CN105939755A - Lead implantation method - Google Patents
Lead implantation method Download PDFInfo
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- CN105939755A CN105939755A CN201480071598.1A CN201480071598A CN105939755A CN 105939755 A CN105939755 A CN 105939755A CN 201480071598 A CN201480071598 A CN 201480071598A CN 105939755 A CN105939755 A CN 105939755A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0517—Esophageal electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0507—Electrodes for the digestive system
- A61N1/0509—Stomach and intestinal electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
- A61B2017/00827—Treatment of gastro-esophageal reflux
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Electrotherapy Devices (AREA)
Abstract
A method of laparoscopically implanting an electrically stimulating lead proximate the lower esophageal sphincter (LES) of a patient includes delivering the lead through a port of a laparoscope inserted into the abdominal cavity of the patient through an incision in the abdominal wall. The stimulating electrode is implanted in or proximate the muscularis layer of the lower esophageal wall to treat esophageal reflux disease (GERD). The lead includes a needle and suture at its distal end for pulling the electrode into the muscular wall of the LES. Clips are applied to the suture attached to the distal end of the lead to prevent retrograde movement of the electrode. The lead also includes an anchoring member for anchoring the portion of the lead proximal to the electrode. The method and lead used with the method allow the surgeon to work within the confined anatomy present at the gastroesophageal junction and prevents backwards movement and dislodgment of the electrode. The implantation procedure can be combined with a hiatal hernia repair to repair the hernia and prevent recurrence of a hiatal hernia.
Description
Cross reference
The application depends on and is filed on November 20th, 2013, entitled " lead-in wire method for implantation "
U.S. Provisional Patent Application numbering 61/906,825 and obtain priority
The application be also be filed in JIUYUE in 2012 2 days, entitled " endoscope's lead-in wire method for implantation "
The continuous part application of patent application number 13/602,184, this application depends on and is filed in 2011
On JIUYUE 2, there is the U.S. Provisional Patent Application 61/530,781 of same title and obtain priority.
The application also relates to be filed on February 26th, 2014, entitled " implantable electricity irritation lead-in wire "
The continuous part application of patent application number 14/191,085, this application depends on and is filed in 2013
On February 26, there is the U.S. Provisional Patent Application 61/769,732 of same title and obtain priority.
Aforesaid plurality of application quotes in full in this as reference.
Technical field
This specification relates generally to the electricity irritation of a kind of biological tissue, to provide disorderly for biological physiology
Treatment.More particularly, this specification relates to a kind of conduction near lower oesophageal sphincter (LES) and draws
The method that the peritoneoscope of line is implanted.
Background technology
Neural and surrounding tissue electricity irritation is used for processing multiple situation.Such as, electricity irritation can be used for recovering
The limbs come with wound or the partial function of manifold.Electricity irritation can be additionally used in minimizing pain.Specifically,
Electricity irritation can be used for processing the disorder being associated with gastrointestinal tract (GI) system, and such as fat stomach function regulating esophagus is anti-
Stream is sick (GERD).
Obesity is the common situations in developed country's (including the U.S.) and main public health problem.
In 2009, the U.S. adults more than 2/3rds, about 1.27 hundred million populations are overweight or fat.Number
According to show to have every year 300000 Americans due to obesity relevant complication premature death.The U.S. has very
Many children are also overweight or fat.Therefore, overweight American sum is to rise at expected future
's.Estimate that the U.S. will spend 100,000,000,000 dollars in direct or indirect medical expense every year due to obesity
With loss the productivity on.This trend is also clearly in a lot of other developed countries.
For adult, Body Mass Index (BMI) is used for determining that a people is the most overweight or fat.One people
BMI by its body weight (using pound as unit) is multiplied by 703 and then by sum divided by height
(using inch as unit) square.The BMI of individual represents with kilogram every square.If he/her
BMI 25 and 30kg/m2Between, then adult is considered as overweight.Obesity is defined as its BMI
30 to 40kg/m2Between.More than 30kg/m2BMI be associated with significant complication.Morbid state
Obesity is defined to body weight and exceedes ideal body weight 100 pounds, or Body Mass Index (BMI) is more than 40kg/m2。
About the 5% of U.S. population meets at least one standard MO.Morbid obesity and a lot of diseases
Relevant with disorder, including, such as diabetes；Hypertension；Heart disease；Apoplexy；Dyslipidemia；Sleep
Asphyxia；Pick-wickian syndrome；Asthma；Waist and intervertebral disc disorder；Buttocks, knee, ankle and
The heavy burden osteoarthritis of foot；Thrombophlebitis and pulmonary infarction；Intertrigo dermatitis；Stress incontinence；Stomach
Esophageal reflux disease (GERD)；Cholelithiasis；And, liver cirrhosis and hepatocarcinoma.For women, infertile, sub
Palace cancer and breast carcinoma are also associated with morbid obesity.In sum, the disease being associated with morbid obesity shows
Write and reduce the probability obtaining average life.Sequela in affected crowd with 10 or higher
The factor increases annual death rate.
Gastroesophageal reflux disease (GERD) is another common health problem, and primary and two grades
In treatment stage, management is expensive.This situation be due to, when acid is back to esophagus from stomach, food
Road mucosa is exposed to gastric acid and causes.Acid compromises esophageal mucosa membrane injury, causes heartburn, ulcer, hemorrhage
With scab, and long-term complication, such as Barrett ' s esophagus (precancerous lesion esophagus internal layer) and
The adenocarcinoma of esophagus.
