WO2010036434A1 - Fluid recirculation debris handling system - Google Patents
Fluid recirculation debris handling system Download PDFInfo
- Publication number
- WO2010036434A1 WO2010036434A1 PCT/US2009/049221 US2009049221W WO2010036434A1 WO 2010036434 A1 WO2010036434 A1 WO 2010036434A1 US 2009049221 W US2009049221 W US 2009049221W WO 2010036434 A1 WO2010036434 A1 WO 2010036434A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- screen
- lumen
- sleeve
- return lumen
- longitudinal member
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
- A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
- A61B2018/046—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in liquid form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/14—Female reproductive, genital organs
- A61M2210/1433—Uterus
Definitions
- Endometrial ablation is a procedure conducted to reduce or eliminate excessive uterine bleeding by ablating the innermost lining of the uterus, known as the endometrium.
- One method of ablating the endometrium is by using the HydroThermAblator® System (HTA) which circulates heated fluid in the uterus.
- HTA HydroThermAblator® System
- a sheath is inserted into the uterus via the cervix to introduce and circulate the heated fluid and to maintain a target ablation temperature through the uterus.
- An ablation sheath generally includes an inlet lumen via which the heated fluid is introduced into the uterus and a return lumen via which the fluid may be returned, heated and circulated back into the body to maintain the target ablation temperature.
- the present invention is directed to a device for circulating fluid to a target site within a living body, comprising a longitudinal member including an inlet lumen supplying fluid to the target site and a return lumen withdrawing fluid from the target site, the return lumen surrounding the inlet lumen and a screen coupled to a distal end of the longitudinal member, the screen including a plurality of openings extending therethrough from a radially inner surface forming a radially outer wall of a distal portion of the return lumen to an outer surface thereof.
- FIG. 1 shows a perspective view of a device according to a first exemplary embodiment of the present invention
- Fig. 2 shows a longitudinal cross-sectional view of the device of Fig. 1 ;
- Fig. 3 shows a lateral cross-sectional view of the device of Fig. 1 ;
- Fig. 4 shows a perspective view of a distal end of the device of Fig. 1 ;
- Fig. 5 shows a longitudinal cross-sectional view of a device according to a second exemplary embodiment of the present invention
- Fig. 6 shows a perspective view of a distal end of the device shown in Fig. 5;
- Fig. 8 shows a perspective view of a device according to a fourth exemplary embodiment of the present invention.
- the present invention relates to devices for treating an endometrial lining of a uterus.
- the present invention relates to devices for circulating heated fluid through hollow organs such as the uterus to treat tissue therein (e.g., the endometrium).
- tissue therein e.g., the endometrium
- Exemplary embodiments of the present invention provide a device for circulating fluid, including a distal tip that prevents the debris from returning into and occluding the device, thereby preventing any impedance of the circulatory flow of the fluid.
- this invention is described in conjunction with the ablation of the endometrium, the invention may be used in conjunction with the treatment of the tissue of any hollow organ.
- a device 100 comprises a longitudinal member 102 and a screen 104 located at a distal end 106 thereof.
- the device 100 may be sized and shaped to be inserted into an internal space of a living body, in particular, to be inserted into a uterus via a cervix.
- an outer diameter of the device 100 may range from approximately 7.0 mm to 7.7 mm to ensure ease of insertion of the device 100 into the uterus via the cervix.
- the longitudinal member 102 comprises a first sleeve 108 housed within a second sleeve 110 which is housed within a third sleeve 112.
- the sleeves 108, 110, 112 in this example are co-axial.
- An inlet lumen 1 14 within the first sleeve 108 extends from a proximal end (not shown) connectable to a supply of ablation fluid so that, when in a desired position within the body, fluid introduced thereinto flows into the uterus via a distal opening 122.
- the first sleeve 108 may be formed of a metal such as, for example, stainless steel.
- a hysteroscope 116 may also be introduced into the body via the lumen 114 with fluid continuing to flow in an annular space between the hysteroscope and the wall of the lumen 114 as shown by the arrows in Fig. 2.
- the metal material of the first sleeve 108 guides a sometimes sharp tip of the hysteroscope 116 without catching on or damaging the material of the first sleeve 108.
