CN106913377B - High frequency surgical cutting ring for flexible endoscopy - Google Patents
High frequency surgical cutting ring for flexible endoscopy Download PDFInfo
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- CN106913377B CN106913377B CN201511036266.2A CN201511036266A CN106913377B CN 106913377 B CN106913377 B CN 106913377B CN 201511036266 A CN201511036266 A CN 201511036266A CN 106913377 B CN106913377 B CN 106913377B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00107—Coatings on the energy applicator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00482—Digestive system
- A61B2018/00494—Stomach, intestines or bowel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00601—Cutting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1407—Loop
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Abstract
The invention relates to a polypectomy ring comprising two ring segments, with one ring segment being completely electrically insulated and with the other ring segment being electrically insulated only in the proximal region and not in the distal region.
Description
Technical Field
The invention relates to a high-frequency surgical cutting ring for an instrument or as a component of an instrument for the endoscopically controlled removal of polypoidal or flat-growing diseased mucosal regions of the gastrointestinal tract (so-called lesions). In addition, these instruments are called polypectomy devices or (with parts representing the whole) polypectomy rings.
Technical Field
One of the first such instruments was described in 1971 in german utility model patent No. 71115781. These instruments, as at present, consist essentially of a flexible approximately 2m long catheter made of plastic, a metallic steering wire movable in the catheter, a hf surgical metal cutting ring at one end of the steering wire (the so-called distal end), and an operating handle at the other end of the steering wire and catheter (the so-called proximal end). For more than forty years, the guide tubes and cutting rings of these instruments have been used through the so-called instrument channel or working channel of a flexible endoscope, in order to remove gastrointestinal mucosal lesions with high-frequency surgery in order to prevent gastrointestinal cancer.
If, for example, these instruments can only remove relatively small lesions (< 2cm) approximately twenty years ago, there is a current trend whereby large lesions (> 2cm) can be removed. Of course, this trend faces some problems. The larger the lesion, the greater the likelihood of a significant tumor being present in the lesion. Therefore, oncologists require in particular to remove large lesions in healthy tissue, i.e. up to adjacent healthy tissue. In order to be able to check pathologically reliably: whether the lesion in healthy tissue is indeed removed, whether a tumour (cancerous tissue) already exists in the removed lesion, and if so, whether the tumour has penetrated into the lymphatic and/or venous vessels, i.e. has a risk of metastasis into other organs, the pathologist requires that the lesion be removed in one piece, i.e. in pieces and including the submucosa underlying the lesion, at least the upper third of the submucosa (so-called sm 1). In order to meet this requirement of pathologists, it is desirable, for example, to inject physiological saline into the submucosa so that the submucosa swells, i.e., thickens, as a result of the absorption of the physiological saline. Of course, the specific conductivity of the submucosa can also be increased thereby, which disadvantageously lengthens the so-called initial cutting delay, in particular during the initial cutting phase in the case of hf surgical removal. Since the lesion has to be removed at a safe distance of about 5mm in view of the above requirements of the oncologist, a mucosal area with a diameter of 4cm has to be removed in one piece by high frequency surgery, for example when the lesion size is 3 cm.
Furthermore, the removal of large lesions (> 2cm) by means of a hf surgical cutting ring or polypectomy ring in one piece by hf surgical methods is problematic insofar as at least 0.5A is required per cm of hf-surgically effective ring length for the hf surgical cutting during the initial cutting phase, i.e. in the time between the activation of the hf current generator and the activation of the arc between the polypectomy ring and the tissue, which is necessary for the hf surgical cutting of the tissue, for the hf surgical cuttingIs effectiveSo as to be able to produce a cut with as little delay as possible (so-called initial cut delay). In the case of an excessively long initial cutting delay, there is the risk that the organ wall below the lesion is thermally damaged and that a so-called post-polypectomy perforation of the organ wall may occur after the operation. Since the high-frequency generator usable in endoscopy can only provide a maximum of 1.5 to 2.0AIs effectiveSo that only an effective loop length of 3 to 4cm (which corresponds to a diameter of approximately 1 to 1.5 cm) is sufficient to remove the lesion without delay, resulting in: large lesions in particular (> 2cm) cannot be removed completely in one piece. Therefore, large lesions are either excised in a plurality of smaller pieces using polyp excision rings that have been available so far (so-called predatory technology), or using Endoscopic Submucosal Dissection (ESD) methods developed in japan. The predation technique does not meet the above requirements of the pathologist for the removal of lesions in one piece. ESD is difficult and very time consuming in application.
