CN101516422A

CN101516422A - Methods and devices for stimulation of an organ with the use of a transectionally placed guide wire

Info

Publication number: CN101516422A
Application number: CNA200780034847XA
Authority: CN
Inventors: K·D·斯帕克斯; C·R·布里内尔森; M·A·伊姆朗
Original assignee: IntraPace Inc
Current assignee: IntraPace Inc
Priority date: 2006-08-03
Filing date: 2007-08-03
Publication date: 2009-08-26

Abstract

Devices, systems and methods are provided for electrical stimulation of a body organ, particularly within the gastrointestinal tract. In preferred embodiments, the stomach is the organ within the gastrointestinal tract which is targeted for such stimulation. A guide wire (100) or other delivery device is positioned within the body so as to transect the stomach wall. Devices and systems are then advanced over the guide wire for attachment to the stomach wall. The guide wire may be placed by endoscopic, open, laparoscopic or a modified percutaneous approach. In a modified percutaneous approach, the stomach is accessed without the use of general anesthesia by advancing a needle (120) through the abdomen, transecting the stomach wall with the needle and advancing the guide wire through the needle. In some embodiments, particularly for use in obese patients, the modified percutaneous approach includes advancing a trocar (130) through the tissue of the patient toward the outer surface of the organ and advancing the needle through the trocar prior to transecting the wall with the needle.

Description

Utilize the guide wires stimulatory organs's of crosscut placement method and apparatus

Background technology

People have advised gastrointestinal tract is carried out electricity irritation with treatment motion sickness and other gastrointestinal disease.Proposed the electricity irritation of various ways, for example pace-making (pacing), electricity shrink stimulation or other stimulation, in order to treatment various diseases or condition of illness, for example regurgitation or obesity.Also propose to conduct treatment of obesity by utilizing electricity irritation to change the stomach mobility or excite nerve.For example, a kind of Therapeutic Method makes stomach keep food with the long persistent period.Also propose to utilize electricity irritation to slow down gastric emptying and be called the disease of dumping syndrome with treatment, in this disease, stomach empties small intestinal at a high speed with abnormal, thereby causes various gastrointestinal disorders.

Early stage trial to gastric stimulation devices comprises the electrode that is positioned at nasal feeding tube or catheter tip.The nasal feeding tube per nasal enters stomach.Use the outside stimulus device to apply electricity irritation by managing terminal electrode.Refurn electrode is positioned at abdominal part.When needs stimulated, this device needed the per nasal step.

Be used to regulate other devices of stomach speed usually by implanting by the abdominal part opening contact stomach outside of opening the generation of abdomen surgical operation or laparoscopically surgical operation.For example, the electrode utilization lead that extends through abdominal part is attached on the coat of the stomach.Described lead links to each other with the pacemaker device, described pacemaker device remote location implant subcutaneous or muscle under in the recess (pocket).

People wish to use improved implanting device, system and method to come stimulating gastrointestinal road, especially stomach.For instance, this device and system should be easy to implant, and are suitable for life-time service, safe and effective aspect treatment disease or symptom.Especially, this method should be particularly suitable for treating the obese patient, and they are because the situation of self can have special needs and restriction.The present invention satisfies at least a portion purpose at least.

Summary of the invention

The invention provides the device, the system and method that the human organ that especially is positioned at gastrointestinal tract are carried out electricity irritation.In a preferred embodiment, stomach is as the organ in the gastrointestinal tract of this stimulation target.Therefore, stomach is used herein to illustration purpose, yet, will be appreciated that the present invention can be used for other organ, hollow organ, the intravital organized layer of body or unit.Stomach is the hollow organ who comprises coat of the stomach, and described coat of the stomach has the inner surface in towards organ inside (that is, towards the gastric chamber) and the outer surface that deviates from organ (that is, towards peritoneal cavity).The present invention includes the guide wires that is positioned at body interior or other transporter so that the crosscut coat of the stomach.Therefore, guide wires (comprises) to extend through outer surface, coat of the stomach and inner surface at any angle vertical with coat of the stomach.In a preferred embodiment, guide wires is passed esophagus and is stretched out from patient's oral area from inner surface, and/or passes peritoneal cavity and stretch out from patient's abdominal part from outer surface.Therefore, device and system can be transported to the coat of the stomach that is used to implant by oral area and/or by abdominal part.In certain embodiments, first element of system of the present invention is carried by oral area, and second element of system of the present invention is carried by abdominal part, and wherein, first and second elements are the parts that are used to stimulate the system of coat of the stomach.

In one aspect of the invention, provide to be used for device is attached to method on the intravital hollow organ walls of patient, described wall has towards the inner surface of organ inside and deviates from the outer surface of organ.In certain embodiments, described method comprises makes the guide wires location, wherein, guide wires crosscut organ walls and pass tissue to extend to the patient external, described device is advanced towards described organ from the patient is external on guide wires, wherein, described device comprises at least one lead with at least one electrode.Described method also comprises described device is attached on the organ walls, makes the paired wall of described at least one positioning of electrode stimulate.

In certain embodiments, the guide wires localization step is included under the situation of not using general anesthesia enters organ by improved percutaneous method, wherein, described improved percutaneous method comprises that making pin pass patient tissue advances towards the extraorgan surface, utilizes the described wall of described pin crosscut and make guide wires pass described pin to advance.Improved percutaneous method can also comprise that making the trocar pass patient tissue advances towards the extraorgan surface, and makes described pin pass described trocar propelling before utilizing the described wall of described pin crosscut.Described device is attached to comprises on the described wall and make described at least one positioning of electrode in described wall.The step of described at least one positioning of electrode in described wall can be comprised make in the Musclar layer of described at least one positioning of electrode in described wall or against this Musclar layer location.In certain embodiments, the step of attached described device can comprise pulse generator or stimulator implanted and is positioned at the intravital hollow organ of patient outside.Perhaps, attached described device can comprise stimulator is attached on the organ walls, makes stimulator implant in the hollow organ.In this case, the guide wires localization step can be comprised make guide wires extend through patient's oral area, described method also comprises to be made stimulator pass oral area and advances towards the inner surface of hollow organ walls on guide wires.Alternatively, the step of attached described device can comprise the tissue that the stimulator implantation is positioned at the hollow organ outside.

When described device comprises maintenance (retention) member, described device is attached to comprises on the organ walls retention element is positioned in the organ walls.In some cases, described organ comprises stomach, and described wall comprises Musclar layer and tela submucosa at least.In this case, retention element is positioned at comprise in the organ walls retention element is positioned between Musclar layer and the tela submucosa.Can recognize, when described device comprises fixed component and during near the conical section of described fixed component, described device is attached to comprises on the organ walls and make fixed component, the described wall of conical section crosscut simultaneously against extraorgan's surface alignment.

In another aspect of this invention, provide the device that will have first and second portion to be attached to method on the intravital hollow organ walls of patient.Described wall has the inner surface and the outer surface that deviates from described organ towards described organ inside.Described method comprises: make the guide wires location, wherein, the wall of the described organ of described guide wires crosscut; The first of described device is advanced on described guide wires along the direction towards described hollow organ walls inner surface; The second portion that makes described device along with advance on described guide wires towards the opposite direction of described hollow organ walls outer surface; With described first and second portion are combined so that described device is attached on described hollow organ's the wall.

In certain embodiments, the guide wires localization step is comprised make guide wires extend through patient's oral area, the propulsive step of described first is comprised make described first to pass oral area and on guide wires, advance towards the inner surface of described hollow organ walls.In some cases, the guide wires localization step is comprised make guide wires extend through patient's abdominal part, the propulsive step of described second portion is comprised make described second portion pass abdominal part and on guide wires, advance towards the outer surface of described hollow organ walls.In other cases, the guide wires localization step is included under the situation of not using general anesthesia enters organ by improved percutaneous method, wherein, described improved percutaneous method comprises that making pin pass patient's abdominal part advances towards the extraorgan surface, utilizes the described wall of described pin crosscut and make guide wires pass described pin to advance.In some cases, improved percutaneous method can also comprise that making the trocar pass patient's abdominal part advances towards the extraorgan surface, and makes described pin pass the described trocar before utilizing the described wall of described pin crosscut to advance.