Gastric electrical stimulation (GES) is intended to treatment obesity and GERD.GES uses implanted, pacemaker class
As device, so that low-level electricity irritation is passed to gastrointestinal tract.For obesity, GES is transported by upset
Dynamic cycle and/or stimulate enteric nervous system and operate, thus when increasing the satiety that sufferer experienced lasting
Between.This step relates to doctor's outer layer by electrical lead suture to coat of the stomach.Lead-in wire is then attached to be implanted to
Abdominal part is implanted to the device under skin.Being the external programmer for device communication, doctor sets up applicable
Electricity irritation level in sufferer.Manufactured by IntraPaceImplanted gastric stimulation devices currently exists
Europe can be used for treatment obesity.
In another example, Medtronic offers for sale and uses Enterra TM therapy, its instruction
When conventional Drug therapy does not act on for the chronic nausea relevant to gastroparesis and the treatment of vomiting.
Enterra TM therapy uses slight electric pulse to stimulate stomach.According to Medtronic, this electricity irritation
Help to control the sign relevant to gastroparesis, including nausea and vomiting.
Electricity irritation has been proposed to be used in the treatment of GERD, and its moderate stimulation is provided to lower esophagus and includes about
Flesh (LES).Such as, transferring the US patent number 6 of applicant of the present invention, in 901,295,
Provide " method and apparatus of a kind of electricity irritation for lower oesophageal sphincter (LES) ".Electrode group quilt
It is placed in esophagus, is arranged through and causes the contraction of LES around tissue and neural electricity irritation.Electricity
Stimulate by impulse generator, apply with the cycle of persistent period and the cycle of change of change, to produce
Contraction needed for life.Treatment is probably the whole life that maybe may continue sufferer of short-term, to obtain expectation
Therapeutic effect.Stimulating electrode group can be used alone or can be combined with the electrode of sensing esophagus wriggling and makes
With.Electrode group can be by gastroscope, by performing the operation or being inserted by radiology.The invention quoted relies on
Some physiological change in sensing esophagus, the such as change of esophagus pH value, and detect the backflow of acid.
Once recognizing the change of esophagus pH value, system produces electricity irritation, attempts closing LES immediately and inhaling
Receive the generation of acid backflow.US patent number 6,901,295 is incorporated in this entirely through reference.
Typically, the lead-in wire stimulated for LES is implanted in lower esophageal wall by peritoneoscope.LES
In lead-in wire implant the different challenge of implantation caused with other parts (including stomach) at human body.One
Main challenge is near the LES shortage for doctor working place.Another main challenge is
The exposure of the muscular tissue of LES.LES muscular tissue is hidden by the fatty tissue covered, and stomach food
The position of the intersection in road is difficult to.Additionally, having existing gastrointestinal tract structure disturbance, (esophagus splits
Hole hernia) sufferer in the case of, suitably lead-in wire prevents from being difficult to.Generally, the electrode of lead-in wire
Not optimally place near destination organization.Further, if lead-in wire anchors the most suitably, it will become
Must come off, and treatment will become invalid.Therefor it is required that a kind of narrow dissection at LES is empty
The efficiently and accurately method implanted between, wherein goes between and is firmly fixed and/or anchor near destination organization
Gu.What is also needed is a kind of efficiently and accurately method going between and implanting, it will include that Hernia hiatus is made
A part for method for implantation.
Summary of the invention
Subject description discloses a kind of conductive lead wire for implanting, institute near the lower oesophageal sphincter of sufferer
Stating lead-in wire to include: the elongate body of conduction, it has proximally and distally and is covered in insulant；
At the adapter of described proximal end, it is used for being connected to impulse generator；At least one anchors (anchoring)
Component, is positioned close to the described far-end of described lead-in wire body；At least one electrode, is positioned close to institute
State the described far-end of lead-in wire body and away from least one anchorage element described；The seam of at least one segment length
Line, has the first end and the second end in contrast to described first end, and wherein said first end is attached to described
The described far-end of lead-in wire body；Pin, be attached to described in described second end of suture of at least one segment length；
And at least one fixing component, it is possible to by the suture of at least one segment length described in being applied to removedly.
Alternatively, elongate body includes straight plain conductor.Alternatively, elongate body includes the gold of winding
Belong to wire.Alternatively, elongate body includes turning on (conducting) cable.
At least one fixing component can include any one of folder, suture, U-clamp or anchoring piece.
Alternatively, at least one anchorage element includes the butterfly-shaped (butterfly with at least one opening
tab).Alternatively, at least one anchorage element includes the suture sleeve pipe with at least one groove.
This specification also discloses a kind of conductive lead wire for implanting near the lower oesophageal sphincter of sufferer,
Described lead-in wire includes: the elongate body of conduction, and it has proximally and distally and is covered in insulant
In；At the adapter of described proximal end, it is used for being connected to impulse generator；Division at described far-end
Element, for being divided into two or more branch by described elongate body；Two or more branches, from
Described splitting element disperses, and each branch has proximally and distally；At least one anchorage element, orientates as
Described near-end near each branch；At least one electrode, is positioned close to the described far-end of each branch；
The suture of at least one segment length, has the first end and the second end in contrast to described first end, wherein said
First end is attached to the described far-end of each branch；Pin, be attached to described in the suture of at least one segment length
Described second end；And at least one fixing component, it is possible to described in being applied to removedly at least one section
The suture of length.
Alternatively, elongate body includes straight plain conductor.Alternatively, elongate body includes the gold of winding
Belong to wire.Alternatively, elongate body includes turning on cable.
At least one fixing component can include any one of folder, suture, U-clamp or anchoring piece.
Alternatively, at least one anchorage element includes butterfly-shaped with at least one opening.Alternatively,
At least one anchorage element includes the suture sleeve pipe with at least one groove.
