JP3588465B2 - Blood flow stimulator - Google Patents

Abstract

Medical apparatus for therapeutically and/or prophylactically treating a blood-circulation abnormality in a patient's leg. The apparatus is provided with an inflatable cuff (11) for application of inflation pressure to the calf of a leg of the patient together with an inflatable foot pump (14) for application of inflation pressure at the plantar region between the ball and heel of the foot, and control means (12) therefor whereby to intermittently provide an applied torniquet action to the leg such as to reduce the availability of superficial veins to carry the venous return flow that is stimulated by the foot pump action, but at the same time being insufficient to materially affect access to deep veins which are the primary target of therapeutic or prophylactic treatment.

Description

【Technical field】
[0001]
The present inventionFor the first timeAs considered, the present invention relates to a method and apparatus for treating and / or prophylactically treating a thrombotic or potential thrombotic condition in a human limb, especially a foot. Such thrombotic conditions generally occur in deep veins, and thus the term deep vein thrombosis is abbreviated herein as DVT.
[Background Art]
[0002]
Non-patentedLiterature1 and 2Is a venous clotDepending on the case handHas begun to accumulate significant evidence of the success of using so-called foot pumps to reduce the chances of thromboembolism following potentially fatal surgery. Use of foot pumpWhenIsPatent documents 1, 2, 3and4Means and methods as disclosed and discussed herein. The disclosures of these patents are incorporated herein by reference..
[0003]
For the purposes of the present invention, a foot pump of the indicated characterapparatusIsNon-Patent Document 3The Gardner / Fox departure reported in 1983SmartTo use, ielegThe plantar veins provide a reservoir for blood to return through the venous system, and transferring the weight support from one leg to the other in gait does not affect the effect of the vein check valve It is sufficient to state that this necessarily entails a temporary extension of the plantar vein and a temporary contraction of the plantar vein volume so as to drive the flow of the vein back to the heart via the. Significantly, this venous return does not include muscle effects. The patentLiteratureDisclosure of foot pumps is intended for patients who canCan getIntermittent weight supportMachineProvides a mechanical alternative. The mechanical alternative is to apply a relatively short compression pulse to the underside of the foot, between the toes and the heel, sufficient to temporarily reduce the volume of the plantar vein. Overload, thus leading to increased return flow of veins to the heart, primarily through the deep veins of the feet.
[0004]
In situations where a mechanical foot pump is used to treat a thrombotic condition in the foot, deep veinsgrowthDo orgrowthThe cutaneous vein exhibits abnormal flow with each stimulation of the foot pump due to the resistance of the deep vein to the stimulated flow, as it is partially or totally interrupted by the accumulation of clots that have formed. This also causes severe distress and results in a prolonged abnormal dependence on the skin veins. In addition, if a thrombolytic agent such as streptokinase is introduced into the circulatory system for the purpose of resolving the clot state, the venous return to the cutaneous vein is converted.Is deepveinTotargetTreatmentIt is a detour. If this iswhat ifIt is possible to focus more effectively on the delivery of thrombolytics at the location of deep veins in thrombosisMadeThen an unnecessarily large proportion of thrombolytics is introducedMust beOr the treatment time is longer than necessaryMay beIt is determined to mean that.
[Non-patent document 1]  Stranks / Mackenzie / Grover / Fail, "The AV impulse system is semi-articulated for hip fracture Reduces post-natal deep vein thrombosis and swelling ", Journal of Bone Joint Surgery (UK), Vol. 74-B, No. 5, Se ptember 1992, pp. 775-778, references cited therein. Including literature
[Non-patent document 2]  Bradley / Krugener / Jager, Intermittent in preventing deep vein thrombosis after nodal arthroplasty Effect of plantar vein compression '', The Journal of Arthroplasty. Vol.8, No.1, 1993
[Non-Patent Document 3]  "A human leg venous pump-preliminary report Bristol Medico-Chirurgical Journal; Gardner and Fox; pp.109-112; July 1983
[Patent Document 1]  U.S. Patent Re.32,939
[Patent Document 2]  U.S. Patent Re.32,940
[Patent Document 3]  U.S. Patent 4,696,289
[Patent Document 4]  U.S. Patent 4,721,101
DISCLOSURE OF THE INVENTION
[Problems to be solved by the invention]
[0005]
It is a general object of the present invention to provide improved methods and means for treating blood circulation abnormalities in a human foot.
A particular object of the present invention is to provide improved methods and means for treating and / or prophylactically treating deep vein thrombosis (DVT) conditions in the foot.
Another special purpose is to stimulate venous return stimulated by a foot pump, the deep vein of its flowDistributionTo provide improved methods and means of managing with emphasis on
[0006]
Yet another special purpose is a means which can be applied selectively to the improvement of venous and arterial flow for patients lying in bed with their feet raised above the torso to achieve said purpose. It is to provide.
