DEVICE AND A METHOD FOR FACILITATING MONITORING THE CROSS-SECTION OF A GASTRIC SLEEVE DURING FORMATION THEREOF

• US 20120277525A1
• Filed: 10/11/2010
• Published: 11/01/2012
• Est. Priority Date: 10/09/2009
• Status: Active Grant

• Current Assignee: Flip Technologies Limited (Medtronic Plc)
• Original Assignee: Flip Technologies Limited (Medtronic Plc)
• Inventors: O'Dea, John
• Granted Patent: US 9,439,633 B2
• Time in Patent Office: Days
• US Class Current: 600/104
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/0003 of parts of the instruments
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10187 : Indicators for the level of inflation or deflation

Abstract

A device (1) for monitoring the transverse cross-section of a gastric sleeve (3) as the gastric sleeve (3) is being formed in a stomach (4) during a sleeve gastrectomy procedure comprises a catheter (15) with a primary balloon (19) located thereon towards a distal end (17). The primary balloon (19) is located in the stomach, and the portion of the stomach which is to form the gastric sleeve (3) is stretched around the primary balloon (19) when the primary balloon (19) has been inflated to a diameter approximating to the diameter to which the sleeve (3) is to be formed. As the stomach (4) is being sutured to form the sleeve (3) the pressure within the primary balloon (19) is monitored to avoid excessive stretching of the stomach around the primary balloon (19). The diameter of the primary balloon (19) is also monitored to avoid necking of the sleeve (3) during suturing of the stomach (4).

Claims

1-76. -76. (canceled)

77. A device for monitoring of the transverse cross-section of a gastric sleeve during formation thereof in a subject during a sleeve gastrectomy, the device comprising an elongated catheter extending between a proximal end and a distal end, a primary inflatable element defining a primary hollow interior region located on the catheter towards the distal end thereof, and a first communicating means communicating with the primary hollow interior region of the primary inflatable element for accommodating an inflating medium into the primary hollow interior region for inflating thereof, characterised in that the primary inflatable element when inflated is adapted to substantially define a desired transverse cross-section of the gastric sleeve.

78. A device as claimed in claim 77 in which the primary inflatable element when inflated is adapted to substantially define the interior of the gastric sleeve, and preferably, the primary inflatable element is of a non-elastic material, and advantageously, the primary inflatable element is of an elastic material.

79. A device as claimed in claim 77 in which the primary inflatable element defines a main portion extending from the proximal end thereof to a distal portion of greater transverse cross-section than the transverse cross-section of the main portion when the primary inflatable element is inflated, and preferably, an intermediate portion of the primary inflatable element located between the distal portion and the main portion tapers proximally from the distal portion to the main portion when the primary inflatable element is inflated, and preferably, the primary inflatable element is adapted to extend through the stomach from the lower oesophageal sphincter, and advantageously, the primary inflatable element is adapted to extend into the antrum adjacent the pylorus, and the distal portion of the primary inflatable element is adapted

80. A device as claimed in claim 79 in which the distal portion of the primary inflatable element tapers distally towards the catheter when the primary inflatable element is inflated, and the distally tapering portion of the primary inflatable element is adapted for locating in the antrum, and preferably, the main portion of the primary inflatable element is of substantially constant transverse cross-sectional area when the primary inflatable element is inflated.

81. A device as claimed in claim 77 in which the primary inflatable element is of circular transverse cross-section when inflated, and preferably, the catheter extends through the primary inflatable element, and the primary inflatable element defines with the catheter an annular hollow interior region when inflated.

82. A device as claimed in claim 77 in which a primary pressure sensing means is provided for monitoring the pressure of inflating medium in the primary inflatable element, and preferably, the primary pressure sensing means is located in the catheter within the primary inflatable element.

83. A device as claimed in claim 77 in which at least one primary stimulating electrode is located in the primary hollow interior region on one of the catheter and an inner surface of the primary inflatable element for receiving a primary stimulating signal, and at least one primary sensing electrode is located within the primary hollow interior region on one of the catheter and an inner surface of the primary inflatable element axially spaced apart from the at least one primary stimulating electrode for producing a primary signal indicative of one of the transverse cross-sectional area and the diameter of the primary inflatable element in response to the primary stimulating signal when the primary inflatable element is inflated with an electrically conductive inflating medium, and preferably, a pair of spaced apart primary stimulating electrodes are provided, and a plurality of spaced apart primary sensing electrodes are provided between the primary stimulating electrodes and spaced apart therefrom, and advantageously, a second communicating means is provided for communicating with the primary stimulating and sensing electrodes.

