WO2018152423A1 - Method and apparatus for percutaneous sensor delivery - Google Patents

Method and apparatus for percutaneous sensor delivery Download PDF

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Publication number
WO2018152423A1
WO2018152423A1 PCT/US2018/018522 US2018018522W WO2018152423A1 WO 2018152423 A1 WO2018152423 A1 WO 2018152423A1 US 2018018522 W US2018018522 W US 2018018522W WO 2018152423 A1 WO2018152423 A1 WO 2018152423A1
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WO
WIPO (PCT)
Prior art keywords
delivery system
needle catheter
percutaneous delivery
percutaneous
plunger rod
Prior art date
Application number
PCT/US2018/018522
Other languages
French (fr)
Inventor
Galen OHNMACHT
Original Assignee
Ohnmacht Galen
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 Ohnmacht Galen filed Critical Ohnmacht Galen
Publication of WO2018152423A1 publication Critical patent/WO2018152423A1/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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00809—Lung operations
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/397—Markers, e.g. radio-opaque or breast lesions markers electromagnetic other than visible, e.g. microwave
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3987—Applicators for implanting markers

Definitions

  • the present invention relates generally to thoracic surgery, and more specifically, to an improved percutaneous delivery system that accurately deposits a wired electromagnetic emitter "tag" to mark target locations in the lung for surgery.
  • COPD chronic obstructive pulmonary disease
  • Surgical options include lung volume reduction surgery, lung transplant, and bulleetomy. Although these surgeries can improve quality of life and prolong survival they are highly invasive. Consequently, thoracic surgeons employ non-invasive treatment planning methods using computed tomography (CT) scanning, magnetic resonance imaging (MRI), or fluoroscopic technologies. These different technologies allow the surgeon to identify potential targets in the images. The surgeon can then mark an identified target on the computer. However, the patient's body is a dynamic thing. Movements in position or internal changes (e.g., a collapsed lung) may render a marked site obsolete. What is weeded is a more enduring site marker.
  • CT computed tomography
  • MRI magnetic resonance imaging
  • implanted markers or clips for surgical guidance is known in ihe art.
  • a radiologist may mark the location by inserting a simple radio-opaque wire at the location of the lesion while viewing an image of the breast under mammography.
  • the surgeon follows the wire to find the exact location of the lesion, so as to be certain of removing tissue from the correct area of the breast. This approach significantly reduces the occurrence of false negative biopsy findings and increases the overall diagnostic accuracy of the procedure.
  • an improved percutaneous delivery system that accurately deposits a wired electromagnetic emitter, or "tag.” to mark target locations in the lung (or elsewhere in the body) for surgery.
  • the delivery system comprises a percutaneous needle catheter configured to penetrate into an organ such as the lung without having to use a bronchoscope at all
  • the needle catheter lias a lumen for passing a cylindrical electromagnetic marker with attached guidewires to a target site within the lung, and a plunger for deploying the marker with trailing guidewires intact, and for allowing removal of the needle catheter.
  • the marker when a biopsy is subsequently performed, the marker generates an electromagnetic signal to mark the exact location of the lesion, so as to be certain of removing ⁇ issue from the correct area of the lung.
  • FIG. 1 is a side perspective view of a percutaneous delivery system according to an embodiment of the invention
  • FIG. 2 is a partial cutaway view of the probe 20 of FIG. 1 ,
