U.S. patent application number 09/765732 was filed with the patent office on 2001-05-24 for surgical and pharmaceutical site access guide and methods.
Invention is credited to Burney, Bryan T., Miller, Michael E., Schroeder, David L..
Application Number | 20010001811 09/765732 |
Document ID | / |
Family ID | 22374646 |
Filed Date | 2001-05-24 |
United States Patent
Application |
20010001811 |
Kind Code |
A1 |
Burney, Bryan T. ; et
al. |
May 24, 2001 |
Surgical and pharmaceutical site access guide and methods
Abstract
A guide (100) is provided for biopsy and microtherapy which
includes an introducer cannula (120) defining a lumen (125) sized
to receive a diagnostic or therapeutic item therethrough and a
lateral opening (124) in communication with the lumen (125)
adjacent the first end (121) of the cannula (120). The invention
also includes a solid tip (130) having an anatomically distal end
(131) secured to the first end (121) of the cannula (120) and a
proximal end (132) configured to pierce tissue. A ramp (135) is
disposed within the cannula (120) at an end (136) of the lateral
opening (124) adjacent the first end (121) of the cannula (120).
The ramp (135) is inclined toward the lateral opening (124),
whereby the item will be deflected through the lateral opening
(124) as it advances within the lumen (125) and exits the cannula
(120). In some embodiments, the item is a biopsy needle, ablation
means or a radiopharmaceutical seed. The invention also includes
methods of obtaining a biopsy sample and methods for treating
lesions.
Inventors: |
Burney, Bryan T.; (Fishers,
IN) ; Schroeder, David L.; (Franklin, IN) ;
Miller, Michael E.; (Trafalgar, IN) |
Correspondence
Address: |
Deborah R. Beck
Baker & Daniels
Suite 2700
300 North Meridian Street
Indianapolis
IN
46204
US
|
Family ID: |
22374646 |
Appl. No.: |
09/765732 |
Filed: |
January 11, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09765732 |
Jan 11, 2001 |
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09117755 |
Aug 4, 1998 |
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09117755 |
Aug 4, 1998 |
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PCT/US97/02103 |
Feb 10, 1997 |
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PCT/US97/02103 |
Feb 10, 1997 |
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08599381 |
Feb 9, 1996 |
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5800389 |
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Current U.S.
Class: |
604/93.01 ;
600/562; 600/567; 604/158; 604/159; 604/164.01; 604/264 |
Current CPC
Class: |
A61B 10/0283 20130101;
A61M 2025/018 20130101; A61B 10/0233 20130101; A61B 17/3417
20130101; A61B 2010/0225 20130101; A61B 17/3401 20130101; A61B
10/0275 20130101; A61B 10/0266 20130101; A61B 17/3468 20130101;
A61B 2090/3908 20160201 |
Class at
Publication: |
604/93.01 ;
604/164.01; 604/264; 604/158; 604/159; 600/562; 600/567 |
International
Class: |
A61M 031/00; A61M
037/00; A61B 010/00 |
Claims
What is claimed is:
1. A system for diagnosing and treating a lesion inside a patient,
comprising: a guide having a cannula having a first end and a
second end and defining a lumen therebetween opening at an aperture
at said second end, said cannula defining a lateral opening in
communication with the lumen adjacent said first end, and a solid
tip having an anatomically distal end secured to the first end of
said cannula and a proximal end configured to pierce tissue; and
ablation means for ablating said lesion through said cannula.
2. The system of claim 1 wherein said ablation means includes an
ablation chemical.
3. The system of claim 2 wherein said composition is an
alcohol.
4. The system of claim 3 wherein said composition is ethanol.
5. The system of claim 2 wherein said composition is
cyanoacrylate.
6. The system of claim 1 further comprising biopsy means for
obtaining a biopsy sample of the lesion, said biopsy means
insertable through said aperture, said lumen and said lateral
opening;
7. The system of claim 6 wherein said biopsy means comprises a
hollow biopsy needle having an anatomically proximal end and a
distal end, said needle sized and configured to be movably and
rotatably received within said lumen, said proximal end sized and
configured to exit from said lumen through said lateral opening and
having an edge to pierce tissue to obtain a biopsy sample when said
biopsy needle is advanced into the tissue.
8. The system of claim 7 wherein said distal end of said tip is
sloped to form a ramp adjacent and inclined toward said lateral
opening, whereby the biopsy needle will be deflected through said
lateral opening as it exits said cannula.
9. The system of claim 1, further comprising: an introducer stylet
sized to be received within said lumen, said introducer stylet
having a length sufficient to block said lateral opening when said
introducer stylet is received within said lumen.
10. The system of claim 1 further comprising a plurality of depth
markings located in spaced relation on said cannula.
11. The system of claim 10 wherein said markings are
radiographic.
12. A system for treating a lesion within a patient's body,
comprising: an introducer having a cannula having a first end and a
second end and defining a lumen therebetween, the second end of the
cannula defining an aperture, said cannula defining a lateral
opening in communication with the lumen adjacent said first end,
and a solid tip having an anatomically distal end secured to the
first end of said cannula and a proximal end configured to pierce
tissue; and a radiopharmaceutical composition disposed within said
cannula.
13. The system of claim 12 wherein said composition includes
Iodine-125.
14. The system of claim 13 wherein said composition includes
Palladium-103.
15. The system of claim 13 wherein said composition includes
radioactive seeds.
16. A system for diagnosing a lesion within a patient's body,
comprising: an introducer having a cannula having a first end and a
second end and defining a lumen therebetween, the second end of the
cannula defining an aperture, said cannula defining a lateral
opening in communication with the lumen adjacent said first end,
and a solid tip having an anatomically distal end secured to the
first end of said cannula and a proximal end configured to pierce
tissue; and a localization wire disposed within said cannula, said
localization wire having a diameter that is smaller than a
dimension of said lateral opening.
17. A system for diagnosing a lesion within a patient's body,
comprising: an introducer having a cannula having a first end and a
second end and defining a lumen therebetween, the second end of the
cannula defining an aperture, said cannula defining a lateral
opening in communication with the lumen adjacent said first end,
and a solid tip having an anatomically distal end secured to the
first end of said cannula and a proximal end configured to pierce
tissue; and a visualization agent disposed within said cannula.
18. The system of claim 17 wherein said agent is a contrast
agent.
19. The system of claim 18 wherein said agent is methylene
blue.
20. A method of delivering therapeutic items to a pathological site
inside a patient's body, comprising: providing a guide introducer,
said introducer having a cannula having a first end and a second
end and defining a lumen therebetween; a tip disposed at the first
end of the cannula and closing the lumen at the first end; the
lumen having an aperture at the second end of the cannula, the
aperture sized and configured to receive an item; and the cannula
defining a lateral opening in communication with the lumen, the
lateral opening sized and configured to allow exit of the item from
the lumen; inserting the introducer into the patient at the site;
inserting a first item through the aperture and into the lumen;
advancing the first item through the lumen and out through the
lateral opening at an angle relative to the introducer and into the
site; and rotating the introducer after advancing the first item
through the lumen; inserting a second item through the aperture and
into the lumen; and advancing the second item through the lumen and
out through the lateral opening at the same angle relative to the
introducer to place the item at a location eccentric from the first
site.
21. The method of claim 20 wherein the second site is located in a
plane defined by the first site and the introducer.
