WO2014209735A1 - Cathéter à ballon avec section de ballon mate - Google Patents

Cathéter à ballon avec section de ballon mate Download PDF

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Publication number
WO2014209735A1
WO2014209735A1 PCT/US2014/043111 US2014043111W WO2014209735A1 WO 2014209735 A1 WO2014209735 A1 WO 2014209735A1 US 2014043111 W US2014043111 W US 2014043111W WO 2014209735 A1 WO2014209735 A1 WO 2014209735A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
catheter
section
finish
distal
Prior art date
Application number
PCT/US2014/043111
Other languages
English (en)
Inventor
Stephanie Elise RIVERA
Original Assignee
Cook Medical Technologies Llc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Cook Medical Technologies Llc filed Critical Cook Medical Technologies Llc
Priority to EP14741453.6A priority Critical patent/EP3013406A1/fr
Publication of WO2014209735A1 publication Critical patent/WO2014209735A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • 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
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • 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
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • 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
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • Embodiments of the present invention relate to medical devices and more particularly to devices and methods for inflating a balloon having a tacky surface at a distal end of a catheter.
  • stones may develop in the kidneys and migrate down the ureters. Sometimes such stones become lodged in the ureters, requiring intervention for their removal.
  • gallstones may develop in the gallbladder, and migrate down the biliary duct (the common bile duct), through the ampulla of Vater, and out the Sphincter of Oddi into the duodenum. As with kidney stones, such stones occasionally become lodged in the biliary duct, the pancreatic duct or the ampulla of Vater. Indeed, gallstones can be of such a size as to be unable to pass through the Sphincter of Oddi. In either case, intervention is again required for their removal.
  • Silicone has been identified as a suitable replacement for latex in many applications and potentially could replace latex as an extraction balloon.
  • silicone is generally tacky and tends to stick to other materials, including materials that it is packaged with.
  • the silicone balloon will tend to adhere to an underlying catheter. This is potentially a problem, as the balloon may inflate unevenly during a procedure. In some instances, the silicone balloon may inflate only in the region adjacent an inflation port, while remaining adhered to the catheter at other locations.
  • FIG. 1 illustrates a partially inflated balloon catheter 100 in which an inner surface of a balloon 102 is adhered to an outer surface of a catheter 104.
  • the balloon 102 has inflated in an area immediately adjacent an inflation port 106, but is otherwise adhered to the catheter 104 in the other areas.
  • the inflation pressure may overcome the adhesion between the outer surface of the catheter 104 and the inner surface of the balloon 102, or the balloon 102 may continue to inflate only adjacent the inflation port 106 eventually failing. Both outcomes are unsatisfactory and the use of a silicone balloon, or any balloon that adheres to the outer surface of the catheter such as thermoplastic elastomers, is therefore limited in application.
  • Embodiments of the invention include an extraction balloon catheter.
  • the extraction balloon catheter is comprised of a tubular member and a balloon.
  • the tubular member has a longitudinal lumen, an outer surface, a proximal section, a balloon section, and a distal section.
  • the outer surface of the proximal section has a polished finish and the outer surface of the balloon section has a matte finish.
  • a port is disposed in the balloon section, the port providing fluid communication between the longitudinal lumen and the outer surface of the of the balloon section.
  • the balloon is disposed about the balloon section of the tubular member and is secured to the outer surface at a proximal balloon end and to the outer surface at a distal balloon end.
  • Another embodiment includes a method for manufacturing a balloon extraction catheter.
  • a catheter having a lumen is divided into a balloon section and a non-balloon section.
  • the surface finish of the balloon section of the catheter is modified to have a matte finish.
  • a port is formed in the catheter with the port providing fluid communication between the outer surface of the balloon section and the longitudinal lumen.
  • a balloon is placed over the balloon section of the catheter and a distal end of the balloon is secured to the catheter. A proximal end of the balloon is then secured to the catheter.
  • an extraction balloon catheter comprises a tubular member and a balloon.
  • the tubular member has a longitudinal lumen and a balloon section.
  • the tubular member has a first outer surface with a first average surface irregularity and the balloon section has a second outer surface with a second average surface irregularity.
  • the first average surface irregularity is less than the second average surface irregularity.
  • a port is disposed in the balloon section with the port providing fluid communication between the longitudinal lumen and the second outer surface.
  • the balloon is disposed about the balloon section of the tubular member and is secured to the catheter at a proximal balloon end and to the catheter at a distal balloon end.
  • FIG. 1 is a side view of a distal end of a partially inflated prior art balloon catheter showing the outer surface of the catheter adhering to the balloon.
  • FIG. 2 is a side view of a distal end of an embodiment of an extraction balloon catheter according to the present invention.
  • FIG. 3 is a detailed view of the surface of the catheter of FIG. 2.
  • FIG. 4 is a side view of the distal end of the embodiment of the extraction balloon catheter of FIG. 2 with the balloon inflated.
  • each of the expressions “at least one of A, B and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
  • distal and proximal will be used to describe the opposing axial ends of the inventive balloon catheter, as well as the axial ends of various component features.
  • distal is used in its conventional sense to refer to the end of the apparatus (or component thereof) that is furthest from the operator during use of the apparatus.
  • proximal is used in its conventional sense to refer to the end of the apparatus (or component thereof) that is closest to the operator during use.
  • a catheter may have a distal end and a proximal end, with the proximal end designating the end closest to the operator heart during an operation, such as a handle, and the distal end designating an opposite end of the catheter, such as treatment tip.
