New! View global litigation for patent families

US20040097878A1 - Distensible dilatation balloon with elastic stress response and manufacture thereof - Google Patents

Distensible dilatation balloon with elastic stress response and manufacture thereof Download PDF

Info

Publication number
US20040097878A1
US20040097878A1 US10637575 US63757503A US2004097878A1 US 20040097878 A1 US20040097878 A1 US 20040097878A1 US 10637575 US10637575 US 10637575 US 63757503 A US63757503 A US 63757503A US 2004097878 A1 US2004097878 A1 US 2004097878A1
Authority
US
Grant status
Application
Patent type
Prior art keywords
balloon
balloons
stress
process
elastic
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
Application number
US10637575
Inventor
Jere Anderson
Louis Jandris
Michael Barbere
Richard Murphy
Original Assignee
Anderson Jere R.
Jandris Louis J.
Barbere Michael D.
Murphy Richard T.
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
Family has litigation

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • A61L29/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0019Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/42Component parts, details or accessories; Auxiliary operations
    • B29C49/46Component parts, details or accessories; Auxiliary operations characterised by using a particular environment or blow fluids other than air
    • B29C2049/4602Blowing fluids
    • B29C2049/4605Blowing fluids containing an inert gas, e.g. helium
    • B29C2049/4608Nitrogen
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2022/00Hollow articles
    • B29L2022/02Inflatable articles
    • B29L2022/022Balloons
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7542Catheters

Abstract

Balloons and balloon catheters with a superior overall combination of distensibility, elastic stress response and strength. The improved properties of the balloons result from the method or process used to form the balloons, as well as the polymeric materials used in said balloon forming process. Additionally, the enhanced combination of properties of the balloons will not be adversely affected by the novel sterilization process contemplated by this invention.

