GB2556107A

GB2556107A - Medical tube clamp

Info

Publication number: GB2556107A
Application number: GB1619649.5A
Authority: GB
Inventors: Cotton Stephen
Original assignee: Brightwake Ltd
Current assignee: Brightwake Ltd
Priority date: 2016-11-21
Filing date: 2016-11-21
Publication date: 2018-05-23
Anticipated expiration: 2036-11-21
Also published as: GB201619649D0; GB2556107B

Abstract

A clamp 1 for securing a medical tube inserted into a patients body. Clamp 1 comprises: a clamp body defining an opening 6 for accommodating the medical tube; an outer portion 13; and a sealing element 14 to engage with the medical tube and thereby forming a seal around the external surface of the medical tube. Clamp 1 may comprise a fastener to fasten the clamp 1 to the patient. The sealing element 14 and outer portion 13 may be provided with a channel that extends from an outermost edge of the outer portion 13 relative to the sealing element 14 to the opening 6 defined by the sealing element 14, where the medical-tube can pass through the channel. The channel may have open and closed configurations. Outer portion 13 may comprise two components 2 that are moveable relative to one another between open and closed positions and where the components 2 may be hinged together and where the clamp 1 may be provided with a catch 10 for holding it in a closed position. Clamp 1 may be used in combination with a wound dressing. Described as applicable in clamping medical drain tubes, such as a chest drain tube.

Description

(54) Title of the Invention: Medical tube clamp

Abstract Title: Clamp for securing medical tubes inserted through the skin of a patient.

(57) A clamp 1 for securing a medical tube inserted into a patient’s body. Clamp 1 comprises: a clamp body defining an opening 6 for accommodating the medical tube; an outer portion 13; and a sealing element 14 to engage with the medical tube and thereby forming a seal around the external surface of the medical tube. Clamp 1 may comprise a fastener to fasten the clamp 1 to the patient. The sealing element 14 and outer portion 13 may be provided with a channel that extends from an outermost edge of the outer portion 13 relative to the sealing element 14 to the opening 6 defined by the sealing element 14, where the medical-tube can pass through the channel. The channel may have open and closed configurations. Outer portion 13 may comprise two components 2 that are moveable relative to one another between open and closed positions and where the components 2 may be hinged together and where the clamp 1 may be provided with a catch 10 for holding it in a closed position. Clamp 1 may be used in combination with a wound dressing. Described as applicable in clamping medical drain tubes, such as a chest drain tube.

At least one drawing originally filed was informal and the print reproduced here is taken from a later filed formal copy.

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Title - Medical tube clamp

The present invention relates to a clamp for a medical tube, particularly a medical drain tube, such as a chest drain tube.

It is often necessary in medical situations to insert a tube into the body of a patient through an artificial stoma or surgical incision, such as a medical drain for removal of fluids from the body such as pus, blood or trapped gasses. Medical drains often remain in place for a significant length of time, such as days of even weeks, particularly in the case of chest drains.

The sites at which medical drains enter the body are particularly vulnerable to infection as contaminants are able to track along the exterior surface of the tube. In addition, the medical drain tube may move in and out of the body (known as “pistoning”) in response to movement of the patient if the tube is not properly secured, causing irritation at the entry site and further increasing the risk of contaminants entering the body. Medical drains are conventionally sealed and secured at the point at which they enter the body by a makeshift construction, such as of petroleum gauze, medical tape and polyurethane film, although these are bulky, prone to leaking and provide an unreliable barrier against infection. Medical drain tubes may also be secured to the body by suturing the tube directly to the skin, which causes both significant pain to the patient and damage to the skin, thus creating a further potential site for infection.

There has now been devised an improved means for securing medical tubes inserted through the skin of a patient which overcomes or substantially mitigates the above-mentioned and/or other problems associated with the prior art.

