Auto-aligning ablating device

The present invention relates to a medical device for excised tissue in the gastrointestinal tract and how to use it.

The basic function of the human esophagus is the transport of solid and liquid nutrients from the mouth to the stomach. The esophagus has the inherent contractile ability to provide physiological peristalsis in the antegrade direction (towards the stomach). In addition, the esophagus secretes pH-neutral mucus to protect its inner surface from acid-induced damage and to facilitate the passage of food. The stomach contains a mixture of food and liquid ingested by mouth, acids and enzymes from the inner surface of the stomach, bile and enzymes from the liver and pancreas. The lower esophageal sphincter and diaphragm muscles act as valves at the intersection of the esophagus and stomach, preventing regurgitation of gastric contents into the esophagus. This lower esophageal sphincter remains normally closed until parasympathetic activity or mass of food results in its relaxation, allowing food to travel from the esophagus to the stomach. A distension of the stomach, especially the heart of the stomach, results in a sudden relaxation of the lower esophageal sphincter, resulting in an exhalation event (belching). Certain foods, drugs, and beverages containing caffeine or theophylline (xanthine) may improperly relax the lower esophageal sphincter, followed by regurgitation. The effects of anatomy on aging or hiatal hernia may also result in regurgitation in the patient.

Patients with abnormal functioning of the lower esophageal sphincter may have dysphagia (difficulty swallowing), heartburn due to regurgitation, chest pain symptoms, and other related symptoms. A common sign of chronic gastroesophageal reflux is erosive esophagitis. When chronically exposed to harmful gastric contents, the inner surface of the esophagus may cause inflammation, erosion, or ulcerative destruction. Chronic GERD and consequent erosive esophagitis can lead to a pre-stage of cancer known as Barrett's esophagus or intestinal metaplasia, which is a genetic change associated with damage in epithelial cells.

For example, a co-pending, generally owned, treatment catheter with an expandable electrode support, as described in US Application No. 10 / 754,445 filed January 9, 2004. It can be used to treat the area around the esophagus to remove the abnormal lamina propria of the esophagus, using high frequency (RF) energy. If successful, treatment results in alteration formation and regeneration of the normal mucosal layer, which is virtually free of damaged epithelial cells, which is characteristic of Barrett's esophagus.

<p num="0005"> However, in some cases, such radiofrequency resection procedures may not be completely successful and may leave one or more abnormal mucosal areas. Those local areas can be approached with a device designed with a surface area that is more suitable for excising the local area of mucosal disease. In addition, some patients with Barrett's esophagus may be on the baseline with a very limited illness in a non-peripheral or very short area that may be suitable for local resection rather than peripheral resection. unknown.</p>

<p num="0006"> In general, in one embodiment, the invention features a resection structure, and a resection device comprising a support structure suitable for supporting the resection structure in the gastrointestinal tract of a patient, and a method of use thereof. The support structure of the excision device, in one embodiment, includes a longitudinal support having a longitudinal axis and a rotary support. The rotary support is suitable for making at least a portion of the excised structure movable with respect to the longitudinal axis of the longitudinal support.</p><p num="0007"> The practice of the present invention may include one or more of the following features. The rotary support is adaptable to rotate with at least one degree of freedom. In another embodiment, the rotary support is adaptable to rotate with at least two degrees of freedom. Further in practice, the rotary support is adaptable to rotate with at least three degrees of freedom.</p><p num="0008"> The rotary support may include a stopper member suitable for limiting the range of rotational motion. The rotary support can include a moving resistor. In one embodiment, the moving resistor comprises a spring. In another embodiment, the rotary support includes a lock suitable to prevent rotation of the excised structure.</p><p num="0009"> In one embodiment, the excision device includes an actuator mechanism suitable for preventing rotation of the excision structure.</p><p num="0010"> The support structure can include an endoscope. Alternatively, the support structure includes a catheter.</p><p num="0011"> The excised structure can include at least one electrode. In one practice, multiple excision structures are supported by the support structure. In another practice, the excised structure is capable of cold tissue excision.</p><p num="0012">In general, in another aspect, the invention advances the excision structure into the gastrointestinal tract, supports the excision structure with a support structure in the gastrointestinal tract, and separates at least part of the excision structure from the support structure on the tissue surface. It features a method of excising tissue in the gastrointestinal tract, which comprises the steps of rotating towards and activating the excised structure to excise the tissue surface.</p><p num="0013"> Implementations of the present invention can include methods of tissue resection. Here, the rotating process involves applying a force between the excised structure and the tissue surface. In another embodiment, the step of advancing the excision structure comprises advancing the plurality of excision structures, and the rotation step is multiple by applying a force between one or more of the plurality of excision structures and the tissue surface. Includes rotating at least one or more of the excision structures of the.</p><p num="0014"> The rotation step can include rotating at least a portion of the excision structure around at least one axis of rotation. In one embodiment, the rotation process involves rotating at least a portion of the excision structure around at least two axes of rotation. Further in practice, the rotation step involves rotating at least a portion of the excision structure around at least three axes of rotation.</p><p num="0015"> In one practice, the method of removing tissue further comprises limiting the range of rotation of the excised structure. In another embodiment, the method further comprises resisting rotation of the excision structure while rotating the excision structure. In a further practice, the method further comprises locking the excision structure to prevent rotation of the excision structure.</p><p num="0016"> The step of advancing the excision structure can include advancing the endoscope into the gastrointestinal tract. In one practice, the support step involves supporting the excised structure with an endoscope.</p><p num="0017"> In one practice, the excision structure comprises at least one electrode and the activation step comprises supplying electrical energy to the electrodes. In another practice, the excision structure can be cryoexcised, and the step of activating involves supplying the excised structure with a very chilled liquid.</p>

