Implantable devices for controlling the internal circumference of an anatomic orifice or lumen

• US 20040148021A1
• Filed: 08/29/2003
• Published: 07/29/2004
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Mitralsolutions, Inc.
• Inventors: Lee, Leonard Y., Cartledge, Richard G.
• Granted Patent: US 7,297,150 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

An implantable device for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

Claims

1. An implantable device for controlling the internal circumference of an anatomic orifice or lumen, comprising:

an annular ring;

means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen;

means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference; and

means associated with said annular ring for maintaining said ring in said first circumference and, upon said annular ring being adjusted to said second circumference, for maintaining said annular ring in said second circumference;

whereby the circumference of said anatomic orifice or lumen can be adjusted by adjusting the circumference of said annular ring from said first circumference to said second circumference.

2. The implantable device of claim 1, wherein said means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen comprises a plurality of barbs extending from said annular ring for engaging the tissue around said anatomic orifice or lumen.

3. The implantable device of claim 2, wherein each of said barbs is oriented in a consistent, tangential direction with respect to the annular ring such that rotational motion of the annular ring in a first direction will engage said retention barbs with the desired tissue, and rotational motion of the annular ring in a direction opposite to said first direction will disengage said retention barbs from said desired tissue.

4. The implantable device of claim 3, wherein each of said barbs further comprises a hook at its free end.

5. The implantable device of claim 1, wherein said means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen comprises an outer fabric sheath covering said annular ring through which sutures can be placed to suture said implantable device to said tissue around said anatomic orifice or lumen.

6. The implantable device of claim 1, wherein said means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen comprises a plurality of grommets spaced around the periphery of said annular ring.

7. The implantable device of claim 6, wherein said sutures can be placed and then through the underlying tissue to anchor said annular ring to the tissue around said anatomic orifice or lumen.

8. The implantable device of claim 6, wherein said grommets are comprised of a material which is sufficiently soft that a suture can be placed through said grommet and through the underlying tissue to anchor said annular ring to the tissue around said anatomic orifice or lumen.

9. The implantable device of claim 6, wherein said grommets comprise tabs comprised of a material which is sufficiently soft that a suture can be placed through said tab and through the underlying tissue to anchor said annular ring to the tissue around said anatomic orifice or lumen.

10. The implantable device of claim 6, wherein said grommets comprise tabs, and wherein said tabs define holes through which a suture can be placed and then through the underlying tissue to anchor said annular ring to the tissue around said anatomic orifice or lumen.

11. The implantable device of claim 1, wherein said means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference comprises corrugations.

12. The implantable device of claim 6, wherein said device comprises alternating sections of corrugations and grommets spaced around the periphery of said annular ring.

13. The implantable device of claim 1,

wherein said annular ring comprises a hollow tube formed into an annular shape, said tube having interspaced smooth and corrugated sections disposed around its circumference,

wherein said means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen comprises said tube being sufficiently soft such that a suture can be passed through said tube and hence through the underlying tissue;

wherein said means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference comprises said corrugated sections; and

wherein said means associated with said annular ring for maintaining said ring in said first circumference and, upon said annular ring being adjusted to said second circumference, for maintaining said annular ring in said second circumference comprises said corrugated sections being sufficiently stiff that once said annular ring is placed in a given configuration, it will tend to remain in said given configuration when acted upon by normal anatomic forces at said selected anatomic orifice or lumen.

14. The implantable device of claim 1,

wherein said annular ring comprises a hollow tube formed into an annular shape, said tube having interspaced smooth and corrugated sections disposed around its circumference,

wherein said means by which said annular ring can be fastened to the tissue around an anatomic orifice or lumen comprises said tube having portions of narrowed circumference such that a suture can be passed around said tube at said portions of narrowed circumference and hence through the underlying tissue;

wherein said means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference comprises said corrugated sections; and

wherein said means associated with said annular ring for maintaining said ring in said first circumference and, upon said annular ring being adjusted to said second circumference, for maintaining said annular ring in said second circumference comprises said corrugated sections being sufficiently stiff that once said annular ring is placed in a given configuration, it will tend to remain in said given configuration when acted upon by normal anatomic forces at said selected anatomic orifice or lumen.

15. The implantable device of claim 1, wherein said means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference comprises:

teeth formed on at least a portion of said annular ring;

a gear engaging said teeth of said annular ring; and

said gear and said teeth being arranged such that turning said gear effects relative movement between a first end of said annular ring and a second end of said annular ring to adjust the circumference of said annular ring from a first circumference to a second circumference.

16. The implantable device of claim 15, further comprising a wheel positioned tangentially to said gear such that said portion of said annular ring which engages said gear passes between said gear and said wheel.

17. The implantable device of claim 15, wherein said gear is mounted in fixed relation to said second end of said annular ring, and wherein said teeth are formed adjacent said first end of said annular ring.

18. The implantable device of claim 15, further comprising means for turning said gear from a location remote from said gear, such that said circumference of said implant can be adjusted after closure of surgical incisions and resumption of physiological flow through said orifice or lumen.

19. The implantable device of claim 18, wherein said means for turning said gear from a remote location is disengageable from said gear after completion of adjustments.

20. The implantable device of claim 1, wherein said means associated with said annular ring for permitting adjustment of the circumference of said annular ring from a first circumference to a second circumference comprises:

a worm gear; and

means operatively associated with a first end of said annular ring for engaging said worm gear such that rotation of said worm gear effects relative movement between said first end of said annular ring and a second end of said annular ring to adjust the circumference of said annular ring from a first circumference to a second circumference.

21. The implantable device of claim 20, wherein said worm gear has a first angled gear head at its driven end, and further comprising a shaft in offset relation to said worm gear and having a second angled gear head at a first end thereof, said first and second angled gear heads drivably engaging such that rotation of said shaft drives said worm gear.

22. The implantable device of claim 21, further comprising means for turning said shaft from a location remote from said worm gear, such that said circumference of said implant can be adjusted after closure of surgical incisions and resumption of physiological flow through said orifice or lumen.

23. The implantable device of claim 22, wherein said shaft and said means for turning said shaft from a remote location are disengageable from said worm gear after completion of adjustments.