Magnetic components for use in forming anastomoses, creating ports in vessels and closing openings in tissue

• US 6,719,768 B1
• Filed: 08/12/2000
• Issued: 04/13/2004
• Est. Priority Date: 04/29/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Ventrica, Inc. (Medtronic Plc)
• Inventors: Reo, Michael L., Gittings, Darin C., Cole, David H., Crews, Samuel T., Carson, Dean F., Lepulu, Keke J.
• Primary Examiner(s): Izaguirre, Ismael
• Application Number:
  US09/638,805
• Time in Patent Office: 1,340 Days
• Field of Search: 606/153, 606/215, 606/156, 128/898
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• 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 2017/00876 magnetic
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/94 : Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: H01F 41/026 : protecting methods against environmental influences, e.g. oxygen, by surface treatment magnetic particles with skin H01F1/061, H01F1/09, H01F1/24, H01F1/33 and G11B5/706
• CPC Class Codes: H01F 7/0263 : Closures, bags, bands, engagement devices with male and female parts

Abstract

Methods and devices for forming an anastomosis between hollow bodies utilize magnetic force to couple anastomotic securing components and connect the lumens of the hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created without using suture or any other type of mechanical fasteners, although such attachment means may be used in practicing some aspects of the invention. The securing components have the ability to produce a magnetic field and may include materials or assemblies. A component may also be used to form a port into the lumen of a vessel, the component being attached to the vessel by mechanical and/or magnetic means. Magnetic components may include means for concentrating the magnetic flux between respective components to increase the attraction force, thereby enhancing the security of the anastomosis. Also, rather than form a port communicating with a lumen of a vessel or other cavity, the components may have an occlusion surface and be used to close an opening in tissue, e.g., an atrial septal defect.

Claims

1. A device for forming a magnetic port in a hollow body having a lumen, the device comprising:

a component capable of producing a magnetic field and having an opening configured to be placed in communication with the lumen of the hollow body; and

a housing disposed on an exterior of the component, the housing providing a substantially sealed enclosure containing the component, the housing having a plurality of members cooperating to provide the sealed enclosure containing the component, wherein one housing member is a dish and another housing member is configured to close the dish and seal the component therein;

wherein the housing is formed of a biocompatible material adapted to be implanted in a patient.

2. The device of claim 1, wherein the housing provides a hermetically-sealed enclosure containing the component.

3. The device of claim 1, wherein the housing-comprises a metallic material.

4. The device of claim 3, wherein the housing comprises a plurality of titanium members joined by welding.

5. The device of claim 1, wherein the housing includes an indicator of the polarity of the magnetic field produced by the component.

6. A device adapted to be coupled to tissue using magnetic force, the device comprising:

a first securing component capable of producing a magnetic field, the first securing component being adapted to attract a second securing component that is capable of producing a magnetic field; and

a magnetic force-increasing mechanism for increasing the magnetic force attracting the first and second securing components when the first securing component is positioned in proximity to the second securing component.

7. The device of claim 6, wherein the magnetic force-increasing mechanism has a magnetic permeability greater than 1.0.

8. The device of claim 7, wherein the magnetic force-increasing mechanism has a magnetic permeability greater than 100.

9. The device of claim 7, wherein the magnetic force-increasing mechanism is configured to alter the magnetic flux density of the first securing component.

10. The device of claim 9, wherein the magnetic force-increasing mechanism is configured to concentrate magnetic flux in a desired location.

11. The device of claim 10, wherein the second securing component is plate-shaped and the force-increasing mechanism comprises a separate channel-shaped strip of material disposed along and forming an extension of at least one edge of the first securing component.

12. The device of claim 6, wherein when the first securing component is positioned a given distance from the second securing component the magnetic force attracting the components is from about 5% to about 75% higher than the magnetic force attracting the components without the flux concentration mechanism.

13. The device of claim 12, wherein when the first securing component is positioned a given distance from the second securing component the magnetic force attracting the components is at least 20% higher than the magnetic force attracting the components without the flux concentration mechanism.

14. The device of claim 12, further comprising a second securing component sized and configured generally complementarily to the first securing component, wherein the second securing component is capable of producing a magnetic field that attracts the first securing component and includes a flux concentration mechanism.

15. The device of claim 14, wherein the first securing component includes a portion for mechanically engaging the second securing component to couple the securing components mechanically and by magnetic force.

16. A device adapted to be coupled to a blood vessel having a lumen so as to produce a magnetic field adjacent the blood vessel, the device comprising:

at least one securing component sized and configured to be secured to a blood vessel having a lumen, the one securing component being capable of producing a magnetic field;

wherein the one securing component has an indicator that indicates the polarity of the magnetic field to a user carrying out a procedure on the blood vessel.

17. The device of claim 16, wherein the indicator comprises a visual marker on the one securing component that indicates a selected polarity of the magnetic field.

18. The device of claim 16, further comprising a delivery device supporting the one securing component, and wherein the indicator comprises a predetermined portion of the one securing component that is aligned with the delivery device to ensure that the one securing component is located with the selected polarity oriented in a desired position.

19. The device of claim 16, further comprising a second securing component that produces a magnetic field and is attracted to the one securing component, wherein the second component also has an indicator that indicates the polarity of the magnetic field produced by the second component to ensure that the. securing components are positioned to ensure their attraction.

20. The device of claim 19, wherein the one securing component is adapted to be coupled to a target vessel to form a magnetic port that communicates with the vessel lumen, and the second securing component is adapted to be coupled to the one securing component to form a vascular anastomosis using magnetic force.

