EP0515463A1 - Catheter de liberation d'un agent microcide - Google Patents

Catheter de liberation d'un agent microcide

Info

Publication number
EP0515463A1
EP0515463A1 EP91904028A EP91904028A EP0515463A1 EP 0515463 A1 EP0515463 A1 EP 0515463A1 EP 91904028 A EP91904028 A EP 91904028A EP 91904028 A EP91904028 A EP 91904028A EP 0515463 A1 EP0515463 A1 EP 0515463A1
Authority
EP
European Patent Office
Prior art keywords
catheter
sleeve
coating
cavity
lumen
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.)
Withdrawn
Application number
EP91904028A
Other languages
German (de)
English (en)
Other versions
EP0515463A4 (en
Inventor
Anthony J. Conway
Philip J. Conway
Richard D. Fryar, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rochester Medical Corp
Original Assignee
Rochester Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US07/462,832 external-priority patent/US5137671A/en
Priority claimed from US07/487,422 external-priority patent/US5098379A/en
Application filed by Rochester Medical Corp filed Critical Rochester Medical Corp
Publication of EP0515463A1 publication Critical patent/EP0515463A1/fr
Publication of EP0515463A4 publication Critical patent/EP0515463A4/en
Withdrawn legal-status Critical Current

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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0062—Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
    • 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
    • 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