In another aspect of this invention, provide a kind of lead that the intravital hollow organ walls of patient is stimulated, described wall has towards the inner surface of organ inside, deviates from the outer surface of organ and therebetween a plurality of layers.Described lead comprises guidewire body, and described guidewire body has near-end, far-end and guide wire lumen, and described guidewire inner chamber extends through at least a portion of described guidewire body, and described near-end is configured to be attached on the power supply.Described lead also comprises the retention element of arranging near described far-end, and described retention element extends radially outwardly and is configured to be positioned between the layer of described wall from described guidewire body.Described lead also comprises at least one electrode, and described electrode is along described wire arrangements, make when described retention element be positioned at described wall layer between the time, be supplied to the electric energy of described at least one electrode that wall is stimulated.

In certain embodiments, when the layer of described wall comprised Musclar layer and tela submucosa, described retention element was configured to be positioned between described Musclar layer and the tela submucosa.Can recognize that described at least one electrode can be arranged along described retention element.

Can also recognize that described lead can also comprise the fixed component of arranging near described retention element, described fixed component extends radially outwardly and is configured to contact the surface of described wall from described guidewire body.In this case, described at least one electrode can optionally be arranged along described fixed component.Perhaps, described at least one electrode can be arranged along the section of described guidewire body between described retention element and fixed component.In this case, described at least one electrode has spiral, ring, the vertical shape of band or its combination.

When the layer of described wall comprised Musclar layer and tela submucosa, described retention element and fixed component can be spaced apart, make described retention element can be positioned between described Musclar layer and the tela submucosa, and described fixed component can be against the surface alignment of described organ.

In another aspect of this invention, provide a kind of being used for that device is attached to method on the intravital hollow organ's of patient the wall, described device comprises at least one lead with at least one electrode.Described method comprises: make first guide wires location, make the wall of described guide wires at the described organ of primary importance crosscut; Described stimulator is advanced on described first guide wires; Be attached to described stimulator on the wall of described organ in described primary importance; Make second guide wires location, make the wall of described guide wires at the described organ of second position crosscut; Described at least one lead is advanced on described second guide wires; With described at least one lead is attached on the wall of described organ in the described second position, make described at least one positioning of electrode become to stimulate described wall.

When described hollow organ has outer surface, described outer surface towards between described organ and patient are external, extend organize the time, described first guide wires location is included under the situation of not using general anesthesia enters described organ by improved percutaneous method.In this case, described improved percutaneous method comprises that making pin pass patient tissue advances towards the outer surface of described organ, utilizes the described wall of described pin crosscut and make described first guide wires pass described pin to advance.Similarly, described second guide wires location can be included under the situation of not using general anesthesia enter described organ by improved percutaneous method, wherein, described improved percutaneous method comprises that making pin pass patient tissue advances towards the outer surface of described organ, utilizes the described wall of described pin crosscut and make described second guide wires pass described pin to advance.

Description of drawings

Fig. 1 has shown guide wires or other transporter that passes coat of the stomach crosscut layout.

Fig. 2 has for example shown makes the guide wires location by endoscopic procedures.

Fig. 3 has shown for example by opening abdomen, making the guide wires location through peritoneoscope or improved percutaneous method.

Fig. 4 A-4F has shown the embodiment that improves the percutaneous method.

Fig. 5 A-5B has shown and has been positioned to the guide wires of passing coat of the stomach and stretching out from patient's oral area from patient's abdominal part.

Fig. 6 has shown the embodiment of a device, and described device can advance on the guide wires that the crosscut that is used to stimulate coat of the stomach is arranged.

Fig. 7 A-7B has shown the cross sectional representation of the device shown in Figure 6 that engages with coat of the stomach.

Fig. 8 has shown the side view of device shown in Figure 6.

Fig. 9 A-9C, 10,11 has shown the exemplary electrode that is positioned on the device shown in Figure 6.

Figure 12 has shown the device embodiment with conical section.

Figure 13 has shown the device embodiment with distal ports, and described distal ports is distad extended from fixation retention feature.

Figure 14 has shown another embodiment of a device, and described device can transmit by the guide wires that crosscut is arranged.

Figure 15,16,17 has shown the system example that can be attached to by means of the guide wires that one or more crosscut is arranged on the coat of the stomach.

Figure 18 has shown another example of the system on the coat of the stomach that can be attached to by means of the guide wires that crosscut is arranged.

Figure 19 A-19C has shown the another example of the system on the coat of the stomach that can be attached to by means of the guide wires that crosscut is arranged.

Figure 20,21,22 has shown the embodiment of the transporter that uses along the direction of the guide wires of arranging perpendicular to crosscut substantially in transporter and system.

The specific embodiment

With reference to figure 1, guide wires 100 or other transporter are positioned at body interior so that crosscut coat of the stomach W.Stomach is the hollow organ who comprises coat of the stomach W, and described coat of the stomach has towards the inner surface IS of gastric chamber L with towards peritoneal cavity PC outer surface OS.Therefore, guide wires 100 (comprises) to extend through outer surface OS, coat of the stomach W and inner surface IS at any angle vertical with coat of the stomach W.

In certain embodiments, as shown in Figure 2, guide wires 100 extends through the esophagus E of patient P continuously and stretches out from patient's oral area M.This location of guide wires 100 typically utilizes endoscopic procedures to realize.In this method, endoscope's induction system 102 can be used for making stimulating apparatus or system to pass esophagus E and be sent among the L of gastric chamber, and described stimulating apparatus or system are attached on the coat of the stomach W at described gastric intracavity.In some cases, endoscope's induction system 102 comprises soft endoscope or endoscopic instrument, is used for setting at gastric being used for the attached optimum position of device.Endoscope typically comprises one or more conduit, and the instrument that is used for attached stimulating apparatus or system is inserted through described conduit.U.S. Patent No. 6,535 has been described the exemplary embodiment of this endoscope induction system 102 and endoscope's delivered stimulation devices and system in 764, and the content of described patent is hereby incorporated by.

In other embodiments, as shown in Figure 3, guide wires 100 extends through the peritoneal cavity PC of patient P continuously and stretches out from patient's abdominal part.Therefore, guide wires 100 is process between intraperitoneal any internal organs, passes all cortexes of peritoneum, Musclar layer and relevant fascia, subcutaneous fat and patient, extends to the health outside.This location of guide wires 100 typically utilizes out abdomen or endoscopic procedures to realize.U.S. Patent application No.11/249 has described the stimulating apparatus that can utilize out abdomen or transmit through laparoscopic procedures and the exemplary embodiment and the method example of system in 661, and this application is hereby incorporated by.Typically, stomach utilizes hollow needle to thrust the stomach from the stomach outside at the conductor configurations position of hope.Enter in the stomach by laparoscopy or by opening the abdomen surgical method.Guide wires is positioned to pass hollow needle and enters in the stomach.Take out hollow needle subsequently, make guide wires stay the appropriate position, described guide wires stretches in the stomach by abdominal part at the conductor configurations position.Lead is promoting on the guide wires and is being attached on the coat of the stomach subsequently.

For some patients, open abdomen or through laparoscopic procedures for example because the complication risk that increases and not too desired or be restricted for people.Open abdomen and laparoscopically surgical operation and all need general anesthesia.In laparoscopy, utilize CO ₂Or other nonflammable gas expands patient's peritoneal cavity, thereby makes peritoneal cavity be converted to true chamber from virtual chamber.This expansion is upwards lifted patient's diaphragm, causes dyspnea.Therefore, the patient is in general anesthesia, breathes to be controlled thus.A plurality of trocars insert the inflation intraperitoneal subsequently, make video camera and other operating theater instruments can import abdominal part.Operate by observing the video image that transmits by photographing unit subsequently.Usually, first trocar provides the passage that makes video camera enter abdominal part, so that monitor surgical procedures.Clamp inserts in second trocar usually to move or to keep the part of stomach or other internal organs according to the action type that will carry out.The 3rd trocar provides and has been used to handle clamp or through the passage of peritoneoscope pliers.The quadruplet bobbin is used to introduce instrument to carry out operating procedure.Program complexity and the clinical complication relevant with making a plurality of trocars location with implement general anesthesia to the obesity patient can make these patients be subjected to the restriction of surgical procedure.

Therefore, can utilize improved percutaneous method that guide wires 100 is located as shown in Figure 3.The embodiment that has shown this improvement percutaneous method among Fig. 4 A-4F.Referring to Fig. 4 A, the far-end 110 of endoscope 112 advances and enters gastric chamber L by esophagus E.In a preferred embodiment, endoscope 112 comprises at least by the visual optical element at least of its far-end 110, and that uses when blowing for treatment gastric chamber L penetrates wherein inner chamber and lighting mechanism.Gastric chamber L is insufflated to the degree of hope, to allow to observe inner surface IS or the mucomembranous surface of coat of the stomach W.Position on the inner surface IS is identified as target implantation position 114, to place the part of stimulating apparatus or system, for example stimulation leads electrode or anchoring section.Can watch inner surface IS to realize this identification by using optical element.Alternatively or in addition, can be by determining to realize this identification via the hope path of an abdominal part part.Wish that the path typically makes the distance minimization between the patient skin stomach function regulating inner chamber L, and reduce the chance of contact internal organs when the path forms.In order to realize this purpose, light 116 penetrates illuminating the target implantation position 114 of hope from endoscope 112 by means of lighting mechanism, and the adjacent regions of abdominal part.

