WO2006065517A1 - Catheter having an ultra soft tip and methods for making the same - Google Patents
Catheter having an ultra soft tip and methods for making the same Download PDFInfo
- Publication number
- WO2006065517A1 WO2006065517A1 PCT/US2005/043017 US2005043017W WO2006065517A1 WO 2006065517 A1 WO2006065517 A1 WO 2006065517A1 US 2005043017 W US2005043017 W US 2005043017W WO 2006065517 A1 WO2006065517 A1 WO 2006065517A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- distal
- catheter
- distal end
- proximal
- disposed
- Prior art date
Links
Classifications
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- 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
-
- 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
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- the invention generally relates to intravascular catheters. Specifically, the present invention relates to intravascular balloon catheters including a soft distal tip.
- Intravascular balloon catheters are used in a wide variety of medical procedures to diagnose and treat vascular abnormalities such as aneurysms, stenotic lesions, intracranial shunts, etc. Such balloon catheters may be used for purposes of dilation, occlusion, flow control, tissue reformation, or the like. Balloons, in particular generally elastic balloons, have also been included on guide catheters to arrest blood flow near a treatment site while another treatment device is extended into a treatment area beyond or distal of the balloon and guide catheter.
- Intravascular balloon catheters are commonly navigated through the vasculature to access remote regions of the human body.
- a catheter In order to navigate a vasculature during an intended medical procedure, a catheter must possess opposing characteristics of trackability and flexibility, while retaining a relatively low profile. It is also beneficial that catheters possess a soft distal tip to lessen injury to a vessel wall during navigation through the vasculature.
- the hardness or durometer of polymer materials such as those typically used in catheters is commonly measured using the Shore Hardness Test.
- the Shore Hardness of such materials may be measured by using either the Shore A or Shore D scale.
- the Shore A scale is used for softer materials, while the Shore D scale is used for harder materials. Both scales range from 0 to 100, where the upper end of the Shore A scale overlaps the lower end of the Shore D scale.
- a Shore A durometer of 90 is approximately equal to a Shore D durometer of 40.
- the durometer of the distal tip of exemplary prior art catheters typically are in the range of 35D to about 7OD.
- Such distal tips are disclosed in U.S. Patent No. 6,652,507 issued to Pepin and U.S. Patent No. 6,368,301 issued to Hamilton et al., the disclosures of each of which are incorporated in their entirety by reference herein.
- the distal tip may come into contact with a vessel wall.
- a hard distal tip formed of the material of the elongate shaft may injure a vessel wall such as a diseased vessel wall.
- the invention is directed to an intravascular balloon catheter having an ultra soft distal tip.
- the catheter is a guide catheter including an elastic balloon mounted proximate its distal end.
- the inflated elastic balloon arrests blood flow near a treatment site while a treatment device extends through the lumen of the guide catheter beyond its distal end to treat the vessel.
- one embodiment of the invention includes an elongate shaft having a braided reinforcement layer.
- the reinforcement member can include a metallic or polymeric braided member, single or multiple layers of coiled material or a micromachined tubular member.
- the micromachined tube can be a hypotube including slots or a spiral cut, for example, to create desired stiffness and flexibility.
- a polymer layer is disposed about the braided reinforcement layer and may extend distal of the distal end of the braided reinforcement layer.
- An inflatable balloon is disposed about the distal portion of the elongate shaft and is secured to the polymer layer. A distal portion of the material of the inflatable balloon extends beyond the distal end of the polymer layer to form an ultra soft distal tip.
- the material of the inflatable balloon and the distal tip is preferably a highly compliant polymer such as a thermoplastic rubber elastomer, providing the catheter with an ultra soft distal tip.
- Figure 1 is a plan view of a balloon catheter in accordance with the invention
- Figure 2 is a cross-sectional view of the distal portion of a catheter in accordance with the invention
- Figure 3 is a cross-sectional view showing another embodiment of a distal portion of a catheter in accordance with the invention.
- Figure 4 is a cross-sectional view showing another embodiment of a distal portion of a catheter in accordance with the invention. Detailed Description of Preferred Embodiments
- FIG. 1 shows an intravascular balloon catheter in accordance with the invention.
- Catheter 10 includes a proximal portion 20 and a distal portion 30.
- the proximal portion 20 may include a hub assembly 40 for communicating with the interior of the catheter.
