CA1050376A - Silicone catheter and process for manufacturing same - Google Patents
Silicone catheter and process for manufacturing sameInfo
- Publication number
- CA1050376A CA1050376A CA231,065A CA231065A CA1050376A CA 1050376 A CA1050376 A CA 1050376A CA 231065 A CA231065 A CA 231065A CA 1050376 A CA1050376 A CA 1050376A
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- hole
- tubular body
- silicone
- outer 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
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
- A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
-
- 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
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
-
- 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
- A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
-
- 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
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
- Y10T156/1056—Perforating lamina
- Y10T156/1057—Subsequent to assembly of laminae
Abstract
ABSTRACT OF THE DISCLOSURE
An improved catheter comprising a tubular body portion comprising a primary lumen and an inflation lumen and an outer covering, a portion of which is inflatable to form an anchoring bubble, wherein a layer of thermoplastic material is applied around the tubular catheter body in the region underlying the anchoring bubble, the thermoplastic layer containing a hole through which an inflation medium can be injected from the inflation lumen to expand a portion of the outer covering to form the anchoring bubble and the thermoplastic layer being composed of a material to which the outer covering does not adhere.
An improved catheter comprising a tubular body portion comprising a primary lumen and an inflation lumen and an outer covering, a portion of which is inflatable to form an anchoring bubble, wherein a layer of thermoplastic material is applied around the tubular catheter body in the region underlying the anchoring bubble, the thermoplastic layer containing a hole through which an inflation medium can be injected from the inflation lumen to expand a portion of the outer covering to form the anchoring bubble and the thermoplastic layer being composed of a material to which the outer covering does not adhere.
Description
~S~137~
The present invention concerns improvements in the method for manufacturing a silicone catheter, a tubular medical device for insertion into the body for the purpose of injecting or withdrawing fluids. Although the :invention is described in the following specification with particular reference to a Foley catheter for insertion in the urethra, the invention is equally applicable to similarly constructed medical devices such as endotracheal tubes, tracheal tubes, Dennis tubes (used for de-compressing the intestinal tract prior to or after gastrointestinalsurgery), rectal catheters, Trocar catheters, hematuria balloon catheters, heart cathPters, and others. In addition, the concepts of this invention could also be applied to similarly constructed non-medical devices.
The typical Foley catheter consists of a tube or shaft containing a primary lumen which is the conduit for removal or insertion o~ the appropriate fluid. Within this primary lumen and attached to the wall thereof is at least one secondary, smaller lumen which is the conduit for the injection of an appropriate gas or fluid for inflation of a balloon anchoring the catheter ;nside the patient. The anchoring balloon generally consists of a thin, elastic material extending around the exterior of the catheter near its tip and attached at its edges or shoulders to the exterior of the catheter. A hole in the tube wall permits the inflation gas or fluid to enter underneath the elastic material and expand it to a balloon-like configuration.
In use the catheter is inserted into the body cavity, and an inflation fluid is pumped through the secondary lumen to expand the anchoring balloon. This prevents accide~tal removal of the catheter from the patient and stations the catheter in the .
-- 1 ~
~:)SC~376 1 appropriate position for efficient use. Once the catheter is so anchored, body fluids can be drained or therapeutic fluids can be injected into the body through the primary lumen. When the catheter is no longer needed, the inflation balloon is deflated by releasing the inflation fluid or gas and the catheter is withdrawn from the body.
Although this basic design for a catheter has been used for a number of years, serious problems remain in the design and method of construction of these devices. In particular, there are problems with the previous methods which have been used to provide the elastic exterior portion which forms the anchoring bubble. For example, in United States Patent No. 3,734,100 issued to Walker et al. a catheter construction is descri~ed in which a separate cuff portion is glued at its shoulders to the surface of the catheter. Although the patent illustrates the exterior surface of the catheter as being smooth and regular, unfortunately, in practice the thickness of the cuff portion and the effects of the glue cause surface irregularities at the cuff's shoulders.
Thus, in a typical catheter produced by the process of Walker et al.
tbe shoulders of the c~ff will protrude beyond the remaining exterior surface of the catheter. This situation is undesirable because such irregularities impede the insertion or withdrawal of the catheter and increase the discomfort to the patient. In addition, such a catheter construction is generally not amenable to mechanîzed production, and manufacture of the catheters by hand causes additional imperfections and defects.
As an alternative, it has been suggested to cover the exterior of the catheter tube in the area underlying the bubble with a masking (release~ material, coating the tip of the catheter including the bubble region with a flexible, inflatable material, and subsequently removing the underlying masking material.
~ 2 ~
~OS~376 For example, in the patents to Harautuneian ~U.S~ Patent Nos.3,292,627 and 3,304,353) the use of a water soluble masking material is suggested. However, there are several problems with this design. First, in simulkaneously removing the water soluble relea~e material and inflating the anchoring bubble, difficulties in the dissolution of the release material frequently cause particles to become lodged in the inflation lumen preventiny further expansion of the anchoring bubble. Similarly, as dis-cussed in Harautuneian's United States Patent No. 3,452,756, the masking layer may only dissolve in the localized area adjacent the hole to the inflation lumen. Thus, the anchoring bubble may expand preferentially in that area and cause localized pressure injuries to the body tissue. The same general type of system is shown in British Patent No. 1,234,037--Steer et al.
Alternatively, U.S. Patent No 3,544,668 issued to Dereniuk illustrates the use of a gel as a masking layer beneath the anchoring balloon. Following the formation of the outer skin on the catheter, the gel lay~r is volatilized by heat. This method is difficult to practice because the outer covering of the catheter must be applied before the release coating has dried or is touched.
