TREA

Constraining structure with non-linear axial struts

Follow

Information

  • Patent Grant
  • 11583424
  • Patent Number
    11,583,424
  • Date Filed
    Tuesday, October 29, 2019
    4 years ago
  • Date Issued
    Tuesday, February 21, 2023
    a year ago
Information
Abstract
A constraining structure for use with a balloon catheter can include multiple longitudinal struts and multiple, sinusoidal shaped radial rings. The constraining structure can expand to form a pattern of channels including substantially square windows. The constraining structure can modify, restrict, and control a shape and/or size of the balloon when inflated. Inflating the balloon catheter within the constraining structure can provide nonuniform pressure on a vessel wall adjacent the balloon.
Description
BACKGROUND OF THE INVENTION
Field of the Invention

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.


SUMMARY OF THE INVENTION

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.





BRIEF DESCRIPTION OF THE DRAWINGS

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:



FIG. 1 show the layout of the constraining structure design adjacent to the balloon scheme, where the distal and proximal ends of the constraining structure are placed over the balloon legs, the constraining rings are spaced apart along the balloon length over the working length of the balloon, and an array of longitudinal waved struts interconnect between the constraining rings and the ends.



FIG. 2 shows a scheme of the inflated device with circumferential and longitudinal pattern of channels and pillows.





DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

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 FIG. 1 in which two (or more) longitudinal struts are connected to the distal end of the balloon and two (or more) other interlacing struts connected to the proximal end of the balloon create “push/pull” forces during inflation and longitudinal struts are moving in opposing directions during inflation in order to apply compressive forces on the balloon and allow it to shorten. This “tilt” function supports expansion of the pillows at lower pressure. The longitudinal waved struts form longitudinal channels over the balloon outer surface and together with the circular channels formed by the rings it results in substantially square pattern of channels (“windows”) and balloon pillows protruding in the windows.

Claims
  • 1. A balloon catheter comprising: a catheter shaft;an inflatable balloon positioned at a distal portion of the catheter shaft; anda constraining structure mounted over the balloon and fixedly attached to the catheter shaft, the constraining structure comprising a plurality of struts, wherein each of the plurality of struts does not extend an entire length of the balloon,wherein the balloon catheter is configured to transition between a collapsed configuration and an expanded configuration,wherein in the expanded configuration, the plurality of struts form longitudinal channels in an outer surface of the inflatable balloon.
  • 2. The balloon catheter of claim 1, wherein the balloon catheter is biased to the collapsed configuration.
  • 3. The balloon catheter of claim 1, wherein in the collapsed configuration, the constraining structure is closed on the inflatable balloon.
  • 4. The balloon catheter of claim 1, wherein in the collapsed configuration, the inflatable balloon is folded.
  • 5. The balloon catheter of claim 1, wherein the constraining structure comprises nitinol.
  • 6. The balloon catheter of claim 1, wherein the constraining structure comprises an elastic polymer.
  • 7. The balloon catheter of claim 1, wherein the constraining structure comprises fibers.
  • 8. The balloon catheter of claim 1, wherein the constraining structure comprises mesh.
  • 9. The balloon catheter of claim 1, wherein each of the plurality of struts is only connected to one of a proximal end and a distal end of the constraining structure.
  • 10. The balloon catheter of claim 1, wherein the plurality of struts are interconnected by a plurality of constraining rings.
  • 11. The balloon catheter of claim 10, wherein in the expanded configuration, the plurality of constraining rings form circular channels in an outer surface of the inflatable balloon.
  • 12. The balloon catheter of claim 1, wherein when expanded, the constraining structure is configured to apply compressive forces on the inflatable balloon.
  • 13. The balloon catheter of claim 1, wherein the constraining structure is configured to prevent longitudinal elongation of the inflatable balloon.
  • 14. The balloon catheter of claim 1, wherein the constraining structure is configured to shorten when expanded by the inflatable balloon.
  • 15. The balloon catheter of claim 1, wherein the constraining structure is configured to constrain the inflatable balloon in both longitudinal and radial directions.
  • 16. A balloon catheter comprising: a catheter shaft;an inflatable balloon positioned at a distal portion of the catheter shaft; anda constraining structure mounted over the balloon and fixedly attached to the catheter shaft, the constraining structure comprises nitinol, the constraining structure comprising a plurality of struts, wherein each of the plurality of struts does not extend an entire length of the balloon,wherein the balloon catheter is configured to transition between a collapsed configuration and an expanded configuration.
  • 17. The balloon catheter of claim 16, wherein the balloon catheter is biased to the collapsed configuration.
  • 18. The balloon catheter of claim 16, wherein in the collapsed configuration, the constraining structure is closed on the inflatable balloon.
  • 19. The balloon catheter of claim 16, wherein in the collapsed configuration, the inflatable balloon is folded.
  • 20. The balloon catheter of claim 16, wherein each of the plurality of struts is only connected to one of a proximal end and a distal end of the constraining structure.
  • 21. The balloon catheter of claim 16, wherein the plurality of struts are interconnected by a plurality of constraining rings.
  • 22. The balloon catheter of claim 21, wherein in the expanded configuration, the plurality of constraining rings form circular channels in an outer surface of the inflatable balloon.
  • 23. The balloon catheter of claim 16, wherein when expanded, the constraining structure is configured to apply compressive forces on the inflatable balloon.
  • 24. The balloon catheter of claim 16, wherein the constraining structure is configured to prevent longitudinal elongation of the inflatable balloon.
  • 25. The balloon catheter of claim 16, wherein the constraining structure is configured to shorten when expanded by the inflatable balloon.
  • 26. The balloon catheter of claim 16, wherein the constraining structure is configured to constrain the inflatable balloon in both longitudinal and radial directions.
Parent Case Info

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.

US Referenced Citations (197)
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
Foreign Referenced Citations (18)
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
Non-Patent Literature Citations (6)
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.
Related Publications (1)
Number Date Country
20200139093 A1 May 2020 US
Provisional Applications (1)
Number Date Country
61596618 Feb 2012 US
Continuations (2)
Number Date Country
Parent 14936458 Nov 2015 US
Child 16666925 US
Parent 13761525 Feb 2013 US
Child 14936458 US