and may be expanded using a dilator, sheath introducer, or catheter.

  The method may further include performing thoracoscopic surgery through the opening.

  The closure element may include a cannula or sheath introducer configured to maintain the closure device in a preloaded state, and the surgical procedure is performed through the cannula or sheath introducer.

  The tissue may be blood vessel or heart tissue.

  The surgical procedure may be transapical valve replacement or repair.

  In accordance with a preferred embodiment of the present invention, a surgical device comprises a plurality of anchors configured to be driven and pushed into tissue and at least one elastic closure element extending between the anchors. The elastic closure element moves from a first configuration in which the anchors are located at a first distance from each other to a second configuration in which the anchors are located at a second distance shorter than the first distance. Shaped to propel the anchor, the surgical device maintains the anchor in the first configuration during the surgical procedure and is subsequently moved by the closure element toward the second configuration. It is formed so that it is possible.

  According to a preferred embodiment of the present invention, a surgical device comprises a driver configured to drive and push a plurality of anchors into tissue in a first configuration in which the anchors are positioned at a first distance from each other. And the device is adapted to maintain the driven anchor in the first anchor configuration and toward the second configuration in which the anchors are closer together than when the anchor is in the first anchor configuration. It is configured to selectively release the driven anchor to allow it to be moved by the closure element.

  The driver may be configured to drive each anchor, for example, by a) colliding with each anchor, or b) colliding with a pin configured to transmit momentum from the driver to the anchor.

  The driver may be configured to be actuated from a proximal position to a distal position. In the distal position, the driver may impart momentum to each anchor by a) impacting each anchor, or b) impacting a pin configured to transmit momentum from the driver to the anchor. . The driver may be configured to be actuated by a spring.

  In accordance with a preferred embodiment of the present invention, the device is coupled to the anchor and a plurality of anchors, at least one tissue compression band coupled to the anchor configured to propel the anchors toward each other. And a driver configured to drive the anchor with a tissue compression band and push it into the tissue, the tissue compression band for closing the tissue opening disposed between the anchors pushed into the tissue. It has sufficient elasticity to propel the anchors pushed into the tissue toward each other.

  The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  Each anchor may include a distal tip configured to puncture tissue when the respective anchor is driven distally and pushed into the tissue.

  Each anchor may include an anchoring protrusion configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.

  The anchoring protrusion is an airfoil, and the airfoil may extend from the proximal end of the distal tip proximally and radially to the free end.

  The wing may include a plurality of cutting projections extending proximally at a free end of the wing.

  The wing may include a plurality of longitudinally extending ridges that provide a plurality of cutting projections extending proximally at the free end of the wing.

  The tissue compression band may include at least one of a band, an elastomeric band, and a band made of silicon.

  The tissue compression band may include first and second ends, each of the first and second ends having at least one protrusion extending radially from the end, and Each of the plurality of anchors includes a coupling element.

  The coupling element may be configured to maintain engagement between the tissue compression band and the anchor by preventing the band from leaving the anchor.

  The device may include a plurality of tissue compression bands.

  Each of the tissue compression bands may contact two or more of the anchors.

  Each of the tissue compression bands may contact two anchors.

  The tissue compression band may overlap with other tissue compression bands.

  Four tissue compression bands may overlap to form a square.

  Four tissue compression bands may overlap to form a diamond.

  In the first configuration, the anchor may be arranged along a ring-shaped periphery.

  In the first embodiment, the anchors may be arranged in a square shape.

  The driver may be configured to drive a plurality of anchors simultaneously.

  The driver may be configured to drive the anchor a predetermined distance.

  The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  A trigger may be formed to release the spring load element from the preload position to drive the plurality of anchors.

  The trigger may be located in the handle.

  The plurality of anchors and tissue compression bands may be formed from a bioabsorbable material.

  The tissue compression band may have a relaxed state in which the tissue compression band performs one of (i) applying no force to the anchor and (ii) applying minimal force. In the tensioned state, the tissue compression band applies a force that propels the anchors toward each other.

  The tissue compression band may be in a relaxed state before being driven by the driver and pushed into the tissue.

  The tissue compression band may be in tension after being driven by the driver and pushed into the tissue.

  The tissue compression band may be coupled to the anchor at a point disposed within the tissue after the anchor is driven into the tissue by the driver.

  According to a preferred embodiment of the present invention, the device comprises a plurality of anchors and at least one tissue compression band coupled to the anchors configured to propel the anchors toward each other, and the tissue The compression band is sufficiently elastic to propel the anchors pushed into the tissue toward each other to close the tissue opening located between the anchors pushed into the tissue.

  According to a preferred embodiment of the present invention, the method couples anchors with sufficient force to implant a plurality of anchors into the tissue and close the tissue openings disposed between the implanted anchors. Propulsion of the implanted anchors in a direction toward each other by the at least one tissue compression band formed.

  According to a preferred embodiment of the present invention, the device is configured to drive a plurality of anchors, a closure plate coupled to the anchors, and a closure plate coupled to the anchors to drive the anchors into the tissue. And a closure plate coupled to the anchor is configured to close the tissue opening disposed between the anchors pushed into the tissue.

  The closure plate may be rigid.

  The closure plate may be configured to propel the anchors toward each other.

  Each anchor may include an elongated body having a distal tip configured to puncture tissue when the respective anchor is driven distally and pushed into the tissue.

  Each anchor may include an anchoring protrusion configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.

  The fixing protrusion may be a wing-like portion, and the wing-like portion may extend from the joint portion between the wing-like portion and the elongated body to the free end in the radial direction.

  The wing may include a plurality of cutting projections extending proximally at a free end of the wing.

  The wings may be formed by cuts that progress radially inward and distally into the elongated body.

  The elongate body and wing may include a plurality of longitudinally extending ridges that provide a plurality of cutting projections extending proximally at the free end of the wing.

  Each of the anchors may include first and second anchoring protrusions configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue. The second fixing protrusions are arranged at respective positions shifted from each other along the length of the elongated body.

  The first and second anchoring protrusions may be first and second wings, respectively, formed by first and second cuts that proceed radially inward and distally into the elongated body; The first and second cuts end at respective positions that are offset from each other along the length of the elongated body.

  The closure element may have sufficient elasticity to propel the anchors pushed into the tissue toward each other to close the tissue openings located between the anchors pushed into the tissue.

  The closure element may include at least one of a band, an elastomeric band, and a band made of silicon.

  Each anchor may include a hook-like protrusion formed to receive a band.

  The hook-like protrusion may be formed to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

  The closure plate may be circular.

  The closure plate may be square.

  The closure plate may comprise a plurality of sliding braces.

  The driver may be configured to drive a plurality of anchors simultaneously.

  The driver may be configured to drive the anchor a predetermined distance.

  The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  A trigger may be formed to release the spring load element from the preload position to drive the plurality of anchors.

  The trigger may be located in the handle.

  The plurality of anchors and closure plates may be formed from a bioabsorbable material.

  According to a preferred embodiment of the present invention, the device comprises a plurality of anchors and a closure plate coupled to the anchor, the closure plate coupled to the anchor between the anchors pushed into the tissue. It is configured to close the deployed tissue opening.

  According to a preferred embodiment of the present invention, the method includes implanting a plurality of anchors into tissue and closing a tissue opening disposed between the anchors pushed into the tissue.

  In accordance with a preferred embodiment of the present invention, the device is coupled to the anchor and a plurality of anchors, at least one closure element coupled to the anchor configured to propel the anchors toward each other. And a driver configured to drive the anchor with the closure element and push it into the tissue, the closure element into the tissue to close the tissue opening disposed between the anchors pushed into the tissue. It has sufficient elasticity to propel the pushed anchors toward each other.

  The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, (e) external force, and (f) hand pressure. .

  Each anchor may include a distal tip configured to puncture tissue when the respective anchor is driven distally and pushed into the tissue.

  Each anchor may include an anchoring protrusion configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.

  The anchoring protrusion is an airfoil, and the airfoil may extend from the proximal end of the distal tip proximally and radially to the free end.

  The wing may include a plurality of cutting projections extending proximally at a free end of the wing.

  The wing may include a plurality of longitudinally extending ridges that provide a plurality of cutting projections extending proximally at the free end of the wing.

  The closure element may include at least one of a band, a tissue compression band, an elastomeric band, and a band made of silicon.

  The closure element may include first and second ends, each of the first and second ends having at least one protrusion extending radially from the end, and Each of the anchors has a coupling element.

  The coupling element may be configured to maintain engagement between the closure element and the anchor by preventing the band from leaving the anchor.

  The device may include a plurality of closure elements.

  Each of the closure elements may contact two or more of the anchors.

  Each of the closure elements may contact two anchors.

  The driver may be tubular and each of the closure elements is wrapped around the tubular driver.

  The tubular driver may comprise at least one pusher pin configured to hold the closure element around the tubular driver in the wrapping position.

  A tubular outer sheath may be annularly arranged around the wrapped closure element.

  An outer sheath may be formed to slide proximally to expose the wrapped closure element.

  The driver may be further configured to drive the anchor radially outward.

  According to a preferred embodiment of the present invention, the method inserts a surgical device having at least one closure element wound around a tubular device and coupled to a plurality of anchors into a tissue opening; Removing the outer sheath from the annular position around the wrapped closure element, driving the anchor coupled to the closure element into the tissue from below the surface of the tissue, and removing the surgical device from the tissue The anchor and the closure element remain inside the tissue.

  According to a preferred embodiment of the present invention, the surgical anchor has a distal end that is tapered toward a distal tip that is configured to pierce tissue and a flexibility that extends proximally from the distal end. And at least one wing extending from the distal end proximally and radially outward to the free end, including a radially outer surface and a radially inner surface, and radially outward The surface includes a ridge extending longitudinally, and the ridge provides a plurality of protrusions extending proximally at the free end.

  The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

  The radially inner surface may be concave.

  The flexible element may be configured to flex in cooperation with a force applied to the anchor.

  The wings may be configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue. The wing may further include a plurality of cutting projections at the free end extending to the free end and extending proximally. The scissors provide a plurality of cutting projections extending proximally at the free end of the wing.

  The anchor may be arranged in a form having a plurality of anchors along a ring-shaped periphery. The anchors may be arranged in a rectangular shape with a plurality of anchors. The anchor may be formed from a bioabsorbable material.

  In accordance with a preferred embodiment of the present invention, a surgical anchor includes a distal end tapered toward a distal tip configured to pierce tissue, a radially outer surface and a radially inner surface. At least one wing extending from the distal end to the proximal side and radially outward to the free end, including a heel extending radially outwardly in a longitudinal direction, the ridge being proximal Providing a plurality of protrusions extending to the free end.

  According to a preferred embodiment of the present invention, the surgical device is an anchor, wherein the anchor is tapered toward a distal tip formed to puncture tissue, and from the distal end. At least one wing extending proximally and radially outward to a free end and extending from the distal end of the shoulder of the anchor; and a flexible element extending proximally from the distal end The shoulder is located at the intersection of the flexible element and the distal portion of the wing, or located distal to the intersection, and driving the anchor into the tissue A driver configured to apply a driving force to the anchor shoulder for pushing into the wing, wherein the wing includes a radially outer surface and a radially inner surface, the radially outer surface being longitudinal. A cocoon extending in the direction It is seen to provide a plurality of projections which folds extending proximally to the free end.

  The anchor may be arranged in a form having a plurality of anchors and the driver may be configured to drive the anchors simultaneously or to drive the anchors a predetermined distance. The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  The wings may extend proximally beyond the shoulder, and the driver includes a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally into the tissue. Yes.

  In accordance with a preferred embodiment of the present invention, the surgical device has a distal end that is tapered toward a distal tip that is configured to pierce tissue, and proximally and radially outward from the distal end. A surgical anchor including at least one wing extending toward the free end toward the free end; at least one window configured to allow the wing to expand to a relaxed position; and A delivery mechanism having a distal end including at least one constriction element configured to compress, wherein the wing includes a radially outer surface and a radially inner surface, the radially outer surface The window includes a longitudinally extending ridge, the ridge provides a plurality of protrusions extending proximally on the free end, and the wing is positioned in a relaxed position before the delivery mechanism ejects the anchor. Placed in While the delivery mechanism ejects the anchor, the wings face the stenosis element so that it narrows from the relaxed position to the compressed position, and the wings return to the relaxed position once ejected from the delivery mechanism. Is formed.

  According to a preferred embodiment of the present invention, the surgical anchor has a distal end that is tapered toward a distal tip that is configured to pierce tissue and a flexibility that extends proximally from the distal end. And at least one hook extending from the distal end to the proximal side and radially outward to the free end, including a radially outer surface and a radially inner surface. The outer surface includes a longitudinally extending ridge, the ridge provides a plurality of protrusions extending proximally at the free end, and a flexible stem is allowed for the at least one ridge and the distal tip It is flexible. The radially inner surface may be concave.

  The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force. The flexible stem may be configured to flex in cooperation with a force applied to the anchor.

  The saddle may be configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue. The hook may extend to the free end and include a plurality of cutting protrusions extending proximally at the free end. The scissors may provide a plurality of cutting projections extending proximally at the free end of the scissors.

  The anchor may be arranged in a form having a plurality of anchors along a ring-shaped periphery. The anchors may be arranged in a form having a plurality of anchors in a square shape. The anchor may be formed from a bioabsorbable material.

  The flexible stem may further comprise a proximal eyelet configured to receive the closure element. The closure element may be a suture.

According to a preferred embodiment of the present invention,
Surgical equipment
An anchor, wherein the anchor tapers toward a distal tip configured to pierce tissue, and extends from the distal end proximally and radially outward to a free end At least one saddle that extends from the distal end of the shoulder of the anchor and a flexible stem that extends proximally from the distal end, the shoulder being flexible with the flexible stem A driving force applied to the anchor and the shoulder of the anchor for driving the anchor and pushing it into tissue A scissor including a radially outer surface and a radially inner surface, the radially outer surface including a longitudinally extending heel, and the heel is proximal A plurality of laterally extending projections are provided at the free end.

  The anchor may be arranged in a form having a plurality of anchors, and further, the driver is configured to drive the anchors simultaneously. The driver may be configured to drive the anchor a predetermined distance. The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

  A saddle may extend proximally beyond the shoulder. The driver may include a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and push it into the tissue.

  In accordance with a preferred embodiment of the present invention, the surgical device has a distal end that is tapered toward a distal tip that is configured to pierce tissue, and proximally and radially outward from the distal end. A surgical anchor including at least one hook extending toward the free end toward the free end, at least one window configured to allow the hook to expand to a relaxed position, and compressing the hook A delivery mechanism having a distal end including at least one constriction element configured to compress to a position, wherein the saddle includes a radially outer surface and a radially inner surface; The radially outer surface includes a longitudinally extending ridge, the ridge provides a plurality of protrusions extending proximally at the free end, and the ridge is in a relaxed position before the delivery mechanism ejects the anchor. Placed in the window to send While the mechanism ejects the anchor, the saddle faces the stenosis element so that it narrows from the relaxed position to the compressed position, and the saddle returns to the relaxed position once ejected from the delivery mechanism. Is formed.

