T-fastener suture delivery system

• US 9,592,044 B2
• Filed: 02/09/2012
• Issued: 03/14/2017
• Est. Priority Date: 02/09/2011
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Weir, Steven A., Howell, Glade H., Barenboym, Michael, Eliasen, Kenneth A., Cohn, Matthew J.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/370,100
• Publication Number:
  US 20120203250A1
• Time in Patent Office: 1,860 Days
• Field of Search: 606/139, 606/142, 606/144, 606/148, 606/232
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128

Abstract

A delivery device for inserting a plurality of T-fastener-equipped sutures into a body of a patient in a spaced-apart configuration for the purpose of securing the stomach wall against the abdominal wall, also known as gastropexy, is disclosed. The suture delivery device is configured to deliver multiple sutures using a single needle and without need for reloading, saving time and effort for the clinician and simplifying the suture placement process. In one embodiment, a T-fastener-equipped suture delivery device comprises a housing, a hollow needle extending from the housing, and a plurality of T-fastener-equipped sutures at least partially disposed within one of the needle and the housing. An ejection assembly for successively ejecting the T-fasteners from a distal end of the needle without reloading the delivery device is also included in the housing.

Claims

1. A T-fastener-equipped suture delivery device, comprising:

a housing including a plurality of housing inclined teeth positioned on an interior wall thereof, the plurality of housing inclined teeth defining a plurality of housing pockets;

a hollow needle extending from the housing;

a plurality of T-fastener-equipped sutures at least partially disposed within one of the needle and the housing, each of the T-fastener-equipped sutures comprising a T-fastener and a suture portion, wherein three T-fasteners are initially disposed in linear fashion within the needle of the device; and

an ejection assembly for successively ejecting the T-fasteners from a distal end of the needle without reloading the delivery device, the ejection assembly including;

an actuator designed for movement in a distal direction to eject the T-fasteners from the distal end of the needle, the actuator having a first position and a second position distal to the first position, the T-fasteners ejected from the distal end of the needle in the second position, the actuator returned to the first position following ejection of each of the T-fasteners; and

an ejector component designed for distal only step-wise movement, the elector component including;

a plurality of elector inclined teeth defining a plurality of elector pockets, the actuator designed to engage the elector pockets; and

an ejector arm including a portion designed to engage the housing pockets.

2. The device as defined in claim 1, wherein the T-fasteners are ejected one-by-one in a step-wise fashion.

3. The device as defined in claim 2, wherein the ejection assembly is manually actuated, and wherein each manual actuation of the ejection assembly causes one T-fastener to be ejected from the distal end of the needle.

4. The device as defined in claim 3, wherein the ejection assembly includes a push rod disposed in the needle to eject the T-fasteners.

5. The device as defined in claim 4, wherein the push rod is operably connected to the ejector component.

6. The device as defined in claim 5, wherein the ejector component is operably connected to the actuator, which provides a movement force to the ejector component for selectively advancing the ejector component in the distal direction.

7. The device as defined in claim 6, wherein the actuator is capable of back-and-forth linear ratcheting movement within the housing to successively move the ejector component distally in step-wise fashion so as to cause the push rod to eject the T-fasteners from the distal end of the needle with each step-wise distal movement of the ejector component.

8. The device as defined in claim 7, wherein the actuator includes a pair of actuator arms designed to move to a more proximal pocket of the plurality of ejector pockets defined by the ejector inclined teeth upon each ratcheting movement of the actuator to enable the step-wise distal movement of the ejector component.

9. The device as defined in claim 8, wherein the actuator is returned to the first position after each ratcheting movement by a spring disposed in the housing.

10. The device as defined in claim 9, wherein the actuator is manually activated by an interface on an exterior portion of the housing.

11. The device as defined in claim 1, wherein the suture portion of each T-fastener-equipped suture initially extends proximally from the corresponding T-fastener within the needle into the housing, wherein a plurality of external bolsters is initially disposed on the needle, and wherein each external bolster is distally slidable off the needle and on to the suture portion after ejection of the corresponding T-fastener so as to secure the T-fastener-equipped suture to the patient.

12. The device as defined in claim 1, wherein at least one of the T-fasteners initially disposed within the needle includes a longitudinally extending indentation to enable the suture portion of each T-fastener more distally disposed in the needle to freely pass the at least one T-fastener.

