Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: Disclosed are cell encapsulation devices and methods for transplanting cells, such as pancreatic endoderm cells, into a host. In some examples, a cell encapsulation can comprise a lumen configured to receive cells therein, a cell-excluding membrane, where the lumen is internal to the cell-excluding membrane, and a non-woven fabric layer external to the cell-excluding membrane, where the non-woven fabric layer and the cell-excluding membrane comprise perforations. The device can further comprise a woven mesh external to the non-woven fabric layer, where the non-woven fabric layer provides protection to the cell-excluding membrane from direct contact with the woven mesh.

Abstract: Disclosed are devices and methods for transplanting cells, such as pancreatic endoderm cells, into a host. The devices include a non-woven fabric external to a cell-excluding membrane, and the non-woven fabric and/or cell-excluding membrane can be perforated. Treatment of the host with immunosuppressive reagents, required to inhibit allograft rejection due to perforations in the cell delivery device, does not compromise maturation or function of transplanted pancreatic endoderm cells.

Abstract: A biocompatible membrane composite including a cell impermeable layer and a mitigation layer is provided. The cell impermeable layer is impervious to vascular ingrowth and prevents cellular contact from the host. Additionally, the mitigation layer includes solid features. In at least one embodiment, mitigation layer has therein bonded solid features. In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded or otherwise connected to each other to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned external to or within the biocompatible membrane composite to provide support to and prevent distortion. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: Disclosed herein is a device which is intended to deliver and maintain reduced pressure to body surfaces for application of reduced pressure wound therapy (RPWT) also known as negative pressure wound therapy (NPWT). During application of this type of therapy, a substantially airtight seal is formed around a section of tissue to be treated. This seal is formed by a dressing which provides fluid communication from a section of tissue to a reduced pressure source. Disclosed herein is a dressing system which is configured to enhance usability and functionality of this dressing. First, the system may be configured to allow full rotation of the fluid communication conduit to the reduced pressure source along the axis substantially normal to the dressing. Second, the system may be configured to include a one-way valve to prevent backflow of any drainage fluids. Third, the system may be configured with transparent windows covered by opaque flaps to allow inspection through the dressing.

Abstract: Cell encapsulation devices for biological entities and/or cell populations that contain at least one biocompatible membrane composite are provided. The cell encapsulation devices mitigate or tailor the foreign body response from a host such that sufficient blood vessels are able to form at a cell impermeable surface. Additionally, the encapsulation devices have an oxygen diffusion distance that is sufficient for the survival of the encapsulated cells so that the cells are able to secrete a therapeutically useful substance. The biocompatible membrane composite is formed of a cell impermeable layer and a mitigation layer. The cell encapsulation device maintains an optimal oxygen diffusion distance through the design of the cell encapsulation device or through the use of lumen control mechanisms. Lumen control mechanisms include a reinforcing component that is also a nutrient impermeable layer, internal structural pillars, internal tensioning member(s), and/or an internal cell displacing core.

Abstract: A biocompatible membrane composite including a first layer (cell impermeable layer), a second layer (a mitigation layer), and a third layer (a vascularization layer) is provided. The mitigation layer may be positioned between the cell impermeable layer and the vascularization layer In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned on either side of the biocompatible membrane composite or within the biocompatible membrane composite to provide support to and prevent distortion of the membrane composite. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: A biocompatible membrane composite that can provide an environment that is able to mitigate or tailor the foreign body response is provided. The membrane composite contains a mitigation layer and a vascularization layer. A reinforcing component may optionally be included to provide support to and prevent distortion of the biocompatible membrane composite in vivo. The mitigation layer may be bonded (e.g., point bonded or welded) or adhered (intimately or discretely) to an implantable device and/or cell system. The biocompatible membrane composite may be used as a surface layer for implantable devices or cell systems that require vascularization for function but need protection from the host's immune response, such as the formation of foreign body giant cells. The biocompatible membrane composite may partially or fully cover the exterior of an implantable device or cell system. The mitigation layer is positioned between the implantable device or bioactive scaffold and the vascularization layer.

Abstract: Disclosed herein is a device which is intended to deliver and maintain reduced pressure to body surfaces for application of reduced pressure wound therapy (RPWT) also known as negative pressure wound therapy (NPWT). During application of this type of therapy, a substantially airtight seal is formed around a section of tissue to be treated. This seal is formed by a dressing which provides fluid communication from a section of tissue to a reduced pressure source. Disclosed herein is a dressing system which is configured to enhance usability and functionality of this dressing. First, the system may be configured to allow full rotation of the fluid communication conduit to the reduced pressure source along the axis substantially normal to the dressing. Second, the system may be configured to include a one-way valve to prevent backflow of any drainage fluids. Third, the system may be configured with transparent windows covered by opaque flaps to allow inspection through the dressing.

Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: Embodiments herein describe tools and instruments for holding, transferring, delivering, deploying an implantable device and methods and means of aseptically storing and shipping the implantable device including but not limited to a device case for protecting, housing and filling the device, a surgical sizer for preparing the implantable site, a deployer for transferring the implantable device from the device case and delivering or deploying the implantable device at the prepared implantable site.

