CA1065227A - Retention catheter and method of manufacture - Google Patents
Retention catheter and method of manufactureInfo
- Publication number
- CA1065227A CA1065227A CA257,607A CA257607A CA1065227A CA 1065227 A CA1065227 A CA 1065227A CA 257607 A CA257607 A CA 257607A CA 1065227 A CA1065227 A CA 1065227A
- Authority
- CA
- Canada
- Prior art keywords
- polyurethane
- tube
- thermosetting
- balloon
- thermoplastic
- 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
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
- 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
-
- 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
-
- 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
Abstract
ABSTRACT
An all plastic retention catheter of the Foley type having a body of a thermoplastic polyurethane and a balloon of a thermosetting polyurethane. The catheter may be fabri-cated by a method wherein the thermosetting polyurethane balloon sleeve is molded with integral bands of a thermoplastic balloon sleeve is molded with integral bands of a thermoplastic poly-urethane polymer spaced at either end of the sleeve and sub-sequently sealed to the catheter body by fusing the thermo-plastic bands to the body material with heat or solvent.
An all plastic retention catheter of the Foley type having a body of a thermoplastic polyurethane and a balloon of a thermosetting polyurethane. The catheter may be fabri-cated by a method wherein the thermosetting polyurethane balloon sleeve is molded with integral bands of a thermoplastic balloon sleeve is molded with integral bands of a thermoplastic poly-urethane polymer spaced at either end of the sleeve and sub-sequently sealed to the catheter body by fusing the thermo-plastic bands to the body material with heat or solvent.
Description
-o~
BACKGROUND OF THE INVENTION
Field of the Invention m is invention relates to balloon or Foley type retention catheters. More particularly this invention relates to an all plastic catheter having a thermosetting polyurethane balloon, and further to a method for sealing the balloon to a thermoplastic polyurethane catheter body.
Description of Prior Art Retention type catheters have been in use for many years and traditionally comprise a flexible and resilient tubular body portion having elongated drainage and inflating -~
lumens extending longitudinally therethrough. An opening is ~ --provided in the catheter wall extending into communication with the inflating lumen and an inflatable sack or balloon is secured to the catheter over the opening whereupon intro-duction of fluid pressure through the inflating lumen will cause the sack or balloon to distend. The distal end of the catheter adapted for insertion into the patient is normally closed off and rounded and drainage eyes are provided in the catheter wall in communication with the drainage lumen, said eyes being located intermediate the balloon and the catheter distal end. At the opposite proximal end of the catheter, funnel portions are provided in communication with the inflat-ing and drainage lumens, respectively, the tubular body normally being bifurcated adjacent its proximal end, whereupon the proximal ends of the inflating ends drainage lumen extend angularly from each other. Catheters of this general type are illustrated in USP Nos. 2,248,934 and 2,308,404.
~ t7 Although catheters of the general type described supra have been conventionally made of rubber, recent developments have been directed toward the fabrication of all plastic catheters which reportedly show less tendency for the formation of undesirable calcium or other salts in the drainage lumen, and which have a high degree of bio-compatibility. Such all-plastic catheters are described for example in USP Nos. 3,392,627, 3,528,869 and 3,539,674.
Typical plastic materials which have been utilized in the fabrication of catheters include polyurethane, poly-vinyl chloride and copolymers of vinyl chloride with vinyl acetate or ethylene. Particularly preferred compositions for catheter bodies are the elastomeric grades of poly-urethane such as "Estane" * polyester-polyurethane of the B.F. Goodrich Chemical Company. Balloons of thermoplastic polyurethanes,however, have been found to require higher inflation pressures than conventional latex balloons and to take a permanent set after prolonged inflation possibly causing trauma to the patient upon withdrawal. As a result, it has been suggested to use latex balloons with poly-urethane catheter bodies as in USP Nos. 3,112,748 and 3,850,720. In such constructions the latex balloons may be "Teflon"-coated to render them less irritating to the patient while largely preserving the desirable balloon inflation/deflation properties of latex. Even "Teflon"*
coating, however, does not completely eliminate tissue reaction to the latex material.
* Registered Trademark ..
- . . : ~ . : , ' ~52Z~ .
It is accordingly an object of the present invention to provide an all plastic catheter having improved inflation/
deflation properties, It is a further object of this inven-tion to provide an all plastic catheter having a thermosetting polyurethane balloon member. A yet further object of this invention is to provide a method for securely attaching a thermosetting polyurethane balloon to a thermoplastic poly-- urethane catheter body. Yet other objects of the invention ' will be apparent from the ensuing descriptions and examples.
SUMMARY
A Foley type retention catheter is constructed having a thermoplastic polyurethane body member and a thermosetting polyurethane balloon member. In one method of assembly, the balloon member is cast over a mandrel previously covered at each end wi-th bands of thermoplastic polyurethane polymer correspnding to the areas of the balloons to be sealed to the ~
catheter tube. The thermoplastic polyurethane bands bond to ~ -the thermosetting polyurethane balloon material at the inter-face between the materials during curing of the balloon material.
The balloon is subsequently sealed to the catheter body by uniting these thermoplastic polyurethane bands to the thermo-plastic polyurethane catheter body with heat or solvent, According to a broad aspect of the present invention, there is provided a retention catheter which comprises an elongated flexible thermoplastic polyurethane tube having a distal end and a proximal end and having a drainage lumen and an inflation lumen defined by the walls of the tube and extend-ing from the proximal end to near the distal end~ The infla-tion lumen terminates in an inflation port in the wall of the tube near the distal end thereof. The drainage lumen terminates in a drainage port in the wall of the tube intermediate the inflation portion and the distal end. A cylindrical thermo-~0~5~ 7 setting polyurethane balloon sleeve encircles a longitudinal section of the tube containing the inflation port and has end margins sealed to the tube on either side of the inflation port.
The end margins comprise bands of thermoplastic polyurethane in-tegral with the inner surface of the balloon sleeve.
According to a further broad aspect of the present invention, there is provided a method of fabricating articles of thermosetting and thermoplastic polyurethane components which comprises contacting solid thermoplastic polyurethane with a thermosetting polyurethane resin, The thermosetting ~ polyurethane resin is cured while in contact with the thermo-.~ plastic polyurethane whereby bonding occurs between the surface of the thermoplastic polyurethane and the thermosetting poly-urethane. Thereafter the thermosetting polyurethane component is joined to the thermoplastic polyurethane component by fusing the thermoplastic polyurethane section of the thermosetting , - polyurethane component to the thermoplastic polyurethane component.
DESCRIPTION OF DRAWINGS
FIGURE 1 is an elevational view with parts broken -away and sectioned of the distal end of a Foley catheter hav- :
ing a thermosetting polyurethane balloon mounted over a thermo-plastic polyurethane catheter body.
- 4a -: , ,J
j .
, ETH~ 7 1~)ti5~ 7 FIGI~E 2 is an elevational view with part sectioned for clarity of the catheter body and the balloon of FIGURE 1.
FIGURE 3 shows the same assembly as FIGURE 2 with the balloon thereof in~lated.
FIGURE 4 is an elevational view of the balloon -~
mandrel covered at each end with a band of thermoplastic poly-- urethane.
FIGURE 5 is a cross-sectional view of the balloon mold with the mandrel in place and covered by a thermosetting - 10 polyurethane balloon material.
FIGURE 6 is an elevational view wlth parts broken away and sectioned of the plastic balloon molded according to FIGURE 5.
FIGURE 7 ls an elevatlonal view with parts broken away and sectioned of an alternate balloon constructlon show-ing a thermosettlng polyurethane band havlng a decreasing thickness.
