Opinion ID: 806478
Heading Depth: 3
Heading Rank: 3

Heading: Chariker-Jeter References

Text: The Chariker-Jeter references consist of two published articles (“Chariker-Jeter I” and “Chariker-Jeter II,” respectively), J.A. 10044–47; J.A. 10050–56, and Dr. Chariker’s 1989 public use of the system described in the articles on Gary Aderholt (“Chariker-Jeter public use”). Both Chariker-Jeter I and Chariker-Jeter II describe the same “closed wound drainage system.” J.A. 10052. As described in Chariker-Jeter II, the drainage system is created by: 11 KINETIC CONCEPTS v. SMITH & NEPHEW
normal saline using a 30ml syringe with a 19- gauge needle.
line. Open completely and lay across the wound bed.
Shorten the fenestrated drain as necessary so that the flat drain is confined to the wound bed. The drain is never placed in the fistula 2 tract. In the case of fistula drainage at skin level, the fenes- trated portion of the drain is simply centered over the cutaneous opening. It may be helpful to encir- cle the cutaneous wound with a pectin-based skin barrier in order to create a “trough” in which to situate the fenestrated drain.
Open and fluff into wound to completely cover the drain and fill the defect to skin level. In the case of a cutaneous fistula, only enough moist gauze to cover the flat fenestrated drain is required.
Prep, etc.) to all skin that will be covered by the film dressing. Allow to dry until slick.
least 1inch of intact skin beyond the wound edges. Place the film dressing over the packed wound. Carefully crimp the adhesive film dressing around the Jackson-Pratt tube to seal.
of Stomahesive Paste where the film dressing is 2 A “fistula” is generally considered to be a hole in an organ. Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., 554 F.3d 1010, 1016 (Fed. Cir. 2009). KINETIC CONCEPTS v. SMITH & NEPHEW 12 crimped around the tube. This ensures air-tight closure. 8. Reinforce this site with waterproof “pink tape” as illustrated. 9. Turn your attention now to the connection of the Jackson-Pratt to continuous suction. (Do not attempt to use the bulb of the Jackson-Pratt sys- tem.) With some brands of canister and tubing, all that is necessary is to cut the funnel end off the tubing and the small J-P tubing will fit snugly into the larger lumen tube. The junction should be taped securely with pink tape. Otherwise you may use small “Christmas tree” connector or can- nibalize IV tubing to get a small plastic adapter to connect the tubing. 10. Turn on continuous suction to the upper range of the low setting (approximately 60 to 80 mmHg) and observe the wound site. The dressing should contract noticeably. If it does not, the system is not closed and wound drainage will not be effi- ciently removed. When this occurs, fistula drainage will accumulate, causing skin damage and leakage outside of the dressing. Another indica- tion that you have not obtained a closed suction system is a whistling sound indicating that the dressing is not air-tight. J.A. 10052 (footnote added). Chariker-Jeter II explains that “[o]ur clinical observations suggest that fistula effluent does inhibit wound healing. . . . By minimizing the inflammatory response [associated with the presence of effluent], fibroplasia is reduced. This, we believe, encourages rapid wound contraction and re- epithelialization.” J.A. 10055. Finally, with respect to the Chariker-Jeter public use, Dr. Chariker testified that he treated Mr. Aderholt in 13 KINETIC CONCEPTS v. SMITH & NEPHEW 1989 with his closed suction wound drainage system. “[Mr. Aderholt] was injured with a log chain that flew off another truck into his truck, entered his chest, his abdomen, ruptured his lung, his [diaphragm], his pancreas, his spleen, his stomach.” J.A. 22032:8–11. With the aid of pictures of Mr. Aderholt’s treatment, Dr. Chariker stated that his treatment was an example of the drainage system facilitating the healing of a wound on a patient without a fistula. J.A. 22035:6–38:11.