U.S. patent application number 10/172788 was filed with the patent office on 2003-01-23 for device, system and method for implantation of filaments and particles in the body.
Invention is credited to Banks, Thomas F., Makower, Joshua, Redmond, Russell J., Vidal, Claude.
Application Number | 20030015203 10/172788 |
Document ID | / |
Family ID | 26677995 |
Filed Date | 2003-01-23 |
United States Patent
Application |
20030015203 |
Kind Code |
A1 |
Makower, Joshua ; et
al. |
January 23, 2003 |
Device, system and method for implantation of filaments and
particles in the body
Abstract
A method of introducing continuous lengths of filament into the
body in surgical procedures in which it is desirable to place a
significant amount of material into the body through a small
portal. The material so introduced may serve to bulk a tissue or
cavity of the body or to occlude a vas, as well as to introduce
diagnostic or therapeutic agents into a site in the body. A device
for implementing the method has a mechanism for feeding the
filament through a conduit in such a manner that sufficient force
is applied to the filament that it is forced into the desired site.
In one embodiment, a system of reciprocating cannulae and
synchronized grippers is used to supply the requisite force to the
filament.
Inventors: |
Makower, Joshua; (Los Altos,
CA) ; Vidal, Claude; (Santa Barbara, CA) ;
Banks, Thomas F.; (Santa Barbara, CA) ; Redmond,
Russell J.; (Goleta, CA) |
Correspondence
Address: |
JOHN S. PRATT, ESQ
KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET
SUITE 2800
ATLANTA
GA
30309
US
|
Family ID: |
26677995 |
Appl. No.: |
10/172788 |
Filed: |
June 13, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10172788 |
Jun 13, 2002 |
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09587755 |
Jun 6, 2000 |
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09587755 |
Jun 6, 2000 |
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08734638 |
Oct 21, 1996 |
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6090063 |
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60008259 |
Dec 1, 1995 |
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60016792 |
May 7, 1996 |
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Current U.S.
Class: |
128/831 ;
128/832; 128/843; 600/300; 604/13; 604/500; 606/138; 606/144;
606/148; 606/227; 623/1.11; 623/1.3 |
Current CPC
Class: |
A61B 17/12022 20130101;
A61B 17/12181 20130101; A61B 17/12131 20130101; A61B 90/39
20160201; A61B 17/12113 20130101; A61B 17/0469 20130101; A61B
17/12145 20130101; A61B 17/12186 20130101; A61B 2017/00349
20130101; A61B 2017/00526 20130101; A61B 17/12109 20130101; A61B
17/12099 20130101 |
Class at
Publication: |
128/831 ; 604/13;
128/843; 623/1.3; 604/500; 600/300; 128/832; 606/227; 623/1.11;
606/138; 606/144; 606/148 |
International
Class: |
A61F 006/06 |
Claims
What is claimed is:
1. A method for modifying a tissue property of a subject, the
method comprising: a. providing a quantity of filament; b. opening
a portal in the body of the subject; c. inserting the filament
through the portal into a region in the vicinity of the tissue; and
d. localizing the filament in the region so as to modify the tissue
property.
2. A method according to claim 1, wherein the property includes at
least one of the mass, bulk, orientation, rigidity, flexibility,
springiness, and permeability of the tissue.
3. A method for bulking tissue of a subject, the method comprising:
a. providing a quantity of filament; b. inserting the filament into
a region in the vicinity of the tissue; and c. localizing the
filament in the region so as to achieve bulking of the tissue.
4. A bulking method according to claim 3, wherein the step of
inserting includes the step of introducing the filament with the
aid of an endoscope.
5. A bulking method according to claim 3, wherein the step of
inserting includes the step of introducing the filament with the
aid of a laparoscope.
6. A bulking method according to claim 3, further comprising the
step of driving fluid through the portal into the tissue to dilate
the region to be occupied by the filament.
7. A method for coapting walls of a vas to increase the resistance
to flow of a bodily material within the vas, the method comprising:
a. providing a quantity of filament; b. inserting the filament into
the vicinity of the wall of the vas.
8. A method for occluding a vas of a subject, the method
comprising: a. providing a quantity of filament; b. inserting the
filament into the vas; and c. localizing the filament in a region
so as to achieve the occlusion of the vas.
9. An occluding method according to claim 8, wherein the step of
providing filament further comprises the step of training the
filament to take a preset shape.
10. An occluding method according to claim 8, wherein the step of
providing filament further comprises the step of providing filament
that has been coated with an clotting compound.
11. A method for preventing pregnancy in a subject, the method
comprising: a. providing a quantity of filament; b. inserting the
filament into a region in the vicinity of the fallopian tube of the
subject; and c. localizing the filament in the region so as to
achieve the occlusion of the fallopian tube.
12. A method for sterilizing a subject, the method comprising: a.
providing a quantity of filament; b. inserting the filament into a
region in the vicinity of the ductus deferens of the subject; and
c. localizing the filament in the region so as to achieve the
occlusion of the ductus deferens.
13. A method for clotting of an ulcer fed by a blood vessel, the
method comprising: a. providing a quantity of filament; b.
inserting the filament into a region in the vicinity of the blood
vessel; and c. localizing the filament in the region so as to stop
the supply of blood to the ulcer.
14. An ulcer clotting method according to claim 13, wherein the
step of providing filament further comprises the step of preloading
the filament with at least one therapeutic agent.
15. An ulcer clotting method according to claim 13, wherein the
step of providing filament includes the step of providing
electrically conducting filament and the method further comprises
the step of applying radio-frequency energy for heating the
filament.
16. A method of inserting a filament into the body, the method
comprising: a. providing a filament having an end with shape
memory; b. opening a portal in the body of the subject; c.
inserting the filament through the portal; and d. causing the
filament end to assume the shape in its memory.
17. A method for treating an aortic aneurism having an aneurysmal
pocket, the method comprising: a. delivering a stent graft
percutaneously; b. providing a quantity of filament; c. inserting
the filament into the aneurism; and d. localizing the filament in a
region of the aneurysm so as to clot off the aneurysmal pocket.
18. A method for treating a bleeding esophageal varix in a subject,
the method comprising: a. providing a quantity of filament; b.
inserting the filament into a region in the vicinity of the
bleeding varix; and c. localizing the filament in the region so as
to occlude the bleeding varix.
19. A method for treating a bleeding esophageal varix according to
claim 18, wherein the step of providing filament further comprises
the step of providing filament preloaded with at least one
therapeutic agent.
20. A method for treating a bleeding esophageal varix according to
claim 18, wherein the step of providing filament includes the step
of providing electrically conducting filament and the method
further comprises the step of applying radio-frequency energy for
heating the filament.
21. A method for providing chemotherapy in a subject having
malignant tissue, the method comprising: a. providing a quantity of
filament preloaded with at least one therapeutic agent; b.
inserting the filament into a region in the vicinity of the
malignant tissue; and c. localizing the filament in the region.
22. A method for releasing a drug into a subject, the method
comprising: a. providing a quantity of filament; b. preloading the
filament with at least one therapeutic agent; and c. inserting the
filament into the body of the subject.
23. A method for catalyzing biochemical reactions in the body of a
subject, the method comprising: a. providing a quantity of filament
having requisite catalytic properties; and b. inserting the
filament into the body of the subject.
24. A method for monitoring of biochemical processes in situ, the
method comprising: a. providing a quantity of filament; b.
preloading the filament with at least one diagnostic agent; c.
inserting the filament into the body of the subject; and d.
monitoring the response of the agent.
25. A method for providing birth control in a subject, the method
comprising: a. providing a quantity of filament; b. preloading the
filament with at least one contraceptive agent; and c. inserting
the filament into the body of the subject.
26. A method for supporting cell growth in a subject, the method
comprising: a. providing a quantity of filament; b. inserting the
filament into the subject; and c. localizing the filament in a
reticulate manner so as to form a matrix; and d. allowing the
entrance of cells into the matrix.
27. A method as in any one of the preceding claims further
comprising the step of injecting a fluid into the body of the
subject in conjunction with the filament.
28. A method for sewing tissue, the method comprising: a. providing
a quantity of filament; b. feeding an end of the filament into a
hollow shaft having a tip; c. inserting the hollow shaft into the
tissue; d. advancing the filament along the shaft into the tissue;
and e. binding the filament so as to suture the tissue.
29. A method for sewing tissue according to claim 30, wherein the
hollow shaft of steps (b), (c), and (d) has a longitudinal axis and
the tip is deformed so as to lie off the axis to facilitate curving
the path of the filament into the tissue.
