Compression device and method for shape memory alloy implants

1 . An apparatus for compressing a shape memory material implant to be implanted in a patient, comprising:

opposing dies configured to grasp the shape memory material implant, when placed therebetween;

an actuator for actuating said opposing dies toward each other such that said opposing dies impart forces being in substantially direct opposition to each other, against the shape memory material implant, when placed therebetween, so as to compress the shape memory material implant; and

a uniformity controller for providing uniform compression of a given type of shape memory material implant.

2 . An apparatus according to claim 1 , wherein said uniformity controller comprises a mechanical stop for inhibiting further movement of said opposing dies towards each other past a set distance therebetween.

3 . An apparatus according to claim 1 , wherein said actuator comprises a lever mechanism for imparting the opposing forces against the shape memory material implant.

4 . An apparatus according to claim 1 , wherein each of said opposing dies comprises a concave surface, with said concave surfaces configured to cradle the shape memory material implant.

5 . An apparatus according to claim 3 , wherein said apparatus comprises two handles pivotably intersecured to rotate about a common axis, the pivotably intersecured handles forming said lever mechanism, and said two handles are integrated with said opposing dies, respectively, such that movement of said handles actuates said opposing dies to impart the opposing forces against the shape memory material implant, when moved from an open position to a closed position.

6 . An apparatus according to claim 5 , wherein said opposing dies are positioned opposite the common axis from said two handles.

7 . An apparatus according to claim 6 , wherein said concave surfaces of said opposing dies are each substantially semicylindrical in shape, with longitudinal axes of said semicylindrical concave surfaces being arranged substantially perpendicular to the common axis of said handles.

8 . An apparatus according to claim 7 , wherein longitudinal ends of said semicylindrical concave surfaces distal to the common axis of said handles define a window in which the shape memory material implant is inserted into said apparatus when said handles are in the open position.

9 . An apparatus according to claim 2 , wherein said opposing dies are modular opposing dies removably secured to said apparatus.

10 . An apparatus according to claim 9 , wherein said mechanical stop is integrated with at least one of said modular opposing dies.

11 . An apparatus according to claim 2 , wherein said actuator comprises a four-bar linkage interconnected with said opposing dies so as to operate said opposing dies in parallel to impart the substantially opposing forces.

12 . An apparatus according to claim 1 , wherein said uniformity controller comprises a gauge for indicating to a user of said apparatus the amount of relative movement between said opposing dies.

13 . An apparatus according to claim 12 , wherein each of said opposing dies comprises a concave surface, with said concave surfaces configured to cradle the shape memory material implant.

14 . An apparatus according to claim 12 , wherein said gauge comprises a graduated scale for measuring an actuation amount of said opposing dies during compression of a shape memory material implant.

15 . An apparatus according to claim 12 , wherein said opposing dies are modular opposing dies removably secured to said apparatus.

16 . An apparatus according to claim 12 , wherein said actuator comprises a four-bar linkage interconnected with said opposing dies so as to operate said opposing dies in parallel to impart the substantially opposing forces.

17 . A method of inserting a shape memory material implant into a patient, comprising the steps of:

providing the shape memory material implant which is compressible and capable of expanding to an expanded form, from a compressed form, when exposed to a predetermined condition;

placing the shape memory material implant in a mechanical actuator with opposing dies, such that the shape memory material implant is grasped between the opposing dies, wherein the mechanical actuator provides controlled, repeatable actuation of the dies;

actuating the opposing dies of the mechanical actuator toward each other when the shape memory material implant is positioned therebetween, to compress the shape memory material implant into the compressed form;

inserting the compressed shape memory material implant into the patient at a medically efficacious location; and

exposing the compressed shape memory material implant to the predetermined condition so as to cause the shape memory material implant to expand to the expanded form.

18 . The method according to claim 17 , wherein the mechanical actuator is hand operated such that said actuating step involves hand actuating the opposing dies.

19 . The method according to claim 17 , wherein the mechanical actuator comprises a graduated scale for measuring a compression level, and said actuating step involves actuating the opposing dies to compress a given shape memory material implant positioned therebetween to a specified level, using the graduated scale to measure the relative movement of the opposing dies.

20 . The method according to claim 17 , wherein the predetermined condition is a temperature above a transition temperature, and said method further comprises the step of reducing the temperature of the shape memory material implant to ensure that the shape memory material implant is below the transition temperature, prior to said actuating step, wherein the body temperature of the patient heats the shape memory material implant above the transition temperature so as to cause the shape memory material implant to expand to the expanded form, after said inserting step.

21 . The method according to claim 19 , wherein the opposing dies are modular, and said method further comprises steps of selecting a pair of modular dies to be used with a given shape memory material implant, and securing the selected pair of modular dies in the mechanical actuator prior to said step of placing the reduced temperature shape memory material implant in the mechanical actuator.

22 . The method according to claim 19 , wherein said actuating step comprises the sub-steps of:

i) actuating the opposing dies to compress the shape memory material implant along a first axis of the shape memory material implant;

ii) rotating the compressed shape memory material implant; and

iii) actuating the opposing dies again to compress the shape memory material implant along a second axis of the shape memory material implant.

23 . The method according to claim 21 , wherein the opposing dies are modular, and different sets of dies are used for compression along the first and second axes, respectively.

24 . An apparatus for compressing a shape memory material implant to be implanted in a patient, comprising:

compression means for compressing the shape memory material implant when placed in said compression means, from an expanded form to a compressed form;

actuation means for actuating said compression means from an open position, in which said shape memory material implant can be inserted into said compression means, to a closed position in which said compression means compresses said shape memory material implant; and

inhibition means for inhibiting said compression means to compress said shape memory material implant past a specified compression level.

25 . The apparatus according to claim 24 , wherein said inhibition means comprises a mechanical stop positioned to prevent further actuation of said compression means past the specified compression level.

26 . The apparatus according to claim 24 , wherein said inhibition means comprises a gauge for indicating to a user a level of compression applied to a shape memory material implant compressed by said compression means, so that the user may inhibit compression past the specified compression level.