Abstract
The present invention provides an apparatus and method for creating hemostasis at a subcutaneous vascular puncture. The method and apparatus is intended, but not limited to, vascular punctures following trans-radial arterial procedures, e.g. catheterization and percutaneous coronary intervention.
Claims
1. A tissue puncture closure assembly, comprising: a closure device, comprising: a footplate composed of a biodegradable metal with an opening extending therethrough; a filament passing through the opening, the filament having a first end and a second end; and wherein the second end of the filament has a diameter that is larger than a diameter of the opening;
2. The assembly of claim 1, wherein the biodegradable metal is magnesium alloy.
3. The assembly of claim 1, further comprising a surface modification layer on the footplate which affects the rate of dissolution of the footplate.
4. The assembly of claim 3, wherein the surface modification layer is composed of an acid and an accelerant.
5. The assembly of claim 4, wherein the acid is an inorganic acid selected from a group consisting of sulfuric acid, nitric acid, hydrochloric acid, phosphoric acid, and phosphonic acid.
6. The assembly of claim 4, wherein the acid is an organic acid selected from a group consisting of citric acid, tartaric acid, acetic acid, and oxalic acid.
7. The assembly of claim 4, wherein the accelerant is a soluble transition metal salt.
8. The assembly of claim 1, wherein the filament is composed of a bioabsorbable material selected from a group consisting of Polyglycolic acid polymer, Polyglactin copolymer, Poliglecaprone copolymer, Polydioxanone polymer, and Catgut.
9. The assembly of claim 1, wherein the filament is composed of a non-bioabsorbable material selected from a group consisting of Polypropylene, Nylon (polyamide), Polyester, PVDF, PTFE, ePTFE, silk, stainless steel, and nitinol.
10. The assembly of claim 1, wherein the filament is either a braided construction or a monofilament construction.
11. The assembly of claim 1, further comprising: a delivery device comprising a cannulated delivery shaft and a cannulated pusher tube, the cannulated pusher tube concentrically positioned within the cannulated delivery shaft; wherein the footplate is within a distal end of the delivery shaft.
12. The assembly of claim 11, wherein the filament extends proximally through the pusher tube.
13. The assembly of claim 11, wherein at least one of the cannulated delivery shaft and the cannulated pusher tube is composed of a polymer selected from a group consisting of Pebax, Silicone, Nylon (polyamide), Polyurethane, PTFE, FEP, ETFE, and HDPE.
14. The assembly of claim 11, wherein distal force on the cannulated pusher tube relative to the cannulated delivery shaft moves the footplate distally through the delivery shaft.
15. The assembly of claim 11, further comprising one or more axial slits extending at least partially through the cannulated delivery shaft.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:
[0043] FIGS. 1a and 1b are perspective views of the footplate and filament in a pre-deployed a post-deployed orientation and configuration respectively, according to a preferred embodiment of the present invention.
[0044] FIG. 1c is a perspective view of the distal end of the filament, according to a preferred embodiment of the present invention.
[0045] FIG. 1d is a partially sectioned side view of the distal end of the filament and the connection method of the footplate thereto, according to a preferred embodiment of the present invention.
[0046] FIGS. 2a-2d are views depicting a method of piercing and swaging a footplate to facilitate fixation of a filament, according to an embodiment of the present invention.
[0047] FIG. 3a shows a partially sectioned side view of the introducer sheath, fully inserted in the patient's wrist and artery, according to an embodiment of the present invention.
[0048] FIG. 3b is a partially sectioned side view of the introducer sheath, pulled proximally such that its distal end is just slightly inside the patient's artery, according to an embodiment of the present invention.
[0049] FIG. 4 is a partially sectioned side view of the closure device partially inserted into the introducer sheath, according to an embodiment of the present invention.
[0050] FIG. 5a is a partially sectioned side view of the closure device fully inserted and locked onto the proximal hub of the introducer sheath, according to an embodiment of the present invention.
[0051] FIG. 5b is a partially sectioned perspective view of the closure device fully inserted and locked onto the proximal hub of the introducer sheath, according to an embodiment of the present invention.