30. A method for modifying a tissue property of a subject, the
method comprising: a. providing a quantity of filament; b. feeding
an end of the filament into a hollow shaft having a tip; c.
inserting the hollow shaft into a region that includes at least a
portion of the tissue; d. advancing the filament along the shaft
into the tissue; and e. localizing the filament in the region so as
to modify the tissue property.
31. A method according to claim 32, wherein at least a portion of
the shaft includes a passageway, and the step (b) includes the step
of advancing the filament through the passageway.
32. A method for delivering anesthesia into a tissue comprising the
steps of. a. providing a quantity of filament; b. preloading the
filament with at least one liquid anesthetic agent; c. feeding an
end of the filament into a hollow shaft having a tip; d. inserting
the hollow shaft into a region that includes at least a portion of
the tissue; e. advancing the filament along the shaft into the
tissue.
33. A method as in any one of the preceding claims, wherein the
filament is a length of suture.
34. A method as in any one of the preceding claims further
comprising the step of severing the filament such as to provide a
desired length of filament within the body of the subject.
35. A method according to claim 34, wherein the step of severing
the filament includes determining the desired length of the
filament during a clinical procedure.
36. A method for delivering a stent into a vas of a body, the
method comprising: a. preloading the stent into a shaft; b.
inserting the shaft into the vas; c. advancing a filament along the
shaft into the body so as to propel the stent in advance of the
filament; and d. retracting the filament.
37. A method for modifying a tissue property of a subject, the
method comprising: a. providing a quantity of suture material in
particulate form; b. suspending the suture material in a liquid
carrier to create a suture suspension; c. opening a portal in the
body of the subject; and d. inserting the suture suspension through
the portal into a region that includes at least a portion of the
tissue.
38. A method according to claim 37, wherein the property includes
at least one of the mass, bulk, orientation, rigidity, flexibility,
springiness, and permeability of the tissue.
39. A method for removing filament from a site in the body
comprising: a. inserting a hollow shaft into the site; b. hooking
the filament with a hooked tool; c. withdrawing the filament via
the hollow shaft.
40. A device for inserting a filament having a diameter into a site
in the body of a subject, the vice comprising: a. a conduit having
an axis, an interior wall, a distal end for inserting into the
site, and a proximal end; and b. a feeding mechanism for supplying
the filament incrementally along the axis of the conduit so as to
emerge from the distal end into the site in a manner such that
support is provided across all lengths of the filament longer than
three times the diameter of the filament.
41. A device for inserting a filament having a diameter into a site
in the body of a subject, the vice comprising: a. a conduit having
an axis, an interior wall, a distal end for inserting into the
site, and a proximal end; b. an inner cannula having an inner
diameter corresponding generally to the diameter of the filament;
c. a mounting arrangement permitting axial movement of the inner
cannula; and d. an actuator mechanism for urging the inner cannula
in axial reciprocation consisting of forward motion and retrograde
motion with respect to the mounting arrangement.
42. A device according to claim 41, wherein the inner diameter of
the inner cannula is approximately equal to the diameter of the
filament.
43. A device according to claim 41, wherein the mounting
arrangement includes an outer cannula disposed coaxially with and
external to the inner cannula.
44. A device according to claim 41, wherein the feeding mechanism
further comprises a gripper for grasping the filament synchronously
with forward motion of the inner cannula.
45. A device according to claim 41, wherein the feeding mechanism
further comprises a second gripper acting out of phase with the
first gripper for retaining the filament during retrograde motion
of the inner cannula.
46. A device according to claim 41, wherein the feeding mechanism
further comprises a brake for retaining the filament during
retrograde motion of the inner cannula.
47. A device according to claim 41, wherein the inner cannula
comprises distinct distal and proximal segments.
48. A device according to claim 41, further comprising a
containment spring for retracting the distal segment of the inner
cannula toward the proximal segment of the inner cannula during
retrograde motion of the distal segment of the inner cannula.
49. A device according to claim 41, wherein the mounting
arrangement includes a tip for penetrating body tissue.
50. A device according to claim 41, wherein the mounting
arrangement further comprises a window, disposed proximally to the
tip of the mounting arrangement and having a distal edge, for
feeding the filament into the site.
51. A device according to claim 41, wherein the device further
comprises a rotation arrangement for holding the mounting
arrangement in a chosen azimuthal angle with respect to the axis of
the conduit.
52. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; b. a plurality of conveyor belts
engaged against the filament; and c. at least one pulley for moving
the conveyor belts.
53. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; b. a toothed wheel for advancing the
filament; and c. an idler wheel for retaining the filament in
contact with the toothed wheel.
54. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; b. a first and second strut for
holding the filament against the wall of the conduit; c. a
reciprocating shaft disposed along the wall of the conduit having a
head articulated downward from a bend in the shaft and a channel
disposed proximally with respect to the head; d. a partial pivot
disposed across the conduit in a sense perpendicular to the axis of
the conduit and distally with respect to the head of the shaft for
forcing the shaft head into engagement with the filament; and e. a
mechanism for driving the shaft in an advancing direction such that
the filament is advanced into the tissue until the channel of the
reciprocating shaft aligns with the partial pivot, permitting it to
spring back into its original shape and to disengage the
filament.
55. A device as in any one of claims 40, 41, or 52-54 inclusive,
wherein the conduit includes one of a rigid, semi-rigid, and
flexible tubular structure.
56. A device as in any one of claims 40, 41, or 52-54 inclusive,
further comprising: a. an inlet for receiving fluid; b. a channel
for directing the flow of fluid toward the site; and c. a fluid
control for regulating the injection of fluid into the channel.
57. A device according to claim 56, wherein the channel is
identical to the conduit inserted into the site.
58. A device as in any one of claims 40, 41, or 52-54 inclusive,
further comprising a storage arrangement for storing filament
before it is supplied by the feeding mechanism.
59. A device according to claim 58, wherein the storage arrangement
is a spool.
60. A device as in any one of claims 40, 41, or 52-54 inclusive,
further comprising a rewind mechanism for retracting filament from
the site.
61. A device as in any one of claims as in any one of claims 40,
41, or 52-54 inclusive, further comprising a counter for tracking
the length of filament which has been fed into the body site.
62. A device as in any one of claims 40, 41, or 52-54 inclusive,
further comprising a filament cutter.
63. A device according to claim 62, wherein the filament cutter
comprises: a. a torquable head, disposed adjacent to the distal end
of the conduit, having a rotation axis coincident with the axis of
the conduit and an off-axis window for passing the filament into
the site in the body; b. a shearing surface disposed on at least
one of the distal end of the conduit and the torquable head such
that rotation of the torquable head severs the filament; and c. a
means for rotating the torquable head about the rotation axis of
the torquable head.
64. A device according to claim 63, wherein the means for rotating
the torquable head is a torque wire disposed along the axis of the
conduit.
65. A device according to claim 41, further comprising a filament
cutter, the filament cutter comprising: a. a stop disposed within
the mounting arrangement proximally to the distal end of the
mounting arrangement; and b. a sharpened edge disposed on at least
one of the inner cannula and the stop such that motion of the inner
cannula against the stop causes cutting of the filament.
66. A device according to claim 50 further comprising a filament
cutter having a mechanism for driving the inner cannula past the
distal edge of the window of the mounting arrangement in such a
manner as to cause shearing of the filament.
67. A device according to claim 40, 41, or 52-54 inclusive, further
comprising a motor for repetitively cycling the feeding
mechanism.
68. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; and b. a feeding mechanism for
supplying the filament along the axis of the conduit so as to
emerge from the distal end; and c. a filament cutter for shearing
the filament.
69. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; and b. a feeding mechanism for
supplying the filament continuously along the axis of the conduit
so as to emerge from the distal end; and c. a filament cutter for
shearing the filament.
70. A device for inserting a filament having a diameter into a site
in the body of a subject, the device comprising: a. a conduit
having an axis, an interior wall, a distal end for inserting into
the site, and a proximal end; and b. a feeding mechanism for
supplying the filament incrementally along the axis of the conduit
so as to emerge from the distal end; and c. a filament cutter for
shearing the filament.
71. A device for removing a filament from a site in the body of a
subject, the device comprising: a. a conduit having a distal end
for inserting into the site; and b. a hook for snagging and
withdrawing the filament through the conduit.
Description
TECHNICAL FIELD
[0001] The present invention relates to a device and method for
therapeutic insertion of suture and other materials into body
tissue in filamentous and particulate form.
BACKGROUND OF THE INVENTION
[0002] Increasingly in medicine and surgery, the need arises to
place a mass of material either into body tissue or into a space in
the body proximate to body tissue for various clinical purposes.
