Source: http://www.google.fr/patents/US20100152772
Timestamp: 2018-01-18 08:33:16
Document Index: 234908622

Matched Legal Cases: ['art.\n52', 'art.\n59', 'art.\n76', 'art.\n81', 'art.\n83', 'art.\n84', 'art.\n92', 'art.\n94', 'art.\n107', 'art.\n108', 'art 4', 'art 4', 'art 331', 'art 332']

Brevet US20100152772 - Interventional medical closure device - Google Brevets
An interventional medical closure device is suitable for assisting closure of an opening through a blood vessel wall after completion of an interventional procedure within the internal lumen of the blood vessel. The device comprises a closure element, a grasping element for grasping the closure element,...http://www.google.fr/patents/US20100152772?utm_source=gb-gplus-shareBrevet US20100152772 - Interventional medical closure device
Numéro de publication US20100152772 A1
Numéro de demande US 12/637,948
Autre référence de publication EP1879505A2, EP1879505B1, EP2260770A2, EP2260770A3, EP2260770B1, US7753935, US8906050, US20060287673, US20100222796, WO2006117766A2, WO2006117766A3
Numéro de publication 12637948, 637948, US 2010/0152772 A1, US 2010/152772 A1, US 20100152772 A1, US 20100152772A1, US 2010152772 A1, US 2010152772A1, US-A1-20100152772, US-A1-2010152772, US2010/0152772A1, US2010/152772A1, US20100152772 A1, US20100152772A1, US2010152772 A1, US2010152772A1
Inventeurs Gerard Brett, David Ronan, Liam Mulloy, Steven Horan
Cessionnaire d'origine Gerard Brett, David Ronan, Liam Mulloy, Steven Horan
Citations de brevets (105), Référencé par (4), Classifications (20), Événements juridiques (1)
US 20100152772 A1
2. A method as claimed in claim 1 wherein the method comprises the step of passing a grasping element through the tissue wall to grasp the closure element within the lumen.
3. A method as claimed in claim 2 wherein the grasping element is passed across the opening.
4. A method as claimed in claim 3 wherein the grasping element is passed through the second part of the tissue wall on the second side of the opening, across the opening, and through the first part of the tissue wall on the first side of the opening.
5. A method as claimed in any of claims 1 to 4 wherein the longitudinal axis of the opening subtends an acute angle with the longitudinal axis of the lumen.
6. A method as claimed in claim 5 wherein the longitudinal axis of the opening subtends an angle of approximately 45° with the longitudinal axis of the lumen.
7. A method as claimed in any of claims 1 to 6 wherein the axis along which the closure element is moved subtends an acute angle with the longitudinal axis of the lumen.
8. A method as claimed in claim 7 wherein the axis along which the closure element is moved subtends an angle in the range of from 5° to 65° with the longitudinal axis of the lumen.
9. A method as claimed in claim 8 wherein the axis along which the closure element is moved subtends an angle in the range of from 15° to 55° with the longitudinal axis of the lumen.
10. A method as claimed in claim 9 wherein the axis along which the closure element is moved subtends an angle of approximately 30° with the longitudinal axis of the lumen.
11. A method as claimed in any of claims 1 to 10 wherein the longitudinal axis of the opening intersects the external surface of the tissue at a first intersection point, the axis along which the closure element is moved intersects the external surface of the tissue at a second intersection point, the longitudinal axis of the opening intersects the axis along which the closure element is moved at a third intersection point, and a transverse axis of the lumen extends perpendicular to the longitudinal axis of the lumen through the third intersection point, the first intersection point and the second intersection point being on opposite sides of the transverse axis.
12. A method as claimed in any of claims 1 to 11 wherein the axis along which the closure element is moved subtends an angle in the range of from 70° to 130° with the longitudinal axis of the opening.
13. A method as claimed in claim 12 wherein the axis along which the closure element is moved subtends an angle in the range of from 80° to 120° with the longitudinal axis of the opening.
14. A method as claimed in claim 13 wherein the axis along which the closure element is retracted subtends an angle of approximately 105° with the longitudinal axis of the opening.
15. A method as claimed in any of claims 1 to 14 wherein the opening comprises a puncture opening.
16. A method as claimed in any of claims 1 to 15 wherein the method comprises the step of dilating the opening.
17. A method as claimed in any of claims 1 to 16 wherein the method comprises the step of inserting the closure element into the lumen.
