Source: https://patents.google.com/patent/US9782570B2/en
Timestamp: 2018-04-24 03:29:02
Document Index: 613579712

Matched Legal Cases: ['Application No. 60', 'art 18', 'Application No. 13861353', 'Application No. 09773059', 'Application No. 10170623', 'Application No. 06766111', 'Application No. 05735055', 'Application No. 10169255', 'Application No. 09773059', 'Application No. 06809092', 'Application No. 2015', 'Application No. 201380071889']

US9782570B2 - Balloon catheter - Google Patents
US9782570B2
US9782570B2 US14551866 US201414551866A US9782570B2 US 9782570 B2 US9782570 B2 US 9782570B2 US 14551866 US14551866 US 14551866 US 201414551866 A US201414551866 A US 201414551866A US 9782570 B2 US9782570 B2 US 9782570B2
US14551866
US20150126966A1 (en )
A rapid exchange balloon catheter including: an outer conduit having a lumen and a wall surrounding the lumen, the wall including a lateral opening formed therein; an inner conduit having a proximal end and a distal end; a sealing sleeve for sealing the lateral opening of the outer conduit; a balloon whose proximal margin is attached to the outer surface of the distal end of the outer conduit, and whose distal margin is attached to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit; a pushing-pulling mechanism disposed in the outer conduit; and a fluid port for the introduction of an expansion fluid and for the removal of the expansion fluid.
This application is a continuation of U.S. Utility patent application Ser. No. 12/083,436, filed Mar. 13, 2009, which is the U.S. national phase of International Application No. PCT/IB2006/002955, filed 13 Oct. 2006, which designated the U.S., which is a continuation application of U.S. Utility patent application Ser. No. 11/477,812, filed 30 Jun. 2006, and claims priority to U.S. Provisional Patent Application No. 60/726,160, filed 14 Oct. 2005, and the entire contents of each of which are hereby incorporated by reference.
In one preferred embodiment of the rapid exchange balloon catheter system of the present invention, the inner and outer conduits are characterized by their ability to withstand axially directed forces in the range of between 2 and 20 Newton without undergoing significant deformation. In the context of the present invention, the term “significant deformation” refers to changes in conduit length in excess of 5% of the total length of said conduit. While these conduits may be constructed of any suitable material capable of withstanding the aforementioned forces, in a preferred embodiment, the inner and outer conduits are constructed either from a biocompatible polymer (which in a preferred embodiment is selected from the group consisting of braided nylon thread and nylon thread that has undergone orientation treatment) or from flexible stainless steel tube. In one preferred embodiment of the rapid exchange balloon catheter system of the present invention, the balloon is, characterized by having, in its inflated state, a pre-folding profile, i.e. it has shape which is capable of assisting and guiding the intussusception of the distal portion thereof upon proximal movement of the inner conduit in relation to the outer conduit.
It should be noted that in each of the embodiments of the catheter, systems of the present invention disclosed and described hereinabove, a lubricant (such as silicone oil or mineral oil) may be present in order to facilitate the mutual sliding of the various conduits.
c) pulling the inner conduit of said balloon catheter in a proximal direction, such that the distal and/or proximal end(s) of said balloon intussuscept(s),
The requisite procedure is typically carried out in the inflated state of the balloon. By using the catheter of the invention for such procedures the operator may manipulate the catheter length and the shape and volume of balloon 11 a by pulling displacement rod 18 b, thereby moving slidable internal tube 13 proximally further into inner tube 14, as demonstrated by arrows 8 a. As a result, the distal end of balloon 11 a collapses and folds internally, as shown in FIG. 10, which increases the pressure of the inflation fluid. Whenever the pressure of the inflation fluid inside the hollow interior of hollow outer shaft 6 and in balloon 11 a is above a predetermined threshold value a slender passage of discharge valve 16 is expanded to allow portions of inflation fluid to exit via discharge valve outlet 15 and thereby reduce the pressure of inflation fluid below said threshold value.
