CA2237429A1 - Improved electrosurgical hemostatic method and device - Google Patents
Improved electrosurgical hemostatic method and device Download PDFInfo
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- CA2237429A1 CA2237429A1 CA002237429A CA2237429A CA2237429A1 CA 2237429 A1 CA2237429 A1 CA 2237429A1 CA 002237429 A CA002237429 A CA 002237429A CA 2237429 A CA2237429 A CA 2237429A CA 2237429 A1 CA2237429 A1 CA 2237429A1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
-
- 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
- A61B18/1206—Generators therefor
-
- 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
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
- A61B18/1447—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod wherein sliding surfaces cause opening/closing of the end effectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
-
- 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
- A61B18/1402—Probes for open surgery
-
- 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
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00875—Resistance or impedance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/032—Automatic limiting or abutting means, e.g. for safety pressure limiting, e.g. hydrostatic
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physics & Mathematics (AREA)
- Plasma & Fusion (AREA)
- Otolaryngology (AREA)
- Surgical Instruments (AREA)
Abstract
An electrosurgical instrument is provided for cauterization and/or welding of tissue of varying impedance, thickness and vascularity especially in the performance of endoscopic procedures. The instrument compresses the tissue between one pole of a bipolar energy source located on one interfacing surface, and a second interfacing surface applying pressure in a predetermined range. A second pole is located one of the two interfacing surfaces. In a preferred embodiment, the second pole is located on the same interfacing surface as the first pole and an insulator electrically isolates the two poles. A preferred application of the invention is in a cutting instrument wherein a hemostatic line is formed along a cut line using RF energy.
Description
IMPROVED ELECl ~OSURGICAL HEMOSTATIC METHOD AND DEVICE
.
Field of the Invention This invention relates to an improved electrosurgical instrument and method for ~li~Lion, cr~ tion and/or tissue welding in the ~lÇul~-~ance of surgical procedures, ec~~ y çn-losropic procedures.
Back~,lound of the Invention Surgical procedures requiring cutting of tissue can cause bleeding at the site of the cufflng. Before surgeons had the means to control bleeding many surgical u~d~ul~,s were quite ~lifficult to pelrul~ because of excessive blood loss.
~mos~cic is even more crucial in çndosc~pic or l~arosoop;c surgery where if the bl~iing is not kept under control, the laparoscopy must be ~b~n~on~d and the patient's body cut to pelÇul"~ open surgery so that i~ ce~;ble ble~1ing may be controlled.
Thus, various terhniq!)es have been adapted to control bleeding with varying 2 0 degrees of success such as, for example, suturing, applying clips to blood vessels, and stapling, as well as eles;lloca~l~ly and other thermogenic t~ni~ es Advances in tissue joining, tissue repair and wound closure also have permitted surgical procedures previously not possible or too risky.
Initially, sut~lring was one of the prirnary means for providing hPmost~cic and joining tissue. Before other h~most~tic and tissue repair means were introduced,surgeons had to spend a great deal of time sewing the tissue of patients back together.
Surgical clips were introduced as a means to close off blood vessels, particularly when cutting highly vascularized tissue. Application of surgical clips, however, can be cumbersome in certain procedures. The vessels must;be i~lentifi~
.
Then a clip must be individually applied on both sides of the int~n-led cut of each ntified vessel. Also, it may be difficult to find some vessels, particularly where the vessel is surrounded by fatty tissue.
Surgical staplers have been effective in decreasing the arnount of time it takesto fasten tissue together. There are various types of surgical staplers. Staplers have been used for tissue joining, and to provide hemostasis in conjunction with tissue cutting. Such devices include, for example, linear and circular cutting and stapling instruments. Typically, a linear cutter has parallel rows of staples with a slot for a cutting means to travel between the rows of staples. This type of surgical stapler secures tissue for improved cutting, joins layers of tissue, and provides h-~most~cic by applying parallel rows of staples to layers of surrounding tissue as the cutting means cuts ~l~en the parallel rows. These types of cutting and stapling devices have been used su~ecs~ y in procedures involving fleshy tissue such as muscle or bowel, particularly in bowel rese~tion procedures. Circular cutting and stapling devices have ~c~es~r.llly been used, for example, in ~ ...otic ~1O~1~5 where a lumen is rejoined. However, the results with cutting and stapling devices have been less than O~ lUIII where the procedure involves cuthng highly vascularized tissue, such as...es, .~le-y or adnexa, which are prone to having h~most~cis plob'~-nc.
Electrocautery devices have also been used for effecting h~most~cic Monopolar devices utili~ one electrode ~Ccoci~tpd with a cutting or cau~ g instrument and a remote return electrode, usually adhered ~l~t~rn~lly to the patient.
More recently, bipolar instruments have been used because the cauterizing current is 2 5 generally limited to tissue between two electrodes of the instrument.
Bipolar forceps have been used tor cutting and/or c~ tion in various procedures. For example, bipolar forceps have been used in sterili7~tion procedures where the fallopian tubes are sealed off. Generally, bipolar forceps grasp tissue 30 between two poles and apply electrical current through the grasped tissue. Bipolar forceps, however, have certain drawbacks, some of which include the tendency of the current to arc between poles when tissue is thin or the forceps to short when the poles of the forceps touch. The use of forceps for c~ tion is also very ter~ e ~epen~lent and the forceps are not adapted to ~imult~n~ously C~tcr~,c a larger area of 5 tissue.
Bipolar scissors have been disclosed where two scissors blades act as two electrodes having in~llAtPd shearing surfaces. This device me~h~nir~lly cuts tissue as cr~]l~tin~ electrical current is delivered to tissue in the current path. Bipolar scissors 10 are also highly technique dependent in their use.
In prior devices, such as the device described in US Patent 5,403,312, cle.;llùsutgical energy has been delivered to biologic tissue in order to create a region of c~ tion, as, for example, on either side of an inricion, thus preventing blood 15 and other bodily fluids from leaking out of the inriC;on In such a device, if ffssue gra~ed by the jaws is co..lpllsscd too much by applying e~ccessive ~JI~UIC to the region of c~ tirJn~ the tissue grasped by the end err~ur may be torn or crushed.If the tissue is not compressed enough becau~ to little ~ u~ is applied to the region of c~gulAtion, the tissue in the region of co~ tion may not be not effectively or 2 0 uni~llllly ~u~-i2ed because fluid (e.g. blood) could remain in the region ofion In prior art devices, the surgeon has u~d tactile fee~lh~rl~ and visual clues to ~t~nnin~ the arnount of pressure to apply to the region in order to obtain optimum co~ tion. In instruments wherein the region of c~A~llAtion is partially or fully obscured, either by the end effector or by tissue, and is, therefore, not visible to 25 the surgeon, it is particularly difficult for the surgeon to ensure that the a~pluyli~te pressure is being applied by the end effectors to ensure proper c~ tion. It would, Ll,e.~Ç(,re, be adv~nt~geouc to develop an electrosurgical instrument wherein the surgeon is not required to adjust the pressure applied by the end effector prior to applying electrosurgical energy to tissue in the region of c~A~ tion It would further be adv~m~gPous to design an instrument wherein the pressure applied to the tissue prior to co~ tion is within a predetermined range.
One known method of varying the pressure applied to the tissue by the jaws of 5 the end effector involves varying Ihe gap betw~ll the jaws depending upon the tissue being grasped. However, such an arr~ng~rn~nt would n~r~ccit~te the use of dirr. .e~l-instruments, llirr~ru t end effectors or dirr~e~ staple cartridges ~lPpen~ing upon the tissue being gr~cre~- It would, ll~erefol~ be adv~nt~eous to design an ihl~L,ulllenl ~he~ein the pr,~ r~ applied by the end effector would vary with the thirl~ness and 10 makeup of the tissue being grasped.
Non electrosurgical en~ocutters such as those described in US Patent 5,597,107, employ a relatively stiff lower jaw m~mber which inc-lu~les a staple cartridge in conjunction with a more flexible upper mPmber which acts as an anvil 15 against which the staples are formed. In such insllul~ , the anvil is ~ner~lly m~mlf~r,tnred to be as stiff as possible, within the limits of size, materials and other design consi~prationc and the spring rate of such an anvil may be, for example, in the range of 350450 pounds per inch. A stiff anvil helps to ensure that the staples form prU~Ll~ when the instrument is fired. Spring rate, in terms of tissue collll.l~;on 2 0 forces in conventi~n~l staplers with gap spacing pins, is used in conjunction with the gap pin to create and m~int~in a minimnm gap between the staple cartridge and the anvil, setting the height of the formed staple. Therefore, the ~iecign~ors of convention~l stapling instruments with gap spacing pins are primarily in~ d in the forrn~ ion of a simple beam with consistent gap to form c~nCi~t~nt staples. In other ~l~cignc, the gap 25 pin is not used and the anvil is ~eCigne~ with s~ffirient ~;rr"Ps~ to f~rilit~te the form~tion of tissue. It would, therefore, be adv~nt~geol~c to design an electrosurgical instrument where the spring rate of the anvil is ~lfficiently stiff for the formation of staples while exerting a pressure in a range which f~Cili~t~s the proper cauterization of tissue.
Summary of the Invention It is therefore an object of the present invention to provide a hemostatic ele~llo~llr~,ical instrument which can exert pressure in a range to efficiently ?;ovide 5 improved hPmost~cis in multiple tissue types and thicknPc~, e.g., in fleshy or vascular tissue areas, and high, low or combination impedance tissues. Hernost~cic is used herein to mean genPrally the arresting of bleeding inr~ ine by co~ tion, caule,izdlion and/or tissue joining or welding.
Another object of the invention is to provide an improved cutting and stapling device with an elecl ~.y means for tissue welding or r.~te~ on along a cutting path wherein the device is adapted to grasp tissue and exert a pressure within apr~1elJ..,.inPd range in order to provide improved hPmos~cic prior to cutting the tissue.
These and other objects of the invention are described in an el~;llu~,,.gical device having an end effector with opposing interfacing surr~ces ~c~ A with jawsfor en~ging tissue therebetween, and two electrically op~;le poles located on one or both of the opposing surfaces. The poles are isolated from each other with an 2 0 in~ ting material, or, where the poles are on opposite in~Ç~ g surfaces, they may be offset from each other so that they do not directly oppose each other on illL~ Cillg s,lrLdces. In particular, an elec~ tgi~al device according to the present invention inellldPs a subs~nti~lly fixed lower jaw. Further, an electrosurgical device accor&lg to the present invention includes a subst~nti~lly flexible upper jaw having a spring rate in the range of between approxi~.,ately 200 pounds per inch and apploJ.il.lalely 600 pounds per inch. More particularly, the spring rate of the upper jaw is appro~ lalely 275 pounds per inch.
An electrosurgical instrument of a preferred embodiment co,.lp~esses tissue to a pressure within a predeterrnined range in a coll.pr~s~ion zone between a firstEND-402 interfacing surface and a second interfacing surface and applies electrical energy through the compression zone. The first interfacing surface is comprised of: a first pole of a bipolar energy source, which interfaces with the co,l.pl~sed tissue in the co",ples~ion zone; and a second pole electrically isolated from the first pole and 5 located on the same or opposite interfacing surface. Electrically isolated poles are defined herein to mean electrodes isolated from each other by an in~ ting material in the end effector and/or offset from each other on opposing ~UlGlCes.