84. A device as claimed in claim 77 in which a secondary inflatable element defining a secondary hollow interior region is located on the catheter spaced apart from the primary inflatable element and to one end of the primary inflatable element for locating the catheter with the primary inflatable element located in the stomach, and preferably, the secondary inflatable element is located distally of the primary inflatable element for engaging the duodenum, with the pylorus located between the primary and secondary inflatable elements, and advantageously, the secondary inflatable element is distally spaced apart from the primary inflatable element a distance in the range of 10 mm to 30 mm, and preferably, a third communicating means is provided for communicating the secondary hollow interior region of the secondary inflatable element for accommodating an inflating medium into the secondary hollow interior region for inflating the secondary inflatable element, and preferably, the third communicating means is independent of the first communicating means for facilitating inflating of the secondary inflatable element independently of the primary inflatable element, and advantageously, the secondary inflatable element is of an elastic material.

85. A device as claimed in claim 84 in which at least one secondary stimulating electrode is located within the secondary hollow interior region on one of the catheter and an inner surface of the secondary inflatable element for receiving a stimulating signal, and at least one secondary sensing electrode is located in the secondary hollow interior region on one of the catheter and the inner surface of the secondary inflatable element axially spaced apart from the at least one secondary stimulating electrode for producing a secondary signal indicative of one of the transverse cross-sectional area and the diameter of the secondary inflatable element in response to a secondary stimulating signal applied to the at least one secondary stimulating electrode when the secondary hollow interior region is inflated with an electrically conductive medium, and preferably, a pair of spaced apart secondary stimulating electrodes are provided, and the at least one secondary sensing electrode is located between the secondary stimulating electrodes and spaced apart therefrom, and advantageously, a fourth communicating means is provided for communicating with the secondary stimulating and sensing electrodes, and preferably, the catheter extends through the secondary inflatable element and defines with the secondary inflatable element the secondary hollow interior region of annular shape when the secondary inflatable element is inflated.

86. A device as claimed in claimed in claim 77 in which an inflating means is provided for inflating the primary and secondary inflatable elements, and preferably, the inflating means is adapted for inflating the primary and secondary inflatable elements independently of each other, and advantageously, the inflating means comprises a primary inflating means adapted for inflating the primary inflatable element and a secondary inflating means adapted for inflating the secondary inflatable element.

87. A device as claimed in claim 77 in which a signal generating means is provided, the signal generating means being adapted for applying a primary stimulating signal to the at least one primary stimulating electrode, and preferably, the signal generating means is adapted for applying a secondary stimulating signal to the at least one secondary stimulating electrode, and advantageously, a signal processing means is provided for processing the primary signal produced on the at least one primary sensing electrode, and preferably, the signal processing means is adapted for determining one of the transverse cross-sectional area and the diameter of the primary inflatable element adjacent each primary sensing electrode from the corresponding primary signal produced thereon, and advantageously, the signal processing means is adapted for determining one of the transverse cross-sectional area and the diameter of the secondary inflatable element adjacent each secondary sensing electrode from the corresponding secondary signal produced thereon, and preferably, a display means is provided for displaying data indicative of the one of the transverse cross-sectional area and the diameter of the primary inflatable element adjacent the respective ones of the primary sensing electrodes, and advantageously, the display means is adapted for displaying data indicative of one of the transverse cross-sectional area and the diameter of the secondary inflatable element adjacent each secondary sensing electrode, and preferably, the data indicative of the one of the transverse cross-sectional area and the diameter of the primary element is displayed numerically, and advantageously, a graphical representation of the primary inflatable element is displayed on the display means, and preferably, the display means is adapted for displaying the pressure of the inflating medium in the primary hollow interior region of the primary inflatable element.

88. A device as claimed in claim 77 in which an imaging means is located for producing signals indicative of a captured image of the interior of the gastric sleeve, and preferably, the imaging means is located on the catheter, and advantageously, the imaging means is located within the primary inflatable element, and preferably, the imaging means is located intermediate the primary inflatable element and the secondary inflatable element, and advantageously, the imaging means is located adjacent the distal end of the catheter, and preferably, the imaging means is recessed into the catheter, and advantageously, the imaging means comprises a CMOS imaging chip, and preferably, a fifth communicating means is provided for communicating with the imaging means, and advantageously, the display means is adapted for displaying an image of the interior of the gastric sleeve captured by the imaging means from the signals produced by the imaging means, and preferably, the data processing means is adapted for processing the signals received from the imaging means prior to the captured image of the interior of the gastric sleeve being displayed on the display means, and preferably, the primary inflatable element is of a transparent material.

