SURGICAL INSTRUMENT HAVING BENDABLE ACTUATOR

A surgical instrument comprises an actuator, an extension tube and a controller, wherein the near end of the extension tube is connected with the controller, the far end of the extension tube is connected with the actuator, and the actuator can rotate relative to the far end of the extension tube. The controller comprises a bend control mechanism capable of moving in at least one direction. The extension tube comprises a first flexible component and moves in at least one direction through the bend control mechanism. The first flexible component enables the actuator to rotate relative to the far end of the extension tube towards at least one side. A bendable magazine is further provided. The actuator can bend relative to the far end of the extension tube by a larger angle through the flexible components, thereby being suitable for medical treatment under more complex clinical conditions.

BACKGROUND OF THE INVENTION

Technical Field

The invention relates to a medical instrument, in particular to an endoscope instrument.

Description of Related Art

A surgical stapler is a surgical instrument. According to the action principle of the surgical stapler, two corresponding actuators (generally comprising a anvil assembly and a cartridge assembly) are closed to clamp tissue, and metal suturing staples in the cartridge of the stapler are then pushed out to suture tissue. Certain staplers are further provided with a cutter used for incising sutured tissue.

With the advance in technology, traditional surgery methods are gradually replaced by endoscope surgery. As for the endoscope surgery, a plurality of small incisions with the diameter of 5-12 mm are punctured at different positions of the abdomen or the chest, a camera lens and various special surgical instruments are inserted into the abdomen cavity through these incisions, images, taken by the camera inserted into the abdomen cavity, of various visceral organs in the abdomen cavity are transmitted to a video screen to be observed by a surgeon, and the surgery is completed through extracorporeal operation by means of various surgical instruments. An endoscope stapler plays a key role in the surgery.

However, endoscope surgery also has limitations. As the space in the abdomen cavity or the thoracic cavity is limited, traditional linear endoscope staplers cannot effectively reach the surgical site to clamp, transect and staple tissue under certain extreme conditions, and thus endoscope staplers provided with bendable actuators are created.

The Endo GIA Universal stapler and magazine of American Tyco Healthcare Company (later renamed as Covidien) are typical products with the above function. The product of the patent application No. US2010/0237131A1 to America adopts a hinge-eccentric rigid connecting rod hinge structure to achieve deflection of an actuator. Limited by the structural design principle, the maximum bending angle of the actuator of the magazine is only 45° . In the surgery requiring an actuator to bend by a large angle, focuses on certain parts cannot be removed through the actuator capable of bending by a small angle. For instance, in low rectal rectectomy, as the entry angle of an instrument is limited by the space of the pelvic cavity, although the actuator of the magazine bends, the actuator still cannot suture or dissect tissue perpendicular to the rectum in part of surgery, and consequentially, patents with tumors at low positions cannot be treated through the instrument.

Thus, in this field, a surgical instrument provided with an actuator capable of bending by a larger angle is needed to adapt to medical treatment under more complex clinic conditions.

BRIEF SUMMARY OF THE INVENTION

For this reason, the invention aims to provide a surgical instrument. The surgical instrument comprises an actuator, an extension tube and a controller, wherein the near end of the extension tube is connected with the controller, the far end of the extension tube is connected with the actuator, and the actuator is capable of rotating relative to the far end of the extension tube; the controller comprises a bend control mechanism capable of moving in at least one direction; and the extension tube comprises a first flexible component and moves in at least one direction through the bend control mechanism, and the first flexible component enables the actuator to rotate towards at least one side relative to the far end of the extension tube.

According to one aspect, the extension tube further comprises a second flexible component, and the far end of the first flexible component and the far end of the second flexible component are respectively connected to the two sides of the central axis of the actuator. When moving in a first direction, the bend control mechanism drives the first flexible component to move towards the near end of the bend control mechanism and drives the second flexible component to move towards the far end of the bend control mechanism, and then the actuator is driven to rotate towards a first side relative to the far end of the extension tube. When moving in a second direction, the bend control mechanism drives the first flexible component to move towards the far end of the bend control mechanism and drives the second flexible component to move towards the near end of the bend control mechanism, and then the actuator is driven to rotate toward a second side relative to the far end of the extension tube.