<figref num="1">FIG. 1 is a diagram of a cutting device of the present invention including coordinate axes illustrating the degree of freedom of movement.</figref><figref num="2A">FIG. 2A is a cross-sectional view of a rotary support and a structural support including coordinate axes illustrating the degree of freedom of movement.</figref><figref num="2B">FIG. 2B is a cross-sectional view of a structural support including another rotational support and coordinate axes illustrating freedom of movement.</figref><figref num="2C">FIG. 2C is a diagram of another rotary support and another rotary support including coordinate axes illustrating freedom of movement.</figref><figref num="2D">FIG. 2D is a diagram of another structural support that includes another rotary support.</figref><figref num="2E">FIG. 2E is a diagram of another rotational support and another structural support including coordinate axes illustrating freedom of movement.</figref><figref num="3A">FIG. 3A is a diagram of the excision device of the present invention.</figref><figref num="3B">FIG. 3B is a diagram of another rotary support.</figref><figref num="3C">FIG. 3C is a diagram of another rotary support.</figref><figref num="4A">FIG. 4A is a diagram of the excision device of the present invention combined with an endoscope in the gastrointestinal environment.</figref><figref num="4B">FIG. 4B is a diagram of the excision device of the present invention including lip components and electrode traces combined with an endoscope.</figref><figref num="4C">FIG. 4C is a diagram of the excision device of the present invention including lip parts, ports and lines combined with an endoscope.</figref><figref num="5">FIG. 5 is a diagram of the excision device of the present invention including a structural support having two rotary supports, two longitudinal supports and a traction excision structure combined with an endoscope.</figref><figref num="6">FIG. 6 is a diagram of a cutting device of the present invention including a moving resistor.</figref><figref num="7A">FIG. 7A is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="7B">FIG. 7B is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="8A">FIG. 8A is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="8B">FIG. 8B is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="9A">FIG. 9A is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="9B">FIG. 9B is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="10">FIG. 10 is a diagram of a cutting device of the present invention including another moving resistor.</figref><figref num="11A">FIG. 11A is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="11B">FIG. 11B is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="11C">FIG. 11C is a diagram of the cutting device of the present invention including another moving resistor.</figref><figref num="12">FIG. 12 is a diagram of a cutting device of the present invention including an actuator mechanism.</figref><figref num="13">FIG. 13 is a diagram of the excision device of the present invention connected to the endoscope.</figref><figref num="14A">FIG. 14A is a diagram of another embodiment of the excision device.</figref><figref num="14B">FIG. 14B is a diagram of another embodiment of the excision device.</figref><figref num="14C">14C is an end view of the excision device shown in FIGS. 14A and 14B.</figref>

The new features of the invention are described in detail in the appended claims. A better understanding of the features and advantages of the invention will be obtained by reference to the following detailed description of exemplary embodiments in which the principles of the invention are utilized, and the accompanying drawings.

Devices and methods for removing tissue in the gastrointestinal tract of a patient or object are provided using an excision device that includes a support structure suitable for supporting the excised structure in the gastrointestinal tract. The support structure of the excision device includes a longitudinal support having a longitudinal axis and a rotary support. The rotary support is suitable for allowing at least a portion of the cut structure to rotate about the longitudinal axis of the longitudinal support. According to the present invention, the excision device is advanced to the gastrointestinal tract. Optionally, the excision device can be supported at the distal end of the endoscope. The excised structure can rotate and deflect towards the tissue surface, and the excised structure can be activated to excise the tissue surface. Within the gastrointestinal tract, tissue surface sites of various sizes can be selectively excised using the devices and methods described herein.

For the purposes of this disclosure, any portion composed of mucosa and muscle that extends between the mouth and anus and functions for digestion and excretion is considered as part of the digestive tract. Such parts include, but are not limited to, the esophagus, stomach, small intestine, appendix, large intestine, colon, rectum and anal canal.

As shown in FIG. 1, in general, the excision device 100 of the present invention includes a support structure 111 capable of supporting the excision structure 130. The rotary support 116 includes a longitudinal support 114 that has a longitudinal axis and supports the excised structure 130. The rotary support 116 is adapted to allow at least a portion of the longitudinal support 114 to rotate with respect to the longitudinal axis of the longitudinal support and to allow at least a portion of the excision structure 130 to rotate. The rotation of the longitudinal support 114 as enabled by the rotary support includes, but is not limited to, for example, rotation, swivel, twist, spin. It is envisioned that the longitudinal support 114 can rotate away from the longitudinal axis of the support 114 toward the longitudinal axis or along the longitudinal axis.

