Low-cost disposable tourniquet cuff apparatus and method

• US 20070135835A1
• Filed: 12/14/2005
• Published: 06/14/2007
• Est. Priority Date: 12/14/2005
• Status: Active Grant

• Current Assignee: Western Clinical Engineering Ltd.
• Original Assignee: Western Clinical Engineering Ltd.
• Inventors: Jameson, Michael, McEwen, James, Glinz, Kenneth, Upward, Allen
• Granted Patent: US 8,137,378 B2
• Time in Patent Office: Days
• US Class Current: 606/203
• CPC Class Codes: A61B 17/1322 comprising a flexible encircling member A61B17/135 takes precedence
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/0023 disposable

Abstract

Low-cost tourniquet cuff apparatus includes: an inflatable bladder formed of flexible material having a bladder width dimension when the bladder is uninflated and a having a bladder length dimension sufficient for encircling a limb of a surgical patient at a desired location on the limb and for overlapping upon itself, wherein the bladder includes a bladder first inner surface facing a bladder second inner surface along the bladder length dimension and across the bladder width dimension when the bladder is uninflated; securing means for securing the overlapping bladder around the limb at the desired location; port means communicating pneumatically with the inflatable bladder and releasably connectable to a tourniquet instrument for supplying the bladder with pressurized gas; and stiffener means having a predetermined stiffness and having a stiffener width dimension less than the bladder width dimension, wherein the stiffener means is non-releasably attached to the bladder first inner surface within the inflatable bladder. The stiffener means may have a stiffener length dimension that is at least equal to the limb circumference. A method of making the low-cost tourniquet cuff allows the cuff elements to be simply assembled and then sealed in one operation using radio-frequency welding or a similar process.

Claims

1. Low-cost disposable tourniquet cuff apparatus for encircling a patient'"'"'s limb at a desired location on the limb to stop blood flow past the cuff, comprising:

a first sheet formed of flexible material that is impermeable to gas;

a second sheet formed of flexible material impermeable to gas that is positioned facing the first sheet;

a gas-tight seal joining the first sheet to the second sheet around a perimeter to form an inflatable bladder within the perimeter, wherein the bladder has a bladder width dimension and a bladder length dimension greater than the circumference of a patient'"'"'s limb at a desired location;

securing means adapted to allow surgical staff to secure the cuff apparatus around the limb at a desired location on the limb so that the bladder overlaps upon itself;

port means communicating with the bladder and releasably connectable to a tourniquet instrument for establishing a pneumatic passageway for pressurized gas between the bladder and the tourniquet instrument; and

stiffener means formed of material that is less flexible than the first sheet, wherein the stiffener means has a stiffener width dimension less than the bladder width dimension and has a stiffener length dimension less than the bladder length dimension, and wherein the stiffener means is attached to the first sheet within the bladder and away from the perimeter.

2. The apparatus of claim 1 wherein the length dimension of the stiffener means is at least equal to the circumference of the limb at the location.

3. The apparatus of claim 1 wherein the first and second sheets have side edges oriented in a direction substantially parallel to the length dimension, and wherein the apparatus includes tie strap means adapted to facilitate application by surgical staff to encircle and secure the cuff apparatus around the limb, wherein the tie strap means extends from between the first and second sheets past the side edges in a direction substantially perpendicular to the length dimension and wherein the tie strap means is non-releasably attached to the first sheet and to the second sheet.

4. The apparatus of claim 1 wherein the first sheet and the second sheet are formed of materials that include first and second thermoplastic polymers respectively that are in physical contact with each other near the perimeter, wherein the first and second polymers have properties that facilitate welding together, and wherein the gas-tight seal is formed by welding together the first and second sheets around the perimeter.

5. The apparatus of claim 4 wherein the stiffener means and the first sheet are in contact within a predetermined area, wherein the stiffener means is formed of material that includes a thermoplastic stiffener polymer within the area having a physical property that facilitates molecular diffusion between the first polymer and the stiffener polymer upon application of heat and pressure, and wherein the stiffener means is attached to the first sheet by welding within the predetermined area.

6. The apparatus of claim 5 and including barrier means for preventing welding between the stiffener means and the second sheet, wherein the stiffener means includes a stiffener surface facing the second sheet, and wherein the barrier means forms a barrier between the stiffener surface and the second sheet.

7. The apparatus of claim 5 and including barrier means for preventing welding between the stiffener means and the second sheet, wherein the stiffener means includes a stiffener surface facing the second sheet, wherein the stiffener surface is formed of material that includes a thermoplastic stiffener polymer, and wherein the barrier means is formed by preselecting the stiffener polymer to have a physical property that inhibits molecular diffusion between the stiffener polymer of the stiffener surface and the second thermoplastic polymer of the second sheet.

8. Low-cost tourniquet cuff apparatus comprising:

an inflatable bladder formed of flexible material having a bladder width dimension when the bladder is uninflated and a having a bladder length dimension sufficient for encircling a limb of a surgical patient at a desired location on the limb and for overlapping upon itself, wherein the bladder includes a bladder first inner surface facing a bladder second inner surface along the bladder length dimension and across the bladder width dimension when the bladder is uninflated;

securing means for securing the overlapping bladder around the limb at the desired location;

port means communicating pneumatically with the inflatable bladder and releasably connectable to a tourniquet instrument for supplying the bladder with pressurized gas; and

stiffener means having a predetermined stiffness and having a stiffener width dimension less than the bladder width dimension, wherein the stiffener means is non-releasably attached to the bladder first inner surface within the inflatable bladder.

