TREA

Method to secure an elastic component in a valve

Follow

Information

  • Patent Grant
  • 8753320
  • Patent Number
    8,753,320
  • Date Filed
    Tuesday, July 5, 2011
    13 years ago
  • Date Issued
    Tuesday, June 17, 2014
    10 years ago
Information
Abstract
An apparatus for controlling fluid flow to provide long-term access to the vascular system, and methods of making the same, are disclosed. Exemplary embodiments of the present invention describe a wedge or other similarly shaped geometrical feature for fixing an elastic component and controlling an internal stress of the elastic component.
Description
BACKGROUND

Pressure activated safety valves have been incorporated into medical devices such as peripherally inserted central catheters (PICCs), ports, dialysis catheters and tunneled central catheters which provide long term access to the vascular system, etc. These valves generally include an elastic component that controls flow and/or pressure through the device to prevent flow therethrough when the device is not in use. The elastic component may be a slitted, flexible membrane extending across a lumen generally constructed so that, when subjected to a fluid pressure of at least a threshold magnitude, edges of the slit separate from one another to permit flow through the lumen. When the pressure applied to the membrane drops below the threshold level, the slit reseals to prevent leakage from or into the device. It is desirable to keep the flexible disk in place during high pressure and/or flow while maintaining the desired flow control characteristics of the membrane.


SUMMARY OF THE INVENTION

The present invention is directed to a valve comprising a flexible member including a slit formed on a central portion thereof and a first housing defining a first lumen extending therethrough, the first housing including a first contacting surface adapted, when the slit of the flexible member is aligned with the first lumen, to contact a first side of the flexible member the first housing defining a relief area extending about a perimeter of the first contacting surface radially outside the central portion relative to a longitudinal axis of the first lumen in combination with a second housing adapted to mate with the first housing with a second lumen defined by the second housing aligned with the first lumen and separated therefrom by the flexible member, the second housing including a second contacting surface which, when the first and second housings are mated to one another in an operative configuration with the flexible member pinched therebetween, contacts a second side of the flexible member opposite the first side thereof along the longitudinal axis, a radially outer portion of the second contacting surface including a protrusion aligning with and extending into the relief area when the first and second housings are mated in the operative configuration, the protrusion bending a peripheral portion of the flexible member about a radially outer edge of the first contacting surface into the relief area to maintain the flexible member at a desired position separating the first and second lumens so that, when subject to a fluid pressure of at least a predetermined magnitude, the slit of the flexible member opens to permit fluid transfer between the first and second lumens and, when subject to a fluid pressure less than the predetermined magnitude, the slit of the flexible member remains closed preventing fluid transfer between the first and second lumens.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 shows a longitudinal cross-sectional view of a device according to an exemplary embodiment of the present invention;



FIG. 2 shows a longitudinal cross-sectional view of a disk portion of the device of FIG. 1; and



FIG. 3 shows an enlarged view of portion of an edge of the disk portion of the device shown in FIG. 2.





DETAILED DESCRIPTION

The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to an apparatus for controlling fluid flow through medical devices specifically for sealing devices which remain in place in the body to provide long term access to the vascular system. To improve the performance of pressure activated safety valves, exemplary embodiments of the present invention describe a wedge or other similarly shaped geometrical feature for fixing an elastic component and controlling an internal stress of the elastic component.


As shown in FIGS. 1-3, a device 100 according to an exemplary embodiment of the present invention comprises a first housing 102, a second housing 104 and an elastic component 106. As shown in FIG. 1, the first housing 102 and the second housing 104 maybe coupled to one another to fix the elastic component 106 therebetween. For clarity, the elastic component 106 is shown between the first and the second housings 102, 104 before being pinched into the final position. The first housing 102 may form a distal end 108 of the device 100 and includes a first connection 134 for connecting to a first conduit which extends, for example, to a target body structure to and/or from which it is desired to transfer fluids. The second housing 104, at a proximal end 110 of the device 100, includes a second connection 136 for connecting to a second conduit which remains external to the body. The elastic component 106 is fixed between the first and the second housings 102, 104 to control a fluid flow therethrough.


