Surgery – Instruments – Means for concretion removal
Reexamination Certificate
1999-12-29
2001-10-16
Smith, Jeffrey A. (Department: 3732)
Surgery
Instruments
Means for concretion removal
Reexamination Certificate
active
06302895
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to baskets for retrieving material from within a body. More particularly, the invention relates to medical retrieval baskets that have atraumatic distal ends that are contoured or tipless both to minimize the chances of damage to tissue during use and to enhance the ability of the basket to capture material (e.g., stones) disposed or lodged in “pockets” or other areas that are difficult to access in the body.
BACKGROUND INFORMATION
Known stone retrieval devices typically have baskets that are constructed by joining multiple legs together at a base of the basket and at a distal end or tip of the basket such that a “cage” is formed. At the distal tip, the individual legs are joined by soldering, adhesives, etc. such that a protruding tip results. This protrusion or outward projection at the distal end of the basket can poke tissue and cause tissue trauma. In general, the tips or ends of known baskets protrude outward and thus can cause damage by poking or piercing tissue. Also, the protruding tips of known baskets generally do not permit access to or intimate contact with certain areas within the body such as “pockets,” and thus stones residing in such areas are difficult or impossible to retrieve with known baskets.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a retrieval device that does not have a substantially protruding distal basket end or basket tip. That is, a basket according to the invention is substantially atraumatic and does not have any significant distal protrusion or outward projection that can poke tissue, pierce tissue, or otherwise cause trauma to tissue or inhibit or hinder capturing of material.
It is yet another object of the invention to provide a method of using such baskets to retrieve material from within a body. The material can be biological or foreign matter. The material can be, for example, urological stones or any of a variety of any other types of material within a body.
It is another object of the invention to provide a medical device that permits access to and/or intimate contact with certain areas of the body such as pockets where material to be retrieved (e.g. stones) might reside or be lodged, impacted, or embedded. A tipless or contoured basket arrangement can access these areas and retrieve material from those areas whereas a conventional basket with a traumatic tip would not be able to do so because of the protruding tip that prevents intimate contact between the distal end of the basket and body tissue.
A medical device according to the invention is used to treat an internal organ which includes a material such as a calculus or a thromboembolus. The medical retrieval device typically includes an elongated member, a handle, a sheath, and a basket. The elongated member extends within a sheath along an axis from a proximal end to a distal end. The elongated member and the sheath are sized for insertion into a body. The handle is located at the proximal end of the elongated member and the sheath. The basket is positioned at the distal end of the elongated member opposite to the handle. The basket may be withdrawn into or extended from the distal end of the sheath by moving the basket relative to the sheath via an actuating mechanism on or near the handle. Thus, the basket is moveable between a collapsed position, where the basket is enclosed within the sheath, and an extended or opened position, where the basket is extended from and out of the distal end of the sheath.
In one aspect, the invention relates to a medical device comprising a plurality of legs forming a basket. A tip, at a distal end of the basket, comprises two or more legs entwined together. A basket tip, according to the invention, is atraumatic, i.e., substantially devoid of points or protrusions that might otherwise poke or cause injury to tissue.
Embodiments of this aspect of the invention can include the following features. For example, the basket of the device can have three or more legs. Also, the legs of the basket can be formed from a single wire or a plurality of wires. The device can have an elongated member extending from a proximal end of the basket. The elongated member and the basket legs can be formed from a single (common) wire. The tip of the basket can be formed by entwining the basket legs. Entwining the legs can be accomplished in similar ways such as by braiding or twisting the legs together. Alternatively, the legs can be coupled together at the tip by knotting, looping or weaving. A portion of a basket tip, according to the invention, is atraumatic, i.e., devoid of points or protrusions that might otherwise poke or cause injury to tissue, and it enhances the ability of the basket to capture material located in difficult to access areas of the body.
In another aspect, the invention relates to a medical device comprising a distal end portion and a plurality of legs extending proximally from the distal end portion. The distal end portion and the plurality of legs are formed integrally from a single twisted wire.
Embodiments of this aspect of the invention can include the following features. For example, at least a portion of one of the legs can be braided. The legs can be formed from at least one twisted wire. The plurality of legs can be twisted together at the distal basket end portion to form an atraumatic basket. At least one of the legs can be braided.
In yet another aspect, the invention relates to a medical device comprising a distal end portion and a plurality of pairs of basket legs extending proximally from the distal end portion. Each of the pairs of baskets legs can be formed from a single twisted wire. The distal end portion can be formed by coupling together the pairs of basket legs.
Embodiments of this aspect of the invention can include the following features. For example, the legs can be formed of metal, or polymers, or any other suitable material such as a composite material. The legs can be joined at a basket base to other legs and/or affixed to an elongated member. The legs can be joined at the base by crimping, twisting, soldering, gluing, welding, or by other means known to one skilled in the art.
Methods of making and using such devices are also part of the invention. One method of making a device is to introduce a plurality of crimps along the length of a wire. The wire is then subjected to tension and twisted to cause a length of the wire to twist on itself thereby forming a braided leg. A number of legs can be made from the single length of wire. One or more wires can be inserted between the twists of a braided leg to form additional legs of the basket. The inserted wire can be twisted, as described above, to form one or more additional braided legs.
One method of retrieving material from a body using such devices includes inserting the device into a body and capturing the material with the device. The device is then withdrawn from the body to remove the captured material from the body.
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Copy of
Carpenter Tina M.
Gobron Stephane
Que Like
Ward Tim E.
White William Curtis
Sci-Med Life Systems, Inc.
Smith Jeffrey A.
Testa Hurwitz & Thibeault LLP
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