DESCRIPTION OF PREFERRED EMBODIMENTS
The catheter bodies for use in the present inventlon may be fabricated in accordance with conventional procedures.
In one typlcal procedure, manufacturlng beglns wlth the forma-; tion of a plastlc catheter shaft, usually by extruslon, to form cylindrlcal tube 10 having a longltudlnal internal partltion 12 which divldes the interlor of the catheter shaft 10 into a drainage lumen 14 and an inflation lumen 16 as illustrated in FIGURES 1-3. The extrusion proce~s produces an open ended . . ~
SZ;~7 cylindrical tube and the distal tip 18 of the catheter ~haft - lO is rounded and closed off by means of a conventional heat moldlng. An inflation port 20 is punched into the wall of the catheter shaft 10 near the distal end of the catheter and in communlcation with the inflation lumen 16. This step must be done before the inflation balloon is attached since the inflation port 20 must ultlmately be within the balloon.
A~ an optional flnal step in the preparation of the catheter shaft, a coating of release agent 22 may be applied clrcumferentially about the catheter shaft lO in the neighbor-hood of the inflation port 20 and for a short distance above and below the port. The purpose of such coating is to provlde good separation between the catheter shaft lO and the balloon which ls attached thereover at a later stage of the manufactur-ing proces6. Release agents such as siloxane or colloidal hy-drated alumlna are well known ln the art and commonly employed ;
in catheter manufacture.
The next step in the manufacturlng process i8 to put a similar coating of a release agent,preferably siloxane, over cyllndrical mandrel 24 of FIGURE 4 so that the polyurethane sleeve whlch is ultlmately to form the inflation balloon can be preformed upon mandrel 24 and later easily removed therefrom.
The catheter body is preferably fabricated of thermo-pla~tic polyurethane, and the dis~imilarity between the thermo-plastic polyurethane body and the thermosetting polyurethane balloon makes it dlfflcult to provide a strong adhesive bond between the two materlals. Whereas catheters of the prlor art constructed entlrely of thermoplastic polyurethanes are conveniently a6sembled by fusing as descrlbed for example ln U.S. Patent 3,528,869, such heat sealing 1~ ineffective :~Q~5~
., :
; between the thermoplastic and thermosetting polyurethanes.
This problem of sealing the balloon to the catheter shaft is avoided by a method wherein thermoplastic polyurethane bands are integrally molded within the thermosetting poly-urethane sleeve to provide a composite balloon sleeve with a heat sealable area at each end. In the practice of this - method, a good bond is achieved at the interface of the thermoplastic polyurethane bands and the thermosetting polyurethane body of the sleeve. While not wishing to be bound by theory, it is believed that while the uncured thermosetting balloon material is in contact with the thermo-plastic urethane bands previously placed on the mandrel, the polymeric isocyanate in the balloon formulation cross-links with the surface of the thermoplastic polyurethane by allo-phanate and biuret bonds. After the balloon sleeve is cured, - the exposed surfaces of the thermoplastic polyurethane bands which have not been influenced by the cross-linking can be made to flow and fuse to the thermoplastic polyurethane catheter body by application of heat or solvent.
In a preferred embodiment, composite balloon sleeve 26 is preformed upon mandrel 24 by first covering each end of the mandrel with bands 28 of a thermoplastic polyurethane as illustrated in FIGURE 4. The width of the bands corres-ponds to the desired seal area for the balloon. The bands may be cut from thin walled thermoplastic polyurethane tubing and slipped over the ends of the mandrel, or may be formed in place by coating the ends of the mandrel with a solution of a thermoplastic polyurethane. Suitable thermoplastic polyurethane solutions commercially available include "Witco-bond F-2"*, a product of Witco Chemical Corp., Chicago, Illinois, * Registered Trademark 7 : . . , . :, :- . , ~ SZZ~
and B.F. Goodrich Co.'s "Estane"* brand of high molecular weight polyurethane material, such as "Estane"* 5740 x 101 (a moderately high modulus polyester type polyurethane), "Estane"* 5702 (a low modulus polyester type polyurethane), blends of these two, and "Estane"* 5740 x 140 (a moderately high modulus polyether type thermoplastic polyurethane).
The polymer solutions can be applied to the mandrel by dipping or any other convenient method including spraying, transfer coating, wiping or brushing.
After the ends of the mandrel have been covered . .
with the thermoplastic polyurethane, the mandrel is centered : -in mold 32 which is then charged with an amount of thermo~
setting polyurethane resin 30 sufficient to fill the mold with the mandrel positioned therein as shown in FIGURE 5.
Resin 30 is cured in the mold to form about 6 to 20 : thousandths of an inch. The sleeve is subsequently removed from the mold and stripped from the mandrel to obtain the composite structure shown in FIGURE 6, a balloon sleeve 26 having a thermosetting polyurethane body 30 with integral bands of thermoplastic polyurethane molded within the ends thereof.
Subsequently, as illustrated in FIGURE 1, a sleeve 26 is slipped over catheter body 10 to surround the shaft in the neighborhood of the inflation port 20. Balloon sleeve 26 and catheter body 10 are preferably separated by a thin 4' film of release agent 22 over that portion of the body between bands 28 at either end of sleeve 26.
Once in position, the sleeve 26 is permanently sealed to catheter body 10 by activating thermoplastic bands 28 with heat or solvent in order to fuse the bands to the *Registered Trademark 8 ~ i5'~
catheter body. ~eating may be accomplished by radio frequency, induction, dielectric or direct application -~
through heated molds. One method employing heated molds is disclosed in USP 3,528,860. The mold comprises a pair of ring elements sized to match the diameter of the - catheter at the balloon section and designed to surround the end portions of the sleeve. The inner surfaces of the - rings may be outwardly tapered to a smaller diameter corres- -ponding to the diameter of catheter body, the effect of the taper being to reduce the size of the ridge at the point where the balloon joins the catheter body. During the seal-ing operation, fluid pressure is introduced into the catheter body 10 through drainage lumen 14 to prevent the collapse of body 10 under the molding pressure. Alternatively, the seal may be accomplished by application of a solvent or additional thermoplastic polyurethane solution which acts as an adhesive for the thermoplastic polyurethane polymer.
After sealing the balloon to the catheter body, the catheter may be finished by smoothing the joint at the balloon by trimming or filling with a polyurethane polymer if necessary, and by cutting drainage eyes 34 through the wall of shaft 10 to communicate with drainage lumen 14.
Polymer 30 forming the body of balloon 26 is a thermosetting polyurethane having elongation and recovery properties which permit the catheter balloon to be readily inflated with low pressures and with a low order of perma-nent elongation set. Preferably, the balloon material has an elongation to break of more than 400 percent and an elongation set, i.e., residual increase in balloon circum-ference after deflation, of less than about 15 percent after S~7 remaining fully inflated in urine at 37C for one week. Com-parative data on specific properties of the thermosetting poly-urethane balloons of the present invention and typical propert-ies of other conventional catheter balloon materials are presented below.
Balloon Wall BreakElongation Inflation MaterialThickness ElonqationSet _ Pressure mermosetting ' ' polyurethane (A) 15 mils 535% 5-11% 4.1 psi Thermosetting polyurethane (B) 18 510 0-5 8.6 Thermoplastic Pharma-seal polyurethane 10-15 400-600 180-200 17 Silicone rubber "Travenol"* 15-20 500-700 60-70 8.1 "Teflon"* coated latex (Kosan) 15-20 500-800 30-40 7.9 In the above table, thermosetting polyurethane balloons -~ A and B were each cast with integral bands of a thermoplastic polyurethane in theseal areas at each end of the balloon by ; precoating the ends of the balloon mandrel with a solution of "Witcobond F-2"* polymer. Thermosetting polyurethane (A) was formulated from "Cyanaprene A9"* polyester-polyurethane prepolymer .~. .