These purposes include the bulking of tissue as a therapy for
intrinsic sphincteric deficiency (ISD) which gives rise to
incontinence. In some types of incontinence, a decrease in urethral
resistance leads to urinary leakage during stress. This leakage is
embarrassing, and may cause the person to change their life-style
to avoid activity. Recently, various injectable materials have been
suggested for the purpose of `bulking` the periurethral space,
coapting the urethra, and thus increasing the urethral
resistance.
[0003] Other clinical applications include the implantation of
material include the occlusion of aneurysms, arteriovenous
malformations (AVMs), and fistulas, as well as the occlusion of the
blood supply to tumors, especially cranial tumors, prior to surgery
to reduce bleeding during surgery.
[0004] To insure that such procedures are minimally invasive, it
was clinically determined that bulking, for example, should be
accomplished through needle injection. Due to the use of a needle,
it was believed that it was necessary to reduce the material to a
liquid suspension or particulate so that it might be capable of
being passed through a needle into the tissue. This reduced the
number of candidate materials significantly. Teflon (PTFE)
particles, silicone particles, collagen suspensions, and various
other materials were tried. Most of the problems associated with
the therapy were associated with the material. For example,
collagen resorbed too quickly, creating the need for many repeat
therapies. Teflon particles migrate through the body and are thus
clinically undesirable.
[0005] Known technology has similarly limited the materials which
can be delivered transvascularly, endoscopically, or via a conduit
in conjunction with a laparoscope. Articles that are delivered by
pushing and utilization of these devices are limited, typically,
either to fluids or to relatively stiff solids.
[0006] The controlled release of drugs from polymer and from
surgical suture is another therapeutic modality known in the art.
Application of this technique, however, has hitherto required the
insertion of suture using conventional methods of pulling the
suture into the tissue, as by means of a sewing needle or tweezers,
raising difficulties of access to the site of implantation.
SUMMARY OF THE INVENTION
[0007] The present invention expands the domain of materials that
may be used for bulking as well as for other cellular and drug
delivery applications. The invention allows for a filament, as
defined below, to be introduced through a needle or other conduit,
allowing such well-known biocompatible materials as those used in
suture to be considered. With this novel advance, not only can the
material have a bulking effect, but depending on the other
properties of the filament used, it may add other mechanical
attributes such as springiness, rigidity, flexibility, mass,
orientation, and permeability. Further, the material being
introduced may be a solid, compressed particulate or composite,
thereby opening up a range of possible functions the material may
perform such as drug delivery, radiation, chemotherapy or
thermotherapy. The three-dimensional nature of the end result may
be very appropriate to provide a scaffolding for cellular ingrowth
for cells either injected with the filament, or those induced to
grow into the matrix.
[0008] The device is capable of placing a significant amount of
material in the body through a small portal, i.e., an opening in
the body as defined below. This material may preloaded with a drug,
or cells, or some other active material to produce some desired
effect with the body. The dosage may be controlled by the length of
the filament and the nature of the preloading, and may be modified
at the time of delivery to the length of choice. Such a method may
be useful for the delivery of subcutaneous heparin, insulin,
contraceptive substances, and other pharmaceuticals useful for
heart disease, smoking cessation, etc. The advantage of this
approach over other subcutaneous drug delivery devices is its
extremely low profile, and the ease in which it is positioned
within any site in the body, in particular, in the proximity of the
tissue to be affected.
[0009] In accordance with a preferred embodiment of the invention,
a method is provided for modifying a tissue property of a subject,
wherein the method consists of providing a quantity of filament,
opening a portal in the body of the subject, where both "filament"
and "portal" are defined below, inserting the filament through the
portal into a region in the vicinity of the tissue, and localizing
the filament in the region so as to modify the tissue property. The
tissue property to be modified may include the mass, bulk,
orientation, rigidity, flexibility, springiness, and permeability
of the tissue. The filament is inserted directly, or with the aid
of an endoscope or a laparoscope. Embodiments of the invention
provide methods for bulking the tissue of a subject, coapting the
walls of a vas, where "vas" is defined below, occluding a vas,
preventing pregnancy, sterilizing a subject, clotting an ulcer,
treating an aortic aneurism, treating a bleeding esophageal varix,
providing chemotherapy, releasing a drug, catalyzing biochemical
reactions, providing birth control, supporting cell growth in a
subject, sewing body tissue, delivering anesthesia, and delivering
a stent into a vas. Each of the aforesaid methods has the steps of
providing a quantity of filament and inserting it into the body.
The filament may be preloaded as described above. In further
embodiments of the invention, a continuous length of filament may
be severed to provide a desired length of filament within the body
of the subject, and fluid may also be injected into the subject in
conjunction with the filament. Additionally, in accordance with an
alternate embodiment of the invention, suture is provided in
particulate form, suspended in a liquid carrier to create a suture
suspension, and inserted through a portal in the body of a subject
to modify a tissue property that includes at least one of the mass,
bulk, orientation, rigidity, flexibility, springiness, and
permeability of the tissue.
[0010] In another embodiment of the invention, a method is provided
for removing filament from a site in the body that consists of the
steps of inserting a hollow shaft into the site, hooking the
filament with a hooked tool, and withdrawing the filament via the
hollow shaft.
[0011] In accordance with another aspect of the invention, a device
is provided that has a conduit for insertion into a designated site
in the body, and a feeding mechanism for supplying filament along
the axis of the conduit in a manner such that support is provided
across all lengths of the filament longer than three times the
diameter of the filament. The conduit may be rigid, as well as
semi-rigid or flexible.
[0012] In one embodiment of the invention, the feeding mechanism
has an inner cannula with an inner diameter corresponding generally
to the diameter of the filament and a mounting arrangement, which
may be a coaxial outer cannula, for permitting the axial movement
of the inner cannula. Finally, an actuator mechanism is provided
for urging the inner cannula in axial reciprocation consisting of
forward motion and retrograde motion with respect to the mounting
arrangement. In alternate embodiments, the actuator mechanism may
have a combination of grippers or a gripper and a brake.
Additionally, the inner cannula may have distinct proximal and
distal segments and a containment spring for retracting the distal
segment toward the proximal segment during retrograde motion of the
distal segment.
[0013] In further embodiments of the present invention, a tip may
be provided on the mounting arrangement for penetrating body
tissue, and a window may be provided proximally to the tip to allow
filament to be fed into the site. Filament cutters are provided in
several alternate embodiments to allow desired lengths of filament
to be left in the body. In one filament cutter embodiment, a
torquable head is disposed adjacent to the distal end of the
conduit with a shearing surface disposed on at least one of the
torquable head and the distal end of the conduit such that rotation
of the torquable head severs the filament. In another filament
cutter embodiment, a shearing surface is provided on at least one
of the inner cannula and mounting arrangement of the device such
that relative motion of the inner cannula and mounting arrangement
cause shearing of the filament.
[0014] Other filament feeding mechanisms are provided in alternate
embodiments of the invention which include conveyor belts engaged
against the filament, a toothed wheel and idler wheel for advancing
the filament, and a reciprocating shaft which drives the filament
forward in the shaft and then springs back in disengagement from
the filament. A motor may be employed for repetitively cycling the
feeding mechanism.
[0015] In accordance with another aspect of the present invention,
a device is provided for removing a filament from a site in the
body where the device consists of a conduit and a hook for snagging
and withdrawing the filament through the conduit.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a schematic illustration of a filament injection
device 1 in accordance with a preferred embodiment of the present
invention.
[0017] FIG. 2 illustrates the principal components of a filament
injection device in accordance with a preferred embodiment of the
present invention.
[0018] FIGS. 3A-3C show cross-sectional views of a filament feeding
mechanism in the advancement stage of a filament feeding cycle in
accordance with the embodiment of the invention shown in FIG.
2.
[0019] FIGS. 4A and 4B show cross-sectional views of a filament
feeding mechanism in a the reset stage of a filament feeding cycle
in accordance with the embodiment of the invention shown in FIG.
2.
[0020] FIG. 5 shows an exploded view of a filament feeding
mechanism according to an embodiment of the invention.
[0021] FIG. 6 is a cross-sectional view of the distal tip of a
filament feeding mechanism in accordance with an embodiment, of the
invention.
[0022] FIGS. 7A and 7B are cross-sectional views of the distal tip
of FIG. 6, showing a filament cutting mechanism according to an
embodiment of the invention.
[0023] FIG. 7C is a perspective view of the distal tip of a conduit
in accordance with an embodiment of the invention showing an
alternate filament cutting mechanism.
