US20110178537A1 - Tissue repair implant and delivery device and method - Google Patents

Abstract

A device having an implant driver configured to anchor a first implant to a first portion of tissue and to anchor a second implant to a second portion of tissue, the first and second anchors being coupled to respective first and second sutures, and a winder configured to twist the first and second sutures together as the sutures are refracted, thereby bringing the first portion of tissue into approximation with the second portion of tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/296,868, filed on Jan. 20, 2010, which is expressly incorporated herein in its entirety by reference thereto.
• Further, each of the following is hereby incorporated in its entirety by reference thereto: U.S. patent application Ser. No. ______, Attorney Docket No. 14895/3, filed on Jan. 20, 2011, U.S. patent application Ser. No. ______, Attorney Docket No. 14895/5, filed on Jan. 20, 2011; and U.S. patent application Ser. No. ______, Attorney Docket No. 14895/6, filed on Jan. 20, 2011.
FIELD OF THE INVENTION
• The present invention relates to a tissue implant and delivery device and method.
BACKGROUND INFORMATION
• Some surgical interventions require the approximation of a first tissue and a second tissue. Known devices for drawing two tissues toward each other require instrument access to the outer surfaces of the tissues being brought toward each other. For example, where the two tissues are part of the same organ, these instruments require access from the outside of an organ where the tissues are part of the same organ. This may lead to trauma to surrounding tissues and increase the risk of infection. Thus, there is a need for a less invasive device and method for approximating two tissues.
• Moreover, there is a need for a tissue approximation mechanism and method that is simple to operate and only requires access to the space between the tissues being approximated. Further, there is a need for a reliable tissue approximating mechanism that may be precisely implemented.
• Further, there is a need for a mechanism and method that reduces procedural costs and allows access to difficult-to-reach locations of the anatomy.
SUMMARY
• According to example embodiments of the present invention, a surgical device comprises an implant driver configured to anchor a first implant to a first portion of tissue and to anchor a second implant to a second portion of tissue, the first and second anchors being coupled to respective first and second sutures, and a winder configured to twist the first and second sutures together as the sutures are retracted, thereby bringing the first portion of tissue into approximation with the second portion of tissue.
• The implant driver may be configured to anchor the implants by using a hydraulic driver. The hydraulic driver may use saline as a hydraulic fluid.
• The device may further comprise a clamping element configured to clamp together the sutures after the winding. The clamping element may be further configured to trim the an excess length of each suture disposed proximally to a location of the clamping.
• The first implant and/or second implant may be a fastener having a plurality of anchoring filaments configured to resist retraction of the fastener from the first portion of tissue.
• At least one of the implants may be a fastener having a plurality of wings configured to resist retraction of the fastener from the first portion of tissue.
• At least one of the implants may be a self-expanding anchor.
• At least one of the implants may be disk-shaped.
• The self-expanding anchor may include a plurality of tissue-piercing teeth configured to penetrate the entire thickness of the first portion of tissue.
• According to example embodiments of the present invention, a surgical device comprises a hollow needle having an inner chamber and a sharp tip configured to pierce a tissue, a first self-expanding anchor having a collapsed position and an expanded position, the first anchor being positionable within the inner chamber when in the collapsed position, a first suture extending through the needle and attached to the first anchor, and an actuator configured to drive the needle containing the first anchor into a first predetermined position in a first portion of tissue, wherein the needle is retractable from the first predetermined position to leave the first anchor in the first predetermined position, the first anchor expanding from the collapsed position to the expanded position upon retraction of the needle.
• The device may further comprise a second self-expanding anchor having a collapsed position and an expanded position, the second self-expanding anchor being positionable within the inner chamber when the second self-expanding anchor is in the collapsed position, and a second suture extending through the needle and attached to the first anchor, wherein the actuator is configured to drive the needle with the second anchor into a second predetermined position in a second portion of the tissue, the needle being retractable from the second predetermined position to leave the second anchor in a position distally beyond the second portion of tissue, the second anchor expanding from the collapsed position to the expanded position upon retraction of the needle. Each of the first and second sutures may be a braided suture.
• The device may include an actuator configured to distally retract the first suture and the second suture into a distal end of the device, thereby pulling the first anchor and the second anchor together, the pulling of the first anchor and the second anchor together causing the first portion of tissue to be pulled toward the second portion of tissue.
• The sutures may be twisted as they are distally retracted.
• The device may further comprise a clamp configured to join the first suture to the second suture and cut excess portions of the first suture and the second suture distal to the joint of the first suture to the second suture.
• According to example embodiments of the present invention, a surgical system includes a first implant coupled to a first suture, a second implant coupled to a second suture, and an implant driver configured to position the first implant in a first predetermined position in relation to a first tissue, and to position the second implant in a second predetermined position in relation to a second tissue, the implant driver configured to draw the sutures together to bring the implants into apposition thereby bringing the first tissue and the second tissue into apposition, wherein the implants are configured to pierce both the first tissue and the second tissue at an interface of the first and second tissues when the first and second tissues are in apposition.
• The first implant may be a first disk and the second implant is a second disk.
• The first disk may include a plurality of projections each configured to cut entirely through the first tissue and the second disk includes a plurality of projections each configured to cut entirely through the second tissue.
• According to example embodiments of the present invention, a method comprises positioning a first implant in a first predetermined position adjacent a first tissue, positioning a second implant in a second predetermined position adjacent a second tissue, bringing the first and second tissues into apposition by pulling the first and second implants into apposition with each other, and creating multiple puncture wounds in the first and second tissues with the first and second implants to allow the first and second tissues to heal together in the region of the puncture wounds.
