Surgical staple-clip and applier

• US 8,998,935 B2
• Filed: 08/28/2008
• Issued: 04/07/2015
• Est. Priority Date: 12/17/2002
• Status: Expired due to Fees

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Hart, Charles C
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US12/200,582
• Publication Number:
  US 20080319456A1
• Time in Patent Office: 2,413 Days
• Field of Search: 606/158, 606/139, 606/142, 606/143, 606/151, 606/157, 606/213, 606/215, 606/232
• US Class Current: 606/157
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00858 high friction or non-slip
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1225 for clipping and cutting in a single operation

Abstract

A surgical staple-clip including a clip component and a securing member is used in a wide range of surgical procedures. The staple-clip may be introduced to a surgical site in an un-assembled condition through a small port or trocar. An applier for the staple-clip comprising a pair of opposed jaw-like channels is provided to position and apply the clip component and the securing member. The clip component is positioned around a target tissue and is compressed or clamped upon the tissue using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the clip component is properly applied, the securing member is urged forward and over the clip component to secure the staple-clip. The clip component may include traction enhancement features such as surface interruptions, bumps, valleys and ridges. With the staple-clip of the invention, the force required to constrict or occlude the tissue is separate from the force required to secure and maintain the staple-clip in position and, as a result, the body tissue is not over-compressed and nourishment to the body tissue is maintained. Other aspects of the invention include thumb actuated clip appliers for use in hand assisted laparoscopy (HAL) In one embodiment, a clip applier includes a handle and a thumb actuated mechanism that is used to slidably release clips onto a body tissue or vessel by sliding the thumb actuated mechanism forward and backward using only one hand. In another aspect of the invention, a two-stage clip is disclosed having a clip component and a staple component for securing the clip after it has been properly positioned.

Claims

1. A medical device to constrict or occlude a body tissue or vessel, comprising:

a first tissue-engaging member having a first end, a second end opposite the first end, opposed walls and a first connecting wall defining a first elongate channel extending from the first end to the second end and the first elongate channel being open at the first end and the second end;

a second tissue-engaging member opposed to the first tissue-engaging member having a first end, a second end opposite the first end, opposed walls and a second connecting wall defining a second elongate channel extending from the first end to the second end and the second elongate channel being open at the first end and the second end; and

a securing member for securing the first and the second tissue-engaging members such that front faces of the first and the second connecting walls are opposed to each other, the securing member comprising a spring clip generating a securing force;

wherein the securing member has a distal-most face defining a tapered surface that is slidably advanceable into the first and the second elongate channels to securely clamp the first and the second tissue-engaging members around the body tissue or vessel.

2. The medical device of claim 1, wherein each of the front faces of the first and the second connecting walls includes a plurality of tissue-penetrating elements.

3. The medical device of claim 2, wherein the first and the second connecting walls and the tissue-penetrating elements are formed as an integral, one-piece construction.

4. The medical device of claim 2, wherein the tissue-penetrating elements are formed in a plurality of rows.

5. The medical device of claim 4, wherein the number of tissue-penetrating elements per row and the number of rows vary according to each application.

6. The medical device of claim 4, wherein the tissue-penetrating elements are aligned or staggered.

7. The medical device of claim 2, wherein the tissue-penetrating elements and the securing member have cross-sections of any configuration including polygonal, circular and elliptical configurations.

8. The medical device of claim 1, wherein the force required to secure and maintain adequate traction is independent from a force required to constrict or occlude the body tissue or vessel.

9. The medical device of claim 8, wherein only a compressive force needed to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue.

10. The medical device of claim 9, wherein tissue necrosis due to over-compression is eliminated.

11. The medical device of claim 1, wherein at least one of the first and the second tissue engaging-members includes a plurality of at least one of bumps, ridges, slots, and holes.

12. The medical device of claim 1, wherein the securing member provides uniform pressure across the occluded tissue or vessel.

13. The medical device of claim 1, wherein the first elongate channel defines a first longitudinal axis, the second elongate channel defines a second longitudinal axis, and the securing member is an elongate member sized and configured to slide into the first elongate channel and the second elongate channel and to extend along the first longitudinal axis and the second longitudinal axis to secure the first tissue-engaging member and the second tissue-engaging member.

14. The medical device of claim 1, wherein the first tissue-engaging member, the second tissue-engaging member, and the securing member are sized and configured to be introduced to the body tissue or vessel through a surgical port in an unassembled configuration.

15. A medical device to constrict or occlude a body tissue or vessel, comprising:

a first tissue-engaging portion having a first end and a second end opposite the first end and a first face extending from the first end to the second end, the first face including a plurality of tissue penetrating elements or protrusions;

a second tissue-engaging portion opposing the first tissue-engaging portion having a first end and a second end opposite the first end and a second face extending from the first end to the second end, the second face including a plurality of tissue penetrating elements or protrusions; and

a spring clip comprising a distal-most face defining a tapered surface slidably advanceable over the first and the second tissue-engaging portions, the spring clip providing a substantially uniform securing pressure along the first tissue-engaging portion from the first end to the second end of the first tissue-engaging portion and along the second tissue-engaging portion from the first end to the second end of the second tissue-engaging portion.

16. The medical device of claim 15, wherein only a force required to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue or vessel.

17. The medical device of claim 16, wherein tissue necrosis due to over-compression is eliminated.

18. The medical device of claim 15, wherein the device is formed from any medically acceptable metal or plastic material.

19. The medical device of claim 18, wherein the metal includes titanium and stainless steel.

20. The medical device of claim 15, wherein the spring clip is slidably couplable with the first and the second tissue-engaging portions between an un-assembled condition and an assembled condition in which the spring clip is advanced over the first and the second tissue-engaging portions such that surfaces of the spring clip engagingly contact the first and second tissue-engaging portions from the first end to the second end of the first tissue-engaging portion and from the first end to the second end of the second tissue-engaging portion to provide the substantially uniform pressure.

21. The medical device of claim 15, wherein the first face of the first tissue-engaging portion is integrally formed with the plurality of tissue penetrating elements of the first face in a one-piece construction.