18. A method as claimed in claim 17 wherein the closure element is inserted through the opening into the lumen.
19. A method as claimed in any of claims 1 to 18 wherein the method comprises the step of maintaining the position of the closure element substantially fixed within the lumen prior to grasping.
20. A method as claimed in any of claims 1 to 19 wherein the method comprises the step of passing one or more medical devices through the opening into the lumen to perform at least one interventional procedure within the lumen.
21. A method as claimed in any of claims 1 to 20 wherein the closure element is moved to engage an internal surface of the tissue.
22. A method as claimed in claim 21 wherein the closure element engages the internal surface of the tissue on the first side of the opening and on the second side of the opening.
23. A method as claimed in any of claims 1 to 22 wherein the method comprises the step of engaging the external surface of the tissue.
24. A method as claimed in claim 23 wherein the external surface of the tissue is engaged on the first side of the opening and on the second side of the opening.
25. A method as claimed in any of claims 1 to 24 wherein the method comprises the step of applying a compressive force to the external surface of the tissue and/or to the internal surface of the tissue.
26. A method as claimed in claim 25 wherein the compressive force is applied on the first side of the opening and on the second side of the opening.
27. A method of performing an interventional procedure, the method comprising the steps of:
28. A method as claimed in claim 27 wherein the longitudinal axis of the opening intersects an external surface of the tissue at a first intersection point, the axis along which the closure element is moved intersects the external surface of the tissue at a second intersection point, the longitudinal axis of the opening intersects the axis along which the closure element is moved at a third intersection point, and a transverse axis of the lumen extends perpendicular to the longitudinal axis of the lumen through the third intersection point, the first intersection point and the second intersection point being on opposite sides of the transverse axis.
29. A method of performing an interventional procedure substantially as hereinbefore described with reference to the accompanying drawings.
30. An interventional medical closure device comprising:
a grasping element for grasping the closure element within an internal lumen of a tissue;
31. A device as claimed in claim 30 wherein the grasping element is engageable with the closure element to grasp the closure element.
32. A device as claimed in claim 31 wherein the grasping element is engageable with the closure element in a snap-fit manner.
33. A device as claimed in claim 31 or 32 wherein a distal end of the grasping element is engageable with a proximal end of the closure element.
34. A device as claimed in any of claims 30 to 33 wherein the device comprises a guide element for guiding passage of the grasping element.
35. A device as claimed in claim 34 wherein the guide element is configured to guide passage of the grasping element across an opening through a tissue wall.
36. A device as claimed in claim 35 wherein the guide element is configured to guide passage of the grasping element through a second part of a tissue wall on a second side of an opening through the tissue wall, across the opening, and through a first part of the tissue wall on a first side of the opening.
37. A device as claimed in any of claims 35 to 36 wherein the guide element comprises an outlet part out of which the grasping element may pass.
38. A device as claimed in claim 37 wherein the outlet part is movable relative to a main body portion of the guide element.
39. A device as claimed in claim 38 wherein the outlet part is movable between a delivery configuration and a guiding configuration.
40. A device as claimed in any of claims 30 to 39 wherein the device comprises an introducer sheath to dilate an opening through a tissue wall.
41. A device as claimed in any of claims 30 to 40 wherein the device comprises a delivery element to deliver the closure element into an internal lumen of a tissue.
42. A device as claimed in claim 41 wherein the delivery element is engageable with an internal surface of a tissue to maintain the position of the closure element substantially fixed within an internal lumen of the tissue prior to grasping.
43. A device as claimed in claim 42 wherein the delivery element comprises an engagement element for engagement with an internal surface of a tissue.
44. A device as claimed in claim 43 wherein the engagement element is movable relative to a main body portion of the delivery element.
45. A device as claimed in claim 44 wherein the engagement element is movable between a delivery configuration and an engagement configuration.
46. A device as claimed in any of claims 30 to 45 wherein the closure element is engageable with an internal surface of a tissue.
47. A device as claimed in claim 46 wherein the closure element comprises an engagement element for engagement with an internal surface of a tissue.
48. A device as claimed in any of claims 30 to 47 wherein the device comprises an external engagement element for engagement with an external surface of a tissue.
