Suturing devices and methods

Description

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems, and methods. In particular, the present disclosure relates to devices and methods for suturing of openings in body lumens. More specifically, the present invention relates to devices and methods for closing arterial and venous puncture sites.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as, for example, angioplasty, catheterization, and the placement of stents, are commonly performed by inserting a hollow needle through the skin and tissue of a patient into the patient's vascular system. A guide wire is then often advanced through the needle and into the patient's blood vessel. The needle is then removed, enabling an introducer sheath to be advanced over the guidewire into the vessel, e.g., in conjunction with, or subsequent to, a dilator. A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.

In practice, the introducer sheath is often inserted into the patient's vasculature using the modified Seldinger technique. In the Seldinger technique, a needle is first inserted into the vessel and a guide wire then follows through the needle. Next, the needle is removed and a sheath/dilator combination is advanced over the guide wire. The dilator expands the puncture in the vessel to a size suitable to receive the distal end of an introducer sheath. After the distal end of the sheath is disposed within the vessel, the dilator and guide wire are removed, thereby allowing access to the vessel lumen or other body lumen via the inserted introducer sheath.

Upon completing the diagnostic and/or treatment procedure, the devices and introducer sheath are removed, leaving a puncture site in the vessel wall. One will that it is desirable to close the puncture site in vessel wall. Closing the wound can be difficult due to substantial bleeding that can occur through an open wound in a blood vessel. One method of closing the puncture site includes applying external pressure to the puncture site until clotting and wound sealing occur; however, the patient must remain bedridden for a substantial period after clotting to ensure closure of the wound. This procedure can be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It also can be uncomfortable for the patient and may require that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.

Another method of puncture site closure is the use of bioabsorbable fasteners or sealing plugs. Bioabsorbable fasteners or sealing plugs can overcome many of the disadvantages associated with manual compression. Typically, these approaches rely 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 can suffer from a number of disadvantages. For example, it can be difficult to properly locate the interface of the overlying tissue and the adventitial surface of the blood vessel. Placing the plug too far from that interface can result in failure to provide hemostasis, and subsequent hematoma and/or pseudo-aneurysm formation. Conversely, if the plug intrudes into the artificial lumen, intravascular clots and/or collagen pieces with thrombus attached can form and embolize downstream, causing vascular occlusion. Also, thrombus formation on the surface of a plug protruding into the lumen can cause a stenosis, which can obstruct normal blood flow. Other possible complications include infection, as well as adverse reaction to the collagen or other implant.

Yet another approach for vascular closure includes the use of suture-applying devices. Conventional suture-applying devices are introduced through the tissue tract and advanced until a distal end of the device extends through the puncture site. One or more needles in the device are then deployed and used to draw suture through the blood vessel wall. Next, the suture is secured to provide closure of the puncture site. While suture-applying devices can overcome many of the difficulties associated with other puncture site closure devices and methods, locating the tissue surrounding a puncture site can be difficult using some suture-applying devices and methods. Some complications that may arise by misplaced or insufficiently anchored sutures include oozing, excessive bleeding, and potential knot loosening.

BRIEF SUMMARY

Briefly summarized, implementations of the present invention provide devices and methods for closing openings in a body lumen efficiently and quickly. For example, one or more implementations of the present invention provide suturing devices with tissue ports configured to allow for location of body lumen wall tissue surrounding a puncture site with increased accuracy and ease. This method can provide for suture deployment over the guide wire permitting rapid re-access to the vessel by the clinician. Furthermore, one or more implementations of the present invention can reduce miss-deployment of needles, and can allow for closure of larger body lumen openings.

For example, in one implementation, a suturing device configured to close an opening in a body lumen can include a shaft having a distal end and a proximal end. The distal end of the shaft can be defined by the distal most surface of the shaft. The shaft can include a first needle exit opening extending through the distal end thereof. The shaft can further include a second needle exit opening extending through the distal end thereof. The suturing device can further include a foot member secured to the distal end of the shaft. Additionally, the suturing device can include first and second needle capture devices removably secured to the foot member. The suturing device can also include at least one length of suture removably secured to the foot member. The at least one length of suture can have a first end secured to the first needle capture device and a second end secured to the second needle capture device.

In another implementation, a suturing device configured to close an opening in a body lumen can include a shaft having a distal end and a proximal end. The suturing device can also include a foot having a proximal tissue location surface and a distal tip. Additionally, the suturing device can include a spinal member connecting the foot member to the shaft. Also, the suturing device can include an actuator configured to move the foot from a first configuration, in which the tissue location surface is adjacent the distal end of the shaft, to a deployed configuration, in which the tissue location surface is distally separated from the distal end of the shaft by a length of the spinal member.

In yet another implementation, a suturing device configured to close an opening in a body lumen can include an elongate member including a proximal portion and a distal portion. The suturing device can also include first and second needle lumens extending through the proximal portion of the elongate member to first and second needle exit openings. Furthermore, the suturing device can include first and second needle capture devices secured to the distal portion of the elongate member. The first and second needle capture devices can be aligned with the first and second needle exit openings. Additionally, the first and second needle capture devices can be separated from the first and second needle exit openings by one or more tissue ports extending into the elongate member between the proximal portion and the distal portion. The suturing device can also include at least one length of suture within the distal portion of the shaft. The at least one length of suture can have a first end secured to the first needle capture device and a second end secured to the second needle capture device.

In addition to the foregoing, an implementation of a method of closing an opening in a body lumen wall can involve advancing a suturing device over a guidewire into the body lumen. The suturing device can include a shaft, a foot secured to a distal end of the shaft, and at least one tissue port located between the distal end of the shaft and the foot. The method can also involve advancing a pair of needles simultaneously through the shaft, out of needle exit openings in the distal end of the shaft, through wall tissue of the body lumen located in at least one tissue port, and into a pair of needle capture devices secured to the foot. Additionally, the method can involve withdrawing the pair of needles and the pair of needle capture devices from the suturing device, thereby at least partially withdrawing a suture connected to the pair of needle capture devices from the foot. Further, the method can involve employing the suture to close the opening in the body lumen wall.

Another implementation of a method of closing an opening in a body lumen wall can involve advancing a suturing device into the opening of the body lumen wall. The suturing device can include a shaft and a foot secured to a distal end of the shaft. The method can further involve articulating the foot from a first configuration in which the foot is adjacent a distal end of the shaft to a deployed configuration in which the foot is distally separated from the distal end of the shaft. The method can also involve advancing one or more needles through the shaft, through wall tissue of the body lumen located in between the shaft and the foot, and into one or more needle capture devices secured to the foot. The method can additionally involve employing the suture to close the opening in the body lumen wall.

One implementation includes a suturing device configured to close an opening in a body lumen. The suturing device may have a shaft having a distal end and a proximal end. Additionally, the suturing device can include a first needle lumen disposed within the shaft, the first needle lumen terminating at a first needle exit opening at the distal end of the shaft and a second needle lumen disposed within the shaft, the second needle lumen terminating at a second needle exit opening at the distal end of the shaft. The suturing device also can include a guide member slidably located within the shaft and extending past the distal end of the shaft and a foot member coupled to the guide member, a proximal end of the foot member being positioned proximally to the distal end of the shaft. Furthermore, the suturing device can include a first needle capture device removably secured to the foot member and a second needle capture device removably secured to the foot member. The suturing device also can incorporate at least one length of suture removably secured to the foot member, the at least one length of suture having a first end secured to the first needle capture device and a second end secured to the second needle capture device.

One or more other implementations include a suturing device configured to close an opening in a body lumen. The suturing device can have a shaft having a distal end and a proximal end, a first needle lumen disposed within the shaft, the first needle lumen terminating at a first needle entrance opening at the distal end of the shaft, and a second needle lumen disposed within the shaft, the second needle lumen terminating at a second needle entrance opening at the distal end of the shaft. The suturing device also can include a guide member slidably positioned within the shaft and extending past the distal end of the shaft, the guide member having a first needle and a second needle, the first and second needles having piercing ends oriented in a proximal direction. Moreover, the suturing device can include a cable connected to the first and second needles, the cable being configured to move the needles in the proximal direction and a length of suture having a first and second ends thereof secured to the first and second needles. Additionally or alternatively, the suturing device can include a foot coupled to the guide member, the foot having a first needle connector lumen and a second needle connector lumen, the first and second needle connector lumens being configured to guide the first and second needles out of the guide member and into the first and second entrance openings in the shaft.

Implementations of the present invention also include a method of closing an opening in a body lumen. The method can have various acts, which can include but are not limited to inserting a guide member of a suturing device through the opening and into the body lumen and inserting a foot of the suturing device into the opening and capturing tissue surrounding the opening in one or more tissue ports of the foot. Additionally, the method can include an act of adjusting a shaft of the suturing device in a manner that needle exit openings located in the shaft correspond with needle capture devices located in the foot. Furthermore, the method can include an act of passing a plurality of needles through the shaft, out of the needle exit openings, through the tissue surrounding the opening, and into corresponding needle capture devices. The method also can include an act of retrieving the plurality of needles together with the corresponding needle capture devices, thereby passing a length of suture attached to the needle capture devices through the tissue surrounding the

Additional features and advantages of exemplary implementations of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary implementations. The features and advantages of such implementations may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such exemplary implementations as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It should be noted that the figures are not drawn to scale, and that elements of similar structure or function are generally represented by like reference numerals for illustrative purposes throughout the figures. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be 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 illustrates a perspective view of a suturing device with a passive foot in accordance with an implementation of the present invention;

FIG. 2 illustrates an exploded, cross-sectional view of the suturing device of FIG. 1;

FIG. 3 illustrates a cross-sectional view of the suturing device of FIG. 1 with the needles thereof deployed;

FIG. 4 illustrates a perspective view of a needle capture device and associated needle for use in the suturing device of FIG. 1;

FIG. 5 illustrates a partial, cross-sectional view of the suturing device of FIG. 1 taken along the line 5-5 of FIG. 1;

FIG. 6 illustrates a cross-sectional view of the suturing device of FIG. 1 taken along the line 6-6 of FIG. 1;

FIGS. 7A-7G illustrate cross-sectional views of a body lumen, showing a method for closing an opening in the wall of the body lumen using the suturing device of FIG. 1;

FIG. 8A illustrates a perspective view of another suturing device having a non-articulating foot in accordance with an implementation of the present invention;

FIG. 8B illustrates a cross-sectional view of the suturing device of FIG. 8A taken along the line 8B-8B of FIG. 8A;

FIG. 8C illustrates a cross-sectional view of the suturing device of FIG. 9A taken along the line 8C-8C of FIG. 8B;

FIG. 9A illustrates a perspective view of a suturing device having a non-articulating foot in accordance with another implementation of the present invention;

FIG. 9B illustrates a cross-sectional view of the suturing device of FIG. 9A taken along the line 9B-9B of FIG. 9A;

FIG. 9C illustrates a cross-sectional view of another implementation of the suturing device of FIG. 9A;

FIG. 10A illustrates a perspective view of a suturing device with an articulating foot in parked configuration in accordance with an implementation of the present invention;

FIG. 10B illustrates an enlarged view of the shaft and articulating foot of the suturing device of FIG. 10A;

FIG. 11A illustrates a perspective view of the suturing device of FIG. 10A with the articulating foot in a deployed configuration;

FIG. 11B illustrates an enlarged view of the shaft and articulating foot of the suturing device of FIG. 11A;

FIG. 11C illustrates a further enlarged view of the articulating foot of the suturing device of FIG. 11A;

FIG. 12A illustrates an end view of a foot actuator mechanism with a locking mechanism for use in the suturing device of FIG. 10A in accordance with an implementation of the present invention;

FIG. 12B illustrates the foot actuator mechanism and locking mechanism of FIG. 12A with the locking mechanism engaged;

FIGS. 13A-13I illustrate cross-sectional views of a body lumen, showing a method for closing an opening in the wall of the body lumen using the suturing device of FIG. 10A;

FIG. 14 illustrates a perspective view of a suturing device with a replaceable foot in accordance with one implementation of the present invention;

FIG. 15A illustrates a cross-sectional view of a suturing device with a replaceable foot in accordance with one implementation of the present invention;

FIG. 15B illustrates a cross-sectional view of a suturing device with a replaceable foot in accordance with another implementation of the present invention;

FIG. 16A illustrates a top view of a foot of a suturing device in accordance with one implementation of the present invention;

FIG. 16B illustrates a top view of the foot illustrated in FIG. 16B shown in a deformed state;

FIG. 17A illustrates a cross-sectional view of a suturing device with a replaceable foot in a pre-deployed configuration in accordance with yet another implementation of the present invention;

FIG. 17B illustrates a cross-sectional view of a suturing device of FIG. 17A in a deployed configuration;

FIG. 18 illustrates a partial cross-sectional view of a suturing device in accordance with still another implementation of the present invention shown in a deployed configuration; and

FIGS. 19A-19F illustrate cross-sectional views of a body lumen, showing a method for closing an opening in the wall of the body lumen using the suturing device of FIG. 14.

DETAILED DESCRIPTION

As previously mentioned, implementations of the present invention include devices and methods for closing openings in a body lumen efficiently and quickly. For example, one or more implementations of the present invention provide suturing devices with tissue ports configured to allow for location of body lumen wall tissue surrounding a puncture site with increased accuracy and ease. This method can provide for suture deployment over the guide wire permitting rapid re-access to the vessel by the clinician. Furthermore, one or more implementations of the present invention can reduce miss-deployment of needles, and can allow for closure of larger body lumen openings.

In particular, one implementation of the present invention can include a suturing device having a body including a shaft and a foot for insertion into an opening in a body lumen. The body can include tissue ports between the shaft and the foot configured to receive tissue of the body lumen surrounding the opening. The foot can include a suture secured to needle capture devices. Needles can be advanced within the shaft, through tissue within the tissue ports, and into the needle capture devices. The needle capture devices can then be withdrawn, thereby harvesting the suture, which can then be used to close the opening in the body lumen.

In some implementations of the present invention, the tissue ports in the body of the suturing device can be passive. In other words, the tissue ports can be formed between the shaft and the foot and remain open at all times. In alternative implementations, the tissue ports can be non-passive. In such implementations, the foot can articulate between a pre-deployed configuration and deployed configuration. In the pre-deployed configuration the tissue ports can be at least partially closed. For example, in one implementation the foot can abut against the shaft when in the pre-deployed configuration. In the deployed configuration the tissue ports can be open. For example, in one implementation the foot can be distally displaced from the foot when in the deployed configuration, thereby opening tissue ports between the foot and the shaft. In implementations including an articulating foot, the foot can be used to draw or push tissue surrounding an opening in a body lumen into the tissue ports.

Additionally, one or more implementations of the present invention include devices and procedures that allow a medical practitioner to insert a first suturing device over a guidewire into a tissue opening, deploy at least one suture, and remove the suturing device from the tissue opening before removing the guidewire. One will appreciate that this can allow the medical practitioner to run an additional suturing device over the same guidewire if the medical practitioner is not able to close the tissue opening using the first suturing device. For example, if needles used to harvest the suture of the first suturing device miss-deploy or otherwise fail to harvest the suture, the medical practitioner can remove the first suturing device and deploy another without having to place a second guidewire.

As an initial matter, as used herein, the term “proximal” refers to a direction toward a user (i.e., a medical practitioner or surgeon) of a suturing device and away from the patient, or a location closer to the user of the suturing device. As used herein, the term “distal” refers to a direction towards the patient and away from the user of the suturing device, or a location closer to the patient.

Turning now to the Figures, FIG. 1 shows an implementation of a suturing device 100 for closing an incision, a puncture, a passage, or opening through tissue or a body lumen. In particular, the implementation shown by Figure in is a suturing device 100 that includes passive tissue ports. In some examples, the suturing device 100 can close communication with a blood vessel or other body lumen. As shown in FIG. 1, the suturing device 100 can include a body or elongate member 102. The body 102 can have an annular configuration positioned about a central axis. For example, the body 102 illustrated in FIG. 1 includes a circular cross-section. In additional implementations, the body 102 may include other noncircular shapes as well, such as elliptical or other symmetrical or non-symmetrical shapes.

In any event, the body 102 can include a proximal portion or shaft 104 and a distal portion or foot 106. FIG. 1 further illustrates that the suturing device 100 can include a flexible, guidebody 109 extending distally from the distal end of the foot 106. As explained in greater detail below, the guidebody 109 can be advanced along a guidewire into a body lumen. Thus, at least the distal portion of the guidebody 109 can be formed from a flexible or elastomeric material that is biocompatible, particularly with blood. For example, in some implementations the guidebody 109 can be composed of a biocompatible polymeric material, such as, for example, silicone rubber, polyolefin, polyurethane, polytetrafluoroethylene, nylon, pebax, KYNAR, or similar materials. In additional implementations, the guidebody can be coated or impregnated with a lubricant, bioactive agent, such as an anticoagulant material, Polyvinylpyrrolidone (PVP), or the like. For example, the bioactive agent may have any therapeutic effect. Examples of additional suitable therapeutic properties may include anti-proliferative, anti-inflammatory, antiplatelet, anti-fibrin, antithrombotic, antimitotic, antibiotic, antiallergic, antioxidant properties, and/or other therapeutic properties.

For example, a bioactive agent may be used to reduce scar tissue response when after the guidebody is withdrawn from the tissue of a body lumen. Reducing scar tissue response, structural tissue response, restenosis, and/or thrombosis may facilitate access to the tissue after the opening has been sutured. For example, if a device did not use a beneficial agent to reduce scar tissue response, structural tissue response, restenosis, and/or thrombosis after deployment, these and/or other tissue responses may hinder future access to the tissue.

The foot 106 can include a flared portion that extends radially outward of the guidebody 109 and/or shaft 104. The foot 106 may be machined or cast from a composite material, such as, for example, carbon fiber. In some implementations, the foot 106 can be molded as two separate halves which can be subsequently affixed together. In yet further implementations, the foot 106 may comprise a biocompatible material, such as, for example, stainless steel, nylon, or similar materials.

The shaft 104 can include a proximal end 108 and a distal end 110 (i.e., the terminal end or surface of the shaft 104). The shaft 104 can comprise a biocompatible material, such as stainless steel, carbon fiber, nylon, another suitable polymer, or similar materials. Furthermore, in some implementations the shaft 104 may be flexible to accommodate insertion into a body lumen. In alternative implementations, the shaft 104 may comprise a rigid construction so as to avoid substantial deflection during use.

A handle 112 can be secured to the proximal end 108 of the shaft 104. The handle 112 can be of sufficient dimensions to allow a medical practitioner to grasp the handle 112 and use it to manipulate the suturing device 100 during use. Furthermore, the handle 112 can support a needle actuation handle 114. The proportions of the needle actuation handle 114 and needles 122/124 may be change with respect to each other to improve needle stroke and column strength. The handle 112 and the needle actuation handle 114 may include a bioabsorbable metal, alloy, polymer, plastic, composite, other materials, or combinations thereof.

