HK1185244B - System and method for transapical access and closure - Google Patents

Description

Systems and methods for transapical access and closure

Technical Field

The present invention relates generally to devices and methods for performing cardiovascular surgery, and more particularly to interventional and closure techniques related to transapical cardiac diagnostics and interventions.

Background

Minimally invasive diagnostic and interventional procedures continue to increase in U.S. and foreign hospitals, as well as the need for certain procedures involving the placement of relatively large devices at target locations within critical tissue structures. Procedures such as aortic valve replacement have traditionally been addressed by highly invasive open surgical procedures. More recently, such procedures have been attempted using natural lumen (i.e., through the large blood vessels after first surgically percutaneous or percutaneous access to such vessels) access and delivery systems. Referring to fig. 1, such systems are typically configured to access the aortic valve (12) location inside the heart (2), for example, by an antegrade approach, which generally requires advancing the instruments through three of the four chambers of the beating heart (right atrium 22, left atrium 8, and left ventricle 20, across the mitral valve 10 and septum), or a retrograde approach, which generally requires advancing the instruments along the aortic arch from the descending aorta (4) to the ascending aorta (6) and adjacent aortic valve (12). Each of these approaches presents certain clinical challenges to the surgical team, some of which can be avoided by using the so-called transapical approach, in which the surgeon creates a percutaneous access to the area around the apex (26) of the heart through a surgical thoracotomy, then directly accesses the left ventricle (20) using a needle or other device intended to access the left ventricle (20) around the apex (24) of the left ventricle, then creates a temporary access opening to the left ventricle using one or more dilators. A conventional interventional aspect is shown in fig. 2, wherein a needle device (34) pierces a myocardial wall (30) to access the left ventricle (20) around the location of the left ventricular apex (24). It also shows a guide wire (36), which guide wire (136) can be advanced towards and through the aortic valve (12) to assist in the diagnostic and interventional aspects of the procedure. With these and other devices such as dilators, the left ventricular access port can be utilized, for example, to replace an aortic valve if bleeding and tissue damage around the access port can be successfully reduced during such procedures. After such a procedure, the instrument needs to be removed and the access port closed, typically leaving behind the prosthetic valve or a portion thereof. Successful closure of transapical trauma on the patient's beating heart is clearly critical to such procedures, as is minimization of blood loss. Conventional transapical closure techniques typically involve the application of small sutures to create a purse-string effect to close the wound as the instrument is withdrawn, but it can be difficult to reproducibly create an acceptable closure using these techniques without going through a larger thoracotomy or modified instrument. In other words, one of the key difficulties of transapical intervention is transapical wound closure. Indeed, it is believed that transapical interventions can provide enhanced stability and control during procedures such as aortic valve replacement due to the fact that: the surgical practitioner may have a relatively direct mechanical connection to the associated instrument relative to other available connections, such as antegrade or retrograde vascular approaches using more compliant catheter-type tools. For this reason, it is more desirable to successfully address the challenges of transapical access and closure.

Disclosure of Invention

One embodiment is directed to a device for closing a defect in a tissue wall, the device comprising: a base member having a proximal end and a distal end and a sealing member disposed therebetween, the proximal end configured to be manually manipulated by a surgical operator; wherein the seal member defines an outer seal boundary defining an outer seal diameter; a first plurality of bendable strut members coupled to a distal end of the base member and configured to occupy a collapsed configuration when bent into position toward the base member and an extended configuration when unconstrained; wherein, in the collapsed configuration, each of the bendable strut members protrudes from a coupling joint with the distal portion of the base member, swings towards the proximal end of the base member, and bends towards the outer sealing boundary; a proximal cuff (hub) member movably coupled to the base member and advanceable along a length of the base member; and a second plurality of bendable strut members coupled to the proximal ring cuff member and configured to occupy a collapsed configuration when bent into position toward the base member and an extended configuration when unconstrained; wherein, in the collapsed configuration, each of the bendable strut members protrudes from a coupling joint with the proximal ring cuff member and swings toward the distal end of the base member. The apparatus may also include a tubular delivery member defining a delivery lumen through which the base member, the first plurality of bendable strut members in the collapsed configuration, the proximal collar member, and the second plurality of bendable strut members in the collapsed configuration may be advanced by inserting the base member relative to the tubular delivery member. The tubular delivery member has an outer diameter configured to be inserted through a defect formed in the tissue wall such that the base member can be further inserted to place the first plurality of bendable strut members through the tissue wall, out of the delivery lumen, and into the expanded configuration of the first plurality of bendable strut members. The first plurality of bendable strut members may assume an extended shape having a diameter greater than a diameter of the tubular delivery member after being extended into the extended configuration. The base member may include an elongated shape having movement control features configured to controllably resist movement of the proximal ring sleeve member relative to the base member. The outer sealing boundary may have a substantially circular shape. The first plurality of bendable strut members may comprise two or more elongate members having a proximal end fixedly coupled to the distal end of the base member in a dependent anchoring configuration and a distal end free to move in the dependent proximal anchoring configuration. The distal end of the bendable leg members may be sharpened. A plurality of the bendable strut members may be substantially evenly radially distributed about a longitudinal axis of the distal end of the base member. The first plurality of bendable leg members may include a pair of bendable leg members. The first plurality of bendable leg members may include three or more bendable leg members. The first plurality of bendable strut members may comprise nitinol. The second plurality of bendable strut members may comprise two or more elongate members having a proximal end fixedly coupled to the proximal ring member in a dependent anchoring configuration and a distal end free to move in the dependent proximal anchoring configuration. The distal end of the bendable leg members may be sharpened. The second plurality of bendable strut members may comprise two or more elongate members having proximal ends fixedly coupled to the proximal ring member in a catenary anchor configuration and distal ends engaged in an atraumatic loop configuration. The second plurality of bendable strut members may comprise nitinol. The apparatus may also include a catheter defining an inner lumen and having an outer diameter, wherein the inner lumen is sized to removably receive the tubular delivery member, and wherein the outer diameter is sized to be insertable through a defect formed in the tissue wall. The apparatus may also include a fabric component coupled to the second plurality of bendable strut components and configured to transmit a load applicable to the strut components through adjacent tissue structures.

Drawings

Fig. 1 illustrates various aspects of human cardiac anatomy.

Fig. 2 illustrates a conventional transapical intervention.

Fig. 3A through 3Z-3 illustrate various aspects of various embodiments of a system for creating transapical access for diagnostic and/or interventional procedures and closure after such procedures.

Fig. 4 illustrates various aspects of a method for creating transapical interventions for diagnostic and/or interventional procedures and closures following such procedures, in accordance with aspects of the device embodiment illustrated in fig. 3A through 3Z-3.

Fig. 5A-5B illustrate an embodiment in which imaging and measurement tools may be utilized to assist in the precise orientation and placement of a transapical access port.

Fig. 6 illustrates various aspects of a method for creating transapical access for diagnostic and/or interventional procedures and such post-operative closure in accordance with aspects of the device embodiment illustrated in fig. 5A and 5B.

Figures 7A-7B illustrate an embodiment in which imaging and measurement tools may be utilized to assist in the precise positioning and placement of a transapical access port closure device.

Fig. 8 illustrates various aspects of a method for creating transapical access for diagnostic and/or interventional procedures and such post-operative closure in accordance with aspects of the device embodiment illustrated in fig. 7A and 7B.

Fig. 9A-9G illustrate aspects of an embodiment of a system for creating a transapical intervention for diagnostic and/or interventional procedures and closing after such procedures using one or more helical needles for suture placement.

Fig. 10A-10B illustrate aspects of suture and anchor deployment embodiments in which anchors are placed across the thickness of the subject tissue structure, such as in the left ventricular cavity.

11A-11B illustrate aspects of suture and anchor placement embodiments in which the anchors are placed within the thickness of the subject tissue structure, such as in the muscular wall of the left ventricle.

Fig. 12 illustrates one embodiment of a barbed suture and anchor assembly.

Fig. 13A illustrates various aspects of a method for forming and closing a transapical intervention in which an anchor is placed across the thickness of a subject tissue structure, such as in a left ventricular cavity.

