CA1191064A - Catheter with selectively rigidified portion - Google Patents

Catheter with selectively rigidified portion

Info

Publication number
CA1191064A
CA1191064A CA000412222A CA412222A CA1191064A CA 1191064 A CA1191064 A CA 1191064A CA 000412222 A CA000412222 A CA 000412222A CA 412222 A CA412222 A CA 412222A CA 1191064 A CA1191064 A CA 1191064A
Authority
CA
Canada
Prior art keywords
catheter
tip portion
coating
polymer
hydrated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000412222A
Other languages
French (fr)
Inventor
William J. Norton
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.)
CR Bard Inc
Original Assignee
CR Bard Inc
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 to US33629081A priority Critical
Priority to US336,290 priority
Application filed by CR Bard Inc filed Critical CR Bard Inc
Application granted granted Critical
Publication of CA1191064A publication Critical patent/CA1191064A/en
Application status is Expired legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0054Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A61M2025/0065Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body which become stiffer or softer when becoming wet or humid, e.g. immersed within a liquid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081Soft tip

Abstract

ABSTRACT OF THE DISCLOSURE

A catheter having a relatively soft body formed of a hydrophobic elastomer and a tip portion coated with a water insoluble hydrophilic polymer grafted thereto to impart, in the dry state, rigidity to the tip portion. In use the hydrophilic coating absorbs or adsorbs water with resultant softening of the coating so as to render the tip portion soft.
A method of facilitating placement of a catheter utilizing a transitorily rigidified tip portion is taught.

Description

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The present invention relates generally to provision of elastomeric tubing having utility for medical devices and particularly urethral and venous catheters. Such catheters normally are considered to be indwelling catheters in that they are placed and retained within the urethra or a vein for an extended period of time. Since the catheters in use comprise a foreign body they tend to cause considerable irritation of the tissue with which they come in contact.
The problem attendant minimizing irritation of tissue arising from an indwelling catheter is aggravated by the fact that it is generally preferable to provide a relatively rigid tip for the indwelling portion to facilitate passage of the catheter through the ur~thra or vein. It will be appreciated that the relatively rigid tip portion of the indwelling catheter only enhances the irritation of the adjacent~tissue, i.e., bladder wall or inner wall of the vein. Thus, the invention herein resides in the proYision of catheters constructed so as to have a tip portion that is relatively rigid so as to facilitate placement of the catheter, which relatively rigid tip portion in use becomes relatively less rigid whereby irritation of adjacent tissue is minimized.
A specific example of an instance where it is desirable to have different physical properties in various sections of a catheter is with respect to a urethral ratheter wherein a relatively rigid curved tip is desirable to assist in the insertion o the catheter through the urethra which is . `' ~ .

9~Q64 curved and restrictive in the uppex seetion.
In U.S. Patent No. 3;865,666 to Shoney it is recogni~ed that from a structural point of view a cat~eter, such as a urinary catheter, must be sufficiently rigid to ensure that as it traYerses the urinary tract for placement in the bladder the catheter tube will not bend to an extent which results in occluding or reducing the size of the drainage lumen and the in~lation lumen utilized to expand a balloon to retain the tip of the catheter within the bladder. While Shoney describes a catheter having a relatively rigid tip portion a significant problem arises by virtue of the fact that the tip portion maintains its rigidity in use thus leading to potential irritation of the bladder wall.
Catheters of the utility discussed herein are generally formed of silicone polymers which due to the hydro-phobic characteristic of the silicone may then be provided with a hydrophilic coating derived from N-vinyl pyrrolidone (NVP~ or acrylate and methacrylate monomers.
U.S. Patent No. 4,055, 682 to Merrill is directed to a catheter having a silicone body portion rendered hydrophylic by contacting it with NVP and exposing the catheter and NVP
to ionizing radiation at high dosage rates. The hydrophilic polymeric layer of Merrill is so thin that the stiffness of the catheter after deposition of the polymeric layer, when dry, is not substantially greater than that of an uncoated catheter of , J ~ the dame composition and degree of crosslinking.
U.S. Patents Nos. 3,566,874 and 3,695,921 to Shepherd et al are representative of indwelling Foley urethral catheters made of natural or synthetic rubber and having an external , . ,, . .. , . . . . , , . . , . ., . ., , _, , , . .,, .. _ ..

"
~19~
coating of a hydrophilic acrylate or methacrylate polymer grafted thereto for the stated purpose of reducing irritation and infection considered to normally accompany the use of catheters. Howe~er, it has been found that problems are en-countered in use when substantially the entire outer surface of the catheter within the urethra or vein is coated with a hydrophilic polymer fiince as discussed in Patent No. 3,566,874 the resultant hydrophilic layers are stiff when dry.