As shown in FIG. 1 by the representation of the axes of the longitudinal structures 114x, 114y, 114z, the rotary support 116 allows the longitudinal structure 114 to move within some possible degrees of freedom. be able to. Although FIG. 1 and subsequent figures show only a single direction indicating possible rotation around each axis, it can be shown to rotate bidirectionally around a given axis.

As shown in FIGS. 1 and 2A, the rotary support 116 can be configured and arranged so that the longitudinal structure 114 can rotate freely with three degrees of freedom. The three degrees of freedom are indicated by three axes, x, y and z. In these and later figures, the axis labeled "yes" indicates free bidirectional movement around the axis, while the axis labeled "no" does not have free movement around the axis. .. It is envisioned that the rotary support can be adapted to rotate with at least one degree of freedom, at least two degrees of freedom, or at least three degrees of freedom. It is further envisioned that the excision device could be configured and placed to provide linear or floating motion of the longitudinal structure along the x, y or z plane (not shown). .. For example, a sponge or elastic longitudinal support would expect linear compression in the y direction (not shown).

As shown in FIGS. 2B to 2E, the rotary support 116 can be configured and arranged so that the longitudinal structure 114 can rotate freely with two degrees of freedom. In the embodiments of FIGS. 2B and 2D, the longitudinal support is free to rotate around the x and y axes, but does not rotate about the z axis (coordinate axes in FIG. 2B and x shown in FIG. 2D). And y-axis). In the embodiments shown in FIGS. 2C and 2E, the longitudinal support is free to rotate around the x and z axes, but does not rotate about the y axis.

As shown in FIG. 5, the structural support 111 can include a single rotary support 116 coupled with two longitudinal supports 114, each supporting the excised structure 130. The longitudinal support 114 and the base 112 can be made of an elastic material including, but not limited to, silicone or urethane. It is envisioned that the excision device 100 can also include two or more longitudinal supports 114 coupled to one or more rotary supports 114.

The rotary supports are shown in FIGS. 1, 2A, 2B, 2D, 2E, 3A to 3C, 4A to 4B, 5, 6, 7, 7A to 7B, 8A to 8B, As shown in FIGS. 9A-9B, 10, 11A-11C, 12 and 14A-14C, the base 112 portion can be further included. Details As will be described later, in general, the base 112 is configured and arranged to provide a means for attaching or connecting the excision device 100 to an elongated member including, but not limited to, an endoscope or a catheter, for example.

The portion of the rotary support 116 is configured and arranged to include any of many shapes and structures for connecting the rotary support 116 to the longitudinal support 114 and providing rotation to the longitudinal support 114. Can be done. Possible shapes include, but are not limited to, for example circular shapes, constant diameter tubular shapes, variable diameter tubular shapes, and oblong spherical shapes. Possible structures include, but are not limited to, for example one or more hinges, springs, universal joints, ball joints, or pin joints.

As shown in FIGS. 1, 2A, 4B and 5, in one embodiment, the rotary structure 116 is a ball-shaped portion of the longitudinal support 114 that can be set in a recess or receiver, such as a socket. Can be included. In another embodiment, as shown in FIG. 2B, the rotating structure 116 can include a ball-shaped portion having a protrusion 117. In this embodiment, the protrusion 117 engages the slot 115 of the longitudinal support 114, which allows the longitudinal support 114 to rotate on two axes, the x and y axes, excluding the z-axis. To. The engagement of the slot 115 with the protrusion 117 of the longitudinal support prohibits the rotation of the longitudinal support 114 around the z-axis.

In another embodiment, as shown in FIG. 2C, the rotary support 116 can include an elongated sphere or football-shaped portion. As shown in the coordinate axes diagram, the embodiment shown in FIG. 2C is configured and arranged to allow rotation of the longitudinal support 114 (not shown) with respect to the two axes. As shown, rotation of the longitudinal support 114 (not shown) can occur on the x and z axes instead of the y axis.

As shown in FIG. 2D, in yet another embodiment, the support structure 111 may include a universal joint having a pin 119 and a rotary support 116. As shown, this embodiment allows rotation of the longitudinal support 114 (not shown) on the x and y axes. It is envisioned that two or more universal joints can be included in the support structure 111. As shown in FIG. 2E, in yet another embodiment, the rotating structure 116 can include a spring. As shown in the coordinate axis diagram, this embodiment allows the longitudinal support 114 to rotate on the x and z axes rather than on the y axis.

As shown in FIGS. 3A-3C and 14A-14C, in other embodiments, the support structure 116 can include a structure with pins 119. Pin 119 can penetrate a portion of the longitudinal support 114, the rotary support 116, and in some cases the base 112 (or the connecting element 120 of the base 112) of the support structure 111, thereby longitudinal. It is envisioned that the directional support 114 and the rotary support 116 are connected. Rotation around the pin 119 by the longitudinal support 114 provides rotation of at least a portion of the longitudinal support 114 with respect to the longitudinal axis of the longitudinal support. It is envisioned that one or more universal joints can be used in connection with one or more pins 119 to provide rotation to the longitudinal support (not shown).

