Methods and devices for delivering occlusion elements
A device for delivering an occlusion element, or other medical device, which includes a fluid dissolvable bond. The occlusion element is coupled to the delivery element with the fluid dissolvable bond. The bond may be dissolved by delivering a fluid through the delivery element either through the delivery element itself or through a tube positioned in the delivery element.
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The present application is a continuation-in-part of Methods and Devices for Delivering Occlusion Elements, Ser. No. 09/780,587, filed Feb. 9, 2001, the full disclosures of which are incorporated herein by reference.
BACKGROUND OF THE INVENTIONThe present invention relates to the delivery of medical devices and, in particular, occlusion elements. Occlusion elements, such as coils, are delivered to occlude vascular regions and malformations for various reasons. For example, occlusion elements, such as coils, may be delivered into an aneurysm to occlude the aneurysm. Other uses of occlusion elements include treatment of AVM's and other malformations.
SUMMARY OF THE INVENTIONThe medical device, such as the occlusion element, is coupled to a delivery element with a material which is dissolvable with a fluid. The material forms a dissolvable connection between the delivery element and the occlusion element. The occlusion element is advanced through the patient's vascular system and, at the appropriate time, the material is dissolved. The dissolvable material is preferably dissolved with a fluid which is delivered to the material through the delivery element or through a tube positioned in the delivery element. The fluid may be delivered, withdrawn or otherwise circulated around the material with the tube and delivery element in any suitable manner. Alternatively, the material may be dissolved with the patient's own blood. Finally, the fluid may also be contained within the delivery element but separated from the material until the desired time. Although the present invention provides a few exemplary fluids and dissolvable materials, the fluid and dissolvable material combination may be any suitable combination without departing from the scope of the invention.
The occlusion element may be embedded in the material. For example, the occlusion element may have a coil, a plurality of filaments, a ball or a cage embedded in the material. The embedded portion may also be in a biased position, either expanded or collapsed, when embedded in the material. In this manner, the embedded portion helps to mechanically disturb the dissolvable portion to release the device as the material dissolves. For example, the embedded portion may be a stacked coil which expands when released. The delivery element itself may also have a portion embedded in the material, such as a number of filaments, to further secure the delivery device to the occlusion element.
A blocking element may also be provided which protects part of the dissolvable material from exposure to blood or other fluids. The blocking element may be positioned within a cavity in the material. The cavity may be a throughhole through which the fluid is delivered when dissolving the material. The blocking element may also help to protect the connection from kinking and other mechanical disturbances which occur when advancing the occlusion element through small, tortuous vessels. The blocking element can prevent inadvertent mechanical detachment when the device is bent or otherwise deformed during advancement through the patient. The occlusion element itself may also have a blocking portion which prevents contact between the patient's blood and the material thereby inhibiting premature dissolution of the material. The blocking portion may be a plug of material such as solder.
A flexible sheath may also be positioned over the material to protect the material. The sheath may be solid or may have openings or slits therein to promote flow through the sheath when dissolving the material. The delivery element may also have a fluid distributing portion which distributes the fluid for dissolution of the material.
These and other advantages of the invention will become apparent from the following description of the preferred embodiments, claims and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Referring to
The occlusion element 6 is shown as a short section of coil for clarity but may be any suitable occlusion element 6 such as those described in U.S. Pat. Nos. 5,855,578, 5,853,418, 5,749,894 and 5,749,891 which are hereby incorporated by reference. In the preferred embodiment, the occlusion element 6 is made of platinum wire or ribbon which forms coils 7. Of course, any suitable materials and structure may be used to form the occlusion element 6. The delivery element 8 is preferably a tube 11 having at least one lumen 12, however, the delivery element 8 may also be a solid element such as a wire or mandrel without departing from the scope of the invention. The occlusion element 6 is mounted to the end of the delivery element 8 and extends from the delivery element.
The system 2 of
The occlusion element 6 is mounted to the delivery element 8 with the fluid dissolvable material 10 which forms a dissolvable bond or connection 11. The fluid is preferably delivered to the dissolvable material 10 from the source of fluid 16 so that the dissolution of the material 10 may be controlled by delivery of the fluid. Although it is preferred to deliver the fluid to dissolve the material 10, however, the fluid may also simply be the patient's own blood. Such a device may be practiced with various aspects of the invention described herein without departing from the scope of the invention.
