SE1150147A1

SE1150147A1 - Femoralkompressionsanordning

Info

Publication number: SE1150147A1
Application number: SE1150147A
Authority: SE
Inventors: Tobias Adenmark
Original assignee: St Jude Medical Systems Ab
Priority date: 2011-02-23
Filing date: 2011-02-23
Publication date: 2012-08-24
Also published as: SE536650C2

Abstract

Abstract A fen1oral compression device (11) for conipressing a fen1oral artery (12) of a patient,coniprising a base plate (13) provided with two opposing extensions, each of the twoopposing extensions coniprising a member for affixing a belt (14), which is adapted to bearranged around a patient”s body, an inﬂatable air cushion (15), provided with a back plate(19), for conipressive bearing against a puncture site, and a pump (16) connected to theinﬂatable air cushion for inﬂation of the air cushion. The fen1ora1 device further coniprises aspacer (18) having a height and being adapted to be n1ounted between the inﬂatable air cushion and the base plate. (Figure 3)

Description

TitleFemoral compression device Field of the inventionThe present invention relates generally to a femoral compression device and in particular to a femoral compression device comprising a pressurizing means adaptable to varying body constitutions of a patient.

Background of the InventionFemoral compression devices for applying pressure on a patient°s femoral artery after completion of an interventional procedure are known. An example of such a femoralcompression device is disclosed in the patents US 5,307,811 and EP 0 462 088, which areassigned to the present assignee and are incorporated herein by reference for thecompression devices and methods disclosed therein.

A femoral compression device according to these publications comprises basically apressurizing means for compressive bearing against a puncture site at a femoral artery of apatient, a belt adapted to be fixed around the patient”s body, and a base plate supporting thepressurizing means and being provided with two extensions. In use, the pressurizing means,which e.g. has the form of an inﬂatable semi-spherical air cushion, is positioned over thefemoral artery, and the belt, which extends from the end of the first extension, around thepatient°s body and to the end of the second extension, is tightened. To apply pressure on thefemoral artery, the inﬂatable semi-spherical air cushion is inﬂated by a pump to a certainpredeterrnined pressure, which is read from a pressure gauge.

The air cushion may be a replaceable air cushion unit preferably packaged in a sterilepackage to minimize the risk of contamination of a part which is in contact with an area on apatient”s body, and which can be exposed to the risk of infection. An example of such adevice is disclosed in US 5,542,427, which is assigned to the present assignee.

In use, the inﬂatable air cushion is positioned over a femoral artery of a patient, and the belt,which extends from the end of the first extension, around the patient°s body and to the endof the second extension, is tightened. Then, the inﬂatable air cushion is inﬂated by a handpump to a certain intemal pressure, thereby expanding the air cushion such that the femoralartery is compressed in order to prevent bleeding through a puncture hole being made in theartery wall. The intemal pressure, which can be read from a pressure gauge provided on thepump, should be raised to a value between the diastolic pressure and the systolic pressure - which is a procedure that has proven to work very well for the vast maj ority of patients.

An inherent characteristic of a pneumatic device, and in particular of the inﬂatable aircushion described above, is that the internal pressure only within a certain operating rangecorresponds to an increased length of stroke (i.e. increased expansion of the air cushion).For a pressurizing means in the forrn of an inﬂatable air cushion, this feature implies thatwhen the air cushion has reached its maximal expansion, a further increase of the internalpressure does not expand the air cushion any more, which, in tum, means that no morecompression pressure can be applied on the femoral artery. Norrnally, i.e. for the vastmajority of patients having a normal or ordinary body constitution, this is of no problemsince the stroke length (i.e. the expansion) of the air cushion corresponds to the expansionneeded to completely, or almost completely, compress the artery such that the ﬂow of bloodtherethrough is significantly reduced, to thereby prevent bleeding from the puncture wound.In other words, the operating range of the air cushion ranges from a minimum value wherethe ﬂow of blood is essentially unrestricted to a maximum value where the ﬂow of blood isessentially completely stopped.