Definitions

  • the present invention relates to catheters for insertion into body cavities or the like and having means for killing microorganisms growing in regions or adjacent to the exterior surface of the catheter.
  • the present invention also relates to methods for making the same and products made by the inventive methods.
  • catheters can be described as some sort of tube like device which is inserted into a portion of a person's body in order to transport fluids or gases in or out of that particular portion of the body. In passing through any particular portion of the body in order to reach its destination, the catheter will come into contact with various tissues in the body. For example, a catheter used to drain one's bladder (such as a "Foley" catheter) must pass through the urethral tract in order to reach the bladder. A nasogastric catheter must pass through the nasal passageway and the esophagus in order to reach the stomach. Some catheters, such as these, are inserted through existing passageways in order to reach their destinations, while others are inserted through surgically created passageways.
  • a catheter used to drain one's bladder such as a "Foley" catheter
  • a nasogastric catheter must pass through the nasal passageway and the esophagus in order to reach the stomach.
  • the rubbing and chafing which normally occurs is usually caused by unavoidable slight movements of the catheter tube resulting from movement of the patient.
  • various portions of the catheter are often connected with equipment outside of the body which may or may not move in response to the movement to the body.
  • the catheter must also move in reaction to the movement of the portions of the body to which it is engaged.
  • Such movements may conflict with the lack of movement of an apparatus outside of the body to which the catheter is connected, or movement of different body portions may cause movement of the catheter with respect to one or both of the respective body portions which is inconsistent with the maintenance of relative spacial contact with outer surfaces of the catheter in one or both of the respective body portions.
  • body movement generally causes slight twists, pulls and/or pushes on the catheter which can rub, irritate and chafe against the tissues in the respective adjacent passageway or body portion.
  • a nasogastric catheter is an obvious example of this latter problem.
  • the nasal passageway and the throat invariably become sore.
  • the slight rubbing of the tube inside these passageways each time the patient moves his or her head or body, causes extreme discomfort once the tissues have become irritated by previous rubbing and chafing against the catheter.
  • the passageway remains sore for a significant period of time after the catheter has been removed, and is a significant source of discomfort during the hospitalization or treatment.
  • the present invention provides advantages over the prior art catheters and over the prior art methods for manufacturing catheters, and also offers other advantages over the prior art and solves other problems associated therewith.
  • an elongated catheter comprising an interior surface and an exterior surface.
  • the interior surface defines a lumen passing through the catheter.
  • the catheter further includes an enclosed sleeve cavity between the interior and exterior surfaces which encircles a portion of the lumen.
  • the sleeve cavity has an inner wall and an outer wall, wherein the outer wall is a resilient sleeve which can stretch generally independently of the inner wall and the cavity contains an amount of suitable bactericidal agent in a suitable carrier substance, wherein the inner wall and the outer wall are joined together at distal and proximal ends of the sleeve cavity.
  • the resilient sleeve includes diffusion permitting means for permitting the bactericidal agent to diffuse out of the cavity when the sleeve is an aqueous environment, but otherwise substantially restricting the bactericidal agent to the sleeve cavity unless the contents of the sleeve cavity are acted upon by a measurable mechanical or unless a measurable pressure differential exists across the resilient sleeve.
  • said diffusion permitting means will include a plurality of micropores which permit the bactericidal agent to diffuse across the resilient sleeve into suitable aqueous environments from the sleeve cavity when the aqueous environment lacks a concentration of bactericidal agent equal to that of the carrier substance.
  • the microcidal or bactericidal agent releasing catheter of the present invention will provide significant advantages over the prior art devices which provide no bactericidal capability.
  • the present invention also provides advantages over catheters including bactericidal agent containing carrier substances within a cavity separated from the surrounding environment by a wall having large openings for the transfer of the carrier substance into the surrounding environment. The use of these large openings will be appreciated to be ineffective to provide appropriate release of the bactericidal agent into the surrounding environment as this release is unrestricted.
  • such a device will be difficult to store and also difficult to handle and/or insert in an appropriate environment such as a urethral tract or the like. Because the present invention provides significantly better control over the transfer of the bactericidal agent into the environment surrounding the catheter, a transfer regulated by the natural forces generally associated with diffusion into an aqueous environment, the present invention provides new technology which is needed in the catheter art.
  • the resilient sleeve of the present catheter will allow the portion of the catheter defining the lumen to move independently of the exterior surface of the catheter proximate the sleeve cavity, so that when the catheter is forced to move in response to movement of a portion of the body, the resilient sleeve of the catheter will not necessarily have to move with the movement of the other portions of the catheter.
  • the resilient sleeve of the outer wall can stretch and twist to stay in the same relative contact with or adherence to proximate or adjacent body tissues, while the inner wall and the lumen are permitted to move in to the respective adjacent body tissues without disrupting the relative contact or adherence existing between the exterior surface of the resilient sleeve and these adjacent body tissues.
  • the resilient sleeve can stretch so that the movement of the rest of the catheter will not necessitate relative displacement of the adjacent tissues in respect to the exterior surface proximate the sleeve, because the sleeve can stretch and stay in the same position with respect to the adjacent tissues, thereby reducing the potential for rubbing, chafing and irritation of these tissues.
  • the present invention offers substantial improvements over the prior art. Some of these improvements relate to the comfort provided by the sleeved catheters of the present invention, while others have to do with the automated catheter manufacturing methods, the preferred materials used to make the catheters, the price of the present catheters in view of the methods and materials used, and the like.
  • Foley-type self retaining catheters provide an artificial conduit from the bladder to an external collection device.
  • Prior art Foley catheters generally consist of a round bilu en tube which serves as a "drainage pipe" from the bladder to the external collection device.
  • the urethral tract itself which is generally less than two inches long in women and several inches long in men, is actually believed to be a fairly flat ribbon-shaped passageway.
  • Foley catheters When Foley catheters are inserted into the bladder via the urethra, the catheter is generally forced into the urethra so as to force the ribbon-shaped passageway to open and to remain open for as long as the patient is catheterized.
  • the present sleeved catheters which include a resilient sleeve which can move independently of other portions of the catheter, particularly the main portion of the catheter surrounding the interior lumen or lumens, can provide significant relief in respect to the physical stress upon the body tissues adjacent to the catheter, particularly those of the urethral tract in contact with a sleeved Foley catheter of the present invention.
  • the present invention includes an exterior surface which yields to the adjacent body tissues with which it is in contact when other portions of the catheter are moved.
  • the exterior surface of the present invention includes a resilient sleeve which, in preferred embodiments, surrounds a significant amount of a cushioning or a lubricating substance which enables the resilient sleeve to provide the surrounding adjacent body tissues with a soft, "cushy" collar around the catheter which reduces mechanical stress on these adjacent body tissues.
  • the present invention reduces stress on the adjacent body tissues in the following ways.
  • the conduit portion of the catheter can be moved and twisted independently of the exterior surface of the resilient sleeve portion of the sleeved catheter. Normal patient activity will cause both external and internal pressures on the catheter which will bias it toward movement in one direction or another. Since the thin resilient sleeve is separated from the main conduit portion of the catheter by a cushioning substance, preferably a lubricating gel or the like, it can easily move, stretch, compress and the like independently of the less flexible main conduit portion of the catheter which surrounds the lumen or lumens thereof. It is important to appreciate that this works in two ways.
  • the comfort sleeve will, with negligible resistance, adjust its shape and position to conform to these movements without resistance or movement of the main conduit portion of the catheter.
  • external movement of the main conduit portion of the catheter such as twisting, stretching, bending and the like, can take place essentially independently of the thin resilient sleeve of the exterior surface.
  • the resilient sleeve is able to conform to the actual shape of the passageway through which it extends when inserted into the body. This is preferred over the generally non-compliant cylindrical tube which most catheters provide.