The handle 112 can have any number of suitable configurations. In some embodiments, the handle 112 can have a syringe grip configuration. For instance, the handle 112 can include opposing loops, which can accommodate user's fingers therein. Alternatively or additionally, the handle 112 can incorporate locations for user's fingers (e.g., the handle 112 can extend outward and bend away from the user). As such, the user can have a secure grip of the handle 112 as well as of the shaft 104.

The foot 106 can be secured to the distal end 110 of the shaft 104 by a spinal member 116. The spinal member 116 can separate the distal end 110 of the shaft 104 from the foot 106, and thus, define one or more tissue ports 118, 120. In some embodiments, the spinal member 116 comprises stainless steel, nitinol, or a similar material. The spinal member 116 can be composed of a biocompatible material that is substantially resistant to deformation, and therefore, can maintain alignment between the needle lumens 126, 128 and the needle capture devices 136, 138. It should be appreciated that the needle lumens 126, 128 can have any number of suitable configurations. For instance, the needle lumens 126, 168 can be substantially straight or linear. Alternatively, the needle lumens 126, 128 can be bent, angles, or may have any number of non-linear configurations. In any event, however, the needle lumens 126, 128 can be shaped, positioned, and oriented in a manner that allows the needles 122, 124 align with the needle capture devices 136, 138. One will appreciate that the spinal member's resistance to deformation can help ensure that needles 122, 124 are not miss-deployed. Furthermore, the spinal member can serve to maintain structural integrity between the shaft 104 and foot 106. Examples of suitable materials include stainless steel, polytetrafluoroethylene, nylon, polyamids, and similar materials.

Furthermore, FIG. 5 illustrates that the spinal member 116 can have a width equal to approximately the diameter of the foot 106. Thus, referring again to FIG. 1, the spinal member 116 can define two tissue ports 118, 120 separating the distal end 110 of the shaft 104 from the foot 106. In alternative implementations, the spinal member 116 can have a width smaller than the diameter of the shaft 104, and thus, define a single circumferential tissue port. Alternatively, the suturing device 100 can include three or more tissue ports.

In any event, the body 102 can include one or more tissue ports 118, 120 separating the distal end 110 of the shaft 104 from the foot 106. As explained in greater detail below, the tissue ports 118, 120 can be configured to receive tissue surrounding an opening, such as a puncture wound, in a body lumen wall. The tissue ports 118, 120 can thus help locate the tissue surrounding an opening, and allow for the suturing of the tissue to close the opening.

Referring now to FIGS. 2 and 3, an exploded cross-sectional view and an assembled cross-sectional view, respectively, of the suturing device 100 are illustrated. As shown, the needle actuation handle 114 can include one or more needles secured thereto. In particular, the implementation shown in FIGS. 2 and 3 includes a first needle 122 and a second needle 124. In additional implementations, the suturing device 100 can include a single needle or three or more needles.

One or more of the needles for use with the suturing devices of the present invention can be provided as substantially described in U.S. Pat. No. 6,136,010 issued to Modesitt et al. and/or U.S. Pat. No. 5,792,152 issued to Klein et al., which are incorporated herein by reference in their entirety. As such in some implementations, the needles for use with the present invention can be flexible. Alternatively, needles for use with the present invention can be rigid. In particular, the needles can include sufficient column strength so as to avoid any meaningful deflection as they are advanced through tissue. By having a rigid construction, the needles can pass from the shaft 104, through tissue within the tissue ports 118, 120, and into the foot 106 without deflection. One will appreciate that this can help decrease or eliminate miss-deployment of needles sometimes associated with flexible needles. For example, a rigid construction can help ensure that the needles 122, 124 pass into the foot, instead of deflecting and missing the foot 106, or more specifically engagement features within the foot 106.

In any event, the needle actuation handle 114 can be engageable with or be secured to one or more needles. For example, FIG. 2 illustrates that the needle actuation handle 114 can be secured to the first needle 122 and the second needle 124. The needle actuation handle 114 can be sized to be positioned within a receptacle 125 extending into the proximal end 108 of the handle 112 and/or shaft 104. The needle actuation handle 114 can allow a medical practitioner to advance the needles 122, 124 into the shaft 104 and then the foot 106. Specifically, the needle actuation handle 114 can be configured such that a medical practitioner can advance the needles 122, 124 in a proximal direction toward the patient, and then subsequently in a distal direction away from the patient. In alternative implementations, the suturing device 100 may not include a needle actuation handle 114. In such implementations, the proximal ends of the needles 122, 124 can be configured to held and manipulated by the medical practitioner to advance and retract the needles 122, 124.

In some embodiments, the suturing device 100 can incorporate a spring, which can resist and/or prevent unintentional movement of the needle actuation handle 114. In other words, the spring may have to be compressed to advance the needle actuation handle 114. Accordingly, the spring may prevent unintentional engagement of the needles 122, 124 with the needle capture devices 136, 138.

FIGS. 2 and 3 illustrate that the shaft 104 of the body 102 can include a plurality of axial lumens therein. For example, FIGS. 2 and 3 illustrate that the shaft 104 can include a pair of needle lumens 126, 128. The needle lumens 126, 128 can extend from the proximal end 108 to the distal end 110 of the shaft 104. In particular, the distal end 110 end of the shaft 104 can include a first needle exit opening 130 and a second needle exit opening 132, at the respective ends of the needle lumens 126, 128. The needle lumen 126, 128 can guide the needles 122, 124 from the proximal end 108 of the shaft 104, through the shaft 104, and out of the needle exit openings 130, 132.

In addition to the needle lumens 122, 124, the shaft 104 can include additional lumens. For example, the shaft 104 can include a foot position verification lumen, such as that described herein below in reference to the suturing device 300 shown in FIGS. 10A-13I. Additionally, as shown in FIGS. 2 and 3, the shaft 104 can include a guidewire lumen 134. The guidewire lumen 134 can extend along the length of the shaft 104, through the foot 106, and through the guidebody 109. The guidewire lumen 134 can extend substantially along the central axis of the suturing device 100 as shown in FIGS. 2 and 3, or alternatively be offset from the central axis of the suturing device 100. Furthermore, in some implementations, the guidewire lumen 134 can serve as the spinal member 116.

The guidewire lumen 134 can receive or follow a guidewire left in place after a diagnostic or medical procedure. In particular, as explained in greater detail below, a medical practitioner can insert the suturing device 100 into a body lumen or other site to be repaired by sliding the guidewire lumen 134 over the pre-placed guidewire. For example, a medical practitioner can place an opening 135 in the distal end of the guidebody 109 over a guidewire (not shown). The guidewire can then extend through the guidewire lumen 134 and out of the needle actuation handle 114. Thus, the guidewire can extend out of the proximal end of the suturing device 100 without interfering with the needles 122, 124, needle lumens 126, 128, or suture. The guidewire can be removed after placement of the suturing device 100 in a body lumen, after deployment of the needles 126, 128, or after removal of the suturing device 100 from the patient, as considered prudent by the medical practitioner.

In addition to the guidewire lumen 134, the foot 106 can include one or more needle capture devices. For example, FIGS. 2 and 3 illustrate that the foot 106 can include a first needle capture device 136 and a second needle capture device 138. In alternative implementations, the foot 106 can include one needle capture device or three or more needle capture devices. One will appreciate that the number of needle capture devices in the foot 106 can correspond to the number of needles 122, 124 and needle lumens 126, 128 in the shaft 104. Each needle capture device 136, 138 can correspond to and be aligned with a needle lumen 126, 128, and a needle exit opening 130, 132. One will appreciate that by being aligned, the needles 122, 124 can pass out of the needle exit openings 130, 132, through the tissue ports 118, 120 and into the needle capture devices 136, 138.

The needle capture devices 136, 138 can be secured to a suture 140 removably stored within a suture lumen 142 within the foot 106 and/or guidebody 109. For example, FIGS. 2 and 3 illustrates that the suturing device 100 includes a length of suture 140 having its respective ends secured to the first and second needle capture devices 136, 138. In particular, as illustrated by FIG. 6, the suture lumen 142 can extend at least partially around the guidewire lumen 134 and allow the suture 140 to wrap from the first needle capture device 136 to the section needle capture device 138. In alternative implementations, each needle capture device 136, 138 can have two or more sutures, ends or otherwise, secured thereto. As explained in greater detail below, multiple sutures may be desirable when closing larger openings or punctures within a body lumen.

The various implementations of the present invention may include any of a variety of suture types, such as, for example, monofilament or braided sutures. The sutures may be absorbable or non-absorbable, and may be made of polyester, polypropylene, polyglycolic acid, nylon, silk, or any of a variety of different materials.

Referring again to FIGS. 2 and 3, the suture 140 and the suture lumen 142 can extend from the foot 106 into the guidebody 109. In alternative implementations, the entire suture, or a substantially portion thereof, may be housed within the foot 106. For example, in some implementations, the suture 140 can be coiled and stored within the flared portion of the foot 106. In yet further implementations, the suture 140 can be stored or attached to the outer surfaces of the foot 106 or guidebody 109.

As shown by FIGS. 2 and 3, the needle capture devices 136, 138 can be configured to receive and secure the needles 122, 124 to the suture 140. In particular, once the needles 122, 124 are advanced into the needle capture devices 136, 138, the needle capture devices 136, 138 can lock the needles 122, 124 therein. Thereafter, when the needles 122, 124 are retracted from the foot 106 and the shaft 104, the needles 122, 124 can pull the suture 140 at least partially from the foot 106, through the needle lumens 126, 128, and out of the proximal end 108 of the shaft 104 or suturing device 100. In particular, by retracting the needles 122, 124, the suture 140 can be removed from the foot 106. Specifically, the suture 140 can pass out of the opening of the suture lumen 142 in the tissue location surface 144 (FIG. 5). Once the suture 140 has been harvested from the suturing device 100, the medical practitioner can remove the suturing device 100, retrieve the suture 140, and use it to close or otherwise seal an opening in a body lumen.

The needle capture devices 136, 138 can be substantially flush with a tissue location surface 144 (i.e., the surface of the foot opposite the distal end 110 of the shaft 104) as shown in FIGS. 2 and 3. Alternatively, the needle capture devices 136, 138 can reside further within the foot 106, as explained in greater detail below with reference to FIG. 9C. In such implementations, the foot 106 can include needle receiving lumens or funnels that extend from the tissue location surface 144 to the needle capture devices 136, 138, and that can guide the needles 122, 124 into the needle capture devices 136, 138.

As shown by FIGS. 2 and 3, the needles 122, 124 can be advanced in a distal direction from the proximal end 108 of the shaft 104 within the needle lumens 126, 128 by pressing the needle actuation handle 114 into the receptacle 125 of the handle 112 and/or shaft 104. The needles 122, 124 can advance out of the needle exit openings 130, 132, through tissue located within the tissue ports 118, 120, and into the needle capture devices 136, 138 within the foot 106. By being inserted into the needle capture devices 136, 138, the needle needles 122, 124 can be locked or secured to the suture 140. The needles 122, 124 and suture 140 can then be withdrawn proximately through the needle tracts formed in the tissue within the tissue ports 118, 120, and proximally out of the shaft 104 through the needle lumens 126, 128. In particular, by retracting the needles 122, 124, the suture 140 can be removed from the foot 106. Specifically, the suture 140 can pass out of the opening of the suture lumen 142 in the tissue location surface 144 (FIG. 5). Once the needles 122, 124 and suture 140 have been withdrawn from the foot 106, the suturing device 100 can be withdrawn from the patient. The suture 140 can then be drawn tight, closing the opening in the body lumen. A surgical knot or other suture securing device (e.g., a cleat) can complete the closure of the opening in the body lumen.

As previously mentioned, the needles 122, 124 can be configured to engage the needle capture devices 136, 138. One will appreciate that the needles 122, 124 and the needle capture devices 136, 138 can include various configurations so long as the needle capture devices 136, 138 can secure the needles 122, 124 to the suture 140, and allow the suture 140 to be harvested. For example, the needle capture devices 136, 138 of the present invention can include a net or other structure configured to receive and lock a needle to the suture 140.

In some implementations, as illustrated by FIG. 4, a needle 122a can include a barbed end 146 defining a recessed engagement surface 148. The needle capture device can comprise a needle attachment fitting or cuff 136. Specifically, the needle attachment cuff 136 can have a roughly cylindrical shape and include an axial channel 150 configured to receive the barbed end 146 of needle 122a therein. In additional implementations, the needle attachment cuff 136 can include shapes other than cylindrical ones, such as, for example, conical. The needle attachment cuff 136 can include one or more features configured to lock the barbed end 146 of the needle 122a therein. For instance, as shown in FIG. 4, the needle attachment cuff 136 can include at least one tab 152. The tab 152 may be mechanically formed to be smaller than the diameter of surface 148. The tab 152 can be resiliently biased into channel 150. As the needle 122a advances into the needle attachment cuff 136, the barbed end 146 can displace the tab 152 clear of the channel 150 so as to allow the barbed end 146 of the needle 122a to pass axially into the channel 105 of the needle attachment cuff 136. Once the barbed end 146 is disposed axially beyond the tab 152, the tab 152 tab can flex back into the channel 150 over the recessed surface 148, thereby locking the needle 122a to the needle attachment cuff 136. One will appreciate that each needle attachment cuff can include more than one tab 152, which can increase the reliability of the attachment between the needle 122a and the needle attachment cuff 136.

Additionally, FIG. 4 illustrates that the needle attachment cuff 136 can include a collar 154 to facilitate attachment of the needle attachment cuff 136 to suture 140. For instance, the collar 154 can be crimped about the suture 140 to mechanically affix the suture 140 to the needle attachment cuff 136. In addition and/or instead of mechanical crimping, the suture 140 may be bonded to the needle attachment cuff 136 using an adhesive, heat, fasteners, knots, or the like. As shown by FIG. 5, the foot 106 can house the needle attachment cuff 136. Or in other words, the needle attachment cuff 136 can extend distally into the tissue location surface 144 of the foot 106. In particular, in one implementation, the foot 106 can house a pair of needle attachment cuffs 136 on opposing sides of the spinal member 116 and/or guidewire lumen 134 (i.e., within the tissue ports 118, 120). FIG. 6A illustrates a cross-sectional view of the flexible guidebody 109. As shown by FIG. 6A, and as previously mentioned, the guidewire lumen 134 and suture lumen 142 can extend into the flexible guidebody 109 in one or more implementations.

As mentioned previously, the needle capture devices 136, 138 can be removably secured to the foot 106 so they can be withdrawn proximally into the shaft 104 as the needles 122, 124 are withdrawn. Additionally, one will appreciate that the outer body of the needle capture devices 136, 138 can be configured with a taper or other feature to help allow the needle capture devices 136, 138 to be readily pulled through paths formed by the needles 122, 124 in tissue located within the tissue ports 118, 120 when the practitioner retracts the needles 122, 124 and the needle capture devices 136, 138 from the patient.

Reference is now made to FIGS. 7A-7G, which illustrate one implementation of a method of using the suturing device 100 to close an opening 210 in a body lumen 200. Specifically, the suturing device 100 can be inserted in a distal direction into the body lumen 200. This can be accomplished with or without the use of a guidewire. FIGS. 7A-7G illustrate an example in which a guidewire 202 is used.

In particular, FIG. 7A illustrates that after accessing a body lumen, in this case a blood vessel 200, (using the Seldinger or a Modified Seldinger technique, for example), a guidewire 202 may be left extending into skin 204 and down through tissue 206 along a tissue tract 208, which may have been formed by an introducer sheath previously placed in connection with a intravascular medical or diagnostic procedure. As shown by FIG. 7A, the guidewire 202 may enter the body lumen 200 through an opening or puncture site 210 formed in the body lumen wall 212. The guidewire 202 may extend along the body lumen 200. As illustrated by FIGS. 7A-7B, the flexible guidebody 109 can be advanced over the guidewire 202 in a monorail fashion, so that the guidewire 202 helps direct the suturing device 100 along the tissue tract 208 into the body lumen 200 through the opening 210.

As shown by FIGS. 7B-7C, the suturing device 100 can be slowly advanced until resistance is encountered as the tissue ports 118, 120 cross the lumen wall 212 into the body lumen 200. The resistance can be provided by the radial flare of the foot 106 and/or by the distal end of the shaft 104. Alternatively, or additionally, the suturing device 100 can be advanced until blood is observed in a position indicator, such as that described below in relation to suturing device 300. In any event, once properly positioned, the suturing device 100 can be stabilized permitting the tissue 214 surrounding the opening 210 to rebound into the tissue ports 118, 120, as depicted in FIG. 7C.

As shown in FIG. 7D, once the tissue 214 has entered into the tissue ports 118, 120, the needles 122, 124 can be advanced in a distal direction within the needle lumens 126, 128, out of the needle exit openings 130, 132, distally across the tissue ports 118, 120 through the tissue 214, and into the needle capture devices 136, 138. The needles 122, 124 and needle capture devices 136, 138 can then be withdrawn out of the foot 106, proximally across the tissue ports 118, 120 through the tissue 214, and out of the proximal end of the suturing device 100, as depicted by the arrow in FIG. 7E. FIG. 7E further shows that by withdrawing the needles 122, 124 and needle capture devices 136, 138, the distal end of the suture 140 can be withdrawn proximally out of the opening of the suture lumen 142 in the tissue location surface 144 and out of the foot 106.

As indicated by the arrow of FIG. 7F, the suturing device 100 can next be withdrawn from the body lumen 200 and out of the tissue tract 208. The suture can then be severed, leaving sufficient length for the user to grasp the suture (by hand or with a tool) as well as to closure the opening 210, as further described below. As shown by FIG. 7F, the guidewire 202 can remain in place during the entire sequence to this point if desired. Thus, if the suture 140 fails to capture the tissue 214, or otherwise allow for the suture 140 to close the opening 210, another suturing device 100 can be inserted along the guidewire 202, and the above procedure repeated. One will appreciate that the ability to reuse the guidewire 202 if a problem is encountered can reduce the time, effort, and cost associated with resolving the problem and obtaining a dry closure of the body lumen 200.

Finally, FIG. 7G illustrates that the guidewire 202 can be pulled from the patient. At this point, or prior thereto, the suture 140 can be employed to close the opening 210 in the body lumen 200. In particular, a surgical knot 158 can be tied securing the wound closure. A knot pusher, for example, the knot pushers described in U.S. Pat. No. 5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755 issued to Wood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be used to advance the loosely tied knot to the exterior surface of the vascular vessel. In some implementations, the medical practitioner can then tie a suitable surgical knot 158 using the respective lengths of suture 140 to close the opening 210 (FIG. 7A). In other embodiments, the suture 140 can be secured using a variety of knot replacement technologies such as those disclosed in U.S. Pat. No. 7,108,710 issued to Anderson. Each of the above-identified patents are incorporated herein by reference in their entirety.

