WO2009002828A2 - Tearaway sheath assembly with hemostasis valve - Google Patents

Tearaway sheath assembly with hemostasis valve Download PDF

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Publication number
WO2009002828A2
WO2009002828A2 PCT/US2008/067631 US2008067631W WO2009002828A2 WO 2009002828 A2 WO2009002828 A2 WO 2009002828A2 US 2008067631 W US2008067631 W US 2008067631W WO 2009002828 A2 WO2009002828 A2 WO 2009002828A2
Authority
WO
WIPO (PCT)
Prior art keywords
valve
hub
sheath
proximal end
distal end
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/US2008/067631
Other languages
English (en)
French (fr)
Other versions
WO2009002828A3 (en
WO2009002828A9 (en
Inventor
Mark S. Fisher
W. Shaun Wall
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.)
Medical Components Inc
Original Assignee
Medical Components 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 Medical Components Inc filed Critical Medical Components Inc
Priority to MX2009011663A priority Critical patent/MX2009011663A/es
Priority to ES08771567.8T priority patent/ES2677323T3/es
Priority to CN2008800191957A priority patent/CN101918064B/zh
Priority to EP08771567.8A priority patent/EP2164553B8/en
Priority to CA2684712A priority patent/CA2684712C/en
Priority to EP18000282.6A priority patent/EP3456372A1/en
Priority to AU2008268632A priority patent/AU2008268632B2/en
Priority to JP2010513437A priority patent/JP5613560B2/ja
Publication of WO2009002828A2 publication Critical patent/WO2009002828A2/en
Publication of WO2009002828A3 publication Critical patent/WO2009002828A3/en
Publication of WO2009002828A9 publication Critical patent/WO2009002828A9/en
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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M2039/0646—Duckbill-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
    • A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal

