The present invention relates to an electrosurgical instrument, in particular for laparoscopic operations, as well as to electrodes for such instruments.
Following the surgical removal of a hollow vessel portion, e.g. with an intestinal resection due to a tumor having affected a bowel section, the two hollow vessel portions have to be reconnected at their opened ends in such a manner that a continuous pathway is produced. This is referred to as end-to-end anastomosis. As a standard, the two opened ends are reattached to each other with clip suturing devices.
In particular with operations on the small and large intestines, leaky suture connections (suture insufficiency) occur from time to time, which are associated with a serious progress of disease and a high mortality rate, too.
An alternative to stitching the hollow vessel portions is thermofusion technology (TFT). Thermofusion by means of high frequency technology (HF) is based on the denaturation of proteins which are contained in many tissue types. This allows to weld collagen-containing tissue. During the welding process, the tissue is heated up to temperatures above the protein denaturation temperature, and together with the intra- and extracellular matrix is converted into a gel-like state. After compression of the tissue faces, the liquefied tissue cools down to a fused mass, effecting a reliable connection of the tissue.
For the purpose of welding the hollow vessel portions, the tissue grasped between two clamping jaws is exposed to electrical current which flows between electrodes provided on the two clamping jaws.
For preventing the sealing or welding from breaking down, the parameters acting on the tissue have to be detected and controlled. In order to ensure this, a precise control of temperature, pressure, tissue impedance, distance and position is required.
It is desirable to realize a uniform treatment of the tissue which is held between the clamping jaws, so that all zones are reliably reached and no zone is exposed to an excessively high current. To this end, it has to be ensured that the HF electrodes are uniformly spaced from each other and aligned so as to be parallel to each other.
The prior art does not disclose any instruments of suitable size for being used for the above-mentioned hollow vessels and tissue types. With regard to coagulation instruments of smaller size, as shown e.g. in EP 1 747 762 A2, a non-parallel alignment of the HF electrodes occurs during closing the clamping jaws, which is due to the type of construction.
Related state of the art is known from the documents DE 20 2004 009 427 U1 and DE 699 29 230 T2.
The distance between the electrodes can be maintained by spacers which are attached to the clamping jaws. If, however, a higher number of spacers is provided on the clamping jaws, as is shown for instance in EP 1 656 901 B1, EP1 952 777 A1, EP 1 372 507 A1 or US 2004/122423 A1, it is inevitable that the tissue is perforated by the spacers, as it will be compressed under the spacers in the closed state of the clamping jaws such that there will be permanent tissue damage. This has negative effects on the result of the sealing process.
If the contact pressure of the clamping jaws is reduced in order to avoid any perforation of the tissue, and if the tissue is only clamped under the spacers, this leads to an angular deflection of the clamping jaws.
As the spacers are further made from an electrically non-conductive material for avoiding a short-circuit between the HF electrodes, a so-called coagulation shade develops in the vicinity of said spacers, which means that the tissue portions are encapsulated in the vicinity of or under the spacers, hence are not supplied with electrical current or only to an insufficient extent, and an unsatisfactory welding of the vessel portions will occur.
If the number of the spacers is reduced, it is inevitable that the distance between the individual spacers increases. If the clamping jaws are pressed against each other with high contact pressure, the clamping jaws and the electrodes will be bent between the spacers even if stiff materials are used, so that distance of the electrodes is smaller between the spacers than at the spacers. These differences in the distances of the electrodes results in a non-homogenous penetration of the tissue with HF energy.
The present invention is based on the object to provide an instrument which improves, by means of thermofusion technology, the result of an end-to-end anastomosis of hollow vessels such as small and large intestines, or in general with any tissue connections, and ensures in particular a uniform distance of opposing HF electrodes without causing damage on the tissue.
A further object of the present invention is the provision of electrodes which are suitable for said instrument.
An electrosurgical instrument according to the invention comprises mutually movable instrument legs each comprising one or more electrodes (electrode faces) between which tissue can be clamped and treated in electrothermal manner. The scissor-like movement of the instrument legs relative to each other is delimited by at least two spacers which are spaced from each other in the longitudinal extension of the instrument legs and act on the instrument legs. At least one electrode face portion subjected to deflection in a closed position of the instrument legs is formed to be bow-shaped in the longitudinal direction of the legs and contrary to the bending direction which is to be expected, in particular so as to be concave toward the opposing leg.
