Method for performing a gastrectomy

A method for performing a gastrectomy (stomach reduction surgery).

BACKGROUND OF THE INVENTION

The present invention pertains to an apparatus that is positioned in a hollow viscus organ and functions as a template for creating a lumen of a desired shape and size in the organ from the tissue of the organ, and the method of using the apparatus in creating the lumen.

SUMMARY

The apparatus of the invention is employed in creating a lumen of a desired shape and size in a hollow viscus organ from tissue of the organ. In particular, the present invention is employed in creating a tubular gastric sleeve from the tissue of a patient's stomach.

The apparatus is comprised of an elongate, flexible tube having opposite proximal and distal ends. The tube has several lumens or pathways that extend through the interior of the tube between the proximal and distal ends of the tube.

A directional, steerable feature extends through one of the lumens of the tube. The directional, steerable feature is manually operable at the tube proximal end to direct and steer the tube distal end in different directions relative to the length of the tube.

An anchor feature is provided at the tube distal end and is manually operable from the tube proximal end. The anchor feature selectively anchors or secures the tube distal end to tissue of a hollow viscus organ. In particular, the anchor feature can be selectively operated to secure the tube distal end in the beginning of the small intestine or duodenum of a patient.

An exterior surface dimension adjustable feature is provided adjacent the tube distal end. The adjustable feature is also manually operable at the tube proximal end. The adjustable feature can be selectively enlarged and reduced in shape configuration and circumferential dimensions. When enlarged, the exterior surface of the adjustable feature has its largest circumferential dimension at the end of the adjustable feature that is adjacent the tube distal end. From this end of the enlarged adjustable feature the circumferential dimension of the feature gradually decreases as the adjustable feature extends toward the tube proximal end.

A suction communication feature is provided along at least a portion of the tube length. The suction feature is also operable at the tube proximal end. Manual operation of the suction feature supplies suction pressure along at least a portion of the tube length that draws the tissue of the hollow viscus organ toward the exterior surface of the tube.

In use of the apparatus the tube distal end is first inserted through the patient's esophagus and then into the patient's stomach. The anchor feature at the tube distal end is guided from the stomach interior past the patient's pyloric valve and into the beginning of the small intestine or duodenum. The anchor feature is then operated to secure the tube distal end in its position. The length of the tube is then manually pulled from the proximal end to position the tube, and in particular the exterior surface dimension adjustable feature along the lesser curvature of the stomach and adjacent the stomach incisura. The exterior surface dimension adjustable feature is then enlarged. The suction communication feature is then operated, causing portions of the stomach wall to be drawn to and wrapped around the exterior surface dimension adjustable feature. The position of the adjustable feature along the stomach lesser curvature is then demarcated on the stomach exterior. Opposing portions of the stomach wall are then affixed together along the side portion of the enlarged dimension adjustable feature that is opposite the stomach lesser curvature, thereby creating a tubular gastric sleeve from the patient's stomach. The exterior surface dimension adjustable feature is then reduced in size, and the anchor feature is disengaged from the stomach. The apparatus is then removed from the patient's stomach leaving the gastric sleeve. The gastric sleeve will then function as a new gastric reservoir with an interior configuration that is without any significant, limiting constriction in the sleeve interior configuration in the area of the stomach incisura or other tenuous area of the reservoir after the apparatus has been removed.

DESCRIPTION OF THE APPARATUS OF THE INVENTION AND ITS METHOD OF USE

The apparatus of the invention12is designed for use in surgical procedures in creating a lumen of a desired shape and size in a hollow viscus organ from the tissue of the organ. In one example of the method of using the apparatus disclosed herein, the apparatus is designed to be introduced through the esophagus of a human patient and into the patient's stomach. The apparatus if then positioned along the lesser curvature of the stomach and is used as a template or guide in creating a lumen of a desired shape and size in the stomach from stomach tissue wrapped around the apparatus. The apparatus12is therefore constructed of biocompatible materials typically employed in the constructions of surgery devices.

Although the apparatus12of the invention and its method of use are described herein as creating a lumen of a desired shape and size in the stomach from the tissue of the stomach, it should be understood that the apparatus12of the invention is designed to be used as a template or guide in creating a lumen of a desired shape and size in a hollow viscus organ, not necessarily the stomach.

The apparatus12is basically constructed as a bougie having an elongate flexible, tube14with opposite proximal16and distal18ends. A plurality of separate bores or lumens represented by dashed lines20inFIG. 1extend through the interior of the tube14from the tube proximal end16toward the tube distal end18. The lumens provide separate paths of communication through the interior of the tube14that communicate a plurality of manually operable controls22at the tube proximal end16with a plurality of features of the apparatus12that are positioned along portions of the tube length adjacent the tube distal end18.

The extreme distal end of the apparatus tube length is formed as a blunt tip26having a smooth exterior surface. This enables the distal end tip26to easily pass over or through body tissue without causing damage to the tissue. If desired, an illumination light and/or endoscope opening28could be provided in the distal end tip26of the tube. The light and/or endoscope would be connected by any known appropriate communication means through one of the lumens20extending through the length of the tube14with a manually operable control32provided for the light or endoscope at the tube14proximal end16. In this manner, illumination light could be provided at the tube distal end tip26. This enables the location of the tip26in the stomach to be identified through the stomach wall from the abdominal cavity. Additionally, an endoscope visual image could be provided at the tube distal end tip.