[0024] FIG. 7D is a cross-sectional view of the filament cutting
mechanism of FIG. 7C.
[0025] FIG. 8 is a cross-sectional view of an filament feeding
mechanism according to an alternate embodiment of the
invention.
[0026] FIG. 9 is a schematic of a powered drive system for cycling
the shaft 27 with the touch of a button.
[0027] FIG. 10 illustrates a layout of an alternative embodiment of
the system.
[0028] FIG. 11A is a cross section of the result after the device
has been used to coapt the walls of a tubular structure within the
body.
[0029] FIG. 11B illustrates an embodiment of the invention for
treatment of an ulcer.
[0030] FIG. 12 illustrates an embodiment of the invention for
removing a filament in the body after it has been placed.
[0031] FIGS. 13A-13C illustrate use of the device of FIG. 1 for
passing suture through and around tissue, and, in FIG. 13C, for
creating a series of linked loops.
[0032] FIG. 14 illustrates the mechanism through which particle may
be injected into the body in accordance with another embodiment of
the invention.
[0033] FIGS. 15A and 15B show respectively a descended bladder of a
female subject and the same bladder after it has been elevated by
use of a filament implanted in accordance with an embodiment of the
invention;
[0034] FIG. 16 shows an embolism that has been achieved in a blood
vessel by means of a filament implanted in accordance with an
embodiment of the invention;
[0035] FIG. 17 shows an aneurysm that has been filled by means of a
filament implanted in accordance with an embodiment of the
invention.
[0036] FIGS. 18 through 26 illustrate various embodiments of the
invention for achieving the movement of a filament along a desired
path so as to permit implantation of the filament;
[0037] FIGS. 18A and 18B illustrate an embodiment for achieving
movement of a filament utilizing a pair of conveyor belts
symmetrically engaged against the filament;
[0038] FIG. 19 illustrates an embodiment for achieving movement of
a filament utilizing a toothed drive wheel against which the
filament is engaged by an idler wheel;
[0039] FIG. 20 illustrates an embodiment, similar to that of FIG.
19, utilizing a toothed drive wheel against which the filament is
engaged by an idler wheel, but wherein the filament is also engaged
against the drive wheel by a guide having an arcuate surface that
general conforms to the radius of the drive wheel;
[0040] FIGS. 21A and 21B illustrate and embodiment, similar to that
of FIG. 19, utilizing a toothed drive wheel against which the
filament is engaged by an idler wheel, but wherein the idler wheel
is soft;
[0041] FIG. 22 illustrates an embodiment for achieving movement of
a filament utilizing a toothed drive wheel against which the
filament is engaged by a tubular guide;
[0042] FIGS. 23A and 23B illustrate an embodiment for achieving
movement of a filament utilizing a drive wheel against which the
filament is engaged by an idler belt;
[0043] FIGS. 24A through 24E illustrate an embodiment for achieving
movement of a filament utilizing a pair of axially reciprocating
tubular members, within which the filament is disposed, in
conjunction with a periodically clamping finger;
[0044] FIGS. 25A through 25E illustrate an embodiment similar to
that of FIGS. 24A through 24E but in which the coil springs of the
latter figures are supplanted by complementary mating extensions of
the tubular members;
[0045] FIGS. 26A and 26B illustrate an embodiment for achieving
movement of a filament utilizing a pair of arms that are caused to
reciprocate axially while being alternately opened and closed at
the opposite ends of each stroke;
[0046] FIGS. 27A through 3 ID illustrate embodiments of the
invention in which a region proximate to a tip of a cannula
carrying a filament is provided with an arrangement, for cutting
the filament, utilizing a concentrically disposed member and a
window in both members through which the filament is placed and
severed;
[0047] FIGS. 27A and 27B illustrate an embodiment wherein the outer
member is pulled proximally with respect to the inner member to
achieve cutting;
[0048] FIGS. 28A and 28B illustrate an embodiment wherein the outer
member is pushed distally with respect to the inner member to
achieve cutting;
[0049] FIGS. 29A through 29C illustrate an embodiment wherein the
inner and outer members are rotated with respect to one another to
achieve cutting;
[0050] FIGS. 30A through 30D illustrate the way a tip, having a
cutting arrangement of one of the types described above, may be
employed in conjunction with a suitable window to prevent the
presentation of undue pressure, by the distal end of the filament,
on tissue of the subject on whom the invention may be used; and
[0051] FIGS. 31A and 31B, and 32A and 32B, illustrate a possible
configuration for a case for an embodiment similar to that of FIGS.
26A and 26B.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0052] In order to provide an overall understanding of the present
invention, the method, system, and device of the invention will be
discussed with reference to the application of the invention to
provide tissue bulking. However, it will be understood by persons
of ordinary skill in the art that the general method, system, and
device, described herein, are equally applicable to all cases in
which filament injection would have value. A list of possible uses
for the technology includes, but is not limited to, the injection
of a filament-based system of drug delivery into tissue, the
subcutaneous or interstitial injection of a filament for the
purpose of bulking, shaping, applying pressure, or adding other
mechanical properties (such as springiness or rigidity), and the
injection of a filament to act as a matrix or lattice in which a
cellular process may proceed (i.e. bone replacement, healing,
implanted cellular scaffolding).
[0053] Other clinical uses include the injection into the body of a
filament bearing other properties such as radiopacity, magnetism,
radioactivity--radiation, or fluorescence, all suited for
application as a clinical tracer or therapeutic agent. Similarly,
the filament may have chemical properties which allow it to serve
as a tracer of specified biochemical processes or as a catalyst to
stimulate or enhance desired reactions within the tissue. This
invention represents a new concept in the delivery and retrieval of
mass as well as of therapeutic and diagnostic agents.
[0054] The applications of tissue bulking alone are manifold, once
it is appreciated that tissue bulking may be achieved conveniently
and at low risk using the method, system, and device of the present
invention. Tissue bulking applications include, but are not limited
to periurethral bulking of the urinary sphincter, support of the
urethra, therapy of vesicourethral reflux, prevention of esophageal
reflux via the gastroesophageal sphincter, and treatment of the
anal sphincter for treatment of fecal incontinence. Other
applications of tissue bulking which may be achieved using the
present invention include the bulking of blood vessels, both
internally or externally, in association with the treatment of
bleeding ulcers. The applications listed are given by way of
example, though it is to be understood that the scope of the
invention is not limited to the applications listed but includes
all applications wherein filamentous material is usefully injected
into the body.
[0055] As used in this specification and in the claims hereto
appended, a material, provided in a threadlike form, will be
referred to as "flaccid" if its buckling stress, measured in units
of force per unit cross-sectional area of the material, is less
than or comparable to the shear strength that is typical of soft
body tissue (such as the dermis). Shear strength is expressed in
the same units as stress. Buckling stress, as is known in the
mechanical arts, refers to the force per unit area applied axially
to a member which causes deformation of the member in a direction
orthogonal to the axis of the member. It is also known in the
mechanical arts that the buckling stress of a member is
proportional to the off-diagonal compressive modulus, (i.e., the
ratio of axial compressive stress to the strain induced transverse
to the axial direction) and inversely proportional to the square of
the ratio of unsupported length to diameter of the member. Thus,
the longer or finer a thread is, the less force per unit area is
required to cause it to buckle.
[0056] Clearly, it is known that rigid, needle-shaped implements,
such as all manner of needles or staples, may be driven into tissue
upon application of sufficient axial force along the direction of
insertion. By way of contrast, the present invention teaches a
method of inserting materials which are flaccid rather than rigid.
In view of the definition of "flaccid" provided above, flaccid
materials are inherently incapable of being driven into tissue by
the application of axial force. These materials are referred to,
collectively, as "filament." More particularly, as used in this
specification and in the claims hereto appended, the term
"filament" refers to a flaccid material, and may include
biocompatible materials such as polypropylene, Nylon, DACRON.TM.,
polybutylester, polybutylethylene, polyglycolic acid (PGA), and
variations thereof, and any other material, naturally occurring,
biological, or man-made, which has been chosen for a particular
application on the basis of biocompatibility, biodegradability, or
any other desirable property. Other filament materials useful in
particular clinical applications are composite, woven, or solid,
and include silk, metal, `gut`, collagen, clastin, cartilage and
bone. The term "filament" encompasses, particularly, all materials,
such as polypropylene, currently supplied and used as suture
material and referred to thereas. Additionally, the term "filament"
encompasses the use of materials having shape memory, such as
nitinol, which may be used to particular clinical advantage.
