Systems, methods, and devices for closing holes in body lumens

Information

  • Patent Grant
  • 10980531
  • Patent Number
    10,980,531
  • Date Filed
    Wednesday, August 1, 2018
    6 years ago
  • Date Issued
    Tuesday, April 20, 2021
    3 years ago
Abstract
A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a foot portion having one or more feet slidably mounted relative thereto. The feet are movable between a deployed position and a delivery position. The feet include cuffs removably mounted therein, with sutures connected between the cuffs. When the feet are in the deployed position and the needles are advanced, the needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.
Description
BACKGROUND
1. Technical Field

The present disclosure relates generally to techniques and devices for closing openings in body lumens. More particularly, the present disclosure relates to systems, devices, and methods for percutaneous closure of arterial and venous puncture sites, which are usually accessed through a tissue tract.


2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are now performed translumenally. A catheter is introduced to the vascular system at a convenient access location and guided through the vascular system to a target location using established techniques. Such procedures require vascular access, which is usually established using the well-known Seldinger technique. Vascular access is generally provided through an introducer sheath, which is positioned to extend from outside the patient's body into the vascular lumen. When vascular access is no longer required, the introducer sheath is removed and bleeding at the puncture site stopped.


One common approach for providing hemostasis (the cessation of bleeding) is to apply external force near and upstream from the puncture site, typically by manual compression. This approach suffers from a number of disadvantages. For example, the manual compression procedure is time consuming, frequently requiring one-half hour or more of compression before hemostasis is achieved. Additionally, such compression techniques rely on clot formation, which can be delayed until anticoagulants used in vascular therapy procedures (such as for heart attacks, stent deployment, non-optical PTCA results, and the like) wear off. The anticoagulants may take two to four hours to wear off, thereby increasing the time required before completion of the manual compression procedure.


Further, the manual compression procedure is uncomfortable for the patient and frequently requires analgesics to be tolerable. Moreover, the application of excessive pressure can at times totally occlude the underlying blood vessel, resulting in ischemia and/or thrombosis. Following manual compression, the patient typically remains recumbent from four to as much as twelve hours or more under close observation to assure continued hemostasis. During this time, renewed bleeding may occur, resulting in blood loss through the tract, hematoma and/or pseudo-aneurysm formation, as well as arteriovenous fistula formation. These complications may require blood transfusions and/or surgical intervention.


The incidence of complications from the manual compression procedure increases when the size of the introducer sheath grows larger, and/or when the patient is anticoagulated. The compression technique for arterial closure can be risky, and is expensive and onerous to the patient. Although using highly trained individuals can reduce the risk of complications, dedicating such personnel to this task is both expensive and inefficient. Nonetheless, as the number and efficacy of translumenally performed diagnostic and interventional vascular procedures increases, the number of patients requiring effective hemostasis for a vascular puncture continues to increase.


To overcome the problems associated with manual compression, the use of bioabsorbable sealing bodies is one example approach that has been proposed. Generally, this example approach relies on the placement of a thrombogenic and bioabsorbable material, such as collagen, at the superficial arterial wall over the puncture site. While potentially effective, this approach suffers from a number of drawbacks. For example, bioabsorbable sealing bodies may lack a solid mechanical attachment of the sealing body to the tissue. Due to the lack of a solid mechanical attachment, the sealing body can wander within the tissue tract or move out of the puncture site, thus causing late bleeds. Conversely, if the sealing body wanders and intrudes too far into the arterial lumen, due to the lack of a solid mechanical attachment, intravascular clots and/or collagen pieces with thrombus attached can form and embolize downstream, causing vascular occlusion.


In addition to not having a solid mechanical attachment to the tissue, the sealing bodies may rely upon expandable materials to achieve hemostasis. Again, the expandable materials lack the security of a hard mechanical closure, thus potentially causing late bleeds and prolonging hemostasis.


For these reasons, it would be desirable to provide improved devices and methods to seal body lumen puncture sites. It would be particularly desirable to provide percutaneous devices and methods for suturing the puncture sites required for percutaneous vascular procedures.


BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. Embodiments of the present invention provide systems, methods, and devices for closing an opening in tissue. Embodiments of the invention can be configured to close an opening within a body lumen.


For instance, in one exemplary embodiment, a device for closing an opening in tissue includes an elongate member, a plurality of needles, a foot housing, and a foot. The elongate member has a plurality of needle lumens extending from the proximal end toward the distal end. The needles are disposed within and are advancable from the plurality of needle lumens. The foot housing is disposed at the distal end of the elongate member and defines a first opening and a second opening therein. The foot is slidably mounted within the foot housing and through the first opening between a delivery position and a deployed position. The foot includes at least two cuffs removably mounted in a first end and at least two cuffs removably mounted in a second, opposing end. A length of suture is connected between each cuff in the first end of the foot and each cuff in the second end of the foot. The cuffs in the first end of the foot are positioned below and accessible through the second opening in the foot housing and the cuffs in the second end of the foot are positioned outside the foot housing when the foot is in the deployed position. In contrast, the cuffs in the first end of the foot are substantially inaccessible through the second opening in the foot housing when the foot is in the delivery position.


According to another implementation of the present invention, a device for closing an opening in a body lumen includes an elongate member and a plurality of needles as mentioned. In addition, the device includes a foot portion disposed at the distal end of the elongate member and a plurality of feet slidably mounted on the foot portion. Each foot of the plurality of feet is slidable between a delivery position and a deployed position. The plurality of feet move both proximally along the length of the foot portion and radially away from the central axis of the foot portion when moving from the delivery position to the deployed position. Also, each foot of the plurality of feet has a cuff removably mounted therein. A length of suture is connected between each pair of cuffs. The device also includes a track and track guide system to facilitate movement of the feet between the delivery and deployed positions.


In still another exemplary embodiment, a needle includes a shaft having a proximal end, a distal end, and a longitudinal axis, and a plurality of needle tips extending from the distal end of the shaft. The plurality of needle tips can be generally aligned with and parallel to one another. Alternatively, the plurality of needle tips can be generally parallel to and offset from one another.


These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.





BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:



FIG. 1 is an elevation view of a closure device in accordance with one exemplary embodiment of the present invention;



FIG. 2 is another elevation view of the closure device of FIG. 1, showing a foot in a deployed position;



FIG. 3 is a close-up view of a distal end of the closure device of FIG. 1, showing the foot in the deployed position;



FIG. 3A is a cross-sectional view of the distal end of the closure device of FIG. 1, with the foot in the delivery position;



FIG. 3B is a cross-sectional view of the distal end of the closure device of FIG. 1, with the foot in the deployed position;



FIG. 4A is a top view of one exemplary foot for use in connection with the closure device of FIG. 1;



FIG. 4B is a top view of another exemplary foot for use in connection with the closure device of FIG. 1;



FIG. 4C is a top view of another exemplary foot for use in connection with the closure device of FIG. 1;



FIG. 4D is a top view of another exemplary foot for use in connection with the closure device of FIG. 1;



FIG. 4E is a top view of another exemplary foot for use in connection with the closure device of FIG. 1;



FIG. 5A is a top view of the front side of the distal end of the closure device of FIG. 1, showing needles being deployed toward a first end of the foot;



FIG. 5B is an elevation view of the back side of the distal end of the closure device of FIG. 1, showing needles being deployed toward a second end of the foot;



FIG. 6 is an elevation view of an exemplary needle for use in connection with a closure device similar to the closure device of FIG. 1;



FIG. 6A is a close-up view of a distal end of the needle of FIG. 6;



FIG. 7A is a top view of the front side of the distal end of a closure device similar to the closure device of FIG. 1, showing a needle from FIG. 6A being deployed toward a first end of the foot;



FIG. 7B is an elevation view of the back side of the distal end of a closure device similar to the closure device of FIG. 1, showing a needle from FIG. 6A being deployed toward a second end of the foot;



FIG. 8 is a close-up, side view of the distal end of the closure device of FIG. 1 inserted into a vessel through a puncture site;



FIG. 9 is a view similar to FIG. 8, except that the foot of the distal end has been deployed or expanded within the vessel;



FIG. 10 is a view similar to FIG. 9, except that needles have been deployed through the vessel wall and into cuffs mounted on the foot;



FIG. 11 is a view similar to FIG. 10, except that the needles have been drawn proximally, thereby drawing the cuffs and attached sutures through the vessel wall;



FIG. 12 illustrates the needles completely withdrawn into the elongate member and the foot withdrawn back into the delivery position prior to removal of the distal end from the vessel;



FIG. 13 illustrates the distal end of the device removed from the vessel after the sutures have been drawn through the vessel wall;



FIG. 14 illustrates a plunger and the needles withdrawn from the device;



FIG. 15 illustrates a needle housing detached from the plunger and, in phantom, separated into two halves;



FIG. 16 illustrates the sutures, needles, and needle housing halves freed from the closure device;



FIG. 17 illustrates a cross-sectional view of the vessel wall showing the suture tied to close the opening in the vessel wall;



FIGS. 17A-17C illustrate various suture patterns used to close an opening in a vessel wall;



FIG. 18 is an elevation view of a closure device in accordance with another exemplary embodiment of the present invention;



FIG. 19 is another elevation view of the closure device of FIG. 14, showing foot lobes in deployed position;



FIG. 20A is a cross-sectional view of the distal end of the closure device of FIG. 18 taken along cutting plane 20A-20A of FIG. 18, showing cuffs mounted within the foot lobes;



FIG. 20B is a partial cutaway view of the distal end of the closure device of FIG. 18, showing a foot lobe in a delivery position and, in phantom view, in a deployed position;



FIG. 21 is a close-up view of the distal end of the closure device of FIG. 18 inserted into a vessel through a puncture site;



FIG. 22 is a view similar to FIG. 21, except that the foot lobes of the distal end have been deployed within the vessel;



FIG. 23 is a view similar to FIG. 22, except that needles have been deployed partially through the vessel wall toward the cuffs mounted in the foot lobes;



FIG. 24 is a view similar to FIG. 23, except that the needles have been drawn proximally after engaging the cuffs, thereby drawing the cuffs and attached sutures through the vessel wall; and



FIG. 25 illustrates the needles completely withdrawn into the elongate member and the foot lobes withdrawn back into the delivery position prior to removal of the distal end from the vessel.





DETAILED DESCRIPTION

As used herein, the term “distal” is generally defined as in the direction of the patient or away from a user of a device. In the context of a medical device intervention with or through a vessel wall, “distal” herein refers to the interior or the lumen side of the vessel wall. Conversely, “proximal” generally means away from the patient or toward the user. In the context of a medical device intervention with or through a vessel wall, “proximal” herein refers to the exterior or outer side of the vessel wall.


The term “suturing” is herein intended to include the process of joining two surfaces or edges together with a fastener or so as to close an aperture, opening, or wound, or join tissues. The fastener is usually a suture such as a thread of material (either polymeric or natural), gut, wire, or the like. The term fastener as used herein also includes clamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches, VELCROC, buttons, and other coupling members.


Referring to the Figures, suture applying devices that are suitable for suturing and sealing of percutaneous vascular puncture sites, such as those made to the femoral artery in a patient's groin, will be described. It will be appreciated, however, that the devices of the present invention can be readily adapted for use with punctures made to other hollow body organs and lumens, although it may be necessary to modify the dimensions and other particular aspects of the devices to accommodate the different usage environments.



FIGS. 1 and 2 illustrate one example embodiment of a closure device 100. Closure device 100 includes a proximal end 102 and a distal end 104. As shown in FIGS. 1 and 2, closure device 100 includes an elongate member 106 that has a proximal end 108 and a distal end 110. As discussed in greater detail below, elongate member 106 is generally tubular and includes one or more lumens that extend generally from proximal end 108 to distal end 110. The one or more lumens may be used to facilitate the delivery of device 100 over a guidewire or to deliver one or more needles into a patient. In one embodiment, elongate member 106 is formed of a rigid material such as a stainless steel or other biocompatible material that is rigid. Alternatively, elongate member 106 may be formed of a flexible material such as those materials utilized to form catheter shafts, introducer sheaths, or other medical devices. Suitable materials include polyvinyl chloride (PVC), peak, PTFE, nylon, or any other similar materials.


Connected to proximal end 108 of elongate member 106 is an actuator mechanism 112. Actuator mechanism 112 includes a handle 114 to facilitate manipulation of device 100. Actuator mechanism 112 also includes a plunger 116 used to deploy and retract needles from elongate member 106, and a lever 118 used to selectively deploy and retract a foot, as discussed in greater detail below.


As shown in FIGS. 1 and 2, distal end 104 of device 100 includes a foot portion 120 attached to or extending from distal end 110 of elongate member 106. In the illustrated embodiment, foot portion 120 is in the form of a foot housing. Elongate member 106 and foot portion 120 may be discrete pieces that are coupled together, or elongate member 106 and foot portion 120 may be integrally formed as a single piece.


A foot 122 is movably disposed within foot portion 120. Foot 122 moves between a delivery position, in which foot 122 is positioned substantially or entirely within foot portion 120 (as illustrated in FIG. 1), and a deployed position, in which foot 122 extends at least partially out of foot portion 120 (as illustrated in FIG. 2). When foot 122 is in the delivery configuration, distal end 104 can be inserted through a puncture site and into a body lumen of a patient. Once distal end 104 is positioned within the body lumen, foot 122 may be moved to the deployed position. When in the deployed position, foot 122 increases the profile of distal end 104, which prevents distal end 104 from being inadvertently pulled out of the body lumen through the puncture site. Additionally, foot 122 may also be used as a locator to assist a physician in properly positioning distal end 104 within the body lumen. As will be discussed in greater detail below, foot 122 is operatively connected to lever 118 such that foot 122 may be selectively moved between the delivery position and the deployed position by actuating lever 118.



FIGS. 1 and 2 further illustrate that device 100 optionally includes a flexible guidebody 124 extending distally from the distal end of foot portion 120. As explained in greater detail below, guidebody 124 can be advanced along a guidewire into a body lumen. Accordingly, at least the distal portion of guidebody 124 can be formed from a flexible or elastomeric material that is biocompatible, particularly with blood.


Turning attention to FIG. 3, a close up perspective view of distal end 104 is illustrated. As can be seen in FIG. 3, foot 122 includes a first or distal end 126 and a second or proximal end 128. In the illustrated embodiment, each of first and second ends 126, 128 includes two cuff receptacles 130. A cuff 132 (with an associated end of a suture 134) is releasably disposed within each cuff receptacle 130. Each suture 134 is connected between cuffs 132 disposed in opposing ends of foot 122. A surface of each cuff receptacle 130 may taper or be funnel shaped so as to guide advancing needles into engagement with cuffs 132 when foot 122 is in the deployed position.


As shown in the cross-sectional view of FIG. 3A, foot 122 is in the delivery position such that foot 122 is positioned substantially entirely within foot portion 120. In contrast, FIGS. 3 and 3B illustrate foot 122 in the deployed position. That is, in the deployed position, second end 128 of foot 122 extends outside of foot portion 120 while first end 126 remains positioned within foot portion 120. Foot portion 120 includes an opening or window 136 to enable second end 128 to move in and out of foot portion 120 between the delivery and deployed positions.


