US20140358176A1 - Soft Tip Balloon Catheter - Google Patents
Soft Tip Balloon Catheter Download PDFInfo
- Publication number
- US20140358176A1 US20140358176A1 US14/463,088 US201414463088A US2014358176A1 US 20140358176 A1 US20140358176 A1 US 20140358176A1 US 201414463088 A US201414463088 A US 201414463088A US 2014358176 A1 US2014358176 A1 US 2014358176A1
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- US
- United States
- Prior art keywords
- segment
- balloon
- distal
- layer
- tubular member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1034—Joining of shaft and balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
- A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2677/00—Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, for preformed parts, e.g. for inserts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
- B29K2995/0037—Other properties
- B29K2995/0049—Heat shrinkable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2009/00—Layered products
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2022/00—Hollow articles
- B29L2022/02—Inflatable articles
- B29L2022/022—Balloons
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2023/00—Tubular articles
- B29L2023/005—Hoses, i.e. flexible
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
- B29L2031/7543—Balloon catheters
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
- Y10T156/1005—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina by inward collapsing of portion of hollow body
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
- Y10T156/1007—Running or continuous length work
- Y10T156/1015—Folding
Definitions
- the presently disclosed subject matter relates to intraluminal balloon catheters for use in percutaneous transluminal coronary angioplasty (PTCA) or stent delivery systems or the like.
- PTCA percutaneous transluminal coronary angioplasty
- the disclosed subject matter relates to a balloon catheter and system having an improved distal tip.
- Intraluminal balloon catheters are well known and beneficial for a variety of medical uses, including diagnostics, therapeutics, and treatment.
- balloon catheters can be used for a number of different vascular and/or coronary applications.
- PTCA percutaneous transluminal coronary angioplasty
- a dilatation catheter having an inflatable balloon on the distal portion thereof is advanced into the coronary anatomy over the guidewire until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with inflation fluid one or more times to a predetermined size to open up the vascular passageway.
- the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilatation, but not over-expand the artery wall.
- an intravascular prosthesis generally called a stent
- Stents may also be used to repair vessels having an intimal flap or dissection or to generally strengthen a weakened section of a vessel or to maintain its patency.
- Stents are usually delivered to a desired location within a coronary artery in a contracted condition on a balloon of a catheter, which is similar or identical in many respects to a balloon angioplasty catheter.
- the balloon, and thus the stent is expanded within the patient's artery to a larger diameter.
- the balloon is deflated to remove the catheter with the stent implanted at the site of the dilated lesion.
- an intraluminal catheter with a soft distal tip it is desirable to provide an intraluminal catheter with a soft distal tip to prevent or minimize injury to the vessel during advancement of the catheter therein.
- One challenge has been forming a connection between the soft tip and the catheter.
- the joint or connector needs to be sufficiently strong to prevent disengagement of the soft tip, and yet prevent kinking at the junction between the soft tip and catheter shaft.
- a method of fabricating a balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein.
- a balloon is formed with a working length, a distal neck, and a distal leg, the distal leg having a first segment with a first diameter and first wall thickness and a second segment with a second diameter and second wall thickness.
- the second diameter is larger than the first diameter and the second wall thickness is thinner than the first wall thickness.
- the distal end of the inner tubular member is positioned in the balloon, with the first segment of the distal leg disposed proximate the distal section of the inner tubular member and the second segment of the distal leg extending distally beyond the distal end of the inner tubular member.
- Heat is applied to the distal leg of the balloon to bond at least a portion of the first segment to the distal section of the inner tubular member and to reduce the second diameter of the second segment of the distal leg.
- forming the balloon can include melt-extruding a thermoplastic polymeric material to form a tube having a distal leg, the distal leg having a first segment and a second segment, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion.
- the extruded tube can be placed within a capture member or mold, having a first portion with a first diameter and a second portion with a second diameter, and blown or expanded to the desired configuration.
- the polymeric material of the extruded tube further can be biaxially oriented by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube.
- the method can include positioning a mandrel in the lumen of the inner tubular member such that the mandrel extends beyond the second segment of the distal leg of the balloon.
- a heat shrink tubing can be positioned around the outside of at least the first and second segments of the distal leg of the balloon. Heat can be applied to the heat shrink tubing and distal leg of the balloon so as to shrink the heat shrink tubing to force the second segment of the distal leg onto the mandrel.
- the mandrel can have a tapered or contoured shape to form a corresponding shape of the distal leg.
- a method of fabricating a multilayer balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein.
- a multilayer balloon is formed having at least a first layer and a second layer, a working length, a distal neck, and a distal leg, the distal leg having a first segment and a second segment.
- the first layer is made of a first polymer material having a first durometer and the second layer is made of a second polymer material having a second durometer.
- the second layer is an outer layer relative to the first layer and the second durometer is harder than the first durometer. At least a portion of the second layer is removed from at least the distal leg of the balloon.
- the distal section of the inner tubular member is positioned in the balloon, with at least the second segment of the distal leg extending beyond the distal leg of the inner tubular member.
- the first distal leg segment of the balloon is bonded to the inner tubular member.
- the first layer can comprise Pebax having a first durometer between about 55D and about 63D and the second layer can comprise Pebax having a second durometer between about 70D Pebax and about 72D Pebax.
- the portion of the second layer can be removed with a rotary device.
- a rotary device and support mandrel can rotate the balloon shaft and a cutting bit can remove a portion of the second layer.
- the multilayer balloon can be formed such that the second segment of the distal leg has a diameter greater than the first segment of the distal leg. A portion of the second layer can be removed from the second segment.
- a mandrel can be positioned in the inner lumen of the inner tubular member so as to extend beyond the second segment of the distal leg of the balloon.
- a heat shrink tubing can be positioned around the outside of the first and second segments. Heat can be applied to the heat shrink tubing and the distal leg to bond at least a portion of the first segment to the distal section of the inner tubular member. The heat shrink tubing can force the second segment onto the mandrel, thus reducing the diameter of the distal leg to form a monolithic distal dip.
- FIG. 1 schematically depicts a representative embodiment of a balloon catheter in accordance with certain aspects of the disclosed subject matter with the distal portion of the balloon catheter enlarged and in cross-section.
- FIG. 2A and FIG. 2B are transverse cross-sectional views of alternative embodiments of the catheter shaft along line 2 - 2 .
- FIG. 3 is a flow diagram of a method of fabricating a balloon catheter according to one embodiment of the disclosed subject matter.
- FIG. 4 is a longitudinal cross-sectional view of a melt-extruded tube placed in a capture member to form a balloon according to one embodiment of the disclosed subject matter.
- FIG. 5 is a longitudinal cross-sectional view of a schematic representation of portion of a balloon catheter being fabricated in accordance with the disclosed subject matter.
- FIG. 6 depicts a longitudinal cross-sectional view of ra representative embodiment of a distal portion of the balloon catheter fabricated according to a method of the presently disclosed subject matter.
- FIG. 7 is a flow diagram of a method of fabricating a multilayer balloon catheter according to another embodiment of the disclosed subject matter.
- FIG. 8 is a schematic diagram showing removal of at least a portion of a layer of a multilayer balloon according to one embodiment of the disclosed subject matter.
- FIG. 9 is a longitudinal cross-sectional view of a schematic representation of a portion of a balloon fabricated according to the method of FIG. 7 .
- a method of fabricating a balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein.
- a balloon is formed with a working length, a distal neck, and a distal leg, the distal leg having a first segment with a first diameter and first wall thickness and a second segment with a second diameter and second wall thickness.
- the second diameter is larger than the first diameter and the second wall thickness is thinner than the first wall thickness.
- the distal end of the inner tubular member is positioned in the balloon, with the first segment of the distal leg disposed proximate the distal section of the inner tubular member and the second segment of the distal leg extending distally beyond the distal end of the inner tubular member.
