Devices and methods for forming magnetic anastomoses and ports in vessels Number:6,802,847 from the United States Patent and Trademark Office (PTO) owispatent Methods and devices for forming magnetic anastomoses between hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created with or without a mechanical connection between the components. The anastomotic components may have various constructions and may be secured to a vessel in various manners, for example, magnetically, mechanically or adhesively. Also provided are alternative delivery devices, as well as devices for checking the position of a component on a loaded delivery device, and for checking the seal between a vessel and an anastomotic component secured thereto.<H anastomoses, magnetic, Devices, and, met, 6802847.html, Patent, pto, 6802847

Title: Devices and methods for forming magnetic anastomoses and ports in vessels

Abstract: Methods and devices for forming magnetic anastomoses between hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created with or without a mechanical connection between the components. The anastomotic components may have various constructions and may be secured to a vessel in various manners, for example, magnetically, mechanically or adhesively. Also provided are alternative delivery devices, as well as devices for checking the position of a component on a loaded delivery device, and for checking the seal between a vessel and an anastomotic component secured thereto.

Patent Number: 6,802,847 Issued on 10/12/2004 to Carson, et al.

Inventors: Carson; Dean F. (Mountain View, CA); Reo; Michael L. (Redwood City, CA); Cole; David H. (San Mateo, CA); Gittings; Darin C. (Sunnyvale, CA); Lepulu; Keke (Redwood City, CA); Sharkawy; A. Adam (Union City, CA); Kessler; Adam (Fremont, CA)
Assignee: Ventrica, Inc. (Menlo Park, CA)

Appl. No.: 09/915,226

Filed: July 23, 2001

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
638805	Aug., 2000
562599	Apr., 2000	6352543

Current U.S. Class: 606/153

Field of Search: 606/153,215,184,185 623/1.36,903 600/12 128/899

References Cited [Referenced By]

U.S. Patent Documents


3986493	October 1976	Hendren, III
4154226	May 1979	Hennig et al.
4210132	July 1980	Perlin
4258705	March 1981	Sorensen et al.
4397311	August 1983	Kanshin et al.
4679546	July 1987	van Waalwijk van Doorn et al.
4784646	November 1988	Feingold
4809713	March 1989	Grayzel
4889120	December 1989	Gordon
4899744	February 1990	Fujitsuka et al.
4904256	February 1990	Yamaguchi
5330486	July 1994	Wilk
5411508	May 1995	Bessler et al.
5441507	August 1995	Wilk
5507629	April 1996	Jarvik
5595562	January 1997	Grier
5611689	March 1997	Stemmann
5681260	October 1997	Ueda et al.
5690656	November 1997	Cope et al.
5702412	December 1997	Popov et al.
5817113	October 1998	Gifford, III et al.
5830224	November 1998	Cohn et al.
5895404	April 1999	Ruiz
5904147	May 1999	Conlan et al.
5906579	May 1999	Vander Salm et al.
5997467	December 1999	Connolly
6068637	May 2000	Popov et al.
6099542	August 2000	Cohn et al.
6113612	September 2000	Swanson et al.
6173715	January 2001	Sinanan et al.
6190353	February 2001	Makower et al.
6352543	March 2002	Cole
6419681	July 2002	Vargas et al.

Foreign Patent Documents


29513195	Dec., 1996	DE
29713335	Jul., 1997	DE
2123300	Dec., 1998	RU
736966	May., 1980	SU
1025420	Jun., 1983	SU
1179978	Sep., 1985	SU
1438738	Nov., 1988	SU
2018266	Mar., 1989	SU
1537228	Jan., 1990	SU
1595534	Sep., 1990	SU
1629040	Feb., 1991	SU
1635966	Mar., 1991	SU
1277452	Jun., 1991	SU
1361753	Apr., 1992	SU
1725851	Apr., 1992	SU
1766383	Oct., 1992	SU
1769863	Oct., 1992	SU
WO 97/13463	Apr., 1997	WO
WO 97/27897	Aug., 1997	WO
WO 00/09040	Feb., 2000	WO
WO 00/69364	Nov., 2000	WO
WO 00/74579	Dec., 2000	WO
WO 01/39672	Jun., 2001	WO
WO 01/82803	Nov., 2001	WO