22. A method for treating a lesion inside a patient's body,
comprising: providing an access guide introducer, the introducer
having a cannula having a first end and a second end and defining a
lumen therebetween the lumen opening at an aperture at the second
end, a tip disposed at the first end of the cannula and closing the
lumen at the first end, and the cannula defining a lateral opening
in communication with the lumen, inserting the introducer into the
patient near the lesion; manipulating the introducer to place the
lateral opening adjacent the lesion; and advancing an ablating
chemical composition through the lumen and out through the lateral
opening to contact the lesion with the composition.
23. A method for diagnosing and treating a lesion inside a
patient's body, comprising: providing an access guide introducer,
the introducer having a cannula having a first end and a second end
and defining a lumen therebetween, the lumen opening at an aperture
at the second end, a tip disposed at the first end of the cannula
and closing the lumen at the first end, and the cannula defining a
lateral opening in communication with the lumen; inserting the
introducer into the patient near the lesion; manipulating the
introducer to place the lateral opening adjacent the lesion;
inserting a biopsy needle having an anatomically proximal end and a
distal end through the aperture and into the lumen; advancing the
biopsy needle through the lumen so that the proximal end of the
biopsy needle projects through the lateral opening at an angle
relative to the introducer and into a first lesion site to obtain a
first biopsy sample; withdrawing the proximal end of the biopsy
needle from the first site and into the lumen of the introducer;
and advancing an ablating chemical composition through the lumen
and out through the lateral opening to contact the lesion with the
composition.
24. The method of claim 23 further comprising: rotating the
introducer with the proximal end of the biopsy needle contained
within the lumen and further advancing the biopsy device to eject
the proximal end of the biopsy needle from the lumen through the
lateral opening at the same angle relative to the introducer to a
second lesion site to obtain a second sample from a location
eccentric from the first site; and withdrawing the proximal end of
the biopsy needle from the second site into the lumen of the
introducer.
25. The method of claim 24, further comprising: withdrawing the
biopsy needle from the lumen; providing a second biopsy needle
having a bend adjacent an anatomically proximal end of the needle,
the bend deflecting the proximal end of the second needle at an
angle away from a longitudinal axis of the second needle; inserting
the second needle through the aperture and into the lumen;
advancing the second needle so that the proximal end projects
through the lateral opening at a different angle relative to the
introducer to obtain a second sample.
26. A biopsy needle introducer, comprising: a cannula having a
first end and a second end and defining a lumen therebetween, the
lumen sized to receive a biopsy needle therethrough; the second end
of the cannula defining an aperture, the aperture sized and
configured to receive a biopsy needle for passage into the lumen;
said cannula defining a lateral opening in communication with the
lumen adjacent said first end, the lateral opening sized and
configured to allow exit of an anatomically proximal end of the
biopsy needle from the lumen; and a solid tip having an
anatomically distal end secured to the first end of said cannula
and a proximal end configured to pierce tissue.
27. The biopsy needle introducer of claim 26 wherein the distal end
of the tip is sloped to form a ramp adjacent and inclined toward
the lateral opening, whereby a biopsy needle will be deflected
through the lateral opening as it exits the cannula.
28. The biopsy needle introducer of claim 27 wherein the distal end
of the tip blocks a portion of the lateral opening.
29. The biopsy needle introducer of claim 27 wherein the distal end
of said tip has an outer diameter smaller than an inner diameter of
the first end of the cannula and the distal end of said tip is at
least partially disposed within said lumen at the first end of the
cannula.
30. The biopsy needle introducer of claim 29 wherein the tip is
secured to the cannula by an interference fit.
31. The biopsy needle introducer of claim 30, wherein said said
cannula is crimped onto said solid tip.
32. The biopsy needle introducer of claim 29 wherein the tip is
secured to the cannula by welding.
33. The biopsy needle device of claim 29 wherein the tip is secured
to the cannula with an adhesive.
34. The biopsy needle introducer of claim 27, further comprising:
an introducer stylet sized to be received within the lumen, the
introducer stylet having a length sufficient to block the lateral
opening when the introducer stylet is received within the
lumen.
35. The biopsy needle introducer of claim 34, wherein the
introducer stylet has an angled end configured to mate with the
ramp when the introducer stylet is received in the cannula.
36. The biopsy needle introducer of claim 26, further comprising a
hub attached to the second end of the cannula, said hub defining a
channel having a first end and a second end, the first end in
communication with the aperture for delivering a biopsy needle to
the lumen.
37. The introducer of claim 36 wherein said hub is funnel shaped,
the first end of the channel having an interior radius that is
smaller than an interior radius of the second end of the channel,
the channel tapering from the second end of the channel to the
first end of the channel to guide a biopsy needle from the hub to
the lumen.
38. A biopsy device, comprising: an introducer including a cannula
having a first end and a second end and defining a lumen
therebetween, a tip disposed at the first end of the cannula and
closing the lumen, the cannula defining an aperture at the second
end of the cannula, the aperture sized and configured to receive a
biopsy needle, and said cannula defining a lateral opening in
communication with the lumen adjacent said first end, the lateral
opening sized and configured to allow exit of a biopsy needle from
the lumen; and a hollow biopsy needle having an anatomically
proximal end and a distal end, said needle sized and configured to
be movably and rotatably received within the lumen, the proximal
end sized and configured to exit from said lumen through the
lateral opening and having an edge to pierce tissue to obtain a
biopsy sample when the biopsy needle is advanced into the
tissue.
39. The biopsy device of claim 38, further comprising a ramp
disposed within said cannula at an end of the lateral opening
adjacent the first end of the cannula, said ramp being inclined
toward the lateral opening, whereby said biopsy needle will be
deflected through the lateral opening as it advances within the
lumen and exits the cannula.
40. The biopsy device of claim 39, further comprising a hub
attached to said second end, said hub defining a channel having a
first end and a second end, the first end in communication with the
aperture for delivering a biopsy needle to the lumen.
41. The biopsy device of claim 40 wherein said hub is funnel
shaped, the first end of the channel having an interior radius that
is smaller than an interior radius of the second end of the
channel, the channel tapering from the second end of the channel to
the first end of the channel to guide a biopsy needle from the hub
to the lumen.
42. The biopsy device of claim 39, further comprising an introducer
stylet sized to be received within the lumen, the introducer stylet
having a length sufficient to block the lateral opening when the
introducer stylet is received within the lumen.
43. The biopsy device of claim 42, wherein said introducer stylet
has an angled end configured to mate with said ramp when said
introducer stylet is received in the cannula.
44. The biopsy device of claim 39 wherein said needle includes a
bend adjacent the proximal end of said needle, the bend deflecting
the proximal end of said needle at an angle away from a
longitudinal axis of said needle when said bend extends outside
said cannula.
45. The biopsy device of claim 39, further comprising a biopsy
needle stylet sized and configured to be received within said
biopsy needle.
46. The biopsy device of claim 45 wherein the biopsy needle stylet
has a penetrating point that extends from the proximal end of the
biopsy needle when the biopsy stylet is inserted into said biopsy
needle.
47. The biopsy device of claim 46 wherein the penetrating point is
rounded.
48. The biopsy device of claim 46 wherein the penetrating point has
a trocar geometry.
