The present invention is a balloon catheter for angioplasty procedures, comprising an elastic constraining structure mounted over the balloon where the structure has a mechanism of expansion to control the balloon inflation.
Conventional angioplasty balloons expand in an artery lesion at the least resistant areas of the lesion causing “dog bone” effect at the lesion ends and overexpansion in the softer areas, resulting in trauma to the vessel wall. Conventional angioplasty is associated with vessel displacement and its main mechanism of action is plaque compression where the vessel is significantly displaced or “pushed out” before reaction force can be generated and plaque compression takes place. During this process the balloon may expand in the axial direction (in addition to radial), a phenomenon that accelerates propagation of “cracks” in the vessel wall (dissections). This elongation continues after the balloon engages the lesion and the vessel wall and cause longitudinal stretch
This mechanism of action causes a high rate of failure due to the vessel trauma (randomize studies in legs arteries document up to 40% acute failure rate and poor long term results with 20%-40% patency in one year). Attempts to modify the mechanism of action were mainly aimed at increasing the local force by adding cutting blades, wires or scoring elements that can penetrate into the vessel wall and create pre defined dissection plans. Those devices are used when encountering resistant lesions otherwise hard to crack open with conventional balloons. None of those technologies was designed to provide an alternative mechanism that leads to a gentler dilatation by minimizing vessel displacement and reducing the radial forces during balloon dilatation.
According to the present invention, a device that modifies the properties of an angioplasty balloon in order to provide uniform inflation and extraction of longitudinal forces in order to facilitate plaque extrusion and minimize vessel trauma. In the device presented herein, a novel constraining structure prevents non-cylindrical expansion using constraining rings that are spaced apart along the balloon working length leading to creation of small balloon segments (pillows) separates by grooves that facilitate plaque extrusion. The constraining structure also prevents longitudinal elongation of the balloon since it has a structure that shortens during expansion and constrains the balloon in both longitudinal and radial directions.
Computer simulation shows a decrease in radial forces using a balloon with the constraining structure. The constraining structure causes reduction in the rate of vessel dissections and perforations thru formation of an array of balloon pillows that provide gentle contact with the vessel wall and thru the formation of channels between these pillows that allow plaque flow and strain relief areas in the vessel wall.
Conventional balloon angioplasty does not provide strain relief to the vessel wall and suffer from high rate of dissections.
Other devices, such as cutting balloons and scoring devices (for example U.S. Pat. No. 7,691,119 Farnan) made to address resistant lesions by adding elements that can cut or score into the vessel wall and significantly, increase the local force (“focus force angioplasty”), but do not provide strain relief and gentle contact with the vessel wall. On the contrary, these devices include aggressive metallic components that are made to break hard plaque and mark their metal footprint on the vessel wall.
The constraining structure of the present invention takes advantage of the fact that by forcing the balloon into pillows topography the excessive length of the balloon is directed into a three dimensional shape and the surface area of the balloon increases. This mechanism shortens the overall balloon length during inflation and minimized longitudinal vessel stretch. Other devices such as stents or scoring cages that have structures over a balloon are using the balloon as an “activator” or expandable shell designed to increase the diameter of the stent or scoring stent and allow the balloon to inflate in full both radially and longitudinally and are therefore designed to expand as big as the inflated balloon, while the design present herein is made smaller than the inflated balloon, specifically aimed to modify, restrict and control the balloon inflated shape and size.
The combination of the advantages of the device described herein result in controlled non aggressive and predictable lesion dilation that addresses a major health concern.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
A balloon catheter comprising a catheter shaft and an inflatable balloon at its distal end and an elastic constraining structure is mounted over the balloon. The constraining structure is made from an elastic material such as Nitinol, elastic polymers or high strength fibers or mesh.
The device natural configuration is collapsed. Unlike “self-expending stents” it is not “self-expending” but to the contrary “self-closing”: prior to expansion the constraining structure is tightly closed on the folded balloon. When the balloon is inflated the constraining structure is expanded by the balloon force up to a diameter smaller than the free inflated diameter of the balloon. The structure will self compressed back to a small diameter when the balloon is deflated. Typically the distal end and a proximal end of the constraining structure are fixedly attached to the catheter at both sides of the balloon to prevent it from disengaging with the catheter. Attachment is made by means of adhesive or thermal bonding or other method known in the art.