However, for those patients where the femoral artery is embedded in a very thick layer ofadipose tissue, it can be difficult to determine whether the air cushion has reached itsmaximal expanded state, in which no more compression of the femoral artery is possible.And when a pressure gauge is used, this problem is even more pronounced because thepressure gauge continues to show increasing values even though the air cushion has reachedits maximal expansion. This behavior may give an inexperienced user a deceitful impressionthat the compression pressure on the femoral artery actually is increasing. Needless to say, such a misjudgment may give rise to very serious complications.

Summary of the InventionThe above-mentioned problem is so lved by the present invention according to the independent claim.

Preferred embodiments are set forth by the dependent claims.

The present invention is therefore directed to an improved femoral compression device, anda general object of the invention is to provide such a compression device for use on patientswith a thick layer of adipose tissue at the site of an open puncture in the femoral artery.Embodiments of the invention are directed to a femoral compression device, for use on patients with an excessive amount of adipose tissue in the lower torso region, comprising an inﬂatable air cushion, a pump, a belt adapted to be fixed around the patient°s body, and abase plate supporting the pressurizing means and being provided with two extensions.According to the present invention the inﬂatable air cushion is raised from the base plate bymounting a spacer between the base plate and the air cushion. This effectively moves therange of expansion of the air cushion away from the base plate, pressing the excessiveadipose tissue to the sides, and ensuring proper access to the compression site. In use theinﬂatable semi-spherical air cushion is positioned over the femoral artery, and the belt,which extends from the end of the first extension, around the patient°s body and to the endof the second extension, is tightened. To apply pressure on the femoral artery, the inﬂatablesemi-spherical air cushion is inﬂated by a pump effectively compressing the artery such thatthe flow of blood therethrough is significantly reduced, to thereby prevent bleeding from the puncture wound.

Brief Description of the DrawingsFigure l is a cross-sectional view of a previously proposed femoral compression device attached to the body of a patient having a normal amount of adipose tissue overlying afemoral artery.

Figure 2 is a cross-sectional view of a previously proposed femoral compression deviceattached to the body of a patient having an excessive amount of adipose tissue overlying afemoral artery.

Figure 3 illustrates a first embodiment of a femoral compression device according to thepresent invention.

Figures 4a-4d illustrate perspective views of different embodiments of the spacer accordingto the present invention.

Figure 5 is a cross-sectional view of an altemative embodiment of the spacer.

Detailed Description of Preferred EmbodimentsFigure l illustrates how a previously proposed femoral compression device l is attached to the body of a patient in order to apply compression pressure on a femoral artery 2 in which apuncture hole has been made. The compression device l comprises basically a base plate 3,a belt 4 and an inﬂatable air cushion 5, which can be inﬂated by a pump 6, which isprovided with a pressure gauge 7.

The patient illustrated in figure l has a normal body constitution, with an average amount of adipose tissue being localized between the skin and the femoral artery 2. When in a semi- inﬂated state, i.e. less than fully expanded, the air cushion 5 can therefore compress theartery 2 such that no blood penetrates through the puncture hole in the femoral artery 2.Herein, the expression “norrnal body constitution” refers to a body constitution to which thisexisting femoral compression device l is adapted, i.e. the stroke length (the expansion) ofthe air cushion 5 is sufficient for the pressure force being applied therewith to be transmittedthrough the layer of adipose tissue and compress the femoral artery 2.

Another case is illustrated in figure 2, where a femoral compression device l' has beenattached to the body of an overweight patient to apply compression pressure on a femoralartery 2' in which a puncture hole has been made. The femoral compression device l' offigure 2 is identical with the femoral compression device l shown in ﬁg. l, and comprisesbasically a base plate 3', a belt 4' and an inﬂatable air cushion 5', which can be inﬂated by apump 6', which is provided with a pressure gauge 7'. In this case, an excessive amount ofadipose tissue is localized between the skin and the femoral artery 2', essentially filling upthe space within the boundaries defined by the base plate, the belt and the air cushion. Thispreviously proposed femoral compression device l' was not designed for this type ofpatient, and, as is illustrated in the figure, even in the fully expanded state, the air cushion 5'cannot compress the femoral artery 2' enough to stop bleeding through the puncture holetherein. In particular it should be noted that pressure gauges 7 and 7' display the sameintemal pressure for the two cases illustrated in figure l and figure 2, respectively.