Other References

Esformes, et al., "Biological Effects of Magnetic Fields Generated with CoSm Magnets," pp. 81-87. .
Fuestel, et al., "Kontinente Kolostomie durch Magnetverschluss," Dtsch. Med. Wschr. 100 (1975), pp. 1063-1064 (includes English Abstract). .
Obora, et al., "Nonsuture Microvascular Anastomosis Using Magnet Rings: Preliminary Report," Surg. Neurol., vol. 9, Feb. 1978, pp. 117-120. .
Kanshin, et al., "Sutureless anastomoses in gastrointestinal surgery with and without steady magnetic field," Arkh Patol, 1978; 40(8):56-61 (with English Abstract). .
Pirusyan, et al., "Some Regularities of Tissue Squeezing and Regeneration Under Formation of "Unstitch" Anastomoses of the Alimentary Canal's Hollow Organs," 1979, pp. 13-17 (includes English abstract). .
Obora, et al., "Nonsuture Microvascular Anastomosis using Magnet Rings," Jan. 16, 1980, pp. 497-505. (English translation in provided.). .
Yanase, "An Experimental Study on Traumatic Changes in Microvessels Produced by Pressure Clamping," Aust N.Z. J. Surg. vol. 50-No. 4, Aug., 1980, pp. 423-428. .
Jansen, et al., "Clinical Applications of Magnetic Rings in Colorectal Anastomosis," Surgery, Gynecology & Obstetrics, vol. 153, Oct. 1981, pp. 537-545. .
Myshkin, et al., "Use of Permanent Magnets in Sutureless Anastomoses," 1987, pp. 47-52 (English translation is provided). .
Kanshin, et al., "A Goal-Oriented Local Approach to the Prevention of Postoperative Purulent Complications," 1991, pp. 24-27. (English abstract is provided). .
Stepanov, et al., "The treatment of intestinal fistulae in children by applying a by-pass anastomosis using magnetic devices," Khirugiia (Mosk), Nov.-Dec. 1992, pp. 11-12 (English abstract is provided.) .
Fukumura, et al., "Development of a Magnetically Operated Artificial Urethral Sphincter," ASAIO Journal, 1993, pp. M283-M287. .
Bondemark, et al., "Orthodontic Rare Earth Magnets--In Vitro Assessment of Cytotoxicity," British Journal of Orthodontia, vol. 21, No. 4, Nov. 1994, pp. 335-341. .
Cope, "Evaluation of Compression oCholecystogastric and Cholecystojejunal Anastomoses in Swine after Peroral and Surgical Introduction of Magnets," Journal of Vascular and Interventional Radiology, vol. 6, No. 4, Jul.-Aug. 1995, pp. 546-552. .
Cope, "Creation of Compression Gastroenterostomy by Means of the Oral, Percutaneous, or Surgical Introduction of Magnets: Feasibility Study in Swine," Journal of Vascular and Interventional Radiology, vol. 6, No. 4, Jul.-Aug. 1995, pp. 539-545. .
Bondemark, et al., "Long-term effects of orthodontic magnets on human buccal mucosa--a clinical, histological and immunohistochemical study," Eur J Orthod, 20(3): Jun. 1998, pp. 211-218. .
Cope, "Stent Placement of Gastroenteric Anastomoses Formed by Magnetic Compression," Journal of Visceral Intervention, vol. 10, No. 10, Nov.-Dec. 1999, pp. 1379-1386..

Primary Examiner: Jackson; Gary
Attorney, Agent or Firm: Hoekendijk; Jens E.

Parent Case Text

The present application is a continuation-in-part of application Ser. No. 09/638,805, filed Aug. 12, 2000, which is a continuation-in-part of application Ser. No. 09/562,599, filed Apr. 29, 2000 now U.S. Pat. No. 6,352,543. This application also claims priority from provisional application Ser. No. 60/255,635, filed Dec. 13, 2000, and application Ser. No. 09/851,400, filed May 7, 2001. The entire disclosure of each of the above-referenced patent applications is expressly incorporated herein by reference.

Claims

What is claimed is:

1. A method for securing a magnetic component to a hollow body, the method comprising the steps of: providing a component capable of producing or being attracted by a magnetic field, the component having an opening adapted to be placed in communication with a lumen of a hollow body; positioning a placement member in a first configuration within a lumen of a hollow body at a selected location, the placement member being capable of producing or being attracted by a magnetic field; using magnetic attraction between the component and the placement member to position the component at a selected location; securing the component to the hollow body so as to place the opening of the component in communication with the lumen of coupling the hollow body; changing the placement member from the first configuration to a second configuration; and: removing the placement member from the lumen of the hollow body.

2. The method of claim 1, wherein the hollow body is a blood vessel and adhesive is used to secure the component to the wall of the hollow body.

3. The method of claim 2, wherein adhesive is used to secure the component to the end of the hollow body.

4. The method of claim 1, wherein the first configuration is expanded and the second configuration is collapsed.

5. The method of claim 4, wherein the first configuration is inflated with fluid.

6. The method of claim 5, wherein the first configuration is inflated with a magnetic fluid.

7. The method of claim 1, wherein the first configuration corresponds to a first orientation, and the second configuration corresponds to a second orientation that the placement member is moved to from the first orientation.

8. The method of claim 1, wherein the hollow body is a blood vessel and the placement member comprises a catheter.

9. A method for securing a magnetic anastomotic component to a hollow body, the method comprising the steps of: providing an anastomotic component capable of producing or being attracted by a magnetic field, the component having an opening adapted to be placed in communication with a lumen of a hollow body; positioning a placement member in a first configuration within a lumen of a hollow body at a selected location, the placement member being capable of producing or being attracted by a magnetic field; using magnetic attraction between the anastomotic component and the placement member to position the component at a selected location; securing the anastomotic component to the hollow body; and changing the placement member from the first configuration to a second configuration; and removing the placement member from the lumen of the hollow body with a lumen of a hollow body and a portion adapted to be coupled to another anastomotic component.

10. The method of claim 9, further comprising coupling of the anastomotic component to another anastomotic component secured to another hollow body to form an anastomosis between the two hollow bodies.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to forming anastomoses between hollow anatomical bodies and also forming ports that pass into the interior or lumen of hollow bodies. More particularly, the invention relates to using magnetic force to form anastomoses and creating magnetic ports in vessels.

