Methods and devices for delivering occlusion elements

US 20050222580A1
Filed: 02/18/2005
Published: 10/06/2005
Est. Priority Date: 02/09/2001
Status: Abandoned Application

First Claim

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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.

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Abstract

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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105 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.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 13, 14, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
- - 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.
  - 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.
  - 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.

9. The method of claim 9, wherein the dissolvable material is a natural polymer.
- View Dependent Claims (10, 11, 12)
- - 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.

15. The method of claim 15, wherein the polymer is a methacrylate polymer.

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.
- View Dependent Claims (67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104)
- - 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.

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Current Assignee
Stryker Corporation
Original Assignee
Concentric Medical, Inc. (Stryker Corporation)
Inventors
Gifford, Hanson S. III, Sepetka, Ivan, Pierce, Ryan, Gia, Son, Aboytes, Maria, Patel, Tina, Ken, Christopher

Application Number

US11/061,127
Publication Number

US 20050222580A1
Time in Patent Office

Days
Field of Search
US Class Current

606/108
CPC Class Codes

A61B 17/12022   Occluding by internal devic...

A61B 17/1214   Coils or wires

A61B 17/12145   having a pre-set deployed t...

A61B 17/1215   comprising additional mater...

A61B 2017/00477   Coupling A61B2017/0046 take...

A61B 2017/12059   Joint of soluble material

A61M 25/007   Side holes, e.g. their prof...

Methods and devices for delivering occlusion elements

First Claim

1 Assignment

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Abstract

74 Citations

105 Claims

Specification

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Methods and devices for delivering occlusion elements

First Claim

1 Assignment

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0 Petitions

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Accused Products

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Abstract

74 Citations

105 Claims

Specification

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Use Cases

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