US20110257608A1 - Multi-Slit High Flow Valve - Google Patents
Multi-Slit High Flow Valve Download PDFInfo
- Publication number
- US20110257608A1 US20110257608A1 US13/170,511 US201113170511A US2011257608A1 US 20110257608 A1 US20110257608 A1 US 20110257608A1 US 201113170511 A US201113170511 A US 201113170511A US 2011257608 A1 US2011257608 A1 US 2011257608A1
- Authority
- US
- United States
- Prior art keywords
- slits
- catheter system
- tip
- valve member
- conical
- 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.)
- Abandoned
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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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- 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
- A61M39/22—Valves or arrangement of valves
- A61M39/24—Check- or non-return valves
Definitions
- these semi-permanent catheters When not in use, these semi-permanent catheters may be sealed, for example, by valves such as Pressure Actuated Safety Valves (PASV) which open only when fluid pressure exceeds a preselected threshold pressure.
- PASV's often include a slitted membrane with edges that separate from one another to open the valve only when fluid pressure applied thereto exceeds a threshold level and which are drawn together to seal the valve whenever the pressure falls below this threshold level.
- the present invention is directed to a valve comprising a housing defining a valve lumen adapted for fluid connection with a lumen of a catheter and a substantially conical valve member coupled to the housing and extending across the valve lumen to control flow therethrough in combination with a plurality of slits extending through the valve member and separated from one another circumferentially around the valve member and a ramp formed within a distal end of the valve lumen extending proximally from a distal tip of the valve member toward a ramp vertex separated from the distal tip by a predetermined distance.
- FIG. 1 shows an exemplary embodiment of the multi-slit high flow valve membrane according to the invention.
- FIG. 2 shows a second exemplary embodiment of the multi-slit high flow valve according to the invention.
- the present invention may be further understood with reference to the following description and to the appended drawings, wherein like elements are referred to with the same reference numerals.
- the present invention relates to valves used selectively sealing a proximal end of a catheter and more specifically relates to high flow multi-slit membranes used in catheter valves.
- a valve membrane for a high flow PASV comprises a ramp feature within the conic tip to divert the instrument away from a vertex of the conic tip toward one or more of the slits.
- a high flow multi-slit membrane for use in a PASV valve 100 comprises a tubular housing 102 with a generally conical valve member 104 extending from a distal end thereof.
- the valve member 104 may be integrally formed with the housing 102 or may be bonded thereto by welding, molding operations, etc.
- an outer surface of the valve member 104 preferably mates with a distal end of the housing 102 to form a smooth junction.
- the housing 102 may be integrally formed with or connected to a catheter within which the valve 100 is to be deployed.
- the housing 102 and the valve member 104 may be located within a connector to be coupled to a proximal end of the catheter.
- the valve member 104 presents a concave face to flow impinging upon it from the lumen 110 of the tubular housing 102 with multiple slits 106 being formed in the membrane 104 to permit the passage of fluid when they are open.
- the membrane 104 prevents passage of fluids therethrough.
- the membrane 104 and slits 106 are designed to open only when a fluid pressure exerted thereagainst is at least a desired threshold pressure. When the pressure is below this threshold pressure, the valve is closed.
- This valve 100 is bi-directional with the pressure required to aspirate fluids preferably being greater than that required for injection. For example, the pressure required to aspirate fluids from the valve 100 may be three times that required to inject fluids through the valve 100 .
- the slits 106 extend substantially longitudinally (i.e., in a plane including a longitudinal axis of the valve 100 ) along the surface of the valve member 104 , and may be spaced evenly around a circumference thereof or in any desired pattern.
- the slits 106 generally do not extend into a vertex portion 108 of the member 104 , so that the member 104 remains sealed whenever the pressure is below the threshold value.
- a ramp 110 is formed inside the vertex portion 108 to direct objects inserted therethrough to the one or more of the slits 106 .
- the end of a guidewire encounters a surface 112 of the ramp 110 which deflects it away from the longitudinal axis of the valve 100 toward the distal ends of the slits 106 .
- the surface 112 may be formed in any shape serving to deflect an instrument inserted through the valve away from the longitudinal axis as it approaches the vertex portion 108 .
- the surface 112 may comprise a dome shaped portion with a surface that is convex away from the cone tip 108 .
- valves according to the present invention improve the flow of fluid therethrough.
- the exemplary ramp 110 eliminates a location in which blood may pool (e.g., the concavity of the vertex portion 108 ), thereby reducing the risk of thrombus formation.
- the improved design also promotes an optimal flow through the valve by eliminating a stagnation spot in the tip cone where the fluid flow stagnates.