According to one aspect, the bend control mechanism comprises a gear, a first rack and a second rack. The gear is engaged with the first rack and the second rack. The first rack is connected with the near end of the first flexible component, and the second rack is connected with the near end of the second flexible component.

According to one aspect, the extension tube further comprises a magazine sleeve, magazine inner tubes, a bend control rod, a gear, a first rack and a second rack, wherein the magazine inner tubes and the magazine sleeve are arranged coaxially; the gear is rotatably arranged on the magazine inner tubes, the first rack and the second rack are arranged on the two sides of the gear, and the gear is engaged with the first rack and the second rack; and the bend control rod is arranged in the magazine sleeve, the near end of the bend control rod is connected with the bend control mechanism, the far end of the bend control rod is fixedly connected with the first rack, the first rack is further fixedly connected with the near end of the first flexible component, and the second rack is fixedly connected with the near end of the second flexible component. The bend control mechanism controls movement of the bend control rod: when moving towards the near end of the bend control mechanism, the bend control rod pulls the first rack and then pulls the first flexible component, and the actuator is pulled by the first flexible pulling piece to rotate towards a first side relative to the far end of the extension tube; and when moving towards the far end of the bend control mechanism, the bend control rod pushes the first rack and then drives the second rack to move towards the near end through the gear so as to pull the second flexible component, and the actuator is pulled by the second flexible pulling piece to rotate towards a second side relative to the far end of the extension tube.

According to one aspect, the magazine inner tubes include a first magazine inner tube and a second magazine inner tube, the first magazine inner tube and the second magazine inner tube are coaxial with the magazine sleeve, and the gear is rotatably arranged on the first magazine inner tube or the second magazine inner tube.

According to one aspect, the actuator comprises an anvil assembly and a cartridge assembly, wherein the cartridge assembly comprises a cartridge, one or more suturing staples, one or more staple pushing blocks, and a cartridge holder. The surgical instrument further comprises a driving assembly. The driving assembly comprises a cutter and a flexible cutter bar. The near end of the anvil assembly is movably connected with the near end of the cartridge holder. The driving assembly drives the actuator to switch to in a first state or a second state.

According to one aspect, the rotation angle of the actuator towards at least one side relative to the far end of the extension tube is any numerical value from 0° to 180° .

According to one aspect, the far end of the extension tube is connected with the actuator through one or more hinges, the first flexible pulling piece does not pass through the center of the hinge so that at least one flexible pulling piece can provide rotation torque for the actuator with the hinge as the rotation axis, and the actuator is driven to rotate towards at least one side relative to the far end of the extension tube.

The invention further provides a bendable magazine. The bendable magazine comprises a magazine body, an intermediate connecting part and an actuator connected with the magazine body through the intermediate connecting part, wherein the magazine body comprises a bend control mechanism and at least one flexible component; and the bend control mechanism is capable of moving in at least one direction, and then at least one flexible component enables the actuator to rotate towards at least one side relative to the magazine body.

According to one aspect, the magazine is applicable to an endoscope stapler.

According to one aspect, the magazine further comprises a second flexible component, and the far end of the first flexible component and the far end of the second flexible component are respectively connected to the two sides of the central axis of the actuator. When moving in a first direction, the bend control mechanism drives the first flexible component to move towards the near end of the bend control mechanism and drives the second flexible component to move towards the far end of the bend control mechanism, and then the actuator is driven to rotate towards a first side relative to the far end of the magazine body; and when moving in a second direction, the bend control mechanism drives the first flexible component to move towards the far end of the bend control mechanism and drives the second flexible component to move towards the near end of the bend control mechanism, and then the actuator is driven to rotate toward a second side relative to the far end of the magazine body.

According to one aspect, the bend control mechanism of the magazine comprises a gear, a first rack and a second rack. The gear is engaged with the first rack and the second rack. The first rack is connected with the near end of the first flexible component, and the second rack is connected with the near end of the second flexible component.