A further difficulty encountered with the prior art processes for manufacturing a catheter is that they are not applicable to the most useful catheter material, silicone. It has been found that silicone is more compatible with human tissue than previously used rubber and plastic materials and that the incidence of infection in the body tissues is appreciably reduced with silicone catheters. Although attempts have been made to apply silicone coatings over conventional catheter tube materials, silicone bonds poorly with the majority of these other materials.
~1~50376 1 Accordingly, i~ is preferable to construct the entire catheter of silicone. Because of silicone's hydrophobic nature, however, it is difficult to apply coatings such as those in the Harauteneian and Dereniuk patents to silicone. Thus, in addition to the problems generally encountered with water soluble or volatile release coatings, a further defect is that these coatings are not useful in preparing silicone catheters.
In view of the foregoing, it is an object of the present invention to provide an improved catheter construction and a method for facilitating the construction of these catheters.
It is also an object of this invention to provide an improved silicone catheter and a method for constructing catheters made entirely of silicone.
It is also an object of this invention to provide a method for constructing catheters in a mechanized operation.
It is a further object of this invention to provide a catheter which does not suffer the defects of localized swelling of the anchoring bubble or the plugging of the inflation lumen caused by the particles from the release coating.
SUMMARY OF THE INVENTION
The invention comprises an improved catheter design and a method for constructing this catheter.
The catheter comprises a tubular body comprising a larger primary lumen and a smaller inflation lumen; a smooth tip at the distal end of the catheter body which seals the primary and inflation lumens; an outer covering enclosing the tubular catheter body and the tip; the tubular catheter body containing a first hole to permit communication of fluids through the outer covering between the exterior of the tube and the primary lumen and a second hole permitting communication between the exterior of i~S(~376 1 the tube and the inflation lumen but not throu~h the outer covering;
and a thin thermoplastic tape surrounding the tube underneath the outer covering and overlapping the second hole, the width of the tape corresponding to the desired base of the anchoring bubble formed by inflation of a portion o:E the outer layer, the tape containing a hole adjacent said second hole to permit the inflation of the anchoring bubble and the tape comprising a material to which said outer layer does not adhere.
The method comprises the steps of forming a tubular catheter body comprising a larger primary lumen and a smaller inflation lumen inside the primary lumen, forming a first hole in the wall of the tu~ular body to permit communication between the inflation lumen and the exterior of the tube, forming a smooth tip to the distal end of the tubular body, applying a thin layer of thermoplastic tape to the exterior of the tubular body under-neath the portion of the outer la~er which forms the anchoring bubble and overlapping the first hole, applying an outer layer of covering material which does not adhere to the thermoplastic tape to the exterior of the tubular body to form a covered tube, forming a second hole in the covered tube to permit communication between the primary lumen and the exterior of the covered tube and forming a third hole in the thermoplastic tape adjacent the first hole.
DESCRIPTION OF THE DRAWINGS
The invention is illus~rated by the following drawings in which FIGURE 1 iS a "top view'l of the uninflated catheter.
FIGURE 2 is a "side view" of the uninflated catheter.
FIGURE 3 is a cross section of the uninflated cat~eter taken along line 3.
FIGURE 4 is a cutaway "side view" of the catheter ~050376 1 illustrating the inflated anchoring bubble.
FIGURE 5 is a cross section of the uninflated catheter taken along line 4.
Referring to the drawings, the first step in the pre-paration o the catheter is the formation of tube 10 comprising primary lumen 12 and inflation lumen 14. The cross-sectional shape and orientation of these two channels may take ~arious forms other than that shown in FIGURES 3 and 5. However, to provide the minimum amount of resistance for insertion into the 1~ patient, it is desirable that the exterior cross section of the tube be essentially round. Formation of this tube can be accom-plished by any ordinary procedure, such as extrusion, wherein a continuous length of tubing is formed. The tubing is then cut to the appropriate length desired for the catheter.
After the tubular body of the catheter is formed, an inflation hole 18 is formed in the extexior of the tube to provide a passage to the inflation lumen. This hole is located at an ~appropriate distance from the distal end of the catheter tube where the anchoring bubble is to be located. The distal end of the catheter refers to the end which is inserted into the patient.
The hole can be formed by any standard procedure, such as cutting or punching the exterior of the catheter tube.
Following the formation of the inflation hole a layer of thermoplastic material 20 is wrapped around the tube so that it covers the inflation hole. An appropriate thermoplastic material is a thermoplastic tape whose adhesive side adheres to the exterior of tube 10 but whose opposite side does not adhere to the subsequen-tly applied outer layer of the catheter. The wrapping of the thermoplastic tape can be accomplished by hand or by mechanical means in such a manner that the ends of theitape overlap very slightly. This will insure that the outer covering which forms the anchoring bubble will not adhere to any portion of 1 the underlying tu~e. In addition, the thermoplastic tape should be thin, for example less than .05 inch and, preferably, approxi-mately 0.004 inch in thickness. This should avoid any impairment to the insertion of the catheter into the body caused by an enlargement of the outside diameter of the catheter tube in the region adjacent the thermoplastic tape.
Following the application of the. thermoplastic tape a tip 16 is formed on the distal ~nd of the catheter. Although the tip shown in the drawing is semi-spherical in shape, the actual configuration of the tip can take any form which facilitates the insertion of the catheter into the body. Preferably the tip is molded to the tubular body, for example, by placing the end of the tube into an open metal form filled with liquid material.
This method of forming the tip is preferred, since it provides a secure seal of the inflation lumen at 22. Without such a seal it would be difficult, if not impossible, to inflate and maintain the anchoring bubble.
