The present invention relates to a surgical port that may be used for inserting a surgical tool into a body cavity during minimally invasive or endoscopic surgery (such as laparoscopic surgery) .

Background of the Invention

Endoscopic surgery involves indirect visualization of the operative field with a small camera or optic fibers. Endoscopic surgery is generally done by way of multiple small incisions into which surgical ports are inserted, through which the camera and surgical instruments are inserted .

The endoscopic instruments, which traverse the ports, perform their functions inside the body but are operated by means of handles that extend outside the body. Since the operated area is inflated by gas during the endoscopic surgery, the ports are required to prevent gas leakage, thus maintaining the pressure within the surgical area.

Ports (sometimes referred to as sleeves) are inserted into the body, through layers of skin, fascia and muscle, using an introducer. The introducer (sometimes referred to as Trocar, for example Hasson Trocar, Unimax medical systems Inc. and Endopath Excel Trocar, Ethicon Endosurgery Inc.) has a sharp entry point (allowing penetration of the abdominal wall) and is rigid, to allow pushing it forward through the layers. Some Introducers have bladed points, allowing incision and entry through the skin, and some Introducers have "bladeless" or blunt points, and are inserted through the abdominal wall after a small incision has been made by a scalpel.

In all prior art ports and introducers, each of these is a separate element and a separate tool, and insertion of the port into the body requires an introducer to be used.

Ports may be dispersed around the abdominal cavity and the number of ports may vary, for example there may be 3 or 5 ports per surgery.

Another possibility is to use a single entry port in the area of the umbilicus, this single port containing multiple (for example 3 to 5) separate ports, allowing the introduction of multiple tools at the same site. This surgical approach is called "SPA" Single Port Access. The same approach can be achieved similarly by inserting multiple separate ports in the same single area.

Examples of commonly-performed endoscopic surgical operations include laparoscopic hemicolectomy, laparoscopic cholecystectomy and laparoscopic hysterectomy.

US 3,613,684 relates to a trocar catheter formed with a rigid shaft like stylet and an encircling catheter made of plastic material. The catheter has a molded rigid distal end member with a conical shape, a closed rounded tip fixed to a flexible tube, and at least one fluid opening through the side. The rigid distal end member has an interior that conforms to the shape of the stylet tip. The device may be used in emergency cases where the catheter is forced through the chest wall of a patient over the stylet which is then withdrawn to let fluid pass through the catheter or for suprapubic cystostomy procedures.

US 4,863,438 relates to a device that includes a flexible, hollow tube portion having a resiliently deformable mushroom shape tip at the inner end thereof to retain the tube in the stomach or other viscera of a patient.

US 4,535,773 relates to a surgical instrument having a normally closed valve assembly at its proximal end which may be manually opened to receive an implement terminating in a sharp blade and point for puncturing the wall of an anatomical cavity.

Prior art methods require incisions of the body at least of the size of the ports. Large incisions make the healing process more difficult. There still is a need for an efficient manner of enabling insertion of delivery tools through a port without the need for large incisions.

It is therefore an object of the present invention to provide a method and means for enabling insertion of delivery tools through a port in an efficient manner providing an incision as minimal as possible.

Other objects and advantages of the present invention will become apparent as the description proceeds. SUMMARY OF THE INVENTION:

The present invention relates to a flexible laparoscopic port suitable for use in inserting a surgical tool into a body cavity. The port comprises a flexible, elongate hollow sleeve connected to an introducer tip at its distal end. The distal tip is usually rigid and has a diameter less than that of the hollow flexible sleeve. A rigid rod is passed through the sleeve connecting with the distal tip. After the port is inserted into the body by means of the rod, the rod disconnects from the introducer tip and is retracted. The distal tip having a natural curved state in relation to the sleeve, returns to its natural curved state after being disconnected from the rod. An appropriately- sized exit aperture on the distal portion of the sleeve, proximal to the distal introducer tip, and on the opposite side of the proximal aperture of the sleeve (facing it), enables delivery of tools though the port into the body.

The proximal direction herein refers to the direction closest to the operator. The distal direction herein refers to the direction further away from the operator.

The present invention relates to a flexible port for use in endoscopic or laparoscopic surgery, comprising:

(a) a tubular sleeve having a proximal entry aperture and a distal exit aperture, wherein said sleeve comprises a first, linear portion that is continuous at its distal end with a shorter second, curved portion; and

(b) a rigid introducer tip located at the distal extremity of said curved portion; wherein said distal exit aperture pierces the side wall of said curved portion of the tubular sleeve in such a way that said distal and proximal apertures could be connected by an imaginary straight line passing therebetween .