• Further features and aspects of example embodiments of the present invention are described in more detail below with reference to the appended Figures.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1A and 1B illustrate the insertion and manipulation of a catheter into an organ.
• FIGS. 2A and 2B illustrate a needle extending from the catheter ofFIGS. 1A and 1B and piercing a tissue wall of the organ.
• FIGS. 3A to 3C sequentially illustrate the opening of the needle and deployment of a plate or implant from the needle.
• FIGS. 4A to 4E sequentially illustrate the withdrawal of the needle from the tissue wall and into the interior of the catheter.
• FIGS. 5A and 5B sequentially illustrate the re-maneuvering of the catheter to a proximal position.
• FIG. 6A illustrates the maneuvering of the catheter from the proximal position to a second tissue wall of the organ.
• FIG. 6B shows the piercing of the second tissue wall by the needle and deployment of a second plate or implant.
• FIG. 6C illustrates the retraction of the needle.
• FIG. 7A illustrates the catheter after being maneuvered to the proximal position.
• FIGS. 7B and 7C sequentially illustrate the pulling together of the two plates or implants.
• FIGS. 7D and 7E sequentially illustrate the withdrawal of the catheter from the organ.
• FIGS. 8A to 8E sequentially illustrate the retraction and twisting of respective lines or cords attached to each plate or implant.
• FIGS. 8F to 8G sequentially illustrate the clipping and joining of the respective lines or cords attached to each plate or implant.
• FIG. 9 illustrates surgical implants with piercing teeth.
• FIG. 10A illustrates a surgical implant.
• FIG. 10B is a cross-sectional view of the implant ofFIG. 10A.
• FIG. 10C is an illustration of a distal end portion the surgical implant ofFIG. 10A.
• FIG. 11 illustrates a needle configured to carry an anchoring fastener.
• FIG. 12 illustrates a distal tip portion of an anchoring fastener.
• FIG. 13 illustrates an anchoring fastener with wings.
• FIG. 14 is a schematic illustration of a surgical device to approximate tissues with anchoring fasteners.
• FIG. 15A illustrates the driving of an anchoring fastener through a first tissue and into a second tissue using the device ofFIG. 14.
• FIG. 15B illustrates the first and second tissues ofFIG. 15A with the anchoring fastener implanted in the first tissue and the suture attached to the anchoring fastener extending through the first tissue.
• FIG. 15C illustrates the first and second tissues ofFIG. 15B with a second anchoring fastener driven through the second tissue and into the first tissue and with the device twisting the sutures attached to the anchoring fasteners.
• FIGS. 15D to 15F sequentially illustrate the retraction, twisting, and clamping of sutures attached to the anchoring fasteners ofFIG. 15C to join the two tissues.
• FIG. 15G shows fasteners driven into the tissues at angles and locations that differ from the procedure ofFIGS. 15A to 15F.
DETAILED DESCRIPTION
• FIGS. 1A to 8G illustrate an implant device orcatheter3000 that is maneuverable between twoopposed layers951 and952 oftissue950 in order to close or narrow a gap or distance between theopposed layers951 and952 oftissue950. Referring toFIG. 1A, theimplant device3000 is maneuvered between afirst layer951 oftissue950 and a second, opposedlayer952 oftissue950. The tissue may be, e.g., tissue of a stomach. As illustrated inFIG. 1B, the distal end of thehousing3001 of the catheter orimplant device3000 is maneuvered to be in proximity or contact with and directed toward thefirst layer951 oftissue950. Thehousing3001 may be maneuvered by any appropriate mechanism, e.g., guide wires.
• After positioning and orienting thehousing3001, a sharp-pointed implant-carrying needle orsleeve3100 is distally extended from thehousing3001 to pierce and penetrate thefirst layer951 oftissue950, as illustrated, e.g., inFIGS. 2A and 2B. Theneedle3100 may be formed of, e.g., a shape-memory material, e.g., nitinol or spring-loaded steel.
• After theneedle3100 has pierced and extended a distance beyond thefirst layer951 oftissue950, as illustrated inFIGS. 2A and 2B, the distal portion of theneedle3100 expands, or flowers, outwardly, with four adjacent extensions or leaves3105 separated by longitudinal slits therebetween, as illustrated, e.g, inFIG. 3A. Although four extensions or leaves3105 are provided, it should be understood that any appropriate number may be provided. Moreover, the distal end of theneedle3100 may have one or more elastic portions that provide analogous expansion. It is noted that the needle2100 described above may have a structure analogous to that ofneedle3100 to allow for retraction of the sleeve2100.
• When theleaves3105 open or expand outwardly, a button-like implant orplate3200 is exposed from the interior of theneedle3100. Theplate3200, which is formed, e.g., from a shape memory alloy such as, e.g., nitinol, or spring-loaded steel, springs from a folded position that allows for storage inside thenon-expanded needle3100, into a deployed or expanded position as sequentially illustrated inFIGS. 3A to 3C.
• Although theplate3200 has a flattened, cylindrical shape, it should be understood that theplate3200 may be designed to have any appropriate shape and/or size depending on, e.g., the particular application.
• After theplate3200 is released and expanded, theneedle3100 proximally retracts back into thehousing3001, as sequentially illustrated inFIGS. 4A to 4E. As theneedle3100 retracts, acord3300, e.g., a braided suture, which is attached to theplate3200 and extends into and through theneedle3100 is exposed between theplate3200 and theneedle3100. Further, as theneedle3100 retracts, thecord3300 is pulled distally to the extent that theplate3200 contacts an exterior or distal surface of thefirst layer951 oftissue950, as illustrated, e.g., inFIG. 4C.
• Thecord3300 is formed of a plurality ofthreads3305, e.g., absorbable or non-absorbable suture material, that extend through various apertures in theplate3200 in a button-like manner to secure the cord to theplate3200. It should be understood, however, that thecord3300 may be a single strand and/or attached to theplate3200 by any other appropriate mechanism.
• FIGS. 5A and 5B sequentially illustrate the re-maneuvering of the catheter to a proximal position, while allowing a corresponding length ofcord3300 to be distally released from thehousing3001.
• FIG. 6A illustrates the maneuvering of the catheter from the proximal position to a second wall orlayer952 oftissue950 of the organ, thesecond layer952 being opposed and spaced apart from thefirst layer951 oftissue950.FIG. 6B shows the piercing of thesecond layer952 by aneedle3100, which may be thesame needle3100 that pierced thefirst layer951, or asecond needle3100 separate from thefirst needle3100.FIG. 6B further shows the deployment of a second button-like implant orplate3200 on the distal surface of thesecond layer952 oftissue950 in analogous manner to the deployment of thefirst plate3200 described above.
