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Title:
AV-FISTULA BANDAGE
Document Type and Number:
WIPO Patent Application WO/2003/099143
Kind Code:
A1
Abstract:
The invention consists of an AV fistula bandage intended for use at the conclusion of sessions of dialysis treatment. The AV fistula bandage comprises a pressure body 1 provided with a pressure surface 2 intended for the application of pressure at the point of insertion of one or more dialysis needles and an armband 3 intended to hold the pressure surface 2 in place against the point of insertion. The pressure body 1 is fixed via a rigid intermediate section 4 to the armband 3. The form of the pressure surface is mainly spherically formed.

Inventors:
Hansson, Jenny (. Sevallagatan 5 A, Västerås, Västerås, S-723 42, SE)
Sandström, Bengt (. Blåklockevägen 11, Västerås, Västerås, S-722 46, SE)
Application Number:
PCT/SE2003/000804
Publication Date:
December 04, 2003
Filing Date:
May 19, 2003
Export Citation:
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Assignee:
Hansson, Jenny (. Sevallagatan 5 A, Västerås, Västerås, S-723 42, SE)
Sandström, Bengt (. Blåklockevägen 11, Västerås, Västerås, S-722 46, SE)
International Classes:
A61B17/132; A61F5/32; (IPC1-7): A61B17/132; A61F5/32
Attorney, Agent or Firm:
GROTH & CO. KB (Box 6107, Västmannagatan 43, Stockholm, S-102 32, SE)
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Claims:
CLAIMS
1. AV fistula bandage, intended for use at the conclusion of sessions of dialysis treatment, comprising a pressure body (1) with a pressure surface (2) intended for the application of pressure at the point of insertion of one or more dialysis needles, an armband (3) intended to hold the pressure surface (2) against the point of insertion, characterized in that the form of the pressure surface (2) being mainly spherical.
2. AV fistula bandage according to with claim 1, characterized in that the AV fistula bandage including fixing devices arranged to hold the pressure body to the armband (3).
3. AV fistula bandage according to claim 2, characterized in that the armband (3) having two ends and the fixing device being fixed to the pressure body (1) and showing first and second fixings arranged to be fixed at one end of the armband (3) respectively.
4. AV fistula bandage according to claim 2 or 3, characterized in that the fixing device comprises an intermediate section (4) with a rigid extension projecting in each direction from the attachment body, direction in this context being the direction of the armband.
5. AV fistula bandage according to any of the preceding claims, characterized in that the pressure body (1) and the intermediate section (4) being integrated in one piece.
6. AV fistula bandage according to any of the preceding claims, characterized in that the intermediate section (4) being designed with a waist (5).
7. AV fistula bandage according to claim 4, characterized in that the armband (3) being arranged to be attached to the intermediate section (4) by being threaded through holes (6) provided in both ends (7,8) of the intermediate section (4) and then fixed in place by means of Velcro strips.
8. AV fistula bandage according to claim 4, characterized in that the armband (3) being arranged to be attached to the intermediate section (4) by the intermediate section (4) being provided with hooks at both ends (7,8) which engage in holes provided for this purpose in the armband (3).
9. AV fistula bandage according to claim 4, characterized in that the armband (3) being arranged to be attached to the intermediate section (4) by the armband (3) being provided with hooks at both ends intended to engage in holes provided for this purpose in the intermediate section (4).
10. AV fistula bandage according to any of the claims 49, characterized in that the attachment of the armband (3) to the intermediate section (4) being adjustable at both ends (7,8).
11. AV fistula bandage according to any of the preceding claims, characterized in that the intermediate section (4) being of Plexiglass.
12. AV fistula bandage according to any of the preceding claims, characterized in that the pressure body (1) being of a plastic material.
13. AV fistula bandage according to claim 12, characterized in that the plastic material being of a sticky type.
14. AV fistula bandage according to any of the claims 113, characterized in that the spherical surface (2) being provided with an adhesive coating.
15. AV fistula bandage according to any of the claims 113, characterized in that the spherical surface (2) having a structured surface.
Description:
AV-FISTUT A BANDACE Field of the Invention This application relates to an AV fistula bandage intended for use at the conclusion of sessions of dialysis treatment. The AV fistula bandage comprises a pressure body provided with a pressure surface intended for applying pressure at the points of insertion of one or more dialysis needles and an armband intended to hold the pressure surface at the point of insertion.