The apparatus tube14is also provided with a directional or steerable feature that extends from the distal end18through one of the lumens20to a manually operable control36of the feature at the tube proximal end16. Any conventional or known directional or steerable feature could be employed in the construction of the apparatus12for this purpose. The directional/steerable feature would be operable at the proximal end16of the tube14to direct and steer the distal end18of the tube in different directions relative to the length of the tube14. Examples of known directional/steerable features include those that employ wires that extend along different sides of the tube length that are pulled in tension to curve and direct the different sides of the tube length. Additionally, shape memory wires or other equivalent means could be employed as the directional/steerable feature of the apparatus12.

The apparatus12is also provided with an anchor feature42at the tube distal end18. In the embodiment of the apparatus12shown inFIG. 1, the anchor feature42is an inflatable balloon that communicates through one of the lumens20with a control44at the tube proximal end16. The balloon anchor feature42is shown in solid lines in its deflated condition inFIG. 1, and in dashed lines in its inflated condition inFIG. 1. The manually operable control44provided at the tube length proximal end16controls the selective inflation and deflation of the balloon42. In its deflated condition the balloon42is dimensioned to enable it to be inserted through the esophagus and into the stomach interior and from the stomach interior past the pyloric valve or sphincter and into the beginning of the small intestine or duodenum. With the balloon42so positioned, inflating the balloon42anchors the distal end portion18of the apparatus12in the duodenum. In this manner, the apparatus distal end18is securely anchored to the stomach tissue. In addition, the anchor feature42could be provided with an illuminating light that is controllable at the manual control44. The anchor feature light would enable identifying the location of the anchor feature inside the stomach by viewing the light through the stomach well from inside the abdominal cavity.

In different embodiments of the apparatus12, the balloon anchor feature42could be replaced with other equivalent types of anchors. For example, the balloon anchor feature24could be replaced with selectively extendable hooks or prongs48shown in dash lines inFIG. 1that would also function to anchor the apparatus distal end18to the stomach tissue.

An exterior surface dimension adjustable feature52is also provided on the apparatus12along a portion of the tube14. As shown inFIG. 1, the exterior surface adjustable feature52extends completely around the tube and along a significant portion of the tube14length adjacent the distal end19of the tube, but is spaced along the tube length and is separate from the anchor feature42. The exterior surface adjustable feature52communicates through one of the lumens20with a manual control54provided for the feature at the tube proximal end16. The control54is manually operated to selectively move the adjustable feature52between a retracted condition shown in solid lines inFIG. 1and an extended or enlarged condition shown in dashed lines inFIG. 1. In the retracted condition the circumferential dimension of the adjustable feature52enables insertion of the feature through the esophagus of a patient and into the stomach of the patient. When manually operated to move to its enlarged condition in dashed lines inFIG. 1, the exterior surface56of the adjustable feature52has a shape configuration and circumferential dimensions along the length of the feature that enable it to be used as a template in creating a lumen of a desired shape and size in a hollow viscus organ from the tissue of the organ. In the example ofFIG. 1, the adjustable feature52is used as a template for creating a lumen of a desired shape and size in the stomach tissue surrounding the adjustable feature52in performing the desired method of the invention that will be later described. One example of the desired shape configuration and circumferential dimensions of the exterior surface56of the adjustable feature52in its enlarged condition is shown in dashed lines inFIG. 1. The adjustable feature has a generally annular cross-section configuration defined by the circular cross-section of the tube14at its center and the exterior surface56of the adjustable feature52. The exterior surface56extends around an interior volume of the adjustable feature52with the tube14at the center of the volume. The length of the adjustable feature52extends from a proximal end58of the exterior surface56to a distal end60of the exterior surface. As seen inFIG. 1, the circumferential dimension of the enlarged exterior surface56increases as it extends from adjacent the proximal end58to adjacent the distal end60. It should be understood that the exterior surface adjustable feature52in its enlarged condition could have other desired shape configurations and size dimensions depending on its intended use. As shown inFIG. 1, the exterior surface circumferential dimensions of the enlarged feature52are largest toward the distal end18of the tube14. The exterior surface circumferential dimensions of the enlarged feature52gradually become smaller as the adjustable feature52extends along the portion of the tube length toward the proximal end16of the tube14.

An example of an exterior surface adjustable feature52that could be employed on the apparatus12is an inflatable balloon having a desired exterior configuration with desired circumferential dimensions when in the enlarged or inflated condition of the balloon, and when deflated the balloon returns to the retracted condition of the feature52represented by the solid lines inFIG. 1. The adjustable feature would communicate through one of the lumens20through the tube to a manual control54to selectively inflate and deflate the adjustable feature52. As an alternative to an inflatable balloon, the exterior surface adjustable feature52could be a mechanical linkage system that enlarges and retracts in the same manner as an inflatable balloon, or other equivalent means of performing the functions of the exterior surface adjustable feature52.

