The presently disclosed subject matter relates to methods and devices for managing appendages in a patient subject. In certain embodiments, the methods and devices may be employed for removal of the appendix of a patient subject.
The appendix is a finger-shaped, blind-ended tube that is part of the gastrointestinal (GI) tract. The GI tract includes an upper portion and a lower portion. The lower GI tract includes most of the small intestine and the large intestine, which includes the colon, rectum, and anal canal. The appendix is attached to the cecum, a small pouch considered to be the beginning of the large intestine. The appendix is open to the GI tract and may be susceptible to blockage and infection. The infection or obstruction can cause bacteria in the appendix to grow out of control, leading to appendicitis. Depending on the severity of the appendicitis, surgical removal of the appendix or appendectomy, may be necessary to treat the infection. Appendicitis is a common condition that affects approximately 7% of the US population.
Appendectomies are one of the more common emergency surgical procedures. During an open appendectomy, an incision about 2 to 4 inches in length may be made in the lower right side of the abdomen, and the appendix removed through the incision. To access the appendix, the abdominal muscles need to be separated. During a less invasive laparoscopic appendectomy, multiple small incisions may be made and a laparoscope used to remove the appendix through one of the incisions. Appendectomies can be expensive and may present additional risk to the patient. For acute or severe appendicitis, an appendectomy is the standard of care.
Described herein are methods and devices for management of the appendix that can engage and invert the appendix for excision and removal as part of a minimally invasive procedure.
In some embodiments, a method for management of the appendix may comprise inserting an inverter apparatus into the colon through cecum of a subject to reach the appendix, inverting the appendix, positioning one or more closure devices around a base portion of the inverted appendix, closing the base portion of the inverted appendix with the one or more closure devices, positioning a separation apparatus at the base portion of the inverted appendix adjacent to the one or more closure devices, separating the inverted appendix from the cecum with a separation apparatus, and removing the separated appendix from the subject. The method may include engaging the inverter apparatus with an interior wall of the appendix and pulling the inverter apparatus into the cecum to invert the appendix. In certain embodiments, the base of the inverted appendix may be substantially aligned with an outer wall of the cecum. Optionally, the method can further comprise reducing the size of the inverted appendix to facilitate removal of the inverted appendix from the subject. In some embodiments, a size reduction apparatus may be positioned around the inverted appendix in the cecum and engaged to reduce the size of the inverted appendix.
Also disclosed is a medical device for minimally invasive appendectomies. In some embodiments, a medical device may comprise a head that comprises at least one arm that extends outwardly from a first position of the head, and a handle connected to a second position of the head, where the first position and the second position are opposite one another. In some embodiments, the at least one arm may comprise a hooked, pointed, jagged, or rounded tip. In certain embodiments, the inverter device may include a plurality of arms. In other embodiments, the medical device may comprise a port with negative pressure.
Also disclosed is a kit for minimally invasive appendectomies. In some embodiments, the kit may comprise an inverter apparatus, one or more closure devices, and a separation apparatus. In certain embodiments, the kit may further comprise a size reduction apparatus. Optionally, the kit may include a catheter.
The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying description and drawings, in which some, but not all embodiments of the presently disclosed subject matter are shown. The presently disclosed subject matter can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.
Described herein are methods for management of the appendix that can engage and invert the appendix for excision and removal as part of a minimally invasive appendectomy procedure. The methods may use a colonic catheter to engage and invert the appendix, and secure the appendix for excision. The methods for the minimally invasive appendectomy do not require open surgery or laparoscopic surgical procedures to remove the appendix and suture the subject closed. Rather, the methods may use minimally invasive colonic access and procedures used by gastroenterologists in colonoscopies and polypectomies. Colonic access may be gained via the anal canal and a colonic catheter passing into the appendix via the colon and cecum. This approach can allow for lower costs than surgical procedures and the less invasive methods may bring fewer adverse risks than open surgery or laparoscopic surgical procedures.