• As illustrated inFIG. 6C, theneedle3100 is then retracted proximally into thehousing3001, which then returns to a proximal position as illustrated inFIG. 7A, in analogous manner to that described above, with asecond cord3300 being attached to thesecond plate3200.
• FIGS. 7A to 7C sequentially illustrate the pulling together of the two plates orimplants3200 by drawing the twocords3300 proximally into thehousing3001, and joining and clipping the twocords3300. By drawing the twocords3300 into thehousing3001, the twoplates3200, each attached to a respective one of thecords3300 are drawn together. As a result of the contact between the proximal faces of the twoplates3200 and the respective distal faces of the twoopposed layers951 and952 of tissue900, thelayers951 and952 oftissue950 are drawn together, as illustrated, e.g., inFIG. 7C. After joining and clipping of the twocords3300, the implantingdevice3000 is retracted from the surgical site, e.g., organ, as illustrated sequentially inFIGS. 7D and 7E. Thus, the above procedure results in the implantation of two opposed, button-like plates3200 joined bycords3300 to hold twoopposed layers951 and952 oftissue950 in a drawn-together position, as illustrated, e.g., inFIG. 7D.
• FIGS. 8A to 8G sequentially illustrate the pulling and clipping of the twocords3300 by the implantingdevice3000, which is illustrated in cross section. Referring toFIG. 8A, thehousing3001 is in the proximal position corresponding toFIG. 7A. Eachcord3300 extends into the distal opening of thehousing3001 and along the length in the internal bore of thehousing3001. Each cord also extends into a distal opening of atubular sleeve3400, which is also disposed in the internal bore of thehousing3001. At a distal end of thetubular sleeve3400 are a pair of hooked twistingarms3405. As illustrated sequentially inFIGS. 8B to 8E, thecords3300 and the twistingarms3405 are retracted proximally with respect to thehousing3001, while thetubular sleeve3400 rotates about its longitudinal axis. The rotation of thetubular sleeve3400 about its longitudinal axis causes the twistingarms3405 to engage therespective cords3300 and revolve around the longitudinal axis of thetubular sleeve3400. The continued revolution of the twistingarms3405 causes the engagedcords3400 to be continually and progressively twisted as thecords3300 and thesleeve3400 proximally retract, until thecords3300 have reached their desired end position and therespective plates3200 have reached their desired approximation, as illustrated inFIG. 8E. It is noted that the degree of retraction of thecords3300 may be adjusted to achieve varying degrees of closure between the twolayers951 and952 oftissue950. The hooked shape of the twistingarms3405 holds the cords a predetermined distance from the longitudinal axis of thesleeve3400. This allows for greater control of the twisting of thecords3300.
• Although thetubular sleeve3400 rotates about its longitudinal axis with respect to thehousing3001 and thetissue950, it should be understood that both thehousing3001 and thesleeve3400 may rotate with respect to thetissue950. For example, thesleeve3400 may be non-rotatable, or substantially non-rotatable, with respect to thehousing3001, with thesleeve3400 proximally retracting with respect to thehousing3001 and thetissue950 as thesleeve3400 andhousing3001 rotate together to twist thecords3300.
• When the desired position ofFIG. 8E is reached, therespective cords3300 are fastened together and trimmed by pair ofclip members3500. Theclip members3500 are brought from an initial position, illustrated, e.g., inFIG. 8E, into contact with a distal portion of the twists of thecords3300, as illustrated inFIG. 8F. In order to join and trim thecords3300, theclip members3500 are further closed until they lock together and separatedistal implant portions3305 of thecords3300 from proximalexcess portions3310 of thecords3300. At this stage, the lockedclip members3500 are released from the distal end of the implantingdevice3000, thereby separating and releasing the implantedportions3200,3305, and3500 from the implantingdevice3000, allowing retraction and removal of the implantingdevice3000 from the surgical site. Thus, the implanted portions are left in their implanted position, maintaining the first andsecond layers951 and952 oftissue950 in the desired approximation relative to each other.
• Although theclip members3500 simultaneously join the implantedportions3305 of thecords3300 and cut theexcess portions3310 from the cords3300 (e.g., by opposed cutting members at proximal locations on therespective clip members3500, which come together to separate theexcess portions3310 as theimplant portions3305 are fastened together), it should be understood that theexcess portions3310 may be trimmed at a different time and/or by a mechanism separate from theclip members3500.
• Further, although theimplant portions3305 are joined by clamping and locking twoopposed clip members3500, it should be understood that other joining mechanisms may be provided. For example, where, e.g., thecords3300 are made of polymeric materials, theimplant portions3305 may be welded or melted together, e.g., by application of heat, pressure, and/or high-frequencies.
• The use of theplates3200 may be particularly suitable for applications where a structure has a cavity on the distal or opposite side of thelayer951 or952. However, in other applications, it may be preferable to replace one or more, e.g., all, of theplates3200 with one of the anchoring fasteners, e.g.,fasteners250,350,550 described below. In this regard, the suture3300 (e.g., a braided material) would be attached to thefastener250,350,550, at the distal end thereof, as set forth in greater detail below, and extend into the distal end of the housing, e.g.,housing3001, in the manner described above. The remaining operation would be analogous to that described above with respect to theplates3200, with thesutures3300 being retracted, joined, and trimmed. However, one or more (e.g., all) of the tissue portions would be pulled by the engagement of an anchoring fastener (e.g.,fastener250 or300), rather than the button-like plate3200. The fastener may be deposited in any manner disclosed herein, including, e.g., directly firing the fastener into the tissue or insertion via a needle such as, e.g., the needle2100. It should be understood that more than two implants (e.g.,plates3200 and/or fasteners, e.g.,fasteners250,350) may be provided, with more than twocords3300 being retracted, twisted and joined.
• The cords/sutures3300,plates3200, and/orclip members3500 may be formed entirely or partly of a bioabsorbable material, e.g., polyglycolic acid (PGA), or a PGA copolymer.
• FIG. 9 illustrates a pair of piercing pledgets orimplants4200. The piercing implants may be provided in a surgical system having all of the features described above with respect to thesurgical device3000, with piercing implants ordisks4200 being provided in place of theimplants3200. Although bothimplants3200 have been replaced byimplants4200 it should be understood that one piercingimplant4200 may be used in combination with animplant3200 described above.
• As illustrated inFIG. 9, theimplants4200 have been deployed and secured in the same manner described above with regard toimplants3200. It is noted thatimplants4200, likeimplants3200 are self-expanding and may be deployed from theneedle3100. For simplicity, thecords3300 andclip elements3500 are not shown inFIG. 9.