In some cases, particularly for closure of large openings or punctures, it may be advantageous to provide multiple sutures 140 across the opening 210, either in parallel, in an “X” pattern, or in another configuration. For example, FIGS. 8 and 9 illustrate various views of a suturing device 100a similar to suturing device 100, except that suturing device 100a includes the use of more than two needles and associated needle lumens, needle capture devices, sutures, and the like. In particular, the suturing device 100a can include four needle lumens 124, 126, 124a, 126a, and four associated needles, four needle capture devices, and two sutures. Additional implementations of the present invention having multiple suture systems may have six, eight, or ten or more needles, or may even have odd numbers of needles and needle capture devices, particularly where one or more needle capture devices have a plurality of suture ends extending there from. This can allow a wide variety of stitching patterns to be provided by such multiple loop implementations.

More particularly, FIG. 8 illustrates that the suturing device 100a can include a shaft 104 and a distal portion or foot 106. FIG. 8 further illustrates that the suturing device 100a can include a flexible, guidebody 109 extending distally from the end of the foot 106. The foot 106 can include a flared portion that extends radially outward of the guidebody 109 and/or shaft 104. The shaft 104 can include a proximal end 108 and a distal end 110. A handle 112 can be secured to the proximal end 108 of the shaft 104. The handle 112 can be of sufficient dimensions to allow a medical practitioner to grasp the handle 112 and use it to manipulate the suturing device 100a during use. Furthermore, the handle 112 can support a needle actuation handle 114.

Furthermore, as illustrated by FIGS. 8 and 9A, the spinal member 116a can have a circular cross-section and a diameter several times smaller than the diameter of the shaft 104 and/or foot 106. Thus, the suturing device 100a can include a single, circumferential tissue port 118a. In yet further implementations, suturing devices of the present invention can include a single tissue port that extends only partially around the circumference of the shaft 104 and foot 106. In additional implementations, suturing devices of the present invention can include three, four, five, or more tissue ports.

FIGS. 8A and 8B further illustrate that the suturing device 100a can include one or more suture exit slots 160. The suture exit slots 160 can extend from inside the foot 106 and/or guidebody 109 from the sutures 140, radially outward and in a proximal direction. The suture exit slots 160 can replace the opening of the suture lumen 142 in the tissue location surface 144 used in the suturing device 100 and function to allow the sutures 140 to be pulled radially out from the foot 106 and/or guidebody 109 as the needles and needle capture devices are withdrawn proximally from the suturing device 100a. In other words, the sutures 140 can be pulled out of, and separated from foot 106 and/or guidebody 109 as the needles and needle capture devices are distally withdrawn (i.e., before the shaft 104, foot 106, and guidebody the suturing device 100a are withdrawn). One will appreciate that by having the suture exit slots 160, the space needed within the foot 106 and/or guidebody to house the sutures 140 may be reduced.

FIGS. 8B, 8C further illustrate that the suturing device 100a can include retaining slots 161. The retaining slots 161 can be configured to allow the foot 106 to receive and retain therein needle capture devices 136a, 138a. For example, the ports within the foot 106 within which the needle capture devices 136a, 138a can have a diameter smaller than the outer diameter of the needle capture devices 136a, 138a. The retaining slots 161 can allow the ports, which hold the needle capture devices 136a, 138a within the foot 106, to expand to receive the needle capture devices 136a, 138a. Once within the ports of the foot 106, the retaining slots 161 can allow the ports to bias toward and retain the needle capture devices 136a, 138a therein.

As alluded to earlier, the suturing devices of the present invention can include needle receiving lumens or funnels for guiding the needles into the needle capture devices 136a, 138a. For example, FIGS. 9A and 8C illustrate that the needle capture devices 136a, 138a can reside within the foot 106 a distance from the tissue location surface 144. Needle receiving lumens or funnels 162 can extend from the tissue location surface 144 to the needle capture devices 136a, 138a. The funnels 162 can have a diameter at the tissue location surface 144 that is larger than the diameter of the needle capture devices 136a, 138a. The diameter can then taper as the funnels extend toward the needle capture devices 136a, 138a. One will appreciate in light of the disclosure herein that the funnels 162 can thus guide the needles into the needle capture devices 136a, 138a in the event that they are slightly deflected out of alignment when passing through tissue.

Additional or alternative implementations, as illustrated in FIG. 9A, in lieu of or in addition to the exit slot, a suturing device 100a′ can include a foot 106a′ that has a retaining channel 162′, which house the sutures 140. After engaging the suturing device 100a′ with the vessel wall, and connecting the needles with needle capture devices, the sutures 140 can be pulled out of the retaining channel 162′. Furthermore, in at least one implementation, the sutures 140 can be positioned on the outside of the foot 106a′ (i.e., the foot may not have any channels or retaining slots therein). In other words, as illustrated in FIG. 9B, the sutures 140 may spill over the side of the foot 106a′.

In addition, although in some implementations the foot 106′ may have an approximately circular cross-sectional shape (e.g., the shape at the tissue location surface 144 (FIG. 8C), the shape of the foot may vary from one implementation to another. For instance, as illustrated in FIG. 9C, the suturing device can incorporate a foot 106a″ of a suturing device 100a″. The foot 106a″ may have an oval cross-sectional shape. It should be appreciated, however, that the foot can have any number of suitable shapes.

While the implementations described hereinabove included passive tissue ports or non-articulating foot, the present invention is not so limited. As previously mentioned, implementations of the present invention can also include suturing devices with an articulating foot or non-passive tissue ports. Such implementations can include a foot that articulates between a pre-deployed configuration and deployed configuration. In the pre-deployed configuration the tissue ports can be at least partially closed. In the deployed configuration the tissue ports can be open. For example, in one implementation the foot can be distally displaced from the shaft when in the deployed configuration, thereby opening tissue ports between the foot and the shaft. In implementations including an articulating foot, the foot can be used to draw or push tissue surrounding an opening in a body lumen to be repaired into the tissue ports.

For example, FIGS. 10A-11B illustrate perspective view of a suturing device 300 with an actuating foot 106a in accordance with an implementation of the present invention. The suturing device 300 can include a body 102a comprising a proximal portion or shaft 104a and a distal portion or foot 106a. FIGS. 10A-12B further illustrate that the suturing device 300 can include a flexible, guidebody 109a extending distally from the end of the foot 106a. The foot 106a can include a flared portion that extends radially outward of the guidebody 109a. The shaft 104a can include a proximal end 108 and a distal end 110. A handle 112a can be secured to the proximal end 108 of the shaft 104a. The handle 112a can be of sufficient dimensions to allow a medical practitioner to grasp the handle 112a and use it to manipulate the suturing device 300 during use. Furthermore, the handle 112a can support a needle actuation handle 114a.

Similar to the suturing device 100, the suturing device 300 can include one or more needles 122, 124 secured to the needle actuation handle 114a. The needle actuation handle 114a can be sized to be positioned within a receptacle extending into the proximal end of the handle 112a. The needle actuation handle 114a can allow a medical practitioner to advance the needles 122, 124 into the shaft 104a and foot 106a. In particular, the shaft 104a can include one or more needle lumens 126, 128 extending from the proximal end 108 to the distal end 110 of the shaft 104a. The needle lumen 126, 128 can guide the needles 122, 124 from the proximal end 108 of the shaft 104a, through the shaft 104a, and into the foot 106a.

Additionally, the foot 106a can include one or more needle capture devices. For example, FIGS. 10B and 11B illustrates that the foot 106a can include a first needle capture device 136 and a second needle capture device 138, each removably secured within a tissue location surface 144 of the foot 106a. Each needle capture device 136, 138 can correspond to and be aligned with a needle lumen 126, 128. Referring now to FIG. 11C, the suturing device 100a can include retaining slots 161a configured to allow the foot 106a to receive and retain therein needle capture devices 136, 138.

The needle capture devices 136, 138 can be secured to a suture 140 removably stored within the foot 106a and/or guidebody 109a. For example, a length of suture 140 can have its ends secured to the first and second needle capture devices 136, 138. As previously mentioned, the needle capture devices 136, 138 can be configured to receive and secure the needles 122, 124 to the suture 140. In particular, once the needles 122, 124 are advanced into the needle capture devices 136, 138, the needle capture devices 136, 138 can lock the needles 122, 124 therein. Thereafter, when the needles 122, 124 are retracted from the foot 106a and the shaft 104a, the needles 122, 124 can pull the proximal ends of the suture 140 from the foot 106a, through the needle lumens 126, 128 and out of the proximal end 108 of the shaft 104a.

As shown by FIG. 11C, the suture 140 can extend from the needle capture devices 136, 138, out of retaining slots 161a, along the outer wall of the foot 106a, and into the guidebody 109a via suture exit slot 160a. As the needles 122, 124 are retracted from the foot 106a and the shaft 104a, the distal portion or loop of the suture 140 can be pulled from the guidebody 109a and foot 106a. In particular, as the suture 140 is pulled proximately, the suture 140 can exit the guidebody 109a and foot 106a via the suture exit slot 160a and retaining slots 161a. Once the suture 140 has been pulled from the guidebody 109a and foot 106a, the suturing device 300 can be proximately withdrawn from the patient. As shown in FIG. 11C, the suture exit slot 160a can extend generally radially outward from the center of the guidebody 109a. The radial configuration can help ensure that the suture exit slot 160a does not catch or pull on tissue as the suturing device 300 is withdrawn.

The suturing device 300 can further include a foot actuator mechanism 302. As shown in FIGS. 10A-11B, a medical practitioner can slide the foot actuator mechanism 302 distally toward the foot 106a, thereby causing the foot 106a to be distally displaced from a first configuration (FIGS. 10A-10B) in which the foot 106a abuts against the distal end 110 of the shaft 104a and a deployed configuration (FIGS. 11A-11B) in which the foot 106a is distally separated from the distal end 110 of the shaft 104a.

As shown by FIGS. 11A-11B, by actuating the foot 106a into the deployed configuration, a tissue port 118b can be opened up between the foot 106a and the shaft 104a. As discussed previously, the tissue port 118b can receive tissue surrounding body lumen opening to be closed using the suturing device 300. As shown in FIGS. 11A-11B, when in the deployed configuration the foot actuator mechanism 302 can distally displace a spinal member 116b within the shaft 104a, thereby distally displacing the foot 106a secured, which may be secured to the spinal member 116b. Thus, the spinal member 116b can help define the tissue port 118b.

The foot actuator mechanism shown in FIGS. 10A and 11A comprises a tab 302 directly secured to the spinal member 116b. In such implementations, the foot actuator mechanism 302 can the medical practitioner with tactile feedback on how far the foot 106a has been deployed. In particular, in some implementations the distance the foot actuator mechanism 302 slides distally within the handle 112a can have a 1:1 ratio with respect to the distance the foot 106a separates from the distal end 110 of the shaft 104a. In alternative implementations, the distance the foot actuator mechanism 302 slides distally within the handle 112a can have a 2:1 ratio, a 3:1, a 4:1 ratio, or a greater ratio with the distance the foot 106a separates from the distal end 110 of the shaft 104a. In yet further implementations, the distance the foot actuator mechanism 302 slides distally within the handle 112a can have a 1:2 ratio, a 1:4 ratio, or a smaller ratio with respect to the distance the foot 106a separates from the distal end 110 of the shaft 104a.

A wide variety of foot actuation mechanisms can be employed to move the foot 106a between the first configuration (FIGS. 10A-10B) and the deployed configuration (FIGS. 11A-11B). The tab 302 illustrated in FIGS. 10A and 11A is only one example of such a mechanism. In additional implementations, the foot actuation mechanism can include a handle that pivots from a position generally perpendicular to the central axis of the handle 112a to a position generally parallel to the central axis of the handle 112a. In yet further implementations, the foot actuation mechanism can include a handle secured to the spinal member 116b that is positioned between the handle 112a and the needle actuation handle 114a. In such implementations, the medical practitioner can depress the foot actuation mechanism handle at least partially within the handle 112a to deploy the foot 106a. The medical practitioner can then depress the needle actuation handle 114a at least partially within the foot actuation mechanism handle to deploy the needles 122, 124.

In any event, once the foot 106a is deployed (FIGS. 11A-11B) the medical practitioner can proximally withdraw the foot 106a until it abuts against the inner wall of a body lumen to be closed. After which, the medical practitioner can compress the foot 106a and the shaft 104a together thereby urging or pushing tissue into the tissue port 118b. Thus, the articulating foot 106a can function to help ensure that tissue surrounding an opening to be closed is properly positioned within the tissue port 118b prior to deployment of the needles 122, 124.

In some implementations, the foot actuation mechanism 302 can be biased toward the first configuration (FIGS. 10A-10B). For example, FIG. 10A illustrates that the suturing device 300 can include a biasing member 318 configured to bias the foot actuation mechanism 318 toward the proximal end of the handle 112a. FIG. 10A illustrates that the biasing member 318 can comprise a leaf spring. In alternative implementations, the biasing member 118 can include an elastomeric projection, or other structure that provides biasing characteristics similar to a spring, including, for example, a torsion spring, or a twin spring. One will appreciate in light of the disclosure herein that the biasing member 318 can cause the foot 106a to automatically move from the deployed configuration (FIGS. 10A-10B) toward the first configuration (FIGS. 11A-11B) upon release of the foot actuation mechanism 302. Thus, the biasing member 318 can cause the foot 106a to automatically capture tissue and urge the tissue into the tissue port 118b once the tissue location surface 144 is abutted against the inner wall of the body lumen, and the foot actuation mechanism 302 is released. In alternative implementations, the foot actuation mechanism 302 may not include a biasing member, and the actuation of the foot 106a can be a manual procedure performed by the medical practitioner.

In some implementations of the present invention, the suturing device 300 can include a locking mechanism configured to releasably lock the foot 106a in one or more configurations, such as, for example, the first or pre-deployed configuration, the deployed configuration, or a position between the first and deployed configurations. For instance, the locking mechanism can lock the foot 106a, and the foot actuation mechanism 302, in the deployed configuration (FIGS. 10A-10B) to ensure that the foot 106a is not compressed toward the shaft 104a, or vice versa, until the foot location surface 144 is positioned against the inner wall of a body lumen to be repaired. Alternatively or additionally, the locking mechanism can releasably lock the foot 106a in place relative to the shaft 104a once tissue has been captured in the tissue port 118b. This can help ensure that the foot 106a and the shaft 104a pinch or otherwise hold the tissue surrounding an opening to be repaired until the medical practitioner can deploy the needles 122, 124.

For example, FIGS. 12A and 12B illustrate one implementation of a foot actuation mechanism that includes a locking mechanism 324. Specifically, FIGS. 12A and 12B illustrate that the locking mechanism 324 can include a button 320 and one or more protrusions 322. Specifically, in the illustrated implementation, the foot actuation mechanism 302a includes a button 320. When the button 320 is in the decompressed position shown in FIG. 12A, the foot actuation mechanism 302a, and the foot 116a, can freely move relative to the handle 112a and/or shaft 104a. Alternatively, when the button 320 is in the compressed position shown in FIG. 12B, one or more protrusions 322 may extend out from the foot actuation mechanism 302a. When extended, the one or more protrusions 322 may engage corresponding grooves (not shown) located within the handle 112a, thereby locking the foot actuation mechanism 302a and the foot 106a relative to the handle 112a and/or shaft 104a. Thus, the locking mechanism 324 can allow a medical practitioner to lock the foot 106a in one or more positions relative to the shaft 104a.

In order to release the locking mechanism 324, the medical practitioner can decompress the button 320, thereby withdrawing the one or more protrusions 322 into the foot actuation mechanism 302a. When in the decompressed position, the foot actuation mechanism 302a, and the foot 116a, can freely move relative to the handle 112a and/or shaft 104a.

In additional implementations, the suturing devices can include locking mechanisms having other configurations. For example, such locking mechanisms can include spring-loaded tabs (not shown) that extend into the housing 112a or shaft 104a from the foot actuation mechanism. Such spring-loaded tabs can prevent actuation of the foot 106a unless deactivated by compressing a button or other release mechanism similar to the button 320.

In some implementations of the present invention, the suturing device 300 can include both a biasing member 318 and a locking mechanism 324. Alternatively, the suturing device 300 can include one of a biasing member 318 and a locking mechanism 324, or neither a biasing member 318 or a locking mechanism 324. One will appreciate that the inclusion of the biasing member 318 and/or locking mechanism 324 can be based on a medical practitioner's preference.

Referring again to FIGS. 10A-11A, the suturing device can include a foot position indicator lumen 308 (FIGS. 13A-13I) that extends distally from a position port 310 to position indicator 312 located on the shaft 104a. When the foot 106a is properly positioned for deployment within a blood vessel or other body lumen (i.e., the tissue location surface 144 is completely within the body lumen), blood pressure can cause blood to flow into the position port 310, proximally through the indicator lumen 308 (FIGS. 13A-13I) to the position indicator 312.

As shown in FIGS. 10A-11B, the position indicator may optionally comprise a window 312 in which blood within the indicator lumen may be visible. In particular, FIGS. 10A-11B illustrate that the shaft 104a (or in alternative implementations the handle 112a) can include a clear window 312. In further implementations, the position indicator can comprise a length of the indicator lumen 308 that extends outside of the shaft 104a or handle 112a through which blood can flow out, indicating to the medical practitioner that the foot 106a is properly positioned. In yet further implementations, the position indicator can include electrical pressure sensors, electrolytic fluid detectors, or the like.

In additional implementations, the foot 106a or the distal portion of the shaft 104a can include a radiopaque material to increase visibility during placement. Optionally, the radiopaque material can be a layer or coating any portion of the foot 106a or shaft 104a. The radiopaque materials can be platinum, tungsten, silver, stainless steel, gold, tantalum, bismuth, barium sulfate, or a similar material.

It is further contemplated that the external surface and/or internal surface of the devices or members (e.g., exterior and luminal surfaces) as well as the entire body can be coated with another material having a composition different from the primary material. The use of a different material to coat the surfaces can be beneficial for imparting additional properties to the device or member, such as providing radiopaque characteristics, drug-reservoirs, and improved biocompatibility.

In one embodiment, at least one biocompatible polymeric layer can be a coating that is applied over the entire suturing device 300, or to select portions. Examples of such biocompatible polymeric materials can include a suitable hydrogel, hydrophilic polymer, hydrophobic polymer biodegradable polymers, bioabsorbable polymers, and monomers thereof. Examples of such polymers can include nylons, poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols, polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcohol copolymers, ethylenevinylalcohol copolymers (EVAL), propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP), combinations thereof, polymers having monomers thereof, or the like. Additionally, the coating can include hydrophilic and/or hydrophobic compounds, polypeptides, proteins, amino acids, polyethylene glycols, parylene, heparin, phosphorylcholine, or the like.