  • distal refers to a direction that is generally away from the operator along the apparatus during use and the term “proximally” refers to a direction that is generally toward the operator along the apparatus.
  • FIG. 2 illustrates a side view of an embodiment of an extraction balloon catheter 200 according to the present invention.
  • the extraction balloon catheter 200 is comprised of a tubular member, such as a catheter 202, and a balloon 204.
  • the balloon 204 is formed of an elastic material that tends to adhere to the catheter 202. Examples of such materials include silicone and thermoplastic elastomers.
  • the balloon 204 is generally disposed at a distal end of the catheter 202 and is secured to the catheter 202 at a proximal end 224 of the balloon 204 and a distal end 222 of the balloon 204.
  • the catheter 202 has a lumen 206 extending longitudinally from an area proximate the proximal end of the catheter 202 to an area proximate the distal end of the catheter 202.
  • An inflation port 208 provides a fluid communication path between the lumen 206 and an outer surface 210 of the catheter 202.
  • a syringe 212 is shown in fluid commination with the lumen 206, such that the syringe 212 may be used as an inflation device.
  • Other inflation devices are possible and embodiments of the invention are not limited to the use of a syringe 212.
  • the catheter 202 may be formed of multiple sections of material or may be a single material as shown in FIG. 2.
  • the catheter 220 of FIG. 2 has three distinct sections comprising a proximal section 214, a balloon section 216, and a distal section 218.
  • the proximal section 214 and the distal section 218 may have a polished finish with low surface irregularities.
  • the balloon section 216 contains the inflation port and has a matte finish having higher surface irregularities.
  • the polished finish may be necessary to reduce trauma to a patient and inhibit microorganisms from colonizing on the catheter 202.
  • FIG. 3 is a close up view of a surface 300 of a catheter illustrating the difference between a polished finish 302 and a matte finish 304.
  • a polished finish 302 In the area having a polished finish 302, there are relatively little surface irregularities.
  • One method of measuring the surface irregularities is to measure a depth of the surface irregularities and find the average surface deviation. As shown in FIG. 3, the average surface deviation 306 of the polished section 302 is less than the average surface deviation 308 of the matte section 304.
  • Other methods of quantifying the surface irregularities or finish are well known and the average surface deviation is only given to be an example.
  • the average surface deviation of the polished surface may be 3 nanometers while the matte surface may have an average surface deviation of 12 nanometers. In other embodiments the average surface deviation of the matte finish may be at least triple the average surface deviations of the polished section.
  • the balloon 204 is positioned about the catheter 202 such that the balloon 204 is disposed over the balloon section 216.
  • the balloon 204 is secured to the catheter 202 at the balloon's distal 222 and proximal ends 224, leaving a middle portion disposed over the inflation port 208.
  • the balloon 204 may be secured to the catheter 202 within the balloon section 216, or in other embodiments the balloon 204 may be secured external to the balloon section 216, or a combination of the two.
  • the balloon 204 When an inflation fluid is delivered to the interior volume of the balloon 204 through the inflation port 208, the balloon 204 begins to inflate.
  • the matte finish of the balloon portion 216 inhibits the balloon 204 from adhering to the catheter 202, such that the balloon 204 inflates more readily than if it were adhered to the catheter surface.
  • the irregular surface also may allow fluid to flow between the irregularities further enhancing inflation of the balloon 204 when the balloon 204 is adjacent the catheter 202.
  • FIG. 4 illustrates the extraction balloon catheter 200 of FIG. 2 with the balloon 204 in an inflated state.
  • Inflation fluid illustrated by arrows 220 delivered through the inflation port 208 inflates the balloon 204.
  • the inflation fluid may be metered by the inflation fluid source to inject a known amount of fluid to inflate the balloon 204 to a specific size. For instance, if a syringe is the inflation source, the plunger may be advanced to a mark to deliver a specific amount of inflation fluid.
  • a catheter 202 having a longitudinal lumen 206 is divided into a balloon section 216 and a non-balloon section 214, 218.
  • the surface of the balloon section 216 is then modified to have a matte finish.
  • An inflation port 208 is formed in the catheter 202 to provide fluid communication between the outer surface of the balloon section 216 and the longitudinal lumen 206.
  • a balloon 204 is then placed over the matte finish of the balloon section 216.
  • a distal end 222 of the balloon 204 is secured to the catheter 202 and a proximal end 224 is secured to the catheter 202.
  • the balloon section 216 may be modified to have a matte finish through a variety of processes.
  • the surface may be modified by buffing the surface.
  • the balloon section 216 may be blasted by particles to form the matte finish.
  • a stream of plastic pellets could be used to form the matte finish.
  • the matte finish is formed by etching the surface of the balloon section 216.
  • An etching solution may be applied to the balloon section 216 to form the matte finish.
  • the outer surface of the catheter 202 may be polished by passing the catheter 202 through a heated die having a polished surface. The catheter 202 may be heated above its melting temperature and passed through the heated die, decreasing the size of the catheter 202 and polishing the outer surface. This procedure may be done prior to modifying the surface of the balloon section 216.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Vascular Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter à ballon (200) utilisant un ballon non en latex. Le cathéter à ballon inclut un cathéter (202) ayant une surface externe polie et une section de ballon (204) ayant une surface externe mate. Une lumière (206) s'étend d'une extrémité proximale du cathéter à la section de ballon et un orifice de gonflage (208) fournit une communication fluidique entre la lumière et la surface externe de la section de ballon. Un ballon est positionné sur la section de ballon et fixé à une extrémité distale et une extrémité proximale.
PCT/US2014/043111 2013-06-27 2014-06-19 Cathéter à ballon avec section de ballon mate WO2014209735A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14741453.6A EP3013406A1 (fr) 2013-06-27 2014-06-19 Cathéter à ballon avec section de ballon mate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361840237P 2013-06-27 2013-06-27
US61/840,237 2013-06-27