  • the present invention is an improved percutaneous delivery system that employs an introducer in the form of a needle catheter 2 to accurately deposits a probe 20 comprising a w.ned elecuomagitetic emitter, or "tag,” to mark target locations in lite lung ( ⁇ elsewhere in the body ) for surgery.
  • the percutaneous delivery system includes a needle catheter 2 having an elongated tubular shaft 18 ha vine a proximal end 14 and a distal end 12.
  • the shaft 18 is rigid, stainless steel being a suitable rigid material.
  • the distal end 1 2 of the shaft 18 is atraumatic, for example, truncated angularly at end 12 to form a sharp needle edge to penetrate the body tissues while inserting the needle 2 therein. Truncation an inclination of 40"-5 ( .v- from the longitudinal axis of the needle is presently preferred.
  • the percutaneous delivery system also includes a small cylindrical electromagnetic probe 20 slidabie through the inner lumen of needle catheter 2, the probe 20 having a trailing guidewire 34 likewise extending through the inner lumen of needle catheter 2.
  • the probe 20 is pushed there through by an elongate plunger shaft 42.
  • T he plunger shaft 42 is itself tubular with an elongate slot 44 extending from its distal tip to its proximal handle 44. This way the tubular hollow plunger 42 encloses and protects the wires 34 leading to probe 20 as the probe 20 is being inserted, yet the wires can be removed from inside plunger rod 42 after insertion through slot 44.
  • the probe 20 is a tiny cylindrical dev ice for producing an electromagnetic "beacon.”
  • the probe 20 comprises a RF antenna 22. typically having the form of a coil, which is coupled to an internal circuit board 26 to define a resonant circuit.
  • the coil 22 and circuitry 2ft are contained in a sealed, biocompatible housing 28, typically made of a plastic or other non-conducting material.
  • housing 28 includes a base 29 that is bulbous, with a distal recess 33 to fit plunger 42.
  • the recess 33 may be circaamferentially keyed to the distal tip of plunger 42 by ribs or the like to engage for rotation.
  • the bulbous base 29 also provokes rotation of the probe 20 after being ejected from the needle catheter 2. It is intended that the probe 20 rotate 90 degrees immediately upon ejection to lodge itself in. tire lung tissue.
  • a power source (not shown) may be connected to wires 36 to activate the coil 22 and produce the electromagnetic beacon.
  • the probe 20 when a biopsy is subsequently performed, the probe 20 generates an electromagnetic signal to mark the exact location of the lesion, so as to be certain of removing tissue from the correct area of the the. More specifically, the probe 20 generates an RF signal that is projected to a receiver array (not shown). Peak detection is performed for the RF signal and the 2D/3D position of the peak may be determined with sub-pixel resolution. [Markelj et aL. A review of 3D.2D registration methods for image-guided interventions, Med Image Anal.
  • Surgical options include lung volume reduction surgery, lung transplant, and bullectomy. These are highly invasive procedures, and to .minimize trauma thoracic surgeons employ treatment planning methods using computed tomography (CT) scanning, .magnetic resonance imaging (MR!), or fluoroscopic technologies to identify potential targets in the images. Similar techniques are used for planning other surgical procedures these techniques use radiopaque site markers to reflect patient movements in position or internal changes (e.g., a collapsed lung) site marker. However, markers are not typically used for procedures such as lung biopsies due to the difficulty in reaching the target site. There would be great industrial applicability in an improved percutaneous delivery system for delivering a wired
  • electromagnetic emitter or "tag” to mark target locations in the lung for surgery.