49. A biopsy needle introducer, comprising: a cannula having a
first end and a second end and defining a lumen therebetween, the
lumen sized to receive a biopsy needle therethrough; the second end
of the cannula defining an aperture, the aperture sized and
configured to receive a biopsy needle; a hub attached to the second
end of the cannula, said hub including a gripping portion
configured to be held when inserting and positioning the
introducer, said hub defining a channel having a first end and a
second end, the first end of the channel in communication with the
aperture for delivering a biopsy needle to the cannula; and a
flange projecting from said hub at a location anatomically distal
from the gripping portion, said flange configured to prevent
inadvertent needle sticks when a biopsy needle is inserted into the
introducer.
50. The introducer of claim 49 wherein said hub is funnel shaped,
the first end of the channel having an interior radius that is
smaller than an interior radius of the second end of the channel,
the channel tapering from the second end of the channel to the
first end of the channel to guide a biopsy needle from the hub to
the lumen.
51. The biopsy needle of claim 49 further comprising a plurality of
depth markings located in spaced relation on said cannula.
52. The biopsy needle of claim 51 wherein said markings are
radiographic.
53. The introducer of claim 49, further comprising: a closed tip
disposed at the first end of the cannula; and said cannula defining
a lateral opening in communication with the lumen, the lateral
opening sized and configured to allow exit of an anatomically
proximal end of the biopsy needle from the lumen.
54. The biopsy needle introducer of claim 53, further comprising a
ramp disposed within said cannula at an end of the lateral opening
adjacent said first end of said cannula, the ramp being inclined
toward the lateral opening, whereby a biopsy needle will be
deflected through the lateral opening as it exits the cannula.
55. The introducer of claim 54 wherein said hub is funnel shaped,
the first end of the channel having an interior radius that is
smaller than an interior radius of the second end of the channel,
the channel tapering from the second end of the channel to the
first end of the channel to guide a biopsy needle from the hub to
the lumen.
56. The biopsy needle of claim 55 further comprising a plurality of
depth markings located in spaced relation on said cannula.
57. The biopsy needle of claim 56 wherein said markings are
radiographic.
58. A method of obtaining a biopsy sample, comprising: providing a
biopsy introducer, said introducer having a cannula having a first
end and a second end and defining a lumen therebetween; a tip
disposed at the first end of the cannula and closing the lumen at
the first end; the lumen having an aperture at the second end of
the cannula, the aperture sized and configured to receive a biopsy
needle; the cannula defining a lateral opening in communication
with the lumen, the lateral opening-sized and configured to allow
exit of a biopsy needle from the lumen; and a ramp disposed within
said cannula at an end of the lateral opening adjacent the first
end of the cannula, the ramp being inclined toward the lateral
opening, whereby a biopsy needle will be deflected through the
lateral opening as it exits the cannula; inserting the introducer
into the patient at the biopsy site; inserting a biopsy needle
having an anatomically proximal end and a distal end through the
aperture and into the lumen; advancing the biopsy needle through
the lumen so that the proximal end of the biopsy needle projects
through the lateral opening at an angle relative to the introducer
and into a first biopsy sample site to obtain a first biopsy
sample; and withdrawing the proximal end of the biopsy needle from
the first biopsy sample site and into the lumen of the
introducer.
59. The method of claim 58 further comprising performing an imaging
study to determine an appropriate needle path to the biopsy sample
site.
60. The method of claim 58, further comprising: inserting an
introducer stylet into the cannula before inserting the introducer
into the patient, the introducer stylet sized to be received within
the lumen, the introducer stylet having a length such that it will
block the lateral opening when the introducer stylet is received
within the lumen to prevent tissue from entering the lateral
opening when the cannula is introduced into the patient; and
removing the introducer stylet before inserting the biopsy needle
into the introducer.
61. The method of claim 58 further comprising: applying suction to
the biopsy needle to draw a first biopsy sample into the biopsy
needle before withdrawing the biopsy needle from the first sample
site.
62. The method of claim 61 further comprising reciprocating the
biopsy needle within the lumen while applying suction.
63. The method of claim 61 further comprising: inserting a biopsy
needle stylet into the biopsy needle before inserting the biopsy
needle into the lumen; and removing the biopsy needle stylet before
applying suction to the biopsy needle.
64. The method of claim 58, further comprising: removing the biopsy
needle from the introducer after withdrawing the biopsy needle from
the biopsy site; clearing the sample from the biopsy needle;
rotating the introducer; reinserting the biopsy needle through the
aperture and into the lumen after clearing the sample; further
advancing the biopsy device to eject the proximal end of the biopsy
needle from the lumen through the lateral opening at the same angle
relative to the introducer to obtain a second biopsy sample from a
location eccentric from the first biopsy sample; and withdrawing
the proximal end of the biopsy needle from the biopsy sample site
into the lumen of the introducer.
65. The method of claim 58, further comprising: rotating the
introducer with the proximal end of the biopsy needle contained
within the lumen and further advancing the biopsy device to eject
the proximal end of the biopsy needle from the lumen through the
lateral opening at the same angle relative to the introducer to
obtain a second biopsy sample from a location eccentric from the
first biopsy sample; and withdrawing the proximal end of the biopsy
needle from the biopsy sample site into the lumen of the
introducer.
66. The method of claim 58, further comprising: withdrawing the
biopsy needle from the lumen; providing a second biopsy needle
having a bend adjacent an anatomically proximal end of the needle,
the bend deflecting the proximal end of the second needle at an
angle away from a longitudinal axis of the second needle; inserting
the second needle through the aperture and into the lumen;
advancing the second needle so that the proximal end projects
through the lateral opening at a different angle relative to the
introducer to obtain a second biopsy sample.
67. The method of claim 66 wherein the second biopsy sample site is
located in a plane defined by the first biopsy sample site and the
introducer.
68. A method of making a biopsy device, comprising: providing a
hollow cannula defining a lumen sized to receive a biopsy needle
and a lateral opening at a first end of the cannula, the lateral
opening in communication with the lumen, the lateral opening sized
and configured to allow exit of an anatomically proximal end of the
biopsy needle from the lumen; attaching a hub to the second end of
the cannula, the hub defining a channel in communication with the
lumen; and securing an anatomically distal end of a solid tip to
the first end of the cannula, the tip having a proximal end
configured to pierce tissue, the distal end of the tip being sloped
to form a ramp adjacent to and inclined proximally toward said
lateral opening, whereby a biopsy needle will be deflected as it
advances through the lumen and exits the cannula through the
lateral opening.
69. The method of claim 68 wherein the distal end of the tip has an
outer diameter smaller than an inner diameter of the first end of
the cannula and the securing includes inserting the distal end of
said tip into the first end of the cannula.
70. The method of claim 69 wherein the securing includes employing
an interference fit.
71. The method of claim 69 wherein the securing includes
welding.
72. The method of claim 69 wherein the securing includes applying
an adhesive.
Description
FIELD OF THE INVENTION
[0001] The present invention broadly concerns surgical and
pharmaceutical delivery systems. More specifically, the invention
concerns biopsy devices which provide safe and efficient coaxial,
cofocal and eccentric sampling or delivery with only a single guide
device placement.
BACKGROUND OF THE INVENTION
[0002] In the practice of diagnostic medicine, it is often
necessary or desirable to perform a biopsy, or to sample selected
tissue from a living patient for medical evaluation. Cytological
and histological studies of the biopsy sample can then be performed
as an aid to the diagnosis and treatment of disease. Biopsies can
be useful in diagnosing and treating various forms of cancer, as
well as other diseases in which a localized area of affected tissue
can be identified.