Definitions

  • the invention relates to medical devices and more particularly to devices for use in insertion or implantation of catheters and the like into the vasculature of patients.
  • catheters are used in numerous medical procedures.
  • catheters are used for the introduction or removal of fluids from various venous regions and vessels throughout the body, such as for hemodialysis.
  • the procedure by which these catheters are introduced to the body is delicate and complex.
  • One particularly intricate challenge to catheterization is enlarging a hole in the flesh and vessel to be catheterized while minimizing blood loss and trauma to the patient.
  • the vessel is identified by aspiration with a long hollow needle in accordance with the Seldinger technique.
  • a thin guide wire is then introduced, typically through the syringe needle or other introducer device, into the interior of the vessel.
  • the introducer device is then removed, leaving the guide wire within the vessel.
  • the guide wire projects beyond the surface of the skin.
  • the sheath is positioned by placing a dilator, which has a hollow passageway along its longitudinal axis, inside of the sheath and passing both the dilator and the sheath together into the vessel over the guide wire.
  • the dilator expands the opening in the blood vessel to allow for catheter insertion into the vessel.
  • the guide wire and dilator are then removed, leaving the thin-walled sheath in place.
  • the catheter is then inserted into the vessel through the sheath.
  • tear away sheaths are manufactured in a way that aids in the tearing of the sheath at two opposing points on the circumference of the sheath, thereby splitting the sheath into two halves separated longitudinally through the center of the sheath.
  • a sheath is generally constructed with a hub at its proximal end.
  • This hub serves as a handle, a mating point for a dilator, and a flat surface to aid in the prevention of blood loss or contamination.
  • the hub will also have to be split apart in order to clear the catheter.
  • the hub will split along the same lines as the sheath.
  • the hub must be designed with reveals or other weaknesses along two longitudinal lines aligned with the weaknesses in the sheath. Some previous examples of these weaknesses are tabs or webs which connect two halves of the hub, or recesses in the material comprising the hub. The weaknesses in the hub will help the inserting physician to break apart the hub in line with the tear seams on the sheath.
  • tabs or wings that protrude from the center. These tabs not only help the inserting physician to align, insert and withdraw the sheath, but also to pull the sheath so that the sheath can be removed from around a catheter while still leaving the catheter in place.
  • tabs There are a number of different tab configurations, but it is important to have one which allows for easy maneuverability, control, and leverage.
  • One design includes a hub wherein the tabs protrude from the hub perpendicular to a plane which includes the tear seams in the sheath and the longitudinal axis of the sheath.
  • the tabs are diametrically opposed from each other and are spaced in such a way that when the tabs are grasped and pulled apart from each other, the sheath and its hub will split down the middle.
  • Another desirable feature of the tabs is that the tabs provide leverage for breaking apart the hub in a manner that does not cause trauma to the incision in the body.
  • Such a valve would facilitate the insertion of objects such as a catheter, dilator or syringe through the sheath while restricting blood loss and reducing the chance of contaminants entering the patient's bloodstream when the sheath is not engaged with a dilator or a catheter.
  • the dilator is often used to aid in the insertion of the sheath.
  • the dilator has a long tubular section, the outside diameter of which is slightly smaller than the inside diameter of the sheath.
  • the dilator also has a pointed tip on its distal end and a hollow center, which runs along the entire length of the dilator.
  • the dilator is inserted into the body with the guidewire running through its center, thereby allowing the tip of the dilator to follow the guidewire to the place that is to be catheterized.
  • the dilator may have a hub. Like the hub of the sheath, this hub can also serve a number of purposes, such as providing a stable handle to aid in guiding the dilator into the vein, and as a mechanism which can mate with the sheath hub to form a locked connection.
  • a releasably locking dilator and sheath assembly and methods for releasing the dilator from the sheath and longitudinally splitting the sheath are provided.
  • the assembly includes a dilator having a dilator hub and a sheath having a sheath hub.
  • the sheath hub has a valve and two opposing winged tabs, each tab having a perpendicular portion and an angled portion as well as a female threaded portion.
  • the dilator hub has a male threaded portion designed to engage the female threaded portion of the sheath hub.
  • the dilator is released from the sheath by rotating the dilator 90° in relation to the sheath and pulling the dilator out of the sheath.
  • the sheath is longitudinally split by creating a coupling moment on each of the winged tabs thereby forcing the sheath and the sheath hub to split longitudinally. With the sheath, the valve and the sheath hub split longitudinally, the sheath is removed from around a catheter while leaving the catheter in place. [0010] It is desired to provide a hemostasis valve for a splittable sheath, and to provide a sheath assembly with hemostasis valve and sheath hub for use therewith, that are splittable for facilitating removal of the sheath from about an inserted catheter.
  • the present invention is a tearaway sheath assembly having a splittable sheath tube and a splittable hub affixed thereto, with the hub being at the proximal end of the sheath assembly, the sheath tube extending to a smaller diameter distal sheath end, a passageway extending through the assembly from the proximal end to the distal end and defining a longitudinal axis therethrough.
  • the sheath tube includes opposed frangible seams therealong to facilitate peeling or splitting during the tearaway procedure.
  • the assembly of the present invention also includes a splittable hemostasis valve contained and affixed within the hub.
  • the hub comprises two opposing sections joined to each other at frangible joints or webs until intentionally split apart, so that the hub remains an integral one-piece unit until split by the practitioner after insertion of the catheter into a patient's vasculature has been accomplished, with a grippable wing joined to each hub section for handling and for initiating splitting in a manner known in the art.