The constraining structure comprises an array of sinusoidal constraining rings spaced apart along the balloon working length. Each ring has a sinus curve length defined by the length of the ring when fully straitened. For each ring the sinus curve length is smaller than the balloon expanded circumference. When expanded the rings expand to its maximal expansion resulting in a substantially circular ring shape that is smaller in diameter than the balloon diameter and force a substantially circular channel around the balloon outer surface.
Expansion of the constraining rings results in an array of channels along the balloon length and also results in shortening of the balloon. It is easier to understand the shortening caused by the rings as it is obvious that if the rings were removed from an inflated balloon the balloon would elongate.
The maximum expanded diameter of the constraining structure is mainly controlled by the length of the sinus curve rings. The maximum expanded diameter could be 0.15 mm-0.3 mm smaller than the balloon free inflated diameter but it could also be in the range of 0.1 mm to 0.5 mm or exceed this range depending on the material of choice and the specifics of the design. For example for 3 mm balloon the maximum expanded diameter of the structure made of nitinol is in the range of 2.6 mm-2.85 mm. If the maximum expanded diameter is out of the desirable range the device will fail to perform. For example, if the maximum expanded diameter is similar or larger than the balloon free expanded diameter, the constraining structure would not be able to restrict the free expansion of the balloon and pillows will not form. If the structure is too small, the forces applied by the balloon would cause the structure to break and the device will fail, risking patient's safety.
The constraining rings are interconnected by a circumferential array of interlacing longitudinal waved struts. The number of struts is usually twice the number of the sine waves in the constraining ring. For example the structure scheme shows a two waves sine ring and therefore four longitudinal waved struts. Each strut begins near one end of the constraining structure and ends at the last constraining ring near the opposite end. It does not continue all the way to the opposite end in order to allow proper functionality and expansion. The following strut begins near the opposite end of the constraining structure and ends at the last constraining rings near the first end of the balloon, such that the opposing ends are not interconnected by the longitudinal waved struts.
This construction result in the last ring being connected to the ends with half the number of struts only. If the struts were to continue all the way to the opposing end it would restrict the first ring from expanding homogeneously over the balloon as the intermediate rings expand.
The struts connect to the first constraining rings at the external peaks of the ring and thus forming a structure that shortens when expanded. If the struts were connected to the first constraining rings at the internal peaks of the ring than the structure would elongate when expanded.
It is particularly important not to have “spine” or struts that are connected to both proximal and distal end of the balloon. The current structure in
