US20030139762A1 - Angioplasty balloon with thin-walled taper and method of making the same - Google Patents
Angioplasty balloon with thin-walled taper and method of making the same Download PDFInfo
- Publication number
- US20030139762A1 US20030139762A1 US10/357,665 US35766503A US2003139762A1 US 20030139762 A1 US20030139762 A1 US 20030139762A1 US 35766503 A US35766503 A US 35766503A US 2003139762 A1 US2003139762 A1 US 2003139762A1
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- United States
- Prior art keywords
- taper
- slug
- angioplasty balloon
- working length
- shaft
- 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
- A61M25/10—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
-
- 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
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
-
- 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
- B29C67/00—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
- B29C67/0014—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 for shaping tubes or blown tubular films
-
- 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
- B29C2949/00—Indexing scheme relating to blow-moulding
- B29C2949/07—Preforms or parisons characterised by their configuration
- B29C2949/079—Auxiliary parts or inserts
- B29C2949/08—Preforms made of several individual parts, e.g. by welding or gluing parts together
-
- 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
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/25—Solid
- B29K2105/253—Preform
- B29K2105/258—Tubular
-
- 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
- B29L2022/025—Bladders
-
- 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
Definitions
- This invention relates generally to dilation catheters. More particularly, the invention relates to intravascular angioplasty catheter balloons and a method of manufacturing the same.
- Angioplasty is a procedure by which stenotic lesions (atheromatous deposits), found in cases of atherosclerosis.
- a guidewire is inserted into the cardiovascular system, generally via the femoral artery under local anesthesia.
- the guidewire is advanced through the patient's vasculature to the site of the stenosis (stenotic lesion). Placement of the guidewire may be aided by way of fluoroscopic observation.
- a dilatation catheter having a guidewire lumen and distensible balloon portion, is then advanced through the vasculature until the balloon portion, at the distal end of the catheter, traverses or crosses a stenotic lesion.
- the artery is narrowed in the area of the stenotic lesion due to the atheromatous deposits occupying arterial space at the walls of the artery.
- the balloon portion of the catheter is inflated, generally with a fluid, to compress the atheromatous deposits against the walls of the artery. This compression dilates the lumen of the artery leaving an unblocked arterial passage once the guidewire and catheter are removed.
- the uninflated balloon encounters the stenosis, it must first cross at least a portion thereof in order to reach its distal-most destination. Therefore, a flexible, low profile balloon is preferable.
- the ends of the uninflated balloon should taper smoothly and lay low so that the balloon can be threaded into tight passages. It is preferable that the thickness of the balloon material be substantially constant from a working length throughout each taper. In the present context, a thick wall is at least approximately 0.002′′ in thickness while a thin wall is approximately 0.001′′ in thickness.
- pre-necking In which the segment of tubing that will become the taper is first softened by heating and then subjected to a force which forms a narrowed segment in the tubing, referred to here as a neck.
- the objective of pre-necking is to form the taper from this neck.
- the neck expands to form a taper having thinner walls than a taper blown from un-necked tubing.
- the thin taper terminates at a thin shaft.
- the problem of thick, stiff tapers still remains to a certain extent because the pre-necking is performed in a solid or semi-molten state in which the strain applied to the tubing induces crystallization.
- the molecular strands of the polymer become aligned parallel to the load inducing the strain. Once aligned in this manner, the polymer resists further distension.
- a thicker taper for a somewhat thinner taper which nonetheless remains less expansive than the reminder of the balloon.
- the remainder of the balloon which is intended for contacting the wall of a body lumen such as during an angioplasty, is often referred to as the working distance or the working length.
- pre-necked balloons we end up with a thin taper which is less expansive than the working length.
- an angioplasty balloon having a thin taper terminating at a thin shaft. It is desirable that the thin taper have a wall of substantially equivalent thickness to a wall of the working length.
- an angioplasty balloon 40 having a taper wall thickness 76 substantially equivalent to a working length wall thickness 60 .
- the angioplasty balloon 40 is manufactured from a slug 100 having an inner tube 106 within a shortened outer tube 102 .
- the shortened outer tube 102 is fused to the inner tube 106 within a mold until an angioplasty balloon 40 has formed.
- the working length 44 of the angioplasty balloon 40 has formed from the shortened outer tube 102 while the inner tube 106 forms a taper ( 48 , 50 ) at each end of the working length 44 .
- Each taper ( 48 , 50 ) terminates in a shaft ( 42 , 46 ).