The fluid may simply erode or dissolve the bond 12 or the material 10 may be dissolved with additional chemical, thermal or mechanical action. For example, the fluid may be an acid, base or other ionic fluid which chemically dissolves the material 10. For example, hydrogen chloride may be used to dissolve a connection having zinc or hydrogen peroxide may be used to dissolve a connection having iron. The fluid 16 and material 10 may also form a solvent/solute relationship such as Hypan dissolved by a fluid such as dimethyl sulfoxide.
In still another example, the material 10 may be a cross-linked polymer such as a cross-linked alginate. The alginate may dissolve in the presence of a suitable fluid containing a monovalent, divalent, or trivalent cation such as saline. The alginate may be cross-linked in any suitable manner such as with calcium chloride.
In still another example, the material may be a polymer which preferentially dissolves upon a pH or salinity change or upon application of an electric field. Such a polymer is sold under the trade name EUDRAGIT® by Rohm GmbH of Darmstadt, Germany, which is an acrylic polymer and more specifically a methacrylate polymer. The polymer compound has polymer layers bonded together with hydrogen bonds in alternating layers of positive and negative charge. The bond between the polymer layers is broken by application of the pH or salinity change or upon application of an electric field. For example, the fluid 16 may also have a pH which dissolves the material 10 faster than the pH of other fluids which the material 10 is exposed to. Thus, if the material 10 is exposed to blood, saline, contrast and the like, the dissolvable material 10 is preferably selected to at least dissolve slowly, if at all, at the pH of these fluids and more quickly when exposed to the appropriate pH fluid. In a preferred embodiment, the material dissolves at least three times faster, and more preferably at least five times faster at the selected pH than at the pH of other fluids to which it is exposed. The dissolution rate can also be enhanced by flowing fluid into contact with the dissolvable material.
Once the occlusion element is at the desired location, a fluid, such as sodium bicarbonate, having the appropriate pH is delivered to dissolve the material 10. As mentioned above, the material 10 may dissolve slowly in the fluids to which it is exposed so long as the material dissolves faster when exposed to the appropriate fluid. EUDRAGIT®, for example, dissolves slowly in blood or saline, however, the polymer dissolves much faster with the appropriate fluid. In a preferred embodiment, the fluid has a pH of either about 4-6 or about 8-9.5.
In a specific example, EUDRAGIT® L100 and S100 (1:1) are dissolved with an ethyl alcohol/water (95:5 by weight) solvent at a ratio of 0.05 G EUDRAGIT® per gram of solution using a magnetic mixer. Small drops of the EUDRAGIT® solution are then applied to the appropriate area between the medical device or element and the delivery or insertion element. The drop is then dried which may take 1-5 hours during which time the solvent substantially evaporates leaving the EUDRAGIT® material to form the dissolvable bond. If necessary or desired, additional drops or coatings may be applied after the previous drop, coating or application has dried.
Thus, it can be appreciated from the various examples provided above that a number of different combinations of fluid and dissolvable material may be used and numerous other combinations are possible without departing from the invention.
Referring again to
The delivery element 8 may include a sheath 22 extending over an outer surface of the dissolvable material 10. The sheath 22 protects the outer surface of the material 10 to inhibit dissolution of the material 10. The sheath 22 may be any suitable flexible sheath and may be made of any suitable material such as PET. The delivery element 8 has a coil 24 coupled to a tube 26. The coil 24 provides a flexible distal end for advancement of the delivery element 8 through tortuous vessels. The sheath 22 may extend over the coil 24 and tube 26 or only over a portion of the coil 24 and material 10.
Referring to
Referring to
The tube 42 and annular area between the delivery element 8 and tube 42 may also be used to prime the device with a suitable fluid. The priming fluid may be a fluid which does not dissolve the material 10 or which dissolves the material 10 very slowly. The tube 42 and annular area between the delivery element 8 and tube 42 may also be used to actively remove air as well as for delivery of the fluid after advancing the device to the desired release site. Although the devices described herein include a separate tube 42, the device 8 may also simply have two lumens instead of the tube 42 without departing from the scope of the invention.
