Hemostasis device

• US 20060247614A1
• Filed: 04/28/2005
• Published: 11/02/2006
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Sampson, Russel M., Skalnyi, Eugene V.
• Granted Patent: US 7,674,260 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A41D 19/0024 with accessories
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 42/10 Surgical gloves

Abstract

A method and system for achieving hemostasis (the stoppage of bleeding) is described. RF (radio frequency) energy is used to ablate the surface of tissue to stop bleeding. The depth of destruction of the tissue can be controlled so as to desiccate and coagulate the tissue. In one implementation, an electrode carrier including bipolar electrodes is applied to the tissue, and RF energy transmitted through the bipolar electrodes to ablate the tissue. A layer of desiccated tissue can be created as well as coagulation of the tissue to achieve hemostasis.

Claims

1. An apparatus for substantially achieving hemostasis by tissue ablation, comprising:

a base member;

an electrode carrier attached to a surface of the base member, the electrode carrier including one or more bipolar electrodes that are configured to connect to a source of radio frequency energy;

a vacuum line configured to connect to a vacuum source and to draw moisture away from the one or more bipolar electrodes during tissue ablation; and

a controller electrically coupled to the electrode carrier and configured to control the delivery of radio frequency energy to the one or more bipolar electrodes such that tissue in contact with the electrode carrier can be ablated to a desired depth of destruction to achieve substantial hemostasis.

2. The apparatus of claim 1, further comprising:

a porous layer positioned between the base member and the electrode carrier, the porous layer coupled to the vacuum line.

3. The apparatus of claim 1, where the base member and the electrode carrier attached thereto are substantially flexible.

4. The apparatus of claim 3, where the base member comprises a glove including a palm region and finger regions and the electrode carrier is attached to the palm region of the base member.

5. The apparatus of claim 4, further comprising one or more additional electrode carriers, where the one or more additional electrode carriers are attached to the finger regions of the base member.

6. The apparatus of claim 1, where the electrode carrier comprises woven strips of a non-conductive material and where the one or more bipolar electrodes comprise electrode wires woven in a first direction between the strips of non-conductive material.

7. The apparatus of claim 6, where sets of two or more electrode wires are woven in a first direction between each strip of non-conductive material orientated in the first direction, where each set of electrode wires alternates polarity, and a pair of sets of electrode wires comprises a bipolar electrode.

8. The apparatus of claim 1, where the base member is substantially rigid.

9. The apparatus of claim 1, where the base member is substantially cylindrically shaped, and the electrode carrier is attached to an exterior surface of the cylindrically shaped base member.

10. The apparatus of claim 1, where the base member is substantially cylindrically shaped, and the electrode carrier is attached to an interior surface of the cylindrically shaped base member.

11. A system for substantially achieving hemostasis by tissue ablation, comprising:

a hemostasis device including;

a base member;

an electrode carrier attached to a surface of the base member, the electrode carrier including one or more bipolar electrodes, the one or more bipolar electrodes configured to connect to a source of radio frequency energy;

a vacuum line configured to connect to a vacuum source;

a source of radio frequency energy electrically coupled to the one or more bipolar electrodes;

a controller to control the delivery of radio frequency energy from the source of radio frequency energy to the one or more bipolar electrodes such that tissue can be ablated to a desired depth of destruction to achieve substantial hemostasis; and

a vacuum source coupled to the vacuum line and operable to draw bleeding tissue into contact with the electrode carrier and to draw moisture generated during delivery of radio frequency energy to the one or more bipolar electrodes and ablation of the tissue away from the one or more bipolar electrodes and to substantially eliminate liquid surrounding the one or more bipolar electrodes.

12. The system of claim 11, where the hemostasis device further comprises:

a porous layer positioned between the base member and the electrode carrier and coupled to the vacuum line.

13. The system of claim 11, further comprising:

one or more additional electrode carriers; and

a user input device configured to receive input from a user selecting one or more of the electrode carriers, the user input device coupled to the source of radio frequency energy;

where the source of radio frequency energy is operable to deliver radio frequency energy to the one or more electrode carriers based on the user input.