[0003] During the biopsy procedure, care is taken to minimize the
physical trauma inflicted upon the intervening tissues that
surround the affected area or target tissue and at the same time to
protect the practitioner from health hazards. One typical biopsy
procedure includes inserting a hollow biopsy needle through the
intervening tissue into the target tissue to be sampled. The sample
tissue is then harvested through the needle by applying suction
through the needle, typically with a syringe.
[0004] Other more complicated devices have been developed in an
attempt to improve biopsy procedures and results. Three references,
U.S. Pat. Nos. 5,301,684 to Ogirala; 5,425,376 to Banys et al.; and
5,224,488 to Neuffer disclose biopsy devices employing lateral
openings. The Ogirala reference shows a cutting edge on a spring
operated flap over the lateral opening. The Neuffer device includes
a twisted flexible cutting strip contained within the needle.
Turning a handle flexes the strip through the lateral opening. The
surgeon then rotates the device to cut a sample and guide it into
the needle. The Banys patent discloses a biopsy needle attached to
a syringe having a cannula which is slidable over the needle to
alternately expose or cover the lateral opening. Both the cannula
and the lateral opening provide a tissue cutting edge. Using the
Banys device, the surgeon is required to maneuver the needle so
that the sample is placed within the needle and the slide the
cannula to cover the lateral opening and trap the sample within the
needle.
[0005] Another reference of interest, U.S. Pat. No. 3,001,522 to
Silverman, discloses a biopsy device having a pair of resilient
arms which extend from the end of the device. The arms are disposed
at an angle away from the axis of the device and are oppositely
beveled to urge the arms apart as they are inserted into tissue.
The Silverman device does not include a side port or a ramp for
exit of a biopsy needle from an introducer device.
[0006] The prior art biopsy procedures and devices suffer from
several disadvantages. First, they do not adequately address the
need for multiple samplings. It is often desirable to sample the
tissue surrounding a lesion in addition to the lesion itself. Also,
needle aspiration biopsies are prone to sampling errors, which
necessitate reinsertions of the biopsy needle. Furthermore, none of
the known prior devices accommodate the need to reach behind vital
organs and structures because they require a straight path to the
target. Current systems require multiple device insertions to
sample tissue eccentric to the initial needle placement.
Unfortunately, multiple insertions of the biopsy device increase
patient discomfort, surgical time and the risk of
complications.
[0007] Another important consideration in biopsy needle design is
that the amount of tissue harvested be sufficient for the types of
analysis to be done. Although major improvements have been made in
the sensitivity of test procedures and apparatus so that smaller
samples have become sufficient for each test, the number of
different test procedures and the importance of having the
capability for redundant or confirming testing still necessitates
having a suitable sample size. However, the size of the tissue
sample is limited by the size of the opening in the sampling end of
known biopsy needles. Where the size of the tissue collected is
inadequate, multiple device insertions will be required. This is
often complicated by the difficulty in returning to the exact
location required as well as the increased trauma to the
patient.
[0008] Current systems are also limited in that they cause
unnecessary trauma to the patient. For example, lesions located
behind important vascular structures are difficult to reach without
causing damage. Also, pushing a hollow needle through intervening
tissues to the target area results in the accumulation of unwanted
tissue in the needle, which can interfere with or complicate sample
analysis. Finally, the open end of a biopsy needle or the
projecting edge of a cutting cannula can tear the surrounding
tissue unnecessarily, increasing trauma to the patient.
[0009] Current systems which attempt to address some of these
concerns are generally complicated spring-operated or
multi-component devices. Furthermore, these devices require
multiple insertions for sampling eccentric to the initial device
placement. Accordingly, a need has remained for biopsy devices
which compensate for sampling errors and accommodate the need for
safely and efficiently obtaining multiple samples with a single
device placement.
[0010] Once pathology is diagnosed, the site must be accessed for
treatment. Conventionally, malignancies are treated indirectly by
chemotherapy and/or radiation or directly by removal of the lesion.
Each of these approaches has limitations and undesirable side
effects. Surgery carries risks of infections and adverse anesthesia
effects and does not always improve the outcome. Surgery may not be
an option due to patient condition or the location and size of the
tumor. Furthermore, some studies have suggested that surgery may be
associated with the spread of some cancers. Chemotherapy and
radiotherapy affect both normal and malignant dividing cells,
leading to, for example, hair loss, nausea and decreases in all
blood cell types. In spite of the emotional and physical costs
paid, conventional treatments do not always increase length of
survival or quality of life of patients.
[0011] Percutaneous procedures are now favored for their reduced
risks and trauma. Ideally, conditions would be treated locally
through a single port instead of systematically. Such treatments
would be more precise as well as less traumatic and invasive.
Various conditions have been treated percutaneously with some
success using such methods as mechanical, chemical and
radio-ablation. One limitation of these known procedures is the
accuracy of needle placement.
[0012] Transperineal radioactive seed implantation shows great
promise for treating prostate cancer (Grimm et al., New Techs in
Pros. Surg. 2:113-126, 1994). This percutaneous, outpatient
treatment provides more precise and effective dosing than open
approaches with lower morbidity than external beam radiation. While
this procedure represents a major advance in treating prostate
cancer, improvements are still needed in obtaining reproducible and
accurate needle placements. The methods involve multiple needle
placements and removal. A depth reference point must be calculated
by measuring the distance from the hub of the needle for each
placement. It is important that the needle and seed placement be
precise. Needle placements of more than 1-2 mm off the targeted
coordinate must be repositioned. Needle placements which are
otherwise on target must be repositioned if the needle insertion
causes lateral rotation of the prostate. This procedure also
requires at least two surgeons for manipulation of the needles and
stylets to prevent improper deboarding of the pellets.
[0013] Percutaneous fine-needle alcohol ablation has also been used
with some success in the treatment of tumors. Karstrup et al. (AJR:
154: 1087-1090, 1990) disclose ablation of parathyroid tumors under
ultrasonographic guidance. Precise needle placement is essential
due to the important neurological and vascular structures in the
area. The authors recommend small amounts of alcohol and precise
placement of the needle tip to avoid nerve damage.
[0014] Accordingly, there is a need for less invasive and traumatic
and yet more precise and localized treatments of lesions.
SUMMARY OF THE INVENTION
[0015] Briefly describing one aspect of the invention, there is
provided a surgical and pharmaceutical site access guide device
which allows coaxial, cofocal and eccentric sampling and delivery
with a single device placement. The invention includes an
introducer device that includes a cannula having a first end and a
second end and defining a lumen. The second end of the cannula
defines an aperture. The cannula defines a lateral opening in
communication with the lumen adjacent the first end.
[0016] The introducer devices also include a solid tip having an
anatomically distal end secured to the first end of the cannula and
a proximal end configured to pierce tissue. In one aspect of the
invention, a ramp is disposed within the cannula at an end of the
lateral opening adjacent the first end of the cannula. The ramp is
inclined toward the lateral opening whereby the items will be
deflected through the lateral opening as they are advance within
the lumen and exit the cannula.
[0017] In one specific aspect of the invention an introducer also
includes a hub attached to the second end of the cannula which
includes a gripping portion configured to be held when inserting
and positioning the introducer. The hub defines a channel which is
in communication with the aperture.
[0018] In one aspect of the invention, the introducer includes
means for protecting the practitioner from inadvertent needle
sticks. In a specific embodiment of the invention, the means
includes a flange that projects from the hub at a location
anatomically distal from the gripping portion. The flange is
configured to prevent inadvertent needle sticks when a biopsy
needle is inserted into the introducer.