This specification also discloses the using method of any one in a kind of above-mentioned lead-in wire, including: will make
At least one conductive electrode for a part for described lead-in wire is implanted under sufferer by peritoneoscope
Sphincter of gullet (LES) place, described using method includes lower step: by laparoscopically far-end by disease
Suffer from stomach wall in otch and be inserted in the abdominal cavity of this sufferer；By surgical operation by under described sufferer
The preabdomen of esophageal wall exposes at least 2cm；Described conductive electrode is passed through at described laparoscopically end
Mouthful, wherein said lead-in wire includes the elongated metal body having proximally and distally, and described elongate body is electric
Insulant is hidden, and described near-end has the adapter for being connected to type implanting pulse maker, and
And described far-end includes described at least one electrode exposed and anchorage element, described lead-in wire farther includes
First suture, described first suture has the first end and the second end in contrast to described first end, Qi Zhongsuo
State the first end and be attached to the described far-end of described lead-in wire body, and described first pin is attached to described second
End；Target location at the front surface of the lower esophageal wall that described conductive lead wire is advanced to described exposure；Make
With described first pin and described first suture with by described electrode through described LES so that described exposure
Electrode and be placed in the Musclar layer of the wall of described LES or near, and described first pin and described first seam
A part for described second end of line occurs again from the described wall of described LES；By at least one fixing structure
Part is applied to described in described suture in the distance of the described wall at least 2-15mm away from described LES
The described part of the second end；Remove described first pin and the first unnecessary suture；And, single by using
Described anchorage element is fixed as leaning on by the second only pin so that the second suture is connected to described anchorage element
Nearly LES tissue.
At least one fixing component can include any one of folder, suture, U-clamp or anchoring piece.
Alternatively, at least one anchorage element includes butterfly-shaped with at least one opening, and by institute
State the second suture to be connected to the described step of described anchorage element and include described second suture through described
At least one opening.Alternatively, at least one anchorage element includes the suture set with at least one groove
Manage, and the described step that described second suture is connected to described anchorage element includes described second seam
Line passes around at least one groove described.
Alternatively, the first suture includes the barbed micro structure (micro-architecture) of suture.
Alternatively, this using method further comprises the steps of: and repeats described sufferer by surgical operation
The exposure at least 2cm of the preabdomen of lower esophageal wall, until by using single second pin to stitch second
Line is connected to described anchorage element, described anchorage element is fixed as the step near LES tissue, to plant
Enter extra electrostimulation lead.
This using method may also include use external device (ED) to estimate the resistance between each electrode, to guarantee
The electrode pinpoint step in the Musclar layer of described lower esophageal wall.
This using method may also include and illuminates lower oesophageal sphincter by endoscope, with identify for described extremely
The placement of a few electrode and the step of the suitable position of dissection.
This using method may also include by endoscope's estimation wire locations to get rid of described lower esophageal wall
The step of perforation.If this using method also can farther include to have produced wearing of described lower esophageal wall
Hole, then reorientate the step of described lead-in wire.
Alternatively, this implantation is combined with Hernia hiatus repair process, with repair Hernia hiatus and
Prevent the recurrence of Hernia hiatus in described sufferer.
This using method may further comprise the step of: the diaphragm crura membranacea exposing described sufferer；And by least one
Suture is applied to described diaphragm crura membranacea.
This using method may also include the described proximal attachment of described lead-in wire to the impulse generator implanted
Step.
It is disorderly with treatment esophagus that this using method can be used for implanting lead-in wire, such as Gastroesophageal reflux disease
(GERD), achalasia of cardia and esophageal dysmotility.
The foregoing and other embodiment of the present invention is by deeper in detail specifications in the accompanying drawings and the following
Degree it is described.
Accompanying drawing explanation
These and other features of the present invention and advantage will be understood further, because when in conjunction with accompanying drawing
Consider and will be better understood when with reference to inventive feature during detailed description and advantage.
Figure 1A shows and relates to stimulating lead-in wire to be implanted to the lower esophagus of sufferer at least one by peritoneoscope
The flow chart of the step of one embodiment of the method in the muscle of wall；
Figure 1B shows and relates to stimulating lead-in wire to be implanted to the lower esophagus of sufferer at least one by peritoneoscope
The flow chart of the step of another embodiment of the method in the Musclar layer of wall；
Fig. 2 A is the diagram of the linear type electricity irritation lead-in wire of an embodiment according to this specification；
Fig. 2 B is that the bipolar electric of an embodiment according to this specification stimulates the diagram gone between；
Fig. 2 C is the diagram of the linear type electricity irritation lead-in wire of another embodiment according to this specification；
Fig. 2 D is that the bipolar electric of another embodiment according to this specification stimulates the diagram gone between；
Fig. 3 is proximate to the diagram of the anatomic region of the lower oesophageal sphincter (LES) of sufferer, it is shown that
Single bipolar electric through using the method for an embodiment according to this specification to be implanted by peritoneoscope is stung
Swash lead-in wire；
Fig. 4 is proximate to the diagram of the anatomic region of the lower oesophageal sphincter (LES) of sufferer, it is shown that
Two bipolar electrics through using the method for an embodiment according to this specification to be implanted by peritoneoscope are stung
Swash lead-in wire；And
Fig. 5 is the close-up illustration of the distal portions of electricity irritation lead-in wire, it is shown that according to one of this specification
Embodiment is implanted in the electrode in the muscular wall of LES.
Detailed description of the invention
Subject description discloses one, by peritoneoscope, one activity multiple stimulation lead-in wire is implanted to esophagus
Wall, be used for treating at least one functional gastrointestinal disorder (such as Gastroesophageal reflux disease (GERD))
Electric stimulation be used together.In many embodiment, lead-in wire is stimulated to be defined as having one or many
The lead-in wire of individual stimulating electrode.In one embodiment, lead-in wire is stimulated to include having the straight of a stimulating electrode
Line style goes between.In one embodiment, lead-in wire is stimulated to include the two contact outlet with two stimulating electrodes.