Referring to
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Referring to
A method of delivering a medical device, such as an occlusion element 6, is now described in connection with the preferred embodiments, however, it is understood that the method may be practiced with any suitable device. As mentioned above, the invention may be used in any location in the patient's body and use in the cerebral vasculature is described as a particular use of the invention although any other medical device may be delivered to any other part of the body for any other purpose. The guide catheter 5 is introduced into a vessel, such as the femoral artery, and advanced to a suitable location. The microcatheter 12 is then advanced through the guide catheter 5 to a location near the desired site for releasing the occlusion element 6. The invention may be practiced with fewer or more delivery catheters, cannulae or sheaths without departing from the scope of the invention.
The occlusion element 6 is delivered to the desired location by manipulating the delivery element 8. At the desired release time and location, the blocking element (
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The present invention may also be used to deliver a number of elements 6 with the same delivery element 94. Referring to
Referring to
As mentioned above, the detector 118 is particularly useful with the multiple element system described above but may be used to simply alert the user when the element 6 has been detached so that the user manipulates the insertion element appropriately once detachment has occurred. Detecting detachment of the element 6 may also be used to determine when to flush the system with the flushing fluid 112. One method of detecting detachment is to apply energy to the device and detect a change in a measured parameter or characteristic of the energy. For example, the detector 118 may apply a low power RF signal with the standing wave ratio (SWR) being measured. The SWR will change when the element 6 has been released so long as an appropriate frequency and/or wavelength is selected. Other types of energy, such as electrical energy, may be used while measuring other parameters, such as electrical resistance, without departing from the scope of the invention.
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The present invention has been described in connection with the preferred embodiments, however, many variations and alternative embodiments fall within the scope of the invention. For example, the occlusion element may have any shape and may be made of any material. Furthermore, although it is preferred to deliver the fluid to the dissolvable material, the material may also be dissolved by simply coming into contact with the patient's blood without departing from various aspects of the invention. The dissolvable material may completely detach the occlusion element from the delivery element or may require another action, such as withdrawal of the delivery element, to fully release the occlusion element. Finally, the methods and devices of the present invention may be used with any medical device and not necessarily the occlusion elements described herein and use with any suitable medical device falls within the scope of the invention so that the term medical device or element may be substituted for occlusion element or device as used herein. Thus, the description of the preferred embodiments should not limit the invention. The invention has been described in connection with a number of different features, aspects and advantages which should be considered independently and, thus, no single aspect or advantage of the invention should be considered an essential element of the invention. For example, various aspects of the invention may be practiced with or without various aspects such as the blocking element, sheath, or fluid circulation.
Claims
1. A method of delivering an occlusion element, comprising the steps of:
- providing an occlusion element which is coupled to a delivery element with a dissolvable material, the dissolvable material being dissolvable with a fluid, the dissolvable material forming a dissolvable connection between the delivery element and the occlusion element;
- advancing the occlusion element through a patient's vascular system with the occlusion element coupled to the delivery element with at least the dissolvable connection; and
- dissolving the dissolvable material thereby releasing the occlusion element from the dissolvable connection with the delivery element.
2. The method of claim 1, wherein:
- the dissolving step is carried out with the dissolvable material being dissolved faster by the fluid as compared to other fluids contacting the material during the advancing step.
3. The method of claim 1, wherein:
- the providing step is carried out with the dissolvable material dissolving faster at a selected pH as compared to a pH of other fluids which the material contacts during the advancing step; and
- the dissolving step is carried out by delivering a fluid having the selected pH to dissolve the dissolvable material.
4. The method of claim 1, wherein:
- the dissolving step is carried out with the dissolvable material and fluid being a solute and solvent.
5. The method of claim 1, wherein:
- the dissolving step is carried out by delivering a fluid to the dissolvable material, the fluid being an acid..
6. The method of claim 1, wherein:
- the dissolving step is carried out by delivering a fluid to the dissolvable material, the fluid being a base.
7. The method of claim 5, wherein the dissolvable material includes a material selected from the group consisting of zinc and iron.
8. The method of claim 1, wherein the dissolvable material is a polymer.
9. The method of claim 9, wherein the dissolvable material is a natural polymer.
10. The method of claim 9, wherein the dissolvable material is an alginate.
11. The method of claim 9, wherein the dissolvable material is a cross-linked polymer.
12. The method of claim 11, wherein the dissolving step is carried out by delivering a fluid including a cation which dissolves the cross-linked polymer.