Description

    BACKGROUND OF INVENTION
  • [0001]
    Surgical procedures employing balloons and medical devices incorporating those balloons (i.e., balloon catheters) are becoming more common and routine. These procedures, such as angioplasty procedures, are conducted when it becomes necessary to expand or open narrow or obstructed openings in blood vessels and other passageways in the body to increase the flow through the obstructed areas. For example, in an angioplasty procedure, a dilatation balloon catheter is used to enlarge or open an occluded blood vessel which is partially restricted or obstructed due to the existence of a hardened stenosis or buildup within the vessel. This procedure requires that a balloon catheter be inserted into the patient's body and positioned within the vessel so that the balloon, when inflated, will dilate the site of the obstruction or stenosis so that the obstruction or stenosis is minimized, thereby resulting in increased blood flow through the vessel. Often, however, a stenosis requires treatment with multiple balloon inflations. Additionally, many times there are multiple stenoses within the same vessel or artery. Such conditions require that either the same dilatation balloon must be subjected to repeated inflations, or that multiple dilatation balloons must be used to treat an individual stenosis or the multiple stenoses within the same vessel or artery. Additionally, balloons and medical devices incorporating those balloons may also be used to administer drugs to a patient.
  • [0002]
    Traditionally, the balloons available to physicians were classified as either “compliant” or “noncompliant”. This classification is based upon the operating characteristics of the individual balloon, which in turn depended upon the process used in forming the balloon, as well as the material used in the balloon forming process. Both types of balloons provide advantageous qualities which were not available from the other.
  • [0003]
    A balloon which is classified as “noncompliant” is characterized by the balloon's inability to grow or expand appreciably beyond its rated or nominal diameter. “Noncompliant” balloons are referred to as having minimal distensibility. In balloons currently known in the art (e.g., polyethylene terephthalate), this minimal distensibility results from the strength and rigidity of the molecular chains which make up the base polymer, as well as the orientation and structure of those chains resulting from the balloon formation process. The strength resulting from this highly oriented structure is so great that when the balloon is subjected typical inflation or operating pressures (i.e., about 70 psi to over 200 psi), it will not be stressed above the yield point of the polymeric material.
  • [0004]
    The yield point of a material is defined as the stress at which the individual molecular chains move in relation to one another such that when the pressure or stress is relieved, there is permanent deformation of the structure. When a material is subjected to pressure or stress below its yield point, the material will consistently follow the same stress-strain curve when subjected to multiple cycles of applying and relieving the stress or pressure. A material which exhibits the ability to follow the same stress-strain curve during the repeated application and relief of stress is defined as being elastic and as having a high degree of elastic stress response. This elastic behavior is highly desirable in balloons in order to ensure consistent and predictable balloon sizing regardless of the balloon's previous inflation history.
  • [0005]
    A balloon which is referred to as being “compliant” is characterized by the balloon's ability to grow or expand beyond its nominal or rated diameter. In balloons currently known in the art (i.e., polyethylene, polyvinylchloride), the balloon's “compliant” nature or distensibility results from the chemical structure of the polymeric material used in the formation of the balloon, as well as the balloon forming process. These polymeric materials have a relatively low yield point. Thus, the inflation pressures used in dilation procedures are typically above the yield point of the materials used to form distensible balloons. A distensible or “compliant” balloon when inflated to normal operating pressures, which are greater than the polymeric material's yield point, is subjected to stress sufficient to permanently realign the individual molecular chains of the polymeric material. The realignment of individual polymer chains permits the balloon to expand beyond its nominal or rated diameter. However, since this realignment is permanent, the balloon will not follow its original stress-strain curve on subsequent inflation-deflation cycles. Therefore, the balloon balloon upon subsequent inflations, will achieve diameters which are greater than the diameters which were originally obtained at any given pressure during the course of the balloon's initial inflation.
  • [0006]
    The term “elastic”, as it is used in connection with this invention, refers only to the ability of a material to follow the same stress-strain curve upon the multiple applications of stress. See Beer, F. et al., Mechanics of Materials (McGraw-Hill Book Company 1981), pp. 39-40. Elasticity, however, is not necessarily a function of how distensible a material is. It is possible to have an elastic, non-distensible material or a non-elastic, distensible material. This is best illustrated in FIGS. 1, 2 and 3.
  • [0007]
    [0007]FIG. 1 represents an elastic, essentially non-distensible material. If this material was used to form a balloon, the balloon would be considered non-distensible because there is very little change in strain (diameter) as the stress applied is increased (inflation pressure). The balloon would be elastic because it follows essentially the same stress-strain (pressure-diameter) curve with the second application of stress (inflation).
  • [0008]
    [0008]FIG. 2 represents an elastic, distensible material. If this material was used to form a balloon, the balloon would be considered distensible because there is significant change in strain (diameter) as the stress applied is increased (inflation pressure). The balloon would be considered elastic because it follows essentially the same stress-strain (pressure-diameter) curve with the second application of stress (inflation).
  • [0009]
    [0009]FIG. 3 represents an inelastic, distensible material. Like FIG. 2, FIG. 3 shows a significant change in strain (diameter) and would therefore be considered a distensible balloon material. Unlike FIGS. 1 and 2, however, the same stress-strain (pressure-diameter) curve is not maintained upon the second application of stress (inflation).
  • [0010]
    It has been found that the optimal size of a dilatation balloon is about 0.9 to about 1.3 the size of the vessel being treated. See Nichols et al., Importance of Balloon Size in Coronary Angioplasty, J. American College of Cardiology, Vol. 13, 1094 (1989). If an undersized balloon is used, there is a high incidence of significant residual stenosis and a greater need for subsequent dilatation procedures. However, if an oversized balloon is used, there is an increased chance of coronary dissection. Therefore, physicians desire to use a balloon which will closely approximate the size of the occluded vessel or obstructed cavity being treated.
  • [0011]
    Because physiological vessels such as arteries are generally tapered, the nominal or rated diameter of balloons commercially available often do not correspond to the size of the vessel being treated. Physicians, therefore, are often faced with the prospect of using an undersized “compliant” balloon which can be expanded beyond its nominal or rated diameter, or an oversized “noncompliant” balloon which will follow the same stress-strain curve during multiple inflations (i.e., is elastic). Thus, physicians can choose from two general types of balloons depending upon whether they require a balloon which grows beyond nominal diameter. They may choose a “noncompliant” balloon if they require a relatively high strength balloon which will not expand much beyond its nominal or rated diameter, or a “compliant” balloon if they require a balloon which is capable of expanding considerably beyond the normal or rated diameter. As will be shown below, each of these properties is advantageous. However, it would be desirable to have to have a “compliant” or distensible balloon which also has the elastic stress response of a “noncompliant” balloon, as well as sufficient strength to be used in dilatation procedures.
  • [0012]
    Because physicians using a dilatation balloon do not know prior to the procedure what inflation pressures will be required to dilate a given obstruction or stenosis, it is desirable that the balloon being used have strength capable of withstanding the high inflation pressures typically associated with these procedures (i.e., about 70 to over 200 psi). A high strength dilatation balloon, which is capable of withstanding increased inflation pressure, is safer to use since the chances of the balloon bursting during the procedure are minimized.
  • [0013]
    Strength of a balloon is typically quantified by calculating the balloon's wall tensile strength. The overall strength of a balloon can be increased by increasing the balloon's wall thickness. As the wall thickness is increased, the balloon is capable of withstanding higher inflation pressures. However, as the wall thickness of the balloon is increased, the folded profile of the balloon, as well as the balloon's flexibility, may be adversely affected.
  • [0014]
    The relationship between the ultimate strength of the balloon, the inflation pressure which the balloon can withstand and the balloon's wall thickness is determined by the well known membrane equation: Wall Tensile Strength ( psi ) = ( burst pressure ( psi ) ) × ( nominal balloon diameter ) 2 × ( wall thickness )
    Figure US20040097878A1-20040520-M00001
  • [0015]
    Depending upon the material used to form the balloon, the nominal, or rated diameter is achieved typically when the balloon is inflated between to about 5 bars to about 8 bars. The burst pressure is determined at 37° C.
  • [0016]
    Since balloons, particularly dilatation balloons, must have the ability to traverse the confines of the obstructed areas to be treated, it is desirable to have a balloon which has a narrow folded profile. This “profile” represents the smallest opening through which the balloon, in its deflated state, may pass. The profile of the balloon depends in large part upon the wall thickness of the finished balloon (i.e., the sterilized dilatation balloon product). Therefore, it is desirable for a finished balloon product to have a folded profile which is as narrow as possible, particularly if the balloon is to be used in an angioplasty procedure.
  • [0017]
    Another important characteristic of balloons in general, and more specifically dilatation balloons, is the distensibility of the finished balloon product. Distensibility, also referred to as percent of radial expansion, is typically determined by comparing the nominal or rated diameter of the balloon with the diameter at some arbitrarily selected higher pressure (i.e., 10 bars). The distensibility or percent radial expansion is calculated using the following formula with all measurements taking place at about 37° C.: Distensibility = [ Diameter of balloon at 10 bars Nominal balloon diameter - 1 ] × 100 %
    Figure US20040097878A1-20040520-M00002
  • [0018]
    For example, balloons made of polyethylene terephthalate have a low distensibility (i.e., less than about 5% at 200 psi). See for example U.S. Pat. Re. Nos. 32,983 and 33,561 to Levy which discloses balloons formed from polyethylene terephthalate and other polymeric materials.
  • [0019]
    It is also desirable that the balloon be elastic or have a high degree of elastic stress response. Elasticity, which also can be referred to as the repeatability of a balloon, is characterized by the ability of the balloon to consistently follow the same stress-strain curve after being subjected to multiple inflations to normal operating or inflation pressures (i.e., about 10 bars or greater). That is, a balloon which has a high degree of elastic stress response will retain the same diameter-pressure relationship and will consistently obtain the same diameter at the same pressure during repeated inflation-deflation cycles. Balloons which have poor elasticity or a low degree of elastic stress response have a tendency to “creep” or “deform” after multiple inflations and fail to return to their nominal or rated diameters after being subjected to multiple inflations at increased pressures.
  • [0020]
    A dilatation balloon which has a high degree of elastic stress response is particularly desirable when a physician is treating multiple stenoses within the same artery. If the balloon is “inelastic”, after the first stenosis is dilated at an increased pressure, the physician would not know what the balloon's “new” starting diameter is prior to attempting to dilate subsequent stenoses. If the physician fails to correctly guess the balloon's “new” diameter prior to beginning treatment of another stenosis there is an increased risk of oversizing the balloon which could result in coronary artery dissection or other damage to the vessel. Therefore, to ensure the patient's safety, some physicians elect to remove the balloon catheter from the patient and reintroduce a new sterile balloon catheter prior to attempting to dilate subsequent stenosis within the same vessel. However, this is time-consuming and undesirable for the patient. Additionally, the cost of the individual balloon catheters prohibits the use of multiple balloon catheters when treating multiple stenoses within the same vessel. Thus, to minimize the chance of oversizing the balloon when treating multiple stenoses within the same vessel, a physician may attempt to use a dilatation balloon which is noncompliant. However, as discussed previously, because such a balloon will permit little expansion beyond the balloon's rated or nominal diameter, the physician may not have available a balloon of sufficient size to safely treat the other stenoses within the same vessel.
  • [0021]
    Elastic stress response is determined by inflating a balloon to 5 bars at about 37° C. and measuring the balloon's diameter. The balloon is then inflated to a pressure of 10 bars in about 20 seconds and held for an additional 20 seconds at 37° C. The balloon's diameter is then measured. The internal pressure of the balloon is then decreased to 5 bars and the “new” 5 bar diameter of the balloons is determined. For this invention, the elastic stress response or repeatability is calculated using the following equation: Elastic Stress Response = [ Balloon diameter at 5 bars after inflation to 10 bars Balloon diameter at initial 5 bar inflation - 1 ] × 100
    Figure US20040097878A1-20040520-M00003
  • [0022]
    A balloon with maximum or complete elastic stress response permits the balloon, after being inflated to a pressure of 10 bars, to return to the same diameter it had at 5 bars prior to the inflation to the higher pressure. Such a balloon would have maximum repeatability, or an elastic stress response of 0.00. As the repeatability of the balloon decreases, the elastic stress response decreases and, as defined above, numerically becomes greater than 0.00. For example, balloons formed from polyolefin copolymers in the art have poor repeatability and a relatively low degree of elastic stress response and have a numerical elastic stress response of about 9.
  • [0023]
    It would be particularly desirable if a “compliant” balloon was able to possess an adequate degree of distensibility so that the balloon could be inflated to correspond to the size of the vessel being treated, while at the same time being highly elastic to ensure repeatable sizing and a high degree of elastic stress response so that the physician would know the balloon's “new” diameter at all inflation pressures prior to attempting to dilate multiple stenoses within the same vessel. This enhanced combination of properties would allow physicians to conduct dilation procedures in a safer manner in arteries where the physician requires balloon sizing not conveniently provided by “noncompliant” balloon products currently available in the art.
  • [0024]
    Another desirable characteristic of a balloon is flexibility. Improved flexibility will permit a balloon to traverse, not only occluded arteries, but also other obstructed or narrow body cavities and openings resulting in minimal damage to the vessel or cavity through which the balloon catheter is being navigated.
  • [0025]
    A further desirable property of a dilatation balloon, is the optical clarity of the finished balloon product. Although the optical clarity will not adversely affect a balloon's overall ability to dilate a stenosis or obstruction, most physicians will not use a balloon which has a cloudy appearance. The optical characteristics of a balloon or balloon catheter, therefore, must be taken into account when forming a balloon.
  • [0026]
    While the foregoing properties are desirable in balloons, these attributes are typically adversely affected by the sterilization process which all balloons and balloon catheters must be subjected to prior to their use in the human body. For example, when a balloon in the art is exposed to the increased temperature and humidity of a traditional sterilization process (e.g., high humidity, temperature of about 50-60° C., about 12% ethylene oxide and about 88% Freon™ for approximately 12-16 hours) the balloon tends to shrink which causes a corresponding increase in wall thickness. Moreover, this increase in wall thickness will adversely affect the folded profile of the sterilized balloon product. Furthermore, the distensibility of many balloons is adversely affected by the sterilization processes currently used in the art. Therefore, it is also desirable that the sterilization process used to treat balloons and balloon catheters provide adequate sterilization while at the same time not adversely affecting the physical characteristics of the finished balloon or balloon catheter product.
  • [0027]
    It has now been found that novel distensible balloons, particularly dilatation balloons, can be formed by processing a polymeric material composed of polymer chains having sufficient regions of molecular structure with inter-molecular chain interaction to ensure the integrity and strength of the structure, as well as sufficient regions which permit sections of the polymer chains to “uncoil” to permit growth. The balloons contemplated by this invention (i) are sufficiently distensible (i.e., about 5 to about 20%) to allow treatment of various sized arteries, (ii) have a high degree of elastic stress response (i.e., less than about 5.00) which permits the physician to treat multiple stenoses within the same artery without having to be concerned with increasing balloon diameter after repeated inflations and (iii) have strength sufficient to treat hardened stenoses (i.e., greater than about 14,000 psi). The balloons formed using the process of this invention will have an overall advantageous combination of these physical properties i.e., distensibility, elastic stress response and tensile strength, superior to those exhibited by the “compliant” balloons currently available. It has also been found that these enhanced properties will not be adversely affected by subjecting the balloons and balloon catheters formed following the method or process of this invention to a novel sterilization process. This novel balloon forming process and novel sterilization process can be used regardless of whether the balloon is coated.
  • SUMMARY OF THE INVENTION
  • [0028]
    It is an object of this invention to provide a method or process for producing a balloon, preferably a dilatation balloon, which exhibits an improved overall combination of physical properties, such as distensibility, elastic stress response and strength, superior to those exhibited by “compliant” balloons currently known in the art.
  • [0029]
    It is further the object of this invention to provide a novel balloon and a novel balloon catheter in which the balloon exhibits an advantageous overall combination of distensibility, elastic stress response and strength which combination of properties will not be adversely affected by sterilization.
  • [0030]
    Still another object of this invention is to provide an improved sterilization procedure which will not adversely affect the distensibility, elastic stress response and strength of the balloons and balloons of the balloon catheters of this invention.
  • [0031]
    It is still a further object of this invention to provide a process which will ensure that the balloons formed will have improved optical clarity.
  • [0032]
    These objects, as well as others, which will become apparent from the description which follows, are achieved by forming these novel balloons and balloon catheters using the novel process of this invention from certain polymeric materials composed of polymer chains having regions of inter-molecular chain interaction separated by regions in which those individual portions of the polymer chains have the ability to uncoil or stretch. Therefore, the present invention includes (1) novel balloons and balloon catheters which have an improved overall combination of distensibility, elastic stress response and strength, (2) the process or method of forming balloons and balloon catheters from polymeric materials which will result in balloons and balloon catheters exhibiting these improved properties and (3) a novel sterilization process which will not adversely affect these enhanced properties.
  • [0033]
