Emergency hemostasis device utilizing energy

• US 7,674,260 B2
• Filed: 04/28/2005
• Issued: 03/09/2010
• 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.
• Primary Examiner(s): Cohen; Lee S
• Application Number:
  US11/118,653
• Publication Number:
  US 20060247614A1
• Time in Patent Office: 1,776 Days
• Field of Search: 606/41, 607/101
• 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 comprised of a porous layer;

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 included within the porous layer of the base member and configured to connect to a vacuum source, wherein the porous layer is configured to enable the vacuum line to draw tissue towards the 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, where the base member and the electrode carrier attached thereto are substantially flexible.

3. The apparatus of claim 2, 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.

4. The apparatus of claim 3, 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.

5. 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.

6. The apparatus of claim 5, 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.

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

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

a hemostasis device including;

a base member comprised of a porous layer;

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 provided within the porous layer of the base member and configured to connect to a vacuum source, wherein the porous layer is configured to draw tissue towards the bipolar electrodes during tissue ablation;

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

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.

9. The system of claim 8, where the hemostasis device further comprises:

a thermally insulated layer for protecting a user of the hemostasis device from the electrode carrier.

10. The system of claim 8, 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.

11. The system of claim 8, where the base member and the electrode carrier of the hemostasis device are substantially flexible.

12. The system of claim 11, 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.

13. The system of claim 12, 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.

14. The system of claim 8, 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.

15. The system of claim 14, 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.

16. The system of claim 8, where the base member is substantially rigid.

17. 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 comprised of a porous layer, the electrode carrier attached to a first surface of the porous layer 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 included within the porous layer of the base member and coupled to a vacuum source;

activating the vacuum source to draw the bleeding tissue into closer contact with the porous layer and thereby 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.

18. The method of claim 17, where the porous layer is 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.

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

a base member shaped as a glove configured to be worn by a user and comprising a porous layer including a vacuum line couplable to a vacuum source to enable tissue to be drawn to the porous layer during ablation and an insulating layer for protecting the user during ablation;

an electrode carrier attached to the porous layer 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 during 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.

20. The apparatus of claim 19, 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.

21. The apparatus of claim 20, 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.

22. The apparatus of claim 19, 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.

23. The apparatus of claim 22, 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.

24. The apparatus of claim 19, 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.

25. The apparatus of claim 24, 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.