# Patent

## Title
Detachable distal overtube section and methods for forming a sealable opening in the wall of an organ

## Abstract

An overtube for use with an endoscopic surgical instrument. In various embodiments, the overtube may comprise a hollow tubular member that has an implantable tip detachably affixed to a distal end thereof. The implantable tip may have at least one retention member formed thereon to retain the tip within an organ wall. The implantable tip may further have a lumen extending therethrough to form a passageway through the organ wall. A plug member may be provided to selectively seal off the lumen within the implantable tip.

## Background
FIELD OF THE INVENTION
The present invention relates, in general, to surgical devices and methods of use and, more particularly, to devices and methods for forming a sealable passageway through the wall of an organ.
BACKGROUND OF THE INVENTION
Access to the abdominal cavity may, from time to time, be required for diagnostic and therapeutic endeavors for a variety of medical and surgical diseases. Historically, abdominal access has required a formal laparotomy to provide adequate exposure. Such procedures which require incisions to be made in the abdomen are not particularly well-suited for patients that may have extensive abdominal scarring from previous procedures, those persons who are morbidly obese, those individuals with abdominal wall infection, and those patients with diminished abdominal wall integrity, such as patients with burns and skin grafting. Other patients simply do not want to have a scar if it can be avoided.
Minimally invasive procedures are desirable because such procedures can reduce pain and provide relatively quick recovery times as compared with conventional open medical procedures. Many minimally invasive procedures are performed with an endoscope (including without limitation laparoscopes). Such procedures permit a physician to position, manipulate, and view medical instruments and accessories inside the patient through a small access opening in the patient's body. Laparoscopy is a term used to describe such an “endosurgical” approach using an endoscope (often a rigid laparoscope). In this type of procedure, accessory devices are often inserted into a patient through trocars placed through the body wall.
Still less invasive treatments include those that are performed through insertion of an endoscope through a natural body orifice to a treatment region. Examples of this approach include, but are not limited to, cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy. Many of these procedures employ the use of a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulating section near the distal end that can be controlled by the user by utilizing controls at the proximal end. Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)TM.
Some flexible endoscopes are relatively small (1 mm to 3 mm in diameter), and may have no integral accessory channel (also called biopsy channels or working channels). Other flexible endoscopes, including gastroscopes and colonoscopes, have integral working channels having a diameter of about 2.0 to 3.5 mm for the purpose of introducing and removing medical devices and other accessory devices to perform diagnosis or therapy within the patient.
Some surgical applications require the endoscope to be passed through the wall of an organ to gain access to a body cavity. After the procedure is completed within the body cavity and the endoscope is removed, the opening may need to be closed. However, in some situations, it may become necessary to reenter the body cavity through the organ wall after the original opening has been permanently closed. In those instances, the surgeon must reopen the original opening or form a new opening through the organ wall.
Over the years, a variety of different guide tubes and overtubes have been developed for guiding endoscopic surgical instruments into position. However, such instruments generally lack the ability to form a sealable opening through an organ wall through which surgical instruments such as endoscopes, etc. may be passed.
Consequently a need exists for an overtube device that can be used to facilitate the entry and guidance of surgical instruments through a natural orifice in the body and also be employed to form a sealable opening through the wall of an organ that can be reopened if necessary.
The foregoing discussion is intended only to illustrate some of the shortcomings present in the field of the invention at the time, and should not be taken as a disavowal of claim scope.
SUMMARY
In one aspect of the invention, there is provided an overtube for use with an endoscopic surgical instrument. In various embodiments, the overtube may comprise a hollow tubular member that has a proximal end and a distal end. An implantable tip may be detachably affixed to the distal end of the hollow tubular member. The implantable tip may have a lumen extending therethrough. A plug member may be sealingly attachable within the implantable tip to selectively seal off the lumen.
In another general aspect of various embodiments of the present invention, there is provided a surgical method for forming a sealable opening through the wall of an organ located in a body. The method may include providing a hollow tubular member that has a proximal end and a distal end wherein the distal end has an implantable tip detachably affixed thereto and wherein the implantable tip has a lumen extending therethrough. The method may further include supporting the implantable tip adjacent the organ wall and forming a hole through the organ wall. The method may also include implanting the implantable tip in the hole in the organ wall and sealing off the lumen in the implantable tip. Thereafter the hollow tubular member may be detached from the implantable tip.
In still another general aspect of various embodiments of the present invention, there is provided an overtube for use with an endoscopic surgical instrument. In various embodiments, the overtube may include, for example, a hollow tubular member that has a proximal end and a distal end. The overtube may further include an implantable tip that is detachably affixed to the distal end of the hollow tubular member. The implantable tip may have a substantially frusto-conically shaped distal end and at least one retention barb formed thereon. A plug member may be sealingly attachable within the implantable tip to selectively seal off a lumen extending through the implantable tip.