    The present invention contemplates balloons characterized by an improved overall combination of distensibility, elastic stress response and wall tensile strength made by the process comprising subjecting a parison, made of a block copolymer having polymer chains with regions of inter-molecular chain interaction separated by regions in which those individual portions of the polymer chains have the ability to stretch or uncoil to at least one axial stretch and at least one radial expansion step. The expanded parison is then subjected to a heat set step to provide the expanded parison and resulting balloon with thermal and dimensional stability. The invention also contemplates a novel sterilization process in which balloons and balloon catheters, after preconditioning, are exposed to ethylene oxide at a temperature of about 40° C. and a relative humidity of about 50-60% for approximately 6 hours. The balloons and balloon catheters are then subjected to an aeration step in which the ethylene oxide is allowed to dissipate. The novel sterilization process does not adversely affect the improved overall combination of properties exhibited by the balloons of this invention.
  • [0034]
    It should be understood that the foregoing description of the invention is intended merely to be illustrative and that other embodiments and modifications may be apparent to those skilled in the art without departing from the spirit and scope of the invention.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0035]
    The present invention provides for the first time “compliant” balloons, preferably dilatation balloons, which, because of the method or process used to form the balloons, as well as the polymeric materials used in the balloon forming process, produces balloons having a highly desirable combination of distensibility, elastic stress response and strength (i.e., distensibility of about 5 to about 20% and preferably in the range of about 6 to about 17%, elastic stress response of not greater than about 5.00 and preferably in the range of about 0.75 to about 4.00 and wall tensile strength of at least about 14,000 psi, preferably in the range of about 15,000 to about 40,000 psi and most preferably in the range of about 16,000 to about 30,000 psi). The invention also provides a unique method or process using a heat set step in the formation of the balloons of this invention which ensures that the balloons retain their distensibility and strength, and provides balloons with improved optical clarity. Moreover, the invention provides a novel sterilization process which will not adversely affect, to any significant degree, the enhanced combination of properties which are obtained using the novel balloon forming process of this invention.
  • [0036]
    The materials which may be used in this novel process or method include polymeric materials having a molecular structure which are composed of individual polymer chains having regions or zones of inter-molecular chain interaction separated by regions or zones in which those individual portions of the polymer chains have the ability to stretch or uncoil. The ability of regions or zones of individual polymer chains to uncoil permits the chains to move upon the application of stress. However because these zones are held in place or secured at either end by zones exhibiting inter-molecular chain interaction, the uncoiled portions return to their original position once the applied stress is removed.
  • [0037]
    These polymers can be considered to be comprised of polymer chains with individual regions of crystalline and amorphous material and can be referred to as “hard” and “soft” segments respectively. The individual polymer chains are able, to a substantial extent, to coil upon themselves and/or around each other in such a way that soft segments are associated with soft segments and hard segments with hard segments, thereby forming separate “domains” approximating soft and hard bodies of polymer, each exhibiting its own physical properties in varying degrees. The hard segments are comprised of regions which have significant inter-molecular chain interaction. This provides regions with increased strength and increased elastic stress response. In addition to providing strength, the hard segments are sufficiently rigid to permit the soft segments to stretch and uncoil which provides distensibility.
  • [0038]
    The ratio of hard to soft segments and individual chemical structure of the individual segments define the balloon's distensibility, elastic stress response and strength. Therefore, the polymeric material used in accordance with this invention should have hard segments present in an amount sufficient to achieve a high degree of elastic stress response (i.e., not greater than about 5.00) and adequate wall tensile strength (i.e., at least about 14,000 psi), while at the same time having an adequate amount of soft segments to ensure that the balloon is also distensible (i.e., about 5 to about 20%).
  • [0039]
    Examples of polymeric materials which have these alternating zones or regions and which may be used in forming the balloons and balloon catheters of this invention include block copolymers, and physical mixtures of different polymers. Examples of block copolymers which may be used include polyester block copolymers, polyamide block copolymers and polyurethane block copolymers. Examples of the mixtures which may be used include mixtures of nylon and polyamide block copolymers and polyethylene terephthalate and polyester block copolymers. The preferred block copolymer which can be used in accordance with the process of this invention is polyurethane block copolymer. This preferred polymer may be made, for example, by a reaction between
  • [0040]
    a) an organic diisocyanate;
  • [0041]
    b) a polyol; and
  • [0042]
    c) at least one chain extender.
  • [0043]
    The preferred polyurethanes which can be used in this invention may be varied by using different isocyanates and polyols which will result in different ratios of hard to soft segments as well as different chemical interactions within the individual regions of the polymer.
  • [0044]
    An example of the most preferred polyurethane is manufactured by The Dow Chemical Company and marketed under the trade name PELLETHANE 2363-75D. This raw material has a Shore Hardness of about 74 D, a specific gravity of about 1.21, a tensile modulus of about 165,000 psi, a flexural modulus of about 190,000 psi, an ultimate tensile strength of about 6,980 psi and an ultimate elongation of about 250%.
  • [0045]
    In accordance with this invention, the balloons are formed from a thin wall parison of a polymeric material, preferably made of a polyurethane block copolymer, which is treated in accordance with the process of this invention. The novel process contemplated by this invention employs a heat set step which will provide a balloon with temperature and dimensional stability. This stability results from the fact that the balloon is heated above the temperature using in the balloon forming process so that the orientation resulting from the processing conditions is “locked” into position.
  • [0046]
    The balloons and balloon catheters of this invention may be formed using a mold which can be provided with a heating element. The mold receives a tubular parison made of a polymeric material of the type used in accordance with the present invention. The ends of the parison extend outwardly from the mold and one of the ends is sealed while the other end is affixed to a source of inflation fluid, typically nitrogen gas, under pressure. Clamps or “grippers” are attached to both ends of the parison so that the parison can be drawn apart axially in order to axially stretch the parison while at the same time said parison is capable of being expanded radially or “blown” with the inflation fluid. The radial expansion and axial stretch step or steps may be conducted simultaneously, or depending upon the polymeric material of which the parison is made, following whatever sequence is required to form a balloon. Failure to axial stretch the parison during the balloon forming process will result in result in a balloon which will have an uneven wall thickness and which will exhibit a wall tensile strength lower than the tensile strength obtained when the parison is both radially expanded and axially stretched.
  • [0047]
    The polymeric parisons used in this invention are preferably drawn axially and expanded radially simultaneously within the mold. To improve the overall properties of the balloons formed, it is desirable that the parison is axially stretched and blown at temperatures above the glass transition temperature of the polymeric material used. This expansion usually takes place at a temperature between about 80 and about 150° C. depending upon the polymeric material used in the process.
  • [0048]
    In accordance with this invention, based upon the polymeric material used, the parison is dimensioned with respect to the intended final configuration of the balloon. It is particularly important that the parison have relatively thin walls. The wall thickness is considered relative to the inside diameter of the parison which has wall thickness-to-inside diameter ratios of less than 0.6 and, preferably between 0.57 and 0.09 or even lower. The use of a parison with such thin walls enables the parison to be stretched radially to a greater and more uniform degree because there is less stress gradient through the wall from the surface of the inside diameter to the surface of the outside diameter. By utilizing a parison which has thin walls, there is less difference in the degree to which the inner and outer surfaces of the tubular parison are stretched.
  • [0049]
    The parison is drawn from a starting length L1 to a drawn length L2 which preferably is between about 1.10 to about 6 times the initial length L1. The tubular parison, which has an initial internal diameter ID1 and an outer diameter OD1 is expanded by the inflation fluid emitted under pressure to the parison to an internal diameter ID2 which is preferably about 6 to about 8 times the initial internal diameter ID1 and an outer diameter OD2 which is about equal to or preferably greater than about 3 times the initial outer diameter OD1. The parison is preferably subjected to between 1 and 5 cycles during which the parison is axially stretched and radially expanded with an inflation pressure of between about 100 and about 500 psi. Nitrogen gas is the preferable inflation fluid for the radial expansion step.
  • [0050]
    After the desired number of “blow” cycles have been completed, the expanded parison is subjected to a heat set or thermoforming step during which the expanded parison, still subjected to an inflation pressure of about 100 to about 500 psi, is held at a temperature above the temperature at which the balloon was axially stretched and radially expanded, but below the melting temperature of the polymeric material from which the parison was formed. This higher temperature induces crystallization and “freezes” or “locks” the orientation of the polymer chains which resulted from axially stretching and radially expanding the parison. The temperatures which can be used in this heat set step are therefore dependent upon the particular polymeric material used to form the parison and the ultimate properties desired in the balloon product (i.e., distensibility, strength and compliancy). The heat set step ensures that the expanded parison and the resulting balloon will have temperature and dimensional stability. After the heat set step is completed, the mold is cooled to about 37° C. The finished balloon will typically obtain its rated or nominal diameter when inflated to a pressure of about 5 to about 8 bars depending upon the polymeric material used to form the balloon. The balloon thus formed may be removed from the mold, and affixed to a catheter.
  • [0051]
    For example, if the parison is formed from the polyurethane marketed by The Dow Chemical Company under the trade name PELLETHANE 2363-75D and axially stretched and radially expanded at a temperature of about 90-100° C., the heat set step would preferably be conducted at about 105-120° C. If this step was conducted at temperatures much above about 120° C., the tensile strength of the resulting polyurethane balloon would decrease significantly. Moreover, if the heat set step was conducted at temperatures significantly higher than 120° C., the distensibility of the resulting polyurethane balloon would also be adversely affected. However, if the heat set was conducted at temperatures below about 100° C., the polyurethane balloons formed would be dimensionally unstable resulting in balloons with uneven wall thicknesses. Additionally, the lower heat set temperature would result in balloons exhibiting physical properties which would more likely be adversely affected during sterilization. Finally, a balloon having a cloudy appearance, a property which physicians find particularly undesirable, would be another consequence of using a low heat set temperature.
  • [0052]
    It should be noted that some adjustment in the foregoing axial stretch and radial expansion ratios, as well as the expansion and heat set temperatures may be necessary to take into account the difference in physical properties between the polyurethane block copolymer exemplified above and any other polymeric materials which can be used in accordance with this invention.
  • [0053]
    In order to preserve a balloon's distensibility, elastic stress response, wall tensile strength and improved optical clarity, the balloon formed must also be subjected to the novel sterilization process contemplated by the invention. For example, if a sterilization process which is currently available in the art is used (e.g., high relative humidity at about 50-60° C. in the presence of about 12% ethylene oxide and about 88% Freon™ for about 9-16 hours), the elastic stress response, distensibility and the strength of the balloons contemplated by this invention would be adversely affected. When the novel low temperature, low humidity, ethylene oxide sterilization process of this invention is used to sterilize the balloons and balloon catheters of this invention, the elastic stress response, distensibility and strength of the balloons are not adversely affected to any significant degree.
  • [0054]
    The novel low temperature, low humidity sterilization process consists of exposing the balloon or balloon catheter to a preconditioning step at temperature about 35 to about 45° C. and a relative humidity of about 55% for about 15 hours. The balloon or balloon catheter is then treated at a temperature of about 35 to about 45° C. and a relative humidity of about 55% with ethylene oxide, preferably in a concentration of about 100%. After being exposed to ethylene oxide for about 6 hours, the products are aerated and kept at a temperature of about 35 to about 45° C. for about 22 hours, in order to permit the ethylene oxide to dissipate. The sterilized balloon products are now ready for human use.
  • [0055]
    The sterilization process cannot, however, be conducted above the heat set temperature since this would relieve the orientation of the polymer chains which was “locked” into place during heat set process. The sterilization process appears to be an important factor in determining the final physical characteristics of the balloons and balloon catheters of this invention. Therefore, the novel sterilization process is necessary to ensure a clinically useful and safe finished balloon and balloon catheter with an overall advantageous combination of physical properties (i.e., distensibility, elastic stress response and wall tensile strength) superior to those exhibited by the “compliant” balloons of the prior art.
  • EXAMPLE 1
  • [0056]
    A parison was made from the polyurethane manufactured by The Dow Chemical Company and marketed under the trade name PELLETHANE 2363-75D. This material has a Shore Hardness of about 74 D, a specific gravity of about 1.21, a tensile strength of about 165,000 psi, a flexural modulus of about 190,000 psi, an ultimate tensile strength of about 6,980 psi and an ultimate elongation of about 250%. The parison was sealed at one end while the other end was attached to the source of the pressurized inflation fluid, in this example nitrogen gas. Clamps were attached to each end of the parison. The mold was then heated to an operating temperature of about 90-100° C., while the parison was pressurized with nitrogen gas at about 290 psi and held for about 70 seconds.
  • [0057]
    The pressure was then relieved and the parison was subjected to a series of radial expansion or “blow” cycles. During each radial expansion or “blow” cycle, the parison was also axially stretched while being pressured at about 290 psi for about 5 seconds. The pressure was then relieved, and the parison was subject to continued axial stretching for about 5 seconds. The parison was then subjected to another expansion cycle. After three expansion or blow cycles, the original outer diameter had increased from 0.035 inches to 0.1181 inches.
  • [0058]
    The expanded parison was then pressurized to about 190 psi and was subjected to a heat set step during which the expanded parison was held for about 75 seconds at a temperature of about 110° C. The pressurized balloon was then cooled to about 37° C. for about 30 seconds. The pressure was then relieved and the balloon was held vertically in the mold at about 37° C. for about 120 seconds to minimize balloon curvature. The balloon was released from the clamps and removed from the mold. The balloon, having a nominal or rated diameter of 3.0 mm, displayed an improved overall combination of distensibility, elastic stress response and strength when compared to “compliant” balloons of the art and was ready for attachment to a catheter.
  • EXAMPLE 2
  • [0059]
    The balloons formed following the process set forth in Example 1 were placed in a sterilization chamber and kept at a temperature of about 40° C.±3° C. and a relative humidity of about 55% for about 15 hours. The balloons are kept at a temperature of about 40° C.±3° C and were then treated with 100% ethylene oxide. After being exposed to the ethylene oxide for about 6 hours, the balloons were removed from the sterilization chamber and held at a temperature of about 40° C.±3° C. and ambient relative humidity for about 22 hours in order to dissipate the ethylene oxide. At this point, the balloons were sterilized and ready for human use.
  • EXAMPLE 3
  • [0060]
    The effect which the novel sterilization process of this invention has on the balloons formed using the balloon forming process contemplated by this invention are demonstrated below. Balloons with a nominal diameter of 3.0 mm were formed from polyurethane following the process described in Example 1. One group of balloons was subjected to the sterilization process contemplated by this invention and described previously in Example 2, sterilization process contemplated by this invention and described previously in Example 2, while the other group of balloons were subjected to a sterilization process currently used in the art.
  • [0061]
    In that sterilization process (referred to in this Example as “traditional sterilization process”), the balloons were preconditioned at a temperature of about 43° C. and a relative humidity of about 60% for about 24 hours. The balloons were then treated with about 12% ethylene oxide and 88% Freon™ at a temperature of about 54° C. After being treated with the ethylene oxide mixture for about 9 hours, the balloons are removed from the sterilization chamber and kept at a temperature of about 38° C. for about 22 hours.
  • [0062]
    The average wall tensile, burst pressure, elastic stress response and distensibility (i.e., radial expansion) of both sets of balloons were compared below.
    Average Wall Average
    Tensile Burst Average
    Sterilization Strength Pressure Elastic Stress Average
    Conditions (psi) (atm) Response Distensibility
    novel sterilization 16,297 22.0 3.38 9.4%
    conditions
    described in
    Example 2
    traditional 14,497 22.6 10.29* 20.2%
    sterilization
    process
  • EXAMPLE 4
  • [0063]
    The following example demonstrates the importance of the heat set step. Three dilatation balloons with a nominal or rated diameter of 3.0 mm, were formed from polyurethane following the process described in Example 1. The average burst pressure, distensibility and wall tensile strength of balloons formed using different heat set temperatures are compared. The burst pressure and distensibility were determined at 37° C.
    Heat Set T
    Temperature Average Wall Tensile Average Burst Average
    (° C.) Strength (psi) Pressure (atm) Distensibility
    160 14,712 12.8 10.26%
    132 23,364 20.6  5.81%
    118 25,346 22.2  5.96%
  • EXAMPLE 5
  • [0064]
    The following example demonstrates the improved elastic stress response or “repeatability” which can be obtained by the balloons and balloon catheters formed following the process contemplated by this invention. In this example, dilatation balloons with a nominal or rated diameter of 3.0 mm were formed from polyurethane following the process described in Example 1. A number of polyurethane balloons were sterilized following the process previously described in Example 3 (referred to as “traditional sterilization” in this Example). Another group of polyurethane balloons were sterilized using the novel sterilization contemplated by this invention and previously described in Example 2. The elastic stress response of these polyurethanes balloons were compared with the elastic stress response of other sterilized 3.0 mm balloons known in the art.
    Average Average
    Diameter at Diameter at 5 Bars Averag
    Initial 5 Bar After A Single Elastic Stress
    Balloon Inflation Inflation to 10 Bars Response
    Polyurethane 2.96 3.06 3.38
    (sterilization described
    in Example 2)
    Polyurethane 2.72 3.00 10.29 
    (traditional
    sterilization)
    Polyethylene 3.02 3.04 0.66
    terephthalate
    Cross-linked 2.98 3.11 4.36
    polyethylene
    Cross-linked 2.93 3.19 8.87
    polyolefin-ionomer
  • EXAMPLE 6
  • [0065]
    The following example demonstrates the improved overall combination of distensibility, elastic stress response and wall tensile strength obtained by forming balloons by using the process of this invention. Balloons with a nominal or rated diameter of 3.0 mm were formed from polyurethane following the process described in Example 1. The average elastic stress response, distensibility and wall tensile strength of those polyurethane balloons are compared with properties of other 3.0 mm balloons of the art.
    Average Wall
    Average Elastic Average Tensile
    Balloon Stress Response Distensibility Strength (psi)
    Polyurethane 3.38 9.4% 16,297
    Polyethylene 0.66 3.26% 62,081
    terephthalate
    Cross-linked 4.36 9.67% 8,868
    polyethylene
    Cross-linked 8.87 14.64% 6,793
    polyolefin-ionomer