In normal use of the conventional urethral and veinous catheters irritation of adjacent tissue by a relatively rigid catheter is of major concern. The present invention provides a catheter tip structure that is relatively rigid for purposes of placement of the catheter and which subsequent to placement in the body is rendered less rigid so as to minimize irritation of adjacent tissue.
The invention contemplates rendering the tip portion of urethral and ~einous catheters formed of relatively 1exible natural rubber or synthetic rubber, e.g. silicone rubber relatively rigid by the application; e.g., by grafting, to such tip portion a hydrophilic coating such as exemplified by the referenced patents to Merrill and Shepherd et al, which coatings render the tip portion relatively rigid.
U.S. Patent No. 3,695,921 to Shepherd et al dis-closes the provision of hydrophilic acrylate and methacrylatecoatings that are rigid or stiff when dry. U.S. Patent No.
4,055,682 to Merrill discloses catheters having stiffness ~9~o~

imparted thereto by use of a high dose of ionizing radiation, e.g. dose to which portion 36 is subjected, albeit the disclosure of Merrill is primarily directed to the grafting of NVP to silicone catheter body so that the stiffness of the catheter after coating, when dry, is not substantially greater than that of an un-coated catheter of the same composition and degree of crosslinking.
The object of the invention comprising mini-mizing irritation of tissue adjacent the tip of the catheter is achieved by the hydrophilic nature of the "ri~idifying" coating absorbing or adsorbing water and thereby becoming less rigid.
The present invention provides a catheter which comprises an elongated relatively flexible body portion formed of a hydrophobic polymer and including a rigidified tip portion of minor longitudinal extent, the tip portion including a physiological fluid-insoluble hydrophilic non-hydrated polymeric coating for xendering the tip portion relatively rigid in a dry state, the coating being relatively flexible when hydrated by a physiological fluid.
Preferably, the tip portion is arcuate.
The catheter may comprise a Foley or venous catheter and the coating may comprise a hydrophilic polymeric coating formed from a monomer selected from the group comprising N~vinyl pyrrolidone, acrylate and methacrylate.
Th~ invention Eurther provides a method of i - 4 -~1~106~

permanently reversibly rigidifying a predetermined minor tip portion of the length of an elongated rela-tively flexible catheter formed of a hydrophobic polymer to facilitate insertion of the catheter into a body cavity, comp.rising externally coating only the tip portion with a rigidifying physiological fluid-insoluble hydropyhilic non-hydrated polymer which is relatively flexible when hydrated by the aqueous moiety of a physiological fluid.
The inventi.on will be more readily apparent from the following detailed description taken in con-junction with the drawings in which an exemplary em-bodiment of the invention is shown.
Figure 1 is a perspective view of an urethral catheter embodying the invention; and Figure 2 is an enlarged cross-section of the tip portion of the catheter taken along the lines

2-2 of Figure 1.
Referring more specifically to Figures 1 and 2 of the drawings, there is provided an improved conventional constant drainage bag indwelling Foley urethral catheter 10 made of silicone rubber. The catheter 10 includes a tubular body portion 12 ter-minating in a tip portion indicated generally at 14.
The catheter body 10 includes a drainage lumen, not shown, that connects a funnel 16 with a drainage port 18. An inflatable retaining . . ~, ~ 1191~)64 ~ ! ' bag or balloon 20 encompasses the tube 12, at a point inwardly of drainage port 18, and is sealed or otherwise connected thereto in conventional fashion. A ~ongitudinally extending inflation lumen, not shown, terminates in an inflation port 22 which communicates the interior of the balloon 20 with a valve end porti~n or arm 23 for the introduction of air to inflate the balloon 20 to retain the catheter tip 14 in the bladder.
The body portion 12 is formed of a relatively flexible elastom~r, e.g., silicone rubber, which is hydrophobic and generally inert with respect to plysiological fluids it contacts. To facilitate passage of the relatively flexible catheter 10 through the urethra the tip portion 14 is rendered relatively rigid by provision of a rigidifying polymeric coating 24 which is applied, in the exemplary embodiment shown, such as from point 26 at the base of the balloon 20 to the end of the tip portion 14. It is essential to the present invention that the polymeric coating 24 be relatively rigid in a dry state, generally insoluble in physiological liquids, hydrophilic, and relatively flexible when wetted by physiological liquids such as ~rine and blood. The coatiny 2~ thus may comprise a hydrophilic polymer such as formed from NVP or an acrylate or methacrylate mQnomer as set forth in the Merrill and Shepherd et al patents. It will be understood that hydrophilic polymers formed from NVP or acrylate and methacrylate monomers are merely exemplary and that other hydrophilic polymers are ~ satisfactory as lon~ as they impart sufficient rigidity, in a dry state, to the catheter tip portion 14 and are capable of softening in use, within a reasonable time, by absorption of a physiological fluid.
~ 5~