Another object is to enhance the flow in the arteries of the same foot and to achieve the above purpose.
It is another object of the present invention to achieve the above object without obstructing arterial flow.
The general purpose is to achieve the above objectives with a relatively simple device, and to adapt to the subsequent symptoms and tolerances of the patient, and to the changing symptoms of the patient in the course of managing the treatment for the patient. To accommodate the tolerance, to give the operating physician a range of choices.
[Means for Solving the Problems]
[0007]
The present invention preferably provides a location near the ankle (ie,DistalCalf) to achieve the above object by adding the effect of the tourniquet acting intermittently to the foot in a time-adjusted relationship to the stepping pump action, in which case the level of tourniquet action is To support venous return stimulated by the action of a foot pumpUseReduceOf degreeAnd the level of action of the tourniquet is also the primary goal of therapeutic or prophylactic treatment, access to deep veins.RealNot enough to affect qualitatively.
[0008]
The present invention
(1) Therapeutic treatment of abnormal blood circulation in the patient's leg And / or a medical device for prophylactic treatment, wherein the puffy leg is Single inflatable cuff adapted to be applied to patch (11) and said cuff (11) with a local stop to the calf A first pressure level sufficient to induce a band pressure effect; First to allow occasional expansion and then contraction Means (21,26,28,32,40,121,126) and mainly for the big toe Apply negative inflation pressure to the sole between the swelling and the heel. Inflatable foot pump adapted for loading (10,1 4,16,17,18 and 19) and the foot pump is connected to the first Temporarily expands to a peak pressure that exceeds the pressure level of After the second means (21,25,2) to allow contraction 7,31,41,121 ', 125) and adjustment of the first and second means. Acting cyclically for the controlled activation of expansion / contraction Control means (30,130), said single inflatable Cuff (11) and said inflatable foot pump (10,14,1) 6,17,18 and 19) separate hand to supply pressure fluid only In the medical device including a step, the control means (30, 130) includes: Not only the cycle interval of the repetition cycle as shown below, The cuff (11) and the foot pump (10, 14, 16, 17, 18 and And 19) are set in advance to determine the sequence of operations. A medical device characterized by having an imaging device is there.
Record
(A) First, the first means (21, 26, 28, 32, 40, 121, 1) 26), the cuff (11) prevents the effect of tourniquet pressure. Receiving a supply of pressure fluid that is temporarily held in the calf,
(B) The second means (21, 25, 27, 31, 41, 121 ', 125) Thus, the foot pumps (10, 14, 16, 17, 18 and 19) Under the effect of tourniquet pressure on the calf, Temporarily expands to the pressure of the point, the pressure of the apex is achieved After being relaxed from the inflation pressure, and
(C) According to the first means (21, 26, 28, 32, 40, 121, 126) To increase the pressure of the foot pump and at least to start to relax On the other hand, depending on the selected timing relationship, The pressure is relieved, and the timing device of the control means (30, 130) is released. The first position is preceded by a restart of the subsequent periodic operation. Means (21, 26, 28, 32, 40, 121, 126) and the second means (21, 2 5,27,31,41,121 ', 125) Give the cycle completion time interval, the subsequent cycle is 15-60 seconds Is repeated at periodic intervals within the range
[0009]
(2) In the medical device described above, the control means (30, 13 0) is approximately 0 to 5 seconds after the peak pressure is reached. Means that act selectively to relieve foot pump pressure (21,25,27,31,41,121 ', 125).
(3) In the medical device of the above (1), the control means (30,130) is from the expansion of the foot pump and the pressure at the top The cuff for a period beyond the period to mitigate (11) Acts selectively to expand and maintain expansion Means (21, 26, 28, 32, 40, 121, 126).
[0010]
(4) In the medical device of (1), the patient's body is supported. Lift the legs above the level of the bed support The control means (30, 130) are Increase the tourniquet pressure on the calf for a period of time just before inflation Means that act selectively to hold and retain (21, 26, 28, 32, 40, 121, 126).
(5) In the medical device of the above (1), suitable for a calf Treat DVT conditions at the leg position near the cuff used Therefore, the control means (30, 130) controls the foot pump. Raise to peak pressure, and raise the foot pump to peak pressure Cuff pressure only during periods of substantial relief from Means that act selectively to hold the (21, 26, 28, 32, 4 0,121,126).
[0011]
(6) In the medical device of the above (1), the control means (30,130) before expanding the foot pump to peak pressure Not enough to relieve foot pumps from peak pressure At least during the same period due to timing, the increased cuff pressure Means that act selectively to retain (21,26,28,32,40,1 21,126).
(7) In the medical device of the above (1), the control means (30,130) before the start of the expansion of the foot pump Before inflating the cuff and before relieving the cuff pressure Acts selectively to initiate relief of foot pump pressure Including means to do.