14. The system of claim 11, where the base member and the electrode carrier of the hemostasis device are substantially flexible.

15. The system of claim 14, where the base member of the hemostasis device comprises a glove including a palm region and finger regions and the electrode carrier is attached to the palm region of the base member.

16. The system of claim 15, further comprising one or more additional electrode carriers, where the one or more additional electrode carriers are attached to the finger regions of the base member.

17. The system of claim 11, where the electrode carrier comprises woven strips of a non-conductive material and where the one or more bipolar electrodes comprise electrode wires woven in a first direction between the strips of non-conductive material.

18. The system of claim 17, where sets of two or more electrode wires are woven in a first direction between each strip of non-conductive material orientated in the first direction, where each set of electrode wires alternates polarity, and a pair of sets of electrode wires comprises a bipolar electrode.

19. The system of claim 11, where the base member is substantially rigid.

20. The system of claim 11, where the base member is substantially cylindrically shaped, and the electrode carrier is attached to an exterior surface of the cylindrically shaped base member.

21. The system of claim 11, where the base member is substantially cylindrically shaped, and the electrode carrier is attached to an interior surface of the cylindrically shaped base member.

22. A method for blood coagulation, comprising:

positioning an electrode carrier of a hemostasis device in contact with bleeding tissue, the hemostasis device including;

a base member, the electrode carrier attached to a surface of the base member, the electrode carrier including one or more bipolar electrodes connected to a source of radio frequency energy, and a vacuum line connected to a vacuum source;

activating the vacuum source to draw the bleeding tissue into closer contact with the electrode carrier and to draw moisture released from the tissue during ablation away from the one or more bipolar electrodes;

activating the source of radio frequency energy and delivering radio frequency energy to the one or more bipolar electrodes and ablating the tissue in contact with the one or more bipolar electrodes; and

ceasing delivery of the radio frequency energy upon reaching a desired depth of destruction of the tissue;

wherein hemostasis is substantially achieved in a region of the ablation.

23. The method of claim 22, where the hemostasis device further includes a porous layer positioned between the base member and the electrode carrier and coupled to the vacuum line, where upon activating the vacuum source the porous layer facilitates distributing the vacuum across the electrode carrier.

24. An apparatus for achieving hemostasis by tissue ablation, comprising:

a base member shaped as a glove configured to be worn by a user;

an electrode carrier attached to a surface of the base member, the electrode carrier including one or more bipolar electrodes that are configured to connect to a source of radio frequency energy; and

a controller electrically coupled to the electrode carrier and configured to control the delivery of radio frequency energy to the one or more bipolar electrodes such that tissue in contact with the electrode carrier can be ablated to a desired depth of destruction to achieve substantial hemostasis.

25. The apparatus of claim 24, further comprising:

a porous layer positioned between the base member and the electrode carrier, the porous layer including a vacuum line configured to connect to a vacuum source and to draw moisture away from the one or more bipolar electrodes during tissue ablation.

26. The apparatus of claim 24, where the base member includes a palm region and finger regions and the electrode carrier is attached to the palm region of the base member.

27. The apparatus of claim 26, further comprising one or more additional electrode carriers, where the one or more additional electrode carriers are attached to undersides of the finger regions of the base member.

28. The apparatus of claim 24, where the base member includes a main region corresponding to the hand of a glove and finger regions corresponding to fingers of a glove and the electrode carrier is attached to a top side of the main region opposite to a palm side of the main region.

29. The apparatus of claim 28, further comprising one or more additional electrode carriers, where the one or more additional electrode carriers are attached to top sides of the finger regions of the base member.

30. The apparatus of claim 24, where the electrode carrier comprises woven strips of a non-conductive material and where the one or more bipolar electrodes comprise electrode wires woven in a first direction between the strips of non-conductive material.

31. The apparatus of claim 30, where sets of two or more electrode wires are woven in a first direction between each strip of non-conductive material orientated in the first direction, where each set of electrode wires alternates polarity, and a pair of sets of electrode wires comprises a bipolar electrode.