Needle design for male transobturator sling

• US 20060235262A1
• Filed: 02/03/2006
• Published: 10/19/2006
• Est. Priority Date: 02/04/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Gozzi, Christian, Arnal, Kevin R., Rehder, Peter
• Granted Patent: US 7,422,557 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

Described are surgical instruments for use in surgical procedures, related methods, systems, and kits, the instruments including features that optionally include one or more specific dimensions, and features that may result in an ergonomic advantage during use.

Claims

1. A surgical instrument for implanting an implantable material to a pelvic region, the instrument comprising:

a handle having a longitudinal axis and an elongate width dimension normal to the longitudinal axis, the elongate width dimension defining a midplane,

a needle portion extending from the handle along the longitudinal axis, the needle portion comprising

a spacer portion connected to the handle,

a three-dimensional region connected to the spacer portion distal from the handle, and having structure in three dimensions, and

a needle distal end at the distal end of the three-dimensional region,

wherein the needle portion is sized and shaped to extend between an incision substantially adjacent to a patient'"'"'s obturator foramen, through the obturator foramen, and to a medial incision; and

wherein the needle distal end is located at an angle between 20 to 70 degrees from the midplane.

2. The instrument of claim 1, wherein the three-dimensional region defines a curved portion comprising a needle end portion, and an axis of the needle end portion lies in a plane orthogonal to the longitudinal axis of the tool.

3. The instrument of to claim 1, wherein the three-dimensional region comprises a portion shaped like a spiral, helix, or partial helix.

4. The instrument of claim 1, comprising a needle end portion at the terminal inch of the three-dimensional region that comprises a curve.

5. The instrument of claim 4, wherein a line tangent to a needle distal end is tangent to a circle having an origin at the longitudinal axis and a radius defined by the needle distal end.

6. The instrument of claim 1, designed for use in a male transobturator sling installation procedure, wherein

the needle portion is sized and shaped to extend between an incision substantially adjacent to a patient'"'"'s obturator foramen, through the obturator foramen, and to a perineal incision,

the three-dimensional region has a length in the range from 2.2 to 4 inches and a diameter in the range from 2.3 to 5 inches, and

the three-dimensional region defines a helix that includes an axis of a needle end portion within a plane orthogonal to the longitudinal axis of the tool.

7. The instrument of claim 1 designed for use in a male transobturator sling installation procedure, by dissecting a transobturator tissue using an outside-in dissection technique, wherein

8. The instrument of claim 1 in combination with a surgical implant for treating incontinence,

wherein the implant comprises a central support portion and two elongate end portions, and

wherein the needle end portion is adapted to be associated with an end portion of the implant.

9. The combination of claim 8, wherein the implant is a male urethral sling comprising one or more of a widened central support portion, reinforced edge extensions, or both.

12. A method of treating male incontinence comprising the steps of:

creating a pair of lateral incisions substantially adjacent a patient'"'"'s obturator foramen,

creating a medial incision medial to the pair of lateral incisions,

providing a surgical instrument according to claim 1, having a securement surface at the needle distal end,

providing an implantable assembly adapted for treating the incontinence, the assembly having a surface complementary to the securement surface,

passing the three-dimensional region having the securement surface between a lateral incision and the medial incision and through an obturator foramen,

then associating the instrument at the securement surface with the implantable assembly to provide a removable attachment between the instrument and the assembly,

then passing the implantable material through tissue from the medial incision toward a lateral incision.

13. The method of claim 12, wherein the three-dimensional region comprises a portion shaped like a spiral, helix, or partial helix.

14. The method of claim 12, wherein a line tangent to a needle distal end is tangent to a circle having an origin at the longitudinal axis and a radius defined by the needle distal end.

15. The method of claim 12, wherein

the three-dimensional region has a length in the range from 2.3 to 5 inches and a diameter in the range from 2.3 to 5 inches, and

an axis of the needle end portion lies within a plane that is orthogonal to the longitudinal axis of the tool.

16. The instrument of claim 15, wherein a radial distance from a longitudinal axis of the spacer, to the needle distal end, is in the range from 0.7 to 1.4 inches.

10. A surgical instrument for implanting an implantable material to treat incontinence, the instrument comprising:

a handle,

needle extending from the handle, the needle comprising

a spacer portion connected to the handle, and

a three-dimensional region connected to the spacer portion distal from the handle, and having structure in three dimensions including a needle distal end at the distal end of the curved portion,

wherein

the needle portion is sized and shaped to extend between an incision substantially adjacent to a patient'"'"'s obturator foramen, through the obturator foramen, and to a perineal incision;

the three-dimensional region has a length in the range from 2.3 to 5 inches and a diameter in the range from 2.3 to 5 inches, and

an axis of the needle end portion lies within a plane that is orthogonal to the longitudinal axis of the tool.

11. The instrument of claim 10, wherein a radial distance from a longitudinal axis of the spacer, to the needle distal end, is in the range from 0.7 to 1.4 inches.

17. A method of performing a surgical procedure, the procedure comprising a step of rotating a surgical instrument having a handle comprising a midplane, about a longitudinal axis, the method comprising

providing a surgical instrument comprising a handle, a functional section that engages with tissue, a surgical implant, or a surgical instrument, the handle comprising an elongate dimension defining a midplane,

engaging the functional section with one or more of tissue, a surgical implant, and a surgical instrument,

grasping the handle with the midplane approximately parallel to the palm, and

rotating the handle using the hand such that

during the rotation the handle rotates at least ninety degrees, and

during ninety degrees of the rotation the hand traverses ninety degrees between a forty-five degree open palm and a forty-five degree closed palm.

18. The method of claim 17, wherein the functional section of the tool is capable of dissecting tissue.

19. The method of claim 17, wherein the functional section of the tool comprises a three-dimensional region of a needle.

20. A method of claim 17, wherein the instrument comprises

a handle having a longitudinal axis and an elongate width dimension normal to the longitudinal axis, the elongate width dimension defining a midplane,

a needle portion extending from the handle along the longitudinal axis, the needle portion comprising

a spacer portion connected to the handle,

a three-dimensional region connected to the spacer portion distal from the handle, and having structure in three dimensions, and

a needle distal end at the distal end of the three-dimensional region,

wherein the needle portion is sized and shaped to extend between an incision substantially adjacent to a patient'"'"'s obturator foramen, through the obturator foramen, and to a medial incision.