(American Cyanamid Co.) cross-linked with an excess of a poly-functional polyol and plasticized with approximately 18.5 percent dimethoxyethyl phthalate. Thermosetting polyurethane (B) was formulated from "Solithane 790"* urethane prepolymer (Thiokol Chemical Corp.) crosslinked with an excess of a poly-functional polyol and unplasticized. Examples of suitable cross-linking agents include trimethylol propane, 1,4-butane-diol, mixtures of trimethylolpropane and triisopropanol amine, * Registered Trademark z~
other primary and secondary trifunctional polyols. Examples of other suitable plasticizers include the dialkylene glycol dibenzoates. Any non-toxic cross-linking agent or plasticizer conventional for use in formulating thermosetting polyurethane resins may be used although the elongation and inflation characteristics are preferably separately determined for each individual formulation to assure that desirable properties of - the thermosetting polyurethane are retained.
- m e method of fabricating the catheters of the present invention wherein a thermosetting polyurethane balloon component is provided with integral sections of thermoplastic polyurethane over the areas to be joined to a thermoplastic polyurethane tube component has applications beyond the fabrication of catheters.
For example, in the medical field, the same method may be utilized to fabricate artificial heart valves or other prosthetic devices ; where a bicomponent construction of thermosetting and thermo-plastic polyurethane is desired. The method of the present invention is accordingly not limited to the fabrication of catheters, but broadly encompasses a method of fabricating articles of thermosetting and thermoplastic polyurethane com-ponents which comprises contacting solid thermopla~tic poly-urethane with a thermosetting polyurethane resin, curing the thermosetting polyurethane resin while in contact with the thermoplastic polyurethane whereby bonding occurs between the surface of the thermoplastic polyurethane and the thermosetting polyurethane, and thereafter joining the thermosetting poly-urethane component to the thermoplastic polyurethane component by fusing the thermoplastic polyurethane section of the thermo-setting polyurethane component to the thermoplastic polyurethane component.
. - :
, ~ i5~
While the integral thermoplastic polyurethane bands are the preferred method for attaching the thermosetting poly-urethane balloon sleeve to a thermoplastic lumen tube, a single component thermosetting polyurethane sleeve can be attached to a thermoplastic polyurethane catheter body through the use of a selected urethane or epoxy adhesive system. For example, a 40 percent solution of a polyester polyurethane prepolymer in methyl ethyl ketone containing about 0.8 percent by weight of a polymeric isocyanate cross-linking agent provides good bond strength between the thermoplastic and thermosetting polyurethanes when dried at 60C for 24 hours and cured for 2 minutes at 120C. Suitable cross-linking agents are the organic diisocyanates including aromatic, aliphatic and cycloaliphatic diisocyanates and combinations of these. Representative com-pounds include 1,4-tetramethylene diisocyanate, 1,6-hexamethylene diisocyanate, 1,4-cyclohexylene diisocyanate, and 4,4'-methylene-bis-(cyclohexyl isocyanate). While not wishing to be bound by theory, the adhesive mechanism of this system is believed to include hydrogen bonding and cross-linking of the polymeric isocyanate in allophanate and biuret bonding.
While thermosetting polyurethane is the preferred material for the catheter body, other plastic materials such as polyvinyl chloride, polyvinylidene chloride, and silicone elastomers may be used with the thermosetting polyurethane balloon sleeve to obtain a biocompatible all plastic catheter having improved inflation/deflation properties. The plastic materials used in forming the catheters of the present inven-tion may be pigmented or unpigmented. In some cases, pigments designed to give X-ray opacity may be incorporated in the material. In a preferred embodiment of the invention, a small ~
amount of very finely divided white pigment, e.g., about 0.01 to 1 percent by weight of titanium dioxide pigment, is in-corporated in the otherwise transparent material used in form-ing the catheter body to give the final extruded tube a milky translucency or opaque white appearance.
The catheters of the present invention may also include special features which are known in the construction of medicosurgical tubes and which may be required for particular procedures in which the catheters are to be employed. These may include a non-sparking feature (USP No. 3,070,132), X-ray line feature (USP No. 2,847,915) or a tapered section - feature (USP No. 2,940,126).
Yet other variations in catheter compositions, con- ,~
struction and design will be apparent to those skilled in the art, and all such variations as applied to the catheters -~
having a thermosetting polyurethane balloon member are included within the scope of the present invention.
' .
BACKGROUND OF THE INVENTION
Field of the Invention m is invention relates to balloon or Foley type retention catheters. More particularly this invention relates to an all plastic catheter having a thermosetting polyurethane balloon, and further to a method for sealing the balloon to a thermoplastic polyurethane catheter body.
Description of Prior Art Retention type catheters have been in use for many years and traditionally comprise a flexible and resilient tubular body portion having elongated drainage and inflating -~
lumens extending longitudinally therethrough. An opening is ~ --provided in the catheter wall extending into communication with the inflating lumen and an inflatable sack or balloon is secured to the catheter over the opening whereupon intro-duction of fluid pressure through the inflating lumen will cause the sack or balloon to distend. The distal end of the catheter adapted for insertion into the patient is normally closed off and rounded and drainage eyes are provided in the catheter wall in communication with the drainage lumen, said eyes being located intermediate the balloon and the catheter distal end. At the opposite proximal end of the catheter, funnel portions are provided in communication with the inflat-ing and drainage lumens, respectively, the tubular body normally being bifurcated adjacent its proximal end, whereupon the proximal ends of the inflating ends drainage lumen extend angularly from each other. Catheters of this general type are illustrated in USP Nos. 2,248,934 and 2,308,404.
~ t7 Although catheters of the general type described supra have been conventionally made of rubber, recent developments have been directed toward the fabrication of all plastic catheters which reportedly show less tendency for the formation of undesirable calcium or other salts in the drainage lumen, and which have a high degree of bio-compatibility. Such all-plastic catheters are described for example in USP Nos. 3,392,627, 3,528,869 and 3,539,674.
Typical plastic materials which have been utilized in the fabrication of catheters include polyurethane, poly-vinyl chloride and copolymers of vinyl chloride with vinyl acetate or ethylene. Particularly preferred compositions for catheter bodies are the elastomeric grades of poly-urethane such as "Estane" * polyester-polyurethane of the B.F. Goodrich Chemical Company. Balloons of thermoplastic polyurethanes,however, have been found to require higher inflation pressures than conventional latex balloons and to take a permanent set after prolonged inflation possibly causing trauma to the patient upon withdrawal. As a result, it has been suggested to use latex balloons with poly-urethane catheter bodies as in USP Nos. 3,112,748 and 3,850,720. In such constructions the latex balloons may be "Teflon"-coated to render them less irritating to the patient while largely preserving the desirable balloon inflation/deflation properties of latex. Even "Teflon"*
coating, however, does not completely eliminate tissue reaction to the latex material.
* Registered Trademark ..
- . . : ~ . : , ' ~52Z~ .
It is accordingly an object of the present invention to provide an all plastic catheter having improved inflation/
deflation properties, It is a further object of this inven-tion to provide an all plastic catheter having a thermosetting polyurethane balloon member. A yet further object of this invention is to provide a method for securely attaching a thermosetting polyurethane balloon to a thermoplastic poly-- urethane catheter body. Yet other objects of the invention ' will be apparent from the ensuing descriptions and examples.