Preferably, an instrument-closure valve is located either at the proximal extremity of the port or situated in the distal region of the inner bore of the port sleeve.

Preferably, a sealing-valve is located either at the proximal extremity of the port or situated in the distal region of the inner bore of the port sleeve.

Preferably, the valve is located in an expanded-diameter housing at the proximal extremity of the port.

Preferably, the tubular sleeve is comprised of silicon.

Preferably, the port comprises a retention structure fitted around the outside part of the distal region of the sleeve.

Preferably, the retention structure is provided in the form of a flange.

Preferably, the flange is slightly proximal to the end of the linear portion of the sleeve.

Preferably, the distal exit aperture is oval. The present invention related to a flexible port system for use in endoscopic or laparoscopic surgery, comprising:

(a) a flexible port as explained hereinabove; and

(b) a rigid rod that may be inserted into the inner bore of the port such that its distal end may be caused to engage with the proximal face of the rigid introducer tip; wherein upon insertion of said rod, the distal end of the tubular sleeve would become straightened, such that the proximal aperture of said sleeve and the distal extremity of the rigid introducer tip could be connected by an imaginary straight line passing therebetween.

Preferably, the rod distal end engaged with the proximal face of the rigid introducer tip is implemented by an anchoring mechanism.

Preferably, the anchoring mechanism is such that the distal end of the rigid tube is in the form of an "x" shape and compatible with a fitting "x" shaped socket on the proximal side of the introducer rigid tip.

The present invention related to a method for the laparoscopic introduction of a surgical instrument into a body cavity of a subject comprising the steps of:

(a) providing a flexible port system according to system hereinabove, with the rigid rod inserted into the inner bore of the port such that the naturally-curved distal portion of said port is in a straight line with the longer, linear proximal section thereof; (b) creating an entry incision in the abdominal skin and underlying tissues using a surgical blade and/or the rigid introducer tip;

(c) inserting said straightened flexible port into the entry incision created in step (b);

(d) removing the rigid rod from the inner bore of the port, thereby causing the distal portion of said port to revert to its natural curved conformation;

(e) inserting the desired surgical instrument through the proximal entry aperture into the inner bore of said port, such that the distal end of said instrument leaves said inner bore through the distal exit aperture.

Preferably, the body cavity into which the port is inserted is the abdominal cavity. In other embodiments, however, the method of the present invention may be used to provide laparoscopic access to other portions of the body.

BRIEF DESCRIPTION OF THE DRAWINGS:

The present invention is illustrated by way of example in the accompanying drawings, in which similar references consistently indicate similar elements and in which:

- Fig. 1 provides a perspective view of an embodiment of the present invention.

- Fig. 2 provides a longitudinal section view of an embodiment of the present invention.

- Fig. 3 depicts further structural details of an embodiment of the present invention.

- Fig. 4 illustrates an embodiment of the rigid rod of the present invention. - Fig. 5 illustrates a cross section of the distal portion of a typical rigid rod of the present invention .

- Fig. 6 illustrates a view of an embodiment of the present invention.

- Fig. 7 shows the embodiment depicted in Fig. 1 after engagement of the distal end of the introducer tube with the rigid distal tip of the port.

- Fig. 8 shows an embodiment of the present invention with an example of a surgical tool inserted through the port and past the distal aperture.

Description of the invention

The present invention provides a flexible laparoscopic port suitable for use in inserting a surgical tool into a body cavity, wherein said port comprises a flexible, elongate hollow tube fitted with an introducer tip at its distal end.

A novel element of this invention is that the port of the invention does not require a separate introducer tip; rather, the introducing element is a part of the port itself. This novel combination of a flexible sleeve with a rigid introducer tip permits the passage through the port of a tool which has a larger diameter than the diameter of the introducer tip.

The port of the invention is made of flexible biocompatible material (for example Silicon such as Elastosil R401/60 or other plastic or rubber) . The port is uniquely constructed with a rigid Introducer element at its distal end (made, for example, from biocompatible metal such as stainless steel or biocompatible plastic such as IEXF - 0006). The introducer element may either have a sharp distal edge (sharp as a blade, allowing entry into the body), or may have a blunt edge (bladeless), similar to traditional introducers.

The port of the invention may comprise the following elements :

1. Silicon sleeve (tube).

2. Instrument-closure valve - a valve to prevent air leakage while tools are passing through the port towards the abdominal cavity and during the procedure, while tools are inserted through the port.

