Patent Description:
The suction of blood, cleaning liquid, and body fluid during a surgical operation is a very important manoeuvre for ensuring a surgical view and is involved in the safety and precision of the surgical operation.

Many surgical suction devices have been designed over the years, nevertheless many of them showed failings. These are often in the design of the devices as they are either not efficient enough, that is, they leave too much fluid in the surgical field, or can potentially suck on tissue and cause trauma, or also draw in a lot of air which mixes with the blood and therefore creates the risk of micro emboli and haemolysis.

There is therefore the need of improved surgical suction devices which reduce as much as possible the above identified failings.

The object of this disclosure is to provide a surgical suction device which overcomes the drawbacks of the known devices.

According to the invention, the above object is achieved thanks to the subject matter recalled specifically in the ensuing claims, which are understood as forming an integral part of this disclosure.

In one embodiment, the present disclosure concerns a surgical suction device <NUM> comprising:.

wherein the surgical cavity insertion tube <NUM> is connected at a proximal end thereof to the connector <NUM> and at a distal end thereof to the suction tip <NUM>, wherein the suction tip <NUM> comprises an inner hollow shaft <NUM> and an outer hollow shaft <NUM> coaxial to each other, the inner hollow shaft <NUM> having a first central opening <NUM> at a distal end thereof, and the outer hollow shaft <NUM> having an end wall <NUM> at a distal end thereof, wherein the end wall <NUM> has a second central opening <NUM> in axial alignment with the first central opening <NUM> of the inner hollow shaft <NUM>, and wherein the outer hollow shaft <NUM> has one or more openings <NUM> on a lateral wall <NUM> thereof.

The design of the surgical suction device <NUM> object of the present disclosure has taken into account the risk factors involved in using surgical suction and minimised them as well as ensuring that the device functions as efficiently as possible with little interaction from the surgical team using the device.

The invention will now be described in detail, purely by way of an illustrative and non-limiting example and, with reference to the accompanying drawings, wherein:.

In the description that follows, numerous specific details are given to provide a thorough understanding of the embodiments. The embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the embodiments.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment.

In the present description some dimensional parameters are provided. It is intended that dimensional tolerances are to be considered with respect to the specified nominal values as no manufacturing machine can hold dimensions precisely to the nominal value. In the present description a tolerance of ± <NUM> for the indicated nominal values is to be considered.

The present description concerns a surgical suction device.

Referring to <FIG>, the numeral <NUM> denotes the surgical suction device as a whole.

The surgical suction device <NUM> comprises:.

The surgical cavity insertion tube <NUM> is connected at a proximal end thereof to the connector <NUM> and at a distal end thereof to the suction tip <NUM>.

The suction tip <NUM> comprises an inner hollow shaft <NUM> and an outer hollow shaft <NUM> coaxial to each other as shown in <FIG>. The axial through-cavity of the inner hollow shaft <NUM> includes a first central opening <NUM> at a distal end of the inner hollow shaft <NUM>. The outer hollow shaft <NUM> has an end wall <NUM> at a distal end thereof, wherein the end wall <NUM> has a second central opening <NUM> in axial alignment with the first central opening <NUM> of the inner hollow shaft <NUM>. The outer hollow shaft <NUM> has one or more openings <NUM> on a lateral wall <NUM> thereof.

The inner hollow shaft <NUM> and the outer hollow shaft <NUM> have a cylindrical cross-section.

The inner hollow shaft <NUM> and the outer hollow shaft <NUM> can be soldered together or connected by means of a bonding material.

The connector <NUM> is also axially hollow and comprises a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> of the connector <NUM> can be smooth or barbed. The proximal portion <NUM> of the connector <NUM> is configured for coupling to a tubing, for example a ¼ inch internal diameter tubing (not shown), of a vacuum pump which suctions the fluids from the surgical theatre, or suctions the fluids to a cardiotomy or cell saver reservoir. The distal portion <NUM> of the connector <NUM> is instead configured for coupling to the surgical cavity insertion tube <NUM>.

