ENDOLUMINAL TREATMENT METHOD AND ASSOCIATED SURGICAL ASSEMBLY INCLUDING TISSUE OCCLUSION DEVICE
20210361313 · 2021-11-25
Inventors
Cpc classification
A61B2017/0034
HUMAN NECESSITIES
A61B18/1445
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
A61B1/31
HUMAN NECESSITIES
A61B18/22
HUMAN NECESSITIES
A61B2017/32004
HUMAN NECESSITIES
A61B17/320016
HUMAN NECESSITIES
A61B17/072
HUMAN NECESSITIES
A61B18/1442
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
A61B1/05
HUMAN NECESSITIES
A61B1/31
HUMAN NECESSITIES
A61B17/072
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
Abstract
A surgical instrument includes a hollow member having a sidewall provided with a window and a closure member movably connected to the hollow member for alternately covering and uncovering the window. The hollow member has a first clamping surface along an edge of the window, while the closure member has a second clamping surface opposing the first clamping surface and disposable substantially adjacent thereto in a clamping or closure configuration of the instrument. The instrument additionally comprises a tissue occlusion component mounted to at least one of the hollow member and the closure member for acting on tissues gripped between the first clamping surface and the second clamping surface, to couple the tissues to each other.
Claims
1. A method of treating tissue comprising: inserting into a body of a patient an endoscopic instrument having first and second tissue engaging surfaces, the first and second tissue engaging surfaces being adjustable to form a chamber, moving the chamber from a collapsed insertion configuration to an expanded use configuration to form a laterally expanded chamber within a body lumen, wherein the chamber, in the expanded use configuration, provides a working space within the body lumen; inserting a distal portion of a working instrument into the chamber, and extending the working instrument laterally with respect to a longitudinal axis of the endoscopic instrument; and visualizing the distal portion of the working instrument by a visualization device positioned distal of the second tissue engaging surface.
2. The method of claim 1, wherein moving the chamber expands the chamber to only one side of the longitudinal axis of the endoscopic instrument.
3. The method of claim 1, further comprising visualizing a portion of the body lumen using the visualization device.
4. The method of claim 1, wherein visualizing the distal portion of the working instrument includes angling the visualization device so it extends laterally with respect to the longitudinal axis of the endoscopic instrument.
5. The method of claim 1, further comprising severing a tissue mass positioned within the chamber.
6. The method of claim 5, further removing the severed tissue mass from the patient via a first channel in the endoscopic instrument.
7. The method of claim 5, further comprising removing the severed tissue mass from the patient by retaining the severed tissue mass in the chamber and withdrawing the endoscopic instrument from the patient.
8. The method of claim 1, further comprising receiving a polyp within the chamber and severing the polyp from the body lumen utilizing the working instrument inserted through the first channel of the endoscopic instrument.
9. The method of claim 1, further comprising illuminating at least a portion of the chamber to enable a visual inspection of tissue adjacent to, or protruding into, the chamber.
10. A method of treating tissue comprising: inserting into a body of a patient an endoscopic instrument having a sheath and a channel for receiving an endoscope, the endoscopic instrument further including first and second tissue engaging surfaces, the first and second tissue engaging surfaces being adjustable to form a chamber, moving the chamber from a collapsed insertion configuration to an expanded use configuration to form a laterally expanded chamber within a body lumen, wherein the chamber, in the expanded use configuration, provides a working space within the body lumen; inserting a distal portion of a working instrument into the chamber, and extending the working instrument laterally with respect to a longitudinal axis of the endoscopic instrument; and visualizing the distal portion of the working instrument using the endoscope when the endoscope is positioned distal of the second tissue engaging surface.
11. The method of claim 10, wherein moving the chamber expands the chamber to only one side of the longitudinal axis of the endoscopic instrument.
12. The method of claim 10, further comprising visualizing a portion of the body lumen using the endoscope.
13. The method of claim 10, wherein visualizing the distal portion of the working instrument includes angling the endoscope so it extends laterally with respect to the longitudinal axis of the endoscopic instrument.