  • prior art Foley catheters inserted into the urethra put unnatural and unbalanced pressures on the tissues of the urethral wall as it holds the urethra open.
  • the cushioned sleeve of the preferred embodiments of the present invention will provide an exterior surface which is soft and compliant.
  • the preferred catheters of the present invention will conform to the natural shape of the catheterized passageway in which it resides.
  • the present invention also provides preferred catheters which will enable health care professionals to provide patients with catheters which are more accurately sized for the passageway in which they are to be inserted. For instance, most women are fitted with Foley-type self-retaining catheters having outside diameters of 16, 18 and 20 French.
  • the compliance nature of the resilient sleeve of preferred sleeved Foley catheters of the present invention allows the displacement of a portion of the volume in the sleeve cavity, which provides a cushion to the resilient sleeve, to be displaced by portions of the urethral track where it flattens out. Therefore, the preferred embodiments of the present invention will provide an exterior surface which can have a variable outside diameter so as to accommodate urethral tracts having different requirements. Furthermore, the preferred embodiments of the present invention will be more likely than the non-compliant prior art devices to accommodate variations in the wall of the urethral tract.
  • the conduit portion of the catheter will be able to slide back and forth without disrupting the interface between the exterior surface proximate the resilient sleeve and the adjacent body tissues of the passageway in which the catheter resides.
  • the lubricating substance in the sleeve cavity of certain preferred embodiments to be of sufficient thickness that this substance significantly separates the resilient outer sleeve from the outer wall of the conduit portion of the catheter so that the outer sleeve, when inserted in or when residing in a body passageway, will be soft and compliant such that the exterior surface proximate the resilient sleeve will provide accommodation to the differences in the shape of the orifice and the remaining portions of the passageway and will provide a "cushioned", soft interface between the adjacent body tissues and the preferred catheter.
  • Figure 1 is a transverse schematic view of an extruded tube in partial cross-section
  • Figure 2 is a transverse schematic view of an intermediate tube formed from the extruded tube shown in Figure 1;
  • Figure 3 is a schematic view of a portion of a rack or pallet used to retain a plurality of intermediate tubes during a series of steps designed to provide the tubes with overcoat layers of polymeric bonding composition, wherein a single intermediate tube is shown secured to a single support rod and following a first dipping step wherein a portion of the outer surface of the intermediate tube is coating with a lubricating material;
  • Figure 4 is a transverse schematic view of an intermediate tube similar to that shown in Figures 2 and 3, but following a second dipping step wherein the coating of lubricating material on the outer surface of the intermediate tube has been partially removed;
  • Figure 5 is a transverse sectional schematic view of an intermediate tube similar to that shown in Figure 4 following a subsequent dipping steps or steps in which an overcoat layer is formed over the outer surface thereof;
  • Figure 6 is a transverse sectional schematic view of an elongated catheter in accordance with the present invention.
  • Figure 7 is a transverse schematic view of an extruded double lumen tube in partial cross-section
  • Figure 8 is a cross-sectional view of the extruded double lumen tube as seen from the line 8-8 of Figure 7;
  • Figure 9 is a transverse schematic view of the tube shown in Figure 7 after an opening is punched in the outer surface
  • Figure 10 is a cross-sectional view of the tube as shown from the line 10-10 of Figure 9;
  • Figure 11 is a transverse schematic view of the double lumen tube shown in Figure 9 after a portion of the first lumen has been filled with a polymeric bonding composition;
  • Figure 12 is a cross-sectional view of the tube as seen from the line 12-12 of Figure 11;
  • Figure 13 is a transverse schematic view of the double lumen tube shown in Figure 11 after a tip is affixed to a distal end of the tube;
  • Figure 14 is a schematic view of a portion of a rack or pallet used to retain a plurality of tubes during a series of steps designed to provide the tube with an overcoat layer of a polymeric bonding composition;
  • Figure 15 is a transverse schematic view of an intermediate tube similar to the tube shown in Figure 13 at an intermediate stage of manufacture following to the first of a series of dipping steps;
  • Figure 16 is a transverse schematic view of an intermediate tube similar to that shown in Figure 15, but following a second dipping step wherein a coating of bond preventing lubricating agent on the outer surface has been partially removed;
  • Figure 17 is a cross-sectional view of the intermediate tube of Figure 16 as shown from the line 17-17;
  • Figure 18 is a view of an intermediate tube similar to that shown in Figure 16, but after a subsequent dipping step or steps;
  • Figure 19 is a view of an intermediate tube similar to that.shown in Figure 18, but after yet another dipping step or steps;
  • Figure 20 is a cross-sectional view of the balloon catheter shown in Figure 19 from the line 20-20;
  • Figure 21 is a transverse schematic view of a portion of a balloon catheter formed from the intermediate tube shown in Figure 19, following a further dipping step to create an overcoat layer;
  • Figure 22 is a perspective view of a portion of a balloon catheter similar to that shown in Figure 21, but wherein the balloon catheter has been severed through the sleeve cavity and the remaining portion of the sleeve has been twisted to demonstrate its independence of the outer surface of the extruded double lumen tube used to make the balloon catheter;
  • Figure 23 is a transverse schematic view of a balloon catheter similar to that shown in Figure 21, but including an end piece and showing a sectional view of a portion of catheter wherein the balloon portion of the catheter is expanded;
  • Figure 24 is a cross-sectional view of an alternate embodiment of the balloon catheter shown in Figure 23 as that embodiment would be seen from a line similar to the line 24-24 of Figure 23, were Figure 23 to show that embodiment;
  • Figure 25 is a transverse schematic view similar to that shown in Figure 23, but showing another alternate embodiment of a balloon catheter made in accordance with the present invention and including a plurality of first lumen access openings;
  • Figure 26 is a transverse schematic view of yet another embodiment of the present invention similar to the view shown in Figure 23;
  • Figure 27 is a partial side sectional view of the catheter shown in Figure 21 being stamped by a perforating device in a channel-like recess of a stamping block;
  • Figure 28 is a magnified sectional view from the line 28-28 of Figure 27 showing a plurality of pointed extension members which have passed through the resilient sleeve of the catheter to form a plurality of micropores;
  • Figure 29 is a transverse schematic view of yet another embodiment of the present invention similar to the view shown in Figure 26 but showing a third lumen in communication with a sleeve cavity wherein the sleeve includes a plurality of micropores (not shown);
  • Figure 30 is a sectional view of the catheter shown in Figure 29 from the line 30-30;
  • Figure 31 is a transverse schematic sectional view showing a portion of the catheter shown in Figure
  • Figure 32 is a schematic illustration of apparatus used to automate the production of catheters in accordance with the present invention.
  • FIGS 33A, 33B and 33C are flow charts representing certain steps in methods in accordance with the present invention.
  • the present invention provides an elongated catheter 5 (see Figure 6) having an interior surface 7 and an exterior surface 9.
  • the interior surface 7 defines a lumen 8.
  • the elongated catheter 5 is preferably made from a tube 2 (see Figure 1) which is eventually coated with an overcoat layer 42 of resilient polymeric material which binds to an outer surface 14 of the tube 2 unless the bonding of the polymeric material is prevented by other materials or means on the outer surface 14.
  • the overcoat layer 42 of the elongated catheter 5 in accordance with the present invention includes a sleeve 44 which encircles a sleeve cavity 45 which contains lubricating material 38.
  • the lubricating material or substance 38 is effective to permit the sleeve 44 to slide along the outer surface 14 of the tube 2 proximate the sleeve 44 while in lubricated contact with the outer surface 14.
  • the lubricating material serves to separate the soft outer sleeve 44 from the tube 2, such that the outer sleeve 44 provides a soft, cushioned, compliant exterior surface which can adapt and conform under slight pressures to the shape of the passageway in which it is inserted or residing.
  • the amount of the lubricating substance 38 and the sleeve cavity 45 can be minimized to provide for only a limited increase in the outer diameter of the catheter proximate the outer sleeve 44. In other cases, a soft, cushioned, compliant sleeve which can adapt its shape is desirable. In these embodiments, there is a relatively thick coating of lubricant material 38 in the sleeve cavity 45 which will give the sleeve 44 a balloon-like feel and appearance in the exterior surface proximate the sleeve 44.
  • the elongated catheter 5 is preferably made of a flexible elastomeric material such as latex, silicone rubber or the like, most preferably silicone rubber.
  • the lubricating material or substance 38 is preferably any biocompatible lubricating substance which is effective to permit respective polymeric surfaces to slide with respect to one another when in lubricated contact therewith.
