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WO1991010459A1 - Appareil d'introduction a valve hemostatique - Google Patents

Appareil d'introduction a valve hemostatique Download PDF

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Publication number
WO1991010459A1
WO1991010459A1 PCT/US1991/000229 US9100229W WO9110459A1 WO 1991010459 A1 WO1991010459 A1 WO 1991010459A1 US 9100229 W US9100229 W US 9100229W WO 9110459 A1 WO9110459 A1 WO 9110459A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
introducer
hemostasis
hemostasis valve
truncated top
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.)
Ceased
Application number
PCT/US1991/000229
Other languages
English (en)
Inventor
Steven D. Savage
Gregory Brucker
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.)
MGC Diagnostics Corp
Original Assignee
Angeion 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
Application filed by Angeion Corp filed Critical Angeion Corp
Publication of WO1991010459A1 publication Critical patent/WO1991010459A1/fr
Anticipated expiration legal-status Critical
Ceased 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

Definitions

  • the present invention pertains to a medical, disposable, cardiovascular device, and more particularly, pertains to a hemostasis valve introducer.
  • the hemostasis valve introducer is used to precutaneously insert a medical device into a vein or an artery.
  • introducers typically contain a one-way check valve which allows introduction of the medical device in the forward direction; that is, into the body, but does not permit the flow of the blood backward; that is, out of the body.
  • Prior act introducer devices have two main concerns. First, the prior art devices do not reliably seal with multiple insertion and retraction of a medical device either with or without the device in place. Secondly, the prior art introducers have not sealed well with multiple devices in place simultaneously. The main problem with hemostasis valve introducers is the reliability o'f the seal after repeated insertions and retractions of a medical device through the valve and the high drag associated with insertions and retractions of these devices.
  • U.S. prior art patents include U.S. Patent Nos. 4,000,739 for a hemostasis cannula; 4,143,853 for a valve for use with a catheter; 4,424,833 for a self-sealing gasket assembly; 4,430,081 for a hemostasis sheath; 4,436,519 for a removable hemostasis valve; 4,610,665 for a medical instrument; 4,610,674 for a catheter introducing instrument; 4,626,245 for a hemostasis valve; and, 4,682,981 for a medical device.
  • U.S. Patent No. 4,424,433 is a representative prior art patent.
  • the present invention overcomes the deficiencies of the prior art introducer devices.
  • the present invention overcomes these disadvantages by using the natural pressure difference that exists between the body and atmospheric pressure to help insure closure of the valve and uses a thickened, raised portion to provide circumferential force for sealing around the invention device while using very thin materials in other regions to provide for a complete seal.
  • the general purpose of the present invention is to provide a hemostasis valve introducer for use in medical procedures in the vascular system which reliably seals after repeated insertions of a medical device, which seals with a device in place simultaneously, and which seals more reliably when the device has been removed, especially after multiple insertions.
  • a hemostasis valve introducer including a valve housing member with an internal chamber extending therethrough, a cap with a centered hole at one end of the housing, a self-healing valve about or in the internal chamber, an introducer sheath at the other end of the housing, and a tapered strain relief to prevent kinking of the sheath. Snap connections, threaded connections or ultrasonic welding can secure the components.
  • An access port can extend at an angle from the valve housing member for injection of fluids " through the introducer.
  • the valve includes a conical cross section with the core towards the body and a raised ring on the blood side. An optional slit can be provided between the inner diameter points of said ring.
  • a hemostasis valve introducer which reliably seals with multiple insertions and retractions, and which can accommodate a device a substantial period of time and serve rapidly and reliably after the said device is removed.
  • valve for a hemostasis valve introducer which is of lower drag during insertion and retraction; more reliably seals after multiple insertions and retractions; provides for a conical entry angle for introduction of the device which allows for smoother entry of the medical device; and a single valve design so that the valve can be easily fabricated using standard molding and assembly techniques.
  • One object of the present invention is a valve for a hemostasis valve introducer using a conical cross section where the higher pressure difference on the blood side causes the gasket to be forced against itself and, thus, seal along the slit or line of entry through the gasket.
  • the raised portion is approximately .038 in diameter and .010 of an inch thick and this provides circumferential force to seal around devices less than .038 of an inch. For devices larger than this, the natural expansion and elasticity of the gasket will provide an adequate seal.