2. Description of Related Art

Despite the considerable advances that have been realized in cardiology and cardiovascular surgery, heart disease remains the leading cause of death throughout much of the world. Coronary artery disease, or arteriosclerosis, is the single leading cause of death in the United States today. As a result, those in the cardiovascular field continue to search, with varying degrees of success, for new and improved manners of treating cardiovascular disease.

Coronary artery disease is currently treated by interventional procedures such as percutaneous transluminal coronary angioplasty (PTCA), coronary stenting and atherectomy, as well as surgical procedures including coronary artery bypass grafting (CABG). The goal of these procedures is to reestablish or improve blood flow through occluded (or partially occluded) coronary arteries, and is accomplished, for example, by enlarging the blood flow lumen of the artery or forming a bypass that allows blood to circumvent the occlusion. What procedure(s) is used typically depends on the severity and location of the blockage. CABG is typically performed when interventional procedures have been unsuccessful or, for one reason or another, are not available options for a given patient. When successful, these procedures restore flow within the treated vessel(s) and feed blood to myocardial tissue that had previously been insufficiently perfused.

Another proposed treatment places the target vessel, e.g., a coronary artery, in direct fluid communication with a heart chamber containing blood, for example, the left ventricle. Blood flows from the ventricle into a conduit that is in fluid communication with the artery; as such, this treatment may be described as a ventricular bypass procedure. Benefits of this procedure include obviating the need to manipulate the aorta, for example, as is done when a side-biting clamp is used in a typical CABG procedure to create a proximal anastomosis between the bypass graft and the aorta.

The most challenging aspect of CABG (as well as many other procedures that requiring forming an anastomosis) is connecting the graft vessel to the target vessel in a secure, fluid-tight manner. This is conventionally done by hand using suture that is passed through the tissue of the two vessels to create a handsewn connection. The small diameter of coronary vessels (typically 1 mm to 4 mm) makes creating these handsewn anastomoses highly technical and time consuming. The difficulty in forming the sutured anastomosis is exacerbated when access to the target vessel is restricted or limited as compared to open-chest CABG, for example, as in minimally invasive or percutaneous procedures. A number of other medical procedures also require the attachment of hollow anatomical bodies (by sewing or otherwise) and therefore involve the same or similar considerations, for instance, treating peripheral vascular disease or injury and creating arteriovenous shunts.

Many various anastomotic couplings have been proposed in the art, although none has performed well enough to receive any significant level of acceptance in the field. Exemplary problems experienced by some of these couplers include damage to the graft or target vessel wall, for instance, due to piercing, penetrating or overly compressing the tissue, and failure to produce repeatable results. Additionally, producing an anastomotic coupler that creates and maintains a patent connection has been somewhat elusive and hard to achieve.

Accordingly, there is a need in the art for methods and devices for forming a reliable anastomosis between hollow bodies in a relatively quick, easy and repeatable manner.

SUMMARY OF THE INVENTION

According to one embodiment, a method for securing a magnetic anastomotic component to a hollow body is provided and includes steps of providing an anastomotic component capable of producing or being attracted by a magnetic field, the component having an opening, positioning a placement member in a first configuration within a lumen of a hollow body at a selected location, the placement member being capable of producing or being attracted by a magnetic field, and using magnetic attraction between the anastomotic component and the placement member to position the component at a selected location. The anastomotic component is secured to the hollow body, the placement member is changed from the first configuration to a second configuration and then removed from the lumen of the hollow body.

According to another embodiment, a method for securing a magnetic anastomotic to a blood vessel having a lumen includes steps of placing an anastomotic component having an opening adjacent a blood vessel having a lumen, the anastomotic component capable of producing or being attracted by a magnetic field, providing a plurality of separate attachment members each of which is configured to be engaged with the anastomotic component, and securing the anastomotic component to the blood vessel by using the separate attachment members.

According to another embodiment, a method for adhesively securing a magnetic anastomotic component to an end of a hollow body having a lumen is provided. This method includes steps of providing an anastomotic component capable of producing or being attracted by a magnetic field, the component having an opening adapted to be placed in communication with a lumen of a hollow body, applying adhesive to at least one of the anastomotic component and the hollow body adjacent an end of the hollow body, and using the adhesive to secure the anastomotic component to the hollow body adjacent the end of the hollow body.

According to yet another embodiment, a method for securing a magnetic anastomotic component to an end of a hollow body having a lumen is provided and includes steps of providing an anastomotic component including first and second portions, at least one of the first and second portions being capable of producing or being attracted by a magnetic field, positioning the first portion of the anastomotic component within a lumen of a hollow body, positioning the second portion of the anastomotic component at least partially around the exterior of the hollow body, and allowing the first and second portions to compress the tissue of the hollow body to secure the anastomotic component to the hollow body.

According to still another embodiment, a method for checking a seal between an anastomotic component and a blood vessel to which the anastomotic component is secured is provided. This method includes steps of providing an anastomotic component capable of producing or being attracted by a magnetic field, the anastomotic component having an opening, attaching the anastomotic component to a blood vessel in fluid communication with the lumen of the blood vessel, using a cover to block the opening in the anastomotic component, the cover being capable of producing or being attracted by a magnetic field, and using magnetic attraction to maintain a seal between the cover and the anastomotic component and prevent blood from exiting through the opening in the anastomotic component, whereby any blood that does leak may be attributed to leaking at the attachment between the anastomotic component and the hollow body.