As can be seen in FIGS. 3 and 3B, the cuff receptacles 130 and cuffs 132 in second end 128 are generally aligned with one or more needle lumens 140 in elongate member 106 when foot 122 is in the deployed position. As noted above, one or more needles 142 may be passed through or extended from needle lumens 140. Aligning cuff receptacles 130 and cuffs 132 with needle lumens 140 enables needles 142 to be extended from needle lumens 140 toward cuff receptacles 130 so that needles 142 may engage cuffs 132, as discussed in greater detail below.


Foot portion 120 also includes a second opening or window 138. Window 138 provides access to first end 126 of foot 122. More particularly, the cuff receptacles 130 and cuffs 132 in first end 126 are accessible through window 138 when foot 122 is in the deployed position. Additionally, the cuff receptacles 130 and cuffs 132 in first end 126 are generally aligned with one or more needle lumens 140 in elongate member 106 when foot 122 is in the deployed position. As a result of the cuffs 132 in first end 126 being accessible through window 138 and aligned with needle lumens 140 when foot 122 is deployed, needles 142 are extended from needle lumens 140, through window 138, and toward cuff receptacles 130 so that needles 142 may engage cuffs 132, as discussed in greater detail below.


As noted above, foot 122 is movable between a delivery position and a deployed position. In the embodiment illustrated in FIGS. 3-3B, movement of foot 122 to the deployed position is in the direction of arrow A1, while movement of foot 122 to the delivery position is in the direction of arrow A2. Foot 122 may be moved between the delivery and deployed configurations in a variety of ways. The Figures illustrate one exemplary manner in which movement of foot 122 may be accomplished.


In the illustrated embodiment, foot 122 is connected to lever 118 (FIGS. 1 and 2) via cables 144, 146. More specifically, first end 126 of foot 122 is connected to lever 118 via deployment cable 144 and second end 128 of foot 122 is connected to lever 118 via retraction cable 146. When lever 118 is moved from the position shown in FIG. 1 to the position shown in FIG. 2, for example, deployment cable 144 may be drawn proximally up through elongate member 106. As deployment cable 144 is drawn proximally, deployment cable 144 pulls on first end 126 of foot 122. Due to the angle between elongate member 106 and foot portion 120, the pulling of first end 126 by deployment cable 144 causes foot 122 to move in the direction of arrow A1 and toward the deployed position.


Retraction cable 146 works in a similar manner as deployment cable 144 to move foot 122 to the delivery position. More specifically, when lever 118 is moved from the position shown in FIG. 2 to the position shown in FIG. 1, retraction cable 146 is drawn proximally up through elongate member 106. As retraction cable 146 is drawn proximally, retraction cable 146 pulls on second end 128 of foot 122. As best seen in FIG. 3B, when foot 122 is in the deployed position, retraction cable 146 extends through elongate member 106, into foot portion 120, and out window 136 to second end 128. Retraction cable 146 bends to extend from elongate member 106 and out of window 136 toward second end 128. Due to this bend in retraction cable 146, the pulling of second end 128 by retraction cable 146 causes foot 122 to move in the direction of arrow A2 and toward the delivery position.


Foot portion 120 and foot 122 may include additional features that facilitate smooth movement of foot 122 between the delivery and deployed positions. By way of example, foot portion 120 and foot 120 may include a track and track guide system to assist foot 122 in moving smoothly between the delivery and deployed positions. In the illustrated embodiment, foot portion 120 includes track guides 148 on opposing interior surfaces thereof, and foot 120 includes tracks 150 on opposing sides thereof. Tracks 150 are able to slide in track guides 148 as foot 122 moves. Tracks guides 148 and tracks 150 assist in keeping foot 122 aligned and moving smoothly as cables 144, 146 are moved.


Before leaving FIGS. 3-3B, it is worth noting that sutures 134 extend between cuffs 132 around the outside of foot portion 120. More specifically, each suture 134 extends from a cuff 132 in first end 126 of foot 122, out through window 138, and to a cuff 132 in second end 128 of foot 122. By extending sutures 134 between cuffs 132 outside of foot portion 120, sutures 134 can be readily removed from distal end 104 without being caught in foot portion 120. That is, if a suture 134 extended from a cuff 132 in first end 126, through foot portion 120, and out of window 136 to a cuff 132 in second end 128, when the ends of suture 134 were pulled away from foot 122, suture 134 would be caught in foot portion 120. Accordingly, sutures 134 extend between cuffs 132 in opposing ends of foot 120 and through window 138.


Attention is now directed to FIG. 4A, which illustrates a top view of foot 122 and a puncture site PS (shown in phantom lines). In the illustrated embodiment, foot 122 includes four cuff receptacles 130a, 130b, 130c, 130d, four corresponding cuffs 132a, 132b, 132c, 132d, and two sutures 134a, 134b. Suture 134a is connected between cuffs 132a and 132c and suture 134b is connected between cuffs 132b and 132d. When sutures 134a, 134b are used to close a puncture site PS, sutures 134a, 134b form two generally parallel suture loops around puncture site PS, as shown in FIG. 17A. It will be understood that sutures 134a, 134b may be arranged to form other suture loop patterns. For instance, suture 134a could be connected between cuff 132a and 132d and suture 134b could be connected between cuff 132b and 132c. In such a case, sutures 134a and 134b would create a generally X-shaped suture loop pattern when closing puncture site PS.


While foot 122 has been illustrated and described as including four cuff receptacles and supporting four cuffs and two sutures, it will be appreciated that the present invention may include or utilize greater or fewer cuff receptacles, cuffs, or sutures. Additionally, the cuff receptacles, cuffs, and sutures may be arranged in various patterns. FIGS. 4B-4E illustrate a few additional embodiments of feet, with different numbers of cuff receptacles, cuffs, and sutures, and arranged in a variety of ways. Nevertheless, it will be understood that the illustrated embodiments are provided by way of example only, and that the present invention may include still other arrangements and numbers of cuff receptacles, cuffs, and sutures.


With attention to FIG. 4B, there is illustrated a foot 122a that is similar to foot 122 in many respects. Foot 122a has a first end 126a and a second end 128a. In first end 126a are three generally aligned cuff receptacles 130a, 130b, 130c that receive and support cuffs 132a, 132b, 132c, respectively. Similarly, second end 128a includes three generally aligned cuff receptacles 130d, 130e, 130f that receive and support cuffs 132d, 132e, 132f, respectively. Sutures 134a, 134b, 134c are connected respectively between cuffs 132a and 132d, cuffs 132b and 132e, and cuffs 132c and 132f. When sutures 134a, 134b, 134c are used to close a puncture site PS, sutures 134a, 134b, 134c form three generally parallel suture loops around puncture site PS, as shown in FIG. 17B.


Sutures 134a, 134b, 134c may also be connected to cuffs 132a-f so as to form non-parallel suture loop arrangements. By way of example, suture 134a may be connected between cuffs 132a and 132f, suture 134c may be connected between cuffs 132c and 132d, and suture 134b may be connected between cuffs 132b and 132e. In such a case, sutures 134a, 134b, 134c would form a suture loop pattern around puncture site PS like the pattern shown in FIG. 17C. Other patterns could also be achieved by connecting sutures 134a, 134b, 134c to cuffs 132a-f in other combinations.


Turning attention to FIG. 4C, there is illustrated a foot 122b that is similar to foot 122a in many respects. Foot 122b has a first end 126b and a second end 128b. In first end 126b are three cuff receptacles 130a, 130b, 130c that receive and support cuffs 132a, 132b, 132c, respectively. Similarly, second end 128a includes three cuff receptacles 130d, 130e, 130f that receive and support cuffs 132d, 132e, 132f, respectively. Unlike the cuff receptacles in feet 122, 122a, cuff receptacles 130a-f in foot 122b are not all generally aligned. Rather, cuff receptacles 130a, 130c, 130d, 130f are arranged in a generally rectangular pattern, while cuff receptacles 130b, 130e are offset from the other cuff receptacles. More specifically, cuff receptacles 130a, 130c are generally aligned with one another while cuff receptacle 130b is offset therefrom closer to first end 126b. Similarly, cuff receptacles 130d, 130f are generally aligned with one another while cuff receptacle 130e is offset therefrom closer to second end 128b.


Sutures 134a, 134b, 134c are connected respectively between cuffs 132a and 132f, cuffs 132b and 132e, and cuffs 132c and 132d. When sutures 134a, 134b, 134c are used to close a puncture site PS, sutures 134a, 134b, 134c form a generally star shaped suture pattern around puncture site PS, as shown in FIG. 17C. Sutures 134a, 134b, 134c may also be arranged to form other suture patterns, including three generally parallel suture loops as shown in FIG. 17B.



FIG. 4D illustrates a foot 122c that is similar to foot 122b in many respects. The main difference between foot 122b and foot 122c is that cuff receptacles 130a-f in foot 122c are arranged in a generally circular pattern. Arranging cuff receptacles 130a-f in a generally circular pattern enables sutures 134a-c to extend across puncture site PS in a number of directions and in a more evenly spaced manner. As with the previous embodiments, sutures 134a-c may be connected between cuffs 132a-f in various combinations or patterns to provide a desired suture pattern for closing puncture site PS.



FIG. 4E illustrates a foot 122d according to yet another exemplary embodiment of the present invention. As can be seen, foot 122d includes six cuff receptacles 130a-f, and supports six cuffs 132a-f and three sutures 134a-c. In this embodiment, cuff receptacles 130a-f and cuffs 132a-f are all substantially aligned with one another, with sutures 134a-c connected between cuffs 132a-f.


As mentioned above, closure device 100 also includes one or more needles 142 that can be deployed from one or more lumens (such as needle lumens 140) in elongate body 106 and into a patient. The one or more needles 142 can be advanced through needle lumens 140 and into the patient using plunger 116. More specifically, plunger 116 may be linked to or operably associated with the one or more needles 142 such that the one or more needles 142 advance out of needle lumens 140 and into the patient as plunger 116 is moved distally (i.e., towards distal end 104). Likewise, plunger 116 may be adapted to withdraw the one or more needles 142 out of the patient and back into needle lumens 140 when plunger 116 is moved proximally (i.e., away from distal end 104).


Attention is now directed to FIGS. 5A and 5B, in which FIG. 5A is a top view of the front of distal end 104, and FIG. 5B is an elevation view of the back side of distal end 104. When foot 122 is in the deployed position within a vessel, needles 142 are deployed from elongate member 106 into the patient. As needles 142 penetrate a lumen wall, each needle 142 engages and connects to a cuff 132. Once needles 142 are connected to cuffs 132, the needles and connected cuffs are withdrawn out of the patient. Drawing cuffs 132 out of the patient pulls sutures 134 through the lumen wall so that sutures 134 may be tied to close a puncture in the lumen wall.



FIGS. 5A and 5B depict four needles 142 being deployed or extended out of elongate member 106 toward cuffs 132. In particular, on the front side of distal end 104 needles 142a, 142b extend from needle lumens 140a, 140b, respectively, toward cuffs 132a, 132b, respectively. Similarly, on the back side of distal end 104 needles 142c, 142d extend from needle lumens 140c, 140d, respectively, toward cuffs 132c, 132d, respectively. As needles 142a-d advance, needle tips 152a-d engage and connect to cuffs 132a-d, respectively. Needle tips 152a-d and cuffs 132a-d may include complementary features that allow for a secure connection therebetween. Alternatively, needle tips 152a-d and cuffs 132a-d may connect to one another via a friction-fit, or other means.


Similar to and in connection with the discussion of FIGS. 4A-4E, it will be appreciated that device 100 may include different numbers of needle lumens 140 and needles 142. For instance, if foot 122 supports four cuffs, like in FIG. 4A, then device 100 may be designed with four needle lumens and four needles, as shown in FIGS. 5A and 5B. Alternatively, if foot 122 supports six cuffs as shown in FIGS. 4B-4E, device 100 may include six needle lumens and six needles. Thus, device 100 may have a corresponding number of cuffs, needles, and needle lumens.


Although device 100 may have a corresponding number of cuffs, needles, and needle lumens as discussed above, device 100 may also include non-corresponding numbers of cuffs, needles, and needle lumens. For instance, device 100 may include one or more needles that are configured to retrieve or withdraw through a lumen wall more than one cuff as described herein.


For instance, FIGS. 6 and 6A illustrate a needle 154 that may be used to simultaneously retrieve multiple cuffs 132. FIG. 6 illustrates an elevation view of needle 154 while FIG. 6A illustrates a close up perspective view of the distal end of needle 154. As depicted in the Figures, needle 154 includes a shaft 156 and three needle tips 158a, 158b, 158c extending from the distal end of shaft 156. Shaft 156 has a generally rectangular cross-sectional shape and needle tips 158a, 158b, 158c are generally aligned with one another.


Each needle tip 158a, 158b, 158c is configured to engage and connect to a cuff 132 supported by foot 122. Needle tips 158a, 158b, 158c and cuffs 132 may include complementary features that allow for a secure connection therebetween. As depicted in FIG. 6A, each needle tip 158a, 158b, 158c has a generally square cross-sectional shape that can create a friction-based connection with a cuff 132 when needle tips 158a, 158b, 158c are received within cuffs 132. Needle tips 158a, 158b, 158c may have other cross-sectional shapes, including circular, oval, or other regular or irregular shapes.


Although needle 154 is depicted as being generally flat with three needle tips, it will be appreciated that a multi-tip needle according to the present invention may have other configurations. Accordingly, a multi-tip needle may include a plurality of needle tips, including two needle tips or more than three needle tips. Additionally, a multi-tip needle may have a cross-sectional shape that is different from the generally rectangular shape illustrated. For instance, shaft 156 may have a circularly, square, oval, or other cross-sectional shape.


In one embodiment, for example, shaft 156 has a generally V-shaped cross-sectional shape. That is, the opposing sides of shaft 156 are generally aligned with one another while the center portion of shaft 156 is offset from the opposing sides. As a result of this cross-sectional shape of shaft 156, needle tip 158b may be offset from needle tips 158a and 158c. Needle tips 158a, 158b, 158c may also be offset from one another when shaft 156 has other cross-sectional shapes.


Using multi-tip needles, such as needle 154, can reduce the number of needle lumens required in elongate member 106. For instance, two needles 154 (each having three needle tips 158a, 158b, 158c) can be advanced from two needle lumens to retrieve six cuffs rather than advancing six individual needles through six different needle lumens. Forming elongate member 106 with fewer needle lumens can simplify the manufacturing of elongate member 106.



FIGS. 7A and 7B illustrate views similar to those of FIGS. 5A and 5B. More specifically, FIGS. 7A and 7B illustrate front and back views of a distal end 104′ that is similar in many respects to distal end 104. In contrast to FIGS. 5A and 5B, which illustrate four separate needles being advanced from four separate needle lumens, FIGS. 7A and 7B illustrate two multi-tip needles 154 being advanced from two needle lumens 160a, 160b.


In particular, on the front side of distal end 104′, needle 154a extends from needle lumen 160a so that needle tips 158a, 158b, 158c from needle 154a extend toward cuffs 132a, 132b, 132c, respectively, as shown in FIG. 7A. Similarly, as shown in FIG. 7B, on the back side of distal end 104′, needle 154b extends from needle lumen 160b so that needle tips 158a, 158b, 158c from needle 154b extend toward cuffs 132d, 132e, 132f, respectively. As needles 154a, 154b advance, needle tips 158a-c from needle 154a engage and connect to cuffs 132a-c, respectively, and needle tips 158a-c from needle 154b engage and connect to cuffs 132d-f, respectively. Once the needle tips are connected to cuffs 132a-f, needles 154a, 154b can be withdrawn proximally to draw cuffs 132a-f through the lumen wall, thereby pulling the ends of sutures 134a-c through the lumen wall. With the ends of sutures 134a-c pulled through the lumen wall, distal end 104′ can be removed from the body lumen and sutures 134a-c can be tied to close a puncture site in the lumen wall.