49. An interventional medical closure device substantially as hereinbefore described with reference to the accompanying drawings.
50. A method of accessing an interior of a body part, the method comprising the steps of:
51. A method as claimed in claim 50 wherein the longitudinal axis of the incision is inclined relative to the plane of the wall of the body part.
52. A method as claimed in claim 51 wherein the angle subtended between the longitudinal axis of the incision and the plane of the wall of the body part is in the range of from 10° to 80°.
53. A method as claimed in claim 52 wherein the angle subtended between the longitudinal axis of the incision and the plane of the wall of the body part is approximately 45°.
54. A method as claimed in any of claims 50 to 53 wherein the method comprises the step of engaging the flap to move the flap aside to form the opening.
55. A method as claimed in claim 54 wherein the flap is pushed distally to form the opening.
56. A method as claimed in claim 54 or 55 wherein the flap is engaged by an introducer sheath, and/or a delivery catheter, and/or a guide catheter.
57. A method as claimed in any of claims 50 to 56 wherein the method comprises the step of performing a medical procedure using the medical device.
58. A method as claimed in any of claims 50 to 57 wherein the method comprises the step of withdrawing the medical device from the interior of the body part.
59. A method as claimed in any of claims 50 to 58 wherein the method comprises the step of sealing across the opening.
60. A method as claimed in claim 59 wherein the flap is moved back to seal across the opening.
61. A method as claimed in claim 60 wherein the method comprises the step of engaging the flap to move the flap back to seal across the opening.
62. A method as claimed in claim 61 wherein the flap is pulled proximally to seal across the opening.
63. A method as claimed in claim 61 or 62 wherein the flap is engaged by a part of an engagement element.
64. A method as claimed in claim 63 wherein the method comprises the step of moving the part of the engagement element from a delivery configuration to a deployed configuration before engaging the flap.
65. A method as claimed in claim 64 wherein the part of the engagement element is expanded from the delivery configuration to the deployed configuration.
66. A method as claimed in claim 65 wherein the part of the engagement element is inflated from the delivery configuration to the deployed configuration.
67. A method as claimed in any of claims 64 to 66 wherein the method comprises the step of moving the part of the engagement element from the deployed configuration to the delivery configuration after sealing across the opening.
68. A method as claimed in claim 67 wherein the part of the engagement element is contracted from the deployed configuration to the delivery configuration.
69. A method as claimed in claim 68 wherein the part of the engagement element is deflated from the deployed configuration to the delivery configuration.
70. A method as claimed in any of claims 63 to 69 wherein the method comprises the step of piercing the engagement element through the flap.
71. A method as claimed in any of claims 63 to 70 wherein the method comprises the step of piercing the engagement element through the wall of the body part at the opposite side of the incision.
72. A method as claimed in claim 70 or 71 wherein the engagement element is pierced through the flap and/or through the wall of the body part by piercing the flap and/or the wall of the body part with a needle and passing the engagement element through the needle.
73. A method as claimed in claim 72 wherein the method comprises the step of removing the needle from the flap and/or from the wall of the body part to leave the engagement element pierced therethrough.
74. A method as claimed in any of claims 70 to 73 wherein the engagement element is pierced through the flap and/or through the wall of the body part before the incision is created.
75. A method as claimed in claim 74 wherein the incision is created around the engagement element pierced through the flap and/or through the wall of the body part.
76. A method as claimed in claim 74 or 75 wherein the method comprises the step of protecting the engagement element during the step of creating the incision.
77. A method as claimed in any of claims 70 to 76 wherein the method comprises the step of withdrawing the engagement element from the flap after sealing across the opening.
78. A method as claimed in any of claims 71 to 77 wherein the method comprises the step of withdrawing the engagement element from the wall of the body part at the opposite side of the incision after sealing across the opening.
79. A method as claimed in any of claims 59 to 78 wherein the flap moves between a sealing configuration, in which the flap seals across the opening, and an access configuration, in which the flap is moved aside to reveal the opening.
80. A method as claimed in claim 79 wherein the flap moves relative to the wall of the body part.
81. A method as claimed in claim 79 or 80 wherein the flap moves in a substantially hinging manner.
82. A method as claimed in claim 81 wherein the axis of hinging is substantially parallel to the plane of the wall of the body part.
