WO1998044983A1 - Instrument d'introduction de catheter - Google Patents

Instrument d'introduction de catheter Download PDF

Info

Publication number
WO1998044983A1
WO1998044983A1 PCT/CH1998/000122 CH9800122W WO9844983A1 WO 1998044983 A1 WO1998044983 A1 WO 1998044983A1 CH 9800122 W CH9800122 W CH 9800122W WO 9844983 A1 WO9844983 A1 WO 9844983A1
Authority
WO
WIPO (PCT)
Prior art keywords
sealing
catheter
disks
valve
distal
Prior art date
Application number
PCT/CH1998/000122
Other languages
German (de)
English (en)
Inventor
Werner Fritz Dubach
Peter Dittes
Original Assignee
Createchnic Ag
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 Createchnic Ag filed Critical Createchnic Ag
Publication of WO1998044983A1 publication Critical patent/WO1998044983A1/fr

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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0606Haemostasis 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
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis 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
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis 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
    • A61M2039/064Slit-valve
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis 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
    • A61M2039/0653Perforated disc
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0686Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal

Definitions

  • the present invention relates to a catheter introducer with a hamostasis valve for introducing a catheter into a bloodstream.
  • Catheter introducer sets are used for the simple and quick repeated insertion and removal of catheters and other long rod-shaped objects into larger blood vessels. After the percutaneous puncture of the vessel, for example according to the Seidinger method, the proximal area of a working sheath guided by a guidewire is placed in the vessel lumen.
  • This tubular hollow body not only forms a temporary access to the vessel, but also provides a communicating one It is therefore necessary to prevent blood from escaping at the distal end of the working scabbard, where there is normally a valve housing that uses a valve device to seal the channel formed by the working scabbard to the outside of catheters and other elongated medical instruments with different diameters into the working sheath and the subsequent movement of the same without liquid being able to pass through the valve device ter completion of the canal formed by the working divide can also be guaranteed.
  • the entry of air must be prevented when importing, removing and moving the objects, otherwise air bubbles can form in the blood vessel, which can lead to life-threatening embolism.
  • EP-A-0 067 007 ARGON MEDICAL Corp.
  • EP-B-0 157 906 E. WECK Inc.
  • a hemostasis valve which consists of a disc-shaped seal with a central opening and a thimble-like slotted diaphragm made of natural or synthetic rubber and has a lateral support rib.
  • a valve of a medical device is known, the two diaphragms of which consist of elastomers such as natural or synthetic rubber.
  • the disk-shaped diaphragms are provided with intersecting slits on both sides, which, however, do not penetrate the full height of the diaphragms.
  • EP-B-0 308 815 (CORDIS Corp.) describes a separating valve consisting of an elastomeric separating part which has a plurality of radial slots which penetrate the separating part in a helical manner.
  • the separating part consists of silicone rubber with a hardness of 30-50 Shore A and is impregnated with 2 to 10 percent by weight of free silicone as a lubricant.
  • EP-B-0 316 096 (DIAG Corp.) describes an integral hamostasis valve seal which has both a sealing neck and sealing lips.
  • the hamostasis valve described in EP-A-0 369 314 (E. WECK Inc.) has two perforated and one slotted superposed valve disks, all of which consist of latex or silicone rubber.
  • EP-B-0 370 720 TERUMO
  • EP-B-0 370 721 TERUMO
  • integral, molded hamostatic valve bodies made of natural or synthetic rubber which have at least two slotted or pierced cylindrical or dome-shaped elements lying on top of each other.
  • EP-B-0 416 467 (TERUMO) describes a medical valve which consists of a single disc made of natural or synthetic rubber and has two intersecting slots. Each slot has a different opening width on the two sides of the sealing washer. The opening width of the slots on one side are different.
  • EP-A-0 513 969 (DIAG Corp.)
  • EP-B-0 316 096 (DIAG Corp.)
  • EP-A-0 649 317 (UNISURGE Inc.) describes a one-part valve construction of an insertion set made of elastomeric material, which consists of a cylindrical wall and a perpendicular top wall with a central opening and a radially slotted bottom wall projecting downwards.
  • the valve construction is made of hard 40 to 70 Shore A silicone rubber.
  • EP-A-0 692 278 describes a diaphragm of a hamostasis valve made of silicone rubber, the Shore A hardness of which is between 20 and 50.
  • the elastomeric material from which the diaphragm is made is mixed with additives that can make up between 7 and 13 percent by weight of the diaphragm and are said to increase the sliding ability.
  • additives are titanium dioxide, PTFE, graphite and others.
  • valves made of elastomers can be stretched well, but are only slightly compressible.