Abstract

A percutaneous delivery system comprising a needle catheter (2) having a sharp tip for percutaneous access, a plunger rod (6) for insertion in said needle catheter (2), and a probe (20) comprising a wired electromagnetic emitter or "tag," to mark target locations in the lung for surgery. The plunger rod (6) is a hollow tubular lumen with a slot running end-to-end to seat wires running from the probe (20), The probe (20) is slidable within the needle catheter (2) for ejection by the plunger rod (6) to be implanted at a desired location in lung, the wires dislodged from the plunger shaft (6) which is withdrawn, and the needle catheter (2) removed. This leaves the wires in place for external connection to activate the beacon which marks the exact location of the lesion, so as to be certain of removing tissue from the correct area of the lung.

Description

METHOD AND APPARATUS FOR PERCUTANEOUS SENSOR DELIVERY
CROSS-REFERENCE TO RELATED APPLICATION^)
The present application derives priority from U.S. Provisional Patent Application
62/459 793 tiled 16 February 201 7
BACKGROUND OF THE INVENTION
1 . Field of the invention
The present invention relates generally to thoracic surgery, and more specifically, to an improved percutaneous delivery system that accurately deposits a wired electromagnetic emitter "tag" to mark target locations in the lung for surgery.
2. Description of the Background
Millions suffer from chronic obstructive pulmonary disease (COPD), a broad category that includes chronic bronchitis, emphysema, and types of asthma. COPD generally entails a reduction in airflow caused by partial airway occlusion, narrowing and/or reduction in lung elasticity. As a result of the COPD, the airways close prematurely at an abnormally high lung until the patient can only take shallow breaths.
Currently there is no cure for COPD but treatment includes bronchodilator drugs and surgery. Surgical options include lung volume reduction surgery, lung transplant, and bulleetomy. Although these surgeries can improve quality of life and prolong survival they are highly invasive. Consequently, thoracic surgeons employ non-invasive treatment planning methods using computed tomography (CT) scanning, magnetic resonance imaging (MRI), or fluoroscopic technologies. These different technologies allow the surgeon to identify potential targets in the images. The surgeon can then mark an identified target on the computer. However, the patient's body is a dynamic thing. Movements in position or internal changes (e.g., a collapsed lung) may render a marked site obsolete. What is weeded is a more enduring site marker. The use of implanted markers or clips for surgical guidance is known in ihe art. For example, upon identifying a suspicious lesion in the breast, a radiologist may mark the location by inserting a simple radio-opaque wire at the location of the lesion while viewing an image of the breast under mammography. When a biopsy is subsequently performed, the surgeon follows the wire to find the exact location of the lesion, so as to be certain of removing tissue from the correct area of the breast. This approach significantly reduces the occurrence of false negative biopsy findings and increases the overall diagnostic accuracy of the procedure.
Despite the proven usefulness of such simple biopsy markers in certain contexts, they have not been used for procedures such as lung biopsies due to the difficulty in reaching the target site. The surgeon must penetrate into the lung. This is typically done using a bronchoscope, but roughly half of die lung is not reachable by bronchoscopy. What is needed is an improved percutaneous delivery system for delivering a wired electromagnetic emitter, or "tag,'" to mark target locations it) the lung (or elsewhere in the body) for surgery.
SUMMARY OF THE INVENTION
These and other objects are accomplished herein by an improved percutaneous delivery system, that accurately deposits a wired electromagnetic emitter, or "tag." to mark target locations in the lung (or elsewhere in the body) for surgery.
In an embodiment, the delivery system comprises a percutaneous needle catheter configured to penetrate into an organ such as the lung without having to use a bronchoscope at all The needle catheter lias a lumen for passing a cylindrical electromagnetic marker with attached guidewires to a target site within the lung, and a plunger for deploying the marker with trailing guidewires intact, and for allowing removal of the needle catheter. This way, when a biopsy is subsequently performed, the marker generates an electromagnetic signal to mark the exact location of the lesion, so as to be certain of removing {issue from the correct area of the lung.
Other objects, features and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiment and certain modifications thereof,