  • FIG. 1 illustrates a perspective view of a hemostasis valve introducer
  • FIG. 2 illustrates a cross-sectional view of the valve
  • FIG. 3 illustrates a bottom view of the valve
  • FIG. 4 illustrates a top view of the valve
  • FIG. 5 illustrates an exploded view in cross section of the hemostasis valve introducer
  • FIG. 6 illustrates a side exploded view of the elements of the hemostasis valve introducer
  • FIG. 7 illustrates a cross-sectional view of the elements of the hemostasis valve introducer as assembled.
  • FIG. 1 illustrates a perspective view of a hemostasis valve introducer 10 of the present invention including a valve housing member 12 with a central body, an internal geometrically configured chamber, and an interlocking interface on each end as illustrated in FIG. 2.
  • a valve 16 engages about or in the chamber area, and is retained therein by cap 14 as later described in detail in FIG. 2.
  • a tapered strain relief 22 engages about the valve housing central body member 12, and assists in supporting a sheath 24 within the chamber.
  • An optional access port 26 extends outwardly from the valve housing 12.
  • the sheath 24 is tapered at its most distal point to allow for ease of insertion into the body.
  • the components can be mechanically snapped together, mechanically threaded together, ultrasonically welded together, or secured together by any other type of suitable securing materials such as glue or adhesive.
  • FIG. 2 illustrates a cross-sectional view of the valve 16 including a rim 50, conical cross section 52 with a cone 54 pointed towards the body.
  • a raised ring 58 extends about a truncated top 56 of the cone 54.
  • a cylindrical recess 60 with a base 62 is formed into the truncated top 56.
  • a slit 64 extends between the beak of the cone 54 and the base 62 of the cylindrical recess 60.
  • the valve 16 has a diameter of .250 inches and a thickness ranging from 0.015 to 0.065 with the thickness depending on the size of the device to be inserted.
  • the angle of entry on the internal cone can vary from 60 to 80 degrees which again depends on the size of the device to be inserted.
  • the angle on the external portion of the cone can vary from 70 to 90 degrees; thus providing a thicker cross section near the edges and a thinner cross section near the center.
  • Another feature called a raised ring has a thickness of approximately .020 of an inch and has its inner edge on a diameter of .035 inches from about the center of the gasket.
  • the diameter of the raised ring is determined by the size of the guidewire to be inserted into the hemostasis valve introducer, which typically for cardiovascular procedures is 0.35 to 0.38 inches.
  • Contained within the raised circle is the slit 64 which passes through the center " point of the valve and extends across the diameter of the area contained within the raised circle.
  • This slit 64 provides a structure for devices to be inserted through the valve 16.
  • the additional benefit of the raised ring is that it acts as a reinforcement to prevent significant tearing of the gasket when devices are in place; especially those of a larger size.
  • the valve is made of elastomeric materials, such as silicone, natural rubber or thermoplastic elastomers (TPE) .
  • FIG. 3 illustrates a bottom view of the valve 16 where all numerals correspond to those elements previously described.
  • FIG. 4 illustrates a top view of the valve 16 where all numerals correspond to those elements previously described.
  • FIG. 5 illustrates an exploded view in cross section of the hemostasis valve introducer 10 along line 2-2 of FIG. 1 where all numerals correspond to those elements previously described.
  • the valve housing central body member 12 includes an internal chamber area 28, an interlocking section 34 on the valve body, and a slot 31 which engages mating ridge 35 of the sheath 24, preserving the through hole luminal diameter 37.
  • the external distal end of the valve housing central body member 12 engagingly interlocks at interlocking section 34 to e 4 ngage with mating section 33 of the supporting strain relief 22 at the proximal end 22a.
  • the distal tip of the sheath 24a is tapered to provide for ease of insertion.
  • the cap 14 includes a mating section 44 for engaging with the interlocking section 36.
  • the cap 14 sandwiches the valve 16 between the interior surface of the cap and the proximal end of the valve housing central body member 12.
  • the valve housing central body member 12 also includes an annular surface 39 which mates to the optional support gasket 18.
  • the cap 14 includes an access port 46 through the substantially planar surface 48 of the cap 14.
  • the optional access port 26 extends vertically from the valve housing central body member 12 and includes an orifice 38 therein with tube engaging surfaces.
  • FIG. 6 illustrates a side exploded view of the elements where all numerals correspond to those elements previously described.
  • FIG. 7 illustrates a cross-sectional view of the elements assembled where all numerals correspond to those elements previously described.
  • the valve When there is no insertion device present in the hemostasis valve introducer 10, the valve is sufficiently thick to create a seal between blood pressure of the body and the outside environment.
