Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2001-08-15
2004-06-08
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S158000, C606S151000
Reexamination Certificate
active
06746461
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to occlusive medical devices and, in particular, to a clamp which takes advantage of the shape-memory effect to at least temporarily occlude body lumens such as such as blood vessels, bowel, esophagus, stomach, small intestine, colon, and bile ducts.
BACKGROUND OF THE INVENTION
Shape-memory alloys (SMAs) are interesting materials which have the ability to change shape in response to changes in temperature. This ability to “remember” specific shapes corresponds to particular metallurgical phases. If deformed, a SMA can be heated or cooled to invoke a phase transformation which, in turn, induces a change in shape.
Most often, SMAs return to a predetermined shape when heated. When an SMA is cold, or below its transformation temperature, it may be deformed into various shapes and it will retain these shapes. However, when the material is heated above its transformation temperature it undergoes a change in crystal structure which causes it to return to its original shape. If the SMA encounters any resistance during this transformation, it can generate extremely large forces. This phenomenon provides a unique mechanism for remote actuation. For example, shape memory alloys have the ability to act as substitutes for muscle in robotic applications by shortening at a predetermined temperature or electrical current. When cooled, the shape memory metal can then be stretched back out to its initial length.
The most common shape-memory material is an alloy of nickel and titanium called Nitinol. This particular alloy has very good electrical and mechanical properties, long fatigue life, and high corrosion resistance. Above the transition temperature, or transition temperature range, the predominant metallurgical phase of Nitinol is termed austenite. Below the transition, the predominant phase is termed martensite.
The transformation temperatures of SMAs are typically discussed with reference to M
s
and M
f
, the martensitic start and finish temperatures, respectively, and A
s
and A
f
, the austenitic start and finish temperatures, respectively. The transformation between these phases is reversible, such that when alloys are deformed into some first configuration while in the austenitic state, cooled into a martensitic state, deformed into a second configuration, and then re-heated to the austenitic state, the alloy will revert back to the first configuration by virtue of the martensite-to-austenite phase transformation.
Certain SMAs, including Nitinol alloys, also exhibit the ability to form stress-induced martensite as opposed to thermally-induced martensite. In such alloys, the reversible transformation between martensite and austenite occurs by the application and removal of stress rather than heat. These materials are characterized by a temperature M
d
which is greater than A
s
and represents the maximum temperature at which stress-induced martensite can form. By deforming these alloys at a temperature between A
s
and M
d
, the alloy transforms from its austenitic phase to a stress-induced martensitic phase. Upon release of the stress within this temperature range, the alloy reverts back to its austenitic phase and unstressed configuration. The property of Nitinol which allows it to be deformed in its austenitic state so to cause a transformation to stress-induced martensite that is transformed back to austenite by the release of stress is often termed “pseudoelasticity.” Strains of 8% or more are obtained in pseudoelastic Nitinol, thus making this material useful for a wide range of applications where a large amount of recoverable deformation is required.
Over the years, shape memory alloys have been applied to various mechanical devices, including pipe fittings (U.S. Pat. Nos. 4,035,007 and 4,198,081 to Harrison and Jervis), electrical connectors (U.S. Pat. No. 3,740,839 to Otte and Fischer), and switches (U.S. Pat. No. 4,205,293). SMAs have also been used in the medical field. For example, U.S. Pat. No. 3,620,212 to Fannon et al. proposes the use of an SMA intrauterine contraceptive device; U.S. Pat. No. 3,786,806 to Johnson et al. discloses an SMA bone plate, and U.S. Pat. No. 3,890,977 to Wilson proposes the use of an SMA element to bend a catheter or cannula. A useful background is provided in U.S. Pat. No. 4,665,906, which describes medical devices that make use of pseudoelastic Nitinol. In the devices described, austenitic nitinol is deformed to form stress-induced martensite, which is held in its deformed configuration by a restraining member. In this condition, the device is introduced into the body, where it is removed from the restraining member to return to its austenitic state and configuration.
U.S. Pat. No. 4,485,816 discloses the use of a shape memory surgical staple for use in holding the edges of a wound together while it heals. U.S. Pat. No. 5,002,563, discloses the use of shape memory sutures. U.S. Pat. No. 6,001,110 and PCT Publication No. WO 96/16603 describe the use of shape memory materials to address the problem of gastrointestinal bleeding. The '110 patent in particular teaches the use of clips having pseudoelastic properties at body temperature which are used to cause hemostatis of blood vessels located along the gastrointestinal tract. Using pseudoelastic properties found in materials such as Nitinol, the clips are shaped into a first configuration that is useful for ligating blood vessels, deformed to a second configuration to facilitate placement to a desired location within the body, and released from its deformed configuration to allow a spontaneous reversion towards the first configuration.
U.S. Pat. No. 6,193,732 describes a surgical clip made from a metal material which allows the device to be forced into a final shape and then heat treated. Preferably, a shape memory alloy such as Nitinol is used. In that case, the intermediate shape is placed into and held in the desired final condition, and heat treated in that constrained condition at an elevated temperature. After heat treating, the clip is preferably quenched with water or other suitable fluid. According to one embodiment, the clip is manipulated to an open position and locked in place by a secondary member, such as pin. The clip may be opened, for example, by placing the clip in a fixture and forcing the clamp arms open using an angled wedge or other suitable tool. When the clip is constructed of a material having shape memory characteristics, the clamp arms may be completely or partially opened by cooling the surgical clip to a temperature below the transition temperature of the shape-memory alloy. Once opened, the pin is placed between the clamp arms, preferably at or near the apex of the included angle formed by the respective inner clamp surfaces or regions of clamp arms. The pin may be of any convenient cross-sectional shape having an outer dimension sufficient to hold the clamp members in an open condition with a desired operative distal opening.
U.S. Pat. No. 6,096,052 describes a device for occluding a body lumen and, in particular, a contraceptive or sterilization device for occluding a reproductive tract or lumen to prevent the passage of reproductive cells through the tract or lumen. The device generally comprises a tubular member and a mesh member, transversely disposed on the tubular member lumen. The mesh member is permeable to allow for tissue ingrowth, which produces a tissue impregnated mesh occluding the body lumen. The occluding device of the invention can be used in the fallopian tubes of a female patient, the vas deferens of a male patient, or other body lumen. The tubular member is formed from metals such as stainless steel, superelastic or shape memory material such as a nickel-titanium (NiTi) alloy such as Nitinol, platinum, tantalum, gold, or rigid or semirigid biocompatible plastics. In a preferred embodiment, the tubular member is a superelastic material, providing a controlled force on the body lumen during expansion of the tubular member.
Substantially spherical occlusive devices for inserting into b
Gifford Krass Groh Sprinkle Anderson & Citkowski PC
Milano Michael J.
Pantuck Bradford C
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