According to one aspect, the magazine body further comprises a magazine sleeve, magazine inner tubes, a bend control rod, a gear, a first rack and a second rack, wherein the magazine inner tubes and the magazine sleeve are arranged coaxially, the gear is rotatably arranged on the magazine inner tubes, the first rack and the second rack are arranged on the two sides of the gear, and the gear is engaged with the first rack and the second rack; the bend control rod is arranged in the magazine sleeve, the near end of the bend control rod is connected with the bend control mechanism, the far end of the bend control rod is fixedly connected with the first rack, the first rack is further fixedly connected with the near end of the first flexible component, and the second rack is further fixedly connected with the near end of the second flexible component. The bend control mechanism controls movement of the bend control rod: when moving towards the near end of the bend control mechanism, the bend control rod pulls the first rack and then pulls the first flexible component, and the actuator is pulled by the first flexible pulling piece to rotate towards a first side relative to the far end of the magazine body; and when moving towards the far end of the bend control mechanism, the bend control rod pushes the first rack and then drives the second rack to move towards the near end through the gear so as to pull the second flexible component, and the actuator is pulled by the second flexible pulling piece to rotate toward a second side relative to the far end of the magazine body.

According to one aspect, the magazine inner tubes include a first magazine inner tube and a second magazine inner tube. The first magazine inner tube and the second magazine inner tube are coaxial with the magazine sleeve. The gear is rotatably arranged on the first magazine inner tube or the second magazine inner tube.

According to one aspect, the rotation angle of the actuator towards at least one side relative to the far end of the magazine body is any numerical value from 0° to 180° .

According to the surgical instrument of the invention, the flexible components are adopted to enable the actuator to bend relative to the far end of the extension tube, and thus the actuator is capable of bending by a larger angle to adapt to medical treatment under more complex clinic conditions. For instance, surgery can be performed on parts with limited spaces (such as the thoracic cavity and the pelvic cavity) more conveniently, and thus the problems which cannot be solved by other surgical instruments are solved. The surgical instrument provided with the actuator capable of bending by a large angle of the invention can achieve focus excision, tissue incision and suturing at various inaccessible positions and thus is beneficial to more patients. For instance, for patient suffering from rectal cancer, the actuator of the surgical instrument is still capable of rotating to be perpendicular to the rectum when located at the lowermost position of the rectum, and thus more patients suffering from low rectal cancer can receive minimally invasive surgery.

Furthermore, the surgical instrument of the invention not only can be applied to surgery, but also can be applied to relevant treatment and diagnosis.

Furthermore, invention not only can be applied to endoscope staplers, but also can be applied to closers, electric scalpels and other products.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments are described in detail with the accompanying drawings. If possible, identical reference signs are used for indicating identical or similar parts in the drawings. Specific embodiments and effects realized are used only for illustration and do not limit the scope of the invention or the claims.

The expression ‘illustrative’ in the description refers to ‘being used as demonstrations or examples or for illustration’. Any ‘illustrative’ realization in the description is not definitely interpreted as being superior to or better than other realizations.

For a brief description, the instrument of the invention is explained with a stapler as an example. Those skilled in the field understand that the surgical instrument provided with the bendable actuator of the invention is not limited to endoscope staplers.

The technique of the invention can also be applied to other products such as closers and electric scalpels.

FIG. 1is a design diagram of a surgical instrument in one embodiment of the invention. As is shown inFIG. 1, the surgical instrument comprises an actuator100, an extension tube200and a controller300. The extension tube200is movably connected with the far end of the controller300and connected with the near end of the actuator100. The extension tube200forms a connecting passage and is used for transmitting the motion of the controller300to the actuator100. The controller300is used for controlling operation of the instrument.

The surgical instrument of the invention can adopt an integrated design, namely, as a whole, the extension tube200is connected with the far end of the controller300and the near end of the actuator100. The length of the extension tube200can be changed according to different indications and specific conditions of patients.

As is shown inFIG. 1, the surgical instrument of the invention can also adopt a separated design. In the embodiment shown byFIG. 1, the surgical instrument adopting the separated design can comprise a stapler400and a magazine500. In use, the stapler400and the magazine500can be assembled into a whole in a certain assembly manner. In the separated design, one stapler can be matched with various types of magazines in surgery.

