CA2107690C - Co-extruded medical balloons and catheter using such balloons - Google Patents
Co-extruded medical balloons and catheter using such balloonsInfo
- Publication number
- CA2107690C CA2107690C CA002107690A CA2107690A CA2107690C CA 2107690 C CA2107690 C CA 2107690C CA 002107690 A CA002107690 A CA 002107690A CA 2107690 A CA2107690 A CA 2107690A CA 2107690 C CA2107690 C CA 2107690C
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- catheter
- layers
- layer
- structural layer
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1034—Joining of shaft and balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
- A61B2017/00783—Valvuloplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1038—Wrapping or folding devices for use with balloon catheters
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
- Y10T428/1393—Multilayer [continuous layer]
Abstract
A medical balloon and a catheter utilizing the balloon (8) and a mechanism to attach the balloon (8) to the catheter tube, and method of making the balloon. The attachment mechanism forms a joint (10, 11) and comprises a plurality of co-extruded and coextensive layers of different polymeric materials (8A, 8B, 20A, 20B) at least one of which is a base structural layer (8B, 20B) and the other of which (8A, 20A) is formed of polyethylene and copolymers thereof or of Selar. The base structural layer is thicker than the other layer. The attachment mechanism can be the balloon itself or it can be a sleeve (20A, 20B), either of which is heat sealed to the catheter tube (3). In either case, the diameter of the catheter at the joint (10, 11) is substantially the same as the tube.
Description
2 1 ~ 7 6 9 0 PCr/US92/03351 CO--EXTRUDED MEDICAL BALLOONS
AND
CATHETER USING SUCH BALLOONS
Background of the Invention The present invention relates to balloons for medical devices and medical devices utilizing such balloons. More particularly, the present invention relates to medical or surgical balloons and catheters using such balloons, par-ticularly those designed for angioplasty, valvuloplasty and urological uses and the like. The balloons of the present invention can be tailored to have expansion pro-perties which are desired for a particular use and can be inflated to a predetormin~d diameter and still be resis-tant to the formation of pin holes and leakage.
Description of the Prior Art In the past, polyethylene, polyethylene terapthalate and polyamide balloons have been used with medical cathet-ers. Polyethylene balloons are particularly advantageous because they can be heat bonded to a like-material sub-strate and have a relatively low tip diameter, that is the profile of the tip at the connecting joint between the balloon and the catheter can be fairly small. Also, the polyethylene balloons are soft so that they can pass through blood vessels without trauma. Moreover, polyethy-lene balloons are resistant to the propagation of pin holes, primarily because the walls are thick. But since they are thicl~, they are large and pass by tight lesions only with great difficulty.
Balloons of polyethylene terapthalate provide low 35 deflated profiles and can have thin walls because such materials have high tensile strengths and adequate burst strength. On the other hand, polyethylene terapthalate balloons require adhesives to bond them to the catheters and adhesive bonding frequently is not dependable and it .
_ _ _ _ _ _ _ _ . _ .. . ...... . ..... .. _ . .... . _ .... . . _ _ _ . _ _ WO92/19316 ~ O7i~9`G -2- PCI`/US92/033~1 thickens the catheter at the point of the bond. IIJL~OV
polyethylene terapthalate can have poor pin hole resis-tance largely due to the very thin walls.
Summary of the Invention According to the present invention, it has been discov-ered that the drawbacks of the polyethylene and the poly-ethylene terapthalate h;~ 1 1 onnc o~ the prior art can be remedied through the use of laminated balloon CUII:~LUC
lO tions which compri6e a tubular body formed o~ a plurality of co ~.LLLuded and coextensive layers of different poly-meric materials.
According to one aspect of the invention, the multi-layered balloon, ' in~c the advantages of both materials 15 in a balloon, but does not have the disadvantages of either. The balloon includes a layer of a relatively thick, biaxially oriented ethylenic polymeric material such as polyesters, polycarbonates, polyethylene teraptha-late and their copolymers, or polyamides such as Nylon.
20 These materials constitute a base structural layer (or layers) and give the balloon its tensile strength and pro-vide rOr "wear" resistance. The base structural layer may have a thickness between about 0 . 2 and l . 0 mil . or higher.
A second layer is co-extruded with the base structural 25 layer and is coextensive therewith. The second layer pre-ferably is a polyolefin such as polyethylene and copolym-ers thereof and can be heat-bonded to a catheter, that is adhesives need not be used. The heat bondable second layer can be disposed on one and preferably both sides of 30 the base structural layer.
In accordance with another aspect of the present inven-tion, the base z-~Luu~uL~ll layer again is a material that does not itself readily thermally bond to a polyethylene catheter tubing. In those cases, sleeves of mutually 35 bondable materials are slipped over the j oints between the catheter and the balloon and the sleeves are heated to join the balloon to the sleeve and simultaneously join the sleeve to the catheter whereby to act as a f luid-tight seal between the catheter and the balloon.
WO92~19316 2 1~ 7 6 ~ O PCI/US92/033~1 With regard to multilayered balloons, the 6econd layer (or layers) which is dispo5ed on the base structural layer and co-extruded therewith can also serve as a barrier bet-ween the base structural layer and the environment. For 5 example, when a polyamide such as Nylon is used as the base ~LLu~:LuLal layer, a thin layer of maleic anhydride-modified ethylenic polymers such as Plexar can also be co-extruded with it. When layers are tl i ~pos~d on both sides of the base structural layer they keep moisture from effecting the Nylon ' s properties. Additional layers some-times may also be co-t:xLLuded to bind and tie dissimilar layers together in the co-extrusion operation. When Nylon is used, for example, no tying layers are n.ocP~fiAry bet-ween it and the heat bondable layer. In other cases, however, as when polyester or polycarbonate polymers are used as the base ~LLU~:LULa1 layer, adhesion ~nhA- L
may be necessary. Such adhesive Pnh~-- L may take the form of ultraviolet light irradiation of the product or the incorporation of a co _.SLL ~Ided tying adhesive layer .
With regard to the use of a multilayered sleeve to join the balloon to the catheter, any conventional medical bal-loon material can be used that does not bond to the catheter without adhesives. The multilayered sleeve can be f ormed of a base layer of the same material as the bal-loon with a polyethylene layer ~ osPd on at least the inner side of the sleeve. The polyethylene will adhere to both the catheter and the balloon and form a joint with heat treatment alone.