The proximal portion <NUM> of the connector <NUM> is substantially frusto-conical, or anyway has a diameter increasing from a first end <NUM> to a second end <NUM>, wherein the second end <NUM> is provided with a ridge <NUM> so that the person connecting the vacuum pump tubing to the surgical cavity insertion tube <NUM> in theatre is able to see and feel the area which should not be touched, i.e. the surgical cavity insertion tube <NUM>.

The end wall <NUM> of the outer hollow shaft <NUM> is shaped to define an apex <NUM>, which is spaced - in an axial direction - from a corresponding end of a cylindrical portion <NUM> of the inner hollow shaft <NUM>. In a preferred embodiment the end wall <NUM> of the outer hollow shaft <NUM> is substantially dome-shaped.

The design of the outer hollow shaft <NUM> allows the surgical suction device <NUM> to be more effective than known devices as it ensures that its function is atraumatic and does not suck in tissue.

As shown in <FIG>, the one or more openings <NUM> present on the lateral wall <NUM> of the outer hollow shaft <NUM> comprises/comprise at least one series of openings distributed according to a circumference of the outer hollow shaft <NUM>. Preferably, the one or more openings <NUM> comprises/comprise a plurality of said series of openings, which are spaced from one another in an axial dimension of the outer hollow shaft <NUM>.

The inner hollow shaft <NUM> is configured, at an end region opposite to the first central opening <NUM>, for coupling with the surgical cavity insertion tube <NUM>.

The inner hollow shaft <NUM> is configured, at an intermediate region thereof, for coupling with an inner surface <NUM> of the outer hollow shaft <NUM>.

In one embodiment, the inner hollow shaft <NUM> has at least one coupling element, such as a ridge <NUM>, located at an end region opposite to the first central opening <NUM>, for coupling within the surgical cavity insertion tube <NUM>. The at least one coupling element or ridge <NUM> is made of such a size to enable the coupling between the surgical cavity insertion tube <NUM> and the suction tip <NUM> to still hold when a <NUM> N axial force is applied at a rate of <NUM>/min for <NUM> seconds. The size of the at least one ridge <NUM> is also determined in function of the Shore hardness and elasticity of the surgical cavity insertion tube <NUM>. The process of ethylene oxide sterilization which the device is subject to before use forms the surgical cavity insertion tube <NUM> around the at least one ridge <NUM> creating a strong point of joint.

In one embodiment, the inner hollow shaft <NUM> has an intermediate flange <NUM>, for abutment, on one side thereof, at the respective end of the outer hollow shaft <NUM>, and for abutment, on the opposite side thereof, at the respective end of the surgical cavity insertion tube <NUM>. The flange has preferably a length G of about <NUM>.

In one embodiment, the inner hollow shaft <NUM> has a tapered portion <NUM> extending from the flange <NUM> in the direction of the distal end thereof. The tapered portion <NUM> has a maximum outer diameter not greater than the inner diameter of the outer hollow shaft <NUM>. Preferably, the tapered section <NUM> has an outer diameter of about <NUM>. The tapered portion has preferably a length H of about <NUM>.

In one embodiment, the flange <NUM> has an outer diameter substantially equal to an outer diameter of the outer hollow shaft <NUM> at a distal end thereof, and to an outer diameter of the surgical cavity insertion tube <NUM> at a proximal end thereof, such that - in the assembled condition - the outer surfaces of the elements <NUM>, <NUM>, <NUM> at issue are substantially flush. In this case there is an atraumatic external transition between the suction tip <NUM>/outer hollow shaft <NUM> and the surgical cavity insertion tube <NUM>, so that no damages can be determined to the body parts of the patient. In a preferred embodiment, the flange <NUM> has an outer diameter of about <NUM>.

In a preferred embodiment, a proximal portion <NUM> of the inner hollow shaft <NUM> (on which the at least one coupling element or ridge <NUM> is located) has an outer diameter of about <NUM>. In a preferred embodiment, a distal portion <NUM> of the inner hollow shaft <NUM> (adjacent to the first central opening <NUM>) has an outer diameter of about <NUM>. In a preferred embodiment, the inner hollow shaft <NUM> has an inner diameter of about <NUM>.

