Tissue compression device with pressure indicator

• US 10,034,671 B2
• Filed: 08/16/2016
• Issued: 07/31/2018
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Saatchi, Sanaz, Berglund, Joseph, Flannery, Conor, Hoff, Mark, Mason, Brian Joseph, Miyashita, Yusuke, Pieron, Remy O'Leary, Williams, Justin
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US15/238,461
• Publication Number:
  US 20160354091A1
• Time in Patent Office: 714 Days
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/132 Tourniquets sphygmomanometer A61B5/022
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61F 5/32 Adjustable pressure pads
• CPC Class Codes: A61H 1/006 Apparatus for applying pressure or blows for compressive stressing of a part of the skeletal structure, e.g. for preventing or alleviating osteoporosis
• CPC Class Codes: A61H 9/0092 Cuffs therefor

Abstract

Tissue compression devices having pressure indicators and methods of using the same. The tissue compression devices provide feedback to a user with respect to the pressure being applied to selected tissue at a selected location such as a radial artery to assist the user in applying the desired amount of pressure to the tissue (such as the pressure needed to achieve hemostasis at an access site). The pressure indication may be provided by a ring indicator that moves between two configurations (e.g., a concave configuration and a convex configuration), a bellow chamber in a housing, a bladder located below a bladder window, etc.

Claims

1. A tissue compression device comprising:

a base comprising a bottom surface and a top surface, wherein the base comprises a bladder orifice formed through the base from the bottom surface to the top surface;

retention structure attached to the base, the retention structure configured to retain the base over a selected location, wherein the bottom surface of the base is configured to face selected tissue at the selected location and wherein the top surface of the base is configured to face away from the selected tissue when the base is retained over the selected location;

a bladder operably attached to the base, wherein a lower surface of the bladder faces the selected tissue when the retention structure retains the base over the selected location, and wherein an upper surface of the bladder faces away from the lower surface of the bladder;

a ring indicator positioned above and in contact with the upper surface of the bladder, wherein the ring indicator is in a concave configuration, wherein a force exerted by the upper surface of the bladder on the ring indicator moves the ring indicator from the concave configuration to a convex configuration, and wherein an inner edge of the indicator ring is further away from the bottom surface of the base when the ring indicator is in the convex configuration than when the ring indicator is in the concave configuration;

wherein the tissue compression device defines a compression axis extending through the upper surface of the bladder, the bladder orifice in the base, and the lower surface of the bladder when the base is retained over the selected location by the retention structure.

2. A device according to claim 1, wherein the ring indicator is configured to move from the concave configuration to the convex configuration when fluid pressure in the bladder reaches a selected level.

3. A device according to claim 1, wherein the ring indicator comprises an indicator surface facing away from the upper surface of the bladder and a contact surface facing and in contact with the upper surface of the bladder, wherein the indicator surface faces the compression axis when the ring indicator is in the concave configuration and wherein the indicator surface faces away from the compression axis when the ring indicator is in the convex configuration.

4. A device according to claim 3, wherein the ring indicator comprises an indicator color that contrasts with a color of the upper surface of the bladder.

5. A device according to claim 1, wherein the device further comprises a dial attached to the base, and wherein the ring indicator is attached to the dial.

6. A device according to claim 5, the device further comprising:

a plurality of dial posts extending from the top surface of the base, wherein the plurality of dial posts are arranged around a perimeter of the bladder orifice, wherein each post of the plurality of dial posts comprises an inner surface facing the bladder orifice and an outer surface facing away from the bladder orifice;

wherein the dial is mounted on the plurality of dial posts, the dial comprising a dial channel that comprises an opening facing the top surface of the base, an inner wall facing the inner surfaces of the plurality of dial posts, and an outer wall facing the outer surfaces of the plurality of dial posts;

mating features on the inner surface of the plurality of dial posts and the inner wall of the dial channel that are configured to move the dial towards the top surface of the base when the dial is rotated in a first direction about the compression axis and are also configured to move the dial away from the top surface of the base when rotated in a second direction about the compression axis.

7. A device according to claim 6, wherein the mating features comprise raised ribs on the inner surfaces of the plurality of dial posts and recesses formed into the inner wall of the dial channel, wherein the raised ribs are located within the recesses.

8. A device according to claim 6, wherein the dial comprises a dial orifice, and wherein the upper surface of the bladder is visible through the dial orifice.

9. A device according to claim 8, wherein the ring indicator comprises an indicator surface facing away from the upper surface of the bladder and a contact surface facing and in contact with the upper surface of the bladder, wherein the indicator surface faces the compression axis when the ring indicator is in the concave configuration and wherein the indicator surface faces away from the compression axis when the ring indicator is in the convex configuration, and wherein the indicator surface of the ring indicator is visible to a viewer viewing the upper surface of the bladder along the compression axis through the dial orifice when the ring indicator is in the concave configuration.