~ 64 ~l It will thus be appreciated that the hydrophilic coating 24 comprises means for rendering the catheter tip portion 14 relatively rigid to facilitate placement and wherein upon indwelling placement in the bladder the tip portion 14 is rendered relatively flexible so as to minimize irritation of the bladder wall.
It will be apparent that other variations may be perceived by those skilled in the art without dPparting from the scope of my invention as defined in the appended claims.

~ (6~ ~
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Claims (7)

The embodiments of the invention in which an ex-clusive property or privilege is claimed are defined as follows:
1. A catheter comprising an elongated relatively flexible body portion formed of a hydrophobic polymer and including a rigidified tip portion of minor longitudinal extent, said tip portion including a physiological fluid-insoluble hydrophilic non-hydrated polymeric coating for rendering the tip portion relatively rigid in a dry state, said coating being relatively flexible when hydrated by a physiological fluid.
2. The catheter of claim 1 wherein the tip por-tion is arcuate.
3. The catheter of claim 1 comprising a Foley catheter.
4. The catheter of claim 1 comprising a venous catheter.
5. The catheter of claim 1 wherein said coating comprises a hydrophilic polymeric coating formed from a monomer selected from the group comprising N-vinyl pyrro-lidone, acrylate and methacrylate.
6. A method of permanently reversibly rigidify-ing a predetermined minor tip portion of the length of an elongated relatively flexible catheter formed of a hydro-phobic polymer to facilitate insertion of the catheter into a body cavity, comprising externally coating only the tip portionwith a rigidifying physiological fluid-insoluble hydrophilic non-hydrated polymer which is relatively flexible when hydrated by the aqueous moiety of a physiological fluid.
7. The method of claim 6 wherein said polymer com-prises a hydrophilic polymer formed from a monomer selected from the group comprising N-vinyl pyrrolidone, acrylate and methacrylate.
CA000412222A 1981-12-31 1982-09-27 Catheter with selectively rigidified portion Expired CA1191064A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US33629081A true 1981-12-31 1981-12-31
US336,290 1981-12-31

Publications (1)

Publication Number Publication Date
CA1191064A true CA1191064A (en) 1985-07-30

Family

ID=23315428

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000412222A Expired CA1191064A (en) 1981-12-31 1982-09-27 Catheter with selectively rigidified portion

Country Status (11)

Country Link
JP (1) JPS58118766A (en)
AU (1) AU8984682A (en)
BR (1) BR8206824A (en)
CA (1) CA1191064A (en)
DE (1) DE3247576A1 (en)
ES (1) ES267884Y (en)
FR (1) FR2519255A1 (en)
GB (1) GB2112646B (en)
IT (1) IT1154592B (en)
NL (1) NL8203898A (en)
SE (1) SE8205603L (en)

Families Citing this family (32)

