Syringe activated-valve for flushing a catheter and methods thereof

This invention relates to a syringe-activated valve for flushing a catheter for delivering an implant to an anatomical site, such as a patent foramen ovale in a patient and method thereof. In one embodiment, a catheter includes a proximal end, a distal end, a “Y” connector at the proximal end, the “Y” connector having a guide wire port and a connector port, a syringe activated valve having a first end and a second end, the second end of syringe-activated valve connecting to the connector port of the “Y” connector, and a syringe connecting to the first end of the syringe-activated valve. Saline is injected by the syringe through the syringe-activated valve into the proximal end of the catheter, thereby flushing air from the catheter lumen out of the distal end of the catheter.

FIELD OF INVENTION

The invention relates to a delivery system including an intravascular catheter and a syringe activated valve for delivering an implant, a method of flushing an intravascular delivery catheter, and specifically to the use of a syringe activated valve in flushing air bubbles out of the delivery catheter.

BACKGROUND OF THE INVENTION

An intravascular catheter is typically used to introduce an implant, e.g., an intracardiac occluder, into a patient's body. Generally, an intravascular catheter is an elongate tube having an elongate lumen extending from the proximal to the distal end of the catheter. Before a delivery catheter is introduced into the patient's body, air trapped in the catheter must be removed. To do so, doctors typically inject saline to flush the catheter. Most commonly, saline is introduced by a syringe into the delivery catheter at its proximal end, and saline is flushed out of the distal end of the catheter. As the saline passes from proximal to distal through the catheter, the air bubbles are flushed from the catheter lumen and pushed out of the distal end of the catheter.

A catheter flushing port is usually an integrated part of the delivery catheter. The flushing port is typically one port of a Y-shaped connector at the proximal end of the delivery catheter. A typical catheter flushing mechanism includes a syringe for introducing saline, and a three-way stopcock for connecting the syringe to the flushing port of the “Y” connector thereby creating a liquid flow-path from the proximal end to the distal end of the catheter for the saline. A second port of the “Y” connector allows a delivery wire such as a guide wire to slide through the catheter.

FIG. 1illustrates a typical form of a catheter flushing system10known to the prior art. It is used to remove air trapped in the catheter before the catheter is introduced into a patient's body. In this form, a delivery wire302slides through the guide wire port308of a “Y” connector320. A syringe200for introducing saline is connected by a three-way stopcock306to the connector port310of the “Y” connector320. The three-way stopcock306opens to create a liquid flow-path for the saline. Connections between the syringe304and the three-way stopcock306and between the three-way stopcock306and the “Y” connector320are standard luer locks. To flush the catheter, the three-way stopcock306is manually switched to open the flow path for saline between the syringe200and the connector port of the “Y” connector320. The operation of the stopcock requires that the clinician hold the syringe, actuate the three-way stopcock to open the flow path and inject the saline to remove air in the delivery catheter. The clinician must then close the stopcock, remove the syringe and introduce the catheter into the patient, e.g., into the femoral artery. As a result, the simple act of flushing the delivery catheter is technically difficult.

The present invention addresses this difficulty.

SUMMARY OF THE INVENTION

In one aspect, this invention relates to a delivery system for delivering an implant such as a septal occluder to an anatomical site, for example, a patent foramen ovale (PFO) in a patient's body. The delivery system includes an intravascular catheter having a connector, a syringe activated valve joined to the connector and a port for introducing the implant into the intravascular catheter for delivery to the anatomical site in the patient. In one embodiment according to the invention, the syringe-activated valve is permanently and irreversibly joined to the connector.

In one embodiment of the invention the syringe-activated valve is permanently joined to a Y-connector. The syringe-activated valve may be a slit-type, compression, or stopper valve, for example.

In one embodiment of the invention, the syringe-activated valve has a valve housing including a proximal end, a distal end, and an axial bore including a proximal cylindrical bore, a distal cylindrical bore, and a shoulder positioned between the proximal cylindrical bore and the distal cylindrical bore. In a particular embodiment, the syringe-activated valve further includes a sealing member enclosed by the valve housing. The sealing member is slideably and axially disposed in the axial bore and is compressible between a relaxed state and a compressed state. As the sealing member is compressed the valve transitions between an open position and a closed position.

