WO2023174954A1

WO2023174954A1 - Apparatus for and method of handling implanted catheter assemblies

Info

Publication number: WO2023174954A1
Application number: PCT/EP2023/056516
Authority: WO
Inventors: Palle Munk Hansen
Original assignee: PH Innovations ApS
Current assignee: PH Innovations ApS
Priority date: 2022-03-16
Filing date: 2023-03-14
Publication date: 2023-09-21
Anticipated expiration: 2024-09-16
Also published as: GB2616641B; GB2616641A; GB202203633D0

Abstract

Apparatus for handling a proximal end of a CVC comprises a bag (200) of standard size and formed of one sheet of material welded or bonded together at its seams (220-222) and having a first bag open at the top (206) and a second bag open at the bottom (208). The bag is made of a breathable and waterproof non-woven material. For bathing, specifically showering, the second bag closed at its top end is used and the end of the first bag is folded over the second bag to close the second bag. A lanyard (240) is located at the top, closed, end of the bag. Once the patient has finished showering, the closure mechanism can be released, the proximal end of the CVC removed from the second bag, having been kept dry and clean.

Description

APPARATUS FOR AND METHOD OF

HANDLING IMPLANTED CATHETER ASSEMBLIES

Field of the Invention

The present invention relates to apparatus for and a method of handling implanted medical assemblies such as catheter assemblies, particularly assemblies that may be left long term in a patient for the administration of drugs, processing of bodily fluids and so on. The invention is not limited to catheter assemblies and can be useful in the handling of any medical device attached to or partially implanted within a patient.

Background of the Invention

The preferred embodiments of the invention relate to the handling of catheter assemblies such as central venous catheters (CVCs).

A central venous catheter (CVC) is a long, flexible, usually Y-shaped tube that in use is inserted through one of the central veins in a patient’s neck, chest or groin to allow access to the bloodstream. A CVC is often much longer than a standard intravenous catheter and is positioned deeper in the body, into the larger blood vessels. A CVC often remains in the body for a significant period of time, from weeks to months.

The CVC has a proximal end that remains outside of the patient and is often located in the upper chest area. It may comprise one or more end tubes typically arranged in a Y-shaped configuration. The end tube or tubes provide access points to the bloodstream and are closed or capped off when not in use. The internal section of the CVC, specifically its distal tip, may be disposed for some treatments to rest in the right upper chamber of the heart.

A CVC can be used for a multitude of medical procedures, including administering medicine, nutrition or chemotherapy, drawing blood and/or receiving dialysis treatment. A CVC can also be used for haemodialysis treatment. The end tube or tubes from the catheter may be coupled directly to intravenous apparatus or to a dialysis machine, for example. They may also be used to draw blood from the patient, avoiding the need for needles during routine or recurring blood tests.

While a CVC provides many advantages, it can suffer from a number of disadvantages, including, for example, the risk of serious infection from or through the CVC. Infections may be localized, for instance at the area of the insertion site, or they may be systemic, that is affect the whole body.

Infection is responsible for the removal of around 30 to 60% of implanted CVCs and hospitalization rates are higher in CVC patients than patients with other types of dialysis accesses. The most dangerous infectious complication is catheter-related bloodstream infection (CRBSI), which can be associated with high rates of morbidity and mortality.

There is also the risk of blood clots forming around the internal opening of the catheter, which can slow or block entirely the blood flow. When this occurs, the clots need to be dissolved before care can resume.

CVCs may also risk damaging blood vessels, particularly over prolonged use. CVCs can cause vessel stenosis in the vessel, particularly at the insertion site, which can damage the vessel walls and also restrict or stop the flow of blood in the vessel.

Summary of the Present Invention

The present invention seeks to provide improved apparatus for and a method of handling implanted medical assemblies.

According to an aspect of the present invention, there is provided an implantable medical device holder for holding a proximal, exposed, end of an implantable medical device when implanted in a patient, the holder including: a bag structure comprising: a first bag having an open top, closed sides and a closed base; a second bag having a closed top, closed sides and an open base, and a closure mechanism for closing the open base of the bag; and a neck lanyard coupled or configured to be coupled to the bag structure for holding the bag on a person; wherein the first bag is configured to hold a proximal end of an implanted medical device in a downwardly extending direction through the open top of the first bag, and the second bag is configured to hold the proximal end of the implanted medical device in an upwardly extending direction through the open base of the second bag.

The holder is able to be used both as a day bag, to hold the free ends of an implanted catheter, for example, when not in use, and as a bathing bag to keep the free ends of the implanted catheter secure and dry during bathing.

In the preferred embodiment, the first and second bags are disposed in a overlying relation (one in front of the other) and may share a common wall. In an embodiment, the second bag is shorter than the first bag and shares a wall of the first bag, such that the opening of the second bag can be accessed along the common side of the first bag.

In the preferred embodiment, the closure mechanism comprises a part of the bag structure able to be folded over the open base of the second bag. The foldable part of the bag structure preferably includes a part of the first bag. In other embodiments, the foldable part may be an individual section of bag material.

Advantageously, there is provided a fastener for holding the foldable part of the bag structure in the folded condition.

It is preferred that the foldable part of the bag structure comprises at least one drain aperture for drainage of water or other fluid during bathing.

In other embodiments, the closure mechanism may be a mechanism attached to the first bag, such as a hook and eye fastening (such as Velcro™), an adhesive fastening, a string or ribbon, and so on.

The fastening may act to fasten the first bag as well, if desired.

The lanyard may be a separate component attached to the bag structure, preferably though an attachment element of the bag structure. In other embodiments, the lanyard may be an integral part of the bag structure. Advantageously, the bag structure is made of or coated with a water impermeable material. The bag structure is preferably made of a water impermeable non-woven material.

The bag is preferably made of a waterproof material, optionally a breathable material, preferably a non-woven material. The preferred material has bacterial resistant properties, by the nature of the material itself and/or by a coating on or constituent of the material. The bag may be made of a polypropylene or polyethylene material, or other suitable material. Other examples include biodegradable materials. The chosen material is preferably non-toxic and hypo allergenic.