  • the hub also provides distinct opposing gaps between the two opposing sections that are joined at frangible sections within the gaps, where the gaps that are aligned with opposed frangible seams of the sheath tube, so that upon splitting of the hub by the practitioner, the sheath tube also splits apart as the tearaway procedure continues.
  • a valve contained within the proximal end of the hub is also splittable when the hub is intentionally split but otherwise remains intact to provide hemostasis; the valve is selectively openable prior to splitting to permit insertion therethrough of a dilator and later of a catheter forming a seal therewith and therearound, but otherwise remains closed to prevent blood effusion.
  • the splittable valve is of a duckbill type and has an elongate structure with distal and proximal ends, the duckbill structure being disposed at its distal end, and comprising a pair of angled converging side walls, and includes a slit partially across the converging ends of the side walls and preferably through the axial center of the valve. Proximally of the slit distal end, the valve transitions to a cylindrical or tubular structure at its proximal end.
  • a cap is securable to the proximal end of the sheath hub to secure the valve in a tubular proximal end portion of the hub; and, further, the cap is preferably comprised of two separate parts separated along a radial aligned with the gaps of the hub and the seams of the sheath tube with each half affixed to a respective section of the hub at the proximal end, to prevent inhibiting the splitting procedure by the practitioner.
  • the hub of the sheath assembly of the present invention includes a valve-containing proximal portion adjacent its proximal end, and include a distal portion that is affixed to a proximal end of the sheath tube.
  • the two opposing sections of the hub have opposing gaps spacing them apart, but have frangible sections within the gaps to maintain the two opposing hub sections joined to each other until intentionally split.
  • the opposing gaps are aligned with the frangible seams of the sheath tube.
  • the frangible sections are located at a transition portion axially between the proximal hub portion and the distal hub portion and at the distal end of the valve-containing proximal portion where the hub diameter narrows, and comprise thin web sections.
  • FIG. 1 and 2 are isometric views of a PRIOR ART sheath/dilator assembly, and the sheath of the assembly shown with the dilator removed;
  • FIG. 3 is an enlarged isometric view of the tearaway sheath assembly of the present invention, showing the sheath hub and valve cap at the proximal end of the sheath tube and the hub's gaps aligned with seams of the sheath tube;
  • Fig. 4 is an exploded view of the assembly of Fig. 3 and also showing the splittable valve
  • Fig. 5 is a cross-section view of the exploded sheath assembly of Fig. 4;
  • Fig. 6 is a cross-section view of the hub, valve and cap of Fig. 4, assembled
  • Fig. 7 is an elevation view of the sheath assembly proximal end of Fig. 3 peering directly into the gap of the hub showing the location of the hub frangible webs;
  • Fig. 8 is a cross-sectional front view of the assembly of Fig. 7 rotated about 90 degrees from that of Fig. 7, showing the frangible web joining the two hub sections;
  • Fig. 9 is a transverse cross-section of the sheath assembly taken just proximally of the distal end of the splittable valve of the present invention.
  • a sheath assembly 10 comprising a dilator 12 and a sheath 14, and having a longitudinal axis "L".
  • Dilator 12 has a dilator hub 16 at its proximal end, and its distal end portion 18 extends beyond the distal end 20 of sheath 14 to a distal tip 22.
  • Sheath 14 includes a sheath tube 24 and a sheath hub 26 at the proximal end of the sheath tube, and is seen in Fig. 2 with the dilator removed.
  • Sheath hub 26 is seen to have grippable wings 28 to facilitate the initiation of splitting by the practitioner to peel away the sheath from an inserted catheter (not shown).
  • the sheath tube has a pair of opposed frangible seams 30, and sheath hub 26 includes frangible webs along opposed gaps 32 that are aligned with seams 30.
  • the proximal end 34 of sheath 14 includes a threaded locking arrangement for locking with the dilator hub 12 prior to removal of the dilator.
  • Sheath assembly 100 of the present invention is illustrated in Figures 3 to 9.
  • the sheath assembly includes a sheath tube 102 with a proximal end portion 104 and extending to a distal end, with a passageway 106 (Fig. 4) extending therebetween defining a longitudinal axis.
  • the sheath tube 102 includes a pair of opposed seams or frangible sections 108 that define weaknesses along which the sheath tube is easily split by the practitioner after insertion of the catheter's distal portion into the vasculature of a patient (not shown). Referring primarily first to Fig.
  • a sheath hub 110 is affixed to the proximal end portion 104 of the sheath tube at the distal end portion 112 of the hub.
  • a pair of wings or tabs 114 extend from respective opposed sections 116,118 of hub 110, for gripping by the practitioner for initiating the splitting of the sheath assembly for tearing it away from the catheter, by their being pried toward the sheath distal end such that the splitting of the hub begins at its proximal end 120 and separating hub sections 116,118 completely from each other along a pair of opposed gaps 122.
  • Also seen in Fig. 3 is a portion of a frangible section 124 disposed along the inside edge of gap 122; the frangible section or webs on both sides join together the two hub sections 116,118.
  • hub 110 is exploded from sheath tube 102; splittable valve 150 is exploded from hub 110; and the two halves 182 of cap 180 are exploded from hub 110 and valve 150.
  • Hub 110 includes a large diameter cylindrical portion 126 extending to its proximal end, and a frustoconical transition section 128 joins cylindrical portion 126 to small diameter distal end portion 112.
  • Large diameter cylindrical portion 126 defines therein a large valve -receiving cavity 130 Seen projecting proximally from cylindrical portion 126 is a seating flange 132 associated with seating of the two halves of cap 180, and within gap 122 can be seen a seating flange 134 associated with seating of splittable valve 150.
  • Splittable valve 150 will now be described with reference to Figures 4 and 5.
