Patent Application
20190262068
The present disclosure relates to a medical bipolar high-frequency electrotome (electric knife), particularly a bipolar high-frequency electrotome with a smallest loop and an insulation protection function.
Endoscopic submucosal dissection (ESD) refers to an endoscopic minimally invasive technology for submucosal dissection of a lesion of greater than 2 cm by using a high-frequency instrument. Compared with conventional surgical operations, on the basis of effecting a radical cure of tumors, ESD well retains physiological functions of gastrointestinal tract, significantly improves patients' postoperative quality of life, and currently has become a preferred treatment method for early cancers and precancerous lesions of gastrointestinal tract including esophagus (Gotoda T, Kondo H, Ono H, et al. A new endoscopic mucosal resection procedure using an Insulation-tipped electrosurgical knife for rectal flat lesions: report of two cases[J]. Gastrointest Endosco, 1999, 50:560-563).
For ESD, a high-frequency current is output by an external device to form a loop by a human body, and a high-density current is formed at a knife wire portion with a relatively small sectional area to realize cutting. Currently, high-frequency knives for endoscopic submucosal dissection may be classified into two types according to manners in which currents thereof form the loops. One is monopolar high-frequency electrotome, and the other is bipolar high-frequency electrotome. The monopolar high-frequency electrotome has a shortcoming that the high-frequency current will pass through most area of the human body. The high-frequency current of the bipolar high-frequency electrotome, however, merely flows through a minimum area of the human tissues, that is, merely flows around lesion tissues. Since the high-frequency current passes through a small area of the human body, and will not injure muscularis mucosae, the bipolar high-frequency electrotome is considered as a safest high-frequency electrotome. However, in order to ensure that the high-frequency current can successfully reach lesions tissues to be treated via a conducting wire, sufficient contact of an active electrode and an inert electrode with human tissue parts has to be ensured, but current product designs of the bipolar high-frequency electrotome can hardly ensure that the active electrode and the inert electrode are simultaneously in contact with the tissues during a surgical process, particularly at some parts of natural orifices of the human body where it is difficult to perform an operation, formation of a current loop can hardly be ensured, thus resulting in a unreliable and unstable cutting, which directly adversely affecting operation efficiency and patients' safety. Therefore, it is necessary to develop a bipolar high-frequency electrotome which is more reliable and stable in cutting, with insulation protection for a cutter head, and higher safety performance.
An object of the present disclosure is to provide a bipolar high-frequency electrotome for cutting and dissection in treatment of gastrointestinal tract early cancers and precancerous lesions, which is provided with a minimum stable loop and an insulation protection head, to ensure reliability and safety of surgical cutting.
The present disclosure provides a bipolar high-frequency electrotome, comprising a cutter portion, a main body part, and an operation portion.
The cutter portion, provided at a distal end of the bipolar high-frequency electrotome, comprises a first electrode portion, a second electrode portion, and an insulation member; wherein the first electrode portion is an active electrode for tissue cutting, can be pushed out or taken back with respect to a front end of the main body part, and comprises a tubular portion and a bulge; the second electrode portion is an inert electrode, and comprises a rod-shape portion and a protruding portion which is located at a distal end of the rod-shape portion; the protruding portion of the second electrode portion is located at a distal end of the first electrode portion; a rod-shape portion of the second electrode portion is inserted into the first electrode portion; and the insulation member is configured to insulate the first electrode portion from the second electrode portion.
The main body part comprises an insulation sheath and a position-limiting part. The insulation sheath is insulative at least on an outer circumferential face, and runs between the cutter portion and the operation portion; the position-limiting part is located inside the insulation sheath, and comprises a fixed insulation part for position-limiting and a movable part for position-limiting.
The operation portion is provided at a proximal end side of the main body part, has a first conducting wire connected with the first electrode portion, and has a second conducting wire connected with the second electrode portion, and can enable the cutter portion to be pushed out or taken back with respect to the front end of the main body part.
Preferably, an extent to which the distal end of the first electrode portion extends outwards in a direction perpendicular to an axis of the main body part is greater than a radius of a cross section of the tubular portion of the first electrode portion, forming a bulge at the distal end of the first electrode portion.