3. Sealing valve - a "leaflet-type" valve, which prevents air leakage in a "static" position - i.e. with or without tools inserted through the port, when no tools are passing through the port. This element is indicated by part number 32 in Fig. 2.

4. Integrated Introducer Tip - The flexible (for example, Silicon) port is overmolded on a rigid introducer, as previously described. The introducer may be bladeless or may have a sharp, cutting, tip.

With regard to the sealing elements (items 2 and 3 in the above list), it is to be noted that said elements may be arranged in various different ways within the port sleeve. Thus, in one preferred embodiment of the device, instrument-closure valve may be located in an expanded- diameter housing at the proximal extremity of the port, while the sealing-valve is situated in the distal region of the inner bore of the port sleeve. In another preferred embodiment, the position of each of the two valves is reversed, i.e. the proximal housing contains the sealing- valve while the instrument-closure valve is located in the distal portion of the device. Of course, other valve arrangements are also possible, and these too are included within the scope of the present invention.

The combination of flexible port/sleeve with an integrated rigid, introducer/trocar tip requires a combination of different materials. For example, a flexible silicon port and a rigid plastic or metal introducer tip. This combination requires use of biocompatible plastic materials (for example, biocompatible Nylon) that can bear the high temperatures of the Silicon injection process during manufacture by means of an overmoldxng process.

Designated holes 40 around the "neck" of the introducer tip (Fig. 3) allow the silicon to flow easily through and around the rigid introducer tip (for example, around the plastic tip) and allows to "tighten" the flexible and rigid members to each other during the overmoldxng process.

This unique solution of integrating the port and the introducer tip permits reduction of the diameter of the final product, since there is no need to build a port that is inserted over a separate introducer (thus essentially requiring an introducer external diameter which would fit the internal diameter of the port). Consequently, the diameter of the introducer may be smaller than the diameter of the port/sleeve. This is a unique feature of this invention, and permits the insertion of tools which require a large diameter, as well as curved tools (which also require larger diameter due to the curvature) through smaller diameter introducers.

The diameter of the introducer determines the size of the incision or hole in the abdominal wall, and, as previously explained, it is advantageous to have a small diameter introducer, since reducing this diameter results in a more rapid healing process and reduces the complication rates, such as the possibility of post-surgical hernia at the incision site.

For example, a port of this invention may have a sleeve having a 7mm internal diameter, allowing insertion of curved tools and of 7mm tools, while the diameter of the introducer (and hence the diameter of the abdominal incision) is smaller, for example 5mm. Other examples include the use of a 10mm diameter sleeve with an integrated 5mm introducer tip, and a 7mm sleeve with a 3mm introducer tip. The sleeve being flexible (e.g. silicon) enables its expansion thus expanding its diameter to that of the inserted tool.

Exemplary sizes of the port of the invention are length of 3cm to 15cm, internal diameter of 3mm to 15mm and external diameter of 3.5mm to 17mm. In one preferred embodiment of the device 10 (as shown in the perspective view presented in Fig. 1) the port/sleeve tube may be constructed from either two separate portions, or as a single element having two portions each with a different shape or orientation. The tube may be designed having a straight section 12 from its proximal end (i.e. the end closest to the operator) extending to a flange 20 (an optional element which is described in more detail hereinbelow) and a curved section 14 extending from said flange to the distal end of the rigid introducer tip 18. This novel curved shape at the distal part may be created during manufacturing (as part of the over-molding process). In this way, the curved shape becomes set as the "baseline" or "default" or "resting state" sleeve conformation, i.e. the conformation to which the port device will return after any external force acting thereon is removed.

According to one embodiment of the present invention the curvature is such that the angle between the straight section 12 and the introducer tip 18 is substantially around 60°, as shown in Fig. 3.

Before inserting the port into the body, the rigid tip, which may have a proximal anchoring mechanism, may be anchored to a rigid tube or rod (shown by part number 24 in Figs. 1, 4) which is inserted through the flexible sleeve (the rigid tube can be made, for example, from biocompatible metal such as stainless steel or biocompatible plastic such as IEXF -0006), and which has an anchoring mechanism on its distal side which is compatible with a comparable mechanism on the proximal side of the integrated introducer rigid tip. Thus, before using the port the flexible sleeve (by means of a rigid tube inserted into it) and the rigid introducer are anchored to each other, in a reversible manner. This anchoring causes the curved distal part of the flexible sleeve to straighten (since a straight rigid tube is inserted through the sleeve and then becomes anchored to the rigid tip), as shown in Fig. 7. It may be seen from this figure that rigid distal tip 18 is now positioned along the same longitudinal axis as the straight portion 12 of the sleeve and the tubular portion 24 of the introducer. The port (containing the rigid tube in its internal bore) may now be inserted through the abdominal wall.