In the preferred embodiments, the bag structure is made of sheeting material formed from synthetic flash spun high-density polyethylene fibres, such as Tyvek™. In other embodiments it may be made of non-perforated polyethylene, or any other water impermeable biocompatible material.

Preferably, the or each bag is made of material having a wall thickness of between 0.05 mm to 0.5 mm when using a non-woven material. In the case where the holder is made of polyethylene such as LDPE or LLDPE the or each bag may have a wall thickness of 0.01 -0.05 mm.

According to another aspect of the present invention, there is provided an implantable medical device holder for holding a proximal end of an implantable medical device when implanted in a patient, the holder including a bag and a neck lanyard attached to the bag, the bag being closed apart from an opening adjacent the lanyard.

The holder allows for holding the proximal end of an implanted medical device, such as a CVC, comfortably with the bag held by the lanyard around the patient’s neck on the patient’s chest at a convenient height.

In an embodiment, the bag has a length of between 150 mm to 250 mm and a width of between 15 mm to 60 mm.

The bag may have a single, common chamber, although in other embodiments it may have a plurality of chambers, for example one for each end of the medical device. Each chamber is open at the top, that is at an end of the bag adjacent the lanyard. Thus, for a medical device comprising at the exposed end of the medical device two proximal connector tubes, for example, the bag may have two chambers, while for a device having three proximal connector tubes, the bag may have three chambers. In this manner, each proximal connector tube, or other connector, of the medical device can be located into a respective chamber of the bag. All embodiments disclosed herein may have a bag with one of more chambers of this type.

Advantageously, the neck lanyard has first and second ends each connected to a respective side of the bag, said respective sides being opposing sides.

It is to be understood that the lanyard may be provided as a separate component that is attached to the bag, or may have one end that is attachable, in which case the lanyard may be length adjustable at its connectable end or ends.

Preferably, the or each bag is made of material having a wall thickness of between 0.05 mm to 0.5 mm when using a non-woven material. In the case where the holder is made of polyethylene such as LDPE or LLDPE the or each bag may have a wall thickness of 0.01 mm to 0.05 mm.

According to another aspect of the present invention, there is provided a kit comprising a plurality of holders as disclosed herein, wherein the plurality of holders include at least one first holder having a neck lanyard of a first length and at least one second holder having a neck lanyard of a second length, when all of the holders within the plurality have a bag of the same dimensions.

According to another aspect of the present invention, there is provided an implantable medical device holder for holding a proximal, exposed, end of an implantable medical device when implanted in a patient, including a bag having a closed top, closed sides and an open base; a neck lanyard coupled to the closed top of the bag; and a closure mechanism for closing the open bottom end of the bag.

Advantageously, the bag has a length in the region of 50 mm to 120 mm and a width in the region of 15 mm to 60 mm. It has been found that such dimensions can be used as a standard, holding securely the exposed end of the implanted medical device and thereby avoiding the need to multiple different bags sizes. Any of the bags disclosed herein may be made of a non-woven material, such as a waterproof breathable material. The bag is preferably made of a polypropylene or polyethylene material.

The bag may be made of two leaflets of material bonded or welded at their edges, apart from at the open end of the bag. Bonding may, for example, be by heat bonding, pressure bonding, chemical bonding, adhesive bonding and so on. Other options include sewing. It may be made of two sheets of material or of a single sheet of material folded to form two leaflets. Each sheet may be a single layer sheet or a multiple sheet layer.

According to another aspect of the present invention, there is provided a kit for handling an implanted medical assembly having a proximal end exposed outside of the patient, the kit including at least one day holder and at least one bathing holder.

Other aspects and advantages of the teachings herein will become apparent to the skilled person from the description of the preferred embodiment that follows.

Brief Description of the Drawings

Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:

Figures 1 A to 1 C shows a variety of schematic diagrams of different versions of central venous catheter systems;

Figure 2 shows an example of a dual lumen CVC system fitted through the jugular vein of a patient;

Figure 3 is a schematic diagram of a first example of apparatus for the management of a CVC system;

Figure 4 is a diagram showing further details of the example of Figure 3;

Figure 5 is a schematic diagram of another example of apparatus similar to that of Figures 3 and 4;

Figure 6 is a schematic diagram of an example of another device for holding the proximal ends of a CVC for patient bathing purposes; Figure 7 is a view similar to Figure 6, showing the apparatus in use;

Figure 8 is an enlarged view of a part of the apparatus of Figure 7;

Figure 9 is a view of another example for apparatus similar to that of Figures 6 to 8;

Figure 10 is a schematic diagram of another example of apparatus similar to that of Figures 6-8;

Figure 11 is a schematic diagram of another example similar to that of Figure 10;

Figures 12 and 13 show an example of closure mechanism for the embodiments of apparatus shown in Figures 6-11 ;

Figure 14 is another example of closure mechanism;

Figure 15 is a schematic diagram of an embodiment of medical device holder;

Figures 16A to 16C show a prototype example of holder according to Figure 15 in different modes of use;

Figure 17 is a schematic diagram, in front elevation, of a preferred embodiment of the present invention;

Figure 18 is an enlarged view of a part of the devise of figure 17;

Figure 19 is a schematic diagram of the rear elevation of the embodiment of device of Figure 17;

Figure 20 is a perspective view of a sheet of material folded in preparation for forming the first and second pockets of the apparatus;

Figures 21 to 25 are photographs of a example of the embodiment of device of Figures 15 to 20 in different modes of use;

Figure 26 is a schematic diagram, in front elevation view, of another embodiment of device according to the present invention;

Figure 27 is a schematic view showing the operation of the preferred embodiment of apparatus, in both the day use and also in the showering use;

Figure 28 is a front elevational view of another embodiment of apparatus; and

Figure 29 is a rear elevational view of the embodiment of Figure 28. Description of the Preferred Embodiments

Described below are a variety of examples and embodiments of apparatus according to the teachings herein. These examples and embodiments focus upon a central venous catheter (CVC) application. It is to be understood, however, that the teachings herein are not limited to a particular medical application. Furthermore, it is to be understood that while certain characteristics of the examples and embodiments described below, such as materials used, dimensions and so on are given, these are exemplary only unless indicated as having a particular significance or purpose and that it is intended to be specific to a defined aspect of the invention.