The special shape of the electrode(s) can ensure that the distance of the opposing electrode faces, in consideration of the bending load in the closed position of the instrument legs, is substantially of equal size over the entire electrode length and the full electrode face. This design shape of the electrodes also ensures that there is a substantially constant surface pressure of the tissue to be connected. This results in consistent prerequisites for HF surgery, in particular with respect to the tissue impedance. In this way, the quality of the sealed tissue zones can be better monitored as seen from the viewpoint of electrical control. The special design of the electrodes and spacers avoids short-circuits between the electrodes. What is more, the special configuration results in a homogenous distribution of the electric current in the tissue.
Due to the bow-shaped curvature (which is concave with respect to the contact side) of the electrode(s), the distance between the spacers can be enlarged and hence the total number of the spacers can be reduced without running into danger that the electrode faces fall below the minimum spacing.
As already mentioned at the outset, the tissue to be sealed is damaged too much with an excessively high number of spacers, in particular if these are arranged/fixed on the electrode faces. This means that the (nub-shaped) spacers would perforate the clamped tissue. Further, many coagulation shadows are produced.
The electrosurgical instrument according to the invention and the electrodes, according to the invention, of such an electrosurgical instrument provide for an optimum tradeoff between the maximum parallel alignment of the HF electrodes, on the one hand, and a homogenous fusion of the tissue with minimum tissue damage, on the other hand.
Thus, any tissue damages caused by the spacers due to the excessive force impact on the clamped tissue are prevented and a reliable fusion of the individual tissue components is ensured by constant force conditions, the parallel arrangement of the electrodes, the clearly defined distance of the electrodes and the homogenous distribution of electrical current in the tissue. The special shape of the electrodes (i.e. concave with respect to each other) avoids short-circuits between the electrodes and leaks in the sealed tissue layers in particular in the longitudinal center zone of the legs.
This results in consistent prerequisites for HF surgery, in particular with respect to the tissue impedance. In this way, the quality of the sealed tissue zones can be better monitored as seen from the viewpoint of electrical control.
Especially with particularly long instrument legs or those which are centrally supported on actuation levers, it has to be ensured that the electrode faces maintain the desired distance in the middle zone and do not fall below said distance due to bending loads. The bow-shape of the electrodes with a larger spacing in the center portion allows to do without a spacer which would act on the middle portions of the instrument legs, whereby the total number of required (nub-shaped) spacers can be reduced.
According to a further or independent aspect, at least one electrode face portion arranged between the two spacers which are spaced from each other in the longitudinal extension of the instrument legs can be formed so as to be bow-shaped or concave at least in the longitudinal center portion.
This preferably means, on the one hand, that the electrode as a whole or at least its electrode face facing the tissue to be treated, is preformed so as to be bow-shaped (or concave) along its entire longitudinal extension. Due to the bow-shaped preform, the electrode acts as a kind of leaf spring if it is pressed against the opposing electrode, which is pressed into a flat shape by the contact pressure of the instrument leg and in this way achieves the desired parallel alignment with the other electrode.
However, it is sufficient to give the (concave) preform only to those electrode face portions which are subject to a bending load, i.e. the portions between two support points of the electrodes or between two spacers.
The electrode face portion can be preformed according to the bending load to be expected in the closed position of the instrument legs in such a manner that it does not fall below a minimum spacing between the electrode faces which is defined by the spacers in the closed position of the instrument legs.
This ensures that the electrode faces do not fall below the minimum spacing (in fact at no point) which is essential for a uniform penetration with electrical current and that the electrode faces have a substantially equal distance relative to each other over the entire length.
The electrode face portion can be preformed according to the bending load to be expected in the closed position of the instrument legs in such a manner that it will be bent so as to be substantially straight in the closed position of the instrument legs.
This ensures a parallel alignment of the electrode faces relative to each other, in spite of large distances between the spacers in the closed position of the instrument legs.
The electrode face portion can be preformed according to the number and the distances of the spacers as well as according to the elasticity module and the geometrical moment of inertia of the respective instrument leg.