[0052] FIG. 5c is a close-up detail of the distal end of the closure device in the default configuration after the closure device has been fully inserted and locked to the proximal hub of the introducer sheath, according to an embodiment of the present invention.
[0053] FIG. 6 is a partially sectioned perspective view of the closure device and introducer sheath in the configuration where the actuator has been turned 90 degrees clockwise, according to an embodiment of the present invention.
[0054] FIG. 7a is a partially sectioned side view of the closure device and introducer sheath where the actuator has been pushed in the distal direction to complete the push cycle, according to an embodiment of the present invention.
[0055] FIG. 7b is a partially sectioned perspective view of the closure device and introducer sheath (collectively, the closure system) of FIG. 7a, where the actuator has been pushed in the distal direction to complete the push cycle, according to an embodiment of the present invention.
[0056] FIG. 7c is a close-up, partially sectioned side view of the distal end of the closure device where the footplate has been delivered internal to the patient's artery, according to an embodiment of the present invention.
[0057] FIG. 8a is a partially sectioned side view of the closure device and introducer sheath in the configuration of a completed push cycle and where the closure device and the introducer sheath (together as a single unit) have been partially removed from the patient and where the footplate has been approximated against the wall of the artery, according to an embodiment of the present invention.
[0058] FIG. 8b is a close-up partially sectioned perspective view of FIG. 8a where the footplate is approximated against the anterior inside wall of the patient's artery and the filament extends proximally and is exposed proximal of the patient's skin, according to an embodiment of the present invention.
[0059] FIG. 9a is a partially sectioned side view of the closure device, the blood vessel and the tissue tract, and the filament is exposed and being grasped by the user in the configuration of the deployment sequence where the footplate is fully seated and the closure device deployment apparatus and the introducer sheath (together as a single unit) have been retracted proximally and upward away from the patient, according to an embodiment of the present invention.
[0060] FIG. 9b is a close-up of the distal portion of the closure device's implant (footplate and filament) shown in FIG. 9a, according to an embodiment of the present invention.
[0061] FIG. 10 is a partially sectioned side view of the closure device, the blood vessel and tissue tract, and the user posture in the configuration of the deployment sequence where the footplate is fully seated and the closure device deployment apparatus has been completely removed from the patient and the proximal margin of the filament is entirely exposed outside of the patient, according to an embodiment of the present invention.
[0062] FIGS. 11a-11d are partially sectioned side views of filament locking methods according to embodiments of the present invention.
[0063] FIG. 12 is a partially sectioned side view and a top view of a hemostatic pad positioned approximate to the patient's wrist for use in conjunction with a filament locking device (e.g. an alligator clip) according to an embodiment of the present invention.
[0064] FIG. 13 is a partially sectioned side view of the remaining portion of the closure device, the blood vessel and tissue tract, and the user posture in the configuration of the deployment sequence where the footplate has completely dissolved where all that remains of the closure device is the filament in the subcutaneous tissue tract and the temporary filament locking device (e.g. an alligator clip) which remains positioned at the skin surface, according to an embodiment of the present invention.
[0065] FIG. 14 is a partially sectioned side view of the remaining portion of the closure device, the blood vessel and tissue tract, and the user posture in the configuration after the footplate has completely dissolved and the operator has removed the temporary filament locking device (e.g. an alligator clip) and completely removes the filament from the patient by grasping and pulling the filament proximally, according to an embodiment of the present invention.
[0066] FIG. 15 is a sectioned side view of the blood vessel and tissue tract after the filament has been completely removed from the patient, rendering the arteriotomy fully hemostatic, according to an embodiment of the present invention.
DETAILED DESCRIPTION
[0067] As mentioned earlier, vascular procedures are commonly performed through a puncture in either the radial artery or the ulnar artery. To close the puncture, often a compression device is utilized, which applies direct pressure to the skin surface on the inside of a patient's wrist, directed to compress the skin and subcutaneous tissue overlying the artery. These types of closure apparatus; however, can compress and collapse the arterial lumen, frequently rendering it non-patent. As an alternative to these outside-in devices, the present invention describes a method and apparatus that creates hemostasis of an artery from the inside-out, i.e. a trans-radial or trans-ulnar closure device that applies expansive force rather than compressive force against the wall of a blood vessel.