In a ~refe~l~d embodiment, the co"~ s~ion zone is an area defined by a 10 col~plession ridge on one of the intelr~illg surfaces which co",presses the tissue against the other interfacing surface. Also, there may be a co",l.lession ridge on both ~.,~lr~ing surfaces. A co~ tion zone is defined by the first pole, the second pole, and an insulator in~ tin& the first pole from the se~ond pole. The second pole, located on one of the interfacing surfaces, is gen~r~lly ~ Pnt to the in~ tor on the 15 same int~.r~.h-g surface or across from the in~ tcr on an opposing surface. Ihis n&~rn~nt electrically isolates the two poles and enables the current path belween the first and second poles to cross through a desired area of tissue.
It is believed that the tissue Colll~res~ion norrn~li7P.s tissue imperl~n-~e by 20 rebl~ing structural dirre~l,ces in tissue which can cause impedance dirÇ~ll,nces.
Co,~ .,~ion also stops si~ific~nt blood flow and squ~7Ps out blood which acts as a heat sink, particularly when flowing through blood vessels. Thus, CO"~r~ ~ion optimi_es delivery of energy to tissue in part by enabling the rate of energy delivery to exceed the rate of ~ sir~iQn due to blood flow. The arr~ngernPnt of the electrodes, 25 which make up the poles, is ill~pol~lt to ensure that the current passing between the two poles passes though the co"lple;,~ion _one. Also, in~ tion or isolation of the op~o~i~ poles from each other on the instrument permits tissue colllpressioll without shorting of the instrument poles or electrical arcing cornmon in bipolar in~L~u",c.lls.
In one embodiment of the present invention, the pressure initially applied to tissue in the co~ r~s~ion zone is between appru~ lalely 30 pounds per square inch (psi) and apl)ro~illlaoely 250 psi. In a further embodiment of the present invention, the pressure initially applied to tissue in the cc"llp,~s~ion zone is belweel~ app.u~cima~ly 5 75 psi and 250 psi. In a further embodiment of the present invention, the pr~,i,sure initially applied to tissue in the co,lll~lession zone is between ~l~lu~ tely 115 pSi and 185 psi.
Thus, the tissue colll~r, ~ion and the arr~n~m~nt of the electrodes permit 10 more efflcient cauterization and offer the advantage of achieving hemQst~ci~ in a wide range of tissue impedance, thickness and v~ularity.
In an alternative embodiment of the invention, the first pole is located on a first in~.r~.~g surface of a first jaw and the second pole is located on the same jaw as the 15 first pole, but not on the illte.r~chlg surface.
The present invention also provides a device capable of co~ ting a line or path of tissue along or lateral to a cut line or a cutting path. In one emb~limPnt the first pole comprises an elong~ted electrode. The elon~tPd electrode along with the 20 ~dja(~Pnt in~ tor form a ridge to cOlllL)l~,a~ the tissue to be cauterized. The second pole is ~ rPnt the insulator on an op~;le side of the inc~ tor from the first pole.
In one preferred embo~limPnt a cufflng means for cutting tissue is inco.~l~d into the device and the device provides hetnost~tir lines a~j~rPnt to the path of the 2 5 cufflng means. Of course, cutting may occur at anytime either before, during or after cauterization or welding. In one variation of this yrefell~d embodiment, stapling means is provided on one or both sides of the cutting path.
In one embodiment, an indicator means ~"...ll...ir~tes to the user that the 3 o tissue has been cauteri~d to a desired or ~lede~l"ined degree. ' In another embodiment, tne coqgulqtion is completed prior to any mPrhqnirql cutting, i.e."qrtl~qtion of the cutting means. If an indicator means is used, once tissue is c~u~l~;d, the cutting means may be ~rnl~tecl to cut between the parallel bars while the rows of staples are applied to the tissue.
In another embodiment, the h~most~tic device is incorporated into a linear cutter similar to a linear cutting me~h~ni~ql stapler. In this embodiment the hPmost~tir device cu~ ises two parallel and joined elon~qtPd electrode bars which form one pole, and a slot for a cutting means to travel between the bars. Optionally, one or 10 more rows of staples may be provided on each side of the slot and bars to provide additional k...,o~l~c;c. In operation, tissue is clamped b~ en two jaws. Electrical energy in the form of radio frequency current is applied to the co-"plessed tissue to ~uh li~e the blood vessels along the two parallel bars.
Another em~liment provides a means for ~Pt~ing abnormal iml~eA~nre or other elf~ p~ which are out of a p~ ~- ~-,in~ range. For example, the means for ~let~ing may be used to indicate when the in~LIu~l,e,lL has been applied to tissue PYhihiting imre~qnre out of range for ~nticipqt~ good cQ~ lqtion It may also be used for dPt~ting other instrument abnonn~lities It is possible to detect the20 abnormal con-lieion, for esample, by using COlllp~iSOllS of norrnal ranges of initial tissue impe~nc~ in the interface electronics. This could be sensed in the first few milli~n~s of the application of RF energy and would not present a si~;r~c~
Lll.,~ Lic dose of energy. A warning mPeh~nicm may be used to warn the user when the impe~nre is out of range. Upon repocitioning of the instrument, the same 25 me~ -lent criteria would apply and if the tissue impedance was again out of range, the user would again be warned. This process would contin.le until the normal imre~nre range was satisfied and good cQ~llqtion could be ,qntiriptqtP~
Similarly another embodiment provides a tissue welding and cauterizing 30 cutting device similar to an intr~lnmin~l stapler. Preferably, the poles are formed in two c~n~P~ ;c circle electrodes sep~dl~d by an insulator. The electrodes which make up the poles may be located on either the stapler cartridge or the anvil.
These and other objects of the invention will be better understood from the 5 following q.~t.qrllP~ Detailed Description of the Drawings, when taken in CO~ CliO
with the Detailed Description of the invention.
Detailed Description of the Drawings Figure 1 is a side elevational view of an ~-ndo~;c ele~ au~ly linear stapling and cutting instrument of one embodirnent of the present invention;
Figure 2 is a side cross ~non~l view of the ins~ument of Figure 1;
Figure 3 is a partial cross se~t~onql view of the dis~l end of the in~i.lUlll~ of Figure 1 in an open L~;l;on;
Figure 4 is a partial cross sectional view of the distal end of the instrument of Figure 1 in a closed, unfired position;
Figure 5 is a partial cross ~non~l view of the distal end of the instrument of Figure 1 in a closed, fired position;
Figure 6 is a front cross se~nQn~l view of the dist~ end of the in~L~u~--ent of 2 5 Figure 3 taken along the line 6-6;
Figure 7 is a bottom isolated view of the anvil jaw of the instrument of Figure l;
3 o Figure 8 is a top isolated view of a cartridge of the instrument o~Figure l;
Figure 9 is a side cross sectional view of the jaw of Figure 7 along the line 9-9;
Figure 10 is a flow chart illustrating a feecl~rl~ system of the present invention;
Figure 11 is a front cross se~tion~l view of the end effector of another Pmbor imPnt of the presen~ invention;
Figure 12 is a front cross ~tion~l view of the end effector of another embodiment of the present invention;
Figure 13 is a front cross se~tiorl~l view of the end effector of another em~impnt of the present invention;
Figure 14 is a front cross s~tion~l view of the end effector of another çmbo limPnt of the present invention;
2 0 Figure 15 is a bottom isolated view of the anvil of another embodiment of the present invention;
Figure 16 is a bottom isolated view of the anvil of another embodiment of the present invention;
Figure 17 illustrates a cross sectional view of the distal end of another embodiment of the present invention;
Figure 18 is front cross section~l view of the end effector of Figure 17;
Figure 19 is a front cross sectiQ~ view of the end effector of another embodiment of the present invention;
Figure 20 is a top view of a cartridge of a circular cutter of the present 5 invention;
Figure 21 is a bottom view of the anvil of a circular cutter of the present invention.
1 0 Figure 22 is a cross se~tion~l view of the end effector ao~or~ g to a further embodiment of the present invention.
Detailed Description of the ~lcfell~,d Emb~limPnt~
R~ferrin~ now to Figs. 1-9, there is illllctr~b~d a l)leL.~Gd embodiment of the present illvcllLi~ll. An çn-los~op.c cle~ u~L.~ Iinear cutting and stapling il~sllu~
10 is shown having a body 16 coupled to a shaft 30 with a lumen e~ n.l;.~g .etl~uugh and an end err~or 50 eYten~ling from the distal end 21 of the shaft 30.
The shaft 30 is forrned of an insulative material and has an electrically c~n~lctive 2 0 sheath 38 e~t~Pn~ling through its lumen. A channel 39 eYt~Pn-ling through the sheath 38 guides co axial movement of a driver means 44 within the channel 39. In this particular emb~imPnt, the driver means 44 in~ PS a firing trigger 14 ~ca~i~tP~ with the body 16, coupled to a flexible firing rod 40 coupled to a driving rod 41, coupled to a block 43. The block 43 is coupled to a cut~ng means 11 and a staple driving wedge 13, which the driving means 44 advances by way of the block 43 into the end effector 50.
The end effector 50 comprises two i"tcLr~ing jaw members 32, 34. The end effector 50 is secured by way of jaw member 34 to the channel 39. The jaw mPm~er3o 32 is movably secured to jaw member 34. The body 16 has a clamping~trigger 12 for CA 02237429 l998-05-l2 closing the jaws 32, 34 which longitudinally advances a close rack 45 coupled to the y~o~ al end of the sheath 38. The close rack 45 advances the sheath 38 co-axially through the shaft 30. The sheath 38 advances over a c~mming surface 27 of jaw 32 to close the jaws 32 and 34 onto tissue situated between the jaws. As described in more 5 detail below, the close rack 45 also acts as a switch to close the circuit which oommllni~t~s electrical energy to the end effector 50.
Referring now to Figs. 3-9 and 22 an enlargement of the end effector 50 of the instrument 10 is illustrated. The jaw members 32 and 34 are shown in an ur,~l~..,ped 1 o position in Figure 3, in a clarnped, unfired position in Figure 4 and in a clamped, fired position in Figure 5. Jaw member 32 compris~s an anvil 18, a U-shaped first pole 52 P-tPn~ing lollgitl~in~lly with respect to the jaw 32, and a U-shaped inc~ ting material 55 surrounding the outside of the first pole 52. Jaw m~mber 32 has an inner surface 33 which faces an inner surface 35 of jaw 34. The inner surface 33 includes first pole 52 which comprises two electrically c4----.-U--i~'~l;-.g electrode bars 53, 54 comprised of s~qinlPcc steel or ~ minllm, e~tPn-ling ~lbs~nti~lly along the length of the inner surface 33. The bars 53, 54 are se~dted by a knife channel 42 PstPnlline loneitu~in~lly through the first pole's center to form its U-shape. The surface of the bars are formed in flat strips to provide more surface area contact with tissue. Two 2 0 series of pockets 36, 37 located on anvil 18, for receiving staple ends, extend along the inner surface 33, lateral to and outside of bars 53, 54 ~ec~ ely. The electrode bars 53, 54 and the incli~ting m~teri~l 55 form a ridge 56 el~tPn~ling out relative to the anvil portion 33a of the iMer surface 33 (Figure 6). The anvil 18 is formed of an ele~ i~lly c~n~ctive material and acts as a second pole electrically opposite to the 2 5 first pole. The anvil 18 is isolated from the first pole 52 by the U-shaped in.~ ting material 55.