It should be appreciated that the lead-in wire that stimulates with any number of stimulating electrode can be used for the side of this specification
Method.Laparoscopically far-end is inserted in the abdominal cavity of this sufferer by the otch in the stomach wall of sufferer.Doctor
The raw at least 2cm then exposing abdominal part esophagus.At least one stimulates lead-in wire to be passed by laparoscopic port
Pass, and (one or more) electrode proceeds to the target location of the muscle parts in esophageal wall.Draw
Line includes elongated plain conductor, and it has the covering layer of electric insulation and has proximally and distally.For drawing
For line, far-end is for describing the end being positioned close to destination organization, and near-end is for describing
It is connected to the end of type implanting pulse maker (IPG), as mentioned below.
In one embodiment, elongate body includes straight plain conductor.In another embodiment, elongated
Body includes the plain conductor of winding.In another embodiment, elongate body includes turning on cable.One
In individual embodiment, the far-end of lead-in wire includes at least one branch or far-end, the most each branch or far-end bag
Include the electrode of anchorage element and exposure.In various embodiments, anchorage element includes that having at least one opens
Butterfly-shaped of mouth.In one embodiment, each butterfly-shaped includes two openings.In other embodiments,
Anchoring mechanism includes the suture sleeve pipe with at least one groove.The suture (monofilament or multifibres) of nonabsorable
Length continue from each branch of lead-in wire or the far-end of far-end, and at itself and the far-end being attached to branch
End include suture needle.In one embodiment, suture includes nylon.In one embodiment, seam
Line includes the barbed micro structure of suture, such as Covidien V-LockTM.Pin and suture will be for exposing
Electrode be sent in the muscle of LES.Electrode is placed in or the muscle of close LES.Multiple other
In embodiment, electrode is located on or near front coat of the stomach, stomach cardia or in the 3cm of LES.Such as, exist
In one embodiment, lead-in wire includes two electrodes, one of them be positioned in front coat of the stomach or near, and separately
One be positioned in LES or stomach cardia or near.Pin and suture occur outside the wall of LES again.Draw
Line has fixing component or at least one folder being applied to it near the part of the far-end of suture, to prevent
Inversely move and/or displacement.In various embodiments, folder is made up of metal.In one embodiment, folder
It it is titanium system.In various embodiments, it is clipped in the position away from LES wall at least 2-15mm to apply
To suture, to allow to relax in some pressed from both sides between LES.Folder is used as the retainer of far-end, to prevent
Electrode slides backward from LES Musclar layer and skids off LES Musclar layer too far.There is provided lax to allow around
The gentle expansion of GI tissue, passing through as food lumps, thus reduce tensioning or injured chance.Pin
Then it is removed with too much suture.There is the single pin of suture for by the open seam in butterfly-shaped
Close, or sew up around the composition in suture sleeve pipe, so that lead-in wire is held in place.These are being anchored suture
During being applied to butterfly-shaped or suture sleeve pipe, the electrode zone of implantation is moved rearwards by, and causes the of folder
One purposes is to prevent the sliding backward of electrode.The near-end of lead-in wire is then attached to be implanted to sufferer
IPG in the subcutaneous pocket portion of abdominal part.
In various embodiments, the suture up to 10cm is retained in the far-end of folder.This provides multiple excellent
Gesture.In the case of folder is applied to suture the most securely, it will tend to sliding.If folder is along suture
Slide and do not lose in abdominal cavity, being then preferred.Short suture ends is stiff and is intended to make
Become the wound of peripheral organs (such as, liver).The suture section of section may easily puncture and damage surrounding
Tissue.Additionally, long suture is also useful during the removing of lead-in wire.Long suture ends is used as folder
Localizer with the far-end of electrode.It is to remove the first step of electrode by folder from the distal resection of suture.
In one embodiment, first stimulates lead-in wire implanted, and its positioning of electrode is on the front surface of esophagus
Lower esophageal wall muscle in.In various embodiments, extra stimulation lead-in wire is including about near lower esophagus
It is implanted in the muscle of lower esophageal wall at the extra anatomical position of flesh (LES).
In various embodiments, method as described above farther includes to use external device (ED) each to estimate
Implant electrode between resistance, to guarantee electrode being accurately positioned in the Musclar layer of target anatomical location
Step.
In a lot of sufferers suffering GERD, the anatomic region of LES is owing to chronic esophagitis is by " upwards
Push away " or lifting.In many embodiment, light source is inserted into by endoscope in these sufferers, and
Light assists towards the front surface of LES to guide doctor to minimize dissection to LES by help simultaneously
Implantation process.
In various embodiments, method as described above farther includes to estimate wire locations by endoscope
To get rid of the step of the perforation of described lower esophageal wall or coat of the stomach.If be detected that perforation, then lead-in wire is withdrawn by
Or reorientate.
In various embodiments, method as described above is for being implanted to have Hernia hiatus by lead-in wire
In sufferer.The method also includes dissection and the exposure of the region of anatomy near diaphragm crura membranacea.Doctor is by outward
Section's operation dissects the region of anatomy of surrounding by laparoscopically method.In one embodiment, including leaning on
At least 100mm of the esophageal tissue of nearly LES2Region be used for implanting.In many embodiment, on
Method of stating is carried out in Hernia hiatus repair process, to repair described hole hernia and to prevent Hernia hiatus
Recurrence, as with reference to CO-PENDING, be filed on August 23rd, 2013, entitled " for biology
The device of the electricity irritation of system and implant system " patent application number 13/975, described by 162,
This full patent texts is incorporated in this as reference.
