JP2002503513A - Instruments for detection of abnormal myoelectric activity and electrosurgical procedures - Google Patents

Abstract

(57) [Summary] The sphincter treatment instrument has a support member. The sphincter potential mapping device includes a mapping electrode. The sphincter potential mapping device is coupled to the support member and is configured to detect abnormal myoelectric activity of the sphincter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD OF THE INVENTION

BACKGROUND OF THE INVENTION Cross-Related Application This application is related to US patent application Ser. No. 08/731, filed Oct. 11, 1996.
372, which is a continuation-in-part application of U.S. patent application Ser. No. 08 / 319,373, filed Oct. 6, 1994, which is hereby incorporated by reference.
No. 08 / 286,862 filed on Aug. 4, 1994, which is a continuation-in-part of U.S. patent application Ser. No. 08 / 272,162, filed Jul. 7, 1994. No. 3, filed on June 2, 1994.
No. 08 / 265,459, filed on Nov. 4, which is also a continuation-in-part of the "GERD Treatment Apparatus" filed concurrently.
s and Method ", which is a lawyer case number 14800
-748, and all applications are inventor St.
uart D. Made under the name of Edwards, all of which are incorporated herein by reference.

FIELD OF THE INVENTION [0002] The present invention relates generally to devices for detecting and treating abnormal myoelectric activity, and more particularly to detecting and treating sphincter and / or stomach.

Description of the Related Art Gastroesophageal reflux disease (GERD) is a common gastroesophageal disorder in which the contents of the stomach are reduced due to insufficiency of the lower esophageal sphincter (LES). Excreted into the esophagus. These contents are so acidic that they can be esophageal insult, resulting in numerous complications of varying medical severity. The incidence of GERD reported in the United States is on the order of 10% of the population (Castell DO;
Johnston BT: Gastroesophageal Reflux
Disease: Current Strategies For Patie
nt Management. Arch Fam Med, 5 (4): 221-
7; (April 1996)).

[0004] Acute symptoms of GERD include heartburn, lung injury and chest pain. In chronic conditions, GERD causes the esophagus to suffer from ulceration, or esophagitis, and can cause severe complications, including esophageal obstruction, significant blood loss and esophageal perforation. Severe esophageal ulceration occurs in 20-30% of patients over the age of 65. In addition, GERD causes adenocarcinomas, or esophageal carcinomas, which have a higher incidence than any other cancer (Reynolds JC: Influence).
Of Pathology, Severity, And Cost
On The Medical Management Of Gastro
esophageal Reflux Disease. Am J Health
h System Pharm, 53 (22 Suppl 3): S5-12 (19
November 15, 1996)).

[0005] One of the potential causes of GERD may be LES or abnormal electrical signals in the stomach. Such a signal can cause a higher than normal frequency of relaxation of the LES, permit the acidic gastric contents to be repeatedly excreted into the esophagus, and can also cause the above complications. Studies have shown that abnormal electrical signals in the stomach and intestines can cause perfusion in these organs (Kelly KA et al .: D
uodental-gastric Reflux and Slowed G
atric Emptying by Electrical Packing
of the Canine Duodental Pacesetter
Potential. Gastroenterology. 1977 Mar;
72 (3): 429-433). In particular, medical studies have shown that these signals can be attributable to abnormal electrical activity or sites of electrical foci (Karstrom LH et al .: Ectopic Jejunal Case).
makers and Entergastric Reflux after
Roux Gastronomy: Effect Intersinal
Pacing. Surgery. 1989 Sep; 106 (3): 486-4
95). Similar abnormal electrical sites in the heart that cause contraction of the myocardium and exhibit a life-threatening pattern or dysrhythmia can be identified, and US Pat.
419, using a mapping and ablation device. However, there are currently no devices or associated medical treatments available for electrical mapping and treatment of abnormal electrical sites in the LES and stomach as a means of treating GERD.

[0006] Current drug therapies for GERD include histamine receptor blockers, which reduce gastric acid secretion, and other drugs that can completely block gastric acid. However, while drugs may provide short-term relief, they do not address the underlying cause of LES failure.

[0007] Surgical correction of GERD includes open procedures that require the percutaneous introduction of instruments into the abdomen. One such procedure, Nissen fundoplication, involves building a new "valve" that supports the LES by wrapping the fundus around the lower esophagus. This surgery is an abdominal incision procedure with a high success rate but with the usual risks of abdominal surgery, including postoperative infection, hernia formation at the surgical site, internal bleeding and perforation of the esophagus or cardia. In fact, in the last decade, a study of 344 patients has reported a 17% morbidity and 1% mortality with this treatment (
Urschel, JD: Complications of Antirefl
ux Surgary, Am J Surg 166 (1): 68-70; (1
July 993)). This complication rate raises both medical costs and the recovery phase of the procedure, and cannot be applied to certain patient populations (eg, the elderly and immune-compromised).

[0008] Through efforts to perform Nissen fundoplication in a less invasive manner,
Laparoscopic Nissen fundoplication was developed. Laparoscopic Nissen fundoplication is described in Dalemagne et al. (Surgical Laparoscop).
y and Endoscopy, Vol. 1, No. 3, (1991), pp
. 138-43) and Hindler et al. (Surgical Laparos)
copy and Endoscopy, Vol. 2, No. 3, (1992)
Pp. 265-272), except that the surgical procedure is performed by means of multiple surgical cannulas introduced with trocars inserted in various parts of the abdomen. And substantially the same steps.

Another attempt to perform fundoplication using a less invasive method is reported in US Pat. No. 5,088,979. In this procedure, an invagination device containing a plurality of needles is inserted orally into the esophagus with the needles in the retracted position. These needles are extended to engage the esophagus and wrap the appendage esophagus beyond the gastroesophageal junction. A remotely operated stapling device (this is passed through an operating channel in the stomach wall,
Percutaneously introduced) is actuated to secure the invaginated gastroesophageal junction to the enclosed gastric wall surrounding it.

Yet another attempt to perform fundoplication using a less invasive method is reported in US Pat. No. 5,676,674. In this procedure, an incision is made by a jaw-like device, and fastening of the invaginated gastroesophageal junction to the fundus is performed in an oral manner using a remotely operated fastening device, resulting in an abdominal incision. Is no longer necessary. However, this procedure still traumatizes the LES and carries a postoperative risk of gastroesophageal leakage, infection and foreign body reaction, and the last two sequelae are foreign bodies (eg, surgical staples) implanted in the body Sometimes it happens.

Although the method reported above is less invasive than laparotomy Nissen fundoplication, some still involve making an incision in the abdomen, and are therefore associated with abdominal surgery. There is a high morbidity and mortality rate and convalescence period. Others carry the high risk of infection associated with placing foreign objects in the body. All methods are LE
With the trauma to S, there is a risk of leakage occurring at the newly created gastroesophageal junction. Nothing provides a means to detect and treat abnormal electrical sites that cause abnormal LES relaxation and gastroesophageal reflux.

There is a need to provide an instrument for detecting and treating abnormal myoelectric activity of the sphincter and / or stomach. There is another need to provide an instrument for detecting and treating the electrical focus of abnormal myoelectric activity of the sphincter and / or stomach. There is a further need to detect and treat the electrically conductive pathways of abnormal myoelectric activity of the sphincter and / or stomach.

[0013] Accordingly, it is an object of the present invention to provide an instrument for diagnosing and treating the sphincter and / or stomach.

Another object of the present invention is to provide an instrument for diagnosing and treating GERD.

It is a further object of the present invention to provide a device for detecting and treating abnormal myoelectric activity of the sphincter and / or stomach.

It is yet another object of the present invention to provide an instrument for detecting and treating the electrical focus of abnormal myoelectric activity of the sphincter and / or stomach.