- Heat is applied to the distal leg of the balloon to bond at least a portion of the first segment to the distal section of the inner tubular member and to reduce the second diameter of the second segment of the distal leg.
- the balloon catheter generally comprises an elongated catheter shaft at least including an inner tubular member 210 extending a length thereof; see ( 110 ) in FIG. 3 and FIG. 5 .
- the inner tubular member 210 has a distal section 212 , a distal end 215 , and a lumen 217 extending therein.
- the inner tubular member 210 can be composed of, for example, multi-layered tubing having lubricious inner liner and bondable outer layer such as nylon or Pebax® polyether block amide (hereinafter Pebax), or any of other suitable materials for the intended purpose.
- the elongated catheter shaft has a proximal shaft section 412 with an inflation lumen 490 and, if desired, a guidewire lumen 217 defined therein.
- An adapter 417 having an arm 424 can be disposed on a proximal end of the catheter shaft for providing access to the inflation lumen 490 .
- the arm 424 thereby can be configured to be connected to a source of inflation fluid (not shown).
- the adapter 417 can be configured for access to the guidewire lumen 217 .
- the guidewire 423 can be introduced through the adapter 417 into the guidewire lumen 217 .
- the elongated inner tubular member 210 can have a guidewire lumen 217 extending therein such that the guidewire 423 can extend from the adapter 417 through the lumen 217 and distally beyond a distal end of the catheter.
- the guidewire lumen can extend along only a distal portion of the inner tubular member.
- Such a configuration is conventionally known as a rapid exchange balloon catheter, which generally includes a short guidewire lumen extending to the distal end of the shaft from a guidewire port located distal to the proximal end of the shaft. Additional configurations and adaptations are disclosed in U.S. Pat. No. 8,052,638, which is hereby incorporated by reference in its entirety.
- a balloon 220 is disposed at a distal end 215 of the inner tubular member 210 .
- the balloon includes an inner chamber 450 defined within a working length of the balloon, a distal neck 225 and a proximal neck 290 .
- the interior chamber 450 of the balloon 220 is in fluid communication with the inflation lumen 490 extending the length of the catheter shaft member 412 .
- the inflation lumen can be defined within the inner tubular member 210 , such as a dual lumen configuration as is known in the art and depicted in FIG. 2A .
- the inflation lumen can be defined as an annular space 490 between the inner tubular member 210 and an outer tubular member as depicted in FIG. 2B and generally known as a coaxial arrangement.
- at least the working length 222 of the balloon is disposed concentrically around the inner tubular member 210 . In this manner, and regardless of whether a dual lumen or a coaxial arrangement is provided, when a pressurizing medium is introduced into through the inflation lumen 490 the balloon can expand.
- the length of the balloon catheter disclosed herein can generally be about 108 to about 200 centimeters, preferably about 135 to about 150 centimeters, and typically about 140 centimeters for PTCA, and can have other suitable dimensions for other various applications.
- the inner tubular member can have, for purpose of example and not limitation, an OD of about 0.43 mm to about 0.66 mm, and an ID of about 0.38 mm to about 0.46 mm depending on the diameter of the guidewire to be used with the catheter.
- the balloon can have a length of about 8 mm to about 100 mm, and an inflated working diameter of about 1.5 mm to about 15 mm.
- a balloon is formed as noted at ( 120 ) in FIG. 3 .
- a balloon 220 is formed ( 120 ) with a working length 222 , a distal neck 225 , and a distal leg 227 .
- the distal leg 227 has a first segment 230 with a first diameter 235 and a first wall thickness 237 .
- the distal leg has a second segment 240 with a second diameter 245 and a second wall thickness 247 .
- the second diameter 245 is greater than the first diameter 235 and the second wall thickness 247 is thinner than the first wall thickness 237 .
- the balloon can have a proximal neck (not shown in FIG. 5 ) and a proximal leg (not shown in FIG. 5 ).
- the balloon 220 can be composed of a wide variety of suitable materials, for example, nylon, co-polyamide such as Pebax (poly ether block amide), polyester, co-polyester, polyurethane, polyethylene, or the like.
- the balloon 220 can be a multilayer balloon, as discussed in more detail below. More detailed lists of suitable materials are provided in U.S. Pat. Nos. 7,074,206 and 8,052,638, each of which is hereby incorporated by reference in its entirety.
- the balloon 220 can be formed using a technique similar to that disclosed in U.S. Pat. Nos. 6,620,127, 7,906,066 and 8,052,638, each of which is hereby incorporated by reference in its entirety.
- FIG. 3 and FIG. 3
- the balloon 220 can be formed by melt-extruding ( 121 ) a thermoplastic polymeric material to form a tube 320 , then blow molding or forming in a mold 350 to a blown balloon having a distal leg 327 , the distal leg 327 having a first segment 330 and a second segment 340 at a temperature less than ( 122 ) an elevated temperature of the melt-extrusion under high pressure, for example between about 150 and about 500 psi.
- the extruded tube 320 can be placed ( 123 ) within a mold or capture member 350 .
- the extruded tube is radially expanded under suitable conditions by introducing a pressurized fluid into the tube lumen until the outer surface of the extruded tube engages and conforms to the inner surface of the capture member.
- the polymeric material of the extruded tube 320 can be biaxially oriented ( 124 ) by axially expanding the extruded tube 320 with a load applied on at least one end of the tube 320 while radially stretching the extruded tube 320 with a pressurized media in the tube lumen.
- the balloon can be foamed using a two stage blow mold process such as disclosed in U.S. Patent Publication No. 2012/0065718, which is hereby incorporated by reference in its entirety.
- a two stage blow mold process such as disclosed in U.S. Patent Publication No. 2012/0065718, which is hereby incorporated by reference in its entirety.
- the balloon can be blown initially in a first stage as disclosed in U.S. Patent Publication No. 2002/0065718, with the first and second segments of the distal leg having substantially equal or uniform diameter.
- the second segment of the distal leg can be formed with a diameter larger than the first segment of the distal leg.
- the capture member 350 can have a first portion 360 with a first diameter 365 and a second section 370 with a second diameter 375 .
- the first diameter 365 can be smaller than the second diameter 375 as shown in FIG. 4 .
- the first segment 330 of the tube 320 radially expands and conforms to the inner surface of the first portion 360 of the capture member 350 .
- the second segment 340 of the tube 320 radially expands and conforms to the inner surface of the second portion 370 of the capture member 350 . Because the diameter of the first portion 360 is smaller than the diameter of the second portion 370 , the first segment of the resulting balloon will have a diameter less than the second of the resulting balloon.
- the first segment 330 and second segment 340 of the tube 320 can initially have the same wall thickness. However, as the second segment 340 expands to a greater diameter than the first segment 330 , the resulting second segment will have a thinner resulting wall thickness than the resulting wall thickness of the first segment, thereby forming the balloon 220 of FIG. 5 .
- the capture member 350 can have a portion 355 having a shape and diameter 357 corresponding to the remainder of the balloon, including the working length 322 , the distal neck 325 , the proximal neck, and the proximal leg.
- the balloon with the desired leg can be formed in a single capture member 350 .
- one or more separate capture members can be provided, each corresponding to different portions of the balloon.
- the balloon can be formed in a single inflation step, or in additional inflation steps to further stretch and align the polymeric material.
- the distal end 215 of the inner tubular member 210 is positioned ( 130 ) in the balloon 220 .
- the first segment 230 of the distal leg 227 is disposed proximate the distal section 212 of the inner tubular member 210 .
- the second segment 240 of the distal leg 227 extends distally beyond the distal end 215 of the inner tubular member 210 .
- the distal end 215 of the inner tubular member 210 can be disposed beyond the first segment 230 but not beyond the second segment 240 .
- the distal section 212 can be disposed such that the distal end 215 is proximate a portion of the first segment 230 .
