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Publication Number
US-10004513-B2
Publication Date
2018-06-26
Expiration Date
Abstract
An occlusion system can include an expandable implant that can be delivered to a bodily lumen. The implant can be carried on an engagement section of a catheter used in the system. The implant can be assembled onto the catheter by coupling a cover member of the implant with a support member of the implant. When assembled, the system can be advantageously configured to have a low delivery profile to facilitate delivery through catheters having a size of less than 7 Fr, and in some cases, less than 6 Fr.
Core Innovation
The invention relates to an endoluminal bodily lumen occlusion system that includes an expandable, membrane-covered implant carried on a catheter engagement section. The implant includes a helical member and is described as an occlusive device having a cover member and a support member. The cover member is membrane-covered and is coupled to the catheter engagement section via the cover member being placed relative to an aperture in the catheter sidewall.
The invention further describes manufacturing and/or assembling the occlusive implant by coupling a cover member to a support member and deploying the assembly through a guide sheath and a handle assembly. Proximal and distal release sliders and elongate wires are used to radially restrain proximal and distal implant sections in catheter apertures, notches, or slots until release. The system emphasizes an expandable self-expanding support carried on the catheter engagement section.
In addition, the implant carrier assembly is described with cover member structures including extension members and slits, and a closed end formed by everting an end section of the cover member. Manufacturing is described as positioning and coupling the support member over the cover member, then inserting or restraining an end portion of the support member at an engagement section of the catheter so that the cover member is coupled and an end of the cover member is closed. Materials and device geometry are described including nitinol and PTFE/ePTFE, and manufacturing includes piercing and everting operations to engage and close the cover member.
Claims Coverage
The provided independent claims are three distinct manufacturing methods. Across them, the inventive features consistently cover coupling a cover member to a catheter using a support member at an engagement section, and closing the cover member while engaging an elongate member extending in a catheter lumen; additionally, the claims specify cover-member everting and/or piercing, and define the support member as either self-expanding and/or a helical coil (in dependent claims).
Cover member covering catheter aperture for coupling
covering an aperture in a sidewall of a catheter with a cover member; positioning a support member over the cover member; inserting an end portion of the support member into the aperture to engage the end portion with the catheter, thereby coupling the cover member to the catheter
Evert cover member over support member end portion
everting an end section of the cover member over the end portion of the support member
Urging support member end portion into aperture and coupling while closing cover end
positioning a cover member over an aperture in a sidewall of a catheter; urging an end portion of a support member into the aperture to engage the end portion with the catheter, thereby coupling the cover member to the catheter; closing an end of the cover member
Engaging elongate member within catheter lumen with support member end portion
engaging an elongate member, extending within a lumen of the catheter, with the support member end portion
Cover member covering first engagement section and restraining support member end portion at first engagement section
covering a first engagement section of a catheter with a cover member; positioning a support member over the cover member; restraining an end portion of the support member at the first engagement section to engage the end portion with the catheter, thereby coupling the cover member to the catheter; closing an end of the cover member
Restricting coupling configuration to helical coil or self-expanding support (dependent features)
The support member is defined in dependent claims as comprising a helical coil and/or a self-expanding frame/self-expanding support.
Overall, the independent claims cover methods that couple a membrane-covered cover member to a catheter at an aperture or first engagement section using a support member, then close an end of the cover member and engage an elongate member extending within the catheter lumen with the support member end portion. Dependent features described in the claim set specify everting of a cover-member end section, closing by coupling cover-member end sections, and piercing the cover member to engage the elongate member with the support-member end portion, with the support member characterized as self-expanding and/or a helical coil.
Stated Advantages
Low delivery profile for catheters less than 7 Fr.
Low delivery profile for catheters less than 6 Fr via cover members with multiple extension members.
Rapid/secure occlusion with reduced risk of migration.
Documented Applications
Endoluminal bodily lumen occlusion using an expandable, membrane-covered implant carried on a catheter engagement section.
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