13. The method of claim 8, wherein the polymer is in the form of polymer layers bonded together.
14. The method of claim 13, wherein the polymer is an acrylic polymer.
15. The method of claim 15, wherein the polymer is a methacrylate polymer.
16. The method of claim 13, wherein the dissolving step is carried out by delivering a fluid having a pH different than blood.
17. The method of claim 13, wherein the dissolving step is carried out by using a fluid having a salinity different than blood.
18. The method of claim 17, wherein the dissolving step is carried out with the fluid having a pH of 4-6.5.
19. The method of claim 17, wherein the dissolving step is carried out with the fluid having a pH of 8-95.
20. The method of claim 17, wherein the dissolving step is carried out with the fluid having a pH of less than 7.0.
21. The method of claim 17, wherein the dissolving step is carried out with the fluid having a pH of greater than 7.4.
22. The method of claim 1, further comprising the step of:
- changing a temperature of the dissolvable material during the dissolving step.
23. The method of claim 22, wherein:
- the temperature changing step is carried out by delivering the fluid at a temperature which changes the temperature of the dissolvable material.
24. The method of claim 22, wherein:
- the temperature changing step is carried out by directly heating the dissolvable bond.
25. The method of claim 24, wherein:
- the temperature changing step is carried out by using resistive heating.
26. The method of claim 1, wherein:
- the dissolving step is carried out by delivering the fluid to the material to dissolve the dissolvable material.
27. The method of claim 26, wherein:
- the dissolving step is carried out with the fluid being delivered through the delivery element.
28. The method of claim 27, wherein:
- the dissolving step is carried out with a tube positioned in the delivery element, the tube having a lumen, the tube and delivery element defining a space therebetween, the fluid being delivered through one of the lumen and the space and the fluid being withdrawn through the other of the lumen and the space.
29. The method of claim 1, wherein:
- the providing step is carried out with the occlusion element forming coils.
30. The method of claim 1, wherein:
- the providing step is carried out with the dissolvable material having a cavity.
31. The method of claim 30, wherein:
- the providing step is carried out with the cavity being a throughhole.
32. The method of claim 1, further comprising the step of:
- positioning a blocking element to impede fluid contact with a least a protected portion of the dissolvable material, the blocking element being movable to a position spaced apart from the protected portion of the dissolvable material.
33. The method of claim 32, wherein:
- the blocking element is positioned in a cavity in the dissolvable material.
34. The method of claim 33, wherein:
- the providing step is carried out with the blocking element being a tube; and the method further comprising the step of retracting the tube to expose at least part of the dissolvable material.
35. The method of claim 33, wherein:
- the providing step is carried out with the blocking element being a tube; and
- the dissolving step being carried out with the fluid passing through the tube.
36. The method of claim 1, wherein:
- the providing step is carried out with a flexible sheath extending over the dissolvable material, the flexible sheath being attached to the delivery element.
37. The method of claim 1, wherein:
- the providing step is carried out with the occlusion element having a portion embedded in the dissolvable material.
38. The method of claim 37, wherein:
- the providing step is carried out with the embedded portion being embedded in the dissolvable material in an expanded position, the embedded portion being naturally biased toward a collapsed position; and
- the dissolving step is carried out so that the portion of the occlusion element is no longer embedded in the material thereby permitting the portion to move toward the collapsed position.
39. The method of claim 37, wherein:
- the providing step is carried out with the portion embedded in the material including a plurality of filaments.
40. The method of claim 37, wherein:
- the providing step is carried out with the portion embedded in the dissolvable material being a coil.
41. The method of claim 1, wherein:
- the providing step is carried out with the occlusion element having a plurality of flexible fibers embedded in the dissolvable material.
42. The method of claim 1, wherein:
- the providing step is carried out with the portion embedded in the material including a ball.
43. The method of claim 1, wherein:
- the providing step is carried out with the portion embedded in the material including a cage.
44. The method of claim 1, wherein:
- the providing step is carried out with a flexible sheath covering at least a portion of the dissolvable material.