If the instrument legs are pressed against each other in the closed position for gripping and treating tissue, the bending load depends, apart from the number and the distances of the spacers, substantially on the material and geometric properties of the instrument legs which usually have a higher flexural rigidity than the electrodes attached thereon. Against this background, it is reasonable to determine the preform of the electrode faces depending on the characteristics of the instrument legs as a whole.
Instead of only forming the electrode face so as to be bow-shaped, the complete instrument leg along with the electrode face can be formed to be bow-shaped (concave in the sense of the above description).
If the two instrument legs have similar properties (in terms of flexural flexibility), the mutually opposing electrode faces of the instrument legs can be formed to be mirror-symmetric. This facilitates the manufacturing of the electrodes, as they can be used for any of the two instrument legs.
If the spacers act exclusively on proximal and distal end portions of the instrument legs, the entire middle zone of the electrode faces can be formed to be bow-shaped (concave).
This means that the middle zone of the electrodes, which is essential for the treatment of the tissue, can be kept free from any spacers. This avoids tissue damages and coagulation shadows which are induced by the spacers.
The spacer acting on the distal end portions of the instrument legs can be formed by a protrusion which is arranged on a distal end portion of an instrument leg between two electrode faces and points toward the other instrument leg, or by a protrusion which is provided (fixed) on one electrode face or several protrusions which are provided (fixed) on various electrode faces. The spacer acting on the proximal end portions of the instrument legs can be formed by a spacer module (component) which is formed to be separate from the instrument legs and comprises at least one material tongue (tongue platelet) which is clamped between the instrument legs in the closed position, or by the cooperation between at least one rotation limiting pin provided on one of the instrument legs and a guide slot which is formed in the actuation lever and in which the rotation limiting pin is guided.
Due to this special arrangement of the spacers, the electrode faces can be kept free from spacers, whereby the risk of tissue damages and coagulation shadows can be further minimized.
An electrode according to the invention, in particular for an already described electrosurgical instrument is formed to be bow-shaped or concave at least in portions in the longitudinal direction and contrary to a bending direction which is to be expected.
Using an electrode according to the invention in an electrosurgical instrument allows the compensation of any bending loads which are to be expected due to its special (concave) preform during the compression of the legs; in this way, uniform distances between the electrodes are achieved and falling short of minimum distances as well as short-circuits can be avoided.
At a distal end portion and at a proximal end portion, the electrode may comprise one protrusion each which acts as a spacer, in particular made of a non-conducting material, and the electrode between the protrusions can be formed to be bow-shaped or concave.
On the one hand, an electrode of this type ensures in the installed state that two instrument legs keep the minimum spacing relative to each other (predetermined by the protrusions) along the entire length of the legs and, on the other hand, that the minimum spacing is maintained also between the spacers in spite of any bending loads, at least is not less than said minimum spacing.
It is to be noted that the above-mentioned aspects and features both may exist individually and be combined in grouped fashion.
Regarding the basic mode of operation and the mechanical structure of the instrument 2, reference is made for instance to the published document WO 2011/097469 A2.
Each of the instrument legs 4 and 6 comprises two electrode faces 20 (20-1, 20-2, 20-3 and 20-4) which are spaced apart from each other in the transverse direction of the legs, extend parallel in the longitudinal direction and can be supplied with HF voltage. If there is any tissue between the instrument legs 4 and 6 in their closed position, the surgeon is able to coagulate, to sever or to weld it by means of the electrode faces 20. Further, a (not shown) special electrosurgical knife or a cutting device can be arranged between the electrode faces 20.
In order to avoid a short-circuit between the electrode faces 20 of the two instrument legs 4 and 6 and to ensure that a homogenous electrical current (homogenous in the longitudinal direction) flows through the tissue clamped between the electrode faces 20, the electrode faces 20 have to remain preferably equally spaced also in the closed position. To this end, the instrument 2 has its distal portion of at least the lower and/or upper instrument leg 6, 4 on the two parallel electrode faces 20-3 and 20-4 provided with (nub-shaped) protrusions 22 which project beyond the electrode faces 20-3 and 20-4 by a predetermined measure which corresponds to the desired distance between the electrode faces 20, and which come into contact with the corresponding electrode faces 20-1 and 20-2 of the upper instrument leg 4 and in this way act as spacers on the distal end portions of the two instrument legs 4 and 6. These protrusions 22, 23 can be applied by gluing, soldering or injection-molding, or can be applied in any other way so as to be fixed or detachable.