Whereas many of the foregoing materials may be formed into a
wire-shaped member that is not flaccid as defined herein, the term
"filament" in this description and the accompanying claims is
limited to the embodiment of such materials in their flaccid
forms.
[0057] Since the "filament" is flaccid, it will be appreciated that
materials of this category, if pressed, unguided, against the
surface of body tissue, are likely to buckle rather than to cleave
the surface, penetrate into the body tissue, or expand or dissect a
space into the tissue.
[0058] When a filament is bent, such as under its own weight or due
to compressive buckling, the inner regions yield under compression.
Force applied to the distal end of a bent filament by driving it
against a surface is no longer truly axial and has a vector
component which leads to further bending. Plastic deformation may
inhibit the return of the filament to the original configuration
even after removal of the load. However, the filament need not
undergo any plastic deformation if it is suitably introduced and
trapped within the body tissue, in accordance with the present
invention.
[0059] In the prior art, suture is treated as a flaccid material in
that it is pulled through tissue, as by a needle or tweezers,
rather than pushed. For suture or other filament sufficiently fine,
large forces per unit cross-sectional area can be developed, using
the teachings of the present patent, over small cross sectional
areas. The force per unit area applied by the tip of the filament
can readily exceed the shear strength of the body tissue so that
the filament can thereby cleave and penetrate the tissue. The
recognition of this ability of a filament, using the methods of
this invention, to penetrate body tissue, enables the host of
clinical applications which are described herein.
[0060] As used in this description and in the appended claims, a
"portal" for insertion of filament into the body refers to any
naturally existing or created opening into the body or a tissue.
The invention teaches the insertion of filament into the vicinity
of a tissue, where, as used in this description and in the appended
claims, a "vicinity" includes at least a portion of the tissue
itself, as well as its walls, and proximate tissue or body cavity.
Since some tissues may be too small, fragile, or sensitive to
permit direct insertion of filament, filament may be inserted, in
accordance with the teachings of the present invention, into
proximate tissue that is near but not directly associated with the
target tissue.
[0061] Additionally, insertion of filament may be achieved via a
vas, where, as used in this description and in the appended claims,
the term "vas" refers to any duct, vessel, passageway or cavity
occurring in the body, either by natural anatomical formation or
through surgical intervention.
[0062] FIG. 1 illustrates a filament injection device 1 in
accordance with a preferred embodiment of the present invention.
Here a needle 6 is inserted through the skin 2 into the body 3. A
small filament 5 is injected into an interstitial space 4. The
needle 6 is attached to a housing 7 which has an inlet 11 for
fluid, a fluid control 8 for fluid injection, an injection control
9 to advance the filament, and a cut control 10. Those skilled in
the art will recognize that needle 6 may also be a rigid, flexible,
deformable, malleable, semi-rigid or semi-flexible cannula or
catheter inserted percutaneously, endoscopically or
transvascularly. Further, filament 5 may also be a resorbable or
non-resorbable suture, wire, or any of the other materials
comprised within the definition of "filament" given above. This
filament may be a composite material embedded with drugs, cells, or
radioactive substances. The combination of drugs with polymer to
provide programmed release of the drugs within the body is known,
as described in A. Loh, Controlled Release of Drugs from Surgical
Suture, 1987, which is herein incorporated by reference. The
insertion into the body of a filament which has been preloaded with
a therapeutic or diagnostic agent, whether by techniques of
embedding or impregnating within the filament material or otherwise
bonding to the filament, whether at the time of manufacture or at
the time of insertion into the body, is included within the scope
of the invention. While no other working channels are shown in the
device, those skilled in the art will recognize that the
modification of the device to permit additional instrumentation to
be passed within or along-side the device does not depart from the
invention. Such other channels may be provided for introducing
energy guides, wires, endoscopic visualization devices or surgical
tools. The device as shown would be easily advanced into the
periurethral space for tissue bulking or drug delivery to treat
incontinence, or the perivascular space for venous reconstitution
or drug delivery, or the interstitial space within a tumor for
chemotherapy, radiation or magnetic thermal therapy.
[0063] In this specification and in the appended claims, the term
"distal" denotes the end of the filament injection device 1, or the
end of any of the component parts of filament injection device 1
such as conduit 6, which is located toward the point of delivery of
filament 5 into the body 3. Conduit 6 serves as the delivery
cannula through which filament 5 is introduced into the body of the
subject. Similarly, in this specification and in the appended
claims, the term "proximal" denotes the end of the filament
injection device 1 or the end of any of the component parts of
filament injection device 1 which is located away from the point of
delivery of filament 5 into the body 3. Because of the need to
minimize the diameter of distal end 12 of filament injection device
1, in order to avoid leaving a large hole in the body 3 of the
subject, the bulkier suture feeding mechanism typically resides in
the bulkier proximal section 7 of the device. Therefore, the
feeding mechanism, described below, cannot pull on the filament but
must push it forward. In order to allow for pushing a flaccid
material into the body, the zone between feeding mechanism 7 and
conduit 6 over which filament 5 is unsupported must be kept to a
minimum. In some preferred embodiments of the invention, there is
no unsupported length of filament 5, while, in other embodiments, a
length of filament 5 is unsupported, and is, typically, no larger
than three times the characteristic diameter of the filament.
[0064] Referring now to FIG. 2, wherein the principal components of
a filament feeding device used, in accordance with a preferred
embodiment of the invention, to advance the filament into the
tissue. Inner cannula 14 is a tubular section having a diameter
closely matched to the diameter of filament 5 for which inner
cannula 14 provides support. Inner cannula 14 prevents filament 5
from buckling or jamming as a result of the axial force pushing it
into the body, and is, in turn, retained axially within a coaxial
outer cannula 15. In alternate embodiments, inner cannula 14 may be
retained by other manner of mounting arrangements, to include
channels, as is well known to a person of ordinary skill in the
art.
[0065] FIG. 3A shows a cutout window 16 in the proximal section of
inner cannula 14. Cutout window 16 exposes a small section of
filament 5 and allows actuating pad 17 to couple filament 5 and
inner cannula 14 to an actuator mechanism 502 (shown in FIG. 5).
Actuating pad 17 is referred to, functionally, as a "gripper." FIG.
3B shows actuating pad 17 depressed in a direction 18 transverse to
filament 5 in order to engage it securely. FIG. 3C shows the
advancement, by means of the action of actuator mechanism 502
(shown in FIG. 5), of actuating pad 17 to the left, and the
advancement, along with actuating pad 17, of both inner cannula 14
and filament 5 such that a length of filament 5 equal to the
distance 19 of motion of actuating pad 17 is urged into the body
tissue.
[0066] FIGS. 4A and 4B illustrate the next step of the filament
feeding action, the reset part of the cycle, wherein actuating pad
17 is retracted from contact with filament 5 and is urged
proximally, in retrograde direction 404, such that inner cannula 14
and actuating pad 17 return to their original proximal position. In
a preferred embodiment of the invention, inner cannula 14 has a
distal segment 408 and a proximal segment 410, separated by
containment spring 412. The direction 406 of retraction of the
distal segment 408 of inner cannula 14 is referred to as the
retrograde direction. During the reset part of the filament feeding
cycle, the filament 5 itself is prevented from coming back out of
the body tissue by means of friction brake 402, located proximally
to actuating pad 17, which secures filament 5 within the proximal
segment 410 of inner cannula 14. Retraction of distal segment 408
of inner cannula 14 is achieved, in a preferred embodiment of the
invention, by means of the force supplied by containment spring 412
in compression. The feeding action described allows a high force
per unit cross-sectional area to be applied in advancing filament 5
into the body tissue while a lower force is supplied by containment
spring 412 to retract the distal segment 408 of inner cannula
14.
[0067] Referring now to FIG. 5 wherein the components of a filament
feeding mechanism, designated generally by numeral 500, are shown
in exploded view. Actuator mechanism 502 is shown to comprise a
thumb pad 504 which the physician uses to advance slider 506
forward to a stop in the slider guide 508. By pressing on distal
part 505 of thumb pad 504, the physician causes activator pad 17
(shown in FIGS. 4A and 4B) to come into contact with filament 5
(shown in FIG. 4A), and, as he also urges thumb pad 504 forward, he
feeds a discrete amount of filament 5, paid off of spool 510 along
feed axis 512, into the body tissue, according to the mechanical
principle described above with reference to FIG. 3. In an alternate
embodiment, the actuation of filament advancement is accomplished
by means of an electrical stepper, using mechanical principles
known to persons having ordinary skill in the art. The amount of
filament fed in each advancement step of the feeding cycle is,
typically, on the order of 5 mm. However, design and adjustment of
filament feeding mechanism 500 can provide for a longer or shorter
length of filament to be fed in each advancement step, indeed, any
desired length of filament may be provided per advancement step. To
reset the mechanism for the next feeding, the physician depresses
the proximal part 503 of thumb pad 504, thereby freeing pawl 514
from a ratchet rack 522 contained in a body 524, and allowing thumb
pad 505 and distal segment 408 of internal cannula 14 (shown in
FIG. 4B) to retract, according to the principle discussed above
with reference to FIGS. 4A-4B. Since the actuating pad 17 is now
held up away from the filament 5 and since the suture is held in
its forward position by brake 402, the length of filament
previously fed remains in the body tissue.