BRIEF DESCRIPTION OF THE FIGURES
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain various principles of the present invention.
FIG. 1 is a diagrammatical view illustrating the use of one embodiment of a surgical instrument of the present invention inserted through a patient's mouth and esophagus to create a sealable opening through the stomach wall;
FIG. 2 is an exploded assembly view of the distal end of an overtube and an implantable tip of various embodiments of the present invention;
FIG. 3 is a cross-sectional view of the overtube and implantable tip of FIG. 2 taken along line 3-3 in FIG. 2;
FIG. 4 is a partial assembled view of the overtube and implantable tip depicted in FIGS. 2 and 3;
FIG. 5 is an exploded assembly view of a portion of another overtube and implantable tip embodiment of the present invention;
FIG. 6 is a cross-sectional view of another implantable tip and overtube embodiment of the present invention with a plug embodiment of the present invention installed within the implantable tip;
FIG. 7 is a cross-sectional view of the overtube and implantable tip of the embodiments depicted in FIGS. 2-4 with the distal end of the implantable tip positioned adjacent the wall of an organ;
FIG. 8 is another cross-sectional view of the overtube and implantable tip of FIG. 7 with a hole-forming instrument extending through an endoscope positioned within the overtube to form an incision in the organ wall;
FIG. 9 is another cross-sectional view of the implantable tip and overtube of FIG. 7 with the tip implanted in the organ wall and the endoscope extending therethrough into a body cavity;
FIG. 10 is another cross-sectional view of the implantable tip and overtube of FIGS. 7-9 with a plug installed in the implantable tip; and
FIG. 11 is another cross-sectional view of the plugged implantable tip of FIG. 10 with the overtube detached from the implantable tip.