In a preferred embodiment, the inner hollow shaft <NUM> has a total length A of about <NUM>. In a preferred embodiment, the proximal portion <NUM> of the inner hollow shaft <NUM> has a length C of about <NUM>. In a preferred embodiment, the distal portion <NUM> of the inner hollow shaft <NUM> has a length D of about <NUM>.

In a preferred embodiment, the at least one coupling element or ridge <NUM> is spaced from the proximal end of the inner hollow shaft <NUM> of about <NUM>. In a further preferred embodiment, the inner hollow shaft <NUM> has at least two ridges <NUM>, spaced from each other of about <NUM>.

In one embodiment, the one or more openings <NUM> comprises/comprise a first series of openings <NUM> located at a distance of at least <NUM> from the apex <NUM> of the end wall <NUM>.

In one embodiment, the one or more openings <NUM> have a diameter not greater than <NUM>.

In one embodiment, the second central opening <NUM> is at the apex <NUM> of the end wall <NUM>.

In one embodiment, the second central opening <NUM> has a diameter of about <NUM>.

In a preferred embodiment, the outer hollow shaft has a total length I of about <NUM>. In a preferred embodiment, the cylindrical portion <NUM> of the outer hollow shaft has a length J of about <NUM>.

In one embodiment, a distance K between the distal end <NUM> of the inner hollow shaft <NUM> (where the central opening <NUM> is located) and the apex <NUM> of the end wall <NUM> of the outer hollow shaft <NUM> is not more than <NUM>% of a distance L between the distal end <NUM> of the inner hollow shaft <NUM> and a distal edge <NUM> of the flange <NUM>.

In one embodiment, a distance M between the distal end <NUM> of the inner hollow shaft <NUM> and an inner surface <NUM> of the outer hollow shaft <NUM> is not more than <NUM>. When the distance M is about <NUM> or <NUM> as the prior art devices then, with the side openings <NUM> exposed to air, the central opening <NUM> at the distal end of the outer hollow shaft <NUM> becomes very inefficient at sucking in blood and other fluids unless the flow of the vacuum pump is very high. Nevertheless, high pump flow rates damage the blood. The preference in theatre is thus to preserve as much of the patient's blood as possible. A sucker with a distance M greater than <NUM> draws in more air and this air will cause activation in the blood (haemolysis) and creates the potential for air emboli.

In one embodiment, a distance N between an inner surface of the outer hollow shaft <NUM> and an outer surface of the inner hollow shaft <NUM> at the portion <NUM> thereof is not greater than <NUM>.

The dimensions as well as the relative and/or absolute distances between different portions of the inner and outer hollow shafts allow the device object of the present description to not suck air into the suction line and thus not cause blood activation and micro emboli.

According to the invention as claimed, the suction tip <NUM> has a weight per unit length greater than four times the weight of the same length of the surgical cavity insertion tube <NUM>. The relative weight of the suction tip <NUM> versus the surgical cavity insertion tube <NUM> ensures that:.

In one embodiment, the outer hollow shaft <NUM> and the inner hollow shaft <NUM> are made of a rigid material, preferably surgical steel.

Claim 1:
A surgical suction device (<NUM>) comprising:
- a connector (<NUM>),
- a surgical cavity insertion tube (<NUM>), and
- a suction tip (<NUM>),
wherein the surgical cavity insertion tube (<NUM>) is connected at a proximal end thereof to the connector (<NUM>) and at a distal end thereof to the suction tip (<NUM>), wherein the suction tip (<NUM>) comprises an inner hollow shaft (<NUM>) and an outer hollow shaft (<NUM>) coaxial to each other, the inner hollow shaft (<NUM>) having a first central opening (<NUM>) at a distal end thereof, and the outer hollow shaft (<NUM>) having an end wall (<NUM>) at a distal end thereof, wherein the end wall (<NUM>) has a second central opening (<NUM>) in axial alignment with the first central opening (<NUM>) of the inner hollow shaft (<NUM>), and wherein the outer hollow shaft (<NUM>) has one or more openings (<NUM>) on a lateral wall (<NUM>) thereof, the device characterized in that the suction tip (<NUM>) has a weight per unit length greater than four times the weight of same length of the surgical cavity insertion tube (<NUM>).