SUMMARY
A Foley type retention catheter is constructed having a thermoplastic polyurethane body member and a thermosetting polyurethane balloon member. In one method of assembly, the balloon member is cast over a mandrel previously covered at each end wi-th bands of thermoplastic polyurethane polymer correspnding to the areas of the balloons to be sealed to the ~
catheter tube. The thermoplastic polyurethane bands bond to ~ -the thermosetting polyurethane balloon material at the inter-face between the materials during curing of the balloon material.
The balloon is subsequently sealed to the catheter body by uniting these thermoplastic polyurethane bands to the thermo-plastic polyurethane catheter body with heat or solvent, According to a broad aspect of the present invention, there is provided a retention catheter which comprises an elongated flexible thermoplastic polyurethane tube having a distal end and a proximal end and having a drainage lumen and an inflation lumen defined by the walls of the tube and extend-ing from the proximal end to near the distal end~ The infla-tion lumen terminates in an inflation port in the wall of the tube near the distal end thereof. The drainage lumen terminates in a drainage port in the wall of the tube intermediate the inflation portion and the distal end. A cylindrical thermo-~0~5~ 7 setting polyurethane balloon sleeve encircles a longitudinal section of the tube containing the inflation port and has end margins sealed to the tube on either side of the inflation port.
The end margins comprise bands of thermoplastic polyurethane in-tegral with the inner surface of the balloon sleeve.
According to a further broad aspect of the present invention, there is provided a method of fabricating articles of thermosetting and thermoplastic polyurethane components which comprises contacting solid thermoplastic polyurethane with a thermosetting polyurethane resin, The thermosetting ~ polyurethane resin is cured while in contact with the thermo-.~ plastic polyurethane whereby bonding occurs between the surface of the thermoplastic polyurethane and the thermosetting poly-urethane. Thereafter the thermosetting polyurethane component is joined to the thermoplastic polyurethane component by fusing the thermoplastic polyurethane section of the thermosetting , - polyurethane component to the thermoplastic polyurethane component.
DESCRIPTION OF DRAWINGS
FIGURE 1 is an elevational view with parts broken -away and sectioned of the distal end of a Foley catheter hav- :
ing a thermosetting polyurethane balloon mounted over a thermo-plastic polyurethane catheter body.
- 4a -: , ,J
j .
, ETH~ 7 1~)ti5~ 7 FIGI~E 2 is an elevational view with part sectioned for clarity of the catheter body and the balloon of FIGURE 1.
FIGURE 3 shows the same assembly as FIGURE 2 with the balloon thereof in~lated.
FIGURE 4 is an elevational view of the balloon -~
mandrel covered at each end with a band of thermoplastic poly-- urethane.
FIGURE 5 is a cross-sectional view of the balloon mold with the mandrel in place and covered by a thermosetting - 10 polyurethane balloon material.
FIGURE 6 is an elevational view wlth parts broken away and sectioned of the plastic balloon molded according to FIGURE 5.
FIGURE 7 ls an elevatlonal view with parts broken away and sectioned of an alternate balloon constructlon show-ing a thermosettlng polyurethane band havlng a decreasing thickness.
DESCRIPTION OF PREFERRED EMBODIMENTS
The catheter bodies for use in the present inventlon may be fabricated in accordance with conventional procedures.
In one typlcal procedure, manufacturlng beglns wlth the forma-; tion of a plastlc catheter shaft, usually by extruslon, to form cylindrlcal tube 10 having a longltudlnal internal partltion 12 which divldes the interlor of the catheter shaft 10 into a drainage lumen 14 and an inflation lumen 16 as illustrated in FIGURES 1-3. The extrusion proce~s produces an open ended . . ~
SZ;~7 cylindrical tube and the distal tip 18 of the catheter ~haft - lO is rounded and closed off by means of a conventional heat moldlng. An inflation port 20 is punched into the wall of the catheter shaft 10 near the distal end of the catheter and in communlcation with the inflation lumen 16. This step must be done before the inflation balloon is attached since the inflation port 20 must ultlmately be within the balloon.
A~ an optional flnal step in the preparation of the catheter shaft, a coating of release agent 22 may be applied clrcumferentially about the catheter shaft lO in the neighbor-hood of the inflation port 20 and for a short distance above and below the port. The purpose of such coating is to provlde good separation between the catheter shaft lO and the balloon which ls attached thereover at a later stage of the manufactur-ing proces6. Release agents such as siloxane or colloidal hy-drated alumlna are well known ln the art and commonly employed ;
in catheter manufacture.
The next step in the manufacturlng process i8 to put a similar coating of a release agent,preferably siloxane, over cyllndrical mandrel 24 of FIGURE 4 so that the polyurethane sleeve whlch is ultlmately to form the inflation balloon can be preformed upon mandrel 24 and later easily removed therefrom.
The catheter body is preferably fabricated of thermo-pla~tic polyurethane, and the dis~imilarity between the thermo-plastic polyurethane body and the thermosetting polyurethane balloon makes it dlfflcult to provide a strong adhesive bond between the two materlals. Whereas catheters of the prlor art constructed entlrely of thermoplastic polyurethanes are conveniently a6sembled by fusing as descrlbed for example ln U.S. Patent 3,528,869, such heat sealing 1~ ineffective :~Q~5~
., :
; between the thermoplastic and thermosetting polyurethanes.
This problem of sealing the balloon to the catheter shaft is avoided by a method wherein thermoplastic polyurethane bands are integrally molded within the thermosetting poly-urethane sleeve to provide a composite balloon sleeve with a heat sealable area at each end. In the practice of this - method, a good bond is achieved at the interface of the thermoplastic polyurethane bands and the thermosetting polyurethane body of the sleeve. While not wishing to be bound by theory, it is believed that while the uncured thermosetting balloon material is in contact with the thermo-plastic urethane bands previously placed on the mandrel, the polymeric isocyanate in the balloon formulation cross-links with the surface of the thermoplastic polyurethane by allo-phanate and biuret bonds. After the balloon sleeve is cured, - the exposed surfaces of the thermoplastic polyurethane bands which have not been influenced by the cross-linking can be made to flow and fuse to the thermoplastic polyurethane catheter body by application of heat or solvent.
In a preferred embodiment, composite balloon sleeve 26 is preformed upon mandrel 24 by first covering each end of the mandrel with bands 28 of a thermoplastic polyurethane as illustrated in FIGURE 4. The width of the bands corres-ponds to the desired seal area for the balloon. The bands may be cut from thin walled thermoplastic polyurethane tubing and slipped over the ends of the mandrel, or may be formed in place by coating the ends of the mandrel with a solution of a thermoplastic polyurethane. Suitable thermoplastic polyurethane solutions commercially available include "Witco-bond F-2"*, a product of Witco Chemical Corp., Chicago, Illinois, * Registered Trademark 7 : . . , . :, :- . , ~ SZZ~
and B.F. Goodrich Co.'s "Estane"* brand of high molecular weight polyurethane material, such as "Estane"* 5740 x 101 (a moderately high modulus polyester type polyurethane), "Estane"* 5702 (a low modulus polyester type polyurethane), blends of these two, and "Estane"* 5740 x 140 (a moderately high modulus polyether type thermoplastic polyurethane).
The polymer solutions can be applied to the mandrel by dipping or any other convenient method including spraying, transfer coating, wiping or brushing.
After the ends of the mandrel have been covered . .
with the thermoplastic polyurethane, the mandrel is centered : -in mold 32 which is then charged with an amount of thermo~
setting polyurethane resin 30 sufficient to fill the mold with the mandrel positioned therein as shown in FIGURE 5.
Resin 30 is cured in the mold to form about 6 to 20 : thousandths of an inch. The sleeve is subsequently removed from the mold and stripped from the mandrel to obtain the composite structure shown in FIGURE 6, a balloon sleeve 26 having a thermosetting polyurethane body 30 with integral bands of thermoplastic polyurethane molded within the ends thereof.