[0019] In one specific embodiment, a biopsy needle having a bend
adjacent an anatomically proximal end of the needle is provided.
The bend deflects the proximal end of the needle at an angle away
from the longitudinal axis of the needle.
[0020] The invention also includes methods for obtaining a biopsy
sample and methods of making a guide device. According to
procedures for obtaining a biopsy sample of this invention, a
biopsy needle introducer of this invention is inserted into a
patient at the biopsy site. The biopsy needle is then inserted into
the lumen of the introducer and advanced until the proximal end of
the biopsy needle projects through the lateral opening at an angle
relative to the introducer and into the biopsy sample site.
[0021] In one aspect of the invention, the biopsy needle is
withdrawn from the sample site and the introducer rotated. The
biopsy needle is then reinserted into the introducer and advanced
to obtain a second biopsy sample from a location eccentric from the
first biopsy sample site.
[0022] In another aspect of the invention, the introducer is
rotated with the proximal end of the biopsy needle contained within
the lumen. The biopsy needle is then readvanced to eject the
proximal end of the biopsy needle from the lumen to obtain a second
biopsy sample site from a location eccentric from the first biopsy
sample site.
[0023] The invention also provides methods of making guide devices.
According to the methods of this invention, a hollow cannula
defining a lateral opening in communication with the lumen is
provided, a hub is attached to an end of the cannula and the solid
tip is secured to the cannula. In one aspect of the invention, the
securing step includes inserting an end of the tip into the first
end of the cannula, crimping the cannula onto the tip for temporary
fixation and then welding the tip to the cannula.
[0024] In still another embodiment, systems are provided for
diagnosing and treating a lesion inside a body. The systems include
guide devices in combination with biopsy needles, localization
wires, visualization wires, ablation means and pharmaceuticals.
Advantageously, a lesion can be biopsied and treated through a
single placement of the guide device. Multiple locations of a
lesion can be biopsied and treated through a single device
placement.
[0025] The invention also includes methods for delivering
therapeutic items to a pathological site inside a patient's body.
The methods include inserting an introducer guide of this invention
into the patient near the site and manipulating the cannula to
position the lateral opening adjacent the site. A pharmaceutical
agent such as an ablation composition can then be advanced through
the lumen of the cannula to the site.
[0026] Accordingly, it is an object of the invention to provide a
surgical and pharmaceutical site access guide device which allows
coaxial, cofocal and eccentric sampling and/or delivery to the site
with a single device placement. One advantage of the present
invention is that it compensates for placement errors without
requiring multiple device placements. Another advantage of this
invention is that it accommodates the need for obtaining multiple
samples/deliveries around a lesion or target tissue without
requiring multiple device placements.
[0027] Another object of the invention is to provide improved
devices having safety features. The present invention provides
means for protecting practitioners from inadvertent needle sticks.
The designs of this invention also decrease the trauma to the
patient.
[0028] Finally, it is an additional object of this invention to
provide tools for percutaneous procedures which are cost effective
to make and relatively easy to use. The present invention provides
simpler, more efficient operation which may decrease surgical time
and increase accuracy. This invention provides elegant constructs
which are less likely to malfunction than the more complicated
spring operated and/or multi-component devices found in the prior
art.
[0029] These and other objects, advantages and features are
accomplished according to the devices and methods of the following
description of the preferred embodiment of the present
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 is a side elevational view of a biopsy assembly
according to this invention.
[0031] FIG. 2 is a side view of the needle introducer shown in FIG.
1 with a partial longitudinal section of the proximal end of the
introducer.
[0032] FIG. 3 is an enlarged side cross-sectional view of the
needle introducer shown in FIG. 2.
[0033] FIG. 4 is an enlarged side cross-sectional view of the
biopsy assembly shown in FIG. 1.
[0034] FIG. 5 is an enlarged top cross-sectional view of the
proximal end of the needle introducer shown in FIG. 2.
[0035] FIG. 6 is an end cross-sectional view of the introducer
shown in FIG. 2 taken along lines 6-6.
[0036] FIG. 7 is a side elevational view of the biopsy assembly
shown in FIG. 1 with a biopsy needle stylet in place.
[0037] FIG. 8 is a side elevational view of the introducer of FIG.
2 having an introducer stylet in place.
[0038] FIG. 9 is an enlarged side cross-sectional view of the
proximal end of the needle introducer shown in FIG. 2 with an
introducer stylet in place.
[0039] FIG. 10 is an enlarged side cross-sectional view of the
proximal end of a biopsy assembly incorporating a biopsy needle
having a bend.
[0040] FIG. 11 is a side view of an introducer guide of this
invention.
[0041] FIG. 12 is an enlarged side longitudinal view of the
introducer shown in FIG. 11.
[0042] FIG. 13 is an enlarged longitudinal view of the introducer
of FIG. 11 loaded with pharmaceutical pellets.
[0043] FIG. 14 is a side elevational view of the introducer of FIG.
11 loaded with a mechanical ablation needle.
[0044] FIG. 15 is a side elevational view of the introducer of FIG.
11 loaded with a chemical ablation needle.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0045] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated devices, and such further applications of the
principles of the invention as illustrated therein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
[0046] The present invention provides surgical and pharmaceutical
site access guide devices and methods for accessing locations
within the body. This invention is advantageous anytime it is
beneficial to change the direction or location of a device
placement such as for biopsy, breast mass needle localization wire
placement, ablation or radioactive seed placement. The present
invention provides many benefits such as extremely precise tissue
sampling and improved safety features. This invention compensates
for sampling and placement errors and accommodates the need for
obtaining multiple samples without multiple device placements by
converting peri-target placement into successful placement without
repositioning the device. Devices according to this invention also
allow the practitioner to safely reach behind important vascular
structures to obtain samples from target tissue or lesions. The
invention also protects the tissue surrounding the lesion from
unnecessary trauma. Furthermore, the present invention also
provides features which protect the practitioner from inadvertent
needle sticks.
[0047] This invention also answers the need for improved devices
and methods for percutaneous treatments. In one aspect, the
invention provides guide devices for locally treating a lesion
within the body of a patient. The guide devices provide less
traumatic and minimally invasive yet highly accurate placement of
therapeutic agents at a lesion. In another embodiment, methods are
provided for accessing, diagnosing and treating a lesion with a
single guide placement. These methods significantly reduce trauma,
risk and patient inconvenience.
[0048] A biopsy device assembly 10 in accordance with one preferred
embodiment of the present invention is depicted in FIG. 1.
Generally, the biopsy assembly 10 includes a biopsy needle 11 and
an introducer 15 which is more clearly shown in FIG. 2. The
introducer 15 includes a cannula 20 having a first end 21 and a
second end 22. The cannula 20 defines a lumen 25 which extends
between the first end 21 and the second end 22 of the cannula 20 as
shown more clearly in FIG. 3. A tip 30 which closes the lumen 25 is
disposed at the first end 21 of the cannula 20. The cannula 20
defines an aperture 23 at the second end 22 of the cannula 20. The
aperture 23 is in communication with the lumen 25 and is sized and
configured to receive a biopsy needle 11 for passage into the
lumen.