- the working length 44 , taper ( 48 , 50 ), and shaft ( 42 , 46 ) each have substantially equivalent wall thicknesses ( 60 , 66 , 76 ).
- FIG. 1 is a perspective partially sectioned view of the angioplasty balloon of the present invention.
- FIG. 2 is a side sectional view of the slug of the present invention.
- FIG. 3 is a side sectional view of the angioplasty balloon of the present invention.
- FIG. 4 is a flow chart of a method of manufacturing the angioplasty balloon of the present invention.
- the angioplasty balloon 40 of the present invention is shown partially sectioned.
- the angioplasty balloon 40 has a working length 44 which extends proximally into a proximal taper 48 and proximal shaft 42 .
- the working length 44 extends distally into a distal taper 50 and distal shaft 46 .
- a balloon lumen 52 is surrounded by the angioplasty balloon 40 .
- the working length 44 has an inner diameter 58 , an outer diameter 56 , and a working length wall thickness 60 there between.
- the diameters ( 58 , 56 ) are between 1.5 and 15.0 mm and fairly constant throughout the working length 44 of the angioplasty balloon 40 .
- the working length wall thickness 60 is between 0.010 mm and 0.045 mm and fairly constant throughout the working length 44 of the angioplasty balloon 40 .
- the distal shaft 46 has an inner shaft diameter 64 , an outer shaft diameter 62 , and a shaft wall thickness 66 there between.
- the diameters ( 64 , 62 ) are between 0.600 mm and 0.720 mm and fairly constant throughout the distal shaft 46 of the angioplasty balloon 40 .
- the shaft wall thickness 66 is between 0.010 mm and 0.051 mm and fairly constant throughout the distal shaft 46 of the angioplasty balloon 40 .
- the length of the angioplasty balloon 40 between the distal shaft 46 and the proximal shaft 42 , generally ranges from 10 mm to 40 mm. However, this is merely a matter of design choice.
- the proximal shaft 42 is fairly dimensionally equivalent to the distal shaft 46 . However, the proximal shaft 42 is adaptable to communicating with an external supply of fluid pressure and/or delivering such to the angioplasty balloon 40 .
- the working length 44 adjoins the distal shaft 46 by way of a distal taper 50 .
- the distal taper 50 has an inner taper diameter 80 and an outer taper diameter 78 which diminish from the working length 44 to the distal shaft 46 providing a smooth transition there between.
- a taper wall thickness 76 is found between the inner taper diameter 80 and the outer taper diameter 78 .
- the proximal taper 48 is comparable to the distal taper 50 in dimensions and construction.
- the angioplasty balloon 40 is affixed to the distal portion of a catheter (not shown).
- the balloon lumen 52 communicates with an inflation lumen of the catheter to provide inflation, fluid or otherwise, to the angioplasty balloon 40 .
- tapers ( 48 , 50 ) and the working length 44 expand until the full diameters ( 56 , 58 , 62 , 64 , 78 , 80 ) are achieved.
- tapers ( 48 , 50 ) and the working length 44 lie flattened or folded.
- the tapers ( 48 , 50 ) are able to collapse to a comparably low profile.
- the flattened tapers ( 48 , 50 ) have flexibility comparable to that of the flattened working length 44 . These characteristics are advantageous because they lessen the resistance encountered by the uninflated balloon as it is forced through a tight stenosis or sharp curves of vasculature. As a result, the angioplasty balloon 40 can be maneuvered into more difficult stenoses and is less likely to traumatize the artery.
- FIG. 2 a cross sectional view of a slug 100 is shown.
- the slug 100 is made of a shortened outer tube 102 surrounding an inner tube 106 and being in communication therewith.
- the inner tube 106 has been inserted into the shortened outer tube 102 .
- the shortened outer tube 102 has an outer proximal end 103 and an outer distal end 104 .
- the shortened outer tube 102 has an outer tube outer diameter 110 , an outer tube inner diameter 112 and an outer tube wall thickness 114 there between.
- the shortened outer tube 102 is of a length less than that of the inner tube 106 .
- the inner tube 106 has an inner proximal end 108 and an inner distal end 109 .
- the inner tube 106 has an inner tube outer diameter 112 , an inner tube inner diameter 118 and an inner tube wall thickness 120 there between.
- FIGS. 2 - 4 a cross sectional view of an angioplasty balloon 40 formed from the slug 100 is shown.
- the slug 100 has been placed within a mold (not shown) which defines a desired angioplasty balloon 40 profile.