The coatings can also be provided on the suturing device 300 or portion thereof to facilitate the loading or delivery of beneficial agents or drugs, such as therapeutic agents, pharmaceuticals and radiation therapies. As such, the material and/or holes can be filled and/or coated with a biodegradable material.

FIGS. 10A-11A further illustrates that the suturing device 300 can include one or more balloons 304 secured to the foot 106a. The balloons 304 can be inflated by sending air or another fluid into a balloon lumen 306 extending from the shaft 104a into the foot 106a (e.g., a connector, such as a luer, can be couple to a proximal end of the balloon lumen 306 to allow connection to a fluid source). Once inflated, the balloons 304 can effectively increase the surface area of the tissue location surface 144 and aid in locating the tissue surrounding an opening in a body lumen to be closed, as explained in greater detail below. One will appreciate that a medical practitioner can inflate the balloons 304 after receiving an indication from the position indicator 312 that the foot 106a is in a position ready for deployment. In particular, the balloons 304 can be inflated prior actuating the foot actuator mechanism 302 to deploy the foot 106a or after deploying the foot 106a.

In any case, the balloons 304 can help ensure that the foot 106a cannot be proximally withdrawn back through the body lumen when the foot 106a and shaft 104a are compressed together to draw tissue into the tissue port 118b. One will appreciate that the balloons 304 can provide the aforementioned functions without dilating or otherwise damaging the opening in the body lumen to be closed. In particular, because the balloons 304 can be deflated prior to passing the foot 106a distally or proximally through the body lumen, the balloons 304 can avoid damaging the tissue surround the opening of a body lumen to be closed.

FIGS. 13A-13I illustrate one implementation of a method of using the suturing device 300 to close an opening 210 in a body lumen 200. The method can include inserting the suturing device 300 in a distal direction into the body lumen 200. This can be accomplished with or without the use of a guidewire. FIGS. 13A-13I illustrate an example in which a guidewire 202 is used. It should be appreciated that, although the tissue tract 208 is illustrated at approximately 90° relative to the body lumen, the tissue tract 208 can be oriented at any number of suitable angles, which can vary from one embodiment to the next. For example, the tissue tract 208 can be oriented at a 45° relative to the body lumen 200.

As shown by FIG. 13A, the guidewire 202 may enter the body lumen 200 through an opening or puncture site 210 formed in the body lumen wall 212. The guidewire 202 may extend along the body lumen 200. As illustrated by FIGS. 13A-13B, the flexible guidebody 109a and the guidewire lumen 134 can be advanced over the guidewire 202 in a monorail fashion, so that the guidewire 202 helps direct the suturing device 300 along the tissue tract 208 into the body lumen 200 through the opening 210.

As shown by FIGS. 13A-13B, the suturing device 300 can be slowly advanced until the position port 310 passes by the body lumen wall 212. Once past the body lumen wall 212, blood pressure can cause blood to flow into the position port 310, proximally through the indicator lumen 308 to the position indicator (FIGS. 10A-11B). In alternative implementations, blood can pass out of the end of the indicator lumen 308, notifying the medical practitioner that the foot 106a is in a position within the body lumen 202, and is ready for deployment.

When the foot 106a is positioned within the body lumen 202, the medical practitioner can slide the foot actuation mechanism 302 distally along the handle 112a (FIGS. 10B and 11B), thereby causing the foot 106a to distally separate from the distal end 110 of the shaft 104a, as shown by FIG. 13C. In other words, the foot 106a can be articulated from a first configuration, in which the tissue location surface 144 of the foot 106a is abutted against the distal end 110 of the shaft 104a, to a deployed position, in which the tissue location surface 144 of the foot 106a is distally separated from the distal end 110 of the shaft 104a. As illustrated by FIG. 13C, by deploying the foot 106a, a tissue port 118b can be opened between the foot 106a and the shaft 104a. Once in the deployed position, the medical practitioner can compress a locking mechanism 324 (FIGS. 12A and 12B) to lock the foot 106a relative to the shaft 104a.

As shown by FIG. 13D, the medical practitioner can optionally inflate the one or more balloons 304. The balloons 304 can effectively increase the surface area of the tissue location surface 144 of the foot 106a. The medical practitioner can then slowly retract the suturing device 300 until resistance is felt when the tissue location surface 144 and/or the balloons 304 abut against the inner surface of the body lumen wall 212. By so doing, the distal end 110 of the shaft 104a can pass back through the opening 210 in the body lumen

Once the shaft 104a is located on the proximal side of the body lumen wall 212, and the foot 106a is positioned on the distal side of the body lumen wall 212, the tissue 214 of the body lumen wall 212 adjacent the opening 210 can at least partially rebound or otherwise extend into the tissue port 118b, as shown by FIG. 13D. At this point, with the foot 106a locked in place, the medical practitioner can disengage the locking mechanism 324 (FIGS. 12A-12B). After the locking mechanism 324 is disengaged, the biasing member 318 (FIG. 10A), if included, can draw the shaft 104a and the foot 106a together. Otherwise, the medical practitioner can manually draw the shaft 104a and the foot 106a together using the foot actuation mechanism 302. The action of the foot 106a and the shaft 104a compressing toward each other can draw the tissue 214 further into the tissue port 118b, as depicted in FIG. 13E. In other words, the distal surface 110 of the shaft 104a and the tissue location surface 144 of the foot 106a can draw or push the tissue 214 into the tissue port 118b toward the spinal member 116b.

Next the medical practitioner can optionally lock the foot 106a in place relative to the shaft 104a using the locking mechanism 324 (FIGS. 12A and 12B). If the suturing device 300 includes a biasing member 318, the foot 106a may not be locked in place at this point. In any event, once the tissue 214 is positioned within the tissue port 118a, the needles 122, 124 can be deployed as shown in FIG. 13F. In particular, needles 122, 124 can be advanced in a distal direction within the needle lumens 126, 128, out of the needle exit openings 130, 132, distally across the tissue port 118a through the tissue 214, and into the needle capture devices 136, 138, as indicated by the arrows of FIG. 13F. This can be done by pushing the needle actuation handle 114a into the handle 112a (FIGS. 10A and 11A). The needles 122, 124 and needle capture devices 136, 138 can then be withdrawn out of the foot 106a, proximally across the tissue port 118b through the tissue 214, and out of the proximal end suturing device 300, as depicted by the arrows in FIG. 13G. One will appreciate that withdrawing the needles 122, 124 and needle capture devices 136, 138 can at least partially withdraw the proximal ends of the suture 140 from the foot 106a, allowing the ends of the suture 140 to be retrieved by the medical practitioner.

Furthermore, as shown by FIG. 13G, as the needles 122, 124, are withdrawn, the distal end of the suture 140 (i.e., the suture loop) can be pulled from the guidebody 109a and foot 106a via the suture exit slot 160a.

At this point, or before or after, if desired, the medical practitioner can withdraw the guidewire 202 from the body lumen 200 and the suturing device 300, as shown by FIG. 13H. FIG. 13H illustrates that the suturing device 300 can then be withdrawn from the body lumen 200 and out of the tissue tract 208. The medical practitioner can articulate the foot 106a from the deployed position to the first position using the foot actuation mechanism 302 either before or during the withdrawal of the suturing device 300. Once the suturing device 300 has been removed, the suture 140 can be employed to close the opening 210 in the body lumen 200, as shown by FIG. 13I. In particular, a surgical knot 158 can be tied thereby closing the opening in the body lumen 200.

In one or more embodiments, the foot of the suturing device may be interchangeable and may be selected and coupled to a particular shaft based on the size of the opening in the body lumen that is intended to be closed. Thus, the user can select a suitable foot that corresponds with the opening in the body lumen. For example, a larger sized foot may be selected for closing larger openings, and a smaller sized foot can be chosen for closing smaller openings in the body lumen.

The larger sized foot can have tissue ports located or formed thereon such that the tissue surrounding the larger opening may be captured within the tissue ports. For instance, the tissue ports of the larger foot may be located at an appropriate distance from the center axis of the suturing device, such as to correspond with the dimensions of the opening that is intended to be closed by the suturing device. Similarly, the smaller sized foot may have tissue ports that accommodate capturing the tissue surrounding the smaller openings in the body lumen. Additionally, the needle capturing devices, located in the foot of the suturing device, may be positioned at an appropriate distance from the center axis of the suturing device, such that the needle capturing devices are located over the tissue surrounding the opening, and the needles may pass through the tissue and into the needle capturing device.

Moreover, while the foot of the suturing device may be interchangeable to accommodate closure of a particular sized opening in the body lumen, in some embodiments, the shaft of the device may remain unchanged irrespective of the particular foot that is being used. The shaft may be adjusted to correspond with the particular foot being used in the suturing device. More specifically, the needle lumens of the shaft may be adjusted and/or may be moved to a position that would allow the needles to exit the needle lumens and pass through the tissue. Furthermore, after adjusting the shaft, the needles can be aligned with the needle capture devices located in the corresponding foot. For example, adjusting the shaft can include moving the needle exit openings outward, so the needles exit the shaft at locations that allow the needles to couple with the needle capture devices.

In further embodiments, the suturing device may include a guide member that secures the foot. The guide member can be slidably positioned within the shaft. Thus, the foot can move together with the guide member, as the guide member slides or moves relative to the shaft of the suturing device. The user may position the guide member and at least a portion of the foot in the opening of the body lumen, such that the foot and/or the guide member can capture at least a portion of the tissue surrounding the opening.

In some embodiments, the needles can be housed in the shaft, as described above. However, the guide member also may house the needles and at least a portion of the suture.

Thus, the needles located in the guide member can be advanced proximally, toward the shaft and can enter needle lumens in the shaft. Furthermore, the foot may have one or more channels or lumens that can guide the needles from the guide member and toward the needle openings (leading up to the needle lumens) in the shaft.

Referring now to FIG. 14 which illustrates one embodiment of a suturing device 400 that incorporates an interchangeable foot. The suturing device 400 may be substantially the same as any one of the suturing devices 100, 100a, 300 (FIGS. 1-13I), and combinations thereof, except as described below. The suturing device 400 may have a body 402 that includes a shaft 404 and an interchangeable foot 406. As noted above, the foot 406 can be removable and replaceable. The foot 406 also can be chosen by the user based on the size of the opening in the body lumen that is intended to be closed.

The shaft 404 may have a proximal end 408 and a distal end 410, the proximal end 408 being closer to the user of the suturing device 400. Additionally, the suturing device 400 can have a handle 412, which can help the user to grasp and hold the suturing device 400 during the operation thereof. The suturing device 400 also may have an actuation handle 414 that may actuate the suturing device 400 (e.g., by engaging the needles with the needle capture devices, as further described below).

In some embodiments, as noted above, the foot 406 is coupled to a guide member 416. The guide member 416, in turn, may be slidably located within the shaft 404. Accordingly, the foot 406 may move together with the guide member 416 relative to the shaft 404. For instance, the foot and the guide member can move in a distal and/or proximal direction along the center axis of the shaft 404.

Furthermore, the user may select an appropriately sized foot 406, for example, based on the size of the opening in the body lumen. Thus, suturing device 400 can have an interchangeable foot 406, such that the foot 406 of a first size may be selected, coupled to, and/or removed from the guide member 416. The foot 406 also may be substituted for another foot of a different size and/or shape. Similarly, the foot 406 and the guide member 416 (as a coupled pair or a single unit) may be selected and exchanged as the single unit. In any case, the user may choose and/or replace a previously chosen foot 406, such that the foot 406 is appropriately sized relative to the opening in the body lumen.

The foot 406 can have one or more tissue ports 418, which can accept tissue surrounding the opening in the body lumen. As described above, the size of the foot 406 can be selected based on the size of the opening that is intended to be closed. Hence, the size, locations, and shapes of the tissue ports 418 may correspond with a particular size of the opening. In other words, the tissue ports 418 can be sized such that tissue surrounding the opening fits within the tissue ports 418.

In some embodiments, the shaft 404 can house multiple needles, such as needles 430, 432. The 430, 430 can pass through the tissue ports 418, thereby passing through the tissue surrounding the opening. To allow the needles 430, 432 to pass through the tissue ports 418, the foot 406 can have clearance slots (or holes) 419.

In one or more embodiments, the shaft 404 can have multiple leafs 448, which can be located near the distal end 410 of the shaft 404. For example, the shaft 404 can have multiple slots 405, which can divide or section the distal portion of the shaft 404, thereby forming multiple leafs 448. As further described below, the leafs 448 can flex outward thereby flexing the needles 430, 432 to a predetermined angle. As such, the user can adjust the size of the shaft 404 by flexing the leafs 448, such as to facilitate closure of an opening of a particular size. The leafs 448 also can flex inward (i.e., substantially back to their original positions).

Moreover, the shaft 404 also may have different configurations, which may depend on the particular foot 406 that is used. For instance, as illustrated in FIG. 15A, a suturing device 400a can have a shaft 404a that can be used together with a foot 406a. Similar to the suturing device 400 (FIG. 14), the suturing device 400a may be substantially the same as any one of the suturing devices 100, 100a, 300, and combinations thereof (FIGS. 1-13I), except as described below. In some embodiments, the suturing device 400a can have a guide lumen 420 that can be configured to accept the guide member 416.

Specifically, the guide lumen 420 may be sized such that guide member 416 can freely slide in the proximal and/or distal direction along a length of the guide lumen 420 (i.e., the guide member 416 can have a slip fit within the guide lumen 420). In some embodiments, at least a portion of the guide lumen 420 can have a clearance (e.g., approximately 0.005″) between the outside wall of the guide member 416 and the wall of the guide lumen 420. It should be noted that the clearance can vary from one embodiment to another.

Also, in one or more embodiments, at least a portion of the guide lumen 420 can have friction or interference fit with the guide member 416. For example, an interference-fit portion 421 of the guide lumen 420 can have an interference fit, while a slip-fit portion 422 can have a slip fit with the guide member 416. Consequently, the user may force the guide member 416 along the guide lumen 420, such that the guide member 416 slides along the guide lumen 420 when the user applies a force thereto. When the user stops applying force to the guide member 416, however, the guide member 416 may remain fixed within the guide lumen 420. The lengths of the interference-fit portion 421 and/or the slip-fit portion 422 may vary from one implementation to another.

In some implementations, the length of the interference-fit portion 421 or of the slip-fit portion 422 may be the same as the length of the guide lumen 420. Furthermore, the clearance between the guide member 416 in the guide lumen 420 along the slip fit portion 422 can vary and can be greater or less than 0.005″. Accordingly, the ease of movement or the amount of force necessary to move the guide member 416 along the guide lumen 420 also can vary from one embodiment to another.

Additionally or alternatively, the suturing device 400a can include a clip or clamp that can secure the guide member 416 to the shaft 404a, to prevent relative movement thereof. Also, the user can hold the guide member 416 during the procedure, in order to keep the guide member 416 and/or the foot 406a stationary relative to the shaft 404a. In any event, the guide member 416 and the foot 406a can remain fixed at a desired position relative to the shaft 404a.

Once the user selects an appropriately sized foot, such foot (e.g., the foot 406a) can be coupled to the guide member 416. For example, the foot 406a can have an attachment lumen 424 that can accept the guide member 416. In at least one embodiment, the foot 406a also may have one or more snap-in features 426. The snap-in features 426 may correspond with protrusions 428 on the guide member 416. Thus, the foot 406a can slide over the guide member 416, such that the snap-in features 426 snap over the protrusions 428, thereby securely coupling the foot 406a to the guide member 416.

It should be appreciated that other implementations may include various types of connections between the foot 406a and the guide member 416, which may permanently or removably couple the foot 406a to the guide member 416. For example, the foot 406a and the guide member 416 can have corresponding locking tapers, such as the foot 406a can be coupled and locked to the guide member 416. Additionally or alternatively, the foot 406a and the guide member 416 may form an interference fit therebetween, such that the foot 406a is securely coupled to the guide member 416. Moreover, in some instances, the foot 406a may be permanently bonded to the guide member 416, such as by gluing or welding the foot 406a to the guide member 416.

The guide member 416 and, consequently, the attachment lumen 424 can have a non-circular cross-sectional shape, which can radially orient the foot 406a relative to the shaft 404a. In other words, the corresponding cross-sectional shapes of the guide member 416 and the attachment lumen 424 may prevent the foot 406a from rotating about the guide member 416. For instance, the guide member 416 can have a non-cylindrical shape (e.g., partially elliptical and partially circular shape, square, etc.), such that the foot 406a can fit over the guide member 416 only in a single, predetermined axial orientation. Similarly, the cross-sectional shape of the guide lumen 420 and of the attachment lumen 424 can correspond with the cross-sectional shape of the guide member 416. Thus, radial orientation of the shaft 404a, foot 406a, and guide member 416 can be fixed relative to each other.

Fixing the radial orientation of the foot 406a (e.g., about the center axis of the suturing device) relative to the shaft 404a can ensure that the needles can engage the needle capture devices located in the foot 406a. In other embodiments, the foot 406a can be radially fixed with respect to the shaft 404a using various other connections. For example, as described above, the foot 406a may be permanently coupled to the guide member 416. Accordingly, the foot 406a may have a permanent radial orientation with respect to the guide member 416.

In one or more embodiments, the guide member 416 can extend past a distal end of the foot 406a. Accordingly, the user can feed at least a portion the guide member 416 through the opening in the body lumen. As the guide member 416 is fed through the opening an into the body lumen, the foot 406a can remain attached to and can move together with the guide member 416. In some instances, the foot 406a may remain outside of the patient's body, while the guide member 416 is initially positioned within the body lumen.

Additionally or alternatively, the suturing device 400a also can include a guidewire (e.g., similar to the guidewire 202 (FIG. 7A)), which can pass through the guide member 416. Hence, first the guidewire can be inserted through the opening and into the body lumen, and, subsequently, the guide member 416 together with the foot 406a can slide over the guidewire and moved into position within the opening. Consequently, in some embodiments, the guide member 416 need not and may not protrude past the distal end of the foot 406a.

Similar to the suturing devices described above, in connection with FIGS. 1-13I, the suturing device 400a also can include multiple needles, such as needles 430, 432 coupled to the actuation handle 414. Such needles 430, 432 (more specifically, respective piercing ends 431, 433 of the needles 430, 432) can engage and couple to corresponding needle capture devices 434a, 436a. The needle capture devices 434a, 436a can be similar to or the same as the needle capture devices 136, 138 (FIGS. 3, 4). In some embodiments, the needle capture devices 434a, 436a can be positioned substantially parallel to the center axis of the suturing device 400a. Alternatively, as described in more detail below, the needle capture devices 434a, 436a can be oriented on an angle relative to the center axis. The needles 430, 432 can slide in the proximal and/or in the distal direction within corresponding needle lumens 438, 440, located in the shaft 404a. Moreover, the needles 430, 432 can exit the shaft 404a at respective needle exit openings 439, 441, which may be located at the distal end 410a. In other words, the needle lumens 438, 440 can terminate at the needle exit openings 439, 441, at the distal end 410a for the shaft 404a.