According to the present invention, the balloons have advantages of both the polyethylene and the materials of the base structural layer. When polyethylene terapthalate is the base, very thin walls can be u6ed with high burst :~LLe~lyL~l. For example, when a typical 3.0 mm. diameter maleic anhydride-modif ied ethylenic polymer is coated on a Nylon base ~;LLU~;LULa1 layer, the resulting balloon can have a wall thickness of 0.5 mil. and a low deflated pro-file which is comparable with polyethylene terapthalate balloons and is much lower than polyethylene balloons.
Nhen using Nylon, the material that is used is biaxially orientable and has higher tensile strength than polyethy-lene material, thereby resulting in a much thinner wall f or comparative burst strength .
It has been found that pin hole resistance of the con-struction of the present invention is comparable to poly-ethylene and substantially superior to polyethylene terap-thalate. A balloon co-extruded with Selar has superior abrasion resistance and pin hole resistance then polyethy-lene terapthalate balloons. Polyamide material is super-ior to polyethylene terapthalate and polyethylene mater-ials in pin hole resistance. The balloon itself is soft for non-traumatic passage through blood vessels and is comparable to polyethylene because polyamide is not as stiff as polyethylene terapthalate.
In a specific embodiment of a multilayered extruded balloon, it has been found that the use of the above men-tioned Selar PT resin, a trademarked compound (preferably available as Selar PT 4368 from E. I. Dupont de Nemaurs Co.
of Wilmington, Delaware) as a layer disposed on the base structural layer (or blended with polyethylene teraptha-late) will make the balloon more resistant to abrasion and provide it with a softer feel. Selar co-extrusion in mul-ti-layered balloons rlimin;F:h~: pin hole formation and will minimize failure when working with calcified lesions.
Moreover, the Selar may be used as the inner layer of the balloon for use with procedures which include internal electrodes or radiopaque markers which could puncture it.
's--AI' - 4a - 21 07690 According to a broad aspect of the invention there is provided a catheter for medical purposes and which comprises a tubular member having a distal end and at least one lumen disposed therethrough. A balloon 5 having at least one open end is also provided. The open end of the balloon is sealed at a joint to the distal end.
The interior of the balloon is in communication with the lumen. The balloon has an elongated tubular body and comprises a plurality of co-extruded layers of different 10 polymeric materials. One of the layers is a base structural layer and another of the layers is disposed radially outside the base structural layer.
According to a further broad aspect of the present invention, the co-extruded layers of the different 15 polymeric materials, neither of which is heat sealable to the tubular member. A sleeve is also provided for connecting the medical balloon to the catheter. The sleeve is disposed over the joint and comprises an elongated tubular body having a predet~rmi ned diameter and 20 capable of adhering to both the medical balloon and the catheter. The sleeve comprises a plurality of co-extruded and coextensive layers of different polymeric materials, at least one of the layers being a polymeric layer and another of the layers being selected f rom the group 25 consisting of polyethylene and copolymers thereof.
According to a further board aspect of the present invention, there is provided a medical balloon for attachment to a catheter shaft. The balloon has ends spaced f rom each other by a central body portion with at 3 o least one of the ends being attachable to the shaf t . The central body portion is inflatable from one diameter to a larger diameter. The balloon comprises a plurality of co-extruded and coextensive layers of polymeric materials The layers are bonded to each other. One of the layers ls - 4b - 2 1 07690 a base structural layer. Another of the layers is an abrasion resistant layer having an abrasion resistance greater than that of the base structural layer.
According to a still f urther broad aspect of the 5 present invention, the layers that are bonded to each other are comprised of at least one layer being a base structural layer and another of the layers being comprised of Selar.
Brief Description o~ the Drawings Figure 1 is a side elevational view of a catheter with a multi-layered balloon. The balloon is shown in the distended condition;
Figure 2 is a view of the same catheter in the folded condition;
Figure 3 is a cross-sectional view of the balloon of the present invention taken along line 3-3 of Figure 1 showing the polymeric layers in the balloon.
WO 92/19316 2 ~ 9 Q PCI~US92/03351 Figure 4 is a cross-sectional view taken along the line 4-4 of Figure 2 showing the balloon in its folded condi-tion .
Figure 5 is a cross seCtional view of a distended bal-5 loon disposed at the end of a catheter and joined to the catheter by a sleeve.
Description of the Preferred F~ho~1ir-nts An illustrative catheter 1 is shown in Figures 1 and 2.
Catheter 1 includes a catheter tube 3 having a proximal end 5, a distal end 6 and a tip 7. A distended co-extruded medical balloon 8 of the present invention is shown in Figure 1 secured to the outside of the distal end 6 and the tip 7, the co-extrusion being critical to the present invention. The interior of the balloon 8 is in communication with at least one lumen (not shown in this Figure) of the catheter tube 3. To form the tip 7 tand the portion of the catheter between the distal end 6 and the tip 7 to support the balloon 8) a portion of the catheter tube 3 is cut away so that only the lumen that houses an internal guide wire 14 remains (as shown in dotted lines within the balloon 8).
Extending through the interior of the tube 3 are a plu-rality of lumens (shown in Figures 3 and 4) which can serve a variety of functions, for example, housing the guide wire 14, inserting materials into the blood stream or inflating or deflating the balloon. Except for the balloon 8, all of the various components perform functions which are generally appreciated and known in the art.
To use, the catheter 1 (as shown in Figure 2) is inserted into the cardiovascular system until the co-extruded balloon 8 is located at the site of an occlusion.
At this stage, the balloon 8 is typically folded and col-lapsed and has an external diameter less than the inf lated - 35 diameter, as can be seen by a comparison of Figures 1 and 2. once the balloon 8 is maneuvered to the location of the occlusion, a ~L~s:~uLizing fluid is inserted at the proximal end 5 of the catheter tube 3 for inflation of the balloon 8. The fluid unfolds the balloon 8 until it pre-_ _ _ _ _, _ . . . _ WO 92/19316 2 ~ 6 ~10 -6- PCI`/US92/03351~
sents a relatively smooth "Yr~nll~rl profile for imparting forces that are radially outwardly directed at the desired site within the body in order to achieve the desired result of lesion dilation, re6triction reduction or simi-lar treatment.