- a return lumen 118 formed in an annular space between an outer surface of the first sleeve 108 and an inner surface of the second sleeve 110 opens to the outside of the device 100 via a plurality of slots 130 extending through a screen 104 which is mounted over the distal end 106.
- the screen includes an opening 126 through which fluid from the distal opening 122 of the lumen 114 passes into the uterus. Negative pressure may be applied to the return lumen 118 to draw fluid from the region surrounding the distal end 106 through the screen 104 into the return lumen 118 for withdrawal from the body.
- An insulative gap 120 is formed in an annular space between an inner surface of the third sleeve 112 and an outer surface of the second sleeve 110.
- the insulative gap 120 may be filled with air to minimize heat transfer from the fluids flowing through the inlet lumen 114 and the fluid return lumen 118 to non-targeted tissue adjacent to the device 100 to prevent burns and/or other damage to this surrounding tissue
- the second sleeve 110 which forms part of insulative gap 120, may be formed of a plastic or other thermally insulative material. As would be understood by those skilled in the art, one or more additional layers of insulation may be provided if desired. 8fl As shown in Fig.
- the first sleeve 108 extends distally past the second sleeve 110 such that an opening 122 of the inlet lumen 114 is distally beyond a distal opening 124 of the return lumen 118.
- fluid entering the return lumen 118 will do so via the screen 104 at locations proximal of the distal opening 122 of the lumen 114.
- a staggered flow pattern is established such that all of the fluid flow through the inlet lumen 114 is forced into the uterus and back to the return lumen 118. This staggered flow pattern creates greater turbulence within the uterus and allows for better heat distribution through the uterus.
- the screen 104 is coupled to the distal end 106 of the device such that a distal end 126 of the screen 104 is substantially aligned with the opening 122 of the inlet lumen 114 formed by the first sleeve 108.
- the screen 104 may be coupled to the longitudinal member 102 by any number of coupling means.
- the screen 104 may include a male mating component 132 that is receivable within the insulative gap 120 between the second and third sleeves 110, 112, which acts as a female mating component. The male mating component 132 and the female mating component of the insulation gap 120 may be locked together.
- the screen 104 includes an open distal end 126 substantially similar in diameter to a diameter of the inlet lumen 114.
- the screen 104 is substantially dome-shaped with an outer surface of the screen 104 curved and a proximal end 128 of the screen 104 shaped to be received within the insulative gap 120 between the inner surface of the third sleeve 112 and the outer surface of the second sleeve 110.
- the cervix is generally dilated to approximately 8mm to reduce the force required to insert an HTA device therethrough.
- the dome shape of the screen 104 and the tapered distal end 126 reduce the force required to insert the device 100 into the body possibly allowing the insertion of the device 100 with a lesser amount of dilation reducing trauma to the surrounding tissue. Additionally, the dome shape of the screen 104 may increase the structural stability of the screen 104, as loads during insertion are distributed substantially evenly around a circumference of an outer surface of the screen 104. It will be understood by those of skill in the art, however, that although the screen 104 is shown to be dome-shaped, the screen 104 may take a variety of shapes. These shapes will generally include a taper with the distal opening 126 being smaller than the proximal end 128 to facilitate insertion.
- the screen 104 may be hemispherically shaped to provide an optimal level of strength.
- the screen 104 may have a truncated conical shape to facilitate insertion into the cervical cavity.
- the screen 104 may be have a substantially parabolic dome shape such that the screen 104 may retain a level of strength, while still facilitating insertion into the cervical cavity.
- the distal end 126 of the screen 104 extends from a distal end 138 of the first sleeve 108 proximally past a distal end 140 of the second sleeve 110 such that return fluid must first pass through the screen 104 to access the opening 124 of the return lumen 118.
- the screen 104 includes a plurality of slots 130 distributed around at least a portion of a circumference thereof with each slot extending along at least a portion of the length of the screen 104 (i.e., parallel to a longitudinal axis of the device 100) and passing from an opening in an outer surface 134 through an inner surface 136 of the screen 104.
- each slot 130 may be made smaller than a width of the return lumen 118 to ensure that any debris that is able to pass through the screen 104, is too small to occlude the return lumen 118.
- the slots 130 increase the total area available for fluid to enter the return lumen 118 without substantially affecting the pressure in the return lumen 118.