• Theimplants4200 differ from theimplants3200 in that they are each provided with a plurality of tissue-piercingteeth4205 extending from the surface that contacts the respective layers oftissue951 and952. These sharp pointed projections are interspersed, e.g., according to a predetermined density per unit area, over the tissue contacting face of eachimplant4200. Theteeth4205 have a length selected to fully penetrate the respective layer oftissue951,952. That is, theteeth4205 have a length that allows the sharp tip to penetrate and extend beyond the opposed face of the tissue, e.g., the interior surface of an organ where thetissues951 and952 are opposed walls of the same organ. This full penetration forms a wound that causes collagen to naturally be produced from the tissue and flow, via the holes formed by theteeth4205, into the space between the twoopposed tissues951 and952. This is advantageous in that it facilitates healing together of the two apposedtissues951 and952.
• FIGS. 10A and 10B illustrate a surgical micro implant orfastener250 that may be used in connection with a surgical system as described above. However, one or more of the disk-like implants3200 and/or4200 are replaced byimplant250.FIG. 10B is a cross-sectional view of thesurgical implant250 ofFIG. 10A with a cross-sectional plane extending along and including the longitudinal axis of thefastener250 ofFIG. 10A. Thefastener250 has thesuture3300 extending proximally from aproximal end285 of thefastener body255. In this regard, when a driver fires thefastener250, e.g., by application a saline or other precise hydraulic force or any other appropriate mechanism, the depth to which thefastener250 is driven is limited by the amount of slack in thesuture3300. This may be accomplished by fixing a proximal end and/or other proximal portion of thesuture3300 to a structure, e.g., a fixed position within the driver device, with a predetermined length and/or slack between the fixing location and thefastener body255.
• Referring to the cross-sectional view ofFIG. 10B, thesuture3300 may extend longitudinally into aninterior location290 of thefastener body255. An example manufacturing method may include molding, coextruding, or otherwise forming the fastener head905 over thesuture3300. It should be appreciated however, that any appropriate manufacturing method may be employed. Further, although asuture3300 of non-stretchable material is provided, it should be understood that other materials, e.g., stretchable materials, may be provided. However, it may be preferable that, even if stretchable, the material have a predeterminable extension limit for particular driving momentums and/or applications. Further, a braided, non-braided, mono-filament, and/or multi-filament material may be provided.
• Although thefastener250 includesmicro filaments275 to anchor into a tissue and resist proximal dislocation after implantation, it should be understood that any other anchoring mechanism, e.g., wings as described above, may be provided. Moreover, any of the features disclosed with regard to the other example implants disclosed herein may be provided in conjunction with thefastener250.
• FIG. 11 shows aneedle5600 that includes many features in common withneedle3100 described above. However, theneedle5600 is configured to position thefastener250 to the predetermined location within thetissue951,952.
• Further, it may be desirable to form theneedle5600 to have a smaller resting or initial diameter than the fastener contained therein. For example, as illustrated inFIG. 11, theneedle5600, when thefastener650, which is identical tofastener250, is inserted into theneedle5600, themetal bands5605 bulge outwardly to form expanded gaps between theadjacent metal bands5605. This may be advantageous to allow the filaments and/or other anchoring mechanism(s) to engage the adjacent tissue and resist proximal movement of the fastener as theneedle5600 is retracted. For example, as illustrated inFIG. 11, themicro anchoring filaments675 of thefastener650 are exposed through the longitudinally extending gap betweenadjacent bands5605 of theneedle5600, thus allowing thefilaments675 to engage surrounding tissue even at the initial stages of the retraction of theneedle5600. In this regard, the engagement of thefilaments675 with the tissue may be sufficient in and of itself to allow proximal retraction of theneedle5600 while leaving thefastener650 in its implanted position. It should be understood, however, that other mechanisms, e.g, a push rod, may be provided in connection with theneedle5600 to facilitate retraction of theneedle5600 while retaining theimplant650 in its predetermined location. Since some applications do not require full penetration of the implant, theneedle5600 may only need to penetrate to a depth that does not compromise or pierce the outer surface of thetissue951,952.
• The discussion herein, including the discussion below, of the features ofimplant250 also apply to theother implants350,550,650 disclosed herein, except to the extent that any differences in features are explicitly mentioned.
• Thesurgical implants250, which may be absorbable or non-absorbable, are designed to penetrate a viscera or tissue planes. Theimplants250 are designed to penetrate into the tissue under controlled rapid deployment to a predetermined depth. The implant is shaped similarly to a needle with a predetermined geometry. Eachimplant250 has anelongated body255 that tapers in a distal region to a needle-like tip260. Eachimplant250 may be deployed, e.g., by being pushed from a precisely placed hollow needle or tube containing theimplant250. Theimplants250, as well as any other example implants disclosed herein, may be formed using e.g., micromachining techniques.
• Themicro implants250 may have a diameter of one millimeter, or approximately one millimeter, and a length that is in a range from 5 millimeters to 10 millimeters. According to example embodiments, the diameter is less than one millimeter. According to example embodiments, the diameter is in a range from 0.8 millimeters to 1.2 millimeters. It should be understood, however, that other dimensions may be provided.
• Thebody255 of eachimplant250 has specifically designedmicro anchoring filaments275 which arise from the core of theimplant250 to extend outwardly therefrom. The anchoringfilaments275 are located around the circumference and along at least a portion of the length of thebody255 of theimplant250. This allows theimplant250 to resist removal once it has penetrated the tissue.
• Thefilaments275 may have any suitable dimensions. For example, it may be advantageous to provide a filament tip (i.e., free end) diameter of 0.1 millimeters and tapering toward a diameter of 0.25 millimeters at the body.
• The core, which is, e.g., cylindrical, has a constant diameter along a substantial length of thebody255 of theimplant250. For example, the core of theimplant250 has a constant cross-section, and constant diameter, from a proximal end to a substantially conically shaped tapered portion toward thetip260. It should be understood however, that theimplants250 may have a more continuous taper and/or have a constant or non-constant rate of taper.