The elastic component 106 may be any flexible membrane (e.g., in the form of a disk) including a slit (not shown) for controlling fluid flow therethrough such as, for example, a silicone disk. The elastic component 106 may operate as a bi-directional valve allowing fluid to flow through the device 100 in either direction whenever the valve is subjected to a fluid pressure of at least a threshold value. Alternatively, the elastic component 106 may operate as a uni-directional valve allowing fluid to flow in only one direction or having different threshold values for each of the two directions of flow therethrough. The elastic component 106 is configured to open only when fluid pressure exerted thereagainst reaches a predetermined threshold magnitude. The slit opens via a deformation of the elastic component 106 with edges of the slit moving away from one another to allow fluid to flow therethrough. Once fluid pressure falls below the threshold magnitude, the slit reseals preventing fluid from flowing therethrough. It will be understood by those of skill in the art that the elastic component 106 may include more than one slit extending therethrough.


As shown in FIGS. 2-3, the first housing 102 includes a lumen 112 extending therethrough and a disk-facing surface 114, which contacts the elastic component 106. The disk-facing surface 114 includes a substantially planar central portion 128 surrounding the lumen 112 and a relief area 120 radially outside the planar central portion 128 (relative to a longitudinal axis of the first and second housings 102, 104). The relief area 120 may be formed as a recess extending around a radially outer edge of the disk-facing surface 114 for accommodating an outer perimeter 132 of the elastic component 106. The relief area 120 further includes an edge 122 over which the outer perimeter 132 of the elastic component 106 may be bent. It will be understood by those of skill in the art that the relief area 120 may be formed as either a continuous recess about the perimeter of the disk-facing surface 114 or as a series of recesses spaced from one another around the circumference of the disk-facing surface 114. In a preferred embodiment, the relief area 120 forms a ring-shaped recess about a circumference of the disk-facing surface 114.


The second housing 104 includes a lumen 116 extending therethrough and a disk-facing surface 118, which contacts the elastic component 106. The disk-facing surface 118 includes a substantially planar central portion 130 surrounding the lumen 116 and a protrusion 124 surrounding the planar central portion 130. The protrusion 124 extends distally away from the planar central portion 130 around a radially outer edge of the disk-facing surface 118. The protrusion 124 may be, for example, wedge-shaped including an angled surface 126 which contacts a radially outer portion of the elastic component 106 bending it over the edge 122 distally into the relief area 120. It will be understood by those of skill in the art that the protrusion 124 may extend continuously about the outer perimeter of the disk-facing surface 118 or may be formed as a series of protrusions separated from one another circumferentially about the outer perimeter of the disk-facing surface 118 by a series of recesses or gaps. In a preferred embodiment, the protrusion 124 is substantially ring-shaped and extends continuously around a circumference of the disk-facing surface 118.


The relief area 120 and the protrusion 124 of the first and the second housings 102, 104, respectively, enhance retention of the elastic component 106 applying compression to the elastic component 106 radially inward toward the longitudinal axis of the first and second housings 102, 104, respectively, to counteract tension to which the elastic component 106 is subjected as it is pinched between the first and second housings 102, 104 and stretched into the relief area 120. Initially, as the elastic component 106 is being pinched between the first and second housings 102, 104, as the outer edge of the elastic component 106 is bent around the edge 122 into the relief area 120, the central portion of the elastic component 106 is stretched radially outward drawing edges of the slit away from one another and puckering the central portion of the elastic component. Then, as the first and second housings 102, 104 are moved further toward one another, the elastic component 106 is pinched between the protrusion 124 and the edge 122 reducing a thickness of this portion of the elastic component 106 and urging the material pinched away from this area toward the slit—i.e., compressing the elastic component 106 radially to bring the edges of the slit back together sealing the valve. The planar portion 130 of the disk-facing surface 118 keeps the central portion of the elastic component 106 substantially flat so that the elastic component 106 does not pucker, aligning edges of the slit while under compression. In addition, the bending of the peripherally outer portion of the elastic component 106 over the edge 122 into the relief area 120 reduces the likelihood that the elastic component 106 will be pulled out of position between the first and second housings 102, 104 when subjected to excess pressure. That is, the outer perimeter 132 of the elastic component 106 extends radially outward of the edge 122 in the relief area 120 with the outer perimeter 132 acting as an anchor holding the elastic component 106 in place.