[0049] The cannula 20 also defines a lateral opening 24 which is in
communication with the lumen 25. The lateral opening 24 is
preferably adjacent the first end 21 of the cannula 20. The lateral
opening 24 is sized and configured to allow exit of a biopsy needle
from the cannula as it is advanced through the lumen 25.
[0050] The lateral opening 24 allows the practitioner to sample
multiple areas within a sampling zone defined around the introducer
15. The introducer 15 can be rotated so that the lateral opening 24
will be exposed to different areas within the sampling zone, so
that a biopsy needle 11 can be directed into these different areas.
In this way, a single placement of the biopsy device, or
introducer, provides cofocal and eccentric sampling as well as
coaxial sampling. Typical biopsy needles allow coaxial sampling by
varying the depth of the needle placement but require additional
device placements for cofocal or eccentric sampling. This
invention, on the other hand, allows the practitioner to return to
the precise location within the target tissue with a second biopsy
needle by leaving the introducer in place.
[0051] As shown in FIGS. 3-5, the introducer 15 preferably includes
a ramp 35 disposed within the cannula 20 at an end 36 of the
lateral opening 24 adjacent the first end 21 of the cannula 20. The
ramp 35 is inclined toward the lateral opening 24. In the operation
of the biopsy assembly 10, a biopsy needle 11 will be deflected
through the lateral opening 24 as it is advanced through the lumen
25 and exits the cannula 20. The ramp 35 provides controlled exit
of the biopsy needle 11. The slope of the ramp may be altered to
obtain a desired angle of deflection of the needle 11 as it exits
the lateral opening 24.
[0052] In a preferred embodiment, the solid tip 30 is preferably a
separate component which is secured to the first end 21 of the
cannula 20 as shown in FIGS. 2-5. The anatomically distal end 31 of
the tip 30 can be secured to the cannula 20 using any suitable
means. The tip 30 includes a shaft 33 extending between the distal
end 31 and the proximal end 32. The tip 30 also includes an
anatomically proximal end 32 which is configured to pierce tissue.
The proximal end 32 preferably extends beyond the first end 21 of
the cannula 20. The solid tip 30 can be provided in any length
which suits the particular application. Varying the length of the
solid tip varies the distance from the proximal end 32 to the
lateral opening 24 and from the proximal end 32 of the tip 30 to
the proximal end 12 of the needle 11.
[0053] It is contemplated that the proximal end 32 has a
configuration that is suited for the particular tissue to be
sampled. For example, the tip may be beveled. In one embodiment,
the tip has a trocar geometry. The multiple bevels of the trocar
tip are useful in combination with a higher gage cannula for use in
denser tissue. In one specific embodiment, a trocar tip is used
with an 18 gage cannula. A single bevel is useful in combination
with a thinner gage cannula for applications which require steering
or for use in less dense tissue. For example, sampling lymph node
tissue generally requires a smaller gage cannula, and consequently
is better served by a single bevel tip.
[0054] Turning back to the distal end 31 of the tip 30, this end is
preferably sloped to form the ramp 35. In a specific embodiment, as
shown more clearly in FIG. 3, a portion 34 of the shaft 33 extends
slightly into the lateral opening 24. This provides a smooth exit
of the biopsy needle 11 through the lateral opening 24 and prevents
catching of the needle 11 on the cannula 20 near edge of the
lateral opening 24.
[0055] Preferably, the distal end 31 of the tip 30 has an outer
diameter D.sub.t which is smaller than an inner diameter D.sub.c of
the first end 21 of the cannula 20. The distal end 31 of the tip 30
is then at least partially disposed within the lumen 25 at the
first end of the cannula 20. The tip 30 can be secured to the
cannula 20 by an interference fit. Preferably, the cannula 20 is
crimped onto the solid tip 30 to hold the tip in the desired
position within the cannula while the tip is laser welded to the
cannula. It is contemplated that the cannula 20 can also be secured
to the tip 30 by any other suitable means including an
adhesive.
[0056] In a preferred embodiment, the invention includes a hub 40
attached to the second end 22 of the cannula 20 as depicted in FIG.
2. Referring also to FIG. 6, hub 40 defines a channel 45 for
delivering a biopsy needle to the cannula 20. The channel 45
includes a first end 46 and a second end 47. The first end 46 of
the channel 45 surrounds the second end 22 of the cannula 20 and is
in communication with the aperture 23. The channel 45 of the hub 40
is preferably funnel shaped as shown in FIGS. 2 and 6. The first
end 46 of the channel 45 has an interior radius R.sub.i that is
smaller than the interior radius R.sub.2 of the second end 47 of
the channel 45. The channel 45 tapers from the second end 47 of the
channel 45 to the first end 46 of the channel 45 to guide a biopsy
needle from the hub 40 to the lumen 25 of the cannula 20.
[0057] The hub 40 also preferably includes a fitting end 43
adjacent the second end of the channel. The fitting end 43 is
configured for engagement with a stylet or a syringe. It is
contemplated that the fitting end 43 will be of any suitable
configuration including, but not limited to, a Luer.RTM.
fitting.
[0058] The hub 40 preferably includes a gripping portion 41 as
shown in FIG. 2. The gripping portion 41 is configured to be held
by the practitioner during insertion and positioning of the
introducer 19. In one embodiment, the gripping portion 41 of the
hub 40 includes a flattened portion 42 which provides the
practitioner with a more stable grip on the hub 40 as depicted in
FIG. 7. The flattened portion 42 also provides a tactile reference
point for the location of the lateral opening 24. Preferably the
flattened portion 42 is oriented on the same side of the cannula 20
as the lateral opening 24; however, any orientation is contemplated
as long as it indicates the relative position of the lateral
opening 24.
[0059] Referring again to FIG. 1, the cannula 20 of the introducer
19 preferably includes a plurality of depth markings 27 located in
spaced relation along the cannula 20. These markings are preferably
arranged in groups of five to give a ready visual indication of the
depth of insertion of the cannula 20. Where the cannula 20 is
composed of titanium, at least some of the depth markings 27 are
preferably radiographic.
[0060] The present invention provides means for protecting the
practitioner from health risks. In one preferred embodiment, the
introducer 15 includes a flange 50 projecting from the hub 40 at a
location anatomically distal from the gripping portion 41. The
flange 50 is configured to prevent inadvertent needle sticks when
the practitioner is holding the hub 40 during insertion of a biopsy
needle into the introducer. This is particularly valuable when a
biopsy needle is reinserted into the introducer. In light of the
attention given to blood borne diseases in recent years, the need
for such features is self evident. Any size or shape flange is
contemplated which will protect the practitioner's fingers from
needle sticks. Preferably, the flange is circular and extends from
the hub at least 15 mm. Most preferably, the circular flange
includes a flattened portion which prevents rolling of the device
when it is placed on a flat surface. Alternatively, the flange can
be hexagonal or octagonal providing many flat sides.
[0061] Referring now to FIGS. 8 and 9, the invention contemplates
an introducer stylet 55 which includes a shaft 57 and a grip 60.
The shaft 57 is sized to be received within the lumen 25.
Preferably, the introducer stylet 55 has a length sufficient to
block the lateral opening 24 when the introducer stylet 55 is
received within the lumen 25. Most preferably, the introducer
stylet 55 has an angled end 58 which is configured to mate with the
ramp 35 when the introducer stylet 55 is received within the
cannula 20. Blocking the lateral opening 24 is important to reduce
trauma to the surrounding tissue and preserve the integrity of the
sample by preventing tissue from entering the lateral opening 24 as
the introducer is guided into the patient. Trauma can be further
reduced by providing an atraumatic feature, such as bevel 58', to
the end 58 of the stylet 55. The introducer stylet 55 also provides
stiffness to the introducer cannula 20 to facilitate insertion.