- the slug 100 has been heated and pressurized, whereupon the shortened outer tube 102 and the inner tube 106 have filled the mold. During heating, the shortened outer tube 102 and the inner tube 106 have fused.
- the proximal taper 48 and the distal taper 50 have been formed by expansion of the inner tube 106 and the shortened outer tube 102 within the mold (not shown).
- the angioplasty balloon 40 has been formed.
- the shortened outer tube 102 has formed the working length 44 .
- the inner tube 106 and the outer distal end 104 have formed the distal taper 50 .
- the inner tube 106 and the outer proximal end 103 have formed the proximal taper 48 .
- the tapers ( 48 , 50 ) form easily as the angioplasty balloon 40 easily expands within the mold due to the configuration of the shortened outer tube 102 and the inner tube 106 .
- This ease of expansion is due to the substantial disorientation of the molecular structure of the polymer compound of the tubes ( 102 , 106 ).
- the tubes ( 102 , 106 ) are extruded at molten temperatures hot enough to randomize the molecular alignment of the polymer. Generally, this randomization of molecular structure is followed by pre-necking which eliminates the randomization to a degree.
- the present invention provides a slug 100 which allows the reduction or complete elimination of pre-necking. With a reduction or elimination of pre-necking, little or no orientation is imposed upon the polymer and the tubes ( 102 , 106 ) retain most, if not all, of their distensibility.
- having a larger diameter shortened outer tube 102 furthers a larger diameter working length 44
- a smaller diameter inner tube 106 furthers smaller diameter shafts ( 42 , 46 ).
- the shortened outer tube 102 may be fused to the inner tube 106 before or during the formation of the angioplasty balloon 40 within the mold. Fusion prior to molding of the angioplasty balloon 40 may be achieved by various combinations of heat and pressure. Preferably, the temperature during fusion will exceed the glass transition temperature of the polymer. Above the glass transition temperature, the tubing is easily deformed. Below the glass transition temperature, the polymer resists deformation. Additionally, the tubes ( 102 , 106 ) should be made of compatible materials, especially if fusion is to occur prior to the angioplasty balloon 40 being blown.
- the tubes ( 102 , 106 ) will be made from the same or compatible polymers.
- both may be made of a polyetherblockamide material, commercially available as PEBAX® 7033 (PEBAX) or a like material, producing an angioplasty balloon 40 of uniform composition.
- the shortened outer tube 102 may be made of PEBAX while the inner tube 106 is made of a polyamide such as nylon. This will produce a two layer composite working length 44 having nylon shafts ( 42 , 46 ).
- the use of a nylon inner tube 106 to produce a two layer composite working length 44 may provide an angioplasty balloon 40 capable of withstanding pressures higher than conventionally possible.
- PEBAX-Nylon compositions are utilized where the tubes ( 102 , 106 ) are fused while the angioplasty balloon 40 is blown, a high temperature (about 235° F.) and high pressure (300 p.s.i. or more) will be required.
- thermoplastic copolyester commercially available as Hytrel® (a polyether-ester block copolymer) or Amitel®.
- Thermoplastic copolyesters can be difficult to blow into a balloon shape because they lose their strength when heated.
- a composite of thermoplastic copolyester with PET (which readily forms a balloon shape) can produce a two layered angioplasty balloon 40 .
- the tubes ( 102 , 106 ) may be made of identical or different polyolefins.
- the slug 100 may be comprised of more than two tubes assembled together to achieve different shaft 42 or working length 44 properties.
- One of the tubes ( 102 , 106 , or another) may be a co-extruded tube of two or more layers.
- the slug 100 may or may not be pre-necked at its outer proximal end 103 , its outer distal end 104 , or both.
- Diameters ( 56 , 58 , 62 , 64 ) may be constant or variable while the taper diameters ( 78 , 80 ) may have identical or different characteristics as between the proximal taper 48 and the distal taper 50 .
Abstract
An angioplasty balloon and method of manufacture are provided. The balloon has a working length and a taper each having a substantially equivalent thickness. This allows the balloon to be steered easily through vasculature to the site of a stenosis prior to inflation during an angioplasty procedure. The taper thickness in particular is achieved through use of a specially designed multi-tubular slug which is molded to form the angioplasty balloon of the present invention.
Description
- 1. Field of the Invention
- This invention relates generally to dilation catheters. More particularly, the invention relates to intravascular angioplasty catheter balloons and a method of manufacturing the same.