- Additional benefits of the exemplary embodiment of the valve according to the invention include increased total slit area compared to a conventional flat membrane, thus permitting the higher flow rates necessary for power injection.
- the exemplary valve also shows a reduced overall diameter for a given size of valve, consequently reducing the size of the housing required.
- the exemplary conic valve may be manufactured by molding, which is an easily repeatable and cost effective process.
- a valve 200 according to a second embodiment of the invention comprises a housing 202 defining a lumen 204 extending therethrough.
- a valve portion 206 of the valve 200 is generally conical in shape and, in most applications, will form the distal end of the valve 200 .
- a concave side of the interior of the valve portion 206 faces incoming fluid in the lumen 204 with multiple slits 208 extending through the valve portion 206 to permit flow from the lumen 204 to an exterior of the valve 200 .
- the slits 208 are open only when subject to a fluid pressure of at least a threshold level and remain closed at all other times.
- the slits 208 extend in a substantially longitudinal direction along the surface of the valve membrane 204 , converging toward a tip 210 of the cone of the valve portion 206 .
- a valve including only a single slit may also be employed.
- the flow rates for such single slit valves will be lower than that for multi-slit valves.
- the slits may be curved or in any other desired shape so long as the do not open through the distal-most tip of the housing.
- An elongated ramp 212 which extends inside the valve portion 206 upstream from the tip 210 may be, for example, conical with a proximal tip 214 that extends proximally beyond distal ends 216 of the slits 226 .
- the surface 218 of the elongated ramp 212 is shaped to direct an object such as the tip of a guidewire moving distally through the lumen 204 away from the tip 210 .
- the slope of the surface 218 (i.e., for a conical ramp 212 , an angle of the cone) is preferably selected to direct a distal tip of an instrument inserted through the lumen 204 radially away from a longitudinal axis of the valve 200 toward the distal ends 216 of the slits 208 preventing the instrument from becoming trapped in the tip 210 .
- ramp 212 As an alternative to the conic shape described for the ramp 212 , other shapes may be used to more positively guide the tip of an instrument into the slits 208 . Those skilled in the art will understand that any shape for the ramp 212 may be used which slopes toward the slits 208 to guide the tip of an instrument thereto.
Abstract
Description
- This application claims the priority to the U.S. Provisional Application Ser. No. 60/853,917, entitled “Multi-Slit High Flow Valve,” filed Oct. 24, 2006. The specification of the above Provisional application is incorporated herewith by reference.
- When repeated and prolonged access to the vascular system is required, it is often impractical and dangerous to insert and remove a needle for each session. Thus, patients are often fitted with semi-permanent catheters to facilitate vascular access and reduce discomfort.
- When not in use, these semi-permanent catheters may be sealed, for example, by valves such as Pressure Actuated Safety Valves (PASV) which open only when fluid pressure exceeds a preselected threshold pressure. PASV's often include a slitted membrane with edges that separate from one another to open the valve only when fluid pressure applied thereto exceeds a threshold level and which are drawn together to seal the valve whenever the pressure falls below this threshold level.
- In addition to typical fluid infusion and withdrawal procedures, certain patients require power injections of fluids to, for example, perform CT and/or MR studies. Using the same peripherally inserted central catheter (PICC) for the typical infusion/withdrawal procedures as well as the power injections simplifies these procedures. However, as power injections require considerably higher flow rates and pressures than most other procedures, using the same PICC for power injections subjects the PICC to stress levels which are not sustainable by conventional PASV's. Some recent designs of high flow membranes for PASV's have been found suitable for power injection including, for example, U.S. Published Patent Application No. 20050043703 to Greg Nordgren (“the ‘703 application), which is hereby incorporated by reference in its entirety. The ‘703 application describes conical, high flow rate, multi-slit membranes for PASV's.
- In one aspect, the present invention is directed to a valve comprising a housing defining a valve lumen adapted for fluid connection with a lumen of a catheter and a substantially conical valve member coupled to the housing and extending across the valve lumen to control flow therethrough in combination with a plurality of slits extending through the valve member and separated from one another circumferentially around the valve member and a ramp formed within a distal end of the valve lumen extending proximally from a distal tip of the valve member toward a ramp vertex separated from the distal tip by a predetermined distance.
-
FIG. 1 shows an exemplary embodiment of the multi-slit high flow valve membrane according to the invention; and -
FIG. 2 shows a second exemplary embodiment of the multi-slit high flow valve according to the invention. - The present invention may be further understood with reference to the following description and to the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to valves used selectively sealing a proximal end of a catheter and more specifically relates to high flow multi-slit membranes used in catheter valves.