• The anchoringfilaments275 extend outwardly at an angle with respect to the longitudinal axis of theimplant250. In this regard, the filaments, in addition to extending outwardly away from the longitudinal axis, also extend in a proximal direction, away from thetip260. This allows for thefilaments275 to slide along the pierced tissue during distal driving or insertion. However, proximal movement of theimplants250 from the inserted position is prevented or resisted by engagement of the outer, free ends of thefilaments275 with the relatively soft tissue. Thefilaments275 may be flexible or substantially rigid. Thefilaments275 should, however, have sufficient stiffness or strength to resist proximal withdrawal of theimplant250 from the inserted position. Further, although thefilaments275 are illustrated as being straight, it should be understood that some or all of thefilaments275 may be at least partially curved, and/or have one or more bends between straight portions and/or curved portions. Moreover, thefilaments275 of a givenimplant250 may have constant or differing lengths, radial extensions, and/or angles with respect to the longitudinal axis of theimplant250.
• Themicro filaments275 may be provided with any appropriate density and relative spacing, depending on the particular application. For a given application, a greater density (i.e., a greater number of filaments per unit of surface area) of smaller filaments may be provided, or a lesser density of larger filaments (optionally reinforced with a shape memory alloy, e.g., nitinol and/or spring-loaded steel), while presenting the same or comparable suture retention or “pull through strength.” The optional reinforcement could be a “V” shaped portion formed of shape memory alloy, e.g, nitinol and/or spring-loaded steel. Thefilaments275 may be absorbable or non-absorbable in whole or in part.
• Although thefastener250 usesmicro filaments275 to anchor thefastener250 into the tissue, it should be appreciated that any appropriate anchoring mechanism may be provided. for example, spring loaded tabs may be provided.
• Eachimplant250 has aproximal surface285 via which a driving force may be applied, e.g., by saline hydraulics, a spring force or any other appropriate mechanism. Theproximal surface285 of theimplant250 corresponds to the surface from which thesuture3300 proximally extends and is the same or substantially the same as the diameter of the core220. However, any appropriate location or dimensions may be provided for thesurface285.
• Although theimplants250 have cores with circular cross sections, it should be understood that other cross-sections may be provided, e.g., rectangular, triangular, oval, polygonal, and/or any other regular or irregular shape. Further, it should be understood that the anchoringmicro filaments275 may be evenly spaced apart or may have non-uniform spacing. Moreover, the filament density, i.e., the number of thefilaments275,575,675 per unit of surface area of the core may be constant, or may vary.
• FIG. 12 shows a distal end portion of animplant550, which is identical to theimplant250 except for the distal end portion illustrated inFIG. 12. The distal arrangement includes threeconcave surfaces580 that distally converge to form thesharp point560. Separating the threeconcave surfaces580 are three tapered cutting edges585. Thesetapered cutting edges585 may facilitate penetration of tissue, e.g., soft tissue. Although the end portion illustrated inFIG. 12 includes threeconcave surfaces580 separated by three correspondingtapered cutting edges585, it should be understood that any appropriated number ofconcave surfaces580 andcorresponding cutting edges585 may be provided.
• Moreover,FIG. 13 illustrates a surgical micro implant orfastener350 that has features in common with thefastener250 and may be used in conjunction with any of the fastening applications described herein. However, thefastener350 includes acorrugated body351. Thebody351 includesgrooves353 that extend axially along the length of thebody351. Thus, extending circumferentially around thebody351, a plurality ofgrooves353 alternate with a plurality ofridges355. Further, thefastener body351 includes a pair of split portions orwings357 and358. The split portions are formed by respective splits orcuts359 into thebody351. In this regard, thesplits359 may be formed by making a cut radially into thebody351 and extending in an axial direction. Thus, the two splitportions357 and358 are attached to the remainder of thebody351 at a distal position and extend proximally to free ends. The free ends include a plurality of sharp protrusions along a curved surface. These points are formed due to the corrugations. In particular, theridges355 form the sharp protrusions. In particular, theridges355 form the sharp protrusions, as illustrated in the inset partial side view inFIG. 13, which are advantageous for gripping tissue and preventing distal sliding of thefastener250. Although each splitportion357 and358 includes three such protrusions as illustrated, it should be understood, that thefastener350 may be designed such that one or more of the split portions has any other number of protrusions, including a single sharp protrusion. For example, if a larger number of sharp protrusions are desired, thebody351 could be more densely corrugated (i.e., a greater number of alternatinggrooves353 andridges355 could be provided) and/or the angle of the cut or slice could be adjusted. Further, the length of proximal extension of the projections may be adjusted by varying the depth of thegrooves353 with respect to theridges355.
• Thesplit portions357 and358 do not substantially impede distal insertion into tissue but resist proximal movement from an insertion location by engaging the tissue. It has been discovered that the combination of the pointed and/or sharp-edged proximal ends of thesplit portions357 and358 with the alternating ridges on the proximal end of the split portions creates improved performance.
• Further, the split portions orwings357 and358 are axially offset from each other. For example, split357 is axially located at position a along axis x and split358 is axially located at position b along axis x. This allows for greater structural strength of the other portions of thebody351 as compared to a non-offset configuration. In particular, since the cuts progress continually radially inward as they progress distally, a non-offset portion would have a substantially smaller amount of material in cross-section in the distal end of the cut. This would lead to a mechanically weak point or region along the axis of the body and could lead to mechanical failure, especially in fasteners of small dimensions.
• The distal tip of thefastener350 is pyramidal, with a sharp point, and a plurality of surfaces separated by edges that converge at the sharp point. Although four planar surfaces are provided, it should be appreciated that any appropriate suitable number of surfaces may be provided and that one or more or all of the surfaces may be non-planar.
• Thefastener350 also includes ahooked end portion360. The hooked portion may be suitable for coupling any other temporary and/or permanent implant. For example, the hook may be used to secure thesuture3300. However, thefastener350 may advantageously be formed with thesuture3300 extending therewith, e.g., by being molded or co-extruded with thesuture3300, as described with regard tofastener250. Moreover, the hooked end portion may be dispensed with.