9. The apparatus of claim 8 wherein the stiffener means has a stiffener length dimension that is at least equal to the limb circumference.

10. The apparatus of claim 8 wherein the bladder first inner surface is formed of material that includes a first predetermined thermoplastic polymer, wherein the stiffener means has a first stiffener surface facing the bladder first inner surface, and wherein the stiffener means is adapted to facilitate welding of the first stiffener surface to the bladder first inner surface, thereby attaching the stiffener means to the bladder first inner surface.

11. The apparatus of claim 10 wherein the first stiffener surface of the stiffener means is formed of material that includes a second predetermined thermoplastic polymer within a predetermined area, and wherein the physical properties of the first and second polymers are preselected to facilitate welding of the first stiffener surface to the bladder first inner surface within the predetermined area.

12. The apparatus of claim 10 wherein the stiffener means further includes a second stiffener surface facing the bladder second inner surface, and wherein the second stiffener surface is adapted to inhibit welding between the second stiffener surface and the bladder second inner surface.

13. The apparatus of claim 10 wherein the stiffener means further includes a second stiffener surface facing the bladder second inner surface, and wherein a predetermined area of the bladder second inner surface is adapted to inhibit welding between the second stiffener surface and the bladder second inner surface.

14. Low-cost tourniquet cuff apparatus for encircling a patient'"'"'s limb at a desired location on the limb, comprising:

a first sheet formed of flexible material that is impervious to gas and that includes a first thermoplastic polymer;

a second sheet formed of flexible material impermeable to gas that is positioned facing the first sheet and that includes a second thermoplastic polymer;

a gas-tight seal joining the first sheet to the second sheet around a perimeter to form an inflatable bladder within the perimeter, wherein the bladder has a bladder width dimension and a bladder length dimension greater than the circumference of a patient'"'"'s limb at a desired location;

securing means adapted to allow surgical staff to encircle the cuff apparatus around the limb at a desired location on the limb so that the bladder overlaps upon itself;

port means communicating with the bladder and releasably connectable to a tourniquet instrument for establishing a pneumatic passageway for pressurized gas between the bladder and the connected tourniquet instrument;

stiffener means formed of material that is less flexible than the first sheet, wherein the stiffener means has a stiffener width dimension less than the bladder width dimension and a stiffener length dimension less than the bladder length dimension, wherein the stiffener means includes a first stiffener surface facing the first sheet and formed of a material that includes a thermoplastic stiffener polymer, wherein the polymers of the first stiffener surface and the first sheet are preselected to have physical properties that facilitate welding together, and wherein the stiffener surface is welded to the first sheet within the bladder and away from the perimeter; and

barrier means adapted to prevent welding between the stiffener means and the second sheet.

15. A method of making a low-cost disposable tourniquet cuff for encircling a patient'"'"'s limb at a desired location on the limb to stop blood flow past the cuff, including the steps of:

positioning a stiffener between a first sheet and a second sheet, wherein the first and second sheets are formed of flexible material adapted for welding together;

attaching the stiffener having a predetermined stiffness to the first sheet within a predetermined perimeter so that the stiffener is located away from the perimeter;

positioning a port at a predetermined location relative to the stiffener and the first sheet and within the perimeter;

welding the first sheet to the second sheet around the perimeter to form an inflatable bladder within the perimeter, wherein the bladder has a bladder width dimension and a bladder length dimension that is greater than the circumference of a patient'"'"'s limb at a desired location, and wherein the bladder encloses the stiffener attached to the first sheet;

welding the port at the location to establish a gas-tight passageway for pressurized gas to flow between the inflatable bladder through the stiffener and the first sheet and a releasably connectable tourniquet instrument.

16. The method as described in claim 15 and including the step of attaching securing means to the bladder to allow surgical staff to secure the bladder when the bladder encircles the limb at a desired location and overlaps upon itself.

17. The method as described in claim 15 and including the step of inserting a barrier between the stiffener and the second sheet within the perimeter before the first sheet is welded to the second sheet, to prevent the stiffener from being welded to the second sheet during the step of welding the port to establish the gas-tight passageway.

18. A method of making a low-cost disposable tourniquet cuff for encircling a patient'"'"'s limb at a desired location on the limb to stop blood flow past the cuff, including the steps of:

positioning a stiffener on a first sheet at a predetermined location within a predetermined perimeter and away from the perimeter, wherein the first sheet is formed of flexible material that is adapted for welding near the perimeter;

positioning a port within the perimeter at a predetermined location relative to the first sheet and the stiffener to establish a pneumatic conduit though the first sheet and the stiffener;

establishing a barrier to prevent welding between the stiffener and a second sheet near the port;

positioning the second sheet over the first sheet so that the second sheet covers the stiffener and the area enclosed by the perimeter and is adapted for welding to the first sheet around the perimeter;

welding the first sheet to the second sheet around the perimeter to form an inflatable bladder within the perimeter wherein the bladder encloses the stiffener and has a bladder width dimension greater than the stiffener width dimension and a bladder length dimension that is greater than the circumference of a patient'"'"'s limb at a desired location; and

welding the port at the location to establish a gas-tight passageway for pressurized gas to flow between the inflatable bladder through the stiffener and the first sheet and a releasably connectable tourniquet instrument.

19. The method as described in claim 18 wherein the step of welding the first sheet to the second sheet and step of welding the port at the location are performed simultaneously.