It will be understood by those of skill in the art that the compression force for closing the slit may be controlled by altering the angle of the angled surface 126 and a position of the protrusion 124 in relation to the edge 122. In a preferred embodiment, the angled surface 126 may be angled from between approximately 40E to 50E and more preferably, at an angle of approximately 45E. The location of the edge 122 may be determined by the angled surface 126, which is positioned to the periphery of the flexible member 106. Thus, the compression force may be controlled as desired. It will also be understood by those of skill in the art that the amount of compression on the slit and/or the elastic component 106 is one of the factors determining the pressure gradients needed to open and close the slit. Other factors may include, for example, a flexibility, a thickness, and a material of the elastic component 106.


It will be apparent to those skilled in the art that various modifications and variations may be made in the structure and the methodology of the present invention, without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided that they come within the scope of the appended claims and their equivalents.

Claims
  • 1. A device to provide access to the vascular system of a patient, comprising: a valve component comprising a flexible membrane having a radially outer portion situated between a first mateable housing portion and a second mateable housing portion, said flexible membrane comprising a slit configured to open under a threshold fluid pressure and an outer edge displaced into a recess by at least one of the first and second mateable housing portions, the recess defined by at least one of the first and second mateable housing portions; anda catheter in fluid communication with said valve component.
  • 2. The device of claim 1, wherein at least one of the first and second mateable housing portions includes a compression surface configured to displace the outer edge of the flexible membrane, and the recess is positioned radially outward from the compression surface.
  • 3. The device of claim 1, wherein one of the first and second mateable housing portions includes a protrusion, and the flexible membrane is bent by the protrusion.
  • 4. The device of claim 3, wherein the recess is located opposite the protrusion.
  • 5. The device of claim 1, wherein the first and second mateable housing portions define first and second lumens therethrough, respectively, and the flexible membrane incorporates one or more slits therethrough, the one or more slits being aligned to permit fluid communication between the first and second lumens when open.
  • 6. The device of claim 1, wherein one of the first and second mateable housing portions includes a first surface angled relative to a plane defined by the flexible membrane, the first surface being configured to apply radially compressive pressure to the flexible membrane when the flexible membrane is compressed between the first and second housings.
  • 7. The device of claim 6, wherein the recess is located opposite the first surface.
  • 8. A device to provide access to the vascular system of a patient, comprising: a valve component comprising a flexible membrane having a radially outer portion situated between a first mateable housing portion and a second mateable housing portion, said flexible membrane comprising a slit configured to open under a threshold fluid pressure and an outer edge displaced into a recess by a protrusion of the first mateable housing portion, the recess defined by the second mateable housing portion; anda catheter in fluid communication with said valve component.
  • 9. The device of claim 8, wherein the recess is defined by the second housing and located opposite the protrusion.
  • 10. The device of claim 8, wherein the protrusion has a surface angled relative to a plane defined by the flexible membrane, the surface being configured to apply radially compressive pressure to the flexible membrane when the flexible membrane is compressed between the first and second housings.
  • 11. The device of claim 8, wherein the first and second mateable housing portions define first and second lumens therethrough, respectively, and the flexible membrane incorporates at least one slit therethrough, the at least one slit being aligned to permit fluid communication between the first and second lumens when open.
CROSS-REFERENCE TO PRIOR APPLICATIONS

This application is a continuation application of U.S. patent application Ser. No. 12/501,809 filed Jul. 12, 2009.

