US 20070093809 A1
A sphincter treatment apparatus has an introducer means including a distal portion means. An expandable device means includes a plurality of arm means. Each arm means of the plurality has a distal section means and a proximal section means. Each of distal sections means of the arm means are coupled and each of the proximal sections means of the arm means are coupled to the introducer means distal portion means. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is introduceable from the introducer means into a selected site of the sphincter. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter.
1. A sphincter treatment apparatus comprising:
an introducer having an introducer lumen,
an expandable device coupled to the introducer, the expandable device including a first arm with a proximal section and a distal section and a second arm with a proximal section and a distal section, the first and second arm distal sections being coupled, at least one of the first and second arms including an arm lumen coupled in fluid communication with the introducer lumen for delivery of a fluid, the expandable device being configured to at least partially dilate a sphincter in a deployed state, and
an energy delivery device coupled to the expandable device.
2. An apparatus as in
wherein at least a portion of the energy delivery device is advanceable into the sphincter.
3. An apparatus as in
wherein the at least one of the first and second arms includes an aperture coupled to the introducer lumen and adapted to provide a path for delivery of the fluid from the introducer.
4. An apparatus as in
wherein the fluid is cooling fluid.
5. A method of treating a sphincter comprising:
providing an introducer, the introducer carrying an expandable device,
providing an energy delivery device coupled to the expandable device,
deploying the introducer to a targeted tissue site at or near a sphincter,
expanding the expandable device to at least partially dilate the sphincter,
delivering energy from the energy delivery device to the targeted tissue site, and
delivering a cooling fluid from the introducer.
6. A method as in
wherein the expandable device includes a first arm with a proximal section and a distal section and a second arm with a proximal section and a distal section, the first and second arm distal sections being coupled.
7. A method as in
wherein at least one of the first and second arms includes a lumen.
8. A method as in
wherein the introducer includes a lumen.
9. A method as in
wherein the cooling fluid is delivered at a sensed flow rate, further comprising,
measuring the temperature of at least one of the tissue site and the energy delivery device, and
comparing the measured temperature to a pre-set desired temperature.
10. A method as in
maintaining the flow rate if the measured temperature does not exceed the desired temperature.
11. A method as in
increasing the flow rate if the measured temperature exceeds the desired temperature.
This application is a divisional of application Ser. No. 10/838,292, which is a divisional of application Ser. No. 09/971,085, filed Oct. 4, 2001 (now U.S. Pat. No. 6,749,607), which is a continuation of application Ser. No. 09/036,092, filed Mar. 6, 1998, now abandoned.
This invention relates generally to an apparatus to treat sphincters, and more particularly to an apparatus to treat esophageal sphincters.
Gastroesophageal reflux disease (GERD) is a common gastroesophageal disorder in which the stomach contents are ejected into the lower esophagus due to a dysfunction of the lower esophageal sphincter (LES). These contents are highly acidic and potentially injurious to the esophagus resulting in a number of possible complications of varying medical severity. The reported incidence of GERD in the U.S. is as high as 10% of the population (Castell DO; Johnston BT: Gastroesophageal Reflux Disease: Current Strategies For Patient Management. Arch Fam Med, 5(4):221-7; (1996 April)).
Acute symptoms of GERD include heartburn, pulmonary disorders and chest pain. On a chronic basis, GERD subjects the esophagus to ulcer formation, or esophagitis and may result in more severe complications including esophageal obstruction, significant blood loss and perforation of the esophagus. Severe esophageal ulcerations occur in 20-30% of patients over age 65. Moreover, GERD causes adenocarcinoma, or cancer of the esophagus, which is increasing in incidence faster than any other cancer (Reynolds JC: Influence Of Pathophysiology, Severity, And Cost On The Medical Management Of Gastroesophageal Reflux Disease. Am J Health Syst Pharm, 53(22 Suppl 3):S5-12 (1996 Nov. 15)).
Current drug therapy for GERD includes histamine receptor blockers which reduce stomach acid secretion and other drugs which may completely block stomach acid. However, while pharmacologic agents may provide short term relief, they do not address the underlying cause of LES dysfunction.
Invasive procedures requiring percutaneous introduction of instrumentation into the abdomen exist for the surgical correction of GERD. One such procedure, Nissen fundoplication, involves constructing a new “valve” to support the LES by wrapping the gastric fundus around the-lower esophagus. Although the operation has a high rate of success, it is an open abdominal procedure with the usual risks of abdominal surgery including: postoperative infection, herniation at the operative site, internal hemorrhage and perforation of the esophagus or of the cardia. In fact, a recent 10 year, 344 patient study reported the morbidity rate for this procedure to be 17% and mortality 1% (Urschel, JD: Complications, Of Antireflux Surgery, Am J Surg 166(1): 68-70; (1993 July)). This rate of complication drives up both the medical cost and convalescence period for the procedure and may exclude portions of certain patient populations (e.g., the elderly and immuno-compromised).