Jaw member 34 comprises a cartridge chaMel 22 and a cartridge 23. The cartridge 23 inr~ s a track 25 for the wedge 13, knife chaMel 26 elctPn-ling 3 o longitudinally through the center of the cartridge 23, a series of driveFs 24 e~tPn-ling into track 25 and staples 100 arranged in two sets of parallel double rows. When tissue is engaged between the jaws 32, 34, the driver means 44 may be ~ tPd or fired using trigger 14 to advance the cutting means 11 and wedge 13 through the ~n~d tissue to staple and cut the tissue. When the firing me~h~ni~m 14 is ~rtl~t~d the wedge 13 is advanced through the track 25 causing the drivers 24 to displace ~w~ds the staples 100, thereby driving the staples 100 through tissue and into anvil pockets 36, 37.
In the embodirnent of the invention illustrated in Figure 22, ~im~nSion B, which is measured from inner surface 33 of jaw member 32 to tissue surface 80 of U-shaped in~ ting material 55, is preferably in the range of from app,u~i",~ely 0.0 inches to appruA~ tPly 0.045 inches and preferably appro~i".~tely 0.0 inches.
Dillle.~s;on C, which is measured from inner edge 82 to outer edge 84 of U-shaped insulator 55 along tissue surface 80, is preferably in the range of from a~pluA;lll~t~ ly 0.01 inches to ~ro,d.llalely 0.04 inches and preferably applù~ ely 0.02 inches.
Dim~n~ion E, which is Ille~.ll~d from inner edge 86 to outer edge 88 of first pole 52 as measured along tissue surface 90, is preferably in the range of from appro~ ;ly .002 inches to .04 inches and preferably ~ro~i.llately .020 inches. DimPn~ion G,which is measured from tissue surface 90 to tissue surface 92 with jaws 32 and 34 closed, is preferably in the range from a~l)ro~illl~tPly 0.0 inches to a~ploAilllalely 0.020 inches and preferably ay~roAilllately 0.001 inches. Dimension G is measured without tissue engaged.
A knob 15 located on the distal end of the body 16 rotates the shaft 30, sheath 2 5 38, channel 39 and end effector S0 which are directly or indirectly coupled to the knob 15 so that the knob 15 may be used for rotational pl~cem~nt of the end effector jaws 32,34.
Bipolar energy is supplied to the end effector 50 from an electrosurgical generator 60 through wires 19, 20 extending into the body 16 of the instrument. The generator 60 is user controlled by way of a footswitch 65.
Wire 19 which provides electrical current to the first pole, is coupled through a wire or other electrical contact means 61 to electrical contact 62, ~CS~i~t~d with the first pole, located on the distal end of close rack 45. Wire 20 which carries the current of the opposite pole, is coupled through a wire or other electrical contact means 66 to a disc comact 67 located at the distal end of the close rack 45 and 1 0 cl~ll ically isolated from contact 62.
A disc contact 63, ~ccoci~ted with the first pole, located at the distal end of the body 16 is in eleotrical comml-ni~tion with a wire or other contact means 64. Contact means 64 extends through channel 39 to end effector jaw 32 where it contacts first 1 5 pole 52. The disc contact 63 permits the knob 15 to rotate while contact is m~int~in~d ~ ,veen the disc contact 63 and the contact means 64. The contact means 64 is electrically in~ tP~ from the sheath 38.
When the clamping trigger 12 is ~ t~'.d, the close rack 45 moves distally so 20 that the contact 62 comes in electrical c~.,li~tion with the disc contact 63 and the disc contact 67, ~C~ -Pd with the second pole 51, comes in electrical contact with the electrically cor~ rtive sheath 38. The sheath 38 moves over the c~mming surface 27 of the electrically conductive anvil 18 which acts as the return electrode. Thus the electrical circuit is closed when and only when the clamping trigger 12 is closed.
In operation, the end effector 50 of the instrument is located at a tissue site where tissue is to be cut. The jaw members 32, 34 are opened by pressing a release button 70 which releases a button spring 71 and permits the close rack 45 to move proximally. Tissue is then placed belween the h~lr~il~g inner surfaces 33, 35 3 o ~ ely of the jaw members 32, 34. The clamping trigger 12 is StI1~71~ l to cause the sheath 38 to move over the c~mming surface 27 and thereby close the jaws 32, 34 and ~imult~n~usly close the electrical circuit as described above. The electrode bars 53, 54 and the inc~ hng material 55, which together form the ridge 56, colllyle~ the tissue ag~unst the inner surface 35 of jaw member 34. A user then applies RF energy 5 from the generator 60 using the footswitch 65 or other switch. Current flows through the cull,plessed tissue be~een the first pole 52, i.e. the bars 53, 54, and the second pole 51, i.e., the anvil 18.
In one embodiment of the present invention the initial pressure applied to 0 COIllpfeSS the tissue in the compression zone is between ~pru~llldLely 30 pounds per square inch (psi) and 250 psi. More particularly, in a further embodiment of thepresent invention the initial pressure applied to C~ p~SS the tissue in the COIllpl~_~iOll zone is l~c~ween ~plo~;",~ely 75 psi and 250 psi. More particularly in a furtherembodiment of the present invention the initial pll,S~ , applied to COllly~SS the tissue in the co",~-ei,~ion zone is belw~ll appro~ill,aL~ly 75 psi and 175 psi. ~n one emk).lim~nt of the present invention, the initial pressure applied to c~",p~ tissue po~;lionPd between the jaws is aypl~ oly 125 psi. With s(lrrirle~l ple~.l~ applied fluid, inr~ ing blood, is forced out of the tissue in the c~lllpres~ion zone, f~rilit~tin~
~~g~ tion In a~lition~ pl~ss-Jle applied to tissue within the colllyl~s~ion zone2 o f~rilit~t~s coupling of electrosurgical energy to the tissue by forcing the tissue against the electrode.
The pressure exerted by the anvil is a fimrtion of the spring rate of the anvil.By providing a "pre-bend" angle on the anvil it is possible to obtain a pre-load (at a 25 zero gap.) Thus, where a pre-bend angle is applied, the anvil may be viewed as a y~ s~d beam. A P.~fe--~,d value of preload is in the range of between 12 and 18 pounds with a ple&-led value of approAil..aL~ly 15 pounds. The spring rate of the anvil is more accurately a function of the stiffness of the ~system", where the system includes the anvil, channel, cartridge, tube, etc. Each of the elemrnt~ of the system has a particular spring rate and each may be suitably modified to increase the stiffness of the system.
In one embodiment of the present invention, that the spring rate of jaw 32 is between ~pfu~ tely 225 pounds per inch and appn~Ai~ldlely 350 pounds per inch.
More particularly, the spring rate of anvil 18 on jaw 32 is preferably in the range of appr~,~..a~ly 275 pounds per inch.
Preferably the bipolar energy source is a low impe~n~e source providing radio frequency energy from about 300 kHz to 3 MHZ. Preferably, the current delivered to the tissue is from 0.1 to 1.5 amps and the voltage is from 30 to 200 volts RMS.
An audible, visible, tactile, or other fee~ c~ system may be used to indicate 1 5 when ~, rr;c:e~ .,dl-on has o~u~l~d at which point the RF energy may be turned off. An example of such a f~Al,~r~ system is described below. After the RF energy is turned off, the cutting means 11 is advanced and the staples 10û are fired using the firing trigger 14. Firing is accomplished by rotating the firing trigger 14 acting as a lever arm about pivot 14a. The driver means 44 advances the cutting means 11 andwedge 13. The cutting means 11 cuts the tissue in bel~n the bars 53, 54 where the issue has been ~L~t~,~ed. Thus, the cut line is lateral to the c~ tion lines formed by the bar electrodes. The wedge 13 sim-llt~nP~usly advances the drivers 24 into the staples 100 causing the staples 100 to fire through tissue and into the pockets 36, 37 of the anvil 18. Staples lûû are applied in two longib~rlin~l double rows on each side of 2 5 the cutting means 11 as the cutting means cuts the tissue.
Operation of linear staplers are known in the art and are ~i~.cc~, for e~ample, in U.S. patent Nos. 4,608,981, 4,633,874, and U.S. Application Serial No.
07/917,636 i..cc,-~o.dLed herein by l~ference.
' In one embodiment the cartridge provides multifire stapling capabilities by replacing the double row of staples with a single row. In the layaro~yic stapling and cutting devices presently in use, a single shot replaceable car~idge is used. In order to provide better hemostasis, this type of stapler was deci~n~d to provide a double row of 5 staples for each parallel row. Rer~ ;e of the size of the space n~c~c~;~ry to contain the double row of staples, a refireable cartridge with stacked staples has not been prerel,~d because of the additional sp~ required for st~r~ing staples. In the multifire stapling embodiment a single row of staples is used. Using a single row of staples permits st~ ng of staples in the sp~ previously occupied by the second row of 10 staples, providing multifire capabilities. In a further embodiment, no staples are required and the electrical current lines provide the n~SS~ry h~most~ci~, A pr~Çelled embodiment of the present invention inclll(les a f~cl~r~ system n~od to indicate when a desired or predetermined degree of c~ tion has 15 o~ull~d. This is particularly useful where the co~ tion zone is not visible to the user. In a particular embo~imPnt the fe~ system IIICaS.ll~,S electrical p of the system which include c~ tion level.
The Çee~ system may also ~et~rrnine tissue ch~ L,cs at or near a 20 c~gul~tiQn zone which indicate degree of c~ tion The electrical imreA~n-~ of the tissue to which the electrical energy is applied may also be used to indicate c~ tion ('~rnr~lly, as energy is applied to the tissue, the i~,.pe~nr~ will initially doclease and then rise as c~ tion occurs. An er.~lll)lc of the rel~tion~;hir bel~..~n el~lrical tissue impe~nr~ over time and c~ tion is described in Vaellfors, Bertil 2 5 and Bergdahl, Bjoern "~lltorn~tiç~lly controlled Bipolar Elec~ gul~tirn,"
Neurosurg. Rev. p. 187-190 (1984) inco,~oldted herein by re~erence. Also as d~s:crzl;on occurs, impedance illclcases. ~lssue carboni7~tion and or stic~ing to instrument as a result of over application of high voltage may be prevented using a feeAh~r~ system b. sed on tissue impe-l~nt~e characteristics. Other examples of tissue CA 02237429 l998-0=,-l2 characteristics which may indicate co~g~ tion include ~l,peldture and light refl~ct~nr,e.