13. A method for delivering T-fastener-equipped sutures into a body of a patient, the method comprising:

providing a T-fastener-equipped suture delivery device comprising a housing including a plurality of housing inclined teeth positioned on an interior wall thereof, the plurality of housing inclined teeth defining a plurality of housing pockets, a needle extending from the housing and a plurality of T-fastener-equipped sutures at least partially disposed within one of the needle and the housing, each of the T-fastener-equipped sutures comprising a T-fastener and a suture portion, the T-fasteners are initially disposed in linear fashion within the needle of the device;

inserting a distal portion of the needle into the body of the patient;

actuating a push rod to eject a first one of the T-fasteners from the needle into the body of the patient, the actuating including moving an actuator from a proximal position to a distal position, the actuator returning to the proximal position following ejection of the first one of the T-fasteners from the needle, the actuating further including moving an elector component distally, the ejector component including a plurality of elector inclined teeth defining a plurality of ejector pockets, the actuator engaging the ejector pockets, the ejector component further including an ejector arm having a portion engaging the housing pockets to prevent proximal movement of the ejector component;

removing and reinserting the distal portion of the needle into the body of the patient without reloading the delivery device with T-fasteners; and

re-actuating the push rod to eject a second one of the T-fasteners from the needle into the body of the patient.

14. The method as defined in claim 13, wherein the push rod and the actuator are included in an ejection assembly of the delivery device and wherein actuating the push rod further comprises advancing the ejection assembly distally in a step-wise fashion.

15. The method as defined in claim 14, wherein the ejection assembly includes the ejector component, the ejector component operably connected to the push rod, and wherein distally advancing the ejection assembly further comprises distally advancing the ejector component in step-wise fashion via back-and-forth ratcheting movement of the actuator.

16. The method as defined in claim 15, further comprising manually pressing an actuation button to cause the back-and-forth ratcheting movement of the actuator.

17. The method as defined in claim 13, further comprising:

sliding an external bolster off the distal portion of the needle and on to the suture portion after ejection of one of the T-fasteners into the body of the patient; and

binding the suture portion with the external bolster proximate a skin surface of the patient.

18. The method as defined in claim 13, further comprising distally advancing the push rod after ejection of all T-fasteners from the needle such that the push rod acts as a blunting member for a distal tip of the needle.

19. A T-fastener-equipped suture delivery device, comprising:

a housing including a plurality of housing inclined teeth positioned on an interior wall thereof, the plurality of housing inclined teeth defining a plurality of housing pockets;

a hollow needle extending from the housing;

a plurality of T-fastener-equipped sutures at least partially disposed within the needle, each of the T-fastener-equipped sutures comprising a T-fastener portion and a suture portion; and

an ejection assembly comprising;

an ejector component including;

a push rod that extends into the needle, the ejector component selectively movable in a distal direction only to cause the push rod to eject the T-fastener portion of the T-fastener-equipped sutures one-by-one from a distal end of the needle without reloading;

a plurality of ejector inclined teeth defining a plurality of ejector pockets; and

an ejector arm including a portion designed to engage the housing pockets; and

an actuator actuatable by a user to selectively move the ejector component by engaging the ejector pockets, the actuator having a first position and a second position distal to the first position, the T-fastener portion of the T-fastener-equipped sutures ejected from the distal end of the needle in the second position, the actuator returned to the first position following ejection of each T-fastener portion of the T-fastener-equipped sutures.

20. The device as defined in claim 19, wherein the actuator engages in ratcheting back-and-forth movement to move the ejector component distally in step-wise fashion, the actuator being actuated manually by an interface disposed on the housing.

21. The device as defined in claim 20, wherein the actuator includes a pair of actuator arms, each of the pair of actuator arms including a portion designed to engage the ejector pockets, the pair of actuator arms pushing the ejector component distally in step-wise fashion during each back-and-forth movement of the pair of actuator arms.

22. The device as defined in claim 19, wherein the arm of the ejector component engages the housing pockets to prevent proximal movement of the ejector component within the housing.

23. The device as defined in claim 19, wherein the actuator is manually actuated by a push button extending from the housing.

24. The device as defined in claim 19, wherein the actuator is manually actuated by a slide button extending from the housing, the slide button being operably connected to a spring that urges return of the slide button to an initial position.

25. The device as defined in claim 19, wherein the suture portion of each T-fastener-equipped suture initially extends proximally from the corresponding T-fastener within the needle into and through the housing, the suture portion passing out of the housing through a septum disposed in a wall of the housing, wherein a plurality of external bolsters is initially disposed on the needle, and wherein each external bolster is distally slidable off the needle and on to the suture portion after ejection of the corresponding T-fastener so as to secure the T-fastener-equipped suture to a patient.

26. The device as defined in claim 25, wherein each external bolster includes a hole through which the suture portion passes, the suture portion passing through the hole freely in an external bolster first configuration, and the suture portion being captured in an external bolster second configuration.

27. The device as defined in claim 26, wherein each external bolster includes first and second components that are rotatable with respect to one another to selectively capture the suture portion.

28. The device as defined in claim 26, wherein each external bolster includes first and second components that are slidable with respect to one another to selectively capture the suture portion.

29. The device as defined in claim 19, wherein the actuator includes one of rotational and axial sliding movement to move the push rod.