Subsequently, as illustrated in FIGURE 1, a sleeve 26 is slipped over catheter body 10 to surround the shaft in the neighborhood of the inflation port 20. Balloon sleeve 26 and catheter body 10 are preferably separated by a thin 4' film of release agent 22 over that portion of the body between bands 28 at either end of sleeve 26.
Once in position, the sleeve 26 is permanently sealed to catheter body 10 by activating thermoplastic bands 28 with heat or solvent in order to fuse the bands to the *Registered Trademark 8 ~ i5'~
catheter body. ~eating may be accomplished by radio frequency, induction, dielectric or direct application -~
through heated molds. One method employing heated molds is disclosed in USP 3,528,860. The mold comprises a pair of ring elements sized to match the diameter of the - catheter at the balloon section and designed to surround the end portions of the sleeve. The inner surfaces of the - rings may be outwardly tapered to a smaller diameter corres- -ponding to the diameter of catheter body, the effect of the taper being to reduce the size of the ridge at the point where the balloon joins the catheter body. During the seal-ing operation, fluid pressure is introduced into the catheter body 10 through drainage lumen 14 to prevent the collapse of body 10 under the molding pressure. Alternatively, the seal may be accomplished by application of a solvent or additional thermoplastic polyurethane solution which acts as an adhesive for the thermoplastic polyurethane polymer.
After sealing the balloon to the catheter body, the catheter may be finished by smoothing the joint at the balloon by trimming or filling with a polyurethane polymer if necessary, and by cutting drainage eyes 34 through the wall of shaft 10 to communicate with drainage lumen 14.
Polymer 30 forming the body of balloon 26 is a thermosetting polyurethane having elongation and recovery properties which permit the catheter balloon to be readily inflated with low pressures and with a low order of perma-nent elongation set. Preferably, the balloon material has an elongation to break of more than 400 percent and an elongation set, i.e., residual increase in balloon circum-ference after deflation, of less than about 15 percent after S~7 remaining fully inflated in urine at 37C for one week. Com-parative data on specific properties of the thermosetting poly-urethane balloons of the present invention and typical propert-ies of other conventional catheter balloon materials are presented below.
Balloon Wall BreakElongation Inflation MaterialThickness ElonqationSet _ Pressure mermosetting ' ' polyurethane (A) 15 mils 535% 5-11% 4.1 psi Thermosetting polyurethane (B) 18 510 0-5 8.6 Thermoplastic Pharma-seal polyurethane 10-15 400-600 180-200 17 Silicone rubber "Travenol"* 15-20 500-700 60-70 8.1 "Teflon"* coated latex (Kosan) 15-20 500-800 30-40 7.9 In the above table, thermosetting polyurethane balloons -~ A and B were each cast with integral bands of a thermoplastic polyurethane in theseal areas at each end of the balloon by ; precoating the ends of the balloon mandrel with a solution of "Witcobond F-2"* polymer. Thermosetting polyurethane (A) was formulated from "Cyanaprene A9"* polyester-polyurethane prepolymer .~. .
(American Cyanamid Co.) cross-linked with an excess of a poly-functional polyol and plasticized with approximately 18.5 percent dimethoxyethyl phthalate. Thermosetting polyurethane (B) was formulated from "Solithane 790"* urethane prepolymer (Thiokol Chemical Corp.) crosslinked with an excess of a poly-functional polyol and unplasticized. Examples of suitable cross-linking agents include trimethylol propane, 1,4-butane-diol, mixtures of trimethylolpropane and triisopropanol amine, * Registered Trademark z~
other primary and secondary trifunctional polyols. Examples of other suitable plasticizers include the dialkylene glycol dibenzoates. Any non-toxic cross-linking agent or plasticizer conventional for use in formulating thermosetting polyurethane resins may be used although the elongation and inflation characteristics are preferably separately determined for each individual formulation to assure that desirable properties of - the thermosetting polyurethane are retained.
- m e method of fabricating the catheters of the present invention wherein a thermosetting polyurethane balloon component is provided with integral sections of thermoplastic polyurethane over the areas to be joined to a thermoplastic polyurethane tube component has applications beyond the fabrication of catheters.
For example, in the medical field, the same method may be utilized to fabricate artificial heart valves or other prosthetic devices ; where a bicomponent construction of thermosetting and thermo-plastic polyurethane is desired. The method of the present invention is accordingly not limited to the fabrication of catheters, but broadly encompasses a method of fabricating articles of thermosetting and thermoplastic polyurethane com-ponents which comprises contacting solid thermopla~tic poly-urethane with a thermosetting polyurethane resin, curing the thermosetting polyurethane resin while in contact with the thermoplastic polyurethane whereby bonding occurs between the surface of the thermoplastic polyurethane and the thermosetting polyurethane, and thereafter joining the thermosetting poly-urethane component to the thermoplastic polyurethane component by fusing the thermoplastic polyurethane section of the thermo-setting polyurethane component to the thermoplastic polyurethane component.
. - :
, ~ i5~
While the integral thermoplastic polyurethane bands are the preferred method for attaching the thermosetting poly-urethane balloon sleeve to a thermoplastic lumen tube, a single component thermosetting polyurethane sleeve can be attached to a thermoplastic polyurethane catheter body through the use of a selected urethane or epoxy adhesive system. For example, a 40 percent solution of a polyester polyurethane prepolymer in methyl ethyl ketone containing about 0.8 percent by weight of a polymeric isocyanate cross-linking agent provides good bond strength between the thermoplastic and thermosetting polyurethanes when dried at 60C for 24 hours and cured for 2 minutes at 120C. Suitable cross-linking agents are the organic diisocyanates including aromatic, aliphatic and cycloaliphatic diisocyanates and combinations of these. Representative com-pounds include 1,4-tetramethylene diisocyanate, 1,6-hexamethylene diisocyanate, 1,4-cyclohexylene diisocyanate, and 4,4'-methylene-bis-(cyclohexyl isocyanate). While not wishing to be bound by theory, the adhesive mechanism of this system is believed to include hydrogen bonding and cross-linking of the polymeric isocyanate in allophanate and biuret bonding.
While thermosetting polyurethane is the preferred material for the catheter body, other plastic materials such as polyvinyl chloride, polyvinylidene chloride, and silicone elastomers may be used with the thermosetting polyurethane balloon sleeve to obtain a biocompatible all plastic catheter having improved inflation/deflation properties. The plastic materials used in forming the catheters of the present inven-tion may be pigmented or unpigmented. In some cases, pigments designed to give X-ray opacity may be incorporated in the material. In a preferred embodiment of the invention, a small ~
amount of very finely divided white pigment, e.g., about 0.01 to 1 percent by weight of titanium dioxide pigment, is in-corporated in the otherwise transparent material used in form-ing the catheter body to give the final extruded tube a milky translucency or opaque white appearance.
The catheters of the present invention may also include special features which are known in the construction of medicosurgical tubes and which may be required for particular procedures in which the catheters are to be employed. These may include a non-sparking feature (USP No. 3,070,132), X-ray line feature (USP No. 2,847,915) or a tapered section - feature (USP No. 2,940,126).
Yet other variations in catheter compositions, con- ,~
struction and design will be apparent to those skilled in the art, and all such variations as applied to the catheters -~
having a thermosetting polyurethane balloon member are included within the scope of the present invention.
' .