(8) In the medical device according to (2), the selective operation is performed. Means (21,25,27,31,41,121 ', 125) are 0 seconds, 1 At least from the group consisting of seconds, 2 seconds, 3 seconds, 4 seconds and 5 seconds Also includes means for selecting one setting.
[0012]
(9) In the medical device of (2) above, a repetitive cycle The periodic interval of is about 20 seconds.
(10) In the medical device according to the above (1), the cuff (11) The temporary expansion of the foot pump (10,14,16,17,18 and And slower than the temporary expansion of 19).
(11) In the medical device of the above (1), the stepping pon The temporary inflation of the pumps (10,14,16,17,18 and 19) should not exceed 1 second. Done within.
(12) In the medical device of the above (1), the stepping pon (10,14,16,17,18 and 19) temporary inflation 0.5 sec Or within that time.
(13) In the medical device of the above (11), the cuff (11) Temporary inflation takes place in less than 1 second You.
[0013]
(14) In the medical device of the above (1), the operation of the tourniquet pressure Levels for use range from 30 to 100 mmHg.
(15) In the medical device of (1), the operation of the tourniquet pressure is controlled. Levels for use range from 40-60 mmHg.
(16) In the medical device of the above (1), the foot pump The pressure level at the apex of the zhang is in the range of almost up to 225mmHg You.
(17) In the medical device of the above (1), the foot pump The level of pressure at the top of Zhang is at least almost 200mmHg You.
[0014]
(18) In the medical device according to the above (1), the control means (30,130) achieves said first pressure level of cuff inflation The foot pump (10,14,16,17, 18,19) to respond to instantaneous cuff pressure to initiate inflation Pressure response means (10,42) connected to No.
(19) In the medical device of the above (1), the control means (30,130) indicates instantaneous stepping pump pressure The cuff (1 1) Cuff pressure and momentary stepping to initiate contraction Pressure response connected to respond to the difference between Answer means (10,42).
【The invention's effect】
[0015]
The present invention generally refers to the above Improved methods and means of treating You.
In the present invention, particularly the state of deep vein thrombosis (DVT) in the foot Improved method of treating and / or prophylactically treating conditions And means can be obtained.
Another example is venous return stimulated by a foot pump. An improved one that manages with emphasis on deep vein flow Laws and means can be obtained.
[0016]
In addition, the feet were raised above the torso and laid down in bed To improve venous and arterial flow for patients with Can obtain the means that can be used selectively You.
In addition to increasing flow in the arteries of the same foot, The effect described above can be obtained. Obstructing arterial flow And the above-mentioned effect can be obtained.
In addition, the overall effect is relatively simple equipment Effect and subsequent patient's different symptoms and tolerance And manage the treatment of patients In order to adapt to the patient's changing symptoms and tolerances during the process, A range of choices can be given to the clinician making the work.
BEST MODE FOR CARRYING OUT THE INVENTION
[0017]
The present invention will now be described in detail with reference to the accompanying drawings..
at firstFIG.With reference to the present invention, the present inventionDistalShown applied to the calf, the foot pump element 10 is attached to the foot and the tourniquet cuff (cuff) element 11 isFar RankThe pneumatic actuation and control means 12, RequiredConnected to elements 10 and 11 to adjust the action of elements 10 and 1115 to 60 seconds for repetitive cycles In the rangeYou.
[0018]
Foot pump element 10 is suitable for the patentLiteratureThus, a simplified representation of the part is sufficient for this purpose. As shown, the stepping pump element 10 fits into the sole of the foot and engages the arch of the sole, i.e., the heel of the foot.Bulge at the base of the thumbAnd an inflatable bag or bag 14 shaped to fit between. The bag 14 is connected to the pneumatic source and control means 12 by a flexible pipe 15. The foot pump element 10 further includes a head 16 with suitable pads, which surrounds the bag 14 and the instep 17 and is secured with hooks and buckle elements 18, etc. Form a knot around and around. In the example shown, the cap 16 is covered by a cloth slipper 19, which covers most of the foot, but the toes are exposed for medical examination and a reaction test of the covered foot. . In use, the device shown at 12 acts to rapidly inflate the bladder 14, which reacts to the tied skirt 16 to apply pump pressure to the sole and to the foot.At the base of the thumb SwellingAnd heels, pushing them apart from each other, thus applying an upward spreading force and temporarily as occurs when the foot is placed on the ground (ie, weight support) during normal walking. Flatten the arch of the sole, thereby stimulating venous blood flow.
[0019]
Tourniquet cuff element 11 may be a commercially available inflatable article, preferablyDistalForm a perimeter knot around an inflatable bag (not shown) attached to the calf. The only exposed portion of the inflatable cuff element 11 is its flexible supply pipe 20, which receives its inflated / deflated air supply from the control element 12.