Preferably, a cross section of the bulge is circular or polygonal. Preferably, an extent to which the protruding portion of the second electrode portion extends outwards in a direction perpendicular to an axis of the rod-shape portion of the second electrode portion is greater than a radius of the rod-shape portion of the second electrode portion, a surface of the protruding portion of the second electrode portion is a smooth surface without sharp edges, and the protruding portion of the second electrode portion is located at the distal end of the first electrode portion.
Preferably, the insulation member comprises an insulation part and an insulation sleeve. The insulation part is located between the first electrode portion and the protruding portion of the second electrode portion, for insulating the first electrode portion from the protruding portion of the second electrode portion; the insulation sleeve wraps an outer surface of the rod-shape portion of the second electrode portion, and the first electrode portion wraps an outer surface of the insulation sleeve, the rod-shape portion of the second electrode portion, the insulation sleeve and the first electrode portion form a concentric structure.
Preferably, the insulation part is embedded in the protruding portion of the second electrode portion or is flush with an end face of the protruding portion of the second electrode portion, and the first electrode portion is embedded in the insulation part.
Preferably, the position-limiting part comprises a fixed insulation part for position-limiting fixed at a distal end of the insulation sheath, and a movable part for position-limiting provided at a proximal end of the first electrode portion, an extent to which the movable part for position-limiting extends outwards in a direction perpendicular to the axis of the main body part is smaller than an extent to which the fixed insulation part for position-limiting extends outwards in the direction perpendicular to the axis of the main body part, and the fixed insulation part for position-limiting has a distal-end end face beyond or at least flush with a distal-end end face of the insulation sheath, and has a proximal-end end face inserted into the insulation sheath.
Preferably, an outer surface of the fixed insulation part for position-limiting is roughened or barbed.
Preferably, the operation portion further comprises a handle, a button is provided on the handle, and the button on the handle can linearly slide along an axis of the handle, realizing actions of push-out and take-back of the cutter portion by pushing forward or pulling backward the button.
The present disclosure further provides a bipolar cutter head of a high-frequency electrotome, comprising:
a first electrode portion, a second electrode portion, and an insulation member. The first electrode portion is an active electrode for tissue cutting, can be pushed out or taken back with respect to a front end of a main body part, and comprises a tubular portion and a bulge; the second electrode portion is an inert electrode, and comprises a rod-shape portion and a protruding portion which is located at a distal end of the rod-shape portion; the protruding portion of the second electrode portion is located at a distal end of the first electrode portion; the rod-shape portion of the second electrode portion is inserted into the first electrode portion, an extent to which the protruding portion of the second electrode portion extends outwards in a direction perpendicular to an axis of the rod-shape portion of the second electrode portion is greater than a radius of the rod-shape portion of the second electrode portion, and a surface of the protruding portion of the second electrode portion is a smooth surface without sharp edges; and the insulation member is configured to insulate the first electrode portion from the second electrode portion.
Preferably, an extent to which the distal end of the first electrode portion extends outwards in a direction perpendicular to an axis of the main body part is greater than a radius of a cross section of the tubular portion of the first electrode portion, forming a bulge at the distal end of the first electrode portion.
Preferably, a cross section of the bulge is circular or polygonal.
Preferably, the insulation member comprises an insulation part and an insulation sleeve. The insulation part is located between the first electrode portion and the protruding portion of the second electrode portion, for insulating the first electrode portion from the protruding portion of the second electrode portion; the insulation sleeve wraps an outer surface of the rod-shape portion of the second electrode portion, and the first electrode portion wraps an outer surface of the insulation sleeve, the rod-shape portion of the second electrode portion, the insulation sleeve and the first electrode portion form a concentric structure.
Preferably, the protruding portion of the second electrode portion is located at the distal end of the first electrode portion.
Preferably, the insulation part is embedded in the protruding portion of the second electrode portion or is flush with an end face of the protruding portion of the second electrode portion, and the first electrode portion is embedded in the insulation part.
Beneficial Effects:
With respect to the existing bipolar electrotomes, the bipolar high-frequency electrotome provided in the present disclosure has a smaller current loop with two electrodes, and has insulation protection for a head end, thus enabling a safer operation.