It is yet another object of the present invention to provide an instrument for detecting and treating the electrically conductive pathway of abnormal myoelectric activity of the sphincter and / or stomach.

[0018] Another object of the present invention is to provide an instrument for detecting and treating the electrical focus of abnormal myoelectric activity of the lower esophageal sphincter and / or stomach.

It is a further object of the present invention to provide an instrument for detecting and treating the electrically conductive pathway of abnormal myoelectric activity of the lower esophageal sphincter and / or stomach.

These and other objects of the present invention are provided in an instrument for treating a sphincter having a support member. The sphincter potential mapping device includes a mapping electrode. The sphincter potential device is coupled to the support member and is configured to detect either abnormal neuroelectric or myoelectric activity of the sphincter or stomach.

In another embodiment, a device for treating a stomach has a support member. The gastric potential mapping device includes a mapping electrode. The gastric potential mapping device is coupled to the support member and is configured to detect and treat one of abnormal gastric neuroelectric or myoelectric activity.

Accordingly, the potential mapping device also includes one or more treatment electrodes.

DETAILED DESCRIPTION Referring now to FIGS. 1 and 2, mapping myoelectric activity to the treatment site 12 and delivering energy to the sphincter 16 (eg, the lower esophageal sphincter (LES))
Sphincter mapping and treatment instrument 10 used to cause trauma 14 at
The embodiment comprises a flexible elongate shaft 18 (also referred to as shaft 18), which is coupled to an expandable mapping assembly 20 and then
It is connected to one or more mapping electrodes 22.

The expandable mapping assembly 20 establishes a three-dimensional array of mapping electrodes 22. In use, the expandable mapping assembly 20 provides activation time, distribution, potential waveforms of myoelectric and neuroelectric activity in the sphincter 16, which may include LES, and adjacent structures that cause abnormal relaxation of muscle tissue in the sphincter 16. Record Suitable materials for the mapping electrode 22 include gold, platinum, and other metals known to those skilled in the art.

The mapping electrode 22 is configured to be connected to the control device 24. The controller 24 receives and processes the potential recorded by the mapping electrodes 22 on the expandable mapping assembly 20. The controller 24 then generates a potential map 27 of the myoelectric and neuroelectric activity of the sphincter 16 (also referred to as a map). The physician uses the control device 24 and the potential map 27 to
Diagnose abnormalities and symptoms within 6, as well as adjacent structures described further herein. The control device 24 can be connected to an output or display device 29. The display device 29 may include a cathode ray tube, a liquid crystal display, a passive matrix flat screen display or an active matrix flat screen display, a printer, or the like.

The expandable mapping assembly 20 has a central longitudinal axis 28 and is movable along substantially there between a contracted position and an expanded position. This can be achieved through the use of pawl mechanisms known to those skilled in the art and other mechanisms disclosed herein.
The expandable mapping assembly 20 is further configured to be positionable within the sphincter 16 such as an adjacent anatomy such as the LES or gastric cardia. When the expandable mapping assembly 20 is positioned within the desired sphincter muscle 16, the mapping electrode 22 is expanded by the surgeon to the expanded stationary position within the sphincter muscle and the sphincter wall 26 To sense and detect electrical energy or impulses resulting therefrom. At least some portions of the sphincter mapping and treatment instrument 10 may be sufficiently radiopaque to be visible under fluoroscopy and / or be sufficiently acousticogenic to be visible under ultrasonography. possible. Also, as described herein, the sphincter mapping and treatment instrument 10 can include visualization capabilities, including viewing scopes, magnifying eyepieces, fiber optics,
Examples include, but are not limited to, video imaging.

Referring to FIG. 2, shaft 18 is configured to be coupled to expandable mapping assembly 20 and expandable mapping assembly 20
Have sufficient length to be placed in the LES and / or stomach using oral methods. Typical lengths for shaft 18 include, but are not limited to, the range of 40-180 cm. In various embodiments, shaft 18 is flexible, articulated, and steerable, with optical fibers (including lighting and imaging fibers), liquid and gas paths, and sensors and electronic cables. Can be contained. In one embodiment, shaft 18 can be a multi-lumen catheter, as is well known to those skilled in the art.

In another embodiment of the present invention, introducer member 21 (also referred to as an introducer) is used to introduce sphincter mapping and treatment instrument 10 into the LES. The introducer 21 can also function as a sheath for the expandable mapping assembly 20 to keep it undeployed (ie, contracted) during introduction into the LES. In various embodiments, introducer 21 is a flexible, articulated and steerable continuous lumen of sufficient diameter to allow sphincter mapping and advancement of treatment instrument 10 therein. It contains. A typical diameter for the introducer 21 is 0
. Typical lengths are 40-180 cm, whereas 1-2 inches are mentioned
Is mentioned. Suitable materials for introducer 21 include wire reinforced plastic tubing, as is well known to those skilled in the art.

Referring now to FIG. 3, flexible elongate shaft 18 is circular in cross section and has proximal and distal ends (also referred to as ends) 30 and 32.
Having. Shaft 18 may also be coupled at its proximal end 32 to a proximal fitting 34 (also referred to as a handle) for manipulating sphincter mapping and treatment instrument 10 to reach treatment site 12. Can be used to
Shaft 18 may have one or more lumens 36 that extend the entire length of shaft 18 or a portion from shaft proximal end 30 to shaft distal end 32. The shaft lumen 36 can be used as a pathway for catheters, guidewires, pullwires, insulated wires and cables, fluids and fiber optics. The shaft lumen 36 has a connection 38 on or adjacent the proximal fitting 34 (which also
The connector 38 is also connected and / or accessed. Connection 38 may include luer locks, swages, and other mechanical variations known to those skilled in the art. Connections 38 may also include electrical connections 38 ', which may include remo connectors, microconnectors, and other electrical variations well known to those skilled in the art. Furthermore, the connection 38 comprises an optoelectronic connection 38 ′
(Which allows for optical and electronic coupling of fiber optics and / or vision scopes with illumination sources, eyepieces and video monitors). In various embodiments, the shaft 18 can stop at the proximal end 40 of the expandable mapping assembly 20, or extend to or pass through the distal end 42 of the expandable mapping assembly 20. . Suitable materials for shaft 18 include, but are not limited to, polyethylene, polyurethane, and other medical plastics known to those skilled in the art.

Referring now to FIG. 4, in one embodiment of the present invention, the expandable mapping assembly 20 includes one or more elongated arms 44, which have their proximal arm ends 46 and Joined at the distal arm end 48 to form a basket assembly 50. Proximal arm end 46 is attached to distal end 32 of shaft 18, or a support structure, which can be proximal cap 51. Similarly, the distal arm end 48 is also mounted on a support structure, which can be a basket cap 52 distal to the shaft 18. The mounted arm 44 can form a variety of geometric shapes, including, but not limited to, curves, rectangles, trapezoids, and triangles. The arm 44 may have various cross-sectional geometries, including a circle,
Examples include, but are not limited to, rectangles and crescents. Arm 4
4 is a sufficient number (two or more) to prevent herniation of the sphincter wall 26 into the space 53 between the arms 44 while maintaining sphincter mapping and treatment tools 10;
Sufficient spring force (0.01-0.5 pounds) to collectively apply sufficient force to the sphincter wall 26 to open and clear the plication of the sphincter 16 to permit treatment with the sphincter. Having. Suitable materials for arm 44 include, but are not limited to, spring steel, stainless steel, and superelastic shape memory alloys known to those skilled in the art (eg, plastic tubing reinforced with Nitinol or wire).