As is shown inFIG. 1andFIG. 3, the controller300can comprise a bend control mechanism312. For instance, the bend control mechanism312can move in a first direction and in a second direction. As an example, the bend control mechanism312can be a gear reversing mechanism. The bend control mechanism312can comprise a gear512, a first rack510aand a second rack510b.It is understandable that the gear512, the first rack510aand the second rack510bcan also be disposed in the extension tube. A handle component can be used as the controller300. In this case, the controller300can further comprise a bend control spanner313, a fixed handle314, a movable handle316(such as a percussion trigger) oppositely and movably connected with the fixed handle, and a transmission mechanism capable of transmitting the motion of the movable handle316to the actuator. For instance, in operation, the bend control spanner313can be rotated to control the actuator100to rotate by a certain angle at the far end of the extension tube200and on the plane perpendicular to the hinge rotation axis. Every time the bend control spanner rotates to a specific position, the actuator100correspondingly rotates by a certain specific angle. The actuator100can rotate by different angles to adapt to different clinical applications. The percussion trigger is pulled, and then the actuator can continuously clamp, suture and cut human tissue. The function of rotating the bend control spanner to rotate the actuator and the function of operating the percussion trigger to drive the actuator to work are mutually independent. Generally, the operating process of the surgical instrument of the invention is as follows: the bend control spanner is operated first to control the actuator to rotate to an angle suitable for a clinical application, the position of tissue in the jaw of the actuator is then adjusted, and afterwards, the percussion trigger is operated to achieve tissue clamping, suturing and incision.

A detailed description is given as follows with the endoscope stapler adopting the separated design as an example.

FIG. 2andFIG. 3respectively show the overall diagram and the exploded view of the magazine in the surgical instrument in one embodiment of the invention.

In one embodiment of the invention, a bendable magazine500is provided. As an example, the magazine500can comprise a magazine body501, an intermediate connecting part502, an actuator100and a driving assembly160.

As an example, the magazine body501can mainly comprise a magazine sleeve504, a first magazine inner tube506a,a second magazine inner tube506b,a bend control rod508, a first rack510a,a second rack510b,a gear512, a first flexible pulling piece514a,a second flexible pulling piece514b,a first connecting piece516a,a second connecting piece516b,and the like. In the embodiment, the first magazine inner tube506a,the second magazine inner tube506band the magazine sleeve504are arranged coaxially. The gear512is rotatably arranged on the first magazine inner tube506aor the second magazine inner tube506b.Although the FIGs show that multiple magazine inner tubes such as the first magazine inner tube506aand the second magazine inner tube506bare adopted, it is understandable that in certain other embodiments, an integrated magazine inner tube is also available.

The intermediate connecting part502can comprise intermediate connectors518(two intermediate connectors are shown inFIG. 3) and a rivet b520.

The actuator100can comprise an anvil assembly120and a cartridge assembly140and can further comprise an anvil connector180, a gland182and a rivet a184. The anvil assembly120can comprise a staple forming face with a plurality of rows of staple forming slots. The cartridge assembly140can comprise a cartridge142, one or more suturing staples144, one or more staple pushing blocks146and a cartridge holder148. The upper surface of the cartridge142is a tissue contact surface, and the cartridge142is mounted in the cartridge holder148. The near end of the anvil assembly120is movably connected with the near end of the cartridge holder148of the cartridge assembly140, and the anvil assembly120can be switched to be in an open state or a closed state. The driving assembly160is connected with the transmission mechanism and used for, for instance, converting the motion of the percussion trigger into the closing, percussion or opening motion of the actuator100. Generally, the anvil assembly120and the cartridge holder148can respectively comprise a longitudinal groove149aand a longitudinal groove149b,and the longitudinal grooves149a,149ballow the driving assembly160to pass through. When the driving assembly160moves towards the far end of the actuator100through the longitudinal groove149aor the longitudinal groove149b,the anvil assembly120and the cartridge assembly140can be driven to switch to a second state (for instance, the closed state) from a first state (for instance, the open state), a staple pushing slider162and the staple pushing block146are driven to eject the suturing staple144out, the suturing staple144is then formed in one staple forming slot in the staple forming surface of the anvil assembly120, and vice versa. Thus, the actuator is driven by the driving assembly to switch to the first state or the second state.

Generally, the driving assembly160can comprise a slider162, a cutter164and a flexible cutter bar166. The cutter164is used for incising tissue between a plurality of rows of staple lines after the tissue is sutured by the suturing staple144.

The magazine body501, the intermediate connector518and the actuator100can be connected through one or more rotary hinges such as a hinge552aand a hinge552b.As an example, the two hinges552a,552bare spatially in parallel and perpendicular to the bendable plane of the actuator.

