TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to medical devices and in particular to a holding device for laparoscopic instruments, which facilitate the performance of laparoscopic procedures entirely through the umbilicus.

BACKGROUND OF THE INVENTION

Laparoscopic or minimally invasive surgery includes the use of several relatively small ports into the abdomen by which different types of instruments and accessories are introduced and used for different surgical interventions.

Said laparoscopic surgery, typically includes the use of a trocar assembly. A trocar assembly includes a trocar positioned within the lumen of a cannula. The trocar and cannula are advanced through a body cavity wall so as to create a small hole or a port site wound therein. The trocar is then completely removed from the lumen of the cannula such that the cannula's lumen provides an entrance for laparoscopic instruments into the interior of the body cavity. The body cavity is then insufflated with an inert gas, such as C02, to provide easier access to the organs contained therein. Once the surgery is complete the cannula is completely removed from the port site wound to rapidly desufflate the body cavity.

Laparoscopic instruments (graspers, dissectors, scissors, retractors, etc.) are placed through two or more additional trocar sleeves (cannula) for the manipulations by the surgeon and surgical assistant(s).

Various laparoscopic methods and surgical devices are already known for the completion of medical procedures. However, the prior art has encountered substantial difficulties in the performance of laparoscopic procedures.

Minimally invasive surgical techniques require the insertion and removal of laparoscopic instruments or cameras through the lumen of the cannula. In addition, these surgical techniques require that the cannula itself be moved relative to the port site wound such that the cannula is advanced further into, or withdrawn from, the body cavity. Moving the cannula in the above described manner facilitates a surgeon's ability to optimally locate instruments \vithin the body cavity thereby helping to ensure the successful completion of the medical procedure. However, the aforementioned manipulations of the laparoscopic instruments and cannula may result into contamination of a portion of the exterior surface of the cannula. The contaminated portion of the exterior surface of the cannula may then be advanced into contact with the port site wound during insertion and removal from the port site wound. Furthermore, studies have shown that an inexperienced surgeon may have a tendency to insert and withdraw an instrument through the lumen of the cannula a greater number of times than an experienced surgeon. The above described increased manipulation of the instrument can result in a greater incidence of contamination in the port site wound. Therefore, it is desirable to provide an apparatus which will protect a port site wound from contamination while allowing a surgeon to optimally locate instruments within the body cavity for successful completion of the medical procedure. Therefore, in light of the above discussion, it is apparent that a device which allows unrestricted movement of the cannula relative to the port site wound while reducing the incidence of port site wound infection is desirable.

Although there are various attempts to overcome the deficiencies of the prior art, there still exists a need for a device which allows unrestricted movement of the cannula relative to the port site wound while reducing the incidence of port site wound contamination.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide an improved medical device, which overcomes the deficiencies of the prior art and ensures unrestricted movement of the cannula relative to the port site wound.

A further aspect of the present invention is to provide a medical device for protecting a port site wound from contamination with an infectious agent and is securely positioned on the port site wound.

In accordance with the above objects of the present invention, a medical device for laparoscopic instruments is provided comprising a holding device and a sealing pad, which facilitates the performance of laparoscopic procedures and protects a port side opening defined in a wall of a body cavity.

Further preferred embodiments of the present invention are defined in dependent claims 2 to 7.

Other objects and advantages of the present invention will become apparent to those skilled in the art in view of the following detailed description taken in conjuction with the accompanying drawings, wherein like reference numbers refer to similar parts throughout the drawings, and wherein:

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows a cross-sectional view of the medical device according to the present invention;

Fig. 2 shows a perspective view of the medical device according to the present invention;

Fig. 3 shows a cross-sectional view of an alternative medical device according to the present invention, and

Fig. 4 shows a perspective view of the separate layer of the alternative medical device of Fig. 3 according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to Figure 1, the basic element of the medical device in accordance with the present invention is generally shown at (1) positioned through an opening 30 in a wall 32 of a body cavity 34. The medical device 1 includes a holding device 10 and a trocar assembly 12. The holding device 10 comprises a sealing pad 20 that may be especially useful in order to seal any entrapped gaseous substances (e.g., C02) within the body cavity 34, and/or for the protection against any potential contamination as may be resulted in case of directly

communicating with open air.

The holding device 10 may be made, preferably by injection moulding, from any relatively pliant or elastic material such as soft polymer or silicone, while maintaining re-sealing capabilities.

The sealing pad 20 has a rectangular shape, preferably with the dimensions from about 6.5X 4.5 centimeters and preferably made of a soft silicone type material. It is firmer and thicker in the center whilst thinning out towards the peripheral edge.

The sealing pad 20 has the following dimensions: length from about 7.0 to 5.5 cm and width from about 5.0 to 4.0 cm.