With reference now to FIGS. 8-12, one exemplary method of using device 100 will be discussed. In light of the foregoing discussion, it will be understood that device 100, as used in the following method, may include a plurality of individual needles (e.g., needles 142) delivered through individual needle lumens (e.g., 140), or may include one or more multi-tip needles (e.g., needles 154) delivered through one or more needle lumens (e.g., 160). For simplicity, the following exemplary method will be described with reference to needles 162a, 162b and needle lumens 164a, 164b. Nevertheless, it will be appreciated that needles 162a, 162b may be representative of two or more individual-tip or multi-tip needles. Likewise, needle lumens 164a, 164b may also be representative of two or more needle lumens through which individual-tip or multi-tip needles can be advanced.


As shown in FIG. 8, distal end 104 of device 100 is at least partially inserted into a patient such that foot portion 120 passes through a puncture site 166 in a lumen wall 168. As with many transluminal procedures, device 100 may be introduced into the body lumen using a guidewire. Once foot portion 120 is positioned within the body lumen, foot 122 is moved to the deployed position as shown in FIG. 9. As discussed above, foot 122 may be moved to the deployed position by actuating lever 118. Once foot 122 is in the deployed position, device 100 may be moved proximally so that foot portion 120 and foot 122 engage the interior surface of lumen wall 168. In this manner foot portion 120 and foot 122 may be used as locators to ensure proper placement of distal end 104 within the body lumen.


Once foot 122 has been deployed and positioned within the body lumen as desired, needles 162a, 162b are advanced from needle lumens 164a, 164b as shown in FIG. 10. As discussed above, needles 162a, 162b may be advanced out of needle lumens 164a, 164b by moving plunger 116 (FIG. 1) distally. The advancement of needles 162a, 162b out of needle lumens 164a, 164b causes needles 162a, 162b to extend distally and at least partially radially away from elongate member 106. More specifically, as shown in FIG. 10, needles 162a, 162b extend out of needle lumens 164a, 164b at an angle relative to elongate member 106 so that needles 162a, 162b will pass through lumen wall 168 and to cuffs 132 in foot 122 upon advancement of needles 162a, 162b out of needle lumens 164a, 164b.


As needles 162a, 162b engage cuffs 132 in foot 122, the needle tips of needles 162a, 162b (whether single tip or multi-tip needles) securely engage cuffs 132 to connect cuffs 132 to needles 162a, 162b. With the needle tips securely connected to cuffs 132, needles 162a, 162b are withdrawn out of the patient by moving plunger 116 (FIG. 1) proximally. As needles 162a, 162b are withdrawn, cuffs 132 are also withdrawn out of the patient. More specifically, since cuffs 132 are securely connected to needles 162a, 162b, withdrawal of needles 162a, 162b also causes cuffs 132 to be withdrawn. Even more specifically, as shown in FIG. 11, as needles 162a, 162b are drawn back through lumen wall 168, cuffs 132 are likewise drawn therethrough. As can also be seen in FIG. 11, since suture 134 is connected between cuffs 132, the ends of suture 134 are also drawn through lumen wall 168. As a result, the opposing ends of suture 134 extend through lumen wall 168 on opposing sides of puncture site 166 so that suture 134 spans puncture site 166.


Needles 162a, 162b may be withdrawn completely back into needle lumens 164a, 164b along with cuffs 132 as shown in FIG. 12. Foot 122 is then moved back to the delivery position as also shown in FIG. 12. As discussed above, foot 122 is moved from the deployed position to the delivery position by moving lever 118 from the position shown in FIG. 2 to the position shown in FIG. 1. Once foot 122 is in the delivery position, distal end 104 is removed from the patient, leaving sutures 134 spanning puncture site 166 and extending out of lumen wall 168. Sutures 134 may then be secured together to close puncture site 166.



FIGS. 13-16 illustrate an exemplary manner of removing distal end 104 and closing puncture site 166. The illustrated embodiment uses two or more sutures 134 to close puncture site 166. As discussed above, each suture 134 may be connected between two separate needles 142 or individual needle tips (e.g., 158) on separate multi-tip needles (e.g., 154). In the illustrated embodiment, for instance, three sutures 134a-134c are connected between six needles 142a-142f. Specifically, as best seen in FIG. 16, suture 134a is connected between needles 142a and 142d, suture 134b is connected between needles 142b and 142e, and suture 134c is connected between needles 142c and 142f.


Once needles 142a-142f have been deployed and withdrawn to draw the ends of sutures 134a-134c through lumen wall 168 as discussed above in connection with FIGS. 8-12, distal end 104 may be removed from the patient as shown in FIG. 13. Plunger 116 may then be removed from actuator mechanism 112 as shown in FIG. 14. More specifically, plunger 116 may be drawn proximally relative to actuator 112 until plunger 116 is removed from the proximal end of actuator mechanism 112.


As can be seen in FIG. 14, a detachable needle housing 159 is disposed on the distal end of plunger 116. Housing 159 may hold the proximal ends of needles 142 such that movement of plunger 116 causes a corresponding movement of needles 142. Accordingly, removal of plunger 116 from actuator mechanism 112 may likewise cause needles 142 to be at least partially withdrawn proximally from actuator mechanism 112. FIG. 14 illustrates needles 142 completely withdrawn from actuator mechanism 112.


As shown in FIG. 15, needle housing 159 may be detached from plunger 116 to facilitate the removal of closure device 100 from off of sutures 134. After detaching needle housing 159 from plunger 116, needle housing 159 may be separated into two halves 159a, 159b, as shown in phantom lines in FIG. 15. In the illustrated embodiment, half 159a holds the proximal ends of needles 142a-142c and half 159b holds the proximal ends of needles 142d-142f.


With needle housing 159 detached from plunger 116 and separated into halves 159a, 159b, halves 159a, 159b, with their associated needles 142 and attached sutures 134, may be passed through actuator mechanism 112 and elongate member 106 so as to free sutures 134, needles 142, and halves 159a, 159b from closure device 100. More specifically, half 159a and its associated needles 142 may be passed distally back through actuator mechanism 112 and the needle lumen 140 associated with the needles 142 of half 159a so that half 159a and its needles 142 exit the distal end of needle lumen 140, thereby freeing half 159a and its needles 142 from device 100. Half 159b and its associated needles 142 may similarly be passed back through actuator mechanism 112 and the needle lumen 140 associated with the needles 142 of half 159b so that half 159b and its needles 142 exit the distal end of needle lumen 140 associated therewith, thereby freeing half 159b and its needles 142 from device 100.


Alternatively, closure device 100 may have one or more slots extending the length thereof through which sutures 134 and/or needles 142 may be passed to remove closure device 100 from off of sutures 134. For instance, the slots may open the needle lumens 140 to the external surface of device 100 such that sutures 134 and/or needles 142 may be passed therethrough to remove device 100. In other embodiments, the slots may open the needle lumens 140 to a central internal channel within device 100, such that sutures 134 and needles 142 may be passed from needle lumens 140 into the central channel so that sutures 134, needles 142, and halves 159a, 159b may be passed through the central channel and out the distal end of device 100.


In any case, once closure device 100 has been removed from sutures 134, halves 159a, 159b enable sutures 134a-134c to be arranged in an orderly manner, as shown in FIG. 16, thereby enabling a doctor (or other user) to quickly identify opposing ends of each suture 134. The doctor (or other user) may then cut the opposing ends of each suture from the needles and tie them off individually to close puncture site 166, as shown in FIG. 17. Being able to quickly identify opposing ends of each suture 134 allows the user to better manage the sutures and ensure that puncture site 166 is properly closed. After the sutures have been cut from the needles, the detachable housing may be re-attached to the plunger, or may be disposed.


Depending on the number and arrangement of sutures 134, various closure patterns and knots may be used to close puncture site 166. FIGS. 17A-17C illustrate various example manners of closing puncture site 166. For instance, FIG. 17A illustrates two sutures tied in a parallel arrangement. FIG. 17B illustrates a similar parallel arrangement with three sutures. FIG. 17C illustrates three sutures tied in a star shaped arrangement. Sutures 134 can be secured in any suitable manner, including by tying or with clamps, clips, or other closure devices.


Attention is now directed to FIGS. 18-25 which illustrate a closure device 200 according another exemplary embodiment of the present invention, and a method for using closure device 200. Closure device 200 is similar to closure device 100 in many respects. As a result, the following discussion of closure device 200 will focus primarily on those aspects of closure device 200 that are different from closure device 100.


Closure device 200 includes a proximal end 202 and a distal end 204. As shown in FIGS. 18 and 19, closure device 200 includes an elongate member 206 that has a proximal end 208 and a distal end 210. Elongate member 206 is generally tubular and includes one or more lumens that extend generally from proximal end 208 to distal end 210. The one or more lumens may be used to facilitate the delivery of device 200 over a guidewire or to deliver one or more needles into a patient. As can be se been in FIGS. 18 and 19, elongate member 206 has a generally uniform diameter along its length.


Connected to proximal end 208 of elongate member 206 is an actuator mechanism 212. Actuator mechanism 212 includes a handle 214 to facilitate manipulation of device 200. Actuator mechanism 212 also includes a plunger 216 used to deploy and retract needles from elongate member 206, and a lever 218 used to selectively deploy and retract a plurality of feet.


As shown in FIGS. 18 and 19, distal end 204 of device 200 includes a foot portion 220 attached to or extending from distal end 210 of elongate member 206. Elongate member 206 and foot portion 220 may be discrete pieces that are coupled together, or elongate member 206 and foot portion 220 may be integrally formed as a single piece.


A plurality of feet 222 are movably mounted on foot portion 220. Feet 222 are movable between a delivery position and a deployed position. In the delivery position, which is illustrated in FIG. 18, feet 222 are positioned at a first location along the length of device 200 and are substantially or entirely within a diameter that is about equal to an outer diameter of elongate member 206. In contrast, when feet 222 are in the deployed position as illustrated in FIG. 19, feet 222 are positioned at a second, more proximal location along the length of device 200 and extend radially beyond the outer diameter of elongate member 206.


When feet 222 are in the delivery configuration, distal end 204 can be inserted through a puncture site and into a body lumen of a patient. Once distal end 204 is positioned within the body lumen, feet 222 may be moved to the deployed position. When in the deployed position, feet 222 increase the profile of distal end 204, which prevents distal end 204 from being inadvertently pulled out of the body lumen through the puncture site. Additionally, feet 222 may also be used as a locator to assist a physician in properly positioning distal end 204 within the body lumen. As will be discussed in greater detail below, feet 222 are operatively connected to lever 218 such that feet 222 may be selectively moved between the delivery position and the deployed position by actuating lever 218.



FIGS. 18 and 19 further illustrate that device 200 optionally includes a flexible guidebody 224 extending distally from the distal end of foot portion 220. As with guidebody 124, guide body 224 can be advanced along a guidewire into a body lumen. Accordingly, at least the distal portion of guidebody 224 can be formed from a flexible or elastomeric material that is biocompatible, particularly with blood.


Turning attention to FIGS. 20A and 20B, a horizontal cross-sectional view (taken along cross-sectional lines 20A-20A in FIG. 18) and a partial cutaway view of distal end 204, including foot portion 220 and plurality of feet 222, are illustrated. In the present embodiment, plurality of feet 222 includes four feet, identified as feet 222a, 222b, 222c, 222d, respectively, but may include more or fewer feet. As can be seen in FIG. 20A, feet 222a-d are disposed radially about foot portion 220. Extending through the center of foot portion 220 is an actuator lumen 226, which also extends at least partially through elongate body 206. A rod or cable 228 extends through actuator lumen 226 to connect feet 222a-d to lever 218.


As lever 218 is moved in the direction of arrow A3, as shown in FIG. 19, rod 228 is drawn proximally through actuator lumen 226. The proximal movement of rod 228 causes feet 222a-d to move from the delivery position shown in FIG. 18 to the deployed position shown in FIG. 19. In contrast, as lever 218 is moved in the direction opposite to arrow A3, rod 228 is moved distally through actuator lumen 226, thereby moving feet 222a-d from the deployed position to the delivery position.



FIG. 20B illustrates a cutaway view of distal end 204, showing foot 222a in the delivery and deployed positions. Specifically, FIG. 20B shows foot 222a in solid lines in the delivery position and in phantom lines in the deployed position. As can be seen in FIG. 20B, when in the delivery position, foot 222a is located more distally along the length of distal end 204 than when foot 222a is in the deployed position. In other words, as foot 222a moves from the delivery position to the deployed position (e.g., generally in the direction of arrow A4), foot 222a moves proximally along the length of distal end 204. Correspondingly, as foot 222a moves from the deployed position to the delivery position (e.g., generally in the direction opposite to arrow A4), foot 222a moves distally along the length of distal end 204.


Likewise, when in the delivery position, foot 222a is located radially closer to the center of foot portion 220 (e.g., actuator lumen 226) than when foot 222a is in the deployed position. In other words, as foot 222a moves from the delivery position to the deployed position, foot 222a moves radially away from the center of foot portion 220. Correspondingly, as foot 222a moves from the deployed position to the delivery position, foot 222a moves radially closer to the center of distal end 204.


To facilitate movement of feet 222a-d between the delivery and deployed positions, foot portion 220 and feet 222a-d include a track system. The track system enables feet 222a-d to move along the length of device 200 while also moving radially relative to foot portion 220. In the illustrated embodiment, foot portion 220 includes track guides 230a-d disposed within the outer surface thereof, and feet 222a-d include tracks 232a-d, respectively. Tracks 232a-d are slidably positioned within track guides 230a-d, respectively, so that tracks 232a-d are able to slide within track guides 230a-d as feet 222a-d move between the delivery and deployed positions.


As noted above, FIG. 20B illustrates a partial cutaway view of distal end 204. More specifically, FIG. 20B illustrates a partial cutaway view of distal end 204 showing foot 222a in solid lines in the delivery position and in phantom lines in the deployed position. FIG. 20B also shows that track guide 230a is angled relative to the length of device 200 and/or a central or longitudinal axis A of distal end 204. That is, track guide 230a has a first or distal end 234 that is positioned radially closer to central axis A than a second or proximal end 236.


The angled nature of track guide 230a causes foot 222a to move radially closer to and further away from axis A as foot 222a moves along the length of device 200. For instance, as rod 228 pulls foot 222a in the direction of arrow A4, the angled nature of track guide 230a causes foot 222a to also move in the direction of arrow A5. Similarly, as rod 228 pushes foot 222a in the direction opposite of arrow A4, the angled nature of track guide 230a causes foot 222a to also move in the direction opposite of arrow A5. As a result, foot 222a is able to move both longitudinally along a portion of the length of device 200 as well as radially relative to foot portion 220.


Although FIG. 20B only illustrates track guide 230a and foot 222a, it will be understood that track guides 230b-d and feet 222b-d can have similar or identical configurations. Additionally, track guides 230a-d and tracks 232a-d may also have other configurations than those illustrated. For instance, track guides may be formed on feet 222 while tracks are formed on foot portion 220. Furthermore, while track guides 230 are illustrated as being generally straight, track guides may also be curved so long as they cause feet 222 to move radially as feet 222 move longitudinally.