Referring now to FIG. 4B, a plurality of spaced mapping electrodes 22
Are carried by each arm 44 into engagement with the sphincter wall 26 and are electrically connected to the multiplexer chip 25 through conductors 23, thereby transmitting signals sensed via the electrical connections 38 'to the controller 24. I do. Various geometric patterns for disposing the mapping electrodes 22 on the basket assembly 50 or the expandable mapping assembly 20 will be disclosed later herein. The multiplexer chip 25 transmits only one selected one of the electrode signals to the control device 24 at a time under the influence of the switching signal generated by the control device 24. The switching signals of controller 24 serve to multiplex the electrode signals via electrical contacts 38 '. This reduces the number of electrical paths required through shaft lumen 36. In various embodiments, conductor 23 can be an insulated lead wire, as is well known in the art.

In various embodiments, the expandable mapping assembly 20 or basket assembly 50 also includes one or more energy delivery devices 88 (which also include
(Also called electrodes) and may be connected to a power supply 56. An energy delivery device 88 is used to deliver energy to the treatment site 12 where the trauma 14 occurs.
Further, expandable mapping assembly 20 is configured to facilitate positioning of energy delivery device 88 relative to a selectable depth within sphincter wall 26 or adjacent anatomy. In one embodiment, the mapping electrode 22 can also be used as an energy delivery device.

Referring to FIG. 5A, the arm 44 has an outwardly curved shape memory and an amount of curvature (ie, warpage 54) to expand the basket assembly to engage the sphincter wall 26. Can be selected from a range of 0 to 2 inches from the longitudinal axis 28 of the basket assembly 50. In the case of the curved arm 44 ', the extension arm 4
4 'are circumferentially and symmetrically spaced.

In another embodiment, shown in FIG. 5B, the dilation device 55, which may be a balloon, is connected to the interior or exterior of the basket assembly 50. Balloon 55 is also connected and expanded by shaft lumen 36 using gas or liquid. In various other embodiments (not shown), the arm 44 is 360 °
It may be asymmetrically spaced and / or distributed with less than an arc. Also, the arm 44 can be pre-formed at the time of manufacture, or can be formed by a physician.

Referring now to FIG. 6A, the arm 44 can also be solid or hollow, with a continuous lumen 58 that can be connected to the shaft lumen 36. These connected lumens provide a path for the delivery of fluid or electrode delivery member 60 from shaft 18 to any point on expandable mapping assembly 20. In various embodiments, the electrode delivery member 60 can be an insulated wire, an insulated guide wire, a plastic-coated stainless steel hypotube with an inner wire, or a plastic catheter with an inner wire, all of which are known to those skilled in the art. As shown in FIG. 6B, the arm 44 also includes a partially open channel 62 (which also
2, which serves as a guide track for the electrode delivery member 60. Referring back to FIG. 6A, the arm 44 may have one or more openings 64 at any point along its length, thereby causing the electrodes 88 in or on the sphincter wall 26. Can be controlled and arranged. Referring now to FIG. 7, the opening 64 may have a stepped portion 6 in all or part of its length.
It may have a six or tapered portion 68 which is used to control the depth of penetration of the electrode 88 into the sphincter wall 26. Referring back to FIG. 6A, opening 64, in combination with arm lumen 58 and shaft lumen 36, delivers cooling fluid 70 or electrolyte 72 to treatment site 12, as described herein. Can be used for In addition, the arm 44 may also include a plurality of longitudinally or radially spaced radiopaque and / or acoustically emitting markers or traces (not shown in the drawings and made of suitable materials). (Formed) and allow basket assembly 50 to be viewed via fluoroscopy or ultrasonography. Suitable radiopaque materials include platinum or gold, while suitable sound-generating materials are described in U.S. Patent Nos. 5,688,490 and 5,205,287. As described above, gas-filled fine particles can be used. The arms 44 may also be color coded to facilitate their identification via visual medical imaging methods and devices well known to those skilled in the art (eg, endoscopic methods).

In another embodiment of the invention, the radial support members 74 are mounted on two or more arms 44. Radial support members 74 (also referred to as struts)
The arm 44 extends along the circumference of the basket assembly 50 as shown in FIG.
Can be attached to The opening 64 can extend through the radial support member 74 at one or more locations. Radial support member 74 performs the following functions: i) facilitates opening and erasing sphincter 16; ii) increasing contact between opening 64 and sphincter wall 26; and iii) arm 44. Prevent or reduce the tendency to cluster. The cross-sectional geometry of the radial support member 74 can be rectangular or circular, although other geometries have been found to be equally suitable.

In one embodiment, shown in FIG. 9, the arm 44 is mounted on a distal basket cap 52, which in turn is free to move over the shaft 18, but with the shaft cap 78 Stopped at The one or more pull wires 80
Attached to the distal basket cap 52 and at the proximal fitting 34 of the sphincter mapping and treatment instrument 10 is also attached to the movable fitting 82. Pull wire 80
Is pulled back by the movable fitting 82, the warp 54 of the basket assembly 50
4 ', the basket assembly 50 increases the contact force and the amount of contact applied to the sphincter wall 26 or adjacent structures. The basket assembly 50 can also be deflected from side to side by the deflection mechanism 84. This allows
The physician can remotely point and steer the basket assembly within the body. In one embodiment, shown in FIG. 10, the deflection mechanism 84 includes a second pull wire 80 '.
Which is mounted on the shaft cap 78 and the proximal fitting 3
4 is also mounted on the movable slide 86 integrated therewith.

Turning now to the discussion of energy delivery, suitable power sources 56 and electrodes 88 that can be used in one or more embodiments of the present invention include: (i)
An RF source coupled to a radio frequency (RF) electrode; (ii) an interference light source coupled to the optical fiber; (iii) a non-interfering light source coupled to the optical fiber; (V) a heating fluid, which is connected to the catheter having an open channel configured to receive the heating fluid; (V
i) a cooling fluid, which is connected to a catheter having a closed channel configured to receive the cooling fluid; (vii) a cooling fluid, which receives the cooling fluid. (Viii) a cryogenic fluid; (ix) a resistive heating source; and (x) a microwave source, which has an energy between 915 MHz and 2.45 GHz. And (xi) an ultrasonic power source, which is connected to an ultrasonic emitter, wherein the ultrasonic power source comprises:
Producing energy in the range of KHz to 3 GHz; or (xii) a microwave source. For simplicity of discussion in the remainder of the application, the power supply used is an RF power supply and the electrodes 88 are one or more RF electrodes 88. However, all of the other power and mapping electrodes referred to herein are equally applicable to the sphincter mapping and treatment instrument 10.

For the case of RF energy, the RF electrode 88, together with the ground pad electrode,
It can be operated in either a bipolar or monopolar mode. In the RF energy delivery monopolar mode, a single electrode 88 is used in combination with an irrelevant electrode patch, which is applied to the body to form other electrical contacts to complete an electrical circuit. .
When using more than one RF electrode 88, bipolar operation is possible. Multiple RF electrodes 88 may be used. These electrodes, as described herein,
Can be cooled. RF electrode 88 can be attached to electrode delivery member 60 by using soldering methods well known to those skilled in the art. Suitable solders include Megatrod
e.Magbond Solder supplied by e Corporation (Milwaukee, Wisconsin).

Suitable electrolytes 72 include saline, calcium salt solutions, potassium salt solutions, and the like. Electrolyte 72 increases the conductivity of the target tissue at treatment site 12. When a highly conductive fluid (eg, electrolyte solution 72) is injected into a tissue, the electrical resistance of the injected tissue decreases and, instead, the conductivity of the injected tissue increases. As a result, the tissue surrounding the electrode 88 has little tendency to dry out (as described herein to increase the electrical resistance of the tissue), resulting in a very high potential for this tissue to carry RF energy. Referring to FIG. 11, a tissue zone into which a large volume of concentrated electrolyte 72 has been injected may be sufficiently conductive to actually act as a reinforced electrode 88 '. The effect of the reinforced electrodes 88 'is to increase the amount of current that can be conducted to the treatment site 12, thereby allowing a much larger volume of tissue to be heated over a given period of time.

