EP0836422A1

EP0836422A1 - Laparascopic suturing device and suture needles

Info

Publication number: EP0836422A1
Application number: EP96916426A
Authority: EP
Inventors: Robert J. Greenstein
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-03-08
Filing date: 1996-03-08
Publication date: 1998-04-22
Also published as: AU5917696A; WO1997037594A1; EP0836422A4

Abstract

This invention is a surgical suturing needle (45) which includes an elongated shaft having a first end tapered to a point, a second end, and a medial portion. The medial portion includes an axially aligned groove (46) leading to a blind hole into which a surgical suture (48) is fixedly attached. Also disclosed is a suture needle holder (10) which includes an elongated tube (31) having an internal cavity, a distal rounded surface (35) with an external groove (36) of a depth to retain a suture therein. The suture needle holder also includes a pair of wings (37) adjacent the distal end wherein each wing is pivotally attached to the tube at one end of the wing, and has a needle holder (38) at the other end of the wing. The suture needle holder further includes a control element (32) connected to the pair of wings for controlling the pivoting motion thereof.

Description

LAPARASCOPIC SUTURING DEVICE AND SUTURE NEEDLES

Field of the Invention

This invention is in the field of laparascopic suturing devices and suturing needles used

therewith, and surgical techniques for closure of trochar holes and other openings and wounds

particularly in abdominal surgery.

Background of the Invention

In laparascopic surgery a known device called Deep Suture is a needle holder made by

REMA® Medizintechnik GmbH of Germany, D-7201 Durbheim-Tuttlingen, In Breiten 10 Germany. It is believed that a German patent corresponding to this device is DE 42 10 724 CI, a

copy of which in German is attached hereto as Appendix A and incorporated herein by reference.

While this device has various inherently good features, a number of significant

improvements have been developed as disclosed in this application. The prior device, in

summary, has a central shaft with proximal and distal ends. Extending through the shaft is a

rotatable rod having a control handle at the proximal end and a drive gear at the distal end. A

pair of driven gears are positioned at the periphery of the drive gear at opposite sides thereof,

each driven gear coupled to an arm or wing that pivots radially outward from the shaft when the

control handle is turned. Each wing includes a recess or blind hole for receiving the proximal

end of a suture needle. In operation a single strand of suture material has its ends threaded

through the eye of each of the needles, the suture then extending as a double strand from each

needle. The proximal ends of the needles are then inserted in the wings, and the wings are

pivoted to their retracted position whereby they and the needles are radially inward of the outer cylindrical boundary established by the central shaft. To facilitate this an axial groove is

provided in the shaft into which each needle can move. The device, with wings retracted, is inserted down into the opening in the abdominal wall produced by a trocar. During insertion the

suture is dragged down.

When adequately inserted downward the wings are pivoted to open position exposing the

needles now pointing upward. The shaft is withdrawn until the needles pierce the wall and

protrude out of the wall. These needles are engaged individually by a clamp, forceps or a needle

holder or by a clamping device movable axially on the shaft and drawn through the tissue,

pulling the suture until it forms a loop beneath the opening. The wings, now empty of needles, are pivoted closed, and the shaft is extracted from the opening. The needles are cut off the suture

ends and the suture is tied.

The improvements in this device are described below.

Summary of the New Invention

During the procedure described above the needles may become dislodged and separate

from the wings. The new invention provides in combination an improved needle and improved

insertion device with a groove in the distal end of the central shaft. Each needle has a groove in

its side wall to receive one end of the suture which is secured therein, as by swedging. The

grooves in the needles are preferably inclined downward. The suture exits the groove oriented

angularly downward toward the proximal end of the needle which is also in the direction toward

the wing and toward the distal end of the central shaft.

In operation the needles are situated with their proximal ends in the blind holes in the wings and the suture line extending from each needle is drawn downward to lie in the groove.