- the aggregate area of the slots 130 is approximately five times the cross-sectional area of the return lumen 118. For example, if the cross-sectional area of the return lumen 118 is approximately 0.009 sq. inches, the aggregate area of the slots 130 may be approximately 0.05 sq. inches.
- the distribution of the total area of the slots 130 over the surface of the screen 104 reduces the velocity and pressure with which fluid first contacts the longitudinal member 102 reducing the likelihood of large debris becoming embedded within the slots 130
- a device 200 comprises a longitudinal member 202 and a screen 204 coupled to a distal end 206 thereof Similarly to the device 100, the longitudinal member 202 includes a first sleeve 208, a second sleeve 210, and a third sleeve 212, each of which share a longitudinal axis
- the first sleeve 208 extends slightly distally of the second and third sleeves, 210 and 212, respectively, with an outer wall of a distal portion of the return lumen 218 being formed by an inner surface of a mating component 232 of the screen 204
- the mating component 232 is received within an annular space 220 between the outer surface of the second sleeve 210 and an inner surface of the third sleeve 212 and extends distally to a screen portion 234 of the screen 204 As described above, this annular space 220 serves as an insulation gap minimizing
- the screen 204 may be substantially similar to the screen 104 A distal opening 226 of the screen 204, however, may be smaller than the distal opening 126 and the mating component 232 of the screen 204 may mate with the longitudinal member 202 such that a proximal end 228 of the screen portion 234 substantially aligns with the distal end 238 of the first sleeve 208.
- the screen 204 covers the entire distal end 206 of the longitudinal member 202 to prevent debris from entering the debris lumen 218.
- the aggregate area of the slots 230 is preferably substantially greater than an aggregate cross-sectional area of the inlet and return lumens 217, 218, respectively, so that the flow characteristics of these lumens may remain unchanged even when a significant portion of the area of the slots 230 is blocked by debris removed from the return fluid.
- the screen 204 includes a plurality of slots 230 substantially similar to the slots 130 of screen 104.
- the slots 230 extend around at least a portion of a circumference of the screen 230, and each slot 230 may extend along at least a portion of a length of the screen 204.
- a width of each of the slots 230 is preferably smaller than a width of the opening 224 of the return lumen 218 so that any debris that passes through the screen 204 via the slots 230 will be too small to occlude the return lumen 218.
- a device 300 comprises a longitudinal member 302 and a screen 304 coupled to a distal end 306 thereof.
- the longitudinal member 304 may be substantially similar to either of the longitudinal members 102 and 202, respectively, described above in regard to devices 100, 200.
- the screen 304 may also be substantially similar to the screens 104 and 204, including an open distal end 326 that is smaller in diameter than a proximal end 328 of the screen 304. It will be understood by those of skill in the art that although the screen 304 is shown to be substantially conically shaped, the screen 304 may take a variety of shapes so long as the distal opening 326 is smaller than the proximal end 328. For example, the screen 304 may be dome-shaped.
- the screen 304 further includes a plurality of holes 330 distributed around at least a portion of a circumference and a portion of a length of the screen 404, Each of the holes 330 extends from an outer surface 334 to an inner surface 336 such that return fluid must pass through the holes 330 to access a return lumen (not shown). Each of the holes 330 may be smaller in size than an opening of the return lumen to ensure that any debris that is able to pass through the holes 330 are too small to occlude the return lumen.
- the aggregate area of the holes 330 is preferably substantially greater than an aggregate cross-sectional area of the inlet and return lumens of the longitudinal member 302 so that the flow characteristics of these lumens may remain unchanged even when a significant portion of the area of the holes 330 is blocked by debris removed from the return fluid.
- a device 400 comprises a longitudinal member 402 and a screen 404 attached to a distal end 406 thereof.
- the longitudinal member 402 may be substantially similar to either of the longitudinal members 102 and 202, respectively, described above in regard to devices 100, 200.
- the screen 404 may also be substantially similar to the screens 104, 204 and 304, including an open distal end 426 that is smaller in diameter than a proximal end 428 of the screen 404. It will be understood by those of skill in the art that although the screen 404 is shown to be substantially conically shaped, the screen 404 may take a variety of shapes. As indicated above, tapered shapes may be desired to facilitate insertion. For example, the screen 404 may be dome-shaped, conic, etc.