After these essential elements of the catheter are ormed and assembled, an outer layer of material is applied over the length of the catheter by dipping the catheter into a solution of the covering material. The coating is dried and cured at room temperature and humidity over night or more rapidly at elevated temperatures. Additional coatings may be required to achieve the desired thickness of the outer layerO The procedures for dip coating a catheter with silicone are known to those skilled in the art as shown, for example, in United States Patent No. 3,434,863, issued to Davidson. As illustrated in the drawings, the completed coated catheter has a smooth outer surface which does not present any protrusions which might impede the insertion or extraction of the catheter from the body.
~SV37~
1 Following the formation of the coating, hole 26 is punched in the catheter wall to provide a channel between the primary lumen and the exterior of the catheter. Although this hole can take any shape and size, as shown in the drawings, identical oval holes are punched on opposite sides of the catheter to facilitate injection or withdrawal of fluids from the body.
Finally, an inflation hole 28 is formed in the thermo--plastic tape. This hole is adjacent the inflation hole ~pre-viously cut in the wall of the catheter tube. The thermoplastic tape is pierced by touching the silicone coating over the opening 18 with a hot probe the temperature of which is adjusted to melt the thermoplastic tape but not to affect the silicone outer coating.
The advantages of the present invention are readily apparent from FIGURE 4 whiCh shows the anchoring bubble of the catheter in its inflated position. When the inflation fluid or gas is forced through inflation lumen 14, it inflates the bubble as shown in FIGURE 4. Since the masking material does not have to be dissolved during inflation, the inflation occurs steadily and uniformly and the inflation lumen will not become plugged by particles of partially dissolved masking material.
As mentioned previously, it is desirable to build the entire catheter of sili~one because of its compatibility with human tissues. Typically the tubular catheter body and the tip are made of much harder silicones than that used for the outer covering.
The thermoplastic masking tape may be made of any thin material whose adhesive side adheres to the tubular body of the catheter, whose opposite side does not adhere to the outer coating of the catheter, and which melts at a temperature significantly lower than that of the outer coating. Where the tubular body and outer coating are both made from silicone, a suitable release 3~05Q3'~6 1 material consîsts of unreinforced polyethylene or polypropylene tape having a thickness of approximately 0.005 inch.
Typical properties of materials presently available which are suitable for use in the present invention are designated in Table I.
TABLE I
Tu~ular Body ip Outer Coating_ Shore A
Durometer5~-70 30-70 30-55 1 a Tensile Strength (p.s.i.)900-1400 850-1200 300-900 Elongation (%) 200-500 125-900 350-~00 Tear Resistance (lbs./in.) 60-200 20-100 40 130 Type of Silicone RubberHeat Cured* 2 Part Room** 1 Part Room***
Temperature Temperature ~ulcanizing Vulcanizing * Cured at elevated temperature and pressure in the presence of peroxide.
20 ** Mixed with a catalyst, normally a metallic soap, and cured at room temperature.
*** Cured by exposure to moist air at room temperature.
Following the formation of the catheter illustrated in the drawings it is also desirable to mold to the external end of the catheter suitable appratus containing a provision for injecting gas or fluid into the inflation lumen and for connecting the primary lumen to suitable drainage or injection meansO A
typical device is shown, for example, in United States Patent No. 3,769,981 to McWhorter et al.
A silicone catheter was prepared according to the follow-_ g _ ~050~7~
1 ing procedure. First, a silicone mixture was prepared using the heat cured silicone rubber describ~ed in Table II and 1.0 percent of a catalyst comprising bis 2-4 dichlorobenzoyl peroxide (Cadox TS-50). This mixt~re was extruded into a tube comprising a primary lumen and an inflation lumen arranged as shown in FIGURES 1 through 5. This tube is extruded through a tunnel maintained at about 900F and has a residence time within the tunnel of approximately 1-4 minutes. As the tube leaves the tunnel it is cut to the size appropriate for the particular application of the catheter.
Subsequently, a hole is punched at the distal end of the tubular body of the catheter at the location of the anchoring ba~ oon, the hole providing a passage to the inflation lumen.
At this point the tip is formed on the distal end of the catheter. A liquid two-part silicone rubber (as described in Table II) is poured into a steel mold, and the distal end of the catheter is immediately inserted into the mold. The catheter is permitted to remain in the mold while the silicone tip is cured. The catheter is removed from the mold and cured for four hours at 350F. This process drives off any remaining catalyst and completes the cure of the catheter body.
The catheter is prepared for dip coating by applying a strip of polypropylene tape around the cathetex tube so that it overlaps the previously punched hole. The catheter is then dipped into a 40 percent solvent solution one-part room temperature vulcanized silicone rubber (as described in Table II) and cyclohexane, withdrawn at a slow, steady rate, inverted and dried for 40 minutes at 120F. This dipping and drying procedure is repeated two additional times. On the final (third) coating blue dye is added to the silicone solution to add colour to the 3~ catheter.
:~S~3~
1 Following the final drying step, two elliptical drainage holes are punched in the distal end of the catheter to provide communication of the drainage lumen with the exterior of the catheter. A probe heated to 500F is then applied for about 30 seconds to the catheter skin adjacent the hole to the inflation lumen to form a hole in the polypropylene tape.
The catheter is tested by in~lating and inspecting the anchoring balloon.
TAB~E II
Tubular Body Tip Outer Coating Shore A
Durometer60+5 35+5 40~5 Tensile Strength ~p.s.i.~ll00 925 800 Elongation (~) 350 ~50 70 Tear Resistance ~lbs./in.) 90 25 l00 Type of Silicone 20 RubberHeat Cured 2 Part Room l Part Room Temperature Temperature Vulcanizing Vulcanizing It should be men~ioned that the order of the foregoing steps in the process of producing the catheter of this invention may be varied from that described without any effect on the catheter.
