WO2007005234A1 - Sonde de foley resistant a l'engorgement - Google Patents

Sonde de foley resistant a l'engorgement Download PDF

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Publication number
WO2007005234A1
WO2007005234A1 PCT/US2006/023401 US2006023401W WO2007005234A1 WO 2007005234 A1 WO2007005234 A1 WO 2007005234A1 US 2006023401 W US2006023401 W US 2006023401W WO 2007005234 A1 WO2007005234 A1 WO 2007005234A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
catheter
fluid
lumen
catheter shaft
Prior art date
Application number
PCT/US2006/023401
Other languages
English (en)
Inventor
Anthony J. Conway
Original Assignee
Rochester Medical Corporation
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 US11/170,194 external-priority patent/US20050288630A1/en
Application filed by Rochester Medical Corporation filed Critical Rochester Medical Corporation
Priority to EP06773291A priority Critical patent/EP1898984A1/fr
Publication of WO2007005234A1 publication Critical patent/WO2007005234A1/fr

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
    • 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
    • A61M25/0043—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
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1036—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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • 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
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths

Definitions

  • the invention relates to a Foley-type catheter having a retention balloon. More particularly, the invention relates to a catheter with a retention balloon made of silicone rubber.
  • Foley-type catheters are tube-like devices that are used to drain urine from a patient's bladder.
  • Foley catheters are inserted through the urethra and typically held in place with an inflatable balloon.
  • the balloon is in a deflated position when the catheter is first inserted. Then, once the catheter is in the proper position, the balloon is inflated with a fluid.
  • the inflated balloon is larger in diameter than the diameter of the urethra and thereby physically inhibits movement of the catheter.
  • Foley catheters are also known as "indwelling" catheters because they are designed to be left in place for a period of time.
  • Latex rubber is most often used in the manufacture of Foley catheters.
  • silicone rubber has since been used to make Foley catheters.
  • Silicone rubber does not, however, have the same elastic properties as latex rubber.
  • balloons of Foley catheters made with silicone rubber can exhibit "cuffing.” Cuffing refers to the situation in which the balloon tends to fold over on itself or shift toward the bladder end of the catheter. Because the balloon is attached at its end to the shaft of the catheter, a cuff forms when the outer expanded portion of the balloon pushes over the inner attached end of the balloon. This cuff can remain when the balloon is deflated before withdrawal of the catheter from the patient. The cuff results in the deflated balloon having a larger diameter than it did when it was first inserted. The increased diameter can result in discomfort and injury to patients. Accordingly, a need exists for a silicone rubber Foley catheter that resists cuffing.
  • catheter including a catheter shaft and an inflatable balloon.
  • the catheter shaft defines a first lumen and a second lumen, the first lumen being in fluid communication with an opening located at a distal end of the catheter shaft.
  • the inflatable balloon is positioned in fluid communication with the second lumen of the catheter shaft.
  • the inflatable balloon has a length defined between a first end of the balloon attached to the catheter shaft and a second end of the balloon attached to the catheter shaft. The length of the balloon is about .40 inches or less.
  • kits including a catheter and a pre-filled syringe.
  • the catheter includes a catheter shaft defining a fluid lumen and a capillary lumen, a balloon in fluid communication with the capillary lumen, and an end piece having first and second ports in fluid communication with the fluid and capillary lumen.
  • the syringe is pre-filled with less than about 7cc of fluid, and is constructed to correspond to the configuration of the second port to permit fluid communication between the syringe and the balloon.
  • Still another aspect of the present disclosure relates to a method of manufacturing a catheter having a catheter shaft and an inflatable retention balloon attached to the shaft at first and second ends of the balloon.
  • the balloon has a length between the first and second ends of about .40 inches or less.
  • FIG. IA is a schematic view of a catheter is an original deflated configuration
  • FIG. IB is a schematic view of a catheter in an inflated position wherein the balloon is cuffing
  • FIG. 1C is a schematic view of a catheter in a deflated position wherein the balloon has retained a cuff;
  • FIG. 2 is a partial cross-sectional view of a retention balloon of a Foley catheter made in accordance with the principles of the present disclosure
  • FIG. 3 is a cross-sectional view of an embodiment of a retention balloon having ribs
  • FIG. 4 is a partial cross-sectional view of the retention balloon of the Foley catheter of FIG. 2, shown with the retention balloon of the catheter expanded;
  • FIG. 5 is a partial cross-sectional view of the Foley catheter of FIG. 2, shown with the retention balloon and an end piece;