The needle capture devices 434a, 436a can be connected to each other by a length of suture 442. The length of suture 442 can be located in and/or secured to the foot 406a (e.g., as described above in connection with FIGS. 1-13I). Thus, as the needles 430, 432 move in the proximal direction, the length of suture 442 can be removed and/or detached from the foot 406a. Moreover, after the length of suture 442 is removed and/or detached from the foot 406a, the suturing device 400a can be removed from the opening in the body lumen, without interfering with the length of suture 442.

The foot 406a can have a distal end 444 and a proximal end 446a. In some embodiments, the distal end 444 can have a substantially conical shape, which can facilitate entry of the foot 406a into to the opening in the body lumen. In other embodiments, however, the distal end 444 of the foot 406a can have other suitable shapes, such as semi-spherical, spherical tapered, etc. Hence, as noted above, the shape and size of the distal end 444 of the foot 406a can vary from one embodiment to the next, which may depend on the shape and size of the opening in the body lumen.

Similarly, the proximal end 446a and the distal end 410a also can have various shapes, which may correspond with each other. For instance, the proximal end 446a can be substantially flat and can correspond with a substantially flat distal end 410a. In other embodiments, the proximal end 446a and/or the distal end 410a can have other suitable shapes.

Additionally, as described above, the foot 406a can be fixed to the guide member 416. Accordingly, the user can move the foot 406a with respect to the shaft 404a by moving the guide member 416. Similarly, as the guide member 416 moves within the guide lumen 420, when the foot 406a is coupled to the guide member 416, the foot 406a also can move relative to the shaft 404a, either in the proximal direction (i.e., toward the user) or in the distal direction.

As also noted above, the guide member 416 can be secured at a desired position within the guide lumen 420. Thus, the foot 406a can be secured at a desired position with respect to the shaft 404a. For example, in a pre-deployed configuration the proximal end 446a of the foot 406a can be separated by a distance from the distal end 410a of the shaft 404a. By contrast, in the deployed configuration, the proximal end 446a can abut the distal end 410a. The foot 406a can move toward the shaft 404a, such that the proximal end 446a abuts the distal end 410a, and the foot 406a can remain in such the (deployed) position. Thus, in the embodiment illustrated in FIG. 15A, in the deployed configuration, the flat proximal end 446a can abut the flat distal end 410a and the suturing device 400a can remain in such configuration. As the guide member 416 moves in the distal direction, the proximal end 446a can move away from the distal end 410a.

As the foot 406a enters the opening in the body lumen, the tissue surrounding the opening can be captured in the tissue ports of the foot 406a. In one embodiment, the foot 406a can have multiple tissue ports, such as tissue ports 418a′, 418a″. In other embodiments, the foot 406a can have a single tissue port, which can receive and capture substantially all of the tissue surrounding the opening. For example, the tissue port can surround the entire perimeter of the foot 406a. Additionally, (as described above) the foot 406a can have clearance slots 419a′, 419a″ that can allow the needles 430, 432 to pass through the tissue ports 418a′, 418a″.

The distal end of the shaft and the proximal end of the foot of the suturing device also can have non-flat configurations. For instance, as illustrated in FIG. 15B, a suturing device 400b can have shaft 404b that has a non-flat distal end 410b. The suturing device 400b may be substantially the same as the suturing device 400a (FIG. 15A), except as otherwise described herein. The suturing device 400b can have a foot 406b that can have a proximal end 446b. As described above, the shape of the proximal end 446b can correspond with the shape of the distal end 410b.

More specifically, the foot 406b can have the proximal end 446b that has a tapered (conical) shape. The distal end 410b also can have a tapered shape (e.g., a cone-shaped or a tapered cavity in the distal end 410b). The tapered shape of the proximal end 446b can correspond with the tapered shape of the distal end 410b. For example, the tapered shapes of the corresponding proximal end 446b and distal end 410b can have an approximately 45° angle. An at least one other embodiment, however, the distal end 410b and of the proximal end 446b can have locking angle (e.g., 3° included angle) tapers, which can operate in a similar manner as a luer fitting. Accordingly, when the proximal end 446b is pressed into the distal end 410b, the proximal end 446b can be locked inside of the distal end 410b, thereby securing the foot 406b to the shaft 404b.

Alternatively, the angle of the tapered shapes of the distal end 410b and/or of the proximal end 446b can be non-locking (e.g., self-releasing angle). Consequently, in some embodiments the proximal end 446b may not be locked inside of the distal end 410b. However, the user can secure the proximal end 446b within or abutting the distal end 410b by securing the guide member 416 with respect to the shaft 404b, as described above.

The shaft 404b can have multiple leafs, such as the leaf leafs 448b, which can move outward in response to the pressure applied by the taper of the proximal end 446b on the taper of the distal end 410b. In other words, as the proximal end 446b moves deeper into the distal end 410b, the leafs 448b can flex outward to accommodate the proximal end 446b within the distal end 410a.

In at least one embodiment, the foot 406b can have a stop surface, which can define the most proximal portion of the proximal end 446b. The stop surface can determine the maximum depth of entry of the proximal end 446b into the distal end 410b. More specifically, the stop surface can bottom out on a corresponding limiting surface in the distal end 410b (not shown). Thus, as the stop surface presses against the limiting surface in the distal end 410b, the proximal end 446b reaches a predetermined depth within the distal end 410b.

Consequently, at a predetermined depth, the foot 406b can flex the leafs 448b outward by a predetermined amount. More particularly, the leafs 448b can be flexed to form a predetermined angle therebetween and relative to the center axis of the suturing device 400b.

The suturing device 400b also can include needle lumens 438, 440. Particularly, the needle lumens 438, 440 can guide the needles 430, 432 toward the foot 406b, as the user pushes the actuation handle 414 in the distal direction. Furthermore, in some embodiments, needle lumen portions 454, 455 can be located within the leafs 448b. Thus, when the leafs 448b flex outward to a predetermined angle, the needle lumen portions 454, 455 also can flex outward to a predetermined angle.

As the needles 430, 432 move within the corresponding needle lumens 438, 440 and enter the needle lumen portions 454, 455 located in the leafs 448b, the needles 430, 432 also can be at least partially flexed to a predetermined angle. Hence, the piercing ends 431, 433 can move toward and approach the foot 406b at a predetermined angle (i.e., not parallel to each other). Accordingly, in one or more embodiments, the foot 406b can house needle capture devices 434b, 436b that are positioned at an angle 456 relative to each other and relative to the center axis of the suturing device 400b. More specifically, the angle 456 can be greater than zero (i.e., orientations of the needle capture devices 434b, 436b may be non-parallel to each other).

Furthermore, the angle 456 can be the same as the angle formed between the needles 430, 432, when the leafs 448b flex outward to a predetermined angle. Thus, as the needles 430, 432 move through the portions 450, 454, the needles 430, 432 can align with the needle capture devices 434b, 436b. Consequently, movement of the actuator handle 414 can move the needles 430, 432 in the distal direction, such as to engage the needle capture devices 434b, 436b. Particularly, the needles 430, 432 can pass through the clearance slots 419a′, clearance slots 419a″, pass through the tissue ports 418b′, 418b″, pass through the tissue surrounding the opening (as described below), and enter the needle capture devices 434b, 436b.

As noted above, the foot 406b can be chosen at least in part based on the size and/or shape of the opening in the body lumen. In at least one embodiment, the suturing device 400b can have the same shaft 404b for closing openings of different sizes, by choosing an appropriately sized corresponding foot 406b. For example, a first size of the foot 406b can have a distal end 444b sized and configured to enter the opening of a first size. Likewise, the tissue ports 418b′, 418b″ can be sized and configured to receive the tissue surrounding the first size opening. Furthermore, the needle capture devices 434b, 436b also can be located such that before entering the needle capture devices 434b, 436b, the piercing ends 431, 433 pass through the tissue surrounding the opening in the body lumen. Similarly, the foot 406b of a second size can have the distal end 444b, tissue ports 418b′, 418b″, and the needle capture devices 434b, 436b sized, configured, and located (as applicable to each) in a manner that allows the piercing ends 431, 433 to pass through the tissue surrounding the opening of a second size, and enter the needle capture devices 434b, 436b.

Thus, on the first size foot 406b, the stop surface 452 can be located at a first position, which can allow the proximal end 446b to enter into the distal end 410b and flex the leafs 448b and, consequently, the needle lumen portions 454, 455 to a first predetermined position (i.e., to a predetermined angle). The leafs 448b and the needle lumen portions 454, 455 at the first predetermined angle can correspond with the angle 456 of the first size foot 406b. Accordingly, when the suturing device 400b that has the first size foot 406b is in the deployed configuration, and the proximal end 446b is at its most proximal position with respect to the distal end 410b, the piercing ends 431, 433 can enter and engage the needle capture devices 434b, 436b.

Likewise, when the suturing device 400b that has the second size foot 406b is in the deployed configuration, and the proximal end 446b is at its most proximal position with respect to the distal end 410b, the piercing ends 431, 433 can enter and engage the needle capture devices 434b, 436b. As noted above, the needle capture devices 434b, 436b can be spaced farther apart from each other as compared with the first size foot 406b. The locations of the needle capture devices 434b, 436b and the angle 456 therebetween can correlate with the location of the stop surface 452, as the stop surface 452 can determine the predetermined angle at which the needles 430, 432 can exit the needle lumens 440, 438. Furthermore, positions and angles of the needle capture devices 434b, 436b and location of the stop surface 452 also can correlate with a particular size of the foot 406b, and, more specifically, with a particular size and shape of the distal end 444b. In any event, the suturing device 400b can accept the foot 406b of any size, in a manner that allows the piercing ends 431, 433 to engage the needle capture devices 434b, 436b located in the foot 406b of that particular size.

In some instances, the opening in the body lumen may have a substantially circular shape. Hence, the suturing device can incorporate a foot that has circular or cylindrically shaped tissue ports. Furthermore, the foot of the suturing device also can have but is not limited to a circular cross-section. For example, as illustrated in FIG. 16A, the foot 406 can have a substantially circular shape (as noted above the distal end of the foot 406 can be tapered or generally angled, to facilitate entry of the foot 406 and the tissue ports 418 into the opening).

Additionally, the foot 406 can have needle capture devices 434, 436 located around the tissue ports 418, in a manner that the piercing ends of the needles can pass through the tissue surrounding the opening in the body lumen, before entering the needle capture devices 434, 436. In other words, locations of the needle capture devices 434, 436 as well as positions thereof may depend on the particular size and shape of the foot 406 and of the tissue ports 418, which can correspond with the particular size and shape of the opening in the body lumen. In the embodiment illustrated in FIG. 16A, the foot 406 has two needle capture devices 434, 436. One will appreciate, however, that this disclosure is not so limited. More specifically, the foot 406 can have any number of needles capture devices positioned at different locations on the foot 406, which may vary from one embodiment to another. Similarly, the shaft can accommodate any number of needles that may correspond with the needles capture devices on or in the foot 406. Furthermore, the foot 406 can have a greater number of needles capture devices than the needles located in the shaft of the suturing device. In some embodiments, the guide lumen 420 also can have a substantially circular cross-sectional shape, which can accept correspondingly sized and shaped guide member.

As noted above, the foot 406 also can have snap-in features 426 that can secure the foot 406 to the guide member. In some instances, it may be desirable to remove the foot 406 from the guide number and/or to replace the foot 406 with the foot 406 of a different size. In at least one embodiment, the user can remove the foot 406 from the guide member by pressing on opposing sides of the foot 406, as illustrated with the arrows in FIG. 16B, such as to deform the foot 406. Particularly, the deformation caused by the pressure applied along an axis approximately perpendicular to the axis on which the snap-in features 426 lie can force the snap-in features 426 to move outward as indicated with the arrows. Consequently, as the snap-in features 426 move outward, the snap-in features 426 also move away from the corresponding protrusions on the guide member, thereby releasing the foot 406 from the guide member. Subsequently, the foot 406 can be removed from the guide number and or replaced with another foot 406 (e.g., foot 406 of a different size and/or shape).

In some embodiments, the body of the suturing device can be adjusted independent of the foot thereof. In other words, positions or angles of the leafs can be adjusted without having the proximal end of the foot enter the distal end of the body. For example, FIGS. 17A-17B illustrate one embodiment of a suturing device 400c that incorporates a shaft 404c, which can adjust angles of the leafs without having any portion of a foot 406c enter the any portion of the shaft 404c. It should be noted that, except as otherwise described herein, the suturing device 400c may be substantially the same as the suturing device 400a (FIG. 15A) and/or the same as the suturing device 400b (FIG. 15B).

In some embodiments, the suturing device 400c can include a dial adjustment 520 which can flex leafs 448c outward. More specifically, the dial adjustment 520 can include a knob 522 connected to or integrated with a threaded rod 524. Additionally, the dial adjustment 520 can incorporate a wedge 526 that can be secured to or integrated with a distal end of the threaded rod 524. The shaft 404c can have a threaded channel 528 that can accept the threaded rod 524. Consequently, rotation of the threaded rod 524 can advance and retract the threaded rod 524 along the threaded channel 528 (as the threads of the threaded rod 524 and the threaded channel 528 mesh and interact with each other).

For example, the threaded rod 524 and the threaded channel 528 can have respective right-handed external and internal threads. Thus, as the threaded rod 524 rotates in a clockwise direction, the threaded rod 524 can advance along the threaded channel 528 in the distal direction. Similarly, as the threaded rod 524 rotates in a counterclockwise direction, the threaded rod 524 can advance along the threaded channel 528 in the proximal direction. In other embodiments, the threaded rod 524 and the threaded channel 528 can have respective left-handed external and internal threads. As such, rotation of the threaded rod 524 in the clockwise direction can advance the threaded rod 524 in the proximal direction, while rotating the threaded rod 524 in the counterclockwise direction can advance the threaded rod 524 in the distal direction.

The wedge 526 can have a distal end 530 that may have a substantially wedge-like shape or conical shape (i.e., a taper). Each of the leafs 448c also can have proximal ends 532 that have tapers, which can correspond with the taper of the distal end 530. As the dial adjustment 520 moves in the distal direction, the distal end 530 can engage and press against the tapes of the proximal ends 532. Consequently, when the distal end 530 presses against the proximal ends 532, the leafs 448c can flex outward (FIG. 17B).

In one or more embodiments, a top surface 533 of the shaft 404c can have markings that can correspond with one or more markings on the knob 522 of the dial adjustment 520. Such markings can allow rotation of the dial adjustment 520 by a predetermined amount and/or to a predetermined angular position. When the dial adjustment 520 rotates to a predetermined position, the wedge 526 can advance by a predetermined amount toward the distal end of the shaft 404c. Consequently, the wedge 526 can push on the distal end 530 by a predetermined amount, thereby flexing the leafs 448c to a predetermined angle. In other words, the leafs 448c of the suturing device 400c can be dialed to a predetermined angular position, thereby reconfiguring the suturing device 400c into a deployed configuration.

As noted above, the predetermined angle of the leafs 448c can correspond with the predetermined angle of needle capture devices 434c, 436c located in the foot 406c. Furthermore, locations and angle of the needle capture devices 434c, 436c can be such as to allow the piercing ends 431, 433 of the needles 430, 432 to enter and engage the needle capture devices 434c, 436c. Also, locations and angle of the needle capture devices 434c, 436c can be at least in part based on the size of the opening which is intended to be closed by the suturing device 400c.

In some embodiments, a proximal end 446c can have an inward-facing tapered surface 534. Furthermore, the angle of the inward-facing tapered surface 534 can correspond with the angle formed by the leafs 448c and the deployed configuration. For instance, surfaces 536c, which define the lowermost portion of the leafs 448c, can be substantially perpendicular to the center axis of the shaft 404c. Accordingly, as the leafs 448c flex outward into the deployed configuration, the surfaces 536c can form an angle with respect to the center axis of the shaft 404c. Such angle may be a complementary angle of the predetermined angle formed by the leafs 448c. Consequently, if the foot 406c moves in the proximal direction, such that the inward-facing tapered surface 534 comes into contact with the surfaces 536c, the inward-facing tapered surface 534 and the surfaces 536c can seamlessly abut one another (FIG. 17B).

Additionally, matching the inward-facing tapered surface 534 with the surfaces 536 can help to further locate the foot 406c relative to the shaft 404c. Such locating can facilitate proper engagement of the needles 430, 432 with the needle capture devices 434c, 436c. As described above, the foot 406c can be moved in the proximal direction by moving the guide member 416 in the proximal direction. Furthermore, the foot 406c also can have the snap-in features 426, which can snap about the protrusions 428 of the guide member 416, thereby securing the foot 406c to the guide member 416.

In at least one embodiment, the guide member 416 can have an upper attachment lumen 424c′ and a lower attachment lumen 424c″. The upper attachment lumen 424c′ can have a larger cross-section than the lower attachment lumen 424c″. Thus, the foot 406c can be inserted over the guide member 416, such that the upper attachment lumen 424c′ can pass over the guide member 416, followed by the snap-in features 426 passing over and engaging the protrusions 428, and followed by the lower attachment lumen 424c″. In any event, the foot 406c can be located about the upper attachment lumen 424c′ and/or about the lower attachment lumen 424c″.

Although the suturing devices described above provide the needles from a proximal portion of the device (i.e. from the body), and can move the needles in the distal direction, it should be noted that this disclosure is not so limited. For instance, as illustrated in FIG. 18, a suturing device 400d can have needles 430b, 432d that can move from the distal portion of the suturing device 400d to the proximal portion thereof. Particularly, the suturing device 400d can include a guide member 416d that can house the needles 430d,

Additionally, the guide member 416d can house a cable 540. The cable 540 can be connected to the needles 430d, 432d. Thus, when the cable 540 moves in the proximal direction, the needles 430d, 432d also can move and the proximal direction. The guide member 416d is more fully described in the U.S. Pat. No. 7,445,626, entitled “Device and Method for Suturing Tissue,” the entire content of which is incorporated herein by reference.

Similar to the suturing device 400b (FIG. 15B), the suturing device 400d can include a shaft 404d and a foot 406d. The foot 406d can couple to the guide member 416d (in any number of ways, as described above). At least a portion of the guide member 416d can be located in and/or pass through the shaft 404d (i.e., through a guide lumen 420d within the shaft 404d). The shaft 404d also can have needle lumens 438d, 440d that terminate at first and second needle entrance openings 439d, 441d.

