Patent Application
20160051804
This document relates to implantable medical devices. For example, this document relates to endolumenal sealing devices for repairing defects in a body lumen wall, and to methods for treating defects using the endolumenal sealing devices.
The need to remove lesions from the wall of the colon is common and growing worldwide. The likelihood of having polyps increases with age. Approximately half of the people over the age of 60 have at least one polyp and often more. Polyps are considered pre-cancerous, which means that while they are not cancer, if left untreated they may develop into cancer. Colon lesions are typically found during colon cancer screening tests, such as a colonoscopy or flexible sigmoidoscopy. Lesions of the colon can be in the form of polyps that protrude from the colon lining with a mushroom-like shape, or flat lesions that are flush on the colon wall.
Benign and early malignant lesions of the colon can usually be removed endoscopically using an electrocautery snare, hot snare, cold snare, or electrocautery knife devices. A saline-assisted polypectomy procedure is often used for the removal of large flat colon lesions. The procedure starts with injection of a solution into the submucosal space under the lesion, creating a safety cushion. The cushion lifts the lesion to facilitate its removal and minimizes mechanical or electrocautery damage to the deep layers of the GI tract wall.
When lesions become still larger and invasively encompass more than just the mucosal layers of the colon, a colectomy procedure is often performed whereby the full thickness of the colon wall tissue is removed along with the lesion. This procedure is typically performed using laparoscopic or open surgery techniques rather than endoscopically. Large resections of the colon are not typically performed endoscopically in part because tools and devices to adequately seal the resulting perforation in the colon wall are not available. Such tools and devices are challenging to develop in part because of the relatively hostile colon environment that includes peristaltic movements and fecal matter.
This document provides implantable medical devices. For example, this document provides partially-circumferential endolumenal sealing devices for sealing and repairing defects in a body lumen wall, and methods for treating lumen wall defects using the endolumenal sealing devices. Such defects can include, but are not limited to, vessel aneurysms and GI tract perforations. In some embodiments, the endolumenal sealing devices provided herein are well-suited for use in the GI tract including the colon. That is the case because the sealing devices can be configured to be partially-circumferential, whereby the device can be compliant with the peristaltic movements of the Cl tract. This feature can enable the sealing devices to resiliently remain located in a desired position within the GI tract, such that the defect in the lumen wall is sealed by the presence of the sealing device.
In general, one aspect of this document features an implantable medical device for treating a portion of a body lumen wall. The device comprises a membrane frame; a membrane material disposed on at least a portion of the membrane frame; a first strut extending from the membrane frame; and a second strut extending from the membrane frame, wherein the first and second struts are configured to exert opposing non-orthogonal forces to the membrane frame to thereby press at least a portion of the membrane material into contact with the body lumen wall.
In various implementations, the portion of the body lumen wall being treated by the device may comprise a defect, and the membrane material of the device may be configured to overlay the defect. The first and second struts may optionally each comprise elongate members that are unitary with an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame by one or more of a weld, an adhesive, and a sleeve. The first and second struts may extend from a perimeter of the membrane frame. The first and second struts may each comprise a discrete elongate member that is attached to the membrane frame at two or more points, and that forms a loop that is shaped as a generally elliptical segment when the device is in a fully expanded configuration. The first and second struts may have substantially identical shapes when the device is in a fully expanded configuration. In some embodiments, the membrane material may cover substantially the entire area defined by the membrane frame. In some embodiments, the device may assume a low-profile configuration when the device is maintained in a constraining environment, and the device may expand from the low-profile configuration and assumes an expanded configuration when the device is liberated from the constraining environment. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 120 to 180 degrees. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 60 to 120 degrees. In some embodiments, one or more of the first and second struts may include hinge points such that the one or more of the first and second struts are pivotable in relation to the membrane frame. The membrane material may be optionally configured to inhibit tissue ingrowth and endothelialization into the membrane material. At least a portion of the membrane material may be configured to be separated from the device and remain in a body when the device is removed from the body after treating the portion of the body lumen wall. The device may further comprise a bioabsorbable component that facilitates the separation of the at least a portion of the membrane material from the device. At least a portion of the membrane material that is configured to be separated from the device may be configured to promote tissue ingrowth or endothelialization into the membrane material, and in some embodiments the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 20 to 250 microns. In some embodiments, the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 100 to 200 microns. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a plurality of openings that have an average diameter of about 0.25 to 2.0 millimeters. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a coating of one or more growth factors. In some embodiments, the device further comprises an attachment feature configured for releasably coupling with a delivery device or a retrieval device. The membrane frame in some embodiments may further comprise one or more elongate elements extending between two locations on a perimeter of the membrane frame. The one or more elongate elements extending between two locations on the perimeter of the membrane frame may be non-linear. The device may optionally further comprise one or more radiopaque markers on the membrane frame, or one or more radiopaque markers on one or more of the first and second struts.
In various implementations, the portion of the body lumen wall may comprise a defect and the device may be configured to prevent protrusion of the membrane material into the defect. In some embodiments, the membrane frame has a length of about 0.5 to 15 centimeters. In some embodiments, the device may further comprise one or more tissue anchorage features on the membrane frame, on one or more of the first and second struts, or on both the membrane frame and one or more of the first and second struts. The struts may include atraumatic end portions. In some embodiments, at least portions of the first and second struts or the membrane frame may be coated with a coating that inhibits thrombus formation. Optionally, at least a portion of the membrane material may be modified by one or more chemical or physical processes to enhance particular properties of the materials.
