Patent Description:
A natural orifice transluminal endoscopic surgery (NOTES) is a new research hotspot in a surgical field after multiport minimally invasive surgery and single port minimally invasive surgery. In such a surgery, a surgical instrument is inserted into an abdomen via a natural orifice of human body, such as mouth, colorectum, and bladder, etc., to treat a disease. It is a scar-free operation without any incision on body surface. The natural orifice translumenal minimally invasive surgery does not leave any incision in a human body surface during treating a patient's disease, thereby mitigating a surgical trauma and postoperative pain and increasing a cosmetic effect, thus achieving better physiological and psychological minimally invasive effects.

Most of the surgical instruments currently used are master-slave type operation instruments. Only micro-surgical tools are delivered to a targeted site. A doctor operates remotely by a control mechanism, and the control mechanism is connected to an actuator through a pipeline. In order to adapt for a tortuous body orifice, the pipeline connected between the control mechanism and the actuator is required to be formed into a flexible rod. The surgical tool is fixed at a remote end of the pipeline and is delivered to the targeted site through the body orifice. The pipeline assists the surgical tool for cutting, suturing, knotting, rinsing and other surgical operations. Then, after the operation is completed, the surgical tool is retracted along the natural orifice.

However, during implementing the present disclosure, inventors of the present disclosure have found that during access to the targeted site through the natural body orifice, flexibility of the current pipeline for surgical instrument is insufficient, which will cause damage to the natural orifice; and due to insufficient flexibility, it is rather difficult to achieve certain postures in a process of adjusting a posture of the surgical tool before the operation. At the same time, a stable operating environment is required during the surgical operation, and thus it is required for the pipeline for surgical instrument to provide a stable and reliable support. However, stiffness of the current pipeline for surgical instrument is not enough to ensure stability and accuracy of the operation.

<CIT> discloses a stiffness-controllable joint snake-like mechanism (<NUM>-<NUM>) for a single-port surgical instrument, capable of effectively avoiding collision problems of tools in surgery, thus making the surgical operation more precise and flexible, and bringing higher lifting power. The stiffness-controllable joint snake-like mechanism (<NUM>-<NUM>) comprises: an elastic support frame (<NUM>-<NUM>); an energy exchange means (<NUM>-<NUM>) winded around the elastic support frame (<NUM>-<NUM>); a snake-like framework (<NUM>-<NUM>) fitted over the energy exchange means (<NUM>-<NUM>); an isolation and heat insulating sleeve (<NUM>-<NUM>) fitted over the snake-like framework (<NUM>-<NUM>); and a liquid metal (<NUM>-<NUM>) filled in gaps between the elastic support frame (<NUM>-<NUM>), the energy exchange means (<NUM>-<NUM>), and the snake-like framework (<NUM>-<NUM>). The energy exchange means (<NUM>-<NUM>) controls phase change of the liquid metal (<NUM>-<NUM>) by means of heat exchange, thereby implementing rigid-flexibility conversion of the snake-like mechanism (<NUM>-<NUM>).

The present disclosure provides a sponge-based variable-stiffness support structure for natural orifice surgical instrument and a method for using the same, so as to alleviate technical problems in the relevant art that the pipeline of natural orifice surgical instrument for human body is not flexible enough, thus it is easy to cause damage to the natural orifice, and the stiffness is not enough to ensure the stability and accuracy of the operation.

An embodiment of the present disclosure provides a sponge-based variable-stiffness support structure for natural orifice surgical instrument, configured to support the natural orifice surgical instrument and including: a variable-stiffness sponge pipeline connected with the natural orifice surgical instrument and configured to support the surgical instrument in a natural orifice; a hydrophobic breathable film attached to an outer wall of the variable-stiffness sponge pipeline, and configured to isolate the variable-stiffness sponge pipeline from body fluid in the natural orifice; and a gas delivery assembly connected with the variable-stiffness sponge pipeline, and configured to inject high-pressure air and water vapor into a variable-stiffness sponge pipe of the variable-stiffness sponge pipeline; wherein the variable-stiffness sponge pipeline has a stiffness inversely proportional to content of the water vapor.

In the embodiment of the present disclosure, a spring skeleton is provided in the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline and configured to support the variable-stiffness sponge pipeline.

In the embodiment of the present disclosure, the spring skeleton is made of stainless steel, and a surface of the spring skeleton is coated with an insulating coating.

In the embodiment of the present disclosure, an inner wall of the variable-stiffness sponge pipeline is provided with the hydrophobic breathable film.

In the embodiment of the present disclosure, the gas delivery assembly includes a gas delivery device and a gas delivery line, the gas delivery device is connected with the variable-stiffness sponge pipeline through the gas delivery line, and the gas delivery line is located in the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline.

In the embodiment of the present disclosure, the gas delivery device includes a water vapor generator configured to generate the water vapor therein and a gas pump configured to generate the high-pressure air.