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments and certain modifications thereof when put forth with the accompanying drawings in which;
FIG. 1 is a side perspective view of a percutaneous delivery system according to an embodiment of the invention,
FIG. 2 is a partial cutaway view of the probe 20 of FIG. 1 ,
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention is an improved percutaneous delivery system that employs an introducer in the form of a needle catheter 2 to accurately deposits a probe 20 comprising a w.ned elecuomagitetic emitter, or "tag," to mark target locations in lite lung (οτ elsewhere in the body ) for surgery.
As shown in PIG. 1 , the percutaneous delivery system includes a needle catheter 2 having an elongated tubular shaft 18 ha vine a proximal end 14 and a distal end 12. The shaft 18 is rigid, stainless steel being a suitable rigid material. The distal end 1 2 of the shaft 18 is atraumatic, for example, truncated angularly at end 12 to form a sharp needle edge to penetrate the body tissues while inserting the needle 2 therein. Truncation an inclination of 40"-5(.v- from the longitudinal axis of the needle is presently preferred. As seen in the lower inset, the percutaneous delivery system also includes a small cylindrical electromagnetic probe 20 slidabie through the inner lumen of needle catheter 2, the probe 20 having a trailing guidewire 34 likewise extending through the inner lumen of needle catheter 2. The probe 20 is pushed there through by an elongate plunger shaft 42. T he plunger shaft 42 is itself tubular with an elongate slot 44 extending from its distal tip to its proximal handle 44. This way the tubular hollow plunger 42 encloses and protects the wires 34 leading to probe 20 as the probe 20 is being inserted, yet the wires can be removed from inside plunger rod 42 after insertion through slot 44.
As shown in FIG. 2, the probe 20 is a tiny cylindrical dev ice for producing an electromagnetic "beacon." The probe 20 comprises a RF antenna 22. typically having the form of a coil, which is coupled to an internal circuit board 26 to define a resonant circuit. The coil 22 and circuitry 2ft are contained in a sealed, biocompatible housing 28, typically made of a plastic or other non-conducting material. In the embodiment pictured in FIG. 2. housing 28 includes a base 29 that is bulbous, with a distal recess 33 to fit plunger 42. The recess 33 may be circaamferentially keyed to the distal tip of plunger 42 by ribs or the like to engage for rotation. The bulbous base 29 also provokes rotation of the probe 20 after being ejected from the needle catheter 2. It is intended that the probe 20 rotate 90 degrees immediately upon ejection to lodge itself in. tire lung tissue.
Once the probe 20 is implanted a t a desired location in lung tissue of a patient, the plunger shaft 42 is withdrawn, die wires 36 are removed from its slot 44, and the needle catheter 2 is removed. A power source (not shown) may be connected to wires 36 to activate the coil 22 and produce the electromagnetic beacon.
This way, when a biopsy is subsequently performed, the probe 20 generates an electromagnetic signal to mark the exact location of the lesion, so as to be certain of removing tissue from the correct area of the the. More specifically, the probe 20 generates an RF signal that is projected to a receiver array (not shown). Peak detection is performed for the RF signal and the 2D/3D position of the peak may be determined with sub-pixel resolution. [Markelj et aL. A review of 3D.2D registration methods for image-guided interventions, Med Image Anal.
Figure imgf000007_0001
Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications thereto may obviously occur to those skilled in the art upon becoming familiar with the underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein.
STATEMENT OF INDUSTRIAL APPLICABILITY
Currently there is no cure for COPD but treatment includes bronchodilaior drugs and surgery. Surgical options include lung volume reduction surgery, lung transplant, and bullectomy. These are highly invasive procedures, and to .minimize trauma thoracic surgeons employ treatment planning methods using computed tomography (CT) scanning, .magnetic resonance imaging (MR!), or fluoroscopic technologies to identify potential targets in the images. Similar techniques are used for planning other surgical procedures these techniques use radiopaque site markers to reflect patient movements in position or internal changes (e.g., a collapsed lung) site marker. However, markers are not typically used for procedures such as lung biopsies due to the difficulty in reaching the target site. There would be great industrial applicability in an improved percutaneous delivery system for delivering a wired
electromagnetic emitter, or "tag," to mark target locations in the lung for surgery.