Fig. 4 B has shown the cutaway view of stomach shown in Fig. 4 A that is positioned at patient's abdominal part.The far-end 110 of endoscope 112 is shown as and stretches among the L of gastric chamber, and wherein, light 114 is according to saturating coat of the stomach W and the tissue between wall W and patient skin S.Therefore, can be at the patient skin S of light 114 crosscut abdominal paries arrive the field of illumination outwardly.Typically, the paries anterior gastricus location is passed in this path.Paries anterior gastricus is the most close patient skin (opposite with rear wall) usually, therefore, will provide from the entrance on the skin the short and safe path in gastric chamber, and reduces the chance of contact internal organs.The target implantation position also preferably is positioned to the circumference band of proximity of muscle tissue, and wherein, physical slow wave originates in the stomach.This part of stomach is often referred to the main body or the bottom-main body junction of stomach.Can recognize, can use implantation position optional or that addition method identification is wished.For instance, these methods can comprise the ultrasonic (phased array of forward sight, for example make) by VolcanoTherapeutics, ultrasonic (the rotation of side-looking, for example make) by Boston Scientific, (MRI) interfered in magnetic resonance, computer-aided tomography imaging (CAT) scanning, optical coherence tomography (OCT) or optical coherence bounce technique (OCR).

After the target implantation position 114 that identification is wished, by illuminating of endoscope 112 holding positions 114.If on patient's skin of abdomen S, can see percutaneous light 116, can estimate the source position of described light by suitable precision at the inner surface IS place of coat of the stomach W.Narcotic local injection is carried out in path along the illumination light 116 of percutaneous.Shown in Fig. 4 C, pin 120 passes patient skin S subsequently and along the path of illumination light 116, crosscut coat of the stomach W also enters gastric chamber L.Can use various suitable pins 120, comprise percutaneous esophageal-gastric otomy (PEG) pin.Utilization is positioned at the tip of the pin 120 in the L of gastric chamber, and guide wires 100 is passed pin 120 and is advanced among the L of gastric chamber.Pin 120 is withdrawal fully subsequently, guide wires 100 is stayed the appropriate position, shown in Fig. 4 D.

Some patients, especially among the obese patient, can not on the s skin S of patient's abdominal part, easily see percutaneous light 116.In the obese patient, this may be the reason owing to excessive layers of subcutaneous fat.Perhaps, in some cases, light 116 may be blocked at least in part by spleen, small intestinal or liver organization.When light 116 is not easy to see, form the path by means of the trocar 130, shown in Fig. 4 E-4F.Along projection path with the anesthetis local injection in the L of gastric chamber.Produce little otch on patient skin S, the trocar 130 (for example XcelEndoTip is made by Ethicon Endovascular) with loss prevention tip 132 inserts by described otch, shown in Fig. 4 E.The trocar 130 utilizes traditional blunt method of cutting open to pass abdominal tissues and push, and notes the organ around the damage, for example liver, spleen or small intestinal.The peritoneoscope 134 that is positioned in the trocar 130 by introducing can help visual guidance.When near coat of the stomach W, can see percutaneous light 116.When the tip 132 of the trocar 130 had advanced to the hope implantation position 114 that is positioned at coat of the stomach W place, pin 120 advanced by the trocar 130, and crosscut coat of the stomach W also enters gastric chamber L, shown in Fig. 4 F.As shown in the figure, guide wires 100 is passed pin 120 and is advanced, so that enter gastric chamber L.When guide wires 100 is in the appropriate location, can take out the trocar 130 and pin 120.

In either case, 100 need of guide wires are advanced to the position of distance enough among the L of gastric chamber with maintenance guide wires 100, and can not produce the risk of displacement when taking out the pin 120 and the selectable trocar 130.In certain embodiments, about 10 inches guide wires 100 is advanced among the L of gastric chamber, yet also can advance any suitable length.Similarly, guide wires 100 can have any suitable diameter.In certain embodiments, use the standard 0.035 " guide wires of in Percutaneous Transluminal Angioplasty (PTA), using of diameter.

When guide wires 100 crosscut coat of the stomach W placement, can expand to allow device or system to carry along the path of guide wires 100.Can utilize a series of dilators to realize expansion, described dilator can advance on guide wires 100.Subsequently, device that uses in gastric irritation or system can be transported to coat of the stomach W by abdominal part.

In certain embodiments, shown in Fig. 5 A-5B, guide wires 100 is positioned to the abdominal part from the patient, passes peritoneal cavity PC, passes coat of the stomach W, stretches out from patient's oral area along esophagus E.Therefore, pass patient body and form continuous path, directly enter the inner surface and the outer surface of coat of the stomach from the health outside.Subsequently, device and system can be transported to the coat of the stomach that is used to implant by oral area and/or by abdominal part in guide wires 100.In certain embodiments, first element of system is carried by oral area, and second element of system is carried by abdominal part, and wherein, first and second combination of elements are used to stimulate coat of the stomach.

In order to realize the placement of guide wires 100 along continuous path, guide wires 100 is at first by opening abdomen, being positioned to as shown in Figure 3 through peritoneoscope or improvement percutaneous method.The far-end of guide wires 100 passes patient bottom sphincter of gullet (LES), passes that esophagus E advances and leave from oral area M in the regression mode.Typically, endoscope 112 is positioned in the esophagus E, makes the far-end of guide wires 100 advance along the service aisle of endoscope 112.Therefore, the far-end of guide wires 100 leaves from the near-end inlet of endoscopic working channel, and stretches out from oral area M.Endoscope 112 takes out subsequently, and guide wires 100 is stayed the appropriate position.Alternatively, have the sidepiece location of the pipe of inner chamber along endoscope 112, wherein, the far-end of guide wires 100 pushes in the tube cavity in the mode that falls back, and leaves from oral area M.Pipe can take out subsequently, and guide wires 100 is stayed the appropriate position, and endoscope 112 is remained on appropriate position in the L of gastric chamber.Typically, about at least 300 centimetres guide wire length is enough to guide wires 100 is placed to shown in Fig. 5 B, yet can use any suitable length.

When guide wires 100 was in the appropriate location of crosscut coat of the stomach W, shown in Fig. 2, Fig. 3 or Fig. 5 B, device or system can advance on for the guide wires 100 that stimulates coat of the stomach W to use.Fig. 6 has shown the example of this device 200.In this embodiment, device 200 comprises pulse generator or stimulator 202 and has the conductive wire 204 of at least one electrode 206.Stimulator 202 comprises electronic equipment 208 and power supply 210, and described power supply links to each other with lead 204 electric energy is provided for described at least one electrode 206.Lead 204 is configured to apply electric energy for coat of the stomach W by described at least one electrode 206, and stimulator 202 is configured to implant in position.

In this embodiment, lead 204 comprises the flexible lead body 212 with near-end 214 and far-end 216, and described near-end can link to each other with stimulator 202.For instance, flexible lead body 212 can be comprised of any appropriate material, thermosetting plastic especially, and silicone for example, fluorosilicone, synthetic rubber, such as

The fluoropolymer elastomer of (DuPont Performance Elastomers), such as

The Perfluoroelastomer of (DuPont PerformanceElastomers), other polymer in these families, other polymer, perhaps their combination in any.Flexible lead body 212 also comprises passes the guide wire lumen 218 that far-end 216 extends at least in part, and described far-end is used to make lead 204 to advance on guide wires 100.In this embodiment, lead 204 also comprises retention element 220 and is arranged near the far-end 216 fixed component 222.Member 220,222 extends radially outwardly from guidewire body 212, and is separated by section 224.For instance, section 224 can be comprised of any appropriate material, and comprises quaternary alloy, nylon, Pebax, polyether-ether-ketone (PEEK) or its combination in any of polymer, rustless steel, alloy, for example MP35N (having nominal composition is 35% nickel, 35% cobalt, 20% chromium, 10% molybdenum).In Fig. 6, member 220,222 is shown as circle or dish type, yet member 220,222 can have any suitable shape, comprises ellipse, square, triangle, rectangle, crescent, polygon etc.Member 220,222 is flexible, so that bend to contraction, folding or taper configurations, is used for transmitting by sheath or delivery conduit when lead 204 advances on guide wires 100.For instance, member 220,222 can be comprised of any appropriate material, and comprises thermosetting plastic, silicone for example, and fluorosilicone, synthetic rubber, such as

The fluoropolymer elastomer of (DuPont Performance Elastomers), such as

The Perfluoroelastomer of (DuPont PerformanceElastomers), other polymer in these families, other polymer, perhaps their combination in any.In a preferred embodiment, member 220,222 is made up of the soft silicone, and the hardness of described soft silicone is 50 Shore A.In addition, lead 204 can partly or entirely form by injection moulding or the manufacturing of transfer modling method.In certain embodiments, this allows member 220,222, section 224 and guidewire body 212 to form individual unit.