In some embodiments, a proximal end 446d of the foot 406d can have a tapered shape (similar to the proximal end 446b of the foot 406b (FIG. 15B)). Moreover, a distal end 410d of the shaft 404d can have an internal taper that can correspond with the taper of the proximal end 446d (similar to the suturing device 400b (FIG. 15B)). Thus, the proximal end 446d can enter the distal end 410d, thereby spreading leafs 448d outward. Also, the leafs 448d can be spread to a predetermined angle (as described above).

Needle lumen portions 454d, 455d can be located in the leafs 448d. Hence, when the leafs 448d flex to the predetermined angle, the needle lumen portions 454d, 455d also can flex to a predetermined angle, which can be the same as the predetermined angle of the leafs 448d. The foot 406d can include needle connector lumens 550, 552 which can channel the needles 430d, 432d from the guide member 416d and toward the needle entrance openings 439d, 441d of the needle lumen portions 454d, 455d, and, subsequently, through the needle lumens 438d, 440d. The needle connector lumens 550, 552 can be located at the same predetermined angle as the needle lumen portions 454d, 455d, which can facilitate seamless entry of the needles 430d, 432d into the needle lumen portions 454d, 455d.

Consequently, as the cable 540 moves in the proximal direction, the needles 430d, 432d also can move in the proximal direction and can exit the guide member 416d at corresponding needle exit openings. Subsequently, the needles 430d, 432d can enter the needle connector lumens 550, 552 and can be guided toward the needle entrance openings 439d, 441d of the needle lumens 438d, 440d. As the needles 430d, 432d move further in the proximal direction, the needles 430d, 432d can enter the needle lumen portions 454d, 455d, the needle lumens 438d, 440d, and can exit the shaft 404d at a proximal end thereof. After the needles 430d, 432d exit the shaft 404d, the user can grasp the needles 430d, 432d and can entirely remove the needles from the shaft 404d.

In addition to the needles 430d, 432d, the guide member 416d also can house the length of suture 442, opposing ends of which can be connected to the needles 430d, 432d. As the needles 430d, 432d exit the guide member 416, the needles 430d, 432d can pass through one or more tissue ports (e.g., through tissue ports 418d′, 418d″). As noted above, the tissue surrounding the opening in the body lumen can enter tissue ports 418d′, 418d″, after the foot 406d of the suturing device 400d enters the opening.

As the needles 430d, 432d move out of the needle connector lumens, the needles 430d, 432d can move together with the length of suture 442 and can pass through the tissue ports 418d′, 418d″ and through the tissue surrounding the opening, which can be positioned within the tissue ports 418d′, 418d″. Thus, at least a portion of the length of suture 442 can pass through the tissue surrounding the opening in the body lumen. In addition to removing the needles 430d, 432d from the shaft 404d, the user also can remove the suturing device 400d from the opening. Subsequently, the length of suture 442 can be used to close the opening.

Referring now to FIGS. 19A-19F; FIGS. 19A-19F illustrate an embodiment of a method of using the suturing device 400. It should be noted that the acts illustrated in FIGS. 19A-19F are equally applicable to all of the various embodiments of the suturing device, including but not limited to the embodiments of suturing devices 400a, 400b, 400c, 400d (FIGS. 15A-18). As illustrated in FIG. 19A, the guide member 416 can enter the body lumen 200 through the tissue tract 208 and then through the opening 210. More specifically, the tissue tract 208 can pass through the patient's skin 204 and through the tissue 206. The tissue tract 208 can connect with the opening 210 that passes through the lumen wall 212 and into the body lumen 200. As noted above, the suturing device 400 can move along or together with the guide member 416 into the opening 210. Alternatively, a guidewire can pass through the guide member 416 and into the body lumen 200, and the suturing device 400, together with the guide member 416, can move along the guidewire in to the opening 210.

As the guide member 416 enters the body lumen 200, the suturing device 400 can be in the pre-deployed configuration. In other words, the leafs 448 can be un-flexed or in an original position. Alternatively, as the guide member 416 enters the opening 210 in the body lumen 200, the suturing device 400 can be in the deployed configuration, with the leafs 448 flexed to the predetermined angle (the needles 430, 432 may be in a retracted position). Furthermore, in some embodiments, the proximal end of the foot 406 may be in contact with or separated from the distal end 410 of the shaft 404.

As illustrated in FIG. 19B, after the guide member 416 enters the body lumen 200, the foot 406 and the shaft 404 can move along or together with the guide member 416 through the tissue tract 208. As the suturing device 400 moves through the tissue tract 208, the foot 406 can pass through the lumen wall 212 and enter the opening 210. To the extent that foot 406 has a taper on the distal end thereof, such taper can facilitate the entry of the suturing device 400 into the tissue tract 208 and into the opening 210. Particularly, such taper can facilitate entry of the foot 406 into the opening 210.

As described above, the size and shape of the foot 406 can be chosen at least in part based on the size and shape of the opening 210. In some embodiments, the size of the foot 406 can be such as to dilate the opening 210 to a desired size and/or shape, as the foot 406 enters the opening 210. For example, the foot 406 can dilate the opening 210 to a desired size for closing the opening 210. The tissue 214 surrounding the opening 210 can at least in part tear in response to the dilation caused by the foot 406. In other words, the dilation of the opening 210 can be achieved in part by elastic stretching and in part by tearing.

By choosing an appropriately sized and/or shaped foot 406, the final size of the opening 210 (i.e., the size of the opening after stretching and/or tearing as the foot 406 passes into the body lumen 200) can be controlled. Furthermore, the final size of the dilated opening 210 can be such that would allow the needles 430, 432 to be deployed into the tissue surrounding the opening 210. Among other things, such dilation may eliminate or reduce the risk of tearing the suture out of the tissue 214 surrounding the opening 210 during the closure of the opening 210. It should be noted that tearing, including partial tearing, of the suture out of the tissue 214 can result in an incomplete closure of the opening 210.

Additionally, as illustrated in FIG. 19C, the tissue 214 can contract when the foot 406 passes into the body lumen 200 such that the tissue ports 418 can accept the tissue 214. Particularly, as the tissue 214 enters the tissue ports 418, the tissue 214 can contract within the tissue ports 418 such as to overlap needle capture devices 434, 436. In other words, the tissue 214 can close in around a center portion of the foot 406 located within the tissue ports 418. As the foot 406 captures the tissue 214 within the tissue ports 418, the user may be able to feel the resistance created by such capture to recognize that the suturing device 400 has reached a desired position for closing the opening 210.

In some embodiments, as the suturing device 400 passes through the tissue tract 208, the proximal end of the foot 406 can be pushed into the distal end of the shaft 404 thereby spreading the leafs 448 outward (as indicated by the arrows). As the leafs 448 spread to a predetermined position, the suturing device 400 is reconfigured into the deployed configuration, as described above. The guide member 416 can be pulled in the proximal direction. As the guide member 416 moves in the proximal direction, the foot 406 also can move and the proximal direction thereby entering the distal end of the shaft 404 and spreading the leafs 448. Additionally, as noted above, the leafs 448 can remain spread outward to a predetermined angle for a desired period of time or for desired steps or acts in the method of closing the opening in the body lumen 200.

Once the suturing device 400 is in the deployed position, the actuation handle 414 can actuate the needles 430, 432 (as indicated by the arrows). More specifically, the handle 414 can move the needles 430, 432 in the distal direction, toward the needle capture devices 434, 436. As the needles 430, 432 to pass through the needle lumen portions located in the leafs 448, the needles 430, 432 can flex out word to a predetermined angle which can match the angle of the needle capture devices 434, 436. Consequently, the needles 430, 432 can engage and couple to the needle capture devices 434, 436. Furthermore, when the needles 430, 432 pass through the tissue ports 418, the needles 430, 432 can enter and pass through the tissue 214. Hence, when the needles 430, 432 engage the needle capture devices 434, 436, the needles 430, 432 also can engage in pass through the tissue 214.

As illustrated in FIG. 19D, after the needles 430, 432 engage the needle capture devices 434, 436, the needles 430, 432 can be withdrawn (i.e., moved in the proximal direction), as indicated by the arrows. Thus, as the needles 430, 432 are withdrawn and move in the proximal direction, the needle capture devices 434, 436 as well as the length of suture 442 attached thereto can be pulled together with the needles 430, 432 through the tissue 214. The length of suture 442 can detach from the foot 406 and a portion of the length of suture 442 that is connected to the needle capture devices 434, 436 can enter and pass through the tissue 214. Furthermore, needle capture devices 434, 436 and the length of suture 442 can enter and pass through the respective needle lumens 438, 440 and or the proximal end of the shaft 404, exiting the needle lumens 438, 440 and the shaft 404.

Subsequently, as illustrated in FIG. 19E, the suturing device 400 can be withdrawn from the opening in the body lumen 200 and from the tissue tract 208. More specifically, the shaft 404 and/or the guide member 416 can move in the proximal direction, as indicated by the arrows. The user also can pull the guide member 416 in the proximal direction, thereby pulling on the foot 406 and on the shaft 404 and removing the suturing device 400 from the opening 210 and from the tissue tract 208.

In some embodiments, as the shaft 404 moves in the proximal direction, the distal end of the shaft 404 can separate from the proximal end of the foot 406, allowing the leafs 448 to contract or flex back to their original position, thereby reconfiguring the suturing device 400 into a post-deployed configuration. Also, as the suturing device 400 is removed from the opening 210, the length of suture 442 can remain within the tissue 214. Accordingly, the length of suture 442 can close the opening 210, after the suturing device 400 is removed from the opening 210. Particularly, as illustrated in FIG. 19F, after the suturing device is removed from the opening 210 and from the tissue tract 208, the needle capture devices can be removed from the length of suture 442. Alternatively, the needle capture devices can be removed from the needles and can remain attached to the length of suture 442.

Thereafter, the opening 210 can be closed to promote hemostasis. More specifically, the surgical knot 158 can be formed by tying the ends of the length of suture about the opening 210. Thus, the length of suture 442 together with the surgical knot 158 can pull together the tissue 214 surrounding the opening 210, thereby closing the opening 210.

The embodiments of the present disclosure 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 disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. For example, the sutures described herein can further be prearranged to define a pre-tied knot, such as the pre-tied knots disclosed in U.S. Pat. No. 7,235,087 previously incorporated herein. Additionally, the suturing devices of the present invention can further include barbed sutures, or be used to deploy cleats or other devices to aid in closing a body lumen opening. Furthermore, where structures, elements, acts, steps, or stages have been described with reference to a specified implementation or device; each of the individual structures, elements, acts, steps, or stages, or a combination thereof, are contemplated to be combinable with each other and with other implementations and devices described herein. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A method of closing an opening in tissue, the method comprising: advancing a suturing device through the opening in tissue, the suturing device comprising a proximal portion, a distal elongate portion selectively disposed in relation to the proximal portion, and a plurality of needles;inflating a balloon portion mounted to a foot of the distal elongate portion to increase a surface area of a tissue location surface of the distal elongate portion of the suturing device and subsequently positioning the tissue location surface against an inner surface of a wall of the tissue to prevent the distal elongate portion from being withdrawn proximally through the opening;compressing tissue between the proximal portion and the tissue location surface of the distal elongate portion to present the tissue towards the plurality of needles; andwithdrawing the plurality of needles proximally through the tissue compressed between the proximal portion and the distal portion and into the proximal portion.
2. The method of claim 1, wherein advancing the suturing device through the opening in tissue comprises advancing the suturing device through a tissue tract that is orientated at a 45-degree angle with respect to a longitudinal axis of a body lumen of the tissue.
3. The method of claim 2, further comprising advancing the suturing device along a guidewire placed through the opening.
4. The method of claim 3, further comprising retracting the guidewire from the opening following suturing the opening.
5. The method of claim 1, further comprising advancing the suturing device until blood flows through a position port to a position indicator.
6. The method of claim 1, wherein positioning the the tissue location surface against the inner surface of the wall of the tissue comprises withdrawing the suturing device proximally to contact the balloon portion against the inner surface of the wall of the tissue.
7. The method of claim 1, wherein a proximal end of the distal elongate portion ensures that tissue surrounding the opening is positioned, within a space between the proximal portion and the distal elongate portion, to receive the plurality of needles.
8. A method of closing an opening in a body lumen, the method comprising: advancing a suturing device through the opening in the body lumen, the suturing device comprising a proximal shaft, a distal elongate member selectively disposed in relation to the proximal shaft, and a plurality of needles;inflating a balloon portion mounted to a foot of the distal elongate member to increase a surface area of a tissue location surface of the distal elongate member of the suturing device and subsequently positioning the tissue location surface against an interior surface of a wall of the body lumen;compressing tissue of the wall between the proximal shaft and the tissue location surface to present the tissue towards the plurality of needles and draw the tissue into a space between the proximal shaft and the tissue location surface; andwithdrawing the plurality of needles proximally through the tissue compressed between the proximal shaft and the tissue location surface and into the proximal shaft.
9. The method of claim 8, wherein advancing the suturing device comprises advancing the suturing device through a tissue tract that is orientated at a 45-degree angle with respect to a longitudinal axis of the body lumen.
10. The method of claim 8, further comprising advancing the suturing device along a guidewire placed through the opening.
11. The method of claim 10, further comprising advancing the suturing device until blood flows through a position port to a position indicator.
12. The method of claim 8, wherein compressing the tissue comprises relative movement of the proximal shaft and the tissue location surface.
13. The method of claim 8, wherein the proximal shaft is biased towards the distal elongate member.
14. The method of claim 8, wherein the distal elongate member is biased towards the proximal shaft.
15. The method of claim 8, further comprising locking a position of the distal elongate member in relation to the proximal shaft.
16. A method of closing an opening in a body lumen, the method comprising: advancing a suturing device along a guidewire through the opening in the body lumen until blood flows through a position port to a position indicator, the suturing device comprising a proximal shaft, a distal elongate member selectively disposed in relation to the proximal shaft, and a plurality of needles;inflating a balloon portion mounted to a foot of the distal elongate member to increase a surface area of a tissue location surface of the distal elongate member of the suturing device and subsequently positioning the tissue location surface against an interior surface of a wall of the body lumen, the tissue location surface preventing the distal elongate member from being withdrawn proximally through the opening;following positioning the tissue location surface against the interior surface of the wall of the body lumen, sandwiching tissue between the proximal shaft and the tissue location surface of the suturing device to present the tissue towards the plurality of needles;withdrawing the plurality of needles proximally through the tissue sandwiched between the proximal shaft and the distal elongate member and into the proximal shaft to draw a suture across the opening; andremoving the suturing device and the guidewire and forming a knot in the suture to close the opening.
17. The method of claim 16, wherein the proximal shaft and the distal elongate member are biased towards each other.
18. The method of claim 16, further comprising locking a position of the distal elongate member in relation to the proximal shaft.
19. The method of claim 16, wherein sandwiching the tissue comprises relative movement of the proximal shaft and the distal elongate member.
20. The method of claim 16, wherein sandwiching the tissue comprises drawing the proximal shaft and the distal elongate member towards each other to draw the tissue into a space between the proximal shaft and the tissue location surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/186,730, filed Jun. 20, 2016, entitled “Suturing Devices and Methods”, now U.S. Pat. No. 10,463,353, which is a continuation of Ser. No. 13/791,858, filed Mar. 8, 2013, entitled “Suturing Devices and Methods”, now U.S. Pat. No. 9,370,353, which is a continuation-in-part of U.S. patent application Ser. No. 12/873,728, filed Sep. 1, 2010, entitled “Suturing Devices And Methods,”, now U.S. Pat. No. 8,663,252, the entire contents of which are incorporated by reference herein.

US Referenced Citations (650)

Number	Name	Date	Kind
312408	Wackerhagen	Feb 1885	A
597165	Hall	Jan 1898	A
659422	Shilder	Oct 1900	A
989231	Chamberlain	Apr 1911	A
989234	Davis	Apr 1911	A
1574362	Callahan	Feb 1926	A
1625602	Gould et al.	Apr 1927	A
1940351	Howard	Dec 1933	A
2012776	Hans	Aug 1935	A
2108206	Mecker	Feb 1938	A
2127903	Bowen	Aug 1938	A
2131321	Hart	Sep 1938	A
2371978	Perham	Mar 1945	A
2397823	Walter	Apr 1946	A
RE22857	Ogbrurn	Mar 1947	E
2588589	Tauber	Mar 1952	A
2595086	Larzelere	Apr 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	Verbish	May 1962	A
3104666	Hale et al.	Sep 1963	A
3197102	Bernice et al.	Jul 1965	A
3359983	Elmore	Dec 1967	A
3413397	Bierbaum et al.	Nov 1968	A
3422181	Daniel, 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	Heinrich	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	Frater 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	Fleischhacker	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	Ovil 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	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	Liu 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 et al.	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	Bagnato 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	Van 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	Berthold	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	Della 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	Schoeb 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	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	Hinchliffe	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 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	Zhongren	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 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
5868762	Cragg et al.	Feb 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 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
6464707	Bjerken	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	Sater	Apr 2003	B1
6551330	Bain et al.	Apr 2003	B1
6558399	Isbell et al.	May 2003	B1
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
6676685	Pedros et al.	Jan 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
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
6936054	Chu	Aug 2005	B2
6939357	Navarro et al.	Sep 2005	B2
6955643	Gellman et al.	Oct 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 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
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
7229458	Boecker et al.	Jun 2007	B2
7270672	Singer	Sep 2007	B1
7316704	Bagaoisan et al.	Jan 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
7393363	Ginn	Jul 2008	B2
7431727	Cole et al.	Oct 2008	B2
7442198	Gellman	Oct 2008	B2
7507200	Okada	Mar 2009	B2
7727249	Rahmani	Jun 2010	B2
7753923	St et al.	Jul 2010	B2
7833235	Chu	Nov 2010	B2
7935128	Rioux et al.	May 2011	B2
7967832	Chu	Jun 2011	B2
8057491	Modesitt et al.	Nov 2011	B2
8123762	Chu et al.	Feb 2012	B2
8512375	Torrie et al.	Aug 2013	B2
9820730	Chu	Nov 2017	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
20020049453	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
20030167063	Kerr	Sep 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
20040122449	Modesitt et al.	Jun 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
20040210251	Kontos	Oct 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 et al.	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
20050143761	Modesitt et al.	Jun 2005	A1
20050149065	Modesitt	Jul 2005	A1
20050149066	Stafford	Jul 2005	A1
20050149117	Khosravi et al.	Jul 2005	A1
20050171561	Songer et al.	Aug 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
20060079914	Modesitt et al.	Apr 2006	A1
20060089635	Young et al.	Apr 2006	A1
20060095029	Young et al.	May 2006	A1
20060100664	Pai et al.	May 2006	A1
20060142785	Modesitt et al.	Jun 2006	A1
20060167476	Burdulis et al.	Jul 2006	A1
20060167477	Arcia et al.	Jul 2006	A1
20060173469	Klein et al.	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
20070032798	Pantages et al.	Feb 2007	A1
20070032799	Pantages et al.	Feb 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
20070112304	Voss	May 2007	A1
20070123817	Khosravi et al.	May 2007	A1
20070167959	Modesitt et al.	Jul 2007	A1
20070203506	Sibbitt et al.	Aug 2007	A1
20070276410	McIntosh	Nov 2007	A1
20070282354	McIntosh	Dec 2007	A1
20080009794	Bagaoisan et al.	Jan 2008	A1
20080045979	Ma	Feb 2008	A1
20080065151	Ginn	Mar 2008	A1
20080065152	Carley	Mar 2008	A1
20080287967	Andreas et al.	Nov 2008	A1
20080319458	Reynolds	Dec 2008	A1
20090005793	Pantages et al.	Jan 2009	A1
20090036906	Stafford	Feb 2009	A1
20090048615	Mcintosh	Feb 2009	A1
20090088779	Zung et al.	Apr 2009	A1
20090157105	Zung et al.	Jun 2009	A1
20090254119	Sibbitt et al.	Oct 2009	A1
20100030242	Nobles	Feb 2010	A1
20100130965	Sibbitt et al.	May 2010	A1
20100179572	Voss	Jul 2010	A1
20110066184	Modesitt et al.	Mar 2011	A1
20110071472	Voss	Mar 2011	A1
20110071552	Ma	Mar 2011	A1
20110071567	Modesitt et al.	Mar 2011	A1
20110077670	Modesitt et al.	Mar 2011	A1
20110190793	Nobles	Aug 2011	A1
20110196387	Pantages et al.	Aug 2011	A1
20110196393	Eliachar	Aug 2011	A1
20110270282	Lemke	Nov 2011	A1
20110288563	Gianotti et al.	Nov 2011	A1
20120016383	Sauer et al.	Jan 2012	A1
20120053600	Fortson	Mar 2012	A1
20120150201	Pantages et al.	Jun 2012	A1
20120283749	Sauer	Nov 2012	A1
20120289903	Voss	Nov 2012	A1
20120316579	Ma	Dec 2012	A1
20130006277	Stafford	Jan 2013	A1
20130012962	Stone	Jan 2013	A1
20130066340	Pantages et al.	Mar 2013	A1
20130138122	McIntosh	May 2013	A1
20130190781	Fortson et al.	Jul 2013	A1
20130237999	Ma	Sep 2013	A1
20130267966	Fortson et al.	Oct 2013	A1
20130267967	Fortson et al.	Oct 2013	A1
20130325058	Roorda et al.	Dec 2013	A1
20140180312	Zung et al.	Jun 2014	A1
20140222032	Stafford	Aug 2014	A1
20140236189	Melsheimer et al.	Aug 2014	A1
20150025551	Fortson et al.	Jan 2015	A1
20150119906	Bagaoisan et al.	Apr 2015	A1
20150273186	Voss	Oct 2015	A1
20160135803	McIntosh	May 2016	A1
20160135805	Roorda et al.	May 2016	A1
20160192914	Ma	Jul 2016	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
20180338759	Roorda et al.	Nov 2018	A1
20190175168	McIntosh	Jun 2019	A1
20190261964	Zung et al.	Aug 2019	A1
20190357900	Stafford	Nov 2019	A1