[0062] The biopsy assembly 10 shown in FIG. 1 includes a hollow
biopsy needle 11 having an anatomically proximal end 12 and a
distal end (not shown). The biopsy needle 11 is sized and
configured to be movably, rotatably and coaxially received within
the lumen 25. The proximal end 12 of the biopsy needle 11 is sized
and configured to exit from the lumen 25 through the lateral
opening 24 as shown in FIG. 4. The biopsy needle 11 preferably
includes an edge 13 which is configured to pierce tissue to obtain
a biopsy sample when the biopsy needle 11 is advanced into
tissue.
[0063] Any suitable biopsy needle is contemplated. Standard hollow
biopsy needles are preferred, such as the Mengehni type. The
proximal end 12 of biopsy needle 11 includes an edge or tip that
may be of any suitable configuration. As shown in FIG. 4 the edge
14 may be blunt. As shown in FIG. 10, the edge 14 may be beveled.
The biopsy needle may further include a needle hub which may
include a channel 18 which is preferably funnel shaped as described
above for the introducer hub 40. The biopsy needle hub 19 may also
include a flattened portion 19A which provides a gripping and
reference function as described above.
[0064] In one embodiment the biopsy needle 11 includes a bend 16
adjacent the proximal end 12 of the needle 11 as shown in FIG. 10.
The bend 16 deflects the proximal end 12 of the needle 11 at an
angle .alpha. away from a longitudinal axis 11 of the needle 11
when the bend 17 extends outside the cannula 20. The bend 16
increases the diameter of the sampling zone of the tissue. Multiple
samples in a single plane can also be obtained by providing needles
having bends of varying angles and curves. The angle .alpha. is
preferably between 5.degree. and 30.degree.. The most preferred
angle .alpha. being about 15.degree.. Where the needle 11 is bent,
the ramp 35 may include a concavely curved surface to facilitate
smooth exit of the needle 11 through the lateral opening 24.
[0065] As shown in FIG. 7, the invention also contemplates a biopsy
needle stylet 70. The biopsy stylet 70 facilitates guiding the
biopsy needle 11 through the lateral opening 24. The biopsy needle
stylet 70 includes a handle 71 and a shaft 75. The handle 71 may
include a locking nub 72 which mates with a notch (not shown) on
the biopsy needle hub 17 for locking the biopsy stylet into place.
The shaft 75 of the biopsy stylet 70 is sized and configured to be
received within the biopsy needle 11. Preferably, the biopsy needle
stylet 70 has a penetrating point 76 that extends away from the
proximal end of the biopsy needle 11 when the biopsy needle stylet
70 is inserted into the biopsy needle 11. The penetrating point 76
aids collection of the sample by piercing the tissue before the
tissue is collected within the needle 11. Any suitably shaped
penetrating point is contemplated. For example, penetrating point
76 may be rounded or may have a trocar geometry.
[0066] Methods of obtaining a biopsy sample are also contemplated
by the present invention. Preferably, the methods of this invention
are practiced in combination with an imaging study to determine the
appropriate needle path to the biopsy sample site. The methods
include providing a biopsy introducer of the present invention and
inserting the biopsy introducer into the patient at the biopsy
sample site using standard surgical procedures. Preferably, the
methods of this invention also include inserting an introducer
assembly which includes an introducer stylet inserted into the
cannula. The introducer stylet is sized to be received within the
lumen and preferably has a length such that it will block the
lateral opening when the introducer stylet is received within the
lumen to prevent tissue from entering the lateral opening when the
cannula is introduced into the patient. The introducer stylet also
provides stiffness to the introducer cannula to facilitate
inserting the introducer into tissue. Once the introducer assembly
is inserted, the practitioner removes the introducer stylet.
[0067] Once the introducer is in place, the invention includes
inserting a biopsy needle having an anatomically proximal end and a
distal end through the aperture and into the lumen of the
introducer, advancing the biopsy needle through the lumen so that
the proximal end of the biopsy needle projects through the lateral
opening at an angle relative to the introducer and into a first
biopsy sample site to obtain a first biopsy sample, and then
withdrawing the proximal end of the biopsy needle from the first
biopsy sample site and into the lumen of the introducer. As is well
known in the art, a locking member L such as the one shown in FIG.
1 can be used to control the depth of the introducer.
[0068] The biopsy needle may be provided with a biopsy needle
stylet inserted into the lumen of the hollow biopsy needle. The
practitioner will remove the biopsy needle stylet after the biopsy
needle has been inserted into the lumen of the introducer. The
biopsy needle stylet provides stiffness to the hollow biopsy needle
which facilitates guiding the needle through the lateral opening.
Preferably, the stylet includes a penetrating tip which pierces the
subject tissue as the needle-stylet assembly is advanced through
the lumen of the introducer and into the tissue.
[0069] After the stylet is removed, a sample is collected. The
sample is preferably collected by applying suction to the biopsy
needle to draw a first biopsy sample into the biopsy needle through
its proximal end. Suction may be applied in any suitable manner.
Preferably a syringe will be attached to the Luer fitting on the
hub of the introducer to draw a vacuum. Most preferably, the
collecting step will also include reciprocating the biopsy needle
within the lumen while applying suction so that the needle edge can
help excise the tissue.
[0070] This invention contemplates that multiple samples which are
cofocal, coaxial and eccentric to the original biopsy sample can be
taken in this manner with only a single placement of the biopsy
device. The tissue that is available to be sampled can be increased
by rotating the introducer to change the exposure of the lateral
opening or by altering the shape of the biopsy needle.
[0071] In one embodiment of the invention, the methods include
removing the biopsy needle from the introducer after withdrawing
the biopsy needle from the biopsy site, clearing the sample from
the biopsy needle, rotating the introducer, reinserting the biopsy
needle through the aperture and into the lumen after clearing the
sample, further advancing the biopsy device to eject the proximal
end of the biopsy needle from the lumen through the lateral opening
at the same angle relative to the introducer to obtain a second
biopsy sample from a location eccentric from the first biopsy
sample, and withdrawing the proximal end of the biopsy needle from
the biopsy sample site into the lumen of the introducer. Although
the biopsy needle is removed from the sample site, the introducer
is left in place. Therefore, the practitioner is able to insert the
needle in a precise location relative to the initial sample
site.
[0072] Alternatively, the methods may include rotating the
introducer with the proximal end of the biopsy needle contained
within the lumen and then further advancing the biopsy device to
eject the proximal end of the biopsy needle from the lumen through
the lateral opening. A second biopsy sample may be obtained from a
location eccentric from the first biopsy sample. Additional samples
may be taken which are cofocal, coaxial and eccentric from the
original sample can be taken without clearing the sample from the
needle.
[0073] The methods of this invention also contemplate that the
sample site accessible to the single biopsy device placement can be
broadened by adjusting the angle by which the biopsy needle is
deflected from the cannula. This may be accomplished by either
providing a second biopsy needle having a bend adjacent an
anatomically proximal end of the needle, the bend deflecting the
proximal end of the second needle at an angle away from a
longitudinal axis of the second needle or by bending the first
biopsy needle in a similar manner. The bent needle is similarly
inserted through the aperture and into the lumen and advanced so
that the proximal end projects through the lateral opening at a
different angle relative to the introducer to obtain a second
biopsy sample. For example, the second biopsy sample site may be
located in a plane defined by the first biopsy sample site and the
introducer or may be eccentric to the first site. The invention
contemplates rotating the introducer and bending the needle so that
the desired tissue location may be reached.