Fig. 7 A-7B has shown propulsive device 200 shown in Figure 6 on the guide wires 100 that crosscut is placed, and described guide wires is by opening abdomen, putting into through peritoneoscope or improved percutaneous method.In this embodiment, device 200 passes peritoneal cavity PC and is advanced to coat of the stomach W from patient's abdominal part outside.Coat of the stomach W comprises serosal layer SR, Musclar layer MS, tela submucosa SB and mucous layer MC.With reference to figure 7A, when device 200 advanced, retention element 220 crossed serosal layer SR and Musclar layer MS, till the imaginary space V that arrives between Musclar layer MS and the tela submucosa SB.Imaginary space V is easy to relative performance of sliding by Musclar layer MS and tela submucosa SB and becomes apparent in regional area.Can utilize this characteristic, thereby by saline is expelled to this contact surface, produces local saline " bubble " and Musclar layer MS is gone up the placement that local detachment makes things convenient for retention element 220 from tela submucosa SB through endoscope.Retention element 220 is positioned among the imaginary space V between Musclar layer MS and tela submucosa SB, as shown in the figure.Subsequently can the sucking-off saline bubble.This location automatically is placed on fixed component 222 near near the outer surface 0S of coat of the stomach W, and helps the far-end 216 of lead 204 is fixed on the coat of the stomach W.This makes electrode 206 keep contacting with Musclar layer MS (entire cross section that allows stimulated muscle layer MS) then, and additional surface is provided selectively, wherein, electrode is installed on the described additional surface.In addition, retention element 220 prevents to pull out from far-end 216.Therefore, can use retention element 220 to replace fixed component 222 is sewn to the far-end 216 of appropriate location with fixing cord 204, perhaps can use retention element 220 when fixed component 222 is sewn onto the appropriate location, to stablize lead 204.Alternatively, retention element 220 can be against coat of the stomach W and inner surface IS location, shown in Fig. 7 B, perhaps is positioned between the various layers of coat of the stomach W or inner, shown in Fig. 7 B.

When conveying, retention element 220 its thermosetting inflated configuration of recovery allow the position between member 220 hope ground supports and maintenance layer MS, the SB, and maintenance simultaneously is flexible so that meet the profile of coat of the stomach W when coat of the stomach W moves.In this embodiment, retention element 220 has about 0.25 inch to 1 inch diameter, about 0.005 to 0.040 inch thickness, yet, also can use other size and thickness.In addition, in this embodiment, retention element 220 is that about 30 Shore A are formed to the polymer of 70 Shore A by hardness, but also can use other hardness.In certain embodiments, when polymer hardness increased, the diameter of retention element 220 and wall thickness reduced with the physical property that the wire arrangements support member is provided, cure for a long time and implant the balance between the stability.

Refer again to Fig. 7, fixed component 222 is shown as the outer surface OS location against coat of the stomach W.Fixed component 222 can have any aspect of retention element 220, for example, and size, shape, thickness, hardness etc.In addition, fixed component 222 can comprise to be sewed up or clamping hole 226, is used for fixed component 222 is sewed up or is clamped to outer surface OS or the serosal layer SR of coat of the stomach W, provides crucial positional stability with the far-end 216 of giving lead 204.The hope location of the far-end 216 of lead 204 is by retention element 220 and fixed component 222 together support, and wherein, the part of coat of the stomach W is therebetween.Retention element 220 and fixed component 222 can any spacing separate, for example about 2 millimeters-1 millimeter spacings, preferably 2 millimeters-12 millimeters spacings, more preferably 4 millimeters-10 millimeters spacings.

When beginning to heal after implanting, fibrous capsule typically forms around the far-end 216 of lead 204.This can make retention element 220 be embedded in more securely among the coat of the stomach W.Alternatively or in addition, healing reaction also can form the fibrous tissue recess to seal fixed component 222, fixed component 222 is attached on the outer surface OS of coat of the stomach W securely.

With reference to figure 6, one or more electrode 206 is positioned on the lead 204.Electrode 206 can be comprised of any appropriate material, for example platinum or platinum-iridium are (for example, by Johnson-Mathey, Wayne, Pennsylvania makes), perhaps nonferrous metal, it is that 35% nickel, 35% cobalt, 20% chromium and molybdenum 10% are (for example, by Fort Wayne Metals that alloy or as the quaternary alloy of MP35N for example, described MP35N have nominal composition, Fort Wayne, Indiana makes).Described one or more electrode 206 links to each other with power supply 210 by at least one electric conductor and stimulator 202, especially electronic equipment 208.For instance, electric conductor can be comprised of any appropriate material, and comprises rustless steel, platinum-iridium, alloy, as quaternary alloy or the metal of MP35N.In certain embodiments, described at least one electric conductor comprises multiply strand cable.For example, multiply strand cable can comprise 7 bundles, and wherein, every bundle comprises 19 strands.Per sharely can have for example about 0.0012 " diameter.Such cable configuration can have about 0.018 " nominal diameter.Many other configurations also are suitable for, and for example, a strand diameter is about 0.0012 " to 0.002 ", and cable size is about 0.010 " to 0.020 ".

As shown in Figure 6, first electrode 206 ' " close fixed component 222 is along lead 204 location to be positioned on the section 224 between retention element 220 and the fixed component 222 second electrode 206.Yet, can recognize that described one or more electrode 206 can be arranged in along on a plurality of surfaces of lead 204.For example, with reference to figure 8, electrode 206 can be along the proximal face 232 of the distal surface 230 of retention element 220, retention element 220, along the section 224 between retention element 220 and the fixed component 222, along the distal surface 234 of fixed component 222, arrange along the proximal face 236 of fixed component 222 and/or along the guidewire body 212 near fixed component 222.Fig. 9 A-9C has shown along the exemplary embodiment of the electrode 206 of proximal face 232 layouts of retention element 220.Fig. 9 A has shown the electrode 206 that covers proximal face 232 substantially, centers on guide wire lumen.Fig. 9 B has shown the round-shaped electrode 206 that has around guide wire lumen 218, and wherein, the diameter of described electrode is less than the diameter of retention element 220.Fig. 9 C has shown the electrode 206 with the square shape that departs from guide wire lumen 218.Can recognize that along surface 232 electrodes 206 that can have any amount, and these electrodes 206 can have different shape, size or structure.In addition, can recognize that these examples and explanation are equally applicable to the electrode that the proximal face 236 of the distal surface 234 of distal surface 230, fixed component 222 along retention element 220 and fixed component 222 is arranged.

As mentioned above, one or more electrode 206 can be arranged along the section between retention element 220 and fixed component 222 224.Figure 10 has shown the electrode 206 that covers section 224 substantially.Can recognize that electrode 206 can cover the part or the whole periphery of section 224 along any length of section 224.For example, electrode 206 can comprise the circumferential hoop that extends around the part of section 224, and perhaps electrode 206 can comprise the vertical band that extends along the part of section 224.Vertical belt shape has increased along the contact surface in the crosscut path of passing coat of the stomach W long-pending, and more a plurality of contact points along the crosscut path especially are provided.And when the time spent of doing that vertically takes up stimulating electrode, vertically belt shape helps to provide along the crosscut path distribution density of stimulation energy.Can recognize, the electrode 206 that can have any amount along section 224, and these electrodes 206 can have different shape, size or structure.For example, Figure 11 has shown to have spiral-shaped electrode 206.