[0068] The following detailed description contains certain references to positions identified as distal and proximal. For clarity, these distal and proximal positions differ when referred to respective of; a) the closure device (the medical instrument), and; b) the patient. [0069] a) When referring to the terms distal and proximal with respect to the closure device, distal is identified as the margin of the device that is forward of the user (closest to the patient), whereas proximal is identified as the margin of the device that is closer to the user, e.g. the control assembly is the most proximal portion of the closure device. [0070] b) Quite oppositely, in cases where distal and proximal are referred to respective of positions on the patient, distal is identified as the position on the patient that is farther from the patient's heart, and proximal is identified as the position on the patient that is closer to the patient's heart, i.e. more cranial. By way of example, the tip of a patient's finger is more distal than the patient's wrist.
[0071] Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings.
[0072] In accordance with an embodiment of the present invention, the closure device 100, comprising a footplate 110 (the footplate may include any of the embodiments of the footplate, as discussed infra), and a filament 111 is provided and can be used to seal or close an opening formed through biological tissue, such as a percutaneously formed puncture (the puncture comprises the opening formed through the wall of the blood vessel and the tissue tract contiguous with the opening formed through the biological tissue, which extends through and to the skin overlying the blood vessel), an incision, or some other type of opening formed through biological tissue, such as a blood vessel, organ, or the like, to control (or prevent or stop) bleeding (or the flow of other biological fluid or tissue). For example, the closure device 100 of an embodiment of the present invention can be used to seal an arteriotomy 407, which is an opening, or incision, in an artery, such as the radial artery, and is formed in conjunction with a percutaneously formed puncture (an open tissue tract through the skin and tissue just above the blood vessel) by a clinician during a diagnostic or therapeutic intravascular surgical procedure.
[0073] In accordance with an embodiment of the present invention, and as elaborated in the subsequent descriptions, the closure device 100 may be in a pre-deployed configuration and position, or in a post-deployed configuration and position. A pre-deployed closure device configuration and position includes a configuration and position where the footplate 110 resides within the closure device 100. A post-deployed closure device configuration and position includes a configuration and position where the footplate 110 has been introduced through the arteriotomy 407 in the wall 123 of the blood vessel 121 and the footplate 110 resides inside the blood vessel 121 such that the footplate 110 is approximated against the blood vessel wall 123.
[0074] Referring now to the drawings in which like numbers refer to like parts throughout, FIG. 1a shows a footplate 110 according to an embodiment of the present invention. This embodiment shows a footplate 110 and a filament 111 in a pre-deployed closure device deployment configuration and position, wherein the footplate 110 is within the distal end of the delivery shaft 202 (not shown). The footplate 110 comprises a unitary flat or semi-flat plate with one thru-hole 101, through which a filament 111 passes and is tethered to the footplate 110 by means of a crimped section 33 (hidden) that is located at the most distal end of the filament 111 and is oriented at an angle substantially perpendicular to both the longitudinal axis of the footplate 110 and the longitudinal axis of the closure device 100, and whereby the proximal portion of the filament 111 is a single longitudinally-extending leg 32 which extends proximally, adjacent to the top surface of the footplate 110 and continues to extend proximally inside the pusher tube 201 (not shown) substantially parallel to the longitudinal axis of the footplate 110 and parallel to the longitudinal axis of the closure device 100 (not shown).
[0075] Turning to FIG. 1b, a footplate 110 according to an embodiment of the present invention is illustrated. This embodiment shows a footplate 110 and filament 111 of FIG. 1a in a post-deployed closure device deployment configuration and position, wherein the footplate 110 is displaced outside of the distal end of the delivery shaft 202 (not shown) and resides within the lumen of the blood vessel 121 (not shown) in an orientation substantially perpendicular to the longitudinal axis of the closure device 100 (not shown). The footplate 110 comprises a unitary flat or semi-flat plate with one thru-hole 101, through which a filament 111 passes and whereby the filament 111 is tethered to the footplate 110 by means of a crimped section 33 (hidden) that is located at the most distal end of the filament 111 and whereby the crimped section 33 (hidden) of the filament 111 is substantially perpendicular to the longitudinal axis of the footplate 110 and whereby the proximal portion of the filament 111 is a single longitudinally-extending leg 32 which is substantially perpendicular to the longitudinal axis of the footplate 110 and which continues to extend proximally inside the pusher tube 201 (not shown) and parallel to the longitudinal axis of the closure device 100 (not shown).
