Vention Medical

Made from high-performance materials, high-pressure balloons may be used to dilate and unblock arteries that feed the heart in percutaneous translumenal coronary angioplasty (PTCA). With sizes ranging from 2 to 4 mm in diameter and 10 to 40 mm in length, these balloons feature a rated pressure capability of 10 to 20 atm.

For use in percutaneous translumenal angioplasty (PTA), or the dilatation of arteries other than the coronary arteries, dilation balloons can range in size from 4 to 12 mm in diameter and 20 to 100 mm in length, and have a rated pressure capability of 8 to 20 atm. They may also be formed with different cone angles to meet various balloon taper requirements.

Dilation balloons are most widely used in angioplasty and stent delivery. Yet, at Vention Medical, we understand the growing demand for and application of these high-pressure balloons to dilate restrictions and blockages throughout the body. That’s why we’re constantly working to innovate and advance the use of these balloons for a wide range of dilation procedures, including:

• Esophageal dilatation
• Billiary dilatation
• Urethral dilatation
• Fallopian tube dilatation
• Heart value dilatation (valvuloplasty)
• Tear duct dilatation
• Carpal tunnel dilatation
• Sinus Dilatation

Angioplasty balloons may be formed in various sizes ranging from small coronary size balloons to large diameter balloons used in peripheral arteries.	Balloons may also be formed with different cone angles to meet various balloon taper requirements.	Balloons are formed in a variety of sizes using high performance materials. Pictured here are balloon sizes ranging from 2 to 25mm in diameter. A small round balloon may be used in fallopian tube plasty while a large balloon may be used in valvuloplasty.

Kyphoplasty is a variation of a vertebroplasty that attempts to stop pain caused by a fractured vertebral body and attempts to restore the height and angle of kyphosis of a fractured vertebra (of certain types), followed by its stabilization using injected bone filler material. A small balloon is inflated in the vertebral body to create a cavity within the cancellous bone prior to cement delivery. Once the cavity is created, the procedure continues in a similar manner as a vertebroplasty, but the bone cement is typically delivered directly into the newly created cavity.

High-pressure medical balloons are highly effective in several different drug delivery applications. Unlike intravenous administration, which delivers the drug to unwanted areas throughout the body, these applications localize the medication — sealing off an area to be treated and limiting the amount of often toxic and costly medications used.

How it works

• Two discrete balloons or a "dog bone" shaped balloon can be used to seal off an area to be treated without subjecting too large an area to the medication. This also limits the amount of toxic and/or expensive medication needed.
• Medication is infused through a port in the catheter between the two balloons
• Fluid is drained, area is flushed and the balloons are deflated and retracted

A dog -bone-shaped balloon may be used to deliver drugs much the same way

• Ends of the balloon can be of equal or different sizes, depending on the shape of cavity or vessel
• When inflated, the balloon ends seal off area to be treated
• Medication is infused through a hole or series of holes in the narrower center section of balloon
• Holes can be made in the surface of the balloon with a laser, hot wire or drilling device creating a kind of sponge

Alternatively, an ultra-thin-walled PET balloon may be converted to a microporous membrane, with holes ranging in size from submicron to a few microns in diameter. Drugs can also be coated onto the surface of a balloon and delivered to a specific site in the body, using pressure, heat or laser light to transfer the drug from the balloon’s surface to the cavity wall.

This is a new market in which high-pressure balloons are being used to repair aneurysms as an alternative to open surgery. A balloon-mounted, woven, artificial graft with a stent-like structure built in on each end or over the entire length is wrapped tightly onto the balloon to minimize its profile. The graft, which is longer than the aneurysm, is deployed and attached to the artery wall by inflating the balloon within the artery.

The graft forms a lining that bypasses the weakened area of the artery and it remains in place permanently anchored to the vessel wall. The graft then restores normal circulatory flow after the balloon is deflated and removed.¹ A wide variety of diameters and lengths are required in this procedure. Tapered and custom-shaped balloons are sometimes needed as well.

Footnote
¹ Baxter Healthcare Corporation, PR Newswire, Aug. 11, 1999.

High-pressure balloons can be used to transfer heat or cold — either into or out of a vessel or cavity — and can be readily inflated and deflated so as to provide easy low-profile entry and exit while providing large diameters and surface area when inflated in use. They serve as a very good medium because their ultra-thin walls provide a relatively high rate of heat transfer. The balloons also provide intimate contact with the area being treated, conforming to curves and irregularities in the surface of a vessel.

