Active suture for the delivery of therapeutic fluids

• US 20050125035A1
• Filed: 08/02/2004
• Published: 06/09/2005
• Est. Priority Date: 12/04/2003
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Cichocki, Frank R. Jr.
• Granted Patent: US 7,875,055 B2
• Time in Patent Office: Days
• US Class Current: 606/222
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/06185 hollow or tubular hollow suture needles A61B2017/061
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

An active suture that can be used for the delivery of therapeutic fluids to the tissue surrounding a wound is disclosed. The active suture may include a connector designed to join a fluid source, such as a syringe, conventional IV delivery system, or infusion pump to an internal passageway that is embedded within a braided suture. The internal passageway may be comprised of a fine polymeric tube and is capable of conducting and emitting a fluid into at least a portion of the braided suture and surrounding tissue. The invention enables delivery of an efficacious volume of drug bearing solution on the order of milliliters per day, provides a high level of fluid delivery rate control enabling the physician to start or stop drug administration at his/her discretion, and offers a means of providing more than one type of medication that may be selected post-surgically in accord with unexpected patient symptoms that may arise.

Claims

1. An active suture/needle assembly comprising

an active suture comprising

a braided suture having proximal and distal ends and an outer diameter;

and

a tube having proximal and distal ends and coaxial with at least a portion of the braided suture, said tube having an outer diameter that is less than the outer diameter of the braided suture and having one or more openings therein;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the tube.

2. An active suture/needle assembly comprising

an active suture comprising

a braided suture having proximal and distal ends and an outer diameter;

and

a tube having proximal and distal ends and coaxial with at least a portion of the braided suture, said tube having an inner diameter that is greater than the outer diameter of the braided suture;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the tube.

3. A method of administering a fluid to a wound comprising the steps of:

introducing an active suture/needle assembly comprising

an active suture comprising

a braided suture having proximal and distal ends and an outer diameter, and

(i) at least one passageway coaxial with at least a portion of the braided suture, and having proximal and distal ends and a diameter that is less than the outer diameter of the braided suture, wherein the distal end of the at least one passageway has an opening and is disposed between the proximal and distal ends of the braided suture;

or

(ii) a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends, an outer diameter that is less than the outer diameter of the braided suture, and one or more openings therein;

or

(iii) a coated fiber tow or coated braided suture coaxial with at least a portion of the braided suture, said coated fiber tow or coated braided suture having proximal and distal ends, an outer diameter that is less than the outer diameter of the braided suture, and one or more openings therein;

or

(iv) a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends and an inner diameter that is greater than the outer diameter of the braided suture, wherein the distal end of the tube is disposed between the proximal and distal ends of the braided suture;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the at least one passageway, the tube or the coated fiber tow or coated braided suture;

into tissue surrounding the wound to position the distal end of the at least one passageway or the tube in (iv), or the one or more openings in the tube in (ii) or the coated fiber tow or coated braided suture, at, in the proximity of, or within the wound;

connecting the connector directly or indirectly to a reservoir comprising the fluid;

exerting pressure on the fluid to force the fluid to enter into the connector and the at least one passageway, the tube or the coated fiber tow or coated braided suture; and

allowing the fluid to exit the opening at the distal end of the at least one passageway or the tube in (iv), or the one or more openings in the tube in (ii) or the coated fiber tow or coated braided suture, into the braided suture and then into, or in the proximity of the wound.

4. The method of claim 3, further comprising the steps of

closing at least one layer of tissue of the wound prior to introducing the active suture/needle assembly into the tissue;

closing the remaining layers of tissue of the wound, after the active suture/needle assembly is introduced into the tissue; and

leaving the connector external to the wound.

5. The method of claim 3, further comprising the step of tying a surgical knot in the active suture after the distal end of the at least one passageway, or the one or more openings in the tube or the coated fiber tow or coated braided suture, has been positioned at, in the proximity of, or within the wound.

6. A method of closing a wound using a suture/needle assembly comprising a braided suture having proximal and distal ends and an outer diameter;

a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends and an inner diameter that is greater than the outer diameter of the braided suture, wherein the distal end of the tube is disposed between the proximal and distal ends of the braided suture;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the tube;

comprising the steps of;

connecting the connector on the proximal end of the tube directly or indirectly to a reservoir comprising a fluid;

exerting pressure on the fluid to force the fluid to enter into the connector and the tube;

introducing the suture/needle assembly into tissue surrounding the wound such that the distal end of the tube is at or in the proximity of the wound; and

closing the wound using the braided suture.

7. A method of administering a fluid to a wound that has been closed using a braided suture having an outer diameter;

a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends and an inner diameter that is greater than the outer diameter of the braided suture, wherein the distal end of the tube is disposed between the proximal and distal ends of the braided suture; and

a connector attached to the proximal end of the tube;

such that the distal end of the tube is at or in the proximity of the wound, comprising the steps of;

connecting the connector on the proximal end of the tube directly or indirectly to a reservoir comprising the fluid;

exerting pressure on the fluid to force the fluid to enter into the connector and the tube; and

allowing the fluid to exit the distal end of the tube into at least a portion of the braided suture at or in the proximity of the wound.

8. A method of closing a wound and administering a fluid to a wound using a suture/needle assembly comprising a braided suture having proximal and distal ends and an outer diameter, a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends and an inner diameter that is greater than the outer diameter of the braided suture, wherein the distal end of the tube is disposed between the proximal and distal ends of the braided suture;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the tube;

comprising the steps of;

introducing the suture/needle assembly into a tissue surrounding the wound such that the distal end of the tube is at or in the proximity of the wound;

closing the wound using the braided suture;

connecting the connector on the proximal end of the tube directly or indirectly to a reservoir comprising the fluid;

exerting pressure on the fluid to force the fluid to enter into the connector and the tube; and

allowing the fluid to exit the distal end of the tube into at least a portion of the braided suture at or in the proximity of the wound.

9. A method of closing a wound and administering a fluid to a wound using a suture/needle assembly comprising a braided suture having proximal and distal ends and an outer diameter, a tube coaxial with at least a portion of the braided suture, said tube having proximal and distal ends and an inner diameter that is greater than the outer diameter of the braided suture, wherein the distal end of the tube is disposed between the proximal and distal ends of the braided suture;

a surgical needle attached to the distal end of the braided suture; and

a connector attached to the proximal end of the tube;

comprising the steps of;

connecting the connector on the proximal end of the tube directly or indirectly to a reservoir comprising the fluid;

exerting pressure on the fluid to force the fluid to enter into the connector and the tube;

allowing the fluid to exit the distal end of the tube into at least a portion of the braided suture;

introducing the suture/needle assembly into a tissue surrounding the wound such that the distal end of the tube is at or in the proximity of the wound; and

closing the wound using the braided suture.