In a second general aspect, this document features an implantable medical device for treating a portion of a body lumen wall, the device comprising: a membrane frame; a membrane material disposed on at least a portion of the membrane frame; a first strut extending from the membrane frame; and a second strut extending from the membrane frame, wherein the first and second struts are configured to press at least a portion of the membrane material into contact with the body lumen wall, and wherein the first and second struts each comprise an elongate member that extends from the membrane frame at two or more points and that forms a loop that is shaped as a generally elliptical segment when the device is in a fully expanded configuration.
In various implementations, the portion of the body lumen wall being treated by the device may comprise a defect, and the membrane material of the device may be configured to overlay the defect. The first and second struts may optionally each comprise elongate members that are unitary with an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame by one or more of a weld, an adhesive, and a sleeve. The first and second struts may extend from a perimeter of the membrane frame. The first and second struts may each comprise a discrete elongate member that is attached to the membrane frame at two or more points. The first and second struts may have substantially identical shapes when the device is in a fully expanded configuration. In some embodiments, the membrane material may cover substantially the entire area defined by the membrane frame. In some embodiments, the device may assume a low profile configuration when the device is maintained in a constraining environment, and the device may expand from the low-profile configuration and assumes an expanded configuration when the device is liberated from the constraining environment. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 120 to 180 degrees. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 60 to 120 degrees. In some embodiments, one or more of the first and second struts may include hinge points such that the one or more of the first and second struts are pivotable in relation to the membrane frame. The membrane material may be optionally configured to inhibit tissue ingrowth and endothelialization into the membrane material. At least a portion of the membrane material may be configured to be separated from the device and remain in a body when the device is removed from the body after treating the portion of the body lumen wall. The device may further comprise a bioabsorbable component that facilitates the separation of the at least a portion of the membrane material from the device. At least a portion of the membrane material that is configured to be separated from the device may be configured to promote tissue ingrowth or endothelialization into the membrane material, and in some embodiments the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 20 to 250 microns. In some embodiments, the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 100 to 200 microns. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a plurality of openings that have an average diameter of about 0.25 to 2.0 millimeters. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a coating of one or more growth factors. In some embodiments, the device further comprises an attachment feature configured for releasably coupling with a delivery device or a retrieval device. The membrane frame in some embodiments may further comprise one or more elongate elements extending between two locations on a perimeter of the membrane frame. The one or more elongate elements extending between two locations on the perimeter of the membrane frame may be non-linear. The device may optionally further comprise one or more radiopaque markers on the membrane frame, or one or more radiopaque markers on one or more of the first and second struts.
In various implementations, the portion of the body lumen wall may comprise a defect and the device may be configured to prevent protrusion of the membrane material into the defect. In some embodiments, the membrane frame has a length of about 0.5 to 15 centimeters. In some embodiments, the device may further comprise one or more tissue anchorage features on the membrane frame, on one or more of the first and second struts, or on both the membrane frame and one or more of the first and second struts. The struts may include atraumatic end portions. In some embodiments, at least portions of the first and second struts or the membrane frame may be coated with a coating that inhibits thrombus formation. Optionally, at least a portion of the membrane material may be modified by one or more chemical or physical processes to enhance particular properties of the materials.
In a third general aspect, this document features another implantable medical device for treating a portion of a body lumen wall. The device comprises: a membrane frame; a membrane material disposed on at least a portion of the membrane frame; a first strut extending from the membrane frame; and a second strut extending from the membrane frame, wherein the first and second struts are configured to press at least a portion of the membrane material into contact with the wall of the body lumen, and wherein the first and second struts each comprise an elongate member that is shaped as two arcuate segments and at least one wavy segment when the device is in a fully expanded configuration.
In various implementations, the portion of the body lumen wall being treated by the device may comprise a defect, and the membrane material of the device may be configured to overlay the defect. The first and second struts may optionally each comprise elongate members that are unitary with an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame. The first and second struts may optionally each comprise elongate members that are joined to an elongate member of the membrane frame by one or more of a weld, an adhesive, and a sleeve. The first and second struts may extend from a perimeter of the membrane frame. The first and second struts may each comprise a discrete elongate member that is attached to the membrane frame at two or more points. The first and second struts may have substantially identical shapes when the device is in a fully expanded configuration. In some embodiments, the membrane material may cover substantially the entire area defined by the membrane frame. In some embodiments, the device may assume a low-profile configuration when the device is maintained in a constraining environment, and the device may expand from the low-profile configuration and assumes an expanded configuration when the device is liberated from the constraining environment. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 120 to 180 degrees. The membrane frame may optionally be configured to contact an arcuate portion of the body lumen wall of about 60 to 120 degrees. In some embodiments, one or more of the first and second struts may include hinge points such that the one or more of the first and second struts are pivotable in relation to the membrane frame. The membrane material may be optionally configured to inhibit tissue ingrowth and endothelialization into the membrane material. At least a portion of the membrane material may be configured to be separated from the device and remain in a body when the device is removed from the body after treating the portion of the body lumen wall. The device may further comprise a bioabsorbable component that facilitates the separation of the at least a portion of the membrane material from the device. At least a portion of the membrane material that is configured to be separated from the device may be configured to promote tissue ingrowth or endothelialization into the membrane material, and in some embodiments the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 20 to 250 microns. In some embodiments, the portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may have an average porosity in the range of about 100 to 200 microns. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a plurality of openings that have an average diameter of about 0.25 to 2.0 millimeters. The portion of the membrane material that is configured to promote tissue ingrowth or endothelialization into the membrane material may include a coating of one or more growth factors. In some embodiments, the device further comprises an attachment feature configured for releasably coupling with a delivery device or a retrieval device. The membrane frame in some embodiments may further comprise one or more elongate elements extending between two locations on a perimeter of the membrane frame. The one or more elongate elements extending between two locations on the perimeter of the membrane frame may be non-linear. The device may optionally further comprise one or more radiopaque markers on the membrane frame, or one or more radiopaque markers on one or more of the first and second struts.
