Systems and methods for preventing intravasation during intrauterine procedures

• US 8,834,487 B2
• Filed: 07/23/2010
• Issued: 09/16/2014
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Gruber, William H., Adams, Ronald D., Connors, Kevin G., Pardo, Geoffrey B., Cole, James Daniel, Flaherty, J. Christopher
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US12/842,775
• Publication Number:
  US 20110054488A1
• Time in Patent Office: 1,516 Days
• Field of Search: 606/119, 606/193, 604/22, 604/514, 604/515, 604/517
• 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. An intravasation prevention system for use during an intrauterine procedure, comprising:

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

a mechanical distension device having an expanded state and a collapsed state, wherein the distension device comprises an expandable basket device configured for insertion through the lumen of the elongate flexible tubular sheath and into the uterus while in the collapsed state, and configured to distend the uterus to expose a site therein when in the expanded state;

a visualization device configured for visualizing the site exposed by the distension device, and

a surgical tool configured for accessing the site and for performing a procedure at the site while the mechanical distension device is in the expanded state,

wherein the surgical tool is a morcellator configured to remove a uterine fibroid from the site.

2. The intravasation prevention system of claim 1, further comprising a guidewire, wherein the elongate flexible tubular sheath is configured to transcervically access the uterus by advancing the elongate flexible tubular sheath over the guidewire.

3. The intravasation prevention system of claim 1, wherein the mechanical distension device is configured to achieve an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of at least 40 mm Hg.

4. The intravasation prevention system of claim 1, wherein the mechanical distension device is configured to achieve an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of about 70 mm Hg.

5. The intravasation prevention system of claim 1, further comprising a dilation apparatus configured to dilate a cervix prior to transcervically accessing the uterus with the elongate flexible tubular sheath.

6. The intravasation prevention system of claim 1, wherein the expandable basket device comprises a scaffolding having filaments.

7. The intravasation prevention system of claim 6, wherein the site at which the procedure is performed comprises tissue positioned between the filaments when the mechanical distension device is in the expanded state.

8. An intravasation prevention system for use during an intrauterine procedure, comprising:

an elongate tubular sheath configured for transcervically accessing a uterus, the sheath having a proximal end, a distal end, and a lumen extending therethrough;

a mechanical distension device having an expanded state and a collapsed state, wherein the distension device comprises an expandable basket device configured for insertion through the lumen of the elongate tubular sheath and into the uterus while in the collapsed state, and configured to distend the uterus and expose a site therein while in the expanded state; and

a surgical tool configured for accessing the site and for performing a procedure at the site while the mechanical distension device is in the expanded state, wherein the surgical tool is a morcellator configured to remove a uterine fibroid from the site.

9. The intravasation prevention system of claim 8, further comprising a guidewire, wherein the elongate tubular sheath is configured to transcervically access the uterus by advancing the elongate tubular sheath over the guidewire.

10. The intravasation prevention system of claim 8, wherein the mechanical distension device is configured to achieve an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of at least 40 mm Hg.

11. The intravasation prevention system of claim 8, wherein the mechanical distension device is configured to achieve an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of about 70 mm Hg.

12. The intravasation prevention system of claim 8, further comprising a dilation apparatus configured to dilate a cervix prior to transcervically accessing the uterus with the elongate tubular sheath.

13. The intravasation prevention system of claim 8, wherein the expandable basket device comprises a scaffolding having filaments.

14. The intravasation prevention system of claim 13, wherein the site at which the procedure is performed comprises tissue positioned between the filaments when the mechanical distension device is in the expanded state.

15. An intravasation prevention system for use during an intrauterine procedure, comprising:

an elongate tubular sheath configured for transcervically accessing a uterus, the sheath having a proximal end, a distal end, and a lumen extending therethrough;

a mechanical distension device comprising an inflatable device having an inflated state and a deflated state, wherein the inflatable device is configured for insertion through the lumen of the elongate tubular sheath and into the uterus while in the deflated state, and configured to distend the uterus and expose a site therein while in the inflated state; and

a surgical tool configured for accessing the site and for performing a procedure at the site while the inflatable device is in the inflated state,

wherein the surgical tool is a morcellator configured to remove a uterine fibroid from the site.