On the top surface of the sealing pad and in the central area there is a portion 21 conically shaped wider at the base, with a diameter of about 3.5 cm, and narrowing towards the top with a diameter of about 1.0 cm, in fact in cross-section it resembles the shape of a "volcano".

The center of the conical portion 21 presents an opening through which the trocar is passed and fixed at the same time. The width of the central opening is slightly wider at the top and narrower at the bottom so that the rim of the cone at the bottom would also act as a sealant.

The sealing pad 20 comprises on the bottom surface an adhesive layer 22 that is used to maintain the device against the skin and a backing paper 23, said adhesive layer should be strong enough to keep the pad fixed during surgery without causing adverse skin reactions. The backing paper 23 is removed (peeled off) before placement of the holding device on the skin.

The adhesive layer 22 may be made from any hypoallergenic adhesive material that is latex free, and it does not tear the skin and does not lose adhesion. Said layer 22 shall be breathable and multi-day wear with improved stability and be able to facilitate faster healing and reduce patient discomfort.

It may also contain fine particles of zinc oxide or any material with antibacterial properties, which are added into the adhesive material to help prevent infections

The holding device 10 with its sealing pad 20 helps to stabilize laparoscopic trocars on the abdominal wall skin. Firstly, this device would fix the trocars perpendicular to the skins surface and stop the trocars from sliding out from the abdominal wall during surgery. Additionally, it would assist the surgeon to insert instruments into the abdominal cavity by keeping the trocars stable and at the same time create a sealant around the skin wound, thus, stopping gas escaping from abdominal cavity.

According to an alternative embodiment of the present invention (see Figs. 3 and 4), the bottom surface of the sealing pad 20 comprises a separate layer 24 such as a membrane which on one side comprises the adhesive layer 22 and on the other top side comprises a foldable flap 25.

At the end of the procedure the holding device 10 can be pealed off, thus leaving the separate layer 24 of the sealing pad 20 in contact with the skin surface, just like a skin plaster, to act as a protective cover for the skin incisions. The flap 25 can be unfolded and cover the port site wound. Said layer 24 can be left on the skin for 6-8 days to keep the wound edges together and be waterproof and protective against skin infection at the same time. The trocar assembly 12 comprises a cannula 14 having a lumen 19 extending there through and a trocar 16. Trocar 16 is positioned within lumen 19 of cannula 14. Trocar assembly can be made from any plastic material which is conventionally used in the medical device arts. During laparoscopic surgery, surgical tools are inserted in and out from the abdominal cavity, through the appropriately designed cylindrically shaped instruments of variable length (usually 6-10 cm), the laparoscopic trocars. The trocars are simply inserted by pushing them through an inflated abdominal wall 32 and are held in place simply by skin friction or in some cases by a spiral that is screw shaped and carved around the instruments outer surface. As surgery progresses though, the trocars become increasingly loose within the abdominal skin with the result of sliding in and out together with the surgical tools. Additionally, their angle is rarely perpendicular to the abdominal skin which makes insertion of the long and thin laparoscopic tools tedious and complex. The gas also tends to escape between the trocar and the skin thus loosing intra-abdominal gas pressure.

The use of the holding device 10 of the present invention helps to keep the trocar assembly stable in place and eliminates the need for anyone to hold the medical apparatus in the appropriate position during surgery, thereby freeing them to perform other tasks.

Another advantage of using the holding device 10 is that it helps maintain a substantially gas tight seal between the interior and exterior of a body cavity, which ensures that no unexpected loss of a pneumoperitoneum will occur during the medical procedure. This is especially true when an adhesive layer is used to attach pad member 20 to exterior surface 1 1 1. It should be appreciated that preventing an uncontrolled loss of the pneumoperitoneum is important since such a loss can complicate the medical procedure being performed, and increase the potential that the port site wound will be contaminated with infectious bacteria.

Based upon the above description it will be understood by those skilled in the art that the present invention provides a medical device comprising a holding device with a sealing pad which protects the port site wound and adds only a minimal amount of bulk to the diameter of the trocar assembly.

In addition, the present invention provides a medical device for continuous protection of the port site wound which enables the independent movement of a cannula or trocar assembly, thus allowing the surgeon to functionally utilize the cannula and instruments to their fullest design. The device of the present invention has the advantage over the prior art that it can be retrofit to existing trocar assembly technology. More specifically, the holding device and sealing pad of the present invention can be used with trocar assemblies which are currently commercially available to laparoscopic surgeons.

Moreover, the device of the present invention allows the cannula to be advanced into and withdrawn from the port site wound while still protecting the port site wound from contamination by any types of cells.

While preferred embodiments have been shown and described, obviously minor modifications in design and construction can be effected in the present invention without departing from the spirit and scope thereof, as defined in the appended claims.