- the inner tubular member 210 is disposed within the length of the first segment 230 as shown in FIG. 5 .
- a mandrel 250 can be positioned ( 141 ) in the lumen 217 of the inner tubular member 210 .
- the mandrel 250 can, for example, have a tapered or contoured shape such that the portion of the mandrel extending distally beyond the distal end 215 of the inner tubular member 210 decreases in diameter.
- the mandrel 250 can be positioned to extend beyond the second segment 240 of the distal leg 227 of the balloon 220 .
- the mandrel 250 can be composed of a suitable material, such as metal (e.g., stainless steel or NiTi, coated or uncoated), ceramic, or the like.
- the mandrel 250 is composed of Teflon coated or Paralene coated stainless steel which can allow ease of removal after assembly. During the heating process, the shrink tubing forces the softened or molten material of the second segment against the outer surface of the mandrel to conform to the corresponding shape.
- Electromagnetic energy, such as thermal, laser, or sonic energy, 270 is applied to the distal leg 227 of the balloon 220 to bond ( 140 ) at least a portion of the first segment 230 to the distal section 212 of the inner tubular member 210 and to reduce the second diameter of the second segment 240 of the distal leg 227 .
- Heating ( 143 ) the distal leg 227 of the balloon causes the polymeric material of the balloon 220 to soften, or melt and flow.
- a heat shrink tubing 260 can be positioned ( 142 ) around the outside of at least the first and second segments 230 and 240 of the balloon 220 .
- the heat shrink tubing 260 can be composed of a polymeric material configured to shrink when exposed to heat.
- U.S. Pat. No. 7,951,259 which is hereby incorporated by reference in its entirety, discloses the use of a heat shrink sleeve in fabricating a catheter with a flexible distal end.
- the heat shrink tubing 260 when heated, shrinks and exerts an inward radial force on the second segment 240 . With the polymer of the second segment 240 in a molten or softened, the diameter of the second segment 240 will be reduced by the force exerted by the heat shrink tubing. After the balloon is cooled, the heat shrink tubing is then removed.
- Heating can be accomplished, for example, by laser heating (e.g., using a CO2 laser), contact heating (e.g., using aluminum nitride, resistance, RF), hot air, resistance heating, induction heating or the like.
- a solid state laser is used to heat the shrink tubing and soften the first and second segments 230 and 240 .
- the outer surface of the distal leg 227 can be tapered distally to a smaller outer diameter, while the first segment 230 , in its softened or molten state, forms a bond with the distal section 212 of the inner tubular member 210 .
- FIG. 6 schematically depicts a distal portion of a representative balloon catheter fabricated according to the methods disclosed herein.
- the inner tubular member 210 can have a guidewire lumen 217 extending distally beyond the tip of the catheter.
- the balloon has a working length 222 , a distal neck 225 , and a distal leg comprised of a first segment 230 and a second segment 240 .
- the first segment 230 is bonded to the inner tubular member 210 along a region 460 and generally has a first thickness.
- the second segment 240 after being heated in accordance with a method of the disclosed subject matter, will have a reduced thickness, at least less than the thickness of the first segment.
- the resulting thickness of the second segment can be uniform, or as shown in FIG. 6 , can be tapered. Furthermore, the second segment can have at least an outer diameter less than the outer diameter of the first segment. Additionally the new diameter of the second segment can taper inwardly, such as depicted in FIG. 6 , a diameter 445 .
- the balloon has an interior chamber in fluid communication with the inflation lumen 490 , such that when a pressurizing medium is introduced into through the inflation lumen 490 the balloon can expand.
- a method of fabricating a multilayer balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein.
- a multilayer balloon is formed having at least a first layer and a second layer, a working length, a distal neck, and a distal leg, the distal leg having a first segment and a second segment.
- the first layer is made of a first polymer material having a first durometer and the second layer is made of a second polymer material having a second durometer.
- the second durometer is greater than the first durometer and the second layer is an outer layer relative to the first layer.
- At least a portion of the second layer is removed from at least the distal leg of the balloon.
- the distal section of the inner tubular member is positioned in the balloon, with at least the second segment of the distal leg extending beyond the distal leg of the inner tubular member.
- the inner tubular member is bonded to the first distal leg segment of the balloon.
- an inner tubular member 710 is provided ( 610 ) to form the catheter shaft at least in part.
- the inner tubular member 710 has a distal section 712 , a distal end 715 , and a lumen 717 extending therein.
- the inner tubular member 710 can have same construct as inner tubular member 210 .
- the catheter shaft can be provided with a variety of configurations and constructions, including dual lumen or coaxial configuration and either over-the-wire or rapid exchange guidance configurations.
- a multilayer balloon 720 is formed ( 620 ) with at least a first layer 760 and a second layer 750 .
- the balloon 720 has a working length 722 , a distal neck 725 , and a distal leg 727 as shown in FIG. 9 .
- the distal leg 727 has a first segment 730 and a second segment 740 .
- the balloon can have a proximal neck 290 and a proximal leg 280 as shown in FIG. 1 .
- the first layer 760 is made of a first polymer material having a first durometer
- the second layer 750 is made of a second polymer material having a second durometer.
- the second durometer is greater than the first durometer
- the second layer is an outer layer relative to the first layer.
- the balloon embodied herein has a first layer 760 composed of, for example, Pebax having a durometer of between about 55D and about 63D.
- the second layer 750 can be composed of, for example, Pebax having a durometer of between about 70D and about 72D Pebax.
- the method disclosed herein includes removing ( 630 ) at least a portion 755 of the second layer 750 from the distal leg 727 of the balloon.
- a portion 755 of the second layer 750 can be removed by processing with laser or other thermal ablation process.
- a rotary device 830 with support mandrel 835 for the balloon shaft can be used to rotate the balloon 720 .
- a high speed spindle 810 with a milling or cutting bit 820 can be used to remove at least a portion 755 of the second layer 750 .
- a smart camera (not shown) can be used to map the shaft and taper of the balloon 720 to ensure that the balloon is not damaged in the material removal process.
- the smart camera can, for example, monitor the second layer 750 to determine and control a removal depth. The removal of a portion 755 of the second layer 750 can terminate when the removal depth reaches a predetermined threshold.
- the portion 755 of the second layer 750 that is removed can be limited to the portion of the second layer along the second segment 740 of the distal leg 727 of the balloon. Alternatively, the portion 755 of the second layer 750 that is removed can extends along all or substantially the entire distal leg 727 . In some embodiments, the depth of the portion 755 of the second layer 750 that is removed can be sufficient to expose the first layer 760 . Alternatively, the depth of the material removed can be less than the depth of the second layer so as not to expose the first layer. Additionally, the removed portion 755 can create a tapered distal leg 727 .
- the outer layer material is removed about the second segment 740 of the distal leg, sufficient to expose the first layer 760 along the length of the second segment 740 of the distal leg.
- the length of the second segment 740 of the distal leg can be of any suitable diameter, for example, approximately 0.5 mm for a dilation catheter.
- a distal section 712 of the inner tubular member 710 is positioned ( 640 ) in the balloon 720 with at least a length of the second segment 740 of the distal leg 727 extending beyond the distal end 715 of the inner tubular member 710 .
- the first segment 730 of the distal leg 727 can be disposed proximate the distal section 712 of the inner tubular member 710 .
- the second segment 740 of the distal leg 727 can extend distally beyond the distal end 715 of the inner tubular member 710 in its entirety.
- the distal end 712 of the inner tubular member 710 can be disposed beyond the first segment 730 but not beyond the second segment 740 .
- the distal section 712 can be disposed such that the distal end 715 is proximate a portion of the first segment 730 .
- the inner member 710 is positioned about the length 730 and the length 730 is about 0.5 to about 4 mm.
