Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-10-23
2001-05-08
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06228063
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to anatomical cavity access conduits and more specifically, to such conduits which include means for attaching and sealing them to an anatomical cavity or vessel wall.
2. Description of the Related Art
Conduits are widely used in medical procedures to gain access to various blood vessels, spaces, cavities, and organs in the human body. Such conduits are used to provide direct, limited access to a desired area in the body in which a medical procedure is to be conducted. Such procedures, known as least invasive procedures, require a small portal to be created through the skin, underlying soft tissue, and the walls of the cavity, space, or organ so that instruments used in a medical procedure may be introduced.
Least invasive procedures offer many advantages over open, major surgical procedures. Such advantages include minimal invasiveness and trauma, reduced hospitalization and rehabilitation times, performance of surgery on an outpatient basis, decreased patient discomfort, enhanced post-surgical and diagnostic mobility and more cosmetically pleasing wounds. In addition to these advantages, conduits themselves serve an important functional role by providing a smooth pathway for instruments used in the medical procedure to be inserted and removed from the portal.
In many least invasive procedures, such as transluminal angioplasty or angiography procedures, portals are formed far and remote from the operating site. Typically, these portals are formed in the skin and underlying soft tissue adjacent to the groin or shoulder which provide access to a relatively large artery, such as the femoral or subclavian arteries which leads to the desired operating site. One reason for accessing a cavity, space or organ through a remote portal, is the inability of the conduit used in the prior art to directly access the sides of the cavity, space or organ. Ideally, the conduit should provide direct access to the operating site with minimal bleeding, minimal contamination, and easy removal.
Structurally, the inside diameter of the conduit must be sufficient so that various instruments can be easily inserted and removed therefrom. Generally, the greater the distance between the operating site and the portal site, the more complex the instrument must be to perform the required surgery. For example, instruments used for cardiac surgery must be placed on the tip of a long catheter that must be snaked to the operating site. In order to do so, a multitude of devices must be used to track and control the catheter along it's path.
Unfortunately, one important size limitation of a conduit is the size of the blood vessel or cavity accessed by the conduit. Generally, the outer diameter of a conduit is limited by the inside diameter of the accessed blood vessel or cavity. Since the inside diameter of the conduit is limited by the conduit's outer diameter, the size and shape of the instruments inserted through the conduit are limited by the inside diameter of the conduit. Due to these size limitations, many instruments cannot be sufficiently miniaturized to be inserted through the conduit.
One important limitation of a conduit in the prior art is that it often falls out or protrudes excessively through the portal during use. Not only is this a great inconvenience to the surgeon, but can also cause damage to the underlying blood vessel or organ or occlude the flow of fluid therethrough. Generally, when inserting a conduit through a portal, it is desirable to dispose the conduit through the portal so that the conduit's distal end is just inside the blood vessel or organ in close proximity to the nearest side wall. Typically, sutures or a clamp is used to hold the conduit in place and prevent either its inward or outward movement through the portal. Unfortunately, these methods often fail. An improved means for securely attaching the conduit to the side walls of the portal, blood vessel or organ to prevent migration of the conduit through the portal is therefore needed.
SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide a conduit that provides a seal around the portal to maintain adequate hemostasis and minimal contamination during use.
It is another object of the present invention to provide such a conduit that can be easily and properly inserted into a desired blood vessel or cavity without occluding the blood vessel or cavity.
It is a further object of the invention to provide such a conduit that can be temporarily attached to the side walls of portal to prevent the inward and outward migration of the conduit through the portal during use.
These and other objects of the invention which will become apparent are met by providing a sealing conduit which includes an elongated cylindrical member designed to be inserted through a portal of minimal size formed in anatomical tissue. The cylindrical member is opened at its opposite distal and proximal ends and has an elongated penetrating member disposed therein designed to move longitudinally inside the cylindrical member during use. The cylindrical member has a conical-shaped housing attached at its proximal end which acts as a handling implement for inserting and removing the sealing conduit from the portal. Located inside the housing is an optional valve assembly which selectively closes the upper end of the cylindrical member to prevent contaminates from outside the body from entering the portal during use. The size of the valve assembly can be adjusted to accommodate different size instruments inserted through the sealing conduit.
Attached or integrally formed on the inside surface, near the distal end of the cylindrical member is a flexible, annular lip structure. During assembly, the annular lip structure is folded into a retracted position inside the cylindrical member. When the cylindrical member is properly positioned through the portal, the outer edge of the annular lip structure is forcibly moved through the distal end of the cylindrical member thereby enabling the annular lip structure to unfold into an extended position from the distal end of the cylindrical member, as discussed below.
Disposed longitudinally inside the cylindrical member, is a penetrating member which is used to provide support and plug the cylindrical member when the cylindrical member is initially inserted into a blood vessel or cavity, and to facilitate the penetration of the conduit through the portal and underlying tissue or vessels. The penetrating member can also be used to force the annular lip structure through the distal end of the cylindrical member. In one embodiment shown and described below, the penetrating member has a relieved section in which the folded portion of the annular lip structure resides when the penetrating member is initially disposed into the cylindrical member. When the penetrating member is moved longitudinally downward inside the cylindrical member, the relieved section moves downward inside the cylindrical member thereby forcing the outer edge of the annular lip structure through the distal opening of the cylindrical member. When the annular lip structure is extended from the distal end of the cylindrical member, it automatically unfolds and extends outward from the cylindrical member. The location of the annular lip structure near the distal end of the cylindrical member positions the conduit immediately against the inside surface of the blood vessel or cavity so that fluid flowing through the blood vessel or cavity is not occluded. The annular lip structure is also sufficiently flexible so that when the cylindrical member is pulled outward through the portal when removing the sealing conduit therefrom, the annular lip structure bends inward.
When the sealing conduit is properly positioned through the portal and the annular lip structure is extended from the cylindrical member, a moving means is used to forcibly position the upper surface of the annular lip structure against the inside surface of the surrounding tissue located imm
A-Med Systems, Inc.
Kennedy Sharon
Serke Catherine
Spangler Jonathan
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