CA1181309A - Self-sealing gasket assembly - Google Patents

Self-sealing gasket assembly

Info

Publication number
CA1181309A
CA1181309A CA000411417A CA411417A CA1181309A CA 1181309 A CA1181309 A CA 1181309A CA 000411417 A CA000411417 A CA 000411417A CA 411417 A CA411417 A CA 411417A CA 1181309 A CA1181309 A CA 1181309A
Authority
CA
Canada
Prior art keywords
gasket
sealing
housing
bore
self
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
CA000411417A
Other languages
French (fr)
Inventor
Kenneth A. Spector
Wilfred Samson
Richard M. Demello
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
Application filed by CR Bard Inc filed Critical CR Bard Inc
Application granted granted Critical
Publication of CA1181309A publication Critical patent/CA1181309A/en
Expired 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064—Slit-valve
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0653—Perforated disc
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0666—Flap-valve
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/7722—Line condition change responsive valves
    • Y10T137/7837—Direct response valves [i.e., check valve type]
    • Y10T137/7879—Resilient material valve
    • Y10T137/788—Having expansible port
    • Y10T137/7882—Having exit lip
    • Y10T137/7885—Multiple slit

Abstract

SELF SEALING GASKET ASSEMBLY

ABSTRACT OF THE DISCLOSURE
A molded one-piece, self-sealing gasket maintains its seal at all times including during insertion of a tube, such as a catheter, as well as after the tube is withdrawn.

Description

BACKGROUND OF THE INVENTION

This invention relates to improvements in self-sealing gas-kets, particularly valve-like gaskets through which tubes may be inserted and removed9 and in which the valve-gasket main-tains a seal at all times~ Devices of this type are used in a variety of environments, such as medical environments, in which it is often required to insert one tube thro~gh another tube or into a housing or vessel while maintaining the outer tube, housing or vessel sealed at all times. Other environments in which such devices have been used include gas masks or sealed helmets, to provide a self-sealing valve through which a feed-ing tube or the like may be inserted and withdrawn repeatedly, while maintaining a seal at all times. For example, U.S.
Paten~ No. 2,023,267 to DeS~int Rapt illustrates a gas mask having a self-sealing valYe formed of a plurality of apertured and slitted disks arranged face-to-face through which a feeding tube may be inserted or ~ithdrawn. Similarly, U.S. Patent No.
3,C67,425 to Colley illustrates a modified form of self-sealing device in an aviator's helmet having a different configuration of slits and apertures in the various face-to-face disks.

3~

U.S. Patent No. 4,000,739 to Stevens illustrates an analo-gous use for such a self-sealing gasket arrangement in a cathe-ter introducer. The catheter introducer illustrated in the Stevens patent includes a tube which is intended to be inserted into and which remains in place in a patient's blood vessel. A
fitting on the externally projecting end of the tube is provid-ed with a self-sealing gasketing device to enable catheters to be introduced into the patient's blood vessel through the self-sealing introducer. m e catheter introducer may remain in place in the patient's blood vessel for a period of time during which the various catheters may be inserted and withdrawn as may be determined by the particular medical procedure(s) at hand. Also illustrative of the medical environments where self-sealing valves or plugs may be used are shown in Ring Patent No. 3,45~,183 and Scislowicz Pa~ent ~o. 3,097,646 which show needles or other similar tubular introducer devices are placed in a blood vessel and in which the devices are provided with self-sealing plugs or the like on their outer ends to provide self-sealing access to the blood vessel.
When such a self-sealing device is used in a catheter introducer, it often may be desirable to provide a side entry port through which liquids may be introduced sr through whch the device may be aspirated (i.e. to withdraw blood or other-wise apply suction as desired). m us, it i5 important that the self-sealing valve or pluy maintain its seal over a relatively wide range of pressures to include not only the normal positive pressure of the patient's blood pressure but also the reduced pressure which results from aspiration through the side port.
Also among the desirable features of a self-sealing device is that the seal should not unduly inhibit axial and rctary movement of a catheter through the seal.
The type of self-sealing device as illustrated in the Stevens, DeSaint Rapt and Colley patents is not without its difficulties. mat type of device utilizes a number of slitted and apertured gasket disks in face-~o-face relation. In each of these, it is necessary to manufacture a number of separate disks and to assemble them in a predetermined sequence and array, all of which adds to manufacturing costs. In addition, when used as a self-sealing cannula (as in ~he Stevens device) it has been found that while such multiple gasket devices are not wholly without difficulties. For example, the commercially available version of the device disclosed in the Stevens patent may not perform as well during aspiration as might be desired and in some instances, there is some risk that aspiration may ingest air into the system through the disks. I~ is believed that this is in part due to the use of two thin face-to-face gaskets which typify the Stevens construction.
It is among the general objects of the invention to provide an improved self~sealing gasket cor.figuration for use in catheter introducers and the like.