Referring first to Figure 1 A, this shows an example of a CVC catheter assembly, which includes an elongate catheter 10 having a distal end 12 and a proximal end 14 which in use remains outside of the patient. For this purpose, there is provided a cuff unit 16 fixed to the catheter 10, which may include a tissue ingrowth cuff element 18 and a microbial cuff element 20. The cuff unit 16 will typically locate against the patient’s skin at the percutaneous entry point.

At the proximal end 14 of the catheter, there may be provided a clamp 22 for opening and closing the lumen of the catheter 10, typically by compression in this example, and a connector 24 which conveniently may be provided with a luer fitting 26 as is standard in the art. The example of CVC catheter shown in Figure 1 A has a single lumen and a single connector 24.

By contrast, referring to Figure 1 B this shows another example of CVC catheter similar in form to the catheter shown in Figure 1 A but in which the catheter has a dual lumen and is provided with two proximal tubes 34, 44 extending from a Y-fitting 30. The two proximal tubes 34, 44 communicate to respective lumens within the dual-lumen catheter 10. Each proximal, branch, tube 34, 44 is provided with a clamp and connector 24 with a luer fitting 26, in this example.

The example of Figure 1 C is a tri-lumen catheter with a three-way Y-shaped connector 40 and three proximal branch tubes 46, 48, 40, each provided with a clamp 22 and connector 24. CVC catheters of the types shown in Figures 1 A to 1 C are designed for long-term vascular access and for use in patients who lack adequate peripheral venous access. The distal end 12 of the catheter is typically inserted through the skin of the patient via a percutaneous entry point and into one of the large blood vessels, for instance a vein that opens close to the heart. An example is depicted in schematic form in Figure 2, which shows a dual lumen CVC fitted to a patient from a percutaneous access point at the patient’s chest and which feeds into a location close to the patient’s heart from a venous access side. The bulk of the catheter 10, from the cuffs 18, 20, is located in use inside the patient, whereas the proximal part, that is proximal of the cuffs 18, 20, remains outside the patient, such that the branch tubes can be connected to suitable receptacles of/for fluid.

Once the CVC is located in the patient, various treatments can be performed through the catheter, such as chemotherapy, blood transfusions, administration of bioactive agents or other drugs, to take blood samples and so on. This avoids the patient having to be treated by injection, for example, every time blood samples need to be taken or drugs administered. In some cases, the CVC will remain in place in the patient for a number of days and often for weeks or months. When treatment extends over a very substantial period of time, it is possible the catheter may be replaced, which would also be the case should the catheter cause infection or in some way be damaged.

The catheter 10 must be handled with particular care in order to avoid or at least minimise the risk of infection to a patient, in particular during periods when the catheter is not in use and, for example, when the patient needs to bathe or be involved in some other form of activity.

When the catheter is not being used for a medical procedure, whilst the proximal tubes can be closed by a clamp 22, for example, for comfort of the patient and also to ensure that the catheter is not dislodged from its location within the patient, it is important to keep the proximal part of the catheter 14 in some way supported in position. Current methods involve the patient having to size, cut and form a holding pouch from a length of tubular fabric material, in which one end of the tubular fabric is closed, for example by a knot and the tubular fabric then cut longitudinally to form two strips that can be tied as a lanyard to place around the neck of the patient. The other end of the tubular fabric is left uncut and knotted at its end, such that the uncut portion forms a pouch within which the proximal end of the CVC can be located. The procedure, as can be imagined, is time consuming, laborious and ultimately relies upon the diligence and ability of the patient or a carer to the manufacture of the pouch accurately and to ensure its correct implementation.

The difficulties become even more acute when the patient needs to be bathed, typically showered. For this purpose, it is necessary for the proximal end of the CVC and in particular the connectors 24 to be properly sealed so as to prevent or minimise the risk of infection. The patient will typically strap the connectors 24 in an upright position on their chest, for example by means of adhesive tape, and will do likewise for at least a part of the length of the proximal part of the catheter 10 to prevent it from snagging. This must be done, of course, after cleaning the site of the patient’s chest and thoroughly drying. Subsequent to this, the connectors must be sealed, typically achieved by a waterproof plaster which must be very securely attached to the patient to make sure that there is no potential leakage of bathing fluid into the connectors 26.

Once the patient has finished bathing and is thoroughly dry, the waterproof plaster must then be carefully removed, as well as the holding tape, all while making sure that the connectors do not get soiled and also ensuring that the catheter is not displaced at the percutaneous entry point. All of this makes it complicated and time consuming for a patient, with many associated risks.

The present invention seeks to address these issues with prior art devices.

Referring now to Figure 3, this shows a first example of apparatus for handling an implanted medical assembly such as a central venous catheter (CVC). This particular apparatus comprises a bag or holder 50, typically for daily use, which is coupled to a lanyard or strip 52 preferably of adjustable length and which can be located around the neck of a patient such that the bag or holder 50 rests at the front of the patient’s chest.

Referring to Figure 4, this shows a schematic diagram of the device of Figure 3. In its preferred and simplest form, the bag 50 is made of two sheets of material that are welded or bonded together at their seams 54, 56 and 58 but left open at the top 60. The seams preferably have a width C of between 1 and 10 mm, most preferably of 8 mm ± 1 mm. The internal dimensions of the bag 50, when laid flat, preferably has a width in the range of 15 mm to 60 mm, most preferably of around 60 mm ± 1 mm, and a depth or length B in the range of 150 mm to 250 mm, most preferably of 230 mm ±1 mm. The strap or lanyard 52 preferably has a thickness of between 5 mm and 10 mm, most preferably of 8 mm ± 1 mm, and a length typically of 450 mm or so.