Inserting the catheter l in an artery re~uires that the tube 3 be of a semi-flexible material. Tube 3 preferably is ~--9d of a polyolefin copolymer, for example a con-ventional high density polyethylene. The diameter of the tubing is between about 12 and 16 French and may be coated on the inside and outside surfaces with, for example, a silicone based material to promote slippage in an aqueous environment .
As seen in Figures 3 and 4, the co-extruded balloon 8 results in a laminated construction. The laminates of the construction include a main structural layer 8B which is generally between about 0.2 and 2.5 mil. or thicker, and formed of one or more biaxially oriented polymers such as polyamides, polyesters, polycarbonates and their copolym-ers. Co-extruded with and bonded to the ~LU~_LULal layer 8B is an inner layer 8C of heat bondable polyolef in such as Plexar. Plexar is an anhydride-modified polyethylene and a trademarked product sold by Quantum Chemical Corpo-ration of ~'in~inn~ti, Ohio. The heat bondable layer 8C is attached directly to the distal end 6 of catheter tube 3 and is secured to the balloon 8 by a heat seal joint ll.
A similar joint ll is formed between the balloon 8 and the catheter tip 7.
The heat bondable layer 8C is co-extruded with the ~L, U~ULCLl layer 8B and has a thickness of between about 0.5 and l.O mil. Preferably, two heat bondable layers are co-extruded with the structural layer 8B. The inner layer 8B serves as a r~ ni r`n to provide a heat seal joint lO
between the distal end 6 of the catheter tube 3 and the DLLU~ LULCIl layer 8B of the balloon 8. When two layers are co _~L~uded with the structural layer 8B, the inner layer 8C forms the heat bondable layer and the outer layer 8A
forms a protective sheath for the main structural layer 8B. When polyamides such as Nylon are used as the struc-WO 92/19316 ~ 1 ~1 7 ~ ~ ~ Pcr/us92/0335l tural layer 8B, Plexar can be used as the heat bonding layer 8C. The outer layer 8A can be formed of the same material and provide for softness for non-traumatic pas-~ing through vessels and good pin hole resistance.
An alternative to the construction shown in Figure l, another construction is to dispose a balloon f ormed of a base structural layer 8B of polyethylene terapthalate and an outer layer 8A of polyethylene around the distal end 6 of the catheter tube 3 and then place a sleeve 20 formed of heat bonding layer 2 OC of high density polyethylene on a base layer 20B of Nylon over the end of the balloon 8 whereby the polyethylene of the balloon seals to the poly-ethylene of the sleeve and the Nylon seals to the catheter 3. In cases where additional strength is needed, an inn~ ~ ~ layer can be formed of high density polyethylene and an outermost layer is formed of Nylon with Plexar sandwiched therebetween.
It has been found that where strength, abrasion resis-tance and/or "feel" are important in medical balloons, that a co-extrusion which includes Selar resin can be used to provide for these characteristics. The Selar can be used by itself as the inner and/or outer layer or it can be blended with polyethylene terapthalate. Tests of a l. 6 mil. thick balloon with a Selar outer layer (a 50/50 blend of Selar and polyethylene terapthalate) were conducted by rubbing a balloon inflated to 6 atm. and rubbing it back and forth over medium grade emery cloth until failure.
The balloons with Selar or 50/50 blend layers ~ e~le-l 200 cycles while a l. 8 mil . thick polyethylene terapthalate balloon failed in 87 cycles. Selar is a toughened grade of polyethylene terapthalate and it can be cu ._~LL uded with the base structural layers herein disclosed according to known techniques.
Referring to Figures 3 and 4, the interior of the co-extruded balloon 8 is shown in cross section. In Figure 3, the balloon is shown in its distended or inflated con-dition whereas in Figure 4 the balloon is shown in its deflated or folded condition. The balloon 8 can typically have an outer diameter that can be on the order of roughly WO 92/19316 2 i ~ ~ 6 9 ~ -8- PCI`/US92/03351 1--three to six and even more times the outer diameter of the catheter tube 3. Pressurized fluids used to inflate the balloon include those conventionally used in the art, such as the well known aqueous solutions if they do not pose a problem of leaving residual fluids or chemically reacting with the balloon . Such f luids are introduced into the balloon 8 and removed therefrom through a lumen Ll which is in f luid f low relationship with the interior thereof .
Venting of gasses initially trapped in the catheter and the balloon prior to introduction of the in~lation f luids is accomplished by expelling them through a second lumen L2 also formed in the interior of the catheter tube 3.
Preferably, lumen Ll and L2 are cut off at joint lO so as to leave only a third lumen L3.
The third lumen L3 houses a guide wire 14 that passes through the balloon 8 and the tip 7. The third lumen L3 i5 different then the other two lumens, Ll and L2, in that it extends entirely through the balloon 8 from the distal end 6 to the tip 7 so as to sheath the guide wire. In some ~mhr~;r Ls, it may be desirable to combine the func-tions of lumen6, Ll and L2, to only have a single lumen for inflating or deflating the balloon. Lastly, the lumen defined by L3 provides for a housing for a guide wire 14 which is removably housed in it. Guide wire 14 passes through the entire length of the catheter 3 and through the balloon 8 (while preferably sheathed in lumen L3) and thence into an axial bore (not shown) in tip 7 to emerge from the end of tip 7 (as shown in Figures 2 and 3).
Each of the lumens Ll, L2 and L3 is formed by walls 15 and 16 that are extruded as the catheter tube is extruded from an extrusion machine, as is well known in the art.
The thickness of the walls 15 and 16 can be between 0 . 5 and lO mil., as is well known.
As shown in Figure 4, the diameter of the f olded bal -loon 8 is substantially the same or less than the diameter of the catheter tube 3 so as to provide for easy passage of the catheter through blood vessels. The extruded tub-ing 3 has a nominal wall thickness that generally is on ~he order of six to twelve times the desired wall thick--WO 92119316 ~ 2 1 ~ 7 ~;g ~ PCr/US92/03351 _g_ ness of the balloon 8.
To form the co-extruded balloons, the materials initially are melted separately in extrusion r^^h i nPc .
When melted, the materials are separately forced into an extrusion head and extruded so that they are forced out as - a plurality of layers in the form of a single tube which - critically forms the balloon of the present invention. A
Nylon-Plexar or polyethylene-polyethylene terapthalate balloon may be formed by taking a six inch length of the three layered tubing which is to be manuf actured into a balloon and placing it in a holding f ixture. The left hand end of the tube is attached to a Touhy Borst adapter.