US Referenced Citations (169)
Number Name Date Kind
2446571 Browne Mar 1944 A
2720881 Weaver et al. Oct 1955 A
2755060 Twyman Jul 1956 A
3113586 Edmark, Jr. Dec 1963 A
3159175 MacMillan Dec 1964 A
3159176 Russell et al. Dec 1964 A
3477438 Allen et al. Nov 1969 A
3514438 Nelsen et al. May 1970 A
3525357 Koreski Aug 1970 A
3621557 Cushman et al. Nov 1971 A
3669323 Harker et al. Jun 1972 A
3673612 Merrill et al. Jul 1972 A
3674183 Venable et al. Jul 1972 A
3710942 Rosenberg Jan 1973 A
3788327 Donowitz et al. Jan 1974 A
3811466 Ohringer May 1974 A
3941149 Mittleman Mar 1976 A
3955594 Snow May 1976 A
4072146 Howes Feb 1978 A
4142525 Binard et al. Mar 1979 A
4143853 Abramson Mar 1979 A
4244379 Smith Jan 1981 A
4387879 Tauschinski Jun 1983 A
4405316 Mittleman Sep 1983 A
4434810 Atkinson Mar 1984 A
4447237 Frisch et al. May 1984 A
4468224 Enzmann et al. Aug 1984 A
4502502 Krug Mar 1985 A
4524805 Hoffman Jun 1985 A
4543087 Sommercorn et al. Sep 1985 A
4552553 Schulte et al. Nov 1985 A
4610665 Matsumoto et al. Sep 1986 A
4616768 Flier Oct 1986 A
4646945 Steiner et al. Mar 1987 A
4673393 Suzuki et al. Jun 1987 A
4681572 Tokarz et al. Jul 1987 A
4692146 Hilger Sep 1987 A
4722725 Sawyer et al. Feb 1988 A
4790832 Lopez Dec 1988 A
4798594 Hillstead Jan 1989 A
4801297 Mueller Jan 1989 A
4908028 Colon et al. Mar 1990 A
4944726 Hilal et al. Jul 1990 A
4946448 Richmond Aug 1990 A
4960412 Fink Oct 1990 A
5000745 Guest et al. Mar 1991 A
5009391 Steigerwald Apr 1991 A
5030210 Alchas et al. Jul 1991 A
5084015 Moriuchi Jan 1992 A
5098405 Peterson et al. Mar 1992 A
5125893 Dryden Jun 1992 A
5147332 Moorehead Sep 1992 A
5149327 Oshiyama Sep 1992 A
5167638 Felix et al. Dec 1992 A
5169393 Moorehead et al. Dec 1992 A
5176652 Littrell Jan 1993 A
5176662 Bartholomew et al. Jan 1993 A
5201722 Moorehead et al. Apr 1993 A
5205834 Moorehead et al. Apr 1993 A
5249598 Schmidt Oct 1993 A
5254086 Palmer et al. Oct 1993 A
5324274 Martin Jun 1994 A
5330424 Palmer et al. Jul 1994 A
5336203 Goldhardt et al. Aug 1994 A
5360407 Leonard et al. Nov 1994 A
5370624 Edwards et al. Dec 1994 A
5395352 Penny Mar 1995 A
5396925 Poli et al. Mar 1995 A
5399168 Wadsworth et al. Mar 1995 A
5401255 Sutherland et al. Mar 1995 A
D357735 McPhee Apr 1995 S
5405340 Fageol et al. Apr 1995 A
5411491 Goldhardt et al. May 1995 A
5453097 Paradis Sep 1995 A
5454784 Atkinson et al. Oct 1995 A
5469805 Gibbs et al. Nov 1995 A
5470305 Arnett et al. Nov 1995 A
5484420 Russo Jan 1996 A
5542923 Ensminger et al. Aug 1996 A
5545150 Danks et al. Aug 1996 A
5554136 Luther Sep 1996 A
5562618 Cai et al. Oct 1996 A
5571093 Cruz et al. Nov 1996 A
5575769 Vaillancourt et al. Nov 1996 A
5624395 Mikhail et al. Apr 1997 A
5637099 Durdin et al. Jun 1997 A
5667500 Palmer et al. Sep 1997 A
5707357 Mikhail et al. Jan 1998 A
5743873 Cai et al. Apr 1998 A
5743884 Hasson et al. Apr 1998 A
5743894 Swisher Apr 1998 A
5752938 Flatland et al. May 1998 A