In german laid-open patent application DE 10028413 a1, electrosurgical instruments are known which each comprise an electrode and, in addition, a ring electrode which comprises a so-called electrode core and an insulating sleeve which partially covers the electrode core. Here, the exposed electrode area of the electrode core is reduced symmetrically at the ring tip by an insulating sleeve with a plurality of openings or pores or by an insulating sleeve which surrounds the electrode core only in a circular segment.
Therefore, the current intensity necessary for cutting should be reduced.
Although it is theoretically possible to eliminate the above-mentioned problem of too long an initial cutting delay with the ring electrode, the manufacture of the ring electrode is very costly and therefore expensive.
Another problem when applying all polypectomy rings available to date is: whether the endoscopist or his assistant (e.g., an endoscopy nurse) cannot observe or visually control, particularly during the hf surgical cutting guidance: whether and, if so, how quickly the hf surgical incision ring is closed. Due to the more or less large elasticity of the long catheter on the one hand and the steering wires on the other hand, as well as the considerable friction between catheter and steering wires, and also due to the large axial dead path (hysteresis) between the operating handle and the cutting ring in the polypectomy procedures that have hitherto been available, it is often not possible to reliably control the closure of the ring at the operating handle. Especially in the case of large lesions (> about 2cm), neither the endoscopist nor the assistant can reliably control: after activating the high frequency current generator, the ring cuts, and if so, how fast. However, controlling the closure of the loop and controlling the speed of the cutting guide is very important in terms of the quality of the cut and in particular in terms of cutting the synchronously closed vessel.
DE 202010008674U 1 discloses a surgical instrument which discloses an uninsulated ring section 7 (upper in fig. 14 a) and an insulated ring section 7 (lower in fig. 14 a). Furthermore, both the spreading legs 6 and the pulling element 10 are insulated. By using the spreading legs 6 made of elastic metal strips, a relatively large cross section of the arrangement is obtained, so that the arrangement can only be used in connection with large diameter catheters.
Disclosure of Invention
The object of the invention is to develop a high-frequency surgical incision ring for or as a component of an instrument for the endoscopically controlled removal of polypoidal or flat-growing pathological mucosal regions of the gastrointestinal tract (so-called lesions), in which the above-mentioned problems do not occur.
The object of the invention is, in particular, to develop a surgical incision ring with which the initial incision time can be short, the properties of which are not altered during the guidance of the hf surgical incision by the very hot arc which is necessary for the hf surgical incision, and which nevertheless can be produced as simply and with little effort as possible. Furthermore, the ring should be able to be used with relatively thin catheters, preferably having a diameter of 2.3mm or less.
Furthermore, it is an object of the present invention to develop a hf surgical incision ring, in particular for flexible endoscopy, in which the opening and closing of the ring can be visually controlled or observed by the endoscopist and/or an assistant (e.g. an endoscopist) even when the ring wound around the lesion cannot be seen, which is particularly disadvantageous during the incision guidance.
To this end, the invention proposes a high-frequency surgical incision ring comprising a first ring part and a second ring part, which at their distal ends form a ring tip and which at their proximal ends are connected to an operating wire that can be guided in a catheter, characterized in that the first ring part is completely surrounded by an electrical insulation, the second ring part is completely surrounded by an electrical insulation only in the proximal region and is uninsulated in the distal region.
The hf surgical incision ring includes a first ring portion and a second ring portion. Both ring portions comprise a metal wire, preferably a solid wire, particularly preferably made of steel or nitinol, and the ring portions have a proximal end and a distal end, respectively. The loop portion forms a loop tip with its distal end. Here, the two ring portions may be selectively interconnected at their distal ends as a ring tip. Preferably, each loop portion is formed of one wire at the maximum. Because the connection is omitted, the stability and the service life can be greatly improved. Alternatively, the ring can also be designed in one piece, wherein the two ring parts are formed from one part. The two loop portions are connected at the proximal end to an actuating wire which can be guided in the catheter, wherein the actuating wire is preferably configured such that the two loop portions can therefore be pulled into and/or removed from the catheter. An operating wire is preferably provided for electrically connecting the second ring portion with the hf surgical generator. Furthermore, the first ring portion is fully electrically insulated, while the second ring portion is electrically insulated in the proximal region and not in the distal region (towards the ring tip).
The electrical insulation completely, i.e. the wire which surrounds the ring portion, viewed radially, over an angular range of 360 °, may be an insulating coating, a sheath and/or a hose, preferably a heat-shrinkable plastic hose.
