1. A surgical instrument assembly for use during a surgical procedure to implant an orthopaedic hip prosthesis, comprising:
a trial shaft having (i) a cylindrically-shaped stem, and (ii) a locking screw having a number of threads formed in a distal end thereof, the locking screw being rotatable relative to the cylindrically-shaped stem, and
a discrete trial neck removably secured to the trial shaft, the trial neck having (i) a bore formed therein, with the stem of the trial shaft being received into the bore so as to allow for rotation of the trial neck relative to the trial shaft, and (ii) a locking mechanism operable to selectively lock the rotational position of trial neck relative to the trial shaft.
2. The surgical instrument assembly of claim 1, further comprising a distal reamer having (i) a cutting head that includes a plurality of helical cutting flutes arranged in a geometry that corresponds with the geometry of the distal stem component, and (ii) a threaded bore formed in a superior end thereof, wherein the threads of the locking screw of the trial shaft are threaded into the threaded bore of the distal reamer.
3. The surgical instrument assembly of claim 1, wherein:
the stem of the trial shaft has a number of grooves formed therein, and
the locking mechanism of the trial neck has a locking pawl that is selectively positionable in the number of grooves to selectively lock the rotational position of trial neck relative to the trial shaft.
4. The surgical instrument assembly of claim 1, wherein:
the stem of the trial shaft has a number of grooves formed therein,
the locking mechanism of the trial neck has a locking pawl that is positionable between (i) a locked position in which the locking pawl is positioned in one of the number of grooves of trial neck so as to prevent rotation of the trial neck relative to the trial shaft, and (ii) an unlocked position in which the locking pawl is positioned so as to allow rotation of the trial neck relative to the trial shaft, and
the locking mechanism further includes a locking screw that is rotatable to move the locking pawl between the locked position and the unlocked position.
5. The surgical instrument assembly of claim 1, wherein:
the trial shaft further has an alignment key formed in an outer surface thereof proximate to the threads of the locking screw, and
the alignment key is configured to mate with a keyway formed in a superior surface of the distal stem component so as to align the trial shaft in a predetermined orientation relative to the distal stem component when the trial shaft is secured to the distal stem component.
6. The surgical instrument assembly of claim 1, wherein the locking screw of the trial shaft has a drive socket formed in a proximal end thereof, opposite the distal end in which the threads are formed.
7. A surgical instrument assembly for use during a surgical procedure to implant an orthopaedic hip prosthesis, comprising:
a plurality of trial shafts, wherein each of the plurality of trial shafts has (i) a length that is different from the length of at least some of the other of the plurality of trial shafts, (ii) a cylindrically-shaped stem, and (ii) a locking screw having a number of threads formed in a distal end thereof, the locking screw being rotatable relative to the cylindrically-shaped stem, and
a plurality of trial necks configured to be separately secured to each of the plurality of trial shafts, wherein each of the plurality of trial necks has (i) an offset size that is different from the offset size of at least some of the other of the plurality of trial necks, and (ii) a bore formed therein that is sized to receive the stem of each of the plurality of trial shafts.
8. The surgical instrument assembly of claim 7, wherein:
each of the plurality of trial necks includes a locking mechanism operable to selectively lock the rotational position of trial neck relative to one of the plurality of trial shafts.
9. The surgical instrument assembly of claim 8, wherein:
the stem of each of the plurality of trial shafts has a number of grooves formed therein, and
the locking mechanism of each of the plurality of trial necks has a locking pawl that is selectively positionable in the number of grooves to selectively lock the rotational position of trial neck relative to the trial shaft.
10. The surgical instrument assembly of claim 7, further comprising a distal reamer having (i) a cutting head that includes a plurality of helical cutting flutes arranged in a geometry that corresponds with the geometry of the distal stem component, and (ii) a threaded bore formed in a superior end thereof, wherein the threads of the locking screw of each of the plurality of trial shafts are sized to be threaded into the threaded bore of the distal reamer.
11. The surgical instrument assembly of claim 7, wherein:
each of the plurality of trial shafts further has an alignment key formed in an outer surface thereof proximate to the threads of the locking screw, and
the alignment key is configured to mate with a keyway formed in a superior surface of a distal stem component so as to align the trial shaft in a predetermined orientation relative to the distal stem component when the trial shaft is secured to the distal stem component.
12. A surgical instrument for use during a surgical procedure to implant a distal stem component of an orthopaedic hip prosthesis, comprising:
a proximal trial instrument having an alignment key formed in an outer surface thereof, the alignment key being configured to mate with a keyway formed in a superior surface of the distal stem component so as to align the proximal trial instrument in a predetermined orientation relative to the distal stem component when the proximal trial instrument is secured to the distal stem component.