In various implementations, the portion of the body lumen wall may comprise a defect and the device may be configured to prevent protrusion of the membrane material into the defect. In some embodiments, the membrane frame has a length of about 0.5 to 15 centimeters. In some embodiments, the device may further comprise one or more tissue anchorage features on the membrane frame, on one or more of the first and second struts, or on both the membrane frame and one or more of the first and second struts. The struts may include atraumatic end portions. In some embodiments, at least portions of the first and second struts or the membrane frame may be coated with a coating that inhibits thrombus formation. Optionally, at least a portion of the membrane material may be modified by one or more chemical or physical processes to enhance particular properties of the materials. In some embodiments, the at least one wavy segment of the struts is disposed between the two arcuate segments.
In a fourth general aspect, this document features a method of treating a defect in a body lumen wall. The method comprises: inserting an implantable medical device into the body lumen using a transcatheter technique, wherein the membrane material is configured to overlay the defect. The device comprises: a membrane frame; a membrane material disposed on at least a portion of the membrane frame; a first strut extending from the membrane frame; a second strut extending from the membrane frame, wherein the first and second struts are configured to exert opposing non orthogonal forces to the membrane frame to thereby press at least a portion of the membrane material into contact with the wall of the body lumen; and one or more radiopaque markers attached to the device.
In various implementations, the method may further comprise visualizing the device during the inserting to confirm a positioning of the device as desired in relation to the defect. The method may further comprise detaching the device from a delivery device after confirming that the device has been positioned as desired in relation to the defect. In some embodiments, the defect may comprise an opening in the body lumen wall and the membrane material may be configured to fully overlay the opening. In some embodiments, the method may further comprise removing the device from the body lumen after the opening has been treated by the device. The method may optionally comprise, reconfiguring the device in a low-profile configuration prior to removal of the device. In some cases, the body lumen may comprise an intestine and the defect may comprise an opening in the wall of the intestine. In some cases, the intestine may be the colon. In some cases, the body lumen may be a blood vessel. In particular cases, the defect may be an aneurysm in the blood vessel. Optionally, the method may further comprise selecting the device based on a size of the defect. In some embodiments, the method may further comprise delivering a pharmacological agent to treat the defect.
In a fifth aspect, this document features a method of treating a defect in a body lumen wall. The method comprises: inserting a device into the body lumen using a transcatheter technique, wherein the membrane material is configured to overlay the defect. The device comprises: a membrane frame; a membrane material disposed on at least a portion of the membrane frame; a first strut extending from the membrane frame; a second strut extending from the membrane frame, wherein the first and second struts are configured to press at least a portion of the membrane material into contact with the body lumen wall, and wherein the first and second struts each comprise an elongate member that extends from the membrane frame at two or more points and that forms a loop that is shaped as a generally elliptical segment when the device is in a fully expanded configuration; and one or more radiopaque markers attached to the device.
In various implementations, the method may further comprise visualizing the device during the inserting to confirm a positioning of the device as desired in relation to the defect. The method may further comprise detaching the device from a delivery device after confirming that the device has been positioned as desired in relation to the defect. In some cases, the defect may comprise an opening in the body lumen wall and the membrane material may be configured to fully overlay the opening. In some embodiments, the method may further comprise removing the device from the body lumen after the opening has been treated by the device. The method may optionally comprise, reconfiguring the device in a low-profile configuration prior to removal of the device. In some cases, the body lumen may comprise an intestine and the defect may comprise an opening in the wall of the intestine. In some cases, the intestine may be the colon. In some cases, the body lumen may be a blood vessel. In particular cases, the defect may be an aneurysm in the blood vessel. Optionally, the method may further comprise selecting the device based on a size of the defect. In some embodiments, the method may further comprise delivering a pharmacological agent to treat the defect.
In a sixth general aspect, this document features an implantable medical device for treating a portion of a body lumen wall. The device comprises: a membrane frame; a membrane material disposed on at least a portion of the membrane frame; and two or more struts that each extend from the membrane frame and terminate at a free end, wherein the two or more struts are configured to exert non-orthogonal forces to the membrane frame to thereby press at least a portion of the membrane material into contact with the body lumen wall.
In various implementations, the device may comprise four struts. In some embodiments, the free ends may be configures to be atraumatic ends. Optionally, the two or more struts may each comprise elongate members that are joined to an elongate member of the membrane frame. The two or more struts may each comprise elongate members that are joined to an elongate member of the membrane frame by one or more of a weld, an adhesive, and a sleeve. The membrane frame may further comprise one or more elongate elements extending between two locations on a perimeter of the membrane frame. In some embodiments, the one or more elongate elements extending between two locations on the perimeter of the membrane frame may be non-linear. The device may further comprise one or more radiopaque markers on the membrane frame. The device may further comprise one or more radiopaque markers on one or more of the two or more struts.