- the screen 404 further includes a plurality of slots 430 distributed along at least a portion of a length of the screen 404, each of the slots 430 extending around at least a portion of a circumference of the screen 404.
- Each of the slots 430 extends from an outer surface 434 to an inner surface 436 such that return fluid must pass through the slots 430 to access a return lumen (not shown).
- Each of the slots 430 may be smaller in width than opening of the return lumen to ensure that any debris that is able to pass through the slots 430 is too small to occlude the return lumen.
- the aggregate area of the holes 430 is preferably substantially greater than an aggregate cross-sectional area of the inlet and/or return lumens of the longitudinal member 402 so that the flow characteristics of these lumens may remain unchanged even when a significant portion of the area of the slots 430 is blocked by debris removed from the return fluid.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09790003.9A EP2349374B1 (en) | 2008-09-29 | 2009-06-30 | Fluid recirculation debris handling system |
AU2009297003A AU2009297003B2 (en) | 2008-09-29 | 2009-06-30 | Fluid recirculation debris handling system |
JP2011529039A JP5396480B2 (en) | 2008-09-29 | 2009-06-30 | Fluid recirculation debris treatment system |
CA2735219A CA2735219C (en) | 2008-09-29 | 2009-06-30 | Fluid recirculation debris handling system |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10097208P | 2008-09-29 | 2008-09-29 | |
US61/100,972 | 2008-09-29 | ||
US12/493,793 US8790334B2 (en) | 2008-09-29 | 2009-06-29 | Fluid recirculation debris handling system |
US12/493,793 | 2009-06-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2010036434A1 true WO2010036434A1 (en) | 2010-04-01 |
Family
ID=42058217
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2009/049221 WO2010036434A1 (en) | 2008-09-29 | 2009-06-30 | Fluid recirculation debris handling system |
Country Status (6)
Country | Link |
---|---|
US (2) | US8790334B2 (en) |
EP (1) | EP2349374B1 (en) |
JP (1) | JP5396480B2 (en) |
AU (1) | AU2009297003B2 (en) |
CA (1) | CA2735219C (en) |
WO (1) | WO2010036434A1 (en) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090125010A1 (en) * | 2007-07-06 | 2009-05-14 | Sharkey Hugh R | Uterine Therapy Device and Method |
EP2327382B1 (en) | 2009-11-26 | 2012-07-18 | Hans I. Wallsten | Sterilisation device |
WO2012064864A1 (en) | 2010-11-09 | 2012-05-18 | Aegea Medical Inc. | Positioning method and apparatus for delivering vapor to the uterus |
CA2851355C (en) | 2011-10-07 | 2020-02-18 | Aegea Medical Inc. | Integrity testing method and apparatus for delivering vapor to the uterus |
EP3145425A4 (en) | 2014-05-22 | 2018-02-14 | Aegea Medical, Inc. | Systems and methods for performing endometrial ablation |
CN106794031B (en) | 2014-05-22 | 2020-03-10 | 埃杰亚医疗公司 | Integrity testing method and apparatus for delivering vapor to uterus |
CN109069064B (en) | 2016-02-19 | 2022-05-13 | 埃杰亚医疗公司 | Method and apparatus for determining the integrity of a body cavity |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3924628A (en) * | 1972-12-01 | 1975-12-09 | William Droegemueller | Cyrogenic bladder for necrosing tissue cells |
WO1992019145A2 (en) * | 1991-05-03 | 1992-11-12 | Goldrath Milton H | Endometrium coagulating apparatus and surgical method for thermal destruction of the endometrium |
US5300022A (en) | 1992-11-12 | 1994-04-05 | Martin Klapper | Urinary catheter and bladder irrigation system |
US5968008A (en) | 1997-08-04 | 1999-10-19 | Grams; Guenter A. | Cannula with parallel channels and sliding sheath |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA1244889A (en) * | 1983-01-24 | 1988-11-15 | Kureha Chemical Ind Co Ltd | Device for hyperthermia |
US5571153A (en) * | 1991-09-20 | 1996-11-05 | Wallst+E,Acu E+Ee N; Hans I. | Device for hyperthermia treatment |