- When an internal shape of a conic valve mirrors the external shape (i.e., the internal space is conic), difficulties may arise when attempting to pass a guidewire through the catheter. The tips of guidewires or other instruments may become trapped in the concave vertex of the valve instead of passing through a slit. According to the exemplary embodiments of the present invention, the internal shape of the cone tip of the valve membrane is modified to divert and direct a guidewire or other instrument inserted therethrough into one of the slits. According to exemplary embodiments of the present invention, a valve membrane for a high flow PASV comprises a ramp feature within the conic tip to divert the instrument away from a vertex of the conic tip toward one or more of the slits.
- As shown in
FIG. 1 , a high flow multi-slit membrane for use in aPASV valve 100 according to the invention comprises atubular housing 102 with a generallyconical valve member 104 extending from a distal end thereof. Those skilled in the art will understand that thevalve member 104 may be integrally formed with thehousing 102 or may be bonded thereto by welding, molding operations, etc. Furthermore, an outer surface of thevalve member 104 preferably mates with a distal end of thehousing 102 to form a smooth junction. In addition, those skilled in the art would understand that thehousing 102 may be integrally formed with or connected to a catheter within which thevalve 100 is to be deployed. Alternatively, thehousing 102 and thevalve member 104 may be located within a connector to be coupled to a proximal end of the catheter. Thevalve member 104 presents a concave face to flow impinging upon it from thelumen 110 of thetubular housing 102 withmultiple slits 106 being formed in themembrane 104 to permit the passage of fluid when they are open. When theslits 106 are closed, themembrane 104 prevents passage of fluids therethrough. Typically, themembrane 104 andslits 106 are designed to open only when a fluid pressure exerted thereagainst is at least a desired threshold pressure. When the pressure is below this threshold pressure, the valve is closed. Thisvalve 100 is bi-directional with the pressure required to aspirate fluids preferably being greater than that required for injection. For example, the pressure required to aspirate fluids from thevalve 100 may be three times that required to inject fluids through thevalve 100. - In the exemplary embodiment shown in
FIG. 1 , theslits 106 extend substantially longitudinally (i.e., in a plane including a longitudinal axis of the valve 100) along the surface of thevalve member 104, and may be spaced evenly around a circumference thereof or in any desired pattern. Theslits 106 generally do not extend into avertex portion 108 of themember 104, so that themember 104 remains sealed whenever the pressure is below the threshold value. Aramp 110 is formed inside thevertex portion 108 to direct objects inserted therethrough to the one or more of theslits 106. - Thus, instead of becoming stuck at the vertex of the interior of the
cone tip 108, the end of a guidewire (or other instrument) encounters asurface 112 of theramp 110 which deflects it away from the longitudinal axis of thevalve 100 toward the distal ends of theslits 106. As would be understood by those skilled in the art, thesurface 112 may be formed in any shape serving to deflect an instrument inserted through the valve away from the longitudinal axis as it approaches thevertex portion 108. For example, thesurface 112 may comprise a dome shaped portion with a surface that is convex away from thecone tip 108. - In addition to facilitating passage of a guidewire, valves according to the present invention improve the flow of fluid therethrough. For example, the
exemplary ramp 110 eliminates a location in which blood may pool (e.g., the concavity of the vertex portion 108), thereby reducing the risk of thrombus formation. The improved design also promotes an optimal flow through the valve by eliminating a stagnation spot in the tip cone where the fluid flow stagnates. - Additional benefits of the exemplary embodiment of the valve according to the invention include increased total slit area compared to a conventional flat membrane, thus permitting the higher flow rates necessary for power injection. The exemplary valve also shows a reduced overall diameter for a given size of valve, consequently reducing the size of the housing required. In addition, as described above, the exemplary conic valve may be manufactured by molding, which is an easily repeatable and cost effective process.