DETAILED DESCRIPTION
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating an end of the instrument 20 that protrudes out of the natural orifice. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
The present invention generally relates to various overtube arrangements and methods for use in forming an opening through the wall of an organ. Some embodiments may also be equipped with a seal or a plug for selectively plugging the opening. Those of ordinary skill in the art will appreciate that the various overtube arrangements and methods of the present invention may be effectively used in connection with various types of endoscopes and other surgical instruments without departing from the spirit and scope of the present invention.
FIG. 1 illustrates, in general form, one exemplary surgical instrument 20 of the present invention that can be inserted through a natural orifice to form an opening through the wall of an organ. In the example depicted in FIG. 1, the instrument 20 is inserted through the mouth 10 and esophagus 12 into the stomach 14 to form an opening through the stomach wall 16. Those of ordinary skill in the art will again appreciate, however, that the various embodiments and methods of the present invention may be effectively employed to form openings through other types of organs without departing from the spirit and scope of the present invention.
In various embodiments, the instrument 20 may comprise an overtube 30 that consists of a substantially hollow tubular member 32 that has a proximal end 34 and a distal end 36. The hollow tubular member 32 may be fabricated from, for example, nylon or high density polyethylene plastic or similar materials. The hollow tubular member 32 has a hollow passage 38 therethrough for receiving and supporting surgical instruments such as, for example, a conventional endoscope 60. A variety of different types of endoscopes are known and, therefore, their specific construction and operation will not be discussed in great detail herein. In various embodiments, the endoscope 60 may operably support a video camera (not shown) that communicates with a video display unit 64 that can be viewed by the surgeon during the operation. The endoscope 60 may further have one or more working channels (not shown) extending therethrough for receiving various types of surgical instruments such as a hole-forming device 68, for example. See FIG. 8. The hole-forming device 68 may comprise, for example, a conventional Sphinctorotome, a needle knife or other incisor-type instrument that may be inserted through a working channel in the endoscope 60.
Various embodiments of the surgical instrument 20 may further include an implantable tip 70 that is detachably affixed to the distal end 36 of the hollow tubular member 32. The implantable tip 70 may be fabricated from, for example, silicone, polycarbonate, urethane, stainless steel, etc. As can be seen in FIGS. 2 and 3, the implantable tip 70 may have a proximal end portion 72 sized to be received on the distal end 36 of the hollow tubular member 32. The implantable tip 70 has a lumen or passage 74 extending therethrough that may be substantially coaxially aligned with the hollow passage 38 in the hollow tubular member 32 when the implantable tip 70 is attached to the distal end 36 thereof. In the embodiments depicted in FIGS. 2-4 and 6-11, the implantable tip 70 is detachably retained on the distal end 36 of the hollow tubular member 32 by a string 90. The string 90 may comprise a string or cord manufactured from, for example, nitinol, prolene (suture), or braided stainless steel.
More specifically, in various embodiments the distal end 36 of the hollow tubular member 32 may have two passages 92 that extend therethrough and communicate with two radially extending holes 94 in the distal end 36 of the hollow tubular member 32. See FIG. 2. The radially extending holes 94 correspond to holes 76 in the proximal end 72 of the implantable tip 70. The distal end 36 of the hollow tubular member 36 may have additional radially extending holes 96 therethrough that correspond to holes 78 in the distal end 72 of the implantable tip 70. The implantable tip 70 may then be selectively retained on the distal end 36 of the hollow tubular member 32 by threading or sewing the string 90 through the aligned holes 94, 76 and aligned holes 96, 78 and passing the two ends 91 of the string 90 through the passages 92 so that they are accessible to the surgeon outside of the natural orifice 10. See FIG. 1. In alternative embodiments, the string 90 may pass through the hollow passage 38 in the hollow tubular member 32 instead of through passages 92 formed in the wall of the hollow tubular member 32. Thus, during the surgical procedure, the implantable tip 70 is retained on the distal end 36 of the hollow tubular member 32 by the string 90. When the surgeon desires to detach the implantable tip 70 from the hollow tubular member 32, the surgeon may simply pull one end 91 of the string 90 until it is unthreaded from the implantable tip 70.
In alternative embodiments, the proximal end 72 of the implantable tip 70 may be detachably retained on the distal end 36 of the hollow tubular member 32 by a frictional fit created therebetween or, for example, by at least one detent in the form of a rib 99′ formed on the distal end 36 of the hollow tubular member 32. The rib 99′ is sized to be frictionally received in a circumferentially extending pocket 79′ formed in the proximal end 72 of the implantable tip 70 as illustrated in FIG. 5. In other embodiments, the rib 99′ may be formed on the implantable tip 70 and the pocket formed in the distal end 36 of the hollow tubular member 32. In yet other embodiments, one or more detents may be provided on one of the implantable tip 70 and the distal end 36 of the hollow tubular member 32 received in corresponding pockets in the other of the implantable tip 70 and the hollow tubular member 32. As used herein, the term “detent” is meant to encompass a continuous rib, a segmented rib, a single round or oval member or a series of such members. In other embodiments, the implantable tip 70 may be detachably supported on the distal end 36 of the hollow tubular member 32 by an appropriate adhesive material.
In various embodiments, for example, after the tip 70 has been implanted in the organ wall 16, the hollow tubular member 32 is detached from the tip 70 as will be discussed in further detail below. The hollow tubular member 32 may be detached from the implanted tip 70 by applying a retraction force in the proximal direction “PD” to the proximal end of the hollow tubular member 32. In some applications, for example, to prevent the tip 70 from being dislodged from the organ wall 16 when the hollow tubular member 32 is being detached therefrom, it may be desirable for the hollow tubular member 32 to be constructed to be released from the tip 70 upon application of retraction force to the tube 32 that does not exceed approximately two pounds.
As can also be seen in FIGS. 2-11, the implantable tip 70 may also have a distal end 80 that is substantially frusto-conically shaped. Also in various embodiments, at least one retention member, which may take the form of a barb 82 or other suitable formation, may be formed around the an outer surface 81 of the implantable tip 70 for retaining the implantable tip 70 within the organ wall 16 as will be discussed in further detail below.
Also in various embodiments, a seal or plug member 100 may be provided to seal off or plug the lumen 74 in the implantable tip 70 after the surgical procedures have been completed within the body cavity 18, while, in some embodiments, affording the surgeon with the ability to remove the plug 100 to reopen the lumen 74 if necessary. As can be seen in FIGS. 10 and 11, in some embodiments, the plug 100 may have a body portion 102 that has a series of threads 104 formed thereon for threaded engagement with internal threads 75 formed in the implantable tip 70. The plug 100 may also have an installation tab 106 formed on a proximal end thereof to enable the plug to be gripped by an installation tool. In various embodiments, the plug 100 may be fabricated from, for example, silicone, polycarbonate, urethane, stainless steel, etc. FIG. 6 illustrates an alternative plug 100′ that has a detent in the form of rib 110′ thereon that is oriented to be frictionally received in a circumferentially extending groove 86′ formed in the wall of the implantable tip 70. In still other embodiments, the plug 100 may be retained in position by a frictional fit or by an appropriate adhesive material.
Use of the various surgical instrument embodiments of the present invention will now be described with reference to FIGS. 1 and 7-11. As can be seen in FIG. 1, the instrument 20 may be passed through the patient's mouth 10 into the stomach 14 such that the distal end 80 of the implantable tip 70 is adjacent the stomach (or organ) wall 16. See also FIG. 7. The surgeon may pass the endoscope 60 into the passage 38 in the hollow tubular member 32 to locate the specific surgical site on the stomach wall 16. Thereafter, the distal end 80 of the implantable tip 70 is pressed into the stomach wall 16 and the hole-forming instrument 68 may be passed through a working channel in the endoscope 60 to make an incision 17 in the stomach wall 16 as shown in FIG. 8. After an incision 17 has been made in the stomach wall 16, the surgeon forces the implantable tip 70 through the stomach wall 16 by applying a force to the hollow tubular member 32 in the distal direction “DD” until the barbs 82 of the implantable tip 70 are in retaining engagement with the stomach wall 16 as shown in FIG. 9. After the implantable tip 70 has been installed as shown in FIG. 9, the surgeon may then pass the distal end of the endoscope 60 through the lumen 74 in the implantable tip 70 into the body cavity 18 to perform other surgical procedures.
After the surgical procedure is completed within the body cavity 18, the surgeon may use surgical forceps 120 or other suitable surgical instruments that are passed through the working channel in the endoscope 60 to grip the installation tab 106 of a plug 100 and pass the plug 100 through the passage 38 in the hollow tubular member 32 to bring the plug 100 into sealing engagement with the implanted tip 70 as shown in FIG. 10. The forceps 120 may be used to screw the plug 100 into sealing engagement within the implantable tip 70 (for the embodiments depicted in FIGS. 3 and 7-11) or in alternative embodiments, the surgeon may use the forceps 120 to apply an installation force to the plug 100′ to sealingly seat the plug 100′ within the implantable tip 70. See FIG. 6.
Once the plug 100 or 100′ has been installed within the implantable tip, the forceps 120 and endoscope 60 may be withdrawn form the hollow tubular member 32. The surgeon may then pull one end 91 of the string 90 to cause the string 90 to unthread from the holes in the tip 70 and the distal end 36 of the hollow tubular member 32. After the string 90 has been unthreaded from the tip 70 and the distal end 36 of the hollow tubular member, the surgeon may then withdraw the hollow tubular member 32, leaving the plugged tip 70 implanted in the organ wall 16 as shown in FIG. 11.
As can be appreciated from the foregoing discussion, the unique and novel features of various embodiments of the present invention afford the surgeon with the ability to form an opening through an organ wall by using an endoscope and other surgical instruments inserted through a patient's natural orifice. After completing the surgical procedures, the surgeon may seal off the opening by inserting a plug into the lumen of the implanted tip. In various embodiments, the plug may be selectively removed from the implanted tip to provide access therethrough if needed.
While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments. For example, the use of the various embodiments of the present invention enables a surgeon to form a sealable passage through the wall of an organ by utilizing tools and instruments that may be passed into the body through a natural orifice.
While several embodiments of the invention have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the invention. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the disclosed invention as defined by the appended claims.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include an combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
The invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such equivalents, variations and changes which fall within the spirit and scope of the present invention as defined in the claims be embraced thereby.