Fig. 2 provides a longitudinal section view of a port device of the present invention with the rigid introducer rod partially inserted therein. As may be seen, said rod is fitted with an engagement element 26 at its distal end for engaging with a comparable element 28 on the proximal surface of the rigid distal tip. As the rigid rod is further advanced (not shown), the curved section will become straightened, thereby bringing the rigid distal tip (18 in Fig. 1) into line with the straight portion of the port tube.

According to an embodiment of the present invention, the anchoring mechanism is such that the distal end 25 of the rigid tube 24 is in the form of an x" shape, as shown in cross-section form in Fig. 5. The distal end 25 is compatible with a fitting "x" shaped socket (not shown) on the proximal side of the integrated introducer rigid tip. At this point it should, perhaps, be re-iterated that while the use of both the prior art ports and the present invention require two separate devices (the port itself and an introducer rod) , the manner in which the present invention is constructed is entirely different from said prior art ports. Thus, while the prior art ports require the use of a rigid introducer fitted with a pointed tip (i.e. a conventional trocar tip - whether sharp or blunt), the introducer used in the present invention is essentially a rigid rod fitted with a sleeve-anchoring element at its distal end: the trocar or introducer tip that would normally be present at the distal end of the introducer is now integrated into the distal end of the port itself. As described hereinabove, this unique conformation confers several key advantages on the port of the present invention.

After the port has been passed through the abdominal wall, the internal rigid tube which was previously inserted through the sleeve is disconnected ( un-anchored ) from the integrated introducer tip. This may be done, for example, by rotating the internal rigid tube and thus releasing the anchoring mechanism. The rigid tube is then removed from the sleeve, thereby allowing the operator to pass surgical tools through the port.

A further key difference between prior art ports and the port of the present invention relates to the fact that each of said prior art ports has its distal aperture (i.e. distal exit) right at the distal tip of the port, that is, exactly opposite to the entry aperture, such that the two apertures could be connected by an imaginary straight line. In the port of the present invention, however, the distal aperture is NOT at the distal-most point on the very end of the sleeve. Rather, the distal aperture is located PROXIMAL to the rigid tip, on the side wall of the port tube or sleeve. The functional significance of this conformation will be described hereinbelow.

In a preferred embodiment of the invention, the distal aperture 45 (Fig. 6) is oval (and not round as in prior art ports), thereby increasing the effective diameter of the aperture, and thus allowing larger size tools to be passed through the port and into the abdominal cavity, even while using a small diameter introducer tip. Also, this increases the possibilities of inserting tools at wider angles.

As previously explained, prior to insertion of the port into the abdomen, a rigid tube is inserted into the sleeve, causing the sleeve to straighten ("tensed" state) . In one preferred embodiment of the invention said rigid tube is anchored to the inside of the integral introducer tip by stretching two silicon "ribs" from the silicon port to the upper part of the tube, thus the tube is "pushed" with force into the integrated introducer tip at the distal part of the sleeve, thereby improving the anchoring mechanism.

Pulling out the rigid tube from the port after insertion into the abdominal cavity is then done by releasing the silicon ribs and pulling out the rigid tube, thereby releasing the introducer tip so it can bend sideways (since the "baseline" state is curved) . In this resting conformation, the distal aperture (formed in the side wall of the port), is now aligned with the proximal entry aperture in such a way that an imaginary straight line could pass through both apertures, thereby allowing surgical tools inserted into the port to pass through the distal aperture. Fig. 8 shows an example of a tool 50 inserted through the port 10 and past the distal aperture after the rod 24 has been retracted and the introducer tip 18 has returned to its curved state.

In a preferred embodiment of the present invention, the device is fitted with a retention structure, the purpose of which is to retain the port within the abdominal cavity and to prevent its unintentional removal through the abdominal wall. In one particularly preferred embodiment, the retention structure is provided in the form of a flange (element 20 in Fig. 1) that is fitted around the outside part of the distal region of the sleeve, preferably slightly proximal to the end of the straight portion of the device. One particularly additional advantage of utilizing the flange embodiment of the retention structure is that it also contributes to the gas-tight sealing of the port within the surgical incision. However, it is to be appreciated that the invention also includes within its scope other forms of retention structure (for example, inflatable balloons or sleeves, tubular folds or "bellows" structures, and so on.)

While some of the embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried into practice with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of a person skilled in the art, without departing from the spirit of the invention, or the scope of the claims.