It should be noted that the use of pressure discharge elements and 16 constitutes merely one possible, exemplary means of pressure reduction.
Optionally, a proximal part 18 c of rod 18 is made to be wide enough to occupy a volume of space within a proximal portion 6 b of hollow shaft 6, as shown in FIG. 1F. This piston-like construction 18 c allows for a syringe like action of rod 18 when retracted proximally, causing it to evacuate enough space in the proximal potion 6 b of the lumen of hollow shaft 6. This extra space will then be filled by inflation fluid, thereby preventing pressure accumulation within the catheter during retraction of the rod 18.
As shown in FIG. 10 in its folded state distal cavity 3 a is obtained by the inwardly folded distal sections of balloon 11 a. The volume encompassed by cavity 3 a may be enlarged by (partially or entirely) deflating the balloon in this folded state, thereby filling the enlarged cavity with samples and/or debris from the treatment site. Different distal balloons may be designed to provide various balloon manipulations as exemplified in FIGS. 1D and 1E.
FIGS. 2A to 2C show longitudinal section views of a rapid exchange catheter 20 according to a second preferred embodiment of the invention wherein the diameter of a distal section 24 b of the inner tube 24 a is adapted to receive internal slidable tube 13. In this preferred embodiment the diameter of distal section 24 b of inner tube 24 a is made relatively greater than the diameter of the proximal section thereof. Internal slidable tube is designed to tightly fit into proximal section 24 b and thereby seal its distal opening and prevent leakage of inflation fluid thereinto. Alternatively or additionally, sealing may be achieved by gasket 4 attached to the distal section 24 b of inner tube 24 a such that a distal portion thereof is pressed against an annular portion of the outer surface of slidable internal tube 13. Internal slidable tube 13 and the proximal section of inner tube 24 m may be manufactured to have the same inner diameter, thereby forming a substantially homogenous inner lumen therebetween, particularly when internal slidable tube 13 is advanced all the way into distal section 24 b.
The structure, geometrical dimensions of elements of catheter 50 designated by the same numerals, and the method of manipulating of its length and balloon's volume and shape, are much the same to those elements and manipulating method which were previously described hereinabove and therefore will not be discussed here, for the sake of brevity. Fixed inner tube 54 a and external slidable tube 13 a may be manufactured by an extrusion and laser cutting process from a plastomeric or metallic type of material, preferably from nylon or flexible metal. Their diameters are adapted to provide tight fitting and the necessary sealing of distal openings of fixed inner tube 54 a and of inner tube 54 b. FIGS. 6A to 6C show longitudinal, section views of a sixth preferred embodiment of the invention in which the inner tube 64 of catheter 60 is encompassed in a slidable intermediate tube 33 b. In this preferred embodiment the distal end of balloon 11 a is attached to the slidable intermediate tube 33 b at distal attachment points 2 a provided around the outer surface of a distal section of said slidable intermediate tube. Horizontal opening 38 is provided on an upper side of slidable intermediate tube 33 b. Inner tube 64 protrudes upwardly through horizontal opening 38 towards the upper side of hollow shaft 6 at the location in which it is affixed thereto and provide an access to its lumen via lateral port 12.
For example, after inflating balloon 11 a the operator may pull the proximal section of intermediate tube 33 b (shown by arrow 8 a in FIG. 6B) thereby causing distal section of balloon 11 a to collapse and fold inwardly and deform cavity 3 a, as illustrated in FIG. 60. Horizontal opening 38 is adjusted to allow sliding intermediate tube 33 b proximally into a state in which attachment point 2 a reaches the distal end of shaft 63, and on the other hand, to allow sufficient distal sliding of intermediate tube 33 b in order to enable stretching the full length of balloon 11 a.