21. The device of claim 16, wherein the one securing component comprises an electromagnet coupled to a power source.

22. The device of 21, wherein the electromagnet is contained in a protective housing.

23. A device for forming a port in a first hollow body having a lumen, the device comprising:

a securing component having an opening adapted to be placed in communication with an opening in the wall of the first hollow body so as to be in communication with the lumen of the first hollow body; and

a mechanical attachment portion configured to secure the component to the first hollow body in a desired position, wherein the mechanical attachment portion includes a structure that is at least partially collapsible for delivery through the opening in the wall of the first hollow body and then expandable to engage the wall of the first hollow body;

wherein the securing component is configured to produce a magnetic field adjacent the opening in the first hollow body.

24. The device of claim 23, wherein the collapsible structure comprises a tube with self-expanding arms that are generally coplanar for contacting the wall of the first hollow body when the arms are expanded.

25. The device of claim 24, wherein the tube defines an opening that is aligned with the opening in the securing component.

26. The device of claim 23, wherein the securing component has a laminated structure and includes a layer of biocompatible material to enhance sealing of the opening in the wall of the first hollow body.

27. The device of claim 26, wherein the attachment portion is secured to a separate member formed of a material capable of producing a magnetic field.

28. The device of claim 23, wherein the mechanical attachment portion is adapted to provide the sole attachment between the securing component and the first hollow body.

29. The device of claim 23, wherein the opening in the securing component has a shape selected from the group consisting of circular, elliptical, racetrack, football and canoe-shaped configurations.

30. A delivery device in combination with a component for forming an anastomosis, the combination comprising:

at least one component having an opening adapted to be placed in communication with a lumen of a vessel in a patient'"'"'s body, the component being capable of producing a magnetic field; and

a delivery device including a support portion supporting the component and a retaining portion that is movable with respect to the support portion, wherein the retaining portion is placed in a first position to retain the component and is moved from the first position to release the component;

wherein the retaining portion is movable with respect to the support portion in a direction selected from the group consisting of axial and rotary directions.

31. The combination of claim 30, further comprising a portion for supporting a second component, and wherein the support portion and the retaining portion of the delivery device are configured to contact different areas of the component.

32. The combination of claim 30, wherein the retaining portion comprises a rotatable rod with a portion contacting the component.

33. The combination of claim 30, wherein the retaining portion comprises a wedge slidably disposed with respect to the support portion, the wedge contacting the component when the retaining portion is in the first position.

34. The combination of claim 30, wherein the delivery device has a delivery end adapted to support at least one-component, and the delivery end is laterally offset with respect to a longitudinal axis of the delivery device.

35. The combination of claim 34, wherein the delivery end has a notch adapted to receive tissue as the device is being used to introduce the component into the lumen of a vessel.

36. The combination of claim 30, wherein the component comprises a magnetic material and the delivery device comprises a ferromagnetic material.

38. The method of claim 32, wherein step (b) is performed by altering the construction of at least one of the first and second securing components to concentrate magnetic flux between the components.

37. A method for increasing the magnetic force between first and second anastomotic securing components, the method comprising steps of:

(a) providing first and second anastomotic securing components each of which is capable of producing a magnetic field, the first and second securing components having respective openings adapted to be placed in communication with each other; and

(b) increasing the magnetic force between the first and second securing components by concentrating magnetic flux. between the securing components.

39. The method of claim 37, wherein step (b) is performed by providing the first and second securing components with respective flux concentration mechanisms that are formed of a material having a higher magnetic permeability than air.

40. A method for coupling a securing component to a target vessel in order to form a magnetic port communicating with a lumen of the target vessel, the method comprising steps of:

(a) providing first and second anastomotic securing components each of which is capable of producing a magnetic field, at least one of the securing components having an opening adapted to be placed in communication with the lumen of the target vessel;

(b) coupling the one securing component to the target vessel with the opening in the one securing component communicating with the target vessel lumen by positioning the securing components against opposite surfaces of the wall of the target vessel; and

(c) prior to completing step (b) confirming the orientation of the polarity of the magnetic field produced by the one securing component by checking a visual marker carried on at least one of the securing components.

41. The method of claim 40, wherein step (c) is performed by pre-loading the securing component on a deliver device in a predetermined position that properly orients the polarity of the magnetic field.

42. The method of claim 41, wherein the delivery device removably supports the one securing component to allow removal and reloading of the component if the polarity is improperly oriented.

43. A device for forming a magnetic port in a hollow body having a lumen, the device comprising:

a component capable of producing a magnetic field and having an opening configured to be placed in communication with the lumen of the hollow body; and

a housing disposed on an exterior of the component, the housing providing a substantially sealed enclosure containing the component, wherein the housing comprises a metallic material, the housing also comprises a plurality of titanium members joined by welding;

wherein the housing is formed of a biocompatible material adapted to be implanted in a patient.

44. A device for forming a magnetic port in a hollow body having a lumen, the device comprising:

a component capable of producing a magnetic field and having an opening configured to be placed in communication with the lumen of the hollow body; and

a housing disposed on an exterior of the component, the housing providing a substantially sealed enclosure containing the component, the housing including an indicator of the polarity of the magnetic field produced by the component;

wherein the housing is formed of a biocompatible material adapted to be implanted in a patient.

45. A method of forming an anastomosis between a first vessel and a second vessel, the method comprising steps of:

providing a first anastomotic component and a second anastomotic component, the first and second anastomotic components being magnetically attracted to one another, the first anastomotic component including a mechanical attachment portion having an expandable structure;

introducing the expandable structure of the first anastomotic component through an opening in a first vessel with the expandable structure being in a collapsed condition;

expanding the expandable structure of the first anastomotic component to engage the wall of the first blood vessel thereby coupling the first anastomotic component to the first vessel;

coupling the second anastomotic component to a second vessel; and

moving the second anastomotic component toward the first component so that magnetic attraction between the first and second anastomotic components couples the first and second vessels together.