Claims (17)

  1. 1. A balloon characterized by an improved overall combination of distensibility, elastic stress response and wall tensile strength made by the process comprising:
    a. providing a parison of a block copolymer having regions of inter-molecular chain interaction separated by regions in which those individual portions of the polymer chains have the ability to uncoil, said parison having a predetermined original outer diameter, a predetermined wall thickness and a predetermined length;
    b. subjecting said parison to at least one axial stretch step and at least one radial expansion step at temperature T1 which is below the melting temperature of said block copolymer to increase the diameter and length of said parison to at least 3 times the original diameter and 2 times the original length and to decrease the original wall thickness to at least 20% of the original wall thickness to form an expanded parison; and
    c. heating said expanded parison to a temperature of T2 which is above T1 but below the melting temperature of said block copolymer.
  2. 2. The balloon according to claim 1 wherein said radial expansion step is conducted while said parison is simultaneously subjected to said axial stretch step.
  3. 3. The balloon according to claim 1 wherein said axial stretch and radial expansion steps are conducted at temperature T1 which is greater than the glass transition temperature of said block copolymer.
  4. 4. A balloon according to claim 1 wherein said block copolymer is selected from the group consisting of polyester block copolymers, polyamide block copolymers, polyurethane block copolymers, a mixture of nylon and polyamide block copolymers and a mixture of polyethylene terephthalate and polyester block copolymers.
  5. 5. A balloon according to claim 1 wherein said balloon has a distensibility of about 5 to about 20%, an elastic stress response not greater than about 5.00, and a wall tensile strength greater than about 14,000 psi.
  6. 6. A balloon according to claim 1 wherein said balloon has a distensibility of about 6 to about 17%, an elastic stress response of about 0.75 to about 4.00 and a wall tensile strength of about 16,000 to about 30,000 psi.
  7. 7. A balloon according to claim 1 wherein said block copolymer is a polyurethane having a Shore Hardness of about 74 D, a specific gravity of about 1.21, a tensile modulus of about 165,000 psi, a flexual modulus of about 190,000 psi, an ultimate tensile strength of about 6,980 psi and an ultimate elongation of about 250%.
  8. 8. A balloon according to claim 6 wherein T1 is about 90-100° C. and T2 is about 110-120° C.
  9. 9. A process of forming a balloon characterized by an improved overall combination of distensibility, elastic stress response and wall tensile strength comprising:
    a. providing a parison of a block copolymer having regions of inter-molecular chain interaction separated by regions in which those individual polymer portion of chains have the ability to uncoil, said parison having a predetermined original outer diameter, a predetermined wall thickness and a predetermined length;
    b. subjecting said parison to at least one axial stretch step and at least one radial expansion step at temperature T1 which is below the melting temperature of said block copolymer to increase the diameter and length of said parison to at least 3 times the original diameter and 2 times the original length and to decrease the original wall thickness to at least 20% of the original wall thickness to form an expanded parison; and
    c. heating said expanded parison to a temperature of T2 which is above T1 but below the melting temperature of said block copolymer.
  10. 10. The process according to claim 9 wherein said radial expansion step is conducted while said parison is simultaneously subjected to said axial stretch step.
  11. 11. The process according to claim 9 wherein said axial stretch and radial expansion steps are conducted at temperature T1 which is greater than the glass transition temperature of said block copolymer.
  12. 12. A process according to claim 9 wherein said block copolymer is selected from the group consisting of polyester block copolymers, polyamide block copolymers, polyurethane block copolymers, a mixture of nylon and polyamide block copolymers and a mixture of polyethylene terephthalate and polyester block copolymers.
  13. 13. A process according to claim 9 wherein said balloon formed has a distensibility of about 5 to about 20%, an elastic stress response of not greater than about 5.00 and a wall tensile strength greater than about 14,000 psi.
  14. 14. A process according to claim 9 wherein the balloon formed has a distensibility of about 6 to about 17%, an elastic stress response of about 0.75 to about 4.00 and a wall tensile strength of about 16,000 to about 30,000 psi.
  15. 15. A process according to claim 9 wherein said block copolymer is a polyurethane having a Shore Hardness of about 74 D, a specific gravity of about 1.21, a tensile modulus of about 165,000 psi, a flexual modulus of about 190,000 psi, an ultimate tensile strength of about 6,980 psi and an ultimate elongation of about 250%.
  16. 16. A balloon catheter comprising the balloon of claim 1.
  17. 17. A process for sterilizing balloons and balloon catheters comprising:
    a. subjecting said balloons and balloon catheters to a temperature of about to about 45° C. and a relative humidity of about 55% for about 15 hours;
    b. treating said balloons and balloon catheters at a temperature of about 35 to about 45° C. and a relative humidity of about 55% with ethylene oxide for about 15 hours; and
    c. discontinuing treatment with ethylene oxide and subjecting said balloons and balloon catheters to a temperature of about 35 to about 45° C. for about 22 hours.
US10637575 1992-09-30 2003-08-11 Distensible dilatation balloon with elastic stress response and manufacture thereof Abandoned US20040097878A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US07954750 US5500180A (en) 1992-09-30 1992-09-30 Method of making a distensible dilatation balloon using a block copolymer
US44070095 true 1995-05-15 1995-05-15
US08883261 US6210364B1 (en) 1992-09-30 1997-06-26 Distensible dilatation balloon with elastic stress response
US09192893 US6283939B1 (en) 1992-09-30 1998-11-16 Distensible dilatation balloon with elastic stress
US09942920 US6620381B2 (en) 1992-09-30 2001-08-31 Sterilization process for a distensible dilatation balloon with elastic stress response
US10637575 US20040097878A1 (en) 1992-09-30 2003-08-11 Distensible dilatation balloon with elastic stress response and manufacture thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10637575 US20040097878A1 (en) 1992-09-30 2003-08-11 Distensible dilatation balloon with elastic stress response and manufacture thereof

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09942920 Continuation US6620381B2 (en) 1992-09-30 2001-08-31 Sterilization process for a distensible dilatation balloon with elastic stress response

Publications (1)

Publication Number Publication Date
US20040097878A1 true true US20040097878A1 (en) 2004-05-20

Family

ID=25495874

Family Applications (5)

Application Number Title Priority Date Filing Date
US07954750 Expired - Lifetime US5500180A (en) 1992-09-30 1992-09-30 Method of making a distensible dilatation balloon using a block copolymer
US08883261 Expired - Fee Related US6210364B1 (en) 1992-09-30 1997-06-26 Distensible dilatation balloon with elastic stress response
US09192893 Expired - Lifetime US6283939B1 (en) 1992-09-30 1998-11-16 Distensible dilatation balloon with elastic stress
US09942920 Expired - Fee Related US6620381B2 (en) 1992-09-30 2001-08-31 Sterilization process for a distensible dilatation balloon with elastic stress response
US10637575 Abandoned US20040097878A1 (en) 1992-09-30 2003-08-11 Distensible dilatation balloon with elastic stress response and manufacture thereof

Family Applications Before (4)

Application Number Title Priority Date Filing Date
US07954750 Expired - Lifetime US5500180A (en) 1992-09-30 1992-09-30 Method of making a distensible dilatation balloon using a block copolymer
US08883261 Expired - Fee Related US6210364B1 (en) 1992-09-30 1997-06-26 Distensible dilatation balloon with elastic stress response
US09192893 Expired - Lifetime US6283939B1 (en) 1992-09-30 1998-11-16 Distensible dilatation balloon with elastic stress
US09942920 Expired - Fee Related US6620381B2 (en) 1992-09-30 2001-08-31 Sterilization process for a distensible dilatation balloon with elastic stress response

Country Status (5)

Country Link
US (5) US5500180A (en)
EP (2) EP0592885B1 (en)
JP (1) JPH06304920A (en)
CA (1) CA2107378A1 (en)
DE (2) DE69334289D1 (en)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080051819A1 (en) * 2006-08-25 2008-02-28 Nishith Chasmawala Apparatus and methods for use of expandable members in surgical applications
US7736388B2 (en) 1999-04-09 2010-06-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7753923B2 (en) 1999-04-09 2010-07-13 Evalve, Inc. Leaflet suturing
US7811296B2 (en) 1999-04-09 2010-10-12 Evalve, Inc. Fixation devices for variation in engagement of tissue
US7981139B2 (en) 2002-03-01 2011-07-19 Evalve, Inc Suture anchors and methods of use
US7981123B2 (en) 1997-09-12 2011-07-19 Evalve, Inc. Surgical device for connecting soft tissue
US8029518B2 (en) 1999-04-09 2011-10-04 Evalve, Inc. Methods and devices for capturing and fixing leaflets in valve repair
US8052592B2 (en) 2005-09-27 2011-11-08 Evalve, Inc. Methods and devices for tissue grasping and assessment
US8123703B2 (en) 1999-04-09 2012-02-28 Evalve, Inc. Steerable access sheath and methods of use
US8216256B2 (en) 1999-04-09 2012-07-10 Evalve, Inc. Detachment mechanism for implantable fixation devices
US8343174B2 (en) 1999-04-09 2013-01-01 Evalve, Inc. Locking mechanisms for fixation devices and methods of engaging tissue
US8926620B2 (en) 2006-08-25 2015-01-06 Kyphon Sarl Apparatus and methods for use of expandable members in surgical applications