Fig. 13B illustrates various aspects of a method for forming and closing a transapical intervention in which anchors are placed within the thickness of the subject tissue structure, such as in the muscular wall of the left ventricle.

Fig. 14A and 14B illustrate two embodiments of support structures configured to limit projection of a guide member into a tissue structure, such as a left ventricular wall.

Fig. 14C illustrates an embodiment having a hole configured to remove fluid in situ near the pericardium.

Fig. 14D-14E illustrate an embodiment in which a steerable catheter with visualization and vacuum capabilities can be movably coupled to a collar member positioned around an introducer or similar member.

Figures 15A-15B illustrate an introducer embodiment having a diametrically extendable distal portion.

Figures 16A-16E illustrate aspects of the buckle fastener assembly and its arrangement.

Fig. 17A-17E illustrate aspects of an example helical suture member arrangement.

Fig. 18A-18C illustrate a method for closing a tissue defect with a purse string suture using a helical needle embodiment.

19A-19G illustrate aspects of an arrangement process utilizing a spiral needle assembly.

20A-20G illustrate aspects of a leak-proof assembly arrangement in which an inflatable member may be utilized to prevent leakage around the intersection of an introducer or similar member with a tissue wall.

21A-21J illustrate aspects of a leak-proof assembly arrangement in which an inflatable member with a distal collar member may be utilized to prevent leakage around the intersection of an introducer or similar member with a tissue wall.

Fig. 22A-22K illustrate aspects of a leak-proof assembly arrangement in which an inflatable member and a tapered distal member may be utilized to prevent leakage around the intersection of an introducer or similar member with a tissue wall and to close a wound left after withdrawal of the introducer or similar member.

Fig. 23-25 illustrate various aspects of an example of an arrangement similar to that described with reference to fig. 20A-22K.

Detailed Description

Referring to fig. 3A through 3Z-3, aspects of embodiments of transapical access and closure systems are illustrated. As shown in fig. 3A, a transapical access assembly is shown that includes a needle (34) placed through an elongated dilator member (42) slidably positioned through a working lumen of an introducer cannula (44) that can be manipulated using a proximal handle or collar (46). The assembly has been placed through a thoracotomy formed in a thoracic wall (40) of a patient and is oriented toward a location on the heart (2) determined to be proximate an apex (24) of the left ventricle (20), using information derived from sources such as anatomical markers, preoperative diagnostic imaging information such as radiography and/or fluoroscopy, and intraoperative imaging information derived from, for example, radiography, endoscopy and/or fluoroscopic imaging of portions of the interventional assembly that may be radiopaque (or radiopaque markers that may be secured to portions of the assembly in one embodiment). Referring to fig. 3B, after the needle (34) has been inserted across the wall (48) of the left ventricle (20), the dilator (42) follows the needle, and the introducer sheath (44) follows the dilator, the needle and dilator may be withdrawn, and the introducer (44) left in place to provide transapical access. The needle preferably comprises an approximately 18 gauge conventional stainless steel needle and may be provided with radiopaque markers at known graduated locations and distal tips. The introducer may comprise a stock transapical cannula having a working lumen (50) diameter of between about 22Fr and 26Fr, such as a cannula available under the trademark "Ascendra" (RTM) from edwards scientific corporation. Guidewires may also be used in interventional protocols (protocols) and configured with elongated interventional components known as "quick-change" features, similar to those described, for example, by Paulyock and others in publications such as U.S. Pat. No.5,061,273.

Fig. 3C shows an enlarged schematic view of the guide (44) and left ventricular wall (48) paradigm with reference to the chest wall boundary (40). With the guide (44) in place, as shown in fig. 3B and 3C, a diagnostic and/or interventional procedure may be performed, such as an aortic valve replacement procedure using a prosthesis such as that sold by edwards scientific corporation under the trademark "Sapien" (RTM). Following the diagnostic and/or interventional procedure, a closure procedure may be performed in the configuration shown in figures 3D to 3Z-3. Referring to fig. 3D, the closure device assembly may be inserted through the introducer. The assembly embodiment shown in fig. 3D includes a plurality of distal struts (54) coupled to a disc or sealing member (56) that is coupled to an insertion assembly that includes a thin elongated proximal portion (64) that exits proximally to a position where it can be manipulated by a surgical administrator, and an insertion assembly fixedly coupled to a thicker distal portion (66) of the disc member (56). A proximal ring sleeve member (60) is slidably coupled about the insertion assembly and to the plurality of proximal struts (58). The collar member (60) is removably coupled to a pusher member (68) that leads to a proximal position in which it may be manipulated by a surgical operator to advance or retract the collar relative to other portions of an associated assembly, such as an insertion assembly (64, 66). Such a closure device assembly, when provided to the introducer sheath (44), may be slidably positioned within the working lumen of the delivery sheath (52), and the delivery sheath (52) and closure device assembly are preferably insertable together relative to the introducer sheath (44).

Referring to fig. 3E, an enlarged side view of the closure device is shown showing the distal post (54), the disc member (56), the proximal guide assembly portion (66), the proximal collar (60), and the proximal post (58) in greater detail. In one embodiment, the proximal struts (58) and distal struts (54) comprise nitinol wire that is thermoformed into the arcuate shape shown, which in one embodiment has an outer diameter of about 0.023 inches. Although the illustrated embodiment includes five distal struts (54) and five proximal struts (58), other combinations may be employed, such as 1 proximal/1 distal, 2 proximal/2 distal, 3 proximal/3 distal, 4 proximal/4 distal, 6 proximal/6 distal, and so forth; further, it is not required that the number of proximal struts match the number of distal struts — thus, for example, a 6 proximal/3 distal configuration may be employed. Preferably, the proximal and distal struts are rotatably oriented relative to each other to interdigitate when they are closed, as described below with reference to fig. 3G, and are available for anchoring the sides of the tissue structures toward each other around the defect. Indeed, in some cases, due to the natural dynamics of the tissue comprising the apex of the LV, a successful closure result may be more closely associated with anchoring portions of the tissue surrounding the defect together (i.e., providing/promoting tissue approximation) to allow clotting than a full hemostatic seal.

In one embodiment, the ends of the proximal struts (58) and distal struts (54) are sharpened to facilitate insertion of the ends into tissue so that they may be actuated in opposition. The proximal collar (60) and the disc member (56) may comprise a relatively bio-inert material or composite, at least some portions of which have a greater stiffness than the material comprising the post to facilitate supporting associated structures such as the proximal post portion. For example, in one embodiment, the proximal collar (60) and the disc member (56) comprise titanium metal encapsulated in a relatively inert polymer such as nylon or delrin: (rtm). In another embodiment, the disc member (56) may comprise a compliant solid material, and/or a non-solid construction, such as a structure made of a fabric-like material, such as dacron (rtm), which may be reinforced by an associated external cage or hoop member. A unitary hemostatic pad (70), such as made of a gel foam material, may be coupled to the proximal cuff (60) to prevent bleeding around the interface area between the proximal strut (58) and tissue of the heart wall that may be captured between or adjacent to the proximal strut (58) and the distal strut (54). The outer diameter of the disc member (56) is preferably maximized relative to the delivery cannula (52) and introducer cannula (44) configuration, as the disc member (56) is designed to work as a seal or plug for the kind of trauma left by the transapical access port in cooperation with the proximal post (58) and distal post (54) that are configured to urge nearby tissue against the disc member (56) to close the access port, as described in further detail below. In another embodiment, the disc member may be configured to expand in situ to provide additional wound occlusion/sealing geometric advantages associated with the captured tissue and sets of struts. Each distal strut (54) in the illustrated embodiment is curved to encompass a capture angle of about 35 degrees when in free space, with a relatively smooth and atraumatic curve on the distal side. The proximal struts (58) project from the proximal collar (60) at a similar angle, but without the reverse curvature as in the distal struts (54) in the configuration shown. With reference to the orthogonal view of fig. 3F, it can be more clearly seen that the illustrated embodiment has five struts on the proximal and distal sides. In addition, the proximal portion (66) of the insertion assembly has one or more flat surfaces that interface with flats within the proximal collar (60) to maintain a rotational orientation of the proximal collar relative to the distal struts (54) selected to allow the proximal struts (58) to interdigitate with the distal struts (54) as the proximal collar (60) advances toward the disc member (56), such interdigitation being desirable for grasping tissue without shearing or severing tissue. This relative rotational orientation is shown in the elevation view of fig. 3G. Referring to fig. 3H, another orthogonal view of the same assembly is shown showing two ratchet members (72) movably coupled to the proximal collar (60) and designed to interface with two serrated ratchet tracks formed in the proximal portion (66) of the insertion assembly. As the proximal ring (60) advances over these ratchet tracks, the ratchet member (72) is configured to allow further insertion, but prevent withdrawal (i.e., proximally towards the thoracotomy) of the ring (60). In other words, once the proximal collar (60) has been inserted onto the ratchet track of the proximal portion (66) of the insertion assembly, it is locked in a one-way movement paradigm; until it is inserted onto such a ratchet track, the collar may be withdrawn and inserted using the proximal collar pusher member (element 68 in fig. 3D). Referring to FIG. 3I, a closure device assembly is shown having a different set of proximal struts. The atraumatic proximal struts (59) are configured not to be inserted into adjacent tissue during deployment, but rather to transmit loads relatively atraumatically to such adjacent tissue by hoops thermoformed in the struts using materials and molding techniques similar to those used for the distal struts (54). Fig. 3J shows an elevation view illustrating the proximal and distal struts (59, 54) reinforced by flats or other similar rotationally oriented reinforcement features at the interface between the proximal collar (60) and the proximal portion (66) of the insert assembly. Referring to fig. 3J-i and 3J-ii, a truncated conical fabric component (232) comprising one or more layers of material such as dacron (rtm) fabric may be coupled to the distal aspect of the proximal struts (59, or 58 in other embodiments) to disperse or transfer loads that may be applied to nearby cardiac tissue via such struts due to the fact that: this material has a higher compliance of the structural material than is preferred for the struts and provides a greater surface area to the tissue, as in the illustrated embodiment. The fabric may also help control and/or mitigate minor bleeding that may be present at nearby tissue structure surfaces.