Claims (7)
1. A retention catheter comprising:
a. an elongated flexible thermoplastic polyurethane tube having a distal end and a proximal end and having a drainage lumen and an inflation lumen defined by the walls of said tube and extending from said proximal end to near said distal end, said inflation lumen terminating in an inflation port in the wall of the tube near the distal end thereof, said drainage lumen terminating in a drainage port in the wall of the tube intermediate said inflation port and said distal end, and b. a cylindrical thermosetting polyurethane balloon sleeve encircling a longitudinal section of said tube containing said inflation port and having end margins sealed to said tube on either side of said inflation port, said end margins comprising bands of thermo-plastic polyurethane integral with the inner surface of the balloon sleeve.
a. an elongated flexible thermoplastic polyurethane tube having a distal end and a proximal end and having a drainage lumen and an inflation lumen defined by the walls of said tube and extending from said proximal end to near said distal end, said inflation lumen terminating in an inflation port in the wall of the tube near the distal end thereof, said drainage lumen terminating in a drainage port in the wall of the tube intermediate said inflation port and said distal end, and b. a cylindrical thermosetting polyurethane balloon sleeve encircling a longitudinal section of said tube containing said inflation port and having end margins sealed to said tube on either side of said inflation port, said end margins comprising bands of thermo-plastic polyurethane integral with the inner surface of the balloon sleeve.
2. A catheter of claim 1 wherein said thermosetting polyurethane balloon sleeve is characterized by a break elong-ation in excess of 400 percent and an elongation set of less than about 15%.
3. A method of fabricating articles of thermosetting and thermoplastic polyurethane components which comprises con-tacting solid thermoplastic polyurethane with a thermosetting polyurethane resin, curing the thermosetting polyurethane resin while in contact with the thermoplastic polyurethane whereby bonding occurs between the surface of the thermoplastic poly-urethane and the thermosetting polyurethane and thereafter join-ing the thermosetting polyurethane component to the thermoplastic polyurethane component by fusing the thermoplastic polyurethane section of the thermosetting polyurethane component to the thermoplastic polyurethane component.
4. A method of producing a catheter in which end margins of a thermosetting polyurethane balloon sleeve are sealed to a thermoplastic polyurethane lumen tube comprising the steps of:
a. casting a thermosetting polyurethane balloon sleeve about a mandrel having two bands of a thermoplastic polyurethane polymer previously provided thereon over areas corresponding to said end margins of said balloon sleeve;
b. curing the thermosetting polyurethane balloon sleeve while in intimate contact with said bands of thermo-plastic polyurethane polymer to effect a union between said thermosetting polyurethane and said thermoplastic polyurethane;
c. removing said balloon sleeve from said mold and said mandrel;
d. locating the sleeve in position over the lumen tube and e. sealing said end margins of the sleeve to the lumen tube by bonding said bands of thermoplastic poly-urethane to said tube.
a. casting a thermosetting polyurethane balloon sleeve about a mandrel having two bands of a thermoplastic polyurethane polymer previously provided thereon over areas corresponding to said end margins of said balloon sleeve;
b. curing the thermosetting polyurethane balloon sleeve while in intimate contact with said bands of thermo-plastic polyurethane polymer to effect a union between said thermosetting polyurethane and said thermoplastic polyurethane;
c. removing said balloon sleeve from said mold and said mandrel;
d. locating the sleeve in position over the lumen tube and e. sealing said end margins of the sleeve to the lumen tube by bonding said bands of thermoplastic poly-urethane to said tube.
5. A method of claim 4 wherein said bands of thermo-plastic polyurethane are bonded to said tube by the application of heat.
6. A method of claim 5 wherein said bands of thermo-plastic polyurethane are bonded to said tube by the application of a solvent for said bands and said tube.
7. A method of claim 4 wherein that portion of the tube intermediate the end margins of the balloon sleeve when the balloon sleeve is in position thereon is coated with a release agent prior to locating the sleeve in position over the catheter body.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US05/599,293 US4003382A (en) | 1975-07-25 | 1975-07-25 | Retention catheter and method of manufacture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1065227A true CA1065227A (en) | 1979-10-30 |
Family
ID=24399041
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA257,607A Expired CA1065227A (en) | 1975-07-25 | 1976-07-23 | Retention catheter and method of manufacture |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US4003382A (en) |
| AU (1) | AU498112B2 (en) |
| BR (1) | BR7604784A (en) |
| CA (1) | CA1065227A (en) |
| DE (2) | DE2633506A1 (en) |
| FR (1) | FR2318655A1 (en) |
| GB (2) | GB1547788A (en) |
| IT (1) | IT1192144B (en) |
Families Citing this family (103)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5820277Y2 (en) * | 1977-02-18 | 1983-04-26 | 昌純 高田 | Double contrast sonde for small intestine |
| FR2386406A1 (en) * | 1977-04-08 | 1978-11-03 | Technological Supply | PROCESS FOR THE MANUFACTURE OF A BALLOON CATHETER |
| US4168710A (en) * | 1977-08-10 | 1979-09-25 | The Kendall Company | Balloon cuff and catheter assembly |
| US4331142A (en) * | 1980-01-03 | 1982-05-25 | Riverain Corporation | Cuffed tracheal tube |
| US4386179A (en) * | 1980-05-07 | 1983-05-31 | Medical Research Associates, Ltd. | Hydrocarbon block copolymer with dispersed polysiloxane |
| US4448195A (en) * | 1981-05-08 | 1984-05-15 | Leveen Harry H | Reinforced balloon catheter |
| US4406653A (en) * | 1982-01-26 | 1983-09-27 | Critikon, Inc. | Adhesively mounted catheter balloon |
| US4737219A (en) * | 1985-02-12 | 1988-04-12 | Becton, Dickinson And Company | Method for bonding polyurethane balloons to multilumen catheters |
| US4661095A (en) * | 1985-02-12 | 1987-04-28 | Becton, Dickinson And Company | Method for bonding polyurethane balloons to multilumen catheters |
| US4636272A (en) * | 1985-02-19 | 1987-01-13 | Cordis Corporation | Process for thermally bonding plastic tubes |
| US4681092A (en) * | 1985-05-21 | 1987-07-21 | Kontron Inc. | Balloon catheter wrapping apparatus |
| US4758221A (en) * | 1986-02-18 | 1988-07-19 | St. Louis University | Catheter with a tip manipulation feature |
| US4913701A (en) * | 1988-10-06 | 1990-04-03 | Numed, Inc. | Balloon catheter and method of manufacturing the same |