As with previous embodiments of the invention the inner tube 74 is disposed in the hollow interior of the catheter's hollow outer shaft 76 and a curved section 37 thereof comprising lateral port 12 protrudes outwardly therefrom. A lateral opening 9 is provided on hollow outer shaft 76 from which said curved section 37 of inner tube 74 is protruding outwardly from hollow shaft 76. Lateral opening 9 is sealed by sealing sleeve 79 mounted over an outer surface of hollow outer shaft 76. Sealing sleeve 79 is designed to tightly fit over the outer surface of hollow outer shaft 76, and to seal lateral opening 9 and the attachment area between sealing sleeve 79 and the curved section of inner tube 74 protruding therefrom. Moreover, sealing sleeve is also made slidable to allow its movement distally or proximally within the limits imposed by lateral opening 9.
In this way a movable inner tube 74 is obtained. The operator may inflate (designated by arrows 7 a in FIG. 7A) balloon 11 a and move inner tube distally or proximally by sliding sealing sleeve over hollow shaft 76. Additionally or alternatively, a displacement rod 48 may be employed for this purpose. Displacement rod 48 may be attached to a proximal section of inner tube 74 and a proximal section thereof can be made available to the operator via a proximal opening 75 provided at the proximal end of hollow shaft 76. Proximal opening 75 is designed to allow conveniently sliding displacement rod 48, therethrough while providing suitable sealing thereof and preventing leakage of inflation fluid therefrom.
Sealing sleeve 79 can be manufactured by an extrusion and laser cutting process from a plastomer or metallic type of material, preferably from nylon or flexible stainless steel. The sealing and attachment of sealing sleeve 79 and the curved section 37 of inner tube 74 is preferably obtained by bonding these parts together by thermo-bonding or any other adhesive method such that they can slide together. The diameter of sealing sleeve 79 is adjusted according to the geometrical dimensions of hollow shaft 76. For example, if the diameter of hollow shaft is about OD (outer diameter) 1.2 mm then the diameter of sealing sleeve is made about ID 1.22 mm.
1. A rapid exchange balloon catheter comprising:
an outer conduit having a wall;
an inner conduit having a proximal end and a distal end and a lumen, said inner conduit is suitable for total or partial passage over a guide wire, wherein said proximal end of said inner conduit is angled such that it pierces said wall of said outer conduit and is fixedly and sealingly attached to said wall of said outer conduit to provide a lateral port in said out conduit for insertion of said guide wire into said lumen of said inner conduit;
a slidable intermediate tube movably and slidably disposed between said outer conduit and said inner conduit, said intermediate tube has a proximal end and a distal end, said proximal end of said intermediate tube is a closed end that sealingly and slidably passes through an opening disposed at the proximal end of said outer conduit, said proximal end of said intermediate tube is a sealed end that extends proximally beyond said opening disposed at the proximal end of said outer conduit, said intermediate tube has a lateral elongated opening therein, wherein the angled proximal part of said inner conduit passes through and is disposed within said lateral elongated opening of said intermediate tube such that said slidable intermediate tube may be axially moved proximally and distally within said outer conduit without hindrance from said angled proximal part of said inner conduit;
an inflatable intussusceptable balloon having a proximal balloon margin sealingly attached to the surface of a distal tip of said outer conduit and a distal balloon margin sealingly attached to a surface of the distal end of said slidable intermediate tube, said inflatable balloon is configured to intussuscept upon sliding of said slidable intermediate tube in a proximal direction and to form a distal and/or proximal open cavity within said balloon; and
a fluid port formed in said outer conduit for the introduction of an expansion fluid into the lumen of the balloon, and for the removal of the expansion fluid from a lumen of said balloon.
2. The rapid exchange balloon catheter according to claim 1, wherein the catheter is characterized by its ability to withstand pressure values in the range of 0-25 atmospheres developing within the catheter at various stages of its operation.
3. The rapid exchange balloon catheter according to claim 1, wherein the rapid exchange catheter further includes a pressure regulating mechanism in fluidic communication with the lumen of the outer conduit for reducing or preventing excessive pressure within the lumen of the outer conduit and within the balloon upon proximal axial movement of the slidable intermediate tube in relation to the outer conduit and the intussuscepting of the balloon.