The present invention relates to multiple embodiment.There is provided following disclosure so that there is this area routine and knowing
The people known can put into practice the present invention.The language used in this specification is not necessarily to be construed as arbitrary particular implementation
The general of example is denied, and should not be taken to be limiting claim and exceed containing of term used in literary composition
Justice.The general principle limited in literary composition may be used in other embodiments and application, without departing from the present invention
Spirit and scope.Further, the term of use and term are only used for describing the purpose of exemplary embodiment,
And it is not considered as limiting.Therefore, the present invention is according to comprising and disclosed feature and principle phase one
A large amount of alternative of cause, the widest scope of modifications and equivalents.For purposes of clarity, relate to closing
Details in technologic material known to the technical field of the present invention will not be described in detail, thus will not
Unnecessarily obscure the invention.
Figure 1A shows and relates to stimulating lead-in wire to be implanted to the lower esophagus of sufferer at least one by peritoneoscope
The flow chart of the step of one embodiment of the method in the muscle of wall.In step 102, peritoneoscope is inserted
Entering, its far-end is inserted in the abdominal cavity of sufferer by the otch in the stomach wall of sufferer.Doctor is in step 104
Expose at least 2cm of abdominal part esophagus.In step 106, as the electrode of the part stimulating lead-in wire, so
It is passed by laparoscopic port afterwards, and proceeds to the target location at the Musclar layer of lower esophageal wall
Place.Then, in step 108, be attached to the suture of the far-end of lead-in wire and pin for through LES wall and
Electrode is moved in the Musclar layer of LES.In step 110, one or more folders then can be near lead-in wire
The position of far-end be applied to the suture of lead-in wire, to prevent the reverse mobile of electrode.In step 112,
Then pin and too much suture are removed.Then, in step 114, by using single pin and suture,
Anchorage element is stitched into neighbouring abdominal part with by place for lead-in wire anchoring.In certain embodiments, anchoring structure
Part includes butterfly-shaped with at least one opening, and individually pin is used for single suture through attached
Near abdominal part and at least one opening described are to be secured in place anchorage element.In other embodiments,
Anchorage element includes the suture sleeve pipe with at least one groove, and individually pin is used for individually stitching
Line passes neighbouring abdominal part and around groove to be secured in place by anchorage element.Owing to the wound of pin belongs to
Property, step 112 was typically carried out before step 114.Alternatively, in another embodiment, exist
After fixing for anchorage element, original pin and suture are removed.If extra lead-in wire is by implanted, then
For each extra lead-in wire, repeat step 104 to step 114.
Figure 1B shows and relates to stimulating lead-in wire to be implanted to the lower esophagus of sufferer at least one by peritoneoscope
The flow chart of the step of another embodiment of the method in the Musclar layer of wall.In step 122, peritoneoscope
Far-end be inserted in the abdominal cavity of sufferer by the otch in the stomach wall of sufferer.In step 124, under
Then at least 2cm of the preabdomen of esophageal wall is exposed.In step 126, as one of conductive lead wire
At least one electrode divided is passed by laparoscopically port.In step 128, lead-in wire is advanced to
Target location at the front surface of the lower esophageal wall exposed.Then, in step 130, the first of lead-in wire
Suture and the first pin are through LES so that positioning of electrode in the Musclar layer of LES wall or near, and
A part and first pin of the first suture reappear from wall.In step 132, at least one fixing component
Then the part of the first suture it is applied in the distance away from LES wall at least 2-15mm, to prevent
The reverse of electrode is moved.Then it is removed in step 134, the first pin and the first too much suture.In step
Rapid 136, the anchorage element on lead-in wire is fixed to neighbouring by using single second pin and the second suture
LES organizes to be secured in place by lead-in wire.
Fig. 2 A is the diagram of the linear type electricity irritation lead-in wire 200 of an embodiment according to this specification.
Lead-in wire 200 includes the elongated metal body 205 having proximally and distally.Adapter 201 is positioned at near-end
Place is used for being connected to type implanting pulse maker.Far-end includes anchorage element 211 and electrode 215.Reference
Fig. 2 A, anchorage element 211 includes having butterfly-shaped of two openings 212 for anchoring to after the implantation
Tissue.In other embodiments, butterfly-shaped includes one or three or more openings.Suture 217
The near-end of the far-end that there is near-end and be attached to lead-in wire body 205.Pin 218 is attached to suture 217
Far-end.After the implantation, at least one folder 216 be applied to from LES wall occur sutures 217 in case
Stop being moved rearwards by of electrode 215.
Fig. 2 B is the diagram of the bipolar electric stimulation lead-in wire 220 of an embodiment according to this specification.Draw
Line 220 includes the elongated metal body 225 having proximally and distally.Adapter 221 is positioned at proximal end
For being connected to type implanting pulse maker.Far-end includes bifurcation 229, and it will lead-in wire body 225 points
For Liang Ge branch or far-end 230,240.Each branch 230,240 includes anchorage element 231,241
With electrode 235,245.With reference to Fig. 2 B, each anchorage element 231,241 includes having two openings
232, butterfly-shaped of 242 is for anchoring to tissue after the implantation.In other embodiments, Mei Gedie
Shape sheet includes one or three or more openings.Suture 237,247 has near-end and is attached to lead-in wire
The near-end of each branch 230,240 of 220.Pin 238,248 is attached to each suture 237,247
Far-end.After the implantation, at least one folder 236,246 is applied to each seam occurred from LES wall
Line 237,247 is to prevent being moved rearwards by of electrode 235,245.
Fig. 2 C is the diagram of the linear type electricity irritation lead-in wire 250 of another embodiment according to this specification.