  • the insertion device deforms the valve and the valve takes the shape of the inserted device engaging closely around the inserted device, preventing leakage.
  • the valve Upon removal of the inserted device, the valve moves back together returning to its original position, sealing against loss of blood or body fluids.
  • the elastomeric nature of the material, the conical shape of the gasket, the raised ring, and the pressure difference across the valve all serve to reliably and repeatably return the gasket to its original and sealed configuration.
  • a typical hemostasis valve introducer has three differing geometrical configurations, namely, large medical device in place, small medical device in place, and no device in place.
  • a large device inserted into the valve which is defined as a device which is greater than the inner diameter of the thickened ring, the valve stretches using its natural elasticity, and is firmly drawn around the device by the circumferential tension ,'created in the elastomeric material.
  • the raised ring section of the valve ⁇ prevents the slit from further tearing into a much larger slit and relieving the circumferential tension in the material, and thus, potentially creating a leak.
  • the raised ring With a smaller device in place, less than the diameter of the ring, the raised ring provides a circumferential support area which basically allows the much larger valve to act as a very small valve whose diameter is that of the inner circle.
  • the raised ring provides support such that a thin material contained within the ring does not deform greatly; thus, creating a leak around the device.
  • the slit is forced to remain in essentially parallel plane and to deform around the circular device rather than splitting into a crack which would permit loss of blood.
  • the conical nature of the valve utilizes the pressure difference which exists between the body and the ambient pressure and by nature of being higher on the external side of the valve creates compressive forces within the gasket; thus, forcing the slit together and permitting a better seal under the positive action of the pressure.
  • the present invention utilizes the natural pressure difference that exists between the body and atmospheric pressure to help insure closure of the valve and uses a thickened, raised portion to provide circumferential force for sealing around the device while using very thin materials in other regions to provide for a complete seal.
  • the higher pressure difference on the blood side causes the valve to be forced against itself, and thus, seal along the slit or line of entry through the gasket.
  • the raised portion is approximately .038 in diameter and .020 of an inch thick, and this provides circumferential force to seal around devices less than .038 of an inch.
  • the natural expansion and elasticity of the valve will provide an adequate seal.
  • the other regions of the valve can be made very thin, and as a result, the combination of these features and the thin valve provides a valve with a much lower drag.
  • a typical hemostasis valve introducer is used to introduce a catheter into a blood vessel or any other such medical device into the body.
  • a typical cardiology procedure this is performed by first piercing a blood vessel with a Seldinger needle, that is, a needle with a hollow center.
  • a guidewire is inserted into the blood vessel by passing it through the internal lumen of the Seldinger needle.
  • the needle is then withdrawn leaving a guidewire in place.
  • the dilator is inserted into the introducer and the entire dilator sheath assembly passed over the guidewire.
  • the dilator initially enlarges the blood vessel providing adequate space for the sheath.
  • the guidewire and dilator are then withdrawn, leaving the introducer in the bloodstream.
  • the higher pressure of the body is contained by the hemostasis valve, thus preventing loss of blood or fluids.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention se rapporte à un appareil d'introduction à valve hémostatique (10) utilisable lors d'actes médicaux pratiqués sur le système vasculaire qui nécessitent des introductions répétées d'un dispositif médical, par exemple lors d'actes d'angioplastie ou d'angiographie. Cet appareil d'introduction à valve hémostatique (10) comporte un logement de valve (12) un élément de valve (16) dans le logement de valve (12), un couvercle (14) sur l'extrémité proximale, une gaine (24) à une extrémité distale, ainsi qu'un libérateur de contrainte (22) placé autour de la gaine (24) dans le logement de valve (12). L'appareil d'introduction à valve hémostatique (10) utilise une valve (16) à étanchéité fiable, à résistance par traînée réduite pendant l'introduction et le retrait et à étanchéité accrue pour toutes les plages de diamètres des dispositifs médicaux introduits. Une des caractéristiques originales de l'appareil consiste en un joint d'étanchéité (18) qui comporte une bague surélevée (58) côté sang, laquelle applique une force circonférentielle qui le plaque hermétiquement autour des dispositifs circulaires utilisés et qui assure une fermeture fiable et plus rapide de la valve (16) après le retrait du dispositif médical.
PCT/US1991/000229 1990-01-10 1991-01-09 Appareil d'introduction a valve hemostatique Ceased WO1991010459A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46331790A 1990-01-10 1990-01-10
US463,317 1990-01-10