4. The rapid exchange balloon catheter according to claim 3, wherein the pressure regulating mechanism
comprises a discharge valve in fluidic communication with the lumen of the outer conduit for reducing the pressure of inflation fluid within the lumen of the outer conduit whenever the pressure within the catheter exceeds a threshold value.
5. The rapid exchange balloon catheter according to claim 4, wherein the pressure threshold value of the discharge valve is in the range of 5-20 atmospheres.
6. The rapid exchange balloon catheter according to claim 1, wherein the balloon is characterized by having, in its inflated state, a shape which is capable of guiding the intussuscepting of the distal and/or proximal portion(s) thereof upon proximal movement of the slidable intermediate tube in relation to the outer conduit.
7. The balloon catheter according to claim 6, wherein the balloon is characterized by having, in its inflated state, a distal taper with a rounded distal extremity.
8. The balloon catheter according to claim 1, wherein the inner conduit, the outer conduit and the slidable intermediate tube are characterized by their ability to withstand axially directed forces in the range of between 2 and 20 Newton without undergoing deformation.
9. The balloon catheter according to claim 1, wherein the catheter also includes a lubricant to facilitate the sliding of the slidable intermediate tube along the inner conduit.
10. The balloon catheter according to claim 1, wherein the balloon has a burst pressure within the range of 12-20 atmospheres.
11. The balloon catheter according to claim 1, wherein the catheter also includes a stent mounted on the balloon.
12. A method for collecting and/or removing debris from an internal passage of a mammal, the method comprising the steps of:
a) inserting a rapid exchange balloon catheter into said internal passage, said rapid exchange catheter comprises an outer conduit having a wall, an inner conduit having a proximal end and a distal end and a lumen, said inner conduit is suitable for total or partial passage over a guide wire, said proximal end of said inner conduit is angled such that it pierces said wall of said outer conduit and is fixedly and sealingly attached to said wall of said outer conduit to provide a lateral port in said outer conduit for insertion of said guide wire into said lumen of said inner conduit, a slidable intermediate tube movably and slidably disposed between said outer conduit and said inner conduit, said intermediate tube has a proximal end and a distal end, said proximal end of said intermediate tube is a closed end that sealingly and slidably passes through an opening disposed at the proximal end of said outer conduit, said proximal end of said intermediate tube is a sealed end that extends proximally beyond said opening disposed at the proximal end of said outer conduit, said intermediate tube has a lateral elongated opening therein, wherein the angled proximal part of said inner conduit passes through and is disposed within said lateral elongated opening of said intermediate tube such that said slidable intermediate tube may be axially moved proximally and distally within said outer conduit without hindrance from said angled proximal part of said inner conduit, an inflatable intussusceptable balloon having a proximal balloon margin sealingly attached to the surface of a distal tip of said outer conduit and a distal balloon margin sealingly attached to a surface of the distal end of said slidable intermediate tube, said inflatable balloon is configured to intussuscept upon sliding of said slidable intermediate tube in a proximal direction and to form a distal and/or proximal open cavity within said balloon, and a fluid port formed in said outer conduit for the introduction of an expansion fluid into the lumen of the balloon, and for the removal of the expansion fluid from a lumen of said balloon;
b) advancing said catheter until a distal end thereof has reached a site, at which it is desired to collect and/or trap debris;
c) inflating said balloon with expansion fluid;
d) moving said slidable intermediate tube in a proximal direction, such that the distal and/or proximal end(s) of said balloon intussuscept (s) to form a cavity within said balloon;
e) deflating said balloon, to enlarge said cavity into which said debris is collected and entrapped; and
f) removing said balloon catheter from said internal passage of said mammal, together with said entrapped debris.
13. The method according to claim 12, wherein the internal passage is a blood vessel.
14. The method according to claim 12, wherein said step (b) of inflating also includes deploying a stent mounted on said balloon.
15. The method according to claim 12 wherein said catheter further includes a discharge valve in fluidic communication with said lumen of said outer conduit, and wherein the method also includes the step of discharging expansion fluid from said discharge valve whenever the pressure within said catheter exceeds a threshold value.