Bonding may, for example, be by heat bonding, pressure bonding, chemical bonding, adhesive bonding and so on. Other options include sewing. The bag may be made of two sheets of material or of a single sheet of material folded to form two leaflets. Each sheet may be a single layer sheet or a multiple sheet layer.

The bag may be made of a breathable and preferably waterproof material and preferably of non-woven material. Suitable materials include polypropylene and polyethylene such as LDPE or LLDPE (or any of the other materials disclosed herein), with a wall thickness preferably in the range of between 0.01 mm and 0.05 mm. In other embodiments, the or each bag may be made of material having a wall thickness of between 0.05 mm to 0.5 mm especially when made of a non-woven material. The preferred material has bacterial resistant properties, by the nature of the material itself and/or by a coating on or constituent of the material. A high density polyethylene such as Tyvek™ is a possibility. Other desirable attributes include being biodegradable non-toxic and hypo allergenic.

The bag is intended to be a disposable item which can be disposed of after a single use or after a predetermined period of time

The bag 50 is preferably of a standard length, advantageously within the range of 150 mm to 250 mm as indicated above. It may also have a standard width, preferably within the range indicated herein. Neck lanyard 52 may be provided as a non-adjustable lanyard, so in different lengths to suit different patients, with a bag element 50 of standard size. In other embodiments, the lanyard 52 may be adjustable in any suitable manner known in the art. For this purposes, the neck lanyard 52 could be fixed at one end and attachable, after adjustment, at its other end, for example to an eyelet provided in or on the bag. It has been noted through experience that the free length of a CVC, for example, that remains outside the patient is generally standard irrespective of the overall length of the catheter and in particular of the distal portions of the catheter that is inserted into a patient. As a consequence, the inventor has discovered that it is not necessary to make a holder or bag of a specific size every time but that this can be of a standard size for all patients (or at least a standard size for adult patients versus, for example, a standard size for children). As a result, it is not necessary for patients to have to make up their own holders or bags at home but that these can be provided as a stock item, which considerably facilitates the management of a CVC by patients and also reduces the risk of the CVC not being properly handled, for example by incorrect bag formation and so on.

It is also possible to provide much more appropriate bag materials, for example waterproof bags, than it is when requiring a patient to make a bag of their own accord, in which case the material must be suitable for home manufacture.

With reference to Figure 5, this shows an example of a bag 70 that can be used for a child, for example, in which case the bag can be provided with a particular shape, for instance a happy rabbit, or in which motifs or other patterns are printed onto a non-woven material, either of a specific shape as shown in Figure 5 or on a standard bag shape as shown in Figures 3 and 4.

The bag may have a single, common chamber, although in other examples it may have a plurality of chambers, for example one for each end of the medical device. Each chamber is open at the top, that is at an end of the bag adjacent the lanyard. Thus, for a medical device comprising two proximal connector tubes, for example, the bag may have two chambers, while for a device having three proximal connector tubes, the bag may have three chambers. In this manner, each proximal connector tube, or other connector, of the medical device can be located into a respective chamber of the bag. All embodiments disclosed herein may have a bag with one of more chamber of this type.

Referring now to Figure 6, this shows an example of another bag 80 is designed in particular for use in bathing, specifically showering. The inventor has discovered that it is not necessary to adhere the proximal end of the CVC to the patient’s body by the waterproof plaster or other bandaging, for instance. Instead, the example of Figure 6 provides a bag 80 connected to a lanyard or strap 52, as with the bag of Figures 3 to 5, but in which the bag 80 is closed at its top end 82 and open at or proximate its bottom end or base 84. The lanyard or strip 52 is sized such that the bag 80, when on a patient, lies above the proximal tubes 34 of the CVC when loose. The proximal tubes, and in particular the connectors 24, can therefore be brought up into the bag 80 from its lower end 84 and then held in place by a tie or closure mechanism 86 of the bag, disclosed in further detail below, as can be seen in Figure 7.

As with the previous examples, the bag may have a single, common chamber, although in other examples it may have a plurality of chambers, for instance one for each end of the medical device. Each chamber is open at the top, that is at an end of the bag adjacent the lanyard. Thus, for a medical device comprising two proximal connector tubes, for example, the bag may have two chambers, while for a device having three proximal connector tubes, the bag may have three chambers. In this manner, each proximal connector tube, or other connector, of the medical device can be located into a respective chamber of the bag. All embodiments disclosed herein may have a bag with one of more chamber of this type. There is an advantage having a chamber for each of the proximal connector tubes as this can assist in keeping the proximal connector tubes substantially vertical, which can minimise the risk of water reaching the tube or connector ends by capillary action during bathing.

With reference to Figure 8, this shows an enlarged view of the bag 80 and in which the two connectors 24, in this example, are held securely within the bag 80 by the tie elements 86, which in this example are two strings coupled to the bag 80, for example by being threaded into and out of apertures within the bag. The closure ties 86 not only close the bag 80 but also hold the connectors of the proximal end of CVC in position and supported by the lanyard 52 extending around the patient’s neck.

The bag 80 may be made of the same or similar material as the bag 50 of the example of Figures 3 and 4 and specifically is waterproof such that any water cascading during showering will not enter into the chamber 90 of the bag 80 but will instead flow on the outside of the bag. It is not necessary for the lower end 84 of the bag 80 to be fully closed in watertight manner because of the downward flow of water during showering. The connectors 24 will remain dry and clean throughout this process, as well as being supported in the bag by the lanyard or strap 52 and closure mechanism 86.

Figure 9 shows another example of bag 80’, which in this example is fish-shaped for use by children. As with the example of Figure 6, the bag 80’ could be printed with motifs or other patterns on the material of the bag and this may either be shaped or have a standard shape as in the example of Figures 6-8.