  In accordance with a preferred embodiment of the present invention, the surgical device has a distal end that is tapered toward a distal tip that is configured to pierce tissue, and proximally and radially outward from the distal end. A surgical anchor including at least one hook extending toward the free end toward the free end, a flexible stem extending proximally from the distal end, and a proximal eyelet, and received by the proximal eyelet And a tensioner, a hollow axial core formed to receive the closure element and to allow the closure element to slide through the tensioner Including a tensioner. The closure element may be a suture.

  Further features and aspects of the present invention are described in detail below with reference to the accompanying drawings.

FIG. 2 shows a detailed view of a surgical device and a distal tip of the surgical device according to a preferred embodiment of the present invention. FIG. 2 shows a detailed view of a surgical device and a distal tip of the surgical device according to a preferred embodiment of the present invention. It is a front view which shows the surgical closure apparatus of FIG. 1 in the state in which the partial front view was inserted. Fig. 2 shows the anchor of the self-actuating closure mechanism of the device of Fig. 1; 2 shows a partial assembly of the surgical closure device of FIG. FIG. 5 is a partial view showing the partial assembly of FIG. 4. FIG. 2 is a partial cross-sectional view of the device of FIG. 1 shown in cross-section in a plane that divides two opposing anchors including the longitudinal axis of the device. FIG. 5B is a partial cross-sectional view showing the partial assembly of FIG. 5A with the safety mechanism engaged. FIG. 5B is a partial sectional view showing the partial assembly of FIG. 5A in a state where the safety mechanism is disengaged. FIG. 5B is a partial cross-sectional view showing the partial assembly of FIG. 5A in a state when the trigger is pushed down. FIG. 2 is a partial view showing a working tube and an automatically actuated closing mechanism of the surgical closure device of FIG. 1. It is sectional drawing based on the plane A of FIG. FIG. 8 is a cross-sectional view based on plane A of FIG. 7 when the cannula is disposed in the outer working tube. FIG. 8B is a continuous and schematic illustration of retracting the cannula of FIG. 8B relative to the outer working tube and releasing the closure element. FIG. 8B is a continuous and schematic illustration of retracting the cannula of FIG. 8B relative to the outer working tube and releasing the closure element. FIG. 8B is a continuous and schematic illustration of retracting the cannula of FIG. 8B relative to the outer working tube and releasing the closure element. FIG. 2 is a partial view of the outer working tube of the apparatus of FIG. 1 with an automatically actuated closure mechanism inserted into the tissue. FIG. 2 is a partial view of the outer working tube and cannula with the self-actuating closure mechanism of the apparatus of FIG. 1 inserted into tissue. Fig. 2 shows the self-actuating closure mechanism of the device of Fig. 1 inserted into tissue after removal of the cannula and working tube. 10A schematically illustrates the force applied by the anchor of FIG. 10A. 10A schematically illustrates the force applied by the anchor of FIG. 10A. FIG. 10B shows the anchor of FIG. 10A when retracted to the closed or approximate position of the anchor to close the hole in the tissue. FIG. 10B shows the anchor of FIG. 10A when retracted to the closed or approximate position of the anchor to close the hole in the tissue. Fig. 4 shows a closure element having a V-shape according to a preferred embodiment of the present invention. Figure 3 shows another V-shaped closure element according to a preferred embodiment of the present invention. 1 shows an anchor according to a preferred embodiment of the present invention. Figure 13 shows the anchors of Figure 13 and the closure element of Figure 12 when closing a hole in tissue. 1 shows a surgical closure device according to a preferred embodiment of the present invention. 16 is a front perspective view showing the distal end of the surgical closure device of FIG. 15 with an anchor and a closure element. FIG. 16 is a partial view showing a partial assembly of the apparatus of FIG. FIG. 16 is a side view showing a trigger of the apparatus of FIG. 15. FIG. 16 is a top view showing a trigger of the apparatus of FIG. 15. FIG. 16 is a bottom view showing a trigger of the apparatus of FIG. 15. FIG. 16 is a partial view of the trigger subassembly of the apparatus of FIG. 15 with the trigger in an initial state. FIG. 19 is a partial view of the trigger subassembly of FIG. 18 with the trigger depressed. FIG. 16 is a front cross-sectional view of the partial assembly of the apparatus of FIG. 15 with the key plate in the engaged state and the first position. FIG. 18C is a front cross-sectional view of the partial assembly of FIG. 18C with the key plate in the disengaged state and the first position. FIG. 18C is a front cross-sectional view of the partial assembly of FIG. 18C with the key plate in the disengaged state and the second position. FIG. 16 is a schematic view showing engagement between a trigger bar and a hammer sleeve of the apparatus of FIG. 15. FIG. 16 is a schematic diagram showing the trigger bar of the apparatus of FIG. 15 disengaged from the hammer sleeve. FIG. 16 is a schematic front view showing the latch member and the safety switch of the apparatus of FIG. 15 with the safety switch in an engaged state. FIG. 16 is a schematic front view showing the latch member and safety switch of the apparatus of FIG. 15 with the safety switch in a disengaged state. Fig. 3 shows an anchor pushed into tissue without a closure element. FIG. 20B shows the tissue of FIG. 20A punctured at a location within the perimeter defined by the anchor. FIG. 20B shows an anchor placed around the hole formed in FIG. 20B. FIG. 20B shows the hole of FIGS. 20B and 20C closed by an anchor and closure element. Figure 3 shows an anchor surrounding a punctured tissue. 1 is a perspective view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 1 is a cross-sectional view of a tissue compression band assembly according to a preferred embodiment of the present invention. 1 is a side view of a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 1 is a side view of a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 1 is a perspective view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. FIG. 3 is a front view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. It is a perspective view which shows the pusher plate based on preferable embodiment of this invention. FIG. 3 is a cross-sectional view showing a tissue compression band assembly and pusher pin according to a preferred embodiment of the present invention. Fig. 5 shows a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. Fig. 5 shows a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. Fig. 5 shows a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. Fig. 3 shows tissue closed by a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 3 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 2 is a front view of an end portion according to a preferred embodiment of the present invention. 1 is a front view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 1 is a perspective schematic view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 32 is a perspective view showing a sliding brace of the apparatus of FIGS. 13A and 31B. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 4 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. 1 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 1 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 1 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 1 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a cam of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a sleeve of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a working tube of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows a working tube of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 1 shows an anchor according to a preferred embodiment of the present invention. Fig. 4 shows a deployed arrangement of anchors and closure elements according to a preferred embodiment of the present invention. 1 shows an anchor according to a preferred embodiment of the present invention. 1 shows a tensioning device according to a preferred embodiment of the present invention. 1 shows a tensioning device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. Fig. 4 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention.

  As will be shown in more detail below, preferred embodiments of the present invention allow a tissue opening (eg, a pericardial or myocardial window) to be reliably and effectively closed, which eliminates the need for sutures, for example. By limiting the possibility of human error. In some examples, the surgical device secures a plurality of anchors coupled together by one or more elastic closure elements into the tissue. The anchor is driven and pushed into the tissue in a spaced configuration in which an elastic closure element is provided under tension between the anchors. The anchors are held in a spaced apart arrangement while the surgical procedure is being performed through a tissue opening formed between anchor anchor locations. To close the opening, the device simply releases the anchor from the spaced apart arrangement so that the elastic closure element under tension attracts the anchor, as well as the tissue to which it is anchored, toward the tissue opening. is there. Thereby, the tissue opening is held in a closed state. The tension remaining in the elastic closure element may enter the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force. Counteract the counter force.

  For example, referring to FIGS. 1-10E, the surgical procedure involves positioning the surgical closure device 5 at a surgical entry location, such as a location on the heart wall if access to the interior of the heart is desired. The surgical closure device 5 is then actuated, eg, via a trigger, to drive the plurality of anchors 200 into the tissue at predetermined locations spaced around the surgical entry location. The anchor 200 is preloaded towards the entry position by a pretensioned closure element 300 in the form of an elastic band. Anchor 200 is maintained in these outward positions by cannula 400 and / or outer working tube 100. After the anchor 200 is driven, portions of the surgical device other than the cannula 400, outer working tube 100, anchor 200, and closure element 300 are removed.

  The cannula 400 then provides a working channel. Surgical procedures can be performed through this working channel. For example, tissue 900 can be punctured by extending a trocar through the channel of cannula 400. A catheter, guidewire, and / or other instrument can then be inserted through the working channel based on any appropriate interventional or surgical procedure. To complete the procedure, any catheter or other instrument that extends through the working channel is withdrawn, and cannula 400 and working tube 100 are withdrawn proximally from the surgical entry site. By retracting the cannula 400 and working tube 100, the pretensioned closure element 300 pulls the anchor 200 toward the surgical entry site. As anchor 200 is secured within the tissue surrounding the surgical entry site, this results in the tissue surrounding the surgical entry site being pulled together, thereby closing the surgical entry hole. In contrast to conventional procedures, no suturing is required.

  Although cannula 400 is provided separately from outer working tube 100, it will be appreciated that the preferred embodiment may include only one tube. For example, the cannula 400 is not provided in the device 5, and the working tube 100 functions as a cannula.

  1 and 2 show an example of a surgical closure device 5. The surgical closure device 5 includes a handle 10 that is configured to be held by an operator, eg, a surgeon, for manipulating the surgical closure device 5 during a surgical procedure. A shaft 20 extends distally from the handle 10 and includes a distal end 25. An outer working tube 100 is disposed in the hole of the shaft 20, and the outer working tube 100 extends coaxially along the longitudinal axis x of the shaft 20. The outer working tube 100 is exposed distally through the opening of the shaft 20. The outer working tube 100 has an outer diameter that is smaller than the inner diameter of the shaft 20, so that the outer working tube 100 can slide along the longitudinal axis x. Although each of the outer working tube 100 and the shaft 20 is formed as a right circular cylinder with a coaxial through hole, it will be appreciated that the outer working tube 100 and / or the shaft 20 may have any suitable geometry, e.g., an ellipse. It may comprise a cross-section such as a shape, a polygon, and / or a cross-section that varies along the longitudinal axis x. Furthermore, the geometry of the holes may be significantly different from the outer geometry of the outer working tube 100 and / or the shaft 20.

  Referring to the inset partial view of FIG. 1, the distal end 25 of the shaft 20 includes six notches or slots 26. These notches or slots 26 extend a predetermined distance from the distal tip of the shaft 20 proximally along the longitudinal axis x. The slot 26 may be formed in any suitable form, for example, by forming three cuts in the distal end 25, each cut forming two slots 26 on opposite sides of the axis x. The dimensions of the slot 26 are selected to allow six respective anchors 200 to be placed within the slot 26. In this regard, the wall thickness of the shaft (ie, the distance between the hole and the outer surface) and the width of each slot 26 may be selected to be slightly larger than the respective lateral dimension of the anchor 200. If the anchor 200 has radial protrusions, the width of the slot 26 may be smaller than the diameter of the anchor through the protrusion. Accordingly, the geometry of the slot 26 may require the anchor 200 to be oriented so that the radial protrusions are at least approximately aligned with the longitudinal axis x of the shaft 20. This is because otherwise the anchor 200 will not fit into the slot 26.

  FIG. 3 is a front view of the surgical closure device 5. The slots 26 having the respective anchors 200 are provided at uneven intervals along the circumferential circumference of the shaft 20. Specifically, two slot groups 26 are provided in a state where one group is located on the opposite side of the axis line x from the other group. Each of the two groups includes three slots 26 that are equally spaced. The circumferential spacing between groups is greater than the circumferential spacing between individual slots 26 within each group.

  Referring to the inset partial view of FIG. 3, the slot 26 includes a side wall with longitudinally extending cylindrical grooves 27 for receiving the body 201 of the anchor 200. Further, the closure element 300 attached to the anchor 200 can pass along the cylindrical groove 27. The slot 26 is also elongated in the radial direction to accommodate the wings 207 and 208. These wings are described in detail below in connection with FIG. Furthermore, the presence of a gap between the outer working tube 100 and the end 25 of the shaft 20 allows a closure element 300 to be placed between them, as shown in FIG. .

  FIG. 4 shows an anchor or implant 200. Anchor or implant 200 is configured to be driven and pushed into tissue. The anchor 200 includes a bowl-shaped body 201. The body 201 includes a groove 203 that extends in the axial direction along the length of the body 201. As described above, the plurality of grooves 203 and the plurality of flanges 205 alternately extend in the circumferential direction of the body 201. Furthermore, the anchor body 201 includes a pair of wing-like parts or divided parts 207 and 208. The dividing parts 207 and 208 are formed by respective tears or cuts 209 made in the body 201. In this regard, the split 209 may be formed by forming a cut radially in the body 201 and extending it axially. Thus, the two splits 207 and 208 are attached to the rest of the body 201 at a distal location and extend proximally to the free end. The free end includes a plurality of sharp protrusions along the curved surface. These tips are formed on the basis of the wrinkles. Specifically, as shown in the insertion partial side view of FIG. 4, the collar 205 forms a sharp protrusion. These protrusions are advantageous for grasping tissue and preventing the distal slide of anchor 200. Although each split 207 and 208 includes three such protrusions as shown, it should be understood that anchor 200 is one or more of the splits with a single sharp protrusion. It may be configured to have any other number of protrusions including. For example, if a greater number of sharp protrusions are desired, a denser ridge can be applied to the body 201 (ie, the number of alternating grooves 203 and ridges 205 can be increased), and It is also possible to adjust the angle of the cut or slice. Further, by changing the depth of the groove 203 relative to the ridge 205, the length of the protrusion extending proximally can be adjusted.

  Splits 207 and 208 do not significantly prevent distal insertion into the tissue, but resist movement from the insertion site to the proximal side by engaging the tissue. It has been found that the combination of proximal ends having the sharp edges and / or sharp edges of the splits 207 and 208 and the scissors provided alternately at the proximal ends of the splits improves performance.

  Furthermore, the split or wings 207 and 208 are offset from one another in the axial direction. For example, the dividing unit 207 is arranged at a position along the axis xx in the axial direction, and the dividing unit 208 is arranged at a position b along the axis xx in the axial direction. This allows for greater structural strength of the other parts of the body 201 compared to the unshifted configuration. Specifically, the cuts continue to move radially inward continuously as they travel distally, so that in an unshifted configuration, the portion is cross-sectional at the distal end of the cut. The amount of material is significantly reduced. This leads to mechanically weak points or regions along the body axis, which can lead to mechanical defects, especially in the case of small sized anchors. The anchor 200 utilizes a pair of wings 207 and 208 to secure the anchor 200 to resist proximal withdrawal from the tissue, but it should be appreciated that there are any number of wings. Alternatively, or in addition to wings 207 and 208, any other suitable anchoring structure, such as anchoring filaments, may be provided.

  The distal tip of the anchor 200 is in the shape of a pyramid and has a sharp tip and a plurality of faces separated by edges that converge at the sharp tip. Although four flat surfaces are provided, it will be appreciated that any suitable number of surfaces may be provided, and one or more or all of the surfaces may not be flat.