The right hand end of the tube is heat sealed to tempora-rily prevent pressurized air from escaping. The right hand end is attached to a tension line which is pulled for the force of a least 150 grams (for a 3 . 0 mm. diameter balloon). The tubing is heated under a pressure of bet-ween about 100 and 400 psi to about 210F for several sec-onds. Afterwards, the heated area is cooled and the sup-port frame is spread apart slightly so as to expose a pre-det~rm; nr~d section of tubing to permit the balloon area to be reheated to a temperature between about 210 and 220F
to permit the balloon to be PYr;~n~ to a desired diameter under pressure for about 35 seconds. The pressure is then stopped and the deflectors are slid to the ends of the balloon and the balloon is heated for a third time to about 310F to heat set the balloon and hj~iAlly orient the polymeric matrix. This third heating prevents the balloon layers from flaking and prevents the balloon from ~YrAn-lin~ beyond the size at which it will set during the heat setting period. The heat setting takes about 8 sec-onds .
For a Nylon-Plexar balloon, the deflectors from the tubes are then removed and another unheated tube is - 35 mounted into the fixture. The catheter tube is slid inside the balloon so that it engages the heat bondable polyethylene layer. The balloon is bonded to the poly-ethylene shaft by heat bonding in a temperature of about 310F which is long enough to the melt the polyethylene WO 92/19316 2 1 ~ 7 6 9 ~ -lo- PCr/US92/033sl ~
end and the inner layer of the polyethylene together.
It is quite important to recognize that the heat treat-ment steps as described herein essentially prevent the de~min:3tion of the heat bondable layers 8C and 8A from the main structural layer 8B as is required when a lami-nated construction is used as a catheter. Flaking and ~Pl ;~m; nAtion is not a problem, however, with polyethylene terapthalate and Selar layers.
While it is apparent that modif ications and changes may be made within the spirit and scope of the present inven-tion, it is intended, however, only to be limited by the scope of the ~rpPnrl~ claims.
AND
CATHETER USING SUCH BALLOONS
Background of the Invention The present invention relates to balloons for medical devices and medical devices utilizing such balloons. More particularly, the present invention relates to medical or surgical balloons and catheters using such balloons, par-ticularly those designed for angioplasty, valvuloplasty and urological uses and the like. The balloons of the present invention can be tailored to have expansion pro-perties which are desired for a particular use and can be inflated to a predetormin~d diameter and still be resis-tant to the formation of pin holes and leakage.
Description of the Prior Art In the past, polyethylene, polyethylene terapthalate and polyamide balloons have been used with medical cathet-ers. Polyethylene balloons are particularly advantageous because they can be heat bonded to a like-material sub-strate and have a relatively low tip diameter, that is the profile of the tip at the connecting joint between the balloon and the catheter can be fairly small. Also, the polyethylene balloons are soft so that they can pass through blood vessels without trauma. Moreover, polyethy-lene balloons are resistant to the propagation of pin holes, primarily because the walls are thick. But since they are thicl~, they are large and pass by tight lesions only with great difficulty.
Balloons of polyethylene terapthalate provide low 35 deflated profiles and can have thin walls because such materials have high tensile strengths and adequate burst strength. On the other hand, polyethylene terapthalate balloons require adhesives to bond them to the catheters and adhesive bonding frequently is not dependable and it .
_ _ _ _ _ _ _ _ . _ .. . ...... . ..... .. _ . .... . _ .... . . _ _ _ . _ _ WO92/19316 ~ O7i~9`G -2- PCI`/US92/033~1 thickens the catheter at the point of the bond. IIJL~OV
polyethylene terapthalate can have poor pin hole resis-tance largely due to the very thin walls.
Summary of the Invention According to the present invention, it has been discov-ered that the drawbacks of the polyethylene and the poly-ethylene terapthalate h;~ 1 1 onnc o~ the prior art can be remedied through the use of laminated balloon CUII:~LUC
lO tions which compri6e a tubular body formed o~ a plurality of co ~.LLLuded and coextensive layers of different poly-meric materials.
According to one aspect of the invention, the multi-layered balloon, ' in~c the advantages of both materials 15 in a balloon, but does not have the disadvantages of either. The balloon includes a layer of a relatively thick, biaxially oriented ethylenic polymeric material such as polyesters, polycarbonates, polyethylene teraptha-late and their copolymers, or polyamides such as Nylon.
20 These materials constitute a base structural layer (or layers) and give the balloon its tensile strength and pro-vide rOr "wear" resistance. The base structural layer may have a thickness between about 0 . 2 and l . 0 mil . or higher.
A second layer is co-extruded with the base structural 25 layer and is coextensive therewith. The second layer pre-ferably is a polyolefin such as polyethylene and copolym-ers thereof and can be heat-bonded to a catheter, that is adhesives need not be used. The heat bondable second layer can be disposed on one and preferably both sides of 30 the base structural layer.
In accordance with another aspect of the present inven-tion, the base z-~Luu~uL~ll layer again is a material that does not itself readily thermally bond to a polyethylene catheter tubing. In those cases, sleeves of mutually 35 bondable materials are slipped over the j oints between the catheter and the balloon and the sleeves are heated to join the balloon to the sleeve and simultaneously join the sleeve to the catheter whereby to act as a f luid-tight seal between the catheter and the balloon.
WO92~19316 2 1~ 7 6 ~ O PCI/US92/033~1 With regard to multilayered balloons, the 6econd layer (or layers) which is dispo5ed on the base structural layer and co-extruded therewith can also serve as a barrier bet-ween the base structural layer and the environment. For 5 example, when a polyamide such as Nylon is used as the base ~LLu~:LuLal layer, a thin layer of maleic anhydride-modified ethylenic polymers such as Plexar can also be co-extruded with it. When layers are tl i ~pos~d on both sides of the base structural layer they keep moisture from effecting the Nylon ' s properties. Additional layers some-times may also be co-t:xLLuded to bind and tie dissimilar layers together in the co-extrusion operation. When Nylon is used, for example, no tying layers are n.ocP~fiAry bet-ween it and the heat bondable layer. In other cases, however, as when polyester or polycarbonate polymers are used as the base ~LLU~:LULa1 layer, adhesion ~nhA- L
may be necessary. Such adhesive Pnh~-- L may take the form of ultraviolet light irradiation of the product or the incorporation of a co _.SLL ~Ided tying adhesive layer .