According to yet another embodiment, a method for confirming the proper orientation of a magnetic anastomotic component is provided. This method includes steps of providing a delivery device supporting at least one anastomotic component having an opening, the anastomotic component being capable of producing a magnetic field, providing a fixture including at least one portion that is magnetized according to a selected polarity and movable to a location adjacent the anastomotic component, and using the fixture to determine whether the anastomotic component is oriented properly on the delivery device.

According to another embodiment, a magnetic anastomotic component is provided having a first portion with an opening adapted to be placed in communication with a lumen of a hollow body, and a second portion attached to the first portion and including an expandable tubular body configured to be attached to an end of the hollow body. The first and second portions are disposed generally transverse to each other and at least one of them is capable of producing or being attracted by a magnetic field.

According to another embodiment, a magnetic anastomotic component is provided and has an annular body and a plurality of separate attachment members each of which may be selectively engaged with the annular body to secure it to a hollow body. At least one of the annular body and the attachment members is capable of producing or being attracted to a magnetic field.

According to still another embodiment, a device for checking the seal between an anastomotic component and a hollow body to which it is secured is provided. The device includes an expandable structure with a substantially fluid-impervious surface and material capable of producing or being attracted by a magnetic field. The expandable structure may be magnetically attached to a magnetic or ferromagnetic anastomotic component secured to a hollow body by placing the fluid-impervious surface over the component to block flow. The expandable structure is expanded to break the magnetic attraction between the magnetic material and the component.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Other features, aspects, benefits and advantages of the invention will be appreciated from the following detailed description of exemplary embodiments thereof taken in conjunction with the following Figures, wherein:

FIGS. 1-5 are perspective views of anastomotic securing components constructed according to various embodiments of the invention;

FIG. 6 is a perspective view showing two hollow bodies adapted to be joined in communication via an end-to-side anastomosis;

FIG. 7 is a perspective view showing two hollow bodies adapted to be joined in communication via a side-to-side anastomosis;

FIG. 8 is a perspective view showing two hollow bodies adapted to be joined in communication via an end-to-end anastomosis;

FIG. 9 is a perspective view of the two hollow bodies shown in FIG. 6 along with an anastomotic system including anastomotic securing components constructed according to one embodiment of the invention;

FIG. 9A is a sectional view taken along line A--A in FIG. 9;

FIG. 10A is a section view similar to FIG. 9A but including alternative anastomotic securing components used to join the two hollow bodies;

FIG. 10B is a section view similar to FIG. 10A including other alternative anastomotic securing components for joining the two hollow bodies;

FIG. 10C is a section view similar to FIG. 10A but showing an alternative attachment between a hollow body and an anastomotic securing component;

FIG. 10D is a section view similar to FIG. 10C showing another alternative attachment between the hollow body and a securing component;

FIG. 11A is a transverse sectional view taken through an end-to-side anastomosis formed according to one embodiment of the invention;

FIG. 11B is a transverse sectional view taken through an end-to-side anastomosis formed according to another embodiment of the invention;

FIG. 12 is a perspective view showing two hollow bodies provided with anastomotic securing components constructed according to one embodiment to the invention, the two bodies adapted to be joined via a side-to-side anastomosis;

FIG. 13 is a perspective view showing the two hollow bodies of FIG. 12 provided with anastomotic securing components constructed according to another embodiment of the invention;

FIG. 14A zap is a longitudinal sectional view taken through the side-to-side anastomosis formed according to the embodiment shown in FIG. 12;

FIG. 14B is a transverse sectional view taken through the side-to-side anastomosis formed according to the embodiment shown in FIG. 12;

FIG. 15 is a perspective view showing two hollow bodies provided with anastomotic securing components constructed according to one embodiment of the invention, the two bodies adapted to be joined via an end-to-end anastomosis;

FIG. 16 is a perspective view showing the two hollow bodies of FIG. 15 provided with anastomotic securing components constructed according to another embodiment of the invention;

FIG. 17A is a plan view of one of the hollow bodies and securing components shown in FIG. 12;

FIG. 17B is a longitudinal sectional view of the hollow body and securing component shown in FIG. 17A;

FIG. 18A is a plan view of the hollow body of FIGS. 17A-17B and a securing component constructed according to an alternative embodiment of the invention;

FIG. 18B is a longitudinal sectional view of the hollow body and securing component shown in FIGS. 18A;

FIG. 19A is a perspective view of the anastomotic securing component shown in FIGS. 18A-18B, the component positioned in an opening in a hollow body having an occluded lumen;

FIGS. 19B-19C show anastomotic securing components constructed according to further alternative embodiments of the invention, the components being shown positioned in the hollow body of FIG. 19A;

FIG. 20A is a perspective view of a delivery device constructed to one embodiment of the invention, the device being shown in a first position;

FIG. 20B is a perspective view of the delivery device shown in FIG. 20A, the device being shown in a second position;

FIG. 21A is a perspective view of the delivery device shown in FIG. 20A with a securing component constructed to one embodiment of the invention mounted thereon, the delivery device being shown in the first position;

FIG. 21B is a perspective view of the delivery device shown in FIG. 21A, wherein the device is shown in the second position as it is being manipulated to release the securing component;

FIGS. 22A-22F are sectional views schematically illustrating the delivery device shown in FIGS. 20A-20B being used to deploy anastomotic securing components to form an end-to-side anastomosis according to one embodiment of the invention;