Referring now to Figure 10, the example bag 80 is shown in further detail, this being made, in similar manner to the example of Figure 4, of two pieces of material that are welded or otherwise bonded together at their edges (as previously described), at a seam having a thickness B within the range, preferably, of 1 mm to 10 mm. A weld or bonding zone is provided along the sides of the bag as well as the top 82. It will be appreciated that in other examples the bag could be made of a folded sheet of material with the fold line being, in one example at the top 82, and in another example at one of the side seams. The base 84 remains un-bonded or un-welded so as be open for access into the interior of the bag 80.

The strap 52 may be of a given length, such that different versions of bags will be provided for different size patients (for example adult and children sizes) or may otherwise be adjustable in any suitable manner. The bag preferably has an internal dimension, when laid flat, that is dimension A, in the range of 15 mm to 60 mm, most preferably of 60 mm ± 1 mm, and a length C between 50 mm to 120 mm, most preferably of 120 mm ± 1 mm. The straps preferably have a width F of between 5 mm and 10 mm, most preferably of 8 mm ± 1 mm. The edge or bonding zone is preferably as for the first described example, as is the lanyard. The material forming the or each bag may have a thickness in the range of 0.05 mm to 0.5 mm when using a non-woven material. In the case where the bag or bags are made of polyethylene such as LDPE or LLDPE the or each bag may have a wall thickness of 0.01 -0.05 mm.

In the example shown in Figure 10, the bag is provided with a channel 92 that extends horizontally across the bag 80, preferably being a channel made with the same material as the bag itself and which is able to accommodate the strings of the closure mechanism 86, for example as shown in Figure 8. Having a channel for the closing system avoids having to have openings in the bag material itself for closure string to pass through.

The channel 92 preferably has a width E in the region of 5-15 mm and retains a lower section of the bag 80 of length D of preferably between 1 mm and 30 mm. The length D of the bag not only provides integrity to the channel 92 but can also act as a skirt to allow water to drip away from the bag, as will be evident from Figure 8.

Figure 11 shows another example in which the bag 80” has a channel 92 at the very end 84 of the bag 80, in other words omits the skirt of the example of Figure 10. In this particular example, the bag also has a channel 94 at its top end for receiving a strap or lanyard 52’ through the channel. This enables the manufacture of bags 80” which are of a uniform size and for the subsequent attachment of a strap or lanyard 52’ of size suitable for the particular patient, although it is equally envisaged that straps 52’ may be provided in a set of standard sizes, for example: adult size, child size and so on. It also enables, should it be desired, the same strap or lanyard 52’ to be used over and again, and for the bag 80’ to be replaced after each use.

In this example, each channel 92’ and 94 preferably has a width D in a range of 5-15 mm, most preferably of 6 mm ± 1 mm, and the bag itself preferably has dimensions equivalent to the bag shown in Figure 10. A channel 94 may also be provided with the example of Figures 6 to 10.

The bag 80’ may be made of the same material as the other bags disclosed herein, that is of waterproof material which most preferably is also breathable (although not necessarily so in the case of the bags used for showering or other bathing) and is preferably non-woven polypropylene or of a polyethylene such as LDPE or LLDPE.

Figures 12 and 13 show in better detail the arrangement of closure strings as may be provided within the channel 92 of the bag 80. It will be appreciated that bag 80 may include a single channel on one side of the two layers forming the bag but in other embodiments there may be provided a channel on both sides of the bag. Two strings 86 are fed through the channel or channels 92 and then knotted at one end or both ends if two pieces of string are used per closure tie. The strings 86 can then be pulled, as is apparent from Figure 13, to close the bag 80. Depending on the nature of the string used and the material of the bag, there may be sufficient friction for the bag to remain closed just by pulling the strings 86, although it is envisaged also that the strings 86 could be tied, for example in a releasable bow or knot, to ensure that bag 80 remains closed until it is deemed safe to open the bag again and remove the proximal end of the CVC.

The teachings herein are not restricted to an arrangement in which the bag, particularly the bathing bag, are permanently fixed to the neck lanyard. In some examples there may be provided a connector element, such as a clip, to the lanyard to which the bag can be clipped. This can facilitate the fitting of the exposed ends of the implantable medical device into the bag, prior to clipping onto the lanyard. Any suitable coupling device could be used.

With reference to Figure 14, this shows a basic prototype of another example by having characteristics similar to that of the previous examples, in which the closure at the lower end of the bag is a pressed closure, for example of a type that may be found in food bags and the like. The manner in which the bag 80 is closed may vary from the examples shown and this is generally of a material that as long as the closure mechanism does not damage or risk damaging the proximal end of the CVC or other medical device and that it can safely hold the proximal end in position and maintain it dry.

Once the patient has finished showering, for example, the closure mechanism can be released, the proximal end of the CVC removed from the bag and the shower bag then discarded or potentially kept for reuse. Following this, if the CVC is not used immediately, a bag of the type shown in Figures 3-5 can be used to hold the proximal end of the CVC until its subsequent use.

It will be appreciated that the bag used for normal holding of the proximal end of the CVC (for example as shown in Figures 3-5) may be made of a different material or have a different finish from the bag used for showering, of the type shown in Figures 6 onwards, particularly in situations where a patient is potentially sensitive to waterproof material. Figures 15 and 16A to 16C show an embodiment of a holder that can be described as a combination of the holders of Figures 4 and 10 or 11 , for example. It is to be appreciated that Figures 15 and 16 show one example only and that the holder could have other configurations, some of which are described below.

The holder 100 includes a first bag 102 which is has a top end 104 that is closed and a bottom end 106 which is open. In the embodiment shown in Figures 15 and 16A to 16C, the first bag 102 overlies a second bag 110. The second bag 110 has a closed bottom end 112 and an open upper end 114, which in the view of Figures 15 and 16 lies behind the closed end 104 of the first bag 102. Both bags 102 and 110 have closed sides 116, 118, typically provided as a bonding edge or zone as with the earlier described embodiments. At the top end of the holder 100, there is provided a lanyard or strap 120, equivalent to the lanyard of the earlier described examples.