Efforts to perform Nissen fundoplication by less invasive techniques have resulted in the development of laparoscopic Nissen fundoplication. Laparoscopic Nissen fundoplication, reported by Dallemagne et al. Surgical Laparoscopy and Endoscopy, Vol. 1, No. 3, (1991), pp. 138-43 arid by Hindler et al. Surgical Laparoscopy and Endoscopy, Vol. 2, No. 3, (1992), pp. 265-272, involves essentially the same steps as Nissen fundoplication with the exception that surgical manipulation is performed through a plurality of surgical cannula introduced using trocars inserted at various positions in the abdomen.
Another attempt to perform fundoplication by a less invasive technique is reported in U.S. Pat. No. 5,088,979. In this procedure, an invagination device containing a plurality of needles is inserted transorally into the esophagus with the needles in a retracted position. The needles are extended to engage the esophagus and fold the attached esophagus beyond the gastroesophageal junction. A remotely operated stapling device, introduced percutaneously through an operating channel in the stomach wall, is actuated to fasten the invaginated gastroesophageal junction to the surrounding involuted stomach wall.
Yet another attempt to perform fundoplication by a less invasive technique is reported in U.S. Pat. No. 5,676,674. In this procedure, invagination is done by a jaw-like device and fastening of the invaginated gastroesophageal junction to the fundus of the stomach is done via a transoral approach using a remotely operated fastening device, eliminating the need for an abdominal incision. However, this procedure is still traumatic to the LES and presents the postoperative risks of gastroesophageal leaks, infection and foreign body reaction, the latter two sequela resulting when foreign materials such as surgical staples are implanted in the body.
While the methods reported above are less invasive than an open Nissen fundoplication, some still involve making an incision into the abdomen and hence the increased morbidity and mortality risks and convalescence period associated with abdominal surgery. Others incur the increased risk of infection associated with placing foreign materials into the body. All involve trauma to LES and the risk of leaks developing at the newly created gastroesophageal junction.
Besides the LES, there are other sphincters in the body which if not functionally properly can cause disease states or otherwise adversely affect the lifestyle of the patient. Reduced muscle tone or otherwise aberrant relaxation of sphincters can result in a laxity of tightness disease states including, but not limited to, urinary incontinence.
There is a need to provide an apparatus to treat a sphincter and reduce a frequency of sphincter relaxation. Another need exists for an apparatus to create controlled cell necrosis in a sphincter tissue underlying a sphincter mucosal layer. Yet another need exists for an apparatus to create controlled cell necrosis in a sphincter and minimize injury to a mucosal layer of the sphincter. There is another need for an apparatus to controllably produce a lesion in a sphincter without creating a permanent impairment of the sphincter's ability to achieve a physiologically normal state of closure. Still a further need exists for an apparatus to create a tightening of a sphincter without permanently damaging anatomical structures near the sphincter. There is still another need for an apparatus to create controlled cell necrosis in a lower esophageal sphincter to reduce a frequency of reflux of stomach contents into an esophagus.
Accordingly, an object of the present invention is to provide an apparatus that reduces a frequency of sphincter relaxation.
Another object of the invention is to provide an apparatus to create controlled cell necrosis in a sphincter tissue underlying a sphincter mucosal layer. Yet another object of the invention is to provide an apparatus to create controlled cell necrosis in a sphincter and minimize injury to a mucosal layer of the sphincter.
A further object of the invention is to provide an apparatus to controllably produce a lesion in a sphincter without creating a permanent impairment of the sphincter's ability to achieve a physiologically normal state of closure.
Still another object of the invention is to provide an apparatus to create a tightening of a sphincter without permanently damaging anatomical structures near the sphincter.
Another object of the invention is to provide an apparatus to create controlled cell necrosis in a lower esophageal sphincter to reduce a frequency of reflux of stomach contents into an esophagus.
These and other objects of the invention are provided in a sphincter treatment apparatus within an introducer means including a distal portion means. An expandable device means includes a plurality of arm means. Each arm means has a distal section means and a proximal section means. Each of the distal section means of the arm means are coupled and each of the proximal section means of the arm means are coupled to the introducer means distal portion means. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is introduceable from the introducer means into a selected site of the sphincter. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter.
