GB1601691A - Surgical devices - Google Patents

Description

(54) IMPROVEMENTS IN OR RELATING TO SURGICAL DEVICES (71) We, H. G. WALLACE LIMITED, a British Company of Chandlers Row, Port Lane, Colchester, Essex CO1 2JP, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement:- The present invention is concerned with improvements in surgical devices and more particularly is concerned with a flexible cover for facilitating "no-touch" techniques in the introduction of tubular devices into the human body.

When a tubular device such as a catheter is introduced into the human body, care must be taken not to contaminate the outside of the device during its introduction.

On the other hand the device is so flexible that it must be pushed into the human body from a position close to the point of introduction. In order to avoid handling of the device by the nurses's fingers, a sterile sleeve may be provided through which the device is gripped. Handling of the outside of this sleeve is of no importance.

In using such a sleeve, a problem arises when the tubular device is already connected to other apparatus, for example an infusion/transfusion set In this case, the sleeve cannot be slipped off the end of a device without disconnecting the latter. Disconnection entails the possibility of introducing air bubbles or contaminants, either of which may prove fatal to the patient.

The alternative is for the nurse to cut the sleeve longitudinally. This is time-consuming and presents the risk of nicking the patient or the device.

According to one aspect of the present invention, there is provided a cover assembly for protecting against contamination a sterile tubular device during its introduction into a human body, said assembly comprising an elongate sleeve of sterile flexible water-impermeable material and an annular collar fixed to the proximal end of said sleeve, said sleeve having at least one rupturable longitudinal line of weakness to facilitate rupture thereof and said collar being provided with at least one rupturable weakening notch on its periphery to facilitate rupture thereof whereby said sleeve and said collar may be stripped laterally from said tubular device after its introduce tion into the human body by rupture of said weakening and line of weakness.

If desired there may be two longitudinal lines of weakness, so that a strip may be torn from the sleeve. It is undesirable actually to perforate the sleeve because this reduces its effectiveness as a barrier against contamination.

Instead of providing one or more lines of weakness by mechanical means, they can be provided by making the sleeve of an oriented plastics material having anisotropic tenacity, e.g. oriented polyethylene.

Such material has a high tear strength in a peripheral direction, and a much reduced tear strength in the longitudinal direction.

The material is inherently easy to tear longitudinally, even without any score lines or the like.

In another embodiment, the sleeve may include a flexible reinforcing member extending longitudinally, which can be pulled to rupture said line(s) of weakness. For example, a thread of fibrous or metallic material may be incorporated into the sleeve e.g. by stitching to provide a rip cord which can be pulled to rupture the sleeve along its whole length. The reinforcing member must be sufficiently flexible to permit the sleeve to be folded in concertina fashion during use.

In use of the device, the sleeve may be ruptured or opened from either end, whichever is preferable. To avoid excessive folding of the sleeve, it may be ruptured or opened in stages during insertion of the catheter.

One or both ends of the sleeve are preferably provided with one or more cuts, nicks or notches to facilitate tearing. A tab may also be provided on one end or on either end to enable the nurse to take a firm grip of the portion of the sleeve to be torn. This tab may be of coloured plastics material.

Alternatively the line of weakness may be formed by one or more longitudinal seams closed e.g. with a pressure-sensitive adhesive. The seam or seams may readily be peeled when it is desired to remove the sleeve from the catheter or other tubular device.

Preferably the notch provided on the collar is large enough to permit the insertion of the nurse's thumb nails, to enable the collar to be prised open easily. It is important that the sleeve and collar can be removed with relatively little effort, because if excessive force is required, there is a danger of displacing the adjacent cannula.

Thus the sleeve and collar should have sufficient strength to perform their protective function, and should then be openable or rupturable relatively easily. The collar may be fixed to the sleeve e.g. by heat crimping or by a plastics shrink ring which also maintains the collar in a closed position. The shrink ring may have a line of perforations to facilitate tearing.