- the inner tubular member 710 is bonded ( 650 ) to the first distal leg segment 730 of the balloon 720 .
- electromagnetic energy such as thermal energy, can be applied to the distal leg 727 of the balloon 720 to bond at least a portion of the first segment 730 to the distal section 712 of the inner tubular member 710 .
- Applying heat to the distal leg 727 of the balloon can cause the polymeric material of the balloon 720 to soften, or melt and flow.
- the first segment 730 in its softened or molten state, can form a bond with the distal section 712 of the inner tubular member 710 .
- a mandrel can be positioned ( 641 ) in the lumen 717 of the inner tubular member 710 .
- the mandrel can, for example, be tapered such that the portion of the mandrel extending distally beyond the distal end 715 of the inner tubular member 710 decreases in diameter.
- the mandrel can be positioned such that it extends beyond the second segment 740 of the distal leg 727 of the balloon 720 .
- the mandrel can be composed of a suitable material, such as metal, ceramic, or the like.
- a heat shrink tubing can be positioned around the outside of at least the first and second segments 730 and 740 of the balloon 720 as disclosed above with reference to FIG. 5 and with reference to FIG. 7 ( 641 through 643 ).
- the heat shrink tubing when heated, can shrink and exert an inward radial force on the distal leg. Because the applied heat causes the second segment 740 to become molten or softened, the diameter of the second segment 740 can reduce and the second segment 740 can be forced, for example, to conform to the mandrel.
- solid state laser heating as already described is performed to heat the heat shrink tubing.
- the multilayer balloon 720 can be formed such that the first segment 730 has a first diameter and a first wall thickness and the second segment 740 has a second diameter and a second wall thickness as shown in FIG. 5 and with reference to FIG. 4 and FIG. 7 ( 621 through 624 ).
- the second diameter can be larger than the first diameter.
- At least a portion of the second layer can be removed from the second segment 740 .
- the multilayer balloon will be formed and bonded in a manner as previously described. Once bonded, at least a portion of the second layer can then be removed as described.
- inner tubular member can be formed by conventional techniques, such as by extruding and sometimes necking constructs found useful in intravascular catheters as disclosed in U.S. Pat. Nos. 6,277,093 and 6,217,547, each of which is incorporated by reference in its entirety.
- coiled or braided reinforcements may be included in the shaft at various locations, as is conventionally known as disclosed in U.S. Pat. No. 7,001,420 which is incorporated by reference in its entirety.
- the catheter illustrated in FIG. 1 is an over-the-wire balloon catheter
- the catheter of the invention may be a variety of suitable balloon catheters, including rapid exchange type balloon catheters having a guidewire proximal port located distal to the proximal end of the shaft, a guidewire distal port in the distal end of the shaft, and a relatively short guidewire lumen extending therebetween. While individual features of one embodiment of the invention may be discussed or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from a plurality of embodiments.
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Abstract
Method for fabricating a balloon catheter including providing an inner tubular member having a distal section and a distal end with a lumen extending therein and forming a balloon having a distal leg with a first segment having a first diameter and a first wall thickness and a second segment having a second wall thickness. The second diameter is greater than the first diameter and the first wall thickness is greater than the second wall thickness. The distal end section of the inner tubular member can be positioned in the balloon and bonded to the first segment while reducing the diameter of the second segment. Method also provided for fabricating a multilayer balloon catheter including removing at least a portion of an outer layer from the distal leg of the balloon.
Description
- The present application is a divisional of U.S. patent application Ser. No. 13/609,968, filed Sep. 11, 2012, entitled “SOFT TIP BALLOON CATHETER”, the entire content of each of which is incorporated herein by reference.
- 1. Field
- The presently disclosed subject matter relates to intraluminal balloon catheters for use in percutaneous transluminal coronary angioplasty (PTCA) or stent delivery systems or the like. Particularly, the disclosed subject matter relates to a balloon catheter and system having an improved distal tip.
- 2. Description of Related Art
- Intraluminal balloon catheters are well known and beneficial for a variety of medical uses, including diagnostics, therapeutics, and treatment. For example, and not limitation, balloon catheters can be used for a number of different vascular and/or coronary applications. In percutaneous transluminal coronary angioplasty (PTCA) procedures, a guidewire is typically advanced into the coronary artery until the distal end of the guidewire crosses a lesion to be dilated. A dilatation catheter having an inflatable balloon on the distal portion thereof is advanced into the coronary anatomy over the guidewire until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with inflation fluid one or more times to a predetermined size to open up the vascular passageway. Generally, the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilatation, but not over-expand the artery wall. After the balloon is finally deflated, blood flow resumes through the dilated artery and the dilatation catheter and the guidewire can be removed therefrom.
- In addition to or as an alternative of angioplasty procedures, it may be desirable to implant an intravascular prosthesis, generally called a stent, inside the artery at the site of the lesion. Stents may also be used to repair vessels having an intimal flap or dissection or to generally strengthen a weakened section of a vessel or to maintain its patency. Stents are usually delivered to a desired location within a coronary artery in a contracted condition on a balloon of a catheter, which is similar or identical in many respects to a balloon angioplasty catheter. The balloon, and thus the stent, is expanded within the patient's artery to a larger diameter. The balloon is deflated to remove the catheter with the stent implanted at the site of the dilated lesion. See for example, U.S. Pat. No. 5,507,768 (Lau et al.) and U.S. Pat. No. 5,458,615 (Klemm et al.), each of which is hereby incorporated by reference in its entirety.
- It is desirable to provide an intraluminal catheter with a soft distal tip to prevent or minimize injury to the vessel during advancement of the catheter therein. One challenge has been forming a connection between the soft tip and the catheter. For example, the joint or connector needs to be sufficiently strong to prevent disengagement of the soft tip, and yet prevent kinking at the junction between the soft tip and catheter shaft. Additionally, it is beneficial to balance the strength of the connection between the soft tip and the catheter shaft with the need to minimize the stiffness of the distal end of the catheter. Minimizing the stiffness of the distal end of the catheter results in improved maneuverability of the catheter.
- Accordingly, there remains a need to provide a catheter with a soft tip having improved performance.
- In accordance with one aspect of the disclosed subject matter, a method of fabricating a balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein. A balloon is formed with a working length, a distal neck, and a distal leg, the distal leg having a first segment with a first diameter and first wall thickness and a second segment with a second diameter and second wall thickness. As described herein, the second diameter is larger than the first diameter and the second wall thickness is thinner than the first wall thickness. The distal end of the inner tubular member is positioned in the balloon, with the first segment of the distal leg disposed proximate the distal section of the inner tubular member and the second segment of the distal leg extending distally beyond the distal end of the inner tubular member. Heat is applied to the distal leg of the balloon to bond at least a portion of the first segment to the distal section of the inner tubular member and to reduce the second diameter of the second segment of the distal leg.
- In one embodiment, forming the balloon can include melt-extruding a thermoplastic polymeric material to form a tube having a distal leg, the distal leg having a first segment and a second segment, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion. The extruded tube can be placed within a capture member or mold, having a first portion with a first diameter and a second portion with a second diameter, and blown or expanded to the desired configuration. The polymeric material of the extruded tube further can be biaxially oriented by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube.
- In one embodiment, the method can include positioning a mandrel in the lumen of the inner tubular member such that the mandrel extends beyond the second segment of the distal leg of the balloon. A heat shrink tubing can be positioned around the outside of at least the first and second segments of the distal leg of the balloon. Heat can be applied to the heat shrink tubing and distal leg of the balloon so as to shrink the heat shrink tubing to force the second segment of the distal leg onto the mandrel. The mandrel can have a tapered or contoured shape to form a corresponding shape of the distal leg.