Referring to Figure 10, a flow chart illustrates a fee~back system which is 5implemPntPd in a preferred embodiment of the present invention. First, energy is applied to the tissue. Then the system current and voltage applied to the tissue is ~rmin~-l The imped~n-~e value is c~ ted and stored. Based on a filnçtion of the impe~nfe, for example, which may include the impedance, the change in impedance,and/or the rate of change in impe-l~nr~, it is ~lpt~rminpd whether desired coa~ tinn 10has occurred. If c~ tion has occurred to a predeterrnined or desired degree, an in~i~tion means in~ir~tPs that the energy should be turned off. Such an in~lir~ti~n means may include a visible light, an audible sound or a tactile indicator. The feed~rl~ means may also control the ~nel~o[ and turn the energy off at a certainimrefl~nre level. An ~ltern~tive embodiment provides a c~ntin~rJ~ audible sound in 15which the tone varies ~.pen~ing on the im~nr~e level. An ~d~litir,n~l feature provides an error in~ir~tion means for in~i~ting an error or instrument m~lfLlnr,tir,n when the impedance is below a normal minimllm and/ or above a ~ ll range.
Figures 11-14 illustrate ~It~rn~tive c~nfiglration~ of an end effector. In Figure 2011 the first pole 152 and the second pole 151 are both located on the same jaw 132 having the anvil 118. The U-shaped first pole 152 forms the Imife channel 142. A U-shaped in~ tor 155 surrounds the first pole 152 except on the surface 133 so that it is electrically isolated from the second pole 151. The coll-plei.~ion ridge 156 is formed on the cartridge which is made from an electrically non con~ctive material. The 25ridge 156 co"ly~c~ses tissue against the first pole 152 and insulator 155 to form a tissue colllprc;,sion zone.
In Figure 12, the first pole 252 and the second pole 251 are both located on thesame jaw 232 having the anvil 218. The first pole 252 and the second pole 251 each 30are located on opposing sides of the knife channel 242. An in~ tor ~55 surrounds the poles 251, 252 except on the surface 233 50 that the poles 251, 252 are electrically isolated from each other. The eompression ridge 256 is formed on the cartridge which is made from an electrically non con~ctive material. The ridge 256 collly~esscs tissue against the poles 251, 252 and in~ tor 255 to form a tissue compression zone.
In Figure 13, second pole 351 is located on the jaw 332 having the anvil 318 while the first pole 352 is located on the cartridge 323. The U-shaped first pole 352 forms the knife channel 326 and is surrounded by insulator 355a. A U-shaped in~ tor 355b forms the l~ife channel 342 in jaw 332. E~cept for the insulator 355b, 1 0 the jaw is formed of an electncally c~ ctive material which makes up the second pole 351. The first pole 352 and the insulator 355a form the col,-prts~ion ridge 356 which co-l,prcsscs tissue against the surface 333 of jaw 332 ~o form a co~-y~;onwne. The insulator 355b is of sl-fficient width that it prevents poles 351, 352 form co"~ g when the jaws 332,334 are closed.
In Figure 14, the first pole 452 and the second pole 451 are both located on thejaw 434 having the cartridge 423. The first pole 452 and the second pole 451 each are located on opposing sides, forming the knife channel 426 through the cartridge 423.
An insulator 455a surrounds the poles 451, 452 except on the surface 435, so that the poles 451, 452 are electrically isolated from each other. The co-l-y~cs~ion ridge 456 is formed on the cartridge 423 and forms a CO~l~pl~ s~ion zone by colll~ ,ssillg tissue against an insulator 455b disposed on the surface 433 of the jaw 432.
Figure lS illustrates an ~lt~rn~tive embodiment. The first and second poles 2 5 551, 552 and knife channel 542 are arranged in a similar configuration as in Figure 12 except that the first and ~cond poles 551 and 552 each compri~ a series of electrically co~n~ electrodes staggered along the length of the knife channel with in~ ting material in between staggered electrodes.
Figure 16 illustrates staggered electrodes as in Fig 15 but with first pole electrodes 652 and second pole electrodes 651 altemating along the length of the knife channel 642 and on each side of the knife channel 642.
Figs. 17 and 18 illustrate another embodirnent in which first and second poles 751, 752 each comprise staggered electrodes. In this embodiment, the first pole 752 is staggered along each side of the knife channel 126 and located on the CO~ s~ion ridge 756 formed on the car~idge 723. The second pole 751 is staggered along each side of the knife channel 742 on the surface 733 of jaw 732. As can be seen from1 0 Figure 18, the poles 751, 752 are vertically ~lign~ but as ~ JS~t~A in Figure 17, are staggered so that when the jaws 732, 734 are closed, the poles are electrically isolated from each other by insulators 755a, 755b.
Pigure 19 illustrates an alternative embodiment of the end effector. The first pole 852 and the second pole 851 are both located on the jaw 832 having an anvil 818.
The first pole 852 forms the ridge 856 for c~",pr~ lg tissue in a c~",pression zone and is located on interfacing surface 833. The second pole 851 is located on the side of the anvil 818 and not on inte~f~cil~g surface 833.
2 0 Figs. 20 and 21 illustrate a circular cutter of the present invention with stapling means. Figure 20 illustrates the stapler cartridge 900 with an in~l~ing surface 933.
A double row of staple ape.Lul~,s 901 through which staples are driven into tissue are s~ggered about the outer circumference of the surface 932. A first pole 952 er,cil.,les the inner circumference of the surface 933. An insulator 955 electrically isolates the first pole 952 from the portion 933a of the surface 933 surrounding the staple apertures. The staple aperture portion 933a is formed of an electrically c~n~ve material and acts as a second pole. A circular cutting knife 911 is recessed within the cartridge 900 radially inward from the inner circumference of the surface 933.
Figure 21 illustrates an anvil 918 with pockets 937 for receiving staples and a co~ .cssion ridge 956 for colllL,res~ing tissue against the first pole 952 and inc -l~tor 955 of the cartridge. The circular cutter is operated similarly to the circular stapler described in U.S. Patent No. 5,104,025 incorporated herein by reference. Prior to 5 stapling and cutting however, tissue welding electrical current may be delivered between the first pole 952 and the staple aperture portion 933a to tissue.
In an alternative embodiment, the circular cutter may be used without staples.
Electrical current is delivered through the poles to weld and C~ t~ tissue, then the 10 knife may be advanced to cut tissue in a procedure such as an ~n~ct~mosic~
In operation, the jaws of t~he instrument, for example, jaws 32 and 34 of end effector 50, are closed around the tissue which is to be treated. Tissue trappedbetween the instrument jaws is eoln~ress~d as described herein An el~;LIosllrgical illsL,ulllel~L according to the present invention is ber1~firi~l in that coAg~ tirn of tissue is enh~nr~ed since the ples~ s applied force fluid out of the c4 ~ tion region without tearing the tissue. The prcs~ c ranges srerifiPd herein are also beneficial in that, using an instnlment according to the present invention, contact 2 0 between the tissue and electrodes is improved, co~gulation is improved throughout the tissue and charring is reduced.
Several variations of this invention has been described in ~ ion with two specific embo-limPntc involving endo~pic cutting and stapling. Naturally, the 25 invention may be used in numerous applir~tionc where hPmost~cic in desired.
Accordingly, will be understood by those skilled in the art that various eh~ngrs and mo lifir~tionc may be made in the invention without departing from its scope, which is defined by the following claims and their equivalents.
.
Field of the Invention This invention relates to an improved electrosurgical instrument and method for ~li~Lion, cr~ tion and/or tissue welding in the ~lÇul~-~ance of surgical procedures, ec~~ y çn-losropic procedures.
Back~,lound of the Invention Surgical procedures requiring cutting of tissue can cause bleeding at the site of the cufflng. Before surgeons had the means to control bleeding many surgical u~d~ul~,s were quite ~lifficult to pelrul~ because of excessive blood loss.
~mos~cic is even more crucial in çndosc~pic or l~arosoop;c surgery where if the bl~iing is not kept under control, the laparoscopy must be ~b~n~on~d and the patient's body cut to pelÇul"~ open surgery so that i~ ce~;ble ble~1ing may be controlled.
Thus, various terhniq!)es have been adapted to control bleeding with varying 2 0 degrees of success such as, for example, suturing, applying clips to blood vessels, and stapling, as well as eles;lloca~l~ly and other thermogenic t~ni~ es Advances in tissue joining, tissue repair and wound closure also have permitted surgical procedures previously not possible or too risky.
Initially, sut~lring was one of the prirnary means for providing hPmost~cic and joining tissue. Before other h~most~tic and tissue repair means were introduced,surgeons had to spend a great deal of time sewing the tissue of patients back together.
Surgical clips were introduced as a means to close off blood vessels, particularly when cutting highly vascularized tissue. Application of surgical clips, however, can be cumbersome in certain procedures. The vessels must;be i~lentifi~
.
Then a clip must be individually applied on both sides of the int~n-led cut of each ntified vessel. Also, it may be difficult to find some vessels, particularly where the vessel is surrounded by fatty tissue.
Surgical staplers have been effective in decreasing the arnount of time it takesto fasten tissue together. There are various types of surgical staplers. Staplers have been used for tissue joining, and to provide hemostasis in conjunction with tissue cutting. Such devices include, for example, linear and circular cutting and stapling instruments. Typically, a linear cutter has parallel rows of staples with a slot for a cutting means to travel between the rows of staples. This type of surgical stapler secures tissue for improved cutting, joins layers of tissue, and provides h-~most~cic by applying parallel rows of staples to layers of surrounding tissue as the cutting means cuts ~l~en the parallel rows. These types of cutting and stapling devices have been used su~ecs~ y in procedures involving fleshy tissue such as muscle or bowel, particularly in bowel rese~tion procedures. Circular cutting and stapling devices have ~c~es~r.llly been used, for example, in ~ ...otic ~1O~1~5 where a lumen is rejoined. However, the results with cutting and stapling devices have been less than O~ lUIII where the procedure involves cuthng highly vascularized tissue, such as...es, .~le-y or adnexa, which are prone to having h~most~cis plob'~-nc.
Electrocautery devices have also been used for effecting h~most~cic Monopolar devices utili~ one electrode ~Ccoci~tpd with a cutting or cau~ g instrument and a remote return electrode, usually adhered ~l~t~rn~lly to the patient.
More recently, bipolar instruments have been used because the cauterizing current is 2 5 generally limited to tissue between two electrodes of the instrument.
Bipolar forceps have been used tor cutting and/or c~ tion in various procedures. For example, bipolar forceps have been used in sterili7~tion procedures where the fallopian tubes are sealed off. Generally, bipolar forceps grasp tissue 30 between two poles and apply electrical current through the grasped tissue. Bipolar forceps, however, have certain drawbacks, some of which include the tendency of the current to arc between poles when tissue is thin or the forceps to short when the poles of the forceps touch. The use of forceps for c~ tion is also very ter~ e ~epen~lent and the forceps are not adapted to ~imult~n~ously C~tcr~,c a larger area of 5 tissue.
Bipolar scissors have been disclosed where two scissors blades act as two electrodes having in~llAtPd shearing surfaces. This device me~h~nir~lly cuts tissue as cr~]l~tin~ electrical current is delivered to tissue in the current path. Bipolar scissors 10 are also highly technique dependent in their use.
