Fascial closure device

• US 10,448,939 B2
• Filed: 05/09/2017
• Issued: 10/22/2019
• Est. Priority Date: 10/01/2014
• Status: Active Grant

• Current Assignee: Brainchild Surgical Devices LLC
• Original Assignee: Brainchild Surgical Devices LLC
• Inventors: Sherwinter, Danny A.
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/590,589
• Publication Number:
  US 20170238914A1
• Time in Patent Office: 896 Days
• Field of Search: 606148
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/0042 with special provisions for gripping
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00929 isolating electrical current
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

Embodiments include systems and methods for closure of a hole or other defect, for example in context of a laparoscopic surgical procedure. For example, a suturing device and method of use involve inserting the device into a hole, positioning material around the hole into a notch of the device, passing a needle through a cavity in the device and the material positioned in the notch, passing a suture through the eye of the needle, and removing the needle from the material with the suture. The suture can be removed and the process can be repeated with another end of the suture at another location through the material, around the hole. When the suture is passed through the second point of penetration, the suture can now extend both into and out of the material at different points around the hole and can be tied, thereby closing the hole.

Claims

1. A suturing device for closing a hole in a material, the suturing device comprising:

a handle structure extending primarily along a first vector between a first coupling region and a handle region;

a guide structure extending primarily along a second vector between a second coupling region and a distraction region, the second coupling region coupled with the first coupling region, the guide structure further comprising a material capture region located between the second coupling region and the distraction region;

a needle guide cavity, extending along a needle path that originates at a needle guide portal in the first coupling region and passes only partially through the guide structure, interrupted by the capture region; and

a suture guide cavity, extending along a suture path that originates at a suture guide input portal in the first coupling region and terminates at a suture guide exit portal in the capture region,

wherein the needle guide cavity comprises a needle orientation feature having an asymmetric structural feature that interfaces with a corresponding feature on a needle to rotationally guide the needle into only a single orientation when the needle is fully inserted into the needle guide cavity, the single orientation corresponding to an eye of the needle being rotationally aligned with the suture exit portal.

2. The suturing device of claim 1, wherein the second coupling region is coupled with the first coupling region to form an obtuse angle between the first vector and the second vector.

3. The suturing device of claim 1, wherein:

the hole defines a hole axis that passes through the hole, the hole axis being substantially normal to an inner surface of the material adjacent to the hole; and

the material capture region comprises a notch cut-out that defines an inner capture feature oriented according to the first vector, such that, when the guide structure is inserted in the hole with the handle structure located outside the hole and oriented so that the first vector is perpendicular to the hole axis, the inner capture feature is located below the inner surface and is substantially coplanar with the inner surface of the material adjacent to the hole.

4. The suturing device of claim 3, wherein:

the notch cut-out further defines an outer capture feature positioned to be located above the inner surface when the inner capture feature is located below the inner surface; and

the needle path comprises a first sub-path that originates at the needle guide portal and ends at an opening in the outer capture feature, and a second sub-path that originates at an opening in the inner capture feature and ends within the guide structure, the first sub-path being aligned with the second sub-path, such that the needle guide cavity is interrupted by the capture region.

5. The suturing device of claim 1, further comprising:

the needle shaped according to the needle path, the needle having a needle handle, the needle eye, and a needle tip, the needle sized, so that, when the needle is inserted into the needle guide cavity, the needle handle is proximate to the needle guide portal, the needle eye is within the capture region, and the needle tip is within the distraction region.

6. A kit comprising the suturing device of claim 1, and further comprising:

the needle shaped according to the needle path and sized, so that, when the needle is inserted into the needle guide cavity, a handle side of the needle protrudes from the needle guide portal, and a tip side of the needle is within the distraction region.

7. The suturing device of claim 1, wherein:

the needle guide portal comprises the needle orientation feature; and

the asymmetric structural feature is to fully interface with a corresponding feature on a handle of the needle to rotationally align the needle in only the single orientation.

8. The suturing device of claim 1, further comprising:

a release substructure formed in the handle structure and the guide structure, the release substructure positionally corresponding to the needle guide cavity between the needle guide portal and the capture region and sized to permit passage of a suture.

9. The suturing device of claim 1, further comprising:

an insufflation cavity that originates at an insufflation port located on the handle structure and extends to an insufflation exit port located in the guide structure.

10. The suturing device of claim 1, wherein the needle path is linear.

11. The suturing device of claim 1, wherein the handle structure and the guide structure are manufactured as a unitary structure.

12. The suturing device of claim 1, wherein the material is body tissue, and the hole is a defect in the body tissue resulting from removal of a laparoscopic trocar from the body tissue.

13. The suturing device of claim 1, wherein the second coupling region is coupled with the first coupling region, such that the handle structure is removable from the guide structure.

14. A suturing device for closing a hole in a material, the suturing device comprising:

a handle structure extending primarily along a first vector between a first coupling region and a handle region;

a guide structure extending primarily along a second vector between a second coupling region and a distraction region, the second coupling region coupled with the first coupling region, the guide structure further comprising a material capture region located between the second coupling region and the distraction region;

a needle guide cavity, extending along a needle path that originates at a needle guide portal in the first coupling region and passes only partially through the guide structure, interrupted by the capture region;

a suture guide cavity, extending along a suture path that originates at a suture guide input portal in the first coupling region and terminates at a suture guide exit portal in the capture region; and

an instrument guide passage extending along an instrument path that originates at an instrument guide portal in the first coupling region and extends to an instrument exit portal that defines an instrument cavity located within the distraction region,

wherein the distraction region proximate to the instrument cavity comprises a window and a mirror oriented, such that a suture exiting the suture guide exit portal is visible to a camera located in the instrument cavity via the mirror and the window.

15. The suturing device of claim 14, wherein the instrument cavity comprises an access door that is openable to advance a laparoscopic instrument into a region below the capture region.

16. The suturing device of claim 14, further comprising:

an insufflation cavity that originates at an insufflation port located on the handle structure and extends to an insufflation exit port located in the guide structure.

17. A suturing device for closing a hole in a material, the suturing device comprising:

a handle structure extending primarily along a first vector between a first coupling region and a handle region;

a guide structure extending primarily along a second vector between a second coupling region and a distraction region, the second coupling region coupled with the first coupling region, the guide structure further comprising a material capture region located between the second coupling region and the distraction region;

a needle guide cavity, extending along a needle path that originates at a needle guide portal in the first coupling region and passes only partially through the guide structure, interrupted by the capture region;

a suture guide cavity, extending along a suture path that originates at a suture guide input portal in the first coupling region and terminates at a suture guide exit portal in the capture region; and

a release substructure formed in the handle structure and the guide structure, the release substructure positionally corresponding to a suture passage along a wall of the needle guide cavity between the needle guide portal and the capture region sized to permit passage of a suture from within the needle guide cavity to outside the suturing device through the suture passage.

18. The suturing device of claim 17, further comprising:

an insufflation cavity that originates at an insufflation port located on the handle structure and extends to an insufflation exit port located in the guide structure,

wherein the insufflation cavity is separate from the release substructure, such that gas passing through the insufflation cavity does not escape through the release substructure.

19. The suturing device of claim 17, wherein the needle path is linear and asymmetric.