[0020]
FIG.The pneumatic actuation and control means 12 is operated by a compressed air accumulator 21, which in some hospitals is supplied by a suitably regulated central supply. However, as shown, the self-sufficient means 12 includes a safety valve 24 to determine a suitable upper limit for air pressure in the accumulator 21 and includes an air pump 22 driven by a motor 23. The compressed air from the accumulator is passed through a first solenoid operated valve 25 of the normally closed (NC) type to convey the expanded air to the foot pump supply pipe 15 and to the supply pipe 20 for the tourniquet cuff. Via a second normally closed solenoid operated valve 26 for the transport of The third and fourth normally closed solenoid operated valves 27, 28 are respectively connected to the foot pump pipe 15, the cuff pipe 20 to control the discharge of the respective inflatable elements 10, 11 into the surrounding air. Connected. The programmable control means 30 is used for the continuous and appropriately timed operation of each solenoid operated valve, and thus for the adjacent time scaled on the same time scaleFIG. 2 (A)as well asFIG. 2 (B)It should be understood that it can be preset to determine the particular valve opening behavior indicated by the times T1, T3, T4, T6 considered with respect to the graph of FIG.
[0021]
FIG. 2 (A)The graph of FIG. 3 shows a typical inflation / deflation pressure pulse of the foot pump element 10 slightly exaggerated for clarity, andFIG. 2 (B)Is a similar representation of a representative inflation / deflation pressure pulse for tourniquet cuff element 11. FIG. The times T1, T2,..., T6, which are separately identified in each cycle of operation of the device, serve to mark various adjustments, such as between the action of the foot pump and the tourniquet in that cycle. And using the time symbols T1 to T6FIG.It will be understood to indicate the start of operation of the solenoid valve by the means 30 of FIG. It will also be appreciated that the separately adjustable variable orifices 31, 32 in the respective inflation lines to the foot pump 10 and the cuff element 11 provide selective control of the rate of expansion to those elements.
[0022]
FIG. 2 (B)A typical cycle of operation of the device is initiated by an actuation signal from control means 30 at time T1, thus opening valve 26 and inflating cuff 11 as seen in FIG. Since the flow of inflated air from accumulator 21 is preferably adjusted at 32 to relatively slow the rate of inflation of the cuff, a time T2 determined by the program of means 30 based on pneumatic operating experience from accumulator 21. Ends the supply of the accumulator air to the cuff 11 by terminating the excitation of the valve 26 and returning the valve 26 to the normal closed state, and the cuff 11 reaches the level of the cuff pressure Pc.33At a pressure Pc selected for a desired degree of local primary flow restriction to the skin vein, with relatively little flow restriction to the deep veins, temporarily locked in an inflated state. You. Suitably and by way of illustration, this level of cuff inflation pressure is in the range of 30-100 mmHg, preferably 40-60 mmHg, and the cuff inflation rate is relatively slow, with cuff inflation not less than 1 second. It is done in.
[0023]
At time T3, which can be determined by the control means 30 and is shortly after T2, the solenoid valve 25 is actuated to the open state, and thus the inflated air from the accumulator 21 according to the air supply rate selected in the pre-adjustment of the orifice 31. Is inserted into the bag of the foot pump. The rising slope 34 of the inflation air towards the apex foot pump pressure beyond the temporarily locked inflation pressure 33 of the cuff 11 is desirably relatively steep and in the range of less than 1 second; Preferably it is in the range of 0.5 seconds or less. The reaching of the inflation pressure at the top of the foot pump can be signaled by a pre-set pressure sensing switch to terminate the actuation signal to the solenoid valve 25,Figure 1In the circuit shown in FIG. 5, the apex timing operation at T4 vents inflation air from the foot pump element 10 and thus deflate the foot pump bladder 14 as quickly and as quickly as possible upon reaching the apex foot pump pressure, This is performed by a) ending the operation signal to the valve 25 and (b) starting the operation of the solenoid valve 27.FIG. 2 (A)In, the foot pump pressure drop curve 35 is exaggerated to better illustrate the next operation in an exemplary cycle of operation of the device. From experience in the operation of the device, at a particular time T5 (in relation to the selected peak of the foot pump pressure), the deflation pressure curve 35 intersects and drops below the inflation level 33 of the locked cuff. Thus, based on this experience, the control means 30 is set to emit a valve opening signal T6 to the solenoid valve 28 for deflating the cuff.
[0024]
FIG. 3 (A),FIG. 3 (B)as well asFIG.Shows a variant, in which the sensed pressure threshold determines the key of the sequence of cuff and foot pump operation in each cycle. Pneumatic circuitFIG.,FIG. 2 (A)as well asFIG. 2 (B)The same reference numerals are used because they are almost the same as those already described above. Sensing of the predetermined limit threshold for the inflation pressure of the cuff is performed by a pressure sensing switch means 40 in the air supply line from the solenoid valve 26 to the cuff 11 and a predetermined peak of the foot pump pressure. The sensing of the threshold of the limit is effected by means of a pressure sensing switch 41 in the air supply line from the valve 25 to the foot pump 10. And the differential pressure switch 42 is connected to differentially respond to the instantaneous cuff and foot pump pressure, and when the foot pump pressure is sensed as falling to or below the cuff inflation pressure, an electromagnetic An electrical output signal may be generated on line 43 to valve 27.