In the embodiment of the present disclosure, a non-breathable film is attached locally to the variable-stiffness sponge pipeline and configured to isolate the water vapor from variable-stiffness sponge of the variable-stiffness sponge pipeline, so that they cannot contact with each other.

In the embodiment of the present disclosure, the variable-stiffness sponge pipeline has a cross-section of a circular ring, or an elliptical ring.

In the embodiment of the present disclosure, the variable-stiffness sponge of the variable-stiffness sponge pipeline is made of polyvinyl formal.

A further embodiment of the present disclosure provides a surgical instrument assembly, including: a natural orifice surgical instrument and a sponge-based variable-stiffness support structure for natural orifice surgical instrument as described in the above embodiments, the sponge-based variable-stiffness support structure for natural orifice surgical instrument is connected with the natural orifice surgical instrument to support the natural orifice surgical instrument.

According to the embodiments, the present disclosure at least has following beneficial effects:
The variable-stiffness sponge pipeline has good stiff-flexible conversion characteristics. When being assembled with the surgical instrument, the variable-stiffness sponge pipeline may be made to become the flexible state in order to facilitate assembly. And, when the variable-stiffness sponge pipeline along with the surgical instrument is inserted into the natural orifice, the variable-stiffness sponge pipeline may protect human tissue from being scratched by the natural orifice surgical instrument, and may not add extra resistance in the surgical posture adjustment, which reduces the difficulty of posture adjustment. When the surgical operation is performed, the variable-stiffness sponge pipeline may be made to become the stiff state, in order to provide a stable operating platform to ensure stable and accurate surgical operation.

The drawings are used to further understand the present disclosure and form a part of the description. They are intended to interpretate the present disclosure along with the detailed embodiments below, whereas should not be construed as being limited to the present disclosure. In the drawings,.

The sponge-based variable-stiffness support structure for natural orifice surgical instrument and a method for using the same, provided by the embodiments of the present disclosure, utilize variable-stiffness sponge as a base of the support structure and adjust the stiffness of the variable-stiffness sponge, so as to reduce a risk of scratching the natural orifice of human body and ensure the stability of surgical instrument during the operation.

In order to make the objectives, technical solutions, and advantages of the present disclosure clearer, the present disclosure is further described below in detail with reference to specific embodiments and the accompanying drawings.

<FIG> is a schematic diagram of a sponge-based variable-stiffness support structure for natural orifice surgical instrument according to an embodiments of the present disclosure. <FIG> is a schematic diagram illustrating connection of a variable-stiffness sponge pipeline and a gas delivery line in the support structure as shown in <FIG>. <FIG> is a cross-sectional view of the support structure as shown in <FIG> cut along a direction A-A thereof.

An embodiment of the present disclosure provides a sponge-based variable-stiffness support structure <NUM> for natural orifice surgical instrument, as shown in <FIG>, including a variable-stiffness sponge pipeline <NUM> and a gas delivery assembly.

The variable-stiffness sponge pipeline <NUM> is made of variable stiffness sponge, connected with the surgical instrument <NUM> and configured to support it in the natural orifice. A hydrophobic breathable film <NUM> is attached to an outer wall of the variable-stiffness sponge pipeline <NUM> and configured to isolate the variable-stiffness sponge pipeline <NUM> from body fluid in the natural body orifice.

The gas delivery assembly includes a gas delivery device <NUM> and a gas delivery line <NUM>. The gas delivery device <NUM> is connected with the variable-stiffness sponge pipeline <NUM> by the gas delivery line <NUM>. The gas delivery device <NUM> includes a water vapor generator <NUM> and a gas pump <NUM>. The water vapor generator <NUM> may be configured to generate water vapor therein. The gas pump <NUM> may be configured to generate high-pressure air.

The gas delivery line <NUM> is inserted into a variable-stiffness sponge pipe at an end of the variable-stiffness sponge pipeline <NUM>. The water vapor generator <NUM> is used to inject water vapor into the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline <NUM> by the gas delivery line <NUM>. The gas pump <NUM> is used to inject high-pressure air into the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline <NUM> by the gas delivery line <NUM>.

The stiffness of the variable-stiffness sponge pipeline <NUM> is reduced with an increase of the content of the water vapor. Swelling principle of the variable-stiffness sponge is used to control the stiffness of the variable-stiffness sponge pipeline <NUM>. When water vapor is introduced, the variable-stiffness sponge swells, intermolecular force decreases, the stiffness of the variable-stiffness sponge becomes smaller, and then the stiffness of the entire variable-stiffness sponge pipeline <NUM> becomes smaller; and when high-pressure air is introduced, the water vapor in the variable-stiffness sponge can be blown out so as to cause the sponge to reversely swell, molecular gap becomes smaller, and thus the stiffness of the entire variable-stiffness sponge pipeline <NUM> becomes larger.