For example, the tip may be molded to the body b~fore application of the masking tape and the order of forming holes 26 and 28 may be reversed~
The present invention concerns improvements in the method for manufacturing a silicone catheter, a tubular medical device for insertion into the body for the purpose of injecting or withdrawing fluids. Although the :invention is described in the following specification with particular reference to a Foley catheter for insertion in the urethra, the invention is equally applicable to similarly constructed medical devices such as endotracheal tubes, tracheal tubes, Dennis tubes (used for de-compressing the intestinal tract prior to or after gastrointestinalsurgery), rectal catheters, Trocar catheters, hematuria balloon catheters, heart cathPters, and others. In addition, the concepts of this invention could also be applied to similarly constructed non-medical devices.
The typical Foley catheter consists of a tube or shaft containing a primary lumen which is the conduit for removal or insertion o~ the appropriate fluid. Within this primary lumen and attached to the wall thereof is at least one secondary, smaller lumen which is the conduit for the injection of an appropriate gas or fluid for inflation of a balloon anchoring the catheter ;nside the patient. The anchoring balloon generally consists of a thin, elastic material extending around the exterior of the catheter near its tip and attached at its edges or shoulders to the exterior of the catheter. A hole in the tube wall permits the inflation gas or fluid to enter underneath the elastic material and expand it to a balloon-like configuration.
In use the catheter is inserted into the body cavity, and an inflation fluid is pumped through the secondary lumen to expand the anchoring balloon. This prevents accide~tal removal of the catheter from the patient and stations the catheter in the .
-- 1 ~
~:)SC~376 1 appropriate position for efficient use. Once the catheter is so anchored, body fluids can be drained or therapeutic fluids can be injected into the body through the primary lumen. When the catheter is no longer needed, the inflation balloon is deflated by releasing the inflation fluid or gas and the catheter is withdrawn from the body.
Although this basic design for a catheter has been used for a number of years, serious problems remain in the design and method of construction of these devices. In particular, there are problems with the previous methods which have been used to provide the elastic exterior portion which forms the anchoring bubble. For example, in United States Patent No. 3,734,100 issued to Walker et al. a catheter construction is descri~ed in which a separate cuff portion is glued at its shoulders to the surface of the catheter. Although the patent illustrates the exterior surface of the catheter as being smooth and regular, unfortunately, in practice the thickness of the cuff portion and the effects of the glue cause surface irregularities at the cuff's shoulders.
Thus, in a typical catheter produced by the process of Walker et al.
tbe shoulders of the c~ff will protrude beyond the remaining exterior surface of the catheter. This situation is undesirable because such irregularities impede the insertion or withdrawal of the catheter and increase the discomfort to the patient. In addition, such a catheter construction is generally not amenable to mechanîzed production, and manufacture of the catheters by hand causes additional imperfections and defects.
As an alternative, it has been suggested to cover the exterior of the catheter tube in the area underlying the bubble with a masking (release~ material, coating the tip of the catheter including the bubble region with a flexible, inflatable material, and subsequently removing the underlying masking material.
~ 2 ~
~OS~376 For example, in the patents to Harautuneian ~U.S~ Patent Nos.3,292,627 and 3,304,353) the use of a water soluble masking material is suggested. However, there are several problems with this design. First, in simulkaneously removing the water soluble relea~e material and inflating the anchoring bubble, difficulties in the dissolution of the release material frequently cause particles to become lodged in the inflation lumen preventiny further expansion of the anchoring bubble. Similarly, as dis-cussed in Harautuneian's United States Patent No. 3,452,756, the masking layer may only dissolve in the localized area adjacent the hole to the inflation lumen. Thus, the anchoring bubble may expand preferentially in that area and cause localized pressure injuries to the body tissue. The same general type of system is shown in British Patent No. 1,234,037--Steer et al.
Alternatively, U.S. Patent No 3,544,668 issued to Dereniuk illustrates the use of a gel as a masking layer beneath the anchoring balloon. Following the formation of the outer skin on the catheter, the gel lay~r is volatilized by heat. This method is difficult to practice because the outer covering of the catheter must be applied before the release coating has dried or is touched.
A further difficulty encountered with the prior art processes for manufacturing a catheter is that they are not applicable to the most useful catheter material, silicone. It has been found that silicone is more compatible with human tissue than previously used rubber and plastic materials and that the incidence of infection in the body tissues is appreciably reduced with silicone catheters. Although attempts have been made to apply silicone coatings over conventional catheter tube materials, silicone bonds poorly with the majority of these other materials.
~1~50376 1 Accordingly, i~ is preferable to construct the entire catheter of silicone. Because of silicone's hydrophobic nature, however, it is difficult to apply coatings such as those in the Harauteneian and Dereniuk patents to silicone. Thus, in addition to the problems generally encountered with water soluble or volatile release coatings, a further defect is that these coatings are not useful in preparing silicone catheters.
In view of the foregoing, it is an object of the present invention to provide an improved catheter construction and a method for facilitating the construction of these catheters.
It is also an object of this invention to provide an improved silicone catheter and a method for constructing catheters made entirely of silicone.
It is also an object of this invention to provide a method for constructing catheters in a mechanized operation.
It is a further object of this invention to provide a catheter which does not suffer the defects of localized swelling of the anchoring bubble or the plugging of the inflation lumen caused by the particles from the release coating.
SUMMARY OF THE INVENTION
The invention comprises an improved catheter design and a method for constructing this catheter.