According to a first aspect of the invention, there is provided a clamp for a medical tube inserted into the body of a patient, the clamp comprising a clamp body defining an opening for accommodating a medical tube, an outer portion and a sealing element adapted to engage with a medical tube accommodated in the opening such that a seal is formed around the external surface of the tube.

The clamp thus provides a convenient means of securing medical tubes that are inserted through the skin of a patient and reduces the risk of infection by forming a seal around the tube.

The medical tube is typically a medical drain and most commonly a chest drain. The medical tube is typically inserted through the skin of a patient by way of an artificial opening in the skin, such as an artificial stoma, a surgical incision or traumatic wound.

The clamp may be for any conventional medical tube. Such tubes are typically formed of a polymeric material such as PVC or silicone and come in a range of diameters, typically ranging from around 5mm to 40mm.

The seal formed by the sealing element around the external surface of the tube preferably substantially prevents the passage of biological fluids such as blood of wound exudate along the exterior surface of the tube. The seal preferably substantially prevents the passage of infectious agents, and particularly bacteria, along the exterior surface of the tube. The seal is preferably formed around substantially the whole circumference of the medical tube.

The engagement between the sealing element and the medical tube preferably does not significantly deform the tube, and in particular preferably substantially does not pinch the tube or cause restriction of the fluid flow path within the tube. The sealing element preferably engages the medical tube with a substantially even pressure around the circumference of the tube in order to avoid pinching the tube.

The sealing element may engage with a length of the medical tube in order to reduce the pressure required to ensure effective sealing. In particular, the sealing element preferably engages with a length of the tube generally equal to the diameter of the tube, or between about 0.5x to 1.5x the diameter of the tube. Specifically, the sealing element may engage with a 2mm to 40mm length of the tube, more preferably a 3mm to 20mm length of the tube, more preferably a 4mm to 10 mm length of the tube, and most preferably a length of the tube of about 5mm.

The sealing element preferably also grips the medical tube in order to restrict the movement of the tube relative to the clamp. In particular, the grip is preferably sufficient to retain the tube in a substantially fixed position relative to the clamp.

The clamp may comprise a fastening means by which it may be fastened to another object, such that the movement of the clamp, and consequently the medical tube, relative to that other object is restricted. In particular, the clamp may comprise means by which it may be fastened to the patient, or to another object that is itself fastened to the patient, such as a wound dressing, such that movement of the tube relative to the patient is restricted, thus avoiding “pistoning” of the tube and associated irritation and increased risk of infection at the site at which the tube enters the body. In particular, the clamp may be fastened to the skin directly adjacent to the site at which the tube enters the body, or to a dressing that is located at the site at which the tube enters the body. Preferably the fastening means is an adhesive, most preferably the fastening means is an adhesive applied to the patient facing portion of the clamp.

Preferably the opening in the clamp body passes through the clamp body.

The opening may be a channel that is capable of accommodating a length of the tube. In particular, the sealing element preferably engages with a length of the tube generally equal to the diameter of the tube, or between about 0.5x to 1.5x the diameter of the tube. Specifically, the sealing element may engage with a 2mm to 40mm length of the tube, more preferably a 3mm to 20mm length of the tube, more preferably a 4mm to 10 mm length of the tube, and most preferably a length of the tube of about 5mm.

Preferably the opening is a substantially cylindrical channel for accommodating a length of the tube. Preferably the sealing element is present on the walls of the channel. The sealing element may be formed of a different material to the outer portion of the clamp. In particular, the sealing element is preferably formed of a material having a high coefficient of friction in order to grip the tube with sufficient force to restrict movement of the tube relative to the clamp whilst not deforming the tube.

Preferably the sealing element is formed of a rubber-type material, for example a natural or synthetic rubber.

Preferably the sealing element is provided with deformable protrusions that project into the opening and, in use, are deformed around the tube and, in this way, form the seal. Preferably the protrusions are resiliently deformable. The protrusions may be any suitable shape, for example a series of ribs or an array bars or hemispherical bumps. Preferably the protrusions are a series of lateral ribs which run parallel to the top and base of the sealing element. This arrangement is particularly advantageous when the opening is substantially cylindrical. For convenience, the face of the clamp intended to contact the patient is referred to as the base and the face distant from the patient is referred to as the top although these will not necessarily be their actual relative positions in use.