Lead-in wire 250 includes the elongated metal body 255 having proximally and distally.Adapter 251 is positioned at near-end
Place is used for being connected to type implanting pulse maker.Far-end includes anchorage element 261 and electrode 265.Reference
Fig. 2 C, anchorage element 261 includes the suture sleeve pipe with groove 262, for anchoring to after the implantation
Tissue.In other embodiments, suture sleeve pipe includes more than one groove.Suture 267 has closely
End and being attached to goes between the near-end of far-end of body 255.Pin 268 is attached to the far-end of suture 267.
After the implantation, at least one folder 266 is applied to the suture 267 occurred from LES wall, to prevent electrode
265 be moved rearwards by.
Fig. 2 D is the diagram of the bipolar electric stimulation lead-in wire 270 of another embodiment according to this specification.
Lead-in wire 270 includes the elongated metal body 275 having proximally and distally.Adapter 271 is positioned at near-end
Place, is used for being connected to type implanting pulse maker.Far-end includes bifurcation 279, and it will lead-in wire body 275
It is divided into Liang Ge branch or far-end 280,290.Each branch 280,290 includes anchorage element 281,291
With electrode 285,295.With reference to Fig. 2 D, each anchorage element 281,291 include having groove 282,
The suture sleeve pipe of 292, for anchoring to tissue after the implantation.In other embodiments, each seam
Thread casing includes more than one groove.Suture 287,297 have near-end and being attached to go between 270 every
The near-end of individual branch 280,290.Pin 288,298 is attached to the far-end of each suture 287,297.
After the implantation, at least one folder 286,296 be applied to from LES wall occur each suture 287,
297 to prevent being moved rearwards by of electrode 285,295.
Fig. 3 is proximate to the diagram of the anatomic region of the lower oesophageal sphincter (LES) 304 of sufferer, it is shown that
Used the method for an embodiment according to this specification by peritoneoscope implant single bipolar
Electricity irritation lead-in wire 320.The anatomic region of LES 304 is illustrated between esophagus 303 stomach function regulating 305
At linking part.Each lead-in wire 320 includes that Liang Ge branch 322, the most each branch 322 include butterfly-shaped
324 and expose electrode 325.Lead-in wire 320 is the most implanted, thus its electrode 325 is positioned in and leans on
On first side of the esophagus 303 in the Musclar layer of nearly LES 304.Prevent the folder that electrode 325 is moved rearwards by
326 and suture 327 from the remote extension of each branch 322.
Fig. 4 is proximate to the diagram of the anatomic region of the lower oesophageal sphincter (LES) 404 of sufferer, it is shown that
Two that have used the method for an embodiment according to this specification to be implanted by peritoneoscope bipolar
Electricity irritation lead-in wire 420,430.The anatomic region of LES 404 be illustrated at esophagus 403 stomach function regulating 405 it
Between linking part at.Each lead-in wire 420,430 includes Liang Ge branch 422,432, the most each branch
422,432 include butterfly-shaped 424,434 and the electrode 425,435 exposed.First lead-in wire 420 is
Implanted, thus the of the esophagus 403 that is positioned in the Musclar layer near LES 404 of its electrode 425
On side.Second lead-in wire 430 is the most implanted, thus its electrode 435 is positioned near LES 404
Musclar layer in, away from described first side and the second side of esophagus 403 of being distinct from.Prevent
Folder 426,436 that electrode 425,435 is moved rearwards by and suture 427,437 are from each branch 422,432
Remote extension.
Fig. 5 is the close-up illustration of the distal portions 530 of electricity irritation lead-in wire, it is shown that according to this specification
The electrode 535 that one embodiment is implanted in the muscular wall 505 of LES 503.The distal portions 530 of lead-in wire
Including for anchoring to butterfly-shaped 531 of neighbouring abdominal part.It is shown positioned with for butterfly-shaped 531 near drawing
The distal portions 530 of line is at the insertion point 526 in the wall of LES 503.Suture 537 is from electrode 535
Place extend and leave a little at 528 from the wall appearance of LES 503.It is remote that suture 537 includes being applied to it
The folder 536 of end.Folder 537 is leaving a little 528 wall that can not reenter LES 50, and thus prevents
Electrode 535 slides backward out insertion point 526.In one embodiment, drawn by butterfly-shaped 531 anchoring
The distal portions 530 of line prevents electrode 535 slip in the forward direction.
Above-mentioned example is only the signal of the multiple application of the system of the present invention.Although literary composition only describes this
Some embodiments of invention it should be appreciated that, the present invention may be implemented as a lot of other specific
Form, be made without departing from the scope of the present invention or spirit.Therefore, example and embodiment herein is recognized
For being schematically nonrestrictive, and the present invention can revise in the range of appended claims.
Claims (28)
1., for the conductive lead wire implanted near the lower oesophageal sphincter of sufferer, described lead-in wire includes:
The elongate body of conduction, it has proximally and distally and is covered in insulant；
At the adapter of described proximal end, it is used for being connected to impulse generator；
At least one anchorage element, is positioned close to the described far-end of described lead-in wire body；
At least one electrode, be positioned close to described lead-in wire body described far-end and away from described at least
One anchorage element；
The suture of at least one segment length, has the first end and the second end in contrast to described first end, wherein
Described first end is attached to the described far-end of described lead-in wire body；
Pin, be attached to described in described second end of suture of at least one segment length；And
At least one fixing component, it is possible to by the suture of at least one segment length described in being applied to removedly.
Going between the most as claimed in claim 1, wherein said elongate body includes straight plain conductor.
Going between the most as claimed in claim 1, wherein said elongate body includes the plain conductor of winding.