10. A device according to claim 8, wherein the upper surface of the bladder forms a curved surface that bulges upward away from the top surface of the base when the dial compresses the upper surface of the bladder and/or wherein the upper surface of the bladder comprises a matte finish.

11. A device according to claim 6, the device further comprising:

a stop member extending from the top surface of the base, wherein the stop member is located in the channel of the dial;

a plurality of slots formed in the outer wall of the channel, wherein the stop member is configured to engage with the plurality of slots to prevent rotation of the dial about the compression axis in the absence of a force acting to move the stop member out of engagement with the plurality of stops;

a stop member release lever operably connected to the stop member, wherein the stop member release lever is configured such that movement of the stop member release lever moves the stop member out of engagement with the plurality of slots in the outer wall of the dial channel such that the dial can rotate about the compression axis.

12. A device according to claim 11, wherein the device further comprises:

a second stop member extending from the top surface of the base, wherein the second stop member is located in the channel of the dial, wherein the second stop member is configured to engage with the plurality of slots to prevent rotation of the dial about the compression axis in the absence of a force acting to move the second stop member out of engagement with the plurality of stops;

a second stop member release lever operably connected to the second stop member, wherein the second stop member release lever is configured such that movement of the second stop member release lever moves the second stop member out of engagement with the plurality of slots in the outer wall of the dial channel such that the dial can rotate about the compression axis.

13. A device according to claim 1, wherein a first portion of the bladder including the upper surface of the bladder is located above the top surface of the base, and wherein a second portion of the bladder including the lower surface of the bladder is located between the bottom surface of the base and a limb on which the base is retained.

14. A device according to claim 1, wherein the bladder comprises an upper chamber positioned adjacent a lower chamber, wherein the upper chamber is located above the top surface of the base and the lower chamber is located below the bottom surface of the base.

15. A device according to claim 14, wherein the bladder comprises an opening between the upper chamber and the lower chamber, wherein fluid in the upper chamber can pass into or out of the lower chamber through the opening, and wherein inflation of the bladder moves the top layer of the upper chamber away from the top surface of the base and also moves the bottom layer of the lower chamber away from the bottom surface of the base.

16. A device according to claim 14, wherein an outer perimeter of the upper chamber and an outer perimeter of the lower chamber are larger than the bladder orifice as measured in a plane transverse to the compression axis.

17. A device according to claim 14, wherein an outer perimeter of the upper chamber has a different shape than a shape of an outer perimeter of the lower chamber when projected onto a plane transverse to the compression axis.

18. A device according to claim 14, wherein the upper chamber comprises a first upper chamber and wherein the bladder further comprises a second upper chamber located between the first upper chamber and the top surface of the base, wherein fluid within the first upper chamber passes through the second upper chamber when moving into the lower chamber.

19. A device according to claim 14, wherein the lower chamber comprises a first lower chamber and wherein the bladder further comprises a second lower chamber located between the first lower chamber and the bottom surface of the base, wherein fluid within the first lower chamber passes through the second lower chamber when moving into the upper chamber.

20. A device according to claim 1, wherein the bladder comprises a port in fluid communication with the bladder and configured to allow for fluid delivery into the bladder.

21. A device according to claim 1, wherein the bladder comprises a pump configured to deliver fluid into the bladder.

22. A method of monitoring pressure in a bladder of a tissue compression device, the method comprising:

restraining a tissue compression device over a selected location, wherein the tissue compression device comprises;

a bladder comprising an upper surface located above and facing away from a top surface of a base of the tissue compression device;

a ring indicator positioned above and in contact with the upper surface of the bladder, wherein the upper surface of the bladder is located between the ring indicator and the top surface of the bladder, and wherein the ring indicator is in a concave configuration;

increasing fluid pressure within the bladder to cause the upper surface of the bladder to apply a force to the ring indicator sufficient to move the ring indicator from the concave configuration to a convex configuration, wherein an inner edge of the indicator ring is further away from the top surface of the base when the ring indicator is in the convex configuration than when the ring indicator is in the concave configuration.

23. A method according to claim 22, wherein the ring indicator is configured to move from the concave configuration to the convex configuration when the fluid pressure in the bladder reaches a selected level.

24. A method according to claim 22, wherein increasing fluid pressure within the bladder comprises increasing the volume of fluid within the bladder.

25. A method according to claim 22, wherein the tissue compression device comprises a dial attached to the base, and wherein the ring indicator is attached to the dial, and further wherein increasing fluid pressure within the bladder comprises rotating the dial in a first direction about an axis that extends through the upper surface of the bladder to move the dial towards the top surface of the base to compress the bladder.

26. A method according to claim 25, wherein the method further comprises decreasing the fluid pressure within the bladder by rotating the dial in a second direction about the axis to move the dial away from the top surface of the base.