  • FIG. 6 is a schematic illustration of a kit including the Foley catheter of FIG. 5 and a syringe.
  • FIG. IA shows a schematic view of a catheter in a deflated configuration 2.
  • the catheter includes a balloon 4 and a catheter shaft 6.
  • the balloon 4 does not overlap either its distal end 7 or its proximal end 9.
  • the balloon 4 adds only a small increment to the diameter of the catheter shaft 6 because of how the uninflated balloon 4 lies flat over the catheter shaft 6.
  • FIG. IB is a schematic view of a catheter in an inflated configuration 10 wherein the balloon 4 is cuffing.
  • Cuffing refers to the situation in which the balloon 4 tends to be shifted toward the bladder end 15 of the catheter (in the direction of arrow 12) forming a cuff 14, as the balloon 4 itself is pressed against the bladder wall when holding the catheter in place. Since the balloon 4 is attached at its distal end 7 to the catheter shaft 6, the balloon forms a cuff 14 as the outer expanded portion of the balloon 4 is pushed over the inner attached distal end 7 of the balloon 4.
  • FIG. 1C is a schematic view of a catheter in a deflated configuration 20 after having been inflated wherein the balloon formed a cuff 14.
  • the cuff 14 results in the deflated balloon 4 having a larger diameter in an area 22 of the balloon 4 over the cuff 14 than when first inserted.
  • a balloon that has cuffed may be 12 French sizes larger at the cuff, for example, than the actual catheter shaft 6. The increased diameter can result in discomfort and injury to patients.
  • the Foley catheter 100 includes a catheter shaft 104 (FIG. 2) and an end piece 146 (FIG. 5).
  • the catheter shaft 104 includes a retention balloon 158.
  • the catheter shaft 104 of the Foley catheter 100 is constructed from a double lumen tube 102.
  • the double lumen tube 102 defines a fluid conduit lumen 108 and a capillary lumen 106.
  • the retention balloon 158 of the catheter shaft 104 is a multi-layer retention balloon.
  • the retention balloon 158 is constructed of two layers formed on the double lumen tube 102: a balloon layer 142 and a sheath layer 144.
  • each of the balloon layer 142 and the sheath layer 144 is made of silicone rubber, such as Dow Corning C6-515 or other suitable polymeric bonding compositions.
  • the multi-layer retention balloon 158 of the Foley catheter 100 is not bonded to the double lumen tube 102. Rather, a balloon cavity 154 is disposed under the balloon layer 142.
  • the balloon cavity 154 is in fluid communication with the capillary lumen 106 via a capillary lumen access opening 112 formed in the double lumen tube 102.
  • the retention balloon 158 and the balloon cavity 154 expand, as shown in FIG. 4.
  • the balloon layer 142 of the Foley catheter 100 is an integral part of the catheter shaft 104.
  • the balloon layer 142 is an integral part of the catheter shaft 104 by the dipping and stripping methods described in U.S. Patent Application Serial No. 11/170,193 (having Attorney Docket No. 8740.109US01), which application is incorporated herein by reference.
  • a balloon layer formed from cured material that is applied in cured form to a shaft is not an integral part of a catheter shaft.
  • the balloon layer 142 is provided only along a portion of the catheter shaft 104.
  • the sheath layer 144 of the catheter shaft 104 is formed over the entire length of the shaft, hi this manner, the difference between the diameter of the retention balloon 158 and the diameter of the catheter shaft 104 can be controlled simply by adjusting the thickness of the balloon layer 142. While not intending to be bound by theory, it is believed that the added thickness at the retention balloon 158 of the Foley catheter 100 resists balloon cuffing. Adding thickness to the retention balloon 158 also results in a stronger balloon that is less likely to burst.
  • the effective diameter of the shaft 104 and the diameter of the retention balloon 158 are increased commensurately so that the differential between the shaft and retention balloon are kept to an advantageous small amount, for example, about 4 French sizes (e.g., about 0.052 inch) or less than or equal to 4 French sizes (0.052 inch).
  • the retention balloon 158 of the Foley catheter 100 has a length Ll that extends from a first end 117 of the retention balloon 158 to a second end 119 of the retention balloon 158.
  • Each of the first and second ends 117, 119 of the retention balloon 158 are defined at a region where the balloon layer 142 attaches to or is integral with the double lumen tube 102.
  • Foley balloons are typically .60 inches in length, hi the present invention, the length Ll of the retention balloon 158 is preferably less than .45 inches; more preferably less than or equal to .40 inches. hi providing a retention balloon 158 having a shortened length Ll, the occurrence of cuffing is reduced.
  • balloons having the longer length relative to a particular balloon diameter have more length that can stretch and fold over to form a cuff.
  • the shortened length Ll of the present invention reduces the likelihood of cuffing by lessening the amount of length that can stretch, thereby lessening the likelihood that the stretched length will fold over.
  • the inflated diameter D of the retention balloon 158 of the Foley catheter 100 preferably remains the same as compared to conventional balloons.