  • the lubricating substance 38 is a hydrophobic oil or other petroleum based product or water-soluble soap, detergent, gel or the like, either of which is effective to lubricate polymeric surfaces and to generally prevent bonding thereto by other polymeric substances when coated thereby.
  • the lubricating substance 38 is petrolatum.
  • the lubricating substance 38 can be a carrier substance 38 which includes a microcidal or bactericidal agent which is effective to kill microorganisms or bacteria.
  • the carrier substance 38 can be a water-soluble lubricating gel (eg. KY JellyTM, HydrogelTM, and the like), a coating substance formulated to contain aqueous polyvinyl alcohols and the like, petroleum jelly or petrolatum, water-soluble soaps, detergents, bulking agents (such as Glycerin, Methylcellulose, PVP, Sodium Carboxycellulose,
  • a water-soluble lubricating gel eg. KY JellyTM, HydrogelTM, and the like
  • a coating substance formulated to contain aqueous polyvinyl alcohols and the like, petroleum jelly or petrolatum, water-soluble soaps, detergents, bulking agents (such as Glycerin, Methylcellulose, PVP, Sodium Carboxycellulose,
  • the intermediate tube 3 is then secured on a support rod 26 of a rack or pellet 24 which preferably includes a plurality of support rods 26.
  • a plurality of intermediate tubes 3 are secured on the plurality of support rods prior to subjecting the intermediate tubes 3 secured on the support rods 26 to a series of dipping steps in the preferred process.
  • the outer surface is coated from the lowest portion of the tip 20 up to a location on the outer surface 14 designated by the dashed line A, as shown in Figure 3, with the lubricating substance.
  • the lubricating substance coating the outer surface 14 of the tube below a location proximate the dashed line designated B, as shown in Figures 3 and 4 is stripped from the outer surface 14 and the tip 20.
  • the intermediate tube 3 is then coated with a resilient polymeric bonding composition which forms the overcoat layer 42.
  • the overcoat layer 42 bonds to the tip 20 and a portion of the outer surface 14a below the dash line designated B, and to a portion of the outer surface 14b above the line designated A.
  • the overcoat layer 42 forms a sleeve 44 which encircles the lubricating material 38 coating the portion of the outer surface 14a between the dash lines designated A and B, which cooperates with the sleeve 44 to define the sleeve cavity 45 in which the lubricating material 38 proximate the sleeve 44 is contained.
  • a pair of fluid conduit openings 56 are preferably created, most preferably punched, to permit fluid to pass into or out of the lumen 8 proximate the distal end 16.
  • overcoat layer 42 and the wall 11 of the tube are shown in Figure 6 to be separate elements, when made of identical polymeric materials, as is the case with the most preferred embodiments of the present invention which are made of silicone rubber, the wall 11 and the overcoat layer 42 will be bonded together where they interface with one another so that it is virtually impossible to distinguish between the two and so that there is no part line in spite of the fact that a part line is shown in Figures 5 and 6. In the preferred embodiments, where these elements are joined together, it will be appreciated that they form an integral membrane or wall.
  • Preferred embodiments of the elongated catheter 5 will include a plurality of micropores (too small to be shown) in the resilient sleeve 44 which will permit a carrier substance 38 including a microcidal or bactericidal agent to diffuse out of the sleeve cavity 45 when the catheter 5 is inserted into a suitable aqueous environment which lacks the concentration of the specific bactericidal agent or agents as are contained in the carrier substance 38 within the cavity 45.
  • carrier agent, bactericidal agent and sleeve material will allow for diffusion across the resilient sleeve simply by virtue of the structure of the sleeve material and the characteristics of the carrier agent and/or the bactericidal agent.
  • the bactericidal agent will be able to diffuse directly through the resilient sleeve, and no micropores will be required to permit this agent to pass across the barrier the sleeve might otherwise present.
  • the microcidal or bactericidal agent or agents contained within the carrier substance 38 may be any agent which is effective to kill microorganisms or bacteria killing in regions on or adjacent to the exterior surface 9 of the catheter 5.
  • agents include, but are not limited to, antibiotics, including sulfa drugs and the like, and other microcidal and bactericidal agents. Included among these agents are nitrofurantoin, sulfamethoxazole, trimethoprim, mixtures thereof such as BactrimTM and the like, and other equivalents.
  • a pressure differential across the resilient sleeve 44 is a pressure differential across the inside and outside surfaces of the resilient sleeve
  • a micropore is an orifice having a circumferential diameter small enough so that it is effective to retain the carrier substance within a sleeve cavity 45 of an embodiment of the present catheter unless the carrier substance is vaporized or acted upon by forces resulting from a pressure differential across the resilient sleeve 44.
  • any embodiment of the present invention may include a bactericidal agent or agents and the lubricating substance 38 or carrier substance 38 contained within the sleeve cavity 45 of that particular embodiment, and while any of the resilient sleeves 45 of any of these embodiments may contain micropores in accordance with the description herein above, it will be appreciated that these micropores will be so small as to be barely perceptible, if perceptible at all, to the naked eye. Further reference found here and below will provide further description of the micropores discussed herein above (see discussion Figures 27 and 28 herein below) .
  • the first step in making a balloon catheter in accordance with the present invention is providing a double lumen tube 2' , which is preferably extruded and made of silicone rubber.
  • the double lumen tube 2' can be made by any known process which yields a double lumen tube 2' .
  • the tube 2' can be made of any resilient polymeric material, preferably a biocompatible polymeric material which can be inserted into a human body cavity.
  • the double lumen tube 2' includes a smaller capillary lumen 6' and a larger fluid conduit lumen 8' .
  • a capillary lumen access opening 12' is created in an outer surface 14' of the double lumen tube 2' .
  • the capillary lumen access opening 12' communicates with the capillary lumen 6' .
  • an intermediate tube 3' is subsequently prepared from the double lumen tube 2' shown in Figure 9.
  • a measured amount of polymeric bonding composition preferably silicone rubber or another suitable polymeric bonding material
  • a tip 20' is then affixed to the distal end 16' of the tube 2' to complete the formation of the intermediate tube 3' shown in Figure 13.
  • the distal end 16' of the tube 2' is inserted into a molding apparatus (not shown) designed to mold a tip 20' on the end of the tube 2'.
  • a preferred process of the present invention involves securing a plurality of intermediate tubes 3', like the intermediate tube 3' shown in Figure 13, to a rack or pallet 24'.
  • the rack or pallet 24' will include a plurality of support rods 26', each equipped with a retaining clip 28'.
  • the intermediate tubes 3' are secured on the support rods 26' by engaging individual support rods 26' in the larger of the two lumens 8', called the fluid conduit lumen 8', and sliding the intermediate tubes 3' up over the support rods 26' until the proximal ends 30' of the intermediate tubes 3' abut against the base of the retaining clips 28' or, preferably, the tip 20' of each of the intermediate tubes 3' fits snugly against the distal tip 26a' of each of the support rods 26', as shown in Figures 15 and 16.
  • the intermediate tubes 3' can be secured on the support rods 26' without the aid of the retaining clips 28'.
  • the preferred extruded double lumen tubes 2' used to make the intermediate tubes 3' generally have a slight bend in one direction or another when they are hung. This results in a slight bend in the intermediate tubes 3' that permits the intermediate tube 3' to be secured on a support rod 26' without the aid of a clip 28'.
  • the polymeric materials generally used to make the intermediate tubes 3' they also have a tendency to cling to other surfaces and to offer resistance to movement of a surface along a surface of this material as do most polymeric tubes including those tubes 2 described hereinabove.
  • the pallet 24' can be transferred from place to place, and the intermediate tubes 3' on the pallet 24' can be dipped in a series of baths (see Figure 26) prepared to accomplish a series of process steps.
  • the intermediate tube 3' is made entirely of silicone rubber and is secured upon a support rod 26' made of spring steel.
  • the tip 20' and the fill material 18' of the intermediate tube 3' shown in Figure 13 are made of the same material (silicone rubber) as the double lumen 2'. Therefore, the tip 20' and the fill material 18' preferably form integral portions of the intermediate tube 3', which is shown in Figures 15-21.
  • Such materials include petroleum jelly or petrolatum, other oil base substances which form a semi-solid upon cooling to room temperature, liquid soaps which dry to form a semi- solid, aqueous soap or detergent solutions, aqueous polyvinyl alcohol solutions, emulsions, or suspensions, lubricating gels, aqueous or oil based film forming solids emulsions, and the like.
  • hot petrolatum is used, and in another, a liquid soap is used, preferably Liquid Ivory Soap from Proctor & Gamble, Cincinnati, Ohio.
  • a lubricating gel is used, preferably a water-soluble formulation such as KY JellyTM, HydrogelTM, and the like.
  • bond preventing agents or lubricating agents can also be used as a carrier substance for any of the microcidal or bactericidal agents referenced herein above.
  • bactericidal agents which are sensitive to variations in temperature or the like are incorporated into the carrier substance, appropriate modification of the procedure to avoid limiting the effectiveness of the bactericidal agent can be necessary in certain circumstances.
