Method and apparatus for anchoring implants

• US 20060069400A1
• Filed: 09/26/2005
• Published: 03/30/2006
• Est. Priority Date: 09/27/2004
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Theranova, Llc
• Inventors: Burnett, Daniel Rogers, Mangrum, Shane
• Granted Patent: US 7,850,704 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Methods, devices and systems facilitate retention of a variety of therapeutic devices. Devices generally include an anchoring element, which has been designed to promote fibrotic ingrowth, and an anchored device, which has been designed to firmly engage the complementary region of the anchoring element. The anchoring element may be placed in a minimally invasive procedure temporally separated from the deployment of the anchored device. Once enough time has passed to ensure appropriate fixation of the anchoring element by tissue and cellular ingrowth at the site of placement, the anchored device may then be deployed during which it firmly engages the complementary region of the anchoring element. In this manner, a firm attachment to the implantation site may be made with a minimum of required hardware. Some embodiments are delivered through a delivery tube or catheter and while some embodiments may require laparoscopy or open surgery for one or more of the placement procedures. Some embodiments anchor devices within the cardiovascular tree while others may anchor devices within the gastrointestinal, peritoneal, pleural, pulmonary, urogynecologic, nasopharyngeal or dermatologic regions of the body.

Claims

1. A multi-component implant anchoring device consisting of:

An anchoring element and

An anchored device, wherein

Said anchoring element and anchored device may be inserted separately and may form firm attachments to each other upon deployment within the body and wherein

Said anchoring element may incorporate a material or fabric to encourage cellular ingrowth and wherein

Said anchoring element may be inserted a period of time prior to the insertion of the anchored device to allow for fibrotic or cellular ingrowth to firmly secure the element in place and wherein

Said anchored device may contain at least one complementary attachment site for the anchoring element allowing for firm attachment upon implantation and wherein

Said anchored device may consist of one or more of the following devices;

prosthetic aortic, tricuspid or mitral heart valves, abdominal aortic aneurysm stents, coronary stents, gastrointestinal stents, electrical gastric stimulators, electrical intestinal stimulators, gastrointestinal devices anchored in the esophagus, stomach, intestine or rectum, urogynecologic devices anchored within the bladder, uterus, fallopian tubes or vagina, peritoneal devices anchored within the peritoneum, pulmonary devices anchored within the pulmonary tree, nasopharyngeal devices anchored within the nasopharynx, orthopedic devices anchored into bone and/or dermatologic devices anchored into skin.

2. A multi-component implant anchoring device consisting of:

An anchoring element and

An anchored device, wherein

Said anchoring element and anchored device may be inserted separately and may form firm attachments to each other during deployment inside the body

3. The device of claim 2 in which said anchoring element may contain support elements to provide for firm attachment to the surrounding tissues at the site of implantation wherein said support elements may consist of pins, staples, clips, stents, sutures, etc.

4. The device of claim 2 in which said anchoring element may incorporate a material or fabric to encourage cellular ingrowth

5. The device of claim 4 in which said fabric may be a Dacron, polyester, Gore-Tex, PTFE or other ingrowth encouraging material

6. The device of claim 2 in which said anchored device may contain at least one complementary attachment site for the anchoring element

7. The device of claim 6 in which said anchoring ring may provide for firm attachment of said anchored device through the use of screwing, mechanical locking, magnetic attraction, chemical bonding, or interference fitting.

8. The device of claim 6 in which said anchoring ring may provide for firm attachment to said anchored device through the use of pins, staples, clips, stents, or sutures.

9. The device of claim 2 in which said anchoring element and said anchored device can each be collapsed to a size sufficient to allow for minimally invasive, catheter-based delivery

10. The device of claim 2 in which radiographic contrast is incorporated into said anchored device to facilitate localization of anatomic landmarks (such as the coronary ostia) prior to placing said anchored device and also facilitate exact positioning/orientation of the implant.

11. The device of claim 2 in which said anchored device encourages native tissue ingrowth into the anchor with the embedding of elements in the anchor material that would encourage cellular ingrowth.

12. The device of claim 2 in which the anchored device eliminates the frequent complication of migration and inadequate sizing with the anchoring of a device with a known diameter to native tissue.

13. The device of claim 2 wherein said anchored device may consist of, but is not limited to, one or more of the following devices:

prosthetic aortic, tricuspid or mitral heart valves, abdominal aortic aneurysm stents, coronary stents, gastrointestinal stents, gastrointestinal devices anchored in the esophagus, stomach or duodenum, gastrointestinal devices anchored within the gastrointestinal lumen, urogynecologic devices anchored within the bladder, uterus, fallopian tubes or vagina, peritoneal devices anchored within the peritoneum, pulmonary devices anchored within the pulmonary tree, nasopharyngeal devices anchored within the nasopharynx, orthopedic devices anchored into bone and/or dermatologic devices anchored into skin.

14. A method of anchoring an implanted device including:

Placement of an anchoring element, followed by

Deployment of the anchored device wherein

Said anchoring element may firmly engage said anchored device

15. The method of claim 14 in which at least a portion of said anchoring element may encourage native tissue ingrowth and/or cellular ingrowth.

16. The method of claim 14 in which said anchoring element may consist of a ring, a tube, a socket, a port, a catheter, a patch or any other fastener allowing for firm engagement of the complementary region of the anchored device.

17. The method of claim 14 in which said anchoring element may contain support elements, such as pins, staples, clips, stents, sutures, etc., to provide for firm attachment to the surrounding tissues at the site of implantation prior to said native tissue ingrowth and/or cellular ingrowth

18. The method of claim 15 in which at least three days, at least a week, at least a month and/or at least three months may be allowed to pass between the placement of said anchoring element and the deployment of said anchored device

19. The method of claim 14 in which said anchoring ring may provide for firm attachment to said anchored device through the use of screwing, mechanical locking, magnetic attraction, chemical bonding, interference fitting, suturing, stapling, or clipping.

20. The method of claim 14 wherein said anchored device may consist of one or more of several devices including:

prosthetic aortic, tricuspid or mitral heart valves, abdominal aortic aneurysm stents, coronary stents, gastrointestinal stents, electrical gastric stimulators, electrical intestinal stimulators, gastrointestinal devices anchored in the esophagus, stomach or duodenum, gastrointestinal devices anchored within the gastrointestinal lumen, urogynecologic devices anchored within the bladder, uterus, fallopian tubes or vagina, peritoneal devices anchored within the peritoneum, pulmonary devices anchored within the pulmonary tree, nasopharyngeal devices anchored within the nasopharynx, orthopedic devices anchored into bone and/or dermatologic devices anchored into skin.