This application is a continuation of U.S. patent application Ser. No. 14/936,458, filed Nov. 9, 2015, which is a continuation of U.S. patent application Ser. No. 13/761,525, filed Feb. 7, 2013, which claims the benefit of U.S. Provisional Application No. 61/596,618, filed Feb. 8, 2012, the entirety of which is incorporated by reference herein.
Number | Name | Date | Kind |
---|---|---|---|
2701559 | Cooper | Feb 1955 | A |
2854983 | Baskin | Oct 1958 | A |
3045677 | Wallace | Jul 1962 | A |
3467101 | Fogarty et al. | Sep 1969 | A |
3825013 | Craven | Jul 1974 | A |
4327736 | Inoue | May 1982 | A |
4456011 | Warnecke | Jun 1984 | A |
4483340 | Fogarty et al. | Nov 1984 | A |
4637396 | Cook | Jan 1987 | A |
4723549 | Wholey et al. | Feb 1988 | A |
4796629 | Grayzel | Jan 1989 | A |
4921484 | Hillstead | May 1990 | A |
4976711 | Parins et al. | Dec 1990 | A |
4998539 | Delsanti | Mar 1991 | A |
5071407 | Porter et al. | Dec 1991 | A |
5100386 | Inoue | Mar 1992 | A |
5133732 | Wilkor | Jul 1992 | A |
5176693 | Pannek | Jan 1993 | A |
5181911 | Shturman | Jan 1993 | A |
5190058 | Jones et al. | Mar 1993 | A |
5196024 | Barath | Mar 1993 | A |
5222971 | Willard et al. | Jun 1993 | A |
5224945 | Pannek, Jr. | Jul 1993 | A |
5263963 | Garrison et al. | Nov 1993 | A |
5308356 | Blackshear, Jr. et al. | May 1994 | A |
5320634 | Vigil et al. | Jun 1994 | A |
5336178 | Kaplan | Aug 1994 | A |
5336234 | Vigil et al. | Aug 1994 | A |
5344419 | Spears | Sep 1994 | A |
5449372 | Schmaltz et al. | Sep 1995 | A |
5456666 | Campbell et al. | Oct 1995 | A |
5456667 | Ham et al. | Oct 1995 | A |
5460607 | Miyata et al. | Oct 1995 | A |
5484411 | Inderbitzen et al. | Jan 1996 | A |
5501694 | Ressemann et al. | Mar 1996 | A |
5527282 | Segal | Jun 1996 | A |
5556408 | Farhat | Sep 1996 | A |
5562620 | Klein et al. | Oct 1996 | A |
5571086 | Kaplan et al. | Nov 1996 | A |
5607442 | Fischell et al. | Mar 1997 | A |
5609574 | Kaplan et al. | Mar 1997 | A |
5616149 | Barath | Apr 1997 | A |
5620457 | Pinchasik et al. | Apr 1997 | A |
5628746 | Clayman | May 1997 | A |
5628755 | Heller et al. | May 1997 | A |
5643210 | Iacob | Jul 1997 | A |
5643312 | Fischell et al. | Jul 1997 | A |
5695469 | Segal | Dec 1997 | A |
5702410 | Klunder et al. | Dec 1997 | A |
5713863 | Vigil et al. | Feb 1998 | A |
5730698 | Fischell et al. | Mar 1998 | A |
5733303 | Israel et al. | Mar 1998 | A |
5735816 | Lieber et al. | Apr 1998 | A |
5755781 | Jayaraman | May 1998 | A |
5772681 | Leoni | Jun 1998 | A |
5776181 | Lee et al. | Jul 1998 | A |
5797935 | Barath | Aug 1998 | A |
5810767 | Klein | Sep 1998 | A |
5827321 | Roubin et al. | Oct 1998 | A |
5863284 | Klein | Jan 1999 | A |
5868708 | Hart et al. | Feb 1999 | A |
5868719 | Tsukernik | Feb 1999 | A |
5868779 | Ruiz | Feb 1999 | A |
5868783 | Tower | Feb 1999 | A |
5869284 | Cao et al. | Feb 1999 | A |
5904679 | Clayman | May 1999 | A |
5906639 | Rudnick et al. | May 1999 | A |
5919200 | Stambaugh et al. | Jul 1999 | A |
5961490 | Adams | Oct 1999 | A |
5967984 | Chu et al. | Oct 1999 | A |
5987661 | Peterson | Nov 1999 | A |
6013055 | Bampos et al. | Jan 2000 | A |
6036689 | Tu et al. | Mar 2000 | A |
6036708 | Sciver | Mar 2000 | A |
6053913 | Tu et al. | Apr 2000 | A |
6059810 | Brown et al. | May 2000 | A |
6059811 | Pinchasik et al. | May 2000 | A |
6077298 | Tu et al. | Jun 2000 | A |
6102904 | Vigil et al. | Aug 2000 | A |
6106548 | Roubin et al. | Aug 2000 | A |
6129706 | Janacek | Oct 2000 | A |
6156265 | Sugimoto | Dec 2000 | A |
6190403 | Fischell et al. | Feb 2001 | B1 |