Particular embodiments of the subject matter described in this specification can be implemented so as to realize one or more of the following advantages. In some embodiments, the partially-circumferential endolumenal sealing devices provided herein can be deployed into a body lumen of a patient using a minimally invasive transcatheter technique. The partially-circumferential endolumenal sealing devices can seal a defect in a body lumen wall so as to prevent the contents of the body lumen from exiting the lumen. The sealing function provided by the endolumenal sealing devices can promote healing of a body lumen wall defect by isolating the defect from the contents of the body lumen that may otherwise tend to inhibit the healing of the defect. In some embodiments, the partially-circumferential endolumenal sealing devices provided herein can be used treat aneurysms in blood vessels. The endolumenal sealing devices provide resilient fixation and consistent sealing of body lumen wall defects, even when positioned in body lumens that include anatomical movements—such as the peristaltic movements of the GI tract. Further, the endolumenal sealing devices are designed so as to not inhibit such movements. In some embodiments, the partially-circumferential endolumenal sealing devices provided herein can be deployed into a colon to seal a perforation related to a lesion resection. In such circumstances, the endolumenal sealing devices facilitate minimally invasive treatment of large colon lesions. In some embodiments, the partially-circumferential endolumenal sealing devices provided herein are repositionable and retrievable.
Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims.
The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and together with the description, serve to explain the principles of the disclosure, wherein;
Like reference symbols in the various drawings indicate like elements. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.
In reference to
As will be described in more detail below, the partially-circumferential endolumenal sealing device 100 is configured to be implanted in a patient such that the covering material 120 overlays and seals a defect in a body lumen wall. In that manner, the endolumenal sealing device 100 beneficially restricts the transfer of bio materials through the defect, and thereby promotes healing of the defect by isolating the defect from the contents of the body lumen that otherwise may tend to inhibit the healing process of the tissue surrounding the defect.
The partially-circumferential endolumenal sealing device 100 defines a longitudinal axis 130. In situ, the longitudinal axis 130 of the partially-circumferential endolumenal sealing device 100 approximately coincides with a central axis of the body lumen in which the partially-circumferential endolumenal sealing device 100 is placed.
The framework elements 110 support the covering material 120 in a generally expanded arrangement as shown, and maintain the covering material 120 in a desired location overlaying a defect in a body lumen wall. More specifically, the membrane frame 116 directly supports the covering material 120, and the struts 112 and 114 provide a supporting structure to press the combination of the membrane frame 116 and the covering material 120 against the wall of the body lumen. In this general fashion, the partially-circumferential endolumenal sealing device 100 can be placed in a body lumen to seal a defect in the body lumen wall.
The membrane frame 116 and the covering material 120 make contact with a partial circumferential portion of a body lumen wall. That is, rather than making contact with a full 360° circumference of the body lumen wall, the membrane frame 116 and the covering material 120 make contact with an arcuate portion of the body lumen wall that is less than 360°. For example, in various embodiments the membrane frame 116 and the covering material 120 make contact with an arcuate portion of the body lumen wall of about 120° to 180°, or about 90° to 150°, or about 60° to 120°, or about 30° to 90°, or less than 30°.
In some embodiments, the covering material 120 is made of a membranous material that inhibits or reduces passage of blood, and other bodily fluids and materials. In some embodiments, the covering material 120 has a material composition and configuration that inhibits or prevents tissue ingrowth to the covering material 120. In some embodiments, the covering material 120, or portions thereof, has a microporous structure that provides a tissue ingrowth scaffold for durable sealing and/or supplemental anchoring strength of the sealing device. Some embodiments of the covering material 120 comprise a fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer. In some embodiments, the covering material 120 comprises a polyester, a silicone, a urethane, another biocompatible polymer, Dacron, bioabsorbable systems, copolymers, or combinations and subcombinations thereof.
In some embodiments, a first portion of the covering material 120 is formed of a first material and a second portion of the covering material 120 is formed of a second material. For example, as described further in reference to
In some embodiments, a periphery of the covering material 120 or at least some edge portions of the covering material 120 are attached to the membrane frame 116. The attachment can be created by a variety of techniques, such as by stitching the covering material 120 to the membrane frame 116, by adhering the covering material 120 to the membrane frame 116, by cohering portions of the covering material 120 around the membrane frame 116, by using clips or barbs, or by other such techniques or combinations thereof. In some embodiments, the membrane frame 116, or portions thereof, may be coated with a bonding agent, for example fluorinated ethylene propylene (FEP) or other suitable adhesive for bonding the covering material 120 to the membrane frame 116. The adhesive may be applied through contact coating, powder coating, dip coating, spray coating, or any other appropriate means. The membrane frame 116 thereby provides a supportive structural framework for the covering material 120 that is otherwise relatively flaccid.
The first and second struts 112 and 114 provide apposition forces to press and maintain the covering material 120 in a desired location overlaying a defect in a body lumen wall. In situ, the first and second struts 112 and 114 make contact with areas of the body lumen wall, and forces are exerted by the first and second struts 112 and 114 onto the body lumen wall at those contact areas. Those forces are also transmitted by the first and second struts 112 and 114 to the membrane frame 116 so as to bias the membrane frame 116 and the covering material 120 into contact with the body lumen wall. In other words, in use the first and second struts 112 and 114 are preloaded and have ongoing mechanical stresses whereby the first and second struts 112 and 114 exert forces to the membrane frame 116 to press the membrane frame 116 and the supported covering material 120 against the body lumen wall to overlay and seal the defect.
The forces applied by the first and second struts 112 and 114 to the membrane frame 116 are not perpendicular to the longitudinal axis 130 of the partially circumferential endolumenal sealing device 100. Said another way, the first and second struts 112 and 114 apply non-radial apposition forces to the membrane frame 116. Further, the forces exerted by the first and second struts 112 and 114 to the membrane frame 116 can also be described as opposing non-orthogonal forces that press the covering material 120 into contact with the body lumen wall. This design feature of the framework elements 110 eliminates circumferential contact between the body lumen wall and the partially-circumferential endolumenal sealing device 100. In other words, at no transverse cross-section of the body lumen is there a full 360° of circumferential contact with the partially-circumferential endolumenal sealing device 100.