FIG. 23 is a perspective view of an exemplary application according to one embodiment of the invention;

FIG. 23A is an enlarged view of a portion of the embodiment of FIG. 23 but showing a completed anastomosis;

FIG. 24 is a perspective view of another exemplary application according to another embodiment of the invention;

FIG. 24A is an enlarged view of a portion of the embodiment of FIG. 24 but showing a completed anastomosis;

FIG. 25 is a perspective view of an exemplary application according to still another embodiment of the invention;

FIG. 25A is an enlarged view of a portion of the embodiment of FIG. 25 but showing a completed AV shunt with two anastomoses;

FIGS. 26A-26B are exploded perspective views of a device constructed according to one embodiment of the invention for forming a magnetic port in a hollow body having a lumen;

FIG. 26C is an assembled perspective view of the device shown in FIGS. 26A-26B;

FIG. 26D is a sectional view taken along line D--D in FIG. 26C;

FIGS. 27A-27B are sectional views illustrating alternative constructions of the device shown in FIGS. 26A-26D;

FIG. 28 is an exploded perspective view of two devices which are constructed according to another embodiment of the invention and are adapted to be coupled to tissue using magnetic force for forming a magnetic port in a hollow body having a lumen;

FIG. 29 is a sectional view taken through a vessel having a lumen, wherein the devices shown in FIG. 28 are coupled to the tissue of the vessel wall;

FIG. 30 is a sectional view of two magnets positioned in proximity to each other schematically illustrating the magnetic flux lines associated with the magnets;

FIG. 31 is a sectional view showing the two magnets of FIG. 30 provided with flux concentration mechanisms constructed according to another embodiment of the invention and schematically illustrating the magnetic flux lines associated with the magnets of the invention;

FIG. 32A is a perspective view of a device constructed according to another embodiment of the invention which is adapted to be coupled to tissue using electromagnetic force to form a magnetic port;

FIG. 32B is a perspective view of the device shown in FIG. 32A enclosed in a protective housing;

FIG. 33 is a perspective view of a device constructed according to yet another embodiment of the invention which is adapted to close an opening using electromagnetic force;

FIG. 34A is a sectional view taken through a target vessel having a lumen showing the device of FIG. 32B coupled thereto with a graft vessel shown (in phantom) prior to being anastomosed to the device;

FIG. 34B is a sectional view taken through a target vessel having a port defined by an anastomotic component communicating with the vessel lumen with the device of FIG. 33 positioned above the port prior to being used to close the opening;

FIGS. 35A-35B are sequential sectional views taken through a target vessel having a lumen showing an anastomotic component constructed according to another embodiment of the invention being coupled to the wall of the vessel;

FIGS. 36A-36B are, respectively, upper and lower perspective views of a device constructed according to another embodiment of the invention for forming a port in a vessel having a lumen, wherein the device has a mechanical attachment portion shown in a low profile or collapsed orientation;

FIGS. 37A-37C are, respectively, upper plan, side elevation, and lower plan views of the device shown in FIGS. 36A-36B;

FIGS. 38A-38B are, respectively, upper and lower perspective views of the device shown in FIGS. 36A-36B, wherein the mechanical attachment portion of the device is shown in a wide profile or expanded orientation;

FIGS. 39A-39C are, respectively, upper plan, side elevation, and lower plan views of the device as shown in FIGS. 38A-38B;

FIGS. 40A-40C are elevation views sequentially showing the device of FIGS. 36A-39C being deployed in a vessel having a lumen;

FIG. 41A is a perspective view of a delivery device constructed according to another embodiment of the invention, wherein the device has a retaining portion shown in a first position to retain an anastomotic component;

FIGS. 41B-41C are perspective views of the device shown in FIG. 41A but sequentially illustrating the retaining portion being moved to release the component;

FIG. 42A is a perspective view of a delivery device constructed according to still another embodiment of the invention, wherein the device has a retaining portion shown in a first position to retain an anastomotic component;

FIGS. 42B-42C are perspective views of the device shown in FIG. 42A sequentially illustrating the retaining portion being moved to release the component;

FIGS. 43A-43B are partial sectional views of the device shown in FIGS. 42A-42C sequentially illustrating the device being used to couple an anastomotic component to a vessel;

FIGS. 43C is a partial sectional view showing the anastomotic component in its final position;

FIG. 44 is a perspective view sequentially showing a flexible magnetic component constructed according to one embodiment of the invention being collapsed;

FIGS. 45A-45B are perspective views illustrating a flexible magnetic component constructed according to one embodiment of the invention in its expanded and collapsed orientations, respectively.

FIGS. 46A-46B shows alternative flexible magnetic components constructed according to additional embodiments of the invention;

FIG. 46C is a perspective view of a flexible component with a magnetic core constructed according to yet another embodiment of the invention, the component being adapted to substantially or completely close an opening in tissue or another component;

FIG. 46D is a perspective view of an alternative flexible magnetic component with a construction similar to the component of FIG. 46C but having an opening for placement in communication with the lumen of a vessel;

FIG. 46E schematically illustrates and exemplifies delivering the component shown in FIG. 46D in a low profile manner by way of a catheter or sheath;

FIGS. 47A-47B are perspective views showing a device constructed according to another embodiment of the invention for closing openings in tissue in a restrained position for delivery and a partially deployed position, respectively;

FIG. 47C is a fragmentary side elevation view of the device shown in FIGS. 47A-47B but with the device fully deployed; and

FIGS. 48A-48C are elevation views sequentially showing the device of FIGS. 47A-47C being used to close a ventricular septal defect.