According to one example of the invention, the first magazine inner tube506aand the second magazine inner tube506bare coaxial with the magazine sleeve504. The bend control rod508is arranged between the first magazine inner tube506aand the second magazine inner tube506band fixedly connected with the first rack510a.The first rack510aand the second rack510bare respectively arranged on the two sides of the first magazine inner tube506aand are in engaged transmission through the gear512disposed on the rotation axis of the first magazine inner tube506a.The first rack510ais fixedly connected with the near end of the first flexible pulling piece514a.The second rack510bis fixedly connected with the near end of the second flexible pulling piece514b.The first flexible pulling piece514aand the second flexible pulling piece514bpenetrate through the intermediate connector518to be respectively connected to the left side and the right side of the central axis of the actuator100.

According to one example of the invention, the flexible cutter bar166of the driving assembly160is arranged inside the magazine body501and penetrates through the intermediate connector518. The cutter164and the slider162are arranged in the actuator100.

When the magazine500is mounted on the stapler400, the bend control rod508on the magazine500can be controlled to advance or retreat through the bend control mechanism312on the stapler400.

FIG. 4andFIG. 5respectively show a diagram and a local view A of the actuator, in a linear state, of the magazine in the surgical instrument in one embodiment of the invention.

As is shown inFIG. 4, according to one embodiment of the invention, the central axis of the actuator100is collinear with the central axis of the connecting mechanism (such as the magazine body or the extension tube). In this embodiment, the two flexible pulling pieces514a,514bare fixedly mounted on the rivet a184of the actuator100. Through the design, the joints of the flexible pulling pieces514a,514band the actuator deviate from the central symmetry plane where the rotation axes of the two hinges522a,522bare located, and the flexible pulling pieces514a,514bdo not pass through the center of the hinges. Thus, with the hinges as the rotation axes, the flexible pulling pieces provide certain rotation torque for the actuator to drive the actuator to rotate.

FIG. 6andFIG. 7respectively show a diagram and a local view of the actuator, bending towards a first side, of the magazine in the surgical instrument in one embodiment of the invention.

As is shown in the FIGs, when pulled, the bend control rod508pulls the first rack510ato move towards the near end of the magazine500(as indicated by the arrow), and then the first rack510apulls the first flexible pulling piece514a.At the moment, the first rack510adrives the gear512to rotate, the second rack510bis then driven to move towards the far end of the magazine500(as indicated by the arrow), and the second flexible pulling piece514bis released. In this way, the actuator100of the magazine is bent toward the first side (for instance, in the anticlockwise direction shown in the FIGs). The rotation angle of the actuator100relative to the magazine body501is α. By controlling the feed amount of the bend control rod508through the bend control mechanism312on the stapler400, the rotation angle α of the actuator100can be controlled. According to one embodiment of the invention, α can be any numerical value from 0° to 180° (such as 0°, 30°, 45°, 60°, 90°, 120°, 135° and 180°).

As can be seen from the FIGs, the first flexible pulling piece is tensioned, the second flexible pulling piece is released, and thus the actuator is driven to bend. In this embodiment, the gear is engaged with the two racks, and the two racks move in opposite directions, so that when the actuator rotates, the displacement generated by the first tensioned flexible pulling piece and the displacement generated by the second released flexible pulling piece are equal and thus counteracted. In the design of the invention, the opposite displacements of the two flexible pulling pieces can also be counteracted through other methods.

FIG. 8shows a diagram of the actuator, bending towards a second side, of the magazine in the surgical instrument in one embodiment of the invention.

As is shown in the FIG, when pushed, the bend control rod508pushes the first rack510to move towards the far end of the magazine500(as indicated by the arrow), and the first flexible pulling piece514ais released. The first rack510adrives the gear512to rotate, the second rack510bis then driven to move towards the near end of the magazine500(as indicated by the arrow), the second rack510bpulls the second flexible pulling piece514bto make the actuator100of the magazine bend towards the second side (for instance, in the clockwise direction shown in the FIG), and the rotation angle is β. By controlling the feed amount of the bend control rod508through the bend control mechanism312on the stapler400, the rotation angle β of the actuator can be controlled. According to one embodiment of the invention, β can be any numerical value from 0° to 180° (such as 0°, 30°, 45°, 60°, 90°, 120°, 135° and 180°).