Referring to FIG. 3K, beginning again at the interruption in the illustrated deployment process of FIG. 3D, the closure device assembly and associated delivery cannula (52) have been inserted further into the patient. Referring to fig. 3L, when the surgical practitioner desires to begin installation of the closure assembly, the insertion assembly (64, 66) may be advanced relative to the delivery cannula (52) and the introducer (44) to the point where the distal struts (54) are able to bend through the distal ends of the delivery cannula and the introducer cannula (78, 76) and adopt their thermoformed configuration (i.e., the delivery cannula or introducer cannula lumen wall does not constrain them in a more pressurized configuration as they may assume during insertion). Generally, the distal struts (54) are configured to extend through an outer diameter of the introducer sheath (44) so as to be able to capture and anchor adjacent tissue. In one embodiment, the distal struts are configured to expand in diameter by about 20% (i.e., from a contained diameter of about 26Fr to an uncontained diameter of about 31 Fr) when allowed to escape the constraints of the delivery and introducer sheath, and this expansion helps to capture the portion of the annulus of tissue around the surgically created transapical defect that can be drawn inward toward the disc member (56) to create a traumatic occlusion or closure effect. This radial extension (74) of the distal struts is shown in fig. 3L. Referring to fig. 3M, to assist in providing adequate tissue capture () by the distal struts (54) with the distal struts (54) extended into their thermoformed configuration, the introducer sleeve (44) and delivery sleeve (52) can be withdrawn, thereby allowing nearby tissue to migrate inward (80) toward the disc member (56). This extraction may be performed simultaneously or sequentially (FIGS. 3M and 3N show partial sequential extractions-first the introducer sheath 44 and then the delivery sheath 52; FIG. 3O shows simultaneous extraction of both sheaths 44 and 52 together to allow further inward migration 80 of the viscoelastic tissue forming the left ventricular wall 48). The proximally directed distal tip of the distal struts (54) in conjunction with the arcuate, curved nature of the distal struts (54) and their capture by tissue at the beginning of introducer withdrawal as in fig. 3N-3P proximally advanced into the tissue provides significant anchoring and grasping of the tissue toward other tissues, which also closes the wound around the proximal aspect of the device. In other words, the arrangement bunches the nearby tissue toward itself, thereby providing for exposure of a heart chamber consisting primarily of living tissue anchored around a plurality of relatively small distal struts (54). This minimal hardware exposure is preferred for biological tissue coverage (i.e., endothelialization) benefits and avoids discontinuities and/or necrosis in critical intracardiac tissue surfaces that may result from having a large intracardiac device exposure. Referring to fig. 3P, the insertion assembly (64, 66) may then be pulled toward the surgical applier to assist in seating the distal struts (54) in the captured tissue without the distal struts (54) in place (i.e., in view of the modified sharp tips and spring-like nitinol materials described above), at which time a seal of the transapical access wound may be formed due to the interaction of the distal struts (54) and the disc member (60) effectively capturing and bunching inward tissue portions surrounding the left ventricular chamber side of the transapical access wound. Referring to fig. 3Q, the introducer cannula (44) and delivery cannula (52) may be further withdrawn to allow further migration of viscoelastic tissue including transapical access trauma (80). Referring to fig. 3R, the proximal collar (60) and associated proximal strut (58, or element 59 in the case of embodiments such as those shown in fig. 3I and 3J) may be advanced toward the disc member (56) using a proximal collar pusher member (68); in the embodiment shown in fig. 3Q, the introducer sheath has been completely removed; in other embodiments, it may remain and move parallel to the delivery cannula (52). Referring to fig. 3S, the proximal collar (60) may be further advanced (88) and/or the delivery sleeve may be withdrawn (90) to allow the proximal struts (58) to loosen and bend through the distal end of the delivery sleeve and be inserted toward the disc member (56) to capture the proximal portion of the tissue including transapical access trauma and urge them toward the disc member (56), as shown in fig. 3T. At this level of proximal collar (60) insertion, the proximal collar (60) has entered a ratchet track formed in the proximal portion (66) of the insertion assembly, and the one-way locking action of the collar (60) is enhanced to facilitate reliable positioning and maintenance of the closure assembly. At this point, the transapical access wound is effectively closed, with proximal struts (58) and distal struts (54) urging the tissue portions toward disc member (60) to form a sealed wound that will become further bio-integrated at any time.

Referring to fig. 3U, proximal collar pusher member (68) may be separated from the proximal collar (e.g., using a threaded interface that may be controllably separated by rotation of pusher member 68) and withdrawn proximally. Referring to fig. 3V, an optional hemostatic pad (96), such as made of a gel foam material, may be mounted on the proximal aspect of the deployed closure device with a pad insertion member (94) defining a lumen (100) through which portions of the insertion assembly (64, 66) may pass. The pad insertion member (94) may have a truncated conical distal portion (98) configured to broadly abut the hemostatic pad against the target closure device and tissue structure upon further advancement (102) of the pad insertion member (94) and/or retraction (90) of the deployment sleeve (52), as shown in fig. 3X. With the hemostatic pad (96) in place, the pad insertion member (94) may be withdrawn (104) as shown in fig. 3Y, and a cutter assembly including, for example, a cutter (106) and two cutter actuation members (108, 110) may be advanced toward the deployed closure device, as shown in fig. 3Z and 3Z-1. In the illustrated embodiment, the two cutter actuation members (108, 110) are configured to cause the cutter (106) to shear any elongate member passing therethrough, such as any portion of the insertion assembly proximal portion (64) or distal portion (66) that may pass therethrough. Referring to fig. 3Z-2, the insertion assembly proximal portion (64) has been intentionally cut near the deployed hemostatic pad (96) so that when the remaining uncoupled mounting hardware (114) is withdrawn, the amount of hardware left protruding proximally from the closed transapical access wound is minimized. The resulting arranged closure assembly (116) is shown in fig. 3Z-3.