5803078 Brauner Sep 1998 A
5807349 Person et al. Sep 1998 A
5810789 Powers et al. Sep 1998 A
5843044 Moorehead Dec 1998 A
5853397 Shemesh et al. Dec 1998 A
5865308 Qin et al. Feb 1999 A
5944698 Fischer et al. Aug 1999 A
5984902 Moorehead Nov 1999 A
5989233 Yoon Nov 1999 A
6033393 Balbierz et al. Mar 2000 A
6045734 Luther et al. Apr 2000 A
6050934 Mikhail et al. Apr 2000 A
6056717 Finch et al. May 2000 A
6062244 Arkans May 2000 A
6092551 Bennett Jul 2000 A
6099505 Ryan et al. Aug 2000 A
6120483 Davey et al. Sep 2000 A
6152909 Bagaoisan et al. Nov 2000 A
6210366 Sanfilippo Apr 2001 B1
6227200 Crump et al. May 2001 B1
6270489 Wise et al. Aug 2001 B1
6306124 Jones et al. Oct 2001 B1
6364861 Feith et al. Apr 2002 B1
6364867 Wise et al. Apr 2002 B2
6375637 Campbell et al. Apr 2002 B1
6436077 Davey et al. Aug 2002 B1
6442415 Bis et al. Aug 2002 B1
6446671 Armenia et al. Sep 2002 B2
6508791 Guerrero Jan 2003 B1
6551270 Bimbo et al. Apr 2003 B1
6610031 Chin Aug 2003 B1
6726063 Stull et al. Apr 2004 B2
6786884 DeCant et al. Sep 2004 B1
6874999 Dai et al. Apr 2005 B2
6953450 Baldwin et al. Oct 2005 B2
6994314 Garnier et al. Feb 2006 B2
7081106 Guo et al. Jul 2006 B1
7252652 Moorehead et al. Aug 2007 B2
7291133 Kindler et al. Nov 2007 B1
7316655 Garibotto et al. Jan 2008 B2
7435236 Weaver et al. Oct 2008 B2
7601141 Dikeman et al. Oct 2009 B2
7637893 Christensen et al. Dec 2009 B2
7758541 Wallace et al. Jul 2010 B2
8257321 Lareau et al. Sep 2012 B2
20010023333 Wisse et al. Sep 2001 A1
20010037079 Burbank et al. Nov 2001 A1
20020010425 Guo et al. Jan 2002 A1
20020016584 Wise et al. Feb 2002 A1
20020121530 Socier Sep 2002 A1
20020165492 Davey et al. Nov 2002 A1
20020193752 Lynn Dec 2002 A1
20030122095 Wilson et al. Jul 2003 A1
20040034324 Seese et al. Feb 2004 A1
20040064128 Raijman et al. Apr 2004 A1
20040102738 Dikeman May 2004 A1
20040108479 Garnier et al. Jun 2004 A1
20040186444 Daly et al. Sep 2004 A1
20040193119 Canaud et al. Sep 2004 A1
20040210194 Bonnette et al. Oct 2004 A1
20040267185 Weaver et al. Dec 2004 A1
20050010176 Dikeman et al. Jan 2005 A1
20050027261 Weaver et al. Feb 2005 A1
20050043703 Nordgren Feb 2005 A1
20050049555 Moorehead et al. Mar 2005 A1
20050149116 Edwards et al. Jul 2005 A1
20050171490 Weaver et al. Aug 2005 A1
20050171510 DiCarlo et al. Aug 2005 A1
20050283122 Nordgren Dec 2005 A1
20060129092 Hanlon et al. Jun 2006 A1
20060135949 Rome et al. Jun 2006 A1
20060149211 Simpson et al. Jul 2006 A1
20070161940 Blanchard et al. Jul 2007 A1
20070161970 Spohn et al. Jul 2007 A1
20070276313 Moorehead et al. Nov 2007 A1
20080108956 Lynn et al. May 2008 A1
20090292252 Lareau et al. Nov 2009 A1
Foreign Referenced Citations (29)
Number Date Country
20208420 Oct 2002 DE
0128625 Dec 1984 EP
0337617 Oct 1989 EP
0930082 Jul 1999 EP
1016431 Jul 2000 EP
2508008 Dec 1982 FR
2718969 Oct 1995 FR
966137 Aug 1964 GB
2102398 Feb 1983 GB
59133877 Aug 1984 JP
