System and methods for preventing intravasation during intrauterine procedures

• US 7,763,033 B2
• Filed: 09/07/2007
• Issued: 07/27/2010
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Interlace Medical, Inc. (Hologic Incorporated)
• Inventors: Connors, Kevin G., Adams, Ronald D., Gruber, William H., Cole, James Daniel, Pardo, Geoffrey B., Flaherty, J. Christopher
• Primary Examiner(s): Manahan; Todd E.
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US11/852,116
• Publication Number:
  US 20080097467A1
• Time in Patent Office: 1,054 Days
• Field of Search: 606/119, 606/193
• US Class Current: 606/119
• 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 17/12045 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320024 Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2017/4225 Cervix uteri
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/02 : Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61N 5/1016 : Gynaecological radiation therapy

Abstract

Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. 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. Distension is achieved mechanically, rather than with liquid distension media, thereby eliminating the risk of intravasation.

Claims

1. A method of preventing intravasation during an intrauterine procedure, comprising the steps of:

transcervically accessing the uterus with an elongate tubular sheath;

introducing a mechanical distension device through the sheath and into the uterus, while the mechanical distension device is in a retracted state;

distending the uterus by expanding the mechanical distension device from the retracted state into an expanded state so as to distend the uterus and expose a site;

introducing a surgical device while the mechanical distension device remains within the uterus in the expanded state; and

performing a surgical procedure at the site with the surgical device and with the mechanical distension device in the expanded state within the uterus,

wherein the mechanical distension device comprises an inflatable device, wherein the step of introducing the mechanical distension device into the uterus while the mechanical distension device is in a refracted state comprises introducing the mechanical distension device into the uterus with the inflatable device in a deflated state.

2. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the transcervically accessing step comprises advancing the sheath over a guidewire.

3. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the transcervically accessing step is accomplished under local anesthesia.

4. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the distending step achieves an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of at least 40 mm Hg.

5. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the distending step achieves an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of about 70 mm Hg.

6. A method of preventing intravasation during an intrauterine procedure as in claim 1, further comprising the step of dilating the cervix prior to the transcervically accessing step.

7. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the performing a procedure step comprises treating a uterine fibroid.

8. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the step of distending the uterus comprises inflating the inflatable device.

9. A method of preventing intravasation during an intrauterine procedure as in claim 1, wherein the performing a procedure step comprises performing a diagnostic procedure.

10. A method of preventing intravasation during an intrauterine procedure, comprising the steps of:

transcervically accessing the uterus with an elongate tubular sheath;

introducing a mechanical distension device through the sheath and into the uterus, while the mechanical distension device is in a retracted state;

distending the uterus by expanding the mechanical distension device from the retracted state into an expanded state so as to distend the uterus and expose a site;

introducing a surgical device while the mechanical distension device remains within the uterus in the expanded state; and

performing a surgical procedure at the site with the surgical device and with the mechanical distension device in the expanded state within the uterus,

wherein the mechanical distension device comprises an expandable basket, wherein the step of introducing the mechanical distension device into the uterus while the mechanical distension device is in a refracted state comprises introducing the expandable basket into the uterus with the expandable basket in a collapsed state.

11. A method of preventing intravasation during an intrauterine procedure as in claim 10, wherein the step of distending the uterus comprises deploying the expandable basket.

12. A method of preventing intravasation during an intrauterine procedure as in claim 10, wherein the transcervically accessing step is accomplished under local anesthesia.

13. A method of preventing intravasation during an intrauterine procedure as in claim 10, wherein the distending step achieves an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of at least 40 mm Hg.

14. A method of preventing intravasation during an intrauterine procedure as in claim 10, further comprising the step of dilating the cervix prior to the transcervically accessing step.

15. A method of preventing intravasation during an intrauterine procedure as in claim 10, wherein the performing a procedure step comprises treating a uterine fibroid.

16. A method of preventing intravasation during an intrauterine procedure as in claim 10, wherein the performing a procedure step comprises performing a diagnostic procedure.

17. A method of performing a procedure in the uterus, comprising the steps of:

transcervically accessing the uterus with an elongate flexible tubular sheath, having a proximal end, a distal end and at least one lumen extending therethrough, the sheath having an outside diameter of no more than about 9 mm;

introducing a mechanical distension device through the sheath and into the uterus with the mechanical distension device in a retracted state;

distending the uterus by expanding the mechanical distension device from the retracted state into an expanded state, and thereby exposing a site;

introducing a visualization device through the sheath, to visualize the site, while the distension device remains in the uterus in the expanded state;

introducing a surgical device through the sheath and into the uterus while the distension device remains in the uterus and in the expanded state; and

performing a surgical procedure at the site with the surgical device and with the mechanical distension device in the expanded state within the uterus,

wherein the mechanical distension device comprises an expandable basket, wherein the step of introducing the mechanical distension device into the uterus while the mechanical distension device is in a refracted state comprises introducing the expandable basket into the uterus with the expandable basket in a collapsed state.

18. A method of preventing intravasation during an intrauterine procedure as in claim 17, wherein the step of distending the uterus comprises deploying the expandable basket.

19. A method of performing a procedure in the uterus as in claim 17, wherein the method is a diagnostic method.

20. A method of performing a procedure in the uterus as in claim 17, wherein the method is a treatment for a uterine fibroid.