WO2000016844A1 - Dispositif permettant un acces vasculaire - Google Patents

Dispositif permettant un acces vasculaire Download PDF

Info

Publication number
WO2000016844A1
WO2000016844A1 PCT/US1999/014895 US9914895W WO0016844A1 WO 2000016844 A1 WO2000016844 A1 WO 2000016844A1 US 9914895 W US9914895 W US 9914895W WO 0016844 A1 WO0016844 A1 WO 0016844A1
Authority
WO
WIPO (PCT)
Prior art keywords
lip
trench
housing
entrance
fluid path
Prior art date
Application number
PCT/US1999/014895
Other languages
English (en)
Inventor
Brian K. Estabrook
Frank Prosl
Dale Whipple
Robert D. Gage
Joseph Megerman
Original Assignee
Biolink Corporation
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 Biolink Corporation filed Critical Biolink Corporation
Publication of WO2000016844A1 publication Critical patent/WO2000016844A1/fr

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
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes

Definitions

  • the present invention relates to a medical device and more particularly to a device for accessing the vascular system.
  • vascular access Certain medical procedures, such as hemodialysis, require repeated vascular access.
  • Known approaches for vascular access include a Scribner shunt, an arterio-venus (AV) fistula, a polytetrafluoroethylene (PFTE) graft, and catheters implanted in the jugular vein.
  • AV fistula generally the procedure of choice, can require several months for maturation of the fistula (an arterialized vein), and is generally unsuccessful in patents having diabetes or cardiovascular disease.
  • the PFTE graft probably the most commonly used procedure, has serious drawbacks including stenosis and thrombosis.
  • the percutaneous central venous catheter has serious infection and stenosis problems.
  • implantable vascular access devices have been developed that include a subcutaneous docking station or port associated with tubing in permanent communication with the vasculature.
  • a needle or trocar in communication with a fluid supply and treatment apparatus
  • a particular challenge associated with subcutaneously implanted devices is the difficulty in mating the needles with the docking station.
  • the present invention overcomes disadvantages of known subcutaneous ports by providing a device having a readily ascertained topography and easily accessed needle inlets.
  • the configuration of the device also helps to minimize skin and blood cell trauma.
  • a subcutaneous access device in an exemplary embodiment, includes a housing with a pair of lips that define an elongate trench. At the bottom of the trench is a needle access entrance to a fluid path that extends through the housing. The trench is wider at its mouth than at the bottom of the trench and the trench is deeper than it is wide (at the bottom of the trench).
  • the device can include more than one fluid path and it can include a suture attachment structure.
  • the housing can be elongate; and to make it easy to hold in place, the housing can include a depression on its surface of the housing.
  • FIG. 1 is a perspective view of a vascular access device in accordance with the invention
  • FIG. 2 is a view of a first end of the device of FIG. 1;
  • FIG. 3 is a view of a first side of the device of FIG. 1, the opposite side being a mirror image;
  • FIG. 4 is a top view of the device of FIG. 1;
  • FIG. 5 is a bottom view of the device of FIG. 1;
  • FIG. 6 is a view of a second end of the device of FIG. 1;
  • FIG. 7 illustrates an alternative configuration for an entrance to a fluid path
  • FIG. 8 is a schematic representation of a dialysis system, including a device in accordance with the invention, shown implanted within a human chest;
  • FIG. 9 shows the system of FIG. 8 from the side.
  • FIG. 1 is a perspective view of a subcutaneously-implantable vascular access device in accordance with the invention.
  • the device includes a housing 10 having a first lip 12 and a second lip 14 that define an elongate trench 16. As shown in FIG. 3, the trench 16 has an open mouth 18 defined by the first lip 12 and the second lipl4, and a closed bottom 20 defined by the housing 10.
  • the housing 10 defines a fluid path 22 including an entrance 24 (shown in FIGS. 1 and 2) and an exit 26 (shown in FIG. 6). As presented in FIGS. 1 and 2, the entrance 24 of the fluid path 22 is between the first lip 12 and the second lip 14 at bottom of the trench 16.
  • the trench 16 has a first width between the first lip 12 and the second lip 14 at the bottom 20 of the trench, and a second width at the mouth 18 of the trench. As clearly shown in FIGS. 1 and 3, the width of the trench 16 at the mouth 18 is greater than the width of the trench at the bottom 20.
  • the first lip 12 is provided with an inner face 26 that is substantially perpendicular to the bottom 20 of the trench 16.
  • the second lip 14 has an inner face 28 that intersects the bottom 20 of the trench 16 at an acute angle with respect to the first lip 12. In an exemplary embodiment, the acute angle is about 30 degrees.
  • the inner face 26 of the first lip 12 and the inner face 28 of the second lip 14 can be substantially planar.
  • the lips can be the same dimensions, in the illustrated embodiment, the first lip 12 is larger than the second lip 14, and the second lip extends further from the housing 10 than the first lip. The edges of the lips can be radiused.