Also, when the power supply is RF, the power supply 56 (which is now referred to as the RF power supply 56) may have multiple channels and deliver the modulated output to each electrode 88 separately.
This reduces the preferential heating that occurs when more energy is delivered to the more conductive zone, and less heating occurs around the RF electrode 88 located on the less conductive tissue. . If the tissue hydration level or blood infusion rate at the tissue is non-uniform, a single channel RF power source 56 can be used to provide an output that produces a lesion 14 that is relatively uniform in size.

The RF electrode 88 can have various shapes and sizes. Possible shapes include, but are not limited to, circular, rectangular, conical and pyramidal. The electrode surface is smooth or textured and may be concave or convex. Conductive surface of the electrode 88 can range from 0.1mm ² ~100c m ^2. It will be appreciated that other geometries and surface areas may be equally suitable.

In one embodiment, the RF electrode 88 may be needle-shaped with a sharpness and length sufficient to penetrate the smooth muscle of the esophageal wall, sphincter 16 or other anatomy. In this embodiment, shown in FIGS. 12 and 13, the needle electrode 90 is mounted on the arm 44 and has an insulating layer 92 so that the insulating segments 94 other than the exposed segments 95
Cover. For the purposes of this disclosure, an insulator or insulating layer will have a thermal energy flow, R
A barrier to either F energy flow or electrical energy flow. The insulating segment 94 is long enough to extend into the sphincter wall 26 to minimize RF energy transfer to the protection site 97 near or adjacent to the insulating segment 94 (see FIG. 13). Typical lengths for insulating segment 94 are 1-4 mm
But not limited thereto. Suitable materials for the needle electrode 90 include 304
Examples include, but are not limited to, stainless steel and other stainless steels known to those of skill in the art. Suitable materials for the insulating layer 92 include, but are not limited to, polyimide and polyamide.

During the introduction of the sphincter mapping and treatment instrument 10, the basket assembly 5
0 is in a contracted state. Once the sphincter mapping and treatment instrument 10 is properly positioned at the treatment site 12, the needle electrode 90 is deployed by the expansion of the basket assembly 50 so that the needle electrode 90 protrudes into the smooth muscle tissue of the sphincter wall 26. (See FIG. 14). The depth of the needle penetration is selectable in the range of 0.5-5 mm, and the movable bracket is adapted to change the warp 54 of the arm 44 in fixed increments that may be selectable in the range of 0.1-4 mm. This is achieved by aligning 82. Needle electrode 90 is connected to power supply 56 via insulated wire 60.

In another embodiment of the sphincter mapping and treatment instrument 10 shown in FIG. 15, the needle electrode 90 is advanced from the opening 64 in the basket arm 44 to the esophageal wall smooth muscle or other sphincter 16. You. In this case, the needle electrode 90 is
Is electrically connected to the RF power supply 56. In this embodiment, the depth of the needle penetration is selectable by means of a stepped portion 66 or a tapered portion 68 located at the opening 64. Referring to FIG. 16, opening 64 and needle electrode 90 allow sphincter wall 26 to move during insertion of needle electrode 90 into sphincter wall 26.
The penetration angle 96 of the needle electrode 90 (this is also the emergence angle
angle 96) is configured to remain sufficiently constant so that there are no tears or unnecessary trauma to the sphincter wall tissue. This is facilitated by selecting the following parameters and criteria: i) the angle of appearance 96 of the opening 64 (which can vary from 1 to 90 °); ii) the curved portion of the opening 64 An arc radius 98 of 100 (which can vary from 0.001 to 2 inches); iii) the amount of clearance between the opening inner diameter 102 and the needle electrode outer diameter 103 (which is 0.001 ″ and 0). .1 ");
And iv) a lubricious coating (eg, Teflon®) on the electrode delivery member 60
Or other coatings known to those skilled in the art). Also, in this embodiment, the insulating segment 94 can be in the form of a sleeve that can be adjustably positioned outside the needle electrode 90.

In another alternative embodiment, shown in FIG. 17, the electrode delivery member 60 with the needle electrode 90 attached thereto exits the shaft lumen 36 at the distal shaft end 32 and exits the sphincter wall 26.
Can be placed in contact with This process can be facilitated by using a hollow guide member 101 known to those skilled in the art as a guide catheter, through which the electrode delivery member 60 is advanced. The guiding catheter 101 may also include a stepped portion 66 or a tapered portion 68 at its distal end to control the depth of penetration of the needle electrode 90 into the sphincter wall 26.

The RF energy flowing through the tissue causes heating of the tissue due to absorption of the RF energy by the tissue and causes ohmic heating due to the electrical resistance of the tissue. This heating can cause damage to the affected cells and can be substantially sufficient to cause cell death (a phenomenon also known as cell necrosis). For the sake of simplicity in the discussion of the rest of the present application, cell injury includes all cellular effects that occur from (including) energy delivery from electrode 88 to cell necrosis. Cell injury can be achieved as a relatively simple medical procedure using local anesthesia. In one embodiment, the cytotoxicity progresses to a depth of about 1-4 mm from the surface of the mucosal layer of the sphincter muscle 16 or the surface of the adjacent anatomy.

Referring now to FIGS. 18A, 18B, 18C, and 18D, the mapping electrodes 22, RF electrodes 88, and / or openings 64 facilitate mapping and result in the desired placement and pattern of the lesion 14. To do so, it can be distributed in various patterns along the expandable mapping assembly 20 or basket assembly 50. Typical electrode (both mapping and RF modifications) and aperture distribution patterns include a radial distribution 104 (see FIG. 18A), a longitudinal distribution 1
05 (see FIG. 18B), spiral distribution 106 (see FIG. 18C), and distribution 107 of longitudinal and radial combinations (see FIG. 18D), but are not limited thereto. It will be appreciated that other combinations, patterns and geometries for electrode and aperture placement may also be appropriate. These electrodes can be cooled, as described below.

FIG. 19 is a flow chart illustrating one embodiment of a procedure using sphincter mapping and treatment instrument 10. In this embodiment, the sphincter mapping and treatment instrument 10 is first introduced into the esophagus under local anesthesia. The sphincter mapping and treatment instrument 10 may be used alone or with an endoscope (not shown) (eg, US Pat. Nos. 5,448,990 and 5,275,608, the contents of which are incorporated herein by reference). ), Or through a similar esophageal access device known to those skilled in the art. Basket assembly 50 is expanded as described herein. This helps to temporarily expand the LES or to fully erase some or all of the LES folds. In an alternative embodiment, esophageal dilatation and subsequent elimination of the LES fold is accomplished by insufflation of the esophagus (known in the art) using gas introduced into the esophagus through shaft lumen 36 or an endoscope or similar esophageal access device as described above. Technology). Once the procedure is complete, the basket assembly 50
Returns to its pre-deployed (ie, contracted) state, and the sphincter mapping and treatment instrument 10 is withdrawn from the esophagus. As a result, the LES returns roughly to its pre-treatment state and diameter. It can be seen that the above procedure, in whole or in part, is applicable to the treatment of other sphincters in the body.

As described above, using the control device 24 and the potential map 27, the doctor can
Diagnose abnormalities and pathologies in 6 and adjacent structures. More specifically, they are used to identify electrical events, including depolarization, contraction, and repolarization. Using this information, the physician determines a target treatment site 12 within the LES or adjacent anatomical structure. The LES or adjacent anatomical structures serve as focal points 108 or paths 109 for the abnormal electrical signal 111. The abnormal electrical signal 111 causes improper relaxation without abnormal relaxation of the smooth muscle of the LES or other sphincter 16 (see FIG. 20). These target treatment sites 12 are then treated, as described herein, to form a lesion 14 that isolates, or otherwise prevents, the generation and transmission of a sufficient amount of abnormal electrical signal 111, Causes relaxation of the LES or other sphincter wall 26.