The design of the partially-circumferential endolumenal sealing device 100 facilitates a reliable ongoing seal of a defect in a body lumen wall. That is the case notwithstanding the fact that some anatomical environments in which the endolumenal sealing device 100 are used are dynamic, such as the peristaltic motion of the GI tract. One of the design features that facilitates the reliable ongoing seal of the partially-circumferential endolumenal sealing device 100 is the use of opposing non-orthogonal forces to press the covering material 120 into contact with the body lumen wall.
Some advantages of the designs of the sealing devices provided herein (including the feature of using opposing non-orthogonal forces to press the covering material 120 into contact with the body lumen wall) in the context of the dynamic anatomical environment created by peristalsis will now be explained. Peristaltic motion of the GI tract is comparable to wave motions that propel the contents of the GI tract along the GI tract, such as from the small intestines to the large intestines including the colon. Because, as explained above, at no transverse cross-section of the body lumen is there a full 360° of circumferential contact with the partially-circumferential endolumenal sealing device 100, as a peristaltic wave passes by the sealing device 100, only isolated portions of the framework elements 110 are effected at any one time. In result, therefore, the partially-circumferential endolumenal sealing device 100 will ride the peristaltic wave instead of being pushed along by the wave. In result, the partially-circumferential endolumenal sealing device 100 will maintain a reliable ongoing seal of a defect in a body lumen wall. Further, because no portion of the partially-circumferential endolumenal sealing device 100 is fully-circumferential, the peristaltic motion of the GI tract is not inhibited.
Another design feature of the partially-circumferential endolumenal sealing device 100 that facilitates a reliable ongoing seal of a defect in a body lumen wall is the flexibility and elasticity of the framework elements 110. In general, the framework elements 110 exhibit a high level of flexibility and elasticity. For example, in some embodiments at least some portions of the framework elements 110 are made from super-elastic materials such as nitinol. Further, in some embodiments the framework elements 110 have localized hinge-like areas and other features that are configured to be extra flexible. The flexibility and elasticity of the framework elements 110 allows the partially-circumferential endolumenal sealing device 100 to adapt to the dynamic anatomical environment created by peristalsis without migrating from the desired location within the body lumen. In some embodiments, auxiliary tissue anchorage features are included on the framework elements 110. Such anchorage features can provide increased fixation to resist migration of the partially-circumferential endolumenal sealing device 100 within the body lumen.
The flexibility and elasticity of the framework elements 110 make the partially-circumferential endolumenal sealing device 100 capable of transcatheter deployment. That is, in some embodiments the endolumenal sealing device 100 can be elastically collapsed to a low-profile configuration for temporary containment within a lumen of a delivery catheter or sheath. To deploy the endolumenal sealing device 100, the sheath containing the endolumenal sealing device 100 in the low-profile configuration is inserted into the body of a patient and directed to a target site—typically using radiographic visualization (e.g., fluoroscopy), or using endoscopic optics for direct visualization. At the target site, the endolumenal sealing device 100 is caused to emerge from the sheath, after which the endolumenal sealing device 100 self-expands, or is caused to expand, to an enlarged configuration. For example,
It should be understood that when the endolumenal sealing device 100 is deployed in a patient's body, there will typically be constraining forces applied to the endolumenal sealing device 100, such as from the walls of the body lumen in which the endolumenal sealing device 100 resides. Because of those constraining forces, the shape of the endolumenal sealing device 100 within the body will tend to be different than shown in the figures of the instant specification. Said another way, when the endolumenal sealing device 100 is deployed within the body, the endolumenal sealing device 100 will try to expand to its natural fully enlarged configuration, but the endolumenal sealing device 100 may be constrained by the contours of the anatomy at the target site. In that circumstance, the shape of the endolumenal sealing device 100 will tend to conform to the contours of the anatomy.
After the deployment of the endolumenal sealing device 100 at the target site, the contours of the anatomy may change over time. For example, if the endolumenal sealing device 100 is deployed within the GI tract, the peristaltic wave motion of the intestines may change the contours of the anatomy at the target site. In that circumstance, the flexibility and elasticity of the endolumenal sealing device 100 can allow the framework elements 110 to adapt in shape to thereby facilitate resilient ongoing contact between the covering material 120 and the defect.
As will be described in more detail below, it is envisioned that in some circumstances the endolumenal sealing device 100 will be implanted in a patient for a temporary period of time. This treatment technique may be used, for example, when a defect in a body lumen wall, such as a perforation, needs to be sealed off from the contents of the body lumen and allowed to heal (such as allowing a perforation to heal closed). In some such cases, the endolumenal sealing device 100 and other embodiments described herein can be deployed at the site of the defect and later removed after the perforation has healed. Therefore, in some embodiments the endolumenal sealing device 100 is retrievable, as will be described in more detail later. In addition, in some embodiments portions of the endolumenal sealing device 100 are retrievable while other portions will remain at the defect site. For example, in some embodiments portions of the covering material 120 can provide a scaffold for tissue ingrowth or endothelialization to promote healing of the defect. Then, those portions of the covering material 120 can be made to separate from the endolumenal sealing device 100 and stay at the defect site when the other parts of the endolumenal sealing device 100 are retrieved from the patient's body. In some embodiments, the partially-circumferential endolumenal sealing device 100, or portions thereof, are bioabsorbable such that the structure of the partially-circumferential endolumenal sealing device 100 will deteriorate in time. For example, in some such embodiments portions of the framework elements 110 may deteriorate by bioabsorption, after which other portions of the partially-circumferential endolumenal sealing device 100 may be naturally expelled from the GI tract, or otherwise retrieved.