## Claims

1. An overtube for use with an endoscope in a surgical procedure, said overtube comprising:
a hollow tubular member having a proximal end and a distal end;
an implantable tip detachably affixed to said distal end of said hollow tubular member, said implantable tip having an organ engagement portion for retaining said implantable tip within an organ wall, wherein said implantable tip comprises a lumen extending therethrough such that said lumen forms a passage through said organ wall; and
sealing means for selectively unsealing said lumen of said implantable tip, wherein said sealing means is selectively and separably removable from said lumen of said implantable tip, and wherein said sealing means comprises a plug member, wherein said plug member comprises external mating threads, and wherein said lumen comprises internal mating threads for mating engagement with said external mating threads of said plug member.

2. The overtube of claim 1 wherein said implantable tip has a substantially frusto-conically shaped distal end.

3. The overtube of claim 1 further comprising at least one retention member on said organ engagement portion of said implantable tip for retaining said implantable tip in the organ wall.

4. The overtube of claim 1 wherein said implantable tip is attached to said distal end of said hollow tubular member by at least one detent member on at least one of said implantable tip and said distal end of said hollow tubular member.

5. An overtube for use with an endoscopic surgical instrument, said overtube comprising:
a hollow tubular member having a distal portion;
an implantable tip detachably affixed to said distal portion of said hollow tubular member, said implantable tip having an organ engagement portion for retaining said implantable tip within an organ wall, wherein said implantable tip comprises a lumen extending therethrough; and
a plug member configured to selectively unseal said lumen of said implantable tip, wherein said plug member is selectively and separably removable from said lumen of said implantable tip, and wherein said plug member comprises external mating threads, and wherein said lumen comprises internal mating threads for mating engagement with said external mating threads of said plug member.