US5449380A (en) * | 1993-09-17 | 1995-09-12 | Origin Medsystems, Inc. | Apparatus and method for organ ablation |
US5827218A (en) * | 1996-04-18 | 1998-10-27 | Stryker Corporation | Surgical suction pool tip |
US6379350B1 (en) * | 1999-10-05 | 2002-04-30 | Oratec Interventions, Inc. | Surgical instrument for ablation and aspiration |
US20100305557A1 (en) * | 2009-06-02 | 2010-12-02 | Chu Michael S H | HTA Sheath with Removable Scope |
-
2009
- 2009-06-29 US US12/493,793 patent/US8790334B2/en active Active
- 2009-06-30 AU AU2009297003A patent/AU2009297003B2/en active Active
- 2009-06-30 WO PCT/US2009/049221 patent/WO2010036434A1/en active Application Filing
- 2009-06-30 EP EP09790003.9A patent/EP2349374B1/en active Active
- 2009-06-30 JP JP2011529039A patent/JP5396480B2/en not_active Expired - Fee Related
- 2009-06-30 CA CA2735219A patent/CA2735219C/en not_active Expired - Fee Related
-
2014
- 2014-06-25 US US14/314,885 patent/US9504511B2/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3924628A (en) * | 1972-12-01 | 1975-12-09 | William Droegemueller | Cyrogenic bladder for necrosing tissue cells |
WO1992019145A2 (en) * | 1991-05-03 | 1992-11-12 | Goldrath Milton H | Endometrium coagulating apparatus and surgical method for thermal destruction of the endometrium |
US5300022A (en) | 1992-11-12 | 1994-04-05 | Martin Klapper | Urinary catheter and bladder irrigation system |
US5968008A (en) | 1997-08-04 | 1999-10-19 | Grams; Guenter A. | Cannula with parallel channels and sliding sheath |
Also Published As
Publication number | Publication date |
---|---|
AU2009297003A1 (en) | 2010-04-01 |
US20100082021A1 (en) | 2010-04-01 |
EP2349374B1 (en) | 2016-11-02 |
CA2735219C (en) | 2017-08-01 |
US9504511B2 (en) | 2016-11-29 |
AU2009297003B2 (en) | 2014-01-30 |
CA2735219A1 (en) | 2010-04-01 |
US8790334B2 (en) | 2014-07-29 |
JP2012504014A (en) | 2012-02-16 |
EP2349374A1 (en) | 2011-08-03 |
JP5396480B2 (en) | 2014-01-22 |
US20140309629A1 (en) | 2014-10-16 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9504511B2 (en) | Fluid recirculation debris handling system | |
AU734265B2 (en) | Urethral warming catheter | |
US6463331B1 (en) | Application of energy and substances in the treatment of uro-genital disorders | |
CA2649885C (en) | Heat exchange catheter with multi-lumen tube having a fluid return passageway | |
EP0707502B1 (en) | Benign prostatic hyperplasia catheter with urethral cooling | |
US6972014B2 (en) | Open system heat exchange catheters and methods of use | |
US8272383B2 (en) | Systems and methods for male sterilization | |
US7892270B2 (en) | Temperature management system and method for burn patients | |
US20010010011A1 (en) | Central venous catheter with heat exchange membrane | |
EP0552934A2 (en) | Transurethral ablation catheter | |
US8747414B2 (en) | Vacuum device for sealing an anatomical opening | |
US20070185478A1 (en) | Device for local ablation of tissue | |
CN109219409A (en) | Minimally invasive device for intracavitary therapy | |
CN213249508U (en) | Intestinal polyp enucleation device | |
EP3103377A1 (en) | Endoscope with continuous luminal perfusion and reflux functions |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 09790003 Country of ref document: EP Kind code of ref document: A1 |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2011529039 Country of ref document: JP |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2009297003 Country of ref document: AU |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2735219 Country of ref document: CA |
|
ENP | Entry into the national phase |
Ref document number: 2009297003 Country of ref document: AU Date of ref document: 20090630 Kind code of ref document: A |
|
REEP | Request for entry into the european phase |
Ref document number: 2009790003 Country of ref document: EP |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2009790003 Country of ref document: EP |
|
NENP | Non-entry into the national phase |
Ref country code: DE |