FIGS. 49A-49B are, respectively, exploded and assembled perspective views of a magnetic anastomotic component constructed according to one embodiment of the invention;

FIG. 49C is sectional view taken along line C--C in FIG. 49B;

FIGS. 50A-50B are, respectively, exploded and assembled perspective views of a magnetic anastomotic component constructed according to another embodiment of the invention;

FIGS. 51A-51B are, respectively, exploded and assembled perspective views of a magnetic anastomotic component constructed according to yet another embodiment of the invention;

FIGS. 52A-52C are perspective views sequentially showing the formation of a magnetic anastomotic component constructed according to still another embodiment of the invention;

FIG. 53A is a perspective view of a magnetic anastomotic component including an attachment portion constructed according to one embodiment of the invention;

FIG. 53B is a perspective view of the magnetic anastomotic component shown in FIG. 53A with the attachment portion coupled to a vessel;

FIG. 53C is a perspective view of the magnetic anastomotic component shown in FIG. 53A with the attachment portion coupled to a vessel in an alternative manner;

FIGS. 54A-54D are perspective views of a magnetic anastomotic component including an attachment portion constructed according to another embodiment of the invention;

FIGS. 54E-54F are perspective views showing the magnetic anastomotic component illustrated in FIGS. 54A-54D being secured to a vessel;

FIGS. 55A-55B are, respectively, exploded and assembled perspective views of a magnetic anastomotic component constructed according to one embodiment of the invention;

FIG. 55C is a sectional view taken along line C--C in FIG. 49B;

FIGS. 56A-56B are perspective views showing the anastomotic component illustrated in FIG. 5B being magnetically secured to a vessel;

FIGS. 57A-57B are perspective views showing the anastomotic component illustrated in FIG. 5C being magnetically secured to a vessel;

FIGS. 58A-58C are, respectively, a perspective view and sectional views sequentially showing an anastomotic component constructed according to another embodiment of the invention being secured to a vessel magnetically and mechanically;

FIGS. 59A-59B are, respectively, sectional and perspective views showing an anastomotic component constructed according to another embodiment of the invention being secured to a vessel mechanically;

FIGS. 60A-60B are sectional views showing an anastomotic component constructed according to another embodiment of the invention being secured to a vessel mechanically;

FIG. 60C is a plan view of the anastomotic component shown in FIG. 60B secured to the vessel;

FIGS. 61A-61C are perspective views sequentially showing an anastomotic component constructed according to another embodiment of the invention being secured to a vessel mechanically;

FIGS. 62A-62C are perspective views sequentially showing an anastomotic component constructed according to yet another embodiment of the invention being secured to a vessel mechanically;

FIGS. 63A-63B are side elevation views respectively showing a magnetic anastomotic component constructed according to another embodiment of the invention in restrained and unrestrained configurations;

FIGS. 63C-63D are perspective views showing the magnetic anastomotic component illustrated in FIGS. 63A-63B being secured to a hollow body;

FIG. 64A is a plan view of a magnetic anastomotic component constructed according to another embodiment of the invention secured to a vessel mechanically;

FIG. 64B is a sectional view taken along line B--B in FIG. 64A;

FIG. 65A is a plan view of a magnetic anastomotic component constructed according to yet another embodiment of the invention secured to a vessel mechanically;

FIG. 65B is a sectional view taken along line B--B in FIG. 65A;

FIGS. 66A-66C are perspective views sequentially showing a delivery device being used to mechanically secure a magnetic anastomotic component constructed according to another embodiment of the invention to a vessel;

FIG. 67A is an elevation view of a magnetic anastomotic component constructed according to another embodiment of the invention;

FIGS. 67B-67C are sectional views showing the component illustrated in FIG. 67A secured to, respectively, an end and side wall of a vessel;

FIGS. 68A-68B are sectional views showing magnetic anastomotic components constructed according to alternative embodiments of the invention being adhesively secured to a vessel;

FIGS. 69A-69B are perspective views sequentially showing a magnetic anastomotic component constructed according to another embodiment of the invention being adhesively secured to a vessel;

FIG. 70 is a perspective view of a magnetic anastomotic component constructed according to yet another embodiment of the invention to a vessel;

FIGS. 71A-71D show an internal magnet being used to align an outer magnet;

FIGS. 72A-72F are perspective views sequentially showing a magnetic anastomotic component constructed according to another embodiment of the invention being adhesively secured to an end of a vessel;

FIGS. 73A-73D are sectional views sequentially showing a magnetic anastomotic being adhesively secured to the wall of a vessel according to another embodiment of the invention;

FIGS. 74A-74D are sectional views sequentially showing a magnetic anastomotic being adhesively secured to the wall of a vessel according to still another embodiment of the invention;

FIGS. 75A-75D are sequential sectional views showing a magnetic anastomotic being adhesively secured to the wall of a vessel according to one embodiment of the invention;

FIGS. 76A-76D are sequential plan views corresponding to FIGS. 75A-75D;

FIGS. 77 is a perspective view corresponding to FIGS. 75D and 76D;

FIGS. 78A-78C are sectional views sequentially showing the creation of a side-to-side anastomosis using magnetism according to another embodiment of the invention;