Prior art A long-know problem associated with dialysis treatment is to stop the blood flow in the most suitable way following the withdrawal of the needles from the patient fistula when the dialysis is concluded. The pressure of the blood in the fistula is higher than in an ordinary vein as a fistula consists of a vein and an artery which have been operated together. Dialysis treatment always requires the insertion of two needles. These needles are thick and this, in combination with the high pressure in the fistula calls for the correct application of suitable pressure at the insertion points both at the time of withdrawal and for a certain time after, with the object of stopping the bleeding. This time is usually between five and ten minutes but is occasionally up to 30 minutes. The pressure must be applied correctly at the point of insertion if the bleeding is to be stopped. It is of the greatest importance that the pressure applied is sufficiently great to stop the bleeding but not so great as to stop the flow of blood through the fistula as such a stoppage can damage the fistula and cause patient discomfort. The most usual method today to conclude a session of dialysis treatment is for a nurse to apply a sterile compress at the point of insertion, and then press with a finger until the blood flow ceases. This requires that a person sit with the patient, pressing constantly with the appropriate pressure at the point of insertion until the bleeding ceases. When withdrawing the second needle, it may easily happen that the first compress slides away from the insertion point and bleeding begins. The needles may be located a considerable distance apart which adds to the risk that the compress is dislodged during this operation. The application of manual pressure often requires the nurse to change her grip because of numbness of the fingers and it is then easy to glide away from the point of

insertion with the result that bleeding begins. When working with dialysis patients, the pressing after the treatment is an operation that must be repeated constantly. In many cases, the frequent performance of this task results in occupational injury to the dialysis personnel. It is a procedure that occupies much of the personnel's working time, as it must be repeated for every dialysis patient treated.

US 5 873 890 describes a device intended to solve the problem of applying manual pressure at the point of insertion after completed dialysis treatment. The device described in the document consists of a first part consisting of an adhesive tape partly provided with an absorbent material which expands on contact with a fluid and a second part consisting of an armband intended to be applied around the patient's arm. The armband is provided with a rectangular box intended for application over the point of insertion so that pressure is applied. The box is provided on both sides with rigid projections intended to permit the flow of blood in the arm on both sides of the point of insertion when the armband is tightened. The adhesive tape is applied over the point of insertion before the needle is withdrawn. After the needle has been withdrawn, the box is placed over said adhesive tape and the armband is then threaded through a locking stirrup, drawn out on the other side and locked by barbs on the armband engaging said stirrup. The armband can be released and adjusted by means of a special release mechanism.

The device described above is complicated and includes expensive components that cannot be reused. It also has a number of technical disadvantages.

The use of a flat contact surface for the application of pressure is less suitable. Considerable pressure is required over the entire flat surface to obtain a relevant pressure at the point of insertion. A rectangular part for pressure can neither be applied centred over the point of insertion. This is because the needles are always inserted, and withdrawn, at an angle to the arm which means that the box must be located in such a way that the needle can be withdrawn, i. e. displaced from the point of insertion and not centred over it. With a box for application of pressure, it is also difficult to see exactly where the box is applied in relation to the point of insertion.

The invention in accordance with the present application is intended to provide an AV fistula bandage which solves the above problems and thereby provides an AV fistula bandage which in a certain and exact way applies a relevant pressure at the needle insertion point following a session of dialysis treatment.

Description of the invention The special characteristic of the present AV fistula bandage is that the pressure surface is mainly spherically formed. A spherically formed pressure surface permits exact positioning over a point of insertion of one or more dialysis needles. The spherically formed pressure surface also gives a distribution of pressure that declines successively away from the centre. A high pressure is thus obtained at the point of insertion while the total pressure against the arm can be minimized, avoiding the risk of impeding the flow of blood in the arm and/or discomfort to the patient.

In another preferred embodiment, the pressure body and the intermediate part are designed as a single unit. By integrating these parts as a single unit, production on a large scale would be particularly cost-effective.

In a preferred embodiment the pressure body is made of a plastic material that shall be hygienic and easily cleaned. It can be of a transparent plastic which would simplify control of the exact location of the pressure surface over the point of insertion and enable quick detection of any bleeding. The use of a hygienic, easily cleaned plastic material would permit the reuse of the pressure body.

The entire pressure body of one preferred embodiment is made from a plastic material of a sticky type.

In another preferred embodiment, the spherical surface is provided with an adhesive coating.

In a further preferred embodiment, the pressure surface has a structured surface, grooved or with a pattern of projections. By ensuring friction between the surfaces in contact, displacement is prevented when the pressure surface is applied to a sterile compress placed over the insertion point.