  • the trench 16 has a depth from the mouth 18 to the bottom 20 that is greater than the width at the bottom of the trench. As shown in FIG. 2, the width of the trench 16 is substantially equivalent to the diameter of the entrance 24 of the fluid path through the housing.
  • a broader, shaped inlet 30 can be flush with the surface and lead to the entrance 24.
  • the width of the trench 16 is to be distinguished from its length which is shown transversely in FIG. 2.
  • the ends of the trench 16 can be completely open or bound by walls or end-stops 32 and 34 that extend away from the bottom of the trench.
  • the end- stops can be relatively short as shown, or coextensive with the lips.
  • the exemplary device is configured with a second fluid path including an entrance 36 (shown in FIGS. 1 and 2) and an exit 38 (shown in FIG. 6).
  • the entrance 36 of the second fluid path is between the first lip 12 and the second lip 14 at bottom of the trench 16 in a spaced-apart relationship with the entrance 24 of the first fluid path.
  • the entrances 24 and 36 are about 0.09 inches in diameter.
  • the first fluid path and the second fluid path can be linear and parallel, or non linear and intersecting or overlapping.
  • exits 26 and 38 are shown on the end of the housing opposite the entrances 24 and 36, the exits can be positioned at other points on the housing as desired.
  • the disclosed configuration provides a linear flow path from the needle through the device to the exit thereof, which greatly minimizes damage to cells being infused.
  • the structure 40 provides a way to secure the vascular access device to body tissue.
  • the structure 40 is a plate secured to the housing 10.
  • the structure can include one or more apertures 42, 44, 46, and 48 dimensioned to allow suture material to be passed therethrough.
  • the structure 40 can be fixed in relation to the housing 10, it can also be movable with respect thereto.
  • the suture attachment structure 40 can be attached to the housing 10 with a pivot 50.
  • the thickness of a skin and fat layer can make it difficult to ascertain the topography of an implanted vascular access device. Only relatively large features can be identified by touch. Accordingly, the device is provided with a roughly rectangular housing 10 having an aspect ration that is greater than 1.5. Further, a depression 52 on the surface of the housing (shown in FIG. 4) helps to identify landmarks of the device and aids in holding in the device in place.
  • the vascular access device is about 2 inches long, one inch wide, and one half inch thick.
  • FIG. 7 illustrates an alternative configuration for an entrance to the fluid path in which an entrance 54 is circular and recessed below the bottom 20 of the trench 16.
  • a somewhat pyramidal or “mouse hole” shaped inlet 56 leads from the bottom 20 to the entrance 54.
  • FIG. 8 illustrates a vascular access device 58 in accordance with the invention implanted under a region of skin and fat on the right side of a human chest.
  • the device 58 includes a suture attachment structure 60 to which fascia below the device has been sutured.
  • the device 58 is shown in a pocket of flesh created by a single incision 62.
  • First and second cannulas 64 and 66 are shown in communication with fluid path exits. Each cannula is subcutaneous and enters a blood vessel 68.
  • First and second needles 70 and 72 are mated with the device and third and fourth cannulas 74 and 76, respectively.
  • the device 58 is mated to one or more needles as follows.
  • a healthcare provider palpitates the skin to determine the device orientation and the location of the mouth of the trench.
  • the skin is stretched across the mouth of the trench so as to be taut and not draping. Because the trench is deeper than it is wide, the possibility of skin bunching-up and blocking the entrances is greatly reduced.
  • a first needle is pushed through the skin until it strikes the inner surface of the first lip.
  • the first needle is advanced until its tip strikes the bottom of the trench.
  • the tip of the needle is slid along the bottom of the trench until it engages an entrance.
  • the needle is then pushed into the entrance until an internal stop is encountered. If the needle is slid away from an entrance toward the outside of the trench it will abut an end-stop, giving tactile feedback to reverse direction (toward an entrance) and preventing an undesirable needle stick to the patient.
  • the same procedure is then repeated with additional needles, depending on the number of entrances provided in the device.
  • FIG. 9 shows the device 58 from the side, beneath the skin 78 and secured to the fascia 80.
  • the needle 70 is shown having pierced the skin 78, and the tip of the needle is in contact with the inner surface 82 of the first lip 84.
  • the surfaces which are intended for needle contact, such as the lips, trench and entrances, are preferably fabricated from a hard and smooth material so that the needle will not dig into the surfaces.
  • the access port of the present invention provides increased operating time between clotting episodes, reduces infection problems, does not increase cardiac output, doesn't require maturation time, and eliminates post- dialysis bleeding and intra-dialysis bleeding.