In prior devices, such as the device described in US Patent 5,403,312, cle.;llùsutgical energy has been delivered to biologic tissue in order to create a region of c~ tion, as, for example, on either side of an inricion, thus preventing blood 15 and other bodily fluids from leaking out of the inriC;on In such a device, if ffssue gra~ed by the jaws is co..lpllsscd too much by applying e~ccessive ~JI~UIC to the region of c~ tirJn~ the tissue grasped by the end err~ur may be torn or crushed.If the tissue is not compressed enough becau~ to little ~ u~ is applied to the region of c~gulAtion, the tissue in the region of co~ tion may not be not effectively or 2 0 uni~llllly ~u~-i2ed because fluid (e.g. blood) could remain in the region ofion In prior art devices, the surgeon has u~d tactile fee~lh~rl~ and visual clues to ~t~nnin~ the arnount of pressure to apply to the region in order to obtain optimum co~ tion. In instruments wherein the region of c~A~llAtion is partially or fully obscured, either by the end effector or by tissue, and is, therefore, not visible to 25 the surgeon, it is particularly difficult for the surgeon to ensure that the a~pluyli~te pressure is being applied by the end effectors to ensure proper c~ tion. It would, Ll,e.~Ç(,re, be adv~nt~geouc to develop an electrosurgical instrument wherein the surgeon is not required to adjust the pressure applied by the end effector prior to applying electrosurgical energy to tissue in the region of c~A~ tion It would further be adv~m~gPous to design an instrument wherein the pressure applied to the tissue prior to co~ tion is within a predetermined range.
One known method of varying the pressure applied to the tissue by the jaws of 5 the end effector involves varying Ihe gap betw~ll the jaws depending upon the tissue being grasped. However, such an arr~ng~rn~nt would n~r~ccit~te the use of dirr. .e~l-instruments, llirr~ru t end effectors or dirr~e~ staple cartridges ~lPpen~ing upon the tissue being gr~cre~- It would, ll~erefol~ be adv~nt~eous to design an ihl~L,ulllenl ~he~ein the pr,~ r~ applied by the end effector would vary with the thirl~ness and 10 makeup of the tissue being grasped.
Non electrosurgical en~ocutters such as those described in US Patent 5,597,107, employ a relatively stiff lower jaw m~mber which inc-lu~les a staple cartridge in conjunction with a more flexible upper mPmber which acts as an anvil 15 against which the staples are formed. In such insllul~ , the anvil is ~ner~lly m~mlf~r,tnred to be as stiff as possible, within the limits of size, materials and other design consi~prationc and the spring rate of such an anvil may be, for example, in the range of 350450 pounds per inch. A stiff anvil helps to ensure that the staples form prU~Ll~ when the instrument is fired. Spring rate, in terms of tissue collll.l~;on 2 0 forces in conventi~n~l staplers with gap spacing pins, is used in conjunction with the gap pin to create and m~int~in a minimnm gap between the staple cartridge and the anvil, setting the height of the formed staple. Therefore, the ~iecign~ors of convention~l stapling instruments with gap spacing pins are primarily in~ d in the forrn~ ion of a simple beam with consistent gap to form c~nCi~t~nt staples. In other ~l~cignc, the gap 25 pin is not used and the anvil is ~eCigne~ with s~ffirient ~;rr"Ps~ to f~rilit~te the form~tion of tissue. It would, therefore, be adv~nt~geol~c to design an electrosurgical instrument where the spring rate of the anvil is ~lfficiently stiff for the formation of staples while exerting a pressure in a range which f~Cili~t~s the proper cauterization of tissue.
Summary of the Invention It is therefore an object of the present invention to provide a hemostatic ele~llo~llr~,ical instrument which can exert pressure in a range to efficiently ?;ovide 5 improved hPmost~cis in multiple tissue types and thicknPc~, e.g., in fleshy or vascular tissue areas, and high, low or combination impedance tissues. Hernost~cic is used herein to mean genPrally the arresting of bleeding inr~ ine by co~ tion, caule,izdlion and/or tissue joining or welding.
Another object of the invention is to provide an improved cutting and stapling device with an elecl ~.y means for tissue welding or r.~te~ on along a cutting path wherein the device is adapted to grasp tissue and exert a pressure within apr~1elJ..,.inPd range in order to provide improved hPmos~cic prior to cutting the tissue.
These and other objects of the invention are described in an el~;llu~,,.gical device having an end effector with opposing interfacing surr~ces ~c~ A with jawsfor en~ging tissue therebetween, and two electrically op~;le poles located on one or both of the opposing surfaces. The poles are isolated from each other with an 2 0 in~ ting material, or, where the poles are on opposite in~Ç~ g surfaces, they may be offset from each other so that they do not directly oppose each other on illL~ Cillg s,lrLdces. In particular, an elec~ tgi~al device according to the present invention inellldPs a subs~nti~lly fixed lower jaw. Further, an electrosurgical device accor&lg to the present invention includes a subst~nti~lly flexible upper jaw having a spring rate in the range of between approxi~.,ately 200 pounds per inch and apploJ.il.lalely 600 pounds per inch. More particularly, the spring rate of the upper jaw is appro~ lalely 275 pounds per inch.
An electrosurgical instrument of a preferred embodiment co,.lp~esses tissue to a pressure within a predeterrnined range in a coll.pr~s~ion zone between a firstEND-402 interfacing surface and a second interfacing surface and applies electrical energy through the compression zone. The first interfacing surface is comprised of: a first pole of a bipolar energy source, which interfaces with the co,l.pl~sed tissue in the co",ples~ion zone; and a second pole electrically isolated from the first pole and 5 located on the same or opposite interfacing surface. Electrically isolated poles are defined herein to mean electrodes isolated from each other by an in~ ting material in the end effector and/or offset from each other on opposing ~UlGlCes.
In a ~refe~l~d embodiment, the co"~ s~ion zone is an area defined by a 10 col~plession ridge on one of the intelr~illg surfaces which co",presses the tissue against the other interfacing surface. Also, there may be a co",l.lession ridge on both ~.,~lr~ing surfaces. A co~ tion zone is defined by the first pole, the second pole, and an insulator in~ tin& the first pole from the se~ond pole. The second pole, located on one of the interfacing surfaces, is gen~r~lly ~ Pnt to the in~ tor on the 15 same int~.r~.h-g surface or across from the in~ tcr on an opposing surface. Ihis n&~rn~nt electrically isolates the two poles and enables the current path belween the first and second poles to cross through a desired area of tissue.
It is believed that the tissue Colll~res~ion norrn~li7P.s tissue imperl~n-~e by 20 rebl~ing structural dirre~l,ces in tissue which can cause impedance dirÇ~ll,nces.
Co,~ .,~ion also stops si~ific~nt blood flow and squ~7Ps out blood which acts as a heat sink, particularly when flowing through blood vessels. Thus, CO"~r~ ~ion optimi_es delivery of energy to tissue in part by enabling the rate of energy delivery to exceed the rate of ~ sir~iQn due to blood flow. The arr~ngernPnt of the electrodes, 25 which make up the poles, is ill~pol~lt to ensure that the current passing between the two poles passes though the co"lple;,~ion _one. Also, in~ tion or isolation of the op~o~i~ poles from each other on the instrument permits tissue colllpressioll without shorting of the instrument poles or electrical arcing cornmon in bipolar in~L~u",c.lls.
In one embodiment of the present invention, the pressure initially applied to tissue in the co~ r~s~ion zone is between appru~ lalely 30 pounds per square inch (psi) and apl)ro~illlaoely 250 psi. In a further embodiment of the present invention, the pressure initially applied to tissue in the cc"llp,~s~ion zone is belweel~ app.u~cima~ly 5 75 psi and 250 psi. In a further embodiment of the present invention, the pr~,i,sure initially applied to tissue in the co,lll~lession zone is between ~l~lu~ tely 115 pSi and 185 psi.
Thus, the tissue colll~r, ~ion and the arr~n~m~nt of the electrodes permit 10 more efflcient cauterization and offer the advantage of achieving hemQst~ci~ in a wide range of tissue impedance, thickness and v~ularity.
In an alternative embodiment of the invention, the first pole is located on a first in~.r~.~g surface of a first jaw and the second pole is located on the same jaw as the 15 first pole, but not on the illte.r~chlg surface.
The present invention also provides a device capable of co~ ting a line or path of tissue along or lateral to a cut line or a cutting path. In one emb~limPnt the first pole comprises an elong~ted electrode. The elon~tPd electrode along with the 20 ~dja(~Pnt in~ tor form a ridge to cOlllL)l~,a~ the tissue to be cauterized. The second pole is ~ rPnt the insulator on an op~;le side of the inc~ tor from the first pole.
In one preferred embo~limPnt a cufflng means for cutting tissue is inco.~l~d into the device and the device provides hetnost~tir lines a~j~rPnt to the path of the 2 5 cufflng means. Of course, cutting may occur at anytime either before, during or after cauterization or welding. In one variation of this yrefell~d embodiment, stapling means is provided on one or both sides of the cutting path.
In one embodiment, an indicator means ~"...ll...ir~tes to the user that the 3 o tissue has been cauteri~d to a desired or ~lede~l"ined degree. ' In another embodiment, tne coqgulqtion is completed prior to any mPrhqnirql cutting, i.e."qrtl~qtion of the cutting means. If an indicator means is used, once tissue is c~u~l~;d, the cutting means may be ~rnl~tecl to cut between the parallel bars while the rows of staples are applied to the tissue.
In another embodiment, the h~most~tic device is incorporated into a linear cutter similar to a linear cutting me~h~ni~ql stapler. In this embodiment the hPmost~tir device cu~ ises two parallel and joined elon~qtPd electrode bars which form one pole, and a slot for a cutting means to travel between the bars. Optionally, one or 10 more rows of staples may be provided on each side of the slot and bars to provide additional k...,o~l~c;c. In operation, tissue is clamped b~ en two jaws. Electrical energy in the form of radio frequency current is applied to the co-"plessed tissue to ~uh li~e the blood vessels along the two parallel bars.
Another em~liment provides a means for ~Pt~ing abnormal iml~eA~nre or other elf~ p~ which are out of a p~ ~- ~-,in~ range. For example, the means for ~let~ing may be used to indicate when the in~LIu~l,e,lL has been applied to tissue PYhihiting imre~qnre out of range for ~nticipqt~ good cQ~ lqtion It may also be used for dPt~ting other instrument abnonn~lities It is possible to detect the20 abnormal con-lieion, for esample, by using COlllp~iSOllS of norrnal ranges of initial tissue impe~nc~ in the interface electronics. This could be sensed in the first few milli~n~s of the application of RF energy and would not present a si~;r~c~
Lll.,~ Lic dose of energy. A warning mPeh~nicm may be used to warn the user when the impe~nre is out of range. Upon repocitioning of the instrument, the same 25 me~ -lent criteria would apply and if the tissue impedance was again out of range, the user would again be warned. This process would contin.le until the normal imre~nre range was satisfied and good cQ~llqtion could be ,qntiriptqtP~
Similarly another embodiment provides a tissue welding and cauterizing 30 cutting device similar to an intr~lnmin~l stapler. Preferably, the poles are formed in two c~n~P~ ;c circle electrodes sep~dl~d by an insulator. The electrodes which make up the poles may be located on either the stapler cartridge or the anvil.