83. A method as claimed in any of claims 79 to 82 wherein in the access configuration, the flap is located substantially within the interior of the body part.
84. A method as claimed in any of claims 79 to 83 wherein in the sealing configuration, the flap engages the wall of the body part at the opposite side of the incision.
85. A method as claimed in any of claims 79 to 84 wherein the flap is anchored in the sealing configuration.
86. A method as claimed in any of claims 50 to 85 wherein the medical device comprises a guidewire, and/or an introducer sheath, and/or a delivery catheter, and/or a guide catheter.
87. A method as claimed in any of claims 50 to 86 wherein the body part comprises a blood vessel.
88. A method as claimed in any of claims 50 to 87 wherein the incision is substantially arch-shaped in profile.
89. A method of accessing an interior of a body part substantially as hereinbefore described with reference to the accompanying drawings.
90. A medical device comprising an incising element for creating an incision in a wall of a body part with at least one flap of tissue wall at a side of the incision.
91. A device as claimed in claim 90 wherein the incising element is configured to create an incision with the longitudinal axis of the incision inclined relative to the plane of a wall of a body part.
92. A device as claimed in claim 90 or 91 wherein the incising element is configured, to create an incision in a wall of a body part, the wall having a medical element pierced through the wall.
93. A device as claimed in claim 92 wherein the incising element is configured to create the incision around the medical element pierced through the wall of the body part.
94. A device as claimed in claim 93 wherein the incising element is movable between an open configuration and a closed configuration to create the incision around the medical element.
95. A device as claimed in claim 94 wherein in the closed configuration, the incising element has an opening for receiving the medical element therethrough.
96. A device as claimed in any of claims 90 to 95 wherein the incising element is configured to create an incision having an arch-shape in profile.
97. A device as claimed in any of claims 90 to 96 wherein the incising element has a cutting part movable between a first configuration and a second configuration.
98. A device as claimed in claim 97 wherein the cutting part is biased towards the second configuration.
99. A device as claimed in claim 98 wherein the incising device has a restraining part to restrain the cutting part in the first configuration.
100. A device as claimed in claim 99 wherein the cutting part is movable relative to the restraining part to release the cutting part to move to the second configuration.
101. A device as claimed in claim 99 or 100 wherein the restraining part comprises an outer sheath.
102. A device as claimed in any of claims 97 to 101 wherein the first configuration is a contracted configuration.
103. A device as claimed in any of claims 97 to 102 wherein in the first configuration, the cutting part is substantially tubular.
104. A device as claimed in any of claims 97 to 103 wherein the second configuration is an expanded configuration.
105. A device as claimed in any of claims 97 to 104 wherein in the second configuration, the cutting part is at least partially substantially frusto-conical.
106. A device as claimed in claim 105 wherein the cutting part is substantially frusto-conical around only part of the circumference of the part.
107. A device as claimed in claim 106 wherein the cutting part has a recess around part of the circumference of the part.
108. A device as claimed in any of claims 90 to 107 wherein the device comprises an engagement element, a part of the engagement element being engagable with a flap of tissue wall at a side of an incision to move the flap to seal across the opening through the incision.
109. A medical device comprising an engagement element, a part of the engagement element being engagable with a flap of tissue wall at a side of an incision to move the flap to seal across an opening through the incision.
110. A device as claimed in claim 108 or 109 wherein the part of the engagement element is movable between a delivery configuration and a deployed configuration.
111. A device as claimed in claim 110 wherein the part of the engagement element is expandable I contractible between the delivery configuration and the deployed configuration.
112. A device as claimed in claim 111 wherein the part of the engagement element is inflatable/deflatable between the delivery configuration and the deployed configuration.
113. A device as claimed in any of claims 108 to 112 wherein the part of the engagement element is biodegradable.
114. A device as claimed in any of claims 108 to 113 wherein the device comprises one or more protective elements for protecting at least part of the engagement element during creation of an incision.
115. A device as claimed in claim 114 wherein the protective element is configured to cover at least part of the engagement element.
116. A device as claimed in claim 115 wherein the protective element comprises a protective sheath extendable over the engagement element.