  Anchor 200 also includes a hook-like end 210. The hook-like end 210 is configured to receive one or more closure elements 300. An alignment protrusion 220 is provided on the opposite side of the anchor 200 from the hook-shaped portion 210. The alignment protrusion 220 is formed to rotationally align the anchor 200 about its longitudinal axis xx. The anchor 200 in the illustrated example is aligned with the alignment protrusion 220 and the split portions 207 and 208, and the alignment protrusion 220 and the split portions 207 and 208 are planes that include the longitudinal axis x of the shaft 20 and the longitudinal axis xx of the anchor 200. Needless to say, the alignment protrusions 220 and the splits 207 and 208 include the longitudinal axis xx of the anchor 200 and the longitudinal axis x of the shaft 20 and the device 20. May be intersected and aligned along a plane that is transverse to the plane containing the longitudinal axis xx, eg, a vertical plane. Further, alignment protrusions may be provided at any suitable location around the anchor 200 relative to the splits 207 and 208, and any suitable number of alignment protrusions 220 may be provided for a particular anchor 200. Good.

  Anchor 200 may include one or more shoulders. The shoulder is formed by the junction of the wings 207 and 208 and the body 201, or the wings 207 and 208 extend proximally and radially outward from the distal end, or farther than the distal end. Defined by the area of anchor 200 on the distal side. As shown in FIG. 4, the wings 207, 208 have a relaxed, uncompressed position, but can be compressed to a second compressed position closer to the body. Further, the body 201 may be flexible so that forces received within the proximal end affect the position of the wings 207 and 208 and the body or stem 201 relative to the distal end. be able to.

  Although the anchor 200 is illustrated with a closure element 300, it will be appreciated that the anchor 200 may be used with any other closure element, including, for example, the closure elements 1300, 2300 detailed below. .

  The anchor 200 first forms a body 201 with ridges, for example by injection molding or extrusion, and subsequently forms splits 207 and 208 by, for example, making radial cuts in the sides of the body 201. May be manufactured by. As shown, the notch is curved with the angle relative to the longitudinal axis xx of the body 201 (at the proximal entry point) gradually decreasing from the proximal initial cutting location toward the distal end of the anchor 200. And eventually it becomes linear. The segment or incision in the illustrated example is formed to have a curved or changing angle with respect to the longitudinal axis direction xx of the body 201, but of course any suitable incision including a linear incision. May be formed.

  The anchor 200 includes two wings or divisions spaced evenly around the radial circumference of the body 201, but of course any number of divisions including a single division. The portions may be provided at any suitable interval around the radial circumference of the anchor 200.

  Current manufacturing methods enable the application of near nanotechnology. This allows the anchor 200 to be manufactured with a size and complexity that was not possible in the past. Anchor 200 may be injection molded from an absorbent or non-absorbable polymer and then processed to add the features of wings 207 and 208 (eg, by cutting). Although anchor 200 is formed from a polymer, any suitable material, such as a metal or composite material, may be used. Anchor 200 may have a diameter of, for example, 1 millimeter, or approximately 1 millimeter, and a length of, for example, 5 millimeters to 10 millimeters. According to some preferred embodiments, the diameter is less than 1 millimeter. According to some preferred embodiments, the diameter is between 0.8 millimeters and less than 1.2 millimeters. However, it will be appreciated that other dimensions may be provided.

  FIG. 5 shows a partial assembly of the surgical closure device 5. The subassembly includes a trigger 30, a safety slide 35, a safety slide biasing spring 40, a hammer sleeve 500, a drive spring 550, an anvil pin 600, an outer working sleeve 100, and an anchor 200. . In the state shown in FIG. 5, the surgical closure device 5 is loaded and ready to be actuated to drive the anchor 200. In this regard, the proximal end of hammer sleeve 500 contacts the distal end of drive spring 550. The drive spring 550 is in a compressed state as shown in FIG. In order to maintain the hammer sleeve 500 in its proximal position while the compressed drive spring 550 applies a distally directed force, as shown schematically in FIG. 6A, the hammer sleeve 500 latches with the trigger plate 32 of the trigger 30. 6A-6C, the hammer sleeve 500 and the trigger plate 32 are shown in cross-section for ease of illustration. To latch the hammer sleeve 500, the trigger 30 is depressed until the hammer sleeve 500 is pushed proximally while the lip or step over the proximal side of the trigger plate 32 moves proximally. (Eg, as shown in FIG. 4C). Then, as shown in FIG. 6A, the trigger 32 is moved to the non-depressed position (eg, via a spring bias and / or manually). The trigger moves laterally between a depressed position and a non-depressed position by sliding within a lateral channel in the housing of the handle 10. However, any suitable guide mechanism may be provided.

  The safety slide includes a safety rib or bar 38 to maintain the trigger 32 in the non-depressed position so as to prevent or reduce accidental actuation of the anchor 200. The safety rib or bar 38 is positioned adjacent to the trigger plate 32 as shown in FIG. 6A to form a positive or hard stop so that the trigger 30 is not depressed in FIG. 6A. Prevents movement from the position to the depressed position of FIG. 6C. For example, as shown in FIG. 6A, the safety slide 35 includes a pair of lateral protrusions 36. The lateral protrusion is formed to slide longitudinally within a corresponding channel provided in the housing of the handle 10. However, any suitable guide mechanism may be provided. The safety slide 35 also includes a knob portion 37 to facilitate sliding of the safety slide 35 using, for example, one finger of an operator.

  When the operator desires to drive the anchor 200, the operator must first move the safety slide 35 to the drive position. In the drive position, the safety bar 38 does not interfere with the movement of the trigger plate 32. Referring to FIG. 5, the safety slide is propelled or biased toward the proximal safety position by the compression spring 40. Thus, the operator must continuously apply force to the knob 37 until the bottom of the trigger plate 32 moves to a position that prevents or blocks the safety bar 38 from returning to the safe position. Thereby, higher safety can be provided. This is because, in most cases, the operator must coordinate the holding of the safety slide 35 at the driving position while pushing down the trigger 30. Needless to say, however, the safety slide 35 may be formed so as to remain in the driving position without continuously applying force. Furthermore, it goes without saying that the device 5 may be provided without any safety mechanism.

  FIG. 6B shows the safety slide 35 in the drive position. The safety slide is moved distally, ie in the direction of the arrow shown in FIG. 6B, but it goes without saying that the safety switch can be in any suitable direction for moving between the safety position and the firing position. It may be formed to move. After the safety slide 35 is moved to the drive position shown in FIG. 6B, the lower portion of the trigger plate 32 rides over the step 505 of the hammer sleeve 500, thereby being actuated by the compressed drive spring 550. The operator pushes down the trigger 30 with one finger of the operator, for example, until the hammer sleeve 500 is released for movement toward the rear side.

  For example, referring to the partial cross-sectional view of FIG. 6B, the hammer sleeve 500 is spaced from the anvil pin 600 before the trigger is depressed. The anvil pin 600 is slidable along the longitudinal axis x of the shaft 20 within the respective bore of the shaft 20 corresponding to the respective anchor 200. The hammer sleeve 500 gains speed and momentum as it advances. Upon contact with the proximal end of the anvil pin 600, the anvil pin 600 imparts momentum to the anchor 200. This is because the distal end of the anvil pin 600 is aligned with the proximal end of the anchor 200. Thus, the anchor 200 is driven at a considerable speed. This facilitates driving of the anchor 200 into the soft tissue.

  The anchor is preferably driven at a speed in excess of 50 meters per second, more preferably at a speed of 50 to 350 meters per second, and most preferably 350 meters per second. However, it will be appreciated that the anchor 200 may be driven at any suitable speed sufficient for the anchor to puncture tissue.

  Further, the anchor 200 may be driven and pushed into a single or multiple layers of tissue, and the speed may be determined by the structural properties, dimensions, and relative locations of one or more tissues into which the anchor is pushed. May be selected based on

  In order to accurately penetrate soft tissue that is not held or anchored distally, rapid penetration into each tissue layer may be required to provide penetration into the tissue layer. When the anchor 200 is applied at a low speed, the tissue is displaced distally by the anchor 200 without sufficient penetration. Thus, some example delivery mechanisms eject each implant at a relatively high rate as described above. Although Example Device 5 utilizes a spring-loaded mechanical drive mechanism, it will be appreciated that other drivers may be provided. In some examples, saline is used to pressurize the catheter, needle, or other channel inside the tube at a rate such that the plunger ejects the anchor at the correct rate. In a further preferred embodiment, the anchor is pushed using a long push rod that extends the length of the catheter or other tube. The ejection mode may be computer controlled and / or operator controlled. For example, similar to the spring loaded mechanical system of the illustrated example, the driving force can be predetermined and repeated by the operator activating the trigger 30.

  Further, the driver may be configured to drive the anchor 200 to a predetermined depth. In the illustrated example, the depth is controlled by contact between the anchor 200 and a closure element 300 (described in detail below) coupled to a flange or flared portion 405, but any other depth control mechanism is possible. Additionally or alternatively may be provided. For example, depth accuracy can be achieved with a precise hydraulic drive force, engagement with other stoppers, or sutures that are tensioned to limit depth. Further, depth may be monitored using fluoroscopy, echocardiography, intravascular ultrasound, or any other suitable imaging mechanism. The drive mechanism may include pressurized saline or other hydraulic fluid pressurized through the thoracoscopic catheter shaft. In this way, very accurate control can be achieved.

  FIG. 6 is an enlarged partial view of the partial assembly of FIG. As shown, the plurality of closure elements 300 are coupled to the hook portion 210 of the anchor 200. There are four closure elements 300. Each of these is precisely coupled to the hook portions 210 of the two anchors 200. Thus, for example, as shown in FIG. 10, two anchors 200 are attached to exactly two different closure elements 300 and four anchors are attached to exactly one closure element 300. Of course, however, other sequences may be provided.

  FIG. 7 is a partial view of working tube 100, anchor 200, and closure element 300. As shown in FIG. 7, the anchor 200 is driven and pushed into, for example, tissue. The anchor 200 and the closure element 300 form a self-actuating closure mechanism of the surgical closure device 5. During actuation of anchor 200, closure element 300 is also driven a similar distance based on the engagement of closure element 300 and anchor 200.

  Referring to the cross-sectional view of FIG. 8A, the closure element 300 is layered and held along the periphery of the outer working tube 100, thereby preventing the closure element 300 from pulling the anchors 200 toward each other.

  FIG. 8B is the same as FIG. 8A except that the cannula 400 is disposed inside the outer working tube 100. The element shown in FIG. 8B may be separated from the rest of the surgical device 5 to allow a surgical procedure to be performed. For example, by inserting a trocar longitudinally through the interior of the cannula 400, the tissue can be punctured at a location surrounded by the anchor 200 secured within the tissue. Tissue puncture may allow access to the other side of the tissue (such as a built-in interior such as the heart) by thoracoscopic devices including guidewires and catheters, or other surgical and interventional devices.

  Cannula 400 includes six flared portions or flats 405 that extend radially. The cannula 400 extends coaxially within the outer working tube 100. Since the cannula 400 extends distally beyond the distal end of the outer working tube 100, the flat 404 is folded over the distal end of the outer working tube 100. By extending the flat 405 radially beyond the circumferential circumference of the outer working tube 100, the flat 405 forms a positive or rigid stopper. These stops, for example, prevent or resist the inadvertent sliding of the closure element 300 from the end of the outer working tube 100 while a thoracoscopic procedure is being performed through access through the cannula 400.

  When the procedure no longer requires access through the cannula 400, any surgical instrument can be retracted through the cannula 400 via the cannula. At this stage, the tissue hole formed by the trocar should be closed. To do so, the cannula 400 is moved relative to the outer working tube 100, as shown sequentially in FIGS. 8C and 8D. In doing so, the flat 405 formed as a leaf spring pivots into a longitudinal orientation and is retracted. Thus, the flat 405 no longer forms a stop that resists the sliding of the closure element 300 distally along the outer working tube 100. This orientation is shown in FIG. 8D. The flat 405 may be formed from any suitable material, such as a shape memory material such as nitinol, spring steel, and the like.

  The flat 405 may be bistable with two static orientations, one corresponding to an orientation that flares in a radial direction, and the other orientation corresponding to a longitudinal orientation.

  After the flat is retracted, cannula 400 and outer working tube 100 are retracted proximally from the surgical entry site. The closure element remains adjacent to the surgical closure site because the closure element 300 is engaged with the hook-like portion 210 of the anchor 200 secured into the tissue against proximal withdrawal. Thus, retracting the cannula 400 and the outer working tube 100 proximally causes the outer working tube 100 to slide distally with respect to the closure element 300. By retracting cannula 400 and outer working tube 100 further distally, closure element 300 slides off the distal end of outer working tube 100, thereby closing closure element 300 and anchor 200 from cannula 400 and working tube 100. Disengage entirely. Since the closure element 300 is pre-tensioned, the anchor 200 is pulled toward the hole formed at the surgical entry site. Since anchor 200 is anchored in the tissue surrounding the hole, pulling the anchors closer together pulls the surrounding tissue toward the hole. Thus, the hole is squeezed and closed, and the closure element 300 maintains a closing force to keep the hole closed.

  FIG. 9A is a partial view showing the outer working tube 100 with the anchor 200 inserted into the tissue 900. FIG. 9B is the same as FIG. 9B, but shows a flat 405 schematically. Flat 405 extends between outer working tube 100 and closure element 300 to prevent closure element 300 from causing premature or accidental closure of the tissue entry opening. FIG. 9B may be a working arrangement with portions of the surgical device 5 other than the cannula 400, outer working tube 100, anchor 200, and closure element 300 removed. Accordingly, various other surgical instruments, such as catheters, guidewires, and other instruments can be manipulated through the interior of cannula 400 and outer working tube 100.

  FIG. 10 shows the self-actuated closure mechanism, in this case the anchor 200 and closure element 300 inserted into the tissue after removal of the cannula 400 and working tube 100. For purposes of illustration, anchor 200 is shown in an initial drive position within tissue 900. In other words, for ease of illustration, this mechanism is shown as if the anchors 200 are prevented from being drawn together by the closure element 300. The anchor 200 is disposed around a surgical entry opening 905 formed by, for example, a trocar.

  The anchors 200 are arranged in two opposing anchor groups. In order to facilitate the description of the mechanism shown in FIG. 10A, the anchor 200 is labeled with individual symbols 200a, 200b, 200c, 200d, 200e, and 200f. The first group includes anchors 200a, 200b, and 200c, and the second group includes anchors 200d, 200e, and 200f. Each of the anchors of each group is coupled directly to at least one anchor of the other group by a closure element 300. Furthermore, the two anchors in either group are not directly connected to each other by the closure element. That is, each closure element 300 is coupled at one end to the anchors of the first group 200a, 200b, and 200c and at the other end to the anchors of the first group 200d, 200e, and 200f. Therefore, the force applied by the element 300 is mainly directed in the direction from one group to the other group.

  As can further be seen from FIG. 10A, the anchor / closure element mechanism is formed as two V-shaped groups that overlap in opposition. The first V-shaped group is formed from anchors 200a, 200e, and 200c and closure elements 301,304. The second V-shaped group is formed of anchors 200d, 200b, and 200f and closing elements 302, 303.