- the distal portion 30 may include an expandable balloon 50 for use during a medical procedure.
- An elongate shaft 60 may extend from the proximal portion 20 to the distal portion 30.
- FIG. 2 shows a distal portion of a catheter in accordance with the invention.
- Elongate shaft 60 includes a reinforcement member 70 which is depicted for the present embodiment as a braided member 75. It is, however, recognized that the reinforcement member could include single or multiple layers of coiled or helically wrapped material. Alternatively, a micromachined tubular member could be utilized, for example, a slotted hypotube or a spiral cut hypotube.
- the reinforcement member 70, such as braided member 75 may extend substantially the length of the elongate shaft 60.
- the braided member 75 may be formed of materials such as metals, metal alloys, polymers, metal-polymer composites, or other suitable materials.
- suitable materials may include stainless steels (e.g., 304v stainless steel), nickel-titanium alloys (e.g., nitinol, such as super elastic or linear elastic nitinol), nickel-chromium alloys, nickel-chromium-iron alloys, cobalt alloys, nickel, titanium, platinum, or alternatively, a polymer material such as a high performance polymer, or other suitable materials, and the like.
- stainless steels e.g., 304v stainless steel
- nickel-titanium alloys e.g., nitinol, such as super elastic or linear elastic nitinol
- nickel-chromium alloys e.g., nickel-chromium-iron alloys
- cobalt alloys nickel, titanium, platinum, or alternatively, a polymer material such as a high performance polymer, or other suitable materials, and the like.
- the braided member 75 may be covered with a polymer layer 80.
- Polymer layer 80 may substantially permeate the braided member 75, such that braid interstices are substantially filled with the polymer of the polymer layer 80.
- the polymer layer 80 may encase the braided member 75, such that the polymer layer 80 forms a discrete layer over the braided member 75.
- the polymer layer 80 may be formed of a flexible material such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), silicone, fiuoropolymer, liquid crystal polymer (LCP), polyimide, polyamide, polyester, polyethylene (PE), polypropylene, polyvinyl chloride (PVC), polyfiuorocarbon, polyurethane, polysulfone, ethyl vinyl acetate (EVA), polyether block amide (PEBAX), styrene- ethylene/butylenes-styrene (SEBS), styrene-butadiene-styrene (SBS), polyethylene terephthalate (PET), and their mixtures, alloys, blends, copolymers, and block copolymers.
- polymer layer 80 may comprise a thermoplastic polyester elastomer having superior flexibility and- strength characteristics, such as Hytrel® available from DuPont.
- the distal end 35 of the braided member 75 may include a segment 38 free of the polymer layer 80.
- Polymer layer 80 may be stripped from the segment 38 during a manufacturing process or polymer layer 80 may be disposed proximal of segment 38 prior to securing polymer layer 80 to the braided member 75.
- the distal segment 38 may extend a few millimeters. Preferably, segment 38 may be between about 1.0 and about 2.0 millimeters in length.
- a polymer sleeve 90 may be disposed about segment 38 of the braided member 75.
- Polymer sleeve 90 may include a different polymer than that of the polymer layer 80.
- Polymer sleeve 90 may include a low-density polyethylene (LDPE).
- LDPE low-density polyethylene
- Polymer sleeve 90 preferably provides a strong bonding substrate for the material of the balloon 50, whereas the material of the balloon 50 may not be as readily bondable to the polymer layer 80.
- a proximal portion of the polymer sleeve 90 may be disposed about and secured to the braided member 75.
- Polymer sleeve 90 may permeate the interstices of braided member 75, or polymer sleeve 90 may encase the distal segment 38 of the braided member 75 forming a discrete layer.
- a distal portion of the polymer sleeve 90 may extend distal of the distal end 35 of the braided member 75 providing a transition in flexibility of the distal end of the catheter 10.
- a balloon 50 is disposed about a distal portion of the elongate shaft 60.
- the balloon 50 may include a proximal waist portion (not shown), a distal waist portion 100, and an intermediate portion 105.
- the balloon 50 may include a compliant material, such as a thermoplastic rubber elastomer.
- balloon 50 comprises ChronoPreneTM, available from CardioTech International, Inc.
- ChronoPreneTM is a biocompatible elastomeric material having good surface smoothness and excellent elasticity, and may be processed by conventional melt processing methods.
- ChronoPreneTM has a durometer hardness of 5-40 Shore A making it an ultra soft material.