The intermediate section in one preferred embodiment is designed with a waist. This waist permits the withdrawal of the needle, or needles, at a relatively

large angle in relation to the patient's arm. The needles are normally inserted at an angle of 45 ° during the treatment itself and it is preferable to withdraw them at approximately the same angle to minimize patient bleeding and discomfort.

The intermediate part in one preferred embodiment can be fixed at both ends to the different ends of the armband.

In a further preferred embodiment, the armband can be adjusted at both ends of the intermediate section. Both of the fixing points being adjustable permits secure adjustment of the pressure at the point of insertion with no risk of the pressure being displaced from its correct position. This can happen in the case of the technique used in the US 5 873 890 device where the armband is adjusted and tightened at one side only. It is important that the pressure is applied exactly over the point of insertion. When the armband can be adjusted and locked from one side only, as in the case named above, it is easy to displace the pressure body and thereby the application of the pressure from its correct position when the armband is tightened..

The armband in another preferred embodiment can be fixed to the intermediate section by being passed through holes provided in both ends of the intermediate section and then locked with Velcro strips.

In another preferred embodiment the armband is arranged to be fixed against the intermediate section by the intermediate section being provided with hooks at both ends and the armband being provided with holes in which the hooks are engaged.

In an alternative embodiment the armband can be provided with hooks which engage in holes provided in the intermediate section.

The intermediate section of one preferred embodiment is made of Plexiglass.

The use of adhesive tape is less suitable as it can cause wear of the skin. The skin of a dialysis patient must withstand the effects of 2-4 dialysis treatments each week, always applied at the same place on the arm.

When using the AV fistula bandage, the nurse, after the dialysis is concluded, places a sterile compress over the insertion point of the needles and then locates pressure surface 2 of the AV fistula bandage against the compress. Because of the spherical form of the pressure surface 2 of the present invention, the AV fistula bandage can be located very accurately over

the point of insertion. The nurse then attaches the armband 3 in both ends, 7,8, of the intermediate section 4 and adjusts this on both sides until an appropriate pressure is applied centrally over the point of insertion. The armband is then locked in place by one of the methods described above. After the AV fistula bandage is in position, the nurse has both hands free. The needles can therefore be withdrawn in a safe manner with a minimum risk of bleeding. The nurse can then leave the patient and continue with other tasks until the bleeding has ceased after which the AV fistula bandage can be removed.

The main advantage of the AV fistula bandage is that both the nurse's hands remain free. There is often little time available at the conclusion of the treatment and it is then of extra great importance that the nurse's hands are free when the AV fistula bandages is applied. As distinct from the known US 5 873 890 device, no special adhesive tape is required for use with the AV fistula bandage-all that is additionally required is the ordinary sterile compress which is normally used when pressure is applied manually. When the AV fistula bandage is tightened and the pressure checked, i. e. the pressure is sufficient to prevent bleeding and the patient feels no discomfort, it remains in position very firmly and securely. The AV fistula bandage can be cleaned with ordinary disinfecting agents and then reused. This means that the cost of its use is minimized.

Brief description of the illustrations Fig. 1 is a sketch showing the principles of one preferred embodiment of the invention.

Fig. 2 is a top view of the embodiment version in accordance with Fig. 1.

Detailed description of the preferred embodiment of the invention Fig. 1 shows a preferred embodiment of an AV fistula bandage according to the present invention. The AV fistula bandage includes a pressure body 1 provided with a pressure surface 2. The pressure surface is mainly spherically formed. The AV fistula bandage includes an armband 3 that is used to hold the pressure surface 2 of the pressure body 1 against the point of insertion. The pressure body 1 is attached to the armband 3 via a rigid intermediate section 4 with a press-stud 10. The intermediate section 4 is fixed to the pressure body in

an appropriate manner. The armband 3 is attachted to both ends 7,8 of the intermediate section and then drawn firmly tight, adjusted and fixed in position with Velcro strips at both the ends. The figure shows a compress 11 applied at a point of insertion in a fistula 12 in the patient's arm 13.

Fig 2 is a top view of the embodiment according to Fig 1. The intermediate section 4 is provided with a press stud 10 and is designed with a waist 5. The armband 3 is fixed to the intermediate section 4 by being threaded through the hole 6 in the ends 7,8 of the intermediate section and is then tensioned, adjusted and locked at both ends.