The present invention relates to medical devices, and, more particularly, to tissue puncture sealing devices.
Various medical procedures, particularly cardiology procedures, involve accessing a corporeal vessel or other lumen through a percutaneous sheath. The sheath necessarily requires the formation of a hole or opening in the vessel wall so that a medical procedure can be performed via the sheath. After the particular medical procedure has been performed, the sheath must eventually be removed from the vessel and the access hole in the vessel wall must be closed.
Historically, the access hole is closed by the application of prolonged manual pressure over the puncture site by a physician or other trained medical professional. The time involved with this method is extensive and costly. In addition, because patients are often treated with a variety of anticoagulant and thrombolytic agents, the manual pressure required to close the access opening in the vessel wall may be even longer. The discomfort and delay in mobilization for patients resulting from this prolonged manual pressure is significant.
Therefore, a number of vascular closure devices have been developed to close an access opening in the vessel wall more efficiently. For example, closing an access opening in the vessel wall may involve packing a resorbable sealing plug at the hole or sandwiching the hole between the sealing plug and an anchor. Examples of such vascular closure devices and methods are described in U.S. Pat. Nos. 6,179,863; 6,090,130; and 6,045,569 and related patents that are hereby incorporated by reference.
Alternatively, closing an access opening in the vessel wall may include the use of a balloon catheter. For example, an access opening in the vessel wall may be closed by inserting a balloon catheter through the opening in the vessel wall, inflating the balloon, pulling the balloon against the inner wall of the vessel, introducing a procoagulant to the incision site external to the puncture in the vessel wall, and withdrawing the balloon catheter. This method relies on a biochemical reaction between the procoagulant and the blood. The reliance on a biochemical reaction, however, can be problematic. For example, the mixing of the procoagulant with the blood is arbitrary. Therefore, in many cases an exaggerated dose of the procoagulant is applied in an attempt to ensure hemostatis. An exaggerated dose, however, can accidentally enter the blood stream and introduce complications. Moreover, reliance on a chemical reaction based on arbitrary mixing between the procoagulant and the blood often results in an inconsistent seal composition, which in turn results in inconsistent hemostatic sealing performance.
In one of many possible embodiments, the present invention provides an internal tissue puncture sealing apparatus. The internal tissue puncture sealing apparatus comprises a first thin, elongated conduit having a first central lumen and first and second ends. The first end is insertable through the internal tissue puncture and has an inflation segment in fluid communication with the central lumen. The first end includes an expandable member that is selectively inflatable with a fluid via the central lumen. The apparatus also includes a second thin, elongated conduit having a second central lumen receptive of the first thin, elongated conduit. The proximal end of the second conduit has at least one valved side-port in fluid communication with an annulus between the first and second conduits. The valved side-port may include a vacuum communication path and a sealant injection path, which enable aspiration of a tissue puncture site and sealing of the puncture.
Another aspect of the invention provides a method of closing a hole in a vessel wall. The method may include inserting an inflatable device through an introducer that is disposed in the vessel, inflating the inflatable device, sealing the inflatable device against an inner wall of the vessel, reducing the pressure inside of the introducer, injecting a sealant into the introducer, deflating the inflatable device, and removing the inflatable device through the sealant. Following removal of the inflatable device, manual pressure may be applied to the hole for a short period of time to ensure continued hemostasis. According to some aspects of the invention, a specially designed introducer is swapped with a standard introducer used to facilitate insertion of vascular tools used to perform a vascular procedure prior to inserting the inflatable device.
The foregoing and other features, utilities and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention as illustrated in the accompanying drawings.
The accompanying drawings illustrate various embodiments of the present invention and are a part of the specification. The illustrated embodiments are merely examples of the present invention and do not limit the scope of the invention.
Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.
As mentioned above, vascular procedures are commonly performed throughout the world and require access to a blood vessel through a puncture or opening in the vessel. Often an introducer sheath is placed in the opening to facilitate access to the vessel by one or more vascular instruments, including puncture closure devices. Proper location of an artery or other lumen is typically indicated by a flow of blood through the lumen into the introducer sheath or other instrument as the instrument enters the vessel. The present invention describes methods and apparatus for sealing the vessel opening or arteriotomy following completion of a vascular procedure. The methods and apparatus may also be used, however, to close punctures caused by accidents or other injuries, and are not limited to use following a vascular procedure. The principles described herein may be used to close internal tissue punctures of any kind in any live body. Therefore, while the description below is directed primarily to closing arteriotomys, the methods and apparatus may be used according to principles described herein with any bodily lumen to close a hole or puncture.
