Methods for closing a gastrotomy

[0001] The present application is a divisional application of and claims the benefit of U.S. patent application Ser. No. 11/981,078, filed Oct. 31, 2007, entitled “Apparatus and Methods For Closing a Gastrotomy” to Rudolph H. Nobis, U.S. Patent Application Publication No. US-2009-0112059-A1, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present invention relates, in general, to surgical devices and methods of use and, more particularly, to devices and methods relating to closing an opening made through the abdominal wall utilizing laparoscopic surgical instruments and procedures.

[0003] 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.

[0004] 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. The trocar must pass through several layers of overlapping tissue/muscle before reaching the abdominal cavity. One of the most significant problems associated with such surgical procedures is the need to provide a secure closure of the gastrotomy site that is required for endoscope passage and, for example, specimen removal. Prior methods required the surgeon to close each of the muscle layers after the procedure is completed.

[0005] 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)™. In the past, however, those instruments suited for insertion through a natural orifice lacked means for performing a gastrotomy that avoids the need for the surgeon to separately close each tissue and muscle layer after the operation is completed.

[0006] Consequently a need exists for devices and methods that can be employed through a patient's natural orifice for closing a gastrotomy while avoiding the need to separately close the hole in each muscle and tissue layer in the abdominal wall.

[0007] 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.

[0008] In one aspect of the invention, there is provided a surgical instrument for forming a gastrotomy. In various embodiments, the instrument comprises a tubular member that has a proximal end and a distal end. A hollow tip is provided on the distal end of the tubular member. The hollow tip has a tip axis and a distal end that extends at an acute angle relative to the tip axis.

[0009] In another general aspect of various embodiments of the present invention, there is provided a surgical instrument for forming a gastrotomy. In various embodiments, the surgical instrument comprises a hollow tip that is configured for attachment to a distal end of an endoscope. The hollow tip has a tip axis extending therethrough and a distal end that extends at an acute angle relative to the tip axis.

[0010] In still another general aspect of various embodiments of the present invention, there is provided a surgical method for forming a gastrotomy through an organ wall that has an inner layer of tissue and at least one outer layer of tissue that is adjacent to the inner layer of tissue, wherein the inner layer of tissue is stretchable from a first relaxed condition to a stretched condition. The method may comprise stretching the inner layer of tissue to a stretched condition relative to the at least one outer layer of tissue and forming a first hole through the stretched inner layer of tissue and a second hole through the at least one outer layer of adjacent tissue such that the first and second holes are aligned with each other to permit passage of a surgical instrument therethrough. The method may further comprise performing a surgical procedure through the aligned first and second holes and thereafter permitting the inner layer to return to the first relaxed condition such that said first and second holes are no longer aligned with each other.

[0019] 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.

[0020] 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.

[0021] The present invention generally relates to devices and methods that may be used in connection with endoscopes to perform a gastrotomy through the stomach wall and thereafter have the gastrotomy site be closed without the need for the surgeon to separately close the opening formed in each layer of muscle and tissue. While the various Figures illustrate one form of endoscope with which the various embodiments of the present invention may be advantageously employed, those of ordinary skill in the art will readily appreciate that the unique and novel features of the present invention may be employed with a variety of other forms of endoscopes without departing from the spirit and scope of the present invention.

[0022] FIG. 1 illustrates, in general form, a surgical instrument 20 of the present invention that can be inserted through a natural orifice to form an opening through the stomach wall 16. 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. In various embodiments, the instrument 20 may comprise a tubular member sized to receive a surgical instrument. In various embodiments, for example, the tubular member may comprise an endoscope 30 that may be inserted through a substantially hollow overtube 40 that is inserted into the stomach 14 through the patient's mouth 10. 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 30 has a distal end 32 and a proximal end 34 and may operably support a video camera 36 that communicates with a video display unit 40 that can be viewed by the surgeon during the operation. The endoscope 30 may further have one or more working channels 38 extending therethrough for receiving various types of surgical instruments. See FIG. 2.