| DE69002295T2 (en) * | 1989-09-25 | 1993-11-04 | Schneider Usa Inc | MULTILAYER EXTRUSION AS A METHOD FOR PRODUCING BALLOONS FOR VESSEL PLASTICS. |
| US5160559A (en) * | 1990-10-31 | 1992-11-03 | Scimed Life Systems, Inc. | Method for forming a guide catheter tip bond |
| US5318531A (en) * | 1991-06-11 | 1994-06-07 | Cordis Corporation | Infusion balloon catheter |
| US5439443A (en) * | 1991-09-30 | 1995-08-08 | Nippon Zeon Co., Ltd. | Balloon catheter |
| US5401241A (en) * | 1992-05-07 | 1995-03-28 | Inamed Development Co. | Duodenal intubation catheter |
| US5531721A (en) * | 1992-07-02 | 1996-07-02 | Scimed Life Systems, Inc. | Multiple member intravascular guide catheter |
| US5500180A (en) | 1992-09-30 | 1996-03-19 | C. R. Bard, Inc. | Method of making a distensible dilatation balloon using a block copolymer |
| US5464437A (en) * | 1993-07-08 | 1995-11-07 | Urologix, Inc. | Benign prostatic hyperplasia treatment catheter with urethral cooling |
| US5456661A (en) * | 1994-03-31 | 1995-10-10 | Pdt Cardiovascular | Catheter with thermally stable balloon |
| NL9401517A (en) * | 1994-09-19 | 1996-05-01 | Cordis Europ | MR visible catheter. |
| US5697946A (en) * | 1994-10-07 | 1997-12-16 | Origin Medsystems, Inc. | Method and apparatus for anchoring laparoscopic instruments |
| JP3500219B2 (en) * | 1995-03-03 | 2004-02-23 | オリンパス株式会社 | Endoscope |
| US20060271091A1 (en) * | 1995-09-18 | 2006-11-30 | Campbell Carey V | Balloon catheter device |
| US5752934A (en) * | 1995-09-18 | 1998-05-19 | W. L. Gore & Associates, Inc. | Balloon catheter device |
| US5868704A (en) * | 1995-09-18 | 1999-02-09 | W. L. Gore & Associates, Inc. | Balloon catheter device |
| US5643209A (en) * | 1995-12-15 | 1997-07-01 | Medtronic, Inc. | High pressure balloon tip |
| US5876376A (en) * | 1996-12-09 | 1999-03-02 | Medtronic, Inc | Catheter balloon bonding stopper |
| US6139525A (en) * | 1997-07-08 | 2000-10-31 | Advanced Cardiovascular Systems, Inc. | Fusion bonding of catheter components |
| US6010521A (en) * | 1997-11-25 | 2000-01-04 | Advanced Cardiovasular Systems, Inc. | Catheter member with bondable layer |
| US5964778A (en) * | 1998-03-17 | 1999-10-12 | Medtronic, Inc. | Balloon attachment at catheter tip |
| US20010001113A1 (en) | 1998-04-21 | 2001-05-10 | Florencia Lim | Balloon catheter |
| US6287314B1 (en) * | 1998-04-21 | 2001-09-11 | Advanced Cardiovascular Systems, Inc. | Stent deploying catheter system |
| US5954694A (en) * | 1998-08-07 | 1999-09-21 | Embol-X, Inc. | Nested tubing sections and methods for making same |
| US6186999B1 (en) * | 1998-08-27 | 2001-02-13 | The Cleveland Clinic Foundation | Rigid clampable cannula |
| US7892201B1 (en) | 1999-08-27 | 2011-02-22 | Gore Enterprise Holdings, Inc. | Balloon catheter and method of mounting same |
| US6375637B1 (en) | 1999-08-27 | 2002-04-23 | Gore Enterprise Holdings, Inc. | Catheter balloon having a controlled failure mechanism |
| US6663646B1 (en) * | 2000-10-24 | 2003-12-16 | Tilak M. Shah | Isotropically expansible balloon articles useful in in vivo lumenal procedures, and method of making such balloon articles |
| US6461326B1 (en) | 2000-10-26 | 2002-10-08 | Scimed Life Systems, Inc. | Fluorescent dyed adhesive for bonding various components in a medical device |
| US6712832B2 (en) | 2001-10-15 | 2004-03-30 | Tilak M. Shah | Low-pressure medical balloons and method of making same |
| ATE533417T1 (en) * | 2002-02-15 | 2011-12-15 | Teleflex Medical Inc | ANCHORING ARRANGEMENT FOR A MEDICAL INSTRUMENT |
| US7147619B2 (en) * | 2002-07-22 | 2006-12-12 | Advanced Cardiovascular Systems, Inc. | Catheter balloon having impregnated balloon skirt sections |
| US6802806B2 (en) | 2002-09-23 | 2004-10-12 | Cleveland Clinic Foundation | Apparatus for use with an inflow cannula of ventricular assist device |
| US20050113856A1 (en) * | 2003-10-15 | 2005-05-26 | Epstein Adam S. | Method of joining materials |
| US7824358B2 (en) * | 2004-07-22 | 2010-11-02 | Thoratec Corporation | Heart pump connector |
| US7691224B2 (en) * | 2005-10-28 | 2010-04-06 | Weller Kip D | Thermal bonding method |
| US7650184B2 (en) * | 2005-12-01 | 2010-01-19 | Boston Scientific Neuromodulation Corporation | Cylindrical multi-contact electrode lead for neural stimulation and method of making same |
| US8460240B2 (en) * | 2006-08-07 | 2013-06-11 | W. L. Gore & Associates, Inc. | Inflatable toroidal-shaped balloons |
| US20080097300A1 (en) * | 2006-08-07 | 2008-04-24 | Sherif Eskaros | Catheter balloon with multiple micropleats |
| US7785290B2 (en) * | 2006-08-07 | 2010-08-31 | Gore Enterprise Holdings, Inc. | Non-shortening high angle wrapped balloons |
| US20080033476A1 (en) * | 2006-08-07 | 2008-02-07 | Greene Joel M | Catheter balloon with controlled failure sheath |
| US9180279B2 (en) | 2006-08-07 | 2015-11-10 | W. L. Gore & Associates, Inc. | Inflatable imbibed polymer devices |
| US20080097374A1 (en) * | 2006-08-07 | 2008-04-24 | Korleski Joseph E | Inflatable shaped balloons |
| US20080140173A1 (en) * | 2006-08-07 | 2008-06-12 | Sherif Eskaros | Non-shortening wrapped balloon |
| US20080125711A1 (en) * | 2006-08-07 | 2008-05-29 | Alpini Alfred A | Catheter balloons with integrated non-distensible seals |
| US8890480B2 (en) * | 2006-11-30 | 2014-11-18 | The Boeing Company | Health management of rechargeable batteries |
| DE102007043830A1 (en) | 2007-09-13 | 2009-04-02 | Lozonschi, Lucian, Madison | Heart valve stent |
| JP2011502016A (en) * | 2007-11-06 | 2011-01-20 | コロプラスト アクティーゼルスカブ | Balloon catheter |
| US20100106051A1 (en) * | 2008-10-24 | 2010-04-29 | Innerspace, Inc. | Single lumen catheter with separate tubes therein |
| US20110288637A1 (en) * | 2009-02-11 | 2011-11-24 | De Marchena Eduardo | Percutaneous Mitral Annular Stitch to Decrease Mitral Regurgitation |
| EP2509538B1 (en) | 2009-12-08 | 2017-09-20 | Avalon Medical Ltd. | Device and system for transcatheter mitral valve replacement |
| CA3040390C (en) | 2011-08-11 | 2022-03-15 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
| US9827092B2 (en) | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
| US10039912B2 (en) * | 2012-07-10 | 2018-08-07 | St. Jude Medical, Atrial Fibrillation Division, Inc. | System and method for coupling a tube with a medical device handle |
| WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
| WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
| US9271752B2 (en) | 2013-03-13 | 2016-03-01 | Swan Valley Medical Incorporated | Method and apparatus for placing a cannula in a bladder |
| US11684747B2 (en) | 2013-03-15 | 2023-06-27 | Conmed Corporation | Multi-lumen shaft used with endoscopic device |
| US9326783B2 (en) * | 2013-03-15 | 2016-05-03 | Rsh, Llc | Removal tool for use with endoscopic device |
| US10463489B2 (en) | 2013-04-02 | 2019-11-05 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
| US11224510B2 (en) | 2013-04-02 | 2022-01-18 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
| US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