As can be seen in FIG. 20B, foot 222a does not extend substantially beyond the outer diameter of elongate member 206 when foot 222a is in the delivery position. As a result, foot 222a is in a relatively compact position and is able to be readily inserted through a puncture site and into a body lumen. In contrast, foot 222a extends radially beyond the outer diameter of elongate member 206 when foot 222a is in the deployed position (as shown in phantom lines in FIG. 20B). Device 200 can be configured so that feet 222a-d, when in the deployed position, extend out radially far enough that feet 222a-d can engage or be positioned adjacent to an interior or distal surface of a body lumen wall.


Returning again to FIG. 20A, feet 222a-d include cuff receptacles 238a-d. Cuffs 240a-d are releasably disposed within cuff receptacles 238a-d, respectively. Sutures 242, 244 are connected between pairs of cuffs 240a-d. In the illustrated embodiment, suture 242 is connected between cuffs 240a, 240c, while suture 244 is connected between cuffs 240b, 240d. When sutures 242, 244 are used to close a puncture site, sutures 242, 244 will form a generally X-shaped suture loop pattern. Nevertheless, sutures 242, 244 may be connected between cuffs 240a-d in such an arrangement so as to form other suture loop patterns. For instance, suture 242 could be connected between cuff 240a and cuff 240d and suture 244 could be connected between cuff 240b and cuff 240c. In such a case, sutures 242, 244 would create two generally parallel suture loops around a puncture site, similar to those shown in FIG. 17A.


As can be seen in FIGS. 19 and 21, feet 222a-d are generally aligned with needle lumens 246a-d in elongate member 206 when feet 222a-d are in the deployed position. As noted above, needles 248a-d may be passed through or extended from needle lumens 246a-d. Aligning feet 222a-d with needle lumens 246a-d enables needles 248a-d to be extended from needle lumens 246a-d toward cuffs 240a-d so that needles 248a-d may engage cuffs 240a-d.


Needles 248a-d can be advanced through needle lumens 246a-d using plunger 216. More specifically, plunger 216 may be linked to or operably associated with needles 248a-d such that needles 248a-d advance out of needle lumens 246a-d as plunger 216 is moved distally (i.e., towards distal end 204). Likewise, plunger 216 may be adapted to withdraw needles 248a-d back into needle lumens 246a-d when plunger 216 is moved proximally (i.e., away from distal end 204).


When feet 222a-d are in the deployed position within a body lumen, needles 248a-d can be deployed from elongate member 206 into the patient. As needles 248a-d penetrate the lumen wall, each needle 222a-d engages and connects to a cuff 240a-d in a manner similar to that described above in connection with needles 142 and cuffs 132. Once needles 248a-d are connected to cuffs 240a-d, needles 248a-d and connected cuffs 240a-d are withdrawn out of the patient. Drawing cuffs 240a-d out of the patient pulls sutures 242, 244 through the lumen wall so that sutures 242, 244 may be tied to close a puncture in the lumen wall.


As with device 100, device 200 may have a corresponding number of cuffs, needles, and needle lumens as discussed above. Also like device 100, device 200 may also include non-corresponding numbers of cuffs, needles, and needle lumens. For instance, device 200 may include one or more needles that have multiple needle tips configured to retrieve or withdraw through a lumen wall more than one cuff as described herein.


With reference to FIGS. 21-25, one exemplary method of using device 200 will be discussed. In light of the foregoing discussion, it will be understood that device 200, as used in the following method, may include a plurality of individual needles (e.g., needles 248) delivered through individual needle lumens (e.g., 246), or may include one or more multi-tip needles (similar to needles 154) delivered through one or more needle lumens (similar to needle lumens 160). For simplicity, the following exemplary method will be described with reference to needles 248 and needle lumens 246. Nevertheless, it will be appreciated that needles 248 may be representative of two or more individual-tip or multi-tip needles. Likewise, needle lumens 246 may also be representative of two or more needle lumens through which individual-tip or multi-tip needles can be advanced


As shown in FIG. 21, distal end 204 of device 200 is at least partially inserted into a patient such that foot portion 220 passes at least partially through a puncture 250 in a lumen wall 252. As with many transluminal procedures, device 200 may be introduced into the body lumen using a guidewire. Once foot portion 220 is positioned within the body lumen, feet 222a-d are moved from the delivery position shown in FIG. 21 to the deployed position shown in FIG. 22. As discussed above, feet 222a-d may be moved to the deployed position by actuating lever 218. Once feet 222a-d are in the deployed position, device 200 may be moved proximally so that feet 222a-d engage the interior surface of lumen wall 252. In this manner, feet 222a-d may be used as locators to ensure proper placement of distal end 204 within the body lumen.


Once feet 222a-d have been deployed and positioned within the body lumen as desired, needles 248a-d are advanced from needle lumens 246a-d as shown in FIG. 23. As discussed above, needles 248a-d may be advanced out of needle lumens 246a-d by moving plunger 216 (FIG. 1) distally. The advancement of needles 248a-d out of needle lumens 246a-d causes needles 248a-d to extend distally and at least partially radially away from elongate member 206. More specifically, as shown in FIG. 23, needles 248a-d extend out of needle lumens 246a-d at an angle relative to elongate member 206 so that needles 248a-d pass through lumen wall 252 and toward cuffs 240a-d in feet 222a-d as needles 248a-d advance out of needle lumens 246a-d.


As needles 248a-d engage cuffs 240a-d in feet 222a-d, the needle tips of needles 248a-d (whether single tip or multi-tip needles) securely engage cuffs 240a-d to connect cuffs 240a-d to needles 248a-d. With the needle tips securely connected to cuffs 240a-d, needles 248a-d are withdrawn out of the patient by moving plunger 216 (FIG. 1) proximally. As needles 248a-d are withdrawn, cuffs 240a-d are also withdrawn out of the patient. More specifically, since cuffs 240a-d are securely connected to needles 248a-d, withdrawal of needles 248a-d also causes cuffs 240a-d to be withdrawn. Even more specifically, as shown in FIG. 24, as needles 248a-d are drawn back through lumen wall 252, cuffs 240a-d are likewise drawn therethrough. As can also be seen in FIG. 24, since sutures 242, 244 are connected between cuffs 240a-d, the ends of suture 242, 244 are also drawn through lumen wall 252. As a result, the opposing ends of each suture 242, 244 extend through lumen wall 252 on opposing sides of puncture site 250 so that each suture 242, 244 spans puncture site 250.


Needles 248a-d may be withdrawn completely back into needle lumens 246a-d along with cuffs 240a-d as shown in FIG. 25. Feet 222a-d are then moved back to the delivery position as also shown in FIG. 25. As discussed above, feet 222a-d are moved from the deployed position to the delivery position by moving lever 218 from the position shown in FIG. 19 to the position shown in FIG. 18. Once feet 222a-d are in the delivery position, distal end 204 is removed from the patient, leaving sutures 242, 244 spanning puncture site 250 and extending out of lumen wall 252. Sutures 242, 244 are then secured to close puncture 250 as shown in FIGS. 17-17C. Sutures 242, 244 can be secured in any suitable manner, including by tying or with clamps, clips, or other closure devices.


The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. It shall be further understood that although the present invention has been described in relation to vessel closure, it is contemplated that the closure component of the present invention may be utilized to close other openings in the body such as PFO openings, or openings formed in organs such as the stomach for certain surgical procedures.

Claims
  • 1. A device for closing an opening in a body lumen, comprising: an elongate member having a plurality of lumens;a plurality of cuff supporting members disposed distal a distal end of the plurality of lumens, each cuff supporting members having a cuff removably mounted therein, with a length of suture being connected between two cuffs, each cuff supporting member being movable between a delivery position and a deployed position, the plurality of cuff supporting members being substantially within a diameter of the elongate member in a delivery position, with the two cuffs being separated by a first distance, and proximally and radially moved away from the delivery position in the deployed position, with the two cuffs being separated by a second distance larger than the first distance; anda plurality of elongate track guides extending in a proximal to distal direction and angularly orientated relative to a central axis of the elongate member, each cuff supporting member cooperating with one of the plurality of track guides.
  • 2. The device of claim 1, further comprising a plurality of needles selectively disposed within the plurality of lumens.
  • 3. The device of claim 2, wherein each needle of the plurality of needles comprises a shaft and a needle tip extending from a distal end of the shaft.
  • 4. The device of claim 3, further comprising a plunger operatively associated with the plurality of needles, wherein distal movement of the plunger advances the plurality of needles from the plurality of needle lumens.
  • 5. The device of claim 2, further comprising a housing associated with the plurality of needles, the housing being selectively removably mounted to a handle receiving the elongate member.
  • 6. The device of claim 1, further comprising an actuator lumen extending at least partially through a portion of the elongate member within which are located the plurality of cuff supporting members.
  • 7. A device for closing an opening in a body lumen, comprising: an elongate member having a proximal end, a distal end, a central passage, and a plurality of lumens extending from the proximal end toward the distal end;a plurality of needles disposed within and advanceable from the plurality of lumens;a plurality of feet disposed distal the plurality of needles and being slidable between a delivery position and a deployed position, the plurality of feet moving both proximally and radially away from a central axis of the elongate member when moving from the delivery position to the deployed position, each foot of the plurality of feet having a cuff removably mounted therein, a length of suture being connected between two cuffs, the plurality of feet being substantially within a diameter of the elongate member in a delivery position, with the two cuffs being separated by a first distance, and proximally and radially moved away from the delivery position in the deployed position, with the two cuffs being separated by a second distance larger than the first distance; anda track associated with each foot of the plurality of feet that facilitates movement of the plurality of feet between the delivery and deployed positions, each track being angularly orientated relative to the central axis of the elongate member.
  • 8. The device of claim 7, further comprising an actuator lumen extending at least partially through a foot portion associated with the plurality of feet.
  • 9. The device of claim 8, further comprising an actuator extending through the central passage of the elongate member and the actuator lumen, the actuator being operatively associated with the plurality of feet such that proximal movement of the actuator causes the plurality of feet to move from the delivery position to the deployed position.
  • 10. The device of claim 7, each needle of the plurality of needles comprises a shaft and a needle tip extending from a distal end of the shaft.
  • 11. The device of claim 7, further comprising a plunger operatively associated with the plurality of needles, wherein distal movement of the plunger causes the plurality of needles to advance from the plurality of lumens and engage the cuffs when the plurality of feet are in the deployed position.
  • 12. The device of claim 7, where each foot includes a curved outer peripheral surface.
  • 13. The device of claim 12, wherein the curved outer peripheral surface is distally tapered.
  • 14. A method for closing an opening in tissue, comprising: inserting an elongate member at least partially into a patient, the elongate member having a plurality of lumens; andmoving a plurality of cuff supporting members slidably associated with the elongate member between a delivery position and a deployed position and being disposed distal a distal end of the plurality of lumens, the plurality of cuff supporting members being substantially within a diameter of the elongate member in the delivery position, with each cuff supporting members having a cuff removably mounted therein, with a length of suture being connected between two cuffs, the two cuffs being separated by a first distance, and proximally and radially moved away from the delivery position in the deployed position, with the two cuffs being separated by a second distance larger than the first distance, the plurality of cuff supporting members being slid along a plurality of elongate track guides extending in a proximal to distal direction, each cuff supporting member being associated with one track of the plurality of tracks, each track being angularly orientated relative to a central axis of the elongate member.
  • 15. A method of claim 14, wherein the two cuffs are diagonally separated across the central axis.
  • 16. A method of claim 14, wherein the two cuffs are separated across the central axis.
  • 17. A method of claim 14, further comprising distally moving a plunger operatively associated with a plurality of needles movable towards the plurality of cuff supporting members, wherein distal movement of the plunger causes the plurality of needles to advance from a plurality of lumens associated with the elongate member and engage the cuffs.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/005,880, filed Jan. 25, 2016, entitled “SYSTEMS, METHODS, AND DEVICES FOR CLOSING HOLES IN BODY LUMENS”, which is a divisional application of U.S. patent application Ser. No. 13/485,388, filed May 31, 2012, now U.S. Pat. No. 9,241,707 entitled “SYSTEMS, METHODS, AND DEVICES FOR CLOSING HOLES IN BODY LUMENS”, the entire contents of which are incorporated by reference herein.