[0068] FIG. 6 shows a cross sectional view of the distal tip of a
filament feed mechanism, according to a preferred embodiment of the
invention. It has been found that if the tip 600 of the filament 5
itself is allowed to push straight into the body tissue at the
start of the procedure, it can occasionally penetrate the tissue
and travel further ahead than clinically indicated, and, instead of
remaining in the area surrounding tip 602 of outer cannula 15 and
creating the intended localization of filament for purposes of
tissue bulking, vas occlusion, or any of the other clinical
purposes of filament localization. A solution to this problem,
according to a preferred embodiment of the invention, is to provide
cutout window 604 in outer cannula 15, immediately proximally to
tip 602. As the filament is urged forward, according to the feeding
method described above, or otherwise, it bends and then buckles
toward the only opening in the area: window 604. Thus the filament
enters the body tissue in a gentle sideways manner, presenting to
the tissue an area large enough that the force per unit area is
insufficient to shear the tissue and to cause inadvertent
penetration. Once a filament coiling process is started in this
manner, the implanted filament remains within the target region of
the body. In order to point the outer cannula window 604 in the
direction in which the filament is to be applied to the tissue, the
outer cannula 15 is fully rotable about its axis in fixed
increments, typically 45-degree increments. A ball plunger
arrangement holds the outer cannula in the chosen orientation,
according to mechanical principles known to a person of ordinary
skill in the art.
[0069] When sufficient filament has been introduced into the body
to achieve the requisite tissue bulking or other clinical
objective, the physician cuts the filament before withdrawing the
device. Thus, in accordance with the present invention, the
filament stored in the filament injection device is longer than the
amount of filament which is intended to be used in the application
at hand. Thus, the desired length may be determined during the
course of the procedure and severed after it is deployed into the
body of the subject. One method of cutting the filament is
described with reference to FIGS. 7A and 7B. In a preferred
embodiment of the invention, stop 702 is provided within lumen 704
of outer cannula 16. Distal end 706 of distal segment 412 of inner
cannula 14 is provided with a sharpened edge. Thus, when sufficient
filament 5 has been injected to constitute the clinically indicated
implant 700, distal segment 412 of inner cannula 14 is thrust
against stop 702, cutting off filament 5. To allow the inner
cannula 14 to advance as far as the cutting stop 702, a trigger 518
(shown in FIG. 5) must be activated by the physician, releasing
slider stop 520 (shown in FIG. 5) which, otherwise, prevents the
advance of inner cannula 14 to the point of cutting off the
filament. In an alternate but equivalent embodiment, the sharpened
edge is provided within lumen 704 of outer cannula 16, while,
mutatis mutandis, the cutting stop is now provided at the distal
edge of inner cannula 14. The cutting action for cutting off the
filament remains as described. In an alternate embodiment, the
cutting function is achieved by providing a high-tolerance fit of
the inner cannula 14 so that when the distal edge 706 of the inner
cannula 14 is pushed past distal edge 606 (shown in FIG. 6) of
window 604 (shown in FIG. 6), filament 5 is sheared. Shearing of
filament 5 may also be achieved, alternatively, through rotation of
inner cannula 14 with respect to outer cannula, where shearing
surfaces are provided on one or both members, as would be apparent
to a person skilled in the art.
[0070] Another method of cutting the filament is described with
reference to FIGS. 7C and 7D. In an alternate embodiment of the
invention shown in FIG. 7C, conduit 708, which can be used in
conjunction with any of the filament feeding mechanisms described
herein, is provided, at its distal end, with a torquable head 710
containing window 712 within distal surface 714. Referring now to
the cross sectional view shown in FIG. 7D, torque is transmitted to
rotate torquable head 710 via torque wire 716 which runs through
conduit 708 so that torque may be applied at its proximal end (not
shown). When torquable head 710 is rotated, filament 5 is cut by
blade inset 718, such that, upon withdrawal of conduit 708 from the
body, the requisite length of filament 5 is left in the body. In
one embodiment of the invention, a cannula 720 is provided through
conduit 708, parallel to filament 5, so that fluid or a guide wire
may be introduce via cannula 720 through port 714 in torquable head
710 into the body region into which filament 5 is being
inserted.
[0071] FIG. 8 shows the detail of how the filament may be advanced
into the tissue. Within the lumen 26 at the tip of needle 6, the
filament is held in a position against the wall by struts 24 and
25. Shaft 27 has a head 21 and a channel 22 spaced back from the
tip of head 21 a small distance. As shaft 27 is advanced, head 21
comes in contract with partial pivot 23 and is forced downward,
engaging filament 5. As shaft 27 continues to advance, filament 5
is pushed forward as head 21 subluxes under pivot 23. With the
continued advancement of shaft 27, eventually channel 22 aligns
with pivot 23, permitting it to spring back into its original
shape, disengaging filament 5. Then, as shaft 27 is withdrawn, head
21 rides over pivot 23, losing contact with filament 5 preventing
inadvertent withdrawal of filament 5. Finally the cycle is complete
when head 21 pops over pivot 23 and snaps back into its original
shape and position at the start of the cycle.
[0072] FIG. 9 illustrates a schematic of a powered drive system for
cycling the shaft 27 with the touch of a button. When switch 38 is
turned on, power to a small motor 35 turns a set of gears 33 and 34
which drive a bar linkage 32 riding in a channel 31. The bar
linkage 32 is attached to the shaft 27 at the point within or near
the channel 31. Power source 37 may be connected to processor 36
which may be capable of correlating, tracking or controlling
`on-time` as it relates to the mass of filament deposited within
the body. Alternatively, those skilled in the art will recognize
that various mechanical methods are easily applied which would
allow the shaft to be man-powered or mechanically driven.
[0073] FIG. 10 illustrates a layout of an embodiment of the system.
Fluid control 8 may drive fluid stored in vessel 43 forward through
the tip of needle 6. A principal purpose of the fluid is to dilate
the space to be occupied by the filament; in this connection, the
fluid may be a suitable liquid such as saline, although the fluid
may also or alternatively include anesthetic, antibiotic, or other
medication. Other methods may also be used for dilation of the
space, including inflation of a temporary balloon. Alternatively,
the implantation of the filament itself may be used to cause
dilation of the space. Further, it is envisioned that an endoscope
may desirably be inserted into the space before, during or after
the treatment to ensure proper placement. Injection port 11
provides access to vessel 43. Injection control 9 is attached to
drive mechanism 45 which is subsequently linked to shaft 27. As
discussed earlier, the movement of shaft 27 drives filament 5
forward. Spool 41 stores filament 5 prior to delivery and acts as a
filament reservoir as filament 5 is advanced. If only a portion of
filament 5 is required, filament 5 may be severed by cutting
mechanism 42 activated by cut control 10.
[0074] FIG. 11A is a cross section of the result after the device
has been used to coapt the walls of a tubular structure 52, or vas
(as defined above), within the body. The tubular structure 52 may
be any within the body such as a ureter, urethra, vein, artery,
bowel, esophagus, stomach, oropharynx or sphincter. Other body
tissue 54 surrounds wall 53 of tubular structure 52. Filament balls
51 have been placed on either side of the tubular structure to
create an increase in resistance to flow, provide a site for local
drug delivery or support internal structures such as valves.
Placement of filament balls 51 within exterior body tissue 54 is
shown by way of example, while placement within or proximal to wall
53 is also within the scope of the invention.
[0075] FIG. 11B illustrates another embodiment of the invention, in
which filament injection device 1 is applied in the treatment of an
ulcer such as a peptic ulcer of the duodenum, stomach, or lower
esophagus. Conduit 6 is shown supplying filament (not shown) into
crater 56 of ulcerated mucosa 57 surrounding blood vessel 58. By
inserting the fiber into the vicinity of blood vessel 58, it is
possible to stop the supply of blood to the ulcer.