The catheter comprises a tubular body comprising a larger primary lumen and a smaller inflation lumen; a smooth tip at the distal end of the catheter body which seals the primary and inflation lumens; an outer covering enclosing the tubular catheter body and the tip; the tubular catheter body containing a first hole to permit communication of fluids through the outer covering between the exterior of the tube and the primary lumen and a second hole permitting communication between the exterior of i~S(~376 1 the tube and the inflation lumen but not throu~h the outer covering;
and a thin thermoplastic tape surrounding the tube underneath the outer covering and overlapping the second hole, the width of the tape corresponding to the desired base of the anchoring bubble formed by inflation of a portion o:E the outer layer, the tape containing a hole adjacent said second hole to permit the inflation of the anchoring bubble and the tape comprising a material to which said outer layer does not adhere.
The method comprises the steps of forming a tubular catheter body comprising a larger primary lumen and a smaller inflation lumen inside the primary lumen, forming a first hole in the wall of the tu~ular body to permit communication between the inflation lumen and the exterior of the tube, forming a smooth tip to the distal end of the tubular body, applying a thin layer of thermoplastic tape to the exterior of the tubular body under-neath the portion of the outer la~er which forms the anchoring bubble and overlapping the first hole, applying an outer layer of covering material which does not adhere to the thermoplastic tape to the exterior of the tubular body to form a covered tube, forming a second hole in the covered tube to permit communication between the primary lumen and the exterior of the covered tube and forming a third hole in the thermoplastic tape adjacent the first hole.
DESCRIPTION OF THE DRAWINGS
The invention is illus~rated by the following drawings in which FIGURE 1 iS a "top view'l of the uninflated catheter.
FIGURE 2 is a "side view" of the uninflated catheter.
FIGURE 3 is a cross section of the uninflated cat~eter taken along line 3.
FIGURE 4 is a cutaway "side view" of the catheter ~050376 1 illustrating the inflated anchoring bubble.
FIGURE 5 is a cross section of the uninflated catheter taken along line 4.
Referring to the drawings, the first step in the pre-paration o the catheter is the formation of tube 10 comprising primary lumen 12 and inflation lumen 14. The cross-sectional shape and orientation of these two channels may take ~arious forms other than that shown in FIGURES 3 and 5. However, to provide the minimum amount of resistance for insertion into the 1~ patient, it is desirable that the exterior cross section of the tube be essentially round. Formation of this tube can be accom-plished by any ordinary procedure, such as extrusion, wherein a continuous length of tubing is formed. The tubing is then cut to the appropriate length desired for the catheter.
After the tubular body of the catheter is formed, an inflation hole 18 is formed in the extexior of the tube to provide a passage to the inflation lumen. This hole is located at an ~appropriate distance from the distal end of the catheter tube where the anchoring bubble is to be located. The distal end of the catheter refers to the end which is inserted into the patient.
The hole can be formed by any standard procedure, such as cutting or punching the exterior of the catheter tube.
Following the formation of the inflation hole a layer of thermoplastic material 20 is wrapped around the tube so that it covers the inflation hole. An appropriate thermoplastic material is a thermoplastic tape whose adhesive side adheres to the exterior of tube 10 but whose opposite side does not adhere to the subsequen-tly applied outer layer of the catheter. The wrapping of the thermoplastic tape can be accomplished by hand or by mechanical means in such a manner that the ends of theitape overlap very slightly. This will insure that the outer covering which forms the anchoring bubble will not adhere to any portion of 1 the underlying tu~e. In addition, the thermoplastic tape should be thin, for example less than .05 inch and, preferably, approxi-mately 0.004 inch in thickness. This should avoid any impairment to the insertion of the catheter into the body caused by an enlargement of the outside diameter of the catheter tube in the region adjacent the thermoplastic tape.
Following the application of the. thermoplastic tape a tip 16 is formed on the distal ~nd of the catheter. Although the tip shown in the drawing is semi-spherical in shape, the actual configuration of the tip can take any form which facilitates the insertion of the catheter into the body. Preferably the tip is molded to the tubular body, for example, by placing the end of the tube into an open metal form filled with liquid material.
This method of forming the tip is preferred, since it provides a secure seal of the inflation lumen at 22. Without such a seal it would be difficult, if not impossible, to inflate and maintain the anchoring bubble.
After these essential elements of the catheter are ormed and assembled, an outer layer of material is applied over the length of the catheter by dipping the catheter into a solution of the covering material. The coating is dried and cured at room temperature and humidity over night or more rapidly at elevated temperatures. Additional coatings may be required to achieve the desired thickness of the outer layerO The procedures for dip coating a catheter with silicone are known to those skilled in the art as shown, for example, in United States Patent No. 3,434,863, issued to Davidson. As illustrated in the drawings, the completed coated catheter has a smooth outer surface which does not present any protrusions which might impede the insertion or extraction of the catheter from the body.
~SV37~
1 Following the formation of the coating, hole 26 is punched in the catheter wall to provide a channel between the primary lumen and the exterior of the catheter. Although this hole can take any shape and size, as shown in the drawings, identical oval holes are punched on opposite sides of the catheter to facilitate injection or withdrawal of fluids from the body.
Finally, an inflation hole 28 is formed in the thermo--plastic tape. This hole is adjacent the inflation hole ~pre-viously cut in the wall of the catheter tube. The thermoplastic tape is pierced by touching the silicone coating over the opening 18 with a hot probe the temperature of which is adjusted to melt the thermoplastic tape but not to affect the silicone outer coating.