Foreign Referenced Citations (93)

Number	Date	Country
0912619	May 1954	DE
9217932	Jun 1993	DE
4210724	Jul 1993	DE
4219724	Dec 1993	DE
4220283	Dec 1993	DE
10211360	Oct 2003	DE
0140557	May 1985	EP
0140757	May 1985	EP
0207545	Jan 1987	EP
0474887	Mar 1992	EP
0478358	Apr 1992	EP
0478887	Apr 1992	EP
0542126	May 1993	EP
0543499	May 1993	EP
0568098	Nov 1993	EP
0589409	Mar 1994	EP
0624343	Nov 1994	EP
0669101	Aug 1995	EP
0669103	Aug 1995	EP
0684012	Nov 1995	EP
0812571	Dec 1997	EP
0669102	Oct 1998	EP
0941698	Sep 1999	EP
0910288	Aug 2002	EP
1407557	Apr 2004	EP
1059544	Mar 1954	FR
2768324	Mar 1999	FR
51-143386	Nov 1976	JP
52-020794	Feb 1977	JP
02-119866	May 1990	JP
05-042161	Feb 1993	JP
05-220794	Aug 1993	JP
820810	Apr 1981	SU
0993922	Feb 1983	SU
1093329	May 1984	SU
1174036	Aug 1985	SU
1544383	Feb 1990	SU
1648400	May 1991	SU
8503858	Sep 1985	WO
9405213	Mar 1994	WO
9413211	Jun 1994	WO
9427503	Dec 1994	WO
9428801	Dec 1994	WO
9505121	Feb 1995	WO
9513021	May 1995	WO
9525468	Sep 1995	WO
9535065	Dec 1995	WO
9609006	Mar 1996	WO
9700046	Jan 1997	WO
9703613	Feb 1997	WO
9707745	Mar 1997	WO
9710764	Mar 1997	WO
9713461	Apr 1997	WO
9717901	May 1997	WO
9720505	Jun 1997	WO
9727897	Aug 1997	WO
9804195	Feb 1998	WO
9842262	Oct 1998	WO
9947049	Sep 1999	WO
0012013	Mar 2000	WO
0051498	Sep 2000	WO
0069342	Nov 2000	WO
0119259	Mar 2001	WO
0135833	May 2001	WO
0236021	May 2002	WO
0262234	Aug 2002	WO
0303598	Jan 2003	WO
0303925	Jan 2003	WO
0394748	Nov 2003	WO
0399134	Dec 2003	WO
2005000126	Jan 2005	WO
2005023119	Mar 2005	WO
2005025430	Mar 2005	WO
2005030060	Apr 2005	WO
2005041782	May 2005	WO
2005063129	Jul 2005	WO
2005065549	Jul 2005	WO
2005092204	Oct 2005	WO
2005112782	Dec 2005	WO
2006026116	Mar 2006	WO
2006052611	May 2006	WO
2006052612	May 2006	WO
2006078578	Jul 2006	WO
2006115901	Nov 2006	WO
2006115904	Nov 2006	WO
2006118877	Nov 2006	WO
2007019016	Feb 2007	WO
2007025014	Mar 2007	WO
2007025017	Mar 2007	WO
2007025018	Mar 2007	WO
2007025019	Mar 2007	WO
2007081836	Jul 2007	WO
2010031050	Mar 2010	WO

Non-Patent Literature Citations (346)