With regard to the use of a multilayered sleeve to join the balloon to the catheter, any conventional medical bal-loon material can be used that does not bond to the catheter without adhesives. The multilayered sleeve can be f ormed of a base layer of the same material as the bal-loon with a polyethylene layer ~ osPd on at least the inner side of the sleeve. The polyethylene will adhere to both the catheter and the balloon and form a joint with heat treatment alone.
According to the present invention, the balloons have advantages of both the polyethylene and the materials of the base structural layer. When polyethylene terapthalate is the base, very thin walls can be u6ed with high burst :~LLe~lyL~l. For example, when a typical 3.0 mm. diameter maleic anhydride-modif ied ethylenic polymer is coated on a Nylon base ~;LLU~;LULa1 layer, the resulting balloon can have a wall thickness of 0.5 mil. and a low deflated pro-file which is comparable with polyethylene terapthalate balloons and is much lower than polyethylene balloons.
Nhen using Nylon, the material that is used is biaxially orientable and has higher tensile strength than polyethy-lene material, thereby resulting in a much thinner wall f or comparative burst strength .
It has been found that pin hole resistance of the con-struction of the present invention is comparable to poly-ethylene and substantially superior to polyethylene terap-thalate. A balloon co-extruded with Selar has superior abrasion resistance and pin hole resistance then polyethy-lene terapthalate balloons. Polyamide material is super-ior to polyethylene terapthalate and polyethylene mater-ials in pin hole resistance. The balloon itself is soft for non-traumatic passage through blood vessels and is comparable to polyethylene because polyamide is not as stiff as polyethylene terapthalate.
In a specific embodiment of a multilayered extruded balloon, it has been found that the use of the above men-tioned Selar PT resin, a trademarked compound (preferably available as Selar PT 4368 from E. I. Dupont de Nemaurs Co.
of Wilmington, Delaware) as a layer disposed on the base structural layer (or blended with polyethylene teraptha-late) will make the balloon more resistant to abrasion and provide it with a softer feel. Selar co-extrusion in mul-ti-layered balloons rlimin;F:h~: pin hole formation and will minimize failure when working with calcified lesions.
Moreover, the Selar may be used as the inner layer of the balloon for use with procedures which include internal electrodes or radiopaque markers which could puncture it.
's--AI' - 4a - 21 07690 According to a broad aspect of the invention there is provided a catheter for medical purposes and which comprises a tubular member having a distal end and at least one lumen disposed therethrough. A balloon 5 having at least one open end is also provided. The open end of the balloon is sealed at a joint to the distal end.
The interior of the balloon is in communication with the lumen. The balloon has an elongated tubular body and comprises a plurality of co-extruded layers of different 10 polymeric materials. One of the layers is a base structural layer and another of the layers is disposed radially outside the base structural layer.
According to a further broad aspect of the present invention, the co-extruded layers of the different 15 polymeric materials, neither of which is heat sealable to the tubular member. A sleeve is also provided for connecting the medical balloon to the catheter. The sleeve is disposed over the joint and comprises an elongated tubular body having a predet~rmi ned diameter and 20 capable of adhering to both the medical balloon and the catheter. The sleeve comprises a plurality of co-extruded and coextensive layers of different polymeric materials, at least one of the layers being a polymeric layer and another of the layers being selected f rom the group 25 consisting of polyethylene and copolymers thereof.
According to a further board aspect of the present invention, there is provided a medical balloon for attachment to a catheter shaft. The balloon has ends spaced f rom each other by a central body portion with at 3 o least one of the ends being attachable to the shaf t . The central body portion is inflatable from one diameter to a larger diameter. The balloon comprises a plurality of co-extruded and coextensive layers of polymeric materials The layers are bonded to each other. One of the layers ls - 4b - 2 1 07690 a base structural layer. Another of the layers is an abrasion resistant layer having an abrasion resistance greater than that of the base structural layer.
According to a still f urther broad aspect of the 5 present invention, the layers that are bonded to each other are comprised of at least one layer being a base structural layer and another of the layers being comprised of Selar.
Brief Description o~ the Drawings Figure 1 is a side elevational view of a catheter with a multi-layered balloon. The balloon is shown in the distended condition;
Figure 2 is a view of the same catheter in the folded condition;
Figure 3 is a cross-sectional view of the balloon of the present invention taken along line 3-3 of Figure 1 showing the polymeric layers in the balloon.
WO 92/19316 2 ~ 9 Q PCI~US92/03351 Figure 4 is a cross-sectional view taken along the line 4-4 of Figure 2 showing the balloon in its folded condi-tion .
Figure 5 is a cross seCtional view of a distended bal-5 loon disposed at the end of a catheter and joined to the catheter by a sleeve.
Description of the Preferred F~ho~1ir-nts An illustrative catheter 1 is shown in Figures 1 and 2.
Catheter 1 includes a catheter tube 3 having a proximal end 5, a distal end 6 and a tip 7. A distended co-extruded medical balloon 8 of the present invention is shown in Figure 1 secured to the outside of the distal end 6 and the tip 7, the co-extrusion being critical to the present invention. The interior of the balloon 8 is in communication with at least one lumen (not shown in this Figure) of the catheter tube 3. To form the tip 7 tand the portion of the catheter between the distal end 6 and the tip 7 to support the balloon 8) a portion of the catheter tube 3 is cut away so that only the lumen that houses an internal guide wire 14 remains (as shown in dotted lines within the balloon 8).
Extending through the interior of the tube 3 are a plu-rality of lumens (shown in Figures 3 and 4) which can serve a variety of functions, for example, housing the guide wire 14, inserting materials into the blood stream or inflating or deflating the balloon. Except for the balloon 8, all of the various components perform functions which are generally appreciated and known in the art.
To use, the catheter 1 (as shown in Figure 2) is inserted into the cardiovascular system until the co-extruded balloon 8 is located at the site of an occlusion.
At this stage, the balloon 8 is typically folded and col-lapsed and has an external diameter less than the inf lated - 35 diameter, as can be seen by a comparison of Figures 1 and 2. once the balloon 8 is maneuvered to the location of the occlusion, a ~L~s:~uLizing fluid is inserted at the proximal end 5 of the catheter tube 3 for inflation of the balloon 8. The fluid unfolds the balloon 8 until it pre-_ _ _ _ _, _ . . . _ WO 92/19316 2 ~ 6 ~10 -6- PCI`/US92/03351~
sents a relatively smooth "Yr~nll~rl profile for imparting forces that are radially outwardly directed at the desired site within the body in order to achieve the desired result of lesion dilation, re6triction reduction or simi-lar treatment.