The sealing member includes a proximal portion, a distal portion, and an intermediate portion. The intermediate portion of the sealing member has a shoulder that interfaces with and cooperates with the shoulder of the valve housing when the valve is in the closed position. In one embodiment, the syringe-activated valve further features a backstop positioned in the distal bore of the valve housing distal to the distal portion of the sealing member and proximal to the distal end of the valve housing, wherein the sealing member occludes the axial bore in the closed position and opens the axial bore in the open position.

In one embodiment of the invention, the backstop is disc shaped and has at least one perforation that extends from the proximal face through the distal face of the backstop. Alternatively, the backstop has at least one gap positioned between the backstop and the wall of the distal axial bore. In yet another embodiment of the invention, the backstop may have a combination of one or more perforations and one or more gaps.

The backstop may feature one or more projections on the proximal face. In one embodiment, the backstop features a cross-shaped projection that extends proximally from the proximal face.

In another aspect, the invention relates to a method for flushing a catheter for delivery of an implant to an anatomical site in a patient. The delivery catheter may be used to deliver, for example, an intracardiac occluder to seal, for example, a patent foramen ovale (PFO) in a patient. In one embodiment, a catheter is provided, including a lumen, a proximal end, a distal end, a “Y” connector at the proximal end, the “Y” connector comprising a connector port and a guide wire port, and a syringe-activated valve comprising a first end and a second end, the second end of the syringe-activated valve connected to the connector port of the “Y” connector. Saline is injected by the syringe through the syringe-activated valve at the connector port into the proximal end of the catheter, thereby flushing air from the catheter lumen out of the distal end of the catheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention will be more completely understood through the following detailed description, which should be read in conjunction with the attached drawings. In this description, like numbers refer to similar elements within various embodiments of the present invention. Within this detailed description, the claimed invention will be explained with respect to preferred embodiments. However, the skilled artisan will readily appreciate that the methods and systems described herein are merely exemplary and that variations can be made without departing from the spirit and scope of the invention.

Specific embodiments of a syringe-activated valve100including, for example, a slit-type valve100, a compression valve100′, and a stopper valve100′ and methods of their use for percutaneous transvascular delivery of an implant to an anatomical site in a patient's body according to the invention are described below

As used herein, the term proximal means closer to the operator while the term distal means further away from the operator than proximal.

As used herein, the term syringe-activated means the engagement and disengagement of a syringe with the valve to reversibly activate the valve from a closed valve position in which a fluid or a gas can not cross the valve, to an open valve position in which a fluid or a gas can cross the valve.

In one aspect, the invention relates to a valve used with an intravascular catheter that delivers an implant to an anatomical site in a patient's body. For example, the valve and intravascular catheter may be used to deliver an intracardiac septal occluder via a percutaneous, transvascular route to a patent foramen ovale in a patient's body.

FIG. 2illustrates a valve100used in an embodiment of the present invention. The exemplary valve100is a slit-type valve including a housing101defining a central axial bore102, and having a first open end104and a second open end106. The first open end104is designed to receive the tip250of a syringe200discussed below in greater detail with respect toFIG. 3. In one embodiment of the slit-type valve100, the first open end104has, for example, a female luer lock connector108that mates with and locks on to a corresponding male luer connector202of the syringe tip250discussed below with respect toFIG. 3. The second open end106of the slit-type valve100connects with a connecting member (not shown) such as a female connector, or a male connector at the proximal end of a fluid line of the delivery catheter300.