  • the agent or substance 38' adheres to the outer surface 14' of the intermediate tube 3', and occupy the capillary lumen access opening
  • the agent is petrolatum, which is heated to about 140-160°F, preferably about 150°F. At these temperatures, the petrolatum will run up into the capillary lumen 6' through the capillary lumen access opening 12' with the assistance of the "capillary effect", which draws the fluid into the capillary lumen 6' to the level of the petrolatum in this first tank 33. In other embodiments the petrolatum is often heated to a lesser degree to allow for a heavier, somewhat thicker coat of lubricating agent on the outer surface 14' .
  • the bond preventing agent in the first tank 33 is liquid soap at room temperature (about 62-74°F) .
  • the bond preventing agent is a carrier substance including a bactericidal agent preferably nitrofurantoin.
  • the carrier can be petrolatum which is preferably heated to about 60 C C for this purpose, or, more preferably, is a water-soluble lubricating gel such as the formulation of HydrogelTM or the like which is maintained at room temperature or preferably about 20°C.
  • the intermediate tubes 3' are coated when they are dipped in a first bath 33a which contains petrolatum which is maintained at a temperature effective to permit the petrolatum to coat the outer surface 14 of the tube while limiting the degree to which the petrolatum runs into the smaller lumen 6' .
  • the petrolatum will run into the first lumen access opening 12', but, preferably, will not run very far into the smaller lumen 6' .
  • the temperature of the petrolatum in the first tank 33 is preferably maintained at about .
  • the intermediate tube 3' is coated with the bond preventing lubricating agent 38' up to a location on the surface 14' of the intermediate tube 3' proximate the dashed line A shown in Figure 15 by dipping the intermediate tube 3' into the first dip tank 33 up to that point. Following this step, the outer surface 14' of the intermediate tube 3' is stripped of the bond preventing lubricating agent 38' up to a location proximate the dashed line designated B in Figures 15 and 16.
  • the intermediate tube is then preferably coated as shown in Figure 16 between the locations proximate the dashed lines A and B.
  • the intermediate tube 3'' shown in Figure 16 is then dipped in a subsequent dip tank holding a second bond preventing agent.
  • the liquid soap can be preferred, although petrolatum and other agents will also work.
  • the intermediate tube 3' shown in Figure 16 is dipped into the tank up to a point on the outer surface 14' of the intermediate tube 3' proximate the dashed line C so as to coat the portion of the intermediate tube 3' from the lowest portion of the tip 20' up to the location proximate the dashed line designated C.
  • any of the bond preventing lubricating agents enumerated above may be used.
  • the bond preventing lubricating agent is hot petrolatum heated to about 130-150°F, preferably about 140°F (about
  • the intermediate tube is then subjected to a further dipping step wherein the intermediate tube shown in Figure 18 is dipped in one or more dip tanks so as to strip the coating of bond preventing agent 39 from the portion of the intermediate tube 3' below a location on the outer surface 14' proximate the dashed line designated D in Figures 18 and 19 so as to strip the tube of bond preventing agent below that location.
  • the tubes 3' are then dipped in a series of dip tanks (see Figure 26) provided to coat the intermediate tube 3' with a polymeric bonding composition, preferably silicone rubber, in a step or steps provided to form the overcoat layer 42', including both the resilient sleeve 44' and balloon portion 58' of the balloon catheter 5' shown in Figure 21.
  • a polymeric bonding composition preferably silicone rubber
  • the intermediate tube 3' is dipped in silicone rubber in two or more successive dipping steps so that the resulting overcoat layer 42' includes underlying and an overlying layers (not shown), which form an integral part of the balloon catheter 5' and are bonded together, and to the outer surface 14' in the portions thereof, 14a', 14b' and 14d', which are located below the dashed line designated D, between the dashed lines designated B and C, and above the dashed line designated A, respectively.
  • the portion 14d' above line A was not coated prior to the final dipping steps designed to provide the overcoat layer 42', and the portion 14a' below line D was stripped of its coating prior to those steps.
  • the proximal end 30' of the balloon catheter 5' is secured to an end piece 46' to form a completed Foley catheter 4' (shown in Figure 23).
  • the end piece 46' can include a cap 48' for closing a proximal end access opening 49' to the fluid conduit lumen 8' and can be equipped with a luer value 50' for engagement in and closure of the proximal capillary lumen access upper opening 52' communicating with the capillary lumen 6' .
  • the sleeved balloon catheter 5' Prior to the attachment of the end piece 46' to the sleeved balloon catheter 5' to form the completed sleeved Foley catheter 4', the sleeved balloon catheter 5' is preferably allowed to air dry to permit solvents in the overcoat layer 42' to evaporate and is subsequently cured at an elevated temperature. Care is taken to keep the curing temperature below the boiling temperatures of the solvent so as to prevent unsightly bubbling of the solvent within the overcoat layer 42'. Because the overcoat layer 42' is preferably made of the same polymeric bonding composition, even though it may be created in a plurality of dipping steps, it is represented in Figures 21-25 as a single overcoat layer 42'.
  • the completed Foley catheter 4' also includes a fluid conduit access opening 56' in an exterior surface 62' of the completed Foley catheter 4'.
  • the fluid conduit access opening 56' communicates with the fluid conduit lumen 8' .
  • a phase of stamping operation is illustrated. In steps subsequent to the formation of the sleeve 44' of the alternate embodiment of the catheter 5' shown in Figure 21, or preferably, after completion of the completed
  • Foley catheter 4' shown in Figure 23 a portion of the catheter 5' or 4' proximate the resilient sleeve 44' is placed in an elongated, channel-like recess 84 in a stamping block 86.
  • the catheter 5' or 4' is preferably cooled first to a temperature below about 32°F.
  • a perforating or stamping device 90 having a plurality of very small, pointed extension members 92 is then used to create a plurality of micropores 81' in the resilient sleeve 44' by stamping the resilient sleeve 44' when it is held within the channel-like recess 84.
  • the elongated, channel-like recess 84 is configured to hold the catheter 4' or 5' proximate the resilient sleeve 44' such that, upon impact, the stamping device 90 perforates only the resilient sleeve 44' in preferred embodiments. It will be appreciated that the polymeric material of the catheter 4' or 5' is not compressible so that the impact of the stamping device 90 is unable to significantly displace the catheter 4' or 5' once it has been pressed to the bottom of the channel-like recess 84 as shown in Figure 27.
  • the resilient sleeve 44' not only has a narrower thickness than the inner wall 21' of the catheter 5', but it is also more flexible, more stretchable, and preferably less rigid than the inner wall 21'.
  • the lubricating substance 38' contained in the sleeve cavity 45' permits the sleeve 44' to slide along and in respect to the outer surface 14' while in lubricated contact therewith and when stretched independently thereof.
  • the resilient sleeve 44' can be twisted in respect to the inner wall 21' without twisting the inner wall 21' or the respective lumens, 6' and 8'.
  • the resilient sleeve 44' can also be stretched without stretching the inner wall 21' of the catheter 5'.
  • this enables the resilient sleeve 44' to stay in relative contact with or in adherence to adjacent body tissues (not shown) with which the resilient sleeve 44' is in contact with even when the remaining portions of the sleeved balloon catheter 5', such as the inner wall 21', are forced to move in response to forces impacting on the catheter 5' at other points along its length.
  • the resilient sleeve 44 can also change from its initial circumferential shape to a more ribbon-like oval shape in order to match the shape or contour of the passageway in which it resides.
  • the volume of the sleeve cavity 45 will preferably increase the outside diameter of the catheter proximate the sleeve portion at least about 5%, preferably about 10%, more preferably about 20%, even more preferably about 25%, even more preferably about 35%, and even more preferably about 50%.
  • the thickness of the lubricating substance in the sleeve cavity 45 is increased so as to increase the volume of the sleeve cavity such that the outside diameter of the catheter proximate the sleeve 44 will be increased from about 50 to 100, or 50 to 200% or more depending on the particular application.
  • the important factor is that the sleeve be soft and compliant so that it can conform to the shape of the particular passageway in which it resides and, at the same time fill the passageway so as to limit the passage of fluids along either the wall of the passageway or the exterior surface of the catheter, and at the same time, to allow the inner conduit portion of the catheter move relatively independently of the exterior surface of the sleeve 44 of the catheter.
  • the end piece 46' is made by a process of injection molding.
  • the proximal end 30' of the sleeved balloon catheter 5' is inserted into an injection molding apparatus (not shown) after the overcoat layer 42' has been cured.
  • the end piece 46' can be added to the intermediate tube 3' prior to the initiation of the dipping process.
  • a polymeric bonding composition preferably silicone rubber, is injected into the mold (not shown) and the end piece 46' is molded onto the proximal end 30' of the balloon catheter 5' to make the completed Foley catheter 4' shown in Figure 23.