117. A device as claimed in claim 115 or 116 wherein the protective element is movable relative to the engagement element between a protecting configuration, in which the protective element covers at least part of the engagement element, and an uncovered configuration.
118. A device as claimed in any of claims 108 to 117 wherein the engagement element is pierceable through a flap of tissue wall.
119. A device as claimed in any of claims 108 to 118 wherein the engagement element is substantially elongate.
120. A device as claimed in any of claims 108 to 119 wherein the device comprises an anchor to anchor the flap sealed across the opening.
121. A device as claimed in claim 120 wherein the engagement element carries the anchor.
122. A device as claimed in claim 120 or 121 wherein the anchor is configured to be located on an external surface of the flap.
123. A medical device substantially as hereinbefore described with reference to the accompanying drawings.
This application is a divisional application of U.S. patent application Ser. No. 11/413,636 filed Apr. 28, 2006, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/676,279, filed Apr. 29, 2005. The entire content of both applications are incorporated herein by reference.
These devices may require additional dilation of the wound post procedure in order to accommodate the size of a staple/clip delivery system;
There is a risk of embolisation of the gel or foam material in the blood stream due to inaccurate deployment or migration post delivery to the tissue tract; Ineffective closure of the puncture wound in the blood vessel may occur as the material is deployed in the tissue tract with an increased risk of haernotoma; These devices are often designed to leave materials on the inside of the blood vessel, thereby increasing the risk of blood flow restriction or occlusion;
The present disclosure is directed to an interventional medical closure device. In one embodiment, the device includes a closure element, a grasping element and a suture. The grasping element is adopted for grasping the suture and the closure element within an internal lumen of a tissue. The closure element includes a first engagement element for engagement with an internal surface of a tissue wall and a second engagement element for engagement with an external surface of the tissue wall. The suture is movable, by the grasping element, through a first part of a tissue wall on a first side of an opening through the tissue wall, across the opening, and through a second part of the tissue wall on a second side of the opening to assist in closure of the opening.
Retracting the closure element across the opening provides direct compression to the tissue wall at the faces of the opening which results in a lower force requirement to achieve more effective sealing of the opening. The invention minimizes the force required which may minimize the pain experienced by the patient. In particular the invention does not rely on a bunching effect by ‘puckering’ the sides of the opening to provide sealing.
In another embodiment the method comprises the step of engaging the flap to move the flap back to seal across the opening. The positive engagement of the flap ensures that the opening is quickly and effectively sealed to minimize blood loss.
In a further embodiment the flap is pulled proximally to seal across the opening. In one embodiment the flap is engaged by a part of an engagement element.
In another embodiment the method comprises the step of moving the part of the engagement element from a delivery configuration to a deployed configuration before engaging the flap. In the delivery configuration, the engagement element has a relatively low profile for passing through the flap/wall of the body part, and for subsequent withdrawal from the flap/wall of the body part; In the deployed configuration, the engagement element may be engaged with the flap to control movement of the flap.
In a further embodiment the flap moves relative to the wall of the body part. In one embodiment the flap moves in a substantially hinging manner.
In a further embodiment the incising device has a restraining part to restrain the cuffing part in the first configuration.
In one embodiment in the first configuration, the cutting part is substantially tubular. In another embodiment the second configuration is an expanded configuration.
In another embodiment the part of the engagement element is expandable 1 contractible between the delivery configuration and the deployed configuration.
In a further embodiment the protective element is configured to cover at least part of the engagement-element.
The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, m which:
FIG. 94 is a perspective view of the device of FIGS. 70 and 71 in the step illustrated in FIGS. 92 and 93;
FIGS. 96 to 101 are partially cross-sectional, side views illustrating further steps in the method of performing an interventional procedure according to the invention using the device of FIGS. 70 and 71
FIG. 126 is a side view of the device of FIG. 122 in the guiding configuration; and FIG. 127 is an enlarged, side view of a part of the device of FIG. 126. Detailed Description
As illustrated in FIGS. 22 and 25, the incising element 3 creates the incision 9 with the longitudinal axis A-A of the incision 9 inclined relative to the p 1 and of the wall 8 of the blood vessel 6. The inclined incision 9 ensures that the flap 7 of tissue wall is created at the side of the incision 9, as illustrated in FIGS. 25 and 28.