As shown in FIGS. 14A-14B, here the support structure 116 includes pins 119 and the rotation of the longitudinal support 114 around the pins 119 is tilted or angled from a neutral position (see FIG. 14A). It can include the range of motion of the longitudinal support 114 up to the position (see FIG. 14B). Both neutral and angled positions are beneficial for treating tissue surfaces. The neutral position, including the low profile, is particularly useful for introducing the excision device 100 and / or removing the excision device 100 from the treatment site.

As shown in FIG. 3B, in another embodiment, in addition to including the pin 119, the rotary support 116 includes a spring 124 (eg, a torsion spring) connected to the pin 119. As shown in FIG. 3C, in yet another embodiment, in addition to including pin 119, the rotary support 116 includes a moving resistor 123 connected to pin 119. In this embodiment, the moving resistor 123 is composed of any of a number of resistant or elastic materials or structures capable of returning the pin to the desired position after a period of deflection or rotation of the pin 119. be able to. Suitable structures are not limited to sleeves or bushings, but include, for example, silicone sleeves or bushings. Suitable materials for wrapping or joining pins include, but are not limited to, silicones, urethanes or other polymers. Other suitable materials and structures are well known to those of skill in the art.

It is envisioned that the structural support can include any combination of the shapes of the rotary supports 116 described herein.

The base of the rotary support can be configured and placed in any of many ways to support the excision device. In some embodiments, the base is configured and arranged to connect the structural support of the excision device to another device, such as a conventional endoscope. For example, the base can be configured and arranged to attach the excision device to the outer surface of the endoscope. Alternatively, the base can be configured and arranged to attach the excision device to the inner surface, outer or inner shape of the endoscope, or to any combination described above. In some embodiments, FIGS. 1, 3B-3C, 4A-4B, 6, 7A-7B, 8A-8B, 9A-9B, 10, 11A-11A. As shown in 11B and FIG. 12, the base 112 is configured and arranged as a sheath. In certain embodiments, the base 112 comprises an elastomeric sheath. In another embodiment, as shown in FIGS. 3A and 14A-14C, the base 112 includes a connecting element 120 and a band or band 126. In one embodiment, the band 126 is an elastomeric band. The connecting element 120 can be provided with a mounting point between the base 112 and the longitudinal support 114. The band 126 can be attached to the connecting element 120 and can function, for example, as a method of attaching an endoscope. The connecting element 120 and band 126 can be made of the same material or, if desired, different materials. As shown in FIGS. 14A-14C, the connecting element 120 may include an angled, tapered or sloping portion up to the longitudinal support 114. As shown, in one embodiment, the tapered portion of the connecting element 120 is located on the connecting element 120 of the base 112 opposite the pin 119. The tapered portion of the connecting element 120 can function to facilitate the removal of the cutting device 100.

As shown in FIGS. 4B-4C, in one embodiment, the base 112 of the rotary support includes a stopper or lip function 113. The lip 113 can be configured and arranged to act as a stopper designed to assist in positioning the excision device 100 with respect to an accessory device such as endoscope 127 as shown. In the embodiments shown in FIGS. 4B-4C, the positioning of the endoscope 127 into the base 112 of the rotary support 116 can be limited by the lip 113. The lip 113 can determine or limit the distal / proximal position of the excision device 100 with respect to the distal end 128 of the endoscope.

Generally, in one embodiment, the excision device 100, as shown in FIGS. 6, 7A-7B, 8A-8B, 9A-9B, 10, 11A-11C, and 12. Includes a mobile resistor 123. Generally, the moving resistor 123 is configured and arranged to passively adjust the rotation of the longitudinal support 114. Advantages of the moving resistor 123 include a reduction in the outer shape of the excision device 100. The reduced contour is effective when accessing the excision device 100 to the desired processing area in the subject and / or removing the excision device 100 from the processing area. For example, the reduced outer shape excision device 100 has little or no chance of the device 100 being struck or caught when accessing or removing the gastrointestinal tract 1. Since the longitudinal support 114 can usually move freely with one or more degrees of freedom, the movement resistor 123 can conveniently serve to adjust the freedom of movement. In some embodiments, the moving resistor 123 comprises an elastic or highly elastic structure attached to or coupled to a longitudinal support 114. In other embodiments, the moving resistor 123 includes various other mechanical means of coordinating the rotation of the longitudinal support 114.

As shown in FIG. 6, in one embodiment, the moving resistor 123 includes a spring. The spring may be any of a cantilever spring (as shown in FIG. 6), a leaf spring, a torsion spring, or many spring types, all of which can be well known to those skilled in the art. Be envisioned. In one embodiment, as shown in FIG. 6, the cantilever spring moving resistor 123 is configured to limit the rotation of the longitudinal support 114 with respect to the distal end 128 of the attached endoscope 127. Can be placed. As shown, the longitudinal support 114 is usually maintained in a neutral position by the spring of the moving resistor 123. As used herein, the "neutral position" is such that the longitudinal axis of the longitudinal support 114 is substantially parallel to the longitudinal axis of the endoscope 127 or other elongated member connected to the excision device 100. Means that. In one embodiment, the moving resistor 123 is attached to the base of the rotary support, or the band, or the connecting element of the base, so that it imparts pretension to the longitudinal support and is attached within. The excision device is fixed at its lowest external position with respect to the endoscope 127 (not shown).