The advantages of the present invention are readily apparent from FIGURE 4 whiCh shows the anchoring bubble of the catheter in its inflated position. When the inflation fluid or gas is forced through inflation lumen 14, it inflates the bubble as shown in FIGURE 4. Since the masking material does not have to be dissolved during inflation, the inflation occurs steadily and uniformly and the inflation lumen will not become plugged by particles of partially dissolved masking material.
As mentioned previously, it is desirable to build the entire catheter of sili~one because of its compatibility with human tissues. Typically the tubular catheter body and the tip are made of much harder silicones than that used for the outer covering.
The thermoplastic masking tape may be made of any thin material whose adhesive side adheres to the tubular body of the catheter, whose opposite side does not adhere to the outer coating of the catheter, and which melts at a temperature significantly lower than that of the outer coating. Where the tubular body and outer coating are both made from silicone, a suitable release 3~05Q3'~6 1 material consîsts of unreinforced polyethylene or polypropylene tape having a thickness of approximately 0.005 inch.
Typical properties of materials presently available which are suitable for use in the present invention are designated in Table I.
TABLE I
Tu~ular Body ip Outer Coating_ Shore A
Durometer5~-70 30-70 30-55 1 a Tensile Strength (p.s.i.)900-1400 850-1200 300-900 Elongation (%) 200-500 125-900 350-~00 Tear Resistance (lbs./in.) 60-200 20-100 40 130 Type of Silicone RubberHeat Cured* 2 Part Room** 1 Part Room***
Temperature Temperature ~ulcanizing Vulcanizing * Cured at elevated temperature and pressure in the presence of peroxide.
20 ** Mixed with a catalyst, normally a metallic soap, and cured at room temperature.
*** Cured by exposure to moist air at room temperature.
Following the formation of the catheter illustrated in the drawings it is also desirable to mold to the external end of the catheter suitable appratus containing a provision for injecting gas or fluid into the inflation lumen and for connecting the primary lumen to suitable drainage or injection meansO A
typical device is shown, for example, in United States Patent No. 3,769,981 to McWhorter et al.
A silicone catheter was prepared according to the follow-_ g _ ~050~7~
1 ing procedure. First, a silicone mixture was prepared using the heat cured silicone rubber describ~ed in Table II and 1.0 percent of a catalyst comprising bis 2-4 dichlorobenzoyl peroxide (Cadox TS-50). This mixt~re was extruded into a tube comprising a primary lumen and an inflation lumen arranged as shown in FIGURES 1 through 5. This tube is extruded through a tunnel maintained at about 900F and has a residence time within the tunnel of approximately 1-4 minutes. As the tube leaves the tunnel it is cut to the size appropriate for the particular application of the catheter.
Subsequently, a hole is punched at the distal end of the tubular body of the catheter at the location of the anchoring ba~ oon, the hole providing a passage to the inflation lumen.
At this point the tip is formed on the distal end of the catheter. A liquid two-part silicone rubber (as described in Table II) is poured into a steel mold, and the distal end of the catheter is immediately inserted into the mold. The catheter is permitted to remain in the mold while the silicone tip is cured. The catheter is removed from the mold and cured for four hours at 350F. This process drives off any remaining catalyst and completes the cure of the catheter body.
The catheter is prepared for dip coating by applying a strip of polypropylene tape around the cathetex tube so that it overlaps the previously punched hole. The catheter is then dipped into a 40 percent solvent solution one-part room temperature vulcanized silicone rubber (as described in Table II) and cyclohexane, withdrawn at a slow, steady rate, inverted and dried for 40 minutes at 120F. This dipping and drying procedure is repeated two additional times. On the final (third) coating blue dye is added to the silicone solution to add colour to the 3~ catheter.
:~S~3~
1 Following the final drying step, two elliptical drainage holes are punched in the distal end of the catheter to provide communication of the drainage lumen with the exterior of the catheter. A probe heated to 500F is then applied for about 30 seconds to the catheter skin adjacent the hole to the inflation lumen to form a hole in the polypropylene tape.
The catheter is tested by in~lating and inspecting the anchoring balloon.
TAB~E II
Tubular Body Tip Outer Coating Shore A
Durometer60+5 35+5 40~5 Tensile Strength ~p.s.i.~ll00 925 800 Elongation (~) 350 ~50 70 Tear Resistance ~lbs./in.) 90 25 l00 Type of Silicone 20 RubberHeat Cured 2 Part Room l Part Room Temperature Temperature Vulcanizing Vulcanizing It should be men~ioned that the order of the foregoing steps in the process of producing the catheter of this invention may be varied from that described without any effect on the catheter.
For example, the tip may be molded to the body b~fore application of the masking tape and the order of forming holes 26 and 28 may be reversed~
Claims (10)
1. A method for forming a catheter comprising the steps of:
(1) forming a tubular body comprising a primary lumen and an inflation lumen;
(2) forming a first hole in said tubular body to permit communication between said inflation lumen and the exterior of said tubular body;
(3) applying a thin layer of thermoplastic material around the exterior of said tubular body to overlap said first hole;
(4) applying an outer layer of covering material to which the thermoplastic material will not adhere, to the exterior of said tubular body to form a covered tube;
(5) forming a second hole in the covered tube to permit communication between said primary lumen and the exterior of said covered tube; and (6) forming a third hole in said thermoplastic material in communication with said first hole in said tube.
(1) forming a tubular body comprising a primary lumen and an inflation lumen;
(2) forming a first hole in said tubular body to permit communication between said inflation lumen and the exterior of said tubular body;
(3) applying a thin layer of thermoplastic material around the exterior of said tubular body to overlap said first hole;
(4) applying an outer layer of covering material to which the thermoplastic material will not adhere, to the exterior of said tubular body to form a covered tube;
(5) forming a second hole in the covered tube to permit communication between said primary lumen and the exterior of said covered tube; and (6) forming a third hole in said thermoplastic material in communication with said first hole in said tube.