The outer portion is preferably adapted to support the sealing element. In a preferred embodiment, the outer portion may be formed of a different material to the sealing element. In this case, the outer portion is preferably shaped to receive the sealing element, most preferably in an interference fit relationship.

The outer portion is preferably formed of a more rigid material than the material of the sealing element. The outer portion can be manufactured using any suitable process, for example by 3D printing, but is preferably injection moulded as this produces higher quality material that can be more readily reused. The outer portion may be formed of any suitable material. The material may be a thermoplastic material. A particularly preferred material is polycarbonate.

The outer portion is preferably provided with protrusions to aid the user in gripping the clamp. Preferably the protrusions are provided on the part of the outer portion that directly surrounds the sealing element. The shaping of the outer portion preferably mirrors that of the sealing element, ie if the sealing element forms a cylindrical opening, the outer portion will comprise a cylindrical projection which is located at the centre of the clamp. In such an embodiment, the projection surrounds the seal and the protrusions are preferably longitudinal ribs that run up the length of the outside of the cylindrical projection.

The outer portion is preferably produced separately to the sealing element and the components assembled subsequently. This simplifies the production process as each production line can be tailored to a particular material.

Alternatively, the clamp may be formed by a two-shot injection moulding process whereby each component that is formed from a different material is formed sequentially by an injection moulding process. Such a process avoids the need for an assembly step.

Preferably the outer portion comprises a flange that extends radially outward from the centre of the clamp around at least half of the circumference of the surgical drain tube.

The plane of the flange is preferably substantially perpendicular to the axis of the tube that is engaged by the sealing element. The flange preferably provides a large flat area on the underside of the clamp which can be adhered to the patient’s skin or to the top layer of a dressing applied to the patient’s skin. The flange acts as a barrier to prevent contaminants entering the body, and, if used in conjunction with an absorbent dressing, deflects fluid into the absorbent portion of the dressing.

Preferably the flange is capable of forming an effective seal against a “base material” which may be the patient’s skin or a dressing.

Preferably the underside of the outer portion is provided with an adhesive or tacky material. The adhesive may be any suitable adhesive for adhering to the skin but preferably the adhesive is an acrylic adhesive, most preferably a high-strength acrylic adhesive. By bonding the clamp to the top side of a chest drain dressing or to the patient’s skin with an adhesive, the clamp, and hence the tube, is secured in place and “pistoning”, ie the movement of the tube into and out of the body, is further reduced.

The adhesive layer is preferably supplied with a release liner when packaged. A release liner keeps the adhesive surface clean and facilitates application of the dressing as the clamp is only adhesive when required.

The sealing element and outer portion of the clamp are preferably provided with a channel that extends from the outermost edge of the outer portion relative to the sealing element to the opening defined by the sealing element, wherein the tube to be clamped may be passed through the channel. This enables the clamp to be applied to a tube without passing a significant length of the tube through the opening defined by the sealing element. This reduces the discomfort to the patient and the risk of the tube moving relative to the patient. Preferably the channel can be closed in use. Preferably the channel is a narrow slit.

The clamp preferably has an open configuration in which the channel is sufficiently wide for the desired tube to be passed laterally through the channel. The clamp preferably also has a closed position in which the channel is sufficiently narrow to prevent ingress of bacteria and fluid. Preferably in the closed position the channel forms a seal.