The moving resistor is configured and arranged to resist the rotation of the longitudinal support and also to allow the force to cause a bias in the rotation of the longitudinal support away from the neutral position. Can be done. In the absence of such force, some embodiments of the moving resistor are intended to return the longitudinal support to a neutral position. It is envisioned that the moving resistor can be configured and arranged to affect the rotation of the longitudinal support around one or more axes of movement. Furthermore, it is envisioned that the axes of movement (eg, the x, y and z axes; see FIG. 1) can be affected differently depending on the movement resistor.

In another embodiment, as shown in FIGS. 7A-7B, the moving resistor 123 may include a sheath that encloses the electrically conductive wire 133. The sheath can be made of an elastic or superelastic material, including but not limited to, for example, silicone. As shown in detail in FIG. 7B, the sheath movement resistor 123 is connected to the longitudinal support 114 at one end. The opposite end of the sheath movement resistor 123 can be secured in a position relating to the endoscope 127 or other elongated structure, for example by a sleeve 138 (FIGS. 7A-7B). In the embodiments shown in FIGS. 7A-7B, the electrically conductive wire 133 can include a zigzag pattern. The pattern can allow the extension of the electrically conductive wire 133 if the moving resistor 123 is extended.

In yet another embodiment, as shown in FIGS. 8A-8B, the moving resistor 123 is an elastic or superelastic material that is connected to or attached to the longitudinal support 114. Bands can be included. Suitable elastic or hyperelastic materials can include, but are not limited to, silicone. As illustrated in FIG. 8A, in one embodiment, the moving resistor is stiffened over the endoscope 127 and is elastic or superelastic, connecting a portion of the longitudinal support 114 to the endoscope 127. A band of material. As illustrated in FIG. 8B, in another embodiment, the moving resistor 123 is a band of elastic or superelastic material that binds a portion of the longitudinal support 114 to the endoscope 127. In the embodiment shown in FIG. 8B, the band is connected to the endoscope 127 by a sleeve 138 attached to the endoscope 127.

In yet another embodiment, as shown in FIGS. 9A-9B, the moving resistor 123 may include a support or tether attached to a portion of the longitudinal support 114. A portion of the support or tether can be connected to the endoscope 127 by a sleeve 138 attached to the endoscope 127. The moving resistor 123 of this embodiment generally maintains the longitudinal support 114 in a neutral position when the distal end 128 of the endoscope 127 attached to the excision device 100 is placed in a relatively straight configuration. can do. If the distal end 128 of the endoscope is deflected as shown in FIG. 9B, the support or tether of the moving resistor 123 can be slackened or pleated on itself. In one embodiment, the moving resistor 123 of the support or tether is configured and arranged to collapse on itself like an accordion when sagging (see FIG. 9B).

In another embodiment, as shown in FIG. 10, the moving resistor 123 can include a finger 121 portion and a recess 122 portion. The finger 121 can be connected to the endoscope 127 by a sleeve 138 or other mounting means, and the recess 122 can be included in the longitudinal support 114. As shown in FIG. 10, the finger 121 can engage the recess 122, whereby the distal end 128 of the endoscope 127 attached to the excision device 100 has a relatively linear configuration. When placed, the longitudinal support 114 is maintained in a neutral position. The fingers 121 and 122 are configured so that the application of force to the offset of the distal end 128 of the endoscope or to the portion of the longitudinal support 114 can reversibly release the finger 121 from the recess 122. Can be placed. Once the fingers 121 are released, the longitudinal support 114 is free to rotate. The reconnection of the fingers 121 and the recess 122 once again keeps the longitudinal support 114 in the neutral position.

As shown in FIGS. 11A-11C, in one embodiment, the moving resistor 123 is an endoscope connected to a skirt or a series connected to a part of the longitudinal support 114. It extends adjacent to the lower end of the length of 127. In this embodiment, the skirt or continuum of the moving resistor 123 fits on the proximal end of the longitudinal support 114 or juxtaposed to the proximal end of the support 114. This arrangement provides a smooth contour to the proximal portion of the longitudinal support 144. Such an outer shape is beneficial in facilitating the removal of the excision device 100 from the treated area by reducing the risk of the support 114 being caught or caught on the tissue surface. The moving resistor 123 can or cannot be attached to the longitudinal support 114 as shown in FIG. 11A or FIG. 11B.

It is envisioned that one or more of the above-mentioned moving resistors can be included in a single cutting device to coordinate the rotation of the longitudinal support. It is also envisioned that the attachment of a portion of the moving resistor to an endoscope, catheter or other structure may include any of a number of attachment means in addition to the attachment of the sleeve. For example, the moving resistor can be attached to the inside or outside of the endoscope or catheter, or in its shape (not shown).

Generally, in one embodiment, the excision device 100 includes an actuator mechanism 134 to positively adjust the rotation of the longitudinal support 114 (see, eg, FIG. 12). In general, the actuator mechanism 134 allows for mutual exchange between a rotation-suppressed longitudinal support 114 and a rotation-free support 114. As shown in FIG. 12, in one embodiment, the actuator mechanism 134 includes a switch 135 and a support 136 or a tether. The switch 135 of the actuator mechanism 134 can be connected to the endoscope 127 connected to the excision device 100. The support 136 can be connected to a part of the longitudinal support 114. In an embodiment, as shown in FIG. 12, the switch 135 of the actuator mechanism 134 is attached to the endoscope by a sleeve 138 and, as shown, one or more including positions "A" and "B". Can be located in position. Switching the actuator mechanism 134 to position "A" pulls the support 136, thus fixing the freedom of rotation of the longitudinal support 114. Further, when in position "A", support 114 is maintained in a neutral position. Switching the actuator mechanism 134 to position "B" loosens the support 136 that pulls the support 114, thereby allowing the rotational movement of the support 114.