The principle for the actuator to bend towards the second side is similar to the principle for the actuator to bend towards the first side and is different in that the second flexible pulling piece is tensioned and the first flexible pulling piece is released.

FIG. 9shows a usage diagram of the surgical instrument in one embodiment of the invention.

The surgical instrument of the invention can be applied to pulmonary surgery and digestive tract (comprising stomach and intestine) surgery. The pulmonary surgery is generally for focus excision. As for the digestive tract surgery, intestinal canals generally need to be reconnected after focus excision.

Generally, the actuator of the magazine of the bendable endoscope stapler can bend, the near end of the actuator is connected with the bend control mechanism in the controller (such as a stapler handle) through an intermediate mechanism (such as the bend control rod508in the FIGs), and the bend control mechanism can be adjusted to control the actuator to bend by multiple angles. In the initial state, the central axis of the actuator is collinear with the central axis of the connecting mechanism, the actuator of the stapler stretches into the pleural cavity or the abdominal cavity through a trocar, the actuator is controlled to bend by a certain angle through extracorporeal control over the bend control mechanism on the handle, and a series of operations such as clamping, transecting and suturing are performed on the surgical site. After the surgery is completed, the actuator is controlled to be in the linear state again through extracorporeal control over the bend control mechanism on the handle and then is pulled out of the body.

For instance, as for the digestive tract surgery, to completely remove a tumor and prevent tumor tissue residues in clinic, the transection line is generally about 5 cm away from the boundary of the tumor. When a rectal cancer tumor is close to the lower portion of the anus of the patient, the actuator of the stapler needs to stretch to a lower position in the narrow pelvic cavity; however, as the entry position of the stapler is limited by the hip bone, of actuator of a stapler with a small bending angle cannot perpendicularly transect the rectum, and consequentially, the surgical risk of incomplete tumor excision is increased.

As can be seen from the FIG, a surgical instrument (with a section line) comprising an actuator with a small bending angle cannot perpendicularly transect the rectum, but a stapler (without a section line) comprising an actuator with a large bending angle can perpendicularly transect the rectum. Moreover, a surgical instrument comprising an actuator with a larger bending angle can transect a tumor (tumor2) at a lower position. When the rotation angle of the actuator of the surgical instrument is further increased, a tumor at a lower position can be incised, and thus the surgical instrument can be well applied to low rectal cancer surgery or other conditions with the in-vivo space limited.

According to the surgical instrument of the invention, the rotation angle of the actuator can reach 90° or even 180° to adapt to extreme applications.

According to another embodiment of the invention, the flexible pulling pieces512a,512bcan be replaced with wire ropes, such as single-strand wires, multi-strand intertwined wires or other flexible components. It should be understood that the flexible pulling pieces and the wire ropes are only for illustrative description and are not used for limiting the invention, and those skilled in the field can think out more other similar flexible components to realize bending of the actuator. These realization modes are also within the scope of the invention.

In addition, it also should be understood that all the embodiments described above can also be realized in surgical instruments such as integrally-designed endoscope staplers. Moreover, all the embodiments can also be realized in other products such closers and electric scalpels.

According to the surgical instrument of the invention, the flexible components are adopted to realize bending of the actuator relative to the far end of the extension tube so that the actuator can bend by a larger angle to adapt to medical treatment under more complex clinic conditions. For instance, surgery can be performed in parts with limited spaces (such as the thoracic cavity and the pelvic cavity) more conveniently, and thus the problems which cannot be solved by other surgical instruments are solved. The surgical instrument provided with the actuator capable of being by a large angle of the invention can achieve focus excision, tissue dissecting and suturing at various unaccessible positions and thus is beneficial to more patients.

The above description and drawings are provided only for illustrative description. Any quotation about the singular forms of elements in the claims, such as the article ‘one’, ‘certain’ or ‘said’, should not be interpreted as the singular number of the elements. For each specific application, those skilled in the field can describe the structure in difference mode, and all these realization modes should fall within the scope of the invention.

Anyone skilled in the field can manufacture or use the invention based on the description before the embodiments disclosed. Various modifications of these embodiments can be easily obtained by those skilled in the field, and the general principle defined in the description can be applied to other embodiments without deviating from the spirit or scope of the invention. Thus, the invention is not limited to the embodiments given in the description, but should be granted the widest scope in accordance with the principle and novelties disclosed in the claims and the description.