Medical fluid flow control valve
First Claim
1. A valve arrangement for controlling a flow of fluid therethrough, wherein the arrangement comprises a seal to be disposed in the fluid flow, the seal having at least one perforation to permit insertion of a medical device therethrough for fluid flow through the seal, where the perforation is open prior to medical device insertion and when the seal is unstressed prior to assembly of the valve, the seal further comprising a material, and the valve further includes a means for causing portions of the seal inwardly from a periphery thereof to be deflected in a direction farther into the valve in a manner sufficient to close the at least one perforation upon engagement of the means with the seal, whenever the seal is unpenetrated by the medical device.
2 Assignments
0 Petitions
Accused Products
Abstract
A valve (10) useful as a fluid flow check valve or as a self-sealing, penetrable, hemostatic valve for sealing a catheter introducer (12) includes a seal (26) which is highly resistant to tearing and leakage, yet is capable of accepting repeated penetrations by devices of a wide variety of diameters. The seal (26) is disk-shaped and is composed of a thermoplastic styrenic elastomer, such as a styrene-ethylene/butylene-styrene block copolymer, of very low durometer (a hardness of no more than about 30 Shore A). The seal (26) is preferably contained in a valve body (40) and is disposed between a valve seat (48) in the valve body (40) and a cap (56) connected to the valve body (40) and becomes deflected upon assembly of the valve. The seal (26) includes at least one perforation (34) closed by such deflection. This deflection also provides the seal (26) with a proximal or upstream concave surface (30), and this deflection along with the clamping of the periphery of the seal by and between the cap and the valve seat, makes it highly resistant to inversion during repeated removals and manipulations of interventional devices passing through the valve (10). The valve (10) of the present invention is particularly advantageous in that it seals the introducer (12) with a high degree of effectiveness when no interventional device lies across its seal (26), and in that it offers a high resistance to tearing when penetrated by devices of large diameter.
172 Citations
37 Claims
- 1. A valve arrangement for controlling a flow of fluid therethrough, wherein the arrangement comprises a seal to be disposed in the fluid flow, the seal having at least one perforation to permit insertion of a medical device therethrough for fluid flow through the seal, where the perforation is open prior to medical device insertion and when the seal is unstressed prior to assembly of the valve, the seal further comprising a material, and the valve further includes a means for causing portions of the seal inwardly from a periphery thereof to be deflected in a direction farther into the valve in a manner sufficient to close the at least one perforation upon engagement of the means with the seal, whenever the seal is unpenetrated by the medical device.
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10. A valve for a fluid flow path, comprising:
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a seal disposed in the fluid flow path, the seal being composed of a low durometer thermoplastic material having a hardness of no more than about 30 Shore A, and the seal having an undeflected condition in which the seal is shaped generally as a disk and the seal having a first and a second opposed face, the seal further having at least one perforation extending through the seal from the first face to the second face where the perforation is open prior to medical device insertion therethrough and when the seal is unstressed prior to assembly of the valve; and
means disposed about the fluid flow path for deflecting the seal so as to close the at least one perforation upon engagement of the means with the seal whenever the seal axially is unpenetrated by the medical device. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A self-sealing, penetrable, hemostatic valve for an introducer for an interventional device, the interventional device having a proximal end, and the valve including a generally disk-shaped seal receiving and sealing around the periphery of the interventional device when inserted in the introducer,
the generally disk-shaped seal comprising a thermoplastic styrene-ethylene/butylene-styrene block copolymer having a hardness of no more than about 30 Shore A, and wherein the valve includes a body for deflecting the generally disk-shaped seal so as to present a concave face towards the proximal end of the interventional device.
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34. A valve having a fluid flow path therethrough, the valve comprising a perforated elastomeric disk closing the fluid flow path, wherein the disk further comprises a thermoplastic styrene-ethylene/butylene-styrene block copolymer having a hardness of no more than about 30 Shore A;
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the perforated elastomeric disk having an undeflected condition with the perforated elastomeric disk further having an opposed first and a second faces and at least one perforation extending through the perforated elastomeric disk from the first face to the second face, the perforation having sidewalls that in the unstressed condition are spaced apart between the first face and the second face thereby being open prior to both assembly of the valve and insertion of a medical device therethrough; and
means connected to the fluid flow path for deflecting the disk so as to close the at least one perforation in the perforated elastomeric disk axially upon deflection of the seal and prior to medical device insertion therethrough. - View Dependent Claims (35, 36)
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37. A valve defining a fluid flow path therethrough, comprising:
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a seal to be disposed in the fluid flow path, the seal being composed of a very low durometer thermoplastic elastomeric styrene-ethylene/butylene-styrene block copolymer having a hardness of no more than about 30 Shore A, and the seal having an undeflected condition in which the seal is shaped generally as a disk and the seal further having an opposed first and a second faces and at least one perforation extending through the seal from the first face to the second face where the perforation is open prior to medical device insertion therethrough and when the seal is unstressed prior to assembly of the valve; and
means connected to the fluid flow path for deflecting the seal so as to close the at least one perforation in the seal upon engagement of the means with the seal and prior to medical device insertion therethrough;
wherein the deflecting means comprises a valve body defining at least part of the flow path, a valve seat formed in the valve body and a cap engageable with the valve body, a periphery of the seal being compressed and clamped between the cap and the valve seat; and
wherein the cap and the valve seat each include respective annular cap and valve seat flanges facing each other and abutting the first and second faces of the seal, respectively, imparting a concave shape to the first face of the seal;
wherein the first and second faces of the seal define a preferred direction of movement through the at least one perforation, and wherein the deflecting means imparts a concave shape to the first face of the facing opposite the preferred direction of movement through the at least one perforation; and
wherein when the seal is in its unstressed condition, the at least one perforation is open and is wider at the second face of the seal than at the first face of the seal.
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Specification