Active suture for the delivery of therapeutic fluids

• US 20050125034A1
• Filed: 12/04/2003
• 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 Richard Jr.
• Granted Patent: US 8,257,393 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 both wound closure and 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 or conventional IV delivery system, 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 comprising:

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

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 is disposed between the proximal and distal ends of the braided suture.

4. The active suture of claim 1, where the at least one passageway is a lumen of a tube.

5. The active suture of claim 1, where the at least one passageway is within a coated fiber tow or a coated braided suture.

6. The active suture of claim 4, where the tube has one or more holes that connect the lumen to the outer surface of the tube.

7. The active suture of claim 5, where the coated fiber tow or coated braided suture has one or more holes that connect the at least one passageway to the outer surface of the coated fiber tow or coated braided suture.

8. The active suture of claim 1, 2 or 3, further comprising a connector located on the proximal end of the at least one passageway, on one end of the tube, or on one end of the coated fiber tow or braided suture, said connector being capable of attachment directly to a hypodermic needle or indirectly to an intravenous delivery system or fluid pump.

9. The active suture of claim 1, 2 or 3 further comprising an inflatable reservoir on the proximal end of the at least one passageway, on one end of the tube, or on one end of the coated fiber tow or braided suture.

10. The active suture of claim 9, further comprising a connector proximal to the inflatable reservoir.

2. An active suture comprising:

a braided suture having an outer diameter; and

a tube coaxial with at least a portion of the braided suture, having an outer diameter that is less than the outer diameter of the braided suture and an inner diameter, and having one or more opening therein;

wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7.

3. An active suture comprising a first braided suture having an outer diameter and having embedded therein a coated fiber tow or coated braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or coated braided suture having an outer diameter that is less than the outer diameter of the first braided suture, and said coated fiber tow or coated braided suture having one or more opening therein.

11. A method of closing a wound using a suture/needle assembly comprising a braided suture having proximal and distal ends, an outer diameter, at least one passageway coaxial with at least a portion of the braided suture, said passageway 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 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, comprising the steps of;

connecting the connector on the proximal end of the at least one passageway 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;

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

closing the wound with the braided suture.

23. The method of claim 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 or 22 where the reservoir is a syringe and pressure is exerted on the fluid via manual operation of the syringe.

12. A method of administering a fluid to a wound that has been closed using a braided suture having proximal and distal ends, an outer diameter, at least one passageway coaxial with at least a portion of the braided suture, said passageway having proximal and distal ends, an opening at the distal end and a diameter that is less than the outer diameter of the braided suture, wherein the distal end of the at least one passageway is disposed between the proximal and distal ends of the braided suture;

and a connector attached to the proximal end of the at least one passageway;

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

connecting the connector on the proximal end of the at least one passageway 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; and

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

24. The method of claim 12, 13, 14, 16 , 17, 18, 20, 21 or 22 where the reservoir is an intraveneous delivery system and pressure is exerted on the fluid by elevating the reservoir to at least 0.5 meter above the wound.

25. The method of claim 12, 13, 14, 16, 17, 18, 20, 21 or 22 where pressure is exerted on the fluid via a pump or an inflatable reservoir.

13. 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, an outer diameter;

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

comprising the steps of;

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

closing the wound with the braided suture;

connecting the connector on the proximal end of the at least one passageway 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; and

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

14. 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, an outer diameter;

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

comprising the steps of;

connecting the connector on the proximal end of the at least one passageway 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;

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

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

closing the wound with the braided suture.

15. 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, an outer diameter that is less than the outer diameter of the braided suture, an inner diameter, and one or more openings therein, wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7;

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;

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

closing the wound with the braided suture.

16. 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, an outer diameter that is less than the outer diameter of the braided suture, an inner diameter, and one or more openings therein, wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7; and

a connector attached to the proximal end of the tube;

such that the one or more openings in 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 one or more openings in the tube into at least a portion of the braided suture at or in the proximity of the wound.

17. 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, an outer diameter that is less than the outer diameter of the braided suture, an inner diameter, and one or more openings therein, wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7;

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 one or more openings in the tube is at or in the proximity of the wound;

closing the wound with 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 one or more openings of the tube into at least a portion of the braided suture at or in the proximity of the wound.

18. 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, an outer diameter that is less than the outer diameter of the braided suture, an inner diameter, and one or more openings therein, wherein the ratio of the outer diameter of the tube to the inner diameter of the tube is greater than 1.7;

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 one or more openings 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 one or more openings in the tube is at or in the proximity of the wound; and

closing the wound with the braided suture.

19. A method of closing a wound using a suture/needle assembly comprising a first braided suture having an outer diameter, a coated fiber tow or braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or braided suture having proximal and distal ends, an outer diameter that is less than the outer diameter of the first braided suture, and 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;

comprising the steps of;

connecting the connector on the proximal end of the coated fiber tow or braided suture 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 coated fiber tow or braided suture;

introducing the suture/needle assembly into tissue surrounding the wound such that the one or more openings in the coated fiber tow or braided suture is at or in the proximity of the wound; and

closing the wound with the first braided suture.

20. A method of administering a fluid to a wound that has been closed using a first braided suture having an outer diameter, a coated fiber tow or braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or braided suture having proximal and distal ends, an outer diameter that is less than the outer diameter of the first braided suture, and one or more openings therein;

and a connector attached to the proximal end of the coated fiber tow or braided suture;

such that the one or more openings in the coated fiber tow or braided suture is at or in the proximity of the wound, comprising the steps of;

connecting the connector on the proximal end of the coated fiber tow or braided suture 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 coated fiber tow or braided suture; and

allowing the fluid to exit the one or more openings in the coated fiber tow or braided suture into at least a portion of the first braided suture at or in the proximity of the wound.

21. A method of closing a wound and administering a fluid to a wound using a suture/needle assembly comprising a first braided suture having proximal and distal ends and an outer diameter, a coated fiber tow or braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or braided suture having proximal and distal ends, an outer diameter that is less than the outer diameter of the first braided suture, and one or more openings therein;

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

a connector attached to the proximal end of the coated fiber tow or braided suture;

comprising the steps of;

introducing the suture/needle assembly into tissue surrounding the wound such that the one or more openings in the coated fiber tow or braided suture is at or in the proximity of the wound;

closing the wound with the first braided suture;

connecting the connector on the proximal end of the coated fiber tow or braided suture 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 coated fiber tow or braided suture; and

allowing the fluid to exit the one or more openings of the coated fiber tow or braided suture into at least a portion of the first braided suture at or in the proximity of the wound.

22. A method of closing a wound and administering a fluid to a wound using a suture/needle assembly comprising a first braided suture having proximal and distal ends and an outer diameter, a coated fiber tow or braided suture coaxial with at least a portion of the first braided suture, said coated fiber tow or braided suture having proximal and distal ends, an outer diameter that is less than the outer diameter of the first braided suture, and one or more openings therein;

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

a connector attached to the proximal end of the coated fiber tow or braided suture;

comprising the steps of;

connecting the connector on the proximal end of the coated fiber tow or braided suture 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 coated fiber tow or braided suture;

allowing the fluid to exit the one or more openings of the coated fiber tow or braided suture into at least a portion of the first braided suture;

introducing the suture/needle assembly into tissue surrounding the wound such that the one or more openings in the coated fiber tow or braided suture is at or in the proximity of the wound; and

closing the wound with the first braided suture.