FIGS. 79A is a perspective view of two vessels provided with respective anastomotic components;

FIG. 79B is a sectional view showing the two vessels joined by a side-to-side anastomosis;

FIG. 79C is a sectional view of the anastomosis shown in FIG. 79B illustrating one of the components being separated from its associated vessel;

FIGS. 80A-80C are sectional views illustrating a device constructed according to one embodiment of the invention being used to check the seal at a junction between an anastomotic component and a vessel;

FIGS. 81A-81C are sectional views illustrating a device constructed according to another embodiment of the invention being used to check the seal at a junction between an anastomotic component and a vessel;

FIGS. 81D-81F are transverse sectional views of the device illustrated in FIGS. 81A-81C;

FIGS. 82A-82C are sectional views illustrating a device constructed according to yet another embodiment of the invention being used to check the seal at a junction between an anastomotic component and a vessel;

FIGS. 83A-83B are, respectively, front and side elevation views of a device constructed according to one embodiment of the invention for confirming proper orientation of a magnetic anastomotic component, the component being shown correctly mounted on a delivery device;

FIGS. 84A-84B are, respectively, front and side elevation views of the device shown in FIGS. 83A-83B showing the magnetic anastomotic component incorrectly mounted on the delivery device;

FIG. 85A is a sectional view of a magnetic anastomotic component constructed according to another embodiment of the invention attached to a vessel in an angled fashion;

FIG. 85B is a sectional view of an anastomosis formed between the vessel and magnetic anastomotic component of FIG. 85A and a second component secured to a second vessel;

FIG. 86A is a perspective view of a two-pole magnetic anastomotic component constructed according to one embodiment of the invention; and

FIG. 86B is a perspective view of a three-pole magnetic anastomotic component constructed according to another embodiment of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1-5 illustrate several exemplary embodiments of anastomotic securing components constructed according to the invention for use in forming an anastomosis between first and second hollow bodies. FIG. 1 shows a securing component 10 with an annular body and an opening 12 defined by the body. The component 10 is generally plateshaped and circular in plan view with a constant (or substantially constant) thickness and width around its perimeter. The securing component 10 is sized and configured to be placed adjacent an opening of a first hollow body that has been prepared for anastomosis to a second hollow body. A second securing component would be placed adjacent an opening of the second hollow body for making the anastomotic connection.

FIG. 2 shows an elliptical anastomotic securing component 14 with an opening 16. The securing component 14 is generally plate-shaped and the opening 16 is configured to provide the securing component 14 with larger end portions 18 than side portions 20. FIG. 3 shows a racetrack-shaped securing component 22 with an opening 24. As in securing component 14, the opening 24 provides securing component 22 with larger end portions 26 than side portions 28. FIG. 4 shows a securing component 30 with an opening 32, two end portions 34, 36 and two side portions 38. The securing component 30 has a generally racetrack-shaped configuration; however, the end portion 36 is larger than the end portion 34 which provides the component 30 with an asymmetric configuration. Stated otherwise, the opening 32 is not centrally located with respect to the body of the component 30, unlike the openings 12, 16 and 24 of respective securing components 10, 14 and 22 shown in FIGS. 1-3. Also, the end 36 provides a tapered leading edge for easier introduction into a hollow body such as blood vessel.

It will be understood that the specific shape and size of the securing components may be varied from the exemplary configurations depicted in FIGS. 1-4. For example, the thickness or width of the securing component may vary along all or part of the body of the component. The anastomotic securing components of the invention are preferably, though not necessarily, plate-shaped, i.e., a first dimension D1 of the component is less than a second dimension D2 of the component (FIG. 1). Typically, the lesser dimension corresponds to a thickness of the component while the larger dimension corresponds to a width or length of the component (or diameter in the case of FIG. 1). Minimizing the thickness of the securing component may be desirable for applications in which one or more components are placed within the lumen of a relatively small hollow body, e.g., a coronary artery, to reduce the amount of foreign material in the bloodstream and minimize flow impedance.

It will be noted that the securing components shown in FIGS. 1-4 are generally flat; however, they could instead be curved or arcuate, or comprise a combination of flat and curved sections. Additionally, in the illustrated and preferred construction the shape of each securing component substantially corresponds to the opening therein. That is, the securing component and its opening preferably have complementary configurations (e.g., elliptical component, elliptical opening). Nevertheless, the securing component could have a noncomplementarily-shaped opening. Finally, while each of the illustrated securing components includes only one opening, more than one opening could be used if desired.

According to preferred embodiments of the invention the anastomotic securing components are formed of or have incorporated therein a material capable of producing a magnetic field that acts to maintain the components in a desired positional relationship. The magnetic field results in the securing components maintaining the first and second hollow bodies in a desired position so as to be in fluid-tight communication. The anastomotic component preferably has magnetic properties and may comprise permanent magnetic, ferro- or ferrimagnetic, or electromagnetic materials or assemblies.

Each of the securing components shown in FIGS. 1-4 is formed substantially entirely of a suitable, magnetic field-producing material such that magnetic force may be generated over the entire area of the component. FIG. 5 shows an alternative embodiment wherein a securing component 40, which has an opening 42 and a racetrack-shaped configuration similar to securing component 22 of FIG. 3, has defined portions capable of producing a magnetic field. Specifically, the securing component 40 includes magnetic field-producing members 44 located at discrete areas which, in the illustrated embodiment, are at the ends of the component. The remaining areas 46 may thus be formed of a different material. It will be recognized that the members 44 could be located at alternative (or additional) areas of the securing component 40. An exemplary reason for providing the securing component 40 with areas 46 is to allow the use of a rigid magnetic material for the members 44 while still permitting the component to be partially or completely collapsed, for example, for delivery through a small incision or port, trocar, catheter, cannula, etc., by folding the areas 46.