Referring to fig. 4, a method of deploying a wound closure device using a technique such as that described with reference to fig. 3A through 3Z-3 is shown. After creating a percutaneous thoracic intervention (e.g., via thoracotomy) (168), the intervention may be surgically created to access the left ventricle (170) and install an introducer cannula (172). The introducer sheath may be used to perform a diagnostic and/or interventional procedure, such as an aortic valve replacement procedure (174), after which the associated diagnostic and/or interventional tools (176) may be withdrawn and closure initiated. In the illustrated embodiment, a transapical wound closure device assembly (e.g., including structures such as elements 54, 56, 66, 58, 60, 64, 68 of fig. 3D) positioned within a delivery cannula (52) can be guided through an introducer cannula (178) and advanced to allow a distal strut to be extended (180) through the introducer cannula and the distal portion of the delivery cannula. The introducer and delivery cannula may be withdrawn simultaneously or sequentially (184), or the device assembly (182) withdrawn to capture a portion of tissue between the distal post (54) and the disc member (56). The proximal collar (60) may be advanced (186) to engage tissue between the proximal post (58) and the disc member (56), with ratcheting mechanical stability provided by an interface feature between the proximal collar (60) and the distal portion (66) of the insertion assembly. With the proximal collar (60) in place such that the proximal struts urge the proximal aspect of the wound toward the disc member (56) and create an additional seal of the wound, the proximal collar advancement member (i.e., pusher member 68) may be removed (188) and the hemostatic pad (96) may be advanced through the introducer and/or delivery cannula using the pad insertion member (94) and against the tissue and proximally available device structure (190) of the pad. The pad insertion member (94) (192) may be removed and the cutter assembly advanced through the introducer and/or deployment sleeve (194). A cutter may be used to cut away (196) a proximal portion of the insertion assembly, and an uncoupled portion (198) may be withdrawn proximally, after which a transapical access port (200) may be closed.

Referring to fig. 5A, a similar configuration to that described with reference to fig. 3A is shown, except that: the introducer sheath (44) in the embodiment of fig. 5A is instrumented using additional techniques, such as an image capture device (118) and an optical coherence tomography ("OCT") device (120), to facilitate placement of the introducer across critical tissue structures, such as the left ventricular wall (48). As shown in the cross-sectional view of fig. 5B, the image capture device preferably comprises a fiber optic bundle or digital imaging chip such as CMOS, CCD, or other high resolution image capture device similar to those employed in so-called "end-chip" laparoscopy, which is coupled to the image processing and/or capture system (element 126, refer back to fig. 5A) by electrically conductive leads in the front bundle that couple the device (118) and system (126). The system may also include an illumination source that may deliver optical radiation to the operating room in situ using a fiber optic bundle (122), which may also include part of a return system (126) that directs the bundle. An irrigation port (124) may also be provided to allow controlled irrigation, vacuum and/or local transport of drugs, contrast media or other solutions to the operating room. As shown in fig. 5B, the OCT device (120) may include a fiber or fiber bundle on the introducer side of a proximal return interferometry system (128) capable of generating image and distance information for the surgical practitioner, such as the thickness of the left ventricular wall (48) just in front of the original site. The combination of intra-operative direct visualization with image capture, irrigation and/or illumination, and intra-operative three-dimensional images and measurement feedback from systems such as OCT, is selected to provide valuable and up-to-date information to the surgical practitioner in selecting an insertion vector location for the relevant instrument. Referring to fig. 6, a method is shown in which, after percutaneous intervention (168) is formed as in fig. 4, left ventricular intervention device configurations may be navigated, positioned, and oriented using up-to-date information from forward-oriented direct visualization and imaging and/or measurement features of on-board (onboard) OCT technology. These same imaging and information techniques can be utilized during insertion of the device components to confirm positioning and continue to provide the surgeon with up-to-date information (204). Subsequently, the diagnostic and/or interventional step (174) and other steps (206) may be performed as described above.

Referring to fig. 7A, an embodiment similar to that described with reference to fig. 3T is shown, except that: the elongate imaging platform (130) has been inserted through the deployed cannula (52) and onto the insertion assembly (64, 66) and the pusher member (68) using the lumen defined through the elongate imaging platform (130). The image capture device (118) and the irrigation port (124) are distally located and coupled to the image capture and illumination system (126) and the irrigation system (127) via an elongate imaging platform (130). Referring to fig. 7B, a cross-sectional view is shown to illustrate various distal members. In the illustrated embodiment, the elongate imaging platform is rotatable relative to the closure device member and left ventricular tissue — to enable various irrigation, image capture, illumination, and other member-mediated, more anteriorly directed activities. On-board OCT (not shown) may also be provided in the form of additional fibers or fiber bundles passing through an elongated imaging platform that proximally interfaces with an OCT interferometric system configured to provide images and measurements. Referring to fig. 8, various aspects of a method are illustrated in which, after other surgical steps (208) such as described above with reference to fig. 4, for example, a transapical closure device (178) may be inserted and the interaction (210) between the left ventricular tissue and the closure device assembly portions observed and embodied by imaging, measuring, and irrigation features that are movable relative to the tissue and the closure device. In one embodiment, for example, the image capture device and irrigation port may be used to examine leaks around portions of the circumference of the proximal aspect of the wound closed by the device. In addition, sealants, drugs, and other solutions may be administered by direct visualization. Subsequently, other steps of diagnosis and/or intervention may be performed (212), such as the steps described above.

Fig. 9A-12 illustrate aspects of other embodiments for closing a wound formed across a tissue structure, such as the wall of the left ventricle, using helically advanced sutures. Referring to FIG. 9A, an introducer sheath (44) has been advanced into the left ventricle using a technique such as that described above. Helical suture closure devices may be used to assist in closure of transapical access wounds following relevant diagnosis and/or intervention with a guide. As shown in fig. 9A, the spiral suturing assembly embodiment includes a needle insertion member (144) fixedly coupled to two spiral needles (132, 134). In the illustrated embodiment, the first helical needle (132) has a helical radius that is greater than a helical radius of the second helical needle (134). Each of the helical needles preferably comprises a relatively stiff and hollow structure made of a material such as stainless steel. A first suture (140) distally coupled to the first distal anchor member (136) passes through the first helical needle (132). Similarly, a second suture (142) distally coupled to the second distal anchor member (138) passes through the second helical needle (134). The ends of the needles (132, 134) are preferably sharp to facilitate access to the associated tissue structure. Fig. 9B and 9C show additional orthogonal views of the distal portion of the helical needle and needle insertion member (144). Fig. 9D shows an enlarged orthogonal view of the first and second helical needles (132, 134) and the distal anchoring members (136, 138) shown previously. The anchoring component is preferably geometrically configured to slidably and removably engage the distal end of the associated helical needle, and in the exemplary embodiment shown, is fastened or hooked to tissue and slidably disengages from the needle distal end upon counterclockwise rotation of the helical needle. In other words, with such embodiments, as the helical needle advances, the needle insertion member (144) rotates clockwise, the anchor is configured to remain in place at the distal end of the needle; once the needle insertion member is counter-clockwise rotated, small features on the anchor members (136, 138) are configured to catch on nearby tissue, pull the anchors out of their temporary received position in the needle tip, and begin pulling the suture through the hollow needle, leaving a helical suture through the distal anchor, as shown, for example, in fig. 10A-10B and 11A-11B. Referring to fig. 9E-9E, various anchor configurations (136, 146, 148) are shown, each having one or more features (150) configured for securing a suture or other tensioning member, and each having geometric features configured to catch on nearby tissue structures when moved backward relative to such tissue structures. Referring to fig. 10A-10B, an embodiment is shown in which the anchors have been helically driven across the thickness of the left ventricular wall (48) so that they are located within the left ventricle. Referring to fig. 10B, they may be stretched following extraction of the guide to close the transapical access wound. In one embodiment, both sutures (140, 142) may be stretched simultaneously. In another embodiment, they may be stretched sequentially. In yet another embodiment, a combination of simultaneous and sequential tensioning may be employed. For example, in one embodiment, first both may be simultaneously tensioned from the surgical operator with manual manipulation at a first tension level (i.e., using a grasper or other instrument placed through the chest wall, or by pulling the suture ends up through a thoracotomy, where they may be manipulated from outside the body), after which a second, higher tension level may be achieved in a first suture having a larger helix diameter, followed by a final "fine-tune" tension to bring a second suture having a smaller helix diameter to a higher tension level that may equal the second tension level of the first suture. It is believed that this approach facilitates complete closure of the wound, where the inner (i.e., proximal to the suture with the smaller helical diameter) portion of the tissue may have been plastically deformed to a greater extent than the outer portion (i.e., proximal to the suture with the larger helical diameter) due to the process of insertion of the blunt surgical intervention tool. FIGS. 11A-11B illustrate a tensioning scheme similar to FIGS. 10A-10B, except that: the helical needle (132, 134) and the anchoring member (136, 138) are advanced only to an intermediate portion of the thickness of the tissue structure wall (i.e., not through as in the embodiment of fig. 10A-10B).