These and other objects of the invention will be better understood from the 5 following q.~t.qrllP~ Detailed Description of the Drawings, when taken in CO~ CliO
with the Detailed Description of the invention.
Detailed Description of the Drawings Figure 1 is a side elevational view of an ~-ndo~;c ele~ au~ly linear stapling and cutting instrument of one embodirnent of the present invention;
Figure 2 is a side cross ~non~l view of the ins~ument of Figure 1;
Figure 3 is a partial cross se~t~onql view of the dis~l end of the in~i.lUlll~ of Figure 1 in an open L~;l;on;
Figure 4 is a partial cross sectional view of the distal end of the instrument of Figure 1 in a closed, unfired position;
Figure 5 is a partial cross ~non~l view of the distal end of the instrument of Figure 1 in a closed, fired position;
Figure 6 is a front cross se~nQn~l view of the dist~ end of the in~L~u~--ent of 2 5 Figure 3 taken along the line 6-6;
Figure 7 is a bottom isolated view of the anvil jaw of the instrument of Figure l;
3 o Figure 8 is a top isolated view of a cartridge of the instrument o~Figure l;
Figure 9 is a side cross sectional view of the jaw of Figure 7 along the line 9-9;
Figure 10 is a flow chart illustrating a feecl~rl~ system of the present invention;
Figure 11 is a front cross se~tion~l view of the end effector of another Pmbor imPnt of the presen~ invention;
Figure 12 is a front cross ~tion~l view of the end effector of another embodiment of the present invention;
Figure 13 is a front cross se~tiorl~l view of the end effector of another em~impnt of the present invention;
Figure 14 is a front cross s~tion~l view of the end effector of another çmbo limPnt of the present invention;
2 0 Figure 15 is a bottom isolated view of the anvil of another embodiment of the present invention;
Figure 16 is a bottom isolated view of the anvil of another embodiment of the present invention;
Figure 17 illustrates a cross sectional view of the distal end of another embodiment of the present invention;
Figure 18 is front cross section~l view of the end effector of Figure 17;
Figure 19 is a front cross sectiQ~ view of the end effector of another embodiment of the present invention;
Figure 20 is a top view of a cartridge of a circular cutter of the present 5 invention;
Figure 21 is a bottom view of the anvil of a circular cutter of the present invention.
1 0 Figure 22 is a cross se~tion~l view of the end effector ao~or~ g to a further embodiment of the present invention.
Detailed Description of the ~lcfell~,d Emb~limPnt~
R~ferrin~ now to Figs. 1-9, there is illllctr~b~d a l)leL.~Gd embodiment of the present illvcllLi~ll. An çn-los~op.c cle~ u~L.~ Iinear cutting and stapling il~sllu~
10 is shown having a body 16 coupled to a shaft 30 with a lumen e~ n.l;.~g .etl~uugh and an end err~or 50 eYten~ling from the distal end 21 of the shaft 30.
The shaft 30 is forrned of an insulative material and has an electrically c~n~lctive 2 0 sheath 38 e~t~Pn~ling through its lumen. A channel 39 eYt~Pn-ling through the sheath 38 guides co axial movement of a driver means 44 within the channel 39. In this particular emb~imPnt, the driver means 44 in~ PS a firing trigger 14 ~ca~i~tP~ with the body 16, coupled to a flexible firing rod 40 coupled to a driving rod 41, coupled to a block 43. The block 43 is coupled to a cut~ng means 11 and a staple driving wedge 13, which the driving means 44 advances by way of the block 43 into the end effector 50.
The end effector 50 comprises two i"tcLr~ing jaw members 32, 34. The end effector 50 is secured by way of jaw member 34 to the channel 39. The jaw mPm~er3o 32 is movably secured to jaw member 34. The body 16 has a clamping~trigger 12 for CA 02237429 l998-05-l2 closing the jaws 32, 34 which longitudinally advances a close rack 45 coupled to the y~o~ al end of the sheath 38. The close rack 45 advances the sheath 38 co-axially through the shaft 30. The sheath 38 advances over a c~mming surface 27 of jaw 32 to close the jaws 32 and 34 onto tissue situated between the jaws. As described in more 5 detail below, the close rack 45 also acts as a switch to close the circuit which oommllni~t~s electrical energy to the end effector 50.
Referring now to Figs. 3-9 and 22 an enlargement of the end effector 50 of the instrument 10 is illustrated. The jaw members 32 and 34 are shown in an ur,~l~..,ped 1 o position in Figure 3, in a clarnped, unfired position in Figure 4 and in a clamped, fired position in Figure 5. Jaw member 32 compris~s an anvil 18, a U-shaped first pole 52 P-tPn~ing lollgitl~in~lly with respect to the jaw 32, and a U-shaped inc~ ting material 55 surrounding the outside of the first pole 52. Jaw m~mber 32 has an inner surface 33 which faces an inner surface 35 of jaw 34. The inner surface 33 includes first pole 52 which comprises two electrically c4----.-U--i~'~l;-.g electrode bars 53, 54 comprised of s~qinlPcc steel or ~ minllm, e~tPn-ling ~lbs~nti~lly along the length of the inner surface 33. The bars 53, 54 are se~dted by a knife channel 42 PstPnlline loneitu~in~lly through the first pole's center to form its U-shape. The surface of the bars are formed in flat strips to provide more surface area contact with tissue. Two 2 0 series of pockets 36, 37 located on anvil 18, for receiving staple ends, extend along the inner surface 33, lateral to and outside of bars 53, 54 ~ec~ ely. The electrode bars 53, 54 and the incli~ting m~teri~l 55 form a ridge 56 el~tPn~ling out relative to the anvil portion 33a of the iMer surface 33 (Figure 6). The anvil 18 is formed of an ele~ i~lly c~n~ctive material and acts as a second pole electrically opposite to the 2 5 first pole. The anvil 18 is isolated from the first pole 52 by the U-shaped in.~ ting material 55.
Jaw member 34 comprises a cartridge chaMel 22 and a cartridge 23. The cartridge 23 inr~ s a track 25 for the wedge 13, knife chaMel 26 elctPn-ling 3 o longitudinally through the center of the cartridge 23, a series of driveFs 24 e~tPn-ling into track 25 and staples 100 arranged in two sets of parallel double rows. When tissue is engaged between the jaws 32, 34, the driver means 44 may be ~ tPd or fired using trigger 14 to advance the cutting means 11 and wedge 13 through the ~n~d tissue to staple and cut the tissue. When the firing me~h~ni~m 14 is ~rtl~t~d the wedge 13 is advanced through the track 25 causing the drivers 24 to displace ~w~ds the staples 100, thereby driving the staples 100 through tissue and into anvil pockets 36, 37.
In the embodirnent of the invention illustrated in Figure 22, ~im~nSion B, which is measured from inner surface 33 of jaw member 32 to tissue surface 80 of U-shaped in~ ting material 55, is preferably in the range of from app,u~i",~ely 0.0 inches to appruA~ tPly 0.045 inches and preferably appro~i".~tely 0.0 inches.
Dillle.~s;on C, which is measured from inner edge 82 to outer edge 84 of U-shaped insulator 55 along tissue surface 80, is preferably in the range of from a~pluA;lll~t~ ly 0.01 inches to ~ro,d.llalely 0.04 inches and preferably applù~ ely 0.02 inches.
Dim~n~ion E, which is Ille~.ll~d from inner edge 86 to outer edge 88 of first pole 52 as measured along tissue surface 90, is preferably in the range of from appro~ ;ly .002 inches to .04 inches and preferably ~ro~i.llately .020 inches. DimPn~ion G,which is measured from tissue surface 90 to tissue surface 92 with jaws 32 and 34 closed, is preferably in the range from a~l)ro~illl~tPly 0.0 inches to a~ploAilllalely 0.020 inches and preferably ay~roAilllately 0.001 inches. Dimension G is measured without tissue engaged.
A knob 15 located on the distal end of the body 16 rotates the shaft 30, sheath 2 5 38, channel 39 and end effector S0 which are directly or indirectly coupled to the knob 15 so that the knob 15 may be used for rotational pl~cem~nt of the end effector jaws 32,34.
Bipolar energy is supplied to the end effector 50 from an electrosurgical generator 60 through wires 19, 20 extending into the body 16 of the instrument. The generator 60 is user controlled by way of a footswitch 65.
Wire 19 which provides electrical current to the first pole, is coupled through a wire or other electrical contact means 61 to electrical contact 62, ~CS~i~t~d with the first pole, located on the distal end of close rack 45. Wire 20 which carries the current of the opposite pole, is coupled through a wire or other electrical contact means 66 to a disc comact 67 located at the distal end of the close rack 45 and 1 0 cl~ll ically isolated from contact 62.
A disc contact 63, ~ccoci~ted with the first pole, located at the distal end of the body 16 is in eleotrical comml-ni~tion with a wire or other contact means 64. Contact means 64 extends through channel 39 to end effector jaw 32 where it contacts first 1 5 pole 52. The disc contact 63 permits the knob 15 to rotate while contact is m~int~in~d ~ ,veen the disc contact 63 and the contact means 64. The contact means 64 is electrically in~ tP~ from the sheath 38.
When the clamping trigger 12 is ~ t~'.d, the close rack 45 moves distally so 20 that the contact 62 comes in electrical c~.,li~tion with the disc contact 63 and the disc contact 67, ~C~ -Pd with the second pole 51, comes in electrical contact with the electrically cor~ rtive sheath 38. The sheath 38 moves over the c~mming surface 27 of the electrically conductive anvil 18 which acts as the return electrode. Thus the electrical circuit is closed when and only when the clamping trigger 12 is closed.
In operation, the end effector 50 of the instrument is located at a tissue site where tissue is to be cut. The jaw members 32, 34 are opened by pressing a release button 70 which releases a button spring 71 and permits the close rack 45 to move proximally. Tissue is then placed belween the h~lr~il~g inner surfaces 33, 35 3 o ~ ely of the jaw members 32, 34. The clamping trigger 12 is StI1~71~ l to cause the sheath 38 to move over the c~mming surface 27 and thereby close the jaws 32, 34 and ~imult~n~usly close the electrical circuit as described above. The electrode bars 53, 54 and the inc~ hng material 55, which together form the ridge 56, colllyle~ the tissue ag~unst the inner surface 35 of jaw member 34. A user then applies RF energy 5 from the generator 60 using the footswitch 65 or other switch. Current flows through the cull,plessed tissue be~een the first pole 52, i.e. the bars 53, 54, and the second pole 51, i.e., the anvil 18.
In one embodiment of the present invention the initial pressure applied to 0 COIllpfeSS the tissue in the compression zone is between ~pru~llldLely 30 pounds per square inch (psi) and 250 psi. More particularly, in a further embodiment of thepresent invention the initial pressure applied to C~ p~SS the tissue in the COIllpl~_~iOll zone is l~c~ween ~plo~;",~ely 75 psi and 250 psi. More particularly in a furtherembodiment of the present invention the initial pll,S~ , applied to COllly~SS the tissue in the co",~-ei,~ion zone is belw~ll appro~ill,aL~ly 75 psi and 175 psi. ~n one emk).lim~nt of the present invention, the initial pressure applied to c~",p~ tissue po~;lionPd between the jaws is aypl~ oly 125 psi. With s(lrrirle~l ple~.l~ applied fluid, inr~ ing blood, is forced out of the tissue in the c~lllpres~ion zone, f~rilit~tin~
~~g~ tion In a~lition~ pl~ss-Jle applied to tissue within the colllyl~s~ion zone2 o f~rilit~t~s coupling of electrosurgical energy to the tissue by forcing the tissue against the electrode.