In another embodiment, the actuator mechanism includes a suction line (not shown). In this embodiment, the rotation of the longitudinal support is regulated by suction, which suction is provided by a suction line configured and arranged so that the proximal portion of the support can be fixed when vacuum is applied. Will be done. In the absence of vacuum, the longitudinal support will be able to rotate freely.

In yet another embodiment, the actuator mechanism is configured and arranged so that the rotation of the longitudinal support is regulated by an electromagnet (not shown). In this embodiment, the application of electromagnet force fixes the longitudinal support in a neutral position. Therefore, when no electromagnet force acts on the longitudinal support, the support can rotate freely.

In one embodiment, the excision structure is an electrode structure configured and arranged to deliver energy, including high frequency energy, to the tissues of the gastrointestinal tract. It is envisioned that such excised structures can include multiple electrodes. For example, two or more electrodes can be part of the excision structure. Energy can be delivered at an appropriate level to achieve excision of mucosal or submucosal tissue, or at an appropriate level that causes damage to those tissues while substantially preserving muscle tissue. As used herein, the term "excision" means thermal damage to tissue or tissue that results in cell necrosis. Thermal damage can be achieved by heating or cooling (eg, freezing) the tissue. Typically, the resection in the present embodiment removes the entire mucosal lining of the treated area, including abnormal mucosa, eg, abnormal columnar growth, from the affected esophageal portion, and of the normal mucosal layer. It aims to enable regrowth. Conveniently, when such an approach is used, recovery will be faster and stenosis formation in the tissue will be minimized. The electrode excision element will also allow a liquid such as saline to penetrate through the longitudinal support and / or the electrode to prevent tissue from sticking to the electrode during excision.

Radiofrequency energy is one advantageous form of excision energy, for example microwave energy, or sources of photons or radiation such as infrared or ultraviolet light, the latter with or combining with improved photosensitizers. It is recognized that other beneficial energies, including such, may be used. Photon sources can include semiconductor emitters, lasers, and other such sources. In another embodiment of the invention, the excision energy medium is a heatable liquid or liquid nitrogen, Freon®, a non-CFC refrigerant, or CO._２It is also recognized that a cooling medium such as can be utilized. For excision using hot or cold liquid or gas, the excision system requires a means of circulating the heating / cooling medium from outside the patient to the heating / cooling balloon or other element and back to the outside of the patient. It is envisioned that it will. Circulatory media means in cryosurgical probes are well known in excision techniques. Suitable circulation means are, for example, U.S. Pat. Nos. 6,182,666 of Dobak, III, U.S. Pat. No. 6,237,355 of Li, and U.S. Pat. No. 6, Kovalcheck, which are also incorporated herein by reference. , 572, 610.

The excised structure can include a bipolar electrode array located in a structure capable of delivering high frequency energy in a bipolar form. Alternatively, the excision structure can include a unipolar electrode structure that is energized by a high frequency power supply combined with a return electrode commonly placed on the skin of the subject, for example the waist constriction. In either case, high frequency energy can be delivered in high energy flux over a very short period of time to damage or excise the mucosa or submucosa without substantially heating or damaging the muscle tissue. .. Here, the excision structure includes a plurality of electrodes, and one or more of the electrodes can be bipolar or unipolar. A combination of bipolar and unipolar electrodes is envisioned.

As shown in FIGS. 1A, 3A, 4A, 5, 6, and 7A-7B, the excision structure 130 can be configured and arranged in any of many in terms of shape and size. .. As shown in FIGS. 3A, 4A, 7A-7B, and 14A-14C, the excision structure 130 can include an electrode array 132. If the excision structure 130 comprises an electrode array 132, the array is typically about 0.5 cm.^２From 9.0 cm^２It has an area in the range of up to. Typical array shapes will include squares, rectangles, circles, or ellipses. In one embodiment, the excision structure 101 is 2.5 cm.^２Has an area of. In another embodiment, the excision structure 101 is 4 cm.^２Has an area of 2 cm x 2 cm.

The longitudinal support is configured and arranged to support the excised structure. The support 114 can be made of any suitable material that can withstand the high energy flux produced by the excision structure 130. The longitudinal support is flexible and allows rotation around two axes, thereby allowing the longitudinal support to rotate further away from the longitudinal axis (not shown). In one embodiment, the longitudinal support is made of an elastic material, for example silicone. Other suitable materials include, for example, urethane or other polymers.