Can recognize that section 224 can have different shape, size and length.For example, Figure 12 has shown the embodiment with conical section 225.In certain embodiments, the nominal angle of conical section 225 is approximately 2 and spends to 10 degree, is preferably about 5 degree.Taper helps the far-end 216 of lead 204 is fixed on the coat of the stomach W.Between the period of digestion, stomach produces the slow contraction wave of propagating towards pylorus from the bottom.Between the period of digestion, the average frequency of the gastric slow wave of gastric is about three times/minute.When each contraction wave arrives lead 204 implantation positions, the Musclar layer MS of stomach will shrink and circumferentially shrink around conical section 225, and thickness increases simultaneously.Because the conical in shape of section 225, the lip-deep circumferential contractility that acts on conical section 225 will become along the force vector of the longitudinal axis effect of conical section 225, so that fixed component 222 is pushed against on the coat of the stomach W, thereby fixed component 222 is supported on the outer surface OS of coat of the stomach W.This being supported with helps between healing stage fixed component 222 is being fixed on the coat of the stomach W.When healing reaction become stable after, the far-end 216 of lead 204 is positioned to provide stable, multiple electricity irritation to coat of the stomach W with wishing.

One or more electrode 206 comprises at least one stimulating electrode and optional at least one refurn electrode.At least one stimulating electrode is positioned at least a portion of coat of the stomach W is stimulated.Therefore, at least one stimulating electrode is typically along the surface alignment of the far-end 216 of lead 204, described electrode implant and/or during healing reaction near the layer of coat of the stomach W or the layer of contact coat of the stomach W.This surface typically comprises the surface of retention element 220, section 224 and/or fixed component 222.In one embodiment, stimulate along one or more stimulating electrodes of these surface alignment Musclar layer MS coat of the stomach W.

In certain embodiments, one or more stimulating electrode also plays the effect of refurn electrode.In other embodiments, the shell of stimulator 202 plays the effect of refurn electrode.In other embodiments, has at least one independent refurn electrode.Described at least one refurn electrode can be arranged in aforesaid any electrode position.For example, at least one refurn electrode can be along arbitrary surface arrangement of retention element 220, section 224 and/or fixed component 222.Alternatively or in addition, at least one refurn electrode can be arranged in position near fixed component 222 along guidewire body 212.Can recognize, can have the stimulating electrode and the refurn electrode of any amount and combination, and they can be arranged in any position.

When at least one refurn electrode near fixed component 222 during along guidewire body 212 location, at least one refurn electrode can contact with nethike embrane or other internal organs after implanting immediately.Yet when carrying out chronic healing, lead 204 typically is wrapped in fibrous pocket or the capsule.Can be used as dummy electrodes around the fibrous capsule of at least one refurn electrode itself and use, it provides at described at least one refurn electrode and leads to conductive contact surfaces between the passage of described at least one stimulating electrode.When forming fibrous capsule, the position of at least one refurn electrode can change slightly from its initial implantation position, but influence is very little.

When fibrous capsule centered on retention element 220 and extends through serosal layer SR, fibrous capsule was organized in and produces molded pocket in the coat of the stomach, and it has the shape of the far-end 216 of lead 204.This is fixed to lead 204 on the appropriate location then.Fibrous tissue itself can play the effect of dummy electrodes, to give at least one refurn electrode conduction energy.Therefore, can stimulation current vectors between at least one stimulating electrode and at least one refurn electrode be described for acute (initial implant) and chronic (after fibers encapsulation) stage.Acutely, the stimulating current that is provided by stimulator 202 will flow along the stimulating electrode that directly contacts with coat of the stomach W with vector between at least one refurn electrode that internal organs or nethike embrane contact.Chronically, the stimulating current that is provided by stimulator 202 will be along being contained in the stimulating electrode in the fibrous pocket at present and also being contained at present in the fibrous pocket but vector outside at serosal layer SR and between localized at least one refurn electrode of its another side flows.

In a particular embodiment, stimulating electrode is along the location, surface (contacting near the layer of coat of the stomach W or with the layer of coat of the stomach W very much) of the far-end 216 of lead 204, and the close fixed component 222 of refurn electrode is along guidewire body 212 location.In this embodiment, the distance between stimulating electrode and the refurn electrode is about 1 centimetre to 10 centimetres.In addition, in this embodiment, the surface area of refurn electrode is obviously greater than the surface area of stimulating electrode.Exemplary ratios between the relative conductive surface areas of refurn electrode and stimulating electrode is 10: 1, yet, also can use other ratio.The ratio of relative conductive surface areas can be regulated, make and to send the clinical symptoms that is enough to limit hope around the electric current density of the tissue of stimulating electrode to, yet the electric current density relevant with the tissue that centers on refurn electrode is distributed and drops to below the threshold value to stimulate surrounding tissue or otherwise it to be produced significantly effect.This structure is called unipolar stimulation.In certain embodiments, the surface area of stimulating electrode is about 0.5 square millimeter to 5 square millimeters, but is not limited thereto.

With reference to figure 7, after fixed component 222 is attached on the serosal layer SR, take out guide wires 100, make lead 204 stay the appropriate position.Guide wires 100 can be taken out by oral area or by abdominal part.Having avoided stomach to contain thing by the oral area taking-up may be transported in the peritoneal cavity.This taking-up typically by oral area realized by the inner chamber in endoscope or other device.

When guide wires 100 was taken out, mucous layer MC goes up the opening that is stayed by guide wires 100 can be by traditional method closure.Typically, this is existing by the inner clamps consolidation.In this process, the Small clamp with hinged jaw is installed in the far-end of deployment catheter.The actuating of catheter proximal end handle is moved hinged jaw.Hinged jaw is opened and is located (typically, by means of endoscope's guidance by sight) across the opening on the mucous layer MC.When jaw engaged with mucous layer MC, jaw was closed to clamp parameatal tissue.By handling proximal handle jaw is locked in the appropriate location subsequently, clip breaks away from from deployment catheter.Deployment catheter is withdrawn in stomach subsequently.Can regulate clamped position as required and towards to realize the rapid closing of mucosa passage.Mucous layer MC quickly-healing, will heal in several days in described position, prevent that gastric juice from flowing into the peritoneal cavity in stomach.

Referring to Figure 13, for example understand another embodiment of lead 204.This embodiment and embodiment illustrated in fig. 7 similar has just increased the distal ports 250 of distad extending from fixation retention feature 220.Figure 13 is propulsive lead 204 on the guide wires 100 that crosscut is placed, and described guide wires is for example by opening abdomen, putting into through peritoneoscope or improved percutaneous method.In this embodiment, lead 204 passes peritoneal cavity PC and is advanced to coat of the stomach W from patient's abdominal part outside.Coat of the stomach W comprises serosal layer SR, Musclar layer MS, tela submucosa SB and mucous layer MC.Retention element 220 is shown as between Musclar layer MS and tela submucosa SB.Alternatively, retention element 220 can be against the inner surface IS of coat of the stomach W location, perhaps is positioned between the various layers of coat of the stomach W or inner.Distal ports 250 extends in the L of gastric chamber.Distal ports 250 can comprise various function element, for instance, and at least one refurn electrode for example, pH pick off, piezoelectric film sensor and/or temperature sensor.In addition, guide wires 100 can extend through the opening on most advanced and sophisticated 252, as shown in the figure, perhaps passes the sidewall of distal ports 250.

For instance, distal ports 250 can have Any shape, length, curvature, size or size.The nominal length of distal ports 250 is about 10 millimeters.In this example, the tip 252 of distal ports 250 is towards the inner surface IS of coat of the stomach W bending.In certain embodiments, distal ports 250 bendings, make most advanced and sophisticated 252 contact mucous layer MC and/or be embedded in mucous layer MC or other functional layer of coat of the stomach W in.In these embodiments, distal ports 250 can comprise stimulating electrode, and wherein, stimulating electrode contacts with the one or more layers of coat of the stomach W.Alternatively, distal ports 250 can comprise refurn electrode.

The lead 204 of Figure 13 can be according to being sent to implantation position with the similar mode of lead shown in Figure 7.Yet when guide wires 100 had been taken out, the opening on the mucous layer MC was kept by distal ports 250.Member on the lead distal end prevents that gastric juice from flowing into the peritoneal cavity from stomach.

When one or more lead 204 among above-mentioned arbitrary embodiment was implanted among the coat of the stomach W, lead was connected on the stimulator 202, and stimulator 202 is implanted the intravital implantation position of patient place.Implantation position can near or against the outer surface OS of stomach, for example near the fixed component 222 that is fixed on the serosal layer SR.Typically, stimulator 202 is positioned at subcutaneous pocket and is fixed on the muscular fasciae by means of stitching, stitching, nailing (darts), rivet or other mechanism.Optionally, guidewire body 212 can be around stimulator 202 or below winding so that described system fitly is embedded in the subcutaneous pocket.Recess is closed subsequently, and subcutaneous path and percutaneous passage are by acceptable surgical method closure.