The sleeve and collar may be made of any suitable sterilizable material, particularly a thermo-plastics material such as polyethylene. The cover may be sterilized in any suitable way, e.g. by radiation, heat or sterilant gas.

Generally the tubular device to be inserted into the body will be surrounded by the sleeve and collar for at least part of its length, the whole being enclosed in a sterile pack. The present invention extends to this combination.

An embodiment of the present invention will now be described by way of example only with reference to the accompanying drawing, which illustrates a cover according to the invention for protecting a catheter during introduction thereof into the human body.

The cover comprises a sleeve 1 and a collar 5. The sleeve 1 is a tube of polyethylene film having a circumference of about 30 mm. There are two longitudinal tear lines 2 and 3 comprising a series of indentations which provide lines of weakness along the sleeve. At one end, in between the two tear lines, there is provided a tab 4 of plastics material.

At the other end of the sleeve is situated the collar 5 comprising a ring 6 moulded integrally with a thinner walled tubular portion 7. The sleeve is heat crimped to the collar at 8. The upper end of the tubular portion 7 comprises a notch 9 aligned between the two tear lines 2 and 3. At the same circumferential position the ring 6 comprises another notch 10. The collar 5 is moulded from polyethylene material.

In order to remove the sleeve from a catheter or the like a nurse merely has to pull tab 4 and rip the sleeve along its whole length. The collar is then readily broken along a line between the notches 9 and 10, and the whole device may be removed from the catheter and disposed of.

WHAT WE CLAIM IS: 1. A cover assembly for protecting against contamination a sterile tubular device during its introduction into a human body, said assembly comprising an elongate sleeve of sterile flexible water-impermeable material and an annular collar fixed to the proximal end of said sleeve, said sleeve having at least one rupturable longitudinal line of weakness to facilitate rupture thereof and said collar being provided with at least one rupturable weakening notch on its periphery to facilitate rupture thereof whereby said sleeve and said collar may be stripped laterally from said tubular device after its introduction into the human body by rupture of said weakening and line of weakness.

2. A cover assembly according to claim 1 having two longitudinal lines of weakness so that a strip may be torn from the sleeve.

3. A cover assembly according to claim 2 wherein a pull tab is provided on one end or on either end of said sleeve.

4. A cover assembly according to claim 1, 2 or 3 wherein the or each line of weakness is a score line or knife cut through part of the thickness of said sleeve.

5. A cover assembly according to claim 1 wherein said sleeve is made of an oriented plastics material which is inherently easy to tear longitudinally, each said line of weakness being defined by said material.

6. A cover assembly according to claim 1 wherein the sleeve includes a longitudinally extending flexible reinforcing member which can be pulled to rupture said sleeve.

7. A cover assembly according to any of the preceding claims wherein one or both ends of the sleeve is/are provided with one or more nicks or notches to facilitate rupture.

8. A cover assembly according to claim 1 wherein the or each line of weakness comprises a longitudinal seam closed with a pressure-sensitive adhesive, which seam may be peeled open.

9. A cover assembly according to any of the preceding claims wherein said collar is fixed to said sleeve by heat crimping.

10. A cover assembly according to any of claims 1 to 8 wherein said collar is fixed to said sleeve by a plastics shrink ring.

11. A cover assembly according to any of the preceding claims wherein said sleeve and collar are made of polyethylene.

12. A cover assembly substantially as hereinbefore described with reference to the accompanying drawing.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (13)