A variety of other diagnostic methods can be used to aid in surface mapping of the sphincter wall 26.
These methods include, but are not limited to: (i) visualization of the inner surface of the esophagus with an endoscope or other visual instrument inserted into the esophagus; (ii) establishing a baseline for the tissue to be treated. Visualization of the internal morphology of the esophageal wall using ultrasonography to establish; (iii) impedance measurements to determine the electrical conductivity between the esophageal mucosal layer and the sphincter mapping and treatment instrument 10.

During the treatment phase of the procedure, the delivery of energy to the treatment site 12 can be performed under feedback control, manually, or a combination of both. Feedback control (described herein) allows the sphincter mapping and treatment instrument 10 to be placed and retained in the esophagus during the procedure with minimal physician care. The RF electrodes 88 can be multiplexed to treat the entire target site 12 or only a portion thereof. Feedback can be included, which is achieved by using one or more of the following methods: (i) visualization; (ii) impedance measurement; (iii) sonography; (iv) temperature measurement. And (v) measurement of sphincter contractility by manometry. By this feedback mechanism, in a desired pattern,
A selected on / off switching of different RF electrodes 88 is possible, which may be continuous from one electrode 88 to an adjacent electrode 88 or may jump between non-adjacent RF electrodes 88. The individual RF electrodes 88 are multiplexed and volume controlled by the controller 23 '.

The area and magnitude of cell injury at the LES or sphincter 16 can vary. However, sufficient target treatment site 12 is needed to achieve a tissue temperature in the range of 55-95 ° C. to cause trauma 14 at a depth in the range of 1-4 mm from the inner surface of LES or sphincter wall 26. It is desirable to deliver energy. Typical energy delivered to the esophageal wall includes, but is not limited to,
Includes ranges between 100 joules and 50,000 joules. In addition, the resulting trauma 14 causes cytotoxicity of sufficient magnitude and area to cause infiltration of the trauma 14 by fibroblasts 110, myofibroblasts 112, macrophages 114 and other cells involved in the tissue healing process. It is desirable to deliver sufficient energy to have (see FIG. 21). As shown in FIG. 22, these cells can
Causes contraction of the tissue around it to reduce its volume or alter its biomechanical properties at the trauma 14, thereby tightening the LES or sphincter 16. These changes are reflected in the deformed trauma 14 'shown in FIG. 19B. The diameter of the wound 14 can vary between 0.1 and 4 mm. Trauma 14 is preferably less than 4 mm in diameter to reduce the risk of thermal damage to the mucosal layer. 1
In an embodiment, a 2 mm diameter trauma 14 at the center of the smooth muscle wall provides a 1 mm buffer zone to prevent damage to the mucosa, submucosa and adventitia, but still reduces the smooth muscle wall thickness. Approximately 50% allows for cell invasion and subsequent sphincter tightening (see FIG. 23).

From a diagnostic standpoint, it is desirable to image this inner surface and the wall or other sphincter 16 of the LES, including the size and location of the lesion 14 created. Control device 2
It is desirable to create a map of these structures that can be entered at 3 'and used to direct the delivery of energy to the treatment site 12. Referring to FIG. 24, this is
This can be accomplished through the use of ultrasound (a well-known procedure), which involves the use of an ultrasound power supply 116 coupled to one or more ultrasound transducers 118 located on the expandable mapping assembly 20 or basket assembly 50. Include use. An output is coupled to the ultrasonic power supply 116.

Each ultrasonic transducer 118 can include a piezoelectric crystal 120 mounted on a backing material 122, which is then mounted on the expandable mapping assembly 20 or basket assembly 50. . Ultrasonic lens 124 is fabricated on electrically insulating material 126 but is mounted on piezoelectric crystal 120. The piezoelectric crystal 120 is connected to the ultrasonic power supply 116 by a conducting wire 128. Each ultrasonic transducer 118 transmits ultrasonic energy to adjacent tissue.
The ultrasonic transducer 118 includes an imaging probe (eg, Hewlett Packa).
rd Company (Palo Alto, California), Model 21362). In one embodiment, two ultrasound transducers 118 are positioned on opposite sides of the expandable mapping assembly 20 or basket assembly 50 to provide an image depicting the size and location of the lesion 14 on the selected sphincter 16. create.

The trauma 14 is located primarily in the smooth muscle layer of the selected sphincter 16 at a depth in the range of 1-4 mm from the inner surface of the sphincter wall 26. However, the trauma 14 can change both in number and location within the sphincter wall 26. It may be desirable to produce a plurality of trauma 14 patterns within the sphincter smooth muscle tissue to obtain a selected tightening of the LES or other sphincter muscle 16. Typical wound patterns shown in FIGS. 25A-D include, but are not limited to: (i) concentric wounds 14, all of which have a constant depth in the smooth muscle layer. Now, uniformly spaced along the radial axis of the sphincter 16; (ii) traumas 14 of wavy or folded circles, which differ in the smooth muscle layer Uniformly spaced at a depth along the radial axis of the sphincter 16; (iii)
Traumas 14 randomly distributed at different depths in the smooth muscle,
Radially uniformly spaced; and (iv) the eccentric pattern of the lesion 14 at one or more radial locations on the smooth muscle wall. Thus, the depth of the RF and thermal energy penetrating sphincter 16 may be controlled and selectable. The selective application of energy to the sphincter 16 may be a uniform penetration of RF energy into the entire target treatment site 12, a portion thereof, or depending on the condition of the sphincter 16, different amounts of RF energy To different sites. If desired, the area of cytotoxicity can be substantially the same for each treatment case.

Referring to FIG. 26, all, or a portion of the area near the electrode-tissue interface 130 is cooled before, during, and after energy delivery to reduce the extent and area of cell injury. It may be desired. In particular, using cooling preserves the mucosal layer of the sphincter wall 26 and, in the vicinity of the trauma 14, protects or otherwise reduces the degree of cellular damage to the cooled zone 132. Let it.
Referring now to FIG. 27, this shows that the opening 64 (this is the shaft lumen 3)
6, in fluid communication with a fluid reservoir 134 and a control unit 136, the operation of which is described herein and controls the delivery of the fluid). By using the cooling liquid 70 delivered by
Can be achieved.

Similarly, it may also be desirable to cool all or a portion of electrode 88. Rapid delivery of heat through the electrode 88 can result in the accumulation of charred biological material on the electrode 88 (due to contact with tissue and fluid (eg, blood)), which can cause Obstruct the flow of both thermal and electrical energy, and
This causes an increase in the electrical impedance exceeding the cutoff value set by the power supply 56. A similar situation may result from desiccation of the tissue adjacent to electrode 88. Cooling of the power supply 88 can be achieved by the coolant 70 delivered by the opening 64 as described above. Referring now to FIG. 28, electrode 88 may also be cooled via a fluid channel 138 in electrode 88, which fluid channel 1
34 and a control unit 136 in fluid communication.

As shown in FIG. 29, one or more sensors 140 may be located adjacent to or over the electrodes 88 to sense the temperature of the sphincter tissue at the treatment site 12. More specifically, the sensor 140 allows for an accurate determination of the surface temperature of the sphincter wall 26 at the electrode-tissue interface 130. This information can be used to control the delivery of both energy and coolant 70 to the inner surface of the sphincter wall 26. In various embodiments, sensor 140 can be located anywhere on expandable mapping assembly 20 or basket assembly 50. Suitable sensors that can be used for sensor 140 include thermocouples, fiber optics, resistive wires, thermocouple IR detectors, and the like. Suitable thermocouples for the sensor 140 include copper constantane (con
T, J, E, and K with the same stantenes, which are well known to those skilled in the art.