Entry
Office action received for U.S. Appl. No. 11/199,496, dated Aug. 21, 2009.
Office action received for U.S. Appl. No. 11/199,515, dated Jun. 10, 2009.
Office action received for U.S. Appl. No. 11/199,515, dated Nov. 13, 2008.
Office action received for U.S. Appl. No. 11/273,107, dated Apr. 9, 2009.
Office action received for U.S. Appl. No. 11/273,107, dated Jan. 18, 2008.
Office action received for U.S. Appl. No. 11/273,107, dated Jun. 2, 2010.
Office action received for U.S. Appl. No. 11/273,107, dated Jun. 14, 2007.
Office Action received for U.S. Appl. No. 11/273,107, dated Oct. 27, 2010.
Office action received for U.S. Appl. No. 11/273,107, dated Oct. 28, 2009.
Office action received for U.S. Appl. No. 11/273,107, dated Sep. 5, 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. 11/363,005, dated Apr. 17, 2008.
Office action received for U.S. Appl. No. 11/363,005, dated Dec. 14, 2007.
Office action received for U.S. Appl. No. 11/363,005, dated Dec. 23, 2008.
Office action received for U.S. Appl. No. 11/363,005, dated Jun. 22, 2007.
Office Action received for U.S. Appl. No. 11/390,937, dated Sep. 7, 2007.
Office Action received for U.S. Appl. No. 11/391,951, dated Jan. 30, 2009.
Office action received for U.S. Appl. No. 11/391,951, dated Jun. 23, 2010.
Office action received for U.S. Appl. No. 11/465,527, dated Feb. 3, 2010.
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. 11/552,593, dated Aug. 21, 2008.
Office action received for U.S. Appl. No. 11/552,593, dated Feb. 5, 2009.
Office Action received for U.S. Appl. No. 11/688,722, dated Mar. 10, 2010.
Office action received for U.S. Appl. No. 11/891,358, dated Apr. 26, 2010.
Office Action received for U.S. Appl. No. 11/891,358, dated Aug. 31, 2011.
Office Action received for U.S. Appl. No. 11/891,358, dated Oct. 19, 2010.
Office Action received for U.S. Appl. No. 11/891,513, dated Apr. 9, 2010.
Office Action received for U.S. Appl. No. 11/891,513, dated Aug. 31, 2011.
Office Action received for U.S. Appl. No. 11/891,513, dated Sep. 28, 2010.
Office Action received for U.S. Appl. No. 11/960,593, dated Apr. 28, 2011.
Office Action received for U.S. Appl. No. 11/960,593, dated Nov. 3, 2010.
Office Action received for U.S. Appl. No. 11/960,593, dated Sep. 14, 2010.
Office Action received for U.S. Appl. No. 11/997,379, dated Feb. 28, 2012.
Office Action received for U.S. Appl. No. 11/997,379, dated Jul. 13, 2011.
Office Action received for U.S. Appl. No. 12/182,836, dated Jun. 23, 2011.
Office Action received for U.S. Appl. No. 12/182,836, dated May 17, 2013.
Office Action received for U.S. Appl. No. 12/182,836, dated Oct. 5, 2010.
Office Action received for U.S. Appl. No. 12/247,012, dated Mar. 16, 2012.
Office Action received for U.S. Appl. No. 12/247,012, dated Oct. 13, 2011.
Office Action received for U.S. Appl. No. 12/257,127, dated Dec. 22, 2010.
Office Action received for U.S. Appl. No. 12/257,127, dated Jan. 12, 2012.
Office Action received for U.S. Appl. No. 12/257,127, dated Jul. 6, 2011.
Office Action received for U.S. Appl. No. 12/334,077, dated Jan. 16, 2013.
Office Action received for U.S. Appl. No. 12/334,077, dated Jul. 21, 2011.
Interview Summary received for U.S. Appl. No. 14/511,730, filed Oct. 31, 2018.
Office Action received for U.S. Appl. No. 08/148,809, dated Oct. 26, 1995.
Office Action received for U.S. Appl. No. 14/511,730, dated Jan. 20, 2017.
US 5,820,544, 06/1974, Semm. (withdrawn)
“Innovation Through Progress”, Rema-Medizintechnik GmbH, Jan. 1992.
U.S. Appl. No. 90/006,469, dated Jun. 27, 2006, Re-Examination Certification.
AD: The Laurus In-Line Endoscopic Suturing Device (The Laurus ND-2600 Needle Driver), Laurus Medical Corp., Rev. Oct. 1994.
Advisory Action received for U.S. Appl. No. 14/511,730, dated May 22, 2019.
Cardio-Thoracic Systems Prospectus dated Mar. 20, 1996. pp. 1-4, 25-40.
Definition of “pair”, Dictionary.com, accessed on May 5, 2014.
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.
Interview Summary received for U.S. Appl. No. 14/511,730, dated Oct. 31, 2018.
Interview Summary received for U.S. Appl. No. 15/005,880, dated Jun. 20, 2018.
Interview Summary received for U.S. Appl. No. 15/192,481, dated Oct. 31, 2018.
Kensey Nash Corporation, Exton PA, “The Hemostatic Puncture Closure Device” 2 pages.
Marshall A.C., Lock J.E., Structural and Compliant Anatomy of the Patent Foramen Ovale in Patients Undergoing Transcatheter Closure, Am Heart J Aug. 2000; 140(2); pp. 303-307.
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.
Merino, A. et al., “A Vascular Hemostasis Device for Percutaneous Interventional Procedures,” Mount Sinai Medical Center, N.Y. (undated).
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.
Notice of Allowance received for U.S. Appl. No. 07/989,611, dated Nov. 3, 1994.
Notice of Allowance received for U.S. Appl. No. 08/148,809, dated Dec. 15, 1995.
Notice of Allowance received for U.S. Appl. No. 08/252,124, dated May 22, 1996.
Notice of Allowance received for U.S. Appl. No. 08/259,410, dated Feb. 6, 1998.
Notice of Allowance received for U.S. Appl. No. 08/824,031, dated Jul. 15, 1999.
Notice of Allowance received for U.S. Appl. No. 08/883,246, dated Sep. 11, 2001.
Notice of Allowance received for U.S. Appl. No. 09/057,108, dated Oct. 25, 2000.
Notice of allowance received for U.S. Appl. No. 09/262,402, dated May 30, 2000.
Notice of Allowance received for U.S. Appl. No. 09/395,901, dated Apr. 20, 2001.
Notice of Allowance received for U.S. Appl. No. 09/395,901, dated Sep. 10, 2001.
Notice of Allowance received for U.S. Appl. No. 09/610,099, dated Dec. 24, 2002.
Notice of allowance received for U.S. Appl. No. 09/651,344, dated Apr. 20, 2004.
Notice of Allowance received for U.S. Appl. No. 09/707,746, dated Nov. 15, 2005.
Notice of Allowance received for U.S. Appl. No. 09/769,109, dated Sep. 9, 2002.
Notice of Allowance received for U.S. Appl. No. 09/988,541, dated Dec. 13, 2005.
Notice of allowance received for U.S. Appl. No. 10/152,272, dated May 13, 2005.
Notice of Allowance received for U.S. Appl. No. 10/335,065, dated Nov. 17, 2005.
Notice of allowance received for U.S. Appl. No. 10/335,147, dated Oct. 4, 2006.
Notice of allowance received for U.S. Appl. No. 10/652,182, dated Feb. 22, 2007.
Notice of Allowance received for U.S. Appl. No. 10/660,288, dated Sep. 30, 2011.
Notice of allowance received for U.S. Appl. No. 10/729,541, dated Jul. 12, 2010.
Notice of allowance received for U.S. Appl. No. 10/729,541, dated Mar. 25, 2010.
Notice of allowance received for U.S. Appl. No. 10/729,541, dated Nov. 16, 2009.
Notice of Allowance received for U.S. Appl. No. 10/737,668, dated Jun. 26, 2008.
Notice of Allowance received for U.S. Appl. No. 10/742,406, dated Jan. 11, 2008.
Notice of Allowance received for U.S. Appl. No. 10/742,406, dated Sep. 10, 2007.
Notice of Allowance received for U.S. Appl. No. 10/746,210, dated Jul. 9, 2008.
Notice of allowance received for U.S. Appl. No. 10/909,531, dated Apr. 29, 2010.
Notice of allowance received for U.S. Appl. No. 10/909,531, dated Aug. 20, 2010.
Notice of Allowance received for U.S. Appl. No. 11/199,496, dated Aug. 18, 2011.
Notice of Allowance received for U.S. Appl. No. 11/199,515, dated Apr. 2, 2010.
Notice of allowance received for U.S. Appl. No. 11/199,515, dated Aug. 2, 2010.
Office Action received for U.S. Appl. No. 12/334,077, dated Oct. 27, 2010.
Office Action received for U.S. Appl. No. 12/334,085, dated Aug. 4, 2011.
Office Action received for U.S. Appl. No. 12/334,085, dated Dec. 23, 2010.
Office Action received for U.S. Appl. No. 12/873,728, dated Aug. 23, 2013.
Office Action received for U.S. Appl. No. 12/873,728, dated May 3, 2013.
Office Action received for U.S. Appl. No. 12/950,338, dated Jun. 15, 2011.
Office Action received for U.S. Appl. No. 12/955,848, dated Jun. 30, 2011.
Office Action received for U.S. Appl. No. 12/955,848, dated Nov. 15, 2011.
Office Action received for U.S. Appl. No. 12/955,863, dated Jan. 6, 2012.
Office Action received for U.S. Appl. No. 12/955,869, dated Oct. 18, 2011.
Office Action received for U.S. Appl. No. 13/022,050, dated Apr. 26, 2012.
Office Action received for U.S. Appl. No. 13/022,050, dated Jul. 11, 2011.
Office Action received for U.S. Appl. No. 13/333,411, dated Apr. 1, 2015.
Office Action received for U.S. Appl. No. 13/333,411, dated Apr. 4, 2016.
Office Action received for U.S. Appl. No. 13/333,411, dated Dec. 18, 2014.
Office Action received for U.S. Appl. No. 13/443,659, dated Nov. 13, 2013.
Office Action received for U.S. Appl. No. 13/455,053, dated Nov. 27, 2013.
Office Action received for U.S. Appl. No. 13/485,388, dated May 21, 2015.
Office Action received for U.S. Appl. No. 13/525,875, dated May 28, 2014.
Office Action received for U.S. Appl. No. 13/525,875, dated Sep. 30, 2014.
Office Action received for U.S. Appl. No. 13/615,523, dated Aug. 18, 2016.
Office Action received for U.S. Appl. No. 13/615,523, dated Feb. 26, 2016.
Office Action received for U.S. Appl. No. 13/615,530, dated Jan. 17, 2013.
Office Action received for U.S. Appl. No. 13/752,095, dated Feb. 20, 2015.
Office Action received for U.S. Appl. No. 13/752,095, dated Oct. 17, 2014.
Office Action received for U.S. Appl. No. 13/791,858, dated Nov. 10, 2015.
Office Action received for U.S. Appl. No. 13/870,628, dated Jul. 13, 2015.
Office Action received for U.S. Appl. No. 14/094,352, dated Dec. 15, 2014.
Office Action received for U.S. Appl. No. 14/094,352, dated Jul. 8, 2015.
Office Action received for U.S. Appl. No. 14/195,308, dated Aug. 11, 2015.
Office Action received for U.S. Appl. No. 14/195,308, dated Dec. 18, 2014.
Office Action received for U.S. Appl. No. 14/511,730, dated Apr. 6, 2020.
Office Action received for U.S. Appl. No. 14/511,730, dated Jan. 25, 2019.
Office Action received for U.S. Appl. No. 14/511,730, dated Jul. 8, 2019.
Office Action received for U.S. Appl. No. 14/511,730, dated Jun. 11, 2018.
Office Action received for U.S. Appl. No. 14/511,730, dated Oct. 13, 2017.
Office Action received for U.S. Appl. No. 14/674,756, dated Jul. 6, 2017.
Office Action received for U.S. Appl. No. 14/674,756, dated Mar. 17, 2017.
Office Action received for U.S. Appl. No. 14/880,894, dated Apr. 2, 2018.
Office Action received for U.S. Appl. No. 14/880,894, dated Aug. 6, 2018.
Office Action received for U.S. Appl. No. 14/880,894, dated Oct. 31, 2017.
Office Action received for U.S. Appl. No. 15/005,880, dated Apr. 10, 2018.
Office Action received for U.S. Appl. No. 15/005,880, dated Nov. 13, 2017.
Office Action received for U.S. Appl. No. 15/090,150, dated Dec. 12, 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.
Office Action received for U.S. Appl. No. 15/186,730, dated Mar. 21, 2019.
Office Action received for U.S. Appl. No. 15/186,730, dated Sep. 5, 2018.
Office Action received for U.S. Appl. No. 15/192,481, dated Jan. 11, 2019.
Office Action received for U.S. Appl. No. 15/192,481, dated Jul. 20, 2018.
Office Action received for U.S. Appl. No. 16/052,263, dated Jun. 2, 2020.
Office Action received for U.S. Appl. No. 90/006,469, dated Sep. 10, 2004.
Office Action received for U.S. Pat. No. 5,613,974 dated Jan. 5, 1996.
Office Action received for U.S. Pat. No. 5,613,974 dated Jun. 5, 1995.
Office Action received for U.S. Appl. No. 5,779,719 dated Jun. 1, 1995.
Office Action received for U.S. Pat. No. 5,792,152 dated Jan. 21, 1997.
Office Action received for U.S. Pat. No. 6,036,699 dated Apr. 13, 1999.
Office Action received for U.S. Pat. No. 6,206,893 dated Jul. 10, 2000.
Office Action received for U.S. Pat. No. 6,355,050 dated Jul. 11, 2001.
Office Action received for U.S. Pat. No. 6,355,050 dated Oct. 13, 1999.
Office Action received for U.S. Pat. No. 6,355,050 dated Oct. 23, 2000.
Office Action received for U.S. Pat. No. 6,358,258 dated Nov. 6, 2000.
Office Action received for U.S. Pat. No. 6,517,553 dated Jun. 17, 2002.
Office Action received for U.S. Pat. No. 6,517,553 dated Oct. 23, 2001.
Office Action received for U.S. Pat. No. 6,558,399 dated Jul. 11, 2002.
Office Action received for U.S. Pat. No. 7,029,480 dated Jun. 10, 2005.
Office Action received for U.S. Pat. No. 7,029,480 dated Mar. 17, 2005.
Office Action received for U.S. Pat. No. 7,029,481 dated Feb. 16, 2005.
Office Action, dated Aug. 9, 2006, U.S. Pat. No. 7,235,087.
Product Brochure “The Proven Solution to Endoscopic Suturing”, Lamus Medical Corp., Irvine, CA (Oct. 1994).
Product Brochure, “SuperStitch—Closure Made Simple(Trademark)”, Sutura, Inc. (2003).
Request for Re-Examination received for U.S. Appl. No. 90/006,469, dated Nov. 29, 2002.
Restriction Requirement received for U.S. Appl. No. 10/746,210, dated Apr. 5, 2007.
Restriction Requirement received for U.S. Appl. No. 11/199,515, dated Aug. 20, 2008.
Restriction Requirement received for U.S. Appl. No. 11/391,951, dated Oct. 28, 2008.
Restriction Requirement received for U.S. Appl. No. 12/257,127, dated Aug. 30, 2010.
Restriction Requirement received for U.S. Appl. No. 12/873,728, dated Sep. 11, 2012.
Serruys, PW et al., A Comparision of Balloon-Expandable-Stent Implantaion With Balloon Angioplast In Patients With Coronary Artery Disease, New England Journal of Medicine, 331:489-495, 1994.
Taber's Cyclopedic Medical Dictionary, 18.sup.th Ed, 1997, p. 747.
U.S. Appl. filed Apr. 24, 2012, Fortson et al., U.S. Appl. No. 13/455,053.
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. filed Sep. 15, 2008, Sibbitt Jr. et al., U.S. Appl. No. 61/097,072.
U.S. Appl. No. 09/395,901, filed Apr. 20, 2001, Notice of Allowance.
U.S. Appl. No. 11/508,662, dated Oct. 26, 2010, Office Action.
U.S. Appl. No. 11/508,715, dated Oct. 18, 2010, Office Action.
U.S. Appl. No. 12/365,397, dated Sep. 13, 2010, Office Action.
U.S. Application filed Nov. 29, 2007, by Modesitt et al., U.S. Appl. No. 90/006,469.
U.S. Provisional Application filed Jan. 30, 2004, by McIntosh, U.S. Appl. No. 60/540,811.
U.S. Provisional Application filed Jun. 25, 2007, by Reynolds, U.S. Appl. No. 60/946,063.
Notice of allowance received for U.S. Appl. No. 11/199,515, dated Dec. 24, 2009.
Notice of Allowance received for U.S. Appl. No. 11/273,107, dated Jun. 2, 2011.
Notice of allowance received for U.S. Appl. No. 11/363,005, dated Jan. 14, 2010.
Notice of allowance received for U.S. Appl. No. 11/363,005, dated Jul. 10, 2009.
Notice of allowance received for U.S. Appl. No. 11/363,005, dated Jul. 23, 2010.
Notice of Allowance received for U.S. Appl. No. 11/389,762, dated Nov. 23, 2007.
Notice of Allowance received for U.S. Appl. No. 11/389,762, dated Sep. 20, 2007.
Notice of allowance received for U.S. Appl. No. 11/465,527, dated Jul. 23, 2010.
Notice of Allowance received for U.S. Appl. No. 11/552,593, dated Jul. 22, 2010.
Notice of allowance received for U.S. Appl. No. 11/552,593, dated Mar. 22, 2010.
Notice of allowance received for U.S. Appl. No. 11/552,593, dated Oct. 13, 2009.
Notice of allowance received for U.S. Appl. No. 11/688,722, dated Jul. 29, 2010.
Notice of Allowance received for U.S. Appl. No. 11/891,358, dated Apr. 10, 2012.
Notice of Allowance received for U.S. Appl. No. 11/891,358, dated Nov. 18, 2011.
Notice of Allowance received for U.S. Appl. No. 11/891,513, dated May 8, 2012.
Notice of Allowance received for U.S. Appl. No. 11/891,513, dated Nov. 1, 2011.
Notice of Allowance received for U.S. Appl. No. 11/960,593, dated Jul. 1, 2013.
Notice of Allowance received for U.S. Appl. No. 11/997,379, dated May 11, 2012.
Notice of Allowance received for U.S. Appl. No. 12/247,012, dated Aug. 13, 2012.
Notice of Allowance received for U.S. Appl. No. 12/257,127, dated Sep. 20, 2012.
Notice of Allowance received for U.S. Appl. No. 12/334,077, dated Oct. 11, 2013.
Notice of Allowance received for U.S. Appl. No. 12/334,085, dated Jan. 9, 2012.
Notice of Allowance received for U.S. Appl. No. 12/873,728, dated Nov. 4, 2013.
Notice of Allowance received for U.S. Appl. No. 12/950,338, dated Aug. 8, 2012.
Notice of Allowance received for U.S. Appl. No. 12/950,338, dated Nov. 1, 2011.
Notice of Allowance received for U.S. Appl. No. 12/955,863, dated May 15, 2012.
Notice of Allowance received for U.S. Appl. No. 12/955,869, dated Mar. 22, 2012.
Notice of Allowance received for U.S. Appl. No. 12/961,239, dated Jul. 26, 2011.
Notice of Allowance received for U.S. Appl. No. 12/966,961, dated Aug. 18, 2011.
Notice of Allowance received for U.S. Appl. No. 13/022,050, dated Jul. 6, 2012.
Notice of Allowance received for U.S. Appl. No. 13/443,659, dated Jun. 11, 2014.
Notice of Allowance received for U.S. Appl. No. 13/455,053, dated Jun. 9, 2014.
Notice of Allowance received for U.S. Appl. No. 13/485,388, dated Oct. 7, 2015.
Notice of Allowance received for U.S. Appl. No. 13/525,875, dated Dec. 10, 2014.
Notice of Allowance received for U.S. Appl. No. 13/593,154, dated Jan. 8, 2013.
Notice of Allowance received for U.S. Appl. No. 13/615,523, dated Nov. 30, 2016.
Notice of Allowance received for U.S. Appl. No. 13/615,530, dated Jun. 12, 2013.
Notice of Allowance received for U.S. Appl. No. 13/752,095, dated Jun. 12, 2015.
Notice of Allowance received for U.S. Appl. No. 13/791,858, dated Mar. 15, 2016.
Notice of Allowance received for U.S. Appl. No. 13/870,628, dated Nov. 12, 2015.
Notice of Allowance received for U.S. Appl. No. 14/094,352, dated Mar. 22, 2016.
Notice of Allowance received for U.S. Appl. No. 14/195,308, dated Dec. 4, 2015.
Notice of Allowance received for U.S. Appl. No. 14/674,756, dated Sep. 18, 2017.
Notice of Allowance received for U.S. Appl. No. 14/880,894, dated Nov. 21, 2018.
Notice of Allowance received for U.S. Appl. No. 15/005,880, dated Jul. 13, 2018.
Notice of Allowance received for U.S. Appl. No. 15/069,515, dated Mar. 20, 2018.
Notice of Allowance received for U.S. Appl. No. 15/186,730, dated Jul. 1, 2019.
Notice of Allowance received for U.S. Appl. No. 15/192,481, dated May 6, 2019.
Notice of Allowance received for U.S. Appl. No. 15/434,907, dated May 7, 2019.
Notice of Allowance received for dated U.S. Appl. No. 11/389,762, dated Nov. 23, 2007.
Office Action received for U.S. Appl. No. 10/357,984, dated Jan. 9, 2006.
Office action received for U.S. Appl. No. 10/357,984, dated Mar. 16, 2006.
Office action received for U.S. Appl. No. 10/357,984, dated Mar. 23, 2007.
Office action received for U.S. Appl. No. 10/357,984, dated Nov. 14, 2007.
Office action received for U.S. Appl. No. 10/357,984, dated Sep. 28, 2006.
Office action received for U.S. Appl. No. 10/652,182, dated Aug. 9, 2006.
Office action received for U.S. Appl. No. 10/660,288, dated Apr. 29, 2009.
Office action received for U.S. Appl. No. 10/660,288, dated Aug. 3, 2009.
Office action received for U.S. Appl. No. 10/660,288, dated Aug. 24, 2006.
Office action received for U.S. Appl. No. 10/660,288, dated Feb. 1, 2007.
Office action received for U.S. Appl. No. 10/660,288, dated Jun. 28, 2007.
Office action received for U.S. Appl. No. 10/660,288, dated Mar. 9, 2006.
Office Action received for U.S. Appl. No. 10/660,288, dated Mar. 29, 2011.
Office action received for U.S. Appl. No. 10/660,288, dated Mar. 30, 2010.
Office action received for U.S. Appl. No. 10/660,288, dated Nov. 15, 2005.
Office action received for U.S. Appl. No. 10/729,541, dated Dec. 12, 2006.
Office action received for U.S. Appl. No. 10/729,541, dated Jan. 8, 2008.
Office action received for U.S. Appl. No. 10/729,541, dated Jun. 18, 2007.
Office action received for U.S. Appl. No. 10/729,541, dated May 1, 2009.
Office action received for U.S. Appl. No. 10/729,541, dated Sep. 23, 2008.
Office Action received for U.S. Appl. No. 10/737,668, dated Feb. 16, 2006.
Office Action received for U.S. Appl. No. 10/737,668, dated Jun. 7, 2007.
Office Action received for U.S. Appl. No. 10/737,668, dated Nov. 2, 2005.
Office Action received for U.S. Appl. No. 10/737,668, dated Nov. 28, 2007.
Office Action received for U.S. Appl. No. 10/737,668, dated Oct. 19, 2006.
Office Action received for U.S. Appl. No. 10/742,406, dated Mar. 23, 2007.
Office action received for U.S. Appl. No. 10/746,210, dated Aug. 21, 2007.
Office Action received for U.S. Appl. No. 10/813,449, dated Aug. 14, 2008.
Office Action received for U.S. Appl. No. 10/813,449, dated Aug. 28, 2009.
Office Action received for U.S. Appl. No. 10/813,449, dated Feb. 3, 2009.
Office Action received for U.S. Appl. No. 10/813,449, dated Jan. 25, 2008.
Office Action received for U.S. Appl. No. 10/813,449, dated Jul. 16, 2007.
Office Action received for U.S. Appl. No. 10/813,449, dated May 27, 2010.
Office Action received for U.S. Appl. No. 10/813,449, dated Sep. 5, 2006.
Office Action received for U.S. Appl. No. 10/813,449, dated Sep. 15, 2008.
Office action received for U.S. Appl. No. 10/877,974, dated Jul. 9, 2008.
Office action received for U.S. Appl. No. 10/909,531, dated Apr. 4, 2007.
Office action received for U.S. Appl. No. 10/909,531, dated Dec. 26, 2007.
Office action received for U.S. Appl. No. 10/909,531, dated Feb. 9, 2009.
Office action received for U.S. Appl. No. 10/909,531, dated Jun. 13, 2008.
Office action received for U.S. Appl. No. 10/909,531, dated Sep. 16, 2009.
Office action received for U.S. Appl. No. 10/948,445, dated Jul. 11, 2007.
Office action received for U.S. Appl. No. 11/199,338, dated Apr. 23, 2008.
Office action received for U.S. Appl. No. 11/199,338, dated Dec. 28, 2007.
Office action received for U.S. Appl. No. 11/199,338, dated Jan. 6, 2009.
Office action received for U.S. Appl. No. 11/199,338, dated Jan. 25, 2007.
Office action received for U.S. Appl. No. 11/199,338, dated Oct. 5, 2007.
Office action received for U.S. Appl. No. 11/199,496, dated Apr. 1, 2009.
Office action received for U.S. Appl. No. 11/199,496, dated Apr. 23, 2010.
Office Action received for U.S. Appl. No. 11/199,496, dated Apr. 28, 2011.
Notice of Allowance received for U.S. Patent No. 2006/0167476 dated Sep. 20, 2007.
Notice of Allowance received for U.S. Pat. No. 5,613,974 dated May 22, 1996.
Notice of Allowance received for U.S. Pat. No. 5,779,719 dated Feb. 6, 1998.
Notice of Allowance received for U.S. Pat. No. 5,792,152 dated Oct. 17, 1997.
Notice of Allowance received for U.S. Pat. No. 6,206,893 dated Oct. 25, 2000.
Notice of Allowance received for U.S. Pat. No. 6,355,050 dated Sep. 11, 2001.
Notice of Allowance received for U.S. Pat. No. 6,358,258 dated Apr. 20, 2001.
Notice of Allowance received for U.S. Pat. No. 6,358,258 dated Sep. 10, 2001.
Notice of Allowance received for U.S. Pat. No. 6,517,553 dated Sep. 9, 2002.
Notice of Allowance received for U.S. Pat. No. 6,558,399 dated Dec. 24, 2002.
Notice of Allowance received for U.S. Pat. No. 7,029,480 dated Nov. 17, 2005.
Notice of Re-Issue received for U.S. Appl. No. 90/006,469, dated Sep. 27, 2005.
Office Ac tion received for U.S. Pat. No. 6,036,699, dated Sep. 14, 1998.
Office Action received for U.S. Pat. No. 6,355,050 dated Jul. 23, 1998.
Office Action received for U.S. Appl. No. 07/989,611, dated Aug. 1, 1994.
Office Action received for U.S. Appl. No. 07/989,611, dated May 12, 1993.
Office Action received for U.S. Appl. No. 08/148,809, dated May 30, 1995.
Office Action received for U.S. Appl. No. 08/148,809, dated Sep. 16, 1994.
Office Action received for U.S. Appl. No. 08/252,124, dated Jan. 5, 1996.
Office Action received for U.S. Appl. No. 08/252,124, dated Jun. 5, 1995.
Office Action received for U.S. Appl. No. 08/259,410, dated Feb. 2, 1995.
Office Action received for U.S. Appl. No. 08/259,410, dated Jun. 1, 1995.
Office Action received for U.S. Appl. No. 08/824,031, dated Apr. 13, 1999.
Office Action received for U.S. Appl. No. 08/824,031, dated Mar. 16, 1998.
Office Action received for U.S. Appl. No. 08/824,031, dated Sep. 14, 1998.
Office Action received for U.S. Appl. No. 08/883,246, dated Apr. 12, 1999.
Office Action received for U.S. Appl. No. 08/883,246, dated Jul. 11, 2001.
Office Action received for U.S. Appl. No. 08/883,246, dated Oct. 13, 1999.
Office Action received for U.S. Appl. No. 08/883,246, dated Oct. 23, 2000.
Office Action received for U.S. Appl. No. 09/057,108, dated Jul. 10, 2000.
Office action received for U.S. Appl. No. 09/262,402, dated Mar. 29, 2000.
Office Action received for U.S. Appl. No. 09/395,901, dated Jun. 27, 2000.
Office Action received for U.S. Appl. No. 09/395,901, dated Nov. 6, 2000.
Office Action received for U.S. Appl. No. 09/610,099, dated Jul. 11, 2002.
Office action received for U.S. Appl. No. 09/651,344, dated Feb. 28, 2003.
Office action received for U.S. Appl. No. 09/651,344, dated Nov. 7, 2003.
Office Action received for U.S. Appl. No. 09/707,746, dated Feb. 16, 2005.
Office Action received for U.S. Appl. No. 09/707,746, dated Jul. 7, 2005.
Office Action received for U.S. Appl. No. 09/769,109, dated Jun. 17, 2002.
Office Action received for U.S. Appl. No. 09/769,109, dated Oct. 23, 2001.
Office Action received for U.S. Appl. No. 09/988,541, dated Aug. 24, 2005.
Office Action received for U.S. Appl. No. 09/988,541, dated Feb. 28, 2005.
Office Action received for U.S. Appl. No. 09/988,541, dated Mar. 17, 2004.
Office Action received for U.S. Appl. No. 09/988,541, dated May 25, 2005.
Office Action received for U.S. Appl. No. 09/988,541, dated Nov. 8, 2005.
Office Action received for U.S. Appl. No. 10/033,689, dated Sep. 30, 2003.
Office action received for U.S. Appl. No. 10/152,272, dated Jan. 24, 2005.
Office Action received for U.S. Appl. No. 10/335,065, dated Jun. 10, 2005.
Office Action received for U.S. Appl. No. 10/335,065, dated Mar. 17, 2005.
Office action received for U.S. Appl. No. 10/335,147, dated Dec. 13, 2005.

Related Publications (1)

	Number	Date	Country
	20200060664 A1	Feb 2020	US

Continuations (2)

	Number	Date	Country
Parent	15186730	Jun 2016	US
Child	16670351		US
Parent	13791858	Mar 2013	US
Child	15186730		US

Continuation in Parts (1)

	Number	Date	Country
Parent	12873728	Sep 2010	US
Child	13791858		US

Suturing devices and methods

Information

Patent Number

Date Filed

Date Issued

Inventors

Original Assignees

Examiners

Agents

CPC

Field of Search

CPC

International Classifications

Term Extension

Abstract