Inserting the catheter l in an artery re~uires that the tube 3 be of a semi-flexible material. Tube 3 preferably is ~--9d of a polyolefin copolymer, for example a con-ventional high density polyethylene. The diameter of the tubing is between about 12 and 16 French and may be coated on the inside and outside surfaces with, for example, a silicone based material to promote slippage in an aqueous environment .
As seen in Figures 3 and 4, the co-extruded balloon 8 results in a laminated construction. The laminates of the construction include a main structural layer 8B which is generally between about 0.2 and 2.5 mil. or thicker, and formed of one or more biaxially oriented polymers such as polyamides, polyesters, polycarbonates and their copolym-ers. Co-extruded with and bonded to the ~LU~_LULal layer 8B is an inner layer 8C of heat bondable polyolef in such as Plexar. Plexar is an anhydride-modified polyethylene and a trademarked product sold by Quantum Chemical Corpo-ration of ~'in~inn~ti, Ohio. The heat bondable layer 8C is attached directly to the distal end 6 of catheter tube 3 and is secured to the balloon 8 by a heat seal joint ll.
A similar joint ll is formed between the balloon 8 and the catheter tip 7.
The heat bondable layer 8C is co-extruded with the ~L, U~ULCLl layer 8B and has a thickness of between about 0.5 and l.O mil. Preferably, two heat bondable layers are co-extruded with the structural layer 8B. The inner layer 8B serves as a r~ ni r`n to provide a heat seal joint lO
between the distal end 6 of the catheter tube 3 and the DLLU~ LULCIl layer 8B of the balloon 8. When two layers are co _~L~uded with the structural layer 8B, the inner layer 8C forms the heat bondable layer and the outer layer 8A
forms a protective sheath for the main structural layer 8B. When polyamides such as Nylon are used as the struc-WO 92/19316 ~ 1 ~1 7 ~ ~ ~ Pcr/us92/0335l tural layer 8B, Plexar can be used as the heat bonding layer 8C. The outer layer 8A can be formed of the same material and provide for softness for non-traumatic pas-~ing through vessels and good pin hole resistance.
An alternative to the construction shown in Figure l, another construction is to dispose a balloon f ormed of a base structural layer 8B of polyethylene terapthalate and an outer layer 8A of polyethylene around the distal end 6 of the catheter tube 3 and then place a sleeve 20 formed of heat bonding layer 2 OC of high density polyethylene on a base layer 20B of Nylon over the end of the balloon 8 whereby the polyethylene of the balloon seals to the poly-ethylene of the sleeve and the Nylon seals to the catheter 3. In cases where additional strength is needed, an inn~ ~ ~ layer can be formed of high density polyethylene and an outermost layer is formed of Nylon with Plexar sandwiched therebetween.
It has been found that where strength, abrasion resis-tance and/or "feel" are important in medical balloons, that a co-extrusion which includes Selar resin can be used to provide for these characteristics. The Selar can be used by itself as the inner and/or outer layer or it can be blended with polyethylene terapthalate. Tests of a l. 6 mil. thick balloon with a Selar outer layer (a 50/50 blend of Selar and polyethylene terapthalate) were conducted by rubbing a balloon inflated to 6 atm. and rubbing it back and forth over medium grade emery cloth until failure.
The balloons with Selar or 50/50 blend layers ~ e~le-l 200 cycles while a l. 8 mil . thick polyethylene terapthalate balloon failed in 87 cycles. Selar is a toughened grade of polyethylene terapthalate and it can be cu ._~LL uded with the base structural layers herein disclosed according to known techniques.
Referring to Figures 3 and 4, the interior of the co-extruded balloon 8 is shown in cross section. In Figure 3, the balloon is shown in its distended or inflated con-dition whereas in Figure 4 the balloon is shown in its deflated or folded condition. The balloon 8 can typically have an outer diameter that can be on the order of roughly WO 92/19316 2 i ~ ~ 6 9 ~ -8- PCI`/US92/03351 1--three to six and even more times the outer diameter of the catheter tube 3. Pressurized fluids used to inflate the balloon include those conventionally used in the art, such as the well known aqueous solutions if they do not pose a problem of leaving residual fluids or chemically reacting with the balloon . Such f luids are introduced into the balloon 8 and removed therefrom through a lumen Ll which is in f luid f low relationship with the interior thereof .
Venting of gasses initially trapped in the catheter and the balloon prior to introduction of the in~lation f luids is accomplished by expelling them through a second lumen L2 also formed in the interior of the catheter tube 3.
Preferably, lumen Ll and L2 are cut off at joint lO so as to leave only a third lumen L3.
The third lumen L3 houses a guide wire 14 that passes through the balloon 8 and the tip 7. The third lumen L3 i5 different then the other two lumens, Ll and L2, in that it extends entirely through the balloon 8 from the distal end 6 to the tip 7 so as to sheath the guide wire. In some ~mhr~;r Ls, it may be desirable to combine the func-tions of lumen6, Ll and L2, to only have a single lumen for inflating or deflating the balloon. Lastly, the lumen defined by L3 provides for a housing for a guide wire 14 which is removably housed in it. Guide wire 14 passes through the entire length of the catheter 3 and through the balloon 8 (while preferably sheathed in lumen L3) and thence into an axial bore (not shown) in tip 7 to emerge from the end of tip 7 (as shown in Figures 2 and 3).
Each of the lumens Ll, L2 and L3 is formed by walls 15 and 16 that are extruded as the catheter tube is extruded from an extrusion machine, as is well known in the art.
The thickness of the walls 15 and 16 can be between 0 . 5 and lO mil., as is well known.
As shown in Figure 4, the diameter of the f olded bal -loon 8 is substantially the same or less than the diameter of the catheter tube 3 so as to provide for easy passage of the catheter through blood vessels. The extruded tub-ing 3 has a nominal wall thickness that generally is on ~he order of six to twelve times the desired wall thick--WO 92119316 ~ 2 1 ~ 7 ~;g ~ PCr/US92/03351 _g_ ness of the balloon 8.
To form the co-extruded balloons, the materials initially are melted separately in extrusion r^^h i nPc .