In another embodiment, an expandable device means is coupled to an introducer distal portion means. The expandable device means includes a first arm means with a proximal and distal section means and a second arm means with proximal and distal section means. The first and second arm distal portion means are coupled. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is coupled to the expandable device means. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter while minimizing cell necrosis of a mucosal layer of the sphincter.
FIGS. 20A-D are lateral views of the sphincter wall illustrating various patterns of lesions created by the apparatus of the,present invention.
Expansion device 20 comprises a plurality of arms 24, with proximal and distal arms ends 25 and 26. Proximal arm ends 25 are coupled to introducer end 19. Expansion device 20 has a central longitudinal axis 28 and is moveable between contracted and expanded/deployed states substantially there along. Expansion device 20 is configured to be positionable in a sphincter 16 (such as the LES) or adjacent anatomical structure (such as the cardia of the stomach) and is further configured to partially dilate sphincter 16 when in the deployed state. Energy delivery devices 22 are configured to be introduceable from introducer 18 and to contact and/or penetrate a targeted treatment site 12 in a sphincter wall 30 or adjoining anatomical structure. They are further configured to deliver energy to treatment site 12.
Referring now to
Introducer 18 may have one or more lumens 32, that extend the full length of introducer 18, or only a portion thereof. Lumens 32 may be used as paths for the delivery of fluids and gases, as well as providing channels for cables, catheters, guide wires, pull wires, insulated wires, and optical fibers.
In another embodiment of the invention depicted in
Referring now to
Arms 24 may form a variety of geometric shapes including, curved, rectangular, trapezoidal, triangular, or any combination thereof Also, arms 24 can have an outwardly bowed shaped memory for expanding basket assembly 38 into engagement with sphincter wall 30. Arms 24 may be preshaped at time of manufacture or shaped by the physician. Arms 24 can have a variety of cross sectional geometries including, circular, rectangular and crescent-shaped. The circumferential spacing of arms 24 can be symmetrical or asymmetrical with respect to a circumference around longitudinal axis 28. Suitable materials for arms 24 include spring steel, stainless steel, superelastic shape memory metals such as nitinol, or stiff shaft plastic tubing as is well known to those skilled in the art. Arms 24 may also be color-coded to facilitate their identification via visual medical imaging methods and equipment, such as endoscopic methods, which are well known to those skilled in the art.
In another embodiment of the invention depicted in
Referring now to
Referring now to
In another embodiment of the invention depicted in
In another embodiment of the invention, energy delivery device 22 is coupled to arm 24. As shown in
Turning now to a discussion of energy delivery, suitable power sources and energy delivery devices 22 that can be employed in one or more embodiments of the invention include or more of the following: (i) a radio-frequency (RF) source coupled to an RF electrode, (ii) a coherent source of light coupled to an optical fiber, (iii) an incoherent light source coupled to an optical fiber, (iv) a heated fluid coupled to a catheter with a closed channel configured to receive the heated fluid, (v) a heated fluid coupled to a catheter with an open channel configured to receive the heated fluid, (vi) a cooled fluid coupled to a catheter with a closed channel configured to receive the cooled fluid, (vii) a cooled fluid coupled to a catheter with an open channel configured to receive the cooled fluid, (viii) a cryogenic fluid, (ix) a resistive heating source, (x) a microwave source providing energy from 915 MHz to 2.45 GHz and coupled to a microwave antenna, or (xi) an ultrasound power source coupled to an ultrasound emitter, wherein the ultrasound power source produces energy in the range of 300 KHZ to 3 GHz. For ease of discussion for the remainder of this application, the power source utilized is an RF source and energy delivery device 22 is one or more RF electrodes 66, also described as electrodes 66. However, all of the other herein mentioned power sources and energy delivery devices are equally applicable to sphincter treatment apparatus 10.
For the case of RF energy, RF electrode 66 may be operated in either bipolar or monopolar mode with a ground pad electrode. In a monopolar mode of delivering RF energy, a single electrode 66 is used in combination with an indifferent electrode patch that is applied to the body to form the other electrical contact and complete an electrical circuit. Bipolar operation is possible when two or more electrodes 66 are used. Multiple electrodes 66 may be used. These electrodes may be cooled as described herein. Electrodes 66 can be attached to advancement member 57 by the use of soldering methods which are well known to those skilled in the art.