45. The method of claim 44, wherein:
- the providing step is carried out with the sheath having openings therein.
46. The method of claim 45, wherein:
- the providing step is carried out with the delivery element having a fluid distributing portion with openings for distributing the fluid;
- the dissolving step being carried out to deliver the fluid through the openings in the distributing portion to dissolve the material.
47. The method of claim 46, wherein:
- the providing step is carried out with the distributing portion being conical.
48. The method of claim 1, further comprising the step of:
- moving the delivery element relative to the occlusion element after the dissolving step to fully release the occlusion element from the delivery element.
49. The method of claim 1, wherein:
- the dissolving step fully releases the occlusion element from the delivery element.
50. The method of claim 1, wherein:
- the providing step is carried out with the occlusion element having a blocking portion which isolates the material from the patient's blood;
- the advancing step being carried out so that the blocking portion isolates the material from the patient's blood during the advancing step.
51. The method of claim 50, wherein:
- the providing step is carried out with the blocking portion being a plug of material.
52. The method of claim 51, wherein:
- the providing step is carried out with the plug of material being solder.
53. The method of claim 50, wherein:
- the providing step is carried out with the blocking portion being a disc.
54. The method of claim 1, wherein:
- the dissolving step is carried out with the fluid being a fluid selected from the group consisting of water, saline and the patient's own blood.
55. The method of claim 1, wherein:
- the providing step is carried out with the material being selected from the group consisting of sugar, salt, mannitol or a combination thereof.
56. The method of claim 1, wherein:
- the providing step is carried out with the delivery element having a plurality of occlusion elements; and
- the dissolving step is carried out a number of times to sequentially release the plurality of occlusion elements.
57. The method of claim 56, wherein:
- the providing step is carried out with the delivery element including a tube in which the plurality of occlusion elements is positioned;
- the dissolving step being carried out by moving the tube relative to the occlusion elements to expose the dissolvable material to the fluid.
58. The method of claim 57, wherein;
- the providing step is carried out with the tube having openings therein through which the fluid passes to contact the dissolvable material.
59. The method of claim 58, wherein:
- the providing step is carried out with the delivery element having an outer tube positioned around the tube; and
- the dissolving step is carried out by delivering the fluid through a lumen positioned between the tube and outer tube.
60. The method of claim 59, wherein:
- the dissolving step is carried out by withdrawing the fluid and dissolved parts of the dissolvable material through another lumen between the tube and outer tube.
61. The method of claim 55, wherein:
- the dissolving step is carried out by using a first fluid to dissolve one of the dissolvable connections and a second fluid, different than the first fluid, to dissolve another of the dissolvable connections.
62. The method of claim 1, further comprising the step of:
- detecting whether the occlusion element has been released from the delivery element.
63. The method of claim 62, wherein:
- the detecting step is carried out by applying energy to the delivery element and detecting a change in a parameter thereby indicating release of the occlusion element.
64. The method of claim 63, wherein:
- the detecting step is carried out by applying RF energy.
65. The method of claim 64, wherein:
- the detecting step is carried out with the parameter being the standing wave ratio.
66. A system for delivering a medical device to a patient, comprising:
- a delivery element; and
- a medical device coupled to the delivery element with a dissolvable material, the dissolvable material forming a dissolvable connection between the medical device and the delivery element, the dissolvable material being dissolvable with a fluid.
67. The system of claim 66, wherein:
- the medical device is an occlusion element for occluding a vascular region.
68. The system of claim 67, wherein:
- the delivery element has a lumen.
69. The system of claim 68, further comprising:
- a fluid source coupled to the lumen.
70. The system of claim 69, wherein:
- the fluid source contains a fluid selected from the group of fluids consisting of the patient's own blood, water, saline, and combinations thereof.
71. The system of claim 66, wherein:
- the material is selected from the group of materials consisting of sugar, mannitol, salt and combinations thereof.
72. The system of claim 66, wherein:
- the dissolvable material has a cavity.
73. The system of claim 72, wherein:
- the cavity has a throughhole.
74. The system of claim 66, further comprising:
- a blocking element positioned to impede fluid contact with a least a protected portion of the dissolvable material, the blocking element being movable to a position spaced apart from the protected portion of the dissolvable material to permit dissolution of the protected portion
75. The system of claim 74, wherein:
- the blocking element is positioned in a cavity in the dissolvable material.