  • the previously known valves must therefore be stretched and deformed in at least two spatial directions in order to accommodate and seal catheters and other objects with different diameters.
  • the elastomer material In order to immediately close the opening formed by the catheter again tightly after removal of the catheter, the elastomer material must return to its original shape. When passing an object through the valve construction, at least the force required to seal the slot must be overcome. Furthermore, the valve structure usually also has to be deformed and stretched.
  • FIG. 1 shows a cross section through the valve-receiving area of the insertion set with the dilator fully inserted, the sealing element eingze_ch.net being omitted to the right of the center line L and left off from the center line;
  • FIG. 2 shows an enlarged view of the hamostasis valve with the surrounding housing, v, cbe ⁇ left of the middle line of the dilator removed and an inserted dilator is shown to the right of the center line;
  • FIG. 3a shows a perspective view of the valve body with three valve disks of the same thickness as an exploded drawing
  • FIG. 3b shows a perspective view of a further embodiment of the valve body
  • FIG. 3c shows a perspective view of a further embodiment of the valve body
  • FIG. 4a shows a cross section through a valve body according to FIG. 3a
  • FIG. 4b shows a cross section through a valve body according to FIG. 3b.
  • FIG. 4c shows a cross section through a valve body according to FIG. 3c.
  • the two-part housing G shown in FIG. 1 consists of a housing body 1 and a housing cap 2.
  • the housing body 1 of the catheter guide set essentially represents a hollow cylinder with a central opening, which tapers gradually from its distal 12 to its proximal 13 area and carries a side connector 11.
  • a valve support surface 19 directly above the entry of the side channel 111 and perpendicular to the longitudinal axis L.
  • a sealing element 10 becomes clamped between the support surface 19 and the latter Valve clamping surface 28 held positively and non-positively.
  • the sealing element 10 divides the interior of the housing G into a distal 21 and a proximal cavity 14.
  • the proximal cavity 14 communicates with the cavity of the central channel Z, which is formed by a working sheath 5.
  • the task of the sealing element 10 is to prevent the passage of liquid from the proximal 14 to the distal 21 cavity and the passage of air in the opposite direction.
  • An inner side wall 15 of the proximal cavity 14 tapers conically downwards and thereby facilitates the insertion of elongated objects into the central channel Z of the working scabbard 5.
  • This working scabbard 5 is an elongated flexible tube which is sealed at its distal end by a proximal wall 13 of the housing body 1 is enclosed and held non-positively.
  • a conical grommet 4 made of stretchable material is inserted over the proximal end 13 of the housing body 1, the inner diameter of which in the unstretched state is smaller than the outer diameter of the proximal housing wall 13.
  • a retaining rib 18 which extends in a ring on the outside of the proximal housing wall 13 engages when the grommet 4 is attached a circumferential recess 44 on the inner side of the bulb and thereby supports the frictional holding of the nozzle 4 on the housing body 1.
  • the nozzle 4 projects beyond the housing body 1 and encloses the working sheath 5 with its proximal area 42 has a side fastening tab 41 which is perforated 43.
  • the bell-shaped housing cap 2 has the inner 22 and an outer wall 23.
  • a plurality of radially resilient retaining fingers 24 extend in the distal extension of the inner housing wall 22, each of which has an inwardly projecting bead 25 and an upper stop surface which is perpendicular to the longitudinal axis L. 27 have.
  • the circumferential, U-shaped annular groove in cross section, which is formed by the inner 22 and outer 23 wall of the cap 2, is dimensioned such that it can accommodate the distal end 12 of the housing body 1 when the cap 2 is placed on the housing body 1 becomes.
  • An elongated dilator tube 31 of a dilator 3 can extend so far into the Working sheath 5 is inserted until a stop 34 of a dial end piece 33 abuts the stop surface 27.
  • the radially resilient holding fingers .24 hold the proximal part of the dilator end piece 33 with their beads 25.
  • the assembly of the catheter insertion unit is extremely simple, since all parts are snapped together and therefore no gluing, welding or screwing is necessary. Only the distal end of the working sheath 5 has to be firmly connected to the housing body 1 by gluing or welding. The other parts can of course still be glued, heat or ultrasonically welded.
  • the valve unit 10 When installing the valve unit 10, the cylindrical sealing disks 102 and the support disk 101 lying above them, the outside diameter D A of which.
  • the inner diameter of the distal housing wall 12 is adjusted, as shown in FIG.
  • the cap 2 When the cap 2 is plugged on, it is pushed over the distal region of the housing wall 12 until a retaining rib 26 running around the inside of the outer wall 26 into one on the outside of the distal one. Casing surrounding recess 16 snaps.