  Since each closure element is wrapped around two anchors to form a single complete loop, the force applied by the respective closure element at each anchor is the two anchors to which the closure element is coupled. Is equal to the sum of the tensions in the two band portions extending between. Furthermore, the force is applied along a line extending between the two anchors to which the closure elements are coupled. In this regard, the forces applied at the anchors 200a, 200b, 200c, 200d, 200e, and 200f are shown in FIG. Is shown in Specifically, F301a represents the force applied by the closure element 301 at the anchor point of the anchor 200a, F301e represents the force applied by the closure element 301 at the anchor point of the anchor 200e, and F302b is the anchor point of the anchor 200b. F302d represents the force applied by the closure element 302 at the anchor point of the anchor 200d, F303b represents the force applied by the closure element 303 at the anchor point of the anchor 200b, F303f represents the force applied by the closure element 303 at the anchor point of the anchor 200f, F304c represents the force applied by the closure element 304 at the anchor point of the anchor 200c, and F304e It represents the force exerted by the closure element 304 in fixed locations in over 200e. In addition, these forces form three pairs of complementary forces that are equal and opposite each other. Specifically, the first pair F301a and F301e, the second pair F302b and F302d, the third pair F303b and F303f, and the fourth pair F304c and F304e. Each pair corresponds to a single closure element 301, 302, 303, 304, respectively, and each closure element 301, 302 between two anchors 200 to which the respective closure element 301, 302, 303, 304 is coupled. , 303 and 304 are directed in directions opposite to each other.

  Since the anchors 200a, 200c, 200d, 200f are each coupled to a single closure element 301, 304, 302, 303, only a single vector F301a, F304c, F302d, F303f, respectively, is shown in FIG. 10B. . Since anchors 200b and 200e are each coupled to two closure elements, two force vectors are associated with each of anchors 200b and 200e in FIG. 10B. That is, the anchor 200b coupled to the closure elements 302 and 303 has two force vectors F302b and F303b acting through the anchor point of the anchor 200b, and the anchor 200e coupled to the closure elements 301 and 304 is There are two force vectors F301e and F304e acting through the anchoring point of the anchor 200b.

  Since the forces represented by vectors F302b and F303b both operate through the same location, i.e., the anchor location of anchor 200b, the resultant force through anchor location of anchor 200b is defined as the sum of two vectors F302b and F303b. It's okay. Similarly, since the forces represented by vectors F301e and F304e both act through the anchor point of anchor 200e, the resultant force through anchor point of anchor 200b is defined as the sum of two vectors F302b and F303b. It's okay. Correspondingly, FIG. 10C schematically shows the resultant force exerted on each anchor by the closure element. The force applied through anchor 200b is represented by composite vector F302f + F303f, and the force applied through anchor 200e is represented by composite vector F301e + F304e.

  Based on the positioning of the anchors 200a, 200b, 200c, 200d, 200e, 200f and the arrangement of the closing elements 301, 302, 303, 304, a higher compressive force is applied in the y-axis direction than in the z-axis direction. The z-axis corresponds to a line extending between the first anchor group 200a, 200b, 200c and the second anchor group 200d, 200e, 200f, and 200a, 200b, 200c and the second anchor group 200d, 200e, 200f, At least approximately equidistant from The y-axis is perpendicular to the z-axis, and both the x-axis and the y-axis extend along the surface of the tissue 900.

  Since the compression force is higher in the direction parallel to the x-axis than in the direction parallel to the z-axis, the opening 905 becomes flat or elongated along the z-axis as shown in the closed state of FIG. 10D. As such, the self-actuated closure device formed by the anchors 200a, 200b, 200c, 200d, 200e, 200f and the closure elements 301, 302, 303, 304 tends to close the opening 905. This can be desirable to maintain a more reliable closed state that is more leakproof.

  As schematically shown in FIG. 10D, the anchors 200a, 200b, 200c, 200d, 200e, 200f are attracted to the closed or approached position, thereby bringing the anchored tissue into the opening 905. Pulling toward it, thereby closing the opening 905 as shown. For ease of illustration, the closure elements 301, 302, 303, 304 are not shown in FIG. 10D. However, FIG. 10E shows the 10D closed state with the closing elements 301, 302, 303, 304. FIG. The forces applied to the anchors 200a, 200b, 200c, 200d, 200e, 200f by the closure elements 301, 302, 303, 304 are similar to those shown in FIGS. 10B and 10C. However, since the exemplary closure elements 301, 302, 303, 304 have spring-like elasticity, as the anchors 200a, 200b, 200c, 200d, 200e, 200f are pulled closer together, the closure elements 301, 302 , 303, 304 may be reduced.

  In the stationary closed position shown in FIGS. 10D and 10E (ie, where the anchors 200a, 200b, 200c, 200d, 200e, 200f settle after moving transiently from the orientation around the working tube 100), each anchor 200a, The force applied by the closure elements 301, 302, 303, 304 through 200b, 200c, 200d, 200e, 200f is caused by the tissue at each location of each anchor 200a, 200b, 200c, 200d, 200e, 200f by the tissue 200a, 200b, Equal to the resistance force applied in the opposite direction applied to 200c, 200d, 200e, 200f.

  FIG. 11 shows another closure element 1300. The closure element 1300 includes three anchor receiving portions 1310, 1320, 1330 arranged in a V-shape, with the portion 1320 disposed at the apex. Arm 1340 extends directly from anchor receiving portion 1310 to anchor receiving portion 1320 and arm 1350 extends directly from anchor receiving portion 1320 to anchor receiving portion 1330. Anchor receiving portions 1310, 1320, 1330 each have a respective opening 1312, 1322, 1332 for receiving a respective anchor, eg, anchor 200 described above, or anchor 1200 described in detail below in connection with FIG. ing. Anchor receiving portions 1310, 1320, 1330 are each toroidal in shape and have a material thickness greater than arms 1340 and 1350. However, it will be appreciated that any suitable geometry may be provided and any suitable material thickness may be provided. The toroidal shape of the anchor receiving portions 1310, 1320, 1330 couples to the anchors 200, 1200 in a manner similar to the band-shaped closure element 300 described above with respect to the anchor 200.

  Closure element 1300 functions in a similar manner as described above with respect to closure element 300, except that only two closure elements are required to generate the same force as shown in FIGS. 10B and 10C. Specifically, the closure element 1300 performs the same function as the closure element 301, 304 or two two closure elements 302, 303 of the second V-shaped group described above with respect to FIG. 10A. Further, the closure element 1300 differs in that each of the single structural elements, ie arms 1320, extends between opposing anchors.

  FIG. 12 shows another closure element 2300. The closure element 2300 includes three anchor receiving portions 2310, 2320, 2330 arranged in a V-shape with the portion 2320 disposed at the apex. Arm 2340 extends directly from anchor receiving portion 1310 to anchor receiving portion 2320 and arm 2350 extends directly from anchor receiving portion 2320 to anchor receiving portion 2330. Anchor receiving portions 2310, 2320, 2330 each have a respective opening 2312, 2322, 2332 for receiving a respective anchor. Anchor 2300 includes all of the features described above in connection with anchor 1300, but arms 2340, 2350 are widened to be approximately the same width as the respective outer diameters of anchor receiving portions 2310, 2320, 2330. It differs only in respect. This can be advantageous to provide additional strength and tension when the arms 2340, 2350 are extended.

  FIG. 13 shows the anchor 1200. Anchor 1200 is identical to anchor 200 described above, except that proximal end 1250 includes a circumferential channel 1255. The circumferential channel 1255 is formed as a continuous radial recess that extends the entire circumference of the anchor 1200. The channel is radially open and includes a first surface 1260 directed distally and a second surface 1265 directed oppositely proximally. A surface 1270 corresponding to the reduced diameter portion 1280 of the anchor 1200 extends between the first surface 1260 and the second surface 1265. Although the reduced diameter portion 1280 is cylindrical and coaxial with the longitudinal axis xx 'of the anchor 1200, it will be appreciated that any suitable geometry and orientation may be provided. For example, the reduced diameter portion 1280 may be frustoconical and / or have a curved cross section when viewed in a direction perpendicular to the longitudinal axis xx 'of the anchor 1200. Further, the surface 1270 of the reduced diameter portion 1280 may vary along the circumference of the anchor 1200.

  The circumferential channel 1255 axially separates the proximal head portion 1285 from the distal remainder of the anchor 1200 body.

  When one or more closure elements 300, 1300, 2300 are coupled to the anchor 1200, the first surface 1260 approaches one or more closure elements 300, 1300, 2300 beyond the channel 1255. Sliding from the end of the anchor 1200 by sliding to the rear side is suppressed. Similarly, the second surface 1265 prevents one or more closure elements 300, 1300, 2300 from sliding distally over the channel 1255. In this regard, the dimensions of the channel 1265, such as the width and depth of the channel 1265, are selected to accommodate a particular number of closure elements 300, 1300, 2300, or a single closure element 300, 1300, 2300. May be.

By fitting and placing the anchors 300, 1300, 2300 around the reduced diameter portion 1280 of the anchor 1200, a particular closure element 300, 1300, 2300 is fitted to the anchor 1200. For example, by anchoring each anchor receiving portion 1310, 1320, 1330, 2310, 2320, 2330 to the reduced diameter portion 1280 via the proximal head portion 1285 of the anchor 1200, the anchor receiving portion 1310 of the anchor 1300 is attached. , 1320, 1330 and / or anchor receiving portions 2310, 2320, 2330 of anchor 2300 can be fitted to anchor 1200. When fitted in this manner, the reduced diameter portion 1280 extends through the respective openings 1312, 1322, 1332, 2312, 2322, 2332 and the anchor receiving portions 1310, 1320, 1330, 2310, 2320, 2330 are channeled. Constrained between first and second walls or surfaces 1260 and 1265 of 1255. In this regard, the openings 1312, 1322, 1332, 2312, 2322, 2332 are
It may have a static diameter that is the same as, larger than, or smaller than the diameter of the reduced diameter portion 1280. However, in order to resist inadvertent disengagement of the closure elements 1300, 2300 from the anchor 1200, it provides a smaller stationary diameter than the first surface 1260, the second surface 1265, and / or the proximal head portion 1285. It may be advantageous.

  The channel 1255 performs a function similar to that of the hook-shaped portion 210. The anchor 1200 does not include a hook-like portion such as the hook-like portion 210 of the anchor 200, but it will be appreciated that in combination with the channel arrangement of the anchor 1200, one or more hook-like portions are provided. May be.

  FIG. 14 shows the plurality of anchors 1200 of FIG. 13 and the closure element 2300 of FIG. 12 when the hole 1905 of the tissue 1900 is closed. Similar to the example described above with respect to anchor 200, the individual instances of anchor 1200 are shown in lower case. In this regard, anchors 1200a, 1200b, 1200c, 1200d, 1200e, and 1200f are arranged in the same form as described above with respect to anchors 200a, 200b, 200c, 200d, 200e, and 200f, And apply the same power to each. The axes yy and zz in FIG. 14 correspond to the axes y and z.

  In FIG. 14, there are first and second cases of closure element 2300. The second case is distinguished by postfixing the letter “′” (prime) with a similar sign. Compared to the overlapping V-shaped arrangement shown in FIG. 10A, arm 2350 of FIG. 14 performs a similar function as closure element 301 and arm 2340 ′ performs a similar function as closure element 302. 2350 ′ performs a similar function as closure element 303 and arm 2340 performs a similar function as closure element 304. Further, similar to the array of FIG. 10A, the two V-shaped arrays are both overlapping and interlocking. That is, when viewed along a line perpendicular to the surface of tissue 900, 1900, each V-shaped array of each form has a first extension intersecting at the proximal side of each opposing V-shaped, A second extension intersecting at the distal side of the V-shape. Thus, referring to FIG. 10A, with respect to the surface of tissue 900, closure element 302 overlaps closure element 301 and closure element 304 overlaps closure element 303. Similarly, referring to FIG. 14, arm 2340 'overlaps arm 2350, and arm 2340 overlaps arm 2350'. However, it will be appreciated that other forms may be provided.

  FIG. 15 illustrates a surgical closure device 1005 according to a preferred embodiment of the present invention. Except as otherwise noted, the surgical closure device 1005 includes features that are the same or similar to all of the features of the surgical device 5 detailed above. Further, the features described with respect to the surgical closure device 1005 may be provided in combination with any features of the surgical closure device 5.

  Surgical closure device 1005 includes a handle 1010 that includes a pistol grip 1015. The pistol grip is configured to be held by an operator, such as a surgeon or intervention person, to operate the surgical closure device 1005 during a surgical procedure. A shaft 1020 extends distally from the handle 10 and includes a distal end 1025. Unlike the surgical closure device 5, the surgical closure device 1005 does not at least initially include an outer working tube or a cannula extending within the outer working tube. Instead, the surgical closure device 1005 includes a centering mechanism 1800 in the form of an elongated tubular shaft with a distal portion 1805. Distal portion 1805 tapers to reduce the diameter at the distal end of centering mechanism 1800. An inner guide hole 1810 extends along the longitudinal axis of the centering mechanism 1800 from the distal end 1815 to the proximal end 1825 of the centering mechanism 1800. When the device is assembled in the state shown in FIG. 15, the longitudinal axis of the centering mechanism 1800 corresponds to the longitudinal axis x ′ of the shaft 1020.

  The centering mechanism 1800 may be particularly advantageous during “over the wire” surgical procedures, such as pericardial puncture. Some pericardial punctures require the needle to be passed through the patient's intercostal opening. Inserting into the patient's thoracic cavity, into the pericardium, guiding the guidewire through the needle, and subsequently removing the needle while leaving the guidewire in place. The opening in the pericardial tissue can be dilated by advancing the dilator over the guide wire, and the dilated opening, or tube, provides room for the catheter. The fluid is drained from the pericardium by guiding it into the pericardium.

  Referring to device 1005, after the flexible guidewire is placed in the desired location within the pericardium and the needle is retracted, the free proximal end of the guidewire is introduced into the distal opening of guide hole 1810, and The guide wire is generally extended through the guide hole 1810 until it extends from the proximal end 1820. The device 1005 is then guided into the patient's body to the location of the pericardial tissue by sliding distally along a guide wire extending through the guide hole 1810. Once the distal end 1025 of the shaft 1020 is positioned to abut the tissue, the six anchors 1200 are driven and pushed into the tissue in substantially the same manner as described above for the anchors 200.

  Referring to FIG. 16, anchor 1200 is mated with two overlapping closure elements 1300, similar to that described above. In contrast to the closure element 300 of the device 5, the closure element 1300 is not held radially outward on the surface of the tube or other structure during the actuation of the anchor 1200. Rather, the closure element 1300 forms the operating window 1060 through the overlapping V-shaped structure of the closure element 1300. Overlapping V-shaped structures are detailed above with respect to closure elements 300, 2300.

  When the guide wire is passed through the guide hole 1810, the centering mechanism 1800 including the guide hole 1810 extends through the operation window 1060, so that the anchor is driven by the guide wire 1810 and any device passing over the guide wire 1810. After that, it is guaranteed to extend through the operation window 1060.

  As shown in FIG. 16, the tension applied to the elastomeric closure element 1300 causes the anchor receiving portions 1310, 1320, 1330 to expand and elastically deform. Thus, the vertices of the V-shaped portion move so as to approach each other. Further, when the vertex is displaced, each anchor 1300 has a Y-shape as shown in FIG.

  After the anchor is driven and pushed into the tissue, the centering mechanism 1800 is separated from the rest of the device 1005 and slides along the longitudinal axis x ′ away from the surgical site and along the guide wire. To be pulled distally. Centering mechanism 1050 can be removed by the operator by pulling proximal knob 1057 protruding proximally from handle 1010 proximally.