  • the retention balloon 158 of the Foley catheter 100 is constructed to expand or inflate to about .80 inches to 1.1 inches in diameter D so that the Foley catheter 100 remains in place during use.
  • the shortened length Ll (FIG. 2) of the Foley catheter 100 provides a retention balloon 158 that is donut-shaped or ring- shaped.
  • the ring-shaped configuration is shorter in length than conventional arrangements to prevent cuffing, but sufficient in diameter to hold the catheter 100 in place.
  • the retention properties of the ring-shaped configuration are undiminished in comparison to conventional Foley catheters, but the discomfort and possibility of injury caused by cuffing during removal of the catheter are significantly reduced.
  • the length Ll to diameter D ratio is no more than about 1.0 to 2.0; more preferably about 1.0 to 3.0.
  • the Foley catheter 100 of the present disclosure includes a drainage eye or fluid conduit access opening 156 located through an exterior surface 162 of the catheter shaft 104.
  • the drainage eye 156 is in fluid communication with the fluid conduit lumen 108.
  • the drainage eye 156 of the catheter shaft 104 is located a distance L2 from the retention balloon 158 of the catheter 100.
  • the distance L2 is defined as the distance between the first end 117 of the retention balloon 158 and a general centerline of the drainage eye 156.
  • the drainage eye is located closer to the bladder neck of the patient's bladder in comparison to conventional arrangements. Providing an arrangement wherein the drainage eye 156 is closer to the patient's bladder neck results in more complete draining of the patient's bladder.
  • a tip 120 of the catheter is not required to be inserted as far into the patient's bladder as compared to conventional arrangement. The required insertion depth for the presently disclosed Foley catheter 100 is reduced, and thereby the catheter 100 is less likely to contact and irritate the back of the patient's bladder wall.
  • the distance L2 of the first end of the balloon 117 and the general centerline of the drainage eye 156 is preferably less than about 1.0 inches; more preferably less than or equal to about .80 inches.
  • the balloon layer 142 of the retention balloon 158 is formed with ribs 160. It is intended that various embodiments of the present invention can include only one, or a combination of the features herein described, including: the multi-layered retention balloon 158, the shortened balloon length Ll, and the ribs 160.
  • the ribs 160 are preferably made of a compound different from that of the sheath layer 144.
  • the balloon layer 142 has a first region 141 and a second region 143.
  • the first region 141 includes the ribs 160.
  • the ribs 160 are made of a less pliable silicone rubber than the silicone rubber of the second region 143 of the balloon layer 142, and than the silicone rubber of the sheath layer 144. That is, the compound of the ribs 160 preferably stretches less easily than the compound of the second region 143 of the balloon layer 142 and the compound of the sheath layer 144.
  • the ribs 160 resist excessive balloon stretching and enhance the structural memory or return of the retention balloon so that the retention balloon 158 is less likely to cuff. While not intending to be bound by theory, it is further believed that positioning the ribs 160 to extend in a direction parallel to the catheter shaft 104 limits stretching of the retention balloon 158 in that direction, further aiding in the resistance of cuffing.
  • the ribs 160 fit within corresponding grooves 115 (e.g., undulations or channels) formed in the double lumen tube 102 of the catheter 100.
  • the ribs 160 rest within the grooves 115 of the double lumen tube 102 so that the diameter of the retention balloon 158 is not affected by the existence of the ribs.
  • the end piece 146 of the Foley catheter 100 is secured to a proximal end 130 of the catheter shaft 104.
  • the end piece 146 defines a first access opening 149 and a second access opening 152.
  • the second access opening 152 is in fluid communication with the capillary lumen 106.
  • a cap 148 is provided for closure of the first access opening 149.
  • a luer valve 150 is also provided. The luer valve 150 is adapted for engagement into and closure of the second access opening 152.
  • fluid such as water
  • the fluid flows through the capillary lumen access opening 112 into the balloon cavity 154 to expand the retention balloon 158.
  • the balloons having the standard length of .60 inches are typically inflated with lOcc of water.
  • Most conventional Foley catheters are sold in kits having syringes pre-filled with 1 Occ of water.
  • the present Foley catheter 100 can be provided in a kit 200.
  • the kit includes the Foley catheter 100 having the shortened length Ll (FIG. 2) and a prefilled syringe 110 (schematically represented).
  • the syringe 110 is pre-filled with about 6 cc of water 111, preferably less than about 7 cc of water 111.
  • the Foley catheter 100 can include a sticker, markings, or other indicia 113.
  • the indicium 113 is located on the luer valve
  • the weight of the retention balloon 158 is reduced, especially when filled with water.
  • the disclosed Foley catheter 100 not only lessens the likelihood of discomfort or injury due to cuffing, the reduced balloon weight of the present Foley catheter 100 also lessens the likelihood of general trauma and irritation to the patient during indwelling periods.