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Publication number Priority date Publication date Assignee Title
US4531943A (en) * 1983-08-08 1985-07-30 Angiomedics Corporation Catheter with soft deformable tip
SE8305444L (en) * 1983-10-04 1985-04-05 Vilhelm Einar Stellan Hjerten Bacteria resistant surfaces
US4798597A (en) * 1987-04-29 1989-01-17 Sherwood Medical Co Flexible composite intubation tube
JPH02299663A (en) * 1989-05-15 1990-12-11 Unitika Ltd Anti-infectious catheter
DE69002295D1 (en) * 1989-09-25 1993-08-26 Schneider Usa Inc Multilayer extrusion process as gefaessplastik for manufacture of balloons for.
US5135516A (en) * 1989-12-15 1992-08-04 Boston Scientific Corporation Lubricious antithrombogenic catheters, guidewires and coatings
JPH0783761B2 (en) * 1990-10-04 1995-09-13 テルモ株式会社 Medical devices
US6524274B1 (en) 1990-12-28 2003-02-25 Scimed Life Systems, Inc. Triggered release hydrogel drug delivery system
US5843089A (en) * 1990-12-28 1998-12-01 Boston Scientific Corporation Stent lining
US5304121A (en) * 1990-12-28 1994-04-19 Boston Scientific Corporation Drug delivery system making use of a hydrogel polymer coating
US5674192A (en) * 1990-12-28 1997-10-07 Boston Scientific Corporation Drug delivery
US5102402A (en) * 1991-01-04 1992-04-07 Medtronic, Inc. Releasable coatings on balloon catheters
US5254089A (en) * 1992-04-02 1993-10-19 Boston Scientific Corp. Medication dispensing balloon catheter
DE4222380A1 (en) 1992-07-08 1994-01-13 Ernst Peter Prof Dr M Strecker In the body of a patient percutaneously implantable endoprosthesis
US5599298A (en) * 1993-12-30 1997-02-04 Boston Scientific Corporation Bodily sample collection balloon catheter method
US5588962A (en) * 1994-03-29 1996-12-31 Boston Scientific Corporation Drug treatment of diseased sites deep within the body
FR2719223B1 (en) * 1994-04-29 1996-10-04 France Chirurgie Instr ophthalmic product.
US5868719A (en) * 1997-01-15 1999-02-09 Boston Scientific Corporation Drug delivery balloon catheter device
US6494861B1 (en) 1997-01-15 2002-12-17 Boston Scientific Corporation Drug delivery system
US6702789B1 (en) 1997-03-11 2004-03-09 Alcove Medical, Inc. Catheter having insertion control mechanism and anti-bunching mechanism
US6306166B1 (en) 1997-08-13 2001-10-23 Scimed Life Systems, Inc. Loading and release of water-insoluble drugs
WO1999049908A1 (en) 1998-03-31 1999-10-07 University Of Cincinnati Temperature controlled solute delivery system
US7976518B2 (en) 2005-01-13 2011-07-12 Corpak Medsystems, Inc. Tubing assembly and signal generator placement control device and method for use with catheter guidance systems
US9192697B2 (en) 2007-07-03 2015-11-24 Hemoteq Ag Balloon catheter for treating stenosis of body passages and for preventing threatening restenosis
MX336844B (en) 2007-01-21 2016-02-03 Hemoteq Ag Medical product for treating stenosis of body passages and for preventing threatening restenosis.
CN101801448B (en) * 2007-07-16 2013-11-27 弗罗森斯有限公司 Systems and methods for removal of urine
ES2550634T3 (en) 2009-07-10 2015-11-11 Boston Scientific Scimed, Inc. Use of nanocrystals for a drug delivery balloon
EP2453938B1 (en) 2009-07-17 2015-08-19 Boston Scientific Scimed, Inc. Nucleation of drug delivery balloons to provide improved crystal size and density
EP2611476B1 (en) 2010-09-02 2016-08-10 Boston Scientific Scimed, Inc. Coating process for drug delivery balloons using heat-induced rewrap memory
US8669360B2 (en) 2011-08-05 2014-03-11 Boston Scientific Scimed, Inc. Methods of converting amorphous drug substance into crystalline form
US9056152B2 (en) 2011-08-25 2015-06-16 Boston Scientific Scimed, Inc. Medical device with crystalline drug coating
WO2013036772A1 (en) 2011-09-08 2013-03-14 Corpak Medsystems, Inc. Apparatus and method used with guidance system for feeding and suctioning

Family Cites Families (5)

* Cited by examiner, † Cited by third party
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US3435826A (en) * 1964-05-27 1969-04-01 Edwards Lab Inc Embolectomy catheter
US3419010A (en) * 1966-01-17 1968-12-31 Cordis Corp Catheter
JPS5821651B2 (en) * 1973-11-19 1983-05-02 High Voltage Engineering Corp
CS173836B1 (en) * 1974-03-19 1977-03-31
US4100309A (en) * 1977-08-08 1978-07-11 Biosearch Medical Products, Inc. Coated substrate having a low coefficient of friction hydrophilic coating and a method of making the same

Also Published As

Publication number Publication date
SE8205603D0 (en) 1982-10-01
SE8205603L (en) 1983-07-01
FR2519255A1 (en) 1983-07-08
IT1154592B (en) 1987-01-21
GB2112646B (en) 1985-10-09
DE3247576A1 (en) 1983-07-07
NL8203898A (en) 1983-07-18
CA1191064A1 (en)
GB2112646A (en) 1983-07-27
IT8224460D0 (en) 1982-11-26
JPS58118766A (en) 1983-07-14
BR8206824A (en) 1983-10-04
ES267884U (en) 1983-04-16
ES267884Y (en) 1983-11-16
AU8984682A (en) 1983-07-07

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