The pressure exerted by the anvil is a fimrtion of the spring rate of the anvil.By providing a "pre-bend" angle on the anvil it is possible to obtain a pre-load (at a 25 zero gap.) Thus, where a pre-bend angle is applied, the anvil may be viewed as a y~ s~d beam. A P.~fe--~,d value of preload is in the range of between 12 and 18 pounds with a ple&-led value of approAil..aL~ly 15 pounds. The spring rate of the anvil is more accurately a function of the stiffness of the ~system", where the system includes the anvil, channel, cartridge, tube, etc. Each of the elemrnt~ of the system has a particular spring rate and each may be suitably modified to increase the stiffness of the system.
In one embodiment of the present invention, that the spring rate of jaw 32 is between ~pfu~ tely 225 pounds per inch and appn~Ai~ldlely 350 pounds per inch.
More particularly, the spring rate of anvil 18 on jaw 32 is preferably in the range of appr~,~..a~ly 275 pounds per inch.
Preferably the bipolar energy source is a low impe~n~e source providing radio frequency energy from about 300 kHz to 3 MHZ. Preferably, the current delivered to the tissue is from 0.1 to 1.5 amps and the voltage is from 30 to 200 volts RMS.
An audible, visible, tactile, or other fee~ c~ system may be used to indicate 1 5 when ~, rr;c:e~ .,dl-on has o~u~l~d at which point the RF energy may be turned off. An example of such a f~Al,~r~ system is described below. After the RF energy is turned off, the cutting means 11 is advanced and the staples 10û are fired using the firing trigger 14. Firing is accomplished by rotating the firing trigger 14 acting as a lever arm about pivot 14a. The driver means 44 advances the cutting means 11 andwedge 13. The cutting means 11 cuts the tissue in bel~n the bars 53, 54 where the issue has been ~L~t~,~ed. Thus, the cut line is lateral to the c~ tion lines formed by the bar electrodes. The wedge 13 sim-llt~nP~usly advances the drivers 24 into the staples 100 causing the staples 100 to fire through tissue and into the pockets 36, 37 of the anvil 18. Staples lûû are applied in two longib~rlin~l double rows on each side of 2 5 the cutting means 11 as the cutting means cuts the tissue.
Operation of linear staplers are known in the art and are ~i~.cc~, for e~ample, in U.S. patent Nos. 4,608,981, 4,633,874, and U.S. Application Serial No.
07/917,636 i..cc,-~o.dLed herein by l~ference.
' In one embodiment the cartridge provides multifire stapling capabilities by replacing the double row of staples with a single row. In the layaro~yic stapling and cutting devices presently in use, a single shot replaceable car~idge is used. In order to provide better hemostasis, this type of stapler was deci~n~d to provide a double row of 5 staples for each parallel row. Rer~ ;e of the size of the space n~c~c~;~ry to contain the double row of staples, a refireable cartridge with stacked staples has not been prerel,~d because of the additional sp~ required for st~r~ing staples. In the multifire stapling embodiment a single row of staples is used. Using a single row of staples permits st~ ng of staples in the sp~ previously occupied by the second row of 10 staples, providing multifire capabilities. In a further embodiment, no staples are required and the electrical current lines provide the n~SS~ry h~most~ci~, A pr~Çelled embodiment of the present invention inclll(les a f~cl~r~ system n~od to indicate when a desired or predetermined degree of c~ tion has 15 o~ull~d. This is particularly useful where the co~ tion zone is not visible to the user. In a particular embo~imPnt the fe~ system IIICaS.ll~,S electrical p of the system which include c~ tion level.
The Çee~ system may also ~et~rrnine tissue ch~ L,cs at or near a 20 c~gul~tiQn zone which indicate degree of c~ tion The electrical imreA~n-~ of the tissue to which the electrical energy is applied may also be used to indicate c~ tion ('~rnr~lly, as energy is applied to the tissue, the i~,.pe~nr~ will initially doclease and then rise as c~ tion occurs. An er.~lll)lc of the rel~tion~;hir bel~..~n el~lrical tissue impe~nr~ over time and c~ tion is described in Vaellfors, Bertil 2 5 and Bergdahl, Bjoern "~lltorn~tiç~lly controlled Bipolar Elec~ gul~tirn,"
Neurosurg. Rev. p. 187-190 (1984) inco,~oldted herein by re~erence. Also as d~s:crzl;on occurs, impedance illclcases. ~lssue carboni7~tion and or stic~ing to instrument as a result of over application of high voltage may be prevented using a feeAh~r~ system b. sed on tissue impe-l~nt~e characteristics. Other examples of tissue CA 02237429 l998-0=,-l2 characteristics which may indicate co~g~ tion include ~l,peldture and light refl~ct~nr,e.
Referring to Figure 10, a flow chart illustrates a fee~back system which is 5implemPntPd in a preferred embodiment of the present invention. First, energy is applied to the tissue. Then the system current and voltage applied to the tissue is ~rmin~-l The imped~n-~e value is c~ ted and stored. Based on a filnçtion of the impe~nfe, for example, which may include the impedance, the change in impedance,and/or the rate of change in impe-l~nr~, it is ~lpt~rminpd whether desired coa~ tinn 10has occurred. If c~ tion has occurred to a predeterrnined or desired degree, an in~i~tion means in~ir~tPs that the energy should be turned off. Such an in~lir~ti~n means may include a visible light, an audible sound or a tactile indicator. The feed~rl~ means may also control the ~nel~o[ and turn the energy off at a certainimrefl~nre level. An ~ltern~tive embodiment provides a c~ntin~rJ~ audible sound in 15which the tone varies ~.pen~ing on the im~nr~e level. An ~d~litir,n~l feature provides an error in~ir~tion means for in~i~ting an error or instrument m~lfLlnr,tir,n when the impedance is below a normal minimllm and/ or above a ~ ll range.
Figures 11-14 illustrate ~It~rn~tive c~nfiglration~ of an end effector. In Figure 2011 the first pole 152 and the second pole 151 are both located on the same jaw 132 having the anvil 118. The U-shaped first pole 152 forms the Imife channel 142. A U-shaped in~ tor 155 surrounds the first pole 152 except on the surface 133 so that it is electrically isolated from the second pole 151. The coll-plei.~ion ridge 156 is formed on the cartridge which is made from an electrically non con~ctive material. The 25ridge 156 co"ly~c~ses tissue against the first pole 152 and insulator 155 to form a tissue colllprc;,sion zone.
In Figure 12, the first pole 252 and the second pole 251 are both located on thesame jaw 232 having the anvil 218. The first pole 252 and the second pole 251 each 30are located on opposing sides of the knife channel 242. An in~ tor ~55 surrounds the poles 251, 252 except on the surface 233 50 that the poles 251, 252 are electrically isolated from each other. The eompression ridge 256 is formed on the cartridge which is made from an electrically non con~ctive material. The ridge 256 collly~esscs tissue against the poles 251, 252 and in~ tor 255 to form a tissue compression zone.
In Figure 13, second pole 351 is located on the jaw 332 having the anvil 318 while the first pole 352 is located on the cartridge 323. The U-shaped first pole 352 forms the knife channel 326 and is surrounded by insulator 355a. A U-shaped in~ tor 355b forms the l~ife channel 342 in jaw 332. E~cept for the insulator 355b, 1 0 the jaw is formed of an electncally c~ ctive material which makes up the second pole 351. The first pole 352 and the insulator 355a form the col,-prts~ion ridge 356 which co-l,prcsscs tissue against the surface 333 of jaw 332 ~o form a co~-y~;onwne. The insulator 355b is of sl-fficient width that it prevents poles 351, 352 form co"~ g when the jaws 332,334 are closed.
In Figure 14, the first pole 452 and the second pole 451 are both located on thejaw 434 having the cartridge 423. The first pole 452 and the second pole 451 each are located on opposing sides, forming the knife channel 426 through the cartridge 423.
An insulator 455a surrounds the poles 451, 452 except on the surface 435, so that the poles 451, 452 are electrically isolated from each other. The co-l-y~cs~ion ridge 456 is formed on the cartridge 423 and forms a CO~l~pl~ s~ion zone by colll~ ,ssillg tissue against an insulator 455b disposed on the surface 433 of the jaw 432.
Figure lS illustrates an ~lt~rn~tive embodiment. The first and second poles 2 5 551, 552 and knife channel 542 are arranged in a similar configuration as in Figure 12 except that the first and ~cond poles 551 and 552 each compri~ a series of electrically co~n~ electrodes staggered along the length of the knife channel with in~ ting material in between staggered electrodes.
Figure 16 illustrates staggered electrodes as in Fig 15 but with first pole electrodes 652 and second pole electrodes 651 altemating along the length of the knife channel 642 and on each side of the knife channel 642.
Figs. 17 and 18 illustrate another embodirnent in which first and second poles 751, 752 each comprise staggered electrodes. In this embodiment, the first pole 752 is staggered along each side of the knife channel 126 and located on the CO~ s~ion ridge 756 formed on the car~idge 723. The second pole 751 is staggered along each side of the knife channel 742 on the surface 733 of jaw 732. As can be seen from1 0 Figure 18, the poles 751, 752 are vertically ~lign~ but as ~ JS~t~A in Figure 17, are staggered so that when the jaws 732, 734 are closed, the poles are electrically isolated from each other by insulators 755a, 755b.
Pigure 19 illustrates an alternative embodiment of the end effector. The first pole 852 and the second pole 851 are both located on the jaw 832 having an anvil 818.
The first pole 852 forms the ridge 856 for c~",pr~ lg tissue in a c~",pression zone and is located on interfacing surface 833. The second pole 851 is located on the side of the anvil 818 and not on inte~f~cil~g surface 833.
2 0 Figs. 20 and 21 illustrate a circular cutter of the present invention with stapling means. Figure 20 illustrates the stapler cartridge 900 with an in~l~ing surface 933.
A double row of staple ape.Lul~,s 901 through which staples are driven into tissue are s~ggered about the outer circumference of the surface 932. A first pole 952 er,cil.,les the inner circumference of the surface 933. An insulator 955 electrically isolates the first pole 952 from the portion 933a of the surface 933 surrounding the staple apertures. The staple aperture portion 933a is formed of an electrically c~n~ve material and acts as a second pole. A circular cutting knife 911 is recessed within the cartridge 900 radially inward from the inner circumference of the surface 933.
Figure 21 illustrates an anvil 918 with pockets 937 for receiving staples and a co~ .cssion ridge 956 for colllL,res~ing tissue against the first pole 952 and inc -l~tor 955 of the cartridge. The circular cutter is operated similarly to the circular stapler described in U.S. Patent No. 5,104,025 incorporated herein by reference. Prior to 5 stapling and cutting however, tissue welding electrical current may be delivered between the first pole 952 and the staple aperture portion 933a to tissue.