Due to the simple construction, the ring has only a first ring part and a second ring part, which ring parts can be pulled into the conduit side by side in parallel. The two loop portions can be formed as relatively thin wires, preferably as one piece, and thus only a small position in the catheter is required. It is therefore also possible to use a relatively thin catheter, for example a catheter having an outer diameter of less than or equal to 2.3 mm.
A number of test series have demonstrated: compared to the above-described prior art ring, the cutting ring according to the invention (in which a portion of the ring is completely insulated and only a short portion of the cutting wire is completely uninsulated) hardly changes its hf surgical properties even in the case of long hf surgical cuts and even in the case of multiple applications, whereas the ring according to the prior art has already changed or even lost its hf surgical properties rapidly during the first application due to the thermal arc which melts or even burns the perforated or partially insulated part. The cutting ring according to the invention is significantly better able to withstand the high temperatures of the arc generated during high-frequency surgical cutting. Thus, the first ring part is preferably completely surrounded by electrical insulation throughout its length, whereas the second ring part is completely surrounded by electrical insulation only in the proximal region and is uninsulated, i.e. has no insulation, in the distal region. The concept "fully encircling" herein relates to the encircling of the circumference of the wire along the loop portion. Thus, the electrically insulating portion should be absolutely free of holes or slits.
Measurements when using different hf surgical generators have proven: even in large lesions, the ring according to the invention shows a much shorter or even negligible short initial cutting delay. Because the endoscope can be mainly used in endoscopy and can provide 1.5AIs effectiveHigh-frequency current generator for high-frequency currents and because at least about 0.5A is required for a largely delay-free initial cutIs effectiveSo that the electrically uninsulated ring sections (so-called cut wires) of the ring according to the invention are preferably only 1 to 3cm long.
During the cutting process, the loop is pulled into the catheter by means of the operating wire, so that the loop closes. In fact, the loop cut into the tissue is always covered by the already cut tissue, so that the cutting process is not visible from the endoscope and therefore also not controllable. In order to make the cutting process endoscopically visible and controllable, at least one of the loop sections and/or the operating wire has at least one marking. The markings preferably comprise alternating black and white or differently colored circles. Thus, a black circle may be applied over the electrically insulating part in colors (e.g. yellow, green, blue, red). Preferably, the rings, for example black, have a length of 0.3 to 1cm and a mutual spacing of likewise 0.3 to 1 cm. It goes without saying that the length and the spacing can be designed arbitrarily. Instead of a black ring, a ring of another color can also be selected, which color preferably deviates significantly from the color of the electrically insulating part. It is also possible to select different ring colors on the insulating part of the ring, for example to mark the opening width of the ring. Thus, for example, a fifth red circle can be arranged between the four black circles. Information about the position or opening width of the ring can also be given by different circles or by different spacings of the circles, for example in the form of a bar code. For this purpose, the catheter preferably comprises a transparent material, so that the marker can also be seen endoscopically in the distal end of the catheter. Furthermore, the catheter can also have colored markings, which provide further information, in particular in combination with markings on the ring. Thus, for example, it is possible to show the interference of a plurality of patterns more precisely or also the position specification of the ring segment in the catheter. Alternatively or additionally, the indicia may comprise numerical values and/or characters. They can in particular display the circumference of the opening width of the ring opening. Thus, the maximum visible value may give the circumference or opening width. If the loop continues to close, the value in the conduit disappears and the next small value corresponding to the smaller opening remains visible. The opposite case is the case of an open loop. The markers disclosed herein cannot be applied only to rings having partial insulation. In particular, the marker may be used in all types of hf surgical incisions that can be pulled into and/or removed from a catheter.
In an advantageous manner, the uninsulated ring section can be equipped with a slip-resistant coating or small teeth oriented radially with respect to the ring wire, which simplifies application on or around slippery lesions and prevents or at least hinders slipping-off of the ring from the slippery mucosa.
In an advantageous manner, all the above-listed rings according to the invention can be equipped or equipped with an operating handle according to WO 2013/064576.
Another aspect of the invention relates to a cutting ring as described above and a catheter in which the operating wire is guided. Preferably, the cutting ring can be pulled into and removed from the catheter by means of the operating wire.
Drawings
Fig. 1 shows a ring according to the invention in an open state.
Fig. 2 shows a ring according to the invention in a partially closed state.
