WO2010065214A4 - Benign prostatic hyperplasia surgical system featuring mechanical coring probe with live aspiration - Google Patents

Benign prostatic hyperplasia surgical system featuring mechanical coring probe with live aspiration Download PDF

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Publication number
WO2010065214A4
WO2010065214A4 PCT/US2009/062284 US2009062284W WO2010065214A4 WO 2010065214 A4 WO2010065214 A4 WO 2010065214A4 US 2009062284 W US2009062284 W US 2009062284W WO 2010065214 A4 WO2010065214 A4 WO 2010065214A4
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WO
WIPO (PCT)
Prior art keywords
probe
cutting
housing
core
sharp
Prior art date
Application number
PCT/US2009/062284
Other languages
French (fr)
Other versions
WO2010065214A2 (en
WO2010065214A3 (en
Inventor
Michael Edward Todd
Original Assignee
Urotech, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Urotech, Inc. filed Critical Urotech, Inc.
Priority to EP09830794.5A priority Critical patent/EP2370005A4/en
Publication of WO2010065214A2 publication Critical patent/WO2010065214A2/en
Publication of WO2010065214A3 publication Critical patent/WO2010065214A3/en
Publication of WO2010065214A4 publication Critical patent/WO2010065214A4/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • 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
    • 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
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/28—Clamping means for squeezing flexible tubes, e.g. roller clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00907—Material properties transparent or translucent for light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B2017/32004—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes having a laterally movable cutting member at its most distal end which remains within the contours of said end
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595—Cauterization
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00607—Coagulation and cutting with the same instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • 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
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Abstract

The invention comprises an atherectomy probe for mechanically cutting core prostatic tissue to alleviate the condition of benign prostatic hyperplasia (BPH) or for use in orthopedic procedures. The blade shapes and lengths are adaptable but in a preferred embodiment the device includes an end-cutting bur tip. The cutting motion may be one of: guillotine (incising between two parallel edges), radial reciprocating (changing radial directions and cuts between two horizontal edges), circular (continuously radial in one direction), and end- cutting, etc.. The power source used to drive the blade may be one of: pneumatic, hydraulic, manual mechanical, electrical, solar, etc. The probe also includes several channels that may be used for providing live aspiration and removal of severed tissue and fluids, as well as insufflation of gases and optionally, pharmaceuticals and/or a secondary therapy. The instrument is designed for use in open, endoscopic, and minimally invasive transurethral or transperineal surgical procedures.