With continued reference toFIG. 2, the valve housing101encloses a substantially cylindrical sealing member110constructed of silicone or some other resilient elastomeric material such as, for example, rubber. Alternatively, the sealing member110has another shape such as a ring, or a partial ring, for example. In another embodiment according to the invention, the sealing member110is activated by a spring mechanism located between the member and the valve housing101. The sealing member110forms a central axial fluid passageway114extending from a first open end104to a second open end106. The proximal end150of the sealing member110includes a slit112. The slit112extends entirely through the proximal end150of the sealing member110from the first open end104into the passageway114. The slit112in its relaxed, uncompressed position is closed thereby preventing passage of fluid or gas from the outside of the valve100into the passageway114. The distal end152of the sealing member110terminates, in one embodiment, at a flat end116of the inner wall of the housing101aligned substantially perpendicular to the long axis of the passageway114. The distal end152of the sealing member110has an opening118in fluid communication with the lumen of the catheter300. In one embodiment, the proximal end of the catheter300is joined via a Y-connector, or alternatively, directly to the housing101of the valve100by a friction fit joint, luer lock, adhesive, or other mechanisms known in the art for joining a catheter to a valve. The opening118at the second end of the sealing member110aligns the passageway114of the valve body with the lumen of the catheter300providing a fluid flow path between the fluid passageway114in the sealing member110and the lumen of the delivery catheter300.

FIG. 3illustrates a change in the shape of the sealing member110of the valve100when the first open end104of the valve100is engaged by, for example, the luer connector202of the syringe200. The sealing member110functions as a seal around the tip250of the syringe200. As the tip250of the syringe200is introduced into the proximal end150of the sealing member110, the otherwise closed slit112at the proximal end150of the sealing member110parts thereby opening a fluid communication from the lumen of the syringe200to the passageway114inside the sealing member110. The open fluid communication permits a liquid, for example, saline, to flow from the syringe200through the valve100to the lumen of the delivery catheter300connected to the distal end of the valve106. When the syringe200is disengaged from the valve100, the slit112of the sealing member110returns to its relaxed closed position thereby sealing the passageway114at the first open end104of the valve100. In other words, the closed slit112prevents fluid or gas from moving across the first open end104of the valve100from the passageway114to outside of the valve100and in the reverse direction from outside of the valve100into the passageway114.

FIG. 4illustrates yet another valve according to an embodiment of the invention. The exemplary valve100′ is a compression valve including a housing101defining a central axial bore102(best viewed inFIG. 5), and having a first open end104and a second open end106. The first open end104is designed to receive the tip250of a syringe200discussed below in greater detail with respect toFIG. 5. In one embodiment of the compression valve100′, the first open end104has, for example, a female luer lock connector108that mates with and locks on to a corresponding male luer connector202discussed below with respect toFIG. 5of the syringe tip250. The second open end106of the compression valve100′ connects directly to or alternatively via a connecting member (not shown) at the proximal end of a fluid line of the delivery catheter300.

With continued reference toFIG. 4, the valve housing101encloses a substantially elongated cylindrical sealing member110′ constructed of silicone or some other resilient elastomeric material such as, for example, rubber. The sealing member110′ forms a central axial fluid passageway114extending from a first open end104to a second open end106. The central axial fluid passageway114is biased to a closed position when the resilient sealing member110′ is in a relaxed, uncompressed state as further described below.

Referring still toFIG. 4, the sealing member110′ in its relaxed, uncompressed state occludes the passageway114thereby preventing passage of fluid or gas from the outside of the valve100into the passageway114. The distal end152of the sealing member110′ terminates, in one embodiment, at a flat end116of the inner wall of the housing101aligned substantially perpendicular to the long axis of the passageway114. The distal end152of the sealing member110′ has an opening118in fluid communication with the lumen of the catheter300. The proximal end of the catheter300is joined by a connector (not shown) or alternatively directly to the housing101of the valve100by a friction fit joint, luer lock, adhesive, or other mechanisms known in the art for joining a catheter to a valve. The opening118at the second end of the sealing member110′ aligns the passageway114of the valve body with the lumen of the catheter300providing a fluid flow path between the fluid passageway114in the sealing member110′ and the lumen of the delivery catheter300.

