Surgery: kinesitherapy – Kinesitherapy – Device with applicator having specific movement
Patent
1994-04-05
1996-11-19
Sykes, Angela D.
Surgery: kinesitherapy
Kinesitherapy
Device with applicator having specific movement
A61H 100
Patent
active
055757626
ABSTRACT:
A gradient sequential compression system for preventing deep vein thrombosis includes a pressure-based system controller for controlling transfers of air from a source of pressurized air to inflatable chambers of a limb sleeve, so that a prophylactic modality is provided to the limb. The controller also includes a plurality of feeder valves pneumatically connected to each of the chambers and a microprocessor-based control unit for opening only one of the feeder valves at a time during an inflation cycle, so that each of the chambers can be independently inflated to predetermined pressure levels. The control unit also regulates the pressures in each of the chambers at the respective pressure levels by repeatedly measuring the pressures and adjusting the pressure levels, if necessary. The predetermined pressure levels can also be selected by a user or health care professional. In addition, the system controller can be programmed into a variety of modes for one or two-limb operation or for handling sleeves of varying length.
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Jobst 510(k) Notice dated Sep. 25, 1989. Exhibits 1A-6G are attached as follows:
Exhibit 1A: photographs of front and rear view of System 2000; Exhibit 1B: photograph of System 2000 with wrap-around pneumatic sleeve and photograph of wrap-around pneumatic sleeve; Exhibit 1C: photograph of System 2000 with disposable wrap-around pneumatic sleeve and photograph of disposable wrap-around pneumatic sleeve.
Exhibit 2A: instructions for operation of Athrombic Pump.RTM. System 2000; Exhibit 2B: instructions for operation of Jobst Athrombic Pump System Wrap-Around Pneumatic Sleeve; Exhibit 2C: instructions for operation of Jobst Athrombic Pump System Disposable Wrap-Around Pneumatic Sleeve; Exhibit 2D: instructions for operation of Athrombic Pump.RTM. Model 116620, Form 586R6; Exhibit 2E: instructions for operation of Jobst.RTM. Anti-Em.RTM. Extremity Pump.RTM., Model 116600, Form 582.
Exhibit 3A: front panel label (artwork)-condensed instructions for Jobst Athrombic Pump.RTM. System 2000; Exhibit 3B: data plate label; Exhibit 3C: front and back view of Wrap-Around Sleeve label; Exhibit 3D: front and back view of Disposable Wrap-Around Sleeve label; Exhibit 3E: description of Air Chamber label.
Exhibit 4A: Jobst brochure entitled, "Venous Thrombosis in the High-Risk Patient", Form 945 (1987); Exhibit 4B: Jobst article entitled: "Deep Vein Thrombosis," Form 294R3 (1981); Exhibit 4C: Jobst brochure entitled, "Anti-Em.RTM. Anti-Em.RTM. Anti-Embolism Extremity Pump.TM.," Form 639 (1974).
Exhibit 5A: Kendall advertisement; Exhibit 5B: Kendall advertisement for T.E.D./SEC Compression System; Exhibit 5C: Kendall Model 5320 operating instructions-T.E.D..RTM. Sequential Compression Device; Exhibit 5D: Baxter advertisement for Pulsatile Anti-Embolism System; Exhibit 5E: Gaymar Industries, Inc. advertisement for Thrombogard; Exhibit 5F: Lyne-Nicholson, Inc. advertisement for Venodyne; Exhibit 5G: Camp International, Inc. advertisement for Hemaflo; Exhibit 5H: Comparative Chart-Compression Systems for Treatment of D.V.T.
Exhibit 6A: Salzman, et al., "Intraoperative external pneumatic calf compression to afford long-term prophylaxis against deep vein thrombosis in urological patients," Surgery, vol. 87, No. 3, 1980, pp. 239-242.
Exhibit 6B: "Prevention of Venous Thrombosis and Pulmonary Embolism," National Institutes of Health Consensus Development Conference Statement, vol. 6, No. 2.
Exhibit 6C: Hull et al., "Effectiveness of Intermittent Pulsatile Elastic Stockings for the Prevention of Calf and Thigh Vein Thrombosis in Patients Undergoing Elective Knee Surgery" (undated); Exhibit 6D: Coe et al., "Prevention of deep vein thrombosis in urological patients: A controlled randomized trial of low-dose heparin and external pneumatic compression boots," Surgery, vol. 83, No. 2, 1978, pp. 230-234; Exhibit 6E: Klein et al., "Prevention of Thromboembolism in Urological Patients" (undated); Exhibit 6F: Whalen et al., "Deep Vein Thrombosis-Prophylaxis" (undated); Exhibit 6G: Salzman et al., "Effect of Optimization of Hemodynamics on Fibrinolytic Activity and Antithrombotic Efficacy of External Pneumatic Calf Compression," Ann. Surg., vol. 206, No. 5, 1987, pp. 636-641.
Letter to Food and Drug Administration dated Dec. 20, 1989 supplementing 510(k).
Letter to Food and Drug Administration dated Nov. 9, 1989 supplementing 510(k). Exhibits 1-5D are attached as follows:
Exhibit 1: Jobst Institute, Inc. Overview of Deep Vein Thrombosis, Pulmonary Embolism and Discussion of Prophylactic Methods.
Exhibit 2: Jobst Nov. 8, 1989 Memorandum to File from Kotwick Regarding: Evolution of the Design of the Jobst Athrombic Pump.
Exhibit 3A: Jobst Institute, Inc., Engineering Study #89102, Introduction & Methods, Title: Electromagnetic Interference Considerations of the Jobst Athrombic Pump System 2000. Exhibit 3B: Jobst Institute, Inc., Engineering Study #89102, Results & Discussion.
Exhibit 4A: Jobst Institute, Inc., Engineering Study #89101, Introduction & Methods, Title: Performance Comparison of the Jobst Athrombic Pumps. Exhibit 4B: Jobst Institute, Inc., Engineering Study #89101, Results & Discussion.
Exhibit 5A: Graor et al., "The Comparative Evaluation of Deep Vein Thrombosis Prophylaxis in Total Joint Replacement Patents: An Interim Report," presented at the 1989 meeting of the American Academy of Orthopaedic Surgeons. Exhibit 5B: Salzman et al., "Prevention of Venous Thromboembolism in Unstable Angina Pectoris," The New England Journal of Medicine, vol. 306, No. 16, 1982. Exhibit 5C: Moser, "Pulmonary thromboembolism: Your challenge is prevention," The Journal of Respiratory Diseases, vol. 10, No. 10, 1989, pp. 83-85, 88, 91-93. Exhibit 5D: Green et al., "Deep Vein Thrombosis in Spinal Cord Injury: Effect of Prophylaxis with Calf Compression, Aspirin, and Dipyridamole," Paraplegia, vol. 20, 1982, pp. 227-234.
International Search Report for PCT/US95/03919, Aug. 3, 1995.
Kendall Healthcare Products Company brochure entitled "A Clinically Proven Home Regimen to Treat Venous Insufficiency" (1989).
Kendall Healthcare Products Company Instruction Manual entitled"SCD.TM. Therapeutic
Bolam Kenneth M.
Borgen James A.
Peeler Donald H.
Ribando Philip P.
Beiersdorf-Jobst, Inc.
Gilbert Samuel
Sykes Angela D.
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