| US10478293B2 (en) | 2013-04-04 | 2019-11-19 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
| US9610159B2 (en) | 2013-05-30 | 2017-04-04 | Tendyne Holdings, Inc. | Structural members for prosthetic mitral valves |
| CN105658178B (en) | 2013-06-25 | 2018-05-08 | 坦迪尼控股股份有限公司 | Feature is complied with thrombus management and structure for prosthetic heart valve |
| CA2919379C (en) | 2013-08-01 | 2021-03-30 | Tendyne Holdings, Inc. | Epicardial anchor devices and methods |
| WO2015058039A1 (en) | 2013-10-17 | 2015-04-23 | Robert Vidlund | Apparatus and methods for alignment and deployment of intracardiac devices |
| JP6554094B2 (en) | 2013-10-28 | 2019-07-31 | テンダイン ホールディングス，インコーポレイテッド | Prosthetic heart valve and system and method for delivering an artificial heart valve |
| US9526611B2 (en) | 2013-10-29 | 2016-12-27 | Tendyne Holdings, Inc. | Apparatus and methods for delivery of transcatheter prosthetic valves |
| WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
| US9986993B2 (en) | 2014-02-11 | 2018-06-05 | Tendyne Holdings, Inc. | Adjustable tether and epicardial pad system for prosthetic heart valve |
| US20170340865A9 (en) * | 2014-03-07 | 2017-11-30 | Translational Biologic Infusion Catheter, Llc | Prolate spheroid-shaped balloon with central hinge |
| CA2937566C (en) | 2014-03-10 | 2023-09-05 | Tendyne Holdings, Inc. | Devices and methods for positioning and monitoring tether load for prosthetic mitral valve |
| JP6826035B2 (en) | 2015-01-07 | 2021-02-03 | テンダイン ホールディングス，インコーポレイテッド | Artificial mitral valve, and devices and methods for its delivery |
| AU2016215197B2 (en) | 2015-02-05 | 2020-01-02 | Tendyne Holdings Inc. | Expandable epicardial pads and devices and methods for their delivery |
| EP4070763A1 (en) | 2015-04-16 | 2022-10-12 | Tendyne Holdings, Inc. | Apparatus for retrieval of transcathter prosthetic valves |
| US10327894B2 (en) | 2015-09-18 | 2019-06-25 | Tendyne Holdings, Inc. | Methods for delivery of prosthetic mitral valves |
| GB2544559A (en) * | 2015-11-23 | 2017-05-24 | Owen Mumford Ltd | Apparatus for medicament delivery |
| AU2016362474B2 (en) | 2015-12-03 | 2021-04-22 | Tendyne Holdings, Inc. | Frame features for prosthetic mitral valves |
| AU2016380259B2 (en) | 2015-12-28 | 2020-10-22 | Tendyne Holdings, Inc. | Atrial pocket closures for prosthetic heart valves |
| JP6461852B2 (en) * | 2016-04-28 | 2019-01-30 | スマート・メディカル・システムズ・リミテッド | Endoscopy tools |
| US10470877B2 (en) | 2016-05-03 | 2019-11-12 | Tendyne Holdings, Inc. | Apparatus and methods for anterior valve leaflet management |
| EP3468480B1 (en) | 2016-06-13 | 2023-01-11 | Tendyne Holdings, Inc. | Sequential delivery of two-part prosthetic mitral valve |
| EP3478224B1 (en) | 2016-06-30 | 2022-11-02 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus for delivery of same |
| EP3484411A1 (en) | 2016-07-12 | 2019-05-22 | Tendyne Holdings, Inc. | Apparatus and methods for trans-septal retrieval of prosthetic heart valves |
| WO2019014473A1 (en) | 2017-07-13 | 2019-01-17 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus and methods for delivery of same |
| WO2019046099A1 (en) | 2017-08-28 | 2019-03-07 | Tendyne Holdings, Inc. | Prosthetic heart valves with tether coupling features |
| CN110548204A (en) * | 2019-10-12 | 2019-12-10 | 郭淑儿 | Integrated inflation-free laryngeal mask and production method thereof |
| US11648110B2 (en) | 2019-12-05 | 2023-05-16 | Tendyne Holdings, Inc. | Braided anchor for mitral valve |
| US11648114B2 (en) | 2019-12-20 | 2023-05-16 | Tendyne Holdings, Inc. | Distally loaded sheath and loading funnel |
| US11678980B2 (en) | 2020-08-19 | 2023-06-20 | Tendyne Holdings, Inc. | Fully-transseptal apical pad with pulley for tensioning |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3292627A (en) * | 1963-03-25 | 1966-12-20 | Pharmaseal Lab | Catheter |
| US3528869A (en) * | 1968-02-28 | 1970-09-15 | Davol Inc | Manufacture of plastic catheter |
| US3539674A (en) * | 1968-07-22 | 1970-11-10 | Davol Inc | Method of manufacturing a plastic catheter |
| US3884242A (en) * | 1971-03-29 | 1975-05-20 | Mpc Kurgisil | Catheter assembly |
| GB1380991A (en) * | 1972-02-01 | 1975-01-22 | Searle & Co | Catheters |
-
1975
- 1975-07-25 US US05/599,293 patent/US4003382A/en not_active Expired - Lifetime
-
1976
- 1976-06-28 AU AU15358/76A patent/AU498112B2/en not_active Expired
- 1976-07-23 IT IT50594/76A patent/IT1192144B/en active
- 1976-07-23 BR BR7604784A patent/BR7604784A/en unknown
- 1976-07-23 GB GB30826/76A patent/GB1547788A/en not_active Expired
- 1976-07-23 CA CA257,607A patent/CA1065227A/en not_active Expired
- 1976-07-23 GB GB13644/77A patent/GB1547789A/en not_active Expired
- 1976-07-23 FR FR7622617A patent/FR2318655A1/en not_active Withdrawn
- 1976-07-26 DE DE19762633506 patent/DE2633506A1/en active Pending
- 1976-07-26 DE DE19762656368 patent/DE2656368A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| AU1535876A (en) | 1978-01-05 |
| BR7604784A (en) | 1977-08-02 |
| AU498112B2 (en) | 1979-02-08 |
| GB1547788A (en) | 1979-06-27 |
| GB1547789A (en) | 1979-06-27 |
| DE2633506A1 (en) | 1977-02-24 |
| IT1192144B (en) | 1988-03-31 |
| FR2318655A1 (en) | 1977-02-18 |
| DE2656368A1 (en) | 1977-04-28 |
| US4003382A (en) | 1977-01-18 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA1065227A (en) | Retention catheter and method of manufacture | |
| US5042976A (en) | Balloon catheter and manufacturing method of the same | |
| US4328056A (en) | Method of making a cuffed tube | |
| CA1050376A (en) | Silicone catheter and process for manufacturing same | |
| US3528869A (en) | Manufacture of plastic catheter | |
| US3438375A (en) | Non-traumatic retention catheter | |
| US4335723A (en) | Catheter having inflatable retention means | |
| US4177815A (en) | Catheter balloon structure | |
| US3832253A (en) | Method of making an inflatable balloon catheter | |
| US5613979A (en) | Puncture resistant balloon catheter | |
| US4950239A (en) | Angioplasty balloons and balloon catheters | |
| US3983879A (en) | Silicone catheter | |
| US4850969A (en) | Retroperfusion catheter and tip construction for use therewith | |
| US4917667A (en) | Retroperfusion balloon catheter and method | |
| US4863442A (en) | Soft tip catheter | |
| US8298192B2 (en) | Balloon assembly with a torque | |
| US3304353A (en) | Method of catheter manufacture | |
| US4227293A (en) | Method of catheter manufacture | |
| US4154243A (en) | Catheter with improved balloon assembly | |
| US3985601A (en) | Method for producing a balloon type catheter having a smooth continuous outer surface | |
| CA1210554A (en) | Method for making a catheter with a soft, deformable tip and resulting product | |
| CA1239322A (en) | Method for bonding polyurethane balloons to multilumen catheters | |
| US3812860A (en) | Retention catheter | |
| CA1137852A (en) | Insert molded catheter and method | |
| US4188954A (en) | Catheter with improved balloon assembly |