- As shown in
FIG. 3 , avalve 200 according to a second embodiment of the invention comprises ahousing 202 defining alumen 204 extending therethrough. As in the embodiment described above, avalve portion 206 of thevalve 200 is generally conical in shape and, in most applications, will form the distal end of thevalve 200. A concave side of the interior of thevalve portion 206 faces incoming fluid in thelumen 204 withmultiple slits 208 extending through thevalve portion 206 to permit flow from thelumen 204 to an exterior of thevalve 200. As described above in regard to theslits 106 of thevalve 100, theslits 208 are open only when subject to a fluid pressure of at least a threshold level and remain closed at all other times. As in the embodiment previously described, theslits 208 extend in a substantially longitudinal direction along the surface of thevalve membrane 204, converging toward atip 210 of the cone of thevalve portion 206. Those skilled in the art will understand that a valve including only a single slit may also be employed. However, the flow rates for such single slit valves will be lower than that for multi-slit valves. In addition, the slits may be curved or in any other desired shape so long as the do not open through the distal-most tip of the housing. - An
elongated ramp 212 which extends inside thevalve portion 206 upstream from thetip 210 may be, for example, conical with aproximal tip 214 that extends proximally beyonddistal ends 216 of the slits 226. Thesurface 218 of theelongated ramp 212 is shaped to direct an object such as the tip of a guidewire moving distally through thelumen 204 away from thetip 210. The slope of the surface 218 (i.e., for aconical ramp 212, an angle of the cone) is preferably selected to direct a distal tip of an instrument inserted through thelumen 204 radially away from a longitudinal axis of thevalve 200 toward thedistal ends 216 of theslits 208 preventing the instrument from becoming trapped in thetip 210. - As an alternative to the conic shape described for the
ramp 212, other shapes may be used to more positively guide the tip of an instrument into theslits 208. Those skilled in the art will understand that any shape for theramp 212 may be used which slopes toward theslits 208 to guide the tip of an instrument thereto. - The present invention has been described with reference to specific exemplary embodiments. Those skilled in the art will understand that changes may be made in details, particularly in matters of shape, size, material and arrangement of parts. Accordingly, various modifications and changes may be made to the embodiments. The specifications and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.
Claims (18)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/170,511 US20110257608A1 (en) | 2006-10-24 | 2011-06-28 | Multi-Slit High Flow Valve |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US85391706P | 2006-10-24 | 2006-10-24 | |
US11/834,101 US7993327B2 (en) | 2006-10-24 | 2007-08-06 | Multi-slit high flow valve |
US13/170,511 US20110257608A1 (en) | 2006-10-24 | 2011-06-28 | Multi-Slit High Flow Valve |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/834,101 Continuation US7993327B2 (en) | 2006-10-24 | 2007-08-06 | Multi-slit high flow valve |
Publications (1)
Publication Number | Publication Date |
---|---|
US20110257608A1 true US20110257608A1 (en) | 2011-10-20 |
Family
ID=38754517
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/834,101 Expired - Fee Related US7993327B2 (en) | 2006-10-24 | 2007-08-06 | Multi-slit high flow valve |
US13/170,511 Abandoned US20110257608A1 (en) | 2006-10-24 | 2011-06-28 | Multi-Slit High Flow Valve |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/834,101 Expired - Fee Related US7993327B2 (en) | 2006-10-24 | 2007-08-06 | Multi-slit high flow valve |
Country Status (4)
Country | Link |
---|---|
US (2) | US7993327B2 (en) |
EP (1) | EP2086620A1 (en) |
CA (1) | CA2667293A1 (en) |
WO (1) | WO2008051647A1 (en) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7435236B2 (en) | 2003-06-27 | 2008-10-14 | Navilyst Medical, Inc. | Pressure actuated valve with improved biasing member |
US8257321B2 (en) | 2008-05-21 | 2012-09-04 | Navilyst Medical, Inc. | Pressure activated valve for high flow rate and pressure venous access applications |
CN102802713B (en) | 2009-06-26 | 2015-09-30 | 科洛普拉斯特公司 | A kind of catheter and the method for catheter described in injection moulding |
US8007468B2 (en) | 2009-07-13 | 2011-08-30 | Navilyst Medical, Inc. | Method to secure an elastic component in a valve |