The temperature data from the sensor 140 is sent to the control unit 136 via an algorithm.
Will be fed back. The algorithm is stored in the microprocessor memory of the control unit 136. Electrically controlled micropumps (not shown) provide fluid at appropriate flow rates and duration through these fluid lines to provide a controlled temperature at the electrode-tissue interface 130. , An instruction is sent (see FIG. 27).

The reservoir of the control unit 136 may have the ability to control the temperature of the coolant 70 by either cooling or heating this fluid. Alternatively, a sufficiently sized fluid reservoir 134 may be used, where the coolant 70 is introduced at or near normal body temperature. Using a thermally isolated reservoir 142, sufficient control of this tissue temperature can be achieved without the need to cool or heat the coolant 70. The flow of the coolant 70 is controlled by a control unit 136 or other feedback control system (described herein) to provide temperature control at the electrical-tissue interface 130.

[0062] A second diagnostic phase may be included after the treatment is completed. This gives an indication of the success of the LES closure procedure and whether a second stage treatment should be performed on all or only part of the esophagus at the present or some later time. This second diagnostic stage is achieved by one or more of the following methods: (i) visualization; (ii)
) Measuring impedance; (iii) ultrasonography; (iv) temperature measurement;
Or (v) Measurement of LES tension and contraction force by manometry.

In one embodiment, the sphincter mapping and treatment instrument 10 is connected to an open or closed loop feedback system. Here, referring to FIG.
An open or closed loop feedback system couples the sensor 346 to the energy source 392. In this embodiment, electrode 314 is one or more RF electrodes 314.

The temperature of the tissue or RF electrode 314 is monitored and the output power of the energy source 392 is adjusted accordingly. The physician can override this closed or open loop system if desired. The closed or open loop system may include and incorporate a microprocessor 394 to switch the output on and off, and to regulate the output. The closed loop system serves as a controller, monitors this temperature, and
A microprocessor 394 is utilized to adjust the output, analyze the result, refeed the result, and then adjust the output.

With the use of the sensor 346 and this feedback control system, tissue adjacent to the RF electrode 314 may cause excessive electrical impedance to develop at the electrode 314 or adjacent tissue, as described herein. , Can be maintained at the desired temperature for a selected period of time without causing interruption of this output circuit to electrode 314. Each RF electrode 314 is a resource that generates an independent output.
ces). This output maintains the selected energy at the RF electrode 314 for a selected length of time.

The current delivered through the RF electrode 314 is measured by a current sensor 396. The voltage is measured by the voltage sensor 398. Next, the output and impedance calculator 400 calculates the impedance and the output. These values are then displayed on the user interface and display 402. Signals representing the output and impedance values are received by controller 404.

The control signal is generated by the controller 404, which is proportional to the difference between the actual measurement and the desired value. This control signal is used by output circuit 406 to adjust the output by an appropriate amount to maintain the desired output delivered at each individual RF electrode 314.

In a similar manner, the temperature detected by sensor 346 provides feedback to maintain the selected output. The temperature at sensor 346 is used as a safety measure to shut off the delivery of energy when the maximum preset temperature is exceeded.
Their actual temperatures are measured by a temperature measurement device 408, and these temperatures are displayed on a user interface and display 402. The control signal is generated by the controller 404 and is proportional to the difference between the actually measured temperature and the desired temperature. This control signal is used by output circuit 406 to adjust this output by an appropriate amount to maintain the desired temperature delivered by sensor 346. At the sensor 346, a multiplexer can be provided to measure current, voltage and temperature, and the energy is transferred in a monopolar or bipolar fashion to the RF electrode 31.
4 can be delivered.

Controller 404 can be a digital or analog controller, or a computer with software. When the controller 404 is a computer, it can include a CPU linked by a system bus. The system may include a keyboard, disk drive, or other non-volatile memory system, display, and other peripherals as is known in the art. A program memory and a data memory are connected to the bus.

The user interface and display 402 includes operator controls and a display. The controller 404 can be coupled to an imaging system, including, but not limited to, ultrasound, CT scanner, radiography, MRI, mammography, and the like. In addition, direct visualization and tactile imaging can be used.

The outputs of current sensor 396 and voltage sensor 398 are used by controller 404 to maintain a selected output level at RF electrode 314. The amount of RF energy delivered controls this amount of power. The profile of the output delivered to the electrode 314 can be provided in the controller 404, and the preset amount of energy to be delivered can also be profiled.

The circuitry, software, and feedback to the controller 404 provide process control and maintenance of the selected output setting, which is independent of voltage or current changes, including: Used to change the process variables of: (i) selected power settings, (ii) duty cycle (eg, on-off time), (iii) bipolar or monopolar energy delivery, and (iv) fluid delivery (
This includes flow rates and pressures). These process variables correspond to the sensor 34
Based on the temperature monitored at 6, it can be controlled and varied while maintaining the desired delivery of output independent of voltage or current changes.

Referring now to FIG. 31, current sensor 396 and voltage sensor 398 are connected to the input of analog amplifier 410. Analog amplifier 410 may be a conventional differential amplifier circuit for use with sensor 346. An output of the analog amplifier 410 is continuously connected to an input of the A / D converter 414 by an analog multiplexer 412. The output of analog amplifier 410 is a voltage representing the sensed temperature of each individual. The digitizing amplifier output voltage is supplied by A / D converter 414 to microprocessor 394. The microprocessor 394 has M
It may be type 68HCII available from autorolla. However, it will be appreciated that any suitable microprocessor or general purpose digital or analog computer can be used to calculate the impedance or temperature.

The microprocessor 394 continuously receives and stores digital images of impedance and temperature. Each digital value received by microprocessor 394 corresponds to a different temperature and impedance.

The calculated output and impedance values can be displayed on the user interface and display 402. Instead of or in addition to a numerical representation of the output or impedance, the calculated impedance and output value can be compared by the microprocessor 394 to the output and impedance limits. When these values exceed a predetermined output or impedance value, a warning can be provided at the user interface and display 402, and the delivery of RF energy can be reduced, changed, or shut off.
A control signal from the microprocessor 394 can change the power level provided by the energy source 392.

FIG. 32 illustrates a block diagram of a temperature and impedance feedback system, which controls the delivery of energy to the tissue site 416 by the energy source 392 and the electrodes 314 and / or the tissue site. It can be used to control the delivery of coolant 70 to 416 by flow regulator 418. Energy is delivered to RF electrode 314 by energy source 392 and applied to tissue site 416. The monitor 420 checks the tissue impedance based on the energy delivered to the tissue and compares the measured tissue impedance with a set point. If the measured impedance exceeds the set value, a disable signal 422 is transmitted to the energy source 392 to stop further energy transfer to the RF electrode 314. If the measured impedance is within acceptable limits, the tissue is subsequently energized.

Control of the coolant 70 to the electrodes 314 and / or the tissue site 416 is performed in the following manner. During the application of the energy, the temperature measurement device 408 causes the tissue site 41
6 and / or measure the temperature of the RF electrode 314. Comparator 424 receives the signal indicating the measured temperature and compares this value to a preset signal indicating the desired temperature. If the tissue temperature is too high, the comparator 424 sends a signal to a flow regulator 418 (which is connected to an electrically controlled micropump (not shown)) and a high coolant flow rate Show the need for If the measured temperature does not exceed the desired temperature, comparator 424 signals flow regulator 418 to maintain this flow at the existing level.