At the proximal portions of the two instrument legs 4 and 6, the distance between the electrode faces 20 is accomplished preferably by a separate spacer module or component 24. This spacer module 24 is a component which is provided/rotatably supported on the pivot joint 17 or forms a part of the pivot joint 17 and is able to freely rotate between the instrument legs 4 and 6 around the swivel axis A. It is received between two hinge flanges of the upper instrument leg 4. It comprises a bearing portion or bearing block provided with two material tongues 28 which extend toward the legs 4, 6, i.e. project radially from the swivel axis A, and whose respective height H (material thickness) corresponds to the minimum spacing S to be achieved between the opposing electrode faces 20-1, 20-3 and 20-2, 20-4, and whose transverse distance and width substantially corresponds to the transverse distance and the width of the electrode faces 20. The spacer module 24 or at least the material tongues 28 are made of an electrically insulating material.
In the closed position (not shown) of the instrument legs 4 and 6, the two material tongues 28 are clamped between the electrode faces 20-1, 20-3 and 20-2, 20-4, whereby the minimum spacing is maintained at the proximal end of the legs 4, 6 between the electrode faces 20-1 and 20-2 on the one side and the electrode faces 20-3 and 20-4 on the other side.
If the instrument legs 4 and 6 are being closed and pressed against each other to carry out an electrothermal treatment on tissue clamped therebetween, the spacers 22, 23 and 24 arranged on the distal and proximal end portions of the instrument legs 4 and 6 come into contact first, as has already been described and is also shown in
The concave, bow-shaped pretension/preform of the electrodes and electrode faces 20 is selected in each case such that it corresponds to the deflection which is to be expected in the closed position of the instrument legs 4 and 6, i.e. that the electrode faces 20 which are slightly concave in the unloaded state (open position of the instrument legs 4 and 6) are bent so as to be straight or flat in the loaded state (closed position of the instrument legs 4 and 6), which means that the original form of the electrode faces 20 is nullified under bending loads.
It can be taken from this sketch that the electrode faces 20 are bent to be straight or flat under bending load, i.e. if the instrument legs 4 and 6 are pressed against each other, so that the upper electrode faces 20-1, 20-2, when the tissue is situated between the instrument legs 4 and 6, and the opposing lower electrode faces 20-3, 20-4 are applied with HF voltage, will have the desired parallel orientation and a substantially uniform distance between them.
Furthermore,
The present invention is not limited to the embodiments described above. Various modifications are possible within the scope of the invention.
Instead of the spacer module 24, it is also possible to provide protrusions on the proximal portion of the electrode faces, in analogy to the distal end.
In the described first embodiment, the electrode faces are concavely pre-formed or bent over their entire longitudinal extension. The electrode faces, however, may also be concavely bent only between two adjoining spacers.
Further, it is possible that only the electrode faces 20-3 and 20-4 or the electrodes of the lower instrument leg 6 are pretensioned in bow-shaped fashion, as especially the lower instrument leg 6 is subject to central bending forces, because it is centrally supported or suspended on the support portion 18 in the manner of a rocker.
If the instrument legs are provided with several support points or spacers in the longitudinal extension, the electrode faces 20 may have several bends.
The original form of the electrode faces 20, of the entire electrode or of the entire instrument legs 4, 6 may differ from a concave bow-shape (and may be V-shaped, for instance), or the original form of the individual electrode faces may differ from each other, as long as it is ensured that the electrode faces 20 (of opposing instrument legs 4, 6) which are deformed in the loaded state, i.e. if the opposing instrument legs are pressed against each other, have a substantially uniform distance relative to each other over their longitudinal extension.
If it is to be expected that in the closed position of the instrument legs 4 and 6 the electrode faces 20 are not bent inward but in outward direction, the electrode faces may also have a curvature which is oriented inward, i.e. a convex curvature.
Number | Date | Country | Kind |
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10 2012 101 257 | Feb 2012 | DE | national |
This application is a continuation of U.S. application Ser. No. 14/377,352, filed Aug. 7, 2014, which is the U.S. National Phase entry of International Application No. PCT/EP2013/052329, filed Feb. 6, 2013, which claims the benefit of priority of German Application No. DE 10 2012 101 257.1, filed Feb. 16, 2012. The contents of U.S. application Ser. No. 14/377,352, International Application No. PCT/EP2013/052329, and German Application No. DE 10 2012 101 257.1 are incorporated by reference herein in their entireties for all purposes.