  When the guide mechanism 1050 is removed, the guide wire exits the guide hole 1810. The proximal free end of the guidewire can then be retracted into the tapered dilator. The dilator can be guided along the guide wire and through the shaft 1020 to the operating window 1060. The dilator can then be further advanced to contact and expand the tube of tissue through which the guidewire extends. After expansion, the dilator can be retracted proximally and disengaged from the guidewire. At that stage, the catheter can be advanced and advanced along the wire through the shaft 1020 and the operating window 1060. The catheter is further advanced into the pericardium through the expanded tissue opening. At this stage, the guide wire can be retracted and pericardial fluid can be drained through the catheter.

  Once drainage is complete, the catheter can be withdrawn proximally through the shaft 1020 from the surgical site. At this stage, there are no surgical components extending through the expanded opening. At this stage, the device 1005 can be retracted proximally from the tissue. By pulling the distal end of the shaft 1020 from the tissue, the anchor 1200 is disengaged or released, allowing the closure element 1300 to pull the anchor 1200 together as shown schematically in FIG. This closes the opening in the same way that the opening 1905 is closed in FIG.

  Referring to the inset partial view of FIG. 15, the distal end 1025 of the shaft 1020 includes six slots 1026 similar to the slots 26 described above in connection with the device 5. In the inset partial view, the anchor 1200 is shown schematically to facilitate illustration of other components of the device 1005.

  Referring to FIG. 16, the slot 1026 of the device 1005 has a cross-sectional shape similar to the slot 26 of the device 5, which allows a small gap between the diameters of the main body of the anchor 1200. It includes a circular ridge that is dimensioned and that corresponds to the circular groove 1027.

  Narrowed portions 1028 extend from opposite sides of the enlarged region 1029 formed by the cylindrical groove 1027. The constricted portion 1028 is formed to receive the splits 1207, 1208 of the anchor 1200, but is narrower than the diameter of the body 1201 of the anchor 1200 so that the anchor 1200 is within the enlarged region 1029 of the circular groove 1027. To be bound by Thus, when received within the slot 1026, the anchor 1200 is held in these axial alignments so that the longitudinal axis xx 'is aligned with the longitudinal axis x' of the shaft 1020.

  End 1025 is formed as a separate member attached to the remainder of shaft 1020. In this regard, the end 1025 can be replaced with a similar end 1025 or an end 1025 having a different configuration, eg, an end that holds the anchor in a different pattern. For example, the end 1025 together with the anchor and closure element forms a single use and discarded cartridge, and a new cartridge can be installed for further treatment. Furthermore, it goes without saying that the end 1025 may be integrally formed as a single member integral with the rest of the shaft 1020.

  Although the surgical closure device 1005 uses a drive mechanism similar to that of the device 5, including a hammer sleeve and an anvil pin (obstructed by the shaft 1020 in FIG. 15), the device 1005 has a different trigger and Includes safety mechanism.

  Referring to FIG. 15, the device 1005 includes a trigger 1030 that extends below the housing 1010 in substantially the same direction as the pistol grip 1015, as will be described in detail below when an operator, eg, a surgeon, grips the pistol grip 1015. To trigger the trigger 1030, the trigger 1030 can be actuated by an operator's finger, for example, the index finger and / or the middle finger, by pulling the grip portion 1031 exposed from the housing 1010 proximally. Yes.

  Referring to FIGS. 15 and 17 to 19, the trigger 1030 can pivot with respect to the handle 1010 about the pivot axis p. The pivot axis p corresponds to the longitudinal axis defined by the pivot pin 1040 to which the trigger 1030 is attached. Specifically, the pivot pin 1040 extends within a corresponding hole 1032 in the trigger 1030. This is illustrated, for example, in FIG. 18C. The axial end of the pivot pin 1040 is mounted in a corresponding recess in the handle 1010.

  The trigger 1030 includes a pair of flat surfaces 1033. These surfaces are separated from each other in opposite directions along the pivot axis p. The flat surface 1033 extends along the region of the trigger around the hole 1032 and extends proximally along the proximal arm 1033.

  The proximal arm 133 extends proximally with respect to the pivot axis p and has a curved upper surface 1034. Side projections 1036 extend from each side of the proximal arm. The side protrusions protrude outward from the respective flat surfaces 1031 and extend generally parallel to the pivot axis p. Each side projection 1036 has a curved upper surface 1037.

  Latch member 1045 includes a lateral portion 1050 disposed distally. When the device is assembled, the transverse portion 1050 extends generally along the pivot axis p and transverse to the longitudinal axis x 'of the shaft 1020. A pair of parallel arms 1055 extends proximally from the lateral portion 1050. Each of the parallel arms 1055 includes a hole 1056 formed to receive the pivot pin 1040 and a pair of opposing surfaces 1057 formed to receive the trigger 1030 therebetween so that the device 1005 can be When in the assembled state, each of the outwardly facing surfaces 1033 of the trigger 1030 faces one of the inwardly facing surfaces 1057 of the arm 1055. When the trigger 1030 is received between the arms 1055 of the latch element 1045 in the assembled state of the device 1005, the hole 1056 is coaxial with the hole 1032 of the trigger 1030 and the pivot pin 1040 is aligned with the two holes 1056 of the arm 1055. , And through each of the apertures 1032 of the trigger 1030, thereby providing a mechanism by which the trigger 1030 and the latch element 1045 can pivot about their common pivot axis p. Accordingly, the latch member 1045 engages the trigger 1030 at the pivot pin 1040 in a manner similar to a clevis. Although trigger 1030 and latch element 1045 pivot about a single common axis p, it should be appreciated that trigger 1030 and latch element 1045 may pivot about separate axes.

  The portion of the arm 1055 that extends proximally from the common axis p includes a lower surface 1058 formed to engage the upper surface 1035 of the proximal arm 1034 of the trigger 1030. Thus, when the trigger is pulled proximally, the trigger pivots about the common axis p in the first rotational direction CW. The first rotation direction CW is the clockwise direction when viewed from the side shown in FIG. 17B.

  The lateral portion 1050 of the latch member 1045 also includes a latch latching protrusion 1052. The latch engaging protrusion 1052 protrudes upward beyond the adjacent structure of the latch member 1045.

  Referring to FIG. 19A, the driver in the form of a hammer sleeve 1500 is in a preloaded proximal position and is driven by a drive spring 1550 (shown in FIG. 17A), similar to the hammer sleeve 500 of the device 5. Driven or biased distally. The drive spring 1550 is coaxially attached to the hammer sleeve 1500 and the shaft 1020 and is directed distally to the hammer sleeve 1500 via a force transmission flange 1560 that extends circumferentially around the hammer sleeve 1500. Apply the power. Although the drive springs 550 and 1550 described in connection with the devices 5 and 1005 are formed as compression springs, it will be appreciated that tension springs or other drive mechanisms may be provided.

  Hammer sleeve 1500 includes a latching channel 1510. The latch latch channel 1510 receives the latch latch projection 1052 and thereby forms a positive stop between the latch latch projection 1052 and the latch latch channel 1510 to prevent movement of the hammer sleeve 1500. To do. To release the hammer sleeve to drive the anchor 1200 in the same manner as described in connection with the device 5, the trigger is pulled distally, thereby triggering in the first rotational direction CW about the pivot axis p. Swivel. Such a swivel orientation is shown in FIG. 19B.

  As shown in FIG. 19B, rotation of the trigger 1030 causes the side projection 1036 to contact and push against the lower surface 1058 of the arm 1055, thereby causing the latch member 1045 to be shown in its trigger position, ie, FIG. 19B. Rotate to the desired position. In the trigger orientation of the abductor member 1045, the rotation of the latch member 1045 causes the distally disposed latch latching protrusion 1052 to disengage from the latching channel 1510 of the hammer sleeve, thereby causing the hammer sleeve to disengage the shaft 1020. Allows driving in the distal direction D along the longitudinal axis x ′, thereby driving the anchor 1020.

  As shown in FIG. 1, there are two safety mechanisms that prevent the release of the hammer sleeve 1500 by the latch member 1045. In order for the device to drive the anchor 1200, both of these safety mechanisms must be disengaged or changed from locked to unlocked at the same time.

  The first safety mechanism includes a pressure sensing mechanism including, for example, a spring loaded contact element 1100 shown in the inset partial view of FIG. The contact element 1100 is formed as a square block. These blocks are in the extended position shown in the inset partial view of FIG. 15, i.e. the extended position where the contact element 1100 extends beyond the distal end face of the shaft 1020, e.g. the contact element 1100 and the distal end of the shaft 1020. The contact element 1100 slides along the longitudinal axis x ′ of the shaft 1020 between a proximal position where the contact element 1100 is pushed proximally relative to the shaft 1020 until flush. The safety release mechanism may include a plurality of spring loaded members, each spring loaded member being able to move independently between the engaged and disengaged positions. The safety release mechanism is configured to prevent the driver from driving the anchor unless all of the spring loaded members are in the engaged position.

  Each contact element 1100 is slidable axially within a correspondingly sized slot 1080 as shown, for example, in FIG. The illustrated example includes four rectangular contact elements, although these contact elements are evenly spaced in approximately 90 degree increments about the longitudinal axis x ′ of the shaft 1020. Of course, any suitable number of contact elements 1100 (including one) having any suitable geometry and disposed at any suitable location may be provided.

  Each contact element 1100 is supported by a respective pressure transmission shaft 1120. The pressure transmission shaft 1120 is slidable in the axial direction within a respective hole 1085 extending parallel to the longitudinal axis x ′ of the shaft 1020. Each pressure transmission shaft 1120 is coupled to a key member 1140 on the proximal side. Key member 1140 extends into and engages key plate 1160 as shown in FIG. 17A. One or more springs exert a spring force on the key member 1140 to propel or bias the contact elements 1100 toward their distal extended positions.

  When the distal end of shaft 1020 is pressed against the tissue that anchor 1200 is desired to be driven through, the tissue applies a pressure directed proximally to contact element 1100. Contact element 1100 is initially in a position extended distally under a spring load. When the pressure applied by the tissue exceeds the spring bias or propulsion force, the contact element is pushed proximally relative to the shaft 1020. Such proximal movement within each slot 1080 is mechanically transmitted to the key element 1140 via the respective pressure transmission shaft 1120, thereby allowing the key member to move proximally beyond the key plate 1160. Move to. In this regard, there is an approximately 1: 1 relationship between the axial movement of each contact element 1100 and the respective key member 1140. However, it will be appreciated that the device may be configured such that the relationship between the axial movement of the key member 1140 and the axial movement of the respective contact element 1100 is other than 1: 1. Further, while the exemplary device 1005 utilizes a sliding shaft 1120 to mechanically couple and transmit the force from the contact element 1100 to the respective key member 1140, the contact element may be coupled to other mechanisms, such as liquids. It may be mechanically coupled to the key member 1140 by a pressure and / or pneumatic system.

  The key plate 1160 can slide within the handle 1010 along an axis transverse to the longitudinal axis x ′ of the shaft 1020 and a pivot axis p defined by the pivot pin 1040. In this regard, the key plate 1160 can slide between a first position shown in FIG. 17A and a second position shown in FIGS. 18B and 19A. The movement of the key plate 1160 between the first position and the second position is performed along a path that lies in a plane that is substantially perpendicular to the pivot axis p. Referring to FIG. 19B, the key plate 1160 moves from the first position to the second position by moving in the direction U. Although the passage through which the key plate 1160 moves between the first position and the second position is linear, it goes without saying that the passage may be non-linear, for example, curved. Furthermore, when the key plate 1160 moves from the first position to the second position, a plane that includes the pivot axis p and intersects the bottom surface 1161 of the key plate 1160 rotates in the first rotation direction CW. Similarly, when the key plate moves from the second position to the first position, the plane rotates in a second rotation direction opposite to the first rotation direction CW.

  The key plate 1160 is slidably supported by a proximal support block 1090 that is fixedly mounted within the handle 1010 of the device 1005. In the illustrated example, the key plate 1140 is supported by the pair of parallel guide ribs 1092 of the support block 1090, so that the key plate 1160 is slidable between the first position and the second position. Since the support block 1090 also supports each of the key members 1140, each of the key members 1140 slides along the longitudinal axis f, g, h, i of the respective shaft 1140 to which the key member 1140 is attached. Can do. Thus, the key member 1140 is allowed to slide axially along the axes f, g, h, i, but with respect to the handle 1010, shaft 1020, and other fixed components of the housing of the device 1005. Restricted to move.

  If any one of the key members 1140 is still engaged with the plate, this means that one of the contact elements 1100 at the distal end of the shaft 1020 has not been fully pushed down proximally. In such a case, the geometry of the key plate 1160 is selected to prevent the key plate 1160 from moving to the second position.

  The geometry of the key plate 1160 is formed so that each of the pressure transmission shafts can pass through the key plate 1160 when the key plate is in either the first position or the second position. However, the geometry of the key plate 1160 does not allow any of the key members 1140 to extend axially into any recess defined by the key plate 1160 when the key plate 1160 is in the second position. . In the illustrated example, this means that the diameter of each key member 1140, as viewed along a line parallel to the direction of movement of the plate 1160, is greater than the diameter of each pressure transmission shaft 1120 to which the key member is coupled. Is also achieved based on the fact that it is also great.

  Referring to FIGS. 18A-18E, the key plate 1160 has a complex cut-out geometry that includes an enlarged region 1165 formed to receive the respective key member 1140 in the axial direction. Referring to FIG. 18A, when the key plate 1160 is in the first position, the structure of the key plate 1160 and the longitudinal axes f, g, h, i of the four respective pressure transmission shafts 1120 pass through the key plate 1160. The gap between each enlarged region 1165 is sufficient to receive the key member 1140 in the axial direction. Referring to FIG. 18B, when the key plate 1160 is in the second position, the gap between the structure of the key plate 1160 and the respective region 1170 where the longitudinal axis of the pressure transmission shaft 1120 passes through the key plate 1160 is It is insufficient to receive the key member 1140 in the axial direction, but is very sufficient to allow the pressure transmission shaft 1120 to pass through.

  As shown in FIG. 18C, the geometry of each key member 1140 is received in a corresponding recess that closely fits in the key plate 1160, so that the key plate 1160 is shown (eg, as shown in FIGS. 18C and 18D). ) Cannot move in the direction U from the first position to the second position (eg shown in FIG. 18E). Referring to FIG. 18D, all four key members 1140 have been pushed proximally through pushing the corresponding contact element 1100 proximally at the distal end of the shaft 1020, thereby causing the key The plate is disengaged from the key member 1140. As shown in FIG. 18D, key member 1140 rides proximally over the structure of key plate 1160, while key plate 1160 is in the first position. At this stage, the region 1170 of the key plate 1140 can receive the shaft 1120. The shaft is reduced in diameter relative to each key member 1140 to which the shaft 1120 is attached. Therefore, the key plate 1140 is in the unlocked state. This is because it can move in the U direction from the first position shown in FIG. 18D to the second position shown in FIG. 18E. As described above, this movement is accomplished by contacting and applying a force between the upper surface 1035 of the proximal extension 1034 of the trigger 1030.

