Apparatuses and methods for retracting intestines during abdominal surgery

Abstract

Apparatuses and methods for preventing the onset and / or progression of bowel edema during abdominal surgery and / or post-operative ileus are provided. The disclosed apparatuses comprise a structure for retracting the bowel during abdominal surgery and a means of applying negative pressure therapy to the bowel during abdominal surgery. Retracting the bowel provides unobstructed access to other regions of the abdominal cavity for the surgeon and the use of negative pressure therapy prevents the onset or progression of edema and / or ileus. Methods of preventing the onset or progression of edema and / or ileus are provided, comprising the deployment of the disclosed apparatuses and the application of negative pressure therapy.

Description

[0001] APPARATUSES AND METHODS FOR RETRACTING INTESTINES DURING ABDOMINAL SURGERY

[0002] FIELD OF THE INVENTION

[0003] The present invention relates generally to apparatuses and methods for use during surgery to facilitate the operative procedure while also improving post operative recovery from abdominal surgery. More particularly, the disclosure relates to apparatuses and methods for preventing bowel edema and the resulting onset and progression of post-operative ileus, a common complication of abdominal surgery. Devices for retaining or retracting the bowel during abdominal surgery are thus provided. The disclosed devices may also be configured to apply negative pressure therapy to the bowel while it is retained or retracted, thus preventing bowel edema, and thus further preventing the onset or progression of post-operative ileus, one cause of which is understood to be fluid retention in the bowel tissue. Methods of using the disclosed devices are also provided herein, with the methods comprising applying the disclosed devices to the bowel during abdominal surgery, applying negative pressure therapy and, thus, delaying or preventing the onset or progression of bowel edema and / or ileus. Thus, the disclosed devices and methods aid surgeons with access to other areas of the abdominal cavity by retracting the bowel out of the operative field during abdominal surgery, while also preventing the onset or progression of ileus.

[0004] BACKGROUND OF THE INVENTION

[0005] Postoperative Ileus (POI) is a transient impairment of bowel motility often resulting after abdominal surgery. POI is caused by intestinal paralysis which is a common cause in delaying the body's return to normal gastrointestinal (“GI”) function. POI also results in significant secondary complications in about 15% of abdominal surgery patients, including issues such as vomiting, pneumonia and wound complications.

[0006] Despite significant research investigating how to reduce this multi-factorial phenomenon, a single strategy has not been shown to reduce POI’s significant effects on length of stay (LOS), the aforementioned secondary complications and the resultant increased hospital costs. POI is often responsible for extended hospital stays because patients require a continuous IV until reestablishment of bowel function as the human body requires continuous support with fluids. Thus, patients cannot be discharged until they have met accepted criteria for return of bowel function. Due to secondary complications, POI may also be responsible for some post-surgical readmissions to the hospital. As noted by others, the duration of the resulting hospital stay varies with the anatomic location of the surgery, the degree of surgical manipulation, and the magnitude of inflammatory responses. When the surgery directly affects the GI track, the resulting POI is often more severe and takes longer to correct. Traditional treatment of POI includes mobilization, administration of laxatives, open abdomen surgical techniques, and prokinetic agents. Accordingly, there is a need for alternative approaches for treating POI.

[0007] During abdominal surgery, the bowel is exposed to ambient air, and fluid during the duration of surgery and also subject to manipulation during the procedure. The combination of exposure to ambient air and fluid along with surgical manipulation causes the accumulation of interstitial fluid and this is thought to perhaps contribute to the development of complications like ileus. This accumulation of fluid manifests as swelling of the bowel (i.e., edema).

[0008] During parts of an abdominal surgery procedure while the bowel is not being directly manipulated, the intestines are often held out of the field of surgery by retractor so as to aid visualization. Various devices for retracting the bowel (or holding it out of the way) are known to surgeons and those of skill in the art. However, state of the art retractors are simply mechanical devices that hold the bowel out of the way in order to provide unimpeded access to other areas - they do not generally provide for any treatment or prophylactic effect.

[0009] Devices for reducing fluid load in bowel tissue after surgery are known. In trauma surgery, where the abdomen can sometimes not be closed immediately after the surgery due to the administration of large volumes of fluid to the patient, the AbThera device from KCI (3M) is often used. The AbThera is placed in the open wound and negative pressure therapy is applied in order to reduce fluid volume, allowing for more rapid closure of the patient’s abdomen. The present applicants have developed a device, the Noleus Leaf, that may be deployed in a patient’s abdomen at the end of surgery in situations where the abdomen can be closed immediately, or when the surgical approach is a minimally invasive one. The device is draped over the bowel tissue and negative pressure therapy is applied to promote fluid reduction and to thus prevent the onset or progression of ileus. The Leaf device can be retracted through a small incision after several days of use. These known devices are not, however, designed to be used during the surgical procedure.

[0010] Accordingly, there is a need for a device that may be applied to bowel tissue during abdominal surgery to retract the bowel in situations where access to other regions of the abdominal cavity is required. In order to prevent the onset or progression of bowel edema and / or ileus, it is desirable for the device to provide for the application of negative pressure therapy during retraction.