In one embodiment, the suture may comprise a barbed suture material, such as those commercially available under the trademark "Quill" (RTM) from angiotechccorporation. Referring to fig. 12, in another embodiment, a relatively high load barbed suture (154) may be formed using a braided suture body material (154) such as dacron (rtm) webbing, small barbs (156) have been inserted into the suture body material with a length sufficient to insert into the suture body material to prevent the barbs (156) from becoming substantially repositioned, and the load bearing capacity in each barb is sufficient to provide a relatively significant net tensile load resistance when applied to an anchored suture that is at least partially disposed between two boundaries (158, 160) of a tissue structure.

The proximal suture ends (152) shown in fig. 10B and 11B can be tied to each other to maintain tension on the sutures, or can be held at a permanent or semi-permanent level of tension using a small buckle or suture tensioner in addition to a conventional pledget and surgical knot that can be used for each suture or for two or more sutures that are tied together.

Referring to fig. 13A, a method for forming, utilizing and closing a transapical access wound using a helical needle configuration such as described with reference to fig. 9A-9G and 10A-10B is illustrated, with some steps similar to those described with reference to fig. 4, for example. Following an intervention (168) to create access to the thoracic cavity, an intervention (170) to create access to the left ventricle, installation of an introducer sheath (172), and a diagnostic and/or interventional procedure (174) using such a configuration, the diagnostic and/or interventional tool may be withdrawn (176) before, after, or during advancement (214) of the helical closure device over the introducer. One or more helical needles may be advanced across the left ventricular wall (216) and, by back-screwing back (218) the helical needles, may leave one or more anchors coupled to sutures that are preferably passed proximally through the helical needles to a position (220) where they can then be controllably stretched by the surgeon to create a transient hoop stress around the introducer sheath to seal around the introducer as the introducer (222, 224) is withdrawn to prevent leakage through reciprocal adjustment of suture stretch. The tension may be fine-tuned (226), as described above, and the suture may be tension-locked in place (228). Finally, additional uncoupled proximal suture material and any other arranged hardware may be removed and the transapical access port (230) closed. Referring to fig. 13B, an embodiment similar to fig. 13A is shown, except that: the helical needle advances only into the middle thickness of the left ventricular wall (232), not completely through such wall.

Referring to fig. 14A, in one embodiment, the introducer sheath (44) may include a support flange (161) structure or feature near its distal end to allow only the introducer sheath (44) to protrude into the left ventricular wall (48) by a predetermined amount (162). In another embodiment, a support sleeve (163) may be movably coupled to the introducer sheath (44) with similar functionality, while in one embodiment such a support sleeve may be adjustably positioned relative to the introducer sheath (44) to allow for adjustment of the predetermined sheath distal protrusion distance (162) using an adjustable mechanical coupling such as the screw-type couplings (164, 166) shown in the embodiment of fig. 14B.

Also shown in fig. 14A is a series of holes (236) in fluid communication with a vacuum source or pump (240) via a vacuum lumen (234) and vacuum line (238). The aperture (236) and vacuum (234) may be used to remove blood and other fluids that may seep or leak from surrounding tissue during surgery. This may be important for transapical procedures to remove blood or other fluids that may, for example, enter the pericardium and potentially cause pericardial tamponade or other undesirable symptoms. The embodiment of fig. 14A features apertures (236) distributed around the support flange structure (161). Referring to fig. 14B, a similar configuration has holes distributed around the distal portion of the support sleeve (163). Referring to fig. 14C, another embodiment shows holes (236) distributed around an introducer sheath (242) without support structures (i.e., there need not be support structures for vacuum holes embodying features in certain embodiments) and with two circumferential sets of holes (236) to provide further vacuum access; many distal hole configurations may be suitable.

Referring to fig. 14D, another embodiment is shown in which an elongate steerable instrument body (350), such as with a manually or electro-mechanically steerable catheter system, may be passed through a lumen (358) formed in a movable collar member (356) coupled around the introducer (44). Preferably, the movable collar member (356) is rotatable and insertable/extractable relative to the introducer (44). Preferably, the steerable instrument body (350) is insertable/extractable and rotatable relative to the movable collar member (356). Preferably, the distal end of the elongated steerable instrument (350) carries an image capture interface (354), such as a digital imaging chip or fiber imaging bundle terminal, as well as an illumination source (such as a fiber optic terminal, which is preferably located proximate to the image capture interface 354) and a vacuum inlet (364, such as the end of a tube proximally leading to the vacuum source 240). The illustrated embodiment has a proximally disposed manual handle and steering interface (348), and guide wires (238, 125) connecting the vacuum source (240) and the illumination/image capture system (126) to the elongate body (350) and distally disposed illumination outlet, image capture interface (354), and vacuum inlet (364). A pull wire (not shown) may operatively couple the steering elements of the proximal control interface (348) to portions of the elongate body to provide controlled steering performance, preferably at least controllable pitch and yaw steering capabilities. A display is operably coupled to the image capture and illumination system (126) to facilitate a surgical operator to view activity within a field of view of the image capture interface disposed distally. The freedom of the cooperating steerable instrument (350) and movable collar member (356) provides the practitioner the ability to move the steerable instrument around the very near area where the introducer (44) has passed through the left ventricular wall (48). The distal portion of the movable collar member (356) may also feature an active image capture interface (352) configured with a field of view oriented distally to substantially capture the distal portion of the steerable instrument (350); the second image capture interface (352) is also operably coupled to the image capture and illumination system (126) and the display (346), and the second illumination outlet is characterized adjacent to the second image capture interface (352). Referring to fig. 14E, an enlarged view of a particular aspect of the illustration of fig. 14D is shown. In practice, the illustrated embodiment may be used to examine the area around the junction of the introducer (44) with the heart wall (48) and evacuate any additional fluid that may be present. For example, in one embodiment, the movable collar member may be first inserted through a percutaneous chest incision and into the position shown in fig. 14D. The roll + insertion/extraction freedom of the image capture interface (352, in one embodiment, a digital imaging chip) and collar member (356) may be used to investigate generally the area around the introducer/heart wall junction, where the field of view of the collar member image capture interface (352) has a distally oriented field of view (360) configured to capture not only the introducer/heart wall junction area, but also the distal portion of the instrument through a working lumen (358) formed within the collar member (356) -as in the illustrated embodiment, where the distal portion of the steerable instrument (350) is positioned through such lumen (358) and freely controllably articulated or bent around the area to investigate nearby structures and extract fluids. The distal portion of the steerable instrument (350) in the illustrated embodiment carries its own image capture interface (354), which also has a distally oriented field of view (362) configured to capture images of nearby tissue, and at least a portion of the distal vacuum interface (364) -to enable the surgical practitioner to navigate the instrument at will, capture images of structures surrounding the instrument, and also capture images of the distal vacuum interface (364). This arrangement allows the operator to use the display to view the scene from the second image capturing interface (352) as well as the scene from the first image capturing interface (354) to move the various structures appropriately, view the substance he wants to evacuate, and operate the vacuum in real time or near real time, visually confirming the substance he is evacuating. In one embodiment, this arrangement may be used to draw off blood and other fluids that may be present in the area to prevent cardiac tamponade or other undesirable fluid-related conditions.