US Referenced Citations (656)
Number Name Date Kind
312408 Wackerhagen Feb 1885 A
597165 Hall Jan 1898 A
659422 Shidler Oct 1900 A
989231 Davis Apr 1911 A
989234 Davis Apr 1911 A
1574362 Callahan Sep 1922 A
1625602 Gould et al. Apr 1927 A
1940351 Howard Mar 1933 A
2012776 Roeder Aug 1935 A
2131321 Hart Oct 1937 A
2108206 Mecker Feb 1938 A
2127903 Bowen Aug 1938 A
2371978 Perham Mar 1945 A
2397823 Walter Apr 1946 A
RE22857 Ogburn Mar 1947 E
2595086 Larzelere Nov 1948 A
2588589 Tauber Mar 1952 A
2610631 Calicchio Sep 1952 A
2646045 Priestley Jul 1953 A
2692599 Creelman Oct 1954 A
2941489 Fischbein Jun 1960 A
2959172 Held Nov 1960 A
3033156 Verlish May 1962 A
3104666 Hale et al. Sep 1963 A
3197102 Bates et al. Jul 1965 A
3359983 Northey Dec 1967 A
3413397 Bierbaum et al. Nov 1968 A
3422181 Chirgwin, Jr. Jan 1969 A
3470875 Johnson Oct 1969 A
3485234 Stevens Dec 1969 A
3587115 Shiley Jun 1971 A
3630205 Listner Dec 1971 A
3653388 Tenckhoff Apr 1972 A
3665926 Flores May 1972 A
3776237 Hill et al. Dec 1973 A
3802438 Wolvek Apr 1974 A
3814104 Irnich et al. Jun 1974 A
3820544 Semm Jun 1974 A
3840017 Violante Oct 1974 A
3874388 King et al. Apr 1975 A
3878848 Hiebert Apr 1975 A
3908662 Razgulov et al. Sep 1975 A
3918455 Coplan Nov 1975 A
3926194 Greenberg et al. Dec 1975 A
3939820 Grayzel Feb 1976 A
3985138 Jarvik Oct 1976 A
4011872 Komiya Mar 1977 A
4018228 Goosen Apr 1977 A
4069825 Akiyama Jan 1978 A
4109658 Hughes Aug 1978 A
4128100 Wendorff Dec 1978 A
4135623 Thyen Jan 1979 A
4161951 Scanlan, Jr. Jul 1979 A
4168073 LaRue Sep 1979 A
4182339 Hardy, Jr. Jan 1980 A
4185636 Gabbay et al. Jan 1980 A
4216776 Downie et al. Aug 1980 A
4217665 Bex et al. Aug 1980 A
4235177 Arbuckle Nov 1980 A
4235238 Ogiu et al. Nov 1980 A
4316469 Kapitanov Feb 1982 A
4317445 Robinson Mar 1982 A
4411654 Boarini et al. Oct 1983 A
4412832 Kling et al. Nov 1983 A
4437465 Nomoto et al. Mar 1984 A
4469101 Coleman et al. Sep 1984 A
4492229 Grunwald Jan 1985 A
4493323 Albright et al. Jan 1985 A
4501276 Lombardi Feb 1985 A
4553543 Amarasinghe Nov 1985 A
4554543 Wyatt et al. Nov 1985 A
4580566 Hsu Apr 1986 A
4586614 Ger May 1986 A
4587969 Gillis May 1986 A
4596559 Fleishhacker Jun 1986 A
4610248 Rosenberg Sep 1986 A
4629450 Suzuki et al. Dec 1986 A
4651733 Mobin-Uddin Mar 1987 A
4655211 Sakamoto et al. Apr 1987 A
4702250 Orvil et al. Oct 1987 A
4723549 Wholey et al. Feb 1988 A
4738666 Fuqua Apr 1988 A
4744364 Kensey May 1988 A
4748982 Horzewski et al. Jun 1988 A
4782954 Reynolds Nov 1988 A
4803984 Narayanan et al. Feb 1989 A
4823794 Pierce Apr 1989 A
4830002 Semm May 1989 A
4836205 Barrett Jun 1989 A
4845851 Warthen Jul 1989 A
4848341 Ahmad Jul 1989 A
4852568 Kensey Aug 1989 A
4890612 Kensey Jan 1990 A
4898155 Ovil et al. Feb 1990 A
4911164 Roth Mar 1990 A
4917089 Sideris Apr 1990 A
4926860 Stice et al. May 1990 A
4929246 Sinofsky May 1990 A
4935027 Yoon NAME Jun 1990 A
4950285 Wilk Aug 1990 A
4957498 Caspari et al. Sep 1990 A
4966600 Songer et al. Oct 1990 A
4981149 Yoon et al. Jan 1991 A
4983168 Moorehead Jan 1991 A
4984581 Stice Jan 1991 A
5002563 Pyka et al. Mar 1991 A
5009643 Reich et al. Apr 1991 A
5021059 Kensey et al. Jun 1991 A
5037433 Wilk et al. Aug 1991 A
5041129 Hayhurst et al. Aug 1991 A
5047039 Avant et al. Sep 1991 A
5059201 Asnis Oct 1991 A
5061274 Kensey Oct 1991 A
5074874 Yoon et al. Dec 1991 A
5078721 McKeating Jan 1992 A
5080664 Jain Jan 1992 A
5089010 Korthoff Feb 1992 A
5100419 Ehlers Mar 1992 A
5100422 Berguer et al. Mar 1992 A
5100432 Matsutani Mar 1992 A
5108421 Fowler Apr 1992 A
5109780 Slouf et al. May 1992 A
5129882 Weldon et al. Jul 1992 A
5129912 Noda et al. Jul 1992 A
5129913 Ruppert Jul 1992 A
5144961 Chen et al. Sep 1992 A
5147373 Ferzli Sep 1992 A
5156788 Chesterfield et al. Oct 1992 A
5160339 Chen et al. Nov 1992 A
5163946 Li Nov 1992 A
5169041 Tan Dec 1992 A
5171251 Bregen et al. Dec 1992 A
5176691 Pierce Jan 1993 A
5178629 Kammerer Jan 1993 A
5192287 Fournier et al. Mar 1993 A
5192294 Blake, III Mar 1993 A
5192301 Kamiya et al. Mar 1993 A
5192302 Kensey et al. Mar 1993 A
5201744 Jones Apr 1993 A
5207703 Jain May 1993 A
5211650 Noda May 1993 A
5217470 Weston Jun 1993 A
5217471 Burkhart Jun 1993 A
5217485 Liv et al. Jun 1993 A
5219358 Bendel et al. Jun 1993 A
5222974 Kensey et al. Jun 1993 A
5234443 Phan et al. Aug 1993 A
5234445 Walker et al. Aug 1993 A
5237985 Hodgson et al. Aug 1993 A
5237996 Waldman et al. Aug 1993 A
5242427 Bilweis Sep 1993 A
5250033 Evans Oct 1993 A
5250053 Snyder Oct 1993 A
5250054 Li Oct 1993 A
5254105 Haaga Oct 1993 A
5254113 Wilk Oct 1993 A
5254126 Filipi et al. Oct 1993 A
5258003 Ciaglia et al. Nov 1993 A
5259846 Granger et al. Nov 1993 A
5275616 Fowler Jan 1994 A
5279311 Snyder Jan 1994 A
5281236 Bognato et al. Jan 1994 A
5281237 Gimpelson Jan 1994 A
5284485 Kammerer et al. Feb 1994 A
5285945 Brinkerhoff et al. Feb 1994 A
5289963 McGarry et al. Mar 1994 A
5290284 Adair Mar 1994 A
5290297 Phillips Mar 1994 A
5290310 Makower et al. Mar 1994 A
5292309 VanTassel et al. Mar 1994 A
5292327 Dodd et al. Mar 1994 A
5292332 Lee Mar 1994 A
5293881 Green et al. Mar 1994 A
5295993 Green Mar 1994 A
5300085 Yock Apr 1994 A
5304184 Hathaway et al. Apr 1994 A
5304185 Taylor Apr 1994 A
5306254 Nash et al. Apr 1994 A
5312024 Grant et al. May 1994 A
5312423 Rosenbluth et al. May 1994 A
5318578 Hasson Jun 1994 A
5320629 Noda et al. Jun 1994 A
5320632 Heidmueller Jun 1994 A
5330445 Haaga Jul 1994 A
5330491 Walker et al. Jul 1994 A
5334217 Das Aug 1994 A
5336229 Noda Aug 1994 A
5336230 Leichtling et al. Aug 1994 A
5336231 Adair Aug 1994 A
5342369 Harryman, II Aug 1994 A
5353974 Maurizio Oct 1994 A
5354279 Hoefling Oct 1994 A
5354312 Brinkerhoff et al. Oct 1994 A
5364407 Poll Nov 1994 A
5364408 Gordon Nov 1994 A
5368595 Lewis Nov 1994 A
5368601 Sauer et al. Nov 1994 A
5374275 Bradley et al. Dec 1994 A
5374278 Chesterfield et al. Dec 1994 A
5376096 Foster Dec 1994 A
5383896 Gershony et al. Jan 1995 A
5383905 Golds et al. Jan 1995 A
5385569 Swor Jan 1995 A
5387221 Bisgaard Feb 1995 A
5387227 Grice Feb 1995 A
5391176 de la Torre Feb 1995 A
5391182 Chin Feb 1995 A
5395332 Ressemann et al. Mar 1995 A
5395349 Quiachon et al. Mar 1995 A
5397310 Chu et al. Mar 1995 A
5397325 Delia Badia et al. Mar 1995 A
5397326 Mangum Mar 1995 A
5403329 Hinchcliffe Apr 1995 A
5403330 Tuason Apr 1995 A
5403331 Chesterfield et al. Apr 1995 A
5403338 Milo Apr 1995 A
5405352 Weston Apr 1995 A
5411481 Allen et al. May 1995 A
5413571 Katsaros et al. May 1995 A
5417684 Jackson et al. May 1995 A
5417699 Klein et al. May 1995 A
5419765 Weldon et al. May 1995 A
5425705 Evard et al. Jun 1995 A
5425737 Burbank et al. Jun 1995 A
5425740 Hutchinson, Jr. Jun 1995 A
5431666 Sauer et al. Jul 1995 A
5433700 Peters Jul 1995 A
5452733 Sterman et al. Sep 1995 A
5454822 Schob et al. Oct 1995 A
5454834 Boebel et al. Oct 1995 A
5458574 Machold et al. Oct 1995 A
5458609 Gordon et al. Oct 1995 A
5462560 Stevens Oct 1995 A
5462561 Voda Oct 1995 A
5464426 Bonutti Nov 1995 A
5466241 Leroy et al. Nov 1995 A
5470338 Whitfield et al. Nov 1995 A
5474568 Scott Dec 1995 A
5476469 Hathaway et al. Dec 1995 A
5476470 Fitzgibbons, Jr. Dec 1995 A
5478309 Sweezer et al. Dec 1995 A
5478353 Yoon Dec 1995 A
5478354 Tovey et al. Dec 1995 A
5480407 Wan et al. Jan 1996 A
5486190 Green Jan 1996 A
5489295 Piplani et al. Feb 1996 A
5492119 Abrams Feb 1996 A
5496332 Sierra et al. Mar 1996 A
5507744 Tay et al. Apr 1996 A
5507755 Gresl et al. Apr 1996 A
5507757 Sauer et al. Apr 1996 A
5507758 Thomason et al. Apr 1996 A
5509902 Raulerson Apr 1996 A
5520655 Davila et al. May 1996 A
5520665 Fleetwood May 1996 A
5520691 Branch May 1996 A
5520702 Sauer et al. May 1996 A
5527321 Sauer et al. Jun 1996 A
5527322 Klein et al. Jun 1996 A
D372310 Hartnett Jul 1996 S
5531700 Moore et al. Jul 1996 A
5536267 Edwards et al. Jul 1996 A
5536273 Lehrer Jul 1996 A
5540701 Sharkey et al. Jul 1996 A
5540703 Barker, Jr. et al. Jul 1996 A
5540704 Gordon et al. Jul 1996 A
5545171 Sharkey et al. Aug 1996 A
5545178 Kensey et al. Aug 1996 A
5545180 Le et al. Aug 1996 A
5549618 Fleenor et al. Aug 1996 A
5549631 Bonutti Aug 1996 A
5554162 DeLange Sep 1996 A
5562684 Kammerer Oct 1996 A
5562686 Sauer et al. Oct 1996 A
5562688 Riza Oct 1996 A
5562728 Lazarus et al. Oct 1996 A
5567435 Hubbell et al. Oct 1996 A
5569269 Hart et al. Oct 1996 A
5569271 Hoel Oct 1996 A
5571120 Yoon Nov 1996 A
5573540 Yoon Nov 1996 A
5578044 Gordon et al. Nov 1996 A
5584842 Fogarty et al. Dec 1996 A
5591177 Lehrer Jan 1997 A
5591179 Edelstein Jan 1997 A
5591206 Moufarrege Jan 1997 A
5593421 Bauer Jan 1997 A
5601572 Middleman et al. Feb 1997 A
5603718 Xu Feb 1997 A
5607435 Sachdeva et al. Mar 1997 A
5609597 Lehrer Mar 1997 A
5611794 Sauer et al. Mar 1997 A
5613974 Andreas et al. Mar 1997 A
5613975 Christy Mar 1997 A
5624446 Harryman, II Apr 1997 A
5626588 Sauer et al. May 1997 A
5632752 Buelna May 1997 A
5643289 Sauer et al. Jul 1997 A
5643295 Yoon Jul 1997 A
5643318 Tsukernik et al. Jul 1997 A
5647372 Tovey et al. Jul 1997 A
5649959 Hannam et al. Jul 1997 A
5653717 Ko et al. Aug 1997 A
5662664 Gordon et al. Sep 1997 A
5669917 Sauer et al. Sep 1997 A
5672174 Gough et al. Sep 1997 A
5674231 Green et al. Oct 1997 A
5676689 Kensey et al. Oct 1997 A
5693061 Pierce et al. Dec 1997 A
5700273 Buelna et al. Dec 1997 A
5707379 Fleenor et al. Jan 1998 A
5713899 Marnay et al. Feb 1998 A
5713910 Gordon et al. Feb 1998 A
5716369 Riza Feb 1998 A
5720574 Barella Feb 1998 A
5720757 Hathaway et al. Feb 1998 A
5722981 Stevens Mar 1998 A
5725552 Kotula et al. Mar 1998 A
5728109 Schulze et al. Mar 1998 A
5728114 Evans et al. Mar 1998 A
5728133 Kontos Mar 1998 A
5728143 Gough et al. Mar 1998 A
5728151 Garrison et al. Mar 1998 A
5741276 Poloyko et al. Apr 1998 A
5741280 Fleenor Apr 1998 A
5746755 Wood et al. May 1998 A
5749890 Shaknovich May 1998 A
5755727 Kontos May 1998 A
5759188 Yoon Jun 1998 A
5759189 Ferragamo et al. Jun 1998 A
5766183 Sauer Jun 1998 A
5766186 Faraz et al. Jun 1998 A
5766217 Christy Jun 1998 A
5769862 Kammerer et al. Jun 1998 A
5779719 Klein et al. Jul 1998 A
5782860 Epstein et al. Jul 1998 A
5782861 Cragg et al. Jul 1998 A
5792151 Heck et al. Aug 1998 A
5792152 Klein et al. Aug 1998 A
5797928 Kogasaka Aug 1998 A
5797929 Andreas et al. Aug 1998 A
5799661 Boyd et al. Sep 1998 A
5810849 Kontos Sep 1998 A
5810850 Hathaway et al. Sep 1998 A
5810884 Kim Sep 1998 A
5814069 Schulze et al. Sep 1998 A
5817113 Gifford, III et al. Oct 1998 A
5820631 Nobles Oct 1998 A
5824010 McDonald Oct 1998 A
5824111 Schall et al. Oct 1998 A
5830125 Scribner et al. Nov 1998 A
5836315 Benderev et al. Nov 1998 A
5836955 Buelna et al. Nov 1998 A
5836956 Buelna et al. Nov 1998 A
5846253 Buelna et al. Dec 1998 A
5848714 Robson et al. Dec 1998 A
5855576 Leveen et al. Jan 1999 A
5855585 Kontos Jan 1999 A
5860963 Azam et al. Jan 1999 A
5860990 Nobles et al. Jan 1999 A
5860991 Klein et al. Jan 1999 A
5861005 Kontos Jan 1999 A
5871490 Schulze et al. Feb 1999 A