Claims

I claim:
1 . A percutaneous delivery system, comprising:
a needle catheter having a sharp distal tip for percutaneous access;
a plunger rod for insertion in said needle catheter, said plunger rod being a hollow tubular lumen with a slot running end-to-end; and
a cylindrical electromagnetic probe siidabie within said needle catheter for ejection by said plunger rod, said probe having electrical wires attached thereto, and said electrical wires fitting within the slot of said plunger rod.
2. The percutaneous delivery system according to claim 1, wherein said needle catheter further comprises an elongated rigid tubular shaft with a proximal end and a distal end.
3. The percutaneous delivery system according to claim 2., wherein the distal end of said needle catheter is truncated for atraumatic penetration.
4. The percutaneous delivery system according to claim 3, w herein the distal end of said needle catheter is truncated at an angle within a range of from 40-50 degrees relative to a longitudinal axis of said needle catheter.
5. The percutaneous delivery system according to claim I , wherein the cylindrical electromagnetic probe comprises a hemispherical end,
6. The percutaneous delivery system according to claim 5„ wherein the cylindrical electromagnetic probe comprises a receptacle at an apex of said hemispherical end for insertion of said plunger.
7. The percutaneous del.ive.ry system according to claim 6, wherein the receptacle at the apex of said hemispherical end is keyed to sard plunger for co-rotation.
8. The percutaneous delivery system according to claim 1 , wherein the cylindrical electromagnetic probe comprises a cylindrical housing enclosing an interna! RF transmitter.
9. The percutaneous delivery system according to claim 8, wherein the internal RF transmitter is connected to said electrical wires.
10. The percutaneous delivery system according to claim 9, wherein the electrical wires include a positive (4 ) power wire and a negative ( -) power wire.
1 1. The percutaneous delivery system according to claim 9, wherein the internal RF transmitter further comprises a microcoil antenna inside sard housing.
12. A percutaneous delivery system, comprising;
a needle catheter having a sharp distal tip for percutaneous access;
a plunger rod for insertion in said needle catheter, said plunger rod being a hollow tubular lumen with an open slot running end-to-end; and
a cylindrical electromagnetic probe sliclable within said needle catheter for ejection by said plunger rod, said probe including a cylindrical housing formed with a hemispherical end and enclosing a circuit board with resident RF transmitter and a mieroco.il antenna, and electrical wires connected to said circuit board and exiting said housing through the hemispherical end thereof.
13. The percutaneous delivery system according to claim .12. wherein the electrical wires include a positive {+) power wire and a negative (-) power wire.
14. The percutaneous delivery system according to claim 12, wherein said needle catheter further comprises an elongated rigid tubular shaft with a proximal end and a distal end.
] 5. The percutaneous deliver)' system according to claim 14, w herein the distal end of said needle catheter is truncated for atraumatic penetration.
16.. The percutaneous delivery system according to claim 1 5, wherein the distal end of said need!e catheter is truncated at an angle within a range of from 40-50 degrees relative to a longitudinal axis of said needle catheter.
17. The percutaneous delivery system according to claim 12, wherein the cylindrical electromagnetic probe comprises a receptacle at an apex of said hemispherical end for insertion of said plunger.
1 8. The percutaneous delivery system according to claim 17, wherein the receptacle at the apex of said hemispherical end is keyed to said plunger for co-rotation.
PCT/US2018/018522 2017-02-16 2018-02-16 Method and apparatus for percutaneous sensor delivery WO2018152423A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762459793P 2017-02-16 2017-02-16
US62/459,793 2017-02-16

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5667514A (en) * 1995-12-04 1997-09-16 Cochlear Ltd. Device and method for inserting a flexible element into soft tissue
US5800445A (en) * 1995-10-20 1998-09-01 United States Surgical Corporation Tissue tagging device
US7004959B2 (en) * 1996-11-15 2006-02-28 Bonutti Ip, Llc Apparatus and method for use in positioning an anchor
US20070283773A1 (en) * 2006-03-23 2007-12-13 Jury Baldewein Inserter instrument implanter sensor
US20080121242A1 (en) * 2004-03-05 2008-05-29 Ian Revie Implantable Marker, Instruments and Methods
US7792586B2 (en) * 2002-02-22 2010-09-07 Cochlear Limited Insertion device for an electrode array
US8538554B2 (en) * 2004-05-10 2013-09-17 Boston Scientific Neuromodulation Corporation Implantable electrode, insertion tool for use therewith, and insertion method

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5800445A (en) * 1995-10-20 1998-09-01 United States Surgical Corporation Tissue tagging device
US5667514A (en) * 1995-12-04 1997-09-16 Cochlear Ltd. Device and method for inserting a flexible element into soft tissue
US7004959B2 (en) * 1996-11-15 2006-02-28 Bonutti Ip, Llc Apparatus and method for use in positioning an anchor
US7792586B2 (en) * 2002-02-22 2010-09-07 Cochlear Limited Insertion device for an electrode array
US20080121242A1 (en) * 2004-03-05 2008-05-29 Ian Revie Implantable Marker, Instruments and Methods
US8538554B2 (en) * 2004-05-10 2013-09-17 Boston Scientific Neuromodulation Corporation Implantable electrode, insertion tool for use therewith, and insertion method
US20070283773A1 (en) * 2006-03-23 2007-12-13 Jury Baldewein Inserter instrument implanter sensor

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