Deploying and fixating an implant across an organ wall

• US 10,874,349 B2
• Filed: 05/07/2016
• Issued: 12/29/2020
• Est. Priority Date: 05/07/2015
• Status: Active Grant

• Current Assignee: Vectorious Medical Technologies Ltd.
• Original Assignee: Vectorious Medical Technologies Ltd.
• Inventors: Goldshtein, Oren, Levi, Yair, Harari, Boaz
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US15/566,329
• Publication Number:
  US 20180098772A1
• Time in Patent Office: 1,697 Days
• Field of Search: 606 1, 606 27, 606 45, 606151, 606185, 606200, 606213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6884 Clamps or clips

Abstract

Implant deployment device for delivering and deploying an implant. Includes: deployment device body for pushing implant in subject'"'"'s blood vessel, across an interatrial septum and into subject'"'"'s heart left atrium; and a handle operatively connected to deployment device and having controls assigned to selectively operate positioning of the deployment device, to facilitate determining compression extent of an implant body, and detaching of deployment device from the implant. Also disclosed are: a method for fixating an elongated implant across an organ wall in a subject'"'"'s body, and a method for sealing a wall opening in a septal wall in a subject'"'"'s body.

Claims

1. A method for fixating an elongated implant across an organ wall in a subject'"'"'s body, the method comprising:

providing the implant attached to an implant deployment device, the implant comprising a rigid implant body enclosed with a compressible tubular skirt maintained stretched to an extended narrow form along said implant body;

forming a wall opening in the organ wall;

passing the implant through said wall opening until a chosen distal portion of said tubular skirt extends posteriorly beyond to the organ wall and a proximal portion of said tubular skirt remains anteriorly behind to the organ wall;

while maintaining said tubular skirt proximal portion confined to said extended narrow form, compressing said tubular skirt distal portion to a first expanded form by at least partly regaining a first preformed shape of said tubular skirt distal portion;

while maintaining said tubular skirt distal portion substantially in said first expanded form, compressing said tubular skirt proximal portion to a second expanded form by at least partly regaining a second preformed shape of said tubular skirt proximal portion; and

detaching said implant from said implant deployment device,

wherein said implant deployment device comprises a deployment device body comprising an inner member with an inner connector and an outer member with an outer connector, and wherein said providing the implant includes detachably connecting said inner connector to an inner connectee provided at a proximal end of said implant body and detachably connecting said outer connector to an outer connectee provided at a proximal end of said tubular skirt,

wherein said detaching said implant from said implant deployment device includes separately and sequentially disconnecting said inner connector from said inner connectee and said outer connector from said outer connectee,

wherein disconnecting said inner connector is followed by disconnecting said outer connector,

wherein said outer connector is connectable to said outer connectee by means of a grasper arrangement, said grasper arrangement comprising grasping jaws configured for locking onto said outer connectee having a mating recess pattern, and said disconnecting said outer connector includes;

after disconnecting said inner connector, forcing said grasping jaws to retract outwardly using said inner member.

2. The method of claim 1, wherein said passing the implant is first facilitated with an outer sheath sized to allow the implant passing thereinside and to maintain said tubular skirt constricted to said extended narrow form.

3. The method of claim 2, wherein said compressing said tubular skirt distal portion to said first expanded form is first facilitated by protruding the implant out of said outer sheath such that said tubular skirt distal portion is unconstricted by said outer sheath and said tubular skirt proximal portion remains constricted by said outer sheath.

4. The method of claim 2, wherein said compressing said tubular skirt proximal portion to said second expanded form is first facilitated by further protruding the implant out of said outer sheath such that both said tubular skirt distal portion and said tubular skirt proximal portion are unconstricted by said outer sheath.

5. The method of claim 1, wherein said tubular skirt comprises a flexible gripping sleeve, wherein a distal end of the flexible gripping sleeve is fixedly connected to a distal periphery of said implant body and a proximal end of the flexible gripping sleeve is slidably connected to said implant body along a path extending proximally to said distal periphery.

6. The method of claim 5, wherein said method further comprises:

gripping against opposing ends of the organ wall around said implant body, with said tubular skirt distal portion compressed to said first expanded form and said tubular skirt proximal portion compressed to said second expanded form, with sufficient force to maintain said implant body aligned across the organ wall.

7. The method of claim 5, wherein said flexible gripping sleeve has a preformed bellows-like structure with foldable units, including a proximal foldable unit comprising said tubular skirt proximal portion and a distal foldable unit comprising said tubular skirt distal portion, connected one with the other directly or with a non-foldable spacing unit therebetween for spacing sized to compensate for width of said organ wall.

8. The method of claim 7, wherein said gripping against opposing ends of the organ wall includes:

forcing said proximal foldable unit into forming a proximal wing extending outwardly-radially relative to said implant body, so as to form a first proximal surface and a second proximal surface interconnected with a proximal edge, and

forcing said distal foldable unit into forming a distal wing extending outwardly-radially relative to said implant body, so as to form a first distal surface and a second distal surface interconnected with a distal edge.

9. The method of claim 1, wherein said compressing said tubular skirt proximal portion includes:

pulling said implant body so as to press said tubular skirt distal portion in said first expanded form against said organ wall until reaching a chosen shaping of said tubular skirt distal portion or a chosen resistance magnitude developable by said organ wall in response to said pulling.

10. The method of claim 1, wherein said providing the implant includes constricting said tubular skirt in said extended narrow form with constricting means.

11. The method of claim 1, wherein said stretching said tubular skirt to said extended narrow form is facilitated by relatively positioning said outer connector or said inner connector at a first connecting distance therebetween.

12. The method of claim 1, wherein said compressing said tubular skirt distal portion to said first expanded form is facilitated by relatively positioning said outer connector or said inner connector at a second connecting distance therebetween.

13. The method of claim 12, wherein said compressing said tubular skirt proximal portion to said second expanded form is facilitated by relatively positioning said outer connector or said inner connector at a third connecting distance therebetween.

14. The method of claim 13, wherein shifting from said second connecting distance to said third connecting distance is applicable only upon releasing a first safety.

15. The method of claim 14, wherein said first safety is releasable only when said outer connector is positioned at said second connecting distance relative to said inner connector.

16. The method of claim 1, wherein said inner connector is connectable to said inner connectee by means of a screw arrangement and said disconnecting said inner connector includes:

holding said outer connectee rotationally fixed with said outer connector; and

revolving, clockwise or counterclockwise, said inner connector relative to said inner connectee until unscrewing said inner connector.

17. The method of claim 1, wherein said compressing said tubular skirt distal portion or said compressing said tubular skirt proximal portion includes allowing said tubular skirt to at least partly conform to outer boundaries of said implant body and of the organ wall.