The present disclosure may be embodied in a variety of ways. In one embodiment, methods of the present disclosure may comprise inserting an inverter apparatus into an interior cavity of the appendix of a subject, engaging the inverter apparatus with an interior wall of the appendix, inverting the appendix by pulling the inverter apparatus into the cecum until the appendix is substantially inverted. In some cases, the base of the inverted appendix may be substantially aligned with an outer wall of the cecum. Once the appendix is substantially inverted, the methods may further comprise positioning one or more closure devices around a base portion of the inverted appendix and closing the base portion of the inverted appendix with the one or more closure devices to prepare the appendix for excision. To excise the appendix, the methods further comprise positioning a separation apparatus at the base portion of the inverted appendix adjacent to the one or more closure devices, separating the inverted appendix from the cecum with the separation apparatus, and removing the separated appendix from the subject. The catheter may include a multi-port head that can accommodate tools such as a camera, irrigation spray, light. The catheter may include an instrument channel that can allow for various tool to be placed through the catheter to reach a target area of the colon or appendix.
Unlike the other appendectomy methods, the methods herein may grasp and invert the appendix inside the cecum, remove the appendix through the colon, with no incision. The appendectomy methods can remove the majority of the appendix from the cecum and substantially prevent infection and appendicitis in high risk patients. The amputated closed stump of the appendix may be rapidly repaved by the host mucosa as a natural surface. The colonic removal of the appendix can provide a long-term solution for managing risk of appendicitis in some patients.
In some embodiments, the inverter apparatus may be a grasping tool that comprises one or more arms. In some cases, the one or more arms may be articulating. Optionally, the arms of the inverter apparatus may comprise a curved tip, a round or jagged tip, hooks, and/or teeth. The tip of the inverter apparatus may engage and hold the interior wall of the appendix for inversion while avoiding penetrating, piercing, or tearing the wall of the appendix. The inverter may include a plurality of arms in certain examples. In other examples, the inverter apparatus may engage with the interior wall of the appendix using negative pressure.
Once the appendix is inverted, the base of the appendage may be sealed or closed. In some embodiments, one or more closure devices may be used to prepare the inverted appendix for excision and to ensure the stump of the excised appendix remains closed. For example, one device may be used, two devices may be used, or three or more devices may be used to close the base of the inverted appendix. In some embodiments, the closure device may comprise at least one of a slip knot, a polymeric zipper tie, a clip, an absorbable elastic band, a suture purse string, a barbed suture, a staple, a strip, or combination thereof. In some examples, the multiple closure devices used may differ or may be identical in kind. In some embodiments, a surgical stapler may be used to place the closure device. In certain embodiments, the surgical stapler may utilize bovine or porcine tissue as a closure device. The closure devices can permit the cecum and colon to function normally, and move food material within the colon once the inverted appendix is excised. In some examples, the closure devices may breakdown and be absorbed by the body. In other examples, the one or more closure devices may remain at the base of the amputated appendix and be quickly covered by proliferation of the host mucosa.
Once the base of the appendix is closed, the inverted appendix may be separated (e.g., cut off). In some cases, the inverter apparatus may remain engaged with the inverted appendix during the separation step. A variety of methods may be used to separate the inverted appendix from the cecum. In some embodiments, the separation apparatus may comprise a metal wire. For example, the separation apparatus may be a metal noose that may lassoed around the base of the inverted appendix and tightened to separate the appendix. In some embodiments, the separation apparatus may be a guillotine-style cutting apparatus. In other embodiments, the separation apparatus may use electromagnetic radiation to separate the inverted appendix. For example, the electromagnetic radiation may be at frequencies between 350-500 kHz. In other examples, the separation apparatus may use electromagnetic radiation at wavelengths between 800-1500 nm. In some embodiments, the separation apparatus may cauterize the inverted appendix. In certain embodiments, ultrasonic vibration or electric current may be used to cut and cauterize the inverted appendix. The separated appendix may remain engaged with the inverter apparatus. In some cases, the separated appendix may be held or contained by the inverter apparatus.
Once separated, the appendix may be removed from subject. In some examples, the appendix may be removed using the inverter apparatus along the pathway of the catheter. By excising the appendix through the colon, the method may eliminate a potential source of infection that can arise from open surgery and laparoscopic incisions of conventional appendectomies.