[0076] FIG. 12 illustrates an embodiment of the invention for
removing a filament in the body after it has been placed. Cannula
61 is advanced into the center of the filament ball and then hook
62 is pushed forward. Once a strand of the filament has been
captured or snagged by the hook 62, the filament and the device may
be withdrawn.
[0077] The present invention may be used for purposes other than
bulking of tissue. In particular, the device of the present
invention may also be used for the delivery of suture for purposes
such as sewing, ligation, and anastomosis. In this mode, the device
may be passed into and through tissue, advancing a singular loop of
suture before being pulled back. As seen in FIGS. 13A-13C, the
procedure may permit the suture to be passed through and around
tissue without the requirement of manipulating a loose needle. Here
needle 71 is passed through tissue 72 with the aid of grasper 73.
Once through the tissue, filament 74 is advanced and grasped by
grasper 73; then the needle 71 may be withdrawn. After the filament
has been deployed as desired, the filament may be severed, and once
the filament is severed, a knot may be tied. Another use is shown
in FIG. 7C. Here, several insertions of needle 71 can be performed
to create a series of linked loops 75 which can ultimately be
tensioned and tied.
[0078] FIG. 14 illustrates the mechanism through which particles
may be injected into the body, in accordance with another
embodiment of the invention, in order to accomplish the same
purposes as taught in this specification with respect to the
injection of filament. Again, as in the case of filament, the
particle may be one of any of the currently available biocompatible
materials, including but not limited to silk, plastic, polymer,
metal, cells, collagen, bone or other material described above in
connection with the definition of the term "filament".
Specifically, as with the filament, the material may also be one of
any available suture materials such as polyglycolic acid (PGA),
polytetrafluoroethylene (PTFE), DACRON.TM., polypropylene, nylon
polyester, silk, polybutylester, stainless steel, titanium, chromic
gut, polybutylester, cotton, or silver. Here, particles 80 are
shown being injected into a created cavity 86 within the body 87.
Particles 80 are passed down the shaft 81 along with a pressurized
fluid 83 from storage chamber 88 propelled by pressure source 84.
The fluid is then withdrawn via channel 82 by suction source 85.
The pressure and suction sources may be manually activated or may
be electronically controlled or otherwise controlled. The
pressurized fluid may be also a gas like CO.sub.2, but may also be
saline, dextrose, antibiotic or other biocompatible agent that acts
either passively to assist the particles to reach their
destination, or performs another purpose such as providing
antibiotic protection, activating the particles once in place, or
providing a means through which the particles may be held in one
place. The particles may be of any size which permits them to be
introduced down the shaft of a cannula, catheter or needle.
[0079] FIGS. 15A and 15B show respectively a descended bladder of a
female subject and the same bladder after it has been elevated by
use of a filament implanted in accordance with an embodiment of the
invention. In these figures the bladder 91 and bladder neck 93 are
shown in relation to the pubic bone 92, the vagina 94, uterus 95,
and anus 96. In accordance with this embodiment, as shown in FIG.
15B, filament 99 is implanted in tissue so as to provide elevation
of the bladder in the region of the bladder neck 93. The filament
99 is inserted using cannula 98 to which is affixed delivery tool
97. Detailed descriptions of the delivery tool 97 are provided
below. It will be appreciated that other organs and tissue may be
similarly supported or relocated using similar techniques.
[0080] FIG. 16 shows an embolism that has been achieved in a blood
vessel by means of a filament implanted in accordance with an
embodiment of the invention. Here filament 106 has been inserted to
create an embolism in the blood vessel 101. Insertion of the
filament is achieved first by appropriate placement of guide wire
103 in a manner known in the art. Catheter 102 is equipped with a
cutter 104 and a side hole 105 from which emanates the filament
106. After an appropriate length of filament has been implanted in
the blood vessel 101, the cutter 104 is used to cut the filament at
the point where it emanates from the catheter, and the catheter and
guide wire are thereupon removed. A technique similar to this may
be utilized in other tissue to prevent flow or leakage.
[0081] FIG. 17 shows an aneurysm that has been filled by means of a
filament implanted in accordance with an embodiment of the
invention. In this figure filament 106 is used to fill aneurysm 111
in blood vessel 101. Again insertion is achieved utilizing guide
wire 103 over which catheter 102 is inserted. The catheter 102 is
used to carry the filament 106, which emerges from side hole 105
and is cut, after a desired length has been implanted, by cutter
104.
[0082] FIGS. 18A through 26 illustrate various embodiments of the
invention for achieving the movement of a filament along a desired
path so as to permit implantation of the filament. It will be
appreciated that these embodiments, which provide an engine for the
advance of filament in a catheter, may be incorporated in a variety
of delivery tools. One type of delivery tool may be in the form of
a completely hand-held unit, which includes a spool or cartridge of
filament, the filament-advance engine, as well as a fitting to
receive a catheter or other insertion device. The entire unit may
be disposable or it may be provided with features making it able to
withstand sterilization in an autoclave or by other means.
Similarly, it is within the scope of the present invention to put
the filament-advance engine in a first case, along with a cassette
or spool of filament, and permit the case to be placed on a table
or otherwise suspended or mounted in a convenient location for use.
In this connection, there may be attached to the case a disposable
cannula for carrying the filament to the site of the operation. The
cannula may be fitted with a suitable handle and control
arrangement, as well as a tip. The cannula, handle and tip may all
be implemented as disposables or alternatively as sterilizable
items. The filament advance engine may be motor driven or hand
driven. In the event that it is hand driven, power to the device
may be provided by successive squeezes of a trigger or lever
against a handle for the tool; the extent of the squeeze may
regulate the extent of the advance of the filament.
[0083] As discussed above, the filament may be a monofilament made,
for example, of a suitable polymer such as nylon, polybutylester,
or polypropylene. Alternatively the filament may be braided. In the
case of a braided filament and in some instances in the case of a
monofilament, the flexibility of the filament may make it difficult
to advance, even in a cannula. Accordingly, in an embodiment of the
invention, the filament is treated with a suitable stiffening
agent, typically at a time prior to placement of the filament in
the delivery tool. This stiffening agent is preferably made up of
an absorbable material, such as starch, but it is within the scope
of the invention to utilize other materials that provide requisite
stiffness and avoid the irritation of tissue. The stiffness of a
filament may also be varied through temperature-effects in situ,
such as by use of the temperature-dependent properties of polymers
and other materials, as known to persons skilled in the art.
[0084] The filament may be provided to the delivery tool in a spool
or other convenient form. In this respect, it should be noted that
it is typical for many filament materials to have some shape
memory, and the manner in which the filament is spooled can affect
the manner in which the filament responds as it emanates from the
delivery tool and even as it is being advanced through the delivery
tool. Accordingly the spooling of the filament may be implemented
in a manner designed to provide characteristics suitable for the
particular implantation task at hand. Where it is desired, for
example, to have the filament tightly occupy a small volume, the
filament may be wound on a spool of small diameter and heated in
place on the spool to cause memorization of the small-radius
associated with the spool. Note that the small-radius may be
retained in shape memory even if the filament must be subsequently
be rewound onto a different spool for insertion into the delivery
tool. It is also possible, of course, to sterilize the filament
after it has been wound onto the spool.
[0085] FIGS. 18A and 18B illustrate an embodiment for achieving
movement of a filament utilizing a pair of conveyor belts
symmetrically engaged against the filament. Here the conveyor belts
121 and 122 engage against the filament 123. The belts are driven
by one or more of the pulleys 124 about which they are mounted. The
filament 123 is fed through an input conduit 126 into an output
conduit 125 that is located preferably close to the location where
the filament emerges from the pair of belts so as to prevent
bunching. The outer diameter of output conduit 125 may be ground
down to allow close proximity between output conduit 125 and
conveyor belts 121 and 122.
[0086] FIG. 19 illustrates an embodiment for achieving movement of
a filament utilizing a toothed drive wheel against which the
filament is engaged by an idler wheel. The toothed drive wheel is
shown as item 131 and the idler wheel as item 132. Also shown are
the input conduit 126 and the output conduit 125. The outer
diameter of output conduit 125 may be ground down to allow close
proximity between output conduit 125 and drive wheels 131 and
132.
[0087] FIG. 20 illustrates an embodiment, similar to that of FIG.
19, utilizing a toothed drive wheel against which the filament is
engaged by an idler wheel, but wherein the filament is also engaged
against the drive wheel by a guide having an arcuate surface that
general conforms to the radius of the drive wheel. Here the guide
is shown as item 141, and it replaces input conduit 126. The
advantage of this arrangement is that it increases the length of
the filament 123 that is engaged by drive wheel 131 and therefore
ensures better traction by the drive wheel 131.