16. The method according to claim 15, wherein said pressure threshold value is in the range of 5-20 atmospheres.
17. The method according to claim 12, wherein said step of inflating comprises inflating said balloon at a pressure of up to 20 atmospheres.
18. The method according to claim 13, wherein said blood vessel is a constricted blood vessel and wherein the step of inflating also comprises inflating said balloon to dilate said constricted blood vessel.
19. The method according to claim 12, further including the step of inserting an interventional tool through the lumen of said inner conduit for treating said internal passage.
20. The method according to claim 12, wherein said step of inserting comprises passing said catheter over a guide wire inserted into said internal passage.
US14551866 2005-07-05 2014-11-24 Balloon catheter Active 2027-01-10 US9782570B2 (en)
US72616005 true 2005-10-14 2005-10-14
US11477812 US8556851B2 (en) 2005-07-05 2006-06-30 Balloon catheter
PCT/IB2006/002955 WO2007042935A3 (en) 2005-10-14 2006-10-13 Balloon catheter
US8343609 true 2009-03-13 2009-03-13
US14551866 US9782570B2 (en) 2005-10-14 2014-11-24 Balloon catheter
US12083436 Continuation US8894680B2 (en) 2005-07-05 2006-10-13 Balloon catheter
PCT/IB2006/002955 Continuation WO2007042935A3 (en) 2005-07-05 2006-10-13 Balloon catheter
US8343609 Continuation 2009-03-13 2009-03-13
US20150126966A1 true US20150126966A1 (en) 2015-05-07
US9782570B2 true US9782570B2 (en) 2017-10-10
ID=37943179
US11477812 Active 2030-05-16 US8556851B2 (en) 2005-07-05 2006-06-30 Balloon catheter
US12083436 Active 2028-05-07 US8894680B2 (en) 2005-07-05 2006-10-13 Balloon catheter
US14551866 Active 2027-01-10 US9782570B2 (en) 2005-07-05 2014-11-24 Balloon catheter
US (3) US8556851B2 (en)
EP (1) EP1948290A4 (en)
KR (1) KR20090005283A (en)
CN (1) CN103285498B (en)
CA (1) CA2625485A1 (en)
WO (1) WO2007042935A3 (en)
CN105496506A (en) * 2015-11-27 2016-04-20 中国人民解放军第二军医大学 Blood vessel repair conduit
JPS5466582A (en) 1977-11-04 1979-05-29 Olympus Optical Co Balloon catheter
JPH02119875A (en) 1988-10-28 1990-05-07 Kanji Inoue Balloon catheter and extending method for its balloon
JPH07136283A (en) 1993-11-17 1995-05-30 Terumo Corp Expansion catheter
WO2008004239A2 (en) 2006-07-06 2008-01-10 Angioslide Ltd. Collecting sheath and method of use thereof
EP1124504A1 (en) 1998-11-06 2001-08-22 Boston Scientific Limited Improved rolling membrane stent delivery system
JP2005514979A (en) 2002-01-10 2005-05-26 ボストン サイエンティフィック リミテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｌｉｍｉｔｅｄ Aspiration balloon catheter for treating vulnerable plaque
CN101972510A (en) 2004-04-22 2011-02-16 安乔斯里德公司 Catheter with balloon
EP1753348A1 (en) 2004-04-22 2007-02-21 Angioslide, Ltd. Catheter
US20080051706A1 (en) 2004-04-22 2008-02-28 Eran Hirszowicz Catheter
CN101583318A (en) 2006-07-06 2009-11-18 安乔斯里德公司 Collecting sheath and method of use thereof
CN102131471A (en) 2008-07-02 2011-07-20 安乔斯里德公司 Balloon catheter system and methods of use thereof
Communication Pursuant to Article 94(3) EPC Dated Feb. 3, 2017 From the European Patent Office Re. Application No. 13861353.4. (7 Pages).
Communication Pursuant to Rules 70(2) and 70a(2) EPC Dated Oct. 4, 2011 From the European Patent Office Re. Application No. 09773059.2.