[0025]
FIG. 3 (A),FIG. 3 (B)as well asFIG.Each pulsation cycle is initiated by an electrical actuation signal from the control means 30 to the solenoid valve 26, which opens the valve 26 and inserts inflated air into the cuff 11 at a relatively low speed determined by a preset adjustment of the orifice 32. . The inflation of the cuff,When a predetermined limit 33 is reached at 40, the switch 40 is actuated to (a) end the actuated open state of the solenoid valve 26 and (b) actuate the solenoid valve 25 to the open state. The valve 25 then injects inflated air into the foot pump 10 at a relatively high speed, determined by a preset adjustment of the orifice 31. When the maximum inflation pressure of the foot pump reaches a preset limit 44 (not less than the cuff limit 33) at 41, the switch 41 is actuated to (a) end the actuated open state of the solenoid valve 25, and (b) ) Activate the solenoid valve 27 (via line 46) and thus begin to retract the foot pump. At that time, when the differential pressure switch 42 senses that the foot pump has contracted to the inflated cuff pressure level, the switch 42 operates to contract the cuff 11. A significant portion 45 of the cycle time is inactive, in which case the two elements 10, 11 require the control means 30 to re-activate the expansion by reactivating the solenoid valve 26 to the open state. Until it is in a contracted or almost contracted state.
[0026]
FIG.It is clear from the above description that when the apex inflation level is sensed by the switch means 41, it causes the foot pump to contract as quickly as possible. that isFIG.CircuitFIG.And cuff inflation and foot pump inflation adjustments may be about the same as described above. However, in some circumstances, it is desirable to keep the inflation pressure peak of the foot pump for a selected relatively short period of time before beginning the deflation process.FIG.In this case, such a holding of the inflation pressure of the foot pump is achieved by the control means 30 simply preselecting a suitable interval between times T3 and T4, for example a selected time interval of 1 to 5 seconds. Obviously you get.FIG.In the case of, a preselected vertex holding time of a similar nature is selectively obtained by placing terminal 47 (of control means 30) of the preselected timer in series with the break in line 46, in which case Such a break for connecting in series to terminal 47 is indicated by an "X" mark 48.
[0027]
Use of the above deviceFIG.By a preset timing such as in orFIG.It is clear that the perceived pressure level as in achieves the foregoing objectives and depends on the following criteria for each cycle.
(A) A first level 33 of temporary tourniquet pressure is applied to the leg. That is, in the case of a diagnosed or suspected DVT condition or occurrence, the cuff 11DistalIs preferably attached to the calf area, which is often distal to the DVT condition. And the DVT stateDistalThe cuff 11 was raised even though it extends to the calfDistalApplication to is recommended.
[0028]
(B) Then relatively quickly, the temporary venous pump pressure rises to a crest level that exceeds the cuff tourniquet effect cuff level.legIs loaded on the sole of the foot. Cuff accepts pump-driven venous flowofSkin veinUseAs deep veins are reduced, deep veins can be targeted with enhanced effects. ifFigure 1If a thrombolytic agent is introduced into the back of the foot (eg, through a localized hole in the slipper 19) as in position A of FIG. 5, direct reception of the thrombolytic agent in the plantar vein may occur, and The presence of a cuff necessarily implies the delivery of a thrombolytic agent to the deep vein with increased efficiency and with the effect of eliminating DVT.
(C) Intravenous pump drive pressure can be relieved immediately or patentedReference 4Can be alleviated after a short apex retention time, with the choice of a physician preferring the treatment of concurrent elevated arterial flow to the leg. Time selected for retention of apical venous pump pressureAny ofNevertheless, the retention time is short compared to the cycle time, so that in each case the arterial flow is not interrupted.
(D) When the venous pressure falls to or below the temporarily applied tourniquet pressure level, the tourniquet pressure is relieved. Even when the tourniquet pressure rise is relatively slow, the arterial flow remains unobstructed if not increased, because the tourniquet pressure loading time is short compared to the indicated range of cycle time. is there.
[0029]
Apart from the use and features of the above procedure of DVT, it is clear that the present invention also applies for patients lying in bed who are further ordered by an orthopedic surgeon to be able to suspend their feet above the heart. is there. In this case, the plantar vein is necessarily above the heart, and thus the slow gravity of the plantar veinanemiaAnd prevent the accumulation of blood in the plantar vein, which may be a problem of the foot pumping action of the artery. like thisanemiaToAvoidAnd at the same time to provide a means of accumulating plantar vein blood for venous return by a foot pump,DistalWhen mounted on the calf and inflated to a pressure in the range described above, for a relatively long period of time up to 10 seconds or at least before actuation of the foot pumpWhenOver a period of 10 seconds, allowing the desired volume of plantar vein to accumulate until the time the foot pump is operated at a predetermined rate to bring it to the already mentioned peak pressure range. Of course, the discharge of the inflation of the foot pump will also cause the cuff to deflate until the adjusted cuff and inflation of the cuff are performed again for the next cycle of foot pump operation.