14. The method of claim 10, further comprising severing a tissue mass positioned within the chamber.
15. The method of claim 14, further removing the severed tissue mass from the patient via a first channel in the endoscopic instrument.
16. The method of claim 14, further comprising removing the severed tissue mass from the patient by retaining the severed tissue mass in the chamber and withdrawing the endoscopic instrument from the patient.
17. The method of claim 10, further comprising receiving a polyp within the chamber and severing the polyp from the body lumen utilizing the working instrument inserted through the first channel of the endoscopic instrument.
18. The method of claim 10, further comprising illuminating at least a portion of the chamber to enable a visual inspection of tissue adjacent to, or protruding into, the chamber.
19. A method of treating tissue comprising: inserting into a body of a patient an endoscopic instrument having first and second tissue engaging surfaces, the first and second tissue engaging surfaces being adjustable to form a chamber therebetween, moving the chamber from a collapsed insertion configuration to an expanded use configuration to form a laterally expanded chamber within a body lumen, the laterally expanded chamber forming a working space within the body lumen; inserting a distal portion of a working instrument into the chamber; visualizing the distal portion of the working instrument using a visualization device positioned distal of the second tissue engaging surface; severing a tissue mass disposed within the chamber using the working instrument; and removing the severed tissue mass from the patient.
20. The method of claim 19, wherein removing the severed tissue mass from the patient comprises at least one of removing the severed tissue mass from the patient via a first channel in the endoscopic instrument and retaining the severed tissue mass in the chamber and withdrawing the endoscopic instrument from the patient.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0072] As illustrated in
[0073] Shutter member 24 is movably mounted to hollow body 22 to cover window 36 during a positioning of anoscope 20 in an anal canal. Shutter member 24 is removable from window 36 to permit hemorrhoidal tissues to protrude through window 36 into anoscope channel 26. More specifically, shutter member 24 is slidably mounted to hollow body 22, is disposed in hollow body 22, and has a shape conforming to sidewall 34 in a region thereof about window 36.
[0074] Shutter member 24 is located in a track 37 in the hollow body. Track 37 takes the form of a shallow depression or recess with longitudinal edges or shoulders 39 serving as guides for the sliding shutter member 24. A transverse edge or shoulder 41 serves as an abutment to continued distal motion of shutter member 24 during an insertion stroke thereof. Shutter member 24 may be locked into track 37, for example, by grooves (not illustrated) in longitudinal edges or shoulders 39.
[0075] Hollow body 22 generally has a longitudinal axis 38, and sidewall 34 is formed with a bulging portion or protrusion 40 located on one side of the axis and extending from proximal end 32 of the hollow anoscope body partially along a length of sidewall 34 towards distal end 28. Window 36 is located in bulging portion 40, and shutter member 24 is slidable along and in engagement with bulging portion 40. As shown in
[0076] Hollow body 22 of anoscope 20 has a rim 42 surrounding opening 30 at proximal end 32. Hollow body 22 is preferably provided along rim 42 with a flange 44 serving as a stop for preventing anoscope 20 from slipping entirely into the anal canal. Hollow body 22 is further provided along rim 42 with a cutout 46 disposed on a side of axis 38 opposite bulging portion 40.
[0077] Cutout 46 facilitates manipulation of any instrument that is inserted into anoscope 20 for operating on hemorrhoidal tissues. In addition, cutout 46 facilitates observation of window 36 and of hemorrhoidal tissues HT protruding into longitudinal channel 26 through window 36.
[0078] In some applications, window 36 may extend in a proximal direction all the way to flange 44. In any case, window 36 is large enough for the admission of hemorrhoids into channel or lumen 26 of anoscope 20. The placement of window 36 in bulging portion or protrusion 40 is conducive to providing window 36 with properly large dimensions.
[0079] Anoscope 20 may be provided as part of a surgical instrument assembly than also includes a hemorrhoid treatment device 48 depicted in
[0080] Jaws 54 and 56 define respective gaps 55 and 57. A distal end portion of instrument shaft SO is U- or C-shaped in cross-section and defines a recess 59 aligned and communicating with gap 55. This asymmetrical shape of the distal end of instrument shaft 50 facilitates a visualization of a surgical site while a distal end portion of hemorrhoid treatment device 48 is inserted into anoscope 20.