89. A device as claimed in claim 77 further comprising a former adapted for locating in the stomach of a subject for facilitating formation of an oversized gastric sleeve therearound, and preferably, the former is a hollow former adapted to accommodate the primary inflatable element therein.

94. A method for monitoring the transverse cross-section of a gastric sleeve during formation thereof in a subject in a sleeve gastrectomy, the method comprising locating the primary inflatable element of the device as claimed in claim 77 in the stomach of the subject, inflating the primary inflatable element with an inflating medium to a transverse cross-section approximating to the internal transverse cross-section to which the gastric sleeve is to be formed, suturing or stapling the stomach to form the gastric sleeve around the primary inflatable element, and monitoring one of the transverse cross-sectional area of the primary inflatable element, the diameter of the primary inflatable element and the pressure of the inflating medium in the primary inflatable element during suturing or stapling of the stomach in order to produce the gastric sleeve of the desired transverse cross-section, and preferably, a representation of the one of the transverse cross-sectional area and the diameter of the primary inflatable element adjacent each primary sensing electrode is displayed on the display means, and preferably, the representations of the one of the transverse cross-sectional area and the diameter of the primary inflatable element adjacent each primary sensing electrode is displayed numerically on the display means, and advantageously, a graphical representation of the primary inflatable element is displayed on the display means.

90. A method for monitoring the transverse cross-section of a gastric sleeve during formation thereof in a subject in a sleeve gastrectomy, the method comprising locating a primary inflatable element in the stomach of the subject, inflating the primary inflatable element with an inflating medium to a transverse cross-section approximating to the internal transverse cross-section to which the gastric sleeve is to be formed, suturing or stapling the stomach to form the gastric sleeve around the primary inflatable element, and monitoring one of the transverse cross- sectional area of the primary inflatable element, the diameter of the primary inflatable element and the pressure of the inflating medium in the primary inflatable element during suturing or stapling of the stomach in order to produce the gastric sleeve of the desired transverse cross-section.

91. A method as claimed in claim 90 in which the pressure of the inflating medium in the primary inflatable element is monitored during suturing or stapling of the stomach in order to determine if the stomach is being excessively stretched around the primary inflatable element during suturing or stapling of the stomach, and preferably, the portion of the stomach which is to form the gastric sleeve is urged around the inflated inflatable element prior to suturing or stapling, and the pressure of the inflating medium in the primary inflatable element is monitored as the portion of the stomach is being urged around the primary inflatable element.

92. A method as claimed in claim 90 in which the primary inflatable element is an elongated primary inflatable element and is located in the stomach to extend from a location adjacent the lower oesophageal sphincter, and preferably, the primary inflatable element extends into the antrum, and advantageously, the primary inflatable element extends to a location adjacent the pylorus.

93. A method as claimed in claim 90 in which the primary inflatable element is located towards a distal end of a catheter, and the primary inflatable element on the catheter is entered orally into the stomach of the subject through the oesophagus, and preferably, a secondary inflatable element is located on the catheter spaced apart from one of a proximal end and a distal end of the primary inflatable element, and the catheter is urged through the stomach of the subject until the secondary inflatable element is located in one of the duodenum and the oesophagus adjacent the corresponding one of the pylorus and the lower oesophageal sphincter, and preferably, the secondary inflatable element is located spaced apart from the distal end of the catheter, and the catheter is manoeuvred until the secondary inflatable element is located in the duodenum adjacent the pylorus, and advantageously, the primary inflatable element is located in the stomach with the pylorus located between the primary and secondary inflatable elements, and preferably, the pylorus is engaged by the primary and secondary inflatable elements, and advantageously, the secondary inflatable element is inflated for locating the primary inflatable element in the stomach.

95. A method as claimed in claim 90 in which the primary inflatable element is inflated with a saline solution, and preferably, the secondary inflatable element is inflated with a saline solution.)

96. A method as claimed in claim 90 in which a former is placed in the stomach prior to forming the gastric sleeve around the primary inflatable element, and the gastric sleeve is formed around the former to a transverse cross-sectional area greater than the desired transverse cross-sectional area, and the stomach is sutured or stapled along a preliminary stapling line, and preferably, on completion of suturing or stapling the stomach along the preliminary stapling line, the former is removed and the primary inflatable element is inflated to the internal transverse cross-sectional area to which the gastric sleeve is to be formed, and the gastric sleeve is formed around the primary inflatable element, and advantageously, the former is an elongated hollow former, and preferably, the primary inflatable element is located in the former, and advantageously, the primary inflatable element is inserted into the stomach in the former.