- In accordance with another aspect of the disclosed subject matter, a method of fabricating a multilayer balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein. A multilayer balloon is formed having at least a first layer and a second layer, a working length, a distal neck, and a distal leg, the distal leg having a first segment and a second segment. The first layer is made of a first polymer material having a first durometer and the second layer is made of a second polymer material having a second durometer. The second layer is an outer layer relative to the first layer and the second durometer is harder than the first durometer. At least a portion of the second layer is removed from at least the distal leg of the balloon. The distal section of the inner tubular member is positioned in the balloon, with at least the second segment of the distal leg extending beyond the distal leg of the inner tubular member. The first distal leg segment of the balloon is bonded to the inner tubular member.
- In one embodiment, the first layer can comprise Pebax having a first durometer between about 55D and about 63D and the second layer can comprise Pebax having a second durometer between about 70D Pebax and about 72D Pebax. The portion of the second layer can be removed with a rotary device. For example, a rotary device and support mandrel can rotate the balloon shaft and a cutting bit can remove a portion of the second layer.
- In one embodiment, the multilayer balloon can be formed such that the second segment of the distal leg has a diameter greater than the first segment of the distal leg. A portion of the second layer can be removed from the second segment. A mandrel can be positioned in the inner lumen of the inner tubular member so as to extend beyond the second segment of the distal leg of the balloon. A heat shrink tubing can be positioned around the outside of the first and second segments. Heat can be applied to the heat shrink tubing and the distal leg to bond at least a portion of the first segment to the distal section of the inner tubular member. The heat shrink tubing can force the second segment onto the mandrel, thus reducing the diameter of the distal leg to form a monolithic distal dip.
- It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter.
- The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide further understanding of the disclosed subject matter. It will be appreciated that the drawings are not to scale, and are provided for purposes of illustration only. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.
-
FIG. 1 schematically depicts a representative embodiment of a balloon catheter in accordance with certain aspects of the disclosed subject matter with the distal portion of the balloon catheter enlarged and in cross-section. -
FIG. 2A andFIG. 2B are transverse cross-sectional views of alternative embodiments of the catheter shaft along line 2-2. -
FIG. 3 is a flow diagram of a method of fabricating a balloon catheter according to one embodiment of the disclosed subject matter. -
FIG. 4 is a longitudinal cross-sectional view of a melt-extruded tube placed in a capture member to form a balloon according to one embodiment of the disclosed subject matter. -
FIG. 5 is a longitudinal cross-sectional view of a schematic representation of portion of a balloon catheter being fabricated in accordance with the disclosed subject matter. -
FIG. 6 depicts a longitudinal cross-sectional view of ra representative embodiment of a distal portion of the balloon catheter fabricated according to a method of the presently disclosed subject matter. -
FIG. 7 is a flow diagram of a method of fabricating a multilayer balloon catheter according to another embodiment of the disclosed subject matter. -
FIG. 8 is a schematic diagram showing removal of at least a portion of a layer of a multilayer balloon according to one embodiment of the disclosed subject matter. -
FIG. 9 is a longitudinal cross-sectional view of a schematic representation of a portion of a balloon fabricated according to the method ofFIG. 7 . - While the presently disclosed subject matter will be described with reference to a few specific embodiments, the description is illustrative of the disclosed subject matter and is not to be construed as limiting. Various modifications to the presently disclosed subject matter can be made to the preferred embodiments by those skilled in the art without departing from the true spirit and scope of the disclosed subject matter as defined by the appended claims. It will be noted here that for a better understanding, like components are designated by like reference numerals throughout the various figures.
- In accordance with one aspect of the disclosed subject matter, a method of fabricating a balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein. A balloon is formed with a working length, a distal neck, and a distal leg, the distal leg having a first segment with a first diameter and first wall thickness and a second segment with a second diameter and second wall thickness. As disclosed herein, the second diameter is larger than the first diameter and the second wall thickness is thinner than the first wall thickness. The distal end of the inner tubular member is positioned in the balloon, with the first segment of the distal leg disposed proximate the distal section of the inner tubular member and the second segment of the distal leg extending distally beyond the distal end of the inner tubular member. Heat is applied to the distal leg of the balloon to bond at least a portion of the first segment to the distal section of the inner tubular member and to reduce the second diameter of the second segment of the distal leg.
- Particular embodiments of this aspect of the disclosed subject matter are described below, with reference to the figures, for purposes of illustration, and not limitation. For purposes of clarity, the balloon catheter and the method of fabricating the balloon catheter are described concurrently and in conjunction with each other.
- A balloon catheter produced according to the disclosed subject matter will now be described, for purposes of illustration and not limitation, with reference to
FIGS. 1 and 2 . The balloon catheter generally comprises an elongated catheter shaft at least including an innertubular member 210 extending a length thereof; see (110) inFIG. 3 andFIG. 5 . The innertubular member 210 has adistal section 212, adistal end 215, and alumen 217 extending therein. The innertubular member 210 can be composed of, for example, multi-layered tubing having lubricious inner liner and bondable outer layer such as nylon or Pebax® polyether block amide (hereinafter Pebax), or any of other suitable materials for the intended purpose. Other examples of suitable materials are identified in U.S. Pat. Nos. 6,277,093 and 6,217,547, each of which is hereby incorporated by reference in its entirety. The elongated catheter shaft has aproximal shaft section 412 with aninflation lumen 490 and, if desired, aguidewire lumen 217 defined therein. Anadapter 417 having anarm 424 can be disposed on a proximal end of the catheter shaft for providing access to theinflation lumen 490. Thearm 424 thereby can be configured to be connected to a source of inflation fluid (not shown). Additionally, for over-the-wire embodiments as described further, theadapter 417 can be configured for access to theguidewire lumen 217. Theguidewire 423 can be introduced through theadapter 417 into theguidewire lumen 217. - In one embodiment, conventionally known as an over-the-wire catheter, the elongated inner
tubular member 210 can have aguidewire lumen 217 extending therein such that theguidewire 423 can extend from theadapter 417 through thelumen 217 and distally beyond a distal end of the catheter. Alternatively, the guidewire lumen can extend along only a distal portion of the inner tubular member. Such a configuration is conventionally known as a rapid exchange balloon catheter, which generally includes a short guidewire lumen extending to the distal end of the shaft from a guidewire port located distal to the proximal end of the shaft. Additional configurations and adaptations are disclosed in U.S. Pat. No. 8,052,638, which is hereby incorporated by reference in its entirety. As depicted inFIG. 1 , for purpose of illustration and not limitation, aballoon 220 is disposed at adistal end 215 of the innertubular member 210. The balloon includes aninner chamber 450 defined within a working length of the balloon, adistal neck 225 and aproximal neck 290. Theinterior chamber 450 of theballoon 220 is in fluid communication with theinflation lumen 490 extending the length of thecatheter shaft member 412. For example, and with reference toFIG. 2A andFIG. 2B , the inflation lumen can be defined within the innertubular member 210, such as a dual lumen configuration as is known in the art and depicted inFIG. 2A . Alternatively, the inflation lumen can be defined as anannular space 490 between the innertubular member 210 and an outer tubular member as depicted inFIG. 2B and generally known as a coaxial arrangement. As embodied herein, at least the workinglength 222 of the balloon is disposed concentrically around the innertubular member 210. In this manner, and regardless of whether a dual lumen or a coaxial arrangement is provided, when a pressurizing medium is introduced into through theinflation lumen 490 the balloon can expand. - For purpose of illustration and not limitation, and with reference to a coronary balloon catheter, the length of the balloon catheter disclosed herein can generally be about 108 to about 200 centimeters, preferably about 135 to about 150 centimeters, and typically about 140 centimeters for PTCA, and can have other suitable dimensions for other various applications. The inner tubular member can have, for purpose of example and not limitation, an OD of about 0.43 mm to about 0.66 mm, and an ID of about 0.38 mm to about 0.46 mm depending on the diameter of the guidewire to be used with the catheter. For purpose of example and not limitation, the balloon can have a length of about 8 mm to about 100 mm, and an inflated working diameter of about 1.5 mm to about 15 mm.