For example, in cryosurgery of the prostate, a specially designed fluid-circulating high-pressure balloon catheter is inserted in the urethra¹. The long thin-walled balloon covers the entire length of the urethra, up into the bladder to protect the urethra and sphincter muscles from being damaged by the extreme cold produced by cryoprobes inserted in the prostate gland. Flexibility, conformability and high heat transfer rates are critical to protect tissue and muscles in the application.

Heat transfer catheters are made in various sizes to accommodate different devices and anatomy.

Footnote
¹ U.S. Patent No. 5,624,392, Saab, "Heat Transfer Catheters and Methods of Making and using Same", April 29, 1997.

Advanced Polymers specializes in the design, development, and manufacture of non-compliant, semi-compliant and compliant medical balloons. Our medical balloons are manufactured from PET, nylon, nylon elastomers, polyurethane, and other thermoplastic elastomers.

NON-COMPLIANT DILATATION MEDICAL 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 spectrum including 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)

Remember: Not all Medical balloons are equal! It is not enough to produce thin-walled balloons. The wall thickness or thinness in the cone and neck area is just as important as a thin body, and in most circumstances, a thin neck and cone are critical for achieving low profile and flexibility (track ability). Advanced Polymers has optimized and perfected the balloon forming process, material and equipment to produce the thinnest and strongest overall balloon.

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis.

SEMI-COMPLIANT DILATATION MEDICAL BALLOONS

• High-strength, thin-walled
• Can be fabricated from PET, Nylon, Polyurethane, other thermoplastic elastomers
• Used for PTCA, PTA, stent delivery 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)

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis.

COMPLIANT MEDICAL BALLOONS

• Low pressure, thin and thick-walled
• Fabricated from Polyurethane, Nylon elastomers, and other thermoplastic elastomers
• Used for occlusion and anchoring in a variety of medical procedures
• Compliance range: 20-100% 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)
• Typically used to replace latex and silicone balloons in critical high-value medical devices.

Advanced Polymers will custom produce a balloon to your specifications on either a production or prototype basis.

High-pressure balloons can be designed to perform several tasks at once. For procedures that require the balloon to perform multiple functions, such as occlusion and device positioning, a high-pressure balloon performs very well.

A treatment for benign prostate hyperplasia (BPH) involves the application of thermal energy to the prostate with a microwave antenna inside a balloon. Microwave energy is emitted through the walls of the balloon, heating the prostate from the inside out as the microwaves penetrate the tissue.

The antenna must be cooled during the procedure to keep it from overheating. That is achieved with a cooling fluid that also cools the lining of the urethra, protecting it from thermal damage. As an added function, a small side lumen is added to the cooling balloon that positions a thermal sensor precisely relative to the curve of the catheter and holds it against the tissue being treated. The sensor can be used to control the energy level of the microwave antenna and cut off power if the temperature gets too high.

This photograph shows the cooling balloon and the sensor side lumen used in the treatment of BPH. The small black dot shown close-up is a temperature sensor.

Balloons can be created with multiple lumens or channels that allow them to perform multiple functions in both the inflated and deflated state, even with a single device.¹

For example, a multiple lumen balloon can be fabricated in a way that allows blood to profuse (flow) through one or multiple lumens, while the other lumens inflate to perform angioplasty.

In another design, one or more of the lumens could be used to contain a diagnostic or therapeutic device, or multiple devices for precise positioning.

Vention Medical offers high-quality multilumen balloons that can meet your unique medical devices and component needs.

A multilumen balloon can be used to perform many functions with a single device. Note the various lumens and their shapes in the cross-section shown below the balloon.

Footnote
¹ U.S. Patent No. 5,342,301, Saab, "Multi-lumen Balloons and Catheters Made Therewith", Aug. 30, 1994.

High-pressure balloons can be used to precisely position a device in a vessel or body cavity. This is a new market for specialty technologies. Elastomeric balloons are often used for positioning; however, high-pressure balloons are preferred when a precise shape or position is required.

An elastomeric balloon can stretch and roll shifting back and forth, which is unacceptable in critical positioning applications. In addition, elastomeric balloons often inflate non-concentrically and unpredictably, which preclude their use in precision applications.

A balloon can be used to center a device such as radioactive seeds in a vessel to deliver radiation in hopes of preventing restenosis. Centering the device ensures symmetrical dosage around the wall. Some procedures concentrate on only one side of a vessel or cavity, such as directional arthrectomy, which cuts away plaque from vessel walls. The procedure uses a cutter that spins at high speed inside a housing. A balloon is mounted to the back of the housing and inflated, pushing the cutter against the wall of a vessel, allowing it to be debulked.