  • micropores are created in the resilient sleeve 44' so that bacterial agent in the carrier substance 38' can diffuse out in appropriate aqueous environment, and the completed catheter 4' is tested to see if it is functional and if it has any leaks. This testing can be done before or after the fluid conduit access opening 56' is created in the exterior surface 62' to communicate with the fluid conduit lumen 8' .
  • the proximal capillary lumen access opening 52' is slipped over a hot water nozzle (not shown), and a measured amount of a hot aqueous solution, preferably water or water containing a trace of surfactant, at a temperature of between about 120-160°F, preferably about
  • the balloon portion 58' of the overcoat layer 42' is the portion of the overcoat layer 42' which is not bonded to the outer surface 14' of the intermediate tube 3' proximate a balloon cavity 54'.
  • the balloon portion 58' of the overcoat layer 42' cooperates with the portion 14c' of the outer surface 14' which remained coated with the bond preventing agent prior to the step of dipping the intermediate tube 3' in the polymeric bonding composition, to define the balloon cavity 54'.
  • the balloon cavity 54' communicates with the capillary lumen 6' via the capillary lumen access opening 12' .
  • the water solution will also remove the remaining bond preventing agent in the balloon lumen 54' and the capillary lumen 6' when it is removed. Although some of the bond preventing agent may come out of the capillary lumen 6 via the proximal capillary lumen access opening 52' during the step of curing the overcoat layer 42', the hot aqueous solution is generally believed to remove most of the bond preventing agent, although a residue may remain.
  • a further test is used to obtain further assurance that there are no leaks in the balloon portion 58. This further test is accomplished by engaging the proximal capillary lumen accessing opening
  • an electrical switch such as a hand switch or, preferably, a foot pedal, is used to release a measured blast of air into the capillary lumen 6' .
  • the air is introduced into the capillary lumen 6' it also enters the balloon cavity 54' via the capillary lumen access opening 12' and inflates the balloon portion 58' and, thereby, expands the balloon cavity 54'.
  • the leak tester is designed to sense any loss of pressure once the balloon portion 58' is inflated, and will given an indication, therefore, if there are any measurable leaks.
  • the completed sleeved Foley catheters 4' that have passed all tests are then packaged, preferably in a material which breathes such as TyvekTM (from DuPont) , and boxed. The boxes are then sterilized with ETO (Ethylene Oxide) and then stored for shipment.
  • ETO Ethylene Oxide
  • the extruded double lumen tube 2' used to make the intermediate tube 3' is a tube (not shown) which has a series of generally parallel undulations running generally parallel with the longitudinal axis of the tube (see Figure 24).
  • a sleeved Foley catheter 4' ' having a ribbed inner surface 60 on the balloon portion 58'' of the completed Foley catheter 4' ' will result because the bond preventing coating 40' (not shown) on the intermediate tube 3'' will reciprocate the undulations in the outer surface 14'' of the intermediate tube 3''. Therefore, when the balloon portion 58'' of the overcoat layer is created, the inner surface 60 will have ribs 59 which reciprocate the undulations in the bond preventing coating material 40' coating the coated portion 14c'' of the outer surface 14' ' .
  • FIG. 25 another embodiment of the present invention provides a completed sleeved Foley catheter 4' ' which has a plurality of capillary openings 12' ' ' that permit greater access to the balloon lumen 54' ' ' from the capillary lumen 6' ' ' and vice versa. This can be very important when wishing to ensure that the access to the capillary lumen 6' ' ' from the balloon lumen 54' ' ' is not blocked once the balloon portion 58''' of the overcoat layer 42''' is expanded.
  • the preferred pallet 24 has 400 spring steel support rods 26 attached to a pallet in 20 rows of 20 rods, wherein each of the rods 26 is about 1 inch from each adjacent rod.
  • Single and double lumen tubing (not shown) is preferably made by extrusion processes known to those of skill in the art.
  • the tubes 2 and 2' are cut to length as the tubing leaves the extruder (not shown) .
  • An opening 12' is created in the outer surface 14' of the double lumen tubes 2', preferably with a hollow drill bit or drill tube (not shown), so as to communicate with the capillary lumen 6' in those tubes 2'.
  • the distal portion 6a' of the capillary lumen 6', located between the distal end 16' of the tube 2' and the capillary lumen access opening 12', is then injected with a measured amount of a polymeric bonding composition, preferably silicone rubber, so that the distal portion 6a' is filled and sealed.
  • a rounded tip 20' is then formed at the distal end 16' of the double lumen tube 2' , preferably by inserting the tube 2' in a molding device (not shown) .
  • FIG 26 another preferred embodiment of the present invention is illustrated in this embodiment of the present invention as sleeved Foley catheter 4' ' ' ' . It is very similar to the catheter shown in Figure 23 except that the space between the balloon cavity 54'''' and the sleeve cavity 45'''' has been decreased so that it will accommodate the urethral sphincter of the bladder.
  • the volume of the lubricating substance 38'''' in the sleeve cavity 45'''' is significantly more than that shown in Figure 23. This is accomplished by increasing the thickness of the lubricating substance 38 which is coated onto the intermediate tube carrying the manufacturing process.
  • the increase in the thickness of the lubricating substance 38'''' allows the sleeved Foley catheter 4'''' to provide a very soft, "cushy", conforming exterior surface $ ' • ' ' proximate the sleeve 44'''' which can accommodate variations in the surfaces with which the catheter 4'''' comes into contact.
  • the sleeve 44'''' also includes a plurality of micropores (too small to be shown) which enable the bactericidal agent in the carrier substance 38''''' to diffuse out of the cavity 45' ' ' ' when the resilient sleeve 44''' '' is located in an aqueous environment wherein the concentration of the bactericidal agent in the aqueous environment is less than the concentration of the bactericidal agent in the sleeve cavity 45' ' ' ' .
  • This particular catheter 5' ' ' ' is useful for long term catheterization where it is desirable to replenish the supply of carrier substance 38'''' located within the sleeve cavity 45''''.
  • Figure 30 a cross-sectional view of the catheter 5'''' is shown. Referring now also to Figure 31, the sleeved
  • Foley catheter 4'''' shown in Figure 26 is shown when inserted into a urethral tract 74 of a woman 70.
  • the balloon portion 58'''' of the catheter 4'''' resides within the bladder 72 of the woman 70.
  • the balloon portion 58'''' is expanded to retain the catheter 4'''' in the urethral tract 74.
  • the lubricating substance 38'''' also allows the inner wall 21'''' or conduit portion 21'''' of the catheter 4' ' ' ' to move back and forth within the urethral tract 74'''' to a limited degree without disrupting the interface between the exterior surface 9'"'' proximate the sleeve 44'''' and the adjacent body tissues of the urethral tract 74.
  • This allows the catheter 4' ' ' ' to move in all directions to a limited degree without disrupting this interface, thereby increasing the comfort of the patient in which the catheter 4''''' resides.
  • the lubricating substance 38' ' ' ' is a carrier substance 38'''' which includes a bactericidal agent.
  • the catheter 4' ' ' ' also includes a plurality of micropores (not shown, too small to be shown) in the resilient sleeve 44'''' which are created using a device 90 like that shown in Figures 27 and 28. It will be appreciated, that the catheter 4' " ' * has been rotated in the channel-like recess 84 so that micropores can be created around the entire circumference of the catheter 4' ' ' ' in a series of stamping steps similar to those described herein above (see prior discussion in reference to Figures 27 and 28).
  • the aqueous environment of the urethral tract will be a region of low bactericidal concentration and will, therefore, due to the aqueous nature of this environment, enable the bactericidal agent in the sleeve cavity 45' ' ' ' to diffuse out of the sleeve cavity 45'''', across the resilient sleeve 44'''' and into the urethral tract 74. This will result in a reduction of elimination of bacteria coming on or adjacent to the exterior surface 9' ' ' ' proximate the resilient sleeve 44''' ' ' .
  • 400 of the intermediate tubes 3' are then mounted vertically on rigid spring steel support rods 26' on a pallet 24' in the manner previously described.
  • the pallet 24' is then moved via a transporting mechanism 22 (see Figure 28) over a series of dip tanks as follows in the following example which will further disclose preferred elements of the present invention.
  • the pallet 24' is stopped over a first tank 33, which contains white USP petrolatum contain nitrofurantoin.
  • the nitrofurantoin containing petrolatum is heated to about 60°C (about 140°F) .
  • the tank is raised so as to immerse the intermediate tubes 3' into the petrolatum to such a depth that the petrolatum reaches the proximal end of the desired sleeve location.
  • the dip tank 33 is then lowered and a portion of the outer surface 14' of the intermediate tubes 3' are coated with the nitrofurantoin containing petrolatum.
  • This portion extends from the general point at which the proximal end of the resilient sleeve 44' will begin, to the distal end 20a' of the tip 20' of the intermediate tube 3'.
  • This step is repeated when it is desireable to build up the thickness of the lubricating substance and the resulting volume of the sleeve cavity so as to increase the resulting increase in the outside diameter of the particular catheter over the circumferential diameter of the conduit portion or tube 2 or 2' of this present invention.
  • the pallet.24' is then automatically advanced and stopped over a second dip tank 35 which contains white USP petrolatum heated to about 120°C (about 250°F) .