When melted, the materials are separately forced into an extrusion head and extruded so that they are forced out as - a plurality of layers in the form of a single tube which - critically forms the balloon of the present invention. A
Nylon-Plexar or polyethylene-polyethylene terapthalate balloon may be formed by taking a six inch length of the three layered tubing which is to be manuf actured into a balloon and placing it in a holding f ixture. The left hand end of the tube is attached to a Touhy Borst adapter.
The right hand end of the tube is heat sealed to tempora-rily prevent pressurized air from escaping. The right hand end is attached to a tension line which is pulled for the force of a least 150 grams (for a 3 . 0 mm. diameter balloon). The tubing is heated under a pressure of bet-ween about 100 and 400 psi to about 210F for several sec-onds. Afterwards, the heated area is cooled and the sup-port frame is spread apart slightly so as to expose a pre-det~rm; nr~d section of tubing to permit the balloon area to be reheated to a temperature between about 210 and 220F
to permit the balloon to be PYr;~n~ to a desired diameter under pressure for about 35 seconds. The pressure is then stopped and the deflectors are slid to the ends of the balloon and the balloon is heated for a third time to about 310F to heat set the balloon and hj~iAlly orient the polymeric matrix. This third heating prevents the balloon layers from flaking and prevents the balloon from ~YrAn-lin~ beyond the size at which it will set during the heat setting period. The heat setting takes about 8 sec-onds .
For a Nylon-Plexar balloon, the deflectors from the tubes are then removed and another unheated tube is - 35 mounted into the fixture. The catheter tube is slid inside the balloon so that it engages the heat bondable polyethylene layer. The balloon is bonded to the poly-ethylene shaft by heat bonding in a temperature of about 310F which is long enough to the melt the polyethylene WO 92/19316 2 1 ~ 7 6 9 ~ -lo- PCr/US92/033sl ~
end and the inner layer of the polyethylene together.
It is quite important to recognize that the heat treat-ment steps as described herein essentially prevent the de~min:3tion of the heat bondable layers 8C and 8A from the main structural layer 8B as is required when a lami-nated construction is used as a catheter. Flaking and ~Pl ;~m; nAtion is not a problem, however, with polyethylene terapthalate and Selar layers.
While it is apparent that modif ications and changes may be made within the spirit and scope of the present inven-tion, it is intended, however, only to be limited by the scope of the ~rpPnrl~ claims.
Claims (18)
1. A catheter for medical purposes, said catheter comprising:
a tubular member having a distal end and at least one lumen disposed therethrough;
a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, wherein one of said layers is a base structural layer and another of said layers is a barrier layer disposed radially outside said base structural layer.
a tubular member having a distal end and at least one lumen disposed therethrough;
a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, wherein one of said layers is a base structural layer and another of said layers is a barrier layer disposed radially outside said base structural layer.
2. A catheter according to claim 1, wherein said barrier layer is formed of a material comprising polyethylene and copolymers thereof.
3. A catheter according to claim 1, wherein said base structural layer has a thickness between about 0.2 and 2.5 mil, and said barrier layer has a thickness between about 0.15 and 1.0 mil.
4. A catheter according to claim 1, wherein said balloon has at least three co-extruded layers, said base structural layer being disposed between two co-extruded layers.
5. A catheter according to claim 1, wherein said base structural layer is of a material selected from the group consisting of polyamides, polycarbonates, polyesters an copolymers thereof.
6. A catheter according to claim 4, wherein the innermost layer of said balloon is of a material selected from the group consisting of polyethylene and copolymers thereof.
7. A catheter according to claim 1, wherein the tubular member is formed of a polyolefin comprising polyethylene and said polyolefin is a member selected from the group consisting of polyamides, polycarbonates, polyesters and copolymers thereof.
8. A catheter for medical purposes, said catheter comprising:
a tubular member having a distal end and at least one lumen disposed therein;
a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, at least one of said layers being a base structural layer and the other of said layers being formed of a Selar.
a tubular member having a distal end and at least one lumen disposed therein;
a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, at least one of said layers being a base structural layer and the other of said layers being formed of a Selar.
9. A catheter for medical purposes, said catheter comprising:
a tubular member having a distal end and at least one lumen disposed therein;
an elongated medical balloon having an open end, said open end being fitted over a joint at said distal end of said tubular member, the interior of said balloon being in communication with said lumen, said balloon having an elongated, expandable tubular body and comprising a plurality of co-extruded layers of different polymeric materials, neither of which is heat sealable to said tubular member;
a sleeve for connecting said medical balloon to said catheter, said sleeve being disposed over said joint and comprising an elongated tubular body having a predetermined diameter and capable of adhering to both said medical balloon and said catheter, said sleeve comprising a plurality of co-extruded and coextensive layers of different polymeric materials, at least one of said layers being a polymeric layer and another of said layers being selected from the group consisting of polyethylene and copolymers thereof
a tubular member having a distal end and at least one lumen disposed therein;
an elongated medical balloon having an open end, said open end being fitted over a joint at said distal end of said tubular member, the interior of said balloon being in communication with said lumen, said balloon having an elongated, expandable tubular body and comprising a plurality of co-extruded layers of different polymeric materials, neither of which is heat sealable to said tubular member;
a sleeve for connecting said medical balloon to said catheter, said sleeve being disposed over said joint and comprising an elongated tubular body having a predetermined diameter and capable of adhering to both said medical balloon and said catheter, said sleeve comprising a plurality of co-extruded and coextensive layers of different polymeric materials, at least one of said layers being a polymeric layer and another of said layers being selected from the group consisting of polyethylene and copolymers thereof
10. A catheter according to claim 9, wherein said tubular member is formed of a material comprising polyethylene and copolymers thereof.
11. A catheter according to either of claims 1 or 9, wherein the diameter of the tubular member and the diameter of the joint is substantially the same.
12. A catheter according to claim 9, wherein the balloon has a layer selected from the group consisting of polyamides, polycarbonates, polyesters and copolymers thereof.
13. A catheter according to claim 9, wherein the sleeve has a layer selected from the group consisting of polyamides, polycarbonates, polyesters and copolymers thereof.
14. A catheter according to either claims 1 or 9, wherein said balloon has two open ends, said catheter further comprising a tip disposed on the other open end, said tip being heat sealed to said balloon.
15. A medical balloon for attachment to a catheter shaft, as recited in claim 1, wherein said base structural layer is biaxially orientated.