Landscapes

  • 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)
  • External Artificial Organs (AREA)

Abstract

Ce dispositif d'accès implanté dans une région sous-cutanée est constitué d'un boîtier (10) dont les deux lèvres (12, 14) définissent un sillon de forme allongée (16). Ce sillon (16) a une embouchure libre (18) définie par la première (12) et la seconde (14) lèvre et un fond fermé défini par le boîtier (10). Ce dernier définit un passage pour liquide ayant une entrée (36, 24) et une sortie (26, 38). L'entrée du passage pour liquide se trouve au fond (20) du sillon (16) entre la première (12) et la seconde (14) lèvre.
PCT/US1999/014895 1998-09-24 1999-06-30 Dispositif permettant un acces vasculaire WO2000016844A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16051898A 1998-09-24 1998-09-24
US09/160,518 1998-09-24

Publications (1)

Publication Number Publication Date
WO2000016844A1 true WO2000016844A1 (fr) 2000-03-30

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Family Applications (1)

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Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004033022A1 (fr) * 2002-10-04 2004-04-22 Scimed Life Systems, Inc. Dispositif d'acces veineux dote d'ailettes de suture detachables
US8382723B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Access port identification systems and methods
US8382724B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
USD676955S1 (en) 2010-12-30 2013-02-26 C. R. Bard, Inc. Implantable access port
USD682416S1 (en) 2010-12-30 2013-05-14 C. R. Bard, Inc. Implantable access port
US8475417B2 (en) 2005-04-27 2013-07-02 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US8608713B2 (en) 1998-12-07 2013-12-17 C. R. Bard, Inc. Septum feature for identification of an access port
US8641676B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Infusion apparatuses and methods of use
US8932271B2 (en) 2008-11-13 2015-01-13 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US8998860B2 (en) 2005-03-04 2015-04-07 C. R. Bard, Inc. Systems and methods for identifying an access port
US9079004B2 (en) 2009-11-17 2015-07-14 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US9265912B2 (en) 2006-11-08 2016-02-23 C. R. Bard, Inc. Indicia informative of characteristics of insertable medical devices
US9474888B2 (en) 2005-03-04 2016-10-25 C. R. Bard, Inc. Implantable access port including a sandwiched radiopaque insert
US9579496B2 (en) 2007-11-07 2017-02-28 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US9603993B2 (en) 2005-03-04 2017-03-28 C. R. Bard, Inc. Access port identification systems and methods
US9642986B2 (en) 2006-11-08 2017-05-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US10307581B2 (en) 2005-04-27 2019-06-04 C. R. Bard, Inc. Reinforced septum for an implantable medical device
US11890443B2 (en) 2008-11-13 2024-02-06 C. R. Bard, Inc. Implantable medical devices including septum-based indicators

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5527278A (en) * 1990-03-01 1996-06-18 Michigan Transtech Corporation Implantable access devices
US5911706A (en) * 1996-06-12 1999-06-15 Estabrook; Brian K. Device for subcutaneous accessibility

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5527278A (en) * 1990-03-01 1996-06-18 Michigan Transtech Corporation Implantable access devices
US5911706A (en) * 1996-06-12 1999-06-15 Estabrook; Brian K. Device for subcutaneous accessibility