76. The system of claim 75, wherein:
- the blocking portion is a tube positioned in the cavity.
77. The system of claim 66, wherein:
- the medical device has an embedded portion which is embedded in the dissolvable material.
78. The system of claim 77, wherein:
- the embedded portion is embedded in the dissolvable material in an expanded position, the embedded portion being naturally biased toward a collapsed position after dissolution of the dissolvable material.
79. The system of claim 77, wherein:
- the portion of the delivery element embedded in the material has a plurality of filaments.
80. The system of claim 77, wherein:
- the portion embedded in the dissolvable material is a coil.
81. The system of claim 66, further comprising:
- a flexible sheath covering at least a portion of the dissolvable material.
82. The system of claim 81, wherein:
- the sheath has openings therein.
83. The system of claim 66, wherein:
- the delivery element has a fluid distributing portion with openings for distributing the fluid.
84. The system of claim 83, wherein:
- the distributing portion is conical.
85. The system of claim 66, wherein:
- the medical element has a blocking portion which protects the material from exposure to fluid outside the delivery device.
86. The system of claim 66, wherein:
- the blocking portion is a plug of material.
87. The system of claim 86, wherein:
- the plug of material is solder.
88. The system of claim 66, further comprising:
- a catheter having a lumen;
- the delivery element being a wire;
- the medical device being mounted to the wire with the dissolvable material.
89. The system of claim 88, further comprising:
- a source of fluid coupled to the lumen, the fluid dissolving the material.
90. The system of claim 66, wherein:
- the delivery element has a helical element;
- the helical element contacting the dissolvable material to enhance the bond between the delivery element and the material.
91. The system of claim 66, wherein:
- the delivery element has a textured surface which contacts the dissolvable material.
92. The system of claim 66, wherein:
- the delivery element has a preloaded portion which exerts a force on at least one of the dissolvable material and the medical device.
93. The system of claim 92, wherein:
- the preloaded portion is compressed in a loaded position and is expanded when in a released position.
94. The system of claim 92, wherein:
- the preloaded portion is radiopaque.
95. The system of claim 94, wherein:
- the preloaded portion has a exposed portion which is exposed in the loaded position, the exposed portion moving inside the medical device when moving to the released position.
96. The system of claim 95, wherein:
- the exposed portion is embedded in the dissolvable material, the dissolvable material being attached to the delivery element.
97. The system of claim 94, wherein:
- the preloaded portion includes a spring.
98. The system of claim 66, wherein:
- the medical device has a preloaded portion which exerts a force on at least one of the material and delivery element.
99. The system of claim 98, wherein:
- the medical device is an occlusion element having coils which are in an expanded shape when embedded in the material and which collapse when the material is dissolved.
100. The system of claim 66, further comprising:
- means for heating the material to enhance dissolution of the material.
101. The system of claim 100, wherein:
- the heating means uses electrical energy and is a resistive heater.
102. The system of claim 66, wherein:
- a number of medical devices are mounted to the delivery element.
103. The system of claim 102, wherein:
- a dissolvable connection is provided between each of the medical devices
104. The system of claim 103, wherein:
- at least two of the dissolvable connections are dissolved with different fluids.
105. A method of delivering a medical device, comprising the steps of:
- providing a medical device which is coupled to a delivery element with a dissolvable material, the dissolvable material being dissolvable with a fluid, the dissolvable material forming a dissolvable bond between the delivery element and the medical device;
- advancing the medical device into a patient with the medical device coupled to the delivery element; and
- dissolving the dissolvable material thereby releasing the medical device from the delivery element.
Type: Application
Filed: Feb 18, 2005
Publication Date: Oct 6, 2005
Applicant: CONCENTRIC MEDICAL, INC., A Delaware Corporation (Mountain View, CA)
Inventors: Hanson Gifford (Woodside, CA), Ivan Sepetka (Los Altos, CA), Son Gia (San Jose, CA), Maria Aboytes (East Palo Alto, CA), Ryan Pierce (Mountain View, CA), Tina Patel (San Carlos, CA), Christopher Ken (San Mateo, CA)
Application Number: 11/061,127