Optionally, the method may further comprise positioning a size reduction apparatus around the inverted appendix in the cecum prior to removing the inverted appendix from the subject. The size reduction apparatus may be engaged to reduce the size of the appendix to facilitate removal of the inverted appendix from the subject. In some cases, a cross-section of the inverted appendix may be reduced to a width less than a width of catheter. In certain embodiments, a cross-section of the inverted appendix may be reduced to a width of 24 French or less. The size of the separated appendix may be reduced by cutting, crushing, chemical degradation, or other means known by those skilled in the art. In some examples, the size reduction apparatus may comprise articulating arms. Optionally, the size reduction apparatus may further comprise a metallic or polymeric mesh. For example, the arms and/or mesh of the size reduction apparatus may comprise stainless steel, a cobalt chrome alloy, a nickel aluminum alloy, or a nickel titanium alloy, such as Nitinol (available from Memory Corporation, Bethel, CT), or other metal alloy known to those skilled in the art. Optionally, the apparatus may be comprised of a metal alloy coated with a polymer. In certain embodiments, the polymer may be a Polytetrafluoroethylene (PTFE) or GORE-TEX (available from W.L. Gore, Flagstaff, AZ). In some embodiments, the size reduction apparatus may comprise a cutting device. In other embodiments, the size reduction apparatus may comprise degradation chemicals, such as an acid or a base.
In some embodiments, the appendix may be incrementally reduced in size for removal. Portions of the appendix may be separated and removed from the colon. In some cases, portions of the appendix may be separated, reduced in size using a size reduction apparatus, and then removed from the colon.
Illustrative examples are given to introduce the reader to the general subject matter discussed herein and are not intended to limit the scope of the disclosed concepts.
Medical devices, such as an inverter apparatus, can be placed using the catheter 260 to access the cecum 120 and appendix 110.
Once the inverter apparatus grasps the wall of the appendix, the inverter apparatus can be partially retracted from the appendix while remaining engaged with the wall of the appendix, to invert the appendix within the cecum.
As shown in
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Once the inverted appendix 115 is closed using closure device 310, the tissue of the inverted appendix 115 can be separated, as shown in
In certain embodiments, the inverter apparatus and size reduction apparatus may be integrated in a single apparatus. In other embodiments, the inverter apparatus, size reduction apparatus, and separation apparatus may be integrated into a single apparatus.
In other embodiments, the present disclosure comprises a medical device. The medical device may comprise a head comprising at least one arm extending outwardly from a first position of the head and a handle connected to a second position of the head. In some embodiments, the first position is approximately 180 degrees from the second position. In some embodiments, the at least one arm may comprise a hooked, pointed, jagged, or rounded tip. The head may comprise a plurality of arms in some examples. In some examples, the medical device may further comprise a mesh.
The at least one arm of the medical device may articulate and/or rotate about the head of the device. In certain examples, the device may comprise a plurality of arms that move in a lateral direction at the head. For example, the device may comprise two arms that rotate towards one another and act as a set of pinchers.
The medical device may comprise a metal alloy or polymeric coating. For example, the arms and/or mesh of the size reduction apparatus may stainless steel, a cobalt chrome alloy, a nickel aluminum alloy, or a nickel titanium alloy, such as Nitinol (available from Memory Corporation, Bethel, CT), or other metal alloy known to those skilled in the art. Optionally, the apparatus may be comprised of a metal alloy coated with a polymer. In certain embodiments, the polymer may be a Polytetrafluoroethylene (PTFE) or GORE-TEX (available from W.L. Gore, Flagstaff, AZ).
In some embodiments, the handle may further comprise a lever to articulate the at least one arm. In some cases, the medical device may be an inverter device.
In other embodiments, the present disclosure comprises a kit for minimally-invasive or non-invasive appendectomies, the kit comprising an inverter apparatus, one or more closure devices, and a separation apparatus, as described herein. Optionally, the kit may further comprise a size reduction apparatus. In certain embodiments, the kit may include a colonic catheter.
The terms “a”, “an”, and “the” refer to “one or more” when used in this application, including the claims. Thus, for example, reference to “an arm” includes a plurality of such arms, unless the context clearly is to the contrary (e.g., a plurality of arms), and so forth.
Various embodiments of the disclosure have been described herein. It should be recognized that these embodiments are merely illustrative of the present disclosure. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. It is expected that skilled artisans can employ such variations as appropriate, and the disclosure is intended to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated or otherwise clearly contradicted by context.
As used below, any reference to methods, devices, or kits is understood as a reference to each of those methods, devices, or kits disjunctively (e.g., “Illustrative embodiment 1-4 is understood as illustrative embodiment 1, 2, 3, or 4.”).
Filing Document | Filing Date | Country | Kind |
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PCT/US21/28786 | 4/23/2021 | WO |