Technical Information

See below to learn more about our medical balloons and their unique features and characteristics.

Data sheets

Applications include:

  • PTCA Catheters
  • PTA Catheters
  • Stent Delivery
  • Kyphoplasty
  • Occlusion
  • Anchoring
  • Positioning
  • Heat Transfer Catheters
  • Photodynamic Therapy (PDT)
  • Laser Balloon Angioplasty
  • Cryogenic Catheters
  • Drug Delivery Balloons and more...

Non-Compliant Dilatation Balloons

  • Ultra high-strength, thin-walled
  • Fabricated from PET
  • Used for PTCA, PTA, stent delivery, and other dilatation procedures
  • Compliance range: 0-10% (typical)
  • Optically clear (or colored)
  • Transmit light over very broad spectrumincluding ND: YAG lasers
  • Sizes range from 0.5 to 50 mm in diameter in virtually any working length
  • Burst pressures typically range from 15-400 psi (1-27 atm)
  • Balloon coatings available

Semi-Compliant Dilatation Balloons

  • High-strength, thin-walled
  • Can be fabricated from PET, Nylon, Polyurethane, other thermoplastic elastomers
  • Used for PTCA, PTA, stent delivery, Kyphoplasty and other dilatation procedures
  • Compliance range: 10-20% (typical)
  • Sizes range from 0.5 to 50 mm in diameter in virtually any working length
  • Burst pressures typically range from 15-375 psi (1-25.5 atm)

Compliant Balloons

  • Low pressure, thin and thick-walled
  • Fabricated from Polyurethane, Nylon elastomers, and other thermoplastic elastomers
  • Used for occlusion, positioning and anchoring in a variety of medical procedures including Kyphoplasty
  • Compliance range: 20-200% or more
  • Sizes range from .5 to 60 mm in diameter in virtually any working length.
  • Burst pressures typically range from 0-30 psi (0-2 atm)
  • Balloons can be designed for volume or pressure inflation

Shapes

Standard Balloon Conical Balloon Square Balloon Spherical Balloon Elliptical Balloon
Standard Balloon Conical Balloon Square Balloon Spherical Balloon Elliptical Balloon
Conical/Square Balloon Long Conical/Square Balloon Conical/Spherical Balloon Long Spherical Balloon Tapered Balloon
Conical/Square Balloon Long Conical/Square Balloon Conical/Spherical Balloon Long Spherical Balloon Tapered Balloon
Dog Bone Balloon Stepped Balloon Offset Balloon Conical/Offset Balloon Your Custom Medical Balloon Shape
Dog Bone Balloon Stepped Balloon Offset Balloon Conical/Offset Balloon Your Design

Standard Cylindrical Balloon

Standard cylindrical balloon

A hollow, plastic cylindrical component consisting of a body, a proximal neck and cone, and a distal neck and cone.

Balloon definitions and terms

Balloon
A hollow, plastic cylindrical component consisting of a body, a proximal neck and cone, and a distal neck and cone.
Balloon Body
The center section of a balloon, normally the largest diameter and thinnest wall section of the balloon.
Balloon Size
The measurement of the outside diameter and length of body section of the balloon. The balloon diameter is generally specified in mm to one decimal place (i.e. 3.5 mm). The balloon length measurement is generally specified in mm as a whole number (i.e. 40 mm).
Burst Pressure
The average pressure to failure of a balloon measured at body temperature. Typically specified in psi, ATM or Bars.
Cone
The transitional area between the body and the neck of a balloon.
Cone Angle
The measurement of the angle from the centerline of the balloon to the surface of the cone section. The cone angle measurement is generally specified as a whole number (i.e. 20° ).
Neck
The smaller diameter end sections of the balloon. Typically a balloon has one proximal and one distal neck. The proximal neck is generally a larger diameter and a thinner wall thickness than the distal neck.
Neck Inside Diameter
The measurement made to the inside diameter of the neck sections of the balloon. The neck inside diameter measurement is generally specified in inches to three decimal places (i.e. 0.035").
PET
Polyethylene Terephthalate (PET) is a thermoplastic polyester. It is not a polyethylene or polyolefin.
Tensile Strength
The radial or hoop tensile strength of a balloon calculated as follows:
TS = (P x D)/DW
Where
TS = Tensile Strength (hoop)
P = Burst Pressure
D = Diameter
DW = Balloon Double Wall Thickness
Double Wall Thickness
The measurement made of the wall thickness in the body section of the balloon. The double wall thickness measurement is generally made to four decimal places or 1/10000 of an inch. The value is typically recorded and expressed in mils (1 mil=0.001") for ease of use and is used as a key measurement for quality control.