Families Citing this family (204)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5500180A (en) * 1992-09-30 1996-03-19 C. R. Bard, Inc. Method of making a distensible dilatation balloon using a block copolymer
US6025044A (en) 1993-08-18 2000-02-15 W. L. Gore & Associates, Inc. Thin-wall polytetrafluoroethylene tube
US6719773B1 (en) 1998-06-01 2004-04-13 Kyphon Inc. Expandable structures for deployment in interior body regions
US5470313A (en) * 1994-02-24 1995-11-28 Cardiovascular Dynamics, Inc. Variable diameter balloon dilatation catheter
US6120523A (en) 1994-02-24 2000-09-19 Radiance Medical Systems, Inc. Focalized intraluminal balloons
US7108826B2 (en) * 1994-03-02 2006-09-19 Boston Scientific Scimed, Inc. High compliance, high strength catheter balloons useful for treatment of gastrointestinal lesions
US6171278B1 (en) 1994-03-02 2001-01-09 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
WO1995023619A1 (en) * 1994-03-02 1995-09-08 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US6146356A (en) * 1994-03-02 2000-11-14 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US5830182A (en) * 1994-03-02 1998-11-03 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US5951941A (en) * 1994-03-02 1999-09-14 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US6406457B1 (en) 1994-03-02 2002-06-18 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US7163522B1 (en) 1994-03-02 2007-01-16 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
WO1996012516A1 (en) * 1994-10-19 1996-05-02 Advanced Cardiovascular Systems, Inc. High strength dilatation balloons
CA2219744A1 (en) 1995-05-24 1996-11-28 Schneider (Usa) Inc. Dilatation balloons containing polyesteretheramide copolymer
US5645789A (en) * 1995-07-20 1997-07-08 Navius Corporation Distensible pet balloon and method of manufacture
US5868704A (en) * 1995-09-18 1999-02-09 W. L. Gore & Associates, Inc. Balloon catheter device
US5752934A (en) * 1995-09-18 1998-05-19 W. L. Gore & Associates, Inc. Balloon catheter device
US20060271091A1 (en) * 1995-09-18 2006-11-30 Campbell Carey V Balloon catheter device
US6027486A (en) * 1996-05-02 2000-02-22 Radiance Medical Systems, Inc. Interactive angioplasty
US5645560A (en) * 1995-12-15 1997-07-08 Cardiovascular Dynamics, Inc. Fixed focal balloon for interactive angioplasty and stent implantation
US5843116A (en) * 1996-05-02 1998-12-01 Cardiovascular Dynamics, Inc. Focalized intraluminal balloons
US6152909A (en) * 1996-05-20 2000-11-28 Percusurge, Inc. Aspiration system and method
US20050245894A1 (en) * 1996-05-20 2005-11-03 Medtronic Vascular, Inc. Methods and apparatuses for drug delivery to an intravascular occlusion
US6554795B2 (en) 1997-03-06 2003-04-29 Medtronic Ave, Inc. Balloon catheter and method of manufacture
US5868705A (en) * 1996-05-20 1999-02-09 Percusurge Inc Pre-stretched catheter balloon
US6325777B1 (en) 1996-05-20 2001-12-04 Medtronic Percusurge, Inc. Low profile catheter valve and inflation adaptor
US6022336A (en) 1996-05-20 2000-02-08 Percusurge, Inc. Catheter system for emboli containment
US6050972A (en) 1996-05-20 2000-04-18 Percusurge, Inc. Guidewire inflation system
US6786888B1 (en) 1996-05-20 2004-09-07 Medtronic Ave, Inc. Low profile catheter for emboli protection
US6270477B1 (en) 1996-05-20 2001-08-07 Percusurge, Inc. Catheter for emboli containment
WO1997044085A3 (en) 1996-05-20 1998-09-17 Percusurge Inc Low profile catheter valve
DE69727234T2 (en) 1996-07-23 2004-11-11 Scimed Life Systems, Inc., Maple Grove A process for producing high-strength dilatation balloon having a high compliance to the treatment of gastrointestinal damage
US7749585B2 (en) * 1996-10-08 2010-07-06 Alan Zamore Reduced profile medical balloon element
US5871692A (en) * 1997-01-14 1999-02-16 Steris Corporation Method and apparatus for cleaning, decontaminating, and sterilizing catheters
US6849068B1 (en) 1997-03-06 2005-02-01 Medtronic Ave, Inc. Aspiration catheter
US20010049517A1 (en) 1997-03-06 2001-12-06 Gholam-Reza Zadno-Azizi Method for containing and removing occlusions in the carotid arteries
US6068623A (en) 1997-03-06 2000-05-30 Percusurge, Inc. Hollow medical wires and methods of constructing same
US6355016B1 (en) 1997-03-06 2002-03-12 Medtronic Percusurge, Inc. Catheter core wire
WO1998038929A1 (en) 1997-03-06 1998-09-11 Percusurge, Inc. Intravascular aspiration system
US6652480B1 (en) 1997-03-06 2003-11-25 Medtronic Ave., Inc. Methods for reducing distal embolization
US6319229B1 (en) 1998-02-19 2001-11-20 Medtronic Percusurge, Inc. Balloon catheter and method of manufacture
US20010008661A1 (en) 1997-05-14 2001-07-19 Eugene J. Jung Jr Balloon for a dilation catheter and method for manufacturing a balloon
CA2232250C (en) * 1997-05-14 2007-06-26 Navius Corporation Balloon for a dilation catheter and method for manufacturing a balloon
US6306166B1 (en) * 1997-08-13 2001-10-23 Scimed Life Systems, Inc. Loading and release of water-insoluble drugs
US6358227B1 (en) * 1997-09-10 2002-03-19 Scimed Life Systems, Inc. Dilatation catheter balloon made from pen based homopolymer or random copolymer
US5976181A (en) 1997-09-22 1999-11-02 Ave Connaught Balloon mounted stent and method therefor
US5948345A (en) * 1998-01-05 1999-09-07 Medtronic, Inc. Method for making medical balloon catheter
CA2283827C (en) * 1998-01-14 2009-02-03 Sumitomo Bakelite Co., Ltd Balloon catheter for puncturing, medical tube introducing device using the catheter and method for use thereof
US6190332B1 (en) 1998-02-19 2001-02-20 Percusurge, Inc. Core wire with shapeable tip
EP1059948B1 (en) 1998-03-04 2004-02-18 Boston Scientific Limited Composition and process for manufacturing pbt catheter balloons
US6287314B1 (en) * 1998-04-21 2001-09-11 Advanced Cardiovascular Systems, Inc. Stent deploying catheter system
US20010001113A1 (en) * 1998-04-21 2001-05-10 Florencia Lim Balloon catheter
DE69942858D1 (en) 1998-06-01 2010-11-25 Kyphon S A R L Expandable, preformed structures for folding in regions within the body
US6287506B1 (en) 1998-07-09 2001-09-11 Schneider (Usa) Inc. Method for reducing dilation balloon cone stiffness
WO2000027461A9 (en) * 1998-11-09 2000-11-30 Datascope Investment Corp Intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane
US6395208B1 (en) 1999-01-25 2002-05-28 Atrium Medical Corporation Method of making an expandable fluoropolymer device
US7637886B2 (en) * 1999-01-25 2009-12-29 Atrium Medical Corporation Expandable fluoropolymer device and method of making
US6955661B1 (en) * 1999-01-25 2005-10-18 Atrium Medical Corporation Expandable fluoropolymer device for delivery of therapeutic agents and method of making
WO2000051660A1 (en) 1999-03-05 2000-09-08 Medtronic, Inc. Polyurethane balloon catheter
JP2000279507A (en) * 1999-03-30 2000-10-10 Nippon Zeon Co Ltd Balloon catheter with low-temperature blow-molded balloon
JP4883433B2 (en) * 1999-05-16 2012-02-22 株式会社ワイエス・メディカル Balloon catheter and method of attachment of the balloon to its preparation and catheter tube
US7892201B1 (en) 1999-08-27 2011-02-22 Gore Enterprise Holdings, Inc. Balloon catheter and method of mounting same
US6572813B1 (en) * 2000-01-13 2003-06-03 Advanced Cardiovascular Systems, Inc. Balloon forming process
DE10026003A1 (en) * 2000-05-25 2001-12-06 Bosch Gmbh Robert stator
US6863861B1 (en) 2000-09-28 2005-03-08 Boston Scientific Scimed, Inc. Process for forming a medical device balloon
US6951674B1 (en) 2000-11-10 2005-10-04 Scimed Life Systems, Inc. Blended polyurethane interventional balloon
US6673302B2 (en) 2001-01-24 2004-01-06 Scimed Life Systems, Inc. Wet processing method for catheter balloons
US6946092B1 (en) 2001-09-10 2005-09-20 Scimed Life Systems, Inc. Medical balloon
US20030032963A1 (en) 2001-10-24 2003-02-13 Kyphon Inc. Devices and methods using an expandable body with internal restraint for compressing cancellous bone
US7005097B2 (en) * 2002-01-23 2006-02-28 Boston Scientific Scimed, Inc. Medical devices employing chain extended polymers
US7029732B2 (en) * 2002-02-28 2006-04-18 Boston Scientific Scimed, Inc. Medical device balloons with improved strength properties and processes for producing same
US20040039410A1 (en) * 2002-08-22 2004-02-26 Brooke Ren High-strength balloon with tailored softness
US8337968B2 (en) 2002-09-11 2012-12-25 Boston Scientific Scimed, Inc. Radiation sterilized medical devices comprising radiation sensitive polymers
US7226472B2 (en) * 2002-10-15 2007-06-05 Boston Scientific Scimed, Inc. Catheter balloon with advantageous cone design
DE50209306D1 (en) 2002-12-31 2007-03-08 Abbott Lab Vascular Entpr Ltd Catheter with a flexible region between the shank and tip and method for its preparation
US20040143283A1 (en) * 2003-01-17 2004-07-22 Mcgill Scott Inflation adaptor and method of use
US20040260237A1 (en) * 2003-06-17 2004-12-23 Paul Squadrito Inflation adaptor with magnetically-assisted loading
US20050004594A1 (en) * 2003-07-02 2005-01-06 Jeffrey Nool Devices and methods for aspirating from filters
US7727442B2 (en) * 2003-07-10 2010-06-01 Boston Scientific Scimed, Inc. Medical device tubing with discrete orientation regions
EP1508348A1 (en) * 2003-08-18 2005-02-23 Medtronic Vascular, Inc. A process for producing a hyper-elastic, high strength dilation balloon made from multi-block copolymers
US20050124976A1 (en) * 2003-12-04 2005-06-09 Devens Douglas A.Jr. Medical devices
US20050127561A1 (en) * 2003-12-16 2005-06-16 Scimed Life Systems, Inc. Method of making expandable-collapsible bodies by temperature gradient expansion molding
US7601285B2 (en) * 2003-12-31 2009-10-13 Boston Scientific Scimed, Inc. Medical device with varying physical properties and method for forming same
US7264458B2 (en) * 2004-01-07 2007-09-04 Boston Scientific Scimed, Inc. Process and apparatus for forming medical device balloons
US20050228428A1 (en) * 2004-04-07 2005-10-13 Afsar Ali Balloon catheters and methods for manufacturing balloons for balloon catheters
US7892478B2 (en) * 2004-04-19 2011-02-22 Boston Scientific Scimed, Inc. Catheter balloon mold form and molding process
US7016394B2 (en) * 2004-04-23 2006-03-21 Ucar Carbon Company Inc. Male-female electrode joint
US20070078439A1 (en) * 2004-05-27 2007-04-05 Axel Grandt Multiple lumen catheter and method of making same
EP1748814A1 (en) 2004-05-27 2007-02-07 Abbott Laboratories Catheter having main body portion with coil-defined guidewire passage
US7794448B2 (en) * 2004-05-27 2010-09-14 Abbott Laboratories Multiple lumen catheter and method of making same
US7658723B2 (en) * 2004-05-27 2010-02-09 Abbott Laboratories Catheter having plurality of stiffening members
EP1748815B1 (en) * 2004-05-27 2009-09-16 Abbott Laboratories Catheter having first and second guidewire tubes and a gap therebetween
US7815627B2 (en) 2004-05-27 2010-10-19 Abbott Laboratories Catheter having plurality of stiffening members
US7785318B2 (en) * 2004-05-27 2010-08-31 Abbott Laboratories Catheter having plurality of stiffening members
US7628769B2 (en) * 2004-05-27 2009-12-08 Abbott Laboratories Catheter having overlapping stiffening members
US7635510B2 (en) * 2004-07-07 2009-12-22 Boston Scientific Scimed, Inc. High performance balloon catheter/component
US7785439B2 (en) * 2004-09-29 2010-08-31 Abbott Laboratories Vascular Enterprises Limited Method for connecting a catheter balloon with a catheter shaft of a balloon catheter
US20060134357A1 (en) * 2004-12-16 2006-06-22 Medtronic Vascular, Inc. Polymer blends for medical balloons
US20060135725A1 (en) * 2004-12-21 2006-06-22 Scimed Life Systems, Inc. New balloon materials
US9586030B2 (en) * 2004-12-23 2017-03-07 Boston Scientific Scimed, Inc. Fugitive plasticizer balloon surface treatment for enhanced stent securement
US20070009564A1 (en) * 2005-06-22 2007-01-11 Mcclain James B Drug/polymer composite materials and methods of making the same
US7691082B2 (en) * 2005-07-01 2010-04-06 Boston Scientific Scimed, Inc. Medical devices