- In accordance with one aspect of the disclosed method, a balloon is formed as noted at (120) in
FIG. 3 . As shown inFIG. 5 , aballoon 220 is formed (120) with a workinglength 222, adistal neck 225, and adistal leg 227. Thedistal leg 227 has afirst segment 230 with afirst diameter 235 and afirst wall thickness 237. The distal leg has asecond segment 240 with asecond diameter 245 and asecond wall thickness 247. Thesecond diameter 245 is greater than thefirst diameter 235 and thesecond wall thickness 247 is thinner than thefirst wall thickness 237. The balloon can have a proximal neck (not shown inFIG. 5 ) and a proximal leg (not shown inFIG. 5 ). - The
balloon 220 can be composed of a wide variety of suitable materials, for example, nylon, co-polyamide such as Pebax (poly ether block amide), polyester, co-polyester, polyurethane, polyethylene, or the like. In some embodiments, theballoon 220 can be a multilayer balloon, as discussed in more detail below. More detailed lists of suitable materials are provided in U.S. Pat. Nos. 7,074,206 and 8,052,638, each of which is hereby incorporated by reference in its entirety. - For purpose of example and as embodied herein, the
balloon 220 can be formed using a technique similar to that disclosed in U.S. Pat. Nos. 6,620,127, 7,906,066 and 8,052,638, each of which is hereby incorporated by reference in its entirety. In one embodiment, and with reference toFIG. 3 andFIG. 4 , theballoon 220 can be formed by melt-extruding (121) a thermoplastic polymeric material to form atube 320, then blow molding or forming in amold 350 to a blown balloon having adistal leg 327, thedistal leg 327 having afirst segment 330 and asecond segment 340 at a temperature less than (122) an elevated temperature of the melt-extrusion under high pressure, for example between about 150 and about 500 psi. The extrudedtube 320 can be placed (123) within a mold orcapture member 350. The extruded tube is radially expanded under suitable conditions by introducing a pressurized fluid into the tube lumen until the outer surface of the extruded tube engages and conforms to the inner surface of the capture member. Furthermore, the polymeric material of the extrudedtube 320 can be biaxially oriented (124) by axially expanding the extrudedtube 320 with a load applied on at least one end of thetube 320 while radially stretching the extrudedtube 320 with a pressurized media in the tube lumen. - In accordance with another aspect, the balloon can be foamed using a two stage blow mold process such as disclosed in U.S. Patent Publication No. 2012/0065718, which is hereby incorporated by reference in its entirety. When using the two stage blow mold process, for purposes of example and not limitation, the balloon can be blown initially in a first stage as disclosed in U.S. Patent Publication No. 2002/0065718, with the first and second segments of the distal leg having substantially equal or uniform diameter. In the second stage, however, and as disclosed herein, the second segment of the distal leg can be formed with a diameter larger than the first segment of the distal leg.
- The
capture member 350 can have afirst portion 360 with afirst diameter 365 and asecond section 370 with asecond diameter 375. Thefirst diameter 365 can be smaller than thesecond diameter 375 as shown inFIG. 4 . When the pressurized media radially expands thetube 320, thefirst segment 330 of thetube 320 radially expands and conforms to the inner surface of thefirst portion 360 of thecapture member 350. Likewise, thesecond segment 340 of thetube 320 radially expands and conforms to the inner surface of thesecond portion 370 of thecapture member 350. Because the diameter of thefirst portion 360 is smaller than the diameter of thesecond portion 370, the first segment of the resulting balloon will have a diameter less than the second of the resulting balloon. Thefirst segment 330 andsecond segment 340 of thetube 320 can initially have the same wall thickness. However, as thesecond segment 340 expands to a greater diameter than thefirst segment 330, the resulting second segment will have a thinner resulting wall thickness than the resulting wall thickness of the first segment, thereby forming theballoon 220 ofFIG. 5 . - In like manner, and as illustrated in
FIG. 4 , thecapture member 350 can have aportion 355 having a shape anddiameter 357 corresponding to the remainder of the balloon, including the workinglength 322, thedistal neck 325, the proximal neck, and the proximal leg. In this manner, the balloon with the desired leg can be formed in asingle capture member 350. Alternatively, one or more separate capture members can be provided, each corresponding to different portions of the balloon. Additionally, the balloon can be formed in a single inflation step, or in additional inflation steps to further stretch and align the polymeric material. - Further in accordance with the disclosed subject matter, and again with reference to
FIG. 3 andFIG. 5 , thedistal end 215 of the innertubular member 210 is positioned (130) in theballoon 220. Thefirst segment 230 of thedistal leg 227 is disposed proximate thedistal section 212 of the innertubular member 210. Thesecond segment 240 of thedistal leg 227 extends distally beyond thedistal end 215 of the innertubular member 210. For example, in some embodiments, thedistal end 215 of the innertubular member 210 can be disposed beyond thefirst segment 230 but not beyond thesecond segment 240. In other embodiments, thedistal section 212 can be disposed such that thedistal end 215 is proximate a portion of thefirst segment 230. As embodied herein, for purposes of illustration and not limitation, the innertubular member 210 is disposed within the length of thefirst segment 230 as shown inFIG. 5 . - As further embodied herein, and as depicted in the method of
FIG. 5 , amandrel 250 can be positioned (141) in thelumen 217 of the innertubular member 210. Themandrel 250 can, for example, have a tapered or contoured shape such that the portion of the mandrel extending distally beyond thedistal end 215 of the innertubular member 210 decreases in diameter. Themandrel 250 can be positioned to extend beyond thesecond segment 240 of thedistal leg 227 of theballoon 220. Themandrel 250 can be composed of a suitable material, such as metal (e.g., stainless steel or NiTi, coated or uncoated), ceramic, or the like. As embodied herein, themandrel 250 is composed of Teflon coated or Paralene coated stainless steel which can allow ease of removal after assembly. During the heating process, the shrink tubing forces the softened or molten material of the second segment against the outer surface of the mandrel to conform to the corresponding shape. - Electromagnetic energy, such as thermal, laser, or sonic energy, 270 is applied to the
distal leg 227 of theballoon 220 to bond (140) at least a portion of thefirst segment 230 to thedistal section 212 of the innertubular member 210 and to reduce the second diameter of thesecond segment 240 of thedistal leg 227. Heating (143) thedistal leg 227 of the balloon causes the polymeric material of theballoon 220 to soften, or melt and flow. In one embodiment, aheat shrink tubing 260 can be positioned (142) around the outside of at least the first andsecond segments balloon 220. Theheat shrink tubing 260, also referred to as a “heat shrink sleeve”, can be composed of a polymeric material configured to shrink when exposed to heat. U.S. Pat. No. 7,951,259, which is hereby incorporated by reference in its entirety, discloses the use of a heat shrink sleeve in fabricating a catheter with a flexible distal end. Theheat shrink tubing 260, when heated, shrinks and exerts an inward radial force on thesecond segment 240. With the polymer of thesecond segment 240 in a molten or softened, the diameter of thesecond segment 240 will be reduced by the force exerted by the heat shrink tubing. After the balloon is cooled, the heat shrink tubing is then removed. Heating can be accomplished, for example, by laser heating (e.g., using a CO2 laser), contact heating (e.g., using aluminum nitride, resistance, RF), hot air, resistance heating, induction heating or the like. As embodied herein, for purposes of illustration and not limitation, a solid state laser is used to heat the shrink tubing and soften the first andsecond segments distal leg 227 can be tapered distally to a smaller outer diameter, while thefirst segment 230, in its softened or molten state, forms a bond with thedistal section 212 of the innertubular member 210. -
FIG. 6 schematically depicts a distal portion of a representative balloon catheter fabricated according to the methods disclosed herein. As previously noted, the innertubular member 210 can have aguidewire lumen 217 extending distally beyond the tip of the catheter. The balloon has a workinglength 222, adistal neck 225, and a distal leg comprised of afirst segment 230 and asecond segment 240. Thefirst segment 230 is bonded to the innertubular member 210 along aregion 460 and generally has a first thickness. Thesecond segment 240, after being heated in accordance with a method of the disclosed subject matter, will have a reduced thickness, at least less than the thickness of the first segment. The resulting thickness of the second segment can be uniform, or as shown inFIG. 6 , can be tapered. Furthermore, the second segment can have at least an outer diameter less than the outer diameter of the first segment. Additionally the new diameter of the second segment can taper inwardly, such as depicted inFIG. 6 , adiameter 445. The balloon has an interior chamber in fluid communication with theinflation lumen 490, such that when a pressurizing medium is introduced into through theinflation lumen 490 the balloon can expand. - In accordance with another aspect of the disclosed subject matter, a method of fabricating a multilayer balloon catheter includes providing an inner tubular member having a distal section, a distal end, and a lumen extending therein. A multilayer balloon is formed having at least a first layer and a second layer, a working length, a distal neck, and a distal leg, the distal leg having a first segment and a second segment. The first layer is made of a first polymer material having a first durometer and the second layer is made of a second polymer material having a second durometer. The second durometer is greater than the first durometer and the second layer is an outer layer relative to the first layer. At least a portion of the second layer is removed from at least the distal leg of the balloon. The distal section of the inner tubular member is positioned in the balloon, with at least the second segment of the distal leg extending beyond the distal leg of the inner tubular member. The inner tubular member is bonded to the first distal leg segment of the balloon.