Claims

AMENDED CLAIMS received by the International Bureau on 16 August 2010 (16.08.2010)
1. A probe configured for transperineal insertion into a prostate for mechanically cutting comprising:
(i) an outer housing with one or more openings or portals in a distal region thereof; (ii) one or more channels within the housing; (iii) an inner cutting core; and
(iv) at least one sharp curved edge for cutting in a distal region of the core; wherein at least one channel conducts a material removal vacuum suction system that provides continuously available suction for simultaneously cutting and aspirating to remove bodily material externally of a patient's body immediately after it is severed and while the cutting core continues to sever and aspirate new bodily material; and wherein at least one opening or portal in the housing is at least partially open during cutting by the core, such that while the sharp curved edge is cutting a first tissue and materials are being suctioned proximally, additional tissue can still be received through the outer housing at all times to be cut by the inner cutting core, for a continuous process.
2. The probe of claim 1 , wherein the probe is an atherectomy probe configured to act upon a prostate and the bodily material removed is targeted bulk prostate tissue such that cutting and removing tissue alleviates a condition of benign prostatic hyperplasia (BPH).
3. The probe of claim 1, wherein the probe is configured to act upon soft tissue and bone for orthopedic applications and the bodily material removed is soft tissue and bone such that cutting and removing material can be used to debride, shave, and/or resurface.
4. The probe of claim 1 , further comprising a hood in the distal region of the core aroundthe sharp edges for cutting, wherein the hood is configured to stabilize the probe and to shield non-target bodily material from cutting.
5. The probe of claim 1, wherein at least one sharp edge for cutting is extendable and retractable through a push-button actuation mechanism that functions to do at least one of: (i) extending the sharp cutting edge(s) and (ii) retracting the housing, and also at least one of: (iii) retracting the sharp cutting edge(s) and (iv) extending the housing.
6. The probe of claim 1, wherein a power source for the probe uses pneumatic energy to drive the inner cutting core and the probe is configured to connect to a surgical console through an identification-sensitive self-sealed cassette and one or more flexible tubing lines having one or more pinch valves thereon for controlling linear aspiration and residual vacuum.
7. The probe of claim 1, wherein at least one sharp cutting edge of the core accesses bodily material through an opening at a distal tip of the housing to provide end-cutting.
8. The probe of claim 1, wherein the sharp cutting edge of the core comprises at least one bur.
9. The probe of claim 8, wherein the bur is capable of being heated to cauterize and coagulate bodily material before, during, and/or after cutting.
10. The probe of claim 1, wherein at least one sharp cutting edge of the core accesses bodily material through a lateral opening in a distal region of the housing to provide side- cutting.
11. The probe of claim 1, further comprising a fiber optic camera and a source of illumination on the probe itself.
12. The probe of claim 1, wherein the core is configured to perform a radial reciprocating cutting style.
13. The probe of claim 1, further comprising at least two openings or portals in the housing through which the cutting core can access bodily material to provide dual port or multi- port cutting action through more than one opening or portal.
14. The probe of claim 13, comprising four openings or portals in the housing through which the cutting core can access bodily material to provide quad port cutting action through four distinct openings or portals.
15. The probe of claim 13, wherein the core is configured to perform guillotine cutting through at least one portal and also to perform radial reciprocating cutting through at least one other portal.
16. The probe of claim 7 for end-cutting, comprising more than one sharp cutting edge, wherein a second sharp cutting edge of the core accesses bodily material through a lateral opening in a distal region of the housing to provide side-cutting in addition to the end- cutting such that the probe can be used to perform side-cutting and/or end-cutting simultaneously, sequentially, alternating, or in a cyclical manner.
17. The probe of claim 10, further comprising one or more additional lateral openings in a distal region of the housing and one or more sharp cutting edges to provide side-cutting wherein the sharp cutting edge(s) of the core access bodily material through the lateral openings in more than one location,
18. The probe of claim 17, wherein at least two lateral openings in the housing are at a same axial position, as measured by a longitudinal distance from a distal tip of the housing, and are at different radial positions around a periphery of the probe.
19. The probe of claim 17, wherein at least two lateral openings in the housing are at different axial positions, as measured by a longitudinal distance from a distal tip of the housing, and are at a same radial position around a periphery of the probe.
20. The probe of claim 17, wherein at least two lateral openings in the housing are at different axial positions, as measured by a longitudinal distance from a distal tip of the housing, and are also at different radial positions around a periphery of the probe.
21. A device for use in performing a surgical procedure through a natural bodily lumen comprising a balloon sheath for luminal protection, through which one or more surgical instruments can be passed, the sheath comprising columnar supports along a longitudinal length thereof and a clear, lubricated tip at a distal end to facilitate anatomic visualization during insertion, wherein the tip can be peeled away following delivery, and wherein the sheath is capable of being tubular-rolled in its deflated condition and unrolls upon inflation with a coolant fluid.
22. A system for treating benign prostatic hyperplasia comprising: (i) the probe of claim 1 ;
(ii) optionally, a luminally protective sheath; and
(iii) a device for simultaneously tamponading, inducing hemostasis, and dilating more than one lumen while minimi7iτig inflammation, comprising two or more tamponading balloons, wherein the balloons can be inflated with a coolant fluid.
23. The system of claim 22, further comprising a microscopic end cauterizing probe to seal a surgical site.
24. The system of claim 22, further comprising a surgical console, an identification-sensitive self-sealed cassette, and one or more flexible tubing lines with one or more pinch valves thereon.
5. A method of treating benign prostatic hyperplasia comprising:
(i) optionally, creating a protective barrier within a bodily lumen;
(ii) inserting a tool to create a small self-sealing puncture through a wall of a lumen and/or through tissue to gain access to a portion of a prostate; (iii) inserting a probe though the puncture into the prostate, wherein a template may optionally be used to guide insertion of the probe; (iv) activating the probe to treat the prostate; (v) withdrawing the probe and inspecting a surgical site for a flow of urine or semen to determine whether a sufficient amount of prostate tissue has been treated; and (vi) inspecting for hemostasis; (vii) optionally, inserting one or more sealants; (viii) optionally, inserting one or more tamponading balloons; (ix) optionally, inflating the tamponading balloons to compress the sealants and then withdrawing the tamponading balloons upon attainment of hemostasis; and (x) optionally, inserting and activating a micro end cauterizing probe to the surgical site to ensure hemostasis is maintained.
PCT/US2009/062284 2008-12-05 2009-10-28 Benign prostatic hyperplasia surgical system featuring mechanical coring probe with live aspiration WO2010065214A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09830794.5A EP2370005A4 (en) 2008-12-05 2009-10-28 Benign prostatic hyperplasia surgical system featuring mechanical coring probe with live aspiration

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12011508P 2008-12-05 2008-12-05
US61/120,115 2008-12-05
US12/430,532 US8603123B2 (en) 2008-04-28 2009-04-27 Benign prostatic hyperplasia surgical system featuring mechanical coring probe with live aspiration
US12/430,532 2009-04-27

Publications (3)

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WO2010065214A2 WO2010065214A2 (en) 2010-06-10
WO2010065214A3 WO2010065214A3 (en) 2010-08-12
WO2010065214A4 true WO2010065214A4 (en) 2010-10-28

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EP (1) EP2370005A4 (en)
WO (1) WO2010065214A2 (en)

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US9039719B2 (en) 2015-05-26
EP2370005A2 (en) 2011-10-05
WO2010065214A3 (en) 2010-08-12
US20120108937A1 (en) 2012-05-03
US20170100149A1 (en) 2017-04-13
US8603123B2 (en) 2013-12-10
US9675373B2 (en) 2017-06-13
US20120109173A1 (en) 2012-05-03
US20090270791A1 (en) 2009-10-29
US9549751B2 (en) 2017-01-24
EP2370005A4 (en) 2017-06-07

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