- ChronoPreneTM is readily bondable with low-density polyethylene (LDPE), such as may be used in the polymer sleeve 90.
- LDPE low-density polyethylene
- the distal waist portion 100 of the balloon 50 may be bonded to the polymer sleeve 90.
- the distal waist portion 100 extends distal of the polymer sleeve 90 to form an ultra soft tip 120.
- the ultra soft tip 120 includes the thermoplastic rubber elastomer of the balloon, thus the ultra soft tip 120 may have a durometer hardness of 5-40 Shore A.
- the ultra soft tip 120 may extend distal of the polymer sleeve 90.
- ultra soft tip 120 extends less than 1.0 millimeters beyond the polymer sleeve 90 to prevent catheter lumen closure or diameter restriction at the distal tip.
- An inner liner 65 may be disposed within the lumen 55 of the reinforcement layer 70.
- the inner liner 65 may extend substantially the length of the catheter shaft or may extend any length thereof.
- the inner liner 65 may end proximal of the distal end of polymer sleeve 90.
- Preferably inner liner 65 extends distal of the distal end of braided member 75.
- Such a configuration creates a stepwise transition from the inner liner 65, to the polymer sleeve 90, to the ultra soft tip 120 created by the distal extension of the distal balloon waist 100.
- Such a multi-step, step-wise transition creates a region near the distal tip having a multi-step reduction in hardness.
- Inner liner 65 may create a lubricious surface having a low frictional coefficient in order to facilitate introduction and advancement of a medical device such as a guidewire or aneurysm treatment catheter (for example, a coil delivery catheter) through the lumen 55.
- Inner liner 65 may include a polymer material such as fluorinated polyethylene, or the like.
- inner liner 65 includes a polytetrafluoroethylene, such as Teflon® available from DuPont.
- Figure 3 shows an alternate embodiment of a distal tip in accordance with the invention.
- polymer layer 80 may be a discrete layer disposed about the braided member 75.
- Polymer sleeve 90 may abut the polymer layer 80 forming an interface and extend distal of the distal end of braided member 75.
- the distal waist portion 100 of balloon 50 extends distal of the polymer sleeve 90 to form an ultra soft distal tip 120.
- the polymer layer 80 may extend substantially the entire length of the braided member 75.
- the polymer layer 80 and the inner liner 65 may co-terminate at the distal end 35 of the braided member 75.
- the distal waist portion 100 of balloon 50 may be bonded to the polymer layer 80 at the distal end of elongate shaft 60.
- the distal waist portion 100 of balloon 50 may extend distal of the distal end 35 of the braided member 75, forming an ultra soft distal tip 120 having a durometer of between about 5 A and about 40A.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2593029A CA2593029C (en) | 2004-12-10 | 2005-11-29 | Catheter having an ultra soft tip and methods for making the same |
EP05852346.5A EP1824551B1 (en) | 2004-12-10 | 2005-11-29 | Catheter having an ultra soft tip |
JP2007545512A JP4937134B2 (en) | 2004-12-10 | 2005-11-29 | Catheter with ultra-soft tip and method for manufacturing the same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/009,667 | 2004-12-10 | ||
US11/009,667 US7815599B2 (en) | 2004-12-10 | 2004-12-10 | Catheter having an ultra soft tip and methods for making the same |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2006065517A1 true WO2006065517A1 (en) | 2006-06-22 |
Family
ID=36585052
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2005/043017 WO2006065517A1 (en) | 2004-12-10 | 2005-11-29 | Catheter having an ultra soft tip and methods for making the same |
Country Status (5)
Country | Link |
---|---|
US (2) | US7815599B2 (en) |
EP (1) | EP1824551B1 (en) |
JP (1) | JP4937134B2 (en) |
CA (1) | CA2593029C (en) |
WO (1) | WO2006065517A1 (en) |
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Also Published As
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JP2008522728A (en) | 2008-07-03 |
US20110035927A1 (en) | 2011-02-17 |
US7815599B2 (en) | 2010-10-19 |
CA2593029A1 (en) | 2006-06-22 |
US20060129176A1 (en) | 2006-06-15 |
JP4937134B2 (en) | 2012-05-23 |
US8973239B2 (en) | 2015-03-10 |
EP1824551A1 (en) | 2007-08-29 |
CA2593029C (en) | 2014-02-18 |
EP1824551B1 (en) | 2019-06-26 |
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