Suitable materials that may be used to form an anastomotic securing component that is capable of producing a magnetic field include NdFeB (Neodymium Iron Boron), SmCo (Samarium Cobalt), and Alnico (Aluminum Nickel Cobalt). NdFeB is currently preferred for its force characteristics. The amount of force exerted will depend on various factors including the materials used, the size of the magnets and the number of magnets. In addition, different applications will call for different force ranges. For instance, it may be desirable to minimize the force as much as possible while still achieving a fluidtight and secure attachment when treating small diameter blood vessels. As an example, in anastomosing coronary vessels, it is preferred to use anastomotic securing components that produce magnetic force in the area of less than 0.25 lbs, and more preferably approximately 0.15 lbs or less.

FIGS. 6-8 depict first and second hollow bodies that have been prepared for anastomosis in three different manners. FIG. 6 shows a first hollow body 50 with an opening 52 that is adapted to be joined to an opening 54 of a second hollow body 56 to form an end-to-side anastomosis. The completed anastomosis places the lumens of the respective hollow bodies in communication. The opening 52 is formed in the wall of the first hollow body 50, for example, by incising or punching the tissue of the wall, while the opening 54 is defined by an end of the second hollow body 56. FIG. 7 shows a first hollow body 58 with an opening 60 adapted to be joined to an opening 62 of a second hollow body 64, thereby forming a side-to-side anastomosis that places their lumens in communication. The openings 60, 62 are formed in the walls of the hollow bodies 58, 64, for example, as described above regarding opening 52. FIG. 8 shows a first hollow body 66 with an opening 68 adapted to be joined to an opening 70 of a second hollow body 72 to form an end-to-side anastomosis. Each opening 68, 70 is defined by an end its associated hollow body 66, 72.

The incision or other opening in the hollow body is preferably sized so as to cooperate with the magnetic anastomotic component(s) being used. For example, a gauge (not shown) may be placed along the vessel and used as a guide to form an incision having the correct length. A plurality of gauges, for example, each comprising a small rod with a handle to facilitate laying the rod along the vessel wall, may be provided for use with different anastomotic components and vessels.

FIGS. 9 and 9A show first and second hollow bodies 74, 76 respectively provided with first and second anastomotic securing components 78, 80 which are used to create an exemplary end-to-side anastomosis according to one embodiment of the invention. As shown best in FIG. 9A, the securing component 78 includes two members 78A, 78B disposed on opposite surfaces of a wall of the first hollow body 74. The securing component 80 includes two members 80A, 80B disposed on opposite surfaces of an everted end of the second hollow body 76. The members forming each securing component 76, 78 may be held in a desired and preferably fixed relative position by magnetic force, with magnetic force also being used to hold the two securing components in position. The securing components 78, 80 are moved together from the position of FIG. 9A to create a fluid-tight anastomosis.

FIGS. 10A-10D depict additional end-to-side anastomoses formed according to other embodiments of the invention. FIG. 10A shows a first securing component 82 coupled to a first hollow body 84 and a second securing component 86 coupled to a second hollow body 88. The securing components 82, 86 have a laminated structure comprising one layer of material capable of producing a magnetic field disposed between two outer layers of different material. In order to produce a magnetic field the components may comprise, for example, permanent magnetic, ferromagnetic, ferrimagnetic or electromagnetic materials or assemblies. Some exemplary materials that may be used include metals, polymers, ceramics, etc.

One example of this embodiment of the invention comprises a securing component having a middle layer of permanent magnetic material (e.g., NdFeB) and two outer layers of ferromagnetic material (e.g., 300 or 400 series stainless steel). The outer layers may be attached to the middle layer by suitable adhesive or magnetic force. One specific example of a securing component constructed according to this embodiment comprises a 0.008" thick inner magnetic layer and two 0.001" thick outer stainless steel layers. It will be understood that this aspect of the invention may be practiced using other materials or assemblies.

A benefit of a laminated construction is that it allows the thickness of the magnetic layer to be reduced because the other layer(s) will provide the assembly with the necessary strength and integrity, even if the magnetic layer is very thin (which typically makes the brittle magnet more easily fractured). In the above example, the steel layers may be very thin yet still able to absorb the load, e.g., the tensile forces that arise during movement of the hollow body or adjacent tissue. The particular overall dimensions of the securing component, as well as the dimensions of individual layer (or layers if a multilayer construction is used) will of course depend on the application. (As examples, for the securing component 22 shown in FIG. 3, the thickness is preferably less than 0.040", and more preferably less than 0.020", e.g., approximately 0.015" or even less, e.g., 0.008".)

The ability to form a very thin securing component allows formation of an anastomosis between relatively small hollow bodies, e.g., coronary blood vessels. Further, the anastomosis can be formed between blood-carrying hollow bodies with one or more of the securing components located in the blood flow path while minimizing the foreign material exposed to blood.

FIG. 10B shows first and second securing components 90, 92 coupled to first and second ho