With respect to the existing bipolar electrotomes, for the bipolar high-frequency electrotome provided in the present disclosure, with the inert electrode provided in front, and the active electrode provided behind, when the electrotome gets into, under guidance of an endoscope, a gastrointestinal lesion from a natural orifice (an oral cavity, an anal cavity) of the human body, the both electrodes can be ensured to contact the tissues at any angle or in any direction, so as to form a current loop for tissue cutting, ensuring reliability of the surgical cutting, and enabling the operation to be safer.
For the bipolar high-frequency electrotome provided in the present disclosure, an insulation protection layer is provided between the active electrode and the inert electrode, which can prevent perforation of a basal layer of tissues caused by high-frequency electric shock during cutting.
For the bipolar high-frequency electrotome provided in the present disclosure, a section area of the inert electrode is greater than a section area of the active electrode, and providing the inert electrode is at the distal end, can serve a protective function of preventing perforation and bleeding during cutting.
For the bipolar high-frequency electrotome provided in the present disclosure, during cutting the bulge formed at a portion of the distal end of the active electrode in contact with the insulation part can lift up tissues swelling up after liquid injection, such that the tissues are away from muscularis mucosae to prevent perforation, meanwhile, the bulge can cut the tissues when the cutter portion moves longitudinally.
1. second electrode portion, 1a. rod-shape portion, 1b. protruding portion, 2. insulation part, 3. first electrode portion, 4. insulation sleeve, 5. position-limiting part, 6. insulation sheath, 7. handle, 8. button, 9. socket, 10a. first conducting wire, 10b. second conducting wire, 11. insulation member, 12. fixed insulation part for position-limiting, 13. movable part for position-limiting, 16. lesion tissue, 17. muscularis mucosae, 18. tubular portion, 19. bulge, 21. cutter portion, 22. main body part, 23. operation portion, 31. first electrode, 32. second electrode, 33. insulation portion
In order to make the object, technical solutions, and advantages of the present disclosure more clear and understandable, the present disclosure is further described in detail below in combination with accompanying drawings and embodiments. It should be understood that the embodiments described herein are merely used to explain the present disclosure rather than limiting the present disclosure.
The present disclosure is further described below in combination with the accompanying drawings and the embodiments, but the present disclosure absolutely is not limited to the following embodiments.
As shown in
Hereinafter, an end of the cutter portion 21 is referred to as a distal end, and an end of the operation portion 23 is referred to as a proximal end.
As shown in
The first electrode portion 3 is an active electrode for tissue cutting, and can be pushed out or taken back with respect to the front end of the main body part 22. The first electrode portion comprises a tubular portion 18 and a bulge 19. The second electrode portion 1 is an inert electrode, and comprises a rod-shape portion 1a and a protruding portion 1b which is located at a distal end of the rod-shape portion 1a. The protruding portion 1b of the second electrode is located at a distal end of the first electrode portion 3, and an extent to which the protruding portion 1b of the second electrode portion 1 extends outwards in a direction perpendicular to an axis of the rod-shape portion 1a of the second electrode portion 1 is greater than a radius of the rod-shape portion 1a of the second electrode portion 1. A surface of the protruding portion 1b of the second electrode portion 1 is a smooth surface without sharp edges. A cross section diameter of the protruding portion is greater than a cross section diameter of the first electrode portion 3. The rod-shape portion 1a of the second electrode portion is inserted into the first electrode portion 3 and is in communication with the operation portion 23. The insulation member 11 is configured to insulate the first electrode portion 3 from the second electrode portion 1, ensuring that the active electrode and the inert electrode are simultaneously in contact with tissues during a surgical process, and the insulation member comprises an insulation part 2 and an insulation sleeve 4. The insulation part 2 is located between the first electrode portion 3 and the protruding portion 1b of the second electrode portion 1, for insulating the first electrode portion 3 from the protruding portion 1b of the second electrode portion 1. The insulation sleeve 4 wraps an outer surface of the rod-shape portion of the second electrode portion, and the first electrode portion wraps an outer surface of the insulation sleeve 4, the rod-shape portion of the second electrode portion, the insulation sleeve and the first electrode portion form a concentric structure.
The insulation member 11 is of an insulation material, and is preferably made of a thermal resistant material such as a ceramic material.