Various other devices and the system of the guide wires transmission that utilizes the crosscut placement can also be provided.For example, Figure 14 has shown the stimulator 202 that can be attached on the coat of the stomach W.Stimulator 202 can advance on guide wires 100, described guide wires by endoscope, open abdomen, pass coat of the stomach W crosscut through peritoneoscope or improved percutaneous method and arrange, as mentioned above.Stimulator 202 comprises anchoring section and main part 310.Anchoring section 300 comprises the elongated member 320 with inflatable far-end 322 and stimulating electrode 324, the ring that the form of described stimulating electrode is made for the corrosion resistant metal conductor, described corrosion resistant metal conductor for example is platinum, gold, tantalum, titanium or its suitable alloy, described ring extends around elongated member 320, near expandable end 322.Main part 310 has electronic equipment 208 and power supply 210, and described power supply provides electric energy for stimulating electrode 324.Locate near stimulating electrode 324 around the recess 326 that elongated member 320 extends, be used for anchoring section 300 is connected to main part 310.The electric contacting part 328 that comprises the corrosion resistant metal ring circumferentially extends around elongated member 320 near recess 326.Electrode 324 and electrical contact element 328 are electrically connected by tinsel or other conductor that extends through elongated member 320.The stimulator and the device that provide in stimulator shown in Figure 14 202 and the U.S. Patent No. 6,535,764 that is hereby incorporated by are similar, and therefore have many similar features and function.

When guide wires 100 is positioned to from abdominal part, passes coat of the stomach and pass oral area when stretching out, shown in Fig. 5 B, the part on the stimulator 202 can be sent to coat of the stomach W by diverse ways.For example, anchoring section 300 can be sent to coat of the stomach W by abdominal part, and main part 310 is sent to the inner surface IS of coat of the stomach W by oral area.Anchoring section 300 and main part 310 can connect together.This can carry out other at design aspect and change, for example bigger expandable end 322, and it can not pass coat of the stomach W during transmitting.

Figure 15 has shown the system example that can be attached to by means of one or more guide wires 100 that crosscut is arranged on the coat of the stomach W.Can place a plurality of guide wires, as shown in the figure, but more typically, single guide wires 100 will be placed on each implantation position in placed in-line mode.Described system comprise with stimulator of describing above with reference to Figure 14 202 and U.S. Patent No. 6,535,764 in stimulator and the similar stimulator 202 of device described, the content of described patent is hereby incorporated by.Stimulator 202 has main part 310 and anchoring section 300, and each in main part and the anchoring section has guide wire lumen that runs through or the pipe that attaches to this that can use in a similar manner.Stimulator 202 is connected on the electrode 334,336 by lead 330,332.Each lead 330,332 has the guide wire lumen of at least a portion of passing, and perhaps has the pipe that attaches to this that can use in a similar manner.Guide wires 100 can be utilized endoscope, opens abdomen, locate through peritoneoscope or improvement percutaneous method, and optionally, in certain embodiments, guide wires 100 can be passed oral area from abdominal part and be stretched out.As required, stimulator 202 and each electrode 334,336 are sent to coat of the stomach W subsequently.Can recognize that some elements can be attached on the coat of the stomach by means of the guide wires that crosscut is arranged, and other element is attached by other method.

Figure 16 has shown another example of the system on the coat of the stomach W that can be attached to by means of one or more guide wires 100 that crosscut is arranged.Equally, can place a plurality of guide wires, as shown in the figure, but more typically, single guide wires 100 will be placed on each implantation position in placed in-line mode.Described system comprises and is filed in the U.S. Patent application No.10/950 that JIUYUE in 2004 was submitted on the 23rd, stimulator and the similar stimulator 202 of device described in 345, and the content of described patent application is hereby incorporated by.Stimulator 202 comprises anchoring section 300 and main part 310, and wherein, stimulator and the device described in stimulator 202 and stimulator of describing above with reference to Figure 14 202 and the U.S. Patent No. 6,535,764 are similar, and the content of described patent is hereby incorporated by.In main part 310 and the anchoring section 300 each has guide wire lumen that runs through or the pipe that attaches to this that can use in a similar manner.Stimulator 202 is connected respectively on the electrode 334,336 by lead 330,332.Each lead 330,332 can have the guide wire lumen of at least a portion of passing, and perhaps has the pipe that attaches to this that can use in a similar manner.Guide wires 100 can be utilized endoscope, opens abdomen, locate through peritoneoscope or improvement percutaneous method, and optionally, in certain embodiments, guide wires 100 can be passed oral area from abdominal part and be stretched out.As required, stimulator 202 and each electrode 334,336 are sent to coat of the stomach W subsequently.Can recognize that some elements can be attached on the coat of the stomach by means of the guide wires that crosscut is arranged, and other element is attached by other method.

In embodiment illustrated in fig. 16, described system also comprises impedance electrodes 340,342 separately, and it is positioned in the impedance of induction gastric food when accepting inquiry.The impedance of stomach provides and food of having swallowed or the relevant information of liquid.In addition, described system comprises pick off 344a that is positioned on the main part 310 and the pick off 344b that stretches out from main part 310.Equally, pick off 344c is positioned on the coat of the stomach W discretely, equally can be by positioning on the guide wires 100 of arranging in crosscut, and described guide wires is by endoscopic procedures, through laparoscopic procedures or by improving the placement of percutaneous method.Pick off 344a, 344b, 344c include one or more pick off, and it provides relevant with status of patient or relevant with patient's gastronintestinal system information feedback.Pick off 344a, 344b, 344c are positioned to the directly induction information relevant with stomach, and can include but not limited to one or more following pick off: temperature sensor, contract sensor, pressure transducer, deformeter, pH pick off, acceleration transducer, optical pickocff.

Figure 17 has shown another example of the system on the coat of the stomach W that can be attached to by means of one or more guide wires 100 that crosscut is arranged.Described system be filed in the U.S. Patent application No.10/992 on November 18th, 2004, system and the device described in 382 are similar, the content of described patent application is hereby incorporated by.Stimulator 202 comprises anchorage part 514 and casting of electronic device 511.Anchorage part 514 comprises expandable distal portion 515 and elongate flexible portion 516, and described elongate flexible portion is connected to extremity 515 on the housing 511.Expandable distal portion 515, elongate flexible portion 516 and optionally housing 511 all have guide wire lumen that runs through or the pipe that attaches to this that can use in a similar manner.Stimulator 202 is connected respectively on the electrode 524,525 by lead 521,522.Each lead 521,522 can have the guide wire lumen of at least a portion of passing, and perhaps has the pipe that attaches to this that can use in a similar manner.Each guide wires 100 can be utilized endoscope, opens abdomen, locate through peritoneoscope or improvement percutaneous method, and optionally, in certain embodiments, each guide wires 100 can be passed oral area from abdominal part and be stretched out.Stimulator 202 and each electrode 524,525 are sent to coat of the stomach W from oral area, abdominal part or both by advancing in suitable guide wires subsequently.For example, expandable distal portion 515 can be passed the outer surface OS that oral area and coat of the stomach W are advanced to coat of the stomach W, and described expandable distal portion is configured to second structure at this from first and launches inflation or otherwise expand, for example spring.Expandable distal portion 515 has the surf zone SA that has a common boundary with outer surface OS.Perhaps, expandable distal portion 515 can be passed abdominal part or peritoneal cavity and advanced and link together with housing 511 or elongate flexible portion 516.Electrode 524,525 can be placed similarly, and anchoring section 530,532 passes coat of the stomach W propelling or passes the abdominal part propelling in guide wires from gastric chamber L on guide wires, and links to each other with lead 521,522.Can recognize that some elements can be attached on the coat of the stomach by means of the guide wires that crosscut is arranged, and other element is attached by other method.

Figure 18 has shown another example of the system on the coat of the stomach W that can be attached to by means of the guide wires that crosscut is arranged.Described system be filed in the U.S. Patent application No.11/249 on October 12nd, 2005, system and the device described in 661 are similar, the content of described patent application is hereby incorporated by.Stimulator 202 comprises the lead 610 continuous with stimulator electronic circuit 620 (in this particular illustration, being subcutaneous stimulator for implantation) (be shown as and implant among the coat of the stomach W).Lead 610 comprises retaining part 629, described retaining part comprises the elongated portion 611 that links to each other with expandable anchor 614, wherein, expandable anchor 614 engages with the outer surface OS of coat of the stomach W and elongated portion 611 extends through coat of the stomach W and stretches among the L of gastric chamber.Lead 610 also comprises the lead-out wire 630 that stretches to the adapter 640 that is used to be connected to stimulator electronic circuit 620 from expandable anchor 614.