The remainder of the suture extends upward toward the handle and is held and guided by the

operator. By pulling upward on said remainder of the suture (which extends as a continuous strand between the needles), the needles are pulled downward to remain securely seated in the

wings. The needles are urged downward because the groove through which the suture is pulled

lies further below the wings than the lower ends of the needles.

Brief Description of the Drawings

Fig. 1 is an exploded elevation of the new device and the new needles.

Fig. 2A is an elevation of the new device, and Figs. 2B, 2C, and 2D are fragmentary

elevations of the distal end of the device at different stages.

Fig. 3 is a fragmentary elevation partially cut away showing the drive mechanism.

Fig. 4 is a sectional view taken along line 4-4 in Fig. 3, with the wings closed.

Fig. 5 is a sectional view similar to Fig. 4 with the wings open.

Fig. 6 is fragmentary section view of the new needle

Figs. 7 and 8 are fragmentary front and side views of the needle of Fig. 6.

Fig. 9 is a fragmentary' front view shown schematically of a needle with a groove

swedged closed capturing the end of a suture.

Fig. 10 is a schematic view of the new device when inserted and the wings are open.

Fig. 1 1 is a schematic view similar to Fig. 10.

Detailed Description of the Preferred Embodiment

Fig. 1 shows a first embodiment 10 of the new suturing device including the central shaft

12 with proximal end 13 and distal end 14. At the proximal end is handle 15 and control knob

16. At the distal end are wings 17, grooves or channels 18 corresponding in length to the needles to receive the needles and guide notch 19. In handle 15 is a cleaning port 20. Along the length of shaft 12 is a depth gage 21. Also shown are needles 21 and suture 22 positioned for insertion

into blind holes 23 in the wings.

Fig. 2A shows device 10 oriented upside down relative to Fig. 1, with the wings 17 in

fully closed condition; Fig. 2B shows the distal end 19 of the device with the wings partially

open; Fig. 2C shows the distal end with the wings fully open; and Fig. 2D shows the distal end

with the suture 22 lying in groove 19.

Figs. 3 and 4 show a typical drive mechanism 30 for the new device, the components

thereof corresponding generally to the device of Figs. 1 and 2A. In Figs. 3 and 4 the shaft 31 has

a distal end 34 with the suture guide groove 36 shown in dotted line. Through shaft 31 is drive

rod 32 coupled to drive gear 41 which is further coupled to driven gears 39, each of which is

secured to a wing 37. Needles 42 are removably situated in blind holes 38 in the wings. The

wings in closed position are designated by 37' in Fig. 3 along with needles 42' in closed position.

Driven gears 39 revolve on pivots 40.

Rotation of control knob (not shown) rotates rod 32 and drive gear 41. This causes

driven gears 37 to pivot radially outward carrying needles 42 to their open position.

Figs. 6-16 show a new needle 45 with its groove 46 and end 47 of suture 48 swedged

therein. The groove 46 may extend to various depths or as a blind hole for receiving the end of

the suture. The groove and/or hole may be formed by cutting, lancing, forging or other

techniques.

Securing the suture end to the needle is thereafter done by swedging, peening or otherwise deforming the metal of the needle adjacent the suture to achieve a clamping action on the suture. Other adhering techniques may be used, but ideally the suture extends from the

needle with substantially little added thickness or effective diameter of the needle.

The groove is oriented to lead the suture out of the side surface of the needle at an angle

downward toward the proximal end of the needle, opposite the point. The angle of exit is

preferably small, as between 1° and 20°. The exit of the groove or the point of exit from the side

surface of the needle is near the proximal end or closer to that end than the point.

Thus, when the needle is seated in the hole in a wing, pulling on the suture will apply a

force tending to keep the needle well-seated down in the hole in the wing, particularly during the

suturing procedure.

The use of a groove and/or blind hole allows the suture to exit at the downward angle and

thus avoid the double thickness of suture if the traditional suture "threaded^"' through the eye at a

general 90° angle therefrom which creates highly undesirable drag as the needle is pulled through the abdominal wall.