5871502 Suryadevara Feb 1999 A
5873876 Christy Feb 1999 A
5876411 Kontos Mar 1999 A
5895404 Ruiz Apr 1999 A
5897487 Ouchi Apr 1999 A
5897564 Schulze et al. Apr 1999 A
5902311 Andreas et al. May 1999 A
5904597 Doi et al. May 1999 A
5904690 Middleman et al. May 1999 A
5904697 Gifford, III et al. May 1999 A
5906631 Imran May 1999 A
5919207 Taheri Jul 1999 A
5921994 Andreas et al. Jul 1999 A
5928266 Kontos Jul 1999 A
5951547 Gough et al. Sep 1999 A
5951590 Goldfarb Sep 1999 A
5954732 Hart et al. Sep 1999 A
5957936 Yoon et al. Sep 1999 A
5957937 Yoon Sep 1999 A
5957938 Zhu et al. Sep 1999 A
5964773 Greenstein Oct 1999 A
5964782 Lafontaine et al. Oct 1999 A
5972030 Garrison et al. Oct 1999 A
5976161 Kirsch et al. Nov 1999 A
5980517 Gough Nov 1999 A
5980539 Kontos Nov 1999 A
5993466 Yoon Nov 1999 A
5993476 Groiso Nov 1999 A
5997555 Kontos Dec 1999 A
6001109 Kontos Dec 1999 A
6009877 Edwards Jan 2000 A
6022372 Kontos Feb 2000 A
6024747 Kontos Feb 2000 A
6036699 Andreas et al. Mar 2000 A
6042601 Smith Mar 2000 A
6048351 Gordon et al. Apr 2000 A
6048354 Lawrence Apr 2000 A
6048357 Kontos Apr 2000 A
6056744 Edwards May 2000 A
6059800 Hart et al. May 2000 A
6068603 Suzuki May 2000 A
6077276 Kontos Jun 2000 A
6077279 Kontos Jun 2000 A
6083242 Cook Jul 2000 A
6102920 Sullivan et al. Aug 2000 A
6117144 Nobles et al. Sep 2000 A
6117145 Wood et al. Sep 2000 A
6126675 Shchervinsky et al. Oct 2000 A
6132439 Kontos Oct 2000 A
6132440 Hathaway et al. Oct 2000 A
6136010 Modesitt et al. Oct 2000 A
6139556 Kontos Oct 2000 A
6143004 Davis et al. Nov 2000 A
6152936 Christy et al. Nov 2000 A
6165183 Kuehn et al. Dec 2000 A
6165204 Levinson et al. Dec 2000 A
6190396 Whitin et al. Feb 2001 B1
6197042 Ginn et al. Mar 2001 B1
6206893 Klein et al. Mar 2001 B1
6206895 Levinson Mar 2001 B1
6221084 Fleenor Apr 2001 B1
6245079 Nobles et al. Jun 2001 B1
6248124 Pedros et al. Jun 2001 B1
6296657 Brucker Oct 2001 B1
6302870 Jacobsen et al. Oct 2001 B1
6306081 Ishikawa et al. Oct 2001 B1
6322580 Kanner Nov 2001 B1
6346111 Gordon et al. Feb 2002 B1
6348059 Hathaway et al. Feb 2002 B1
6355050 Andreas et al. Mar 2002 B1
6358258 Arcia et al. Mar 2002 B1
6395015 Borst et al. May 2002 B1
6397110 Kuzma May 2002 B1
6428472 Haas Aug 2002 B1
6428549 Kontos Aug 2002 B1
6436109 Kontos Aug 2002 B1
6443963 Baldwin et al. Sep 2002 B1
6451031 Kontos Sep 2002 B1
6461366 Seguin Oct 2002 B1
6511489 Field et al. Jan 2003 B2
6517498 Burbank et al. Feb 2003 B1
6517553 Klein et al. Feb 2003 B2
6533812 Swanson et al. Mar 2003 B2
6551329 Kortenbach et al. Apr 2003 B1
6551330 Bain et al. Apr 2003 B1
6558399 Isbell et al. May 2003 B1
6562052 Nobles et al. May 2003 B2
6569159 Edwards et al. May 2003 B1
6569185 Ungs May 2003 B2
6572629 Kalloo et al. Jun 2003 B2
6610072 Christy et al. Aug 2003 B1
6623509 Ginn Sep 2003 B2
6623510 Carley et al. Sep 2003 B2
6626930 Allen et al. Sep 2003 B1
6632237 Ben-David et al. Oct 2003 B2
6641592 Sauer et al. Nov 2003 B1
6663655 Ginn et al. Dec 2003 B2
6676685 Pedros et al. Jan 2004 B2
6695867 Ginn et al. Feb 2004 B2
6716228 Tal Apr 2004 B2
6743195 Zucker Jun 2004 B2
6743241 Kerr Jun 2004 B2
6743259 Ginn Jun 2004 B2
6745079 King Jun 2004 B2
6746457 Dana et al. Jun 2004 B2
6749621 Pantages et al. Jun 2004 B2
6749622 McGuckin, Jr. et al. Jun 2004 B2
6776785 Yencho et al. Aug 2004 B1
6837906 Ginn Jan 2005 B2
6846319 Ginn et al. Jan 2005 B2
6890343 Ginn et al. May 2005 B2
6896692 Ginn et al. May 2005 B2
6911034 Nobles et al. Jun 2005 B2
6936054 Chu Aug 2005 B2
6939357 Navarro et al. Sep 2005 B2
6955643 Gellman et al. Oct 2005 B2
6964668 Modesitt et al. Nov 2005 B2
6969371 Palasis et al. Nov 2005 B2
6969397 Ginn Nov 2005 B2
6997932 Dreyfuss et al. Feb 2006 B2
7001400 Modesitt et al. Feb 2006 B1
7029480 Klein et al. Apr 2006 B2
7029481 Burdulis, Jr. et al. Apr 2006 B1
7033370 Gordon et al. Apr 2006 B2
7048747 Arcia et al. May 2006 B2
7060084 Loshakove et al. Jun 2006 B1
7063710 Takamoto et al. Jun 2006 B2
7063711 Loshakove et al. Jun 2006 B1
7066077 Schnapp et al. Jun 2006 B2
7083635 Ginn Aug 2006 B2
7108710 Anderson Sep 2006 B2
7112225 Ginn Sep 2006 B2
7122002 Okada Oct 2006 B2
7131980 Field et al. Nov 2006 B1
7147646 Dana et al. Dec 2006 B2
7160309 Voss Jan 2007 B2
7179266 Kontos Feb 2007 B2
7229458 Boecker et al. Jun 2007 B2
7235087 Modesitt et al. Jun 2007 B2
7270672 Singer Sep 2007 B1
7316704 Bagaoisan et al. Jan 2008 B2
7326230 Ravikumar Feb 2008 B2
7331979 Khosravi et al. Feb 2008 B2
7335220 Khosravi et al. Feb 2008 B2
7361183 Ginn Apr 2008 B2
7361185 O'Malley et al. Apr 2008 B2
7377927 Burdulis, Jr. et al. May 2008 B2
7390328 Modesitt Jun 2008 B2
7393363 Ginn Jul 2008 B2
7431727 Cole et al. Oct 2008 B2
7442198 Gellman et al. Oct 2008 B2
7445626 Songer et al. Nov 2008 B2
7449024 Stafford Nov 2008 B2
7462188 McIntosh Dec 2008 B2
7507200 Okada Mar 2009 B2
7727249 Rahmani Jun 2010 B2
7753923 St. Goar et al. Jul 2010 B2
7833235 Chu Nov 2010 B2
7837696 Modesitt et al. Nov 2010 B2
7842047 Modesitt et al. Nov 2010 B2
7842048 Ma Nov 2010 B2
7842049 Voss Nov 2010 B2
7846170 Modesitt et al. Dec 2010 B2
7850701 Modesitt Dec 2010 B2
7883517 Pantages et al. Feb 2011 B2
7935128 Rioux et al. May 2011 B2
7967832 Chu Jun 2011 B2
8038688 Modesitt et al. Oct 2011 B2
8048092 Modesitt et al. Nov 2011 B2
8057491 Modesitt et al. Nov 2011 B2
8083754 Pantages et al. Dec 2011 B2
8123762 Chu et al. Feb 2012 B2
8137364 Zung et al. Mar 2012 B2
8172860 Zung et al. May 2012 B2
8202281 Voss Jun 2012 B2
8211122 McIntosh Jul 2012 B2
8252008 Ma Aug 2012 B2
8257368 McIntosh Sep 2012 B2
8267947 Pantages et al. Sep 2012 B2
8313498 Pantages et al. Nov 2012 B2
8323298 Modesitt et al. Dec 2012 B2
8361088 McIntosh Jan 2013 B2
8419753 Stafford Apr 2013 B2
8430893 Ma Apr 2013 B2
8512375 Torrie et al. Aug 2013 B2
8574244 Reynolds Nov 2013 B2
8597309 Stafford Dec 2013 B2
8663248 Zung et al. Mar 2014 B2
8663252 Fortson Mar 2014 B2
8858573 Fortson et al. Oct 2014 B2
8864778 Fortson et al. Oct 2014 B2
8998932 Voss Apr 2015 B2
9155535 McIntosh Oct 2015 B2
9241707 Roorda et al. Jan 2016 B2
9282960 Ma Mar 2016 B2
9301747 Zung et al. Apr 2016 B2
9370353 Fortson et al. Jun 2016 B2
9375211 Stafford Jun 2016 B2
9592038 Pantages et al. Mar 2017 B2
9820730 Chu Nov 2017 B2
9889276 Voss Feb 2018 B2
9993237 Ma Jun 2018 B2
10111653 Roorda et al. Oct 2018 B2
10245022 McIntosh Apr 2019 B2
10426449 Fortson Oct 2019 B2
10426499 Owen et al. Oct 2019 B2
20010046518 Sawhney Nov 2001 A1
20020045908 Nobles et al. Apr 2002 A1
20020095164 Andreas et al. Jul 2002 A1
20020099389 Michler et al. Jul 2002 A1
20020106409 Sawhney et al. Aug 2002 A1
20020107531 Schreck et al. Aug 2002 A1
20020177876 Roby et al. Nov 2002 A1
20020188275 McGuckin Dec 2002 A1
20030093093 Modesitt et al. May 2003 A1
20030171764 Debbas Sep 2003 A1
20030195529 Takamoto et al. Oct 2003 A1
20030233095 Urbanski et al. Dec 2003 A1
20040009205 Sawhney Jan 2004 A1
20040021025 Shiga et al. Feb 2004 A1
20040092964 Modesitt et al. May 2004 A1
20040093027 Fabisiak et al. May 2004 A1
20040097978 Modesitt et al. May 2004 A1
20040127940 Ginn et al. Jul 2004 A1
20040143290 Brightbill Jul 2004 A1
20040158127 Okada Aug 2004 A1
20040158287 Cragg et al. Aug 2004 A1
20040167511 Buehlmann et al. Aug 2004 A1
20040181238 Zarbatany et al. Sep 2004 A1
20040186487 Klein et al. Sep 2004 A1
20040191277 Sawhney et al. Sep 2004 A1
20040215232 Belhe et al. Oct 2004 A1
20040225301 Roop et al. Nov 2004 A1
20040267193 Bagaoisan et al. Dec 2004 A1
20040267308 Bagaoisan et al. Dec 2004 A1
20050059982 Zung Mar 2005 A1
20050070923 McIntosh Mar 2005 A1
20050075665 Brenzel et al. Apr 2005 A1
20050085851 Fiehler et al. Apr 2005 A1
20050085854 Ginn Apr 2005 A1
20050085855 Forsberg Apr 2005 A1
20050121042 Belhe et al. Jun 2005 A1
20050149066 Stafford Jul 2005 A1
20050149117 Khosravi et al. Jul 2005 A1
20050177189 Ginn et al. Aug 2005 A1
20050222614 Ginn et al. Oct 2005 A1
20050245876 Khosravi et al. Nov 2005 A1
20050267528 Ginn et al. Dec 2005 A1
20050273137 Ginn Dec 2005 A1
20060034930 Khosravi et al. Feb 2006 A1
20060047313 Khanna et al. Mar 2006 A1
20060069397 Nobles et al. Mar 2006 A1
20060089635 Young et al. Apr 2006 A1
20060095029 Young et al. May 2006 A1
20060100664 Pai et al. May 2006 A1
20060167477 Arcia et al. Jul 2006 A1
20060173469 Klein Aug 2006 A1
20060253037 Ginn et al. Nov 2006 A1
20060253072 Pai et al. Nov 2006 A1
20060259049 Harada et al. Nov 2006 A1
20070005079 Zarbatany et al. Jan 2007 A1
20070032801 Pantages et al. Feb 2007 A1
20070049967 Sibbitt et al. Mar 2007 A1
20070049968 Sibbitt et al. Mar 2007 A1
20070060895 Sibbitt et al. Mar 2007 A1
20070060950 Khosravi et al. Mar 2007 A1
20070123817 Khosravi et al. May 2007 A1
20070203506 Sibbitt et al. Aug 2007 A1
20070282354 McIntosh Dec 2007 A1
20080009794 Bagaoisan et al. Jan 2008 A1
20080065151 Ginn Mar 2008 A1
20080065152 Carley Mar 2008 A1
20080287967 Andreas et al. Nov 2008 A1
20090254119 Sibbitt et al. Oct 2009 A1
20100130965 Sibbitt et al. May 2010 A1
20110071567 Modesitt et al. Mar 2011 A1
20110190793 Nobles et al. Aug 2011 A1
20110288563 Gianotti et al. Nov 2011 A1
20120016383 Sauer et al. Jan 2012 A1
20120150201 Pantages et al. Jun 2012 A1
20120283749 Sauer Nov 2012 A1
20130012962 Stone Jan 2013 A1
20140236189 Melsheimer et al. Aug 2014 A1
20150025551 Fortson et al. Jan 2015 A1
20150119906 Bagaoisan et al. Apr 2015 A1
20160287229 Zung et al. Oct 2016 A1
20160367234 Fortson et al. Dec 2016 A1
20160367241 Stafford Dec 2016 A1
20180228478 Fortson Aug 2018 A1
20190175168 McIntosh Jun 2019 A1
20190261964 Zung et al. Aug 2019 A1
20190357900 Stafford Nov 2019 A1
20200060664 Fortson et al. Feb 2020 A1
Foreign Referenced Citations (93)
Number Date Country
912619 May 1954 DE
4210724 Jul 1993 DE
9217932 Jul 1993 DE
4219724 Dec 1993 DE
4220283 Dec 1993 DE
10211360 Oct 2003 DE
0 140 557 May 1985 EP
0140757 May 1985 EP
0 207 545 Jan 1987 EP
0 474 887 Mar 1992 EP
0 478 358 Apr 1992 EP
0 478 887 Apr 1992 EP
0 542 126 May 1993 EP
0543499 May 1993 EP
0 568 098 Nov 1993 EP
0 589 409 Mar 1994 EP
0 624 343 Nov 1994 EP
0 669 101 Aug 1995 EP
0 669 102 Aug 1995 EP
0 669 103 Aug 1995 EP
0 684 012 Nov 1995 EP
0 812 571 Dec 1997 EP
0 941 698 Sep 1999 EP
0910288 Aug 2002 EP
1059544 Mar 1954 FR
2768324 Mar 1999 FR
51143386 Nov 1976 JP
5220794 Feb 1977 JP
2119866 May 1990 JP
542161 Feb 1993 JP
05-220794 Aug 1993 JP
820810 Apr 1981 SU
993922 Feb 1983 SU
1093329 May 1984 SU
1174036 Aug 1985 SU
1544383 Feb 1990 SU
1648400 May 1991 SU
WO 8503858 Sep 1985 WO
WO 0135833 Feb 1994 WO
WO 9405213 Mar 1994 WO
WO 9413211 Jun 1994 WO
WO 9427503 Dec 1994 WO
WO 9428801 Dec 1994 WO
WO 9505121 Feb 1995 WO
WO 9513021 May 1995 WO
WO 9525468 Sep 1995 WO
WO 9535065 Dec 1995 WO
WO 9609006 Mar 1996 WO
9701790 Jan 1997 WO
WO 9700046 Jan 1997 WO
WO 9703613 Feb 1997 WO
WO 9707745 Mar 1997 WO
WO 9710764 Mar 1997 WO
WO 9713461 Apr 1997 WO
WO 9717901 May 1997 WO
WO 9720505 Jun 1997 WO
WO 9727897 Aug 1997 WO
WO 9804195 Feb 1998 WO
WO 9842262 Oct 1998 WO