  • Splittable valve 150 is of the duckbill type, so-called because its distal end portion 152 is shaped like a duck's bill, and extends to a transverse distal end wall 154.
  • Distal end portion 152 has two converging side walls 156 extending to distal end wall 154, and a slit 158 is seen formed in distal end wall 154 extending mostly but preferably not completely thereacross (see Fig. 9).
  • Cylindrical wall 160 joins together the lateral ends of side walls 156 and defines a large central cavity 162 extending between distal end wall 154 and proximal end 164 of valve 150. Seen best in Fig.
  • slits 166 of limited axial length are cut into side wall 160 and in seating flange 168, to facilitate splitting of the valve. Furthermore, within large central cavity can be seen V-grooves 170 formed into the cylindrical wall 160 that are aligned with and communicate with the slits 166, and are also aligned with gaps 122 of hub 110 and seams 108 of sheath tube 102 in the completed assembly. Seating flange 168 is T-shaped in cross-section, forming distal and proximal seating recesses 172,174, seen best in Figs. 5 and 6.
  • Cap 180 preferably comprises two completely separate but identical halves 182, for securing valve 150 within valve-receiving cavity 130 of hub 110, and are bonded or fused to the hub.
  • Cap halves 182 when affixed in place to the proximal end of the hub, are separated by gaps 184 aligned with gaps 122 of hub 110 and seams 108 of sheath tube 102 and V-grooves 170 and slits 166 of valve 150.
  • Cap 180 defines a passageway 186 extending therethrough from a beveled lead-in at the cap's proximal end, with passageway 186 sufficiently large in inner diameter for a dilator and a catheter to be movably inserted therethrough.
  • Cap 180 includes an outer flange at the proximal end defining an outer seating recess 188, within which is received flange 132 of hub 110.
  • An outer cylindrical wall 190 extends distally to an end portion 192 that is associated with proximal seating recess 172 of valve 150.
  • An inner cylindrical wall 194 along passageway 186 is spaced inwardly from outer cylindrical wall 190 to define a deep seating recess 196 associated with the proximal end portion of cylindrical wall 160 of valve 150.
  • Valve 150 is seated within large valve -receiving cavity 130 of hub 110.
  • Distal seating recess 174 of flange 168 is disposed or seated within seating groove 136 defined outwardly of seating flange 134 of hub 110.
  • Proximal seating recess 172 of valve 150 is facing proximally for receipt thereinto of end portion 192 of outer cylindrical wall 190 of cap 180 (see Fig. 4).
  • the proximal end portion of cylindrical wall 160 of valve 150 is associated with deep seating recess 196 of cap 180 between its inner and outer cylindrical walls 194,190.
  • proximal end 138 of sheath 102 extends to the distal end of the valve-receiving cavity 130 of hub 110 to maximize the bonded surface area between the proximal end portion of the sheath and the distal end portion 112 of the hub.
  • seating flange 132 projects proximally to be received into outer seating recess 188 of cap 180.
  • cap 180 Bonding or fusing of cap 180 to hub 110 joins the facing surfaces of seating flange 132, outer seating recess 188, the outside surface of outer cylindrical wall 190 and the inside surface of cylindrical wall 126 of hub 110, and proximal ledge 140 around seating flange 132 and the distal face 198 of the outer flange of the cap.
  • Cap halves 182 are affixed to hub 110 in a manner that compresses the seating flange 168 of valve 150 and secures it in place while establishing a seal between the valve and both the cap halves and the hub.
  • FIGs 7 and 8 give a better understanding of frangible sections or webs 124 of hub 110 that join hub sections 116,118.
  • the webs are formed along the inside surface of valve- receiving cavity 130 (Fig. 6) of the hub and are very thin. Preferably, they extend along the intermediate or frustoconical portion 128 of the hub and partially along the cylindrical wall 130, extending to and along seating flange 134.
  • the gaps 122 of hub 110 extend radially inwardly from hub outer surfaces to inner gap end portions 142 that are V-shaped converging at the frangible webs 124, in order for the mold inserts to remain relatively thick, robust and durable over many molding cycles and also to carefully control the thickness of the frangible webs.
  • the webs may have a thickness, for example, of about 0.002 in ( 0.0508 mm), and the width W of the gaps 122 at the outer surfaces can be, for example, about 0.050 in (1.270 mm).
  • frangible sections 170 of the splittable valve 150 may be V-shaped in cross-section, but extending from the inside surface toward the outside surface, preferably about one-half of the thickness, of the cylindrical wall 160.
  • the distal end wall 154 of the valve would be abutted by a proximal end of a guide wire (not shown) during initial placement of the sheath assembly over the guide wire after the guide wire is placed in the vasculature, later by the dilator distal tip inserted through the hub and valve and later by the catheter distal tip, with the slit 158 permitting the diverging side walls to deform as the slit is opened in response to guide wire, dilator or catheter insertion, with the valve maintaining engagement with the outer surfaces of the guide wire, dilator or catheter as it passes therethrough; and the slit will also close against the guide wire upon withdrawal of the dilator from the sheath assembly, forming a hemostasis seal and preventing effusion of blood.
  • the valve may be made of silicone.
  • the hub and the cap may be made of polyethylene or polypropylene.
  • the sheath tube could be made of polyethylene or polytetrafluoroethylene.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/US2008/067631 2007-06-22 2008-06-20 Tearaway sheath assembly with hemostasis valve Ceased WO2009002828A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
MX2009011663A MX2009011663A (es) 2007-06-22 2008-06-20 Ensamble de funda que se arranca con valvula hemostatica.
ES08771567.8T ES2677323T3 (es) 2007-06-22 2008-06-20 Buje para conjunto de vaina desprendible con válvula hemostática
CN2008800191957A CN101918064B (zh) 2007-06-22 2008-06-20 带有止血阀的可撕开鞘
EP08771567.8A EP2164553B8 (en) 2007-06-22 2008-06-20 Hub for a tearaway sheath assembly with hemostasis valve
CA2684712A CA2684712C (en) 2007-06-22 2008-06-20 Tearaway sheath assembly with hemostasis valve
EP18000282.6A EP3456372A1 (en) 2007-06-22 2008-06-20 Tearaway sheath assembly with hemostasis valve
AU2008268632A AU2008268632B2 (en) 2007-06-22 2008-06-20 Tearaway sheath assembly with hemostasis valve
JP2010513437A JP5613560B2 (ja) 2007-06-22 2008-06-20 剥ぎ取り式シース・アセンブリおよび該アセンブリ用のハブ