As used throughout the claims and specification, the term “sealant” is used broadly to encompass any fluid, foam, or gel that does not require a biochemical reaction with bodily fluids to set or cure for sealing purposes. The term “fluid” refers to molecules of a substance that move freely past one another and have the tendency to assume the shape of its container, including liquids, foams, gels, and gasses. A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel, or a fluid passageway through a vascular device. “Aspirate” or “aspirating” means to remove fluids with a suction device. The term “vacuum” means lower pressure than local atmospheric pressure or a device that creates a lower pressure. The words “having” and “including” have the same meaning as the word “comprising.”
Referring now to the drawings, and in particular to
The internal tissue puncture sealing apparatus 100 also includes a second thin, elongated conduit. According to
The introducer sheath 120 also has a distal end 124 and a proximal end 126. The proximal end 126 includes at least one side-port 128 extending into the second central lumen 122. According to
As shown in
The balloon catheter 102 may be inserted into the introducer sheath 120 as shown in
A stopper sleeve or spacer 140 is shown disposed over the balloon catheter 102 to limit the insertion distance of the balloon catheter into the introducer sheath 120. The length of the spacer 140 is chosen such that the first end 106 of the balloon catheter 102 extends beyond the distal end 124 of the introducer sheath 120 by a predetermined distance. According to some embodiments, the predetermined distances is approximately 2.5-4.0 cm. The predetermined distance allows for the balloon 114 of the inflation segment 112 to pass into a vessel as discussed in more detail below. The spacer 140 may comprise a split tube that can be easily removed as desired.
Methods of closing a hole or puncture such as an arteriotomy 144 using the internal tissues puncture sealing apparatus 100 are next discussed with reference to
With the introducer sheath 120 inserted into the arteriotomy, the balloon catheter 102 is introduced through the second central lumen 122 until the first or distal end 106 of the balloon catheter 102, including the inflation segment 112, extends beyond the distal tip 124 of the introducer sheath 120 and into a blood vessel 148. The balloon 114 is in fluid communication with the first central lumen 104. Therefore, opening the catheter valve 118 (
With the balloon 114 in place internally sealing the arteriotomy 144, the side-port valve 130 is opened to allow fluid communication between the annulus 142 and the vacuum syringe 136 as shown in
As the arteriotomy 144 is aspirated, a surgeon or other medical professional may visually inspect the fluid contents evacuated through the translucent valve 130 to assess blood flow through the arteriotomy and thereby ensure proper positioning of the introducer sheath 120 and/or the balloon 114 within the blood vessel 148. A flow of blood may indicate that the balloon 114 is not properly sealing the arteriotomy 144.
When the surgeon is satisfied with the positioning of the introducer sheath 120 and the balloon 114, the side-port valve 130 is toggled to create a fluid communication path between the annulus 142 and the sealant contained by the sealant-containing syringe 138 or other sealant supply as shown in
Following injection of the sealant, the sealant may be optionally activated, cured, or set. The sealant may comprise a gel or foam made of materials including, but not limited to: collagen, polyvinyl alcohol, polyethylene glycol, cyanoacrylates, chitosan, poly-n-acetyl glucosamine. Unlike the materials used in previous devices, none of the materials recited herein is dependent on a biochemical reaction with blood or other bodily fluids to create a hemostatic seal. However, the gels or foams used according to some aspects of the present invention may in some cases be activated or cured by, for example, application of a second fluid, UV light, or other activation mechanisms.
When the sealant is in place adjacent the exterior of the arteriotomy 144, the balloon 114 is deflated as shown in
While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art that various other changes in the form and details may be made without departing from the scope of the invention.