  • the height of the inner cap wall 22 and the position of the recess 16 and the retaining rib 26 are matched to one another so that the valve clamping surface 28 of the inner cap wall 22 is in the axial direction at a distance from the valve support surface 19 when the cap 2 is inserted and snapped into place , which is at most the same size or less than the height H of the sealing element 10 used.
  • the pressure on the support disk 131 and on the proximal sealing disk 102 ′′ is passed on to the sealing disks 102, 102 ′ lying therebetween.
  • the sealing disks compressed in this way expand laterally slightly and thereby bring about the gas- and liquid-impermeable sealing of the sealing element 10 relative to the housing body 1 and an additional sealing of the cut slots 10.
  • the sealing element 10 consists of a distal perforated support and guide disk
  • the central opening 105 of the support and guide washer 101 tapers from distal to proximal.
  • the conical shape of the opening 105 facilitates the insertion of elongated components, such as catheters and guidewires.
  • Proximal to the support disk 101 are sealing disks 102 made of elastic plastic, which have a diametrically extending slot 104 which does not extend to the periphery. The slots 104 penetrate the sealing washers
  • the elastic plastics from which the sealing washers 102 are made have sufficient elasticity to hold the incisions 104 tight under physiological pressure conditions with the catheter removed and to act as a liquid and gas-tight barrier between the proximal cavity 14 and the distal cavity 21.
  • the sealing disks When the catheter is inserted, pulled out and moved, the sealing disks can only be deflected proximally in the axial direction, since the support disk 101 prevents the movement distally. If an object is pushed through the slots 104 of the sealing disks 102, the lips formed by the slots 104 are stretched and deflected in the axial direction proximally and outwards from the central axis L. For objects with small diameters (e.g. guidewires), the deflection is very small and the seal between the sealing element and the object is mainly due to the tension force of the sealing ben 102, which not only seals the slots 104, but also presses the sealing lips against the guidewire so strongly that there is a liquid-tight contact.
  • the tension force of the sealing ben 102 which not only seals the slots 104, but also presses the sealing lips against the guidewire so strongly that there is a liquid-tight contact.
  • the sealing washers 102 are lubricated with silicone oil or another suitable lubricant before assembly impregnated. Due to the tightness of the slots 104 and the peripheral tight sealing of the sealing washers 102 against the inside of the housing wall 12, separate lubricant reservoirs 103 are formed between adjacent sealing washers 102. When an object is inserted through the slots 104 in the sealing washers 102, the friction between the object and the sealing washers 102 are reduced by the lubricant.
  • a linear polymer from the group of polyorganosiloxanes or a mixture of different such polymers or paraffmol is used as the lubricant.
  • the lubricant is quickly rubbed off from the surfaces of the diaphragm which come into direct contact with the object being carried out, as a result of which the desired friction-reducing effect is quickly lost.
  • the rubbed-off lubricant can be replaced by lubricant from the reservoirs 103 between the sealing washers 102. This keeps the frictional resistance low and constant when moving the object. The latter is crucial for sensory control of the cat- Interaction by the doctor and thus decisive for the acceptance of the product by the user.
  • the smallest inner diameter Di of the central through hole 105 is 3.6 mm and the height of the individual sealing disks 102 and 1 mm.
  • the height of the sealing washers 102 can optionally be 0.5 to 3 mm.
  • the smallest width Di of the central opening 105 is expediently chosen such that it is at least 0.2 mm larger than the diameter of the component to be carried out with the largest diameter.
  • the hardness of the sealing washers 102 made of elastomer material is between 30 and 80, but preferably 50 Shore A.
  • the dimensions of the support disk 101, the sealing washers 102, their slots 104 and the diameter of the working sleeve 5 are ideally matched to certain standardized catheter sizes and diameters.
  • the nominal sizes according to DIN 13 273 can advantageously be used.
  • the associated career number can be attached to the spout, for example. Individual, clearly visible parts of the introductory set can also be marked with the corresponding DIN color code.
  • the middle one of the three sealing disks is made of soft-elastic foam plastic material.
  • This foam plastic sealing washer 106 is impregnated with a suitable lubricant and thus acts not only as a sealing element but also as a lubricant reservoir.
  • Soft-elastic foam plastics with a density of 300 to 600 g / 1, preferably 450 g / 1 have the required material properties.
  • it is preferably open-pore. However, it can also be partially closed-pore.
  • the sealing elements according to the invention through the use of plastics with optimally coordinated material properties, the long-term avoidance of excessive frictional resistance through the use of lubricants from lubricant reservoirs and a simple and therefore inexpensive and reliable construction.