**WARNING** start of CLMS field may overlap end of DESC **. Alternatively the line of weakness may be formed by one or more longitudinal seams closed e.g. with a pressure-sensitive adhesive. The seam or seams may readily be peeled when it is desired to remove the sleeve from the catheter or other tubular device. Preferably the notch provided on the collar is large enough to permit the insertion of the nurse's thumb nails, to enable the collar to be prised open easily. It is important that the sleeve and collar can be removed with relatively little effort, because if excessive force is required, there is a danger of displacing the adjacent cannula. Thus the sleeve and collar should have sufficient strength to perform their protective function, and should then be openable or rupturable relatively easily. The collar may be fixed to the sleeve e.g. by heat crimping or by a plastics shrink ring which also maintains the collar in a closed position. The shrink ring may have a line of perforations to facilitate tearing. The sleeve and collar may be made of any suitable sterilizable material, particularly a thermo-plastics material such as polyethylene. The cover may be sterilized in any suitable way, e.g. by radiation, heat or sterilant gas. Generally the tubular device to be inserted into the body will be surrounded by the sleeve and collar for at least part of its length, the whole being enclosed in a sterile pack. The present invention extends to this combination. An embodiment of the present invention will now be described by way of example only with reference to the accompanying drawing, which illustrates a cover according to the invention for protecting a catheter during introduction thereof into the human body. The cover comprises a sleeve 1 and a collar 5. The sleeve 1 is a tube of polyethylene film having a circumference of about 30 mm. There are two longitudinal tear lines 2 and 3 comprising a series of indentations which provide lines of weakness along the sleeve. At one end, in between the two tear lines, there is provided a tab 4 of plastics material. At the other end of the sleeve is situated the collar 5 comprising a ring 6 moulded integrally with a thinner walled tubular portion 7. The sleeve is heat crimped to the collar at 8. The upper end of the tubular portion 7 comprises a notch 9 aligned between the two tear lines 2 and 3. At the same circumferential position the ring 6 comprises another notch 10. The collar 5 is moulded from polyethylene material. In order to remove the sleeve from a catheter or the like a nurse merely has to pull tab 4 and rip the sleeve along its whole length. The collar is then readily broken along a line between the notches 9 and 10, and the whole device may be removed from the catheter and disposed of. WHAT WE CLAIM IS:

1. A cover assembly for protecting against contamination a sterile tubular device during its introduction into a human body, said assembly comprising an elongate sleeve of sterile flexible water-impermeable material and an annular collar fixed to the proximal end of said sleeve, said sleeve having at least one rupturable longitudinal line of weakness to facilitate rupture thereof and said collar being provided with at least one rupturable weakening notch on its periphery to facilitate rupture thereof whereby said sleeve and said collar may be stripped laterally from said tubular device after its introduction into the human body by rupture of said weakening and line of weakness.

2. A cover assembly according to claim 1 having two longitudinal lines of weakness so that a strip may be torn from the sleeve.

3. A cover assembly according to claim 2 wherein a pull tab is provided on one end or on either end of said sleeve.

4. A cover assembly according to claim 1, 2 or 3 wherein the or each line of weakness is a score line or knife cut through part of the thickness of said sleeve.

5. A cover assembly according to claim 1 wherein said sleeve is made of an oriented plastics material which is inherently easy to tear longitudinally, each said line of weakness being defined by said material.

6. A cover assembly according to claim 1 wherein the sleeve includes a longitudinally extending flexible reinforcing member which can be pulled to rupture said sleeve.

7. A cover assembly according to any of the preceding claims wherein one or both ends of the sleeve is/are provided with one or more nicks or notches to facilitate rupture.

8. A cover assembly according to claim 1 wherein the or each line of weakness comprises a longitudinal seam closed with a pressure-sensitive adhesive, which seam may be peeled open.

9. A cover assembly according to any of the preceding claims wherein said collar is fixed to said sleeve by heat crimping.

10. A cover assembly according to any of claims 1 to 8 wherein said collar is fixed to said sleeve by a plastics shrink ring.

11. A cover assembly according to any of the preceding claims wherein said sleeve and collar are made of polyethylene.

12. A cover assembly substantially as hereinbefore described with reference to the accompanying drawing.

13. A cover assembly according to any

of the preceding claims surrounding a tubular device for insertion into a human body, the whole being enclosed in a sterile pack.