Referring to fig. 15A and 15B, another embodiment of an introducer (244) is shown having a radially extendable (i.e., the outer diameter of its distal portion can be controllably extended) distal portion configured to assist in preventing the introducer from being pulled or removed proximal of a tissue wall (48) until desired. As shown in fig. 15A, the introducer (244) may be inserted as described above, but with the depth of insertion increased to allow the distal portion (246) to protrude into the cavity opposite the tissue structure wall (48). When desired, the distal portion (246) can be controllably extended to have a larger outer diameter (254) by rotating the structural component (252) from a proximal position, thereby causing the structural component to be loaded in tension as it is coupled distally (250) with the guide (244). When desired, the structural member (252) can be reversed to restore the distal portion to the configuration shown in fig. 15A again to facilitate removal of the guide (244).

As described above with reference to fig. 10B and 11B, for example, small fasteners may be utilized to maintain tension on the deployed suture. Referring to fig. 16A-16E, one embodiment of a buckle type fastener assembly (256) is shown in which the winding block (258) is configured to be deposited in the block cavity (274) of the buckle body member (260). The winding block (258) includes a hole (264) through which suture material may be secured and/or fastened therethrough and is configured to have suture material wound therearound and pass down a distal exit port to access nearby tissue structures. Fig. 16B shows that the distal exit ports (262) may be positioned at an angle (268) relative to the vertical line (266) that is selected to accommodate the helical pitch of the helical suture being arranged-such that the tension applied through the associated suture is applied at least somewhat parallel to the path of the suture, and is more likely to preserve the helical pattern of the suture arrangement (and is less likely to create shear or cutting loads in nearby tissue in addition to suture loads more perpendicular to the helical pattern; such perpendicular loads are more likely to be present without some reorientation of the suture tension loads). In other words, the angle (268) of the suture passage through the buckle body acts as a force redirector. Figure 16 illustrates a top orthogonal view showing the suture path (272) through the lower buckle body (260). Referring to fig. 16D, in use and prior to full deployment, suture (140) is helically guided from a proximal position around the winding block (258) and through its aperture (264), into the block lumen (274), through the distal exit port (262), and into contact with the subject tissue structure. Referring to fig. 16E, an arrangement is shown to further illustrate the use of the configuration shown. As shown in fig. 16E, the suture (140) has been helically deployed using anchors (136) at its distal end on the opposite surface of a tissue structure, such as the left ventricular wall (48). The buckle body (260) can be first slid over the suture distal exit (262) along with the winding block (258) around which the loop of suture is wound. The suture tension may be locked using a compressive load (276) to press the buckle body (260) against the tissue structure (48), using the female member (293) to retain the winding block (258) within the block cavity (274), and applying a tensile load (291) on the proximal end of the suture (140). The cyclic pattern of suture around the winding block (258), along with the physical restraint of the winding block in the block cavity (274) and associated engagement loads, creates a one-way tensioning mechanism such that slack can be taken up by proximal tension, but movement of the suture in the other direction is prevented by the buckle assembly.

Referring to fig. 17A-17E, a helical suture placement embodiment is shown in which suture material may be carried on an outer track (285) of a helical needle (284) and exit the needle by the action of the helical needle counter-rotating, such as by manually rotating a proximal handle (278) from outside the patient's body. The handle (278) may be coupled to the helical needle (284) by an elongate instrument shaft (280) and a helical needle coupler (282), which may also be coupled to a portion of the instrument, such as an introducer cannula (44). Suture track (285) is shown in greater detail in the enlarged view of fig. 17B. Referring to fig. 17C, in use, the helical needle (284) can be rotated (286) into a tissue structure, such as the left ventricular wall (48), to deploy a suture using a distal anchor (not shown). One of the challenges in deploying sutures from such a track configuration is to tighten the helical suture once it has been helically positioned, since friction becomes an important factor and the non-linearity of viscoelastic tissue magnifies this. When a suture or other tensile member is helically wound around a shaft, as shown in fig. 17D, for example, we have determined that the maximum ratio of applicable loads (F2 to F1 — elements 296 and 294, respectively) can be calculated using the illustrated equation (298), where θ (292) is the helical winding angle on the shaft and μ (290) is the static coefficient of friction between the tensile member material and the shaft (288). Referring to fig. 17E, these relationships may be applied to a helical suture (140) placed in situ through the left ventricular wall (48) between two surfaces (300, 302) of the heart, with the "shaft" or "column" of tissue (304) effectively captured by a helically wound pattern that may be formed by the helical needle placement through a track. The anchors on the opposite side of the distal surface (300) form F2 (296) and pulling proximally forms F1 (294). We found experimentally that in a particular configuration, by pulling proximally (294), we can only tension the distal few coils (306) of a helically arranged suture, while the proximal coil (308) can remain relatively slack. This is a result of the function of equation (298) of FIG. 17D-the friction created by the large surface of the coil is too great to be fully tightened by the applied load. Accordingly, we have created techniques to sequentially tension portions of a helical suture, as further described with reference to fig. 18B and 18C.

Referring to fig. 18A, in a simple configuration, it is desirable to use a helical suture for defect closure (310), drive a helical needle having a track configuration to place the anchor at the desired distal location (312), and may helically retract the needle to separate the suture from the needle suture track (314), after which it may be proximally pulled closed in a purse string fashion to form a wound, and tightened to maintain tension (316). The helical winding angle, friction surface and number of coils may be selected to allow complete tightening by proximal loading.

Referring to fig. 18B, in another embodiment, after similar two steps (310, 312), the helical needle may only be partially withdrawn (318), then proximally pulled to pull on this first portion of helically arranged suture (320). A pledget or other tension retention member can then be advanced into position and the process of stretching the next proximally adjacent helical suture sequence (322) can be performed — and repeated (324) as necessary to effectively form a serial chain of stretched helical sutures that can ultimately be fastened proximally to retain tension (326). This configuration can be used to provide very secure helical tensioning and wound closure. Referring to fig. 18C, similar sequential tightening may be employed around an elongated instrument, such as an introducer, to prevent leakage during use, and to sequentially close after use. As shown in fig. 18C, an elongate instrument can be installed to form a defect in the tissue structure (328). The helical needle and suture assembly may be advanced and stretched over an elongate device (330) to prevent leakage (332) of the device during use. After diagnostic and/or interventional procedures using the elongated instrument (334), the instrument may be sequentially withdrawn while the helical suture is also sequentially tensioned-both remaining in place around portions of the instrument, and also closing/closing tissue (336) where the instrument has been withdrawn. This sequence can be repeated until the defect is closed and the suture secured in place to maintain tension.

Referring to fig. 19A-19G, a spiral suture arrangement around a wound formed by insertion of an introducer (44) and dilator (342) instrument kit is shown. Referring to fig. 19A, the dilator (342) is shown inserted through the working lumen of the introducer catheter (44), both of which are inserted through tissue structures such as the left ventricular wall (48). As described above, the helical needle coupler (282) has also been rotatably inserted across the wall (i.e., on the guide 44) to position the anchoring member (136) carried at the distal end of the helical needle (284) across the ventricular wall (48). The elongated suture member (140) extends proximally from the anchor member (136) around a spiral pattern in a recess (140, in the illustrated embodiment having a "U" or semi-circular cross-sectional shape that extends helically with a needle shape, as shown) formed in the helical needle (284), and then proximally to a position where it can be manually manipulated proximal or distal to the chest wall access port. Referring to FIG. 19B, the practitioner has begun to withdraw the introducer/dilator assembly (44, 342), leaving the needle assembly in place. Referring to fig. 19C, the extraction of the introducer/dilator assembly (44, 342) continues, and the surgical practitioner begins to helically withdraw the helical needle (284) using the needle coupler (292) or other coupled component, while continuing to hold the suture member (140) loose to allow the distal anchor member (136) to remain in place. Referring to fig. 19D, continued rotational withdrawal of the helical needle (284), withdrawal of the introducer/dilator assembly (44, 342), and provision of slack in the suture member (140) enable compression (344) of the viscoelastic tissue into traumatic closure upon exit of the body of the instrument. As described with reference to fig. 18B and 18C, slack may be sequentially removed and the suture members (140) stretched to form a series of purse string stretched configurations within the deployed suture members (140). For example, referring to fig. 19E, with further withdrawal of the helical needle (284) and introducer/dilator assembly (44, 342), tension can be applied in the suture member (140) to create a purse string effect in one or both of the most proximal hoops of the suture (immediately adjacent the anchor member 136), and by attenuating the tension, slack is reformed in the most proximal helical hoops, but the most distal hoops remain in purse string tension. Referring to fig. 19F, this can be repeated after further withdrawal of the helical needle (284) and introducer/dilator assembly (44, 342), to purse string close the next set of hoops immediately proximal of the previously stretched hoops. Further repetition may be utilized to create a very secure closure, as shown in FIG. 19G, wherein after the helical needle (284) and introducer/dilator assembly (44, 342) are fully withdrawn from the wall (48), the suture buckle assembly (256) may be advanced to maintain tension in the deployed and tensioned portions of the helical suture member, as described, for example, with reference to FIG. 16E.