[0074] This invention also provides devices and methods for
treating lesions located within a patient's body. An
introducer-guide 100 is shown in FIG. 11. The guide 100 is similar
to the introducer 15 shown in FIG. 2. In fact, in some methods it
is preferable that the same introducer be used first for diagnosis
and then for treatment of a lesion in a single procedure. The guide
100 includes a cannula 120 having a first end 121 and a second end
122. The cannula 120 defines a lumen 125 which extends between the
first end 121 and the second end 122 of the cannula 120 as shown
more clearly in FIG. 12. A tip 130 which closes the lumen 125 is
disposed at the first end 121 of the cannula 120. The cannula 120
defines an aperture 123 at the second end 122 of the cannula 120.
The aperture 123 is in communication with the lumen 125 and is
sized and configured to receive a therapeutic or diagnostic item
for passage into the lumen 125. It is contemplated that the item
could be mechanical, chemical or photo (laser) ablation means, a
biopsy needle, a breast mass localization wire, a
radiopharmaceutical composition, such as radioactive seeds, a
visualization agent, such as a contrast dye and the like.
[0075] The cannula 120 also defines a lateral opening 124 which is
in communication with the lumen 125. The lateral opening 124 is
preferably adjacent the first end 121 of the cannula 120. The
lateral opening 124 is sized and configured to allow exit of the
item from the cannula as it is advanced through the lumen 125. As
described above for the biopsy system, the introducer 100
preferably includes a ramp 135 disposed within the cannula 120 at
an end 136 of the lateral opening 124 adjacent the first end 121 of
the cannula 120. The ramp 135 is inclined toward the lateral
opening 124 and provides controlled exit of items exiting the
lateral opening 124.
[0076] In the embodiment shown in FIGS. 11 and 12, the lumen is
packed with radioactive seeds 130. The seeds 130 can be implanted
into an organ, such as the prostate, using conventional procedures
which are greatly aided by the use of the guide 100. One procedure
is described in Grimm, 1994. Under ultrasound visualization, the
guide 100 is inserted into the patient. In one embodiment, the
guide 100 is inserted into the prostate and the seeds 130 are
ejected. The guide 100 can then be rotated to direct the lateral
opening 124 in another direction.
[0077] In a preferred embodiment, the guide 100 is inserted near
the prostate. An insertion needle 111 is packed with the seeds 130
and then inserted through the lumen 125 of the guide 100 as shown
in FIG. 13. As described above for the biopsy procedure, the path
of the insertion needle 111 can be adjusted as required to correct
a miss-hit or for multiple seed 130 placements. Once the guide 100
is properly positioned, it serves as a reference point for multiple
insertion needle 111 placements.
[0078] In some embodiments, the therapeutic item is an ablation
means for ablating a lesion such as a tumor. In one embodiment
depicted in FIG. 14, an ablation needle 175 having a cutting edge
176 is provided. This device can be used for mechanical ablation of
small benign lesions such as arterio-venous malformations. In
operation of the device, the guide 100 is inserted into the patient
with the proximal end 132 as close to the lesion as possible. The
ablation needle 175 is inserted through the lumen 125 and out
through the lateral opening 124 to the lesion. Using the guide 100,
innumerable needle passes can be made through the entire
lesion.
[0079] In another embodiment, the ablation means is a chemical
composition such as ethanol or cyanoacrylate. Fine-needle alcohol
ablation is described in Karstrup 1990. (See also, Karstrup, et al.
Br. J Radiol 60: 667-670, 1987 and Solbiati, et al. Radiology 155:
607-610, 1985). The guide 100 of this invention allows precise fine
needle placement into multiple locations with a single guide 100
placement. The cannula 120 of the guide 100 can be adjusted
coaxially or rotated to change the direction of the lateral opening
124. Referring now to FIG. 15, a fine needle 140 is preferably
inserted through the lumen 125 and opening 124 to provide small
controlled doses of ablation agent to multiple locations in the
lesion. This invention addresses the need for highly precise
placement of the ablation agent. As with the biopsy needle
placements described above, the introducers of this invention allow
extremely precise delivery without requiring extremely precise
introducer placement.
[0080] The devices, systems and methods are particularly beneficial
when used in combination with imaging technology, preferably
ultrasonography, CT or MR. Precise, yet minimally invasive,
diagnostic and therapeutic procedures are possible using this
invention under imaging guidance. The path of a needle or other
object can be guided to an exact location. The use of image guided
access for biopsy and therapy is discussed in Dietrich, et al.,
Suppl. to Diag Imaging, Nov. 1996 and Karstrup et al., Acta
Radiological 29:213-216, 1988.
[0081] Although a few embodiments are described here, this
invention is not intended to be limited to these systems and
procedures. The introducer-guides of this invention can be used for
placement for any suitable therapeutic or diagnostic item,
particularly where a change in direction from a fixed initial
position is desired. For example, this invention may also be
employed in galactography, or mammary duct contrast examination.
(Diner, A J R 137:853-856, 1981; Tabar et al, Radiology 149:31-38,
1983; Threatt and Appelman, Radiology 108:71-76, 1973.) The present
invention is useful is procedures such as galactography where the
most difficult step is proper insertion and positioning of a needle
or other item.
[0082] This invention also provides methods of making a guide
device. The methods include: attaching a hub defining a channel to
a hollow cannula and securing an anatomically distal end of a solid
tip to the first end of the cannula. The hub is engaged to the
cannula by conventional techniques such as insert molding.
Preferably, the distal end of the tip has an outer diameter smaller
than an inner diameter of the first end of the cannula and the
securing includes inserting the distal end of said tip into the
first end of the cannula. Preferably, the cannula has a very thin
wall. In one embodiment, the securing includes employing a
mechanical or interference fit, such as crimping the cannula onto
the tip. The securing also preferably includes welding. Most
preferably, the methods include laser welding or brazing the tip
and the cannula after the cannula has been crimped into place on
the tip. In a preferred embodiment, the cannula is crimped onto the
tip so that the ramp formed by the tip is located to ensure that a
biopsy needle advancing through the lumen does not catch on the
portion of the cannula forming the lateral opening. Any methods
which provide a smooth transition between the tip and the cannula
are contemplated. A smooth transition reduces trauma to tissue
during insertion of the device. Any other suitable methods of
securing the tip to the cannula are contemplated including applying
an adhesive.
[0083] The devices of the present invention may be provided in any
suitable size and in any suitable material. For example, in one
embodiment, the components are made from 300 series stainless
steel. Alternatively, some of the components may be composed of
titanium or Inconel. The size of the components are dictated by the
type and location of the tissue to be sampled.
[0084] The present invention includes devices and methods that
provide extremely precise sampling and/or delivery without
requiring extremely precise device placements. The invention
compensates for peri-site placement and accommodates the need for
obtaining multiple placements around a lesion. The invention also
provides safeguards for the practitioner and the patient.
[0085] All publications cited herein are hereby incorporated by
reference in their entirety, as if each were individually
incorporated by reference and fully set forth.
[0086] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
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