  • the second dip tank 35 is raised so as to immerse the intermediate tubes 3' into the super-heated petrolatum so that the super-heated petrolatum comes into contact with the petrolatum coating 38' on outer surface 14' of the intermediate tube 3' from the prior dipping step up to a general location where a distal end of the resilient sleeve 44' will end.
  • the second dip tank 35 is then lowered. This dipping step causes the coating of the petrolatum from the prior dipping step to be largely removed from the portions 14a the outer surface 14' below a location where the distal end of the resilient sleeve 44' will be generally located
  • the fourth tank 40 is then raised to immerse the intermediate catheters 3 to the same depth as previously immersed in the second and third tanks 35 and 37, thereby removing essentially all traces of the petrolatum from this portion of the outer surface 14' .
  • the intermediate catheter tube 3' now has a band 38' of semi-solid petrolatum located around the axial circumference of the intermediate tube 3' in the location where the sleeve cavity 45' will be created .
  • the petrolatum not only coats the portion 14c' of the outer surface 14' located in this area, but also fills a portion of the capillary lumen 6' and plugs the capillary lumen access opening 12', which will eventually be used to inflate the balloon portion 58' of the completed Foley catheter 4' .
  • the pallet 24' is then lowered and automatically advanced to a ninth dip tank 51 containing a low-solids silicone rubber/solvent dispersion which is effective to minimize any disruption of the integrity of the petrolatum coatings 38' and 40' remaining on the intermediate tube 3' proximate the portions 14e and 14c of the outer surface 14' where the sleeve cavity 45' balloon cavity 54' will be created during subsequent dipping steps.
  • the ninth tank 51 is then raised to immerse the intermediate tube 3' in the solution up to a location above the dashed line designated in A in Figure 19. This step can be subsequently repeated at intervals, preferably allowing time for significant solvent evaporation, either in the same tank or in a subsequent tank containing a greater concentration of silicone rubber, until the overcoat layer 42 and the balloon portion 58 of the overcoat layer 42 have a desired balloon thickness.
  • the tank 51 is lowered, the pallet 24' is advanced to a tenth dip tank 53 containing a silicone rubber dispersion having a higher silicone rubber concentration than the dispersion in the ninth dip tank 51, and the tubes 3' are completely immersed again.
  • the preferred thickness over the overcoat layer 42', the resilient sleeve 44' and the balloon portion 58' is 17.5 thousandths of an inch (plus or minus 2.5 thousandths of an inch) .
  • the concentration of silicone rubber in the subsequent tanks are preferably greater than the concentration of the silicone rubber in the ninth tank 51. It is also desirable to alter the silicone rubber used in a final coating to provide greater sheen and a smoother finish, however, the concentration and the solvent may be adjusted as deemed appropriate.
  • the completed Foley catheters 5 are then finished by punching a fluid conduit access opening 56' in the exterior surface 62' such that it communicates with the fluid conduit lumen 8' in a location below or distal to the balloon portion 58' of the overcoat layer 42' and by stamping a plurality of micropores (not shown) in the resilient sleeve 44' to permit the nitrofurantoin to diffuse into aqueous environments such as a urethral tract, thereby minimizing or eliminating bacterial growth therein.
  • the micropores are created by perforating the resilient sleeve 44' with a plurality of very small, pointed extending members 92 on a stamping device 90.
  • the catheter 5' is first cooled to a temperature below 32°F and then placed in an elongated, channel-like recess 84 and stamped with the stamping device 90, to create the micropores.
  • the completed Foley catheters 4' are then sent through the test sequence described hereinabove, during which the balloon portion 58' of each completed Foley catheter 4' is inflated and the petrolatum band 40' within the balloon cavity 54' is largely removed.
  • the present invention provides a method of making sleeved Foley catheters 4' including the following steps:
  • methods of the present invention include the following steps:
  • balloon catheters are produced as follows:
  • first tank 33 which contains white USP petrolatum contain an effective amount of nitrofurantoin to prevent bacterial growth on the exterior surface of the resilient sleeve when inserted into a suitable aqueous environment.
  • the petrolatum is heated to about 60°C.
  • That tank 33 is then raised so as to immerse the intermediate tubes 3' into the petrolatum to such a depth that the petrolatum reaches the proximal end of the desired resilient sleeve location proximate the dashed line designated A in Figure 15.
  • the dip tank 33 is then lowered and a portion of the outer surface 14' of the intermediate tubes 3' are coated with petrolatum.
  • This portion extends from the general point at which the proximal end of the resilient sleeve 44' will begin, to the distal end 2a' of the tip 20' of each intermediate tube 3' .
  • this step can be repeated to increase the thickness of the lubricant coating 38', as well as the ultimate volume of the sleeve cavity 45' and the size of the outside diameter of the catheter 5' proximate the sleeve 44' .
  • Example I presented hereinabove, are then followed generally as outlined in Example I.
  • the pallet 24' is then stopped over a fifth dip tank 41, which contains a liquid soap (Liquid Ivory Soap from Proctor & Gamble Co., Cincinnati, OH 45202).
  • the soap is held at room temperature (between about 60-80°F, preferably 65-72°F) .
  • the fifth dip tank 41 is raised so as to immerse the intermediate tubes 3' into the liquid soap so that the soap coats the tubes 3' up to the dashed line designated by the letter C in Figure 18.
  • the dip tank 41 is then lowered and the liquid soap forms a semi-solid coating 40' on the outer surface 14' of each of the intermediate tubes 3' extending from line designated C to the distal end 20a' of the tip 20' of each of the intermediate tubes 3'.
  • the pallet 24 is then automatically advanced and stopped over a sixth dip tank 43 which contains an aqueous solution containing a trace of a suitable wetting agent or surfactant.
  • a suitable wetting agent or surfactant In a preferred embodiment, three gallons of water is mixed with two ounces of a suitable surfactant. The surfactant will generally be less than one percent of the total volume of the solution.
  • a sixth dip tank 43 is then raised so as to immerse the intermediate tubes 3' in the aqueous fluid up to the dashed line designated by the letter D in Figures 18 and 19.
  • the sixth dip tank 43 is then lowered and the semi-solid liquid soap coating the portion 14a' of the outer surface 14' below the dashed line designated D is substantially removed.
  • the pallet 24' is then automatically advanced and stopped over a eighth dip tank 49 containing a low-solids silicone rubber/solvent dispersion which is effective to minimize any disruption of the integrity of the liquid soap coating 40' remaining on each of the intermediate tubes proximate the portion 14c' of the outer surface 14' where the balloon cavity 54 will be created during subsequent dipping steps (the portion between the dashed lines designated C and D) .
  • the eighth tank 49 is then raised to immerse intermediate tubes 3' in the silicone rubber dispersion.
  • any suitable solvent for providing a suitable dispersion of silicone rubber and coating the particular lubricating agent may be used. It is also believed to be possible to use aqueous solvents, however, they are not preferred at present.
  • this step can be repeated at subsequent intervals, preferably long enough to permit significant solvent evaporation, to add to the thickness of the overcoat layer 42 and the balloon portion 58 of the overcoat layer 42.
  • further steps, involving different solutions can also follow.
  • the fourth dip tank 39 is then lowered and the silicone rubber, coating portions of the outer surface 14' as well as the coating of petrolatum 38' and the coating of soap 40', is allowed to dry.
  • the pallet 24' is then advanced again to a ninth dip tank 51 containing a different silicone rubber dispersions having a solids content which is higher than the solids content in the eighth dip tank 49.
  • the intermediate tubes 31 are immersed again in the subsequent silicone rubber dispersion when the ninth dip tank 51 is raised.
  • the ninth dip tank 51 is then lowered, and the silicone rubber, coating the tubes 3' is allowed to dry.
  • the pallet 24' is then automatically advanced again to a tenth dip tank 53 containing a silicone rubber dispersion including a silicone rubber which provides a high sheen and a smooth texture surface.
  • the tubes 3' are dipped again as before and the tenth dip tank 53 is then lowered and the silicone rubber coating the tubes 3' is allowed to dry.
  • the pallet 24' is then advanced through a drying step followed by a heat cure step, and each completed sleeved balloon catheter 5' is then secured to an end piece 46' , provided with a fluid conduit access opening 56', cooled to below freezing, stamped to provide a plurality of micropores (too small to be shown) in the resilient sleeve, tested, packaged and sterilized.
  • the automated system that Applicants claim will permit completed sleeved Foley catheters 4' to be manufactured at the rate of about 1.600 catheters per hour. Because virtually no handwork is involved in the balloon and sleeve construction, the catheters 4' produced will be consistent and of very high quality.
  • the exterior surface 62' is smoother than hand-glued balloons, and the outside diameter of the balloon portion 58' is essentially identical to the outside diameter of other portions of the completed Foley catheters 4' . It will be appreciated that larger outside diameter balloon portions are undesirable since they are somewhat more difficult to insert and withdraw. and cause additional trauma upon withdrawal.
  • the applicants' new process will permit direct production cost for silicone rubber balloon catheters of all types to be reduced by about 25-50% over the cost estimated for the prior art silicone rubber balloon catheters.