- 2. Description of the Related Art
- Angioplasty is a procedure by which stenotic lesions (atheromatous deposits), found in cases of atherosclerosis. During angioplasty, a guidewire is inserted into the cardiovascular system, generally via the femoral artery under local anesthesia. The guidewire is advanced through the patient's vasculature to the site of the stenosis (stenotic lesion). Placement of the guidewire may be aided by way of fluoroscopic observation. A dilatation catheter, having a guidewire lumen and distensible balloon portion, is then advanced through the vasculature until the balloon portion, at the distal end of the catheter, traverses or crosses a stenotic lesion. The artery is narrowed in the area of the stenotic lesion due to the atheromatous deposits occupying arterial space at the walls of the artery. Once placed, the balloon portion of the catheter is inflated, generally with a fluid, to compress the atheromatous deposits against the walls of the artery. This compression dilates the lumen of the artery leaving an unblocked arterial passage once the guidewire and catheter are removed.
- Looking back to where the uninflated balloon encounters the stenosis, it must first cross at least a portion thereof in order to reach its distal-most destination. Therefore, a flexible, low profile balloon is preferable. In particular, the ends of the uninflated balloon should taper smoothly and lay low so that the balloon can be threaded into tight passages. It is preferable that the thickness of the balloon material be substantially constant from a working length throughout each taper. In the present context, a thick wall is at least approximately 0.002″ in thickness while a thin wall is approximately 0.001″ in thickness.
- Unfortunately, current production methods yield a balloon with stiff and bulky tapers. These limitations are related to the behavior of the balloon material during manufacture, where a piece of polymer tubing is stretched to make the balloon. The balloon is made (“blown”) by placing a segment of polymeric tubing in a mold, heating it to a near-molten state, and pressurizing the tubing until it fills the mold. The, tubing within the mold forms the balloon. The mold is shaped such that the balloon is comprised of a working length with a taper at each end thereof. Each taper joins an unexpanded segment of tubing outside of the mold, referred to here as a shaft. Because the tapers expand less than the working length, they remain stiffer and bulkier. A thin-walled taper would be more desirable.
- One approach to thinning the wall of the taper is a process called “pre-necking” in which the segment of tubing that will become the taper is first softened by heating and then subjected to a force which forms a narrowed segment in the tubing, referred to here as a neck. The objective of pre-necking is to form the taper from this neck. As the balloon is blown, the neck expands to form a taper having thinner walls than a taper blown from un-necked tubing. The thin taper terminates at a thin shaft. However, the problem of thick, stiff tapers still remains to a certain extent because the pre-necking is performed in a solid or semi-molten state in which the strain applied to the tubing induces crystallization. In effect, the molecular strands of the polymer become aligned parallel to the load inducing the strain. Once aligned in this manner, the polymer resists further distension. Thus, due to pre-necking, we have exchanged a thicker taper for a somewhat thinner taper which nonetheless remains less expansive than the reminder of the balloon. The remainder of the balloon, which is intended for contacting the wall of a body lumen such as during an angioplasty, is often referred to as the working distance or the working length. In the case of pre-necked balloons we end up with a thin taper which is less expansive than the working length.
- What is needed, therefore, is an angioplasty balloon having a thin taper terminating at a thin shaft. It is desirable that the thin taper have a wall of substantially equivalent thickness to a wall of the working length.
- It is an object of the present invention to provide an angioplasty balloon having a taper thickness substantially equivalent to a working length thickness.
- It is an object of the present invention to provide an angioplasty balloon having a thin shaft.
- It is an object of the present invention to provide an angioplasty balloon having a wall thickness no greater than 0.002″, and in one embodiment between 0.0005″ and 0.002″.
- It is an object of the present invention to provide a slug capable of being molded into an angioplasty balloon having a taper thickness substantially equivalent to a working length thickness.
- It is an object of the present invention to provide a slug comprising a polymeric inner tube within a shortened polymeric outer tube.
- It is an object of the present invention to provide a method of manufacturing an angioplasty balloon having a taper thickness substantially equivalent to a working length thickness.
- In accordance with these objectives an
angioplasty balloon 40 is provided having ataper wall thickness 76 substantially equivalent to a workinglength wall thickness 60. Theangioplasty balloon 40 is manufactured from aslug 100 having aninner tube 106 within a shortenedouter tube 102. The shortenedouter tube 102 is fused to theinner tube 106 within a mold until anangioplasty balloon 40 has formed. The workinglength 44 of theangioplasty balloon 40 has formed from the shortenedouter tube 102 while theinner tube 106 forms a taper (48, 50) at each end of the workinglength 44. Each taper (48, 50) terminates in a shaft (42, 46). The workinglength 44, taper (48, 50), and shaft (42, 46) each have substantially equivalent wall thicknesses (60, 66, 76). - FIG. 1 is a perspective partially sectioned view of the angioplasty balloon of the present invention.