Number | Name | Date | Kind |
---|---|---|---|
4317445 | Robinson | Mar 1982 | A |
4744364 | Kensey | May 1988 | A |
4890612 | Kensey | Jan 1990 | A |
5021059 | Kensey et al. | Jun 1991 | A |
5061274 | Kensey | Oct 1991 | A |
5108421 | Fowler | Apr 1992 | A |
5192300 | Fowler | Mar 1993 | A |
5192302 | Kensey et al. | Mar 1993 | A |
5222974 | Kensey et al. | Jun 1993 | A |
5275616 | Fowler | Jan 1994 | A |
5282827 | Kensey et al. | Feb 1994 | A |
5290310 | Makower et al. | Mar 1994 | A |
5292332 | Lee | Mar 1994 | A |
5304184 | Hathaway et al. | Apr 1994 | A |
5306254 | Nash et al. | Apr 1994 | A |
5312435 | Nash et al. | May 1994 | A |
5320639 | Rudnick | Jun 1994 | A |
5326350 | Li | Jul 1994 | A |
5334216 | Vidal et al. | Aug 1994 | A |
5342393 | Stack | Aug 1994 | A |
5368601 | Sauer et al. | Nov 1994 | A |
5383896 | Gershony et al. | Jan 1995 | A |
5383897 | Wholey | Jan 1995 | A |
5383899 | Hammerslag | Jan 1995 | A |
RE34866 | Kensey et al. | Feb 1995 | E |
5391183 | Janzen et al. | Feb 1995 | A |
5403328 | Shallman | Apr 1995 | A |
5403329 | Hinchcliffe | Apr 1995 | A |
5405354 | Sarrett | Apr 1995 | A |
5411520 | Nash et al. | May 1995 | A |
5417699 | Klein et al. | May 1995 | A |
5431639 | Shaw | Jul 1995 | A |
5431666 | Sauer et al. | Jul 1995 | A |
5437631 | Janzen | Aug 1995 | A |
5443481 | Lee | Aug 1995 | A |
5462561 | Voda | Oct 1995 | A |
5478352 | Fowler | Dec 1995 | A |
5486195 | Myers et al. | Jan 1996 | A |
5496332 | Sierra et al. | Mar 1996 | A |
5496335 | Thomason et al. | Mar 1996 | A |
5507744 | Tay et al. | Apr 1996 | A |
5507758 | Thomason et al. | Apr 1996 | A |
5527322 | Klein et al. | Jun 1996 | A |
5531759 | Kensey et al. | Jul 1996 | A |
5545178 | Kensey et al. | Aug 1996 | A |
5549633 | Evans et al. | Aug 1996 | A |
5554106 | Layman-Spillar et al. | Sep 1996 | A |
5571181 | Li | Nov 1996 | A |
5591205 | Fowler | Jan 1997 | A |
5593422 | Muijs Van de Moer et al. | Jan 1997 | A |
5601602 | Fowler | Feb 1997 | A |
5601603 | Illi | Feb 1997 | A |
5613974 | Andreas et al. | Mar 1997 | A |
5620461 | Muijs Van De Moer et al. | Apr 1997 | A |
5626601 | Gershony et al. | May 1997 | A |
5643318 | Tsukernik et al. | Jul 1997 | A |
5645566 | Brenneman et al. | Jul 1997 | A |
5649959 | Hannam et al. | Jul 1997 | A |
5653730 | Hammerslag | Aug 1997 | A |
5662681 | Nash et al. | Sep 1997 | A |
5665106 | Hammerslag | Sep 1997 | A |
5674231 | Green et al. | Oct 1997 | A |
5676689 | Kensey et al. | Oct 1997 | A |
5681334 | Evans et al. | Oct 1997 | A |
5700277 | Nash et al. | Dec 1997 | A |
5716375 | Fowler | Feb 1998 | A |
5725498 | Janzen et al. | Mar 1998 | A |
5725551 | Myers et al. | Mar 1998 | A |
5728122 | Leschinsky et al. | Mar 1998 | A |
5728132 | Van Tassel et al. | Mar 1998 | A |
5728133 | Kontos | Mar 1998 | A |
5728134 | Barak | Mar 1998 | A |
5741223 | Janzen et al. | Apr 1998 | A |
5746755 | Wood et al. | May 1998 | A |
5755727 | Kontos | May 1998 | A |
5759194 | Hammerslag | Jun 1998 | A |
5766183 | Sauer | Jun 1998 | A |
5766206 | Wijkamp et al. | Jun 1998 | A |
5782861 | Cragg et al. | Jul 1998 | A |
5792173 | Breen et al. | Aug 1998 | A |
5810810 | Tay et al. | Sep 1998 | A |