[0011] SUMMARY OF THE INVENTION

[0012] In view of the above-described unmet needs, provided herein are apparatuses and methods for retracting the bowel during abdominal surgery, preventing the onset or progression of bowel edema, and preventing the onset and / or progression of post-operative ileus.

[0013] In some embodiments, the provided apparatuses are configured to retract the bowel during abdominal surgical procedures. In related embodiments, the provided apparatuses are also configured to apply negative pressure therapy to the bowel tissue to prevent the onset or progression of bowel edema and / or post-operative ileus.

[0014] In some embodiments, the provided apparatuses may take the form of a pouch or other similar structure that can be drawn closed around the loops of the bowel by drawstrings or other similar closure types. The inventive embodiments are configured to enclose the bowel tissue and then hold it aside so that the surgeon can have unobstructed access to the remainder of the abdominal cavity.

[0015] In some embodiments, the provided apparatuses are at least partially comprised of a film bilayer encompassing an inner scaffolding. The apparatus comprising the film bilayer and scaffolding may selectively be in fluid combination with tubing or other similar structure that can be selectively connected to a negative pressure device. Some or all of the film bilayer may be clear, to allow assessment of the bowel condition.

[0016] In some embodiments, the provided apparatuses may only take the form of a pouch or other similar structure for enclosing the bowel tissue and holding it aside during abdominal surgery.

[0017] In alternative embodiments, the apparatuses may take the form of a pouch or similar structure for enclosing the bowel tissue and holding it aside during abdominal surgery, wherein the apparatuses are also at least partially comprised of a film bilayer encompassing an inner scaffold, and wherein the apparatuses may be selectively connected to a negative pressure device. For avoidance of doubt, each of these alternative configurations, either alone or in combination, are provided within the scope of the current invention.

[0018] In the inventive methods, the inventive apparatuses may be used to retract the bowel during abdominal surgery and, during retraction, negative pressure may be applied to prevent the onset or progression of bowel edema and / or post-operative ileus. The inventive apparatuses may then be removed at the end of the surgery before closure of the abdomen.

[0019] The inventive methods also include embodiments wherein the apparatuses may be used to retract the bowel during abdominal surgery without the application of negative pressure therapy. In these alternative embodiments, the apparatuses may simply take the form of the previously described embodiment taking the form of a pouch or similar structure for retracting the bowel tissue. Alternatively, the apparatus may take the form of a pouch or similar structure for retracting the bowel tissue also at least partially comprising a film bilayer encompassing an inner scaffold. When the apparatuses used in the inventive methods at least partially comprise a film bilayer, they may selectively be connected to a negative pressure device, although this is not required for the apparatuses to operate to retract the bowel tissue during abdominal surgery. Use of the inventive apparatuses and methods do not preclude the use of negative pressure therapy after the surgical procedure, or other known therapeutic approaches. Rather, use of the inventive apparatuses and methods are designed to prevent or ameliorate the onset or progression of edema and / or ileus during the surgical procedure. Solely by way of example, the inventive apparatuses and methods may be deployed during abdominal surgery and, subsequently, the AbThera device or Applicants’ Leaf device may be deployed, depending on the surgical situation.

[0020] BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figures 1 shows a side perspective view of a partially closed bowel retractor device connected to negative pressure tubing according to an embodiment of the present invention.

[0022] Figure 2 shows a top view of a partially open bowel retractor device according to an embodiment of the present invention.

[0023] Figure 3 shows a top view of an open bowel retractor device including the internal scaffolding according to an embodiment of the present invention.

[0024] Figure 4 shows a side view of a bowel retractor device deployed for holding bowel tissue according to an embodiment of the present invention.

[0025] DETAILED DESCRIPTION OF THE INVENTION

[0026] With reference now to the figures and several representative embodiments of the invention, the following detailed description is provided.

[0027] In Figure 1, a bowel retractor device 101 according to an embodiment of the present invention is shown. The bowel retractor device takes the shape of a pouch that may be drawn at least partially closed around the loops of the bowel during a surgical procedure. The bowel retractor device may be joined in fluid communication to vacuum tubing 102 or other suitable means for applying negative pressure to the bowel retractor device 101. Application of negative pressure to the bowel retractor device 101 through the vacuum tubing is provided to apply negative pressure therapy to bowel tissue held within the bowel retractor device for the purpose of preventing or ameliorating bowel edema and / or preventing the onset or progression of ileus.

[0028] In some embodiments, the bowel retractor device 101 of Figure 1 may be configured to be selectively attached to or retained against the abdominal wall or another body structure during an abdominal surgical procedure so that the bowel contained within can be held out of the surgeon’s line of sight when they are not directly operating on the bowel tissue but instead focusing on another area in the abdominal cavity. One of skill in the art will understand conventional means for retaining an element such as the inventive bowel retractor device out of the way during a surgical procedure.

[0029] In Figure 2, a superior view of a bowel retractor device 201 according to an embodiment of the present invention is shown. The bowel retractor device 201 takes the form of a pouch for containing the loops of the bowel during abdominal surgery. The bowel retractor device may be drawn closed by drawstrings 202 or other similar elements for assisting in containing the bowel tissue during the surgical procedure.