- FIG. 2 is a side sectional view of the slug of the present invention.
- FIG. 3 is a side sectional view of the angioplasty balloon of the present invention.
- FIG. 4 is a flow chart of a method of manufacturing the angioplasty balloon of the present invention.
- Referring to FIG. 1, the
angioplasty balloon 40 of the present invention is shown partially sectioned. Theangioplasty balloon 40 has a workinglength 44 which extends proximally into aproximal taper 48 andproximal shaft 42. The workinglength 44 extends distally into adistal taper 50 anddistal shaft 46. Aballoon lumen 52 is surrounded by theangioplasty balloon 40. The workinglength 44 has aninner diameter 58, anouter diameter 56, and a workinglength wall thickness 60 there between. The diameters (58, 56) are between 1.5 and 15.0 mm and fairly constant throughout the workinglength 44 of theangioplasty balloon 40. The workinglength wall thickness 60 is between 0.010 mm and 0.045 mm and fairly constant throughout the workinglength 44 of theangioplasty balloon 40. - Continuing with reference to FIG. 1, the
distal shaft 46 has aninner shaft diameter 64, anouter shaft diameter 62, and ashaft wall thickness 66 there between. The diameters (64, 62) are between 0.600 mm and 0.720 mm and fairly constant throughout thedistal shaft 46 of theangioplasty balloon 40. Theshaft wall thickness 66 is between 0.010 mm and 0.051 mm and fairly constant throughout thedistal shaft 46 of theangioplasty balloon 40. The length of theangioplasty balloon 40, between thedistal shaft 46 and theproximal shaft 42, generally ranges from 10 mm to 40 mm. However, this is merely a matter of design choice. Theproximal shaft 42 is fairly dimensionally equivalent to thedistal shaft 46. However, theproximal shaft 42 is adaptable to communicating with an external supply of fluid pressure and/or delivering such to theangioplasty balloon 40. - The working
length 44 adjoins thedistal shaft 46 by way of adistal taper 50. Thedistal taper 50 has aninner taper diameter 80 and anouter taper diameter 78 which diminish from the workinglength 44 to thedistal shaft 46 providing a smooth transition there between. Ataper wall thickness 76 is found between theinner taper diameter 80 and theouter taper diameter 78. Theproximal taper 48 is comparable to thedistal taper 50 in dimensions and construction. - As configured for angioplasty, the
angioplasty balloon 40 is affixed to the distal portion of a catheter (not shown). Theballoon lumen 52 communicates with an inflation lumen of the catheter to provide inflation, fluid or otherwise, to theangioplasty balloon 40. When pressurized, tapers (48, 50) and the workinglength 44 expand until the full diameters (56, 58, 62, 64, 78, 80) are achieved. However, when not pressurized, tapers (48, 50) and the workinglength 44 lie flattened or folded. When the workinglength 44 is collapsed to its lowest profile, the tapers (48, 50) are able to collapse to a comparably low profile. Additionally, the flattened tapers (48, 50) have flexibility comparable to that of the flattened workinglength 44. These characteristics are advantageous because they lessen the resistance encountered by the uninflated balloon as it is forced through a tight stenosis or sharp curves of vasculature. As a result, theangioplasty balloon 40 can be maneuvered into more difficult stenoses and is less likely to traumatize the artery. - Referring to FIG. 2, a cross sectional view of a
slug 100 is shown. Theslug 100 is made of a shortenedouter tube 102 surrounding aninner tube 106 and being in communication therewith. Theinner tube 106 has been inserted into the shortenedouter tube 102. The shortenedouter tube 102 has an outerproximal end 103 and an outerdistal end 104. The shortenedouter tube 102 has an outer tubeouter diameter 110, an outer tubeinner diameter 112 and an outertube wall thickness 114 there between. The shortenedouter tube 102 is of a length less than that of theinner tube 106. Theinner tube 106 has an innerproximal end 108 and an innerdistal end 109. Theinner tube 106 has an inner tubeouter diameter 112, an inner tubeinner diameter 118 and an innertube wall thickness 120 there between. - Referring to FIGS.2-4, a cross sectional view of an
angioplasty balloon 40 formed from theslug 100 is shown. Theslug 100 has been placed within a mold (not shown) which defines a desiredangioplasty balloon 40 profile. Theslug 100 has been heated and pressurized, whereupon the shortenedouter tube 102 and theinner tube 106 have filled the mold. During heating, the shortenedouter tube 102 and theinner tube 106 have fused. During pressurization, theproximal taper 48 and thedistal taper 50 have been formed by expansion of theinner tube 106 and the shortenedouter tube 102 within the mold (not shown). Once the tapers (48, 50) have been formed in this manner, theangioplasty balloon 40 has been formed. In particular, the shortenedouter tube 102 has formed the workinglength 44. Theinner tube 106 and the outerdistal end 104 have formed thedistal taper 50. Theinner tube 106 and the outerproximal end 103 have formed theproximal taper 48. - Continuing with reference to FIGS.2-4, the tapers (48, 50) form easily as the