  Since the key member 1140 is radially constrained within the handle 1010, when any one or more of the key members 1160 are extended into the cutout geometry of the key plate 1160, the key plate 1160 is Is prevented from moving into position. Thus, if any one of the contact elements 1100 is not fully depressed, the first safety mechanism is in a locked state and engages at least one of the key members 1140 and the key plate 1160.

  Referring again to FIG. 19A, since the key plate cannot move from the first position shown in the locked state, the upper surface 1035 of the proximal arm 1034 of the trigger 1030 and the bottom surface 1161 as the trigger 1030 come into contact with each other. A positive stop is formed, thereby preventing the trigger 1030 from rotating sufficiently to disengage the latch member 1045 from the hammer sleeve 1500. Thus, for device 1055 to drive anchor 1200, all four contact elements 1100 must be depressed. This safety mechanism requires the distal end of the shaft 1020 to properly seat in the tissue before driving the anchor 1200, thereby reducing the possibility of inadvertent or improper driving of the anchor 1200. It is advantageous.

  As shown in FIG. 17, the key plate 1160 is propelled by the spring 1162 toward the first position. Since the operator may need to reposition the distal end of the shaft 1020 prior to driving the anchor 1200, the spring that pushes or biases the contact element 1100 toward the first position is the contact element 1100 It is ensured that the spring returns to its extended position. For example, the operator presses the distal end of shaft 1020 against the first tissue portion such that all four contact elements 1100 are fully depressed, thereby removing all four key members 1140 from key plate 1160. Move proximally. At this stage, the first safety mechanism is disengaged to allow firing when the operator pulls the trigger 1030. Accordingly, the key plate 1160 is slidable between the first position and the second position. If there is no propulsion of the key plate 1160 toward the first position, the key plate 1160 will prevent the key member 1140 from re-engaging with the key plate 1160 (eg, the second position, or the first position and the second position). There is a risk of inadvertently sliding to a position in between. Thus, even if the operator pulls the distal end of the shaft 1020 away from the first tissue portion, for example, to reposition the device 1005, the first safety mechanism remains disengaged, And the contact element 1100 is not returned to these distal extended positions via the biasing spring force. Therefore, the first safety mechanism is not effective at this stage. Since the spring 1162 acts to propel the key plate 1160 toward its first position, the spring may reposition the distal end of the shaft 1020 multiple times without disabling the first safety mechanism. Help to ensure that.

  The housing 1010 includes a window 1013. Window 1013 provides a visual indication to the operator regarding the state of contact element 1100. For example, there may be four discrete indicators corresponding to each contact element 1100. Thus, the operator can see that fewer than all four contact elements 1100 are depressed and will continue to operate the device until all four contact elements 1100 are depressed. Furthermore, the indicator allows the operator to know which particular contact element 100 is not depressed so that the operator can operate the device 100 accordingly.

  Although the pressure sensing of the device 1005 is purely mechanical, it will be appreciated that other pressure sensing devices may be provided. For example, an electronic pressure sensor may be provided.

  The second safety mechanism includes a safety switch 1060. As shown in FIGS. 19A and 19C, the safety switch 1060 is in the first position. In the first position, the first surface 1062 of the safety switch 1060 forms a positive stop against the bottom surface of the latch member 1045, causing the latch member 1045 to rotate about the pivot axis p and the engagement shown in FIG. 19B. Prevent entry into dissociation position.

  The safety switch 1060 is slidably attached inside the corresponding hole of the handle 1010. As shown in FIGS. 19B and 19D, the safety switch 1060 is slidable about its longitudinal axis s between a first position relative to the latch member 1045 and a second position relative to the latch member 1045. In this regard, the first axial end 1066 is exposed from the first side of the housing 1010 and the opposite axial end 1068 is exposed from the second side of the housing 1010. The operator can move the safety switch from the first position to the second position by pressing the first axial end 1066 along the axis s. Similarly, the operator can move the safety switch from the second position to the first position by pressing the second axial end 1068 along the axis s.

  In the second position, the first surface 1062 has moved along the axis s to a position that does not hinder the rotation of the latch member 1045. Accordingly, the latch member 1045 can freely rotate to the second position, thereby releasing the hammer sleeve 1500 and driving the anchor 1200. Thus, the second safety mechanism is engaged when the safety switch is in the first position and disengaged when the safety switch is in the second position.

  The second surface 1064 forms a positive stop to prevent the latch member 1045 from rotating in the CW direction beyond the second position.

  As described above, both safety mechanisms must be disengaged from the device 1005 to drive the anchor 1200. The first safety mechanism ensures that the distal end of the shaft 1020 is properly seated in the tissue, and the second safety mechanism prevents unintentional firing due to inadvertent pulling of the trigger 1030. In this regard, the operator may wish to leave the second safety mechanism engaged until satisfied with the placement of the distal end of the shaft 1020.

  Although the first and second safety mechanisms in the illustrated example are mechanical as a whole, it will be appreciated that other mechanisms may be provided. For example, an electronic element may be incorporated into the system and / or a specific force or pressure value at the location of the contact element is interpreted by the processor to determine whether the anchor 1200 can be driven, for example according to an algorithm. It's okay.

  Referring to FIG. 17A, the handle 1010 is formed as two corresponding halves that are injection molded. One of the halves is shown in FIG. 17A. Each half of the handle 1010 includes a variety of structures configured to receive and support other components within the handle 1010. For example, a plurality of support ribs 1012 mate with corresponding pairs of support slots 1012 in the shaft 1020 to secure the shaft 1020 to the handle 1010 when the device is assembled. In the assembled state, the first and second halves are joined by an anchor 1011. These anchors are screws in the illustrated example. Although an injection molded handle having two halves joined is provided, it will be appreciated that the handle 1010 may be formed in any suitable form.

  According to a preferred embodiment of the present invention, the closure element includes a tissue compression band 330 attached to either end of the anchor 3200. Referring to FIG. 21A, the tissue compression band 330 is shown in a relaxed state (no force applied or minimal force applied). Anchor 3200 is attached to both ends of tissue compression band 3300. Thus, in contrast to other embodiments of the present invention in which an anchor may be coupled to two or more other anchors, in this preferred embodiment, each anchor 3200 is another via a tissue compression band 3300. The anchor 3200 is coupled. This preferred embodiment and its advantages are detailed below.

  Anchor 3200 includes a wing 3207 and a coupling element 3210. Referring to FIGS. 21A-21E, the wing 3207 has a relaxed, uncompressed position and forms a shoulder with the anchor 3200. In this shoulder, the wing 3207 extends proximally and radially outward from the distal end of the anchor 3200, or is more distal than the distal end. As further shown in FIGS. 21A-21E, the wing 3207 includes a radially outer surface and a radially inner surface. The radially outer surface described above in connection with FIG. 4 may include a longitudinally extending ridge. The scissors can provide a plurality of elongated protrusions at the free end of the wing. The radially inner surface may be concave.

  Referring to FIG. 21B, which is a cross-sectional view of tissue compression band assembly 3000, each end of tissue compression band 3300 ends within cavity 3211 of anchor 3200. The wing 3207 of the anchor 3200 protrudes radially outward from the axis of the anchor 3200 beyond the cavity 3211 in a direction away from the distal tip of the anchor 3200. Thus, the wing 3207 forms a separation between the anchor 3200 and the tissue compression band 3300.

  Referring to FIGS. 21C-21D, a coupling element 3210 is used to secure each end of the tissue compression band 3300 within the cavity 3211 of the anchor 3200. The end 3310 of the tissue compression band 3300 may include a protrusion 3311 so that the end 3310 has a larger radius than the main portion of the tissue compression band 3300 and a larger radius than the inner portion of the coupling element 3210. It is like that. When the protrusion 3311 and the coupling element 3210 are disposed within the cavity 3211 of the anchor 3200, they serve to maintain the mechanical coupling between the tissue compression band 3300 and the anchor 3200.

  Referring to FIG. 21E, a tissue compression band assembly 3000 that includes an anchor 3200 and a tissue compression band 3300 is shown. Although each anchor 3200 is shown as including two wings 3207, any number of wings may be provided. As shown in FIG. 21E, a tissue compression band 3300 is coupled to each of the two anchors 3200. The anchor 3200 is disposed at a predetermined angle with respect to the axis of the tissue compression band 3300 so that the tissue compression band 3300 is bent near each end within the coupling portion with the anchor 3200. Yes. The tissue compression band 3300 can pass through the space between the two wings 3207. In this position, the tissue compression band assembly 3000 will be placed in the surgical closure device 5 prior to implantation, with the anchor 3200 placed at a predetermined angle with the axis of the tissue compression band 3300. .

  Referring to FIG. 22, a front view of the end 3025 of the device 5 that includes four tissue compression band assemblies 3000 is shown. Each tissue compression band assembly 3000 is represented as shown in FIG. 21E, with each anchor 3200 positioned at an angle with the axis of the tissue compression band 3300 and positioned within the slot 3026. ing. The tissue compression band 3300 forms a cross pattern over the central region of the end 3025. The central region is targeted to the opening 3905 of the tissue 3900 as described below.

  FIG. 23 is a perspective view of the end 3025 of the device 5. Tissue compression band assembly 3000 is shown loaded on pusher pin 3600. Pusher pin 3600 is shown extending beyond the end of end 3025 in this view.

  The distal end of the device 5 may further include a window and a constriction element. Prior to ejecting the anchor 32300 from the distal end of the device 5, the wings 3207 of the anchor 3200 can be expanded to a relaxed first position so that the wings are not compressed. During ejection from the device 5, the anchor 3200 can face the constriction element, which allows the constriction element to compress the wings to the second compression position. Once the anchor is ejected from the device 5, the wings can expand and return to the relaxed, uncompressed position.

  Referring to FIGS. 24 and 25, pusher plate 3500 includes a pusher pin 3600 having fingers 3610 for acting on a tissue compression band assembly 3000. Finger 3610 faces anchor 3200 at coupling element 3210. The finger 3610 can also face the anchor 3200 at the shoulder. In the shoulder, the wing 3207 extends proximally and radially outward from the distal end of the anchor 3200, or is more distal than the distal end. Finger 3610 contacts anchor 3200 near the distal tip so that wing 3207 extends beyond the contact point between finger 3610 and anchor 3200. The delivery mechanism or driver can drive the anchor by applying a driving force to the shoulder to drive the anchor and push it into the tissue.

  The use of the tissue compression band assembly 3000 to close the opening 3905 of the tissue 3900 is described below. Referring to FIGS. 26A-26D, tissue 3900 is shown having an opening 3905. FIG. A tissue compression band assembly 3000 having a tissue compression band 3300 and an anchor 3200 is shown without the surgical device 5 for convenience. Tissue compression band 3300 connects two anchors 3200 and wing 3207 extends beyond the coupling point between tissue compression band 3300 and anchor 3200. In FIG. 26A, the tissue compression band assembly 300 is shown in its relaxed state (no force applied or minimal force applied) and is located at a distance from the tissue 3900. . In FIG. 26B, the distal tip of anchor 3200 has been pushed through the surface of tissue 3900 on either side of opening 3905. Since the anchor 3200 has only penetrated the tissue 3900 to the extent of the distal tip and has not yet penetrated beyond the coupling element 3210, the wings 3207 remain outside the surface of the tissue 3900.

  In FIG. 26C, anchor 3200 has now penetrated tissue 3900 at a depth equal to the height of anchor 3200. The wing 3207 is now just inside the tissue 3900 on either side of the opening 3905. While tissue compression band 3300 remains largely above the surface of tissue 3900, either end of tissue compression band 3300 penetrates the surface of tissue 3900 by anchor 3200 so that tissue compression band 3300 is in tissue 3900. In contrast, he is tense and enters a tense (ie forced) state. Finger 3610 of pusher pin 3600 remains in contact with anchor 3200. As the anchor 3200 is pushed into the tissue 3900, the tissue compression band 3300 forces the sides of the opening 3905 closer together, reducing the size of the opening 3905.

  In FIG. 26D, the anchor 3200 has now been pushed down a predetermined distance below the surface of the tissue 3900, pulling the tissue compression band 3300 away from the surface of the tissue 3900 and bringing the sides of the opening 3905 together with each other until the opening closes. Push to approach. Finger 3610 of pusher pin 3600 is retracted, leaving tissue compression band assembly 3000 in tissue 3900. As the tissue compression band 3300 tensions against the tissue 3900, the tissue compression band acts on the anchor 3200 and pulls the anchor in a direction opposite to the insertion direction. The wing 3207, as described above, resists this proximal movement and holds the anchor 3200 in place, which maintains the tissue compression band 3300 in its tensioned (ie, forced) state, That keeps the closed opening 3905 closed. Such a closure of the tissue is maintained in a hemostatic state.

  According to the means described herein, several advantages can be obtained. For example, because tissue compression band assembly 3000 can be loaded into surgical device 5 in a relaxed state, the device may be more easily stored and transported, causing the assembly to wear out, fail to function, or cause injury. Is reduced. The assembly enters its tension state only when the anchor 3200 penetrates the tissue 3900.

  Further, the tissue compression band assembly 300 can have a lower mass than a closed implant. Since the anchor body is significantly shorter than other forms, the amount of material required for the anchor 3200 is reduced. Since the tissue compression band 3300 couples to the anchor 3200 just inside the distal tip instead of coupling to the end of the longer proximal body, a longer body is not necessary. The tissue compression band 3300 includes a small protrusion 3310 for mechanical coupling with the anchor 3200 so that it forms a tissue compression band rather than a similar closure device that wraps entirely around the proximal end of the anchor. Less material is needed to do it. The low mass of the assembly makes it possible to more closely follow any movement of the tissue 3900, so that the hemostasis achieved at the first application is more likely to withstand such movement. This is extremely important in certain organs where movement is expected and cannot be prevented, such as the heart. Tracking of motion can also be achieved based on reduced mass and thus reduced momentum.

  The location where the tissue compression band 3300 and anchor 3200 are joined is below the surface of the tissue 3900, thereby forming a more rounded diagram of the forces acting on the tissue 3900 and the opening 3905. The force from the anchor acting on the assembly is located below the surface of the tissue, and partly pulls the compression band downward. Such a force distribution can prevent tissue strangling that can result from a closure device that only applies forces in parallel along the surface of the tissue. A more rounded force distribution can help maintain hemostasis in the tissue and can improve hemostasis.

  In general, this configuration allows for a higher degree of tracking of any movement of tissue 3900. Following the tissue 3900 is a force acting in the x-direction (ie, proximal to the wing 3207 embedded in the tissue) and the y-direction (ie, the direction across the opening 3905 along the length of the tissue compression band 3300). Maintained by the balance with the forces acting on Maintaining such an equilibrium between these forces helps maintain hemostasis in the tissue. Thus, the position of the anchor in the x direction (ie, depth within the tissue) or y direction (ie, the distance between anchors) is important to allow such balance. The force acting in the y direction is greater than or equal to twice the force acting in the x direction. As an example, the tissue compression band 3300 may be 13 mm long in a relaxed state and may be extended to a length of 26 mm in a tensioned state.

  Finger 3610 can push anchor 3200 to a predetermined depth for optimal purchase and tension so as to optimize balance and provide hemostasis within the tissue.