Number | Name | Date | Kind |
---|---|---|---|
3920021 | Hiltebrandt | Nov 1975 | A |
4427014 | Bel et al. | Jan 1984 | A |
5222973 | Sharpe et al. | Jun 1993 | A |
5258006 | Rydell et al. | Nov 1993 | A |
5318589 | Lichtman | Jun 1994 | A |
5891142 | Eggers et al. | Apr 1999 | A |
6030384 | Nezhat | Feb 2000 | A |
6123701 | Nezhat | Sep 2000 | A |
6190399 | Palmer et al. | Feb 2001 | B1 |
6770072 | Truckai et al. | Aug 2004 | B1 |
6802843 | Truckai et al. | Oct 2004 | B2 |
7101373 | Dycus et al. | Sep 2006 | B2 |
7160299 | Baily | Jan 2007 | B2 |
7306599 | Karasawa et al. | Dec 2007 | B2 |
8915913 | Fischer et al. | Dec 2014 | B2 |
9055961 | Manzo et al. | Jun 2015 | B2 |
9867655 | Rothweiler | Jan 2018 | B2 |
10092350 | Rothweiler et al. | Oct 2018 | B2 |
20030014053 | Nguyen et al. | Jan 2003 | A1 |
20040019352 | Kidooka | Jan 2004 | A1 |
20040122423 | Dycus et al. | Jun 2004 | A1 |
20040162557 | Tetzlaff et al. | Aug 2004 | A1 |
20040249374 | Tetzlaff et al. | Dec 2004 | A1 |
20050107784 | Moses et al. | May 2005 | A1 |
20060217709 | Couture et al. | Sep 2006 | A1 |
20060271038 | Johnson et al. | Nov 2006 | A1 |
20080015567 | Kimura | Jan 2008 | A1 |
20080045944 | Fischer | Feb 2008 | A1 |
20080056944 | Nakamura et al. | Mar 2008 | A1 |
20080215048 | Hafner et al. | Sep 2008 | A1 |
20100016857 | McKenna | Jan 2010 | A1 |
20100023043 | Houser | Jan 2010 | A1 |
20100057084 | Hanna | Mar 2010 | A1 |
20100082047 | Cosgrove et al. | Apr 2010 | A1 |
20100204698 | Chapman et al. | Aug 2010 | A1 |
20110082494 | Kerr et al. | Apr 2011 | A1 |
20110184404 | Walberg et al. | Jul 2011 | A1 |
20120083784 | Davison et al. | Apr 2012 | A1 |
20120101501 | Hishimura | Apr 2012 | A1 |
20120150167 | Fischer et al. | Jun 2012 | A1 |
20120271346 | Townsend et al. | Oct 2012 | A1 |
20130274741 | Marczyk et al. | Oct 2013 | A1 |
20140371743 | Rothweiler | Dec 2014 | A1 |
20150216544 | Banfalvi | Aug 2015 | A1 |
20150257819 | Dycus et al. | Sep 2015 | A1 |
20160157930 | Heard | Jun 2016 | A1 |
Number | Date | Country |
---|---|---|
201082191 | Jul 2008 | CN |
101378702 | Mar 2009 | CN |
100544681 | Sep 2009 | CN |
101522127 | Sep 2009 | CN |
103327922 | Sep 2013 | CN |
202004009427 | Aug 2004 | DE |
102004031141 | Jan 2006 | DE |
69925854 | May 2006 | DE |
69929230 | Aug 2006 | DE |
202006016837 | Jan 2007 | DE |
102006042985 | Apr 2007 | DE |
102007053359 | Jun 2009 | DE |
1020080083091 | Aug 2009 | DE |
102008018614 | Oct 2009 | DE |
102009037614 | Feb 2011 | DE |
202012100017 | Mar 2012 | DE |
102012100040 | Jul 2013 | DE |
0986990 | Mar 2000 | EP |
1372507 | Jan 2004 | EP |
1123058 | Dec 2005 | EP |
1747762 | Jan 2007 | EP |
1878400 | Jan 2008 | EP |
1952777 | Jun 2008 | EP |
1656901 | Sep 2009 | EP |
2165662 | Mar 2010 | EP |
1461810 | Jan 1977 | GB |
2000102545 | Apr 2000 | JP |
2002528167 | Sep 2002 | JP |
2004524923 | Aug 2004 | JP |
2004532676 | Oct 2004 | JP |
2006006942 | Jan 2006 | JP |
2006528909 | Dec 2006 | JP |
2007319683 | Dec 2007 | JP |
2008018226 | Jan 2008 | JP |
2009509706 | Mar 2009 | JP |
2009297503 | Dec 2009 | JP |
2010042248 | Feb 2010 | JP |
2010051802 | Mar 2010 | JP |
2010253278 | Nov 2010 | JP |