6206910 | Berry et al. | Mar 2001 | B1 |
6217608 | Penn et al. | Apr 2001 | B1 |
6235043 | Reiley et al. | May 2001 | B1 |
6241762 | Shanley | Jun 2001 | B1 |
6245040 | Inderbitzen et al. | Jun 2001 | B1 |
6258099 | Mareiro et al. | Jul 2001 | B1 |
6261319 | Kveen et al. | Jul 2001 | B1 |
6309414 | Rolando et al. | Oct 2001 | B1 |
6319251 | Tu et al. | Nov 2001 | B1 |
6334871 | Dor et al. | Jan 2002 | B1 |
6361545 | Macoviak et al. | Mar 2002 | B1 |
6416539 | Hassdenteufel | Jul 2002 | B1 |
6454775 | Demarais et al. | Sep 2002 | B1 |
6540722 | Boyle et al. | Apr 2003 | B1 |
6605107 | Klein | Aug 2003 | B1 |
6616678 | Nishtala et al. | Sep 2003 | B2 |
6626861 | Hart et al. | Sep 2003 | B1 |
6652548 | Evans et al. | Nov 2003 | B2 |
6656351 | Boyle | Dec 2003 | B2 |
6695813 | Boyle et al. | Feb 2004 | B1 |
6702834 | Boylan et al. | Mar 2004 | B1 |
6939320 | Lennox | Sep 2005 | B2 |
6942680 | Grayzel et al. | Sep 2005 | B2 |
7156869 | Pacetti | Jan 2007 | B1 |
7186237 | Meyer et al. | Mar 2007 | B2 |
7357813 | Burgermeister | Apr 2008 | B2 |
7686824 | Konstantino et al. | Mar 2010 | B2 |
7691119 | Farnan | Apr 2010 | B2 |
7708748 | Weisenburgh, II et al. | May 2010 | B2 |
7753907 | DiMatteo et al. | Jul 2010 | B2 |
7803149 | Bates et al. | Sep 2010 | B2 |
7931663 | Farnan et al. | Apr 2011 | B2 |
8172793 | Bates et al. | May 2012 | B2 |
8257305 | Speck et al. | Sep 2012 | B2 |
8348987 | Eaton | Jan 2013 | B2 |
8388573 | Cox | Mar 2013 | B1 |
8439868 | Speck et al. | May 2013 | B2 |
9179936 | Feld et al. | Nov 2015 | B2 |
9199066 | Konstantino et al. | Dec 2015 | B2 |
9216033 | Feld et al. | Dec 2015 | B2 |
9375328 | Farnan | Jun 2016 | B2 |
9415140 | Speck | Aug 2016 | B2 |
9649476 | Speck et al. | May 2017 | B2 |
10220193 | Feld et al. | Mar 2019 | B2 |
10232148 | Konstantino et al. | Mar 2019 | B2 |
10524825 | Feld et al. | Jan 2020 | B2 |
10549077 | Konstantino et al. | Feb 2020 | B2 |
11000680 | Konstantino et al. | May 2021 | B2 |
11234843 | Feld et al. | Feb 2022 | B2 |
20020010489 | Grayzel et al. | Jan 2002 | A1 |
20030023200 | Barbut et al. | Jan 2003 | A1 |
20030040790 | Furst | Feb 2003 | A1 |
20030065354 | Boyle | Apr 2003 | A1 |
20030078606 | Lafontaine et al. | Apr 2003 | A1 |
20030114915 | Mareiro et al. | Jun 2003 | A1 |
20030114921 | Yoon | Jun 2003 | A1 |
20030120303 | Boyle et al. | Jun 2003 | A1 |
20030144726 | Majercak et al. | Jul 2003 | A1 |
20030153870 | Meyer et al. | Aug 2003 | A1 |
20030195609 | Berenstein et al. | Oct 2003 | A1 |
20030212449 | Cox | Nov 2003 | A1 |
20040034384 | Fukaya | Feb 2004 | A1 |
20040073284 | Bates et al. | Apr 2004 | A1 |
20040111108 | Farnan | Jun 2004 | A1 |
20040143287 | Konstantino et al. | Jul 2004 | A1 |
20040210235 | Deshmukh | Oct 2004 | A1 |
20040210299 | Rogers et al. | Oct 2004 | A1 |
20040230293 | Yip et al. | Nov 2004 | A1 |
20050021071 | Konstantino et al. | Jan 2005 | A1 |
20050021130 | Kveen et al. | Jan 2005 | A1 |
20050049677 | Farnan | Mar 2005 | A1 |
20050125053 | Yachia et al. | Jun 2005 | A1 |
20050271844 | Mapes et al. | Dec 2005 | A1 |
20060008606 | Horn et al. | Jan 2006 | A1 |
20060015133 | Grayzel et al. | Jan 2006 | A1 |
20060085025 | Farnan et al. | Apr 2006 | A1 |
20060085058 | Rosenthal et al. | Apr 2006 | A1 |
20060149308 | Melsheimer et al. | Jul 2006 | A1 |
20060259005 | Konstantino et al. | Nov 2006 | A1 |
20060271093 | Holman | Nov 2006 | A1 |
20070073376 | Krolik et al. | Mar 2007 | A1 |
