Medical grafting methods and apparatus

• US 6,508,252 B1
• Filed: 10/29/1999
• Issued: 01/21/2003
• Est. Priority Date: 11/06/1998
• Status: Expired due to Fees

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sullivan, Daniel J., Swanson, William J., Berg, Todd Allen, Hindrichs, Paul J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/430,506
• Time in Patent Office: 1,180 Days
• Field of Search: 623/1.23, 623/1.36, 128/898, 604/8, 604/158, 604/159, 604/164, 606/8, 606/153, 606/158, 606/167, 606/170, 606/191, 606/151, 606/194-195, 606/185
• US Class Current: 128/898
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient'"'"'s existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is installed at the operative site primarily by providing at least one graft location with instrumentation inserted through the patient'"'"'s existing tubular body organ structure. Assistance in installing the new tubing may be provided by minimally invasive surgical access openings in the patient'"'"'s chest. The tubing may be delivered through the patient'"'"'s existing tubular body structure or, alternatively, through the surgical access openings.

Claims

1. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

piercing a wall of the tubular body structure at the first location with a distal portion of a first elongated structure inserted into and along a lumen of the tubular body structure to the first location;

piercing a wall of the tubular body structure at the second location with a distal portion of a second elongated structure inserted into and along a lumen of the tubular body structure to the second location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

passing an elongated guide member along the lumen of the tubular body structure, through the wall at one of the first and second locations to the other of the first and second locations;

passing the graft along the lumen of the tubular body structure and over the elongated guide member, through the wall at one of the first and second locations to the other of the first and second locations; and

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations.

2. The method defined in claim 1, wherein the elongated structure has a sharpened distal configuration, and the step of piercing the wall of the tubular body structure at the first location comprises:

piercing the wall of the tubular body structure at the first location with the sharpened distal configuration.

3. The method defined in claim 2, wherein the distal portion of the first elongated structure has a substantially hollow configuration, and the step of piercing the wall of the tubular body structure at the first location comprises:

extending the distal portion of the first elongated structure out of the tubular body structure at the first location such that a fluid-tight seal is provided between the distal portion of the first elongated structure and the wall of the tubular body structure at the first location.

4. The method defined in claim 3, wherein the step of passing an elongated guide member along the lumen of the tubular body structure, through the wall at one of the first and second locations to the other of the first and second locations comprises:

inserting an end portion of the elongated guide member into the hollow distal portion of the first elongated structure and into and along the interior of the first elongated structure.

5. The method defined in claim 1, wherein said tubular body structure has a primary fluid flow direction, the method further comprising:

after the step of passing the elongated guide member, orienting an end portion of the elongated guide member positioned in the lumen of the tubular body structure adjacent the second location in a downstream orientation substantially aligned with the fluid flow direction.

6. The method defined in claim 5, wherein the end portion of the elongated guide member has an atraumatic configuration and the step of orienting comprises:

withdrawing the elongated guide member from the tubular structure such that the end portion of the elongated guide member remaining in the lumen of the tubular body structure is oriented at least partially transverse to the fluid flow direction; and

reinserting the elongated guide member such that the end portion extends in the fluid flow direction.

7. The method defined in claim 5, further comprising:

securing the distal portion of the second elongated structure within the lumen of the tubular body structure.

8. The method defined in claim 1 further comprises:

providing a connector for providing an anastomotic connection between the graft and the tubular body structure; and

attaching the connector to an end portion of the graft.

9. The method defined in claim 8, wherein the connector is configured to expand between a deformed configuration and a relaxed, expanded configuration and the step of attaching comprises:

deforming the connector to the deformed configuration;

inserting the connector into the lumen of the tubular body structure at one of the first and second locations; and

expanding the connector to the expanded configuration in the lumen.

10. The method defined in claim 9, wherein the step of deforming further comprises:

providing a tubular structure coaxially surrounding the connector and maintaining the connector in the deformed configuration; and

at least partially surrounding the connector with the tubular structure.

11. The method defined in claim 10, wherein the step of expanding further comprises:

retracting the tubular structure with respect to the connector to allow the connector to move to the expanded configuration.

12. The method defined in claim 10, wherein the connector comprises a unitary structure disposed annularly about a longitudinal axis and having axially spaced first and second portions, said first portion having a plurality of annularly spaced first members that are deflectable radially out from a remainder of said structure, said second portion having a plurality of annularly spaced second members that are deflectable radially out from a remainder of said structure, and said structure being configured for annular enlargement, wherein the step of expanding comprises:

retracting the tubular structure with respect to the connector to allow the first members and the second members to deflect radially outward.

13. The method defined in claim 8, wherein the connector defines a constant axial length and a cross-section radially expandable between a first diameter sized for insertion through the wall of the tubular body structure at the second location, and a second diameter, the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

after the step of attaching the connector to the end portion of the graft, inserting the connector while in the first diameter through the wall of tubular body structure at the second location; and

expanding the connector from the first diameter to the second diameter while maintaining the constant axial length, thereby securing the end portion of the graft coaxially between the connector and the tubular body structure.

14. The method defined in claim 13, wherein the tubular body structure has a primary fluid flow direction, and the step of inserting the connector comprises passing the connector over the elongated guide member such that the connector is at least partially aligned in the fluid flow direction.

15. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

piercing a wall of the tubular body structure at the first location with a distal portion of a first elongated structure inserted into and along a lumen of the tubular body structure to the first location;

piercing a wall of the tubular body structure at the second location with a distal portion of a second elongated structure inserted into and along a lumen of the tubular body structure to the second location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

passing an elongated guide member along the lumen of the tubular body structure, through the wall at one of the first and second locations to the other of the first and second locations;

passing the graft along the lumen of the tubular body structure and over the elongated guide member, through the wall at one of the first and second locations to the other of the first and second locations;

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations; and

wherein the step of passing an elongated guide member along the lumen of the tubular body structure, through the wall at one of the first and second locations to the other of the first and second locations comprises accessing the elongated guide member with instrumentation inserted into the surgical access opening.

16. The method defined in claim 15, wherein the second elongated structure comprises a deflection structure configured to deflect the distal portion of the elongated guide member towards the interior surface of the wall of the tubular body structure and the step of piercing the wall of the tubular body structure at the second location comprises:

deflecting the distal portion of the elongated guide member towards the interior surface of the wall of the tubular body structure; and

piercing the wall of the tubular body structure with distal portion of the elongated guide member.

17. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

piercing a wall of the tubular body structure at the first location with a distal portion of a first elongated structure inserted into and along a lumen of the tubular body structure to the first location;

piercing a wall of the tubular body structure at the second location with a distal portion of a second elongated structure inserted into and along a lumen of the tubular body structure to the second location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

passing an elongated guide member along the lumen of the tubular body structure, through the wall at one of the first and second locations to the other of the first and second locations;

passing the graft along the lumen of the tubular body structure and over the elongated guide member, through the wall at one of the first and second locations to the other of the first and second locations;

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations; and

wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises;

suturing an end portion of the graft to the tubular body structure adjacent one of the first and second locations.

18. The method defined in claim 17, wherein the step of attaching axially spaced portions of the graft to the tubular body structure further comprises:

providing suturing apparatus through the surgical access opening.