Going between the most as claimed in claim 1, wherein said elongate body includes turning on cable.
Going between the most as claimed in claim 1, at least one fixing component wherein said includes folder, seam
Any one of line, U-clamp or anchoring piece.
Go between the most as claimed in claim 1, at least one anchorage element wherein said include having to
Butterfly-shaped of a few opening.
Go between the most as claimed in claim 1, at least one anchorage element wherein said include having to
The suture sleeve pipe of a few groove.
8., for the conductive lead wire implanted near the lower oesophageal sphincter of sufferer, described lead-in wire includes:
The elongate body of conduction, it has proximally and distally and is covered in insulant；
At the adapter of described proximal end, it is used for being connected to impulse generator；
At the splitting element of described far-end, for described elongate body is divided into two or more points
?；
Two or more branches, disperse from described splitting element, and each branch has proximally and distally；
At least one anchorage element, is positioned close to the described near-end of each branch；
At least one electrode, is positioned close to the described far-end of each branch；
The suture of at least one segment length, has the first end and the second end in contrast to described first end, wherein
Described first end is attached to the described far-end of each branch；
Pin, be attached to described in described second end of suture of at least one segment length；And,
At least one fixing component, it is possible to by the suture of at least one segment length described in being applied to removedly.
Going between the most as claimed in claim 8, wherein said elongate body includes straight plain conductor.
Going between the most as claimed in claim 8, wherein said elongate body includes the plain conductor of winding.
11. go between as claimed in claim 8, and wherein said elongate body includes turning on cable.
12. go between as claimed in claim 8, and at least one fixing component wherein said includes folder, seam
Any one of line, U-clamp or anchoring piece.
13. go between as claimed in claim 8, at least one anchorage element wherein said include having to
Butterfly-shaped of a few opening.
14. go between as claimed in claim 8, at least one anchorage element wherein said include having to
The suture sleeve pipe of a few groove.
The using method of any one in 15. 1 kinds of lead-in wires as described in claim 1 and 8, including:
At least one conductive electrode of a part as described lead-in wire is implanted near sufferer by peritoneoscope
Lower oesophageal sphincter (LES) place, described using method further includes steps of
Laparoscopically far-end is inserted in the abdominal cavity of described sufferer by the otch in the stomach wall of sufferer；
By surgical operation, the preabdomen of the lower esophageal wall of described sufferer is exposed at least 2cm；
Being passed through by described conductive lead wire at described laparoscopically port, wherein said lead-in wire includes having
Elongated metal body proximally and distally, described elongate body is electrically insulated material and is hidden, described near-end
There is the adapter for being connected to type implanting pulse maker, and described far-end include described at least one
The electrode of individual exposure and anchorage element, described lead-in wire farther includes the first suture, described first suture tool
Having the first end and the second end in contrast to described first end, wherein said first end is attached to described lead-in wire originally
The described far-end of body, and described first pin is attached to described second end；
Target location at the front surface of the lower esophageal wall that described conductive lead wire is advanced to described exposure；
Use described first pin and described first suture so that described electrode is passed described LES so that described
The electrode that exposes and be placed in the Musclar layer of the wall of described LES or near, and described first pin and described
A part for described second end of the first suture occurs again from the described wall of described LES；
By at least one fixing component in the distance of the described wall at least 2-15mm away from described LES
It is applied to the described part of described second end of described suture；
Remove described first pin and the first unnecessary suture；And,
By use single second pin with the second suture is connected to described anchorage element and by described anchor
Gu component is fixed as organizing near LES.
16. usings method as claimed in claim 15, at least one fixing component wherein said includes
Any one of folder, suture, U-clamp or anchoring piece.
17. usings method as claimed in claim 15, at least one anchorage element wherein said includes
There is butterfly-shaped of at least one opening, and described second suture is connected to the institute of described anchorage element
State step to include described second suture through at least one opening described.
18. usings method as claimed in claim 15, at least one anchorage element wherein said includes
There is the suture sleeve pipe of at least one groove, and described second suture is connected to described anchorage element
Described step includes passing described second suture around at least one groove described.
19. usings method as claimed in claim 15, wherein said first suture includes the band of suture
The micro structure of thorn.
20. usings method as claimed in claim 15, further include steps of and repeat
By surgical operation by the exposure at least 2cm of the preabdomen of the lower esophageal wall of described sufferer, until by making
With single second pin the second suture is connected to described anchorage element, described anchorage element is fixed as
Near the step of LES tissue, to implant extra electrostimulation lead.
21. usings method as claimed in claim 15, farther include step: use external device (ED)
To estimate the resistance between each electrode, to guarantee accurate in the Musclar layer of described lower esophageal wall of electrode
Location.
22. usings method as claimed in claim 15, farther include step: shone by endoscope
Bright lower oesophageal sphincter, to identify the placement at least one electrode described and the suitable position of dissection
Put.
23. usings method as claimed in claim 15, farther include step: estimated by endoscope
Calculate wire locations to get rid of the perforation of described lower esophageal wall.
24. usings method as claimed in claim 23, farther include step: if produced
The perforation of described lower esophageal wall, then reorientate described lead-in wire.
25. usings method as claimed in claim 15, wherein said implantation and Hernia hiatus reparation
Process is combined, to repair Hernia hiatus and to prevent answering of Hernia hiatus in described sufferer
Send out.
26. usings method as claimed in claim 15, further include steps of
Expose the diaphragm crura membranacea of described sufferer；And,
At least one suture is applied to described diaphragm crura membranacea.
27. usings method as claimed in claim 15, farther include step: by described lead-in wire
Described proximal attachment is to the impulse generator implanted.