Still referring to
In some embodiments, the elastic wire comprising the framework elements 110 may be a spring wire (e.g., L605 steel or stainless steels), shape memory alloy wire (e.g., nitinol or nitinol alloys), super-elastic alloy wire (e.g., nitinol or, nitinol alloys), other suitable types of wire, or combinations thereof. In some embodiments, the elastic wire comprising the framework or portions thereof may be constructed of polymeric materials. For example, in some embodiments a polymeric sleeve is used to couple two metallic wires together. In some such embodiments, the polymeric sleeve can provide a living hinge. In some embodiments, different types of wires are used at different locations of the framework elements 110. For example, stainless steel wires can be used for the struts 112 and 114 while nitinol wire is used for the membrane frame 116, or vice versa. In some embodiments, the framework elements 110 are coated with a coating that inhibits thrombus formation.
Features to enhance the radiographic visibility of the partially-circumferential endolumenal sealing devices provided herein are included in some embodiments. For example, in some embodiments the elastic wire framework elements 110 are constructed of a drawn-filled type of nitinol containing a different metal at the core, such as a radiopaque metal (e.g., platinum, tungsten, tantalum, palladium alloys, and the like). Further, in some embodiments, such as with the endolumenal sealing device 100, radiopaque markers 118 are included on portions of the framework elements 110 (or on the covering material 120).
The framework elements 110 of the partially-circumferential endolumenal sealing devices provided herein can comprise one or more wires. For example, the partially-circumferential endolumenal sealing device 100 comprises three discrete wires that are joined together: (1) the first strut 112, (2) the second strut 114, and (3) the membrane frame 116. The wires can be joined together using a variety of techniques including, but not limited to bonding, welding, gluing, by using a sleeve coupling, and the like, and combinations thereof.
In some embodiments, the membrane frame 116 has the two free ends of its elongate wire member joined together to form a closed shape. A variety of shapes are envisioned, such as ovular, circular, rectangular, triangular, and any other suitable shape. The membrane frame 116 can also be three dimensional in shape. For example, the membrane frame 116 can be saddle-shaped or arcuate and have a curvature that approximately corresponds to the curvature of a body lumen wall that the membrane frame 116 will be in contact with. Such a curvature can be induced in the membrane frame 116 using various techniques including, but not limited to, bending, stretching, pressing, stamping, heat-setting, and the like.
In some embodiments, such as the partially-circumferential endolumenal sealing device 100, the two free ends of the first and second struts 112 and 114 are joined to the perimeter of the membrane frame 116 at two locations. As such, the first and second struts 112 and 114 extend from the membrane frame 116. In some embodiments, the first and second struts 112 and 114 each comprise an elongate member that extends from the membrane frame 116 at two or more points and that forms a loop that is shaped as a generally elliptical segment when the sealing device 100 is in a fully expanded configuration. In some embodiments, the first and second struts 112 and 114 are substantially mirror images of each other. In some embodiments, the first and second struts 112 and 114 are dissimilarly sized or shaped in relation to each other.
As will be described in more detail below (e.g., in reference to
In reference to
The partially-circumferential endolumenal sealing device 150 can be collapsed to a low-profile configuration for transcatheter delivery to a target site within a body lumen, and for transcatheter retrieval therefrom, as can the other partially-circumferential endolumenal sealing devices provided herein. The partially-circumferential endolumenal sealing device 150 can self-expand, or be assisted to expand, to the configuration shown in
The struts 162 and 164 can have wavy portions 163 and 165 respectively. In some embodiments, such wavy portions 163 and 165 can facilitate the application of an increased amount of non-radial apposition forces to the membrane frame 166. The wavy portions 163 and 165 can also enhance the fixation of the struts 162 and 164 to the body lumen wall.
The membrane frame 166 is generally rectangular. However, a rectangular membrane frame 166 is not a requirement when the framework element 160 is a unitary wire. The membrane frame 166 of the unitary wire framework element 160 can be formed into any shape as desired, such as the other shapes of the membrane frame 116 described above.
In reference to
The endolumenal sealing devices provided herein can be used to treat perforations of body lumens, such that the perforation is sealed and allowed to heal while being isolated from the contents of the body lumen that may tend to inhibit the healing process. For example, fecal matter within a colon would tend to inhibit the healing process of a perforation of the colon wall. In such circumstances, the partially-circumferential endolumenal sealing device 100 can be temporarily implanted in the colon such that the covering material 120 overlays the perforation of the colon wall. In result, the perforation will be sealed such that fecal matter will not escape from the colon to contaminate other portions of the body, and the tissue surrounding the perforation will be isolated from fecal matter so that the tissue's healing process will not be inhibited. After the perforation has healed closed, the partially-circumferential endolumenal sealing device 100, or portions thereof, can be removed from the colon of the patient.
In reference to
In some embodiments, the cross members 317 and 318 are arcuately shaped with a curvature that is approximately equal to the curvature of the body lumen wall to facilitate conformance therewith. In some embodiments, the cross members 317 and 318 are arcuately shaped with a greater or lesser degree of curvature in comparison to the curvature of the body lumen wall. In some such embodiments, an additional pressure is applied by the cross members 317 and 318 to the body lumen wall.
The cross members 317 and 318 can be made of the same material as the struts 312 and 314 and the membrane frame 316. Alternatively, the cross members 317 and 318 can be made from a material that is different from the struts 312 and 314 and/or the membrane frame 316. The cross members 317 and 318 can be joined to the membrane frame 316 using the techniques for joining wire members as described elsewhere herein.