[0081] A hemorrhoid occlusion component is mounted to jaws 54 and 56 for acting on tissues gripped between the jaws, to couple the tissues to each other. The hemorrhoid occlusion component may take any form capable of bonding organic tissues, particularly hemorrhoidal tissues, to one another. As depicted in
[0082] Staples 60 may be housed in a disposable cartridge element that may be a portion or the entirely of proximal jaw 54. This variation permits a surgeon, proctologist or other medical practitioner to clamp plural hemorrhoids in the course of a single procedure. After the stapling of one hemorrhoid, as discussed below with reference to
[0083] As illustrated in
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[0086] Jaws 54 and 56, together with rods 86 and 88, may form a disposable occlusion cartridge that is removable from shaft 50. Upon completion of a hemorrhoid treatment procedure on one patient, the cartridge is removed and replaced with a new cartridge for use on another patient.
[0087] In the case of injection mechanism 66, radiant-energy applicator 74, or electrode 82, handle 52 may be provided with a port or connector 85 for enabling the coupling of the hand-held hemorrhoid treatment device 48 to reservoir 72, laser source 80, or RF electric source 84, respectively.
[0088] As further illustrated in
[0089] In the embodiment of the hemorrhoid treatment device 48 shown in
[0090]
[0091] Upon an appropriate positioning of anoscope 20, shutter member 24 is grasped at an external flange or finger grip 90 and pulled in a proximal direction. as indicated by an arrow 92 in
[0092] In an alternative deployment procedure, the distal end portion of hemorrhoid treatment device 48 is inserted into anoscope 20 in such a manner that jaws 54 and 56 are located in channel 26 on the same side of longitudinal axis 38 as bulging sidewall portion 40 (see
[0093] With jaws 54 and 56 located on opposite sides of hemorrhoidal tissues HT, they are approximated, as depicted in
[0094] While jaws 54 and 56 are clamped about neck region 96 of tissues HT as shown in
[0095] In the case of a monopolar cauterization current, the current spread out from tissues HT into the patient's body.
[0096] After the occlusion operation has been performed, handle 52 is operated to separate jaws 54 and 56 from one another and the treatment device 48 is manipulated to separate the jaws from the treated hemorrhoidal tissues HT (
[0097] The hemorrhoidal tissues HT distal to the occluded neck region 96 may be transected with a scalpel or allowed to ischemically regress or self-amputate. Self-amputation occurs within a few days of the occlusion procedure. Ischemic regression takes place within several weeks. Ischemic regression and self-amputation are the result of occlusion of bloods vessels in neck or base region 96.
[0098] Bulging portion or protrusion 40 of anoscope 20 serves as a retractor of collateral anal or rectal tissues. In addition, bulging portion or protrusion 40 creates more work space in the area of hemorrhoidal tissues HT, This design allows for better access to the neck or base 96 of tissues HT, which is located in the submucosal layer close to the rectal muscle.
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[0100] Generally, the manipulating of anoscope 20 to align window 36 with hemorrhoidal tissues is performed after the inserting of anoscope 20 into the anal canal. Anoscope 20 and port member 89 are preferably made of a transparent polymeric material that facilitates visual inspection and locating of the hemorrhoids. Jaws 54 and 56 of the occlusion device are inserted into anoscope 20 after the inserting of anoscope 20 into the anal canal AC, after the manipulating of anoscope 20 to align window 36 with hemorrhoidal tissues HT, and after the protruding of the hemorrhoidal tissues HT through window 36.
[0101] A hemorrhoid treatment instrument or device as disclosed hereinabove may e partially or completely disposable. Where both jaws 54 and 56 are parts of a disposable cartridge removably attached to shaft 50, the proximal portion of the instrument may be utilizable in treating different patients at different times. Alternatively or additionally, where proximal jaw 54 contains a staple magazine, jaw 54 may be replaceable to permit multiple hemorrhoid occlusion procedures on the same patient.