02080796 | Oct 2002 | WO |
2002080797 | Oct 2002 | WO |
2004103156 | Dec 2004 | WO |
2011018153 | Feb 2011 | WO |
2011097469 | Aug 2011 | WO |
2013102602 | Jul 2013 | WO |
2015197395 | Dec 2015 | WO |
Entry |
---|
Japanese Office Action dated Aug. 24, 2016 for Japanese Application No. 2014-530246, including English translation, 9 pages. |
Chinese Office Action dated Oct. 29, 2015 for Chinese Application No. 201280045066.1 with translation, 21 pages. |
German Search Report issued in related German Application No. 10 2011 053 682.5, dated May 18, 2012, 3 pages. |
International Search Report issued in related International Application No. PCT/EP2012/068158, dated Nov. 26, 2012, 3 pages. |
International Search Report and Written Opinion for International Application No. PCT/EP2015/063284, dated Sep. 11, 2015, 11 pages. |
German Search Report for German Application No. 10 2014 108 914.6, dated Mar. 10, 2015, 12 pages. 2. |
Japanese Office Action for Japanese Application No. 2014-556987, dated Dec. 13, 2016 with translation, 5 pages. |
German Search Report issued in related German Application No. 10 2012 100 040.9, dated Aug. 28, 2012, 6 pages. |
International Search report and Written Opinion issued in related International Application No. PCT/EP2012/076945, dated Aug. 30, 2013. 8 pages. |
Japanese Office Action with english translation for Application No. 2014-550685, dated Nov. 22, 2016, 7 pages. |
German Search Report for German Application No. 10 2012 101 257.1, dated Nov. 28, 2012 with partial translation, 5 pages. |
International Search Report and Written Opinion for International Application No. PCT/EP2013/052329, dated May 8, 2013, 13 pages. |
Chinese Office Actioin dated Janruary 4, 2016 for Chinese Application No. 201380011277.8 with translation, 12 pages. |
European Office Action for European Application No. 13 703 781.8, dated Apr. 28, 2017 with translation, 8 pages. |
European Office Action for European Application No. 12 813 879.9, dated May 2, 2017 with translation, 8 pages. |
Notice of Allowance for U.S. Appl. No. 14/377,352, dated May 8, 2017, 23 pages. |
Non Final Office Action for U.S. Appl. No. 14/370,553, dated Jun. 30, 2017, 25 pages. |
Entire patent prosecution history of U.S. Appl. No. 14/377,352, filed Aug. 7, 2014, entitled, “Electrosurgical Instrument Having an Arcuate Electrode Section.” |
Non Final Office Action for U.S. Appl. No. 15/319,883, dated Jan. 28, 2019, 41 pages. |
Chinese Office Action for Chinese Application No. 201580034220.9, dated Nov. 8, 2018 with translation, 11 pages. |
Notice of Allowance for U.S. Appl. No. 14/377,352, dated Sep. 13, 2017, 12 pages. |
Notice of Allowance for U.S. Appl. No. 14/370,553, dated Jun. 15, 2018, 7 pages. |
Korean Office Action for Korean Application No. 10-2014-7025722, dated Oct. 28, 2019, with translation, 11 pages. |
Final Office Action for U.S. Appl. No. 15/319,883, dated Oct. 22, 2019, 19 pages. |
Number | Date | Country | |
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20170360500 A1 | Dec 2017 | US |
Number | Date | Country | |
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Parent | 14377352 | US | |
Child | 15696888 | US |