T-Fastener Suture Delivery System

• US 20120203250A1
• Filed: 02/09/2012
• Published: 08/09/2012
• 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., Eliasen, Kenneth A., Barenboym, Michael, Cohn, Matthew J.
• Granted Patent: US 9,592,044 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• 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;

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; and

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

2. The device as defined in claim 1, wherein the T-fastener are ejected one-by-one in a step-wise fashion, and wherein three T-fasteners are initially disposed in linear fashion within the needle of the device.

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 a 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 an ejector component disposed in the housing, the ejector component being capable of step-wise movement in the distal direction only.

6. The device as defined in claim 5, wherein the one-way distal movement of the ejector component is provided by at least one arm extending from the ejector component, the arm engaging pockets defined by a set of inclined teeth on the interior of the housing.

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

8. The device as defined in claim 7, 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 tip of the needle with each step-wise distal movement of the ejector component.

9. The device as defined in claim 8, wherein the actuator includes at least one arm that engages pockets defined by a set of inclined teeth on the ejector component, the actuator arm successively moving to a more proximal pocket of the inclined teeth of the ejector component as a result of each ratcheting movement of the actuator to in turn enable the actuator to cause step-wise distal movement to the ejector component during the next ratcheting movement.

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

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

12. 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 after ejection of the corresponding T-fastener so as to secure the T-fastener-equipped suture to the patient.

13. 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 of a T-fastener more distally disposed in the needle to freely pass the at least one T-fastener.

14. The device as defined in claim 1, wherein the needle includes a needle hub attached to the housing, the hub including an injection port, wherein a valve is included to prevent gastric fluids from entering the housing from the needle, and wherein at least one of the T-fasteners is hollow and defines a C-shaped configuration, the hollow T-fastener sized to impose a friction force against an inner surface of the needle so as to prevent unintended ejection of the T-fastener from the needle.

15. 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, 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;

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;

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.

16. The method as defined in claim 15, wherein the push rod is included in an ejection assembly of the delivery device and wherein actuating the push rod further comprises distally advancing the ejection assembly distally in a step-wise fashion.

17. The method as defined in claim 16, wherein the ejection assembly includes an ejector component and an actuator disposed in the housing, 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.

18. The method as defined in claim 17, further comprising manually pressing an actuation button to cause the back-and-forth ratcheting movement of the actuator.

19. The method as defined in claim 15, further comprising:

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

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

20. The method as defined in claim 15, 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 the distal tip of the needle.

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

a housing;

a hollow needle extending from the housing;

a plurality of T-fastener-equipped sutures at least partially disposed within the needle; and

an ejection assembly comprising;

an ejector component disposed in the housing and 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-fasteners one-by-one from the distal end of the needle without reloading; and

an actuator actuatable by a user to selectively move the ejector component.

22. The device as defined in claim 21, 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.

23. The device as defined in claim 22, wherein actuator includes at least one arm that engages a set of inclined teeth of the ejector component, the at least one actuator arm pushing the ejector component distally in step-wise fashion during each back-and-forth movement of the actuator.

24. The device as defined in claim 21, wherein at least one arm of the ejector component engages surfaces of the housing to prevent proximal movement of the ejector component within the housing.

25. The device as defined in claim 21, wherein the actuator is manually actuated by a push button extending from the housing.

26. The device as defined in claim 21, 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.

27. The device as defined in claim 21, 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 passing out of the body 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 after ejection of the corresponding t-fastener so as to secure the T-fastener-equipped suture to the patient.

28. The device as defined in claim 27, wherein the external bolster includes a hole through which the suture passes, the suture passing through the hole freely when the external bolster is in a first configuration, the suture being captured by the external bolster when in a second configuration.

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

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

31. The device as defined in claim 21, wherein an actuator includes one of rotational and axial sliding movement to move the push rod.