- Particular embodiments of this aspect of the disclosed subject matter are described below, with reference to the figures, for purposes of illustration, and not limitation. For purposes of understanding, the balloon catheter and the method of fabricating the balloon catheter are described concurrently and in conjunction with each other.
- As embodied herein, and with reference to
FIG. 7 andFIG. 9 , an innertubular member 710 is provided (610) to form the catheter shaft at least in part. The innertubular member 710 has adistal section 712, adistal end 715, and alumen 717 extending therein. As already described herein, the innertubular member 710 can have same construct as innertubular member 210. As previously noted, the catheter shaft can be provided with a variety of configurations and constructions, including dual lumen or coaxial configuration and either over-the-wire or rapid exchange guidance configurations. - As further embodied herein, a
multilayer balloon 720 is formed (620) with at least afirst layer 760 and asecond layer 750. Theballoon 720 has a workinglength 722, adistal neck 725, and adistal leg 727 as shown inFIG. 9 . Thedistal leg 727 has afirst segment 730 and asecond segment 740. The balloon can have aproximal neck 290 and aproximal leg 280 as shown inFIG. 1 . - The
first layer 760 is made of a first polymer material having a first durometer, and thesecond layer 750 is made of a second polymer material having a second durometer. As embodied herein, the second durometer is greater than the first durometer, and the second layer is an outer layer relative to the first layer. For example, and not limitation, the balloon embodied herein has afirst layer 760 composed of, for example, Pebax having a durometer of between about 55D and about 63D. Thesecond layer 750 can be composed of, for example, Pebax having a durometer of between about 70D and about 72D Pebax. - The method disclosed herein includes removing (630) at least a
portion 755 of thesecond layer 750 from thedistal leg 727 of the balloon. Various suitable methods for removal of material from the balloon are described in U.S. Pat. No. 7,9067,836, which is hereby incorporated by reference in its entirety. In one embodiment of the presently disclosed subject matter, for example, aportion 755 of thesecond layer 750 can be removed by processing with laser or other thermal ablation process. As embodied herein, with reference toFIG. 8 , arotary device 830 withsupport mandrel 835 for the balloon shaft can be used to rotate theballoon 720. Ahigh speed spindle 810 with a milling or cuttingbit 820 can be used to remove at least aportion 755 of thesecond layer 750. In some embodiments, for example, a smart camera (not shown) can be used to map the shaft and taper of theballoon 720 to ensure that the balloon is not damaged in the material removal process. The smart camera can, for example, monitor thesecond layer 750 to determine and control a removal depth. The removal of aportion 755 of thesecond layer 750 can terminate when the removal depth reaches a predetermined threshold. - In some embodiments, the
portion 755 of thesecond layer 750 that is removed can be limited to the portion of the second layer along thesecond segment 740 of thedistal leg 727 of the balloon. Alternatively, theportion 755 of thesecond layer 750 that is removed can extends along all or substantially the entiredistal leg 727. In some embodiments, the depth of theportion 755 of thesecond layer 750 that is removed can be sufficient to expose thefirst layer 760. Alternatively, the depth of the material removed can be less than the depth of the second layer so as not to expose the first layer. Additionally, the removedportion 755 can create a tapereddistal leg 727. As embodied herein, for purposes of illustration and not limitation, the outer layer material is removed about thesecond segment 740 of the distal leg, sufficient to expose thefirst layer 760 along the length of thesecond segment 740 of the distal leg. The length of thesecond segment 740 of the distal leg can be of any suitable diameter, for example, approximately 0.5 mm for a dilation catheter. - As noted in
FIG. 9 , adistal section 712 of the innertubular member 710 is positioned (640) in theballoon 720 with at least a length of thesecond segment 740 of thedistal leg 727 extending beyond thedistal end 715 of the innertubular member 710. Thefirst segment 730 of thedistal leg 727 can be disposed proximate thedistal section 712 of the innertubular member 710. Thesecond segment 740 of thedistal leg 727 can extend distally beyond thedistal end 715 of the innertubular member 710 in its entirety. For example, in some embodiments, thedistal end 712 of the innertubular member 710 can be disposed beyond thefirst segment 730 but not beyond thesecond segment 740. In other embodiments, thedistal section 712 can be disposed such that thedistal end 715 is proximate a portion of thefirst segment 730. As embodied herein, theinner member 710 is positioned about thelength 730 and thelength 730 is about 0.5 to about 4 mm. The innertubular member 710 is bonded (650) to the firstdistal leg segment 730 of theballoon 720. For example, in one embodiment, electromagnetic energy, such as thermal energy, can be applied to thedistal leg 727 of theballoon 720 to bond at least a portion of thefirst segment 730 to thedistal section 712 of the innertubular member 710. Applying heat to thedistal leg 727 of the balloon can cause the polymeric material of theballoon 720 to soften, or melt and flow. Thefirst segment 730, in its softened or molten state, can form a bond with thedistal section 712 of the innertubular member 710. - As with methods discussed with reference to
FIG. 3 , throughFIG. 5 above, similar techniques likewise can be applied to the multilayer balloon. For example, a mandrel can be positioned (641) in thelumen 717 of the innertubular member 710. The mandrel can, for example, be tapered such that the portion of the mandrel extending distally beyond thedistal end 715 of the innertubular member 710 decreases in diameter. The mandrel can be positioned such that it extends beyond thesecond segment 740 of thedistal leg 727 of theballoon 720. The mandrel can be composed of a suitable material, such as metal, ceramic, or the like. - Furthermore, a heat shrink tubing can be positioned around the outside of at least the first and
second segments balloon 720 as disclosed above with reference toFIG. 5 and with reference toFIG. 7 (641 through 643). The heat shrink tubing, when heated, can shrink and exert an inward radial force on the distal leg. Because the applied heat causes thesecond segment 740 to become molten or softened, the diameter of thesecond segment 740 can reduce and thesecond segment 740 can be forced, for example, to conform to the mandrel. As embodied herein, solid state laser heating as already described is performed to heat the heat shrink tubing. - Additionally, it is noted that removing at least a portion of the second layer can be performed after the inner tubular member and the distal leg segment are bonded together. In this manner, additional aspects of the method described above with regard to
FIG. 3 throughFIG. 5 also can be employed. That is, themultilayer balloon 720 can be formed such that thefirst segment 730 has a first diameter and a first wall thickness and thesecond segment 740 has a second diameter and a second wall thickness as shown inFIG. 5 and with reference toFIG. 4 andFIG. 7 (621 through 624). The second diameter can be larger than the first diameter. At least a portion of the second layer can be removed from thesecond segment 740. The multilayer balloon will be formed and bonded in a manner as previously described. Once bonded, at least a portion of the second layer can then be removed as described. - To the extent not previously discussed herein, the various catheter components may be formed and joined by conventional materials and methods. For example, inner tubular member can be formed by conventional techniques, such as by extruding and sometimes necking constructs found useful in intravascular catheters as disclosed in U.S. Pat. Nos. 6,277,093 and 6,217,547, each of which is incorporated by reference in its entirety. Additionally, although not illustrated, coiled or braided reinforcements may be included in the shaft at various locations, as is conventionally known as disclosed in U.S. Pat. No. 7,001,420 which is incorporated by reference in its entirety.