Abstract: A surgical tissue therapy device includes a sealant layer and a collection chamber. The sealant layer functions so as to create a sealed enclosure, or space between it and the surface of a patient, by forming an airtight seal around a surgical area of skin trauma. The closed incision tissue therapy device also comprises a collection chamber, which may comprise an elongate tubular chamber with a plurality of longitudinally spaced openings. The collection chamber may be configured to be in fluid communication with the sealant layer and the area of skin trauma and functions as to distribute the negative pressure applied to a surgically closed area of skin trauma. Preferably, the pressure under the sealant layer is reduced by expanding the volume of the enclosure space and thereby decreasing the density of air molecules under the sealant layer. The collection material may comprise a material and/or a configuration that permits length changes based upon the length of the corresponding surgical wound or incision.

Abstract: A medical device includes (a) a capsule including a lumen extending therethrough, a proximal end of the capsule including at least one window extending therethrough; (b) a bushing including a channel extending therethrough, a distal end including at least one arm extending distally therefrom such that a corresponding one of the arms is releasably engagable with a corresponding one of the windows; and (c) a core member including a locking portion and at least one engaging element. The locking portion is sized and shaped to be received within the channel of the bushing to apply a pressure to the arm such that the arm engages the windows. The engaging element extends laterally outward from a portion of the core member such that the engaging element engages a corresponding one of the arms to deform the arms radially inward and out of engagement with the windows.

Abstract: Reduced pressure wound therapy is performed on a sacral region of a patient using an adhesive dressing comprising a flexible planar layer and a non-planar fold-sealing region configured to seal to the intergluteal cleft of a patient. The fold-sealing region is located on an outer edge of the adhesive dressing and comprises a tapered configuration.

Abstract: A medical device is disclosed for delivering energy to a body lumen. The device includes an elongate member including a proximal portion and a distal portion adapted for insertion into a body lumen; and an energy delivery device disposed adjacent the distal portion of the elongate member, the energy delivery device including at least one elongate electrode arm, wherein the elongate electrode arm is configured to transition between a first configuration and a second configuration different than the first configuration. The at least one elongate electrode arm includes an active region configured to contact and deliver energy to the body lumen. When the elongate electrode arm is in the first configuration, at least a portion of the active region of the elongate electrode arm extends radially inward toward a longitudinal axis of the energy delivery device.

Abstract: Disclosed are devices and methods for transplanting cells, such as pancreatic endoderm cells, into a host. The devices include a non-woven fabric external to a cell-excluding membrane, and the non-woven fabric and/or cell-excluding membrane can be perforated. Treatment of the host with immunosuppressive reagents, required to inhibit allograft rejection due to perforations in the cell delivery device, does not compromise maturation or function of transplanted pancreatic endoderm cells.

Abstract: Disclosed herein is a device which is intended to deliver and maintain reduced pressure to body surfaces for application of reduced pressure wound therapy (RPWT) also known as negative pressure wound therapy (NPWT). During application of this type of therapy, a substantially airtight seal is formed around a section of tissue to be treated. This seal is formed by a dressing which provides fluid communication from a section of tissue to a reduced pressure source. Disclosed herein is a dressing system which is configured to enhance usability and functionality of this dressing. First, the system may be configured to allow full rotation of the fluid communication conduit to the reduced pressure source along the axis substantially normal to the dressing. Second, the system may be configured to include a one-way valve to prevent backflow of any drainage fluids. Third, the system may be configured with transparent windows covered by opaque flaps to allow inspection through the dressing.

Abstract: Disclosed herein is a device which is intended to deliver and maintain reduced pressure to body surfaces for application of reduced pressure wound therapy (RPWT) also known as negative pressure wound therapy (NPWT). During application of this type of therapy, a substantially airtight seal is formed around a section of tissue to be treated. This seal is formed by a dressing which provides fluid communication from a section of tissue to a reduced pressure source. Disclosed herein is a dressing system which is configured to enhance usability and functionality of this dressing. First, the system may be configured to allow full rotation of the fluid communication conduit to the reduced pressure source along the axis substantially normal to the dressing. Second, the system may be configured to include a one-way valve to prevent backflow of any drainage fluids. Third, the system may be configured with transparent windows covered by opaque flaps to allow inspection through the dressing.

Abstract: A medical device includes (a) a capsule including a lumen extending therethrough, a proximal end of the capsule including at least one window extending therethrough; (b) a bushing including a channel extending therethrough, a distal end including at least one arm extending distally therefrom such that a corresponding one of the arms is releasably engagable with a corresponding one of the windows; and (c) a core member including a locking portion and at least one engaging element. The locking portion is sized and shaped to be received within the channel of the bushing to apply a pressure to the arm such that the arm engages the windows. The engaging element extends laterally outward from a portion of the core member such that the engaging element engages a corresponding one of the arms to deform the arms radially inward and out of engagement with the windows.

Abstract: A medical device is disclosed for delivering energy to a body lumen. The device includes an elongate member including a proximal portion and a distal portion adapted for insertion into a body lumen; and an energy delivery device disposed adjacent the distal portion of the elongate member, the energy delivery device including at least one elongate electrode arm, wherein the elongate electrode arm is configured to transition between a first configuration and a second configuration different than the first configuration. The at least one elongate electrode arm includes an active region configured to contact and deliver energy to the body lumen. When the elongate electrode arm is in the first configuration, at least a portion of the active region of the elongate electrode arm extends radially inward toward a longitudinal axis of the energy delivery device.