Abstract

Cathéter allongé (4'''') ayant une surface intérieure et une surface extérieure, la surface intérieure définissant un passage (8'''') traversant le cathéter. Le cathéter possède une cavité fermée (45'''') entre les surfaces intérieure et extérieure qui encercle le passage. La cavité possède une paroi interne et une paroi externe, cette dernière étant un manchon élastique qui peut s'étirer généralement indépendamment de la paroi interne. La cavité contient une quantité d'une substance appropriée de lubrification (38'''') efficace pour permettre au manchon élastique de coulisser le long d'une surface externe de la paroi interne tout en contact lubrifiant avec celle-ci lorsqu'il est étiré indépendamment de la paroi interne et comprend un agent bactéricide, la paroi interne et la paroi externe étant jointes aux extrémités proximales de l'extrémité distale de la cavité enfermée. Le manchon élastique comprend une pluralité de micropores qui permettent à l'agent bactéricide de se diffuser dans des environnements aqueux appropriés. Un procédé automatisé de production de ce cathéter comprend une série d'étapes d'immersion automatisées. Un cathéter de ''FOLEY'' ayant une partie ballon (58'''') et un manchon élastique lubrifié, tel que décrit ci-dessus est également divulgué, tout comme le sont des procédés de fabrication de celui-ci.
EP19910904028 1990-01-10 1991-01-08 Microcidal agent releasing catheter Withdrawn EP0515463A4 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US462832 1990-01-10
US07/462,832 US5137671A (en) 1990-01-10 1990-01-10 Methods of making balloon catheters
US07/487,422 US5098379A (en) 1990-01-10 1990-03-01 Catheter having lubricated outer sleeve and methods for making and using same
US487422 1990-03-01
US48946290A 1990-03-06 1990-03-06
US489462 1990-03-06

Publications (2)

Publication Number Publication Date
EP0515463A1 true EP0515463A1 (fr) 1992-12-02
EP0515463A4 EP0515463A4 (en) 1993-02-17

Family

ID=27412880

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19910904028 Withdrawn EP0515463A4 (en) 1990-01-10 1991-01-08 Microcidal agent releasing catheter

Country Status (5)

Country Link
EP (1) EP0515463A4 (fr)
JP (1) JPH05503231A (fr)
AU (1) AU7327491A (fr)
CA (1) CA2073509A1 (fr)
WO (1) WO1991010466A1 (fr)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5261896A (en) * 1990-01-10 1993-11-16 Rochester Medical Corporation Sustained release bactericidal cannula
US5670111A (en) * 1990-01-10 1997-09-23 Rochester Medical Corporation Method of shaping structures with an overcoat layer including female urinary catheter
US5724994A (en) * 1990-12-31 1998-03-10 Uromed Corporation Fluidly expandable urethral plug assembly which receives fluid from an external source and method for controlling urinary incontinence
US5479945A (en) * 1990-12-31 1996-01-02 Uromed Corporation Method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders
US5209726A (en) * 1992-05-04 1993-05-11 Goosen Carl C Self-lubricating urethral catheter and method for self-catheterization
US5779670A (en) * 1995-05-31 1998-07-14 Bidwell; Robert E. Catheter having lubricated sheathing
US5820607A (en) * 1995-06-05 1998-10-13 Board Of Regents, University Of Texas Systems Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections
ES2183191T3 (es) * 1996-06-04 2003-03-16 Cook Inc Dispositivo medico implantable.
US6007521A (en) * 1997-01-07 1999-12-28 Bidwell; Robert E. Drainage catheter system
DE19855521A1 (de) * 1998-12-02 2000-06-08 Tracoe Medizine Ges Fuer Tubus mit abgedichteter Manschette
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
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
AU2015204805B2 (en) 2014-01-09 2018-10-25 Hollister Incorporated Catheter cartridge assemblies and methods of using the same for intermittent catheterization
DK3092023T3 (da) 2014-01-09 2020-01-13 Hollister Inc Kateteranordninger med smurt beskyttelseshylster
WO2016033234A1 (fr) 2014-08-26 2016-03-03 C.R. Bard, Inc Cathéter urinaire
EP3294397A4 (fr) * 2015-05-13 2019-01-16 Innoventions Ltd. Système pour inhiber la formation de biofilm sur des cathéters, d'autres dispositifs installés à demeure ou implantables ou sur d'autres dispositifs
CA3070865A1 (fr) 2017-09-19 2019-03-28 C.R. Bard, Inc. Dispositif de pontage de catheter urinaire, systemes et procedes associes

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3981299A (en) * 1971-03-15 1976-09-21 Harry Elmer Murray Urethral catheter

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2330400A (en) * 1937-09-11 1943-09-28 American Anode Inc Method of making distensible bag catheters and the like
US2390070A (en) * 1941-05-31 1945-12-04 Davol Rubber Co Adhesion preventing agent for catheters and the like
US3169527A (en) * 1963-05-13 1965-02-16 Sheridan Corp Lubricated catheter
US3593713A (en) * 1968-07-12 1971-07-20 Stanley A Bogoff Catheter combination
US3699956A (en) * 1970-10-01 1972-10-24 Tecna Corp Percutaneous lead device
US4863424A (en) * 1983-11-18 1989-09-05 Blake Joseph W Iii Tubular medical device and method of making and using the same
US4623329A (en) * 1983-12-15 1986-11-18 The Procter & Gamble Company Drainage and infusion catheters having a capillary sleeve forming a reservoir for a fluid antimicrobial agent
US4968507A (en) * 1984-06-20 1990-11-06 Merck & Co., Inc. Controlled porosity osmotic pump
US4935260A (en) * 1987-07-17 1990-06-19 Shlenker Robin R T Covering such as a suit, glove, condum or sheath forming a chemical barrier against harmful agents and methods of making the same

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3981299A (en) * 1971-03-15 1976-09-21 Harry Elmer Murray Urethral catheter

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9110466A1 *

Also Published As

Publication number Publication date
AU7327491A (en) 1991-08-05
EP0515463A4 (en) 1993-02-17
WO1991010466A1 (fr) 1991-07-25
JPH05503231A (ja) 1993-06-03
CA2073509A1 (fr) 1991-07-11

Similar Documents

Publication Publication Date Title
US5269770A (en) Microcidal agent releasing catheter with balloon
EP0514400B1 (fr) Catheter ayant un manchon externe lubrifie et son procede de fabrication
US5599321A (en) Sustained release bactericidal cannula
US20130150828A1 (en) Antifungal catheter
EP0515463A1 (fr) Catheter de liberation d'un agent microcide
US5593718A (en) Method of making catheter
US5670111A (en) Method of shaping structures with an overcoat layer including female urinary catheter
US5971954A (en) Method of making catheter
US6383434B2 (en) Method of shaping structures with an overcoat layer including female urinary catheter
US20050177104A1 (en) Cuff resistant foley catheter

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 19920728

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IT LI LU NL SE

A4 Supplementary search report drawn up and despatched

Effective date: 19921230

AK Designated contracting states

Kind code of ref document: A4

Designated state(s): AT BE CH DE DK ES FR GB GR IT LI LU NL SE

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 19930308