• Thefastener350 may be produced by first forming thebody351 with the corrugations, e.g., by injection molding or extrusion, and subsequently formingwings357 and358, e.g., by cutting radially into the side of thebody351. As illustrated, the cut is curved, with an angle (at the proximal entry point), relative to the longitudinal axis of thebody351, that gradually decreases from the proximal initial cutting location toward the distal end of thefastener350 and eventually becoming linear. Although the spit or cut of the illustrated example is made with a curved or varying angle with respect to the longitudinal axis of thebody351, it should be understood that any appropriate cut, including a linear cut, may be made.
• Although thefastener350 includes two wings spaced equally around the radial periphery of thebody351, it should be appreciated that any number of wings, including a single wing may be provided and at any appropriate spacing around the radial periphery.
• Furthermore, it should be understood that the corrugated split-bodied configuration may be employed in combination with any of the other fastener features disclosed herein. For example, thefastener350 may include filaments in addition to the split portions.
• Referring toFIG. 14, asurgical system5000 includes ahandpiece5100 configured to drive thefastener250, for example, to a predetermined depth. The depth is limited, e.g., by a predetermined amount of slack in thesuture3300. The proximal end of thesuture3300 is attached to acapstan5105 configured to adjust the length of thesuture3300 extending fromcapstan5105. In this regard, thecapstan5105, which may be actuated by a motor system or any other appropriate mechanism, may set the slack by reeling off a predetermined length ofsuture3300 prior to driving thefastener250 and/or thecapstan5105 may have a predetermined amount of allowed rotation such that driving of thefastener250 causes the capstan to rotate only the predetermined amount, thereby setting the driving depth of thefastener250. The determination of the depth and/or the driving velocity of thefastener250 may be determined in aprocessor5110 of thehandpiece5100. Thedevice3000 described above may include an analogous handpiece. Although the processing takes place in aprocessor5110 located in thehandpiece5100, it should be understood that the processor may be disposed in other parts of the device, e.g., in theshaft5115 and/or the processing may take place location separate from thehandpiece5100 andshaft5115, e.g., at a remote computing unit that communications, e.g., wirelessly, with the surgical device. Further, it should be understood that thecapstan5110 may be disposed in theshaft5115.
• Theshaft5115 includes many features, e.g., the maneuverability, the winding mechanism and the clipping mechanism, of thecatheter3000 described above.
• During a procedure, thesystem5000 operates in a manner analogous to thedevice3000 described above. However, one or more of theimplants3200 are replaced by theimplants250. Theimplants250 may be hydraulically delivered, or delivered by a piercing needle, or any other appropriate driving mechanism. Regarding hydraulic delivery, it is noted that a very precise force may be delivered at the distal end portion of theshaft5115 to drive thefastener250. This force may be controlled by theprocessor5110 in connection with hydraulics, e.g., in the handpiece. For example, the hydraulic fluid, e.g., saline, may be disposed in a tube extending along theshaft5115. Hydraulics and controls in thehandpiece5100 may then transmit a very precise force, via the hydraulic fluid extending along theshaft5115, to the distal end portion of theshaft5115 to precisely drive thefastener250.
• As illustrated inFIG. 14, thefastener250 has been driven into thetissue951,952. As the shaft is retracted from the implantation location, e.g., to be repositioned at the opposed layer of tissue, thecapstan5105 reels off a corresponding length ofsuture3300. Further after driving a second implant, e.g., anotherfastener250, the twosutures3300 are wound in the manner described above with respect todevice3000. During the winding the capstan may be actuated, e.g., according to control signals from theprocessor5110 to progressively retract thesuture3300. However, the capstan may be controlled to resist any rotation, e.g., where the capstan is mounted to move in connection with a retracting winding tube such as thetube5400 described below. Eachsuture3300 may have its ownrespective capstan5105 or thesutures3300 may share a capstan mechanism. If thesutures3300 share a capstan mechanism, it may be advantageously be configured with a mechanism to retract/extend eachsuture3300 independently, e.g., during the fastener driving procedures. Moreover, the capstan(s)5105 may be coupled to the suture twisting mechanism to avoid any undesired twisting proximal to the twisting interface, e.g, hooks.
• FIG. 15A illustrates the driving of an anchoringfastener250 through afirst tissue1951 and into asecond tissue1952 using the device ofFIG. 14.
• FIG. 15B illustrates the first andsecond tissues1951,1952 ofFIG. 15A with the anchoringfastener250 implanted in the first tissue and thesuture3300 attached to the anchoringfastener250 extending through thefirst tissue1951.
• FIG. 15C illustrates the first andsecond tissues1951,1952 ofFIG. 15B with asecond anchoring fastener250 driven through thesecond tissue1952 and into thefirst tissue1951 and with the device ofFIG. 14A twisting thesutures3300 attached to the anchoringfasteners250.
• FIGS. 15D to 15F sequentially illustrate the retraction, twisting, and clamping of sutures attached to the anchoring fasteners ofFIG. 15C to join the two tissues.
• FIG. 15G shows fasteners driven into the tissues at angles and locations that differ from the procedure ofFIGS. 15A to 15F.
• FIGS. 15D to 15F sequentially illustrate an approximation procedure employing thefasteners250. As illustrated inFIG. 15C, thefasteners250 have been driven into theopposed tissues1951 and1952 and thesutures3300 are in the process of being refracted and twisted in manner analogous to that described above with respect todevice3000. Within thetube portion5115 is a windingtube5400 that rotates and retracts, along with its windinghooks5405 to wind and retract thesutures3300. A pair ofactuatable clip elements5500 are disposed at the distal end portion of thetube5115. Theseelements5400,5405, and5500 have features analogous toelements3400,3405, and3500 described above with regard todevice3000.
• As illustrated inFIG. 15D, thesutures3300 are in a taut state as thetissues1951,1952 are moving toward each other due to the twisting and retraction of the proximal portions of the sutures.
• As illustrated inFIG. 15E, thetissues1951,1952 have been brought into contact with each other and are being held securely by thesutures3300.
• As illustrated inFIG. 15F, theclip elements5500 have been actuated to clip and join thesutures3300 in the same manner described above with regard toclip members3500.
• It is noted that this arrangement does not require penetration of full thickness of therespective tissues1951 and1902 into which theimplants250 are implanted. That is, the sharp tips of the anchoring fasteners are not exposed beyond the outer walls of the tissue need not be pierced. This may be advantageous to reduce trauma to the tissue and limit the possibility of damaging any adjacent tissues. It should be understood, however, that thefasteners250 may be driven to a depth such that the tip extends beyond the outer wall of therespective tissue1951,1952 into which the respective fastener is implanted.