Referring now to
In another embodiment of the invention, the depth of penetration of energy delivery device 22 into sphincter wall 30 is controllable. This can be accomplished by the selection and control of the dimensional relationships (e.g. the amount of clearance between inner and outer diameters) of energy delivery devices 22 and/or advancement member 57 to one or more of the following elements: arm lumen 48, apertures 50 and track 52. Control of penetration depth can also be accomplished through the use of tapered and/or stepped sections in one or more of the preceding elements as is discussed herein. In another embodiment, penetration depth control can be accomplished by the use of one or more of a variety of positional control means, known to those skilled in the art, that are coupled to sphincter treatment apparatus 10. Such positional control means include stepper motor systems, indexing mechanisms and micromanipulators.
Referring now to
Referring now to
As shown in
The diagnostic phase of the procedure then begins and can be performed using a variety of diagnostic methods known to those skilled in the art including the following: (i) visualization of the interior surface of the esophagus via an endoscope or other viewing apparatus inserted into the esophagus, (ii) visualization of the interior morphology of the esophageal wall using ultrasonography to establish a baseline for the tissue to be treated, (iii) impedance measurement to determine the electrical conductivity between esophageal mucosal and submucosal layers 60 and 62 and sphincter treatment apparatus 10, and (iv) measurement and surface mapping of electropotential signals of the LES and surrounding anatomical structures during varying time intervals which may include such events as depolarization, contraction and repolarization of gastroesophageal smooth muscle tissue. This latter technique is done to determine target treatment sites 12 in the LES or adjoining anatomical structures that are acting as electrical foci 107 or electrically conductive pathways 109 for abnormal or inappropriate polarization and relaxation of the smooth muscle of the LES (Refer to
After diagnosis, the treatment phase of the procedure begins. In this phase of the procedure, the delivery of energy to treatment site 12 can be conducted under feedback control, manually or by a combination of both. Feedback control (described herein) enables sphincter treatment apparatus 10 to be positioned and retained in the esophagus during treatment with minimal attention by the physician. Electrodes 66 can be multiplexed in order to treat the entire targeted treatment site 12 or only a portion thereof. Feedback can be included and is achieved by the use of one or more of the following methods: (i) visualization, (ii) impedance measurement, (iii) ultrasonography, (iv) temperature measurement; and, (v) contractile force measurement via manometry. The feedback mechanism permits the selected on-off switching of different electrodes 66 in a desired pattern, which can be sequential from one electrode 66 to an adjacent electrode 66, or can jump around between non-adjacent electrodes 66. Individual electrodes 66 are multiplexed and volumetrically controlled by a controller.
The area and magnitude of cell injury in the LES or sphincter 16 can vary. However, it is desirable to deliver sufficient energy to the targeted treatment site 12 to be able to achieve tissue temperatures in the range of 55-95° C. and produce lesions 14 at depths ranging from 1-4 mms from the interior surface of the LES or sphincter wall 30. Typical energies delivered to the esophageal or stomach wall include, but are not limited to, a range between 100 and 50,000 joules per electrode 66. It is also desirable to deliver sufficient energy such that resulting lesions 14 have a sufficient magnitude and area of cell injury to cause an infiltration of lesion 14 by fibroblasts 110, myofibroblasts 112, macrophages 114 and other cells involved in the tissue healing process (refer to
It is desirable that lesions 14 are predominantly located in the smooth muscle layer of selected sphincter 16 at the depths ranging from 1 to 4 mm from the interior surface of sphincter wall 30. However, lesions 14 can vary both in number and position within sphincter wall 30. It may be desirable to produce a pattern of multiple lesions 14 within the sphincter smooth muscle tissue in order to obtain a selected degree of tightening of the LES or other sphincter 16. Typical lesion patterns shown in FIGS. 20 A-D include, but are not limited to, (i) a concentric circle of lesions 14 all at fixed depth in the smooth muscle layer evenly spaced along the radial axis of sphincter 16, (ii) a wavy or folded circle of lesions 14 at varying depths in the smooth muscle layer evenly spaced along the radial axis of sphincter 16, (iii) lesions 14 randomly distributed at varying depths in the smooth muscle, but evenly spaced in a radial direction and, (iv) an eccentric pattern of lesions 14 in one or more radial locations in the smooth muscle wall. Accordingly, the depth of RF and thermal energy penetration into sphincter 16 is controlled and selectable. The selective application of energy to sphincter 16 may be the even delivery of RF energy to the entire targeted treatment site 12, a portion of it, or applying different amounts of RF energy to different sites depending on the condition of sphincter 16. If desired, the area of cell injury can be substantially the same for every treatment event.
A second diagnostic phase may be included after the treatment is completed. This provides an indication of LES tightening treatment success, and whether or not a second phase of treatment, to all or only a portion of the esophagus, now or at some later time, should be conducted. The second diagnostic phase is accomplished through one or more of the following methods: (i) visualization, (ii) measuring impedance, (iii) ultrasonography, (iv) temperature measurement, or (v) measurement of LES tension and contractile force via manometry.