In this embodiment, the first and second bags 102, 110 could have dimensions equivalent to those of bag 80 of Figures 10 and 11 , and the bag 15 of Figure 4, respectively. In other words, the bag 102 with the open bottom end may have dimensions similar to the bag 80’ and the second bag 110 could have dimensions similar to the bag 50. Most preferably, therefore, both bags will have a width of 60 mm ± 1 mm, an edge or bonding zone most preferably of 80 mm ± 1 mm. The first bag 102 most preferably has a length of 120 mm ± 1 mm and the second bag 110 most preferably has a length of around 230 mm ± 1 mm. The bags 102, 110 may have any of the dimensions of the bags 80, 50 described above. Similarly, the lanyard 120 most preferably has a width of 8 mm ± 1 mm and any of the dimensions of the lanyards previously described. The holder 100 in particular bags 102 and 110 may be made in any of the forms and with any of the materials having any of the characteristics described above in respect of the earlier described embodiments.

The holder 100 also includes a closure or tie mechanism 130 disposed in this example just below the open end 106 of the first bag 102, this example being spaced by a distance of around 10 mm ± 1 mm. The tie mechanism 130 could be in the form of a hook and eye fastener (such as Velcro™). One side of the hook and eye fastener would be affixed to the wall of the second bag 110, with a second strip of the hook and eye fastener being releasable therefrom and able to be coupled thereto in order to hold an end of a medical device.

A hook and eye fastener is considered particularly advantageous in this implementation of this embodiment, although other tying mechanisms could be used, such as a string or cord of the type shown in Figures 12 and 13 or a press-seal as shown in Figure 14, which may be provided as a separate element as shown in Figures 15 and 16 or, in the alternative, as part of the first bag 102 and adjacent to the open end 106. It is envisaged also that in some embodiments the tie mechanism 130 could also act to close the second bag 110, so as to secure the proximal end of the medical device within the second bag 110 also. As an example, the tie mechanism 130 could usefully be a string or cord as shown in Figures 12 and 13.

Referring now to Figure 16A, this shows a photograph of a prototype bag 100 and the proximal end 34 of a medical device. In this prototype, the edges of the bags are sewn rather than bonded, which is a possibility for all described embodiments, as is the top end of the first bag 102. The bottom end of the second bag 110 is closed by folding over of the material forming the bags 102, 110. It will be appreciated that the top of the bag 102 could also be made of folded over material rather than being a separate piece sewn as shown in the prototype in Figures 16A to 16C. A hook and eye fastener 130 is attached to the second bag 110 with a first element 132 of the fastener 130 sewn to the first bag 110 at both ends and a second element 134 sewn at only one end such that that element can be prized away from the first element 102, in a manner that will be will be familiar with anybody having knowledge of hook and eye fasteners.

Referring now to Figure 16B it can be seen that the proximal end 34 of the medical device has been inserted into the first bag 102 from its open bottom end 106 and is held in place by the tie mechanism 130, in this prototype a hook and eye fastener. The hook and eye fastener 130 has been closed over the tubes of proximal end 34 of the medical device so as to hold them in place. The ends of the tubes are held within the first bag 102 and kept clean and dry in the same way as the bags 80, 80’ described above. In this mode, the first bag 110 is not used for the medical device 34, save for being a support for the tie mechanism 130. Referring now to Figure 16C, in this mode, the proximal end 34 of the medical device is located within the first bag 110 in a manner similar to the embodiment of Figure 4. In this mode of operation, the first bag 102 is not used, nor is, in this example, the tie mechanism 130. As explained above, however, in other embodiments the tie mechanism 130 may be such as to be able to tie the second bag 110 in order to secure the proximal end 34 of the medical device in place, should this be desired.

It will be appreciated from Figures 15 and 16A to 16C that the patient need only have a single holder rather than two separate holders as the embodiments described above, for example with reference to Figures 4 and 10/11.

It is preferred that the bags 110 and 102 are made of the same material, although it is not excluded that they may be made of different materials, the bag 102 formed of a waterproof material and the bag 110 made of a breathable material, for example. In such an event, the bags may be separate and attached to one another.

A preferred embodiment of bag structure 200 is shown with reference to Figures 17-19. It is to be understood that this embodiment has many similarities with the previously described embodiments and examples, particularly in relation to the dimensions of the bag structure, the materials used and the purpose.

Referring first to Figure 17, this shows a bag structure 200 which is formed, in the preferred embodiment, from a single sheet of material that is folded twice to create first and second bags. The material includes a first panel 202, which could be described as a rear panel in the view of Figure 17, which is folded over itself at end 204 and returns back up towards the top of the structure shown in Figure 17, with a second fold 206, back on itself to end 208. These two folds create an intermediate panel 210 and a front panel 212. The back panel 202 and the intermediate panel 210 form the first bag, with an opening at the fold line 206. The intermediate panel 210 and the front panel 212 form the second bag, with an opening at the end 208. The first bag is therefore accessible from the top of the structure 200, as seen in Figure 17, whereas the second bag is accessed from the lower end 208. The first bag is closed at its bottom, by the fold 204, while the second bag is closed at its top end, by the fold 206. The sides 220, 222 of the bag are bonded and sealed, as described above. The top of the bag includes a secondary folded section which creates a channel 224 for receipt of a neck lanyard of the type previously described.

The first bag preferably has a total length of around 250 mm ± 2 mm, while the second bag bas a length preferably of around 120 mm ± 1 mm. The top section, which provides the channel for the lanyard, preferably has a height of around 25 mm ± 2 mm. The bag preferably has a width of around 70 mm ± 1 mm. It is to be understood that these dimensions are exemplary only and not limiting. They represent solely a preferred set of dimensions for the bag structure disclosed herein.