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[0103] Tissue occluding instrument assembly 120 additionally comprises a tissue occlusion component 134 mounted to at least one of the hollow member 122 and the closure member 128 for acting on organic tissues gripped between clamping surfaces 130 and 132, to couple the tissues to each other. Tissue occlusion component 134 may be a stapling mechanism, an injection mechanism connectable to a reservoir of a sclerosing composition, or optical fibers connectable to a source of laser radiation.
[0104] Sidewall 124 of hollow member 122 is generally conically curved, so that clamping surfaces 130 and 132 have a curved form, e.g., a C shape or U shape. Clamping surfaces 130 and 132 lie in parallel planes that extend perpendicularly to a longitudinal axis 136 of instrument 120 and remain parallel to one another during opening and closing strokes of closure member 128. Closure member 128 moves parallel to axis 136.
[0105] Hollow member 122 is closed at a distal end 138 and defines a longitudinal channel 140 in which closure member 128 is disposed in part. Window 126 communicates with channel 140. At a proximal end, opposite closed end 138, hollow body 122 is provided with a handle 142 including a extending longitudinally stem 144 (that is oriented at a small angle relative to axis 136) and a substantially transversely extending handgrip 146. Closure member 128 includes a main part 148 formed as a channel member and, at an end of main part 148 opposite clamping surface 132, a handgrip 150 extending parallel to handgrip 146 of handle 142. Stem portion 144 of handle 142 is formed as a channel member that slidingly receiving main part 148 of closure or shutter member 128.
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[0107] Hollow body member 154 and particularly bulging wall 164 thereof is provided with a window or aperture 166 through which organic tissues such as a polyp 168 may protrude during an endoscopic tissue occluding procedure. During such a procedure, endoscope insertion member 158, with hollow body member 154 attached thereto as illustrated, is inserted through a natural body opening such as the anal orifice into an internal lumen such as the colon. Optical components (not illustrated) in the distal end face 170 of endoscope insertion member 158 are used to visually inspect the walls of the body lumen and to detect a surgical site containing polyp 168 or other undesirable tissue mass.
[0108] Tissue occluding instrument assembly 152 further includes a closure or shutter member 172 that includes a tissue clamping surface 174 at a distal end. Surface 174 generally has an arcuate shape and lies in a plane transverse to a longitudinal axis 176 of the instrument assembly. Surface 174 is opposable to another arcuate tissue clamping surface 178 that is attached to hollow body member 154 along a distal edge (not separately labeled) of window 166. Surface 178 also lies in a plane transverse to a longitudinal axis 176 and is accordingly parallel to surface 174.
[0109] Closure or shutter member 172 is attached to a distal end of a rod 180 that is slidably disposed in a channel 182 of hollow body member 154 that extends parallel to axis 176. During an initial phase of a deployment operation, rod 180 is pushed in a distal direction so that closure or shutter member 172 covers or closes opening 166. Upon the reaching of a contemplated surgical site, rod 180 is pulled in a proximal direction to remove closure or shutter member 172 from window 166 and allow polyp 168 to protrude through window 166 into chamber 160.
[0110] Body member 154 is provided in chamber 160 with an opening 184 via which a visual inspection of chamber 160 may be undertaken. Opening 184 may provide visual access to chamber 160 via optical components of endoscope insertion member 158 (exemplarily including an illumination source, a lens, and an optical fiber bundle—none illustrated). Alternatively, as discussed hereinafter with reference to
[0111] Hollow body member 154 may additionally be provided along chamber 160 with openings 186 for enabling access to chamber 160 by the working tips of endoscopic instruments such as a suction device 188. Suction device 188 includes a conical head 190 that engages polyp 168. Upon an application of suction, device 188 is pulled in proximal direction through a working channel 192 of endoscope insertion member or hollow body member 154. Thus, polyp 168 is stretched out to facilitate an occlusion operation in which closure or shutter member 172 is moved in the distal direction so that pedicle or neck tissues 194 of polyp 168 are sandwiched between clamping surfaces 174 and 178. Occlusion componentry 196 then operates through clamping surface 178 and/or surface 176 to effectuate an occlusion of the pedicle or neck tissues 194. Occlusion componentry 196 exemplarily takes the form of a stapling mechanism, an injection mechanism connectable to a reservoir of a sclerosing composition, or optical fibers connectable to a source of laser radiation. In any of the embodiments of a tissue occluding instrument assembly disclosed herein, the tissue occluding componentry may effectuate a heating of the tissues via resistive heat producing elements or electrical current transmission components.