2. The method of claim 1 wherein the step of forming said tubular body comprises extruding a silicone tube comprising a primary lumen and an inflation lumen.
3. The method of claim 2 wherein prior to the step of applying said outer layer of covering material a silicone tip is molded to the distal end of said tube.
4. The method of claim 1 wherein the step of applying an outer layer of covering material comprises dipping said tubular body in a silicone solution to form an outer layer and drying said outer layer.
5. The method of claim 4 wherein the step of forming said third hole comprises subjecting the outer layer of said catheter to a point adjacent said first hole to a heat sufficient to melt a hole in said thermoplastic material without melting said silicone outer layer.
6. In a catheter comprising:
(1) a tubular body comprising a primary lumen and an in-flation lumen;
(2) a smooth tip at the distal end of said tubular catheter body;
(3) an outer covering enclosing said tubular catheter body and said tip;
(4) said tubular body containing a first hole to permit communication through said outer covering between the exterior of said tubular body and said primary lumen and a second hole permitting communication between the exterior of said tubular body and said inflation lumen but not through said outer covering the improvement comprising: a thin layer of thermoplastic material surrounding said tubular body underneath but not adhering to said outer covering and overlapping said second hole, the width of said layer of material corresponding to the desired base of an anchoring bubble formable by inflation of a portion of the outer layer, said layer of thermoplastic material containing a hole in communication with said second hole to permit said inflation.
(1) a tubular body comprising a primary lumen and an in-flation lumen;
(2) a smooth tip at the distal end of said tubular catheter body;
(3) an outer covering enclosing said tubular catheter body and said tip;
(4) said tubular body containing a first hole to permit communication through said outer covering between the exterior of said tubular body and said primary lumen and a second hole permitting communication between the exterior of said tubular body and said inflation lumen but not through said outer covering the improvement comprising: a thin layer of thermoplastic material surrounding said tubular body underneath but not adhering to said outer covering and overlapping said second hole, the width of said layer of material corresponding to the desired base of an anchoring bubble formable by inflation of a portion of the outer layer, said layer of thermoplastic material containing a hole in communication with said second hole to permit said inflation.
7. The catheter of claim 6 wherein said outer layer is formed of silicone.
8. The catheter of claim 7 wherein said tubular body and said smooth tip are formed of silicone.
9. The catheter of claim 6 wherein the layer of thermo-plastic material is unreinforced tape of a member selected from the group consisting of polyethylene and polypropylene.
10. The catheter of claim 9 wherein said outer layer presents a smooth exterior surface for contacting body tissues with-out any protrusions or other variations which would interfere with the easy insertion of said catheter into the body.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US491623A US3926705A (en) | 1974-07-25 | 1974-07-25 | Silicone catheter and process for manufacturing same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1050376A true CA1050376A (en) | 1979-03-13 |
Family
ID=23952992
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA231,065A Expired CA1050376A (en) | 1974-07-25 | 1975-07-08 | Silicone catheter and process for manufacturing same |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US3926705A (en) |
| JP (1) | JPS5135586A (en) |
| AR (1) | AR204206A1 (en) |
| BE (1) | BE831746A (en) |
| CA (1) | CA1050376A (en) |
| CH (1) | CH600894A5 (en) |
| DE (1) | DE2532832A1 (en) |
| FR (1) | FR2279424A1 (en) |
| GB (1) | GB1470023A (en) |
| IT (1) | IT1039272B (en) |
| LU (1) | LU73033A1 (en) |
| NL (1) | NL7508940A (en) |
| SE (1) | SE407746B (en) |
| ZA (1) | ZA754114B (en) |
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| US4212304A (en) * | 1978-04-07 | 1980-07-15 | Medical Engineering Corp. | Uretheral catheter stent |
| DE2837813C3 (en) * | 1978-08-30 | 1981-08-20 | Willy Rüsch GmbH & Co KG, 7053 Kernen | Method of making a medical tube or catheter |
| US4392848A (en) * | 1979-06-25 | 1983-07-12 | The Procter & Gamble Company | Catheterization |
| US4343788A (en) * | 1979-06-29 | 1982-08-10 | The Procter & Gamble Company | Antimicrobial polymer compositions |
| US4479795A (en) * | 1979-06-29 | 1984-10-30 | The Procter & Gamble Company | Antimicrobial polymer compositions |
| US4445891A (en) * | 1980-05-05 | 1984-05-01 | The Kendall Company | Catheter |
| US4445890A (en) * | 1980-05-05 | 1984-05-01 | The Kendall Company | Catheter |
| US4447228A (en) * | 1980-05-05 | 1984-05-08 | The Kendall Company | Catheter |
| US4557773A (en) * | 1981-07-15 | 1985-12-10 | Corning Glass Works | Method for selectively manifolding honeycomb structures |