CA2615452C (en) 2005-07-15 2015-03-31 Micell Technologies, Inc. Polymer coatings containing drug powder of controlled morphology
US8876763B2 (en) * 2005-11-01 2014-11-04 Boston Scientific Scimed, Inc. Composite balloon
US7766893B2 (en) * 2005-12-07 2010-08-03 Boston Scientific Scimed, Inc. Tapered multi-chamber balloon
US20070142772A1 (en) * 2005-12-16 2007-06-21 Medtronic Vascular, Inc. Dual-Layer Medical Balloon
EP1968686A4 (en) 2005-12-16 2009-12-09 Interface Associates Inc Multi-layer balloons for medical applications and methods for manufacturing the same
US7828766B2 (en) 2005-12-20 2010-11-09 Advanced Cardiovascular Systems, Inc. Non-compliant multilayered balloon for a catheter
EP1962940A4 (en) * 2005-12-23 2011-05-25 Bard Inc C R Balloon catheter with centralized vent hole
US8043673B2 (en) 2006-03-02 2011-10-25 Boston Scientific Scimed, Inc. Method to make tube-in-tube balloon
US20070205539A1 (en) * 2006-03-03 2007-09-06 Boston Scientific Scimed, Inc. Balloon mold design
US8858855B2 (en) 2006-04-20 2014-10-14 Boston Scientific Scimed, Inc. High pressure balloon
ES2540059T3 (en) 2006-04-26 2015-07-08 Micell Technologies, Inc. Coatings containing multidrug
US7943221B2 (en) * 2006-05-22 2011-05-17 Boston Scientific Scimed, Inc. Hinged compliance fiber braid balloon
US8434487B2 (en) 2006-06-22 2013-05-07 Covidien Lp Endotracheal cuff and technique for using the same
US8196584B2 (en) 2006-06-22 2012-06-12 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US20070295337A1 (en) * 2006-06-22 2007-12-27 Nelson Donald S Endotracheal cuff and technique for using the same
US9192697B2 (en) 2007-07-03 2015-11-24 Hemoteq Ag Balloon catheter for treating stenosis of body passages and for preventing threatening restenosis
US20100063585A1 (en) * 2006-07-03 2010-03-11 Hemoteq Ag Manufacture, method and use of active substance-releasing medical products for permanently keeping blood vessels open
US7654264B2 (en) 2006-07-18 2010-02-02 Nellcor Puritan Bennett Llc Medical tube including an inflatable cuff having a notched collar
US20080097374A1 (en) * 2006-08-07 2008-04-24 Korleski Joseph E Inflatable shaped balloons
US8460240B2 (en) * 2006-08-07 2013-06-11 W. L. Gore & Associates, Inc. Inflatable toroidal-shaped balloons
US9180279B2 (en) * 2006-08-07 2015-11-10 W. L. Gore & Associates, Inc. Inflatable imbibed polymer devices
US20080097300A1 (en) * 2006-08-07 2008-04-24 Sherif Eskaros Catheter balloon with multiple micropleats
US20080125711A1 (en) * 2006-08-07 2008-05-29 Alpini Alfred A Catheter balloons with integrated non-distensible seals
US20080140173A1 (en) 2006-08-07 2008-06-12 Sherif Eskaros Non-shortening wrapped balloon
US7785290B2 (en) * 2006-08-07 2010-08-31 Gore Enterprise Holdings, Inc. Non-shortening high angle wrapped balloons
JP5184360B2 (en) * 2006-08-21 2013-04-17 株式会社カネカ Balloon catheter
US8609016B2 (en) * 2006-08-28 2013-12-17 Boston Scientific Scimed, Inc. Refoldable balloon and method of making and using the same
US20080053454A1 (en) * 2006-09-01 2008-03-06 Nellcor Puritan Bennett Incorporated Endotracheal tube including a partially inverted cuff collar
US8684175B2 (en) 2006-09-22 2014-04-01 Covidien Lp Method for shipping and protecting an endotracheal tube with an inflated cuff
US8561614B2 (en) * 2006-09-28 2013-10-22 Covidien Lp Multi-layer cuffs for medical devices
US20080078401A1 (en) * 2006-09-29 2008-04-03 Nellcor Puritan Bennett Incorporated Self-sizing adjustable endotracheal tube
US20080078405A1 (en) * 2006-09-29 2008-04-03 Crumback Gary L Self-sizing adjustable endotracheal tube
US8307830B2 (en) 2006-09-29 2012-11-13 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US7950393B2 (en) * 2006-09-29 2011-05-31 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US8807136B2 (en) * 2006-09-29 2014-08-19 Covidien Lp Self-sizing adjustable endotracheal tube
US20080078399A1 (en) * 2006-09-29 2008-04-03 O'neil Michael P Self-sizing adjustable endotracheal tube
US8088100B2 (en) * 2006-10-20 2012-01-03 Boston Scientific Scimed, Inc. Reinforced rewrappable balloon
CA2667228C (en) * 2006-10-23 2015-07-14 Micell Technologies, Inc. Holder for electrically charging a substrate during coating
US8414611B2 (en) * 2006-11-03 2013-04-09 Boston Scientific Scimed, Inc. Main vessel constraining side-branch access balloon
US8398695B2 (en) * 2006-11-03 2013-03-19 Boston Scientific Scimed, Inc. Side branch stenting system using a main vessel constraining side branch access balloon and side branching stent
US9737642B2 (en) * 2007-01-08 2017-08-22 Micell Technologies, Inc. Stents having biodegradable layers
US20080171980A1 (en) * 2007-01-16 2008-07-17 Medtronic Vascular, Inc. Proximal Shaft for Rapid Exchange Catheter
DE112008000881A5 (en) * 2007-01-21 2010-01-21 Hemoteq Ag Medical device for treating obstructions of body passages and prevent the threat of re-closures
US20080210243A1 (en) * 2007-03-02 2008-09-04 Jessica Clayton Endotracheal cuff and technique for using the same
US20080215034A1 (en) * 2007-03-02 2008-09-04 Jessica Clayton Endotracheal cuff and technique for using the same
WO2008131131A1 (en) * 2007-04-17 2008-10-30 Micell Technologies, Inc. Stents having biodegradable layers
EP2170418B1 (en) 2007-05-25 2016-03-16 Micell Technologies, Inc. Polymer films for medical device coating
US20090069878A1 (en) * 2007-08-27 2009-03-12 Boston Scientific Scimed, Inc. Bifurcation post-dilatation balloon and methods
WO2009029674A1 (en) * 2007-08-27 2009-03-05 Boston Scientific Limited Bulging balloon for bifurcation catheter assembly and methods
JP2010537788A (en) * 2007-09-06 2010-12-09 ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. Method and device for the localized delivery of therapeutic agents to the heart valve
US8088140B2 (en) 2008-05-19 2012-01-03 Mindframe, Inc. Blood flow restorative and embolus removal methods
US9220522B2 (en) 2007-10-17 2015-12-29 Covidien Lp Embolus removal systems with baskets
US8585713B2 (en) 2007-10-17 2013-11-19 Covidien Lp Expandable tip assembly for thrombus management
US9198687B2 (en) 2007-10-17 2015-12-01 Covidien Lp Acute stroke revascularization/recanalization systems processes and products thereby
US20100022951A1 (en) * 2008-05-19 2010-01-28 Luce, Forward, Hamilton 7 Scripps, Llp Detachable hub/luer device and processes
US8066757B2 (en) 2007-10-17 2011-11-29 Mindframe, Inc. Blood flow restoration and thrombus management methods
US8926680B2 (en) 2007-11-12 2015-01-06 Covidien Lp Aneurysm neck bridging processes with revascularization systems methods and products thereby
WO2009051780A1 (en) * 2007-10-19 2009-04-23 Micell Technologies, Inc. Drug coated stents
US8750978B2 (en) * 2007-12-31 2014-06-10 Covidien Lp System and sensor for early detection of shock or perfusion failure and technique for using the same
US8940003B2 (en) 2008-02-22 2015-01-27 Covidien Lp Methods and apparatus for flow restoration
US8951545B2 (en) 2008-03-28 2015-02-10 Surmodics, Inc. Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery
US20090254113A1 (en) * 2008-04-04 2009-10-08 Medtronic Vascular, Inc. Dilatation balloon with ridges and methods
CN101977650A (en) 2008-04-11 2011-02-16 曼德弗雷姆公司 Monorail neuro-microcatheter for delivery of medical devices to treat stroke, processes and products thereby
WO2009146209A1 (en) * 2008-04-17 2009-12-03 Micell Technologies, Inc. Stents having bioabsorbable layers
US20090264822A1 (en) * 2008-04-21 2009-10-22 Medtronic Vascular, Inc. Method of Making a Zero-Fold Balloon With Variable Inflation Volume
US20090318863A1 (en) * 2008-06-18 2009-12-24 Boston Scientific Scimed, Inc. Functional Balloon With Built in Lubricity or Drug Delivery System
US9510856B2 (en) 2008-07-17 2016-12-06 Micell Technologies, Inc. Drug delivery medical device
EP2313122A4 (en) * 2008-07-17 2013-10-30 Micell Technologies Inc Drug delivery medical device
US8834913B2 (en) * 2008-12-26 2014-09-16 Battelle Memorial Institute Medical implants and methods of making medical implants
EP2410954A4 (en) * 2009-03-23 2014-03-05 Micell Technologies Inc Peripheral stents having layers
EP2413847A4 (en) * 2009-04-01 2013-11-27 Micell Technologies Inc Coated stents
CA2759015C (en) 2009-04-17 2017-06-20 James B. Mcclain Stents having controlled elution
US20100272773A1 (en) * 2009-04-24 2010-10-28 Boston Scientific Scimed, Inc. Use of Drug Polymorphs to Achieve Controlled Drug Delivery From a Coated Medical Device
CN105214143A (en) * 2009-04-28 2016-01-06 苏尔莫迪克斯公司 Devices and methods for delivery of bioactive agents
US8590534B2 (en) * 2009-06-22 2013-11-26 Covidien Lp Cuff for use with medical tubing and method and apparatus for making the same
EP3064230A1 (en) * 2009-07-10 2016-09-07 Boston Scientific Scimed, Inc. Use of nanocrystals for a drug delivery balloon
WO2011008393A3 (en) * 2009-07-17 2011-03-24 Boston Scientific Scimed, Inc. Nucleation of drug delivery balloons to provide improved crystal size and density
JP2011152181A (en) * 2010-01-26 2011-08-11 Toray Ind Inc Balloon catheter
EP2531140B1 (en) * 2010-02-02 2017-11-01 Micell Technologies, Inc. Stent and stent delivery system with improved deliverability
US8795762B2 (en) 2010-03-26 2014-08-05 Battelle Memorial Institute System and method for enhanced electrostatic deposition and surface coatings
WO2011143237A1 (en) 2010-05-10 2011-11-17 Surmodics, Inc. Glycerol ester active agent delivery systems and methods
WO2012003293A1 (en) 2010-06-30 2012-01-05 Surmodics, Inc. Lipid coating for medical devices delivering bioactive agent
WO2012031236A1 (en) 2010-09-02 2012-03-08 Boston Scientific Scimed, Inc. Coating process for drug delivery balloons using heat-induced rewrap memory
US8703260B2 (en) 2010-09-14 2014-04-22 Abbott Cardiovascular Systems Inc. Catheter balloon and method for forming same
WO2012054129A1 (en) 2010-10-18 2012-04-26 Boston Scientific Scimed, Inc. Drug eluting medical device utilizing bioadhesives
US8177742B1 (en) 2010-12-23 2012-05-15 Kimberly-Clark Wordwide, Inc. Inflatable retention system for an enteral feeding device
WO2012096787A1 (en) 2010-12-30 2012-07-19 Surmodics, Inc. Double wall catheter for delivering therapeutic agent
US20120172796A1 (en) 2010-12-30 2012-07-05 Chappa Ralph A Composition for intravascular delivery of therapeutic composition
US8873900B2 (en) 2011-04-21 2014-10-28 Medtronic Vascular, Inc. Balloon catheter with integrated optical sensor for determining balloon diameter
US9861727B2 (en) 2011-05-20 2018-01-09 Surmodics, Inc. Delivery of hydrophobic active agent particles
JP2018507025A (en) 2015-01-29 2018-03-15 サーモディクス,インコーポレイテッド Delivery of hydrophobic bioactive substance particles
US9757497B2 (en) 2011-05-20 2017-09-12 Surmodics, Inc. Delivery of coated hydrophobic active agent particles
US20130030406A1 (en) 2011-07-26 2013-01-31 Medtronic Vascular, Inc. Textured Dilatation Balloon and Methods
US8669360B2 (en) 2011-08-05 2014-03-11 Boston Scientific Scimed, Inc. Methods of converting amorphous drug substance into crystalline form
US9056152B2 (en) 2011-08-25 2015-06-16 Boston Scientific Scimed, Inc. Medical device with crystalline drug coating
CA2912690A1 (en) 2013-05-16 2014-11-20 Surmodics, Inc. Compositions and methods for delivery of hydrophobic active agents
CA2890205A1 (en) 2012-11-05 2014-05-08 Surmodics, Inc. Composition and method for delivery of hydrophobic active agents
US9132259B2 (en) 2012-11-19 2015-09-15 Abbott Cardiovascular Systems Inc. Multilayer balloon for a catheter
JP2016533218A (en) * 2013-10-15 2016-10-27 ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. High voltage tear balloon
US9668898B2 (en) 2014-07-24 2017-06-06 Medtronic Vascular, Inc. Stent delivery system having dynamic deployment and methods of manufacturing same
JP2017537678A (en) * 2014-10-27 2017-12-21 インターフェイス・アソシエイツ・インコーポレーテッド Method of producing a telescopic balloon utilizing pressurized constraint annealing