Cited By (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8608713B2 (en) 1998-12-07 2013-12-17 C. R. Bard, Inc. Septum feature for identification of an access port
WO2004033022A1 (fr) * 2002-10-04 2004-04-22 Scimed Life Systems, Inc. Dispositif d'acces veineux dote d'ailettes de suture detachables
US8603052B2 (en) 2005-03-04 2013-12-10 C. R. Bard, Inc. Access port identification systems and methods
US8382724B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
US10905868B2 (en) 2005-03-04 2021-02-02 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US10675401B2 (en) 2005-03-04 2020-06-09 Bard Peripheral Vascular, Inc. Access port identification systems and methods
US10265512B2 (en) 2005-03-04 2019-04-23 Bard Peripheral Vascular, Inc. Implantable access port including a sandwiched radiopaque insert
US8585663B2 (en) 2005-03-04 2013-11-19 C. R. Bard, Inc. Access port identification systems and methods
US9474888B2 (en) 2005-03-04 2016-10-25 C. R. Bard, Inc. Implantable access port including a sandwiched radiopaque insert
US11077291B2 (en) 2005-03-04 2021-08-03 Bard Peripheral Vascular, Inc. Implantable access port including a sandwiched radiopaque insert
US10238850B2 (en) 2005-03-04 2019-03-26 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US8382723B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Access port identification systems and methods
US10179230B2 (en) 2005-03-04 2019-01-15 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US8939947B2 (en) 2005-03-04 2015-01-27 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
US8998860B2 (en) 2005-03-04 2015-04-07 C. R. Bard, Inc. Systems and methods for identifying an access port
US9682186B2 (en) 2005-03-04 2017-06-20 C. R. Bard, Inc. Access port identification systems and methods
US9603993B2 (en) 2005-03-04 2017-03-28 C. R. Bard, Inc. Access port identification systems and methods
US9603992B2 (en) 2005-03-04 2017-03-28 C. R. Bard, Inc. Access port identification systems and methods
US8641676B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Infusion apparatuses and methods of use
US8641688B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US10780257B2 (en) 2005-04-27 2020-09-22 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US8475417B2 (en) 2005-04-27 2013-07-02 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US10661068B2 (en) 2005-04-27 2020-05-26 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10625065B2 (en) 2005-04-27 2020-04-21 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10307581B2 (en) 2005-04-27 2019-06-04 C. R. Bard, Inc. Reinforced septum for an implantable medical device
US8545460B2 (en) 2005-04-27 2013-10-01 C. R. Bard, Inc. Infusion apparatuses and related methods
US9937337B2 (en) 2005-04-27 2018-04-10 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US10016585B2 (en) 2005-04-27 2018-07-10 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10052470B2 (en) 2005-04-27 2018-08-21 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US9421352B2 (en) 2005-04-27 2016-08-23 C. R. Bard, Inc. Infusion apparatuses and methods of use
US10183157B2 (en) 2005-04-27 2019-01-22 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10092725B2 (en) 2006-11-08 2018-10-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US10556090B2 (en) 2006-11-08 2020-02-11 C. R. Bard, Inc. Resource information key for an insertable medical device
US9642986B2 (en) 2006-11-08 2017-05-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US9265912B2 (en) 2006-11-08 2016-02-23 C. R. Bard, Inc. Indicia informative of characteristics of insertable medical devices
US9579496B2 (en) 2007-11-07 2017-02-28 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US10086186B2 (en) 2007-11-07 2018-10-02 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US11638810B2 (en) 2007-11-07 2023-05-02 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US10792485B2 (en) 2007-11-07 2020-10-06 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US11890443B2 (en) 2008-11-13 2024-02-06 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US8932271B2 (en) 2008-11-13 2015-01-13 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US10052471B2 (en) 2008-11-13 2018-08-21 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US10773066B2 (en) 2008-11-13 2020-09-15 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US9717895B2 (en) 2009-11-17 2017-08-01 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US9248268B2 (en) 2009-11-17 2016-02-02 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US10912935B2 (en) 2009-11-17 2021-02-09 Bard Peripheral Vascular, Inc. Method for manufacturing a power-injectable access port
US9079004B2 (en) 2009-11-17 2015-07-14 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US11759615B2 (en) 2009-11-17 2023-09-19 Bard Peripheral Vascular, Inc. Overmolded access port including anchoring and identification features
US10155101B2 (en) 2009-11-17 2018-12-18 Bard Peripheral Vascular, Inc. Overmolded access port including anchoring and identification features
USD682416S1 (en) 2010-12-30 2013-05-14 C. R. Bard, Inc. Implantable access port
USD676955S1 (en) 2010-12-30 2013-02-26 C. R. Bard, Inc. Implantable access port

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