The variable-stiffness sponge pipeline <NUM> has good stiff-flexible conversion characteristics. When being assembled with the surgical instrument <NUM>, the variable-stiffness sponge pipeline may be made to become a flexible state in order to facilitate assembly. And, when the variable-stiffness sponge pipeline along with the surgical instrument <NUM> is inserted into the natural orifice, the variable-stiffness sponge pipeline may protect human tissue from being scratched by the natural orifice surgical instrument, and may not add extra resistance in the surgical posture adjustment, which reduces the difficulty of posture adjustment. When the surgical operation is performed, the variable-stiffness sponge pipeline <NUM> may be made to become a stiff state, in order to provide a stable operating platform to ensure stable and accurate surgical operation.

As shown in <FIG>, a spring skeleton <NUM> is provided in the variable-stiffness sponge pipeline <NUM> and configured to support the variable-stiffness sponge pipeline <NUM>. The spring skeleton <NUM> is made of stainless-steel material. A surface of the spring skeleton <NUM> is coated with an insulating coating. The spring skeleton <NUM> enables the variable-stiffness sponge pipeline <NUM> not to be easily collapsed under a condition of large curvature deformation or radial compression, which would cause a hollow structure being blocked.

Further, an inner wall of the variable-stiffness sponge pipeline <NUM> is provided with a hydrophobic breathable film <NUM>.

In the embodiment of the present disclosure, as shown in <FIG>, the gas delivery line <NUM> is arranged in the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline <NUM> and close to the hydrophobic breathable film <NUM>.

<FIG> is a schematic diagram illustrating overall bending of a variable-stiffness sponge pipeline in the support structure as shown in <FIG>. <FIG> is a schematic diagram illustrating local bending of a variable-stiffness sponge pipeline in the support structure as shown in <FIG>.

As shown in <FIG>, a non-breathable film <NUM> is attached locally to the variable-stiffness sponge pipeline <NUM>. The non-breathable film <NUM> may be attached locally to the inner wall of the variable-stiffness sponge pipeline <NUM>. The non-breathable film <NUM> is set to isolate the water vapor from the variable-stiffness sponge of the variable-stiffness sponge pipeline <NUM>, so that the variable-stiffness sponge pipeline <NUM> is locally bent.

In addition, the gas delivery assembly of this embodiment may further include a group of gas delivery lines, including one or more gas delivery lines <NUM> which are respectively inserted into different positions of the variable-stiffness sponge pipe of the variable-stiffness sponge pipeline <NUM>. The local bending of the variable-stiffness sponge pipeline <NUM> is achieved by providing a local gas delivery line <NUM> on the variable-stiffness sponge pipeline <NUM> (changing an access point of the gas delivery line <NUM> to the variable-stiffness sponge pipeline <NUM>). By providing the local gas delivery line <NUM> or attaching the non-breathable film <NUM> to the variable-stiffness sponge pipeline <NUM>, an effect of local variable stiffness is achieved, and the stiffness of surgical instrument is segmentally and differentially controlled to meet the diversified requirements of surgery.

In this embodiment, the variable-stiffness sponge pipeline <NUM> has a cross-section of a circular ring or an elliptical ring.

In this embodiment, the variable-stiffness sponge and the hydrophobic breathable film may be made of non-toxic materials with good tissue compatibility and suitable for the surgical instrument which is in contact with the body tissue. The variable-stiffness sponge preferably includes polyvinyl formal.

<FIG> is a schematic diagram illustrating connection of the support structure as shown in <FIG> with a natural orifice surgical instrument.

In another embodiment of the present disclosure, there is provided a surgical instrument assembly <NUM>, as shown in <FIG>, including: a natural orifice surgical instrument <NUM> and a sponge-based variable-stiffness support structure <NUM> for natural orifice surgical instrument. The variable-stiffness support structure for natural orifice surgical instrument adopts the support structure described above, and is connected with the natural orifice surgical instrument <NUM> to support the natural orifice surgical instrument <NUM>.

<FIG> is a flowchart of a method for using the sponge-based variable-stiffness support structure for natural orifice surgical instrument provided by the present disclosure.

Claim 1:
A sponge-based variable-stiffness support structure (<NUM>) for a natural orifice surgical instrument (<NUM>), configured to support the natural orifice surgical instrument (<NUM>), wherein the sponge-based variable-stiffness support structure (<NUM>) for natural orifice surgical instrument comprises:
a variable-stiffness sponge pipeline (<NUM>) designed to be connected to the natural orifice surgical instrument (<NUM>);
a hydrophobic breathable film (<NUM>) attached to an outer wall of the variable-stiffness sponge pipeline (<NUM>), and configured to isolate the variable-stiffness sponge pipeline (<NUM>) from body fluid in the natural orifice; and
a gas delivery assembly connected with the variable-stiffness sponge pipeline (<NUM>) and configured to inject high-pressure air and water vapor into a variable-stiffness sponge pipe of the variable-stiffness sponge pipeline (<NUM>);
wherein the variable-stiffness sponge pipeline (<NUM>) has a stiffness inversely proportional to content of the water vapor.