[0030]
FIG.Shows other schematic representations of the elements of the device that enable various selected actions of the cuff 11 in timing relation to the foot pump 14, wherein a control unit 130 which can be programmed is indicated by the symbol NC. Provided to determine the sequence and / or combination of operations managed by the four solenoid valves 125, 126, 127, 128, which may be of a normally closed type asFIG.In the figures, flow control devices such as appropriately adjusted variable orifices in each line of these solenoid valves have been omitted to simplify the drawing.FIG.As shown, separate regulator valves 124, 124 'are operated by a single source of pressure fluid and provide a first relatively low regulated pressure from first accumulator 121 which is used to inflate the cuff. , From the second accumulator 121 ′, and a second relatively high regulated pressure used for inflation of the foot pump.
[0031]
furtherFIG. 6 (A)Referring to the programmed timing of the opening of the valve 125, the relatively rapid expansion 134 of the foot pump 14 through the relatively steep rise 134 to the peak of pressure (Pp), followed by the exhaust solenoid valve Due to the actuation of 127 (along with valve 125 in its NC condition), the inflation pressure at the apex is relatively slowly relaxed (135) from the apex of the inflation pressure, or due to the delayed actuation of exhaust solenoid valve 127 (delayed range Δ). It will be appreciated that the gentle and relaxed curve 135 'can be retained and correspondingly delayed. The delayed retention of the peak of the inflation pressure of the foot pump increases the arterial flow.Is specialForgivenessReference 2In detail.
[0032]
The simultaneous program of inflation and relaxation of the cuff 11 is controlled by means 130 for supplying pressure fluid for cuff inflation from the accumulator 121 by actuation of the valve 126, and the inflation of the cuff 11FIG. 6 (B)And the pressure of the foot pump is less relaxed.WhenIs also held down to the level of the cuff inflation pressure.FIG. 6 (A)To be considered alongside the curve of the foot pump pressureFIG. 6 (B)The symbol PC1 is adopted forFIG.,FIG. (A)as well asFIG. 2 (B)To determine the form of DVT reduction described inFIG.Indicates that the control device of FIG.
[0033]
furtherFIG. 6 (C)as well asFIG. 6 (D)By respective cuff pressure curves PC2 and PC3,FIG.The use of these controls is illustrated, especially to assist the patient with the patient lying on the bed, with the feet and foot pump 14 and cuff 11 resting on the heart, and with the patient's legs raised.
For more information,FIG. 6 (A)Cuff inflation pressure curve (PC2) on the same time scale as the inflation curve (Pp) of a foot pumpFIG. 6 (C)Thus, the inflation of the cuff 11 occurs over a significant portion (eg, half) of the entire cycle and occurs as an event that acts to “prime” the plantar vein just prior to inflation of the foot pump. The effect of this is to allow sufficient blood to build up waiting for the pumped venous return.FIG. 6 (C)At the moment when the foot pump begins to expand, the filling is sufficient andFigure 6 (D)Then, the pressure inflation curve of the cuff (PC3) is lessWhenIt also appears to lap the foot pump expansion curve (Pp) during the time the foot pump expansion is on the rise. The results of the effectiveness of pumped venous return areFIG. 6 (C)as well asFigure 6 (D)However, it is preferable that the cuff pressure is sufficiently exhausted at the start of inflation of the foot pump.
[0034]
FIG. 6 (C)as well asFIG. 6 (D)In the "filling" situation indicated by the above patent due to the action of the foot pumpLiteratureAlthough the criteria set out in paragraph 1 above are desirable, i.e., inflation up to 225 mmHg in less than one second, the cuff inflation pressure for "filling" should provide an ascending flow to fill the plantar vein due to the patient's cardiac action. To be possible, it should be on the order of 40-50 mmHg. For patient comfort, rapid inflation of the cuff is not required, andFIG. 6 (B),FIG. 6 (C)as well asFIG. 6 (D)Inclination of all cuffs inside showing little incline (for inflation of foot pumpFIG. 2 (A)) Illustrates this fact graphically.