WO 9947049 Sep 1999 WO
WO 0012013 Mar 2000 WO
WO 0051498 Sep 2000 WO
WO 0069342 Nov 2000 WO
WO 0119259 Mar 2001 WO
WO 02036021 May 2002 WO
WO 02062234 Aug 2002 WO
0303598 Jan 2003 WO
WO 03003925 Jan 2003 WO
WO 03094748 Nov 2003 WO
WO 03099134 Dec 2003 WO
WO 05000126 Jan 2005 WO
WO 05023119 Mar 2005 WO
WO 05025430 Mar 2005 WO
WO 05030060 Apr 2005 WO
WO 05041782 May 2005 WO
WO 05063129 Jul 2005 WO
WO 05065549 Jul 2005 WO
WO 05092204 Oct 2005 WO
WO 05112782 Dec 2005 WO
WO 06026116 Mar 2006 WO
WO 06052611 May 2006 WO
WO 06052612 May 2006 WO
WO 06078578 Jul 2006 WO
WO 06115901 Nov 2006 WO
WO 06115904 Nov 2006 WO
WO 06118877 Nov 2006 WO
WO 07019016 Feb 2007 WO
2007025014 Mar 2007 WO
2007025017 Mar 2007 WO
2007025018 Mar 2007 WO
2007025019 Mar 2007 WO
WO 07081836 Jul 2007 WO
2010031050 Mar 2010 WO
Non-Patent Literature Citations (328)
Entry
US 5,820,544 A, 06/1974, Semm (withdrawn)
U.S. Appl. No. 60/540,811, filed Jan. 30, 2004, McIntosh.
U.S. Appl. No. 60/946,063, filed Jun. 25, 2007, Reynolds.
U.S. Appl. No. 90/006,469, filed Nov. 29, 2002, Modesitt et al.
Cardiac Catheterization and Angiography, 3rd Ed., Lea & Febiger, Philadelphia, pp. 1-49, 52-247. 1986.
Cardio-Thoracic Systems Prospectus dated Mar. 20, 1996. pp. 1-4, 25-40.
Datascope Corporation, Montvale, NJ, Nov. 1991; 1 PG, American Heart Assoc. Meeting, Anaheim.
Elgiloy Brochure, Jun. 23, 1959; Elgin National Watch Co., Elgin, IL.
Kensey Nash Corporation, Exton, PA, “The Hemostatic Puncture Closure Device”, retrieved Oct. 23, 2007, 2 pages.
Laurus Medical Corporation, “Endoscopic Suturing Made Simple,” The Laurus ND-2600 Needle Driver, Irvine, CA., Oct. 1994, 1 page.
Marshall, A.C. & Lock, J.E.; “Structural and compliant anatomy of the patent foramen ovale in patients undergoing transcatheter closure”, Am. Heart Journ., 140(2):303-307, Aug. 2000.
Nakamura, S. et al., Techniques for Palmaz-Schatz Stent Deployment in Lesions With A Large Side Branch, Catheterization and Cardiovascular Diagnosis, 34: 353-361, 1995.
Definition of “pair”, Dictionary.com, accessed on May 5, 2014.
Product Brochure, “SuperStitch—Closure Made SimpleTM”, Sutura, Inc. (2003).
Product Brochure, Laurus Medical Corporation, Irvine, CA “The Laurus In-Line Endoscopic Suturing Device” (Oct. 1994) 1 page.
Rema-Medizintcchnik GmbH, Product Brochure entitled “REMA,” Apr. 2001, 7 pages.
Serruys, PW et al., A Comparision Of Balloon-Expandable-Stent Implantation With Balloon Angioplasty In Patients With Coronary Artery Disease, New England Journal of Medicine, 331:489 495, 1994.
Taber's Cyclopedic Medical Dictionary, 18th Ed., p. 747, Feb. 1997.
U.S. Appl. No. 07/989,611, May 12, 1993, Office Action.
U.S. Appl. No. 07/989,611, Aug. 1, 1994, Office Action.
U.S. Appl. No. 07/989,611, Nov. 3, 1994, Notice of Allowance.
U.S. Appl. No. 08/148,809, Sep. 16, 1994, Office Action.
U.S. Appl. No. 08/148,809, May 30, 1995, Office Action.
U.S. Appl. No. 08/148,809, Dec. 15, 1995, Notice of Allowance.
U.S. Appl. No. 08/252,124, Jun. 5, 1995, Office Action.
U.S. Appl. No. 08/252,124, Jan. 5, 1996, Office Action.
U.S. Appl. No. 08/252,124, May 22, 1996, Notice of Allowance.
U.S. Appl. No. 08/259,410, Feb. 2, 1995, Office Action.
U.S. Appl. No. 08/259,410, Jun. 1, 1995, Office Action.
U.S. Appl. No. 08/259,410, Feb. 6, 1998, Notice of Allowance.
U.S. Appl. No. 08/638,076, Jan. 21, 1997, Office Action.
U.S. Appl. No. 08/638,076, Oct. 17, 1997, Notice of Allowance.
U.S. Appl. No. 08/824,031, Mar. 16, 1998, Office Action.
U.S. Appl. No. 08/824,031, Sep. 14, 1998, Office Action.
U.S. Appl. No. 08/824,031, Apr. 13, 1999, Office Action.
U.S. Appl. No. 08/824,031, Jul. 15, 1999, Notice of Allowance.
U.S. Appl. No. 08/883,246, Jul. 23, 1998, Office Action.
U.S. Appl. No. 08/883,246, Apr. 12, 1999, Office Action.
U.S. Appl. No. 08/883,246, Oct. 13, 1999, Office Action.
U.S. Appl. No. 08/883,246, Oct. 23, 2000, Office Action.
U.S. Appl. No. 08/883,246, Jul. 11, 2001, Office Action.
U.S. Appl. No. 08/883,246, Sep. 11, 2001, Notice of Allowance.
U.S. Appl. No. 09/057,108, Jul. 10, 2000, Office Action.
U.S. Appl. No. 09/057,108, Oct. 25, 2000, Notice of Allowance.
U.S. Appl. No. 09/262,402, Mar. 29, 2000, Office Action.
U.S. Appl. No. 09/262,402, May 30, 2000, Notice of Allowance.
U.S. Appl. No. 09/395,901, Jun. 27, 2000, Office Action.
U.S. Appl. No. 09/395,901, Nov. 6, 2000, Office Action.
U.S. Appl. No. 09/395,901, Apr. 20, 2001, Notice of Allowance.
U.S. Appl. No. 09/395,901, Sep. 10, 2001, Notice of Allowance.
U.S. Appl. No. 09/610,099, Jul. 11, 2002, Office Action.
U.S. Appl. No. 09/610,099, Dec. 24, 2002, Notice of Allowance.
U.S. Appl. No. 09/651,344, Feb. 28, 2003, Office Action.
U.S. Appl. No. 09/651,344, Nov. 7, 2003, Office Action.
U.S. Appl. No. 09/651,344, Apr. 20, 2004, Notice of Allowance.
U.S. Appl. No. 09/707,746, Feb. 16, 2005, Office Action.
U.S. Appl. No. 09/707,746, Jul. 7, 2005, Office Action.
U.S. Appl. No. 09/707,746, Nov. 15, 2005, Notice of Allowance.
U.S. Appl. No. 09/769,109, Oct. 23, 2001, Office Action.
U.S. Appl. No. 09/769,109, Jun. 17, 2002, Office Action.
U.S. Appl. No. 09/769,109, Sep. 9, 2002, Notice of Allowance.
U.S. Appl. No. 09/988,541, Mar. 17, 2004, Office Action.
U.S. Appl. No. 09/988,541, Feb. 28, 2005, Office Action.
U.S. Appl. No. 09/988,541, May 25, 2005, Office Action.
U.S. Appl. No. 09/988,541, Aug. 24, 2005, Office Action.
U.S. Appl. No. 09/988,541, Nov. 8, 2005, Office Action.
U.S. Appl. No. 09/988,541, Dec. 13, 2005, Notice of Allowance.
U.S. Appl. No. 10/033,689, Sep. 30, 2003, Office Action.
U.S. Appl. No. 10/152,272, Jan. 24, 2005, Office Action.
U.S. Appl. No. 10/152,272, May 13, 2005, Notice of Allowance.
U.S. Appl. No. 10/335,065, Mar. 17, 2005, Office Action.
U.S. Appl. No. 10/335,065, Jun. 10, 2005, Office Action.
U.S. Appl. No. 10/335,065, Nov. 17, 2005, Notice of Allowance.
U.S. Appl. No. 10/335,147, Dec. 13, 2005, Office Action.
U.S. Appl. No. 10/335,147, Apr. 17, 2006, Office Action.
U.S. Appl. No. 10/335,147, Oct. 4, 2006, Notice of Allowance.
U.S. Appl. No. 10/357,984, Jan. 9, 2006, Office Action.
U.S. Appl. No. 10/357,984, Mar. 16, 2006, Office Action.
U.S. Appl. No. 10/357,984, Sep. 28, 2006, Office Action.
U.S. Appl. No. 10/357,984, Mar. 23, 2007, Office Action.
U.S. Appl. No. 10/357,984, Nov. 14, 2007, Office Action.
U.S. Appl. No. 10/652,182, Aug. 9, 2006, Office Action.
U.S. Appl. No. 10/652,182, Feb. 22, 2007, Notice of Allowance.
U.S. Appl. No. 10/660,288, Nov. 15, 2005, Office Action.
U.S. Appl. No. 10/660,288, Mar. 9, 2006, Office Action.
U.S. Appl. No. 10/660,288, Aug. 24, 2006, Office Action.
U.S. Appl. No. 10/660,288, Feb. 1, 2007, Office Action.
U.S. Appl. No. 10/660,288, Jun. 28, 2007, Office Action.
U.S. Appl. No. 10/660,288, Apr. 29, 2009, Office Action.
U.S. Appl. No. 10/660,288, Aug. 3, 2009, Office Action.
U.S. Appl. No. 10/660,288, Mar. 30, 2010, Office Action.
U.S. Appl. No. 10/660,288, Mar. 29, 2011, Office Action.
U.S. Appl. No. 10/660,288, Sep. 30, 2011, Notice of Allowance.
U.S. Appl. No. 10/729,541, Dec. 12, 2006, Office Action.
U.S. Appl. No. 10/729,541, Jun. 18, 2007, Office Action.
U.S. Appl. No. 10/729,541, Jan. 8, 2008, Office Action.
U.S. Appl. No. 10/729,541, Sep. 23, 2008, Office Action.
U.S. Appl. No. 10/729,541, May 1, 2009, Office Action.
U.S. Appl. No. 10/729,541, Nov. 16, 2009, Notice of Allowance.
U.S. Appl. No. 10/729,541, Mar. 25, 2010, Notice of Allowance.
U.S. Appl. No. 10/729,541, Jul. 12, 2010, Notice of Allowance.
U.S. Appl. No. 10/737,668, Nov. 2, 2005, Office Action.
U.S. Appl. No. 10/737,668, Feb. 16, 2006, Office Action.
U.S. Appl. No. 10/737,668, Oct. 19, 2006, Office Action.
U.S. Appl. No. 10/737,668, Jun. 7, 2007, Office Action.
U.S. Appl. No. 10/737,668, Nov. 28, 2007, Office Action.
U.S. Appl. No. 10/737,668, Jun. 26, 2008, Notice of Allowance.
U.S. Appl. No. 10/742,406, Mar. 23, 2007, Office Action.
U.S. Appl. No. 10/742,406, Sep. 10, 2007, Notice of Allowance.
U.S. Appl. No. 10/742,406, Jan. 11, 2008, Notice of Allowance.
U.S. Appl. No. 10/746,210, Apr. 5, 2007, Office Action.
U.S. Appl. No. 10/746,210, Aug. 21, 2007, Office Action.
U.S. Appl. No. 10/746,210, Jul. 9, 2008, Notice of Allowance.
U.S. Appl. No. 10/813,449, Sep. 5, 2006, Office Action.
U.S. Appl. No. 10/813,449, Jul. 16, 2007, Office Action.
U.S. Appl. No. 10/813,449, Jan. 25, 2008, Office Action.
U.S. Appl. No. 10/813,449, Aug. 14, 2008, Office Action.
U.S. Appl. No. 10/813,449, Sep. 15, 2008, Office Action.
U.S. Appl. No. 10/813,449, Feb. 3, 2009, Office Action.
U.S. Appl. No. 10/813,449, Aug. 28, 2009, Office Action.
U.S. Appl. No. 10/813,449, May 27, 2010, Office Action.
U.S. Appl. No. 10/909,531, Apr. 4, 2007, Office Action.
U.S. Appl. No. 10/909,531, Dec. 26, 2007, Office Action.
U.S. Appl. No. 10/909,531, Jun. 13, 2008, Office Action.
U.S. Appl. No. 10/909,531, Feb. 9, 2009, Office Action.
U.S. Appl. No. 10/909,531, Sep. 16, 2009, Office Action.
U.S. Appl. No. 10/909,531, Apr. 29, 2010, Notice of Allowance.
U.S. Appl. No. 10/909,531, Aug. 20, 2010, Notice of Allowance.
U.S. Appl. No. 10/948,445, Jul. 11, 2007, Office Action.
U.S. Appl. No. 11/199,338, Jan. 25, 2007, Office Action.
U.S. Appl. No. 11/199,338, Oct. 5, 2007, Office Action.
U.S. Appl. No. 11/199,338, Dec. 28, 2007, Office Action.
U.S. Appl. No. 11/199,338, Apr. 23, 2008, Office Action.
U.S. Appl. No. 11/199,338, Jan. 6, 2009, Office Action.
U.S. Appl. No. 11/199,496, Apr. 1, 2009, Office Action.
U.S. Appl. No. 11/199,496, Aug. 21, 2009, Office Action.
U.S. Appl. No. 11/199,496, Apr. 23, 2010, Office Action.
U.S. Appl. No. 11/199,496, Apr. 28, 2011, Office Action.
U.S. Appl. No. 11/199,496, Aug. 18, 2011, Notice of Allowance.
U.S. Appl. No. 11/199,515, Aug. 20, 2008, Office Action.
U.S. Appl. No. 11/199,515, Nov. 13, 2008, Office Action.
U.S. Appl. No. 11/199,515, Jun. 10, 2009, Office Action.
U.S. Appl. No. 11/199,515, Dec. 24, 2009, Notice of Allowance.
U.S. Appl. No. 11/199,515, Apr. 2, 2010, Notice of Allowance.
U.S. Appl. No. 11/199,515, Aug. 2, 2010, Notice of Allowance.
U.S. Appl. No. 11/273,107, Jun. 14, 2007, Office Action.
U.S. Appl. No. 11/273,107, Jan. 18, 2008, Office Action.
U.S. Appl. No. 11/273,107, Sep. 5, 2008, Office Action.
U.S. Appl. No. 11/273,107, Apr. 9, 2009, Office Action.
U.S. Appl. No. 11/273,107, Oct. 28, 2009, Office Action.
U.S. Appl. No. 11/273,107, Jun. 2, 2010, Office Action.
U.S. Appl. No. 11/273,107, Oct. 27, 2010, Office Action.
U.S. Appl. No. 11/273,107, Jun. 2, 2011, Notice of Allowance.
U.S. Appl. No. 11/363,005, Jun. 22, 2007, Office Action.
U.S. Appl. No. 11/363,005, Dec. 14, 2007, Office Action.
U.S. Appl. No. 11/363,005, Apr. 17, 2008, Office Action.
U.S. Appl. No. 11/363,005, Dec. 23, 2008, Office Action.
U.S. Appl. No. 11/363,005, Jul. 10, 2009, Notice of Allowance.
U.S. Appl. No. 11/363,005, Jan. 14, 2010, Notice of Allowance.
U.S. Appl. No. 11/363,005, Jul. 23, 2010, Notice of Allowance.