63255057 Oct 1988 JP
9038197 Feb 1997 JP
WO-8902764 Apr 1989 WO
WO-9112838 Sep 1991 WO
WO-9206732 Apr 1992 WO
WO-9516480 Jun 1995 WO
WO-9617190 Jun 1996 WO
WO-9623158 Aug 1996 WO
WO-9641649 Dec 1996 WO
WO-9723255 Jul 1997 WO
WO-9726931 Jul 1997 WO
WO-9822178 May 1998 WO
WO-9942166 Aug 1999 WO
WO-0006230 Feb 2000 WO
WO-0044419 Aug 2000 WO
WO-0174434 Oct 2001 WO
WO-03084832 Oct 2003 WO
WO-2005023355 Mar 2005 WO
WO-2008089985 Jul 2008 WO
Non-Patent Literature Citations (13)
Entry
International Search Report and Written Opinion mailed Sep. 3, 2010 for International Application No. PCT/US2010/041698 (10 pages).
Asch, “Venous access: options, approaches and issues,” Can Assoc. Radiol J., vol. 52, No. 3 pp. 153-164 (2001).
Herts et al., “Power injection of contrast media using central venous catheters: feasibility, safety, and efficacy,” AJR Am. J. Roentgenol., vol. 176, No. 2, pp. 447-453 (2001).
Roth et al., “Influence of radiographic contrast media viscosity to flow through coronary angiographic catheters,” Cathet. Cardiovasc. Diagn., vol. 22, No. 4, pp. 290-294 (1991).
Carlson et al., “Safety considerations in the power injection of contrast media via central venous catheters during computered tomogrphic examinations,” Invest. Radiol., vol. 27, No. 5, p. 337-340 (1992).
Kaste et al., “Safe use of powr injectors with central and peripheral venous access devices for pediatrict CT,” Pediatr. Radiol., vol. 26, No. 8, pp. 449-501 (1996).
Herts et al., “Power injection of intravenous contrast material through central venous catheters for CT: in vitro evaluation,” Radiology, vol. 200, No. 3, pp. 731-735 (1996).
Rivitz et al., “Power injection of peripherally inserted central catheters,” J. Vasc. Interv. Radiol., vol. 8, No. 5, pp. 857-863 (1997).
Rogalla et al., Safe and easy power injection of contrast material through a central line, Eur. Radiol., vol. 8, No. 1, pp. 148-149 (1998).
Williamson et al., “Assessing the adequacy of peripherally inserted central catheters for power injection of intravenous contrast agents for CT,” J. Comput. Assist. Tomogr., vol. 25, No. 6, pp. 932-937 (2001).
Chahous et al., “Randomized comparison of coronary angiography using 4F catheters: 4F manual versus ‘Acisted’ power injection technique,” Catheter Cardiovasc. Interv., vol. 53, No. 2, pp. 221-224 (2001).
Walsh et al., “Effect of contrast agent viscosity and injection flow velocity on bolus injection pressures for peripheral venous injection in first-pass myocardial perfusion studies,” Technol. Health Care, vol. 10, No. 1, pp. 57-63 (2002).
Saito et al., “Diagnostic brachial coronary arteriography using a power-assisted injector and 4 French catheters with new shamps,” J. Invasive Cardiol., vol. 9, No. 7, pp. 461-468 (1997).
Related Publications (1)
Number Date Country
20110264054 A1 Oct 2011 US
Continuations (1)
Number Date Country
Parent 12501809 Jul 2009 US
Child 13176054 US