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93679507P 2007-06-22 2007-06-22
US60/936,795 2007-06-22

Publications (3)

Publication Number Publication Date
WO2009002828A2 true WO2009002828A2 (en) 2008-12-31
WO2009002828A3 WO2009002828A3 (en) 2009-02-19
WO2009002828A9 WO2009002828A9 (en) 2009-05-07

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/067631 Ceased WO2009002828A2 (en) 2007-06-22 2008-06-20 Tearaway sheath assembly with hemostasis valve

Country Status (11)

Country Link
US (3) US7744571B2 (https=)
EP (2) EP2164553B8 (https=)
JP (1) JP5613560B2 (https=)
CN (1) CN101918064B (https=)
AU (1) AU2008268632B2 (https=)
CA (1) CA2684712C (https=)
ES (1) ES2677323T3 (https=)
MX (1) MX2009011663A (https=)
PT (1) PT2164553T (https=)
TR (1) TR201808012T4 (https=)
WO (1) WO2009002828A2 (https=)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011130846A (ja) * 2009-12-22 2011-07-07 Piolax Medical Device:Kk 医療用シース
WO2013173438A1 (en) * 2012-05-17 2013-11-21 Medical Components, Inc. Valve for dilator and sheath assembly
WO2017178256A1 (de) * 2016-04-11 2017-10-19 Joline Gmbh & Co. Kg Einführkatheter mit einem ventilkörper
US11291821B2 (en) 2017-03-13 2022-04-05 Boston Scientific Limited Hemostasis valves and methods for making and using hemostasis valves
WO2022265961A1 (en) * 2021-06-17 2022-12-22 Edwards Lifesciences Corporation Removable sheath assembly
US11730942B2 (en) 2015-08-24 2023-08-22 Abiomed, Inc. Hemostatic valve for medical device introducer
US12310621B2 (en) 2016-02-22 2025-05-27 Abiomed, Inc. Introducer sheath having a multi-layer hub
US12350445B2 (en) 2019-03-13 2025-07-08 Abiomed, Inc. Dual hub introducer sheath
US12409299B2 (en) 2019-09-20 2025-09-09 Abiomed, Inc. Bifurcated hub

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CA2684712C (en) 2016-04-05
US7744571B2 (en) 2010-06-29
US8147456B2 (en) 2012-04-03
AU2008268632B2 (en) 2013-10-17
EP2164553A2 (en) 2010-03-24
US20100234807A1 (en) 2010-09-16
US8298189B2 (en) 2012-10-30
CA2684712A1 (en) 2008-12-31
MX2009011663A (es) 2009-11-10
EP2164553B8 (en) 2018-05-16
TR201808012T4 (tr) 2018-06-21
PT2164553T (pt) 2018-06-18
EP3456372A1 (en) 2019-03-20
WO2009002828A3 (en) 2009-02-19
JP5613560B2 (ja) 2014-10-22
EP2164553B1 (en) 2018-04-11
WO2009002828A9 (en) 2009-05-07
US20090018508A1 (en) 2009-01-15
CN101918064B (zh) 2013-08-21
US20100241083A1 (en) 2010-09-23
AU2008268632A1 (en) 2008-12-31

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