13. The surgical instrument of claim 12, wherein the alignment key comprises an elongated rib extending outwardly from a distal end of the proximal trial instrument.
14. The surgical instrument of claim 12, wherein:
the proximal trial instrument comprises a modular proximal trial instrument having a discrete trial shaft and a discrete trial neck, and
the alignment key is formed in a distal end of the trial shaft.
15. The surgical instrument of claim 12, wherein a longitudinal axis of the alignment key extends in the superiorinferior direction.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A method of site-specific delivery of a therapeutic agent or a diagnostic agent to a region of interest within a fluid-filled cavity, vessel, or fluid perfused tissue by ultrasound comprising the steps of:
a. introducing an agent-loaded microbubble population into said region of interest, said microbubble population having a controlled fragility characterized by a wall thickness to diameter ratio that defines a threshold power intensity value of ultrasonic energy where microbubble rupture occurs in the population,
b. applying an ultrasonic signal to the region of interest at a power intensity sufficient to induce microbubble rupture,
c. maintaining said power intensity until at least a substantial number of microbubbles are ruptured.
2. A method according to claim 1 comprising, prior to said step (b) the step of monitoring the location of said microbubbles within said cavity, vessel or tissue to detect the presence of said microbubbles at said region of interest.
3. A method according to claim 2, wherein said location of said microbubbles is monitored by applying an ultrasonic signal to the region of interest at a power intensity below a threshold power intensity value where microbubble rupture occurs.
4. A method according to claim 1, wherein said microbubble population is comprised of microbubbles having diameters within the range of about 1 to about 10 microns.
5. A method according to claim 1, wherein said microbubble population is comprised of microbubbles having an outer shell comprising an outer layer of biologically compatible amphiphilic material and an inner layer of a biodegradable polymer.
6. A method according to claim 5, wherein said amphiphilic material comprises a protein.
7. A method according to claim 6, wherein said protein comprises collagen, gelatin, albumin, or globulin.
8. A method according to claim 5, wherein said biodegradable polymer comprises polycaprolactione, polylactide, polyglycolide, polyhydroxyvalerate, polyhydroxybutyrate, or copolymers thereof.
9. A method according to claim 1 wherein said region of interest is a heart.
10. A method according to claim 1 wherein said region of interest is a kidney.
11. A method according to claim 1 wherein said region of interest is a liver.
12. A method according to claim 1 wherein said threshold intensity of ultrasonic power where microbubble rupture occurs is sufficient to provide a mechanical index between 0.1 and 1.9.
13. A method according to claim 1 wherein said ultrasonic power is produced by a plurality of transducers focused at said region whereby the intensity and wave superimposition at the point of convergence if the emitted ultrasonic beams is sufficient to rupture the microbubbles.
14. A method according to claim 1 further comprising monitoring the release of said therapeutic or diagnostic agent from the microbubbles to determine rate of release and cumulative dosage released by ultrasonically monitoring microbubble rupture.
15. A method according to claim 1 wherein said ultrasonic power is produced by a transducer embodied within the distal portion of a cannula to disrupt said microbubbles as they flow to said region.
16. A method according to claim 1 wherein said ultrasonic power is produced by a transducer near said region.
17. A method according to claim 1 wherein said ultrasonic power is produced by a transducer affixed to an external, wearable object affixed near said region of interest.
18. A method according to claim 1 wherein said therapeutic agent is a drug to limit ischemic injury to a heart.
19. A method according to claim 1 wherein said therapeutic agent is a drug to limit reperfusion injury to a heart.
20. A method according to claim 1 wherein said therapeutic agent is a drug to limit restenosis of a coronary artery.
21. A method according to claim 1 wherein said therapeutic agent is a drug that comprises a fibrinolytic agent, vasodilator, calcium channel blocker, angiogenesis agent, anti-platelet agent, anti-white cell agent, endocardium acting agent, free radical scavenging agent, or anti-restenosis agent.
22. A method according to claim 21 wherein said drug comprises adenosine, adenosine monophosphate, adenosine diphosphate, adenosine triphosphate or chemical derivatives of adenosine.
23. A method according to any one of claims 1-4 and 9-22 wherein said microbubble population is comprised of microbubbles having an outer shell consisting of a single layer of a biodegradable polymer.
24. A method of claim 23, wherein said biodegradable polymer comprises polycaprolactione, polylactide, polyglycolide, polyhydroxyvalerate, polyhydroxybutyrate, or copolymers thereof.
25. A method of claim 24, wherein said biodegradable polymer is polylactide.