Standard balloon ends

Conical Sharp Corner Conical Radius Corner Square End Spherical End Offset Neck
Conical Sharp Corner Conical Radius Corner Square End Spherical End Offset Neck
Your Design        
Your Design        

Biocompatibility

Biocompatibility Test Summary (For 103-XXXX Item Numbers)

Advanced Polymers' PET Balloons meet all requirements for short-term biocompatibility, including ISO 10993 and USP Class VI requirements.

Test Results
ISO 10993-5 Cytotoxicity Passed
ISO 10993-10 SensitizationPassed
ISO 10993-10 Irritation/Intracutaneous ReactivityPassed
ISO 10993-11 Systemic ToxicityPassed
ISO 10993-11 Rabbit PyrogenPassed
ISO 10993-3 GenotoxicityPassed
ISO 10993-4 HemocompatabilityPassed
ISO 10993-6 ImplantationPassed
USP Class VI (including implant)Passed

For a copy of the full biocompatibility test report, click here.
Please note that a password is required.


Biocompatibility Test Summary (For All Part Numbers Other than 103-XXXX)

Study Project Number Result
1 USP Systemic Toxicity Study in the Mouse (Extracts) TU012-500 Pass
2 USP Intracutaneous Toxicity Study in the Rabbit (Extracts) TU013-800 Pass
3 USP Muscle Implantation Study in Rabbit (5 day) TU014-805 Pass
4 Rabbit Pyrogen Study (Material Mediated) TU010-807 Pass
5 Cytotoxicity Study Using the ISO Elution Method MG064-100 Pass
6 Hemolysis Study – In Vitro Procedure (Extraction Method) MG074-100 Pass

Coatings

A wide variety of coatings can be added to the surface of a balloon to enhance or change its properties to meet new requirements. Balloon coatings include the following:

  • Lubricious coatings (hydrophilic and hydrophobic)
  • Abrasion and puncture resistant coatings
  • Tacky or high-friction coatings
  • Conductive coatings
  • Anti-thrombogenic coatings
  • Drug-release coatings
  • Reflective coatings
  • Selective coatings

PUNCTURE RESISTANT BALLOONS FOR STENT DELIVERY AND STENT RETENTION

Advanced Polymers has developed puncture resistant, high-pressure angioplasty balloons to increase safety for high pressure angioplasty and stent delivery procedures. This medical-break through is made possible with the use of a patented coating co-developed and exclusively licensed by Advanced Polymers.

This patented coating virtually eliminates the chance of an angioplasty balloon being punctured or damaged during stent delivery and/or post-stent dilatation. Also, it increases the coefficient of friction between the stent and the balloon surface and provides excellent stent retention, eliminating movement or slippage during delivery and deployment. This is a critical issue for high pressure balloon stenting procedures, as many previously unspoken concerns about stent slippage are coming to the forefront.

The coating, which can be produced from a variety of polymers depending on the application (polyurethane is typical and acrylic are typical), is applied to a balloon after a proprietary surface treatment by dipping it into a liquid form of the chosen polymer, followed by oven drying. The drying process also allows for cross-linking of the coating to occur, which helps to strengthen the coating and provide more durability, better bond adhesion and increased resistance to solvents and other chemicals.

Bonding PET balloons

Polyethylene terephthalate (PET) can be bonded using a number of adhesives including UV cure and/or cyanoacrylate adhesives. Cleanliness and surface preparation are key elements to a successful bond. Additionally, for bonding that must withstand high pressure or stress, a surface treatment is a must. Suggested surface treatments include:

  • Mechanical roughening, i.e., fine sandpaper, micro abrasive blasting. (Note: we find that mechanical roughening is a very inexpensive and effective method of surface treatment. The grit size of the sandpaper should be chosen carefully. For example, using a thin-wall tube (0.0005" or less) would require a fine grit paper, whereas a thicker wall tube (0.002" or more) could use a larger grit. When using mechanical roughening, the user wants to be sure not to over-roughen, which can cause pinholes and lead to premature failure in the PET).
  • Plasma etching or corona-treating (plasma is recommended).
  • Primers (consult your adhesive supplier)
  • Combinations of the above, i.e., mechanical roughening and plasma etching

For your specific use/appllication, we suggest you contact an adhesive manufacturer for a full range of available adhesives and input regarding the appropriate adhesive for your use. Also, be sure to inquire about adhesives recommended for polyester or PET.