20070173923 | Savage et al. | Jul 2007 | A1 |
20080255508 | Wang | Oct 2008 | A1 |
20090036964 | Heringes et al. | Feb 2009 | A1 |
20090038752 | Weng et al. | Feb 2009 | A1 |
20090105686 | Snow et al. | Apr 2009 | A1 |
20090192453 | Wesselman | Jul 2009 | A1 |
20090227949 | Knapp et al. | Sep 2009 | A1 |
20090240270 | Schneider et al. | Sep 2009 | A1 |
20090319023 | Hildebrand et al. | Dec 2009 | A1 |
20100042121 | Schnieder et al. | Feb 2010 | A1 |
20100234875 | Allex et al. | Sep 2010 | A1 |
20100241215 | Hansen et al. | Sep 2010 | A1 |
20100331809 | Sandhu et al. | Dec 2010 | A1 |
20110066225 | Trollsas et al. | Mar 2011 | A1 |
20110071616 | Clarke et al. | Mar 2011 | A1 |
20110152905 | Eaton | Jun 2011 | A1 |
20110172698 | Davies et al. | Jul 2011 | A1 |
20120059401 | Konstantino et al. | Mar 2012 | A1 |
20120083733 | Chappa | Apr 2012 | A1 |
20120245607 | Gershony et al. | Sep 2012 | A1 |
20130046237 | Speck et al. | Feb 2013 | A1 |
20130116655 | Bacino et al. | May 2013 | A1 |
20130190725 | Pacetti et al. | Jul 2013 | A1 |
20130211381 | Feld | Aug 2013 | A1 |
20140276406 | Campbell et al. | Sep 2014 | A1 |
20150209556 | Timothy | Jul 2015 | A1 |
20160100964 | Feld et al. | Apr 2016 | A1 |
20190151627 | Konstantino et al. | May 2019 | A1 |
20190151631 | Feld et al. | May 2019 | A1 |
20200215311 | Konstantino et al. | Jul 2020 | A1 |
20210128891 | Konstantino et al. | May 2021 | A1 |
20210402160 | Konstantino et al. | Dec 2021 | A1 |
20220168120 | Feld et al. | Jun 2022 | A1 |
Number | Date | Country |
---|---|---|
1568165 | Jan 2005 | CN |
0 565 796 | Oct 1993 | EP |
0 623 315 | Nov 1994 | EP |
0 832 608 | Apr 1998 | EP |
1 042 997 | Oct 2000 | EP |
2 035 291 | Mar 2009 | EP |
2005-508709 | Apr 2005 | JP |
2014-528809 | Oct 2014 | JP |
WO 9805377 | Feb 1998 | WO |
WO 9850101 | Nov 1998 | WO |
WO 0057815 | Oct 2000 | WO |
WO 2002068011 | Sep 2002 | WO |
WO 2003041760 | May 2003 | WO |
WO 2005020855 | Mar 2005 | WO |
WO 2011112863 | Sep 2011 | WO |
WO 2013066566 | May 2013 | WO |
WO 2013114201 | Aug 2013 | WO |
WO 2013119735 | Aug 2013 | WO |
Entry |
---|
AngioSculpt XL PT Scoring Balloon Catheter Brochure, AngioScore, Inc., Rev. C, May 2013. |
Bearing Works, (PTFE) Polytetrafluoroethylene material specifications sheet, available online Feb. 11, 2018 at https://www.bearingworks.com/uploaded-assets/pdfs/retainers/ptfe-datasheet.pdf; printed Feb. 21, 2018, in 2 pages. |
Brydson, J.A., “Plastics Materials—Sixth Edition,” 1995, p. 510, available in part online from https://books.google.com/books?id=wmohBQAAQBAJ&lpg=PA510&ots=G_4Q-OMpB4&dq=young's%20modulus%20of%20PEBAx&pg=PA510#v=onepage&q=young's%20modulus%20of%20PEBAx&f=false; printed on May 5, 2017. |
Kadish, A., et al. “Mapping of Atrial Activation With a Noncontact, Multielectrode Catheter in Dogs,” Circulation: Journal of the American Heart Association, (Apr. 1999) 99: 1906-1913. |
International Search Report for Appl. No. PCT/US13/25032, dated Apr. 19, 2013 in 8 pages. |
“Materials Data Book,” Cambridge University Engineering Department, 2003, pp. 1-41. |
Number | Date | Country | |
---|---|---|---|
20200139093 A1 | May 2020 | US |
Number | Date | Country | |
---|---|---|---|
61596618 | Feb 2012 | US |
Number | Date | Country | |
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Parent | 14936458 | Nov 2015 | US |
Child | 16666925 | US | |
Parent | 13761525 | Feb 2013 | US |
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