Publications (1)

Publication Number Publication Date
WO2014209735A1 true WO2014209735A1 (fr) 2014-12-31

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PCT/US2014/043111 WO2014209735A1 (fr) 2013-06-27 2014-06-19 Cathéter à ballon avec section de ballon mate

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EP (1) EP3013406A1 (fr)
WO (1) WO2014209735A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4058124A4 (fr) * 2019-11-12 2024-01-24 Microvention, Inc. Cathéter à ballonnet à caractéristiques améliorées

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3452756A (en) * 1966-10-10 1969-07-01 American Hospital Supply Corp Medical catheter with plastic balloon requiring low inflation force and method of making same
US3544668A (en) * 1968-07-22 1970-12-01 Davol Inc Method of manufacturing a balloon catheter
US4259960A (en) * 1979-10-15 1981-04-07 The Kendall Company Catheter with non-adhering balloon
WO1996026748A2 (fr) * 1995-02-23 1996-09-06 Cv Dynamics, Inc. Dba Medical, Incorporated Catheter a ballonnet dote d'une valve de decharge a impulsions et d'un collier de retention
US20020198492A1 (en) * 2001-06-26 2002-12-26 John Miller Balloon catheter
US20120296366A1 (en) * 2011-05-20 2012-11-22 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
EP2572749A2 (fr) * 2011-09-23 2013-03-27 Covidien LP Cathéter de guidage à ballonnet d'accès distal

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3452756A (en) * 1966-10-10 1969-07-01 American Hospital Supply Corp Medical catheter with plastic balloon requiring low inflation force and method of making same
US3544668A (en) * 1968-07-22 1970-12-01 Davol Inc Method of manufacturing a balloon catheter
US4259960A (en) * 1979-10-15 1981-04-07 The Kendall Company Catheter with non-adhering balloon
WO1996026748A2 (fr) * 1995-02-23 1996-09-06 Cv Dynamics, Inc. Dba Medical, Incorporated Catheter a ballonnet dote d'une valve de decharge a impulsions et d'un collier de retention
US20020198492A1 (en) * 2001-06-26 2002-12-26 John Miller Balloon catheter
US20120296366A1 (en) * 2011-05-20 2012-11-22 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
EP2572749A2 (fr) * 2011-09-23 2013-03-27 Covidien LP Cathéter de guidage à ballonnet d'accès distal

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4058124A4 (fr) * 2019-11-12 2024-01-24 Microvention, Inc. Cathéter à ballonnet à caractéristiques améliorées

Also Published As

Publication number Publication date
EP3013406A1 (fr) 2016-05-04

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