Surgical fastening clip formed of a shape memory alloy, a method of making such a clip and a method of using such a clip
First Claim
1. A surgical fastening clip, comprising:
- a substantially U-shaped member of a shape memory alloy having a martensite transformation temperature below which the alloy transforms to its martensitic state and an austenite transformation temperature above which the alloy transforms to its austenitic state;
the clip being deformable in its martensitic state from a closed configuration to an open configuration and recovering to the closed configuration when heated to transform the alloy to its austenitic state; and
the clip being in the open configuration and capable of being deformed to the closed configuration in its martensitic state so as to apply a first clamping force on an object and so as to apply a second clamping force on the object when the alloy is heated to transform it to its austenitic state, the second clamping force being greater than the first clamping force, the clip including first and second opposing legs joined together at one end thereof, the legs having free ends at the other end thereof, the clip including means for applying a clamping force in a longitudinal direction parallel to the first and second legs when the clip is in the closed configuration and the clip transforms to its austenitic state, the clamping force in the longitudinal direction being provided by shrinkage in the longitudinal direction of at least one of the legs of the clip when the clip transforms to its austenitic state.
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Abstract
A surgical fastening clip of a shape memory alloy which applies a first clamping force to a site when the alloy is in its martensitic condition and a second clamping force to the site when the alloy heats due to surrounding tissue such that the alloy transforms to its austenitic condition. The second clamping force is greater than the first clamping force and prevents the clip from slipping or falling off the clamped site due to shrinkage or movement of the site. For instance, the site could be a blood vessel which becomes thinner due to the compressive force of the clip and shrinks, but the clip maintains a clamping force on the blood vessel due to the shape memory effect of the alloy. A method of using a surgical fastening clip formed of a shape memory alloy by placing opposed legs of the clip around a site, deforming the legs to a closed configuration and heating the clip by the natural surroundings to cause further closing of the legs and thereby increasing the clamping force. A method of making a clip formed of a shape memory alloy by deforming the clip to a closed configuration, heating to the austenitic state, setting the memory of the alloy, cooling to the martensitic state, and deforming the clip to an open configuration.
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Citations
28 Claims
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1. A surgical fastening clip, comprising:
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a substantially U-shaped member of a shape memory alloy having a martensite transformation temperature below which the alloy transforms to its martensitic state and an austenite transformation temperature above which the alloy transforms to its austenitic state; the clip being deformable in its martensitic state from a closed configuration to an open configuration and recovering to the closed configuration when heated to transform the alloy to its austenitic state; and the clip being in the open configuration and capable of being deformed to the closed configuration in its martensitic state so as to apply a first clamping force on an object and so as to apply a second clamping force on the object when the alloy is heated to transform it to its austenitic state, the second clamping force being greater than the first clamping force, the clip including first and second opposing legs joined together at one end thereof, the legs having free ends at the other end thereof, the clip including means for applying a clamping force in a longitudinal direction parallel to the first and second legs when the clip is in the closed configuration and the clip transforms to its austenitic state, the clamping force in the longitudinal direction being provided by shrinkage in the longitudinal direction of at least one of the legs of the clip when the clip transforms to its austenitic state. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of making a surgical fastening clip having a shape memory effect, comprising:
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(i) providing a shape memory alloy having a martensite transformation temperature below which the alloy transforms to its martensitic state and an austenite transformation temperature above which the alloy transforms to its austenitic state, the alloy being deformable in its martensitic state from a closed configuration to an open configuration and recovering to the closed configuration when heated to transform the alloy to its austenitic state; (ii) forming the alloy into a clip having a substantially U-shaped configuration with two spaced-apart opposing legs extending in a longitudinal direction; (iii) forming each of the legs with at least one bend along a length thereof; (iv) deforming the clip such that the opposing legs are squeezed together in a closed configuration; (v) heating the clip in the closed configuration such that the alloy transforms to its austenitic state; (vi) cooling the clip such that the alloy transforms to its martensitic state; and (vii) straightening each of the legs to at least partially remove the bend such that the legs are elongated in said longitudinal direction and deforming the clip such that the legs are moved away from each other from said closed configuration to said open configuration, the clip being open and capable of being deformed in its martensitic state so as to apply a first clamping force on an object and so as to apply a second clamping force on the object when the alloy is heated to transform to its austenitic state, the second clamping force being greater than the first clamping force. - View Dependent Claims (18, 19, 20)
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21. A method of in vitro clamping of living tissue such as a vessel or passageway in a human or animal, comprising:
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(i) placing opposed legs of a generally U-shaped surgical fastening clip which is in an open configuration around a site of living tissue, the clip comprising a shape memory alloy having a martensite transformation temperature below which the alloy transforms to its martensitic state and an austenite transformation temperature above which the alloy transforms to its austenitic state; the clip being deformable in its martensitic state from a closed configuration to an open configuration and recovering to the closed configuration when heated to transform the alloy to its austenitic state; the clip being open and capable of being deformed in its martensitic state so as to apply a first clamping force on an object and so as to apply a second clamping force on the object when the alloy is heated to transform it to its austenitic state, the second clamping force being greater than the first clamping force; (ii) pressing the legs together to the closed configuration so as to apply said first force to the site; and (iii) heating the clip such that the alloy transforms to its austenitic state and the legs are urged together due to the shape memory effect of the shape memory alloy so as to apply said second force to the site. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28)
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Specification