• The arrangement ofFIG. 15F maintains a closure that secures the illustrated end portions of the twotissues1951,1952 together.
• FIG. 15G shows an arrangement that is analogous to the arrangement ofFIGS. 15A to 15F, but differs in that the angle between the axes along which thefasteners250 are driven is less. Further, thefasteners250 are driven through end faces of thetissues1951,1951. In this regard, it should be understood that thefasteners250 may be driven at any appropriate angle (including, e.g., substantially 180 degrees) to each other and at any appropriate angle or location with respect to therespective tissues1951,1952.
• The driver of any example implants disclosed herein may be configured to drive any of the example fasteners described herein to a predetermined depth. The precision of the depth may be accomplished by any appropriate mechanism, e.g., a precise hydraulic driving force, e.g., with saline fluid, engagement with flanges or other similar stops, or a suture that tautens to limit the depth. Further the depth may be monitored using fluoroscopy or any other appropriate imaging mechanism. The driving mechanism may include pressurized saline or other hydraulic fluid that is pressurized through the endoscopic catheter shaft. Thus, very precise control may be accomplished.
• According to example embodiments, a computer system,e.g. including processor5110, may determine the location of two points, e.g., and determine a distance therebetween. The distance may be used as a desired distance to which the fastener is fired. The implanting distance may be set by any appropriate adjustment mechanism, e.g., an adjustable stop or flange, a cord or suture attached to the fastener, and/or precisely controlling the speed and momentum of the fastener during the implantation (e.g., by finely controlling a hydraulic propulsion system). Such measurements, determinations, and/or control of depth may be employed in conjunction with any implantation of fasteners disclosed herein.
• The fasteners are preferably driven at a speed greater than 50 meters per second, more preferably in a range of 50 to 350 meters per second, and most preferably at 350 meters per second. However, it should be understood that the fasteners may be driven at any suitable speed sufficient for the fasteners to puncture tissue.
• Modern manufacturing processes allow for near nano technology applications. This allows theimplant250 and any other implants disclosed herein to be manufactured in a size and complexity that may not have been possible in years past. Theimplant250 may be injection molded of either absorbable or non absorbable polymers and then processed to add the features of the protrudingfilaments275.
• Although theimplants250 are formed of polymer, it should be appreciated that any appropriate material may used, e.g., metal or a composite material.
• In order to accurately penetrate adjacent tissues that are not held or secured on a distal side, a rapid penetration of the layer(s) of tissue may be required in order to effect a desired penetration. If animplant250 is applied slowly, the tissue may be pushed distally away by the implant and/or needle without adequate penetration. Thus, some example delivery mechanisms eject the implant a relatively high velocity. In some preferred examples, saline is used to pressurize the channel within the catheter or needle at such a rate that the plunger will eject theimplant250 at the precise velocity. Other example embodiments utilize a spring-loaded mechanical mechanism to eject the implant. Further example embodiments push the implant using long push rods which run the length of the catheter. The ejection modality is computer-controlled. However, it should be understood that the ejection may be, e.g., operator-controlled. For example, the ejection force may be predetermined and repeatable by a mechanical system, e.g., a spring-loaded system, which is triggered by an operator, e.g., a surgeon.
• Any of the mechanisms and devices described above may be utilized with pressure sensing, e.g., sensing of the pressure required to progress a needle or fastener using any appropriate pressure sensing mechanism. The pressure may be relayed to, e.g., a computer control system, including, e.g,processor5110, in a hand piece, e.g.,handpiece5100, to which the implanting device of any of the embodiments described herein is coupled. Further, imaging data may be obtained, including, e.g., ultrasound or other digital imaging, and relayed to, e.g., the computer control system in a hand piece. This information, including pressure and/or imaging information and/or any other sensed information may be used by the control system to appropriately control the insertion of the various needles and/or implants into the tissue. For example, the control system may control the rate, location, angle, and/or depth of insertion. Such precise control may be particularly advantageous when repairing defects in the heart, which requires very precise placement of implants.
• The various mechanisms described herein provide for a tissue repair system that allows great flexibility. For example, smaller defects may be repairable with a single fastener (e.g., fastener100 or any other fastener described herein), and larger defects may be repairable with a plurality of fasteners, with or without a washer or plate2200, as described above. Larger defects, e.g., hernias or large holes, may be more suited for a mesh1300 application, as described above.
• The various implants described herein, e.g.,fasteners250,350,550,650plates3200, andclip elements3500,4500, may be formed by molding, e.g., injection molding.
• Moreover, thefasteners250,350,550,650 may be provided with a head element that restrains proximal movement of the tissue with respect to the fastener. Further, the head elements may be fixed or movable, e.g., where the fasteners have ratcheted or threaded proximal end portions configured to receive corresponding ratcheting or threaded head elements.
• Further, any of the implantable elements described herein, e.g.,fasteners250,350,550,650,plates32004200, andclip elements3500,5500, and/orsutures3300, may be formed wholly or partly of a material absorbable into the patient's body, or of a non-absorbable material, depending on, e.g., the specific application. For example, these elements may be formed of polyglycolic acid (PGA), or a PGA copolymer. These elements may also, or alternatively, be formed of copolymers of polyester and/or nylon and/or other polymer(s). Moreover, these elements may contain one or more shape-memory alloys, e.g., nitinol and/or spring-loaded steel.
• Absorbable materials may be advantageous where there is a potential for misfiring or improper locating of the various implants. For example, in a situation where a fastener or other implant is driven at an unintended location, or where the tissue does not properly receive the implant, the implant even where not needed, would relatively harmless, as it would eventually absorb into the patient's body.
• Although the present invention has been described with reference to particular examples and exemplary embodiments, it should be understood that the foregoing description is in no manner limiting. Moreover, the features described herein may be used in any combination.

