The present application relates to a puncture locating system and method, and in particular, to a puncture location system utilizing a flexible member to indicate blood pulsations.
During the use of vascular closure systems after vascular interventions, it is often important to know the location of a puncture in the vessel, and in particular, providing for exact placement of vascular sheaths. Typically, a “blood flashback” method is used to position a vascular device.
An embodiment of the present disclosure includes a puncture locating device for locating a puncture in a blood vessel. The puncture locating device includes an elongated dilator having a distal end, a proximal end that is opposite the distal end, an outer surface, an internal channel that extends from the distal end to the proximal end, an inlet opening that is open to the internal channel and is spaced from the distal end, and an outlet opening disposed between the proximal end and the inlet opening. The dilator also includes a flexible barrier attached to the elongated dilator and overlying the outlet opening so that the flexible barrier and the outer surface proximate the outlet opening at least partially define an internal volume. When the elongated dilator is inserted into the puncture of the blood vessel, blood flows into the inlet opening through the channel and out the outlet opening into the internal volume, such that, pulsations in the blood flow cause the flexible barrier to pulse, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel.
Another embodiment of the present disclosure includes a puncture locating device for locating a puncture in a blood vessel. The puncture locating device includes an elongated dilator having a distal end, a proximal end that is opposite the distal end, an outer surface, an internal channel that extends from the distal end to the proximal end, an inlet opening that is open to the internal channel and is spaced from the distal end, an outlet opening disposed between the proximal end and the inlet opening. The puncture locating device includes a blood pulsation indicator overlying the outlet opening so that the blood pulsation indicator and the outer surface proximate the outlet opening at least partially define an internal volume. When the elongated dilator is inserted into the puncture of the blood vessel, blood flows into the inlet opening through the outlet opening into the internal volume, such that, pulsations in the blood flow cause the blood pulsation indicator to pulse, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel.
An embodiment of the present disclosure includes a method for locating a puncture in a blood vessel of a patient. The method includes inserting a guidewire through the puncture into the vessel so that a distal end of the guidewire is inside the vessel and the guidewire extends out of the puncture. The method also includes inserting a proximal end of the guidewire into a distal end of a dilator, the dilator including a proximal end spaced from the distal end, and a plurality of markings along an outer surface of the dilator. The method also includes moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening of the dilator and into an internal volume at least partially defined by the outer surface of the dilator and a flexible barrier attached to the dilator, whereby the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel. The method also includes retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses. The method also includes noting a marking of the plurality of markings on the dilator that is adjacent to the surface of the patient's skin when flexible barrier no longer pulses. This, in turn, provides an indication of a depth at which the puncture is present.
The foregoing summary, as well as the following detailed description of example embodiments of the application, will be better understood when read in conjunction with the appended drawings, in which there is shown in the drawings example embodiments for the purposes of illustration. It should be understood, however, that the application is not limited to the precise systems and methods shown. In the drawings:
Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower” and “upper” designate directions in the drawings to which reference is made. The words “proximally” and “distally” refer to directions toward and away from, respectively, the individual operating the system. The terminology includes the above-listed words, derivatives thereof and words of similar import.
Referring to
Referring to
The elongated dilator is sized for a range of procedures. In one embodiment, the outer surface 39 defines an outer cross-sectional dimension that is substantially perpendicular to the central longitudinal axis A and the outer cross-sectional dimension is at least about 2.50 mm. In one example, the outer cross-sectional dimension is at least about 2.50-5.0 mm. However, dimensions outside of this range are possible.
Referring to
Referring to
As shown in
The flexible barrier 60 may be formed from a polymeric material that is flexible, yet durable enough to withstand pulsatile flow. For example, the flexible barrier may be polyvinylchloride, polyethylene, polyurethane, polyamides, and/or copolymer thereof. The flexible barrier can be planar shape, a sleeve, or form part of pocket, pouch, bag or other structure that can enclose a fluid.
The flexible barrier 60 may overlie the outlet opening to form an internal volume. In the illustrated embodiment, as shown in
The blood pulsation indicator 50 may have configurations other than what is specifically illustrated. For example, in one alternative embodiment, the flexible barrier may be part of a flexible container that is attached to the elongated dilator. For instance, the flexible container may be flexible bag or bladder attached to the dilator.
In addition, the dilator may further comprise a handle member disposed on the elongated dilator. In such an embodiment, the elongated dilator includes a port disposed in the outlet opening 46. The flexible barrier is attached to the handle member such that the port extends from the elongated dilator to the flexible barrier.
Now, in reference to
The puncture sealing system 2 can further include an access sheath 118 that is also configured to be moved along the guidewire 14 toward the puncture site 12 and into the vessel 13 so as to further dilate the puncture site 12 and subsequently provide access to the vessel 13. The access sheath 118 can then receive a vascular sealing device 190 that is configured to seal the puncture site 12. It should be appreciated, however, that the system can include additional dilators that have cross-sectional diameters that are different (e.g. greater) than the diameter of the locating dilator 10 but less than that of the access sheath 118 so that the puncture site 12 can be gradually dilated and prepared for the access sheath 118. Both the locating dilator 10 and the access sheath 118 include respective depth markings that are configured to aid in locating the puncture site 12, as will be further described below.
Now referring to
With continued reference to
As shown in
Now referring to
As shown in
After the sheath dilator 164 has been removed, a vascular closure procedure can be performed through the access channel 168. Therefore, a closure device 190 can be moved into the access channel 168 until a distal portion 192 (e.g. at least a portion of a toggle 194) of the closure device 190 is distal to the distal end of the sheath body 160. As shown in
While the foregoing description and drawings represent the preferred embodiment of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the spirit and scope of the invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. One skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components, which are particularly adapted to specific environments and operative requirements without departing from the principles of the invention. In addition, features described herein may be used singularly or in combination with other features. For example, features described in connection with one component may be used and/or interchanged with features described in another component. The presently disclosed embodiment is therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.