The outer portion preferably comprises two components that are moveable relative to one another between open and closed positions such that, in the closed position, the two portions define a central opening and in the open position a tube can be inserted laterally into the clamp. This enables the tube to be easily inserted into the opening defined by the clamp without disturbing the tube relative to the patient. In particularly preferred embodiments the sealing element may also comprise two components which come together in the closed position to form a seal around the circumference of the tube. The two components may be connected to one another by any suitable means, for example the material of the clamp may be sufficiently resilient to deform sufficiently or the two components may have connecting means at each end of the components. Preferably the two components are hingedly connected to one another. This facilitates reversible movement between the open and closed positions of the clamp and allows this movement to be easily reproducible. A hinged component is also relatively straightforward to manufacture.

Preferably one of the components is provided with a post and the other with a corresponding hook or opening to receive the post. Preferably the second component is provided with both a hook and an opening that are orientated in a stacked arrangement and, to form the hinge, the post is first inserted into the opening and then subsequently into the hook. This arrangement provides a stronger hinge that comes apart less easily once constructed.

The clamp is preferably provided with a means for holding the clamp in a closed position. A suitable means may be selected by the person skilled in the art, for example a tie or resilient band may be placed around the entire clamp. However, preferably the clamp is provided with a catch. Preferably the catch comprises a protruding portion on one component and a corresponding detent on the other. Most preferably one or both of the catch and the detent is formed integrally with the outer portion. A catch is particularly advantageous in that it may be reversibly applied facilitating easy removal of the clamp without having to cut or break any portion of the clamp.

The clamp may be any suitable shape but preferably the clamp is approximately circular in shape. Having a smooth shape means that the clamp is more comfortable in use for the patient as it is less likely to catch on items of clothing, bedding or medical equipment or to protrude uncomfortably against the patient.

The clamp may be produced in different sizes to match the different sizes of medical drain tubing. Medical drain tubing typically has a diameter in the range of 2mm to 25mm.

Although intended primarily for use with a chest drain, it will be understood that it may be employed for use with any tubes that enter the body.

The clamp may be used in conjunction with a suitable dressing for example a chest drain dressing. Thus in a second embodiment there is provided the use of a clamp according to the invention in combination with a wound dressing.

The clamp according to the invention may be produced by a 3D printer.

Hence according to a further embodiment of the invention there is provided a computer readable medium carrying computer executable instructions for a 3D printer to print the surgical drain clamp according to the first aspect of this invention.

In preferred embodiments the instructions are for the 3D printer to print the components of the clamp separately, wherein the components can subsequently be assembled to produce a surgical drain clamp according to the first aspect of this invention.

The invention will now be described in greater detail, by way of example only, with reference to the accompanying drawings, in which

Figure 1 shows a perspective view of a clamp according to the invention;

Figure 2 shows a perspective view of the underside of the clamp of Figure 1;

Figure 3 shows an expanded perspective view of the underside of one portion of the clamp of Figure 1;

Figure 4 shows a perspective view of the underside of a clamp according to the invention in an open position;

Figures 1 and 2 show the tube clamp of the present invention 1 in the closed position. The tube clamp generally comprises two components 2. Each component comprises a semi-circular inner portion 3 and an outer flange 4.

In the closed position the semi-circular inner portions 3 together define a central cylindrical structure 5, the inside of which defines a circular opening 6 having dimensions corresponding to the outside of the tube to be clamped.

The outer flange 4 of each component extends radially outward around the majority of the outer edge of the semi-circular portion 3 and defines an approximately 135° angle around each semi-circular portion 3. The underside of the flange 4 is coated with an acrylic adhesive layer and provides a large flat surface area to aid, in use, attachment of the clamp to the skin or top layer of a dressing applied to the patient.

The outward facing part of the semi-circular inner portion 3 is provided with a series of protrusions 7 which aid gripping the clamp and also increase the structural integrity of the component.

The two components 2 are hingedly connected to one another at corresponding edges of the semi-circular inner portion. One component is provided with a post 8 and the other with a corresponding hook 9 and a hole in a stacked arrangement that receive the post 8. The two components 2 are releasably held together when closed by means of a catch 10 formed integrally with the components. One component provides a protruding member 11 that extends out from the first component and is shaped to extend into a corresponding detent 12 formed in the second component. The catch may be released by pulling the protruding member 11 away from the second component and out of the detent 12.