[0076] Turning to FIG. 1c, a close-up perspective view of the distal margin of the filament 111 described in FIGS. 1a and 1b, according to a preferred embodiment of the present invention is illustrated. This embodiment comprises a crimped, (permanently deformed) distal end 33 of the filament 111 which has been formed to be substantially larger than the diameter of the thru hole 101 (not shown) of the footplate 110 (not shown) such that the filament 111 remains tethered, or attached, to the footplate 110 until the footplate 110 has dissolved in the blood vessel 121 (not shown).
[0077] Turning to FIG. 1d, a side view of the connection method between the footplate 110 and the filament 111 shown in FIGS. 1a and 1b according to a preferred embodiment of the present invention is illustrated. This embodiment shows the footplate 110 with a filament 111 passing through the thru-hole 101 of the footplate 110 and extending in a substantially perpendicular orientation to the longitudinal axis of the footplate 110 such that the crimped distal end 33 of the filament 111 cannot pass through the through the thru-hole 101 of the footplate 110, thus maintaining the tethered connection between the footplate 110 and the filament 111 until such time that the footplate 110 has dissolved in the blood vessel 121 (not shown).
[0078] Turning to FIG. 2a, a footplate 110 according to an embodiment of the present invention is illustrated. This embodiment shows a footplate 110 whereby the footplate 110 comprises a unitary flat or semi-flat plate with a pierced thru-hole 35 whereby the pierced thru-hole 35 has been formed by a sharply tipped cylindrical piercing mandrel 44 that is introduced to the footplate 110 on the top surface of the footplate 112. The resulting geometry formed on (and through) the footplate 110 is that of a pierced thru-hole 35 surrounded by a dimpled, conically deformed feature 36, protruding from the bottom surface 113 of the footplate 110.
[0079] Turning to FIG. 2b, a footplate 110 and a filament 111 according to an embodiment of the present invention is illustrated. This embodiment shows the footplate of FIG. 2a with a filament 111 passing through the pierced thru-hole 35 in the conically deformed feature 36, and extending in a substantially perpendicular orientation to the longitudinal axis of the footplate 110.
[0080] Turning to FIG. 2c, a footplate 110 and a filament 111 according to an embodiment of the present invention is illustrated. This embodiment shows the footplate 110 of FIGS. 2a and 2b with a filament 111 whereby the filament 111 passes through the pierced thru-hole 35 in the footplate 110. A flat-ended reforming mandrel 45 is positioned such that filament 111 passes through a central hole 46 in the flat-ended mandrel 45 and the flat-ended mandrel 45 is positioned approximate to the conically deformed feature 36 on the bottom surface of the footplate 110 and perpendicular to the longitudinal axis of the footplate 110. Further, the footplate 110 is shown positioned against a supporting plate 37. This positioning (collectively, the pre-reforming configuration) readies the footplate 110 and filament 111 for the impending reforming of the dimpled, conically deformed 36 feature on the bottom surface 113 of the footplate 110 described infra.
[0081] Turning to FIG. 2d, a footplate 110 and a filament 111 according to an embodiment of the present invention is illustrated. This embodiment shows the footplate of FIGS. 2a, 2b and 2c with a filament 111 whereby the filament 111 is affixed to the footplate 110 by means of swaging, i.e. a local deformation force applied to the bottom surface 113 of the footplate 110 approximate to the dimpled, conically deformed feature 36 (not shown) around the thru-hole 35 on the footplate 110 in FIG. 2c. The force is applied at the region approximate to where the filament 111 passes, such that the conically deformed feature 36 (not shown) is reconfigured to become substantially flat, thus trapping and affixing the filament 111 to the footplate 110.