| DE3130262C2 (en) * | 1981-07-31 | 1983-06-09 | B. Braun Melsungen Ag, 3508 Melsungen | Venous catheter - method and apparatus for its manufacture |
| DK165672C (en) * | 1982-10-14 | 1993-05-24 | Eschmann Bros & Walsh Ltd | dilatation catheter |
| US4690844A (en) * | 1984-10-26 | 1987-09-01 | Saudagar Abdul S | Method for parting rubber and products formed thereby, and a method of making a blood vessel |
| FR2584288A1 (en) * | 1985-07-08 | 1987-01-09 | Bazenet Jean Pierre | OESOPHAGIC PROBE TYPE INTRACORPOREAL PROBE AND DEVICE FOR MOUNTING BALLOONS OF SUCH A PROBE |
| DE3541478A1 (en) * | 1985-11-23 | 1987-05-27 | Beiersdorf Ag | HEART VALVE PROSTHESIS AND METHOD FOR THE PRODUCTION THEREOF |
| DE3760300D1 (en) * | 1987-02-17 | 1989-08-17 | Hewlett Packard Gmbh | Method for manufacturing a measuring probe |
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| FR2673110B1 (en) * | 1991-02-25 | 1998-10-16 | Synthelabo | PROCESS FOR PRODUCING A BALLOON CATHETER, AND CATHETER OBTAINED. |
| US5729834A (en) * | 1995-01-05 | 1998-03-24 | Sloot; Alexander | Manufacture of an inflatable applique and its method of manufacture |
| US5702372A (en) | 1995-02-08 | 1997-12-30 | Medtronic, Inc. | Lined infusion catheter |
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| US8864730B2 (en) | 2005-04-12 | 2014-10-21 | Rochester Medical Corporation | Silicone rubber male external catheter with absorbent and adhesive |
| US8603029B2 (en) * | 2007-10-10 | 2013-12-10 | Hospi Corporation | Apparatuses and methods for medication administration |
| JP5393684B2 (en) * | 2008-08-11 | 2014-01-22 | テルモ株式会社 | Medical tools |
| CN101648048B (en) * | 2008-08-12 | 2012-03-07 | 上海理工大学 | Intelligent balloon dilatation therapeutic instrument for cricopharyngeal muscle achalasia |
| CN101648047B (en) * | 2008-08-12 | 2012-01-11 | 复旦大学附属华山医院 | Intelligent balloon dilatation controlling device for cricopharyngeal muscle achalasia |
| BRPI0900160A2 (en) * | 2009-02-02 | 2010-10-26 | Do Nascimento Luiz Mauricio Soares | endovascular release and protection system |
| CA2715857A1 (en) | 2009-09-30 | 2011-03-30 | Tyco Healthcare Group Lp | Medical catheter having a design providing low recirculation and reversibility |
| US9707375B2 (en) | 2011-03-14 | 2017-07-18 | Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. | Catheter grip and method |
| US9872969B2 (en) | 2012-11-20 | 2018-01-23 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Catheter in bag without additional packaging |
| US10092728B2 (en) | 2012-11-20 | 2018-10-09 | Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. | Sheath for securing urinary catheter |
| CN104127951B (en) * | 2014-08-13 | 2017-05-17 | 广州维力医疗器械股份有限公司 | Balloon urethral catheter |
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| JP6426068B2 (en) * | 2015-08-10 | 2018-11-21 | 朝日インテック株式会社 | Catheter and balloon catheter |
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| JP7460340B2 (en) * | 2019-09-19 | 2024-04-02 | 信越ポリマー株式会社 | balloon catheter |
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| US1185601A (en) * | 1916-02-11 | 1916-05-30 | Faultless Rubber Co | Process of manufacturing sound-producing instruments. |
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| US3214502A (en) * | 1960-08-08 | 1965-10-26 | Kendall & Co | Method and apparatus for making adhesive tapes |
| US3292627A (en) * | 1963-03-25 | 1966-12-20 | Pharmaseal Lab | Catheter |
| US3634924A (en) * | 1970-04-20 | 1972-01-18 | American Hospital Supply Corp | Method of making multilumen balloon catheter |
| US3734100A (en) * | 1973-05-07 | 1973-05-22 | Medical Products Corp | Catheter tubes |
-
1974
- 1974-07-25 US US491623A patent/US3926705A/en not_active Expired - Lifetime
-
1975
- 1975-01-01 AR AR259689A patent/AR204206A1/en active
- 1975-06-27 ZA ZA00754114A patent/ZA754114B/en unknown
- 1975-06-30 GB GB2757575A patent/GB1470023A/en not_active Expired
- 1975-07-08 CA CA231,065A patent/CA1050376A/en not_active Expired
- 1975-07-11 JP JP50085748A patent/JPS5135586A/en active Granted
- 1975-07-14 CH CH916575A patent/CH600894A5/xx not_active IP Right Cessation
- 1975-07-14 IT IT25364/75A patent/IT1039272B/en active
- 1975-07-18 SE SE7508258A patent/SE407746B/en unknown
- 1975-07-21 LU LU73033A patent/LU73033A1/xx unknown
- 1975-07-23 DE DE19752532832 patent/DE2532832A1/en not_active Ceased
- 1975-07-25 NL NL7508940A patent/NL7508940A/en not_active Application Discontinuation
- 1975-07-25 BE BE158621A patent/BE831746A/en not_active IP Right Cessation
- 1975-07-25 FR FR7523303A patent/FR2279424A1/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| FR2279424B1 (en) | 1982-05-28 |
| ZA754114B (en) | 1976-06-30 |
| AU8284575A (en) | 1977-01-13 |
| US3926705A (en) | 1975-12-16 |
| NL7508940A (en) | 1976-01-27 |
| BE831746A (en) | 1975-11-17 |
| CH600894A5 (en) | 1978-06-30 |
| FR2279424A1 (en) | 1976-02-20 |
| SE7508258L (en) | 1976-01-26 |
| AR204206A1 (en) | 1975-11-28 |
| IT1039272B (en) | 1979-12-10 |
| JPS5320792B2 (en) | 1978-06-28 |
| DE2532832A1 (en) | 1976-02-05 |
| LU73033A1 (en) | 1976-03-02 |
| SE407746B (en) | 1979-04-23 |
| GB1470023A (en) | 1977-04-14 |
| JPS5135586A (en) | 1976-03-26 |
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