28. usings method as claimed in claim 15, the lead-in wire of wherein said implantation is used for treating food
Road is disorderly, such as Gastroesophageal reflux disease (GERD), achalasia of cardia and esophageal dysmotility.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361906825P | 2013-11-20 | 2013-11-20 | |
| US61/906,825 | 2013-11-20 | ||
| PCT/US2014/066578 WO2015077435A1 (en) | 2013-11-20 | 2014-11-20 | Lead implantation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105939755A true CN105939755A (en) | 2016-09-14 |
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ID=53180129
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201480071598.1A Pending CN105939755A (en) | 2013-11-20 | 2014-11-20 | Lead implantation method |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP3071289A4 (en) |
| CN (1) | CN105939755A (en) |
| AU (1) | AU2014352987A1 (en) |
| WO (1) | WO2015077435A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9925375B2 (en) | 2014-12-09 | 2018-03-27 | Mordechay Esh | Non-invasive device and method for treating gastro esophageal reflux disease (GERD) and the digestive system |
| CN111787876A (en) * | 2017-12-21 | 2020-10-16 | 加尔瓦尼生物电子有限公司 | Systems and methods configured to insert an implant in an abdominal wall cavity |
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| US9020597B2 (en) | 2008-11-12 | 2015-04-28 | Endostim, Inc. | Device and implantation system for electrical stimulation of biological systems |
| US8712529B2 (en) | 2010-03-05 | 2014-04-29 | Endostim, Inc. | Device and implantation system for electrical stimulation of biological systems |
| US9345879B2 (en) | 2006-10-09 | 2016-05-24 | Endostim, Inc. | Device and implantation system for electrical stimulation of biological systems |
| US11577077B2 (en) | 2006-10-09 | 2023-02-14 | Endostim, Inc. | Systems and methods for electrical stimulation of biological systems |
| US9724510B2 (en) | 2006-10-09 | 2017-08-08 | Endostim, Inc. | System and methods for electrical stimulation of biological systems |
| US20150224310A1 (en) | 2006-10-09 | 2015-08-13 | Endostim, Inc. | Device and Implantation System for Electrical Stimulation of Biological Systems |
| US9079028B2 (en) | 2008-10-09 | 2015-07-14 | Virender K. Sharma | Method and apparatus for stimulating the vascular system |
| US10603489B2 (en) | 2008-10-09 | 2020-03-31 | Virender K. Sharma | Methods and apparatuses for stimulating blood vessels in order to control, treat, and/or prevent a hemorrhage |
| US11717681B2 (en) | 2010-03-05 | 2023-08-08 | Endostim, Inc. | Systems and methods for treating gastroesophageal reflux disease |
| WO2012142539A1 (en) | 2011-04-14 | 2012-10-18 | Endostim, Inc. | Systems and methods for treating gastroesophageal reflux disease |
| US9925367B2 (en) | 2011-09-02 | 2018-03-27 | Endostim, Inc. | Laparoscopic lead implantation method |
| US10576278B2 (en) | 2012-02-21 | 2020-03-03 | Virender K. Sharma | System and method for electrical stimulation of anorectal structures to treat urinary dysfunction |
| US9782583B2 (en) | 2012-02-21 | 2017-10-10 | Virender K. Sharma | System and method for electrical stimulation of anorectal structures to treat urinary dysfunction |
| US8706234B2 (en) | 2012-02-21 | 2014-04-22 | Virender K. Sharma | System and method for electrical stimulation of anorectal structures to treat anal dysfunction |
| AU2013305543A1 (en) | 2012-08-23 | 2015-03-19 | Endostim, Inc. | Device and implantation system for electrical stimulation of biological systems |
| US9498619B2 (en) | 2013-02-26 | 2016-11-22 | Endostim, Inc. | Implantable electrical stimulation leads |
| EP3041564A4 (en) | 2013-09-03 | 2017-03-29 | Endostim, Inc. | Methods and systems of electrode polarity switching in electrical stimulation therapy |
| EP3220999A2 (en) | 2014-11-17 | 2017-09-27 | Endostim, Inc. | Implantable electro-medical device programmable for improved operational life |
| WO2018094207A1 (en) | 2016-11-17 | 2018-05-24 | Endostim, Inc. | Modular stimulation system for the treatment of gastrointestinal disorders |
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2014
- 2014-11-20 WO PCT/US2014/066578 patent/WO2015077435A1/en active Application Filing
- 2014-11-20 AU AU2014352987A patent/AU2014352987A1/en not_active Abandoned
- 2014-11-20 EP EP14864930.4A patent/EP3071289A4/en not_active Withdrawn
- 2014-11-20 CN CN201480071598.1A patent/CN105939755A/en active Pending
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| US20030195600A1 (en) * | 2002-04-12 | 2003-10-16 | Carole Tronnes | Implantable medical device with captivation fixation |
| US20110071589A1 (en) * | 2009-09-21 | 2011-03-24 | Medtronic, Inc. | Waveforms for electrical stimulation therapy |
| US20120265103A1 (en) * | 2011-03-04 | 2012-10-18 | Shai Policker | Systems and Methods for Treating Gastroesophageal Reflux Disease |
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| US9925375B2 (en) | 2014-12-09 | 2018-03-27 | Mordechay Esh | Non-invasive device and method for treating gastro esophageal reflux disease (GERD) and the digestive system |
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| CN111787876A (en) * | 2017-12-21 | 2020-10-16 | 加尔瓦尼生物电子有限公司 | Systems and methods configured to insert an implant in an abdominal wall cavity |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2014352987A1 (en) | 2016-06-09 |
| WO2015077435A1 (en) | 2015-05-28 |
| EP3071289A1 (en) | 2016-09-28 |
| EP3071289A4 (en) | 2017-05-31 |
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Application publication date: 20160914 |