Extending through the intermediate panel 210 and the rear panel 202 is a series of apertures 230. As shown in the enlarged partial view of the bag structure in Figure 18, there are preferably provided three apertures that are substantially equally spaced across the bag structure and are preferably also spaced by around 10 mm ± 2 mm from the lower edge 218 forming the opening of the second bag.

Figure 19 shows a rear view of the embodiment of bag of Figure 17 and in which the through apertures 230 are clearly visible; as is the overlap forming the lanyard channel 224.

Referring now to Figure 20, this shows the blank form for producing the embodiment of apparatus shown in particularly in Figures 15-19 and also the embodiments of the subsequent Figures in the present application.

As previously described, the apparatus is preferably produced from a single sheet of material that is folded to produce: a) the upwardly opening bag, b) the downwardly opening bag and c) the channel for receiving the lanyard. As can be seen, the sheet of material is provided with a first, elongate, rear section which forms the rear panel 202 of the bag structure 200, the top end of which is folded over itself to produce the channel 224 for the lanyard. The sheet is then folded upwardly to produce a front panel of the first bag and then folded downwardly again to produce the front panel of the second, downwardly opening bag 212. The sheet material can then be fixed at its seams, as previously described, in order to produce the bag structure shown in the drawings and photographs. With reference to Figure 21 , this shows a photograph of a bag structure in accordance with the teachings of Figures 17-20 as it will be used in what could be considered a daily use storage configuration. The bag structure 200 is also shown with a lanyard 240 passing through the lanyard channel 224 and which is passed around the back of the user’s neck to as to support the bag structure 200 at the front of the user (in this example). The lanyard 240 may be of any of the forms described above. It may be provided in a single length typically of at least 90 cm.

In the view of Figure 21 , the proximal end of a CVC catheter 34 has been disposed into the first bag of the structure 200, through the opening provided by the fold line 206. In this configuration, the end 34 of the catheter passes substantially vertically downwards into the first bag, in what could be called a standard holding configuration. With the lanyard fitted around the patient’s neck, the external part of the catheter 34 can be held comfortably within the bag structure 200 and maintained in a clean environment by virtue of the water impermeability of the bag structure 200.

Referring now to Figure 22, this shows the same bag of Figure 21 but in which the proximal end of the CVC catheter 34 has been passed into the second bag, upwardly through the end 208. Referring now to Figure 23, the photograph depicts the lower part of the bag structure 200 folded upwardly over the outside of the second bag of the structure 200, which will effectively enclose the end of the catheter 24 in the second bag. The lower end of the bag structure 200 is preferably folded such that the water drainage apertures 230 are disposed at the fold line, as shown in the photograph of Figure 24. With reference to Figure 25, this shows the bag structure 200 in its final, in use, configuration for bathing. The lower part of the bag structure 200 has been folded over the front of the second bag of the structure and is held in place by means of a suitable clip or other fastener 250. The end of the catheter 34 is held securely in the bag structure 200 and specifically in the second bag, which by virtue of being closed at the top and open at the bottom will keep the end of the CVC catheter 34 dry during bathing, particularly showering. The drain holes, now being at the bottom of the structure 200, will allow drainage of any water that might enter the structure, such as through the folded portion and/or through the opening 202 of the first bag. As can be seen in the photograph of Figure 25, in the preferred embodiment the rear surface of the bag structure 200 is provided with a shower symbol or other suitable marking, which would become visible at the front of the structure 200 when configured for showering, to give a clear visual indication to the user of the correct folding and configuration of the bag for bathing.

It will be apparent that this embodiment need not use any hook and eye fastenings as per the previous embodiment (although it is not excluded that such a fastening could be used if desired). The advantage of avoiding such a fastening is simpler and cheaper manufacture. The clip 250 could be selected or designed for easy removal.

Another embodiment of bag structure 200’ is shown in Figure 26. This structure has many similarities with the embodiment of Figures 17-25, being made preferably of a single sheet of material folded twice to provide first and second bags overlying one another, in the same manner as described above. The difference with this structure and that of Figure 17 in particular is that the outer edges of the structure, when in flat folded sheet form, is that a peripheral band 260 is cut, at cut lines 254, 256 and 258, effectively creating a lanyard 206 out of the bag structure. The first fold line 204 of the embodiment of Figure 17 is replaced, in this example, by an end seal or bond bonded region 264, similar to the bonded edges 220, 222 of the structure. In all other respects, the embodiment of Figure 26 is the same as that of Figure 17 save for the different structural arrangement of the lanyard 260, which in this embodiment is an integral part of the material and bag structure 200’. It will be apparent that this embodiment can be readily manufactured, preferably from a single material, such as Tyvek™.

Referring now to Figure 27, this shows a series of schematic drawings A-E which show how the apparatus 200 can be used in practice. With reference to Figure 27A, the bag, typically held in front of the patient by the lanyard being fitted around a patient’s neck, can be used to accommodate a catheter M34, which is fed through the top opening 206 and all the way down to the bottom of the top opening bag, as can be seen in Figure 27B. The catheter 34 can be removed from the bag, simply by pulling it up through the top opening of the bag assembly. For showering, the catheter end is fed into the opening of the front bag, that is the base opening, upwards into the sealed bag. What then becomes the lowermost flap of the structure can then be folded over itself, as depicted in Figures 27B and then finally clipped in place, in this example by a simple clip 250. Any attachment mechanism may be used.

As can be seen, the structure enables a user to accommodate the catheter ends comfortablyand safely, both during the day and during showering.

Another embodiment of assembly shown in Figures 28 and 29. It is to be understood that apart from the differences noted below, the assembly shown in Figures 28 and 29 is intended to be the same as that shown in other embodiments of the present invention. Figure 28 is a front view of the assembly, whereas Figure 29 is a rear view.

The assembly includes first and second bags with top opening and bottom openings 206, 208 respectively and is manufactured generally in the same way as described above.