Electrode 613 is positioned on the expandable anchor 614, makes that electrode 613 is positioned at coat of the stomach W when lead is implanted.Refurn electrode 617 is positioned on the elongated portion 611 of gastric (alternatively, in the coat of the stomach W).Refurn electrode can be positioned at other position.Expandable anchor 614 forms the plate that engages with the outer surface OS of coat of the stomach W, thereby prevents that lead further is advanced in the stomach and the relative position of maintenance electrode 613 in coat of the stomach W.Described plate can be sewn onto on the outer surface OS.

Lead 610 also comprises guide wires opening 650 and through hole 651, is used for making during inserting lead 610 to guide on the guide wires that crosscut is placed.Guide wires is passed coat of the stomach W and is placed on elongated portion 611 and is shown as on the position of passing coat of the stomach W.Guide wires can be utilized out abdomen, locate through peritoneoscope or improvement percutaneous method, and optionally, in certain embodiments, guide wires can be passed oral area from abdominal part and be stretched out.

Figure 19 A has shown another example of the system on the coat of the stomach W that can be attached to by means of the guide wires that crosscut is arranged.Described system and the U.S. Provisional Patent Application No.60/815 that is filed on June 21st, 2006,640 and be filed in the U.S. Patent application No.11/766 on June 21st, 2007, system of describing in 660 and device are similar, and the content of above-mentioned two pieces of applications is hereby incorporated by.Stimulating system 1000 comprises pulse generator or stimulator 10, and it is implantable in the organ of for example stomach 100, small intestinal or colon.In this embodiment, stimulator 10 comprises the electronic circuit 1200 that is contained in the protecting sheathing 1300, is configured to that electronic equipment anchored to the electronics anchor 2000 on the coat of the stomach W and is configured to electrode 3200 is anchored to lead anchoring section 3000 on the coat of the stomach W.With reference to figure 19B, electronics anchor 2000 can be attached on the coat of the stomach W by passing coat of the stomach W propelling on the guide wires 100 of arranging in crosscut.As shown in the figure, electronics anchor 2000 can advance from coat of the stomach W is outside on guide wires 100.Therefore, anchoring section 2000 can pass abdominal part and be advanced to coat of the stomach W from the health outside.Holding element 2300 can advance from coat of the stomach is inner on guide wires 100.Therefore, holding element 2300 can pass esophagus and be advanced to coat of the stomach W from the health outside.Anchoring section 2000 advances, and makes a part extend through coat of the stomach W, and the outer surface OS location of far-end anchorage part 2050 contiguous coat of the stomach W.Holding element 2300 links with anchoring section 2000 subsequently or combines, and makes the inner surface IS of holding element 2300 contiguous coat of the stomach W locate.

Similarly, referring to Figure 19 C, lead anchoring section 3000 can be attached on the coat of the stomach W by passing coat of the stomach W propelling on the guide wires 100 of arranging in crosscut.As shown in the figure, lead anchoring section 3000 can advance from coat of the stomach W is outside on guide wires 100.Therefore, anchoring section 3000 can pass abdominal part and be advanced to coat of the stomach W from the health outside.Holding element 3600 can advance from coat of the stomach is inner on guide wires 100.Therefore, holding element 3600 can pass esophagus and be advanced to coat of the stomach W from the health outside.Anchoring section 3000 advances, and makes a part extend through coat of the stomach W, and the outer surface OS location of far-end anchorage part 3050 contiguous coat of the stomach W.Holding element 3600 links with anchoring section 3000 subsequently or combines, and makes the inner surface IS of holding element 3600 contiguous coat of the stomach W locate.

In certain embodiments, the guide wires that crosscut is arranged is used for device and system edge are sent to position in the coat of the stomach W perpendicular to the direction of guide wires substantially, for example in Musclar layer MS or between different layers, for example between Musclar layer MS and tela submucosa SB.In order to realize this purpose, can use transporter for example shown in Figure 20 700.In this embodiment, transporter 700 comprises the slender axles 702 that have far-end 704 and radially give prominence to support portion 706, and described support portion is arranged near far-end 704.In certain embodiments, radially outstanding support portion 706 has and aforesaid retention element 220 similar shapes, size, material, form and/or effect, yet, also can use other design.Transporter 700 comprises transmission inner chamber 708, and it passes axle 702 and extends near outstanding support portion 706 localized ports 710.Transmit the size and the shape of inner chamber 708 and port 710 and be arranged to allow for example single stimulating apparatus to pass, described stimulating apparatus for example be U.S. Patent application No.10/109, the stimulating apparatus of description in 296, and this patent application is hereby incorporated by.Especially, size and shape one or more implantable stimulating apparatus of being arranged to be retained among the coat of the stomach W can be by transmission inner chamber 708 and port 710.By make radially outstanding support portion 706 be positioned at hope as in the layer of implantation position or between, radially outstanding support portion 706 can guide to stimulating apparatus the implantation position of hope when stimulating apparatus advances by port 710.Transporter 700 also comprises and is used for propulsive guide wire lumen 712 on guide wires.

Figure 21 has shown that the guide wires 100 (it utilizes out abdomen, locatees through peritoneoscope or improvement percutaneous method) of arranging in crosscut goes up propulsive transporter 700, wherein, radially outstanding support portion 706 with and Fig. 7 in place retention element 220 similar modes and be positioned between Musclar layer MS and the tela submucosa SB.Therefore, transporter 700 passes peritoneal cavity PC and is advanced to coat of the stomach W on guide wires 100.Radially outstanding support portion 706 is positioned between Musclar layer MS and the tela submucosa SB, as shown in the figure.Stimulating apparatus 712 passes subsequently and transmits inner chamber 708 and port 710 (for example utilizing plunger or push rod) propelling, makes support portion 706 will install 712 and guides to the implantation position of wishing in the coat of the stomach W.Can recognize, in other embodiments, guide wires 100 can be passed the transporter 700 that gastric chamber L is advanced to coat of the stomach W by endoscope with on guide wires 100 and be placed, make radially outstanding support portion 706 be positioned in the hope layer of coat of the stomach W or between.

Figure 22 has shown another embodiment of transporter 700, and described transporter comprises the slender axles 702 that have far-end 704 and radially give prominence to support portion 706, and described support portion is arranged near far-end 704.Equally, transporter 700 comprises transmission inner chamber 708, and it passes axle 702 and extends near outstanding support portion 706 localized ports 710.In this embodiment, the size of port 710 can change by the motion of sliding members 714.Sliding members 714 can be withdrawn to enlarge port 710 or to stretch out to dwindle port 710.Optionally, sliding members 714 can withdraw and take off from transporter 700 fully, thereby produces along the opening of the length that transmits inner chamber 708.This is useful in a part that transmits stimulating apparatus or stimulating apparatus, and described stimulating apparatus or its part can laterally be implanted among the coat of the stomach W, passes at least a portion that coat of the stomach extends to gastric chamber L or peritoneal cavity PC but have.For example, the lead with electrode can pass and transmit inner chamber 708 propellings, makes electrode pass port 710 and arrives the implantation position of wishing in the coat of the stomach W, and described lead passes and transmits inner chamber 708 extensions.Sliding members 714 can be withdrawn, and lead is discharged from transmit inner chamber 708.Transporter 700 can take out subsequently, and lead is stayed the appropriate position, and electrode still is implanted in the coat of the stomach W.Therefore, the transporter of Figure 22 can be used to transmit the part of stimulating apparatus, and the U.S. Patent application No.10/109 that for example is hereby incorporated by is described in 296 (especially shown in Fig. 9 A, the 10A), and various leads, the United States Patent(USP) Nos. 5,716,392,5 that for example is hereby incorporated by, 836,994,6,091, described in 992.Can also recognize that guide wires can be passed and be transmitted inner chamber 708 propellings, described transmission inner chamber especially is used in cross drive device among the coat of the stomach W after transporter takes out.