[0035]
In general, it can be said that the peak of foot pump pressure required in the context of a DVT procedure does not require high values as used in situations where DVT is not a problem. In other words, treatment of DVT in which a thrombolytic is infused into the back of the foot relies on a cuff loading the tourniquet with cutaneous veins so that deep veins are more efficiently treated with the thrombolytic. In that case, the cuff pressure is on the order of 50 mmHg, and the foot pump pressure apex in the range of 100-200 mmHg is sufficient, and a gentler ascending gradient (e.g., the foot pump pressure apex in 2 seconds or less) Is sufficient. On the other hand, for another healthy leg that should be lifted above the patient's body, the filling cuff pressure (except for timing) may be about the same as for the DVT procedure, but preferably at least 200 mmHg Is the peak of the inflation pressure of the foot pump.
[Brief description of the drawings]
[0036]
FIG.  Figure 2 is a simplified side view of the device of the present invention, partially cut away at a location installed on a person's foot, and schematically illustrating operatively interrelated elements with respect to the presently preferred configuration.
FIG. 2  (A)IsFIG.Graphical representation of pressure as a function of time to show the action of the foot pump section of the device, (B)IsFIG.FIG. 6 is a graphical representation showing pressure as a function of time to show the effect of the tourniquet cuff portion of the device of FIG.FIG. (A)WhenFIG. 2 (B)Are exaggerated and juxtaposed to better illustrate the timed function of the device.
FIG. 3  (A)Is a simplified graphical representation of foot pump pressure as a function of time to illustrate a modified mode of operation of the present invention., (B)Is a simplified graphical representation of tourniquet cuff pressure as a function of time., FIG. 3 (A)WhenFIG. 3 (B)Are juxtaposed to better show the modified function of the variant.
FIG. 4  FIG. 3 (A)as well asFIG. 3 (B)FIG. 3 schematically illustrates the interrelated elements to show the action relating to the variant of FIG.
FIG. 5  FIG. 4 schematically illustrates the interrelated elements for selectively controlling the mode of operation.
FIG. 6  (A)IsFIG. 2 (A)alike,FIG.Graphical representation of pressure as a function of time to show the action of a foot pump, (B)IsFIG. 2 (B)alike,FIG.To show the effect of tourniquet cuffFIG. 6 (A)Graph showing pressure as a function of time scale, (C)IsFIG.To demonstrate the effect of the first variant of the tourniquet cuffFIG. 6 (A)Graph showing pressure as a function of time scale, (D)IsFIG.To demonstrate the effect of the second variant of the tourniquet cuffFIG. 6 (A)5 is a graphical representation showing pressure as a function of the time scale of FIG.
[Explanation of symbols]
[0037]
Ten        Foot pump element
11        Tourniquet cuff (cuffs) element
12        Air pressure source and control means
14        bag
15        Foot pump supply pipe
16        Cover
17        Instep
18        Hook and buckle elements
19        Cloth slippers
20        Flexible pipe, tourniquet cuff supply pipe
twenty one        accumulator
twenty two        air pump
twenty three        motor
twenty four        safety valve
twenty five        First solenoid operated valve
26        Second solenoid operated valve
27        Third solenoid operated valve
28        Fourth solenoid operated valve
30        Control means that can be programmed
31        Variable orifice
32        Variable orifice
33        Cuff inflation pressure limit
34        Incline up to the top of the foot pump pressure Slant
35        Foot pump pressure drop curve
40        switch
41        Pressure related switch means
42        Differential pressure switch
43        line
44        Limit of expansion pressure of foot pump pressure
45        A component of the cycle time
46        line
47        Timer terminal
48        "X" mark of break point
121      First accumulator
121 '    Second accumulator
124      Regulating valve
124 '    Regulating valve
125      solenoid valve
126      solenoid valve
127      Exhaust solenoid valve
128      Exhaust solenoid valve
130      Control means that can be programmed
134      Relatively towards the top of the foot pump pressure Steep rise
135      Relatively slow from the top of the foot pump pressure Relaxation curve
135 '    Delayed gentle relaxation curve

Claims (19)

A medical device for abnormal therapeutically and / or prophylactically treating a blood circulation in the patient's leg, the cuff (11) which may be a single expansion that is a Let 's that apply to the calf of the leg, First means (21, 21) for allowing the cuff (11) to temporarily inflate to a first pressure level sufficient to induce local tourniquet pressure on the calf and then deflate 26, 28, 32, 40, 121, 126) and an inflatable foot pump (10, 14, ) adapted to apply inflation pressure mainly to the sole of the sole between the bulge of the base of the foot and the heel 16,17,18 and 19) and a second means ( 21,25) for allowing the foot pump to temporarily inflate to a peak pressure above the first pressure level and then contract. , 27,31,41,121 ', 125) and, periodically for periodic actuation of the adjusted expansion / contraction of the first and second means of the And a use control means (30, 130), for supplying a pressure fluid only in the single inflated may cuff (11) and a foot pump capable of the expansion (1 0,14,16,17,18 and 19) a medical device comprising a separate means, all regardless of the control means (30,1 30) periodic interval of repeated cycles as follows, the cuff (11) and the foot pump (10,14,16,1 7. A medical device comprising a timing device preset to determine the sequence of operations of 7, 18 and 19) .