Communication Under Rule 71(3) EPC Dated Aug. 19, 2015 From the European Patent Office Re. Application No. 10170623.2.
Communication Under Rule 71(3) EPC Dated Jul. 6, 2009 From the European Patent Office Re. Application No. 06766111.6.
Communication Under Rule 71(3) EPC Dated Mar. 10, 2010 From the European Patent Office Re. Application No. 05735055.5.
Communication Under Rule 71(3) EPC Dated Mar. 16, 2012 From the European Patent Office Re. Application No. 10169255.6.
Communication Under Rule 71(3) EPC Dated Mar. 24, 2012 From the European Patent Office Re. Application No. 09773059.2.
European Search Report issued for European Patent Application No. 06809092.7-1651 / 1948290, dated Nov. 8, 2013.
International Preliminary Report on Patentability Dated Jul. 24, 2012 From the International Bureau of WIPO Re. Application No. PCT/IL2011/000060.
International Search Report and the Written Opinion Dated Oct. 13, 2015 From the International Searching Authority Re. Application No. PCT/IL2015/050582.
Notice of Allowance Dated Jul. 23, 2014 From the US Patent and Trademark Office Re. U.S. Appl. No. 12/083,436.
Notice of Allowance Dated Jul. 3, 2013 From the US Patent and Trademark Office Re. U.S. Appl. No. 13/001,433.
Notice of Allowance Dated Jul. 9, 2012 From the US Patent and Trademark Office Re. U.S. Appl. No. 12/901,535.
Notice of Allowance Dated Jun. 25, 2010 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/587,179.
Notice of Allowance Dated Jun. 7, 2013 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/477,812.
Notice of Allowance Dated May 6, 2014 From the US Patent and Trademark Office Re. U.S. Appl. No. 13/001,433.
Notice of Allowance Dated Nov. 12, 2013 From the US Patent and Trademark Office Re. U.S. Appl. No. 13/001,433.
Notice of Allowance Dated Nov. 8, 2012 From the US Patent and Trademark Office Re. U.S. Appl. No. 12/901,535.
Notice of Reason for Rejection dated Aug. 8, 2017 From the Japan Patent Office Re. Application No. 2015-546149 and Its Machine Translation Into English. (9 pages).
Office Action and Search Report Dated Jan. 4, 2017 From the State Intellectual Property Office of the People's Republic of China Re. Application No. 201380071889.6 and Its Translation Into English. (12 Pages).
Official Action Dated Feb. 23, 2011 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/477,812.
Official Action Dated Jan. 25, 2016 From the US Patent and Trademark Office Re. U.S. Appl. No. 14/012,624.
Official Action Dated Jul. 28, 2016 From the US Patent and Trademark Office Re. U.S. Appl. No. 13/522,717.
Official Action Dated Jul. 6, 2012 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/477,812.
Official Action Dated Nov. 10, 2016 From the US Patent Trademark Office Re. U.S. Appl. No. 13/522,717. (14 pages).
Official Action Dated Nov. 28, 2011 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/477,812.
Restriction Official Action Dated Aug. 2, 2016 From the US Patent and Trademark Office Re. U.S. Appl. No. 13/520,345.
Restriction Official Action Dated Sep. 13, 2010 From the US Patent and Trademark Office Re. U.S. Appl. No. 11/477,812.
KR20090005283A (en) 2009-01-13 application
WO2007042935A2 (en) 2007-04-19 application
US8556851B2 (en) 2013-10-15 grant
WO2007042935A3 (en) 2009-04-16 application
US20070083158A1 (en) 2007-04-12 application
EP1948290A2 (en) 2008-07-30 application
US20150126966A1 (en) 2015-05-07 application
CN103285498B (en) 2015-11-25 grant
CA2625485A1 (en) 2007-04-19 application
CN103285498A (en) 2013-09-11 application
US20090204069A1 (en) 2009-08-13 application
US8894680B2 (en) 2014-11-25 grant
EP1948290A4 (en) 2013-12-11 application