In one embodiment of the invention, sensor 80 is coupled to an open or closed loop feedback control system 84. Referring now to
The temperature of the tissue, or of RF electrode 314, is monitored, and the output power of energy source 392 adjusted accordingly. The physician can, if desired, override the closed or open loop system 84. A microprocessor 394 can be included and incorporated in the closed or open loop system to switch power on and off, as well as modulate the power. The closed loop system 84 utilizes microprocessor 394 to serve as a controller, monitor the temperature, adjust the RF power, analyze the result, refeed the result, and then modulate the power.
With the use of sensor 346 and feedback control system 84, tissue adjacent to RF electrode 314 can be maintained at a desired temperature for a selected period of time without causing a shut down of the power circuit to electrode 314 due to the development of excessive electrical impedance at electrode 314 or adjacent tissue. Each RF electrode 314 is connected to resources which generate an independent output. The output maintains a selected energy at RF electrode 314 for a selected length of time.
Current delivered through RF electrode 314 is measured by current sensor 396. Voltage is measured by voltage sensor 398. Impedance and power are then calculated at power and impedance calculation device 400. These values can then be displayed at user interface and display 402. Signals representative of power and impedance values are received by a controller 404.
A control signal is generated by controller 404 that is proportional to the difference between an actual measured value, and a desired value. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired power delivered at respective RF electrodes 314.
In a similar manner, temperatures detected at sensor 346 provide feedback for maintaining a selected power. Temperature at sensor 346 is used as a safety means to interrupt the delivery of power when maximum pre-set temperatures are exceeded. The actual temperatures are measured at temperature measurement device 408, and the temperatures are displayed at user interface and display 402. A control signal is generated by controller 404 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 406 to adjust the power output an appropriate amount in order to maintain the desired temperature delivered at the sensor 346. A multiplexer can be included to measure current, voltage and temperature, at the sensor 346, and energy can be delivered to RF electrode 314 in monopolar or bipolar fashion.
Controller 404 can be a digital or analog controller, or a computer with software. When controller 404 is a computer it can include a CPU coupled through a system bus. This system can include a keyboard, a disk drive, or other non-volatile memory systems, a display, and other peripherals, as are known in the art. Also coupled to the bus is a program memory and a data memory.
User interface and display 402 includes operator controls and a display. Controller 404 can be coupled to imaging systems including, but not limited to, ultrasound, CT scanners, X-ray, MRI, mammographic X-ray and the like. Further, direct visualization and tactile imaging can be utilized.
The output of current sensor 396 and voltage sensor 398 are used by controller 404 to maintain a selected power level at RF electrode 314. The amount of RF energy delivered controls the amount of power. A profile of the power delivered to electrode 314 can be incorporated in controller 404 and a preset amount of energy to be delivered may also be profiled.
Circuitry, software and feedback to controller 404 result in process control, the maintenance of the selected power setting which is independent of changes in voltage or current, and is used to change the following process variables: (i) the selected power setting, (ii) the duty cycle (e.g., on-off time), (iii) bipolar or monopolar energy delivery; and, (iv) fluid delivery, including flow rate and pressure. These process variables are controlled and varied, while maintaining the desired delivery of power independent of changes in voltage or current, based on temperatures monitored at sensor 346.
Referring now to
Microprocessor 394 sequentially receives and stores digital representations of impedance and temperature. Each digital value received by microprocessor 394 corresponds to different temperatures and impedances.
Calculated power and impedance values can be indicated on user interface and display 402. Alternatively, or in addition to the numerical indication of power or impedance, calculated impedance and power values can be compared by microprocessor 394 to power and impedance limits. When the values exceed predetermined power or impedance values, a warning can be given on user interface and display 402, and additionally, the delivery of RF energy can be reduced, modified or interrupted. A control signal from microprocessor 394 can modify the power level supplied by energy source 392.
The control of the delivery of cooling medium to electrode 314 and/or tissue site 416 is done in the following manner. During the application of energy, temperature measurement device 408 measures the temperature of tissue site 416 and/or RF electrode 314. A comparator 424 receives a signal representative of the measured temperature and compares this value to a pre-set signal representative of the desired temperature. If the measured temperature has not exceeded the desired temperature, comparator 424 sends a signal to flow regulator 418 to maintain the cooling solution flow rate at its existing level. However if the tissue temperature is too high, comparator 424 sends a signal to a flow regulator 418 (connected to an electronically controlled micropump, not shown) representing a need for an increased cooling solution flow rate.
The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms 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.