FIG. 5illustrates a change in the shape of the sealing member110′ of the compression valve100when the first open end104of the valve100is engaged by, for example, the luer connector202of the syringe200. The sealing member110′ functions as a seal around the tip250of the syringe200. As the tip250of the syringe200is introduced into the proximal end150of the sealing member110′, the otherwise relaxed conformation of the elongated sealing member110′ at the proximal end150of the sealing member110′ is compressed causing the sealing member110′ to be compressed against the inner wall of the valve housing101. As the sealing member110′ is compressed the passageway114opens, as illustrated inFIG. 5, thereby introducing a fluid communication from the lumen of the syringe200to the passageway114inside the compressed sealing member110′. The open fluid communication permits a gas, or liquid, for example, saline, to flow from the syringe200through the valve100′ to the lumen of the delivery catheter300connected to the distal end106of the valve. When the syringe200is disengaged from the valve100′, the sealing member110′ returns to its relaxed closed position thereby sealing the passageway114of the valve100.

FIG. 6illustrates yet another valve according to an embodiment of the invention. The valve100″ is a stopper valve including a housing101″. The housing101″ defines a central axial bore102having a first open end104and a second open end106. The central axial bore102of the valve housing101″ includes a proximal cylindrical portion201and a distal cylindrical portion202. In one embodiment according to the invention, the diameter of the proximal cylindrical portion201is narrower than the diameter of the distal cylindrical portion202. The proximal cylindrical portion201and the distal cylindrical portion202of the central axial bore102interface at a shoulder204having a slope. In one embodiment, the shoulder204extends around the circumference of the valve housing110″ where the proximal cylindrical bore201and the distal cylindrical bore202interface as illustrated inFIG. 6.

With continued reference toFIG. 6, the first open end104receives the tip250of a syringe200discussed below in greater detail with respect toFIG. 8. In one embodiment of the stopper valve100″, the first open end104has, for example, a female luer lock connector (not shown) that mates with and locks on to a corresponding male luer connector202(not shown) discussed below with respect to the syringe tip illustrated inFIG. 8. The second open end106of the stopper valve100″ connects with a connecting member (not shown) at the proximal end of a fluid line of the delivery catheter300or, alternatively, directly to the fluid line of the catheter300.

With continued reference toFIG. 6, the valve housing101″ encloses a sealing member110″ constructed of silicone or some other resilient elastomeric material such as, for example, rubber. The sealing member110″ is shaped much like a bottle stopper and is axially and slideably moveable in the central axial bore102of the valve100″. The sealing member110″ includes a substantially cylindrical proximal portion206, a substantially cylindrical distal portion208and an intermediate portion210that is positioned between and joins the proximal portion206of the sealing member110″ to the distal portion208of the sealing member110″. The intermediate portion210forms a sealing member shoulder214which corresponds to and cooperates with the slope of the shoulder204of the valve housing101″.

In one embodiment of the sealing member110″, one or more of the proximal portion206, intermediate portion210and distal portion208are hollow. In another embodiment of the invention, one or more of the proximal portion206and the distal portion208includes at least one slit (not shown) paralleling the long axis of the sealing member110″. The at least one slit may extend along a portion of or, alternatively, the entire length of the proximal portion206or the distal portion208of the sealing member110″. In one embodiment, one or more slits extend the entire length of the proximal206or distal portion208while at least one other slit extends along only a portion of the proximal206or distal portion208of the sealing member.

With continued reference toFIG. 6, the stopper valve100″ further includes a sealing member backstop212. The backstop212is located in the distal cylindrical portion202of the axial bore102distal to the distal portion208of the sealing member110″ and proximal to the distal end106of the valve100″. In one embodiment, the backstop212is made from materials that are stiffer, i.e., less resilient than the materials that are used to make the sealing member110″. For example, the backstop212is made from materials such as polyethylene, or polypropylene, for example. In an alternative embodiment, the backstop212is made from the same materials as the sealing member110″.