[0030] In Figure 3, an alternative superior view of a bowel retractor device 301 according to an embodiment of the present invention is shown. The bowel retractor device 301 is shown completely flat - i.e., not drawn closed. Cinching (or drawstrings) 302 is shown for pulling the bowel retractor device closed when deployed around bowel tissue. In this and other exemplary embodiments, the bowel retractor device may be at least partially comprised of a film bilayer 303 encompassing an inner scaffolding 304. The film bilayer 303 may be selectively permeable and the scaffolding 304 may be configured to absorb fluid from bowel tissue contained in the bowel retractor device 301. The apparatus 301 comprising the film bilayer 303 and scaffolding 304 may selectively be in fluid combination with tubing or other similar structure that can be selectively connected to a negative pressure device. The device 301 may be configured such that application of negative pressure may draw fluid from bowel tissue contained within the device 301, through the selectively permeable film bilayer 303, into the scaffolding 304, and then out of the device 301 into a collection means (not shown). Some or all of the film bilayer may be clear, to allow assessment of the bowel condition. One of skill in the art will understand how negative pressure therapy works, both in the general sense and specifically when applied to abdominal surgery and, thus, details are not provided in the context of the present invention.

[0031] In Figure 4, a side view of a bowel retractor device 401 is shown. The bowel retractor device is comprised of a film bilayer 402 and a scaffolding 403 to facilitate the application of negative pressure therapy. Pull strings 404 are provided for pulling the device 401 closed around bowel tissue 406 during surgery. Tubing 405 is shown in fluid communication with the device 401, configured such that negative pressure can be applied to the device 401 through the tubing, thus allowing for the application of negative pressure therapy to bowel tissue contained within the device 401.

[0032] Also provided are methods for using the various embodiments of the inventive device disclosed herein. In one representative method, a bowel retractor device according to the present invention is deployed into the surgical field during surgery. In particular, a patient’s bowel is placed within the bowel retractor device and the device is drawn closed to contain the bowel tissue. The closed retractor device is then placed or retained in a position so that the remainder of the abdominal cavity is visible and accessible to a surgeon performing an operation on the abdomen of the patient that does not directly involve the bowel tissue. The closed retractor device is then placed in fluid communication, through tubing, with a negative pressure pump so that negative pressure therapy is applied to the bowel tissue of the patient. Through the application of negative pressure therapy, the inventive device works to prevent the onset and / or progression of bowel edema which may, in turn, work to prevent the onset or progression of ileus.

[0033] One of skill in the art will realize that several variations on the disclosed embodiments are possible while staying within the bounds of the current invention. Solely by way of example, different variations in the number of navigation cameras, robotic arms, markers / labels and end effectors can be used without departing from the invention. As another example, markers and labels of varying sizes, shapes and patterns can be used. As yet another example, numerous variations of surgical tools and surgical approaches to bilateral robotic sewing can be employed without departing from the invention described herein. The embodiments provided are representative in nature.

Claims

WHAT IS CLAIMED IS:

1. A bowel retractor device comprising: a film bilayer; scaffolding internal to the film bilayer; tubing in fluid communication with the internal space of the film bilayer; and one or more closure mechanisms configured to pull the retractor into a closed deployment; wherein the retractor device is configured to hold a patient’s bowel during abdominal surgery.

2. The bowel retractor device of claim 1, further comprising a negative pressure device connected to the tubing and configured to cause the retractor device to pull fluid from the bowel tissue of the patient.

3. The bowel retractor device of claim 1, wherein the retractor is configured to be retained against an abdominal wall of the patient during a surgical procedure.

4. The bowel retractor device of claim 1, wherein the device takes the shape of a pouch to hold the patient’s bowel and drawstrings to pull the pouch closed around the bowel.

5. The bowel retractor device of claim 1, wherein the film bilayer is selectively permeable.

6. The bowel retractor device of claim 1, wherein the scaffolding is configured to absorb fluid from the patient’s bowel.

7. A method of preventing or alleviating ileus in a patient, comprising: deploying around a patient’s bowel a bowel retractor device in a configuration that the bowel is substantially contained within the bowel retractor device, the bowel retractor device comprising: a film bilayer; scaffolding internal to the film bilayer; tubing in fluid communication with the internal space of the film bilayer; and one or more closure mechanisms configured to pull the retractor into a closed deployment; connecting a negative pressure device to the tubing;activating the negative pressure device; and causing the negative pressure device to pull fluid from the patient’s bowel tissue contained in the bowel retractor.

8. The method of preventing or alleviating ileus in a patient of claim 7, further comprising retaining the bowel retractor device against an abdominal wall of the patient.

9. The method of preventing or alleviating ileus in a patient of claim 7, wherein the bowel retractor device takes the shape of a pouch to hold the patient’s bowel and drawstrings to pull the pouch closed around the bowel.

10. The method of preventing or alleviating ileus in a patient of claim 7, wherein the film bilayer is selectively permeable.

11. The method of preventing or alleviating ileus in a patient of claim 7, wherein the scaffolding is configured to absorb fluid from the patient’s bowel.

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