angioplasty balloon 40 easily expands within the mold due to the configuration of the shortenedouter tube 102 and theinner tube 106. This ease of expansion is due to the substantial disorientation of the molecular structure of the polymer compound of the tubes (102, 106). The tubes (102, 106) are extruded at molten temperatures hot enough to randomize the molecular alignment of the polymer. Generally, this randomization of molecular structure is followed by pre-necking which eliminates the randomization to a degree. However, the present invention provides aslug 100 which allows the reduction or complete elimination of pre-necking. With a reduction or elimination of pre-necking, little or no orientation is imposed upon the polymer and the tubes (102, 106) retain most, if not all, of their distensibility. - As a result of the configuration of the
slug 100, less overall tube material is provided to the tapers (48, 50) than to the workinglength 44. This corresponds with the fact that the tapers (48, 50) occupy less overall space than the workinglength 44 in a formedangioplasty balloon 40. Thus, in the formedballoon 40, as the diameters (78, 80) of the tapers (48, 50) diminish from the workinglength 44 to the shafts (42, 46), thetaper wall thickness 76 does not increase appreciably. Low profile and flexibility are achieved. This may be further enhanced by utilizing an innertube wall thickness 120 less than the outertube wall thickness 114. Additionally, having a larger diameter shortenedouter tube 102 furthers a largerdiameter working length 44, while a smaller diameterinner tube 106 furthers smaller diameter shafts (42, 46). These features contribute to low profile and flexibility of theangioplasty balloon 40. - The shortened
outer tube 102 may be fused to theinner tube 106 before or during the formation of theangioplasty balloon 40 within the mold. Fusion prior to molding of theangioplasty balloon 40 may be achieved by various combinations of heat and pressure. Preferably, the temperature during fusion will exceed the glass transition temperature of the polymer. Above the glass transition temperature, the tubing is easily deformed. Below the glass transition temperature, the polymer resists deformation. Additionally, the tubes (102, 106) should be made of compatible materials, especially if fusion is to occur prior to theangioplasty balloon 40 being blown. - Generally, the tubes (102, 106) will be made from the same or compatible polymers. For example, both may be made of a polyetherblockamide material, commercially available as PEBAX® 7033 (PEBAX) or a like material, producing an
angioplasty balloon 40 of uniform composition. Alternatively, the shortenedouter tube 102 may be made of PEBAX while theinner tube 106 is made of a polyamide such as nylon. This will produce a two layercomposite working length 44 having nylon shafts (42, 46). The use of a nyloninner tube 106 to produce a two layercomposite working length 44 may provide anangioplasty balloon 40 capable of withstanding pressures higher than conventionally possible. If PEBAX-Nylon compositions are utilized where the tubes (102, 106) are fused while theangioplasty balloon 40 is blown, a high temperature (about 235° F.) and high pressure (300 p.s.i. or more) will be required. - Other combinations of materials include, for example, polyethylene terephthalate (PET) and a thermoplastic copolyester, commercially available as Hytrel® (a polyether-ester block copolymer) or Amitel®. Thermoplastic copolyesters can be difficult to blow into a balloon shape because they lose their strength when heated. However, a composite of thermoplastic copolyester with PET (which readily forms a balloon shape) can produce a two
layered angioplasty balloon 40. Alternatively, the tubes (102, 106) may be made of identical or different polyolefins. - In addition to the above variations, the
slug 100 may be comprised of more than two tubes assembled together to achievedifferent shaft 42 or workinglength 44 properties. One of the tubes (102, 106, or another) may be a co-extruded tube of two or more layers. Theslug 100 may or may not be pre-necked at its outerproximal end 103, its outerdistal end 104, or both. Diameters (56, 58, 62, 64) may be constant or variable while the taper diameters (78, 80) may have identical or different characteristics as between theproximal taper 48 and thedistal taper 50.