Serial (a) first, by the first means (21,26,28,32,40,121,1 26), said cuff (11) is temporarily held in Kurahagi fu action tourniquet pressure Receiving the supply of pressure fluid,
(B) said second means (21,25,27,31,41,121 ', 125) and more, the foot pump (10,14,16,17,18 and 19) tourniquet pressure action on the calf Temporarily inflates to the apex pressure below, and after the apex pressure is achieved, is relieved from the inflation pressure, and (c) the first means (21,26,28,32,40,121,126) Ri by the, by the expansion of at least against the start of mitigation selected timing relationship foot pump pressure, to relieve cuff pressure from tourniquet action, timing equipment of the control means (30, 130) is subsequent periodic Prior to restarting the operation, the control operation via the first means (21, 26, 28, 32, 40, 121, 126) and the second means (21, 25, 27, 31, 41, 121 ', 125) given period completion time interval between, subsequent cycle is repeated at periodic intervals in the range of 15 to 60 seconds. 2. The medical device according to claim 1, wherein said control means (30,130) is selectively operative to relieve the stepping pump pressure in a range of approximately 0-5 seconds after said peak pressure is reached. (21,25,27,31,41,121 ', 125 ) . 2. The medical device of claim 1 wherein said control means (30,130) controls the inflation of said cuff (11) over a period of time beyond a period for inflating the foot pump and relieving said peak pressure. A medical device comprising means (21, 26, 28, 32, 40, 121, 126) for selectively acting to maintain inflation . 2. The medical device according to claim 1, wherein said control means ( 30,130) controls the inflation of the foot pump for treating legs raised above the level of the bed support supporting the patient's body . period with last minute, raising the tourniquet pressure to wipe Rahagi, medical device comprising: means (21,26,28,32,40,121,126) acting selectively to hold. 2. The medical device according to claim 1, wherein the control means (30,130 ) controls the foot pump to a peak pressure to treat a DVT condition at a leg position near the cuff applied to the calf . raised, and the medical device including means for selectively acting to substantially retain (21,26,28,32,40,121,126) said cuff pressure only during the period that substantially mitigate the foot pump from the pressure of the vertex . The medical device according to Patent Claim 1, wherein said control means (30, 130) in the timing relationship with the least relative to mitigate the foot pump from the apex pressure to inflate the foot pump to vertex pressure same period, the medical device comprising means (21,26,28,32,40,121,126) acting selectively to hold the elevated cuff pressure. The medical device according to paragraph 1 claims, wherein said control means (30, 130) is foot before starting the relaxation of the initiate inflation of the cuff and the cuff pressure before starting the inflation of the foot pump A medical device that includes means for selectively acting to initiate pump pressure relief . 3. The medical device according to claim 2, wherein said selectively acting means ( 21, 25, 27, 31, 41 , 121 ', 125) is 0 seconds, 1 second, 2 seconds, 3 seconds. A medical device comprising means for selecting at least one setting from the group consisting of: 4 seconds and 5 seconds. 3. The medical device according to claim 2, wherein the periodic interval between repetition cycles is about 20 seconds. 2. The medical device according to claim 1, wherein the temporary inflation of the cuff (11) is slower than the temporary inflation of the foot pump (10, 14, 16, 17, 18, and 19). Medical device. 2. The medical device according to claim 1, wherein the temporary inflation of the foot pump (10, 14, 16, 17, 18, and 19) is performed within one second. 2. The medical device according to claim 1, wherein the temporary inflation of the foot pump (10, 14, 16, 17, 18, and 19) is performed within 0.5 seconds or less. 12. The medical device according to claim 11, wherein the temporary inflation of the cuff (11) takes place in less than one second. The medical device according to Patent Claim 1, medical device level effects of stop Chitai pressure is in the range of 30～100MmHg. The medical device according to Patent Claim 1, medical device level effects of stop Chitai pressure is in the range of 40～60MmHg. 2. The medical device of claim 1, wherein the level of pressure at the apex of the foot pump inflation ranges up to approximately 225 mmHg. The medical device according to Claims first of claims, the medical device is substantially 200mmHg also reduced the level of pressure of the apex of the foot pump inflation. The medical device according to paragraph 1 claims, wherein said control means (30, 130) is the foot viewed pump by achieving the first pressure level of the cuff inflation is detected (10,14,16, A medical device including pressure responsive means (10,42) connected to respond to instantaneous cuff pressure to initiate inflation at (17,18,19) . The medical device according to claim 1, wherein the control means (30,130) reduces the contraction of the cuff (11) by detecting that the instantaneous stepping pump pressure has decreased to the instantaneous level of the cuff pressure. medical device comprising a connected pressure responsive means to respond (10, 42) to the difference between cuff pressure and instantaneous foot pump pressure for initiating.

Images