US9043003B2 (en) * | 2009-07-31 | 2015-05-26 | Fisher-Rosemount Systems, Inc. | Graphical view sidebar for a process control system |
US9895524B2 (en) | 2012-07-13 | 2018-02-20 | Angiodynamics, Inc. | Fluid bypass device for valved catheters |
US10610678B2 (en) | 2016-08-11 | 2020-04-07 | Angiodynamics, Inc. | Bi-directional, pressure-actuated medical valve with improved fluid flow control and method of using such |
KR101862201B1 (en) * | 2017-08-31 | 2018-05-29 | 제이에스케이바이오메드(주) | Micro-jet drug injection device with backflow prevention valve |
Citations (9)
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US5571093A (en) * | 1994-09-21 | 1996-11-05 | Cruz; Cosme | Multiple-lumen catheter |
US5928203A (en) * | 1997-10-01 | 1999-07-27 | Boston Scientific Corporation | Medical fluid infusion and aspiration |
US6206849B1 (en) * | 1987-12-22 | 2001-03-27 | Vas-Cath Incorporated | Multiple lumen catheter |
US20020156430A1 (en) * | 2001-04-19 | 2002-10-24 | Haarala Brett T. | Catheter slit valves |
US20040064128A1 (en) * | 2000-05-19 | 2004-04-01 | Isac Raijman | Multi-lumen biliary catheter with angled guidewire exit |
US6786884B1 (en) * | 1999-10-29 | 2004-09-07 | Bard Access Systems, Inc. | Bolus tip design for a multi-lumen catheter |
US20050043703A1 (en) * | 2003-08-21 | 2005-02-24 | Greg Nordgren | Slit valves for catheter tips and methods |
US20050283122A1 (en) * | 2000-04-03 | 2005-12-22 | Greg Nordgren | Slit valves bridging between the tip and distal side wall of catheter tubes and methods |
US7316655B2 (en) * | 1996-10-11 | 2008-01-08 | Medtronic Vascular, Inc. | Systems and methods for directing and snaring guidewires |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4543087A (en) * | 1983-11-14 | 1985-09-24 | Quinton Instrument Company | Double lumen catheter tip |
US4801297A (en) * | 1984-06-01 | 1989-01-31 | Edward Weck Incorporated | Catheter having slit tip |
US5147332A (en) * | 1991-05-17 | 1992-09-15 | C.R. Bard, Inc. | Multi-valve catheter for improved reliability |
US5807349A (en) * | 1997-03-10 | 1998-09-15 | United States Surgical Corporation | Catheter having valve mechanism |
US20030191496A1 (en) | 1997-03-12 | 2003-10-09 | Neomend, Inc. | Vascular sealing device with microwave antenna |
WO2001074434A2 (en) | 2000-04-03 | 2001-10-11 | C.R. Bard, Inc. | Catheter with valved distal tip |
US9933079B2 (en) | 2004-01-29 | 2018-04-03 | Angiodynamics, Inc. | Stacked membrane for pressure actuated valve |
-
2007
- 2007-08-06 US US11/834,101 patent/US7993327B2/en not_active Expired - Fee Related
- 2007-08-09 EP EP07813946A patent/EP2086620A1/en not_active Withdrawn
- 2007-08-09 WO PCT/US2007/075583 patent/WO2008051647A1/en active Application Filing
- 2007-08-09 CA CA002667293A patent/CA2667293A1/en not_active Abandoned
-
2011
- 2011-06-28 US US13/170,511 patent/US20110257608A1/en not_active Abandoned
Patent Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6206849B1 (en) * | 1987-12-22 | 2001-03-27 | Vas-Cath Incorporated | Multiple lumen catheter |
US5571093A (en) * | 1994-09-21 | 1996-11-05 | Cruz; Cosme | Multiple-lumen catheter |
US7316655B2 (en) * | 1996-10-11 | 2008-01-08 | Medtronic Vascular, Inc. | Systems and methods for directing and snaring guidewires |
US5928203A (en) * | 1997-10-01 | 1999-07-27 | Boston Scientific Corporation | Medical fluid infusion and aspiration |
US6120483A (en) * | 1997-10-01 | 2000-09-19 | Boston Scientific Corporation | Medical fluid infusion and aspiration |
US20020165492A1 (en) * | 1997-10-01 | 2002-11-07 | Boston Scientific Corporation | Medical fluid infusion and aspiration |
US6786884B1 (en) * | 1999-10-29 | 2004-09-07 | Bard Access Systems, Inc. | Bolus tip design for a multi-lumen catheter |
US20050283122A1 (en) * | 2000-04-03 | 2005-12-22 | Greg Nordgren | Slit valves bridging between the tip and distal side wall of catheter tubes and methods |
US20040064128A1 (en) * | 2000-05-19 | 2004-04-01 | Isac Raijman | Multi-lumen biliary catheter with angled guidewire exit |
US20020156430A1 (en) * | 2001-04-19 | 2002-10-24 | Haarala Brett T. | Catheter slit valves |
US20050043703A1 (en) * | 2003-08-21 | 2005-02-24 | Greg Nordgren | Slit valves for catheter tips and methods |
Also Published As
Publication number | Publication date |
---|---|
US20080097341A1 (en) | 2008-04-24 |
CA2667293A1 (en) | 2008-05-02 |
US7993327B2 (en) | 2011-08-09 |
EP2086620A1 (en) | 2009-08-12 |
WO2008051647A1 (en) | 2008-05-02 |
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