Citations (93)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3625793A (en) * 1969-09-23 1971-12-07 David S Sheridan Balloon-type catheters and method of manufacture
US3754851A (en) * 1971-06-01 1973-08-28 Monsanto Co Apparatus for forming multiaxially oriented containers
US4003382A (en) * 1975-07-25 1977-01-18 Ethicon, Inc. Retention catheter and method of manufacture
US4154244A (en) * 1977-11-21 1979-05-15 Baxter Travenol Laboratories, Inc. Balloon-type catheter
US4331786A (en) * 1979-10-02 1982-05-25 Ato Chimie Moldable and/or extrudable polyether-ester-amide block copolymers
US4376834A (en) * 1981-10-14 1983-03-15 The Upjohn Company Polyurethane prepared by reaction of an organic polyisocyanate, a chain extender and an isocyanate-reactive material of m.w. 500-20,000 characterized by the use of only 2-25 percent by weight of the latter material
US4385089A (en) * 1977-05-04 1983-05-24 Rhone-Poulenc Industries Process for preparing biaxially oriented hollow shaped articles from thermoplastic materials
US4385635A (en) * 1980-04-25 1983-05-31 Ruiz Oscar F Angiographic catheter with soft tip end
US4410492A (en) * 1981-02-13 1983-10-18 Ben Venue Laboratories, Inc. Sterilizing method incorporating recirculation of chamber atmosphere
US4413989A (en) * 1980-09-08 1983-11-08 Angiomedics Corporation Expandable occlusion apparatus
US4448195A (en) * 1981-05-08 1984-05-15 Leveen Harry H Reinforced balloon catheter
US4456011A (en) * 1980-12-22 1984-06-26 Irene Warnecke Balloon-catheter
US4481323A (en) * 1980-05-07 1984-11-06 Medical Research Associates, Ltd. #2 Hydrocarbon block copolymer with dispersed polysiloxane
US4482518A (en) * 1981-10-02 1984-11-13 Owens-Illinois, Inc. Methods for reducing post-mold shrinkage of hollow oriented polyethylene terephthalate containers
US4490421A (en) * 1983-07-05 1984-12-25 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4528343A (en) * 1981-06-22 1985-07-09 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Antithrombogenic elastomer, molded products of the same, and a process for manufacturing the same
US4675361A (en) * 1980-02-29 1987-06-23 Thoratec Laboratories Corp. Polymer systems suitable for blood-contacting surfaces of a biomedical device, and methods for forming
US4722344A (en) * 1986-05-23 1988-02-02 Critikon, Inc. Radiopaque polyurethanes and catheters formed therefrom
US4737219A (en) * 1985-02-12 1988-04-12 Becton, Dickinson And Company Method for bonding polyurethane balloons to multilumen catheters
US4786556A (en) * 1986-03-24 1988-11-22 Becton, Dickinson And Company Polymeric articles having enhanced antithrombogenic activity
US4820349A (en) * 1987-08-21 1989-04-11 C. R. Bard, Inc. Dilatation catheter with collapsible outer diameter
USRE32983E (en) * 1983-07-05 1989-07-11 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4848344A (en) * 1987-11-13 1989-07-18 Cook, Inc. Balloon guide
US4861830A (en) * 1980-02-29 1989-08-29 Th. Goldschmidt Ag Polymer systems suitable for blood-contacting surfaces of a biomedical device, and methods for forming
US4886506A (en) * 1986-12-23 1989-12-12 Baxter Travenol Laboratories, Inc. Soft tip catheter
US4898591A (en) * 1988-08-09 1990-02-06 Mallinckrodt, Inc. Nylon-PEBA copolymer catheter
US4906244A (en) * 1988-10-04 1990-03-06 Cordis Corporation Balloons for medical devices and fabrication thereof
US4917667A (en) * 1988-02-11 1990-04-17 Retroperfusion Systems, Inc. Retroperfusion balloon catheter and method
US4937134A (en) * 1989-04-17 1990-06-26 The Dow Chemical Company Elastomeric optical interference films
US4938676A (en) * 1988-10-04 1990-07-03 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US4943278A (en) * 1988-02-29 1990-07-24 Scimed Life Systems, Inc. Dilatation balloon catheter
US4950239A (en) * 1988-08-09 1990-08-21 Worldwide Medical Plastics Inc. Angioplasty balloons and balloon catheters
US4950257A (en) * 1988-09-15 1990-08-21 Mallinckrodt, Inc. Catheter introducer with flexible tip
US4952357A (en) * 1988-08-08 1990-08-28 Scimed Life Systems, Inc. Method of making a polyimide balloon catheter
US4963313A (en) * 1987-11-30 1990-10-16 Boston Scientific Corporation Balloon catheter
US4994032A (en) * 1987-12-01 1991-02-19 Terumo Kabushiki Kaisha Balloon catheter
US5017325A (en) * 1988-10-04 1991-05-21 Cordis Corporation Stretch-blow molding method for manufacturing balloons for medical devices
US5055024A (en) * 1988-10-04 1991-10-08 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US5087394A (en) * 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5108415A (en) * 1988-10-04 1992-04-28 Cordis Corporation Balloons for medical devices and fabrication thereof
US5108416A (en) * 1990-02-13 1992-04-28 C. R. Bard, Inc. Stent introducer system
US5156612A (en) * 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
US5156594A (en) * 1990-08-28 1992-10-20 Scimed Life Systems, Inc. Balloon catheter with distal guide wire lumen
US5169464A (en) * 1988-05-26 1992-12-08 Family Health International Method of making a condom by blow extrusion
US5192296A (en) * 1988-08-31 1993-03-09 Meadox Medicals, Inc. Dilatation catheter
US5195970A (en) * 1991-04-26 1993-03-23 Gahara William J Collapsible balloon catheters
US5195969A (en) * 1991-04-26 1993-03-23 Boston Scientific Corporation Co-extruded medical balloons and catheter using such balloons
US5195989A (en) * 1990-09-17 1993-03-23 Scimed Life Systems, Inc. Low profile catheter for increasing lumen size of a blood vessel and guide wire therefor
US5216122A (en) * 1991-05-21 1993-06-01 Union Carbide Chemicals & Plastics Technology Corporation Removal of residual ethylene oxide from poly(ethylene oxide)
US5217434A (en) * 1991-10-15 1993-06-08 Scimed Life Systems, Inc. Innerless dilatation catheter with balloon stretch valve
US5223205A (en) * 1988-10-04 1993-06-29 Cordis Corporation Method for manufacturing balloons for medical devices
US5236659A (en) * 1988-10-04 1993-08-17 Cordis Corporation Tailoring expansion properties of balloons for medical devices
US5250069A (en) * 1987-02-27 1993-10-05 Terumo Kabushiki Kaisha Catheter equipped with expansible member and production method thereof
US5254089A (en) * 1992-04-02 1993-10-19 Boston Scientific Corp. Medication dispensing balloon catheter
US5257974A (en) * 1992-08-19 1993-11-02 Scimed Life Systems, Inc. Performance enhancement adaptor for intravascular balloon catheter
US5264260A (en) * 1991-06-20 1993-11-23 Saab Mark A Dilatation balloon fabricated from low molecular weight polymers
US5265622A (en) * 1990-10-25 1993-11-30 C. R. Bard, Inc. Guidewire having radially expandable member and method for guiding and advancing a catheter using the same
US5281677A (en) * 1992-09-03 1994-01-25 Becton, Dickinson And Company Thermoplastic polyurethane blends
US5290306A (en) * 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US5295978A (en) * 1990-12-28 1994-03-22 Union Carbide Chemicals & Plastics Technology Corporation Biocompatible hydrophilic complexes and process for preparation and use
US5295959A (en) * 1992-03-13 1994-03-22 Medtronic, Inc. Autoperfusion dilatation catheter having a bonded channel
US5300048A (en) * 1993-05-12 1994-04-05 Sabin Corporation Flexible, highly radiopaque plastic material catheter
US5304340A (en) * 1991-09-06 1994-04-19 C. R. Bard, Inc. Method of increasing the tensile strength of a dilatation balloon
US5304134A (en) * 1992-01-17 1994-04-19 Danforth Biomedical, Inc. Lubricious yet bondable catheter channel sleeve for over-the-wire catheters
US5304132A (en) * 1987-05-06 1994-04-19 Jang G David Limacon geometry balloon angioplasty catheter systems and method of making same
US5304135A (en) * 1992-08-13 1994-04-19 Cordis Corporation Axial multi-chamber angioplasty balloon assembly
US5306246A (en) * 1990-11-09 1994-04-26 Boston Scientific Corporation Balloon for medical catheter
US5318532A (en) * 1989-10-03 1994-06-07 C. R. Bard, Inc. Multilumen catheter with variable cross-section lumens
US5318587A (en) * 1989-08-25 1994-06-07 C. R. Bard, Inc. Pleated balloon dilatation catheter and method of use
US5328468A (en) * 1991-10-08 1994-07-12 Terumo Kabushiki Kaisha Balloon for blood vessel-dilating catheter
US5330428A (en) * 1991-05-14 1994-07-19 Scimed Life Systems, Inc. Dilatation catheter having a random copolymer balloon
US5334160A (en) * 1992-05-04 1994-08-02 Scimed Life Systems, Inc. Intravascular catheter with sleeve and method for use thereof
US5334146A (en) * 1990-11-10 1994-08-02 Terumo Kabushiki Kaisha Catheter balloon having varying wall thickness
US5335675A (en) * 1988-11-15 1994-08-09 Family Health International Stress-softened elastomeric films, articles, and method and apparatus for making such films and articles
US5338295A (en) * 1991-10-15 1994-08-16 Scimed Life Systems, Inc. Dilatation catheter with polyimide-encased stainless steel braid proximal shaft
US5342305A (en) * 1992-08-13 1994-08-30 Cordis Corporation Variable distention angioplasty balloon assembly
US5342301A (en) * 1992-08-13 1994-08-30 Advanced Polymers Incorporated Multi-lumen balloons and catheters made therewith
US5344413A (en) * 1991-06-28 1994-09-06 C. R. Bard, Inc. Catheter having a tip connector for rapid catheter exchanges
US5344401A (en) * 1991-12-20 1994-09-06 Interventional Technologies Inc. Catheter balloon formed from a polymeric composite
US5344400A (en) * 1992-04-06 1994-09-06 Terumo Kabushiki Kaisha Balloon catheters containing molded polyarylenesulfide material
US5348538A (en) * 1992-09-29 1994-09-20 Scimed Life Systems, Inc. Shrinking balloon catheter having nonlinear or hybrid compliance curve
US5358486A (en) * 1987-01-09 1994-10-25 C. R. Bard, Inc. Multiple layer high strength balloon for dilatation catheter
US5364357A (en) * 1989-09-25 1994-11-15 Schneider (Usa) Inc. Small diameter dilatation catheter having wire reinforced coaxial tubular body
US5368566A (en) * 1992-04-29 1994-11-29 Cardiovascular Dynamics, Inc. Delivery and temporary stent catheter having a reinforced perfusion lumen
US5387199A (en) * 1992-02-24 1995-02-07 Baxter International Inc. Polymer blends for torque transmitting catheters
US5387225A (en) * 1988-02-29 1995-02-07 Scimed Life Systems, Inc. Dilatation catheter with transition member
US5395332A (en) * 1990-08-28 1995-03-07 Scimed Life Systems, Inc. Intravascualr catheter with distal tip guide wire lumen
US5397306A (en) * 1989-12-20 1995-03-14 Terumo Kabushiki Kaisha Catheter
US5411477A (en) * 1990-05-11 1995-05-02 Saab; Mark A. High-strength, thin-walled single piece catheters
US5447497A (en) * 1992-08-06 1995-09-05 Scimed Life Systems, Inc Balloon catheter having nonlinear compliance curve and method of using
US5525388A (en) * 1992-08-07 1996-06-11 Advanced Cardiovascular Systems, Inc. Dilatation balloon with constant wall thickness
US5556383A (en) * 1994-03-02 1996-09-17 Scimed Lifesystems, Inc. Block copolymer elastomer catheter balloons
US6210364B1 (en) * 1992-09-30 2001-04-03 C. R. Bard, Inc. Distensible dilatation balloon with elastic stress response