The apparatus of the invention12is also provided with a suction pressure communication feature62that communicates through one of the lumens20with a manual control64. The suction feature62enables suction pressure to be delivered to a portion or portions of the apparatus tube14length in response to the manual operation of the control64at the tube proximal end16.FIG. 1shows suction holes62provided in portions of the apparatus tube14length that function as the suction pressure communication feature62. The holes62deliver suction pressure to the exterior surface of the tube14length in the areas of the holes62. In other examples of the apparatus12, the holes62could be replaced by slits in the exterior surface of the tube length or other equivalent means of delivering suction pressure to desired areas of the exterior surface of a tube length. The suction pressure delivered to the holes62by manual operation of the control64causes the stomach or other hollow viscus organ to contract around the apparatus in the areas of the holes. The portions of the stomach tissue or organ tissue are drawn or wrapped around the exterior surface of the adjustable feature52and around the portions of the apparatus tube length having the suction holes62.

The use of the apparatus of the invention12according to the method of the invention is shown in the drawingFIGS. 2-7. InFIGS. 2-7the apparatus12is shown being used as a template or guide in creating a lumen of a desired shape and size in the stomach from the tissue of the stomach. It should be understood that this is only one example of a use of the apparatus and the apparatus is not limited to use in the stomach. The apparatus of the invention12is designed to be used as a template or guide for creating a lumen of a desired shape and size in a hollow viscus organ (not necessarily the stomach) from the tissue of the organ.

FIG. 2shows the apparatus12being inserted distal end18first through the patient's esophagus72and into the interior74of the patient's stomach76. As the apparatus12is moved through the stomach interior74by manually operating the steerable feature control36, the apparatus distal end18is directed toward the pylorus78and is inserted through the pyloric valve82. The illumination light and/or endoscope28may be employed in directing the apparatus distal end18through the valve. Additionally, the illuminating light of the anchor feature42may be used in identifying the location of the apparatus distal end18inside the stomach by viewing the light through the stomach wall from the abdominal cavity.

With the apparatus distal end18inserted through the pyloric valve82and position in the pylorus78, the anchor feature control44is then manually operated to cause the anchor feature42to secure the apparatus distal end18to the stomach tissue.FIG. 3shows the balloon anchor feature42being inflated in the pylorus78and thereby securing the apparatus distal end18to the stomach tissue in the pylorus78.

The tube14of the apparatus12is then manipulated from the apparatus proximal end16to position a portion of the tube length and in particular to position the external surface adjustment feature52against the lesser curvature wall84of the stomach76as shown inFIG. 4. With the exterior surface adjustment feature52so positioned, the control54for the feature52is then manually operated to cause the feature52to enlarge to its desired shape configuration and circumferential dimensions as shown inFIG. 5.

The suction pressure feature62of the apparatus12is then activated by manual operation of its associated control64. This evacuates the stomach interior74through the suction pressure feature62and causes the stomach to contract around the apparatus and in particular around the exterior surface adjustment feature52. The contraction of the stomach causes portions of the stomach tissue along the stomach lesser curvature84to wrap around and envelop the exterior surface adjustment feature52. With portions of the stomach wall along the lesser curvature84wrapped over the exterior surface adjustment feature52, the template configuration of the exterior surface adjustment feature52is demarcated on the stomach wall outside the stomach, making it easier to discern the position of the exterior surface adjustment feature52from outside the stomach.

Opposing portions of the stomach wall are then affixed86together along the side of the exterior surface adjustment feature52that is opposite the stomach lesser curvature84. The opposing portions of the stomach wall can be affixed86together by conventional means such as stapling, suturing, etc. Plication could also be used to reduce the size of the stomach and secure the opposing portions of the stomach wall together along the side of the exterior surface adjustment feature52that is opposite the stomach lesser curvature84. This creates a lumen88of a desired shape and size in the stomach from the opposing portions of the stomach wall wrapped around the exterior surface adjustment feature52. The lumen88created has an interior configuration of a desired shape and size that conforms to the shape configuration and the circumferential size dimensions of the exterior surface adjustment feature52inside the just created lumen88. Due to the shape of the adjustment feature52and in particular the circumferential dimension of the adjustment feature52being larger adjacent the tube distal end18and becoming smaller as it extends toward the tube proximal end16, the interior configuration of the lumen88created is without any significant, limiting constriction in the lumen interior in the area of the stomach incisura or other tenuous area of the lumen interior.

With the lumen88created, the exterior surface adjustment feature52is controlled by its associated control54to return to its retracted condition on the apparatus tube14as shown inFIG. 6. The anchor feature42is also controlled by its associated control44to disengage from the stomach tissue as shown inFIG. 7. The apparatus12can then be removed from the lumen88. The lumen88then functions as a new gastric reservoir with an interior configuration that is without any significant, limiting constriction in the interior configuration of the lumen88in the area of the stomach incisura92or other tenuous interior area of the created lumen88after the apparatus12has been removed.