It should also be noted that the use of the present invention may occur at different points of the surgical procedure then specified previously. For instance, rather than being utilized before the introduction of the closure device it may instead be used to ascertain the depth of the initial incision prior to the surgical procedure being fully performed.
Number | Name | Date | Kind |
---|---|---|---|
4064550 | Dias et al. | Dec 1977 | A |
4760847 | Vaillancourt | Aug 1988 | A |
5021059 | Kensey et al. | Jun 1991 | A |
5108375 | Harrison et al. | Apr 1992 | A |
5193106 | DeSena | Mar 1993 | A |
5282827 | Kensey et al. | Feb 1994 | A |
5292309 | Tassel et al. | Mar 1994 | A |
5306254 | Nash et al. | Apr 1994 | A |
5324306 | Makower et al. | Jun 1994 | A |
5356386 | Goldberg et al. | Oct 1994 | A |
5441517 | Kensey et al. | Aug 1995 | A |
5469847 | Zinreich et al. | Nov 1995 | A |
5514112 | Chu | May 1996 | A |
5755746 | Lifshey et al. | May 1998 | A |
5980492 | Rosen et al. | Nov 1999 | A |
5984895 | Padilla et al. | Nov 1999 | A |
6090130 | Nash et al. | Jul 2000 | A |
6193670 | Tassel et al. | Feb 2001 | B1 |
6425911 | Akerfeldt et al. | Jul 2002 | B1 |
6494848 | Sommercorn et al. | Dec 2002 | B1 |
6682489 | Tenerz et al. | Jan 2004 | B2 |
7025748 | Ashby | Apr 2006 | B2 |
7044916 | Tenerz et al. | May 2006 | B2 |
7073509 | Tenerz et al. | Jul 2006 | B2 |
7285097 | Tenerz et al. | Oct 2007 | B2 |
7618370 | Choi et al. | Nov 2009 | B2 |
7648493 | Forsberg et al. | Jan 2010 | B2 |
7753935 | Brett et al. | Jul 2010 | B2 |
7850654 | Belhe et al. | Dec 2010 | B2 |
8273094 | Belhe et al. | Sep 2012 | B2 |
8382793 | Egnelöv et al. | Feb 2013 | B2 |
8401620 | Velusamy et al. | Mar 2013 | B2 |
8632470 | Stahmann et al. | Jan 2014 | B2 |
9421349 | Miller | Aug 2016 | B2 |
9554785 | Walters et al. | Jan 2017 | B2 |
9592039 | Glazier et al. | Mar 2017 | B2 |
10039606 | Blau et al. | Aug 2018 | B2 |
10182804 | Walters et al. | Jan 2019 | B2 |
10835225 | Walters et al. | Nov 2020 | B2 |
20010044639 | Levinson | Nov 2001 | A1 |
20040147846 | Mueller et al. | Jul 2004 | A1 |
20040243007 | Tenerz et al. | Dec 2004 | A1 |
20050085854 | Ginn | Apr 2005 | A1 |
20050107750 | Barongan | May 2005 | A1 |
20050107820 | Forsberg et al. | May 2005 | A1 |
20060282106 | Cole et al. | Dec 2006 | A1 |
20070123936 | Goldin et al. | May 2007 | A1 |
20080097218 | Vrba | Apr 2008 | A1 |
20080306509 | Osborne | Dec 2008 | A1 |
20080319475 | Clark et al. | Dec 2008 | A1 |
20090082784 | Meissner et al. | Mar 2009 | A1 |
20090156929 | Franco | Jun 2009 | A1 |
20110054456 | Thompson et al. | Mar 2011 | A1 |
20110172767 | Rathi et al. | Jul 2011 | A1 |
20110224721 | Edwards et al. | Sep 2011 | A1 |
20120203328 | Yribarren | Aug 2012 | A1 |
20120283770 | Kramer et al. | Nov 2012 | A1 |
20120296275 | Martin et al. | Nov 2012 | A1 |
20130245644 | Tegels | Sep 2013 | A1 |
20140051994 | Graumann et al. | Feb 2014 | A1 |
20140180332 | Walters | Jun 2014 | A1 |
20150313582 | Phillips | Nov 2015 | A1 |
20150367103 | Pajunk | Dec 2015 | A1 |
20170100113 | Walters et al. | Apr 2017 | A1 |
20170291016 | Fumiyama | Oct 2017 | A1 |
20190142404 | Walters et al. | May 2019 | A1 |
20210045724 | Walters et al. | Feb 2021 | A1 |
Number | Date | Country |
---|---|---|
0664687 | Aug 2003 | EP |
1307141 | Oct 2007 | EP |
3093038 | May 2019 | EP |
Entry |
---|
Nash, et al. “The Angio-Seal Hemostatic Puncture Closure Device, Concept and Experimental Results,” Herz Urban & Vogel, 1999, pp. 597-606, Kensey Nash Corporation, Exton, Pennsylvania, USA. |
PCT International Search Report and Written Opinion dated Jun. 5, 2020, in application PCT/US2020/016492 filed Feb. 4, 2020. |
St. Jude Medical, “Angio-Seal Vascular Closure Device Millennium Platform,” Brochure, 2001, 10 pp. |
Number | Date | Country | |
---|---|---|---|
20200261068 A1 | Aug 2020 | US |