16. A method of forming a balloon for medial purposes, said method comprising:
co-extruding in a tubular shape a base structural layer of a member selected from the group consisting of polyamides, polycarbonates, polyesters and copolymers thereof and a heat sealable layer selected from the group consisting of polyethylene and copolymers thereof;
biaxially orienting said base structural layer by inflating said tube with a gas to a predetermined central diameter greater than the initial diameter of the tubular shape and simultaneously heating the inflated tube to a temperature sufficient to biaxially orient said base layer;
cooling the inflated tubular member;
elevating the temperature of the inflated tube for a second time to said biaxially orienting temperature;
allowing the twice-heated tube to cool and withdrawing the gas whereby the tubular member will assume a generally tubular shape and said main structural layer will remain biaxially orientated and said heat sealable layer will not be biaxially orientated.
co-extruding in a tubular shape a base structural layer of a member selected from the group consisting of polyamides, polycarbonates, polyesters and copolymers thereof and a heat sealable layer selected from the group consisting of polyethylene and copolymers thereof;
biaxially orienting said base structural layer by inflating said tube with a gas to a predetermined central diameter greater than the initial diameter of the tubular shape and simultaneously heating the inflated tube to a temperature sufficient to biaxially orient said base layer;
cooling the inflated tubular member;
elevating the temperature of the inflated tube for a second time to said biaxially orienting temperature;
allowing the twice-heated tube to cool and withdrawing the gas whereby the tubular member will assume a generally tubular shape and said main structural layer will remain biaxially orientated and said heat sealable layer will not be biaxially orientated.
17. A medical balloon for attachment to a catheter shaft, said balloon having ends spaced from each other by a central body portion, at least one of said ends being attachable to said shaft, said central body portion being inflatable from one diameter to a larger diameter, said balloon comprising:
a plurality of co-extruded and coextensive layers of polymeric materials, said layers being bonded to each other, one of said layers being a base structural layer, and another of said layers being an abrasion resistant layer having an abrasion resistance greater than that of said base structural layer.
a plurality of co-extruded and coextensive layers of polymeric materials, said layers being bonded to each other, one of said layers being a base structural layer, and another of said layers being an abrasion resistant layer having an abrasion resistance greater than that of said base structural layer.
18. An elongated medical balloon for attachment to a catheter shaft, said balloon having ends that are spaced from each other by a central body section, said central body portion being inflatable from one diameter to a larger diameter, said balloon comprising a plurality of co-extruded and coextensive layers of polymeric materials, said layers being bonded to each other at least one of said layers comprising a base structural layer and another of said layers being comprised of Selar.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US691,999 | 1991-04-26 | ||
US07/691,999 US5195969A (en) | 1991-04-26 | 1991-04-26 | Co-extruded medical balloons and catheter using such balloons |
Publications (2)
Publication Number | Publication Date |
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CA2107690A1 CA2107690A1 (en) | 1992-10-27 |
CA2107690C true CA2107690C (en) | 1996-12-24 |
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CA002107690A Expired - Lifetime CA2107690C (en) | 1991-04-26 | 1992-04-23 | Co-extruded medical balloons and catheter using such balloons |
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EP (3) | EP0581873B1 (en) |
JP (3) | JP3418872B2 (en) |
CA (1) | CA2107690C (en) |
DE (3) | DE69217928T2 (en) |
WO (1) | WO1992019316A1 (en) |
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1991
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1992
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- 1992-04-23 DE DE69217928T patent/DE69217928T2/en not_active Expired - Lifetime
- 1992-04-23 WO PCT/US1992/003351 patent/WO1992019316A1/en active IP Right Grant
- 1992-04-23 EP EP96202207A patent/EP0742030B1/en not_active Expired - Lifetime
- 1992-04-23 DE DE69233526T patent/DE69233526T2/en not_active Expired - Lifetime
- 1992-04-23 CA CA002107690A patent/CA2107690C/en not_active Expired - Lifetime
- 1992-04-23 DE DE69231210T patent/DE69231210T2/en not_active Expired - Lifetime
- 1992-04-23 EP EP99202606A patent/EP0953364B2/en not_active Expired - Lifetime
- 1992-04-23 JP JP51191392A patent/JP3418872B2/en not_active Expired - Lifetime
-
1993
- 1993-02-04 US US08/013,339 patent/US5366442A/en not_active Expired - Lifetime
-
1995
- 1995-04-24 US US08/427,997 patent/US6136258A/en not_active Expired - Lifetime
-
2000
- 2000-04-03 US US09/542,080 patent/US6482348B1/en not_active Expired - Fee Related
-
2002
- 2002-07-11 JP JP2002202084A patent/JP2003047661A/en active Pending
-
2005
- 2005-06-22 US US11/158,564 patent/US7585289B2/en not_active Expired - Fee Related
-
2006
- 2006-03-15 JP JP2006070432A patent/JP4336689B2/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
EP0953364A2 (en) | 1999-11-03 |
DE69217928D1 (en) | 1997-04-10 |
DE69233526T2 (en) | 2005-11-03 |
EP0581873A1 (en) | 1994-02-09 |
JP3418872B2 (en) | 2003-06-23 |
EP0953364A3 (en) | 2001-10-17 |
EP0742030B1 (en) | 2000-06-28 |
US6136258A (en) | 2000-10-24 |
EP0742030A3 (en) | 1997-02-05 |
EP0581873B1 (en) | 1997-03-05 |
US20050238833A1 (en) | 2005-10-27 |
JPH06507101A (en) | 1994-08-11 |
EP0581873A4 (en) | 1994-03-23 |
JP2003047661A (en) | 2003-02-18 |
WO1992019316A1 (en) | 1992-11-12 |
JP4336689B2 (en) | 2009-09-30 |
US5366442A (en) | 1994-11-22 |
US5195969A (en) | 1993-03-23 |
CA2107690A1 (en) | 1992-10-27 |
DE69217928T2 (en) | 1997-07-31 |
EP0742030A2 (en) | 1996-11-13 |
US7585289B2 (en) | 2009-09-08 |
DE69231210T2 (en) | 2000-11-30 |
EP0953364B1 (en) | 2005-06-08 |
DE69233526D1 (en) | 2005-07-14 |
DE69231210D1 (en) | 2000-08-03 |
JP2006204930A (en) | 2006-08-10 |
EP0953364B2 (en) | 2012-02-08 |
US6482348B1 (en) | 2002-11-19 |
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