As discussed above, a further inﬂation of the air cushion 5' of Fig. 2 results only in anincrease in the intemal pressure within the air cushion 5', without any more compressionpressure being applied on the femoral artery 2'. Furthermore, the read-out from the pressuregauge 7' will- at least in some sense - support and justify such an operation by the user,because the pressure gauge 7' will continue to show increasing values and thereby give theuser the impression that more compression pressure actually is being applied on the femoralartery 2'. In short: when in a not fully expanded state (as in fig. l), more compressionpressure is actually applied on the femoral artery 2 when the air cushion 5 is inﬂated by thepump 6, which is in accordance with the readings from the pressure gauge 7; whereas in afully expanded state (as in ﬁg. 2), no more compression pressure is applied on the femoralartery 2' when the air cushion 5' is inﬂated by the pump 6', which is in contradiction to thereadings from the pressure gauge 7'.

In the situation illustrated in figure 2, an inexperienced user may continue to operate thepump 6' in a (vain) attempt to apply more compression pressure on the femoral artery 2', and when the user realizes that the bleeding is not going to stop, there is a risk that the decision will be that the compression device 1' has been misplaced and has to be moved to anotherposition, which leads to unnecessary bleeding. Here it should be mentioned that extratightening of the belt 4' to some extent could compensate for the above-mentioneddisadvantage of the known femoral compression device 1'. However, this procedure requirescareful consideration by the user, and the risk of a misleading reading from the pressuregauge 7' is still present. In addition, in those patients where the excess adipose tissuecompletely or almost completely f1lls up the space within the boundaries of the base plate,the belt and the air cushion (as illustrated in f1g. 2), further tightening of the belt is notpossible.

Experience from manual compression (performed by a nurse or other medical practitioner)of obese patients has shown that when initializing the procedure, the person performing thecompression needs to penetrate his or her hand deep into the folds of the adipose tissue.According to the present invention a spacer is arranged between the back plate and the aircushion in order to extend the penetration depth of the device into excess adipose tissue,thereby enabling both a considerably improved starting point and working conditions for theprocedure.

In figure 3 is illustrated a femoral compression device 11 according to the present invention.The device comprises a base plate 13, a belt 14 and an inﬂatable air cushion 15, which canbe inﬂated by a pump 16, which is provided with a pressure gauge 17. The air cushion isprovided with a back plate 19 at the side facing the base plate. Further, the device isprovided with a spacer 18 having a height, adapted to be mounted between the inﬂatable aircushion and the base plate 13. That is achieved by attaching the spacer to the base plate andto the back plate of the air cushion. As seen in figure 3, at the starting point of theprocedure, i.e. when the device 11 has been secured to the patient with the belt 14 and theair cushion is yet to be inﬂated, the excess adipose tissue has been pressed aside due to the extension of the compression component by use of a spacer.

The femoral compression device 11 may be assembled in connection with usage bymounting the spacer to the base plate and then attaching the air cushion to the spacer. Thepump is also connected to the air cushion. As an altemative some, or all, parts may beassembled in advance and the femoral compression device, provided with the spacer, is directly ready to be used. This is applicable to all embodiments mentioned herein.

Preferably, the spacer 18 has an essentially circular-cylindrical shape With a cylinder Wallhaving first and second edges 20, 21 (see figure 4a), Wherein the first edge 20 is adapted tobe attached to the back plate 19 of the air cushion and the second edge 21 is adapted to beattached to the base plate 13.