Can recognize that the transporter shown in Figure 20,21,22 is an example, the present invention includes its distortion.For example, port 710 and/or radially outstanding support portion 706 can be arranged in along any position of axle 702 and with the tissue or the skeleton of any hope and aim at.Therefore, when axle 702 when nearside stretches into peritoneal cavity PC, radially outstanding support portion 706 can be against the inner surface IS location of stomach.And port 710 can separate with radially outstanding support portion 706, makes it aim at the hope layer of the stomach that is used to implant, for example Musclar layer MS.Stimulating apparatus or its part are passed port 710 and are advanced the layer that described device is guided to hope.Alternatively, radially outstanding support portion 706 can be arranged near port 710, makes when axle 702 extends to the peritoneal cavity PC from nearside, and support portion 706 is against the outer surface OS location of stomach.Equally, port 710 can separate with support portion 706, makes it aim at the hope layer of the stomach that is used to implant, for example Musclar layer MS.Stimulating apparatus or its part are passed port 710 and are advanced the layer that described device is guided to hope.In addition, transporter can not comprise radially outstanding support portion 706, and port 710 is aimed at simply with coat of the stomach W as required.

Although preamble is for the clear purpose of understanding, the present invention is described in detail by graphic extension and example, but it is evident that, can use various possibilities, improvement project or equivalents, top explanation not should be understood to limit the scope of the invention, and scope of the present invention is defined by the following claims.

Claims

1. one kind is used for device is attached to method on the intravital hollow organ's of patient the wall, and described wall has towards the inner surface of organ inside and deviates from the outer surface of organ, and described method comprises:

Make guide wires location, wherein, the wall of described guide wires crosscut organ and pass tissue to extend to the patient external;

Described device is advanced towards described organ from the patient is external on described guide wires, and wherein, described device comprises at least one lead with at least one electrode; With

Described device is attached on the wall of organ, makes the paired described wall of described at least one positioning of electrode stimulate.

2. the method for claim 1, wherein, the guide wires localization step is included under the situation of not using general anesthesia enters organ by improved percutaneous method, wherein, described improved percutaneous method comprises that making pin pass patient tissue advances towards the outer surface of organ, utilizes the described wall of described pin crosscut and make guide wires pass described pin to advance.

3. method as claimed in claim 2, wherein, described improved percutaneous method comprises that the tissue that makes the trocar pass the patient advances towards the outer surface of organ, and makes described pin pass described trocar propelling before utilizing the described wall of described pin crosscut.

4. method as claimed in claim 2 wherein, is attached to step on the described wall with described device and comprises and make described at least one positioning of electrode in described wall.

5. method as claimed in claim 4 wherein, comprises the step of described at least one positioning of electrode in described wall to make the Musclar layer location of described at least one positioning of electrode in described wall or in the described wall.

6. method as claimed in claim 4 also comprises a stimulator is implanted to the intravital hollow organ of patient outside, wherein, and described stimulator and described at least one lead electrical communication.

7. the step that the method for claim 1, wherein connects described device comprises a stimulator is attached on the wall of described organ, makes described stimulator be implanted among the hollow organ.

8. method as claimed in claim 7, wherein, the guide wires localization step is comprised make guide wires extend through patient's oral area, described method also comprises to be made stimulator pass oral area and advances towards the inner surface of hollow organ's wall on guide wires.

9. the method for claim 1, wherein the step of attached described device comprises the tissue that stimulator implantation is positioned at the hollow organ outside.

10. the method for claim 1, wherein described device comprises retention element, wherein, described device is attached to step on the wall of organ and comprises described retention element is positioned in the wall of described organ.

11. method as claimed in claim 10, wherein, described organ comprises stomach, and described wall comprises Musclar layer and tela submucosa at least, and wherein, making described retention element be positioned at step in the wall of organ comprises described retention element is positioned between described Musclar layer and the tela submucosa.

12. the method for claim 1, wherein, described device comprises the conical section of fixed component and close described fixed component, and wherein, described device is attached to step on the organ walls to be comprised and makes described fixed component against extraorgan's surface alignment when the described wall of described conical section crosscut.

13. a device that is used for having first and second portion is attached to the method on the wall of hollow organ in patient's body, described wall has towards the inner surface of organ inside and deviates from the outer surface of organ, and described method comprises:

Make the guide wires location, wherein, the wall of the described organ of described guide wires crosscut;

The first that makes described device advances on described guide wires along the direction towards the inner surface of described hollow organ's wall;

The second portion that makes described device advances on described guide wires along the rightabout towards the outer surface of described hollow organ's wall; With

Described first and second portion are combined, so that described device is attached on described hollow organ's the wall.

14. method as claimed in claim 13, wherein, the guide wires localization step is comprised make guide wires extend through patient's oral area, and wherein, the propulsive step of described first is comprised make described first to pass oral area and on guide wires, advance towards the inner surface of described hollow organ's wall.

15. method as claimed in claim 13, wherein, the guide wires localization step is comprised make guide wires extend through patient's abdominal part, and wherein, the propulsive step of described second portion is comprised make described second portion pass abdominal part and on guide wires, advance towards the outer surface of described hollow organ's wall.

16. method as claimed in claim 13, wherein, the guide wires localization step is included under the situation of not using general anesthesia enters organ by improved percutaneous method, wherein, described improved percutaneous method comprises that making pin pass patient's abdominal part advances towards the extraorgan surface, utilizes the described wall of described pin crosscut and make guide wires pass described pin to advance.

17. method as claimed in claim 16, wherein, described improved percutaneous method comprises that the abdominal part that makes the trocar pass the patient advances towards the outer surface of organ, and makes described pin pass described trocar propelling before utilizing the described wall of described pin crosscut.

18. the lead that the intravital hollow organ's of patient wall is stimulated, described wall have towards the inner surface of organ inside, deviate from the outer surface of organ and therebetween a plurality of layers, described lead comprises:

Guidewire body with near-end, far-end and guide wire lumen, described guidewire inner chamber extends through at least a portion of described guidewire body, and described near-end is configured to be attached on the power supply;

Near the retention element that described far-end is arranged, described retention element extends radially outwardly and is configured to be positioned between the layer of described wall from described guidewire body; With

At least one electrode, described electrode be along described wire arrangements, make when described retention element be positioned at described wall layer between the time, be supplied to the electric energy of described at least one electrode that described wall is stimulated.

19. lead as claimed in claim 18, wherein, the layer of described wall comprises Musclar layer and tela submucosa, and wherein, described retention element is configured to be positioned between described Musclar layer and the tela submucosa.

20. lead as claimed in claim 18, wherein, described at least one electrode is arranged along described retention element.

21. lead as claimed in claim 18 also comprises the fixed component of arranging near retention element, described fixed component extends radially outwardly and is configured to contact a surface of described wall from described guidewire body.

22. lead as claimed in claim 21, wherein, described at least one electrode is arranged along described fixed component.

23. lead as claimed in claim 21, wherein, described at least one electrode is arranged along the section between described retention element and fixed component of described guidewire body.

24. lead as claimed in claim 23, wherein, described at least one electrode has spiral, ring, the vertical shape of band or its combination.

25. lead as claimed in claim 21, wherein, the layer of described wall comprises Musclar layer and tela submucosa, and wherein, described retention element and fixed component are arranged at interval, make described retention element can be positioned between described Musclar layer and the tela submucosa, described fixed component can be against a surface alignment of described organ simultaneously.

26. one kind is used for device is attached to method on the intravital hollow organ's of patient the wall, described device comprises the stimulator that links to each other with at least one lead with at least one electrode, and described method comprises:

Make first guide wires location, make the wall of described guide wires at the described organ of primary importance crosscut;

Described stimulator is advanced on described first guide wires;

Be attached to described stimulator on the wall of described organ in described primary importance;

Make second guide wires location, make the wall of described guide wires at the described organ of second position crosscut;

Described at least one lead is advanced on described second guide wires;

Described at least one lead is attached on the wall of described organ in the described second position, makes the paired described wall of described at least one positioning of electrode stimulate.

27. method as claimed in claim 26, wherein, described hollow organ has outer surface, described outer surface is towards the tissue that extends between described organ and patient are external, and wherein, the described first guide wires localization step is included under the situation of not using general anesthesia enters described organ by improved percutaneous method, wherein, described improved percutaneous method comprises that the described tissue that makes pin pass the patient advances towards the outer surface of described organ, utilizes the described wall of described pin crosscut and make described first guide wires pass described pin to advance.

28. method as claimed in claim 26, wherein, described hollow organ has outer surface, described outer surface is towards the tissue that extends between described organ and patient are external, and wherein, the described second guide wires localization step is included under the situation of not using general anesthesia enters described organ by improved percutaneous method, wherein, described improved percutaneous method comprises that the described tissue that makes pin pass the patient advances towards the outer surface of described organ, utilizes the described wall of described pin crosscut and make described second guide wires pass described pin to advance.