Claims (30)
1. A slug for manufacturing an angioplasty balloon, said slug comprising:
a shortened outer tube and:
an inner tube, said inner tube being longer in length than said shortened outer tube, said shortened outer tube circumferentially surrounding said inner tube.
2. The slug of claim 1 wherein said shortened outer tube is fused to said inner tube.
3. The slug of claim 1 wherein said outer tube has an outer tube wall thickness greater than an inner tube wall thickness of said inner tube.
4. The slug of claim 1 wherein said shortened outer tube has a constant outer tube inner diameter cooperating with a constant inner tube outer diameter.
5. The slug of claim 1 wherein said shortened outer tube has a variable outer tube inner diameter cooperating with a variable inner tube outer diameter.
6. The slug of claim 1 wherein said shortened outer tube has an end, said end being pre-necked.
7. The slug of claim 1 wherein said slug is comprised of a polymeric material selected from the group consisting of: polyethylene terephthalate, a polyetherblockamide, a polyamide, a thermoplastic copolyester, a polyolefin, and a polyether-ester block copolymer.
8. The slug of claim 1 wherein one of said shortened outer tube and said inner tube is comprised of tubing material, said tubing material being a co-extruded polymer of two or more layers.
9. The slug of claim 1 wherein said slug further comprises an additional tube, said additional tube circumferentially surrounding said inner tube.
10. A method of forming an angioplasty balloon catheter from a slug, said method comprising:
surrounding an inner tube with a shortened outer tube to form said slug;
placing said slug within a mold, said mold defining a desired angioplasty balloon profile; and
molding said slug with said mold to form an angioplasty balloon catheter having a working length extending into a taper which further extends into a shaft.
11. The method of claim 10 further comprising extruding said inner tube and said shortened outer tube in a manner giving randomized molecular alignment to any polymer comprising said inner tube and said shortened outer tube prior to said surrounding.
12. The method of claim 10 further comprising pre-necking an outer end of said shortened outer tube prior to said molding.
13. The method of claim 10 further comprising adding an additional tube circumferentially around said inner tube prior to said molding.
14. The method of claim 10 wherein said molding further comprises:
heating said slug; and
pressurizing said slug to form an angioplasty balloon within said mold, said angioplasty balloon comprising said working length and said taper.
15. The method of claim 14 wherein said heating further comprises providing a temperature above a glass transition temperature of any polymer comprising said slug.
16. The method of claim 14 wherein said pressurizing further comprises providing a pressure of at least 300 p.s.i. within said mold.
17. The method of claim 10 further comprising fusing said shortened outer tube to said inner tube prior to said molding.
18. The method of claim 17 wherein said fusing comprises heating said slug above a glass transition temperature of any polymer comprising said slug.
19. The method of claim 10 wherein said working length has a working length thickness, said taper has a taper thickness, and said shaft has a shaft thickness, said working length thickness, said taper thickness, and said shaft thickness being substantially equivalent.
20. The method of claim 10 wherein said shortened outer tube further comprises an outer end, said molding transforming said shortened outer tube into said working length and said molding creating said taper from said outer end and said inner tube.
21. An angioplasty balloon comprising:
a working length having a working length wall thickness; and
a taper extending from said working length and having a taper wall thickness, said taper wall thickness and said working length wall thickness being substantially equivalent.
22. The angioplasty balloon of claim 21 further comprising a shaft extending from said taper and having a shaft wall thickness, said shaft wall thickness being substantially equivalent to said taper wall thickness and said working length wall thickness.
23. The angioplasty balloon catheter of claim 22 wherein said working length further comprises an inner diameter being substantially constant throughout said working length, said shaft further comprises an inner shaft diameter being substantially constant throughout said shaft, and said taper further comprises an inner taper diameter which diminishes throughout said taper from said working length to said shaft, providing a smooth transition there between.
24. The angioplasty balloon of claim 1 further comprising a two-layer composite capable of withstanding pressures higher than conventionally possible, said two-layer composite comprising said working length.
25. The angioplasty balloon of claim 24 wherein said two-layer composite further comprises at least a portion of said taper.
26. The angioplasty balloon of claim 24 or claim 25 wherein said two-layer composite is a polyetherblockamide-polyamide composite.