As shown in FIGS. 3A, 4A-4B, 7A-7B, and 14A-14C, the cutting device 100 is an electrical connection that includes a conductive wire 133 to connect the cutting structure 130 to the power supply. Can be further included. The conductive wire 133 can include a single wire or a plurality of wires as required to provide controlled energy delivery through a cutting structure. In one embodiment, the conductive wire 133 comprises a low electrical loss wire such as a litz wire. As shown in FIGS. 4A-4B, the conductive wire 133 can be wound or pulled over the distal end of the longitudinal support 114 and passed under the support 114. Such an arrangement advantageously facilitates the rotation of the longitudinal support 114 by preventing restraints or restrictions on rotation.

As shown in FIGS. 4A-4B and 14A-14C, the excision device 100 may further include one or more electrode traces 131. One or more electrode traces 131 can be configured and arranged to follow at least a portion of the longitudinal support 114. One or more traces 131 can electrically communicate with the electrode 132 and the conductive wire 133. It is envisioned that the trace 131 can be an extension of the electrode 132 or another element. As shown in FIGS. 14A-14C, one or more traces 131 can be electrically communicated with the conductive wire 133 by the connection point 140. As shown, the connection point 140 can be attached to the connection element 120 of the base 112. The conductive wire 133 can be detachably connected to the cutting device by the connection point 140, where the connection point is configured and arranged, for example, as an electrical connector.

In another embodiment of the invention, the excision energy medium is a heatable liquid or liquid nitrogen, Freon®, a non-CFC refrigerant, or CO._２It is also recognized that a cooling medium such as can be utilized. For excisions using hot or cold liquids or gases, excision systems require a means of circulating a heating / cooling medium from outside the patient to the heating / cooling balloon or other element and back to the outside of the patient. It is envisioned that there will be. Circulatory media means in cryosurgical probes are well known in excision techniques. Suitable circulation means are, for example, U.S. Pat. Nos. 6,182,666 of Dobak, III, U.S. Pat. No. 6,193,644 of Dobak, III, U.S. Pat. It is disclosed in US Pat. Nos. 6,237,355 and US Pat. Nos. 6,572,610 such as Kovalcheck.

Thus, in another embodiment, as shown in FIG. 4C, the excision structure 130 can be configured and arranged for cryoexcision of tissue. In general, the longitudinal support 114 can support the excision structure 130 or act as the excision structure 130 by providing a conduit or support for delivery of the cooling liquid, allowing cryoexcision of the tissue. In one practice, the excision structure can be something like a balloon or balloon (not shown) that can be filled with liquid or gas. In another embodiment, the excision structure comprises a capsule or box-like element that covers some or all of the surface of the longitudinal support and can be filled with liquid or gas (not shown). In one practice, the longitudinal support is partially or completely hollow to accept liquid or gas. The excised structure or longitudinal support can contain a thermally conductive material to facilitate thermal conduction and is envisioned to achieve cryoexcision of the tissue. It is envisioned that the excised structure or longitudinal support can include a thermally conductive shape that covers all or part of its surface. For example, suitable thermally conductive shapes can be, but are not limited to, stainless steel or thin metal surfaces containing titanium.

It is envisioned that the excised structure or longitudinal support can be configured and arranged to be permeable to a heating or cooling medium (not shown) in some practices. As such, it is envisioned that the medium can be leached through a cut structure or longitudinal support, thereby allowing direct contact between the medium and the tissue surface.

As shown in FIG. 4C, delivery of coolant to the excision structure 130 can include one or more lines 144 and optionally one or more ports 142. Line 144 can be configured and arranged to transport liquids, including highly chilled liquids. Port 142 can provide a connection between line 144 and excision structure 130. The port 142 can be directly connected to the longitudinal support 142. In one embodiment, the port is connected to a longitudinal support to provide a conduit for the excision structure associated with the support (not shown). Alternatively, the port 142 can be directly connected to the excision structure (not shown). In some practices, the line 144 is connected to the longitudinal support 114 by a port 142 (see FIG. 4C). The port can include a nozzle or other shape that is useful for producing a phase change in a gas or liquid that is often achieved by achieving a pressure difference.

By way of example, as illustrated in FIG. 4C, one implementation includes two lines 144 connected to port 142. Both of the lines 144 extend to the attached endoscope 127 (in the figure shown in FIG. 4C, only one line 144 extends visibly to the endoscope 127). The port 142 is directly connected to the underside of the longitudinal support 114 and the upper surface of the longitudinal support 114 acts as the excision structure 130. The longitudinal support 114 can be substantially hollow to allow entry of a medium such as a heated liquid or a cooling liquid.

Optionally, the line of equipment can be provided with return circuits for the flow of fluid to and from the cut structure. For example, as shown in FIG. 4C, in one implementation, two lines 144 and two ports 142 are used, one line 144 can act as an inflow line and the other can act as an outflow line.

In use, the heated or highly cooled liquid can be delivered to the excision structure through the inflow line, thereby activating the excision structure. The operation of the excision structure in a very chilled liquid involves the generation of a liquid-to-gas phase change, i.e. the generation of a pressure difference such as a pressure drop (predetermined ideal gas law: PV = nRT). Can be done. Freeze excision of tissue can be achieved by connecting to the tissue with a very chilled excision structure. Optionally, a continuous flow of heated or highly cooled liquid agent shall be maintained in the excision structure by a continuous or discontinuous flow of liquid agent to and out of the excision structure by the outflow line. Can be done. If desired, after excision, the liquid agent can be removed from the excised structure. Optionally, after removal of the super-liquid agent, another fluid, gas or air having the desired temperature can be introduced into the excision structure.