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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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un instrument d'introduction de cathéter doté d'une valve d'hémostase et destiné à introduire le cathéter dans des vaisseaux sanguins. La valve d'hémostase est logée dans un boîtier (G) constitué de deux parties. Entre les deux parties de boîtier de l'instrument d'introduction, au moins un élément d'étanchéité (10) est placé par liaison de forme et/ou de force afin d'assurer un passage étanche le long des parties allongées. L'élément d'étanchéité (10) est composé d'au moins trois disques d'étanchéité (102) superposés, fendus et réalisés dans un matériau élastique, sur lesquels est posé de façon distale au moins un disque de centrage et d'appui (101). Entre les disques d'étanchéité (102) se trouve respectivement un réservoir (103) de lubrifiant et le disque distal de centrage et d'appui (101) présente une ouverture centrale dont le diamètre diminue vers le côté proximal.
PCT/CH1998/000122 1997-04-10 1998-04-01 Instrument d'introduction de catheter WO1998044983A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH83197 1997-04-10
CH831/97 1997-04-10

Publications (1)

Publication Number Publication Date
WO1998044983A1 true WO1998044983A1 (fr) 1998-10-15

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ID=4196226

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH1998/000122 WO1998044983A1 (fr) 1997-04-10 1998-04-01 Instrument d'introduction de catheter

Country Status (1)

Country Link
WO (1) WO1998044983A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2050403A1 (fr) * 2007-10-17 2009-04-22 Tyco Healthcare Group LP Ensemble d'accès doté d'un mécanisme lubrifiant de joint
US9028448B2 (en) 2008-06-19 2015-05-12 Covidien Lp Access seal with interstitial channels
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
US12048541B2 (en) 2018-06-08 2024-07-30 Smiths Medical Asd, Inc. Blood sequestration device and method

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0067007A1 (fr) 1981-05-28 1982-12-15 Argon Medical Corp. Valve hémostatique amovible
US4634432A (en) * 1985-05-13 1987-01-06 Nuri Kocak Introducer sheath assembly
EP0344907A2 (fr) * 1988-06-02 1989-12-06 C.R. Bard, Inc. Guide métallique aut-étanche et cathéter introducteur
EP0369314A2 (fr) * 1988-11-18 1990-05-23 Edward Weck, Inc. Valve hémostatique
EP0198962B1 (fr) 1984-12-28 1990-06-13 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Dispositif de soupape pour un instrument médical
WO1991012838A1 (fr) * 1990-03-01 1991-09-05 The Regents Of The University Of Michigan Dispositif de perfusion implantable
EP0567142A2 (fr) * 1992-04-24 1993-10-27 United States Surgical Corporation Assemblage de soupape pour introduire des instruments dans des cavités corporelles
EP0308815B1 (fr) 1987-09-21 1994-07-20 Cordis Corporation Valve pour instrument médical
EP0316096B1 (fr) 1987-11-12 1995-02-15 Daig Corporation Canule d'hémostase universelle

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0067007A1 (fr) 1981-05-28 1982-12-15 Argon Medical Corp. Valve hémostatique amovible
EP0157906B1 (fr) 1981-05-28 1989-05-03 Edward Weck Inc. Membrane pour une soupape hémostatique à auto-obturation
EP0198962B1 (fr) 1984-12-28 1990-06-13 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Dispositif de soupape pour un instrument médical
US4634432A (en) * 1985-05-13 1987-01-06 Nuri Kocak Introducer sheath assembly
EP0308815B1 (fr) 1987-09-21 1994-07-20 Cordis Corporation Valve pour instrument médical
EP0316096B1 (fr) 1987-11-12 1995-02-15 Daig Corporation Canule d'hémostase universelle
EP0344907A2 (fr) * 1988-06-02 1989-12-06 C.R. Bard, Inc. Guide métallique aut-étanche et cathéter introducteur
EP0369314A2 (fr) * 1988-11-18 1990-05-23 Edward Weck, Inc. Valve hémostatique
WO1991012838A1 (fr) * 1990-03-01 1991-09-05 The Regents Of The University Of Michigan Dispositif de perfusion implantable
EP0567142A2 (fr) * 1992-04-24 1993-10-27 United States Surgical Corporation Assemblage de soupape pour introduire des instruments dans des cavités corporelles

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2050403A1 (fr) * 2007-10-17 2009-04-22 Tyco Healthcare Group LP Ensemble d'accès doté d'un mécanisme lubrifiant de joint
US9028448B2 (en) 2008-06-19 2015-05-12 Covidien Lp Access seal with interstitial channels
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
USD893711S1 (en) 2016-10-27 2020-08-18 Smiths Medical Asd, Inc. Catheter assembly
US12048541B2 (en) 2018-06-08 2024-07-30 Smiths Medical Asd, Inc. Blood sequestration device and method

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