Claims (20)

1. A surgical device, comprising:

a first anchor coupled to a first suture;

a second anchor coupled to a second suture;

an implant driver configured to anchor a first implant to a first portion of tissue and to anchor a second implant to a second portion of tissue, the first and second anchors being coupled to respective first and second sutures; and

a winder configured to twist the first and second sutures together bringing the first portion of tissue into approximation with the second portion of tissue.

2. The device ofclaim 1, wherein the implant driver is configured to anchor the implants by using a hydraulic driver.

3. The device ofclaim 2, wherein the hydraulic driver uses saline as a hydraulic fluid.

4. The device ofclaim 1, further comprising clamping element configured to clamp together the sutures after the winding.

5. The device ofclaim 4, wherein the clamping element is further configured to trim the an excess length of each suture disposed proximally to a location of the clamping.

6. The surgical device ofclaim 1, wherein the first implant is a fastener having a plurality of anchoring filaments configured to resist refraction of the fastener from the first portion of tissue.

7. The surgical device ofclaim 1, wherein the first implant is a fastener having a plurality of wings configured to resist retraction of the fastener from the first portion of tissue.

8. The surgical device ofclaim 1, wherein the first implant is a self-expanding anchor.

9. The surgical device ofclaim 8, wherein the first implant is disk-shaped.

10. The surgical device ofclaim 9, wherein the self-expanding anchor includes a plurality of tissue-piercing teeth configured to penetrate the entire thickness of the first portion of tissue.

11. A surgical device, comprising:

a hollow needle having an inner chamber and a sharp tip configured to pierce a tissue;

a first self-expanding anchor having a collapsed position and an expanded position, the first anchor being positionable within the inner chamber when in the collapsed position;

a first suture extending through the needle and attached to the first anchor; and

an actuator configured to drive the needle containing the first anchor into a first predetermined position in a first portion of tissue, wherein the needle is retractable from the first predetermined position to leave the first anchor in the first predetermined position, and the first anchor is expandable from the collapsed position to the expanded position upon retraction of the needle.

12. The device ofclaim 11, further comprising:

a second self-expanding anchor having a collapsed position and an expanded position, the second self-expanding anchor being positionable within the inner chamber when the second self-expanding anchor is in the collapsed position; and

a second suture extending through the needle and attached to the first anchor, wherein the actuator is configured to drive the needle with the second anchor into a second predetermined position in a second portion of the tissue, the needle being retractable from the second predetermined position to leave the second anchor in a position distally beyond the second portion of tissue, and the second anchor is expandable from the collapsed position to the expanded position upon retraction of the needle.

13. The device ofclaim 12, wherein each of the first and second sutures is a braided suture.

14. The device ofclaim 12, wherein the device includes an actuator configured to distally retract the first suture and the second suture into a distal end of the device, thereby pulling the first anchor and the second anchor together, the pulling of the first anchor and the second anchor together causing the first portion of tissue to be pulled toward the second portion of tissue.

15. The device ofclaim 14, wherein the sutures are twisted as they are distally retracted.

16. The device ofclaim 14, further comprising a clamp configured to join the first suture to the second suture and cut excess portions of the first suture and the second suture distal to the joint of the first suture to the second suture.

17. A surgical system, comprising:

a first implant coupled to a first suture;

a second implant coupled to a second suture; and

an implant driver configured to position the first implant in a first predetermined position in relation to a first tissue, and to position the second implant in a second predetermined position in relation to a second tissue, the implant driver configured to draw the first and second sutures together to bring the implants into apposition thereby bringing the first tissue and the second tissue into apposition, wherein the first and second implants are configured to pierce both the first and second tissues at an interface of the first and second tissues when the first and second tissues are in apposition.

18. The system ofclaim 17, wherein the first implant is a first disk and the second implant is a second disk.

19. The system ofclaim 18, wherein the first disk includes a plurality of projections each configured to cut entirely through the first tissue and the second disk includes a plurality of projections each configured to cut entirely through the second tissue.

20. A method, comprising:

positioning a first implant in a first predetermined position adjacent a first tissue;

positioning a second implant in a second predetermined position adjacent a second tissue;

bringing the first and second tissues into apposition by pulling the first and second implants into apposition with each other; and

creating multiple puncture wounds in each of the first and second tissues with the first and second implants.

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