In an alternative embodiment, the circular cutter may be used without staples.
Electrical current is delivered through the poles to weld and C~ t~ tissue, then the 10 knife may be advanced to cut tissue in a procedure such as an ~n~ct~mosic~
In operation, the jaws of t~he instrument, for example, jaws 32 and 34 of end effector 50, are closed around the tissue which is to be treated. Tissue trappedbetween the instrument jaws is eoln~ress~d as described herein An el~;LIosllrgical illsL,ulllel~L according to the present invention is ber1~firi~l in that coAg~ tirn of tissue is enh~nr~ed since the ples~ s applied force fluid out of the c4 ~ tion region without tearing the tissue. The prcs~ c ranges srerifiPd herein are also beneficial in that, using an instnlment according to the present invention, contact 2 0 between the tissue and electrodes is improved, co~gulation is improved throughout the tissue and charring is reduced.
Several variations of this invention has been described in ~ ion with two specific embo-limPntc involving endo~pic cutting and stapling. Naturally, the 25 invention may be used in numerous applir~tionc where hPmost~cic in desired.
Accordingly, will be understood by those skilled in the art that various eh~ngrs and mo lifir~tionc may be made in the invention without departing from its scope, which is defined by the following claims and their equivalents.
Claims (16)
1. An electrosurgical device having an end effector, wherein said end effector comprises:
first and second opposing interfacing surfaces said interfacing surfaces capableof engaging tissue therebetween, and said end effector capable of receiving bipolar energy therein, said first and second interfacing surfaces applying a predetermined pressure to said tissue in a range of between approximately thirty pounds per square inch and approximately two hundred fifty pounds per square inch;
electrically isolated first and second poles comprising electrically opposite electrodes capable of conducting bipolar energy therethrough; wherein said firstpole is comprised of one or more first electrodes of a first electrical potential;
wherein said second pole is comprised of one or more second electrodes of a second electrical potential;
wherein at least one of said one or more first electrodes is located on at leastone of said first and said second interfacing surfaces and wherein at least one of said one or more second electrodes is located on at least one of said first and second interfacing surfaces, so that bipolar energy may be communicated between said poles through the tissue; and wherein each said one or more first electrodes is offset from each said one or more second electrodes, at said first and second interfacing surfaces.
first and second opposing interfacing surfaces said interfacing surfaces capableof engaging tissue therebetween, and said end effector capable of receiving bipolar energy therein, said first and second interfacing surfaces applying a predetermined pressure to said tissue in a range of between approximately thirty pounds per square inch and approximately two hundred fifty pounds per square inch;
electrically isolated first and second poles comprising electrically opposite electrodes capable of conducting bipolar energy therethrough; wherein said firstpole is comprised of one or more first electrodes of a first electrical potential;
wherein said second pole is comprised of one or more second electrodes of a second electrical potential;
wherein at least one of said one or more first electrodes is located on at leastone of said first and said second interfacing surfaces and wherein at least one of said one or more second electrodes is located on at least one of said first and second interfacing surfaces, so that bipolar energy may be communicated between said poles through the tissue; and wherein each said one or more first electrodes is offset from each said one or more second electrodes, at said first and second interfacing surfaces.
2. The electrosurgical device of claim 1 wherein said predetermined pressure is in a range of between approximately seventy five pounds per square inch and approximately two hundred fifty pounds per square inch.
3. The electrosurgical device of claim 1 wherein said predetermined pressure is in a range of between approximately one hundred fifteen pounds per square inch and one hundred eighty five pounds per square inch.
4. The electrosurgical device of claim 1 wherein a portion of said second interfacing surface comprises a ridge extending from said second interfacing surface to form a tissue compression zone between interfacing surfaces.
5. The electrosurgical device of claim 4 wherein current flowing between said first and second poles provides coagulation in the compression zone.
6. The electrosurgical device of claim 1 wherein said device includes a cutting element arranged on said device to divide tissue engaged by said end effector through a cutting line when said cutting element is actuated.
7. The electrosurgical device of claim 6 wherein said end effector further comprises at least one staple and at least one driver adapted to apply said at least one staple lateral to said cutting line.
8. The electrosurgical device of claim 1 wherein said one or more first electrodes comprises an electrode having a relatively circular shape and is located on an outer circumference of said first interfacing surface.
9. The electrosurgical device of claim 8 wherein said device includes a cutting element adapted to divide tissue engaged by said interfacing surfaces.
10. The electrosurgical device of claim 9 wherein said end effector further comprises:
at least one staple and at least one driver adapted to drive said at least one staple through tissue.
at least one staple and at least one driver adapted to drive said at least one staple through tissue.
11. An electrosurgical instrument comprising:
a handle, an actuating means coupled to said handle, an end effector coupled to the distal end of said actuating means, a means for communicating bipolar electrical energy from a bipolar energy source to said end effector, said end effector including:
a first interfacing surface, a second interfacing surface, a first pole comprising one or more first electrodes of a first electrical potential located on at least one of said interfacing surfaces, a second pole comprising one or more second electrodes of a second electrical potential located on at least one of said interfacing surfaces, and an insulator arranged to offset each of said one or more first electrodes from each of said one or more second electrodes, at said interfacing surfaces, wherein said actuating means is capable of causing said end effector to engage tissue between the first interfacing surface and the second interfacing surface, and applying a predetermined pressure to said tissue in a range of between approximately thirty pounds per square inch and approximately two hundred fifty pounds per square inch wherein said first pole and said second pole are comprised of electrically opposite electrodes capable of conducting electrical energy supplied from said means for communicating bipolar electrical energy from a bipolar energy source, through tissue adjacent to said one or more first electrodes and said one or more second electrodes.
a handle, an actuating means coupled to said handle, an end effector coupled to the distal end of said actuating means, a means for communicating bipolar electrical energy from a bipolar energy source to said end effector, said end effector including:
a first interfacing surface, a second interfacing surface, a first pole comprising one or more first electrodes of a first electrical potential located on at least one of said interfacing surfaces, a second pole comprising one or more second electrodes of a second electrical potential located on at least one of said interfacing surfaces, and an insulator arranged to offset each of said one or more first electrodes from each of said one or more second electrodes, at said interfacing surfaces, wherein said actuating means is capable of causing said end effector to engage tissue between the first interfacing surface and the second interfacing surface, and applying a predetermined pressure to said tissue in a range of between approximately thirty pounds per square inch and approximately two hundred fifty pounds per square inch wherein said first pole and said second pole are comprised of electrically opposite electrodes capable of conducting electrical energy supplied from said means for communicating bipolar electrical energy from a bipolar energy source, through tissue adjacent to said one or more first electrodes and said one or more second electrodes.
12. The electrosurgical device of claim 11 wherein said predetermined pressure is in a range of between approximately seventy five pounds per square inch and two hundred fifty pounds per square inch.
13. The electrosurgical device of claim 11 wherein said predetermined pressure is in a range of between approximately one hundred fifteen pounds per square inch and one hundred eighty five pounds per square inch.
14. A method of applying bipolar electrosurgical energy to tissue utilizing an electrosurgical device having an end effector, wherein said end effector comprises:
first and second opposing interfacing surfaces, said interfacing surfaces capable of engaging tissue therebetween, and said end effector capable of receiving bipolar energy therein;
electrically isolated first and second poles comprising electrically opposite electrodes capable of conducting bipolar energy therethrough; wherein said firstpole is comprised of one or more first electrodes of a first electrical potential;
wherein said second pole is comprised of one or more second electrodes of a second electrical potential;
wherein at least one of said one or more first electrodes is located on at leastone of said first and said second interfacing surfaces and wherein at least one of said one or more second electrodes is located on at least one of said first and second interfacing surfaces, so that bipolar energy may be communicated between said poles through the tissue; and wherein each said one or more first electrodes is offset from each said one or more second electrodes, at said first and second interfacing surfaces, wherein said method comprises the steps of:
engaging tissue between said interfacing surfaces applying a predetermined pressure to said tissue wherein said pressure is in a range of between approximately thirty pounds per square inch and approximatelytwo hundred fifty pounds per square inch; and applying bipolar electrosurgical energy to said tissue.
first and second opposing interfacing surfaces, said interfacing surfaces capable of engaging tissue therebetween, and said end effector capable of receiving bipolar energy therein;
electrically isolated first and second poles comprising electrically opposite electrodes capable of conducting bipolar energy therethrough; wherein said firstpole is comprised of one or more first electrodes of a first electrical potential;
wherein said second pole is comprised of one or more second electrodes of a second electrical potential;
wherein at least one of said one or more first electrodes is located on at leastone of said first and said second interfacing surfaces and wherein at least one of said one or more second electrodes is located on at least one of said first and second interfacing surfaces, so that bipolar energy may be communicated between said poles through the tissue; and wherein each said one or more first electrodes is offset from each said one or more second electrodes, at said first and second interfacing surfaces, wherein said method comprises the steps of:
engaging tissue between said interfacing surfaces applying a predetermined pressure to said tissue wherein said pressure is in a range of between approximately thirty pounds per square inch and approximatelytwo hundred fifty pounds per square inch; and applying bipolar electrosurgical energy to said tissue.
15. The method of claim 14 wherein said predetermined pressure is in a range of between approximately seventy five pounds per square inch and two hundred fifty pounds per square inch.
16. The method of claim 14 wherein said predetermined pressure is in a range of between approximately one hundred fifteen pounds per square inch and one hundred eighty five pounds per square inch.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/856,520 USH1904H (en) | 1997-05-14 | 1997-05-14 | Electrosurgical hemostatic method and device |
| US08/856,520 | 1997-05-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2237429A1 true CA2237429A1 (en) | 1998-11-14 |
Family
ID=25323832
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002237429A Abandoned CA2237429A1 (en) | 1997-05-14 | 1998-05-12 | Improved electrosurgical hemostatic method and device |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | USH1904H (en) |
| EP (1) | EP0878168A1 (en) |
| JP (1) | JPH1170123A (en) |
| AU (1) | AU6487098A (en) |
| CA (1) | CA2237429A1 (en) |
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-
1997
- 1997-05-14 US US08/856,520 patent/USH1904H/en not_active Abandoned
-
1998
- 1998-05-11 AU AU64870/98A patent/AU6487098A/en not_active Abandoned
- 1998-05-12 CA CA002237429A patent/CA2237429A1/en not_active Abandoned
- 1998-05-13 JP JP10148369A patent/JPH1170123A/en active Pending
- 1998-05-13 EP EP98303753A patent/EP0878168A1/en not_active Withdrawn
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11058478B2 (en) | 2006-05-02 | 2021-07-13 | Aesculap Ag | Laparoscopic radiofrequency surgical device |
Also Published As
| Publication number | Publication date |
|---|---|
| AU6487098A (en) | 1998-11-19 |
| JPH1170123A (en) | 1999-03-16 |
| USH1904H (en) | 2000-10-03 |
| EP0878168A1 (en) | 1998-11-18 |
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Legal Events
| Date | Code | Title | Description |
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| FZDE | Discontinued |