SUMMARY OF THE INVENTION
A construction in accordance with the present invention comprises a self-sealing gasket assembly to permit a tube to be inserted into or withdrawn from a housing while maintaining the interior of the housing under seal, comprising a one-piece disc-shaped gasket having an outer sealing por-tion, an inner sealing portion and a peripheral side-wall portion connecting the inner and outer sealing portions. The inner, outer and side-wall portions are constructed and arranged so that the inner and outer sealing portions are spaced from each other. An aperture is formed in the outer sealing member~ Means are provided defining at least one slit in the inner sealing portion of the member. The inner portion of the gasket has a shoulder formed about its periphery whereby the more central region of the inner sealing member defines an inwardly extending central plug portion, the slit being formed within the plug portion.
~ housing is provided to receive the sealing member, wherein the housing includes an inner bore and an outer bore, the outer bore being larger than the inner bore and defining a shoulder at the juncture of the inner bore and the outer bore, the shoulder in the housing being constructed and arranged to receive the shoulder formed about the periphery of the inner sealing portion of the gasket and to peripherally constrain the plug portion thereby to provide support for the plug portion and the periphery of the gasket.
Means are also provided for securing the periphery of the gasket against the shoulder of the housing.
In brief, the self-sealing gasket i9 molded in a single piece from a resilient material, such as latex rubber, to have an outer sealing portion and an inner sealing portion. The inner and outer sealing portions are joined by an integral peripheral side wall. The outer sealing segment has a central hole which forms a seal about the catheter or like tube when the tube is inserted through the device. The inner sealing segment includes a slotted member which defines a number of flaps. The flaps which remain in their normal closed configuration in the absence of a tube, spread apart upon the introduction of a catheter or like tube. When the catheter is withdrawn, the flaps return to their normal closed and self-sealing configurationO The one-piece molded self-sealing gaske-t is contained within a specially fo~ned cavity which cooperates with the outer peripheral contour of the gasket to provide superior sealing both in a static pressure and aspiration mode, and whether the catheter is in place or not.
In the illustrative embodiment of the inven-tion, the one-piece self-sealing member is contained within a housing attached to the end o-f an introducer tubeO The housing has a hollow interior with a specially formed shoulder surface to receive the - 4a -self-sealing member. The self-sealing member is held in place by an end cap which is secured to the housing~
A side port preferably is formed integrally with the housing to enable liquids to be introduced to the patient, or to facilit-s, ,~
.~ - 4b -ate blood pressure readings or for aspiration, or the like.
It is among the general objects of the invention to provide an improved self-sealing gasket.
A further object of the inventio~ i5 to provide an improved catheter introducer or like device having a self-sealing gasket.
Another object of the invention is to provide a self-sealing device of the type described which provides super-ior sealing yet which does not adversely increase the resist-ance to manipulation of the catheter or other tube extending through the sealO
Anotner object of the invention is to provide a self-sealing device of the type described which is molded in a single integral piece and which results in economies and efficiencies in manufacture of the seal as well as in assembly of the seal into a receptive housing.

DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages of the invention will be appreciated more fully from the following further description thereof, with reference to the accompanying drawings wherein:
FIG. 1 is an illustration of the invention as embodied in the housing of a catheter introducer, broken away and sectioned to illustrate the internal structure of the device;
FIG. 2 is an enlarged sectional illustration of the one-piece self~sealing valve element of ~he present invention;

FIG. 3 is an illustration of the s~lf-sealing valve member as viewed from the left side of FIG. 2; and FIG. ~ is an illustration of the de~ice with a tube extend-ing through the self-sealing valve with the flaps separated.

DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENT

FIG. 1 shows a catheter introducer which incorporates the present invention. The introducer includes an introducer tube 10 which is connected to and extends from a housing 12. me one-piece molded self-sealing gasket, indicated generally by reference character 14 is mounted in the valve housing 12 in a manner described in more detail below. The gasket 14 is retained firmly in place in the housing 12 by an end cap 16.
The housing 12 prefera~ly is provided with a side port 18.
m e introducer tube 10 preferably is formed from fluorinated ethylene and is formed separately with an enlarged head portion 20. The housing 12 preferably is molded directly onto the headed end of the introducer tube 10 and is locked securely and integrally with the introducer tube 10 by engagement with the head portion 20. The housing 12 is formed wlth a hollow interior 22 which forms a forwardly-tapering configuration, indicated at 24, which merges smoothly with the tapering inlet end of the head portion 20 of the introducer tube 10. The side port 18 is molded integrally with the housing 12 to provide a means to communicate directly with the hollow interior 22 in the housing 12.

3~

m e hollow interior 22 of the housing 12 defines a cylind-rical bore 26 which terminates in an enlarged diameter shoulder 28. m e shoulder 28 terminates in an enlarged diameter outer bore 30 which receives the end cap 16. The end cap 16 has an inner portion dimensioned to fit snugly within the outer bore 30. The cap 16 includes an outer peripheral collar 32 which engages the outer end of the housing to determine and limit precisely the extent to which the inner end of the end cap 16 extends into the outer bore 30. The outer end of the end cap 16 may include an extension 34 and a tapered inlet opening 36 may be formed through the end cap. m e inlet 36 is tapered to enable a conventional Luer connector to be attached, if desired.
As shown in FIG. 1, the self-sealing gasket 14 is retained between the en~ cap 1~ and the shoulder 28 of the housing 12.
The shoulder 28 preferably is provided with a circular ridge 38 and an identical ridge 40 is formed on the facing inner surface of the inner end of the end cap 16. When the end cap 16 is fully seated, as determined by engagement of the collar 32 with the end of the housing 12, the ridges 38, 40 engage and effect a firm grip on the gasket 14 As illustrated in enlarged detail in FIGS. 2-4, the gasket member 14 may be considered as having an outer sealing portion 42 and a spaced inner sealing portion 44. The outer and inner seals 42, 44 are molded integrally in a single piece, with a surrounding, connective peripheral side wall 46~ The outer seal 42 is provided with a central aperture 48, preferably a circular hole. The inner seal 44 is provided with a plurality of slits, 50 which are arranged radially from the center of the inner seal 4~. The slits 50 define a plurality of flaps 52 which deflect inwardly as the catheter 51, tube or the like is inserted through the device, as suggested in FIG. 4. me resilient flaps 52 return to their normally closed and sealed configurations automatically when the tube is withdrawn.
~ hen a catheter is in place, the primary seal is effected by the outer seal 42 on the outer surface of the catheter.

When the catheter i5 withdrawn, the seal is effected by the closure of the flaps 52. m e configuration of the valve 14 is such that the flaps 52 effect a full and complete self seal independently and require no backing up, reinforcement or other support~ The hole 48 and space 53 between the seals 42, 44 is of generally T-shaped cross section (FIG~ 2). m e inner seal 44 is of substantially greater ~hickness than the outer seal 42, at least in the more radially inwardly disposed portions.
The inner seal 44 is formed to define a peripheral shoulder 54 which fits against the shoulder 28 of the housing 12. me more central portion of the inner seal 44 includes the thicker plug portion 56 which extends into and fits ~ithin the bore 26 of the housing 120 The outer periphery 58 of the plug portion 56 thus is confined and supported by the bore ~.6.
The thickness of the plug portion 56 on the inner seal 44 should be substantially equal to half of the total thickness of the valve 14. The circle diameter defined by the slits 50 is substantially equal to the inner diameter of the inner cylind rical space 53 in the valve 14.
In using the illustrative embodiment of the invention, the introducer tube 10 may be inserted into the patient's blood vessel by any of the various available surgical techniques for that purpose (e.g. percutaneous, cut down, etc.), as is desired by the particular physician. Once the introducer is properly placed, it may be taped down to the patient's skin or otherwise secured in placeO From tha~ point on, catheters may be intro-duced through the self-sealing gasket 14 of the housing 12 and catheter changes may be made as desired. When used in angio-graphi~ procedures or other surgical techniques in which the physician must be able to feel obstructions to the advancing catheter tip by feeling resistance at the proximal end of the catheter, the resistance offered by the valve 14 of the present invention is relatively insignificant and does not interfere with the surgeon's feel. The side port, of course, may be used in the manner in which side por~s are normally used, for ex-ample, to infuse medicine, intravenous nourishment or to take blood pressure measurements. The side port may be aspirated to wi~hdraw blood samples if desired. In the aspiration mode, the present invention has been found to provide superior sealing results.
It is believed that part of the reason for the improved sealing results of the present invention results from the increased thickness of the plug portion 56 of the rubber gasket 14 and the manner by which that plug portion is mounted to be constrained peripherally within the bore 26 of the housing 12.