27. The angioplasty balloon of claim 22 wherein said shaft is comprised of a polyamide.
28. The angioplasty balloon of claim 21 wherein said taper and said working length comprise an angioplasty balloon, said angioplasty balloon being between 10 mm and 40 mm in length.
29. The angioplasty balloon of claim 22 wherein said working length wall thickness, said taper wall thickness, and said shaft wall thickness are between 0.010 mm and 0.051 mm.
30. The angioplasty balloon of claim 22 wherein said working length further comprises an outer diameter, said shaft further comprises an outer shaft diameter, and said taper further comprises an outer taper diameter, said outer diameter, said outer shaft diameter, and said outer taper diameter being between 0.60 mm and 15.0 mm.
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/357,665 US20030139762A1 (en) | 1999-12-22 | 2003-02-03 | Angioplasty balloon with thin-walled taper and method of making the same |
BR0307373-4A BR0307373A (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball hoop frame |
AU2003207826A AU2003207826B2 (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball rim assembly |
CA002471433A CA2471433A1 (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball rim assembly |
CNB038031892A CN100355471C (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball rim assembly |
EP03706065A EP1471978A1 (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball rim assembly |
MXPA04006843A MXPA04006843A (en) | 2002-02-04 | 2003-02-04 | Collapsible basketball rim assembly. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/470,075 US6641694B1 (en) | 1999-12-22 | 1999-12-22 | Angioplasty balloon with thin-walled taper and method of making the same |
US10/357,665 US20030139762A1 (en) | 1999-12-22 | 2003-02-03 | Angioplasty balloon with thin-walled taper and method of making the same |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/470,075 Division US6641694B1 (en) | 1999-12-22 | 1999-12-22 | Angioplasty balloon with thin-walled taper and method of making the same |
Publications (1)
Publication Number | Publication Date |
---|---|
US20030139762A1 true US20030139762A1 (en) | 2003-07-24 |
Family
ID=23866177
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/470,075 Expired - Lifetime US6641694B1 (en) | 1999-12-22 | 1999-12-22 | Angioplasty balloon with thin-walled taper and method of making the same |
US10/357,665 Abandoned US20030139762A1 (en) | 1999-12-22 | 2003-02-03 | Angioplasty balloon with thin-walled taper and method of making the same |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/470,075 Expired - Lifetime US6641694B1 (en) | 1999-12-22 | 1999-12-22 | Angioplasty balloon with thin-walled taper and method of making the same |
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US (2) | US6641694B1 (en) |
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US20090090366A1 (en) * | 2007-09-20 | 2009-04-09 | Cuevas Brian J | Balloon cuff tracheostomy tube |
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US7011646B2 (en) * | 2003-06-24 | 2006-03-14 | Advanced Cardiovascular Systems, Inc. | Balloon catheter having a balloon with a thickened wall portion |
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US8721624B2 (en) | 2006-06-30 | 2014-05-13 | Abbott Cardiovascular Systems Inc. | Balloon catheter shaft having high strength and flexibility |
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US9216274B2 (en) | 2007-12-17 | 2015-12-22 | Abbott Cardiovascular Systems Inc. | Catheter having transitioning shaft segments |
US9468744B2 (en) | 2007-12-17 | 2016-10-18 | Abbott Cardiovascular Systems Inc. | Catheter having transitioning shaft segments |
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US8444608B2 (en) | 2008-11-26 | 2013-05-21 | Abbott Cardivascular Systems, Inc. | Robust catheter tubing |
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US8052638B2 (en) | 2008-11-26 | 2011-11-08 | Abbott Cardiovascular Systems, Inc. | Robust multi-layer balloon |
US9381325B2 (en) | 2008-11-26 | 2016-07-05 | Abbott Cadiovascular Systems, Inc. | Robust catheter tubing |
US8613722B2 (en) | 2008-11-26 | 2013-12-24 | Abbott Cardiovascular Systems, Inc. | Robust multi-layer balloon |
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US20100130926A1 (en) * | 2008-11-26 | 2010-05-27 | Abbott Cardiovascular Systems, Inc. | Robust catheter tubing |
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US10406329B2 (en) | 2011-05-26 | 2019-09-10 | Abbott Cardiovascular Systems, Inc. | Through tip for catheter |
US11383070B2 (en) | 2011-05-26 | 2022-07-12 | Abbott Cardiovascular Systems Inc. | Through tip for catheter |
US9707380B2 (en) | 2012-07-05 | 2017-07-18 | Abbott Cardiovascular Systems Inc. | Catheter with a dual lumen monolithic shaft |
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