  Additional configurations for the distribution of tissue compression band assemblies are shown in FIGS. FIG. 27A shows a grid-like or box-like arrangement. FIGS. 27B-27D show circular arrangements of anchors having a grid or box-like band configuration at different intervals. FIG. 27E shows a circular array of anchors with 5 tissue compression bands. FIG. 27F shows a grid-like or box-like arrangement with five tissue compression bands. Of course, any number of tissue compression bands may be used. Furthermore, force balance is achieved by the proper distance between the anchors and the proper depth of insertion into the tissue.

  Additional configurations for the distribution of tissue compression band assemblies are shown in FIGS. Two rows of opposing anchors may be provided, with four tissue compression bands linking the anchors diametrically by extending across these rows. Of course, any orientation of the tissue compression band assembly may be used.

  The larger the tissue opening, the more closure elements are required. Therefore, the predetermined arrangement is for closing large holes.

  A preferred embodiment of the large hole closure plate assembly 4000 is shown in FIGS. 29A and 29B. The closure plate assembly includes an anchor 200 coupled to the closure plate 4300. The closure plate 4300 may be a circular disc having a central hole. Anchor 200 is coupled to closure plate 4300 around the plate using coupling element 4310. All anchors 200 extend in the same direction, parallel to the axis of the closure plate. In this configuration, the closure plate 4300 is a rigid plate and has a defined shape that is used to accurately hold the tissue in place. The large hole closure plate 4300 shown in FIG. 29C may be configured as a disc having an opening 4320 around it, whereby the closure plate 4300 is two concentric annular discs coupled via a coupling element 4310. It's similar to. This arrangement has the advantage of using less material and having less mass.

  Alternatively, anchor 200 can be coupled to closure plate 4300 using a hinged coupling element 4330 (as shown in FIGS. 29D and 29E) so that anchor 200 can be It is possible to rotate about the axis formed by the periphery of the closure plate 4300 facing the distal end.

  Other arrangements of large hole closure plate assemblies allow additional movement of the closure plate. For example, as shown in FIGS. 30A and 30B, the large hole closure plate assembly 5000 includes a sliding closure plate 5300 formed from two sliding braces 5350 and 5360. The sliding braces 5350 and 5360 form a semicircle. The semicircle has sliding racks 5351 and 5361 that are respectively located at one of the two open ends of the semicircle. Since the sliding rack 5351 is inserted into the complementary cavity of the sliding brace 5360 and the sliding rack 5361 is inserted into the complementary cavity of the sliding brace 5350, the two sliding braces face each other and the circular sliding closure plate 5300 is formed.

  The sliding closure plate 5300 further includes an anchor 200. Anchors may be used as described above to support closure elements 5301, 5302, 5303, 5304. The closure element may be a band, an integral V-shaped element, or other similar elements described herein. Closure elements 5301-5304 are used, for example, to keep the sliding closure element 5300 closed (ie, holding the sliding braces 5350, 5360 together). Although the closure plate has some freedom of movement in the direction of the sliding racks 5351, 5361, the large hole closure plate assembly 5000 is held firmly and exerts a force on the anchor 200, thereby joining the tissue. Close the large hole opening.

  Another preferred embodiment of a large hole closure plate assembly with some freedom of movement of the closure plate is shown in FIGS. The large hole closure plate assembly 6000 includes a sliding closure plate 6300 formed from two sliding braces 6350 and 6360. The sliding braces 6350, 6360 have a sliding rack 6351, 6361 located at one of the two open ends of the brace, and a sliding cradle 6352, 6362, respectively, located at the other open end of the brace. doing. Since the sliding rack 6351 is inserted into the sliding cradle 6362 of the sliding brace 6360, and the sliding rack 6361 is inserted into the sliding cradle 6352 of the sliding brace 6350, the two sliding braces are combined into the sliding closing plate 6300. Become.

  The sliding closure plate 6300 further includes an anchor 200. The anchor can be used as described above to support the closure element. The closure element may be a band, an integral V-shaped element, or other similar elements described herein. Although the closure plate has some freedom of movement in the direction of the sliding racks 6351, 6361, the large hole closure plate assembly 5000 is retained by applying force to the anchor 200, thereby joining the tissue. Close the large hole opening.

  Another preferred embodiment of a large hole closure plate assembly with some freedom of movement of the closure plate is shown in FIGS. Large hole closure plate assembly 7000 includes a square sliding closure plate 7300 formed from two sliding braces 7350 and 7360. The sliding braces 7350, 7360 have sliding tubes 7351, 7361 located at one end of the brace, and sliding cavities 7352, 7362, respectively, located at the other open end of the brace. Since the sliding tube 7351 is inserted into the sliding cavity 7362 of the sliding brace 7360, and the sliding tube 7361 is inserted into the sliding cavity 7352 of the sliding brace 7350, the two sliding braces are combined into the sliding closure plate 7300. Become.

  The sliding closure plate 7300 further includes an anchor 200. The anchor can be used as described above to support a closure element (not shown). The closure element may be a band, an integral V-shaped element, or other similar elements described herein. Although the closure plate has some freedom of movement in the direction of the sliding tubes 7351, 7361, the large hole closure plate assembly 7000 is retained by applying force to the anchor 200, thereby joining the tissue. Close the large hole opening.

  Tissue closure may be accomplished percutaneously using a percutaneous tissue closure device. Such a device opens tissue by applying force, in contrast to the various embodiments shown herein that apply force to the outer surface of the tissue, thereby opening the tissue from within the tissue. Can approach.

  In a preferred embodiment, a percutaneous tissue closure device 8005 is provided for inserting a closure element below the surface of the tissue and attracting the tissue opening from within the tissue until it is closed. As shown in FIG. 33, percutaneous tissue closure device 8005 includes a working tube 8100 having a distal end about which a pusher pin and a closure element are wrapped around in a pre-application state. The closure element 8300 is shown in FIG. 33 as wrapped around the distal end of the working tube 8100 and attached to the anchor 3200 (described above). The pusher pin 8600 is wound around the work tube 8100 in a state before application. Each pusher pin 8600 may include a pusher collar 8610. In the pre-application state, the closure element 8300 is wrapped around each working tube 8100 along each pusher pin 8600 so that the pusher collar 8610 is around the closure element 8300 just below the coupling element 3210 of the anchor 3200. Fit. In another preferred embodiment, pusher pin 8600 does not include pusher collar 8610.

  The outer sheath 8800 shown in FIG. 34A can be introduced over the outside of the working tube 8100 and the wrapped closure element 8300 and pusher pin 8600. As shown in FIGS. 34B and 34C, the outer sheath 8800 can be removed by sliding it proximally to expose the working tube 8100 and the wrapped closure element 8300 and pusher pin 8600. As also shown in FIGS. 34A-34C, a dilator 8700 is used to dilate the opening in the tissue for application of the closure element 8300.

  Exposed closure element 8300 and anchor 3200 are shown at an angle that is neither parallel nor perpendicular to the axis of working tube 8100 and outer sheath 8800, but not parallel to the axis of working tube 8100 and outer sheath 8800. The closure element 8300 and the anchor 3200 may be arranged in an angle range including a vertical angle.

  The use of the percutaneous tissue closure device 8005 is described below with reference to FIGS. 35A-35H. FIG. 35A shows tissue 8900 being penetrated by guidewire 8710. Guide wire 8710 is attached to device 8005 via dilator 8700. In this view, the outer sheath 8800 covers the working tube 8100 and the wrapped closure element 8300 and pusher pin 8600.

  FIG. 35B shows the device with the dilator 8700 pushed through the tissue 8900 such that the distal end of the working tube 8100 (not shown) on the underside of the outer sheath 8800 is located below the surface of the tissue 8900. 8005 is shown. In FIG. 35C, the outer sheath 8800 has been moved proximally, exposing the wrapped closure element 8300 and pusher pin 8600. For simplicity, only two closure elements 8300 are shown, but any number of closure elements 8300 may be used. FIG. 35D is a close-up view showing closure element 8300 and anchor 3200 still wound (ie, prior to application), with outer sheath 8800 removed to expose the closure element to tissue.

  FIG. 35E shows the extension of the closure element. Extension of the closure element may be done manually and the operator can apply the extension force by pivoting a knob located at the proximal end of the device 8005, or it can be fluid flow, air pressure, hydraulic pressure, or The extension force can be applied by any other external force. As closure element 8300 extends, anchor 3200 is pushed through tissue expanded aperture surface 8910 and into tissue 8900. As shown in FIG. 35F, once extended, the anchor 3200 generally enters the tissue 8900 and the closure element 8300 reaches full extension length. The closure element 8300 may be formed from any suitable shape memory alloy, such as Nitinol, spring loaded steel, or other alloy or material having suitable properties, so that the elongated closure element 8300 can be removed from the anchor 3200. A force is applied in the proximal direction as viewed, and the anchor 3200 is pulled in the direction opposite to the insertion direction. Wings 3207 resist this proximal movement, hold the anchor 3200 in place, and apply a closing force to the tissue 8900 as described above.

  In FIGS. 35G and 35H, the percutaneous tissue closure device 8005 is removed from the tissue 8900, leaving the closure element 8300. The closing force applied by the closing element 8300 in the tissue 8900 keeps the tissue opening closed. Such closure of the tissue is maintained upon hemostasis. Furthermore, since the device operates percutaneously, all of the closing force acts in a direction parallel to the closing element 8300 to help maintain proper hemostatic balance. Furthermore, less material is left in the tissue and no material is left on the surface of the tissue. On the surface of the tissue, the material can interact with other body parts.

  In the preferred embodiment shown in FIGS. 36A and 36B, percutaneous tissue closure device 8005 includes a knob 8035 for initiating a mechanical action to drive anchor 3200 into the tissue. In FIG. 36A, the closure element 8300 is wrapped around the working tube 8100. In FIG. 36B, following rotation of knob 8035, sleeve 8350 is used to drive anchor 3200 attached to closure element 8300 into the tissue percutaneously.

  In a preferred embodiment, the working tube 8100 may include a cam 8150. The mechanical action initiated by pivoting the knob 8035 can then pivot the cam 8150 shown in FIGS. 37A and 37B. As shown in FIG. 37B, as the cam 8150 is pivoted, the sleeve 8350 extends from a wrapped position around the cam 8150 to an extended position. Since the sleeve 8350 is applied to the coupling element 3210 of the anchor 3200, the anchor 3200 is driven radially outward from the cam 8150 as the sleeve 8350 extends. A preferred embodiment is shown in a proximal view in FIGS. 38A and 38B.

  FIG. 39 shows the cam 8150 and one closure element 8300 separated with the anchor 3200 and the elongated sleeve 8350.

  FIG. 40 shows sleeve 8350 in an expanded configuration, including fingers 8351 used to couple with anchor 3200.

  In a preferred embodiment, as shown in FIGS. 41A and 41B, anchor 3200 can be pushed into tissue by driving using working tube 8160 including press 8161 and trough 8162. As shown, press 8161 can drive closure device 8300 and drive anchor 3200 distally into the tissue in the distal direction.

  The closure element 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 disclosed herein may be an elastomer, such as silicone. However, it will be appreciated that the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 may be formed from any suitable material, such as a bioabsorbable material. Further, when the anchors 200, 1200, 3200 are also formed from a bioabsorbable material, the anchors 200, 1200, and / or 3200 and the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, and A self-actuated closed assembly including / or 8300 (typically left in the patient's body after the procedure is completed) can be absorbed into the patient's body. Although a plurality of elastomeric closure elements 300, 1300, 2300, 3300 are described in the context of the preferred embodiment, it will be appreciated that a single continuous closure element may be provided (eg, various anchors 200, A single integral member extending between 1200, 3200). Furthermore, instead of or in addition to one or more elastomeric closure elements, any other propulsion mechanism, such as a spring, may be provided as the closure element. Furthermore, it goes without saying that the reference patterns on which the anchors 200, 1200, 3200 and the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 are oriented are preferred as described herein. It may be different from the embodiment.

In a preferred embodiment of the present invention, the anchor 4200 shown in FIG. 42 will be described. Anchor 4200 includes a distal tip 4230 and a stem 4201 extending proximally from the base of distal tip 4230. Stem 4201 is joined to the base of distal tip 4230 at shoulder 4240. Wings or ridges 4207, 4208 extend proximally and to some extent radially from the base of the distal tip 4230, and are joined to the base of the distal tip 4230 by a shoulder 4240. The hooks 4207, 4208 extend from the distal tip 4230 proximally and radially to the free end. Figure , The free end may further flared outward in the radial direction. Unlike the wings or hooks 207, 208 described above, the wings or hooks 4207, 4208 are not formed from cuts or splits made in the body of the anchor, so the thickness of the stem 4201 is Inclusion of hooks 4207, 4208 is not affected. Wings or saddles 4207, 4208 may have a relaxed, uncompressed position, as shown in FIG. In the non-compressed position, the hooks 4207 and 4208 are not biased and have a hook-like opening W. The flanges 4207 and 4208 can be brought closer to the stem 4201 by being compressed. Various amounts of compression can be applied to the collar, so that the greater the compression, the closer the collar is to the stem. The ridges 4207, 4208 can include a protrusion at the free end of the ridge so that the anchor can be engaged once tissue is deployed. Although two hooks 4207, 4208 are shown, it will be appreciated that any number of hooks may be provided. Similarly, any number of protrusions may be provided at the free end of the saddle, including one sharp protrusion.

  Stem 4201 can be flexible and can be bent or deflected relative to saddles 4207, 4208 and distal tip 4230. Once deployed into the tissue, the flexible stem provides a different force profile acting on the anchor 4200 compared to an anchor having a rigid or unbent stem. A flexible shaft that can be deflected relative to the hook and distal tip forms a living hinge between these elements of the anchor. The force acting on the anchor from its proximal end (a closure element coupled to the proximal end of the anchor) can be absorbed at least in part by the flexible stem, so that the wing or hook of the anchor The effect of these forces applied to the can be reduced. In a given tissue environment, the flexible shaft can increase the likelihood of blocking anchoring by the anchor and thereby prevent the anchor from being partially or completely pulled out of the tissue. Stem 4201 may include an eyelet 4210 at its proximal end. The eyelet can be configured to receive the suture 4400. In a preferred embodiment, the flexibility of the stem 4201 allows the use of suture 4400 as opposed to an elastomeric closure element. In combination, the closure force is applied to the flexible stem 4201 through the suture 4400 in the proximal eyelet 4210 to close the wound as compared to the force required to pull the anchor 4200 from the tissue. The power is reduced. In this way, the wound can be closed more completely.

  It can be said that it is advantageous to reduce the size of the anchor 4200. For example, reducing the thickness of tip 4230, ridges 4207, 4208, and stem 4201 allows more anchors to be deployed in a smaller space within the tissue, allowing for a circular deployment configuration. Referring to FIG. 43, deploying the anchor in a more circular configuration creates a more uniform force distribution around the wound. In combination with the flexible stem 4201 and the proximal eyelet 4210, the uniform force distribution further prevents the anchor 4200 from being pulled out of the tissue and more completely closes the wound.

As another example, reducing the mass of the anchor 4200 helps to increase the speed of pushing into the tissue by driving the anchor 4200. In the case of remote anchoring, the tissue receiving the anchor is not held or fixed during anchor deployment. As noted above, rapid penetration may be required to accurately penetrate soft tissue that is not held or fixed. By reducing the mass of the anchor 4200, the drive speed achieved is increased. In a preferred embodiment, the speed of the driven anchor can be expressed based on the following equation: m is the mass of the anchor, k _spring is the spring constant of the drive spring, F _friction is the coefficient of friction between the anchor and the distal end of the driver, and l ₂ -l ₁ is the difference in spring length. Show.