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2452227A1 (en) * 1974-11-04 1976-05-06 Gernot Klaus Brueck Device for radiation treatment of living bodies
US4376334A (en) 1981-04-27 1983-03-15 Illinois Tool Works Inc. Method of making terminal clamp assembly
EP0439202B1 (en) * 1989-07-24 1993-09-29 Cordis Corporation Apparatus and method for manufacturing balloons for medical devices
US5348486A (en) 1993-08-11 1994-09-20 General Motors Corporation Heat shielded spark plug boot assembly
DE69433506T2 (en) 1993-10-01 2004-06-24 Boston Scientific Corp., Natick Medical, thermoplastic elastomeric balloons containing

Patent Citations (99)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3625793A (en) * 1969-09-23 1971-12-07 David S Sheridan Balloon-type catheters and method of manufacture
US3754851A (en) * 1971-06-01 1973-08-28 Monsanto Co Apparatus for forming multiaxially oriented containers
US4003382A (en) * 1975-07-25 1977-01-18 Ethicon, Inc. Retention catheter and method of manufacture
US4385089A (en) * 1977-05-04 1983-05-24 Rhone-Poulenc Industries Process for preparing biaxially oriented hollow shaped articles from thermoplastic materials
US4154244A (en) * 1977-11-21 1979-05-15 Baxter Travenol Laboratories, Inc. Balloon-type catheter
US4331786A (en) * 1979-10-02 1982-05-25 Ato Chimie Moldable and/or extrudable polyether-ester-amide block copolymers
US4861830A (en) * 1980-02-29 1989-08-29 Th. Goldschmidt Ag Polymer systems suitable for blood-contacting surfaces of a biomedical device, and methods for forming
US4675361A (en) * 1980-02-29 1987-06-23 Thoratec Laboratories Corp. Polymer systems suitable for blood-contacting surfaces of a biomedical device, and methods for forming
US4385635A (en) * 1980-04-25 1983-05-31 Ruiz Oscar F Angiographic catheter with soft tip end
US4481323A (en) * 1980-05-07 1984-11-06 Medical Research Associates, Ltd. #2 Hydrocarbon block copolymer with dispersed polysiloxane
US4413989A (en) * 1980-09-08 1983-11-08 Angiomedics Corporation Expandable occlusion apparatus
US4456011A (en) * 1980-12-22 1984-06-26 Irene Warnecke Balloon-catheter
US4410492A (en) * 1981-02-13 1983-10-18 Ben Venue Laboratories, Inc. Sterilizing method incorporating recirculation of chamber atmosphere
US4448195A (en) * 1981-05-08 1984-05-15 Leveen Harry H Reinforced balloon catheter
US4623347A (en) * 1981-06-22 1986-11-18 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Antithrombogenic elastomer products
US4528343A (en) * 1981-06-22 1985-07-09 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Antithrombogenic elastomer, molded products of the same, and a process for manufacturing the same
US4482518A (en) * 1981-10-02 1984-11-13 Owens-Illinois, Inc. Methods for reducing post-mold shrinkage of hollow oriented polyethylene terephthalate containers
US4376834A (en) * 1981-10-14 1983-03-15 The Upjohn Company Polyurethane prepared by reaction of an organic polyisocyanate, a chain extender and an isocyanate-reactive material of m.w. 500-20,000 characterized by the use of only 2-25 percent by weight of the latter material
USRE32983E (en) * 1983-07-05 1989-07-11 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4490421A (en) * 1983-07-05 1984-12-25 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4737219A (en) * 1985-02-12 1988-04-12 Becton, Dickinson And Company Method for bonding polyurethane balloons to multilumen catheters
US4786556A (en) * 1986-03-24 1988-11-22 Becton, Dickinson And Company Polymeric articles having enhanced antithrombogenic activity
US4722344A (en) * 1986-05-23 1988-02-02 Critikon, Inc. Radiopaque polyurethanes and catheters formed therefrom
US4886506A (en) * 1986-12-23 1989-12-12 Baxter Travenol Laboratories, Inc. Soft tip catheter
US5358486A (en) * 1987-01-09 1994-10-25 C. R. Bard, Inc. Multiple layer high strength balloon for dilatation catheter
US5250069A (en) * 1987-02-27 1993-10-05 Terumo Kabushiki Kaisha Catheter equipped with expansible member and production method thereof
US5304132A (en) * 1987-05-06 1994-04-19 Jang G David Limacon geometry balloon angioplasty catheter systems and method of making same
US4820349A (en) * 1987-08-21 1989-04-11 C. R. Bard, Inc. Dilatation catheter with collapsible outer diameter
US4848344A (en) * 1987-11-13 1989-07-18 Cook, Inc. Balloon guide
US4963313A (en) * 1987-11-30 1990-10-16 Boston Scientific Corporation Balloon catheter
US4994032A (en) * 1987-12-01 1991-02-19 Terumo Kabushiki Kaisha Balloon catheter
US4917667A (en) * 1988-02-11 1990-04-17 Retroperfusion Systems, Inc. Retroperfusion balloon catheter and method
US4943278A (en) * 1988-02-29 1990-07-24 Scimed Life Systems, Inc. Dilatation balloon catheter
US5387225A (en) * 1988-02-29 1995-02-07 Scimed Life Systems, Inc. Dilatation catheter with transition member
US5169464A (en) * 1988-05-26 1992-12-08 Family Health International Method of making a condom by blow extrusion
US4952357A (en) * 1988-08-08 1990-08-28 Scimed Life Systems, Inc. Method of making a polyimide balloon catheter
US4950239A (en) * 1988-08-09 1990-08-21 Worldwide Medical Plastics Inc. Angioplasty balloons and balloon catheters
US4898591A (en) * 1988-08-09 1990-02-06 Mallinckrodt, Inc. Nylon-PEBA copolymer catheter
US5192296A (en) * 1988-08-31 1993-03-09 Meadox Medicals, Inc. Dilatation catheter
US4950257A (en) * 1988-09-15 1990-08-21 Mallinckrodt, Inc. Catheter introducer with flexible tip
US5108415A (en) * 1988-10-04 1992-04-28 Cordis Corporation Balloons for medical devices and fabrication thereof
US5223205A (en) * 1988-10-04 1993-06-29 Cordis Corporation Method for manufacturing balloons for medical devices
US5156612A (en) * 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
US4938676A (en) * 1988-10-04 1990-07-03 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US5017325A (en) * 1988-10-04 1991-05-21 Cordis Corporation Stretch-blow molding method for manufacturing balloons for medical devices
US4906244A (en) * 1988-10-04 1990-03-06 Cordis Corporation Balloons for medical devices and fabrication thereof
US5236659A (en) * 1988-10-04 1993-08-17 Cordis Corporation Tailoring expansion properties of balloons for medical devices
US5055024A (en) * 1988-10-04 1991-10-08 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US5335675A (en) * 1988-11-15 1994-08-09 Family Health International Stress-softened elastomeric films, articles, and method and apparatus for making such films and articles
US4937134A (en) * 1989-04-17 1990-06-26 The Dow Chemical Company Elastomeric optical interference films
US5318587A (en) * 1989-08-25 1994-06-07 C. R. Bard, Inc. Pleated balloon dilatation catheter and method of use
US5364357A (en) * 1989-09-25 1994-11-15 Schneider (Usa) Inc. Small diameter dilatation catheter having wire reinforced coaxial tubular body
US5318532A (en) * 1989-10-03 1994-06-07 C. R. Bard, Inc. Multilumen catheter with variable cross-section lumens
US5087394A (en) * 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5290306A (en) * 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US5397306A (en) * 1989-12-20 1995-03-14 Terumo Kabushiki Kaisha Catheter
US5108416A (en) * 1990-02-13 1992-04-28 C. R. Bard, Inc. Stent introducer system
US5411477A (en) * 1990-05-11 1995-05-02 Saab; Mark A. High-strength, thin-walled single piece catheters
US5395332A (en) * 1990-08-28 1995-03-07 Scimed Life Systems, Inc. Intravascualr catheter with distal tip guide wire lumen
US5156594A (en) * 1990-08-28 1992-10-20 Scimed Life Systems, Inc. Balloon catheter with distal guide wire lumen
US5195989A (en) * 1990-09-17 1993-03-23 Scimed Life Systems, Inc. Low profile catheter for increasing lumen size of a blood vessel and guide wire therefor
US5265622A (en) * 1990-10-25 1993-11-30 C. R. Bard, Inc. Guidewire having radially expandable member and method for guiding and advancing a catheter using the same
US5306246A (en) * 1990-11-09 1994-04-26 Boston Scientific Corporation Balloon for medical catheter
US5334146A (en) * 1990-11-10 1994-08-02 Terumo Kabushiki Kaisha Catheter balloon having varying wall thickness
US5295978A (en) * 1990-12-28 1994-03-22 Union Carbide Chemicals & Plastics Technology Corporation Biocompatible hydrophilic complexes and process for preparation and use
US5195969A (en) * 1991-04-26 1993-03-23 Boston Scientific Corporation Co-extruded medical balloons and catheter using such balloons
US5195970A (en) * 1991-04-26 1993-03-23 Gahara William J Collapsible balloon catheters
US5330428A (en) * 1991-05-14 1994-07-19 Scimed Life Systems, Inc. Dilatation catheter having a random copolymer balloon
US5216122A (en) * 1991-05-21 1993-06-01 Union Carbide Chemicals & Plastics Technology Corporation Removal of residual ethylene oxide from poly(ethylene oxide)
US5264260A (en) * 1991-06-20 1993-11-23 Saab Mark A Dilatation balloon fabricated from low molecular weight polymers
US5344413A (en) * 1991-06-28 1994-09-06 C. R. Bard, Inc. Catheter having a tip connector for rapid catheter exchanges
US5304340A (en) * 1991-09-06 1994-04-19 C. R. Bard, Inc. Method of increasing the tensile strength of a dilatation balloon
US5328468A (en) * 1991-10-08 1994-07-12 Terumo Kabushiki Kaisha Balloon for blood vessel-dilating catheter
US5217434A (en) * 1991-10-15 1993-06-08 Scimed Life Systems, Inc. Innerless dilatation catheter with balloon stretch valve
US5338295A (en) * 1991-10-15 1994-08-16 Scimed Life Systems, Inc. Dilatation catheter with polyimide-encased stainless steel braid proximal shaft
US5344401A (en) * 1991-12-20 1994-09-06 Interventional Technologies Inc. Catheter balloon formed from a polymeric composite
US5304134A (en) * 1992-01-17 1994-04-19 Danforth Biomedical, Inc. Lubricious yet bondable catheter channel sleeve for over-the-wire catheters
US5387199A (en) * 1992-02-24 1995-02-07 Baxter International Inc. Polymer blends for torque transmitting catheters
US5295959A (en) * 1992-03-13 1994-03-22 Medtronic, Inc. Autoperfusion dilatation catheter having a bonded channel
US5254089A (en) * 1992-04-02 1993-10-19 Boston Scientific Corp. Medication dispensing balloon catheter
US5344400A (en) * 1992-04-06 1994-09-06 Terumo Kabushiki Kaisha Balloon catheters containing molded polyarylenesulfide material
US5368566A (en) * 1992-04-29 1994-11-29 Cardiovascular Dynamics, Inc. Delivery and temporary stent catheter having a reinforced perfusion lumen
US5334160A (en) * 1992-05-04 1994-08-02 Scimed Life Systems, Inc. Intravascular catheter with sleeve and method for use thereof
US5447497A (en) * 1992-08-06 1995-09-05 Scimed Life Systems, Inc Balloon catheter having nonlinear compliance curve and method of using
US5525388A (en) * 1992-08-07 1996-06-11 Advanced Cardiovascular Systems, Inc. Dilatation balloon with constant wall thickness
US5342305A (en) * 1992-08-13 1994-08-30 Cordis Corporation Variable distention angioplasty balloon assembly
US5342301A (en) * 1992-08-13 1994-08-30 Advanced Polymers Incorporated Multi-lumen balloons and catheters made therewith
US5304135A (en) * 1992-08-13 1994-04-19 Cordis Corporation Axial multi-chamber angioplasty balloon assembly
US5257974A (en) * 1992-08-19 1993-11-02 Scimed Life Systems, Inc. Performance enhancement adaptor for intravascular balloon catheter
US5338300A (en) * 1992-08-19 1994-08-16 Scimed Life Systems, Inc. Performance enhancement adaptor for intravascular balloon catheter
US5281677A (en) * 1992-09-03 1994-01-25 Becton, Dickinson And Company Thermoplastic polyurethane blends
US5500181A (en) * 1992-09-29 1996-03-19 Scimed Life Systems, Inc. Shrinking balloon catheter having nonlinear compliance curve
US5403340A (en) * 1992-09-29 1995-04-04 Scimed Lifesystems Inc. Shrinking balloon catheter having nonlinear compliance curve
US5348538A (en) * 1992-09-29 1994-09-20 Scimed Life Systems, Inc. Shrinking balloon catheter having nonlinear or hybrid compliance curve
US6620381B2 (en) * 1992-09-30 2003-09-16 Medtronic Ave, Inc. Sterilization process for a distensible dilatation balloon with elastic stress response
US6210364B1 (en) * 1992-09-30 2001-04-03 C. R. Bard, Inc. Distensible dilatation balloon with elastic stress response
US6283939B1 (en) * 1992-09-30 2001-09-04 Medtronic Ave, Inc. Distensible dilatation balloon with elastic stress
US5300048A (en) * 1993-05-12 1994-04-05 Sabin Corporation Flexible, highly radiopaque plastic material catheter
US5556383A (en) * 1994-03-02 1996-09-17 Scimed Lifesystems, Inc. Block copolymer elastomer catheter balloons

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7981123B2 (en) 1997-09-12 2011-07-19 Evalve, Inc. Surgical device for connecting soft tissue
US9510837B2 (en) 1997-09-12 2016-12-06 Evalve, Inc. Surgical device for connecting soft tissue
US8740918B2 (en) 1997-09-12 2014-06-03 Evalve, Inc. Surgical device for connecting soft tissue
US8734505B2 (en) 1999-04-09 2014-05-27 Evalve, Inc. Methods and apparatus for cardiac valve repair
US9510829B2 (en) 1999-04-09 2016-12-06 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7811296B2 (en) 1999-04-09 2010-10-12 Evalve, Inc. Fixation devices for variation in engagement of tissue
US7998151B2 (en) 1999-04-09 2011-08-16 Evalve, Inc. Leaflet suturing
US8029518B2 (en) 1999-04-09 2011-10-04 Evalve, Inc. Methods and devices for capturing and fixing leaflets in valve repair
US9044246B2 (en) 1999-04-09 2015-06-02 Abbott Vascular Inc. Methods and devices for capturing and fixing leaflets in valve repair
US7753923B2 (en) 1999-04-09 2010-07-13 Evalve, Inc. Leaflet suturing
US8057493B2 (en) 1999-04-09 2011-11-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US8123703B2 (en) 1999-04-09 2012-02-28 Evalve, Inc. Steerable access sheath and methods of use
US7736388B2 (en) 1999-04-09 2010-06-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US8216256B2 (en) 1999-04-09 2012-07-10 Evalve, Inc. Detachment mechanism for implantable fixation devices
US8343174B2 (en) 1999-04-09 2013-01-01 Evalve, Inc. Locking mechanisms for fixation devices and methods of engaging tissue
US8409273B2 (en) 1999-04-09 2013-04-02 Abbott Vascular Inc Multi-catheter steerable guiding system and methods of use
US8500761B2 (en) 1999-04-09 2013-08-06 Abbott Vascular Fixation devices, systems and methods for engaging tissue
US8187299B2 (en) 1999-04-09 2012-05-29 Evalve, Inc. Methods and apparatus for cardiac valve repair
US8740920B2 (en) 1999-04-09 2014-06-03 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7981139B2 (en) 2002-03-01 2011-07-19 Evalve, Inc Suture anchors and methods of use
US8052592B2 (en) 2005-09-27 2011-11-08 Evalve, Inc. Methods and devices for tissue grasping and assessment
US8926620B2 (en) 2006-08-25 2015-01-06 Kyphon Sarl Apparatus and methods for use of expandable members in surgical applications
US8043296B2 (en) 2006-08-25 2011-10-25 Kyphon Sarl Apparatus and methods for use of expandable members in surgical applications
US20080051819A1 (en) * 2006-08-25 2008-02-28 Nishith Chasmawala Apparatus and methods for use of expandable members in surgical applications

Also Published As

Publication number Publication date Type
EP1683539A2 (en) 2006-07-26 application
DE69334289D1 (en) 2009-08-13 grant
EP1683539B1 (en) 2010-01-27 grant
EP1683539A3 (en) 2008-11-05 application
US6283939B1 (en) 2001-09-04 grant
US6210364B1 (en) 2001-04-03 grant
US5500180A (en) 1996-03-19 grant
CA2107378A1 (en) 1994-03-31 application
US20020053349A1 (en) 2002-05-09 application
EP0592885B1 (en) 2009-07-01 grant
DE69334318D1 (en) 2010-03-18 grant
EP0592885A2 (en) 1994-04-20 application
US6620381B2 (en) 2003-09-16 grant
JPH06304920A (en) 1994-11-01 application
EP0592885A3 (en) 1995-09-06 application

Similar Documents

Publication Publication Date Title
US6120523A (en) Focalized intraluminal balloons
US6561788B1 (en) Modular mold designs
US5843116A (en) Focalized intraluminal balloons
US5447497A (en) Balloon catheter having nonlinear compliance curve and method of using
US6293959B1 (en) Balloon catheter and stent delivery system having enhanced stent retention and method
US6290485B1 (en) Mold for forming a balloon catheter having stepped compliance curve
US5439443A (en) Balloon catheter
US6890395B2 (en) Medical device formed of ultrahigh molecular weight polyolefin
US6613066B1 (en) Balloon catheter and production method therefor
US5620649A (en) Puncture resistant balloon catheter
US20070265565A1 (en) Mesh-Reinforced Catheter Balloons and Methods for Making the Same
US20090146348A1 (en) Method of fabrication a stent from blow molded tubing
US6270522B1 (en) High pressure catheter balloon
US6287314B1 (en) Stent deploying catheter system
US5797877A (en) Medical device balloons containing thermoplastic elastomers
US5645789A (en) Distensible pet balloon and method of manufacture
US5643279A (en) Method of catheter balloon manufacture and use
US20070142772A1 (en) Dual-Layer Medical Balloon
US5755690A (en) Multiple layer high strength balloon for dilatation catheter
US6896842B1 (en) Medical device balloons containing thermoplastic elastomers
US6027486A (en) Interactive angioplasty
US5328468A (en) Balloon for blood vessel-dilating catheter
US7828766B2 (en) Non-compliant multilayered balloon for a catheter
US6027517A (en) Fixed focal balloon for interactive angioplasty and stent implantation catheter with focalized balloon
US5833657A (en) Single-walled balloon catheter with non-linear compliance characteristic