[0082] Turning to FIG. 3a, an introducer sheath 150 is illustrated according to an embodiment of the present invention. This embodiment shows a cut-away (partially exposed) left side of the introducer sheath 150 fully introduced into a blood vessel 121 at the end of the interventional or diagnostic procedure.
[0083] Turning to FIG. 3b, the introducer sheath 150 of FIG. 3a is shown after it has been pulled proximally such that its distal tip resides only slightly inside of the blood vessel 121, according to an embodiment of the present invention. Also illustrated, according to an embodiment of the present invention, is a radiopaque marker band 207 on the distal portion of the introducer sheath such that the distal portion of the introducer sheath 150 is positioned in the blood vessel 121 such that the radiopaque marker band 207 remains fully inside the blood vessel 121 and can be identified as such under fluoroscopic visualization, as necessary. Such a pre-existing radiopaque marker band 207 is available as a standard feature in some commercially available introducer sheaths.
[0084] Turning to FIG. 4, a left side view of the closure device 100 is shown, according to an embodiment of the present invention. This embodiment shows the left side of the closure device 100 including its proximal control assembly 307 (i.e. the grasper 303 and the actuator 302) in the configuration where the closure device 100 has been partially inserted into the introducer sheath 150.
[0085] Turning to FIG. 5a, a left side view of the closure device 100 according to an embodiment of the present invention is illustrated. This embodiment shows the closure device 100 fully inserted into the introducer sheath 150 and locked to the proximal hub 151 of the introducer sheath 150.
[0086] Turning to FIG. 5b, is a perspective view of the closure device 100 fully inserted and locked to the proximal hub 151 of the introducer sheath 150 shown in FIG. 5a, according to an embodiment of the present invention is illustrated.
[0087] Turning to FIG. 5c, a close-up view of the distal portion of the closure device 100 shown in FIG. 5a, in accordance with an embodiment of the present invention is illustrated. This embodiment shows the delivery shaft 202 extending distally beyond the distal end of the introducer sheath 150, i.e. after the closure device 100 has been fully inserted and locked to the proximal hub 151 (not shown) of the introducer sheath 150.
[0088] Turning to FIG. 6, the closure device 100 according to an embodiment of the present invention is illustrated. This embodiment shows a perspective view of the closure device 100 after the actuator 302 has been rotated 90 degrees with respect to the grasper handle 303, but prior to the actuator 302 being pushed in the distal direction to complete the push cycle (as is shown infra).
[0089] Turning to FIG. 7a, a partially sectioned left side view of the closure device 100 according to an embodiment of the present invention is illustrated. This embodiment shows closure device 100 (including its proximal control assembly) locked to the proximal hub 151 of the introducer sheath 150, after the actuator 302 has been pushed distally relative to the grasper handle 303 such that the footplate 110 has been motivated distally by the pusher tube 201 and released from within the delivery shaft 202 and into the blood vessel 121 that requires sealing, i.e. the completed push cycle deployment configuration and position.
[0090] Turning to FIG. 7b, a partially sectioned perspective view of FIG. 7a is shown, in accordance with an embodiment of the present invention. This embodiment also depicts the completed distal movement of the actuator 302 relative to the grasper handle 303, i.e. the completed push cycle, and shows the displaced footplate 110 in the blood vessel 121.
[0091] Turning to FIG. 7c, is a close-up view of the distal portion of the introducer sheath 150 and closure device 100 (as a mated assembly) shown in FIG. 7a, in accordance with an embodiment of the present invention. This embodiment shows the pusher tube 201 after it has been motivated distally, thus displacing the footplate 110 out of the delivery shaft 202 and into the lumen of the blood vessel 121.
[0092] Turning to FIG. 8a, a partially sectioned left side view of the closure device 100 according to an embodiment of the present invention is illustrated. The embodiment shows the closure device 100, including its proximal control assembly 307, the footplate 110, the filament 111, the pusher tube 201, and delivery shaft 202 in a post-push cycle closure device deployment configuration and position where the entire assembly (the closure device 100 and the introducer sheath 150, together as a single unit) has been partially retracted out of the patient in the proximal direction such that the filament 111 is exposed at a position proximal of the skin incision 405. This proximal retraction of the entire system then seats the footplate 110 to be approximated against the inside wall 123 of the blood vessel 121 to affect immediate hemostasis.