Detailed Description
Fig. 1 shows a high-frequency surgical incision ring 1 for flexible endoscopy according to the invention. The hf surgical incision ring comprises a first ring portion 2 and a second ring portion 3 made of metallic round wires and/or flat wires. The loop portions may also comprise metal strands. These ring portions have proximal and distal ends 11 and 10, respectively. The proximal ends of the loop portions together constitute the proximal end 11 of the loop and are mechanically and electrically conductively connected with the operating wire 8 in the catheter 6, for example by means of a connecting element 12. Preferably, the operating wire is much stiffer than the loop wire.
The distal ends of the ring portions 2 and 3 together form the distal end 10 of the ring 1, which can be configured as a ring projection or ring tip 7. A ring tip so configured is required to be able to pull the ring completely into the distal end 9 of the catheter 6 and to remove the ring from it again.
The first ring part 2 is preferably completely electrically insulating. The second ring portion 3 is electrically insulated in the proximal region 5a and not in the distal region 5 b. The electrically uninsulated region of the ring portion 3 preferably has a length of 1 to 3 cm.
For endoscopic control of the opening and closing of the cutting ring 1, markings 13a, 13b are provided on at least one ring part 2 and/or 3 and/or on the operating wire 8. Preferably, the markers constitute a visible black-and-white contrast or a color contrast that is relatively distinct from one another, such that the markers can be seen through the transparent catheter with the endoscope. In this manner, the axial movement of the operating wire and the marked loop portion within the transparent catheter can be observed and controlled by the endoscope. Fig. 2 shows the loop according to the invention partially pulled into the distal end 9 of the catheter 6. The markers 13a and 13b are visible through the catheter 6. To this end, the conduit 6 comprises a transparent material.
In this way, not only the endoscopist but also the assistant can observe and control on the video monitor: whether the operating wire and/or the marked loop portion is moving axially in the catheter 6 and, if so, how fast. In this way, it is also possible to judge the cutting speed, which is known to have a great influence on the quality of the cut, in particular on the excised lesion and also on the accidental thermal damage of the organ wall lying below the excised lesion. In addition, the cutting speed also has a great influence on the usually intentional simultaneous closure of the severed blood vessels.
List of reference numerals
1 cutting ring
2 first Ring portion
3 second Ring part
5a uninsulated region
5b electrically insulated region
6 guide tube
7 catheter tip
8 operating wire
9 distal end of catheter
10 distal end of cutting ring
11 proximal end of cutting ring
12 connecting element
13a, 13b comparison mark
Claims (14)
1. A high-frequency surgical incision ring (1) comprising a first ring part (2) and a second ring part (3) which form a ring tip (7) at their distal end (10) and are connected at their proximal end (11) to an operating wire (8) which can be guided in a catheter (6),
it is characterized in that the preparation method is characterized in that,
the first ring part (2) is completely surrounded by an electrical insulation,
the second ring part (3) is completely surrounded by an electrical insulation only in the proximal region (5 a) and is uninsulated in the distal region (5 b).
2. Cutting ring according to claim 1, characterized in that the uninsulated area (5b) has a defined length of 10 to 30 mm.
3. The cut ring according to claim 1 or 2, characterized in that visually identifiable markings (13a, 13b) are present on at least the electrically insulating part of the first ring part (2).
4. The cutting ring according to claim 3, wherein the marking is a ring.
5. The cutting ring according to claim 4, wherein the ring has at least two different colors.
6. Cutting ring according to claim 3, characterized in that the marking is a numerical value and/or a character showing the circumference of the ring or the opening width at different ring openings.
7. The cutting ring according to claim 1 or 2, characterized in that at least one of the ring parts (2, 3) has a spring-elastic, metallic strand and/or spring-elastic, metallic round wire and/or flat wire.
8. Cutting ring according to claim 1 or 2, characterized in that the cutting ring (1) can be removed from and/or pulled into the catheter at its proximal end (11) by means of an operating wire.
9. Cutting ring according to claim 1 or 2, characterized in that the uninsulated area (5b) comprises an anti-slip coating or small teeth.
10. The cutting ring of claim 9, wherein the small teeth are oriented radially with respect to the loop wire.
11. The cutting ring according to claim 1 or 2, characterized in that the proximal end of the operating wire (8) and catheter (6) comprises an operating handle.
12. The cutting ring according to claim 1 or 2, characterized in that the operating wire is provided for electrically connecting the second ring portion (3) with a high-frequency surgical generator.
13. Surgical device comprising a cutting ring according to any one of claims 1 to 12 and a catheter in which the operating wire is guided.
14. Surgical device according to claim 13, characterized in that the cutting ring can be pulled into and removed from the catheter (6) by means of the operating wire.