[0112] At the termination of the procedure discussed above with reference to
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[0114] Thus, hollow body member 204 may take the form of an endoscope sheath that is deformable at a distal end to expand chamber 222 from a collapsed insertion configuration to an expanded use configuration as shown particularly in
[0115] A first arcuate clamping surface 230 is located on hollow body member 204, along a distal edge of a window 232 that communicates with chamber 222. A second arcuate clamping surface 234 is attached to the distal end of a closure or shutter member 236. Closure or shutter member 236 is connected to a rod 238 that moves the closure member alternately in a distal and proximal direction for effectuating a closure of window 232 during an insertion operation, an opening of window 232 to enable a protruding of a tissue mass into chamber 222, and a clamping of the protruding tissues during an application of energy to the tissues to effectuate an occlusion thereof. Tissue occluding componentry 240 provided on closure member 236 at surface 234 may take the form of any of the instrumentalities discussed above.
[0116] A suction head 242 of a suction device 244 inserted through working channel 216 may be used to draw a polyp 246 away from a wall 248 of a body lumen to facilitate a tissue occluding operation.
[0117] Tissue occluding instrument assemblies 152 and 202 may be used to treat a variety of pathologies (polyp, wall perforation, bleeding point at a previously placed staple line, etc.) but are generally not useful for treating hemorrhoids. Endoluminal tissue occluding instrument assemblies 152 and 202 may be used for treatment of lesions in natural and artificial lumens other than the colon, including the trachea, the bronchi, blood vessels (arteries and veins), etc.
[0118] Other known types of surgical maneuvers/operations can be performed using tissue occluding instrument assemblies 152 and 202, such as operating on an intimal/endothelial lesion in a vessel (arterial plaque, etc.) or operating on diseased venous or arterial valves. To carry out such additional procedures, a wide range of endoscopic surgical instruments (scissors, grasper, dissector, clip applier, etc.) can be introduced via endoscopic sheath channels 192, 216 to the targeted tissues.
[0119] Where organic tissues are to be severed and then extracted from the patient, the extraction may be implemented either via working channels 192,216 or upon the withdrawal of the entire instrument. In the latter case, the severed specimen is carried in the chamber 160, 222 until outside of the patient.
[0120] Where a surgical operation results in a bleeding vessel, the vessel can be coagulated with RF or injected with sclerosing or hemostatic agent.
[0121] Any diagnostic and surgical maneuvers described here can be performed in conjunction with external maneuvers, for example, laparoscopic maneuvers. This laparo-endoluminal approach is generally known in the field of surgery and may facilitate the performance and safety of the operation while preserving the benefits of minimally-invasive approach. Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. For example, rods 86 and 88 may be fixed to distal jaw 56 and slidably connected to shaft 50. Alternatively, rods 86 and 88 may be fixed to both distal jaw 56 and shaft 50, in which case proximal jaw 54 is slidable along rods 86 and 88 alternately towards and away from jaw 56. Also, more than two rods 86 and 88 may be provided for coupling distal jaw 56 to instrument shaft 50.
[0122] In yet another alternative design, both jaws 54 and 56 are movable along rods 86 and 88 during a clamping or closure stroke. Such a design facilitates hemorrhoid occlusion without tearing of the tissues below the occluded tissue base. If only one jaw 54 or 56 is movable along rods 86 and 88, then the entire instrument could be moved relative to the patient during closure of the jaws to ensure against undesired tissue tears. Where the distal jaw 56 is slidable along rods 86 and 88, the entire instrument is pushed into the patient while the distal jaw is moving in a proximal direction.
[0123] Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.