[0093] Turning to FIG. 8b, a close-up partially sectioned perspective view of the distal position of the closure device 100 shown in FIG. 8a is illustrated, according to an embodiment of the present invention. This embodiment shows the footplate 110 tethered to the filament 111 and positioned approximate to the inside wall 123 of the blood vessel 121 and longitudinally aligned with the longitudinal axis of the blood vessel 121. Also shown is the filament 111 extending proximally from the footplate 110 through the vessel wall 123 and the subcutaneous tissue 406 and further proximally where the filament 111 is exposed proximal (outside) of the skin incision 405.
[0094] Turning to FIG. 9a, a partially sectioned left side view of the closure device 100, according to an embodiment of the present invention is illustrated. The embodiment shows the closure device 100 in a closure device deployment configuration and position where the closure device 100 and the introducer sheath 150 (together, as a mated assembly) has been retracted proximally and upward away from the patient (fully outside of the percutaneous tissue tract in the subcutaneous tissue 406 and the skin incision 405) and positioned to expose enough of the filament 111 to allow the user to grasp the filament 111 and apply gentle tension such that the footplate 110 is held in close approximation with the vessel wall 123 to maintain hemostasis for a period of time before a temporary filament locking device may be applied as described infra.
[0095] Turning to FIG. 9b, a close-up view of the distal portion of the closure device 100 shown in FIG. 9a according to an embodiment of the present invention is illustrated. The embodiment shows the blood vessel 121, the percutaneous tissue tract in the subcutaneous tissue 406, and the skin incision 405 (not shown) in a closure device deployment configuration and position where the footplate 110 is fully seated (approximated) against the vessel wall 123.
[0096] Turning to FIG. 10, a partially sectioned left side view of the blood vessel 121 with the footplate 110 fully approximated and the user hand posture according to an embodiment of the present invention is illustrated. The embodiment shows the closure device 100 (not shown) completely removed from the filament 111 (and the operative site) and the filament 111 being grasped by the operator in order to maintain gentle tension on the filament 111 to facilitate continued contact of the footplate 110 against the vessel wall 123, until a means of temporary securement can be applied to the filament 111 (as is shown infra).
[0097] Turning to FIG. 11a, a temporary filament locking device is illustrated, according to an embodiment of the present invention. In a partially sectioned left side view, the embodiment illustrates a cord lock 421 holding tension on the filament 111 approximate to the skin incision 405 on the patient's wrist 401 such that the tension on the filament 111 maintains approximation of the footplate 110 with the vessel wall 123 for a period of time such that the footplate 110 has substantially dissolved.
[0098] Turning to FIG. 11b shows a temporary filament locking means according to an embodiment of the present invention. In a top view, the embodiment illustrates an adhesive tape filament locking means 423 holding tension on the filament 111 approximate to the skin surface on the patient's wrist 401 and distal (on the patient) of the skin incision 405, or further distal on the patient (e.g. on the palm of the patient's hand), such that the tension on filament 111 maintains approximation of the footplate 110 (not shown) with the vessel wall 123 (not shown) for a period of time such that the footplate 110 (not shown) has substantially dissolved.
[0099] Turning to FIG. 11c shows a temporary filament locking device according to an embodiment of the present invention. In a partially sectioned left side view, the embodiment illustrates an alligator clip 425 holding tension on the filament 111 approximate to the skin incision 405 on the patient's wrist 401 such that the tension on the filament 111 maintains approximation of the footplate 110 with the vessel wall 123 for a period of time such that the footplate 110 has substantially dissolved.
[0100] Turning to FIG. 11d shows a temporary filament locking device according to an embodiment of the present invention. In a partially sectioned left side view, the embodiment illustrates a partially slit closed cell polymer foam pad 426 holding tension on the filament 111 approximate to the skin incision 405 on the patient's wrist 401 such that the tension on the filament 111 maintains approximation of the footplate 110 with the vessel wall 123 for a period of time such that the footplate 110 has substantially dissolved.