In some embodiments, the cross members 317 and 318 are not directly attached to the covering material 320 but rather the cross members 317 and 318 merely support or undergird the covering material 320. In some embodiments, the cross members 317 and 318 are attached, to the covering material 320 or portions thereof by a variety of techniques, such as by stitching the covering material 320 to the cross members 317 and 318, by adhering the covering material 320 to the cross members 317 and 318, by using clips or barbs, or by other such techniques, or combinations thereof. In some embodiments, two layers of covering material 320 are adhered to each other and the cross members 317 and 318 are sandwiched between the layers. In some such embodiments, the two layers of covering material 320 can be completely, or at least partially, joined together using an adhesive, stitching, and the like. In some embodiments, the cross members 317 and 318 are woven through the covering material 320 to interlock the cross members 317 and 318 with the covering material 320.
While the partially-circumferential endolumenal sealing device 300 includes two elongate cross members 317 and 318, and the cross members 317 and 318 extend transversely in relation to the longitudinal axis 330, those particular design attributes are not required of all such elongate elements that provide additional support to the covering material 320. For example, in some embodiments one, three, four, or more than four cross members are used. Further, in some embodiments the cross members extend in other directions, such as parallel with the axis 330, or at diagonals thereto. In some embodiments, the cross members extend in two or more directions, such as in a cross-hatched pattern, for example. Some cross members can have a different mechanical properties (such as modulus of elasticity or stiffness) than other cross members, or be comprised of a different material or size of material.
In reference to
In reference to
The partially-circumferential endolumenal sealing device 400 can be collapsed to a low-profile configuration for transcatheter delivery to a target site within a body lumen, and for transcatheter retrieval therefrom, as can other partially-circumferential endolumenal sealing devices provided herein. The partially-circumferential endolumenal sealing device 400 can self-expand, or be assisted to expand, to the configuration shown in
The partially-circumferential endolumenal sealing device 400 includes a membrane frame 416 with two elongate wire members that are generally parallel with the axis 430 and to which the covering material 420 is attached. In some embodiments, the covering material 420 can be reinforced by one or more elongate cross members, such as the five cross members 417 of the endolumenal sealing device 400. The two elongate wire members of the membrane frame 416 can be combined with the cross members 417 to define a rectangular arcuate framework on which the covering material 420 is disposed.
In this example, the partially-circumferential endolumenal sealing device 400 is configured to contact an arcuate portion of a body lumen wall of about 180°. A similar type of construction can be used to create other partially-circumferential endolumenal sealing devices that have different proportions. For example, some embodiments of partially-circumferential endolumenal sealing devices include an arcuate rectangular framework that is configured to contact an arcuate portion of a body lumen wall of about 120° to 180°, or about 90° to 150°, or about 60° to 120°, or about 30° to 90°, or less than 30°.
In some embodiments, the struts 412 and 414 include wavy segment portions 413 and 415 respectively. In some embodiments, other types of wavy portions or no such wavy portions are included in the struts 412 and 414. The struts 412 and 414 are configured to exert opposing non-orthogonal apposition forces to the membrane frame 416, to thereby press the covering material 420 against the wall of a body lumen, and to overlay and seal a defect in the body lumen wall.
In reference to
The partially-circumferential endolumenal sealing device 450 can be collapsed to a low-profile configuration for transcatheter delivery to a target site within a body lumen and for transcatheter retrieval therefrom, as can other partially-circumferential endolumenal sealing devices provided herein. The partially-circumferential endolumenal sealing device 450 can self-expand, or be assisted to expand, to the configuration shown in
The membrane frame 466 is substantially rectangular, as defined by two elongate wire members that are generally parallel with the axis 475 and four cross members 467. In some embodiments, the membrane frame 466 can incorporate other shapes and constructions of elongate wire frame members, combinations of different types of frame members, hinge points, and the like. The membrane frame 466 is substantially planar. In some embodiments, the membrane frame 466 can be arcuate as described elsewhere herein (e.g., refer to
In some embodiments, the partially-circumferential endolumenal sealing device 450 can include two elongate elements 421 that are generally parallel with the axis 475 and that interconnect the struts 462 and 464. In some embodiments, a unitary wire comprises the two elongate elements 421 and the struts 462 and 464. In some embodiments, two or more wires are joined, together to comprise the two elongate elements 421 and the struts 462 and 464.
The membrane frame 466 can be joined to the two elongate elements 421 that interconnect the struts 462 and 464. For example, in some embodiments, the membrane frame 466 is joined to each of the two elongate elements 421 at two joints 469 as shown. In some embodiments, instead of two joints 469, the membrane frame 466 is joined to each of the two elongate elements 421 by a single joint, an elongated joint, or by three or more joints. In some embodiments, the two joints 469 can function as hinge points. In some such cases, the end portions of the two elongate elements 421 can be flexible and thereby pivotable in relation to the middle portion of the elongate elements 421 that is joined to the membrane frame 466. Such an ability by the elongate elements 421 to pivot can increase the overall flexibility of the partially-circumferential endolumenal sealing device 450, thereby enhancing the device's ability to conform with the contours of the anatomy. In some embodiments, hinge portions are included on the membrane frame 466 to also enhance the device's ability to conform with the contours of the anatomy.
In reference to
The struts 482, 484, 486, and 488 of the partially-circumferential endolumenal sealing device 480 are elongate wire members that each include a first and a second end. The first ends of the struts 482, 484, 486, and 488 terminate at the membrane frame 492 such that the struts 482, 484, 486, and 488 each extend from the membrane frame 492. The second ends of the struts 482, 484, 486, and 488 are free ends 483, 485, 487, and 489 respectively. Therefore, each strut 482, 484, 486, and 488 is an individual supporting member or leg that extends from the membrane frame 492.
