Implants, tools, and methods for treatments of pelvic conditions

• US 10,034,735 B2
• Filed: 02/28/2012
• Issued: 07/31/2018
• Est. Priority Date: 03/28/2011
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Roll, Jessica L., Mujwid, James R., Titus, John E., Bouchier, Mark S., Jagger, Karl A., Felton, Jessica E., Sjoquist, Scott L., Steffens, Danielle E., Alexander, James A., Rowland, Randall P.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/006,875
• Publication Number:
  US 20150305847A1
• Time in Patent Office: 2,345 Days
• Field of Search: 600 29, 600 30, 600 37, 128897-899
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

Described are devices, systems, and combinations useful for monitoring tension in an implant, which may be an implant useful to treat a pelvic condition, the device, system, or combination including an implant and a tension indicator.

Claims

1. A pelvic surgical device comprising:

an implant including a front side and a back side; and

a tension indicator,

the tension indicator having a first end, an opposing second end, and a length extending between the first end to the second end, the tension indicator being disposed on the front side of the implant, the tension indicator comprising;

a first fastener secured to a first position of the implant, the first fastener including a post extending from the tension indicator located on the front side of the implant, the post extending through an aperture of the implant,

a second fastener secured to a second position of the implant,

a middle segment extending along a length between the first position and the second position, the middle segment including a flexible polymeric material, and

a cursor located at the middle segment,

wherein the cursor is configured to move in a first direction relative to a reference in response to a length of the implant between the first position and the second position increasing, and

wherein the cursor is configured to move relative to the reference in a second direction opposite the first direction in response to the length of the implant between the first position and the second position decreasing.

2. The pelvic surgical device according to claim 1, wherein the tension indicator is configured to be removed from the implant.

3. The pelvic surgical device according to claim 1, further comprising a tether connected to the tension indicator.

4. The pelvic surgical device according to claim 1, wherein the reference is selected from:

a marking on the implant,

a feature of the tension indicator, and

a feature of a backer located between the front side of the implant and the tension indicator.

5. The pelvic surgical device according to claim 1, wherein the reference is located on a backer located between the front side of the implant and the tension indicator, and the backer is configured to be removed from the implant.

6. The pelvic surgical device according to claim 1, wherein

the post comprises a distal end comprising an expanded head, the post being held at the aperture by the expanded head, the post configured to be removed from the aperture by manually passing the expanded head through the aperture.

7. The pelvic surgical device according to claim 6, further comprising a backer disposed between the tension indicator and the front side of the implant, wherein the post extends through a backer aperture, and a tether is connected to the tension indicator and the backer on the front side of the implant.

8. The pelvic surgical device according to claim 1, wherein the middle segment comprises an upper connector, a lower connector, and an opening between the upper connector and the lower connector.

9. The pelvic surgical device according to claim 8, wherein the upper connector configured to move toward the lower connector in response to the implant being lengthened.

10. The pelvic surgical device according to claim 8, wherein one or more of the upper connector and the lower connector comprises a spring segment that lengthens as the tension indicator is lengthened from an original state, and that returns to a unlengthened state as the tension indicator returns to the original state.

11. The pelvic surgical device according to claim 1, wherein the implant is a urethral sling comprising:

an extensible mesh comprising a tissue support portion and two extension portions extending away from the tissue support portion; and

two self-fixating tips, one at an end of each extension portion,

wherein the urethral sling has a length between the two ends and a midpoint along the length, and the tension indicator is located against the front surface of the implant that includes the midpoint.

16. A method of placing the pelvic surgical device of claim 1 in a body of a patient, the method comprising:

placing the pelvic surgical device in the patient while positioning the implant to support tissue;

viewing the tension indicator and

adjusting a tension of the implant.

17. The method according to claim 16, further comprising removing the tension indicator from the implant and the patient while the implant remains implanted in the patient.

18. A method of treating urinary incontinence, comprising:

providing the pelvic surgical device according to claim 1;

creating a medial incision in a male or female patient;

dissecting from the medial incision to tissue below a urethra;

placing the implant at a location to support the urethra;

placing a first end of the implant along a tissue path extending from below the urethra toward a first obturator foramen of the patient;

placing a second end of the implant along a tissue path extending from below the urethra toward a second obturator foramen of the patient;

viewing the tension indicator;

releasing the tension indicator from the implant; and

removing the tension indicator from the patient.

12. A pelvic surgical device comprising:

an extensible strip having a front side and a back side;

a tension indicator having a first end, an opposing second end, and a length extending between the first end to the second end along the front side of the strip;

a backer located between the tension indicator and the front side of the extensible strip; and

a tether connected to the tension indicator, and the backer.

13. The pelvic surgical device according to claim 12, wherein

a first segment of the tether secures the tension indicator to the implant at a fastener,

a second segment of the tether is connected to the tension indicator and the backer,

wherein pulling a location of the tether a first distance away from the implant releases the fastener, while slack remains in the second segment, and

wherein pulling the location of the tether an added distance removes the slack, and then removes the tension indicator, the backer, or the tension indicator and the backer, from the patient.

14. The pelvic surgical device according to claim 13, wherein the tension indicator further comprises:

the first end comprising a first fastener,

the second end comprising a second fastener,

a middle segment disposed between the first end and the second end, the middle segment comprising an upper connector, a lower connector, and an opening between the upper connector and the lower connector,

wherein the backer is viewable at the opening.

15. The pelvic surgical device according to claim 14, wherein when the implant is lengthened, the backer is not lengthened, and the tension indicator is lengthened, and the upper connector moves relative to the backer.