Abstract

L'invention se rapporte à un cathéter de type Foley élaboré pour empêcher un ballonnet de rétention situé à l'intérieur dudit cathéter de s'engorger. Le ballon de rétention a une longueur inférieure ou égale à 40 pouces (1 cm). L'invention concerne également un kit comprenant le cathéter de Foley et une seringue contenant environ 6cc en eau.
PCT/US2006/023401 2005-06-29 2006-06-15 Sonde de foley resistant a l'engorgement WO2007005234A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06773291A EP1898984A1 (fr) 2005-06-29 2006-06-15 Sonde de foley resistant a l'engorgement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/170,194 2005-06-29
US11/170,194 US20050288630A1 (en) 2004-01-22 2005-06-29 Cuff resistant foley catheter

Publications (1)

Publication Number Publication Date
WO2007005234A1 true WO2007005234A1 (fr) 2007-01-11

Family

ID=37074690

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/023401 WO2007005234A1 (fr) 2005-06-29 2006-06-15 Sonde de foley resistant a l'engorgement

Country Status (2)

Country Link
EP (1) EP1898984A1 (fr)
WO (1) WO2007005234A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013004236A1 (fr) * 2011-07-01 2013-01-10 Coloplast A/S Cathéter à ballonnet

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269770A (en) * 1990-01-10 1993-12-14 Rochester Medical Corporation Microcidal agent releasing catheter with balloon
WO2000025848A2 (fr) * 1998-11-02 2000-05-11 Mentor Corporation Expansion de tissu prostatique
US6102929A (en) * 1994-09-15 2000-08-15 Mentor Urology, Inc. Prostatic tissue expander

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269770A (en) * 1990-01-10 1993-12-14 Rochester Medical Corporation Microcidal agent releasing catheter with balloon
US6102929A (en) * 1994-09-15 2000-08-15 Mentor Urology, Inc. Prostatic tissue expander
WO2000025848A2 (fr) * 1998-11-02 2000-05-11 Mentor Corporation Expansion de tissu prostatique

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013004236A1 (fr) * 2011-07-01 2013-01-10 Coloplast A/S Cathéter à ballonnet
CN103619402A (zh) * 2011-07-01 2014-03-05 科洛普拉斯特公司 具有球囊的导管
US9504809B2 (en) 2011-07-01 2016-11-29 Coloplast A/S Catheter with a balloon
RU2609458C2 (ru) * 2011-07-01 2017-02-01 Колопласт А/С Катетер с баллоном

Also Published As

Publication number Publication date
EP1898984A1 (fr) 2008-03-19

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