In place of the drain apertures 230 shown, for example, in Figures 17-19 (or in addition to such apertures) the assembly may be provided with side openings for drainage purposes, which can be formed by not bonding the sides of the folded sheet material along the edges 220, 222 at the zones of the openings. In this way, any liquid entering the first bag top opening 206 during showering, for example, can drain away through the side openings 260.

The apparatus is also preferably provided in this embodiment with an adhesive region 270 at the front face of the structure, which is preferably covered by a protective releasable cover strip of a type that will be familiar to a person skilled in the art. When it is desired to shower, the catheter end 34 is placed into the second bag with the closed top and open end 208, such that when the flap portion 204 is folded over the opening 208 it can be fixed to the front of the assembly at the adhesive zone 270. This avoids having to have a separate clip for other fixing mechanism.

Referring now to Figure 29, in some embodiments the bag is also provided with a rear adhesive zone 280, which is preferably also provided with a releasable cover strip for protection until use. The adhesive zone 280 is preferably made of an adhesive that sticks to a person’s skin, such any of the adhesives that would typically be used in plasters and other bandaging, and is provided so that the assembly 200 could be secured to a person without the need of a lanyard as previously described.

The adhesive zones 270, 280 could be disposed at any location on the bag surface, preferably within the zone denoted by the double arrows in each of Figures 28 and 29.

It will be appreciated that these characteristics of the embodiment of Figures 28 and 29 could be included in any of the other embodiments disclosed herein.

It will also be appreciated that in the case of use of a rear facing adhesive element, the bag could be constructed without any lanyard and without any provision for a lanyard.

As mentioned above it is preferred that the fabric is of non-woven material and optionally made of polypropylene resin, which is waterproof, moisture proof, breathable, flexible, lightweight, non-combustible and is also used to decompose, is non-toxic and non-irritating. Such material can also be readily bonded or welded to form a bag and may also be used for the strap or lanyard. Reference is made also to the other desirable attributes disclosed above.

In the described embodiments, the or each bag is shown to have a single compartment or pocket. This is considered to be most convenient for the patient. However, it is also contemplated that one of more of the bags may be provided with a plurality of compartments or pockets (for instance, two, three, for or even more), each designed to receive and hold an individual end piece of the catheter, such as a luer connector or other branch component. This can be advantageous in keeping the individual ends or branches separate, if considered desirable. A plurality of compartments or pockets could readily be formed in each bag, for instance by vertically or longitudinally extending suture lines or bonding lines along the or each bag. It will be appreciated that with an assembly formed of two (or more) bags, as in the claimed invention, either or both of the top loading and bottom loading bags could be provided with multiple compartments or pockets. It is to be understood that embodiments are merely illustrative and also that the features of one embodiment may be combined with the features of any other embodiment disclosed above.

The disclosures in British patent application number GB2203633.9, from which this application claims priority, and in the abstract accompanying this application are incorporated herein by reference.

Claims

1 . An implantable medical device holder for holding a proximal, exposed, end of an implantable medical device when implanted in a patient, the holder including: a bag structure comprising: a first bag having an open top, closed sides and a closed base; a second bag having a closed top, closed sides and an open base, and a closure mechanism for closing the open base of the bag; and a neck lanyard coupled or configured to be coupled to the bag structure for holding the bag on a person; wherein the first bag is configured to hold a proximal end of an implanted medical device in a downwardly extending direction through the open top of the first bag, and the second bag is configured to hold the proximal end of the implanted medical device in an upwardly extending direction through the open base of the second bag.

2. An implantable medical device holder according to claim 1 , wherein the first and second bags are disposed in overlying relation.

3. An implantable medical device holder according to claim 1 or 2, wherein the first and second bags share a common wall.

4. An implantable medical device holder according to any preceding claim, wherein the second bag is shorter than the first bag.

5. An implantable medical device holder according to any preceding claim, wherein second bag shares a wall of the first bag and the opening of the second bag is accessible from a common side of the first bag.

6. An implantable medical device holder according to any preceding claim, wherein the closure mechanism comprises a part of the bag structure able to be folded over the open base of the second bag.

7. An implantable medical device holder according to claim 6, wherein the foldable part of the bag structure preferably includes a part of the first bag.

8. An implantable medical device holder according to claim 6, wherein the foldable part is an individual section of bag material.

9. An implantable medical device holder according to claim 6, 7 or 8, comprising a fastener for holding the foldable part of the bag structure in the folded condition.

10. An implantable medical device holder according to any one of claims 6 to 9, wherein the foldable part of the bag structure comprises at least one drainage aperture.

11. An implantable medical device holder according to any preceding claim, comprising a closure mechanism attached to the first bag.

12. An implantable medical device holder according to claim 11 , wherein the closure mechanism comprises a hook and eye fastening, an adhesive fastening, a string or ribbon.

13. An implantable medical device holder according to claim 11 or 12, wherein the closure mechanism is configured to fasten the first bag as well.

14. An implantable medical device holder according to any preceding claim, wherein the lanyard is a separate component attachable to the bag structure.

15. An implantable medical device holder according to any one of claims 1 to 13, wherein the lanyard is an integral part of the bag structure.

16. An implantable medical device holder according to any preceding claim, wherein the bag structure is made of or coated with a water impermeable material.

17. An implantable medical device holder according to any preceding claim, wherein the bag structure is made of a water impermeable non-woven material.

18. An implantable medical device holder according to any preceding claim, wherein the bag structure is a polypropylene or polyethylene material, or of sheeting material formed from synthetic flash spun high-density polyethylene fibres.

19. An implantable medical device holder according to any preceding claim, wherein the first and second bags are made of material having a wall thickness of between 0.05 mm to 0.5 mm.

20. An implantable medical device holder according to any preceding claim, wherein the first bag has a plurality of chambers.

21 . An implantable medical device holder according to any preceding claim, wherein the first bag has a length of between 150-250 mm and a width of between 50-100 mm.