Publications (1)

Publication Number Publication Date
WO1991010459A1 true WO1991010459A1 (fr) 1991-07-25

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1991/000229 Ceased WO1991010459A1 (fr) 1990-01-10 1991-01-09 Appareil d'introduction a valve hemostatique

Country Status (1)

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5167637A (en) * 1990-11-01 1992-12-01 Sherwood Medical Company Valve membrane for a catheter introducer hemostatic valve
EP0528205A1 (fr) * 1991-08-21 1993-02-24 VYGON GMBH & CO KG Ecluse d'introduction pour un cathéter
US5267966A (en) * 1992-09-28 1993-12-07 Cook Incorporated Hemostasis cannula and method of making a valve for same
WO1994003231A1 (fr) * 1992-07-29 1994-02-17 Minnesota Mining And Manufacturing Company Site et systeme d'injection par voie intraveineuse
US5423762A (en) * 1993-04-15 1995-06-13 Cordis Corporation Modular catheter sheath introducer
US5599317A (en) * 1992-04-29 1997-02-04 Hauser; Jean-Luc Externalized sealed catheter with leakproof access
WO1997015338A1 (fr) 1995-10-24 1997-05-01 Cook Incorporated Cannule d'hemostase
US5895376A (en) * 1996-10-23 1999-04-20 Mayo Foundation For Medical Education And Research Hemostasis valve, system and assembly
US6663599B2 (en) 1992-05-06 2003-12-16 Cook Incorporated Hemostasis cannula
WO2006086711A1 (fr) 2005-02-10 2006-08-17 Cook Incorporated Instrument medical

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3900028A (en) * 1974-02-26 1975-08-19 American Hospital Supply Corp Injection site for sterile medical liquid container
US4436519A (en) * 1981-05-28 1984-03-13 Argon Medical Corp. Removable hemostasis valve
US4655752A (en) * 1983-10-24 1987-04-07 Acufex Microsurgical, Inc. Surgical cannula
US4875062A (en) * 1988-12-27 1989-10-17 Eastman Kodak Company Ion projection print head
US4909798A (en) * 1987-11-12 1990-03-20 Daig Corporation Universal hemostasis cannula
US4946133A (en) * 1988-11-21 1990-08-07 Schneider (U.S.A.) Inc., A Pfizer Co. Hemostasis valve

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3900028A (en) * 1974-02-26 1975-08-19 American Hospital Supply Corp Injection site for sterile medical liquid container
US4436519A (en) * 1981-05-28 1984-03-13 Argon Medical Corp. Removable hemostasis valve
US4436519B1 (fr) * 1981-05-28 1989-04-04
US4655752A (en) * 1983-10-24 1987-04-07 Acufex Microsurgical, Inc. Surgical cannula
US4909798A (en) * 1987-11-12 1990-03-20 Daig Corporation Universal hemostasis cannula
US4946133A (en) * 1988-11-21 1990-08-07 Schneider (U.S.A.) Inc., A Pfizer Co. Hemostasis valve
US4875062A (en) * 1988-12-27 1989-10-17 Eastman Kodak Company Ion projection print head

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5167637A (en) * 1990-11-01 1992-12-01 Sherwood Medical Company Valve membrane for a catheter introducer hemostatic valve
EP0528205A1 (fr) * 1991-08-21 1993-02-24 VYGON GMBH & CO KG Ecluse d'introduction pour un cathéter
US5242413A (en) * 1991-08-21 1993-09-07 Vygon Gmbh & Co. Kg Disc valve for a catheter
US5599317A (en) * 1992-04-29 1997-02-04 Hauser; Jean-Luc Externalized sealed catheter with leakproof access
US6663599B2 (en) 1992-05-06 2003-12-16 Cook Incorporated Hemostasis cannula
US8753317B2 (en) 1992-05-06 2014-06-17 Cook Medical Technologies Llc Hemostasis cannula
US7445611B2 (en) 1992-05-06 2008-11-04 Cook Incorporated Hemostasis cannula
WO1994003231A1 (fr) * 1992-07-29 1994-02-17 Minnesota Mining And Manufacturing Company Site et systeme d'injection par voie intraveineuse
US5405331A (en) * 1992-07-29 1995-04-11 Minnesota Mining And Manufacturing Company IV injection site and system
US5267966A (en) * 1992-09-28 1993-12-07 Cook Incorporated Hemostasis cannula and method of making a valve for same
US5423762A (en) * 1993-04-15 1995-06-13 Cordis Corporation Modular catheter sheath introducer
WO1997015338A1 (fr) 1995-10-24 1997-05-01 Cook Incorporated Cannule d'hemostase
US6221057B1 (en) 1996-10-23 2001-04-24 Mayo Foundation For Medical Education And Research Hemostasis valve, system and assembly
US5895376A (en) * 1996-10-23 1999-04-20 Mayo Foundation For Medical Education And Research Hemostasis valve, system and assembly
WO2006086711A1 (fr) 2005-02-10 2006-08-17 Cook Incorporated Instrument medical

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