WO2007088323A1

WO2007088323A1 - Surgical pack

Info

Publication number: WO2007088323A1
Application number: PCT/GB2007/000111
Authority: WO
Inventors: Christine S. Leeming; Haydn T. Williams
Original assignee: Regent Medical Limited
Priority date: 2006-02-02
Filing date: 2007-01-16
Publication date: 2007-08-09
Also published as: GB0602144D0; GB2434748A

Abstract

A surgical pack is at least partially formed of a gelatinous or foam material having a memory. An outer membrane or skin forms a bladder which is filled with a mouldable gel or foam material.

Description

Surgical Pack

The present invention relates to surgical packs for use during surgery to displace organs and the like, thereby making more space available to the surgeon.

When performing abdominal surgery on internal organs such as the pancreas, the liver or the uterus, it can be necessary to displace the intestines which may block the surgeons view. This will also reduce the risk of them becoming damaged, or cut in any way. Gauze or cotton packs soaked in sterile saline solutions are commonly used to displace the intestines but these packs tend to be rough and can abrade, delicate organ tissue. Furthermore, cotton particles which may be present on such packs can cause infection problems and/or adhesive disease.

Many patents, e.g. US3965907, US4477256, US4515594, US4636208, US4645499, US4917694, US4983173, teach the use of different types of surgical sponges. The most commonly used sponges for this application tend to be fibrous, or contain absorbent particles. The sponges all tend to be manufactured from cotton/gauze material, which serves a dual purpose; both to soak up bodily fluids and to be soft so as not to damage internal organs. This invention does not aim to replace the absorbent nature of the sponges, it merely aims to provide a barrier function, pushing back organs and preventing organs (for example the intestines) from blocking the view of the working surgeon.

US-A-5523134 discloses a surgical pack for displacing organs during surgery in the form of a bladder which is formed of cured elastomer and which is filled with saline solution.

According to the present invention there is provided a surgical pack which is at least partially formed of a gelatinous or foam material having a memory. A surgical pack in accordance with the invention has the advantage that the memory of the gel material allows the pack to be moulded for more effective separation / displacement of organs during surgery. Preferably, the surgical pack is formed as a two part system comprising an outer membrane or skin forming a bladder which is filled with a gel or foam material, in particular a mouldable gel or foam material. However, in an alternative embodiment, the pack is formed entirely from the mouldable gel material having sufficient cohesion to maintain its shape without having to be contained within a bladder. According to one embodiment, polyurethane material of a medical grade is used.

In either embodiment, the outer surface of the pack is substantially non-abrasive and/or lubricious to minimise the possibility of damage to organs with which the pack is in contact.

In the two part system, the outer membrane preferably is substantially smooth, and in particular does not include a filling valve, seam seal or the like which might abrade and/or damage internal organs during use. Instead, the bladder is sealed following filling with the gel material.

Advantageously, the surface may be modified to ensure lubricity throughout its use during an operation. This can be achieved, for example, by binding hydrophilic polymers to the surface or by controlling the surface chemistry of the pack directly. In particular, a Biogel (Registered Trade Mark) coating comprising an acrylate polymer with suitable additives to provide damp slip could be used for this purpose. In the case of other materials, for example polyurethane, however, modification of the surface may not be required since the material itself has been found to be sufficiently smooth to avoid damage to organs. An anti-adhesion coating may also advantageously be used.

Preferably, the outer surface of the pack consists of a polyurethane or silicone based material, thereby ensuring that the pack is impervious.

The gel material is preferably a silicone gel, polyurethane gel or an aqueous based gel material.

In particular, the outer bag which forms the outer surface of the pack is formed from a polyether based polyurethane film and is filled with a polyester based gel. In a particularly advantageous development, the pack includes material which is radio opaque so as to facilitate detection of the pack when it is inserted into a patient.

In one embodiment, the pack is substantially ellipsoid in shape, in particular having a substantially circular cross-section, preferably having a diameter of 6cm, and a length of substantially 12cm.

Claims

1. A surgical pack which is at least partially formed of a gelatinous or foam material having a memory.

2. A surgical pack according to claim 1, formed as a two part system comprising an outer membrane or skin forming a bladder which is filled with a gel or foam material.

3. A surgical pack according to claim 2, wherein the gel or foam material is mouldable.

4. A surgical pack according to claim 2 or claim 3, wherein outer membrane is substantially smooth, and does not include a filling valve, seam seal or the like which might abrade and/or damage internal organs during use.

5. A surgical pack according to any of claims 2 to 4, wherein the outer membrane or skin is formed from a polyether based polyurethane film and is filled with a polyester based gel.

6. A surgical pack according to claim 1, wherein the pack is of one piece construction, formed entirely from a mouldable gel or foam material having sufficient cohesion to maintain its shape without having to be contained within a bladder.

7. A surgical pack according to any of the preceding claims, wherein the gel or foam material is a polyurethane material of a medical grade.

8. A surgical pack according to any of the preceding claims, wherein the outer surface of the pack is substantially non-abrasive and/or lubricious to minimise the possibility of damage to organs with which the pack is in contact.

9. A surgical pack according to any of the preceding claims, wherein the outer surface is modified to ensure lubricity throughout its use during an operation, in particular by binding hydrophilic polymers to the surface or by controlling the surface chemistry of the pack directly.

10 A surgical pack according to claim 9, wherein the outer surface is modified using a Biogel (Registered Trade Mark) coating comprising an acrylate polymer with suitable additives to provide damp slip could be used for this purpose.

11. A surgical pack according to any of the preceding claims, wherein an anti-adhesion coating is applied to the outer surface of the pack.

12. A surgical pack according to any of the preceding claims, wherein the outer surface of the pack consists of a polyurethane or silicone based material, thereby ensuring that the pack is impervious.

13. A surgical pack according to an}' of the preceding claims, wherein the gel material is oen of a silicone gel, polyurethane gel and an aqueous based gel material.

14. A surgical pack according to any of the preceding claims, wherein the pack includes material which is radio opaque so as to facilitate detection of the pack when it is inserted into a patient.

15. A surgical pack according to any of the preceding claims, wherein the pack is substantially ellipsoid in shape, in particular having a substantially circular cross-section, preferably having a diameter of 6cm, and a length of substantially 12cm.