- While the present invention has been described herein in terms of certain preferred embodiments, those skilled in the art will recognize that modifications and improvements may be made without departing from the scope of the invention. For example, although the catheter illustrated in
FIG. 1 is an over-the-wire balloon catheter, the catheter of the invention may be a variety of suitable balloon catheters, including rapid exchange type balloon catheters having a guidewire proximal port located distal to the proximal end of the shaft, a guidewire distal port in the distal end of the shaft, and a relatively short guidewire lumen extending therebetween. While individual features of one embodiment of the invention may be discussed or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from a plurality of embodiments.
Claims (14)
1. A balloon catheter having a monolithic distal tip, prepared by a process comprising the steps of:
providing an inner tubular member having a distal section, a distal end, and a lumen extending therein;
forming a balloon having a working length, a distal neck, and a distal leg, the distal leg having a first segment with a first diameter and first wall thickness and a second segment with a second diameter and second wall thickness, the second diameter being larger than the first diameter and the second wall thickness being thinner than the first wall thickness;
positioning the distal end of the inner tubular member in the balloon, with the first segment of the distal leg disposed proximate the distal section of the inner tubular member and the second segment of the distal leg extending distally beyond the distal end of the inner tubular member;
heating the distal leg of the balloon to bond at least a portion of the first segment to the distal section of the inner tubular member and to reduce the second diameter of the second segment of the distal leg.
2. A method of fabricating a multilayer balloon catheter, comprising:
providing an inner tubular member having a distal section, a distal end, and a lumen extending therein;
forming a multilayer balloon having at least a first layer and a second layer, a working length, a distal neck, and a distal leg, the distal leg having a first segment and a second segment, wherein the first layer is made of a first polymer material having a first durometer, wherein the second layer is made of a second polymer material having a second durometer, the second durometer being greater than the first durometer, and wherein the second layer is an outer layer relative to the first layer;
removing at least a portion of the second layer from the second segment of distal leg of the balloon;
positioning the distal section of the inner tubular member in the balloon, with at least the second segment of the distal leg extending beyond the distal end of the inner tubular member; and
bonding the inner tubular member to the first distal leg segment of the balloon.
3. The method of claim 2 , wherein removing at least a portion of the second layer further includes removing at least a portion of the second layer from the first segment.
4. The method of claim 2 , wherein the first layer comprises a material having a durometer between about 55D and about 63D.
5. The method of claim 4 , wherein the material of the first layer is selected from the group consisting of polyurethane, polyethylene, co-polyamide, polyester, and co-polyester.
6. The method of claim 4 , wherein the material of the first layer comprises polyether block amide.
7. The method of claim 2 , wherein the second layer comprises a material having a durometer between about 70D and 72D.
8. The method of claim 7 , wherein the material of the second layer is selected from the group consisting of polyamide, polyurethane, polyethylene, co-polyamide, polyester, and co-polyester.
9. The material in claim 8 , wherein the material of the second layer comprises polyether block amide or polyamide.
10. The method of claim 2 wherein the at least a portion of the second layer is removed with a rotary device.
11. The method of claim 2 , wherein the at least a portion of the second layer is removed by milling or laser ablation.
12. The method of claim 2 , further comprising monitoring the second layer to determine a removal depth; and
terminating the removing at least a portion of the second layer when the removal depth reaches a predetermined threshold.
13. The method of claim 2 , wherein removing the at least a portion is performed after bonding the inner tubular member to the first distal leg segment of the balloon
14. The method of claim 2 , further comprising:
positioning a mandrel in the lumen of the inner tubular member, the mandrel extending beyond the second segment of the distal leg of the balloon;
positioning a heat shrink tubing around at least a portion of the first and second segments of the distal leg of the balloon; and
heating the heat shrink tubing and first and second segments of the distal leg of the balloon, to bond at least a portion of the first segment to the distal section of the inner tubular member.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/463,088 US20140358176A1 (en) | 2012-09-11 | 2014-08-19 | Soft Tip Balloon Catheter |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/609,968 US8840743B2 (en) | 2012-09-11 | 2012-09-11 | Soft tip balloon catheter |
US14/463,088 US20140358176A1 (en) | 2012-09-11 | 2014-08-19 | Soft Tip Balloon Catheter |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US13/609,968 Division US8840743B2 (en) | 2012-09-11 | 2012-09-11 | Soft tip balloon catheter |
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US20140358176A1 true US20140358176A1 (en) | 2014-12-04 |
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US13/609,968 Active US8840743B2 (en) | 2012-09-11 | 2012-09-11 | Soft tip balloon catheter |
US14/463,088 Abandoned US20140358176A1 (en) | 2012-09-11 | 2014-08-19 | Soft Tip Balloon Catheter |
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US13/609,968 Active US8840743B2 (en) | 2012-09-11 | 2012-09-11 | Soft tip balloon catheter |
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US (2) | US8840743B2 (en) |
EP (1) | EP2895226B1 (en) |
WO (1) | WO2014042801A1 (en) |
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WO2023126091A1 (en) * | 2022-01-03 | 2023-07-06 | Cti Vascular Ag | Angioplasty balloon catheter for treating vascular disease |
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EP2714180B1 (en) | 2011-05-26 | 2018-11-07 | Abbott Cardiovascular Systems Inc. | Catheter with stepped skived hypotube |
WO2014144467A1 (en) | 2013-03-15 | 2014-09-18 | Abbott Cardiovascular Systems Inc. | Reduced material tip for catheter and method of forming same |
US9480824B2 (en) | 2013-12-23 | 2016-11-01 | Hologic, Inc. | Cuff-resistant anchoring balloon for medical device |
JP6706888B2 (en) | 2014-09-04 | 2020-06-10 | アボット カーディオバスキュラー システムズ インコーポレイテッド | Balloon catheter |
CR20150461A (en) | 2014-09-04 | 2015-12-14 | BALL CATHETER | |
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JP2016214821A (en) | 2015-05-19 | 2016-12-22 | アボット カーディオバスキュラー システムズ インコーポレイテッド | Catheter having monolithic multilayer distal outer member |
JP2017184791A (en) * | 2016-03-31 | 2017-10-12 | オリンパス株式会社 | Tube fusing method and tube fusing apparatus |
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2013
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2014
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WO2023126091A1 (en) * | 2022-01-03 | 2023-07-06 | Cti Vascular Ag | Angioplasty balloon catheter for treating vascular disease |
Also Published As
Publication number | Publication date |
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EP2895226A1 (en) | 2015-07-22 |
US20140074020A1 (en) | 2014-03-13 |
EP2895226B1 (en) | 2019-12-18 |
WO2014042801A1 (en) | 2014-03-20 |
US8840743B2 (en) | 2014-09-23 |
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