5810846 | Virnich et al. | Sep 1998 | A |
5810884 | Kim | Sep 1998 | A |
5814065 | Diaz | Sep 1998 | A |
5820631 | Nobles | Oct 1998 | A |
5827299 | Thomason et al. | Oct 1998 | A |
5830130 | Janzen et al. | Nov 1998 | A |
5843124 | Hammerslag | Dec 1998 | A |
5853421 | Leschinsky et al. | Dec 1998 | A |
5855559 | Van Tassel et al. | Jan 1999 | A |
5855585 | Kontos | Jan 1999 | A |
5860990 | Nobles et al. | Jan 1999 | A |
5861004 | Kensey et al. | Jan 1999 | A |
5861005 | Kontos | Jan 1999 | A |
5868762 | Cragg et al. | Feb 1999 | A |
5868778 | Gershony et al. | Feb 1999 | A |
5876411 | Kontos | Mar 1999 | A |
5902311 | Andreas et al. | May 1999 | A |
5906631 | Imran | May 1999 | A |
5910155 | Ratcliff et al. | Jun 1999 | A |
5919207 | Taheri | Jul 1999 | A |
5941897 | Myers | Aug 1999 | A |
5951583 | Jensen et al. | Sep 1999 | A |
5957952 | Gershony et al. | Sep 1999 | A |
5964782 | Lafontaine et al. | Oct 1999 | A |
5976161 | Kirsch et al. | Nov 1999 | A |
5980539 | Kontos | Nov 1999 | A |
5997555 | Kontos | Dec 1999 | A |
6007562 | Harren et al. | Dec 1999 | A |
6007563 | Nash et al. | Dec 1999 | A |
6017359 | Gershony et al. | Jan 2000 | A |
6024747 | Kontos | Feb 2000 | A |
6033401 | Edwards et al. | Mar 2000 | A |
6033427 | Lee | Mar 2000 | A |
6036721 | Harren et al. | Mar 2000 | A |
6042601 | Smith | Mar 2000 | A |
6045569 | Kensey et al. | Apr 2000 | A |
6048357 | Kontos | Apr 2000 | A |
6048358 | Barak | Apr 2000 | A |
6063085 | Tay et al. | May 2000 | A |
6071300 | Brenneman et al. | Jun 2000 | A |
6077279 | Kontos | Jun 2000 | A |
6090130 | Nash et al. | Jul 2000 | A |
6110184 | Weadock | Aug 2000 | A |
6120524 | Taheri | Sep 2000 | A |
6126675 | Shchervinsky et al. | Oct 2000 | A |
6136010 | Modesitt et al. | Oct 2000 | A |
6139556 | Kontos | Oct 2000 | A |
6162192 | Cragg et al. | Dec 2000 | A |
6162240 | Cates et al. | Dec 2000 | A |
6174322 | Schneidt | Jan 2001 | B1 |
6179862 | Sawhney | Jan 2001 | B1 |
6179863 | Kensey et al. | Jan 2001 | B1 |
6183496 | Urbanski | Feb 2001 | B1 |
6193670 | Van Tassel et al. | Feb 2001 | B1 |
6197042 | Ginn et al. | Mar 2001 | B1 |
6206895 | Levinson | Mar 2001 | B1 |
6231561 | Frazier et al. | May 2001 | B1 |
6245080 | Levinson | Jun 2001 | B1 |
6296658 | Gershony | Oct 2001 | B1 |
6398796 | Levinson | Jun 2002 | B2 |
6425911 | Akerfeldt et al. | Jul 2002 | B1 |
6425924 | Rousseau | Jul 2002 | B1 |
6482223 | Nowakowski et al. | Nov 2002 | B1 |
6508828 | Akerfeldt et al. | Jan 2003 | B1 |
6547806 | Ding | Apr 2003 | B1 |
6569185 | Ungs | May 2003 | B2 |
6596012 | Akerfeldt et al. | Jul 2003 | B2 |
6596014 | Levinson et al. | Jul 2003 | B2 |
6682489 | Tenerz et al. | Jan 2004 | B2 |
6712837 | Akerfeldt et al. | Mar 2004 | B2 |
6743195 | Zucker | Jun 2004 | B2 |
6860895 | Akerfeldt et al. | Mar 2005 | B1 |
6929655 | Egnelov et al. | Aug 2005 | B2 |
20040172058 | Edwards et al. | Sep 2004 | A1 |
20040249342 | Khosravi et al. | Dec 2004 | A1 |
20050107826 | Zhu et al. | May 2005 | A1 |
20050149117 | Khosravi et al. | Jul 2005 | A1 |
20050228443 | Yassinzadeh | Oct 2005 | A1 |
20070156084 | Belhe et al. | Jul 2007 | A1 |
Number | Date | Country | |
---|---|---|---|
20070156084 A1 | Jul 2007 | US |