Systems, methods and devices for performing gynecological procedures

• US 9,301,770 B2
• Filed: 08/29/2013
• Issued: 04/05/2016
• Est. Priority Date: 04/06/2007
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Gruber, William Harwick
• Primary Examiner(s): Hicks, Victoria J
• Assistant Examiner(s): PATEL, TARLA R
• Application Number:
  US14/013,775
• Publication Number:
  US 20140107404A1
• Time in Patent Office: 950 Days
• Field of Search: 128831-840, 128/842, 606/119, 606/193, 606/194, 606/198, 606/200, 606/139, 600/104, 600/29, 600/32, 600 33- 35, 600/565, 604/106, 604/107, 604/108
• US Class Current: 1/1
• CPC Class Codes: A61B 1/0615 for radial illumination
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/12018 : Elastic band ligators
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/32007 : with suction or vacuum means
• CPC Class Codes: A61B 2017/320071 : with articulating means for working tip
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 5/6875 : Uterus
• CPC Class Codes: A61F 6/20 : Vas deferens occluders; Fallopian occluders
• CPC Class Codes: A61F 6/225 : transcervical
• CPC Class Codes: A61M 2025/1047 : having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0092 : using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 5/0603 : for treatment of body cavities
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system and devices provide simplified use and reduced risk of adverse events. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor'"'"'s office or clinic.

Claims

1. A system for occluding a body lumen, comprising:

an elongate delivery device configured for insertion into a body lumen; and

a tissue engaging device configured for insertion within a body lumen using the elongate delivery device, the tissue engaging device including a distal element slidably coupled with a proximal element, the distal element having a proximally extending shaft that mates with a locking mechanism of the proximal element,

a proximal facing outer surface of the distal element, a distal facing outer surface of the proximal element, and an outer surface of the distal element shaft collectively defining an annular recess for receiving wall tissue of a body lumen in which the tissue engaging device has been inserted, the annular recess having an axial length determined by a relative position of the distal element to the proximal element,

the distal element shaft comprising a vacuum port disposed on an outer surface thereof, the vacuum port in fluid communication with a vacuum supply lumen extending through the elongate delivery device, such that a vacuum source placed in fluid communication with the vacuum supply lumen when the tissue engaging device is inserted in a body lumen would cause plicated wall tissue of the body lumen to be drawn against the outer surface of the distal element shaft within the annular recess, and wherein movement of the distal element towards the proximal element to thereby shorten the axial length of the annular recess would apply compression to plicated wall tissue drawn into the annular recess to thereby form an occlusion of the body lumen.

2. The system of claim 1, wherein the locking mechanism is configured to prevent relative movement between the first element and the second element that would increase the axial length.

3. The system of claim 2, wherein the locking mechanism has a ratchet structure.

4. The system of claim 1, further comprising a pull wire coupled to a proximal end of the distal element shaft so that movement of the pullwire is a proximal direction relative to the proximal element of the tissue engaging device would cause movement of the distal element towards the proximal element.

5. The system of claim 1, wherein the distal element comprises a tissue adhesive.

6. The system of claim 1, wherein the distal element comprises a sclerosing agent.

7. The system of claim 1, wherein the tissue engaging device has a length less than approximately 30 mm.

8. The system of claim 7, wherein the tissue engaging device has a length less than approximately 20 mm.

9. The system of claim 8, wherein the tissue engaging device has a length less than approximately 10 mm.

10. The system of claim 1, wherein the tissue engaging device has an outer diameter less than approximately 3 mm.

11. The system of claim 10, wherein the tissue engaging device has an outer diameter less than approximately 2 mm.

12. The system of claim 1 wherein the tissue engaging element has an outer diameter less than approximately 1 mm.