U.S. Appl. No. 11/389,762, Sep. 20, 2007, Notice of Allowance.
U.S. Appl. No. 11/389,762, Nov. 23, 2007, Notice of Allowance.
U.S. Appl. No. 11/390,937, Sep. 7, 2007, Office Action.
U.S. Appl. No. 11/391,951, Oct. 28, 2008, Office Action.
U.S. Appl. No. 11/391,951, Jan. 30, 2009, Office Action.
U.S. Appl. No. 11/391,951, Aug. 26, 2009, Office Action.
U.S. Appl. No. 11/391,951, Jun. 23, 2010, Office Action.
U.S. Appl. No. 11/465,527, Feb. 3, 2010, Office Action.
U.S. Appl. No. 11/465,527, Jul. 23, 2010, Notice of Allowance.
U.S. Appl. No. 11/552,593, Aug. 21, 2008, Office Action.
U.S. Appl. No. 11/552,593, Feb. 5, 2009, Office Action.
U.S. Appl. No. 11/552,593, Oct. 13, 2009, Notice of Allowance.
U.S. Appl. No. 11/552,593, Mar. 22, 2010, Notice of Allowance.
U.S. Appl. No. 11/552,593, Jul. 22, 2010, Notice of Allowance.
U.S. Appl. No. 11/688,722, Mar. 10, 2010, Office Action.
U.S. Appl. No. 11/688,722, Jul. 29, 2010, Notice of Allowance.
U.S. Appl. No. 11/891,358, Apr. 26, 2010, Office Action.
U.S. Appl. No. 11/891,358, Oct. 19, 2010, Office Action.
U.S. Appl. No. 11/891,358, Aug. 31, 2011, Office Action.
U.S. Appl. No. 11/891,358, Nov. 18, 2011, Notice of Allowance.
U.S. Appl. No. 11/891,358, Apr. 10, 2012, Notice of Allowance.
U.S. Appl. No. 11/891,513, Apr. 9, 2010, Office Action.
U.S. Appl. No. 11/891,513, Sep. 28, 2010, Office Action.
U.S. Appl. No. 11/891,513, Aug. 31, 2011, Office Action.
U.S. Appl. No. 11/891,513, Nov. 1, 2011, Notice of Allowance.
U.S. Appl. No. 11/891,513, May 8, 2012, Notice of Allowance.
U.S. Appl. No. 11/960,593, Sep. 14, 2010, Office Action.
U.S. Appl. No. 11/960,593, Nov. 3, 2010, Office Action.
U.S. Appl. No. 11/960,593, Apr. 28, 2011, Office Action.
U.S. Appl. No. 11/960,593, Jul. 1, 2013, Notice of Allowance.
U.S. Appl. No. 11/997,379, Jul. 13, 2011, Office Action.
U.S. Appl. No. 11/997,379, Feb. 28, 2012, Office Action.
U.S. Appl. No. 11/997,379, May 11, 2012, Notice of Allowance.
U.S. Appl. No. 12/182,836, Oct. 5, 2010, Office Action.
U.S. Appl. No. 12/182,836, Jun. 23, 2011, Office Action.
U.S. Appl. No. 12/182,836, May 17, 2013, Office Action.
U.S. Appl. No. 12/247,012, Oct. 13, 2011, Office Action.
U.S. Appl. No. 12/247,012, Mar. 16, 2012, Office Action.
U.S. Appl. No. 12/247,012, Aug. 13, 2012, Notice of Allowance.
U.S. Appl. No. 12/257,127, Aug. 30, 2010, Office Action.
U.S. Appl. No. 12/257,127, Dec. 22, 2010, Office Action.
U.S. Appl. No. 12/257,127, Jul. 6, 2011, Office Action.
U.S. Appl. No. 12/257,127, Jan. 12, 2012, Office Action.
U.S. Appl. No. 12/257,127, Sep. 20, 2012, Notice of Allowance.
U.S. Appl. No. 12/334,077, Oct. 27, 2010, Office Action.
U.S. Appl. No. 12/334,077, Jul. 21, 2011, Office Action.
U.S. Appl. No. 12/334,077, Jan. 16, 2013, Office Action.
U.S. Appl. No. 12/334,077, Oct. 11, 2013, Notice of Allowance.
U.S. Appl. No. 12/334,085, Dec. 23, 2010, Office Action.
U.S. Appl. No. 12/334,085, Aug. 4, 2011, Office Action.
U.S. Appl. No. 12/334,085, Jan. 9, 2012, Notice of Allowance.
U.S. Appl. No. 12/873,728, Sep. 11, 2012, Office Action.
U.S. Appl. No. 12/873,728, May 3, 2013, Office Action.
U.S. Appl. No. 12/873,728, Aug. 23, 2013, Office Action.
U.S. Appl. No. 12/873,728, Nov. 4, 2013, Notice of Allowance.
U.S. Appl. No. 12/950,338, Jun. 15, 2011, Office Action.
U.S. Appl. No. 12/950,338, Nov. 1, 2011, Notice of Allowance.
U.S. Appl. No. 12/950,338, Aug. 8, 2012, Notice of Allowance.
U.S. Appl. No. 12/955,848, Jun. 30, 2011, Office Action.
U.S. Appl. No. 12/955,848, Nov. 15, 2011, Office Action.
U.S. Appl. No. 12/955,863, Jan. 6, 2012, Office Action.
U.S. Appl. No. 12/955,863, May 15, 2012, Notice of Allowance.
U.S. Appl. No. 12/955,869, Oct. 18, 2011, Office Action.
U.S. Appl. No. 12/955,869, Mar. 22, 2012, Notice of Allowance.
U.S. Appl. No. 12/961,239, Jul. 26, 2011, Notice of Allowance.
U.S. Appl. No. 12/966,961, Aug. 18, 2011, Notice of Allowance.
U.S. Appl. No. 13/022,050, Jul. 11, 2011, Office Action.
U.S. Appl. No. 13/022,050, Apr. 26, 2012, Office Action.
U.S. Appl. No. 13/022,050, Jul. 6, 2012, Notice of Allowance.
U.S. Appl. No. 13/333,411, Dec. 18, 2014, Office Action.
U.S. Appl. No. 13/333,411, Apr. 1, 2015, Office Action.
U.S. Appl. No. 13/333,411, Apr. 4, 2016, Office Action.
U.S. Appl. No. 13/443,659, Nov. 13, 2013, Office Action.
U.S. Appl. No. 13/443,659, Jun. 11, 2014, Notice of Allowance.
U.S. Appl. No. 13/455,053, Nov. 27, 2013, Office Action.
U.S. Appl. No. 13/455,053, Jun. 9, 2014, Notice of Allowance.
U.S. Appl. No. 13/485,388, May 21, 2015, Office Action.
U.S. Appl. No. 13/485,388, Oct. 7, 2015, Notice of Allowance.
U.S. Appl. No. 13/525,875, May 28, 2014, Office Action.
U.S. Appl. No. 13/525,875, Sep. 30, 2014, Office Action.
U.S. Appl. No. 13/525,875, Dec. 10, 2014, Notice of Allowance.
U.S. Appl. No. 13/593,154, Jan. 8, 2013, Notice of Allowance.
U.S. Appl. No. 13/615,523, Feb. 26, 2016, Office Action.
U.S. Appl. No. 13/615,523, Aug. 18, 2016, Office Action.
U.S. Appl. No. 13/615,523, Nov. 30, 2016, Notice of Allowance.
U.S. Appl. No. 13/615,530, Jan. 17, 2013, Office Action.
U.S. Appl. No. 13/615,530, Jun. 12, 2013, Notice of Allowance.
U.S. Appl. No. 13/752,095, Oct. 17, 2014, Office Action.
U.S. Appl. No. 13/752,095, Feb. 20, 2015, Office Action.
U.S. Appl. No. 13/752,095, Jun. 12, 2015, Notice of Allowance.
U.S. Appl. No. 13/791,858, Nov. 10, 2015, Office Action.
U.S. Appl. No. 13/791,858, Mar. 15, 2016, Notice of Allowance.
U.S. Appl. No. 13/870,628, Jul. 13, 2015, Office Action.
U.S. Appl. No. 13/870,628, Nov. 12, 2015, Notice of Allowance.
U.S. Appl. No. 14/094,352, Dec. 15, 2014, Office Action.
U.S. Appl. No. 14/094,352, Jul. 8, 2015, Office Action.
U.S. Appl. No. 14/094,352, Mar. 22, 2016, Notice of Allowance.
U.S. Appl. No. 14/195,308, Dec. 18, 2014, Office Action.
U.S. Appl. No. 14/195,308, Aug. 11, 2015, Office Action.
U.S. Appl. No. 14/195,308, Dec. 4, 2015, Notice of Allowance.
U.S. Appl. No. 14/511,730, Jan. 20, 2017, Office Action.
U.S. Appl. No. 14/511,730, Oct. 13, 2017, Office Action.
U.S. Appl. No. 14/511,730, Jun. 11, 2018, Office Action.
U.S. Appl. No. 14/511,730, Oct. 31, 2018, Interview Summary.
U.S. Appl. No. 14/511,730, Jan. 25, 2019, Office Action.
U.S. Appl. No. 14/511,730, May 22, 2019, Advisory Action.
U.S. Appl. No. 14/511,730, Jul. 8, 2019, Office Action.
U.S. Appl. No. 14/674,756, Mar. 17, 2017, Office Action.
U.S. Appl. No. 14/674,756, Jul. 6, 2017, Office Action.
U.S. Appl. No. 14/674,756, Sep. 18, 2017, Notice of Allowance.
U.S. Appl. No. 14/880,894, Oct. 31, 2017, Office Action.
U.S. Appl. No. 14/880,894, Apr. 2, 2018, Office Action.
U.S. Appl. No. 14/880,894, Aug. 6, 2018, Office Action.
U.S. Appl. No. 14/880,894, Nov. 21, 2018, Notice of Allowance.
U.S. Appl. No. 15/005,880, Nov. 13, 2017, Office Action.
U.S. Appl. No. 15/005,880, Apr. 10, 2018, Office Action.
U.S. Appl. No. 15/005,880, Jun. 20, 2018, Interview Summary.
U.S. Appl. No. 15/005,880, Jul. 13, 2018, Notice of Allowance.
U.S. Appl. No. 15/069,515, Mar. 20, 2018, Notice of Allowance.
U.S. Appl. No. 15/090,150, Dec. 12, 2018, Office Action.
U.S. Appl. No. 15/090,150, Jul. 5, 2019, Office Action.
U.S. Appl. No. 15/186,730, Sep. 5, 2018, Office Action.
U.S. Appl. No. 15/186,730, Mar. 21, 2019, Office Action.
U.S. Appl. No. 15/192,481, Jul. 20, 2018, Office Action.
U.S. Appl. No. 15/192,481, Oct. 31, 2018, Interview Summary.
U.S. Appl. No. 15/192,481, Jan. 11, 2019, Office Action.
U.S. Appl. No. 15/192,481, May 6, 2019, Notice of Allowance.
U.S. Appl. No. 15/434,907, May 7, 2019, Notice of Allowance.
U.S. Appl. No. 90/006,469, Nov. 29, 2002, Request for Re-Examination.
U.S. Appl. No. 90/006,469, Sep. 10, 2004, Office Action.
U.S. Appl. No. 90/006,469, Sep. 27, 2005, Notice of Re-Issue.
U.S. Appl. No. 90/006,469, Jun. 27, 2006, Re-Examination Certification.
U.S. Appl. No. 14/511,730, Apr. 6, 2020, Office Action.
U.S. Appl. No. 14/511,730, May 20, 2020, Advisory Action.
U.S. Appl. No. 15/090,150, Dec. 31, 2019, Office Action.
U.S. Appl. No. 15/186,730, Jul. 1, 2019, Notice of Allowance.
“Innovation Through Progress”, Rema-Medizintechnik GmbH, Jan. 1992.
“The Hemostatic Puncture Closure Device,” Kensey Nash Corporation. (undated).
AD: The Laurus In-Line Endoscopic Suturing Device (The Laurus ND-2600 Needle Driver), Laurus Medical Corp., Rev. Oct. 1994.
Elgin National Watch Company, Product Borchure entitled “Elgiloy, A Cobalt Nickel Spring Alloy”, 33 pages, 1959.
Ernst, J. et al., “Immediate Sealing of Arterial Puncture Sites After Catheterization and PTCA Using a Vascular Hemostasis Device With Collagen: An International Registry.” (undated).
Faulkner, Catherine B., Letter regarding “VasoSeal Vascular Hemostasis”, Datascope, New Jersey, 1 page, (1991).
Grossman, William. Cardiac Catheterization and Angioplasty, 3rd Ed., Lea and Febiger. Philadelphia: 1986.
Notice of Allowance received for U.S. Appl. No. 11/389,762, dated Nov. 23, 2007.
Office Action received for U.S. Appl. No. 10/813,449, dated Aug. 28, 2009.
Office action received for U.S. Appl. No. 10/877,974, dated Jul. 9, 2008.
Office action received for U.S. Appl. No. 11/316,775, dated Apr. 16, 2008.
Office action received for U.S. Appl. No. 11/316,775, dated Aug. 6, 2008.
Office action received for U.S. Appl. No. 11/508,656, dated Aug. 30, 2010.
Office Action received for U.S. Appl. No. 11/508,656, dated Dec. 9, 2009.
Office action received for U.S. Appl. No. 11/508,656, dated Mar. 25, 2010.
Office action received for U.S. Appl. No. 11/508,662, dated Apr. 14, 2010.
Office action received for U.S. Appl. No. 11/508,715, dated Apr. 26, 2010.
Office Action received for U.S. Appl. No. 11/508,715, dated Jan. 6, 2010.
Office Action received for U.S. Appl. No. 11/891,513, dated Apr. 9, 2010.
Office Action received for U.S. Appl. No. 15/005,880, dated Apr. 10, 2018.
Office Action received for U.S. Appl. No. 15/090,150, dated Dec. 31, 2019.
Office Action received for U.S. Appl. No. 15/090,150, dated Jul. 5, 2019.
Product Brochure “The Proven Solution to Endoscopic Suturing”, Lamus Medical Corp., Irvine, CA (Oct. 1994).
Rema-Medizintechnik, Gmbh, “Innovation Through Progress,” Jan. 1992, pp. 1-8.
Request for Re-Examination received for U.S. Appl. No. 90/006,469, dated Nov. 29, 2002.
The Lamus In-Line Endoscopic Suturing Device (Oct. 1994) 1 page.
U.S. Appl. filed Aug. 24, 2005, Sibbitt, JR et al, U.S. Appl. No. 60/711,279.
U.S. Appl. filed Jun. 30, 2000, Burdulis., U.S. Appl. No. 09/608,832.
U.S. Appl. filed Jun. 30, 2000, Burdulis., U.S. Appl. No. 09/610,564.
U.S. Appl. filed Oct. 14, 2005, Sibbitt Jr. et al, U.S. Appl. No. 60/726,985.
U.S. Appl. No. 11/508,662, Mail Date Oct. 26, 2010, Office Action.
U.S. Appl. No. 12/365,397, Mailed Sep. 13, 2010, Office Action.
Related Publications (1)
Number Date Country
20180338759 A1 Nov 2018 US
Divisions (1)
Number Date Country
Parent 13485388 May 2012 US
Child 15005880 US
Continuations (1)
Number Date Country
Parent 15005880 Jan 2016 US
Child 16052263 US