In general, in another embodiment, the method of removing tissue in the gastrointestinal tract 1 involves advancing the excision device 100, including the excision structure 130 (here, the electrode 132), into the gastrointestinal tract 1 (see, eg, FIG. 4A). ). The excised structure 130 is supported by a structural support 111 within the gastrointestinal tract 1. At least a portion of the excised structure 130 is rotatable away from the structural support 111 and can be directed towards the tissue surface 5. The excision structure 130 can be operated as desired to excise the tissue surface 5.

As illustrated in FIG. 4A, in one embodiment, rotating at least a portion of the excision structure 130 (shown herein as electrode 132) involves the excision structure 130, eg, the electrode 132, and the tissue surface 5. Includes the application of forces between. In another embodiment in which the excision device 100 comprises a plurality of excision structures 130 (see, eg, FIG. 5), the rotating step acts a force between one or more excision structures 130 and the tissue surface 5. Including that.

The method of excising tissue in the gastrointestinal tract is to remove at least part of the excision structure around at least one axis of rotation and / or around at least two axes of rotation and / or around at least three axes of rotation. Including rotating. As described in detail above, the excision device can be configured and arranged to support such movements. For example, as shown in FIG. 1, the support structure 111 of the excision device 100 can include a longitudinal support 114 and a rotary support 116. The excised structure 130 is supported by a longitudinal support 114, while the rotary support 116 is adapted to allow rotation of at least a portion of the excised structure 130. Various structural aspects relating to the rotation of the excision structure 130 of the method are described in detail above.

In another embodiment, the method of rotating at least a portion of the excised structure comprises limiting the range of rotation of the excised structure. Various structural aspects of the features relating to limiting the range of rotation on the x, y and z axes are described above. For example, various rotary supports have been shown to provide freedom of movement with respect to the x, y and z axes.

Further in an embodiment, the method comprises resisting rotation of the excision structure while rotating the excision structure. As mentioned above, the excision device can include the shape of various moving resistors structures configured and arranged to resist rotation of the excision structure. For example, a moving resistor indicates that it regulates the rotation of the longitudinal support and thereby regulates the rotation of the excised structure.

In one embodiment, advancing the excision structure 130, as illustrated in FIG. 4A, involves advancing the endoscope 127 into the gastrointestinal tract 1. An example of one commercially available conventional endoscope 127 is the GIF-Q160 of the Olympus "gastrovideoscope" model. As shown in FIG. 13, certain structures of certain commercially available endoscopes can be modified, but most endoscopes have a maneuverable distal end 128 and for connection to the video screen 160. Includes a shaft 164 with a hub or handle 162 including a port 166 that provides access to an internal working channel within the visual channel 161 and the shaft 164. The power supply 159 can supply power to the endoscope 127 by the power cable 165. As is well known in the technique of endoscopy, dials, levers or other mechanisms (Figure) to allow the operator to selectively steer the distal end 128 of the endoscope 127. (Not shown) will normally be provided on the handle 162. In use, here the excision device 100 is connected or connected to the endoscope 127 and the combination is introduced into the gastrointestinal tract and advanced. In another embodiment, the step of advancing the excision structure involves advancing the catheter into the gastrointestinal tract (not shown).

As shown in FIG. 4A, in one embodiment, the method comprises supporting the excised structure (shown as electrode 132) with an endoscope 127. In use, as illustrated in FIG. 4A, the excision device 100, including the excision structure (shown as electrode 132), can be attached to the distal end 128 of the endoscope to support it. As described in detail above, in some embodiments, the rotary support 116 further includes a base 112 configured and arranged to connect the excision device 100 to the endoscope 127. As such, the base 112 can provide a mounting point for the support of the excision device 100 by the endoscope 127.

In another method, the step of advancing the excision device, including the excision structure, into the gastrointestinal tract comprises advancing the endoscope into the gastrointestinal tract and advancing the excision device beyond the endoscope. For example, the endoscope can be positioned relative to the tissue of interest and then the excision device can be advanced outside the endoscope to remove the tissue of interest.

In another method, the step of supporting the excision device can include inserting the endoscope into the excision device after the excision device has been advanced into the gastrointestinal tract. As detailed in the co-pending U.S. Patent Application Nos. 11/286, 257 and 11/286, 444, filed November 23, 2005, all statements thereof are incorporated herein by reference. The variously formed excision structures can be fitted within the working channel inside the endoscope and can be transported through the channel. As such, the excision structure of the excision device can instead be supported by the internal working channel of the endoscope. It is envisioned that any combination of the methods described herein is possible to support the excision device.

In another embodiment, the excision structure is here at least one electrode, and the step of activating the excision structure can include supplying electrical energy to the electrodes by electrical connection (eg, FIG. 3A, FIG. 4A-4B, 7A-7B, and 14A-14C).

Although preferred embodiments of the invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by embodiments only. Numerous changes, changes and replacements will come to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be used to carry out the invention. The following claims define the scope of the invention, and it is intended that those claims and the methods and structures within their equivalent are covered therein.