Priority Applications (2)
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CN202110880575.7A CN114041871A (en) | 2015-12-28 | 2015-12-28 | High frequency surgical cutting ring for flexible endoscopy |
CN201511036266.2A CN106913377B (en) | 2015-12-28 | 2015-12-28 | High frequency surgical cutting ring for flexible endoscopy |
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CN201511036266.2A CN106913377B (en) | 2015-12-28 | 2015-12-28 | High frequency surgical cutting ring for flexible endoscopy |
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CN202110880575.7A Division CN114041871A (en) | 2015-12-28 | 2015-12-28 | High frequency surgical cutting ring for flexible endoscopy |
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CN106913377A CN106913377A (en) | 2017-07-04 |
CN106913377B true CN106913377B (en) | 2021-08-24 |
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CN201511036266.2A Active CN106913377B (en) | 2015-12-28 | 2015-12-28 | High frequency surgical cutting ring for flexible endoscopy |
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CN114041871A (en) * | 2015-12-28 | 2022-02-15 | 君特·费林 | High frequency surgical cutting ring for flexible endoscopy |
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DE3220940A1 (en) * | 1982-06-03 | 1983-12-08 | Harald 7200 Tuttlingen Maslanka | Diathermy instrument |
US5078716A (en) * | 1990-05-11 | 1992-01-07 | Doll Larry F | Electrosurgical apparatus for resecting abnormal protruding growth |
CN1767869A (en) * | 2003-04-03 | 2006-05-03 | 伊西康内外科公司 | Guide wire having bending segment |
US20070208339A1 (en) * | 2006-03-03 | 2007-09-06 | Sherwood Services Ag | System and method for controlling electrosurgical snares |
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CN104997560A (en) * | 2015-08-18 | 2015-10-28 | 常州乐奥医疗科技有限公司 | Medical electric incision and coagulation device |
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DE102009036158A1 (en) * | 2009-07-28 | 2011-02-03 | Farin, Günter, Dipl.-Ing. | Monopolar polypectomy loops |
DE202010005677U1 (en) * | 2010-06-18 | 2011-10-21 | Mtw - Endoskopie W. Haag Kg | polypectomy |
DE202010008674U1 (en) * | 2010-06-18 | 2011-11-29 | Mtw - Endoskopie W. Haag Kg | Surgical instrument |
GB2485569A (en) * | 2010-11-19 | 2012-05-23 | Gyrus Medical Ltd | Bipolar snare with rotatable guide member |
DE102011085721A1 (en) * | 2011-11-03 | 2013-05-08 | Günter Farin | HF surgical resection instrument with a resection loop for removal of pathological tissue |
US9456862B2 (en) * | 2013-02-19 | 2016-10-04 | Covidien Lp | Electrosurgical generator and system |
WO2014151869A1 (en) * | 2013-03-14 | 2014-09-25 | Boston Scientific Scimed, Inc. | Devices for tissue resection |
CN204379433U (en) * | 2015-01-05 | 2015-06-10 | 张建国 | Mucosa detacher |
CN104546119A (en) * | 2015-01-05 | 2015-04-29 | 张建国 | Mucous membrane detacher |
CN114041871A (en) * | 2015-12-28 | 2022-02-15 | 君特·费林 | High frequency surgical cutting ring for flexible endoscopy |
-
2015
- 2015-12-28 CN CN202110880575.7A patent/CN114041871A/en active Pending
- 2015-12-28 CN CN201511036266.2A patent/CN106913377B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3220940A1 (en) * | 1982-06-03 | 1983-12-08 | Harald 7200 Tuttlingen Maslanka | Diathermy instrument |
US5078716A (en) * | 1990-05-11 | 1992-01-07 | Doll Larry F | Electrosurgical apparatus for resecting abnormal protruding growth |
CN1767869A (en) * | 2003-04-03 | 2006-05-03 | 伊西康内外科公司 | Guide wire having bending segment |
US7951073B2 (en) * | 2004-01-21 | 2011-05-31 | Boston Scientific Limited | Endoscopic device having spray mechanism and related methods of use |
US20070208339A1 (en) * | 2006-03-03 | 2007-09-06 | Sherwood Services Ag | System and method for controlling electrosurgical snares |
CN104997560A (en) * | 2015-08-18 | 2015-10-28 | 常州乐奥医疗科技有限公司 | Medical electric incision and coagulation device |
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CN106913377A (en) | 2017-07-04 |
CN114041871A (en) | 2022-02-15 |
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