The forces applied by the struts 482, 484, 486, and 488 to the membrane frame 492 are not perpendicular to the longitudinal axis 495 of the partially-circumferential endolumenal sealing device 480. Said another way, the struts 482, 484, 486, and 488 apply non-radial apposition forces to the membrane frame 492. Further, the forces exerted by the struts 482, 484, 486, and 488 to the membrane frame 492 can also be described as opposing non-orthogonal forces that press the covering material 494 into contact with the body lumen wall 210. This design feature of the framework elements 490 eliminates circumferential contact between the body lumen wall 210 and the partially-circumferential endolumenal sealing device 480. In other words, at no transverse cross-section of the body lumen 200 is there a full 360° of circumferential contact with the partially-circumferential endolumenal sealing device 480.
As mentioned previously, the struts 482, 484, 486, and 488 of the partially-circumferential endolumenal sealing device 480 include free ends 483, 485, 487, and 489 respectively. In some embodiments, the free ends 483, 485, 487, and 489 are configured as atraumatic ends. For example, the free ends 483, 485, 487, and 489 can be formed to have blunt ends or feet portions that inhibit penetration of the free ends 483, 485, 487, and 489 into the body lumen wall 210. In some embodiments, the free ends 483, 485, 487, and 489 can be configured to penetrate into the body lumen 200 to enhance the anchorage of the sealing device 480 in relation to the body lumen 200.
As with other struts described herein, some or all of the struts 482, 484, 486, and 488 can comprise a variety of different features and configurations including, but not limited to, linear portions, bends, wavy portions, arcuate portions, sinusoidal portions, eyelets, loops, angular portions, anchorage features, spring-like portions, hinges, and the like, and combinations thereof. In some embodiments, the struts 482, 484, 486, and 488 each have the same general shape and features. In some embodiments, one or more of the struts 482, 484, 486, and 488 is different than the others. For example, a particular one or more of the struts 482, 484, 486, or 488 can have a shape and/or features that the others of the struts 482, 484, 486, or 488 do not have.
In reference to
In a first example, in reference to
In a second example, in reference to
In some embodiments, the covering materials, detachable portions, or pad materials used in the endolumenal sealing devices provided herein are modified by one or more chemical or physical processes that enhance certain properties of the materials. For example, in some embodiments, a hydrophilic coating is applied to the materials to improve the wettability and echo translucency of the materials. In some embodiments the covering materials, detachable portions, or pad materials are modified with chemical moieties that promote one or more of endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and resistance to or promotion of thrombosis. In some embodiments the covering materials, detachable portions, or pad materials are modified with one or more covalently attached drug substances (e.g., heparin, antibiotics, and the like) or impregnated with the one or more drug substances. The drug substances can be released in situ to promote healing, reduce tissue inflammation, reduce or inhibit infections, and to promote various other therapeutic treatments and outcomes. In some embodiments the drug substance is a corticosteroid, a human growth factor, an anti-mitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate, to name some examples.
Coatings and treatments may be applied before or after the covering materials, detachable portions, or pad materials are joined or disposed on the wire members of the endolumenal sealing devices. Additionally, one or both sides of the covering materials, detachable portions, or pad materials may be coated. In some embodiments, certain coatings and/or treatments are applied to the material(s) located on some portions of an endolumenal sealing device, and other coatings and/or treatments are applied to the material(s) located on other portions of the endolumenal sealing devices. In some embodiments, a combination of multiple coatings and/or treatments are applied to the covering materials, detachable portions, or pad materials. In some embodiments, certain portions of the device are left uncoated and/or untreated.
In reference to
The partially-circumferential endolumenal sealing device 600 can be collapsed to a low-profile configuration for transcatheter delivery to a target site within a body lumen and for transcatheter retrieval therefrom, as can other partially-circumferential endolumenal sealing devices provided herein. The partially-circumferential endolumenal sealing device 600 can self-expand, or be assisted to expand, to the configuration shown in
As exemplified by the partially-circumferential endolumenal sealing device 600, in some embodiments the partially-circumferential endolumenal sealing devices provided herein include various types of fixation anchors. Some non-limiting examples of various types of fixation anchors are provided in
In reference to
The retrieval cord 730 can be slidably coupled with the strut 712 at various locations on the strut 712. In some such locations on the strut 712, eyelets, bends, loops, and the like, can be used to facilitate the coupling between the strut 712 and the retrieval cord 730. As shown in
When retrieval of the endolumenal sealing device 700 from the body lumen is desired, a retrieval sheath 750 containing a grasping tool 740 can be routed to the location of the endolumenal sealing device 700 in the patient's body. The grasping tool 740 can be used to couple with the retrieval cord 730. As the grasping tool 740 is thereafter retracted, tension is applied to the retrieval cord 730. The tensioning and displacement of the retrieval cord 730 caused by the grasping tool 740 will cause the strut 712 to collapse as illustrated in
In reference to
In comparison to the elliptical segment of
In reference to
In some embodiments, the anchor features are joined directly to the wire members of the struts or membrane frame, such as by welding or gluing. In some embodiments, the anchor features comprise a tube that is cut (e.g., laser cut) and the tube is placed over the wire member of the struts or membrane frame.
While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.
In addition to being directed to the teachings described above and claimed below, devices and/or methods having different combinations of the features described above and claimed below are contemplated. As such, the description is also directed to other devices and/or methods having any other possible combination of the dependent features claimed below.
Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14030535 | Sep 2013 | US |
| Child | 14933169 | US |