[0023] Also in various embodiments of the present invention, a hollow tip 50 may be attached to, or integrally formed on, the distal end 32 of the endoscope 30. In various embodiments, the hollow tip 50 may be attached to the endoscope 30 by, for example, an appropriate adhesive or be pressed onto the distal end 32 and be retained thereon by a “frictional fit”. The hollow tip 50 may be fabricated from, for example, a thermoplastic material and have a tip axis “A-A” that may be substantially coaxially aligned with the central axis of the endoscope 30 when installed thereon. In addition, the hollow tip 50 may be formed with an angled distal end 52 that is angled at an acute angle “α” relative to the tip axis A-A. In various embodiments, the angle α may be, for example, approximately forty-five degrees or from ten degrees to eighty degrees. As will become apparent as the present Detailed Description proceeds, the distal end 52 of the hollow tip is to be formed in such away so that, when pressed against the inner tissue layer 17 of the stomach wall 16, that tissue layer 17 is stretched within the hollow tip 50. In various embodiments, the distal end 52 of the hollow tip 50 may be substantially non-piercing. “Non-piercing” as used herein means that when used as described herein, the tip 50 will not pierce through the organ by itself; however, after the organ is pierced by other means, the hollow tip could be inserted through the opening, if so desired.

[0024] FIGS. 3-6 illustrate use of the instrument 20. FIG. 3 depicts a portion of the stomach wall 16 through which the gastrotomy will be performed. As can be seen in that Figure, the stomach wall 16 may consist of, for example, a first inner layer of tissue 17 known as mucosa or Rugae that lines the stomach wall 16 and at least a second layer of tissue or muscle 18. The inner layer of tissue 17 is stretchable from a relaxed condition (FIGS. 3 and 7) to a stretched condition (FIGS. 4-6). The second layer 18 of tissue may actually comprise more than one layer or amount of muscle and other tissue. It will be appreciated, however, that all of that tissue/muscle 18 and the inner layer 17 make up the stomach wall 16.

[0025] As shown in FIG. 3, the surgeon initially manipulates the endoscope 30 to bring the hollow tip 50 into spaced confronting relationship with the portion of the stomach wall 16 through which the gastrotomy is to be performed. Thereafter, the endoscope 30 is manipulated in such a manner to cause the distal end 52 of the hollow tip 50 to be pressed against the inner layer 17 of the stomach wall 16. Because of the differences between the inside layers 17 and outside layers of tissue 18, the tissue layers 17, 18 stretch at different rates. See FIG. 4. In some embodiments, a vacuum instrument 60 may be passed through a working channel 38 in the endoscope 30 to apply a suction or vacuum within the hollow tip 50 from a source of vacuum 62 (FIG. 1) to draw the inner layer 17 of the stomach wall 16 into stretched sealing engagement with the distal end 52 of the hollow tip 50. See FIG. 5.

[0026] Once the hollow tip 50 is pressed against the inner layer 17 of the stomach wall 16 in the above-described manner, a conventional hole-forming device 70 such as, for example, a conventional Sphinctorotome, a needle knife or other incisor-type instrument is inserted through a working channel 38 to form a continuous hole or passageway 19 through the layers 17 and 18 of the stomach wall 16. See FIG. 5. As can be seen in FIGS. 6 and 7, the continuous hole 19 actually consists of hole segment 19A and hole segment 19B that are aligned with each other. After the hole 19 has been formed through the stomach wall 16, the hole-forming instrument 17 may be withdrawn back through the working channel 38 in the endoscope 30 and other surgical instruments such as, for example, guide wires, dilating balloons, etc. (not shown) may be inserted through the working channels 38 and through the hole 19.

[0027] After the desired surgical procedures such as, for example, Diagnostic Peritonoscopy or Transgastric Cholecystectomy have been performed through the hole 19, the entire instrument 20 may be removed from the site. After the instrument 20 is removed, the inner tissue layer 17 is once again permitted to move to a relaxed state which causes an offset between the hole segments 19A and 19B as represented by the distance “OS” in FIG. 7. The hole segments 19A and 19B are then permitted to naturally seal through the body's normal healing process.

[0028] As can be readily appreciated from the foregoing, the various embodiments of the present invention described above represent a vast improvement over prior devices and methods used to form and thereafter close a gastrotomy. The unique and novel features of the present invention enable the operation to be performed through a natural orifice in the patient and thereby avoid several disadvantages associated with other conventional surgical methods and procedures that require incisions to be made into the abdomen. The present invention may encompass tips that are configured for attachment to a distal end of a surgical instrument and, if desired, supplied and/or sold separately from that instrument. Such tips may be pressed onto or otherwise temporarily attached to the distal end of the instrument to complete the above-described procedure and thereafter removed from the instrument and discarded or reprocessed for future use. Other embodiments of the present invention contemplate permanent attachment of the tip to the distal end of the instrument and still other embodiments envision that the angled distal end of the tip be integrally formed on the distal end of the instrument.

[0029] 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.

[0030] 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 any 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.

[0031] 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.

[0032] 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.

[0033] 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.