However, other cross-sectional shapes of the spacer is naturally possible Within the scope ofthe claims as long as the intended purpose of the spacer is achieved, i.e. enabling the aircushion to be arranged at a more distant level in relation to the base plate such that thedesired pressure is applied to the femoral artery. The cross-sectional shape may e.g. beelliptical or rectangular as long as it may be attached to the base plate and the back plate of the air cushion.

The spacer is preferably made from a transparent material in order see the Wound site Whenpositioning the air cushion in relation to the femoral artery.

For the same purpose the spacer may be provided With at least one opening 23 in thecylinder Wall. In addition, the tubing from the pump to the air cushion may be led throughthe opening.

Two spacers having different heights and provided With an opening 23 are illustrated in figures 4b and 4d The cylinder Wall may have a thinner thickness compared to the thickness at the edges Which improves the visibility of the Wound if the spacer is made from a transparent material.

The ﬁrst and second edges are each provided With at least one attachment member 22 forcooperation With mating attachment members at the base plate and back plate, respectively.The attachment member 22 may e.g. be a knob and a mating hole Which is illustrated infigures 4b-4d.

Altematively, the attachment members are realized by a bayonet joint.

In still another embodiment the spacer is attached to the base plate and the back plate by anadhesive, e.g. by an self-adhesive at each of the edges that is covered by a plastic foil that is peeled off When the spacer is to be mounted to the base plate and back plate.

The height of the spacer is preferably in the range of 10-100 mm. Even larger heights maybe applicable for really obese patients. A set of spacers having different heights may be provided including e. g. five different spacers having heights of e. g. 10, 30, 50, 80 and 100 1'I11'I1.

In an alternative en1bodin1ent the height of the spacer is Variable. Figure 5 is a cross-sectional view of a spacer having a variable height. In this en1bodin1ent the spacer coniprisestwo concentrically arranged tubes 24, 25 interconnected to each other via internal andexternal threads 26, such that When the tubes are rotated in relation to each other the height of the spacer may be varied Which is indicated in figure 5 by the double-arrow.

Although the present invention has been described With reference to specific en1bodin1ents itWill be apparent for those skilled in the art that many variations and n1odif1cations can beperforrned Within the scope of the invention as described in the specification and defined With reference to the clainis below.

Claims

10 15 20 25 30 Claims

1. A femoral compression device (11) for compressing a femoral artery (12) of a patient, comprising a base plate (13) provided With two opposing extensions, each of the two opposing extensions comprising a member for affixing a belt (14) , Which is adapted to be arranged around a patient ”s body, an in ﬂ atable air cushion (15), provided With a back plate (19), for compressive bearing against a puncture site, and a pump (16) connected to the in ﬂ atable air cushion for inflation of the air cushion, characterized in that the femoral device further comprises a spacer (18) having a height and being adapted to be mounted between the in ﬂ atable air cushion and the base plate.

2. Femoral compression device according to claim 1, Wherein said spacer (18) has an essentially circular-cylindrical shape With a cylinder Wall having first and second edges (20, 21).

Femoral compression device according to claim 2, Wherein the edge rst edge (20) is adapted to be attached to the to the back plate (19) of the air cushion (18) and the second edge (21) is adapted to be attached base plate (13).

4. Femoral compression device according to any preceding claim, Wherein said spacer is made from a transparent material.

5. Femoral compression device according to any of claims 2-4, Wherein said cylinder Wall has a thinner thickness compared to the thickness at the edges.

Femoral compression device according to any of claims 2-5, Wherein said spacer is provided With at least one opening in the cylinder Wall.

7. Femoral compression device according to any preceding claim, Wherein said height is in the range of 10-100 mm.

8. Femoral compression device according to any of claims 1-6, Wherein said height is variable.

9. Femoral compression device according to claim 8, Wherein said spacer comprises two concentrically arranged tubes (24, 25) interconnected to each other via internal and external threads (26), such that When the tubes are rotated in relation to each other the height of the spacer is Varied.