Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-02-12
2001-11-20
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C623S003260
Reexamination Certificate
active
06319231
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to generally to medical connectors for fluid transport and, more particularly to, connectors for use with implantable medical devices, such as cardiac assist devices.
2. Related Art
Cardiac assist devices are connected to a patient's vascular system to aid in or completely replace the function of pumping blood throughout a patient's body. Development of cardiac assist devices progressed from relatively bulky and intrusive external devices to completely implantable devices. In these devices, a typical connection between vascular tissue and the cardiac assist device includes a connector having a first half sutured onto the vascular tissue and a second half attached to the cardiac assist device. To join the two halves, conventional connectors typically employ a twisting engagement wherein the connector halves must first be aligned then rotated relative to each other.
Certain disadvantages with these twist-type connectors exist. For example, the mating halves may be difficult to align, resulting in a time-consuming and laborious procedure during surgery. In addition, when using an implantable cardiac assist device, the presence of blood and other fluids in the depth of a poorly visible and severely cramped surgical field results in limited maneuverability of a surgeon's hands, thereby increasing the difficulty in firmly grasping and joining the connector halves and subsequently imparting the rotative action. Further, the rotative action required for engagement of the twist-type connector may damage or twist the vascular tissue to which one half of the connector is attached or damaging the surrounding tissue. Another disadvantage with twist-type connectors is that they can come apart.
Another type of connector, such as that disclosed in U.S. Pat. No. 4,650,486, which attempts to alleviate some of the disadvantages with the twist-type connector, includes two cooperating connector halves, one attached to the cardiac assist device and the other attached to the end of the vascular tissue. The connector halves are attached to each other by sliding one half in a plane relative to the other, with the plane being substantially orthogonal to blood flow.
The disadvantage of this approach when using implantable devices is that the sliding action requires much more space than may be available in the cramped surgical field. For example, to slide such a connector half relative to the other necessarily requires that the space that must be available should be about twice the amount of space as compared to the space required for the final connection. A further drawback to this technique is that the tissue surrounding the connector site may get caught between the two connector halves as they slide relative to each other.
SUMMARY OF THE INVENTION
The present invention is a medical connector for connecting vascular tissue to a medical device that overcomes the above and other disadvantages of conventional connectors. The connector includes one half adapted for attachment to the medical device and another half adapted for attachment to the vascular tissue. The two halves cooperate with each other so as to be self-aligning when moved in an axial direction. Further movement in the axial direction causes the two halves to lock together.
In one particular aspect of the invention, a medical connector for connecting vascular tissue to a medical device is disclosed. The connector includes a base connector adapted to be attached to the medical device; and, a vascular tissue connector adapted to be attached to the vascular tissue. The base connector and the vascular tissue connector cooperate with each other so as to cause each connector to axially align relative to each other when initially brought into contact with each other and engage each other when moved in opposite, axially oriented, directions toward each other. Thus, connection can be easily completed without detailed visualization of the connector in the confined space of the surgical field.
In another aspect of the invention, a medical connector for connecting vascular tissue to a medical device is disclosed. The medical connector includes a first connector half having a retaining ring having a rest position and a biased position and a second connector half having a retaining ring groove formed therein. An alignment feature and an engagement feature, each defined by a portion of said connectors and a portion of said retaining ring, causes the first connector to axially self-align with the second connector and causes the retaining ring to move first into the biased position and then to snap into engagement within the retaining ring groove.
In another aspect of the invention, a medical connector for connecting vascular tissue to a medical device is disclosed. The connector includes a base connector, defining an axis, adapted to be attached to the medical device and a vascular tissue connector, also defining an axis, adapted to be attached to the vascular tissue. A retaining ring having a rest position and a biased position is housed within either the vascular tissue connector or the base connector. A retaining ring groove configured to engage with the retaining ring is formed on an outer circumference of the other connector. An alignment feature and an engagement feature each is defined by a portion of either the base connector or the vascular tissue connector and a portion of the retaining ring. The alignment feature causes the vascular tissue connector to axially self-align with the base connector. Thus, alignment can be easily completed without detailed visualization of the connector, making the present invention particularly beneficial in the confined space of the surgical field. The engagement feature causes the retaining ring to move first into the biased position and then to return at least partially toward the unbiased position so as to snap into engagement within the retaining ring groove when the vascular tissue connector attaches to the base connector in an axially oriented motion. The snap-engagement provides immediate tactile feedback to ensure a complete connection.
In one embodiment, the retaining ring includes a beveled edge. The beveled edge defines at least a portion of the alignment feature. Either the base connector or the vascular tissue connector includes a leading edge defining at least a portion of the alignment feature and includes a radiused edge and a chamfered portion conjoined with and extending away from the radiused edge.
In yet another embodiment either the vascular tissue connector or the base connector includes an annular body having an end face. The end face is completely continuous, thereby reducing tissue snagging when the vascular tissue connector is brought into proximity with the base connector. The annular body has an inner and outer surface. The inner surface has an annular groove formed therein for housing the retaining ring. The outer surface has an opening formed therein extending through to the annular groove of the inner surface to allow a portion of the retaining ring through the body so that the retaining ring can be moved to the biased position to facilitate removal of the vascular tissue connector from the base connector. In another embodiment, the base connector and the vascular tissue connector each have a body. Each body has a substantially minimal profile relative to the vascular tissue.
In still another embodiment, a plurality of o-ring seals are disposed at an interface between the base connector and the vascular tissue connector when connected theretogether. The interface defmes an o-ring seal groove for receiving the o-ring seals in a generally co-axial alignment. An o-ring seal may extend past the o-ring seal groove a predetermined distance, which may be defined by about one-half a diameter of the o-ring seal.
In yet another embodiment, the connector includes a plug connector adapted to be connected to the vascular tissue connector to test for leakage between the vascular tissue connector and the vascu
Abiomed, Inc.
Kennedy Sharon
Nutter & McClennen & Fish LLP
Serke Catherine
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