Telemetrically controlled band for regulating functioning of a body organ or duct, and methods of making, implantation and use
First Claim
1. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
- an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery;
a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct;
a tension element slidably disposed within the elongated member, the tension element including a helical screw thread portion having a first end and a free end, and a spring having a first end and a second end, the first end of the helical screw thread portion coupled to the second end of the spring at a junction, and the first end of the spring coupled to the first end of the elongated member, the spring permitting elastic extension of the tension element; and
a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the free end of the helical screw thread portion of the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct,wherein the rigid dorsal periphery of the elongated member and the spring of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically.
11 Assignments
0 Petitions
Accused Products
Abstract
Apparatus and methods are provided comprising an implantable non-hydraulic ring that encircles and provides a controllable degree of constriction to an organ or duct and an external control that powers and controls operation of the ring. The ring includes a rigid dorsal periphery that maintains a constant exterior diameter, and a compliant constriction system that reduces intolerance phenomena. A high precision, energy efficient mechanical actuator is employed that is telemetrically powered and controlled, and maintains the ring at a selected diameter when the device is unpowered, even for extended periods. The actuator provides a reversible degree of constriction of the organ or duct, which is readily ascertainable without the need for radiographic imaging. Methods of use and implantation also are provided.
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Citations
104 Claims
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1. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a helical screw thread portion having a first end and a free end, and a spring having a first end and a second end, the first end of the helical screw thread portion coupled to the second end of the spring at a junction, and the first end of the spring coupled to the first end of the elongated member, the spring permitting elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the free end of the helical screw thread portion of the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the spring of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a helical screw thread portion having a first end and a free end, and a spring having a first end and a second end, the first end of the helical screw thread portion coupled to the second end of the spring at a junction, the first end of the spring coupled to the first end of the elongated member, and the free end of the helical screw thread portion engaging and extending through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the tension element comprises; a core wire having an end; a cap affixed to the end of the core wire; a first helical spring disposed on the core wire, the helical spring having a square transverse profile; and a second helical spring interwound with the first helical spring to define a pitch of the first helical spring, wherein the second helical spring has a first end fixed to the core wire and a second end free to slidably extend over the core wire for a predetermined length to permit flexion of the tension element, the cap limiting extension of the second free end to maintain the pitch substantially constant.
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80. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elastic membrane is under tension when the loop is in a fully extended position, the elastic membrane contracting substantially without wrinkling when the loop is transitioned to a fully constricted position.
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81. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elongated member is preconditioned for use in a preselected gas to reduce swelling of the elastic membrane.
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82. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elongated member further comprises a valve or hole that facilitates gas exchange and reduces swelling of the elastic membrane.
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83. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elastic membrane is made from a material that possesses diffusion characteristics that impede or enhance diffusion of a preselected gas to reduce swelling of the elastic membrane when exposed to a preselected gas atmosphere.
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84. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery; a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct; a tension element slidably disposed within the elongated member, the tension element including a helical screw thread portion and a compliant portion that permits elastic extension of the tension element; and a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct, wherein the rigid dorsal periphery of the elongated member and the compliant portion of the tension element cooperate to permit straightening of the elongated member to facilitate passage into a patient'"'"'s abdomen laparoscopically, wherein the telemetrically-controlled actuator further comprises; an electric motor; a nut disposed on the helical screw thread portion of the tension element; a gear transmission coupling the nut to the electric motor; an antenna; and a processing circuit electrically coupled between the antenna and electric motor. - View Dependent Claims (85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99)
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100. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop, wherein the helical screw thread comprises; a core wire; a first helical spring disposed on the core wire, the helical spring having rectangular or trapezoidal transverse profile; and a second helical spring interwound with the first helical spring to define a pitch of the first helical spring, the second helical spring having first and second ends operatively associated with the core wire to permit flexion of the helical screw thread while maintaining the pitch substantially constant.
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101. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop, wherein the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elastic membrane is under tension when the loop is in a fully extended position, the elastic membrane contracting substantially without wrinkling when the loop is transitioned to a fully constricted position.
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102. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop, wherein the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elongated member is pre-conditioned for use in a preselected gas to reduce swelling of the elastic membrane.
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103. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop, wherein the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elongated member further comprises a valve or hole that facilitates gas exchange and reduces swelling of the elastic membrane.
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104. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:
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an elongated member having a first end and a second end, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach; a housing disposed on the second end of the elongated member; an electric motor disposed within the housing; an actuator disposed within the housing and coupled to the electric motor; a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator, wherein operation of the actuator causes the tension element to vary a diameter of the loop, wherein the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member, wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible, wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth, wherein the elastic membrane is made from a material that possesses diffusion characteristics that impede or enhance diffusion of a preselected gas to reduce swelling of the elastic membrane when exposed to a preselected gas atmosphere.
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Specification