Referring toFIG. 7, in one embodiment the backstop212is substantially disc shaped and includes a proximal face222and a distal face224. Typically, the disc backstop212has the same diameter as the distal portion208of the sealing member110″. Alternatively, the width of the backstop212is narrower than the diameter of the distal portion208of the sealing member110″. In one embodiment of the invention, the backstop212includes at least one projection218, for example, a cross shaped projection218, illustrated inFIG. 7, extending outwardly from at least one of the proximal and distal face of the backstop212. Alternatively, the at least one projection is cone shaped, rectangular, cylindrical, or pyramidal, for example. In one embodiment, one or more projections on the backstop is in alignment with one or more slits in the sealing member. With this alignment, the sealing member more readily compresses from proximal to distal. The backstop212further includes one or more perforations (not shown) through the backstop212from the proximal to the distal face and or one or more gaps (not shown) between the inner wall of the valve housing101″ and the backstop212to permit fluid communication between the distal cylindrical bore202that is proximal to the backstop212and the distal cylindrical bore202that is distal to the backstop212.

Referring still toFIG. 7, the shoulder214of the sealing member110″ in its relaxed, uncompressed state interfaces with the shoulder204of the valve housing101″ thereby occluding the fluid passageway114much like a stopper inserted into the neck of a bottle.

Referring now toFIG. 8, as a syringe200is inserted into the proximal cylindrical portion201of the central axial bore102, the tip250of the syringe200abuts the proximal end218of the proximal cylindrical portion206of the sealing member110″. As the syringe is advanced distally in the direction of arrow216, the distal end of the distal cylindrical portion208of the sealing member110″ is compressed against the proximal face222of the backstop212. Simultaneously, the shoulder214of the intermediate portion210moves distally away from the shoulder204of the valve housing101″ leaving a gap220between the shoulder214of the intermediate portion210of the sealing member110″ and the shoulder204of the valve housing101″. With the sealing member110″ in the “gapped”, i.e., open position, the passageway114is opened, as illustrated inFIG. 8, thereby introducing a fluid communication from the lumen of the syringe200through the proximal cylindrical bore201, the gap220, the distal cylindrical bore202, and around or through the backstop212. The open fluid communication permits a liquid, for example, saline, to flow from the syringe200through the valve100″ to the lumen of the delivery catheter300connected to the distal end of the valve106. When the syringe200is disengaged from the valve100″, the sealing member110″ returns to its relaxed closed position in which the shoulder of the sealing member110″ interfaces with and cooperates with the shoulder of the valve housing101″ thereby sealing the passageway114of the valve100″.

FIG. 9illustrates a delivery system400for delivering an implant to a patient including an intravascular delivery catheter300. According to one embodiment of the invention, the catheter300includes a connector, for example, a “Y” shaped connector320. The connector320has a first connector port310for the syringe200and a second port for wire302. The delivery system400also includes a syringe activated valve100of one of the valve types shown inFIGS. 2-8and described above in the corresponding text. In one embodiment of the invention, the tip204of the syringe200is inserted into the first open end104of the valve100and secured with a standard luer lock as described above. In other embodiments, the valve is used in connection with other connector and other catheter types.

With continued reference toFIG. 9, if, in addition to injecting saline to remove air in the catheter300, blood must be removed from the catheter lumen, a second syringe can be attached to the valve upon disconnecting the first syringe200. Since the valve100automatically closes when the syringe200is removed, no air can enter into the catheter during the switch over from the first syringe to the second syringe. Operator errors are less likely to occur when utilizing the value described herein to flush an intravascular catheter compared to prior art devices, e.g., a three-way stopcock.

With continued reference toFIG. 9, as saline introduced under pressure from the syringe200by the operator through the passageway114in the valve100, according to the invention described herein, into the delivery catheter300, the air that is trapped in the catheter300is flushed from the distal end of the catheter. The syringe200can then be removed.

According to one embodiment of the invention, the valve100, according to the invention described herein, is an integral part, i.e., manufactured as one piece with the connector or otherwise permanently joined as part of the delivery system400. Alternatively, an existing delivery catheter can be retrofitted to replace prior art valves such as a three-way stopcock306with the valve100according to the invention. As a result, instead of manually opening the stopcock306to allow saline to pass through, a passageway is automatically opened up as the syringe200is attached to the valve100.