In another embodiment, the speed of the driven anchor can be expressed based on the following equation: l is the spring length, and l ₀ -l is the difference in spring length.

  In addition to the driving speed of the anchor 4200, the shape of the anchor 4200 shown in FIG. 42 allows the anchor driving to be controlled, so that the anchor is driven and pushed to a suitable depth inside the tissue. The shape of the anchor 4200 is the shape of the distal tip 4230, the shape of the hooks 4207, 4208, the hook 4203 along the radially outer length of the hooks 4207, 4208, or the proximal of the hooks 4207, 4208. Including the side and radial free end projections 4204, the radially inner concave surfaces of the ridges 4207, 4208, the length of the anchor 4200 including the length of the stem 4201, and the shape of the eyelet 4210. As the anchor 4200 is driven and pushed into the tissue, the anchor experiences a force applied by the tissue. The combination of drive speed and anchor shape prevents the anchor from being driven beyond the required depth. An anchor 4200 deployed into the tissue is shown in FIG.

  As described above, the proximal eyelet 4210 may be configured to receive the suture 4400. In contrast to the elastomeric closure element, once the anchor 4200 is driven and pushed into the tissue with the suture 4400 being advanced through the eyelet 4210, tension is required to close the wound. There is a case. In a preferred embodiment of the invention, a tensioner 4410 can be used to tension the suture 4400. As shown in FIG. 43, the anchor 4200 can be deployed in a circular configuration and the suture 4400 follows a circular pattern through each proximal eyelet 4210. The first end of suture 4400 can be tied to form knot 4420. The suture 4400 then passes through a circular pattern of eyelets, extends through the knot 4420, and extends proximally in a direction away from the wound closure to the tensioner 4410. As an alternative to the knot 4420, the structure is secured to the first end of the suture 4400 or near the first end of the suture 4400, and the suture 4400 slides through the structure. Other structures may be provided in accordance with the present invention as long as this is possible.

  As shown in FIG. 45A, the tensioner 4410 may be a hollow tubular member having a narrowed distal tip 4411 and a hollow axially inner core 4412. The suture 4400 extends through the tensioner 4410 through the hollow core 4412 so that the surgeon or other operator can pull or pull the suture 4400 proximally. In one preferred embodiment, the suture 4400 extends beyond the proximal end of the tensioner 4410 so that the operator can be directly involved in the suture. In another preferred embodiment, the tensioner 4410 can include a proximal end 4413 that can be removed from the body of the tensioner 4410. The suture 4400 can be coupled to the proximal end 4413 of the tensioner 4410 so that once the proximal end 4413 is removed from the tensioner 4410, the operator can use the proximal end 4413 as a suture grip. The suture 4400 can be pulled or attracted. The tensioner 4410 may include scoring, cuts, breaks, grooves, or the like to allow an operator to snap the proximal end suture grip 4413 from the tensioner 4410. In another preferred embodiment, the suture grip 4413 may not be attached to the tensioner 4410.

  As suture 4400 is pulled proximally through tensioner 4410, tensioner 4410 approaches knot 4420 distally. The relative size of the knot 4420 and the diameter of the hollow axially inner core 4412 are such that the knot 4420 is larger than the distal opening of the hollow axially inner core 4412 and does not fit into this opening. There must be. As shown in FIG. 45B, when the suture 4400 is pulled proximally through the tensioner 4410, the suture 4400 is cinched around the circular form of the anchor 4200 and the wound is closed. Thus, using suture 440 and tensioner 4410, the surgeon or operator can control the tension applied to the configuration of suture 4400 and anchor 4200.

  Any of the delivery devices described herein, including delivery devices 5, 1005 and 8005, may be configured to drive anchor 4200. Specifically, the anchor 4200 can be driven by applying a driving force to the shoulder 4240 of the anchor 4200 to drive the anchor 4200 in the distal direction. Delivery devices 5, 1005, and 8005 can include a finger 3610 that contacts anchor 4200 at shoulder 4240 so that wing or ridge 4207, 4208 extends beyond the point of contact between finger 3610 and anchor 4200. Extends proximally. Similarly, stem 4201 can extend proximally beyond the point of contact between finger 3610 and anchor 4200.

  Delivery device 4005 may include the features described above with respect to devices 5, 1005, and 8005. Delivery device 4005 includes a distal end 4025 shown in FIGS. In one preferred embodiment, the delivery device 4005 can be applied endoscopically so that the end 4025 allows the surgeon or operator to see the distal end via the monitoring system. Furthermore, it may be radiopaque.

  46A-D are cross-sectional views illustrating deployment of anchor 4200 from distal end 4025. FIG. 47A-47D show the same deployment as viewed from the outside of the distal end 4025. FIG. The distal end 4025 may include a window 4026. The window 4026 may be formed similarly to the notch or slot 26 described above. Window 4026 differs from slot 26 in that the opening of window 4026 does not extend to the distal end of distal end 4025 but ends with constriction element 4027. Prior to deployment, the anchor 4200 is positioned within the delivery device 4005 and the anchor 4200 may be oriented such that the ridges 4207, 4208 extend into the window 4026. Thus, the window 4026 allows the anchor 4200 to be located inside the delivery device 4005 while allowing the ridges 4207, 4208 to occupy a relaxed, uncompressed position. In this way, the delivery device 4005 can be stored or transported with the anchor 4200 positioned within the delivery device, in which case the saddle-like structural features, such as the response to compressive forces, are affected. Without concern.

  The constriction element 4027 is located between the window 4026 and the ultimate distal end of the distal end 4025. As shown in FIG. 46B, when the deployment of anchor 4200 is initiated and finger 3610 begins to drive anchor 4200 through distal end 4025, barbs 4207, 4208 contact stenosis element 4027. As the anchor 4200 is propelled past the stenosis element 4027, the stenosis element 4027 applies a compressive force to the ridges 4207, 4208, compressing the ridges and causing the stem 4201 to approach. As shown in FIG. 46C, as the driver continues to drive the anchor 4200 and pushes it from the distal end 4026 into the tissue, the saddles 4207, 4208 include the distal end 4026 including the constriction element 4027. Over. Beyond the distal end 4026 and the constriction element 4027, the ridges 4207, 4208 expand toward a relaxed, uncompressed position. In practice, the surgeon or operator presses the distal end 4026 against the tissue at the deployment site. Thus, beyond the distal end 4026, the anchor 4200 is pushed into the tissue. As the ridges 4207, 4208 enter the tissue beyond the stenosis element 4027, the ridges do not fully expand to the relaxed, uncompressed position, thus having a compressed profile, thereby anchoring 4200 is more easily pushed into the tissue. As anchor 4200 continues to enter tissue, ridges 4207, 4208 expand toward the uncompressed position. This expansion of the saddle from the compressed position to the uncompressed position slows the anchor as it is pushed into the tissue and limits the depth at which the anchor is pushed into the tissue. To do.

  As described above, the shape of anchor 4200, including the profile of the ridges 4207, 4208 as the anchor enters tissue, as well as the driving speed of anchor 4200 are responsible for the exact depth at which anchor 4200 is driven. Adjusting the shape of the anchor, including compressing the saddle just prior to entering tissue, allows the surgeon or operator to determine the exact depth for deployment of the anchor.

  In a preferred embodiment of the present invention, the device 4005 consists of a proximal portion and a distal portion. The proximal and distal portions may be separable and may be coupled to confine a kinetically stored force, such as a spring. The spring may be compressed between the proximal portion and the distal portion, and this compression can be retained by a latch latch mechanism having a trigger element. As described above with reference to FIGS. 5C-6C, in the distal direction, the spring may be in contact with a drive element of the device 4005, such as a hammer sleeve or extension arm or finger. When the trigger device is actuated by the operator, the latching mechanism releases the compressed spring. The compression spring extends quickly and transmits its kinetic energy to the anchor to drive it.

  Of course, the use of the exemplary device 5 includes driving the anchors 200, 1200, 3200, 4200 prior to forming the surgical access opening, although it will be appreciated that the anchors 200, 1200, 3200 after forming the opening. 4200 may be driven. Similarly, anchors 200, 1200, 3200, 4200 can be ejected from device 1005 before expanding the hole. However, it is less advantageous to drive the anchor after the opening is formed or the hole is expanded. Because the formation of the opening in the former procedure and the expansion in the latter procedure push the tissue away from the hole, so that the subsequently driven anchor is located close to the opening when the tissue is in a relaxed state. become. Thus, the amount of tissue between the anchors 200, 1200, 3200, 4200 is small, possibly resulting in less compressive force being applied to the tissue as compared to the anchor driven prior to forming the surgical access opening.

  Furthermore, it will be appreciated that the closure device 5, 1005, 8005 may be provided in the context of any suitable surgical device such as a catheter or a flexible thoracoscopic shaft. Furthermore, any suitable drive mechanism for driving the anchors 200, 1200, 3200, 4200 may be provided.

  Of course, although the closure elements 300, 1300, 2300, 3300, 4400, 5300, 6300, 7300, 8300 are formed as a single integral member, any closure element described herein may be It may consist of a plurality of components.

  Further, although the examples described herein are described as firing a plurality of identical anchors 200, 1200, 3200, 4200, respectively, it goes without saying that the driven anchor set is It may include one or more anchors different from other anchors. For example, the situation of non-uniform tissue characteristics and dimensions can be addressed, for example, by firing different types of anchors simultaneously at different locations. In this regard, the devices 5, 1005, 8005 are configured to receive different types of anchors in different slots and / or have interchangeable housing portions to receive various anchors. Good.

  Further, anchors 200, 1200, 3200, 4200 are disclosed in US provisional patent application 61 / 296,868 filed on January 20, 2010, and in the United States filed on January 20, 2011. It may include any of the fasteners or other similar implant features disclosed in patent application No. 13 / 010,766 and using any of the mechanisms disclosed in the above specification. May be driven.

  Further, the implantable elements described herein, such as anchors 200, 1200, 3200, 4200, and / or closure elements 300, 1300, 2300, 3300, 4400, 5300, 6300, 7300, 8300 can be, for example, Depending on the particular application, it may be formed in whole or in part from materials that can be absorbed into the patient's body or from non-absorbable materials. For example, these elements may be formed from polyglycolic acid (PGA) or PGA copolymers. These elements may additionally or alternatively be formed from polyester and / or nylon and / or copolymers of other polymers. In addition, these elements may contain one or more shape memory alloys, such as Nitinol, spring loaded steel, or other alloys or materials with suitable properties.

  Absorbable materials are advantageous when there is a potential for misfire or improper placement of various implants. For example, in situations where the driver drives the anchors 200, 1200, 3200, 4200 at unintended locations, or where the tissue does not properly receive the anchors 200, 1200, 3200, 4200, the anchors 200, 1200, 3200, 4200 are: Even if it is not needed, it is eventually harmless as it is absorbed into the patient's body.

  Exemplary surgical applications have been described above, but the devices 5, 1005, 8005 are not limited to these examples at all.

  Although the invention has been described with reference to specific examples and preferred embodiments, it is to be understood that the description is in no way limiting. Furthermore, the features described herein can be used in any combination.

Claims (21)

A distal end tapered toward a distal tip configured to puncture tissue;
A flexible stem extending proximally from the distal end;
At least one ridge extending from the distal end proximally and radially outward to a free end, comprising a radially outer surface and a radially inner surface;
With
The radially outer surface includes a longitudinally extending ridge, the ridge providing a plurality of protrusions extending proximally on the free end;
The flexible stem is flexible with respect to the at least one hook and the distal tip;
Surgical anchor.   The anchor of claim 1, wherein force is applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.   The anchor according to claim 1, wherein the radially inner surface is concave.   The anchor of claim 1, wherein the flexible stem is configured to flex in cooperation with a force applied to the anchor.   The anchor of claim 1, wherein the saddle is configured to resist proximal movement of the anchor after the anchor is driven and pushed into the tissue.   The anchor of claim 1, wherein the hook-like portion extends to a free end and includes a plurality of cutting protrusions extending proximally at the free end.   The anchor of claim 1, wherein the collar extends to a free end, and the collar provides a plurality of cutting projections extending proximally to the free end of the collar.   The anchor according to claim 1, wherein the anchor is arranged in a form having a plurality of anchors along a ring-shaped periphery.   The anchor according to claim 1, wherein the anchor is disposed in a square shape and having a plurality of anchors.   The anchor of claim 1, wherein the anchor is formed from a bioabsorbable material.   The anchor of claim 1, wherein the flexible stem further comprises a proximal eyelet configured to receive a closure element.   The anchor according to claim 11, wherein the closure element is a suture. An anchor, wherein the anchor is tapered toward a distal tip configured to puncture tissue, and proximally and radially outward from the distal end to a free end At least one ridge extending from the distal end of the anchor shoulder and a flexible stem extending proximally from the distal end, wherein the shoulder is the flexible An anchor disposed at the intersection of the stem of the stem and the distal portion of the saddle-shaped portion or disposed more distally than the intersection;
A driver configured to apply a driving force to the shoulder of the anchor to drive and push the anchor into the tissue;
With
The flange includes a radially outer surface and a radially inner surface, the radially outer surface includes a longitudinally extending flange, and the plurality of protrusions extending proximally includes the plurality of protrusions extending to the free end. To provide,
Surgical equipment.   The surgical apparatus according to claim 13, wherein the anchor is arranged in a form having a plurality of anchors, and further configured to cause the driver to drive the anchors simultaneously.   The surgical apparatus according to claim 14, wherein the driver is configured to drive the anchor a predetermined distance.   The surgical apparatus according to claim 14, wherein the driver comprises a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.   The surgical apparatus according to claim 13, wherein the saddle extends proximally beyond the shoulder.   The surgical apparatus according to claim 13, wherein the driver includes a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and into tissue. A surgical device,
A distal end tapered toward a distal tip configured to pierce tissue, and at least one hook extending from the distal end proximally and radially outward to a free end A surgical anchor including,
A distant comprising at least one window configured to allow the ridge to expand to a relaxed position and at least one constriction element configured to compress the ridge to a compressed position. A delivery mechanism having a distal end;
With
The flange includes a radially outer surface and a radially inner surface, the radially outer surface includes a longitudinally extending flange, and the plurality of protrusions extending proximally includes the plurality of protrusions extending to the free end. To provide
Before the delivery mechanism ejects the anchor, the hook is positioned in the window so as to be in a relaxed position;
While the delivery mechanism ejects the anchor, the saddle faces the stenosis element such that it narrows from the relaxed position to the compressed position, and the saddle is once removed from the delivery mechanism. Formed to return to the relaxed position when ejected;
Surgical equipment. A surgical device,
A distal end tapered toward a distal tip configured to pierce tissue, and at least one hook extending from the distal end proximally and radially outward to a free end; A surgical anchor including a flexible stem extending proximally from the distal end and a proximal eyelet;
A closure element configured to be received by the proximal eyelet;
A tensioner comprising a hollow axial core configured to receive the closure element and to allow the closure element to slide through the tensioner;
A surgical device comprising:   The surgical apparatus according to claim 20, wherein the closure element is a suture.

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