Devices and methods for treatment of damaged tissue
View Patent ↗Methods and devices for treatment of damaged tissue are disclosed, including treatment of wounds by employing non-electrically powered, reduced pressure therapy devices. Maintenance and control of the sub atmospheric pressure exerted may be provided by such devices while minimizing discomfort to the user. The devices may be configured to be worn inconspicuously underneath clothing.
1. A reduced pressure treatment system, comprising:
a flexible polyurethane cover comprising a first side, a second side, and an opening therethrough;
a hydrocolloid adhesive located on the first side of the cover;
a flexible port attached to the second side of the cover, the port comprising a tubing connector and lumen in communication with the opening of the cover;
a tube attached to the port at the tubing connector;
an elongate activation key;
a chamber adapted to create a reduced pressure, said chamber having a distal end wall with an inlet opening, a proximal opening, and a rigid non-circular side wall between the seal end wall and the proximal opening; and
a seal located within the chamber, the seal comprising a perimeter that forms a vacuum-resistant seal with the rigid non-circular side wall of the chamber and is configured to slide along a longitudinal axis of the chamber while creating said reduced pressure and to removably receive the distal end of an elongate activation key;
a proximal end cap attached about the proximal opening of the vacuum chamber, the proximal end cap comprising an activation key opening, and a spring attachment site; and
at least one coiled ribbon spring located in the chamber, the spring comprising a distal end attached to the seal and a proximal end attached to the spring attachment site of the proximal end cap.
2. A reduced pressure treatment system, comprising:
a flexible cover comprising a first side, a second side, and an opening there through;
an adhesive located on the first side of the cover;
a port attached to the second side of the cover, the port comprising a lumen in communication with the opening of the cover;
a tube attached to the port;
a chamber comprising an inlet opening and a rigid side wall; and
a seal mechanism located within the chamber, the seal mechanism comprising a perimeter that forms a vacuum-resistant seal with the rigid side wall of the chamber and is configured to slide along a longitudinal axis of the chamber while creating reduced pressure and to removably receive an activation element; and
a spring mechanism located in the chamber and attached to the seal mechanism.
3. The system of claim 1 , wherein the cover comprises a permeable polyurethane cover.
4. The system of claim 1 , wherein the adhesive comprises a hydrocolloid.
5. The system of claim 1 , wherein the port comprises an elastomeric material.
6. The system of claim 4 , wherein the port comprises a flat, elastomeric base.
7. The system of claim 1 , wherein the port is a flexible port.
8. The system of claim 1 , wherein the spring mechanism comprises a ribbon spring.
9. The system of claim 1 , wherein the spring mechanism comprises a substantially constant force spring.
10. The system of claim 1 , wherein the spring mechanism comprises two ribbon springs.
11. The system of claim 1 , wherein the chamber further comprises a distal end wall and a proximal opening.
12. The system of claim 10 , wherein the inlet opening of the chamber is located on the distal end wall.
13. The system of claim 10 , wherein the rigid side wall of the chamber comprises a non-circular cross-sectional shape.
14. The system of claim 12 , wherein the non-circular cross-sectional shape is an oval shape.
15. The system of claim 10 , further comprising an end cap attached to the proximal opening of the chamber.
16. The system of claim 14 , wherein the end cap comprises an activation opening.
17. The system of claim 15 , wherein spring mechanism is attached to the end cap.
18. The system of claim 1 , wherein the seal mechanism comprises a rigid structure and a soft sealing structure attached to the rigid structure.
19. The system of claim 17 , wherein spring mechanism is attached to the rigid structure.
20. The system of claim 9 , wherein the each of the two ribbon springs comprises an inner surface, an outer surface and edges therebetween.
21. The system of claim 19 , wherein a flat surface of each ribbon spring faces a flat surface of the other ribbon spring.
22. The system of claim 20 , each ribbon spring intersects a line located across a maximum dimension of the seal mechanism.
23. The system of claim 20 , wherein the ribbon springs have opposite coil orientations.
24. The system of claim 1 , further comprising a lubricant on the rigid side wall of the chamber.
25. The system of claim 1 , wherein the seal mechanism is further configured to removably receive an activation element.
26. The system of claim 24 , further comprising an activation element configured to be removably inserted into the chamber to displace the seal mechanism.
27. The system of claim 25 , wherein the activation element is configured to releasably lock the position of the seal mechanism.
28. A system for treating a wound of a patient, comprising:
a sealable wound covering comprising a flexible sealant layer and an integrally formed attachment port having a lumen that passes through the port; and
a non-electrically powered, reduced pressure generating assembly capable of being activated to apply said reduced pressure, comprising:
a suction chamber with a longitudinal axis and an initial non-circular cross-sectional shape transverse to the longitudinal axis and an internal volume of 250 cc or less, said chamber capable of being primed prior to activation, and capable of maintaining its initial non-circular cross-sectional shape after activation;
a piston assembly configured to slide inside the suction chamber along the longitudinal axis and having a non-circular cross-sectional shape transverse to the longitudinal axis;
at least one substantially constant force spring coil coupled to the piston assembly and configured to reduce pressure in the suction chamber by at least 50 mmHg; and
a connector tube configured to releasably attach the chamber to the sealable wound covering at the attachment port, to permit fluid communication between the wound and the reduced pressure generating apparatus through the sealable wound covering.
29. The system of claim 28 , wherein the suction chamber is adapted to collect exudate fluids from the wound.
30. The system of claim 28 , wherein said piston assembly divides said internal volume of said suction chamber into a variable-volume fluid collection chamber and a variable-volume working chamber,
said reduced pressure generating assembly having a removable elongate priming tool for priming the assembly by reducing the volume of the fluid collection chamber and expanding the volume of the working chamber prior to activation, and
an activating device to cause the assembly to apply reduced pressure to the wound by expanding the volume of the fluid collection chamber through discharging potential energy stored in said at least one spring coil.
31. The system of claim 28 , wherein the system is silent during application of the reduced pressure to the wound.
32. The system of claim 28 , wherein said system further comprises a pressure gauge for indicating the level of reduced pressure being applied by the system after activation.
33. The system of claim 28 , wherein said suction chamber comprises a viewing window to visually assess, after activation, at least one of the reduced pressure levels being applied by said assembly and the exudate fluids being collected in said fluid collection chamber.
34. The system of claim 28 , wherein said assembly comprises an indicator to indicate the status of assembly's capacity to continue to generate said reduced pressure.
35. The assembly of claim 28 , wherein said suction chamber maintains its initial non-circular cross-sectional shape over a range of collection volumes of exudate.