The new device and new needles herein described may be used for closing trochar holes

not only in abdominal walls, but in thoracic walls and other deep or difficult to reach areas.

A further feature of this invention is a cleaning port and Luer fitting situated in the handle. When opened the port allows high pressure cleaning solution from a syringe or other

source to flow down the central aperture containing the drive rod and to the gears and wings.

Fig. 10 shows schematically the suturing device 50 inserted through he abdominal wall

51, with the wings 52 open and needles 53 and 54 positioned for penetration of the wall. Suture ends 55 and 56 extend from needles 53 and 54 respectively in a downward direction of arrows 57

through guide notch 19 and thence upward. In practice the segments 58, 59 of the suture as seen in Fig. 1 1 are pulled together and upward along the shaft to be held by the surgeon's finger in

order to maintain secure downward tension on segments 60 and 61 and thus to apply constant

downward seating force on the needles in the wings.

The insertion device is made of stainless steel or equivalent, with a plastic handle or as

available from REMA® referred to above. Suture needles are made pursuant to standard

commercial practice as typically made by Surgical Specialties Corp., P.O. Box 310, Reading, Pa.

19607, also called Sharpoint®, one embodiment being 0.0505 diameter, taper point 1-0

polypropylene or catgut suture 20" double armed. Teaching for needles and sutures may be seen

in U.S. patent No. 3,799,169 which is incorporated herein by reference and a copy is attached

hereto as Appendix B. For the invention herein a suture length of 40-100 cm would be used, one specific preference being 60 cm. Also with this invention needle length would be in the range of

about 3-10 cm. A great variety of commercially available suture material may be selected as

determined by the surgeon and the procedure.

Various other structures and arrangements besides those depicted herein are possible

within the spirit and scope of this invention and as set forth in the claims appended hereto.

Claims

We claim:

1. A surgical suhiring tool, comprising:

a) a suture needle comprising an elongated shaft having a first end tapered to a point, a second end, and a medial portion between the first end and second end, said medial portion having an axially aligned groove leading to a blind hole into which a surgical suture can be fixedly secured; and

b) a suture needle holder comprising:

an elongated tube having a proximal end and a distal end and having an outer wall extending therebetween enclosing an internal cavity;

the distal end having a rounded surface with an external groove of sufficient depth to retain a suture therein;

a pair of wings adjacent the distal cod, each wing being pivotabie from within the tube at a first end and having a second end which is radially extensible, the second end of said wing removably receiving said suture needle; a control element mounted on the proximal end of the tube, operatively connected to said pair of wings for pivoting purposes.

2. The surgical suturing tool of claim 1 wherein said wings are movably stored in a pair of mating recesses in the tube by said control dement to simultaneously rotate the wings, the wings being rotatably inwardly into a closed position which does not extend beyond the outer wall of the tube and to an open position extending radially outwardly from the tube.

3. The surgical suturing tool of claim 2 wherein said control element is a rotatable knob centrally located at the proximal end of said tube.

4. The surgical suturing tool of claim 3 wherein said tube includes an end cap at the distal end, said end cap being rounded and grooved for receiving said suture.

5. The surgical suturing tool of claim 4 wherein said grooved end cap lies adjacent the wings.

6. The surgical suturing tool of claim 2 wherein said suture needle holder further includes a handle mounted on the proximal end of the tube, said handle extending radially outward of the tube.

7. TV surgical suturing tool of claim 1 wherein each of said wings carries a needle-suture combination wherein said needle includes a blind hole for fixedly securing said suture.

8. A method for surgically suturing a wound, comprising the steps of: fastening two swaged suture needles to a suture needle holder, placing the suture within a suture retaining groove; tensioning the suture; inserting the suture needle holder into a wound to be sutured; extending the suture needle away from the suture needle holder, withdrawing the suture needle holder outwardly such that the needle penetrates the tissue to be sutured by the suture needle; disengaging the suture needle from the suture needle holder, pulling the suture needle and suture through the tissue to be sutured; removing the suture needle holder from the patent, and suturing the patient.