After sealing across the opening 10, the engagement element I may remain in position (FIG. 35). An anchoring element 110 is threaded onto the engagement element 1 and positioned on the external wall of the vessel 6. The anchoring element 110 serves to secure the incision area 10 and seal the vessel wall 8. The anchoring element 110 may be of a biodegradable polymer which slides down over the engagement element 1. Alternatively the retaining element part 4 may be deflated from the deployed configuration to the delivery configuration, and the engagement element 1 may be withdrawn from the flap 7 and from the wall 8 of the blood vessel 6.
It will be appreciated that the engagement element 1 may be provided with alternative means of engaging the flap 7. For example alternative means of moving a part of the engagement element 1 between the delivery configuration and the deployed configuration may be employed, for example, by expanding/contracting the part of the engagement element, instead of employing the expandable retaining element part 4.
The medical device of FIGS. 1 to 35 is an example of the double trap system which captures both sides/vessel wall flaps of the incision site 9 with a threaded through element, for example, the engagement element 1 with the expandable retaining element 4. The cutter 3 makes the incision 9 without cutting through the engagement element I which is put in place in the vessel wall 8 prior to the cutting step. This is accomplished by deploying a protective sheath 2 to cover and protect the engagement element 1 before the cutting plunger 3 is activated. Once activated the scissors 12 cuts through the vessel wall 8 with the scissor blades opened. When the blades encounter the sheath 2 protecting the engagement element 1, they ‘scissor’ around the protective sheath 2 and cleanly cut the tissue 8 leaving a smooth incision 9 in the vessel 6. When the device is withdrawn, the scissors 12 opens and is retracted into the body of the cutting device 3.
FIGS. 57 to 68 illustrate the wedge/inverted cone device, which is an example of a single trap system where the cutter 41 is an inverted cone, with a slot removed, which is housed in the introducer sheath 13. The engagement element device 1 is in place prior to insertion of the cutter device 41, and the cutter device. 41 is guided down the tissue channel over the engagement element 1 for placement of the device on the outside of the vessel wall 8. The cutter 41 will cut through the vessel wall 8 while leaving a strip of wall uncut and attached to the body of the vessel wall 8. This strip acts as an anchor tag which, along with the engagement element 1, guides the sealing element 7 back accurately into the opening 10 created by the cutting blade 41 in the vessel wall 8.
The device 300 may be employed to perform an interventional procedure on a blood vessel 320 according to the invention, as illustrated in FIGS. 74 to 121. In this case the blood is flowing through the blood vessel 320 in the direction of arrow E in FIGS. 74 and 75. In use, a tubular needle 321 is extended through the wall 322 of the blood vessel 320 from the external surface 324 of the blood vessel 320 to the internal lumen 323 of the blood vessel 320 (FIG. 74). In this manner a puncture opening 330 is created through the blood vessel wall 322, with a first part 331 of the blood vessel wall 322 on a first side of the opening 330, and a second part 332 of the blood vessel wall 322 on a second side of the opening 330. As illustrated in FIG. 75, the longitudinal axis B-B of the opening 330 subtends an acute angle, in this case approximately 45°, with the longitudinal axis of the internal lumen 323 of the blood vessel 320. A guidewire 325 is introduced through the needle 321 into the internal lumen 323 of the blood vessel 320 (FIG. 76), and the needle 321 is then removed (FIGS. 78).
The device 350 is similar to the device 300 of FIGS. 70 to 121 but utilizes the expanding arm 351. This reduces the profile of the device 350 that has to be inserted through the skin and tissue tract 344. The expandable arm 351 is only deployed once the device 350 is in position at the vessel wall, and the arm 351 is retracted once the suture 305 has been picked up.
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Classification coopérative A61B2017/00637, A61B2017/0464, A61B2017/00349, A61B17/0467, A61B17/32053, A61B2017/22048, A61B17/0057, A61B2017/22038, A61B17/0401, A61B2017/00336, A61B2017/0406, A61B2017/0458, A61B2017/00004, A61B2017/00654, A61B2017/00659
Classification européenne A61B17/3205G, A61B17/00P, A61B17/04A
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BRETT, GERARD;RONAN, DAVID;MULLOY, LIAM;AND OTHERS;SIGNING DATES FROM 20060601 TO 20060602;REEL/FRAME:033748/0345