FASCIAL CLOSURE DEVICE

• US 20170238914A1
• Filed: 05/09/2017
• Published: 08/24/2017
• 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.
• Granted Patent: US 10,448,939 B2
• Time in Patent Office: Days
• 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.

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:

a needle shaped according to the needle path, the needle having a needle handle, a 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:

a 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 cavity comprises a needle orientation feature that, when a needle is inserted into the needle guide cavity, interfaces with the needle to rotationally aligns an eye of the needle with the suture exit portal.

8. The suturing device of claim 7, wherein:

the needle guide portal comprises the needle orientation feature, the needle orientation feature having an asymmetric structural feature that fully interfaces with a corresponding feature on a handle of the needle in only a single orientation, the single orientation corresponding to the needle rotationally aligning the eye with the suture exit portal.

9. 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.

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

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 located between the material capture region and the distraction region.

11. The suturing device of claim 10, wherein the instrument guide cavity is one of a plurality of cavities extending through the suturing device.

12. The suturing device of claim 11, wherein the instrument cavity comprises an access door that is openable to advance a laparoscopic instrument into a region below the capture region.

13. The suturing device of claim 10, wherein the instrument exit portal defines an instrument cavity located within the distraction region.

14. The suturing device of claim 13, 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 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.

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

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

18. 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.

19. A method for closing a pre-existing hole in a material, the method comprising:

positioning a guide structure of a suturing device into the hole until material surrounding the hole is within a capture region of the guide structure; and

forming a suture pass by, for each of a first iteration and a second iteration, each iteration performed at a different corresponding penetration location of the material surrounding the hole and performed using a different corresponding end of a suture;

orienting the suturing device so that the penetration location is located within the capture region;

inserting a needle into a needle guide cavity of the guide structure, thereby passing the needle through the corresponding penetration location until an eye of the needle is located within the capture region past the captured material;

passing the corresponding end of the suture through a suture guide cavity of the guide structure having an exit aligned with the eye of the needle, thereby passing the corresponding end of the suture through the eye of the needle; and

extracting the needle at least partially from the needle guide cavity maintaining the corresponding end of the suture passed there-through, thereby drawing the corresponding end of the suture through the corresponding location of the material.

20. The method of claim 19, further comprising:

subsequent to the forming, extracting the suture from the suturing device via a release substructure without extracting the suturing device from the hole.

21. The method of claim 19, further comprising:

subsequent to the forming, extracting the suturing device from the hole and tying the corresponding ends of the suture to form a stitch.

22. The method of claim 19, wherein:

the positioning is along a distraction vector to distract multi-layered material around the hole;

the hole defines a hole vector that passes into the hole and is substantially normal to an inner surface of the material adjacent to the hole; and

the hole vector and the distraction vector form an acute angle.

23. The method of claim 19, wherein the inserting comprises passing a tip of the needle into a needle guide portal at an originating end of the needle guide cavity and pushing the needle through needle guide cavity until the tip of the needle is in a guard region of the needle guide cavity that is enclosed within the suturing device.

24. The method of claim 19, wherein the inserting comprises aligning an orientation feature of the needle with an orientation feature of the suturing device thereby rotationally aligning the eye of the needle with an exit portal of the suture guide cavity.

25. A system for closing a pre-existing hole in a material, the system comprising:

means for capturing a penetration location of a material surrounding a hole while distracting the material around the hole, the means for capturing comprising;

means for manually orienting the means for capturing with respect to a selected one of a plurality of penetration locations in the material surrounding the hole;

means for guiding a tip and an eye of a needle through the material at the selected penetration location, thereby shielding the tip of the needle from contact external to the means for capturing; and

means for guiding a tip of a suture through the hole and through the eye of the needle.