Suggested adhesive manufacturers:

  • Locite
  • DYMAX

Thermal bonding urethane and other balloon materials

Thermal bonding urethane and other balloon materials

Advanced Polymers Polyester Heat Shrink Tubing and Beahm Designs Split Die Thermal Bonder; an unbeatable combination for Thermal Balloon Bonding.

Background:

Advanced Polymers, Inc. was looking for a reliable fast simple method of bonding its line of polyurethane balloons.The Split Die Thermal Bonder provided an affordable alternative to laser welding, RF die bonding, and adhesive bonding. This unit applies uniform heat to a variety of thermal bonding and modification processes. The cycle begins when hinged dies are heated to a constant temperature controlled by thermocouple feedback. Tubing to be welded or modified, are assembled over a PTFE mandrel, and a Polyester Heat Shrink Tubing, manufactured exclusively by Advanced Polymers, Inc., Salem, NH USA, is positioned over the bond area. The die halves are closed and encompass the shrink tubing to apply uniform heat to the component for the duration specified.

User Benefits:

Provides you with fast, highly repeatable bonds especially when used with Polyester Heat Shrink Tubing. -Allows you to perform highly precise bonds for demanding applications such as short balloon bonds and ultra smooth lap & butt welds. -Adjustable clamp pressure varies compression force on joint. -Compact design provides you with greater work space. SYSTEM SPECIFICATIONS: Temp range: ambient to 525 deg. F., Bond widths: As short as.062 and as long as 1/2" (Custom dies on request). Bond Diameters: Up to 1/2" standard, (Larger on request). Ambient cooling air.

The Bottom Line:

By putting the heat on to the balloon bonds by direct contact with the thin wall heat shrink and using the cooling air to protect the balloon we were able use our Polyester Heat Shrink Tubing to provide a constant compression force uniformly around the melted balloon neck and shaft materials. This compression force made the materials flow together into a single polymer structure as well as provide a smooth, glass-like tapered finish to the bond area.

The Key properties of Advanced Polymers Polyester Heat Shrink Tubing in this application

  • Ultra thin wall results in rapid shrinkage and heat transfer to the parts to be fused.
  • Low shrink temperature and rapid shrinkage allows initial application without part distortion
  • High melt temperature allows use of a high enough temperature to cause the substrate to melt and flow
  • Ultra smooth “glass like” surface finish after forming
  • Easily removed
  • Does not stick to most materials
  • Clear material enables visual monitoring of the process (if required)
  • List Key Technologies: Our cost in development was essentially the cost of the machine, the cost of a few feet of shrink tubing (~$125.00 for a 25' trail kit), the cost of a couple of dozen balloons (~$600), the extrusions they were bonded to (~$25) and one day of engineering time.

How it Happened:

We had been faced with bonding very thin walled, highly elastic urethane balloon necks to a catheter shaft. Adhesives worked only at very low pressures. Although we got adhesion, the necks of the balloon would stretch as the balloon grew under pressure and the peel force was just too great for the adhesive to hold the balloon neck in place. We had done thermal bonding in the past using hot air and our heat shrink tube. The resultant bonds were glass smooth and were incredibly strong. The problem was that the hot air was not easily directed and controlled. The results were that some times the balloon, which is sensitive to heat, would get distorted. It took a great deal of skill and luck to have each part come out acceptable each time. Once we got the Beahm Designs Split Die Thermal Bonder and made the first jaw modifications to accommodate the balloon necks, it was a matter of one day’s worth of engineering work to establish parameters and evaluate the results. In just two or three attempts we had our first bonds. They were evaluated by dissection of the bond areas and burst testing the balloons and found to be as good as our best efforts using other processes.

Conclusion:

We are very pleased with the Thermal Die Bonder and very excited about using our Polyester Heat Shrink Tube with it. The ulta thin walls of the Polyester Shrink Tubing results in rapid shrinkage and heat transfer to the parts to be fused Because the heat shrink tube provides a uniform compression force in the radial direction and by virtue of its longitudinal shrinkage, also provides linear compression of adjacent tubes, we are not only able to make balloon bonds with this equipment, but have been able to make butt joints in single lumen tubes. This machine is very useful in attaching soft tip materials to catheter shafts and in the same operation tapers the ends of the tube. Again the Polyester Heat Shrink Tube imparts an ultra smooth “glass like” finish and can easily taper the tube to a knife-edge without the cost of high priced equipment and tooling. The combination of this thermal die bonder and the use of Polyester Heat Shrink Tubing available exclusively from Advanced Polymers, Inc (Salem, NH, advpoly.com) are unbeatable in terms of cost effectiveness, easy of use and quality.