The foregoing description of a preferred embodiment of the invention is provided for purposes of explanation and description.
Presented. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope of the invention be defined by the following claims and their equivalents:

[Brief description of the drawings]

FIG. 1 is an illustrative side view of the placement of the sphincter mapping and treatment device of the present invention on the upper GI tract, which includes the esophagus and lower esophagus sphincter, and the lower esophagus sphincter.

FIG. 2 shows an energy delivery device, a power supply, a control device in an expanded state and a contracted state,
FIG. 2 is a side view of the present invention illustrating a map, a display device, and a mapping assembly.

FIG. 3 depicts a side view of the present invention illustrating components on a flexible shaft comprising a proximal fitting, a connection, and proximal and distal shaft segments.

FIG. 4A shows a side view of a basket assembly used in an embodiment of the present invention.

FIG. 4B is a side view showing the placement of the mapping electrodes on the basket assembly and the connection of electricity to the controller.

FIG. 5A is a side view of a basket assembly, illustrating the extent of warpage of the basket assembly.

FIG. 5B is a perspective view illustrating a balloon connected to the basket assembly.

FIG. 6A is a side view of the junction of the basket arm and the shaft, illustrating the path used to advance the moveable wire or deliver fluid.

FIG. 6B is a front view of a basket arm in an alternative embodiment of the present invention, illustrating a track on the arm used to advance the moveable wire.

FIG. 7 is a cross-sectional view of a portion of the basket arm, illustrating a stepped portion and a tapered portion at the basket arm opening.

FIG. 8 is a side view of the basket assembly, illustrating its radial support member arrangement.

FIG. 9A is a side view of the sphincter mapping and treatment instrument, illustrating a mechanism used in one embodiment of the present invention to increase the bow of the basket assembly.

FIG. 9B is a view similar to FIG. 9A, showing the basket assembly in an enhanced warp condition.

FIG. 10 is a side view of the sphincter mapping and treatment instrument, illustrating its deflection mechanism.

FIG. 11 is a side view illustrating the use of an electrolyte to make a reinforced RF electrode.

FIG. 12 is a side view of a basket assembly illustrating the use of a needle electrode.

FIG. 13 is a side view illustrating the use of an insulating segment on this needle electrode to protect tissue from RF energy.

FIG. 14 is a side view illustrating placement of a needle electrode on a sphincter wall by expansion of the basket assembly.

FIG. 15 is a side view illustrating placement of a needle electrode on a sphincter wall by advancing an electrode delivery member from an opening in the basket arm.

FIG. 16 is a cross-sectional view illustrating the configuration of a basket arm opening used to select and maintain the angle of penetration of the needle electrode into the sphincter muscle wall.

FIG. 17 is a side view illustrating placement of a needle electrode on the sphincter wall by advancing the electrode delivery member directly from the distal end of the shaft.

FIG. 18A is a side view illustrating the radial distribution of electrodes on the expandable mapping assembly of the present invention.

FIG. 18B is a side view illustrating the longitudinal distribution of electrodes on the expandable mapping assembly of the present invention.

FIG. 18C is a side view illustrating a helical distribution of electrodes on the expandable mapping assembly of the present invention.

FIG. 18D is a side view showing the radial longitudinal distribution of the electrodes on the expandable mapping assembly of the present invention.

FIG. 19 is a flow chart illustrating a sphincter treatment method.

FIG. 20 is a side view of sphincter smooth muscle tissue, which illustrates electromagnetic focus and pathways for the generation and conduction of abnormal electrical signals in the lower esophageal sphincter or other tissue smooth muscle. I have.

FIG. 21 is a side view of the sphincter muscle wall, illustrating the infiltration of tissue healing cells into the trauma in the sphincter smooth tissue following treatment with the sphincter treatment device of the present invention. ing.

FIG. 22 is a view similar to FIG. 21, illustrating the contraction of the trauma site caused by cell infiltration.

FIG. 23 is a side view of the esophageal wall, illustrating a preferred placement of trauma in the smooth muscle layer of the esophageal sphincter.

FIG. 24 is a side view illustrating an ultrasonic transducer, an ultrasonic lens, and a power supply according to one embodiment of the present invention.

FIG. 25A is a side view of a sphincter wall, illustrating various patterns of trauma created by the device of the present invention.

FIG. 25B is a side view of the sphincter wall, illustrating various patterns of trauma created by the device of the present invention.

FIG. 25C is a side view of a sphincter wall, illustrating various patterns of trauma created by the device of the present invention.

FIG. 25D is a side view of the sphincter wall, illustrating various patterns of trauma created by the device of the present invention.

FIG. 26 is a side view of a sphincter wall, illustrating the delivery of cooling fluid to its electrode-tissue interface and the formation of a cooling zone.

FIG. 27 depicts the channels, fluid connections and control units used to deliver fluid to the electrode-tissue interface.

FIG. 28 depicts the channels, fluid connections and control units used to deliver fluid to the RF electrodes.

FIG. 29 is an enlarged side view illustrating the placement of a sensor on the expansion device or basket assembly.

FIG. 30 depicts a block diagram of a feedback control system that can be used with the sphincter mapping and treatment instrument.

FIG. 31 depicts a block diagram of an analog amplifier, analog multiplexer and microprocessor used with the feedback control system of FIG. 30.

FIG. 32 depicts a block diagram of operations performed by the feedback control system depicted in FIG.

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE , KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZW

Claims (73)