[0101] Turning to FIG. 12 shows a hemostatic pad 445 according to an embodiment of the present invention. In both a partially sectioned left side view and a top view showing the patient's hand and wrist 401, the hemostatic pad 445 is positioned such that it is in contact with the skin incision 405 on the patient's wrist 401, and further arranged such that the exposed portion of the filament 111 passes through a partial slit 447 in the hemostatic pad 445. The embodiment further illustrates the hemostatic pad 445 being sandwiched between a filament locking device (e.g. an alligator clip 425) and the skin incision 405 such that the hemostatic pad 445 is captured in firm contact against the skin of the patient's wrist 401.
[0102] Turning to FIG. 13, a partially sectioned left side view of the blood vessel 121, the percutaneous tissue tract in the subcutaneous tissue 406, the skin incision 405, the filament 111, and the temporary filament locking device (e.g. an alligator clip 425) according to an embodiment of the present invention is illustrated. The embodiment shows the tissue layers 431 in a condition after a period of time has elapsed such that the footplate 110 (not shown) has fully dissolved in the blood vessel 121, i.e. the only remaining portion of the closure device 100 (not shown) is the filament 111 (in the percutaneous tissue tract in the subcutaneous tissue 406 and extending out of the skin incision 405) and the temporary filament locking device (e.g. an alligator clip 425), both of which will be removed from the patient (as is shown and described infra).
[0103] Turning to FIG. 14, a partially sectioned left side view of the blood vessel 121, the percutaneous tissue tract in the subcutaneous tissue 406, the skin incision 405 (hidden), the filament 111, and the user posture according to an embodiment of the present invention is illustrated. The embodiment shows the tissue layers 431 in a condition after a period of time has elapsed such that the footplate 110 (not shown) has substantially dissolved, or absorbed, and the temporary filament locking device (e.g. an alligator clip 425, not shown) having been removed from the filament 111. The filament 111 is grasped by the operator and pulled in a proximal direction (away from the patient to completely remove the filament 111 from the patient) while simultaneously holding pressure on the skin surface of the patient's wrist 401 such that the operator's forefinger and middle finger straddle the filament thus providing equal and opposite downward contact force on the skin and subcutaneous tissue 406 (i.e. providing support and resistance to upward tissue displacement) while tension is applied to the filament during removal. At this juncture, the filament 111 is completely removed from the patient and there exists a fully hemostatic condition (i.e. complete cessation of bleeding) at the arteriotomy 407.
[0104] Turning to FIG. 15, a sectioned left side view of the blood vessel 121 and tissue tract in the subcutaneous tissue 406 after the filament 111 (not shown) has been completely removed from the patient, rendering the arteriotomy 407 in the blood vessel 121 fully hemostatic, according to an embodiment of the present invention.
[0105] It should be understood that the values used above are only representative values, and other values may be in keeping with the spirit and intention of this disclosure.
[0106] While several inventive embodiments have been described and illustrated herein with reference to certain exemplary embodiments, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein (and it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by claims that can be supported by the written description and drawings). More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.
[0107] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
[0108] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.
[0109] The use of the terms a and an and the and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms comprising, having, including, and containing are to be construed as open-ended terms (i.e., meaning including, but not limited to,) unless otherwise noted. The term connected is to be construed as partly or wholly contained within, attached to, or joined together, even if not directly attached to where there is something intervening.
[0110] As used herein in the specification and in the claims, the phrase at least one, in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase at least one refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, at least one of A and B (or, equivalently, at least one of A or B, or, equivalently at least one of A and/or B) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
[0111] It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.
[0112] Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as about and substantially, are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.
[0113] The recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein.
[0114] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., such as) provided herein, is intended merely to better illuminate embodiments of the invention and does not impose a limitation on the scope of the invention unless otherwise claimed.
[0115] No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[0116] In the claims, as well as in the specification above, all transitional phrases such as comprising, including, carrying, having, containing, involving, holding, composed of, and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases consisting of and consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
[0117] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. There is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