Another example is the treatment of BPH (benign prostate hyperplasia) or enlarged prostate gland. In this application, an offset balloon can be used to position a device off to the side, directly against a lobe of the gland, to deliver microwave or laser energy only where it is needed or conversely a standard balloon can be used to insure that the device remains centered.

High-pressure balloons are also used to position diagnostic devices in ultrasound imaging and other techniques that require locating them inside vessels or body cavities. Rather than having a complicated steering or positioning mechanism on the end of a catheter, a high-pressure balloon can be used to either center or offset the device, precisely positioning it as required.

On the left is a high pressure, thin walled balloon. On the right is an elastic latex balloon. Elastomeric balloons often unintentionally expand asymmetrically as seen here.	A directional coronary arthrectomy catheter is shown with the balloon inflated. The balloon is mounted on the back of the cutter housing and it is used to push the cutter against plaque. Source: Guidant Corp	High-pressure balloons designed to be offset (top and bottom balloons) and centered (middle balloon). Offset balloons can be used to position various instruments to concentrate on one wall while symmetrical balloons precisely center an instrument in a body cavity.	A balloon with a narrowing in the body can be used to position a device laterally within a structure such as a valve. The larger diameter on either end ensures that the device will not move proximal or distal to any great degree.

High-pressure balloons are commonly used to deploy and post-dilate stents to reduce the rate of arterial restenosis and acute reclosure following angioplasty. Stents are metallic scaffolds implanted to support the walls of arteries and other body cavities. Balloon expandable stents, which are typically machined metal tubes or wire mesh, are crimped over a balloon and inserted into the area of a blockage after angioplasty. Inflating the balloon opens the stent, which remains expanded to keep the vessel open.

The use of high-pressure balloons allows the physician to fully expand the stent until it is in full contact with the arterial wall. The use of a low-compliance balloon allows the added confidence that the stent and the artery will not be over-expanded, and the balloon will not dog-bone and over-expand the artery on either end of the stent. The stent stays in position after the balloon is deflated and removed from the body. Stents are being used with increasing frequency in association with angioplasty procedures. This is one of the largest markets for high-pressure balloons today.

This photograph illustrates an example of an arterial stent in its expanded state. The wire mesh creates a scaffold to maintain a fluid pathway to maximize the blood flow past an arterial blockage. Photo courtesy of IntraTherapeutics	This photograph shows the stent as it is ready to be inserted into an artery. The stent is at its minimum diameter and crimped over a balloon. The balloon will be inflated once the physician positions the device in the desired section of the artery. The expanded stent will then remain in place permanently. Photo courtesy of IntraTherapeutics	This photograph shows the stent expanded by the balloon. The balloon is used to press the stent scaffold against and partially into the arterial wall. This insures the artery will be fully patent and provide the optimum blood flow. Photo courtesy of IntraTherapeutics

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 breakthrough 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 unsaid 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 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.

Advanced Polymers has the capability to produce high-pressure angioplasty balloons in a variety of sizes, configurations, lengths and burst pressures (up to 27 atm/400 psi). Wall thicknesses typically range from 5 – 50 microns (0.0002" – 0.002"), offering minimal invasiveness and the smallest possible profile. Some of AP’s custom capabilities and configurations include unlimited tapered angles, varying diameters and tapered diameters along the length of the balloon. The company recently expanded the available diameters of its balloons as well, with offerings from 0.5mm to 50mm and an increased number of standard sizes between 2 – 12 mm. AP also has patents and patents pending for many unique balloon and catheter designs which are available for license.

Dilatation balloons are employed to dilate and unblock arteries that feed the heart in percutaneous translumenal coronary angioplasty (PTCA).

• Sizes range from 2 to 4 mm in diameter and 10 to 40 mm in length
• Rated pressure capability – 10-20 atm

Balloons are formed in a variety of sizes using high-performance materials. Pictured here are balloon sizes ranging from 2 to 25mm in diameter. A small round balloon may be used in fallopian tube plasty while a large balloon may be used in valvuloplasty.

Dilatation balloons are also used for dilatation of arteries other than the coronary arteries, such as percutaneous translumenal angioplasty (PTA).

• Sizes range from 4 to 12 mm in diameter and 20 to 100 mm in length
• Rated pressure capability – 8-20 atm

Angioplasty balloons may be formed in various sizes ranging from small coronary size balloons to large diameter balloons used in peripheral arteries.

Balloons may also be formed with different cone angles to meet various balloon taper requirements.

Angioplasty balloons may be formed in various sizes ranging from small coronary size balloons to large diameter balloons used in peripheral arteries.	Balloons may also be formed with different cone angles to meet various balloon taper requirements.