[Claims] 1. An instrument for treating a sphincter, comprising: a support member; and a sphincter potential mapping device including a mapping electrode, wherein the sphincter potential mapping device is connected to the support member and located within the sphincter. And a sphincter potential mapping device configured to detect one of the abnormal neuroelectric or myoelectric activity of the sphincter. 2. The device of claim 1, further comprising a treatment electrode coupled to the sphincter myoelectric potential mapping device. 3. The sphincter myoelectric potential mapping device is configured to detect one abnormal focus of the abnormal neuroelectric or myoelectric activity of the sphincter.
The device of claim 1. 4. The device of claim 2, wherein the sphincter potential mapping device is configured to detect an electrical focus of abnormal myoelectric activity of the sphincter. 5. The device of claim 3, wherein the mapping electrode is configured to deliver sufficient energy to treat the focus. 6. The instrument of claim 4, wherein the treatment electrode is configured to deliver sufficient energy to treat the focus. 7. The apparatus of claim 1, wherein the sphincter potential mapping device is configured to detect an electrically conductive pathway of abnormal myoelectric activity of the sphincter. 8. The device of claim 2, wherein the sphincter potential mapping device is configured to detect an electrically conductive pathway of abnormal myoelectric activity of the sphincter. 9. The device of claim 7, wherein the mapping electrode is configured to deliver sufficient energy to treat the pathway. 10. The device of claim 8, wherein the treatment electrode is configured to deliver sufficient energy to treat the pathway. 11. The device of claim 1, wherein the mapping device is configured to be positionable within a lower esophageal sphincter. 12. The sphincter potential mapping device is configured to detect an electrical focus of the abnormal myoelectric activity of the lower esophageal sphincter, and wherein the mapping electrode reduces a period of relaxation of the lower esophageal sphincter. 12. The device of claim 11, wherein the device is configured to form a lesion at the focal point. 13. The sphincter potential mapping device is configured to detect an electrical conductive pathway of the abnormal myoelectric activity of the lower esophageal sphincter, wherein the mapping device removes trauma to treat the pathway. 2. The method of claim 1, wherein the method is configured to:
The device of claim 1. 14. The mapping electrode is configured to create a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 12. The device of claim 11, wherein the device reduces frequency. 15. The mapping electrode is configured to create a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 12. The device of claim 11, which reduces the frequency of symptoms. 16. The mapping electrode is configured to create a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. Claims 1 to reduce the incidence of sequelae
The device of claim 1. 17. The mapping electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, thereby reducing a period of relaxation of the lower esophageal sphincter. The device according to claim 11. 18. The mapping electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 12. The device of claim 11, wherein the device reduces frequency. 19. The device of claim 2, wherein the mapping device is configured to be positionable within a lower esophageal sphincter. 20. The sphincter potential mapping device is configured to detect an electrical focus of the abnormal myoelectric activity of the lower esophageal sphincter, wherein the treatment electrode comprises:
20. The device of claim 19, wherein the device is configured to create a trauma to the focal spot to reduce a period of relaxation of the lower esophageal sphincter. 21. The sphincter potential mapping device is configured to detect an electrical conductive path of the abnormal myoelectric activity of the lower esophageal sphincter, and wherein the treatment electrode is configured to treat the trauma to treat the path. 20. The device of claim 19, wherein the device is configured to form: 22. The treatment electrode is configured to create a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 20. The device of claim 19, wherein the device reduces frequency. 23. The treatment electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 20. The device of claim 19, wherein the device reduces the frequency of symptoms. 24. The treatment electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 20. The device of claim 19, which reduces the incidence of subsequent sequelae. 25. The treatment electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, thereby reducing a period of relaxation of the lower esophageal sphincter. The device of claim 19. 26. The treatment electrode is configured to form a trauma in the lower esophageal sphincter in response to the detection of the abnormal myoelectric activity, whereby gastric contents are refluxed into the esophagus. 20. The device of claim 19, wherein the device reduces frequency. 27. The device of claim 1, further comprising a feedback controller connected to the sphincter potential mapping device. 28. The device of claim 2, further comprising a feedback controller connected to the sphincter potential mapping device. 29. The device of claim 1, further comprising a feedback controller connected to the sphincter potential mapping device and an energy source. 30. The device of claim 2, further comprising a feedback controller connected to the sphincter potential mapping device, the treatment electrode, and an energy source. 31. The device of claim 2, wherein the sphincter potential mapping device includes a plurality of mapping electrodes and a plurality of treatment electrodes distributed on a surface of the support member. 32. The plurality of mapping electrodes and the plurality of treatment electrodes,
32. The device of claim 31, wherein the device is radially distributed along a surface of the support member. 33. The plurality of mapping electrodes and the plurality of treatment electrodes,
32. The device of claim 31, wherein the device is longitudinally distributed along a surface of the support member. 34. The device of claim 1, wherein the sphincter potential mapping device covers a portion of a surface of the support member. 35. The device of claim 1, wherein the sphincter potential mapping device covers substantially all of the outer surface of the support member. 36. The sphincter potential mapping device is sized to be positionable within the sphincter, enabling the sphincter potential mapping device to contact at least a portion of the inner surface of the sphincter. Utensils. 37. The device of claim 1, wherein the sphincter potential mapping device is positionable within the sphincter and sized to non-permanently dilate the sphincter. 38. The device of claim 2, wherein the sphincter potential mapping device covers a portion of a surface of the support member. 39. The device of claim 2, wherein the sphincter potential mapping device covers substantially all of the outer surface of the support member. 40. The sphincter potential mapping device is sized to be positionable within the sphincter, enabling the sphincter potential mapping device to contact at least a portion of the outer surface of the sphincter. Utensils. 41. The device of claim 2, wherein the sphincter potential mapping device is positionable within the sphincter and is sized to non-permanently dilate the sphincter. 42. An apparatus for treating a stomach, comprising: a support member; and a gastric potential mapping device including a mapping electrode, wherein the gastric potential mapping device is connected to the support member, and the stomach abnormality is provided. A device for treating the stomach, comprising: a gastric potential mapping device configured to detect one of a neuroelectric or abnormal myoelectric activity. 43. The apparatus of claim 42, wherein the gastric potential mapping device is configured to detect one of abnormal neuroelectric or myoelectric activity of the gastric cardia. 44. The device of claim 43, further comprising a treatment electrode coupled to the gastric potential mapping device. 45. The apparatus of claim 42, wherein the gastric potential mapping device is configured to detect one electrical focus of the abnormal neuroelectric or myoelectric activity of the stomach. 46. The apparatus of claim 44, wherein the gastric potential mapping device is configured to detect an electrical focus of the abnormal myoelectric activity of the stomach. 47. The apparatus of claim 46, wherein the mapping electrode is configured to deliver sufficient energy to treat the focus. 48. The device of claim 47, wherein the treatment electrode is configured to deliver sufficient energy to treat the focus. 49. The apparatus of claim 42, wherein said gastric potential mapping device is configured to detect an electrically conductive pathway of said abnormal myoelectric activity of said stomach. 50. The apparatus of claim 44, wherein the gastric potential mapping device is configured to detect an electrically conductive pathway of the abnormal myoelectric activity of the stomach. 51. The device of claim 49, wherein the mapping electrode is configured to deliver sufficient energy to treat the pathway. 52. The device of claim 50, wherein the treatment electrode is configured to deliver sufficient energy to treat the pathway. 53. The mapping electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby reducing the frequency of gastric contents refluxing into the esophagus. 44. The device of claim 43, wherein the device reduces. 54. The mapping electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby indicating a sign of gastric contents refluxing into the esophagus. 44. The device of claim 43, wherein the device reduces frequency. 55. The mapping electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby causing the contents of the stomach to flow back into the esophagus. 43. The device of claim 42, which reduces the incidence of sequelae. 56. The mapping electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby reducing the frequency of gastric contents refluxing into the esophagus. 43. The device of claim 42, wherein the device reduces. 57. The treatment electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby increasing the frequency of gastric contents refluxing into the esophagus. 46. The device of claim 44, wherein the device reduces. 58. The treatment electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby indicating that gastric contents are refluxing into the esophagus. 46. The device of claim 44, wherein the device reduces frequency. 59. The treatment electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby causing gastric contents to flow back into the esophagus. 45. The device of claim 44, which reduces the incidence of sequelae. 60. The treatment electrode is configured to form a trauma in the stomach in response to the detection of the abnormal myoelectric activity, thereby reducing the frequency of gastric contents refluxing into the esophagus. 46. The device of claim 44, wherein the device reduces. 61. The device of claim 42, further comprising a feedback control device connected to said gastric potential mapping device. 62. The device of claim 43, further comprising a feedback control device connected to the gastric potential mapping device. 63. The device of claim 42, further comprising a feedback controller connected to the gastric potential mapping device and an energy source. 64. The device of claim 43, further comprising a feedback controller connected to the gastric potential mapping device, the treatment electrode, and an energy source. 65. The apparatus of claim 43, wherein the gastric potential mapping device includes a plurality of mapping electrodes and a plurality of treatment electrodes distributed on a surface of the support member. 66. The plurality of mapping electrodes and the plurality of treatment electrodes,
66. The device of claim 65, wherein the device is radially distributed along a surface of the support member. 67. The plurality of mapping electrodes and the plurality of treatment electrodes,
66. The device of claim 65, wherein the device is longitudinally distributed along a surface of the support member. 68. The device of claim 42, wherein said gastric potential mapping device covers at least a portion of a surface of said support member. 69. The device of claim 42, wherein the gastric potential mapping device covers substantially all of the outer surface of the support member. 70. The gastric potential mapping device is sized to be positionable in the stomach, allowing the gastric potential mapping device to contact at least a portion of the inner surface of the stomach. Utensils. 71. The device of claim 43, wherein said gastric potential mapping device covers at least a portion of a surface of said support member. 72. The device of claim 43, wherein the gastric potential mapping device covers substantially all of the outer surface of the support member. 73. The gastric potential mapping device is sized to be positionable in the stomach, enabling the gastric potential mapping device to contact at least a portion of the interior surface of the stomach. Utensils.