Referring to fig. 20A-22K, embodiments are shown in which an extendable or inflatable member may be used to help prevent leakage around the outside of a deployed introducer or other similar component. Such devices may also be used to assist in closure of an associated wound or defect, as described with reference to fig. 22E-22K.

Referring to fig. 20A, to prevent fluid leakage at the interface between the deployed guide (44) or other similar structure and the left ventricular wall (48) or other similar structure, an inflatable member (376) coupled to a rigid proximal collar member (374) that is preferably slidably and rotatably coupled around the outside (exterior) of the guide (44) may be advanced (370) over the guide (44). The proximal collar member (374) is preferably coupled to a structural manipulation member (366), which may comprise an elongate rod or elongate structural member, and which preferably defines a lumen (368) therethrough, which preferably extends through the proximal collar (374) to an inflatable member (376) to facilitate controlled inflation of the inflatable member (376), which may comprise a balloon or similar bladder configuration configured to have a collapsed configuration (378) such as shown in fig. 20A and an extended configuration (380) such as shown in fig. 20C. The proximal end of the steering component may be manually steered by the operator, or may be coupled to another component that may be so steered, to control the insertion, inflation, and roll of the inflatable component (376) and the collar component (374) relative to the guide (44). Referring to fig. 20B, the assembly has been further inserted (370) in the collapsed state (378) through the inflatable member (376) relative to the guide and tissue structure to more easily intersect the thoracic wall (40) access port. Referring to fig. 20C, the inflatable member (376) has been inflated to its expanded state (380) using the inflation lumen (368), which is similar to a compliant truncated cone shape, as shown. Referring to fig. 20D, the expanded (380) inflatable member (376) may be urged against the meeting introducer (44) and tissue wall (48) region to prevent leakage of fluids, such as blood, through such a meeting. Referring to fig. 20E, the assembly may then be withdrawn (372), returned to its collapsed extendable member (376) state (378) as in fig. 20F, and withdrawn (372) in the collapsed state (378), as shown in fig. 20G.

Referring to fig. 21A-21J, another embodiment is shown wherein the wound or defect temporary seal assistance assembly includes a distal collar member (382) coupled to a proximal collar member (374) by an inflatable member (386). As with the inflatable member (376) of fig. 20A-20G, the inflatable member of fig. 21A-21J and the inflatable member of fig. 22A-22K may comprise an elastic medical balloon-type material, such as polyurethane, configured to substantially stretch and expand when in a final expanded shape, or may comprise a relatively inelastic medical balloon-type material, such as polytetrafluoroethylene or polyethylene terephthalate, configured to assume a final shape and not stretch much beyond such final shape. Referring to the enlarged view of fig. 21B, the distal collar of the illustrated embodiment features a distal surface having prong-like contact elements (384) configured to prevent sliding between the distal collar surface and the tissue against which it is urged. Referring to fig. 21C, the assembly is advanced across the chest wall (40) in the collapsed state (388). Referring to fig. 21D, the extendable member (386) may be extended to an extended state (390) by inflation through the lumen (386), wherein the extendable member (386) forms a shoulder-like reinforced shape around the distal collar (382) suspended and supported by the extendable member (386). Referring to fig. 21E, the assembly is further inserted to urge the distal collar member (382) against tissue surrounding the intersection of the introducer (44) and the tissue wall (48) to prevent fluid, such as blood, from leaking around the introducer (44). The contact element (384) maintains the position of the tissue relative to the introducer (44) and the distal collar (382) in this configuration. Referring to fig. 21F, additional insertion load and/or bulging of the inflatable member (386) may be used to form additional seals at the intersection between the introducer (44) and the tissue wall (48); this additional load can be pulsed at any time to prevent hypovolemia and/or cytolysis of any associated tissue (fig. 21G again shows a configuration without additional load pulses thereon). Referring to fig. 21H, the assembly can be withdrawn relative to the guide (44) and tissue wall (48), back to the collapsed inflatable member state (388) as in fig. 21L, and withdrawn as in fig. 21J.

Referring to fig. 22A-22K, another embodiment is shown in which a tubular support member (394) is coupled to a tapered distal tip member (396) and a circumferential (i.e., doughnut-shaped around the tubular support member; similar to an angioplasty balloon assembly) inflatable member (392) which is shown in its pressurized state (398) in fig. 22A. Referring to fig. 22B, the tubular support member (394) and associated inflatable member (392) and distal tip member (396) may be advanced past the chest wall (40) with the inflatable member (392) in its collapsed configuration. Referring to fig. 22C, the inflation lumen (368) may be used to controllably inflate the inflatable member (392) to its extended state (400). Referring to fig. 22D, the extended assembly may be urged against the defect or wound at the intersection of the guide (44) and left ventricular wall (48), with the tapered distal tip member (396) advanced slightly into the wound or defect to help prevent leakage of fluids, such as blood, through the guide (44)/tissue wall (48) intersection. In one embodiment, the introducer may be left in place as in fig. 20G and 21J, and a closed configuration such as that described above (e.g., with reference to fig. 3A-3Z-3, or fig. 9A-11B) is used to ultimately close the defect or wound left behind by the introducer. In the embodiment shown in fig. 22E-22K, the defect or wound can be closed with the assistance of the leakage prevention assembly described with reference to fig. 22A-22D. Referring to fig. 22E, retraction (402) of the guide (44) may begin with the leak-proof assembly remaining in place as in the configuration of fig. 22D, with the tissue boundaries (404, 406) collapsing around the void (408) left after the guide is withdrawn, allowing the pressurized viscoelastic tissue to re-expand (80) to its natural position. Referring to fig. 22F, introducer extraction (402) continues with the leak-proof assembly remaining in place as in the configuration of fig. 22D. Similarly, in fig. 22G, guide withdrawal (402) continues and the leak-proof assembly remains in place while the tissue wall wound boundary (404, 406) continues to collapse around the void (408) left by the exiting guide (44). With reference to fig. 22H, with sufficient time and clot formation, the wound becomes closed (410) and the leak-proof assembly can be withdrawn. Referring to fig. 22I, the inflatable member (394) may return to its collapsed state (398) and the assembly (372) may be withdrawn through the chest wall (40), as in fig. 22J. Referring to fig. 22K, in another embodiment, a more robust proximal configuration can be used to accomplish a similar procedure: instead of the tubular support member (394) and the structural manipulation member (366) of the embodiment of fig. 22A-22J, a single elongated tubular support member (412) that also defines an inflation lumen (369) therethrough and a working lumen that slidably configures the introducer may be utilized in similar procedures.

Referring to fig. 23-25, various surgical embodiments are shown that have similarities to the embodiments described with reference to fig. 20A-22K. Referring to fig. 23, a thoracic intervention (168) may be formed along with an intervention to the left ventricle (170). An introducer sheath (172) may be installed. The inflatable sealing member may be advanced in the collapsed configuration along the outside of the introducer (414) across the chest access port. The inflatable sealing member may be expanded to an extended configuration (416). The extended configuration may be advanced toward the junction between the introducer and the left ventricular wall (418). The expanded configuration may be urged against the pericardial side of the left ventricular wall (around the introducer) to prevent leakage around the introducer (420). Diagnostic and/or interventional procedures may be performed while continuing to be leak proof through the relevant components and the diagnostic/interventional hardware may be extracted (422). The extended leak-proof configuration may be partially withdrawn and collapsed back to the collapsed configuration (424). The collapsed configuration may be withdrawn across the chest wall (426) and transapical access closure (428) may be performed (428) with the guide remaining in place. After closure is complete, the thoracic access port (200) may be closed.