Insulating the first electrode portion from the second electrode portion using the insulation material prevents failure of the electrotome after the first electrode and the second electrode are in direct conductive connection. With the inactive second electrode portion provided in front, and the active first electrode portion provided behind, when the electrotome gets into, under guidance of an endoscope, a gastrointestinal lesion from a natural orifice (an oral cavity, an anal cavity) of the human body, the both electrode portions can be ensured to contact the tissues at any angle or in any direction, so as to form a current loop for tissue cutting, ensuring reliability of the surgical cutting, and enabling a safer operation.
The main body part 22 comprises an insulation sheath 6 and a position-limiting part 5. The insulation sheath has an outer diameter and flexibility enabling insertion of the insulation sheath through a channel of the endoscope, and is insulative at least on an outer circumferential face and can be resistant to high temperature, and the insulation sheath runs between the cutter portion and the operation portion. The position-limiting part 5 is located inside the insulation sheath 6, for defining a push-out amount of the first electrode portion being pushed out from a distal end of the insulation sheath; the position-limiting part functions of positionally limiting and protecting the cutter portion 21 when taken back into the insulation sheath. When the cutter portion is pushed out, the first electrode portion 3 performs cutting, and when the cutter portion is taken back, the cutter head returns back into the insulation sheath 6, to be positionally limited and protected by the position-limiting part 5.
The position-limiting part 5 comprises a fixed insulation part for position-limiting 12 fixed at the distal end of the insulation sheath, and a movable part for position-limiting 13 provided at a proximal end of the first electrode portion 3. The movable part for position-limiting 13 and the fixed insulation part for position-limiting 12 perform the position limiting by means of steps formed due to different sizes, so as to control an extension amount of the first electrode portion.
The position-limiting part 5 comprises the fixed insulation part for position-limiting 12 fixed at the distal end of the insulation sheath, and the movable part for position-limiting 13 provided at the proximal end of the first electrode portion. An extent to which the movable part for position-limiting 13 extends outwards in a direction perpendicular to the axis of the main body part is smaller than an extent to which the fixed insulation part for position-limiting 12 extends outwards in a direction perpendicular to the axis of the main body part. The fixed insulation part for position-limiting 12 has a distal-end end face beyond or at least flush with a distal-end end face of the insulation sheath, and a proximal-end end face inserted into the insulation sheath. The movable part for position-limiting 13 is a metal part, and is fixed to a fixed point of the first electrode portion 3. The fixed insulation part for position-limiting 12 is fixed at the distal end of the insulation sheath, and the fixed insulation part for position-limiting 12 is made of an insulation material resistant to high temperature, preferably made of a thermal resistant material such as the ceramic material. A surface of the fixed insulation part for position-limiting 12 is roughened or barbed to increase a frictional force with the insulation sheath 6.
When a button 8 on the operation portion 23 is pushed, the first electrode portion 3 and the movable part for position-limiting 13 are driven to extend together towards the distal end. When the distal-end end face of the movable part for position-limiting 13 comes into contact with the proximal-end end face of the fixed insulation part for position-limiting 12, the movable part for position-limiting cannot continue to extend towards the distal end due to a size difference therebetween, thus a position-limiting function is achieved. When the button 8 on the operation portion 23 is pulled back, the cutter portion 21 is driven to get back into the insulation sheath 6. When the insulation part 2 in the cutter portion 21 comes into contact with a side face of the fixed insulation part for position-limiting 12, the steps formed due to the size difference prevent the cutter portion 21 from continuing to return, thus a position-limiting function is effected, meanwhile, the fixed insulation part for position-limiting 12 is of an insulation material, which well protects insulativity of other parts of the whole electrotome except the active electrode.
As shown in
As shown in
An operation process for the bipolar high-frequency electrotome is illustrated with
In a surgical process, a surgeon firstly marks around the lesion tissues 16 by a needle-shape knife (as shown in
The above-mentioned are merely preferred embodiments of the present disclosure, such that a person skilled in the art can understand or implement the invention of the present disclosure. Various modifications and combinations to these embodiments are apparent to a person skilled in the art, and general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure will not be limited to these embodiments shown in the text, but should conform to the broadest scope consistent to the principle and novel features disclosed herein.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201610533233.7 | Jul 2016 | CN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CN2016/092846 | 8/2/2016 | WO | 00 |