_g_ It is believed that the arrangement in which the flaps 52 hinge near the periphery of the plug portion and the additional support for the increased thickness OJ the plug portion 56 by the engagement of the shoul~er 28, 54, are significant contrib-uting factors to the advantages of the pre ent invention.
As mentioned above, the gasket 14 provides a number of advantages not only in operation of the device but as well as in economies of the manufacture. The device is moldable from latex rubber or the like and can be formed in a relatively simple single-molding procedure. During assembly of the intro~
ducer body, there is only a single valve element to be placed in the housing 12.
While the invention has been illustrated as being used in connection with a catheter lntroducer, it should be noted that it is not necessarily limited in scope to use in that sole environment and that the principle of the invention may be incorporated and utilized in other analogous environments and devices.
Thus, it should be understood that the foregoing descrip-tion of the invention is intended merely to be illustrativethereof and that other modifications and embodiments of the invention may be apparent to those skilled in the art without departing from its spirit.
Having thus described the invention, what I desire to claim and secure by Letters Patent is:

Claims (8)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A self-sealing gasket assembly to permit a tube to be inserted into or withdrawn from a housing while maintaining the interior of the housing under seal comprising:
a one-piece disc-shaped gasket having an outer sealing portion, an inner sealing portion and a peripheral sidewall portion connecting the inner and outer sealing portions, the inner, outer and side wall portions being constructed and arranged so that the inner and outer sealing portions are spaced from each other;
an aperture formed in the outer sealing member;
means defining at least one slit in the inner sealing portion of the member;
the inner portion of the gasket having a shoulder formed about its periphery whereby the more central region of the inner sealing member defines an inwardly-extending central plug portion, said slit being formed within the plug portion;
a housing to receive the sealing member, the housing including an inner bore and an outer bore, the outer bore being larger than the inner bore and defining a shoulder at the juncture of the inner bore and the outer bore, the shoulder in the housing being constructed and arranged to receive the shoulder formed about the periphery of the inner sealing portion of the gasket and to peripherally constrain said plug portion thereby to provide support for said plug portion and the periphery of the gasket; and means for securing the periphery of the gasket against the shoulder of the housing.
2. A device as defined in claim 1 further comprising:
said aperture and said space between the inner and outer sealing members being substantially T-shaped in cross section.
3. A device as defined in claim 1 further comprising:
the thickness of the rearwardly-facing sealing member being substantially equal to half of the total thickness of the gasket.
4. A device as defined in claim 3 further comprising:
the thickness of said plug portion being less than the thickness of the inner sealing portion of the gasket.
5. A device as defined in claim 1 wherein the housing comprises a catheter introducer having an introducer sheath extending therefrom and a side port.
6. A device as defined in claim 5 wherein means for securing the gasket comprises a cap receivable within the outer bore of the housing and being adapted to lightly compress the periphery of the gasket member in the region circumscribing the plug.
7. A device as defined in claim 1 wherein the slot means includes a plurality of slots extending radially from the center of the plug portion, the slots defining a circle diam-eter substantially equal to the diameter of said space within the gasket.
8. A device as defined in claim 1 wherein the gasket is molded from latex rubber.
CA000411417A 1981-10-02 1982-09-15 Self-sealing gasket assembly Expired CA1181309A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/307,888 US4424833A (en) 1981-10-02 1981-10-02 Self sealing gasket assembly
US307,888 1981-10-02

Publications (1)

Publication Number Publication Date
CA1181309A true CA1181309A (en) 1985-01-22

Family

ID=23191594

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000411417A Expired CA1181309A (en) 1981-10-02 1982-09-15 Self-sealing gasket assembly

Country Status (2)

Country Link
US (1) US4424833A (en)
CA (1) CA1181309A (en)

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US11931253B2 (en) 2020-01-31 2024-03-19 4C Medical Technologies, Inc. Prosthetic heart valve delivery system: ball-slide attachment
CN115624413B (en) * 2022-05-31 2023-08-29 湖南埃普特医疗器械有限公司 Adjustable sheath tube

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