Referring to FIG. 24, an embodiment similar to that shown in FIG. 23 is shown, but following the step of performing a diagnostic and/or interventional procedure and removing associated instruments (422), at least a first portion of a transapical access closure may be performed first from the inside of the heart (430), followed by retraction of the extended leak protection assembly to accommodate completion of the proximal (i.e., pericardial) installation of the closure device (432), retraction of the collapsed configuration of the leak protection apparatus (434), and closure of the thoracic access (200), prior to withdrawal of the leak protection assembly.

Referring to FIG. 25, an embodiment similar to that shown in FIG. 23 is shown, but after the steps of performing a diagnostic and/or interventional procedure and removing the associated instrument (422), the introducer is slowly withdrawn while leaving the extended leak-proof assembly in place (436) until the introducer is fully withdrawn (438). After a sufficient clotting time, the containment assembly collapses and retracts (440), and the chest access is closed (200).

Any of the foregoing arrangements, including the suture, anchor member and ratchet closure device assembly members, may include absorbable materials in addition to the foregoing non-absorbable materials to facilitate a combination and replacement that may be fully resorbable, leaving a biologically healed transapical access wound.

Various exemplary embodiments of the present invention are described below. These examples are illustrated in a non-limiting sense. They are provided to more broadly illustrate the applicable aspects of the invention. Various modifications may be made to the invention as described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process action or steps, to the objective, spirit or scope of the present invention. Furthermore, as will be appreciated by those skilled in the art, each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to be within the scope of the claims associated with this disclosure.

Any of the devices described for performing a targeted intervention may be provided in a packaged combination for performing such an intervention. These supply "kits" may also include instructions for use and are packaged in sterile trays or containers as are commonly employed for such purposes.

The invention includes methods that may be performed using the subject devices. The methods may include the act of providing such a suitable device. Such provisioning may be performed by the end user. In other words, "providing" an action merely requires the end user to obtain, intervene, approach, locate, set up, enable, power on, and other actions to provide the requisite devices in the subject methods. The methods recited herein may be performed in any order that is logically possible for the recited events and in the recited order of events.

Exemplary aspects of the invention and details relating to material selection and manufacture have been set forth above. Additional details of the present invention can be found in conjunction with the patents and publications cited above and are generally known or appreciated by those skilled in the art. For example, those skilled in the art will appreciate that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gels or silicones) may be used in conjunction with various portions of the device, such as, if desired, larger interfaces for movably couplable portions, e.g., to facilitate low friction manipulation or advancement of such objects relative to other portions of the device or nearby tissue structures. The method-based aspects of the invention may also have the same aspects in terms of additional aspects as commonly or logically employed.

Furthermore, although the invention has been described with reference to several examples optionally incorporating various features, the invention is not limited to the features described or indicated as contemplated with respect to variations of the invention. Various modifications may be made to the invention as described and equivalents (whether set forth herein or otherwise included for the sake of brevity) may be substituted without departing from the true spirit and scope of the invention. Further, where a range of values is provided, it is understood that each intervening value, to the extent that there is no such intervening value, to the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the invention.

Furthermore, it is contemplated that any optional feature of the described variations of the invention may be set forth and protected alone or in combination with any one or more of the features described herein. Reference to an item in the singular includes the possibility that there are a plurality of the same items present. More specifically, as used herein and in the claims associated therewith, the singular forms "a," "an," "the," and "the" include plural referents unless the context clearly dictates otherwise. In other words, use of the article "allows for" at least one "of the subject item in the description above and in the claims that relate to the invention. It should also be noted that such claims are drafted to exclude any optional element. Accordingly, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only," and the like in connection with the recitation of claim elements or use of a "negative" limitation.

To the extent that such exclusive terminology is not used, the term "comprising" in the claims appended hereto shall allow for the inclusion of any additional element, whether or not a given number of elements is enumerated in such claims, or an addition of a feature may be considered to transform the nature of the elements recited in such claims. Unless specifically defined otherwise herein, all technical and scientific terms used herein are to be given a broad, commonly understood meaning, with the understanding that the claims are to be read in their effectiveness.

Claims (18)

1. An apparatus for closing a defect in a tissue wall, comprising:

a. a base member having a proximal end and a distal end and a sealing member disposed therebetween, the proximal end configured to be manually manipulated by a surgical operator;

wherein the seal member defines an outer seal boundary defining an outer seal diameter;

b. a first plurality of bendable strut members coupled to the sealing member and configured to have a collapsed configuration when bent into position toward the sealing member and an extended configuration when unconstrained;

wherein, in the collapsed configuration, each of the first plurality of pliable strut members protrudes from a joint coupled with the seal member, swings toward the proximal end of the base member, and flexes toward the outer seal perimeter; and wherein the outer sealing diameter of the sealing member is configured to be larger than the outer diameter of the base member, the sealing member configured to be implanted through the inner diameter of the tubular delivery member and to assist in sealing the defect in the tissue wall;

c. a proximal collar member movably coupled to the base member and advanceable along a length of the base member; and

d. a second plurality of bendable strut members coupled to the proximal ring cuff member and configured to have a collapsed configuration when bent into position toward the base member and an extended configuration when unconstrained;

wherein, in the collapsed configuration, each of the second plurality of bendable strut members protrudes from a joint coupled with the proximal ring sleeve member and swings toward the distal end of the base member.

2. The apparatus of claim 1, further comprising a tubular delivery member defining a delivery lumen through which the base member, the first plurality of bendable strut members in the collapsed configuration, the proximal collar member, and the second plurality of bendable strut members in the collapsed configuration can be advanced by inserting the base member relative to the tubular delivery member.

3. The apparatus of claim 2, wherein the tubular delivery member has an outer diameter configured to be inserted through a defect formed in the tissue wall such that the base member can be further inserted to place the first plurality of bendable strut members through the tissue wall, out of a delivery lumen, and into an extended configuration of the first plurality of bendable strut members.

4. The apparatus of claim 3, wherein the first plurality of bendable strut members assume an extended shape having a diameter greater than a diameter of the tubular delivery member after extension to the extended configuration.

5. The apparatus of claim 1, wherein the base member comprises an elongate shape having movement control features configured to controllably resist movement of the proximal ring sleeve member relative to the base member.

6. The apparatus of claim 1, wherein the outer seal perimeter has a substantially circular shape.

7. The apparatus of claim 1, wherein the first plurality of bendable strut members comprises two or more elongate members having a proximal end fixedly coupled to the sealing member in a dependent anchoring configuration and a distal end free to move in a dependent proximal anchoring configuration.

8. The apparatus of claim 7, wherein the distal end of the bendable strut portion is sharpened.

9. The apparatus of claim 1, wherein the plurality of bendable strut members are substantially evenly radially distributed about a longitudinal axis of the distal end of the base member.

10. The apparatus of claim 1, wherein the first plurality of bendable leg members comprises a pair of bendable leg members.

11. The apparatus of claim 1, wherein the first plurality of bendable leg members comprises three or more bendable leg members.

12. The apparatus of claim 1, wherein the first plurality of bendable strut members comprises nitinol.

13. The apparatus of claim 1, wherein the second plurality of bendable strut members comprises two or more elongate members having a proximal end fixedly coupled to the proximal ring member in a dependent anchoring configuration and a distal end free to move in a dependent proximal anchoring configuration.

14. The apparatus of claim 13, wherein the distal end of the bendable strut portion is sharpened.

15. The apparatus of claim 1, wherein the second plurality of bendable strut members comprises two or more elongate members having proximal ends fixedly coupled to the proximal ring member in a catenary anchor configuration and distal ends engaged in an atraumatic loop configuration.

16. The apparatus of claim 1, wherein the second plurality of bendable strut members comprises nitinol.

17. The apparatus of claim 3, further comprising a catheter defining an inner lumen and having an outer diameter, wherein the inner lumen is sized to movably receive the tubular delivery member, and wherein the outer diameter is sized to be insertable through a defect formed in the tissue wall.

18. The apparatus of claim 1, further comprising a fabric component coupled to the second plurality of bendable strut components and configured to transfer a load applicable to the strut components through adjacent tissue structures.