The components 2 are each formed from an injection moulded outer portion 13 and a rubber insert 14. The rubber insert has an interference fit in a recess 15 formed in the outer portion 13 as shown in Figure 3. The rubber inserts 14 form the inner wall of the central cylindrical structure and in use contact the tube to be clamped. Each of the rubber inserts is provided with a number of protruding ribs 16 that run parallel to the top and bottom of the cylindrical structure. The nature of the rubber material, and in particular the ribs, helps to hold the tube in position whilst at the same time not deforming the tube.

In use, the open clamp 1 as shown in Figure 4 is placed around the tube to be clamped at the point at which the tube exits the patient’s body and is then moved to the closed position and the catch 10 applied. Downward pressure towards the patient is then applied to ensure that the adhesive on the underside of the flanges is suitably adhered to the skin of the patient or to any dressing applied around the exit point of the tube on the patient.

Claims

1. A clamp for a medical tube inserted into the body of a patient, the clamp comprising a clamp body defining an opening for accommodating a medical tube, an outer portion and a sealing element adapted to engage with a medical tube accommodated in the opening such that a seal is formed around the external surface of the tube.

2. A clamp according to Claim 1 wherein the seal is formed around substantially the whole circumference of the medical tube.

3. A clamp according to any preceding claim wherein the sealing element engages the medical tube with a substantially even pressure around the circumference of the tube.

4. A clamp according to any preceding claim wherein the sealing element engages with a length of the tube generally equal to the diameter of the tube, or between about 0.5x and 1.5x the diameter of the tube.

5. A clamp according to any preceding claim wherein the sealing element grips the medical tube in order to restrict movement of the tube relative to the clamp.

6. A clamp according to any preceding claim further comprising a fastening means by which the clamp may be fastened to the patient, or to another object that is itself fastened to the patient.

7. A clamp according to any preceding claim wherein the opening is a channel that passes through the clamp body and is capable of accommodating a length of the tube.

8. A clamp according to Claim 7 wherein the channel is substantially cylindrical.

9. A clamp according to Claim 7 or Claim 8 wherein the sealing element is present on the internal walls of the channel.

10. A clamp according to any preceding claim wherein the sealing element is formed of a different material to the outer portion of the clamp.

11. A clamp according to any preceding claim wherein the sealing element is formed of a material having a high coefficient of friction.

12. A clamp according to any preceding claim wherein the sealing element is provided with deformable protrusions.

13. A clamp according to Claim 12 wherein the protrusions are a plurality of lateral ribs which run parallel to the top and base of the sealing element.

14. A clamp according to any preceding claim wherein the outer portion is adapted to support the sealing element.

15. A clamp according to Claim 14 wherein the outer portion is shaped to receive the sealing element in an interference fit relationship.

16. A clamp according to any preceding claim wherein the outer portion comprises a flange that extends radially outward from the centre of the clamp around at least half of the circumference of the tube.

17. A clamp according to any preceding claim wherein the sealing element and outer portion are provided with a channel that extends from the outermost edge of the outer portion relative to the sealing element to the opening defined by the sealing element, wherein the tube to be clamped may be passed through the channel.

18. A clamp according to Claim 17 wherein the channel has an open configuration and a closed configuration.

19. A clamp according to Claim 18 wherein the outer portion comprises two 5 components that are moveable relative to one another between the open and closed positions.

20. A clamp according to Claim 19 wherein the components are hingedly connected.

21. A clamp according to any one of Claims 17 to 20 wherein the clamp is provided with means for holding the clamp in a closed position.

22. Use of a clamp according to any preceding claim in combination with a 15 wound dressing.

23. A computer readable medium carrying computer executable instructions for a 3D printer to print a clamp according to any of Claims 1 to 21.

Intellectual

Property

Office

Application No: GB1619649.5 Examiner: Colin Powys