[0088] FIGS. 21A and 21B illustrate an embodiment, similar to that
of FIG. 19, utilizing a toothed drive wheel 131 against which the
filament is engaged by an idler wheel 132, but wherein the idler
wheel at 132 is soft.
[0089] FIG. 22 illustrates an embodiment for achieving movement of
a filament utilizing a toothed drive wheel against which the
filament is engaged by a tubular guide. In this figure the drive
wheel 131 operates through a slot formed in the tubular guide 161.
This embodiment has the advantage of achieving a complete merger of
the input and output conduits.
[0090] FIGS. 23A and 23B illustrate an embodiment for achieving
movement of a filament utilizing a drive wheel against which the
filament is engaged by an idler belt. In this figure the drive
wheel 171 is shown to engage the filament 123 against belt 173 that
is disposed around pulleys 172. The filament emerges through exit
conduit 125.
[0091] FIGS. 24A through 24E illustrate an embodiment for achieving
movement of a filament utilizing a pair of axially reciprocating
tubular members, within which the filament is disposed, in
conjunction with a periodically clamping finger. In these figures
the tubular members 181 and 182 operate within sleeve 185. Tubular
member 181 is caused to move within the sleeve 185 carrying the
filament 123 with it during the feeding phase. The finger 186 is
spring loaded to cause the tip 187 of the finger to press against
the filament 123 in channel 189 of the tubular member 181. During
the reset phase, filament 123 is trapped from retrograde movement
by finger 186. In FIG. 24A, the tubular member 181 is fully
advanced, having just completed a stroke. In FIG. 24B, the tip 187
of finger 186 has been caused to move away from the filament 123 in
channel 189 owing to action of the sliding cam 188. The
disengagement of the finger 186 from the filament permits the
tubular member 181 to slide axially to the left in sleeve 185
without causing any motion of the filament in a leftward direction.
The assembly consisting of the tubular member 181 and the finger
186 with its cam 188 is thus shown fully retracted in FIG. 24C. In
FIG. 24D the cam 188 has been slid to the right, permitting the
finger 186 to engage the filament 123 at the tip 187 of the finger.
The finger so engaged is shown in FIG. 24D. At this point the
tubular member and finger assembly can then advance to the right as
shown in FIG. 24A. In order to maintain the shape of the filament
123, between the termination of the tubular members 181 and 182 is
a spring 183 within the sleeve 185. These springs surround the
filament and tend to reduce any bowing of the filament that would
prevent transmission of force along its length. FIG. 24E shows the
assembly of FIGS. 24A through 24D rotated 90.degree. Here it can be
seen that the sliding cam 188 may receive reciprocating power at
tab 188a. A slot 188b is formed in a portion of the cam through
which protrude posts 181a and 181b that are coupled rigidly to the
tubular member 181. Accordingly, when the cam is urged to the right
and when post 181a hits the leftmost limit of slot 188b, the power
provided at tab 188a will cause the tubular member 181 to move to
the right. When the post 181b encounters the rightmost portion of
slot 188b, the tubular member 181 will be moved to the left. This
arrangement permits the same reciprocating power at tab 188a to
actuate both the cam 188 and the tubular member 181. As shown in
certain other embodiments, it may be necessary or desirable to
provide a suitable arrangement for applying a slight resistance to
leftward motion of the filament when the tubular member 123 is
undergoing retraction from the fully advanced position.
[0092] FIGS. 25A through 25E illustrate an embodiment similar to
that of FIGS. 24A through 24E but in which the coil springs of the
latter figures are supplanted by complementary mating extensions of
the tubular members. In this case the tubular member 181 includes
the extension 191 and the tubular member 182 includes the extension
192. The strokes for advancing the filament in the case of FIGS.
25A through 25D correspond to the strokes described previously in
connection with FIGS. 24A through 24D. Similarly FIG. 25E
corresponds to FIG. 24E. It can be seen in FIG. 25C that as the
tubular members 181 and 182 are separated, some guidance for the
filament 123 is provided by the extensions 191 and 192 of the
tubular members 181 and 182 respectively. Although only a single
pair 191 and 192 of extensions are shown, it is within the scope of
the present invention to provide a plurality of extensions to each
of the tubular members 181 and 182 in such a way that the
extensions meet with each other when the tubular members 181 and
182 are fully advanced to provide the effect of a single conduit;
and when the tubular members are separated, a plurality of
extensions are present around the end of the tubular member to
provide support for the filament.
[0093] FIGS. 26A and 26B illustrate an embodiment for achieving
movement of a filament utilizing a pair of arms that are caused to
reciprocate axially while being alternately opened and closed at
the opposite ends of each stroke. In this figure are shown arms 201
and 202 that include tips 203 and 204 respectively for pinching
filament 123. Cam assembly 205 is arranged to cause successive
opening and closing of the arms 201 and 202 and therefore of the
tips 204 and 203. The cam assembly 205 is also configured to cause
reciprocating motion of the arm assembly in the left-right
direction, that is, in the direction of the length of filament 123.
Furthermore, the cam assembly 205 is configured so that a cycle of
operation causes the tips 203 and 204 to grab the filament 123 when
the arm assembly is in its leftmost position and to retain grip on
the filament until the arm assembly has reached its rightmost
position. At this position, on the arm assembly is caused to open,
whereupon grip of the tips 204 and 203 on the filament 123 is
released. In FIGS. 26A and 26B can be seen spool 207 of material
constituting filament 123 as well as output conduit through which
the filament 123 runs after exiting from the tips 204 and 203. In
the output conduit 207 is a channel into which protrudes pawl 206.
The pawl is angled in such a way that it offers little resistance
to forward motion of the filament, but offers considerable
resistance to rearward motion of the filament (forward motion being
to the right). If it is desired to retract the filament 123 the
arms 201 and 202 may be opened and the spool 207 may be powered to
effectuate rewinding, in which case the pawl 206 may also be
optionally disengaged from the filament. Alternatively, the spool
207 may be driven in reverse through a clutch arrangement and the
advance mechanism constituting the two arms may be run
backwards.
[0094] In the case of the filament-advance engines described above,
it is possible to monitor a number of parameters including the
number of revolutions of the filament spool, or (directly) the
length of filament being unspooled, as well as the number of
reciprocations or drive movements associated with attempts at
moving the filament. The drive movements can be matched against
actual filament movement in order to determine whether slippage is
taking place. If it is determined that slippage is present, an
alarm state may be entered to permit appropriate corrective
action.
[0095] FIGS. 27A through 30D illustrate embodiments of the
invention in which a region proximate to a tip of a cannula
carrying a filament is provided with an arrangement, for cutting
the filament, utilizing a concentrically disposed member and a
window in both members through which the filament is placed and
severed.
[0096] FIGS. 27A and 27B illustrate an embodiment wherein the outer
member is pulled proximally with respect to the inner member to
achieve cutting. In FIG. 27A there is shown inner member 212 in
relation to outer member 213. Filament 211 is carried in the lumen
of the inner member 212 and emanates from window 214. In FIG. 27B
the outer member 213 is pulled proximally with respect to the inner
member 212 so that a scissors action results from the passage of
edge 214 on the outer member 213 by the edge 215 of the inner
member 212. The result is the cutting of filament 211 at the
intersection of edges 214 and 215. The relative motion of the inner
member and outer member 213 causes the window 216 in the outer
member to cease to coincide with the window 214 of the inner
member. It should be noted that design of the edges 214 and 215 may
be implemented in a variety of fashions. In FIGS. 27A and 27B, 214
is beveled and 215 is straight. Alternatively 215 may be beveled
and 214 may be straight. In fact a successful scissors action may
be achieved when windows 214 and 215 are both straight,
particularly if the windows 214 and 216 are configured in such a
way that the intersection of the edges 214 and 215 moves somewhat
helically as outer member 213 is moved proximally.
[0097] FIGS. 28A and 28B illustrate an embodiment wherein the outer
member is pushed distally with respect to the inner member to
achieve cutting. In this figure the design is similar to that shown
in FIGS. 27A and 27B. Here pushing the outer member 221 distally
causes passage of the beveled edge 222 of outer member 221 by the
straight edge 223 of inner member 212 and consequent cutting of
filament 211. Equivalently, edge 223 may be beveled and 222 may be
straight, or both may be beveled, or neither may be beveled.
[0098] FIGS. 29A through 29C illustrate an embodiment wherein the
inner and outer members are rotated with respect to one another to
achieve cutting. The outer member 231 is permitted to rotate around
inner member 212 to cause cutting of the fiber 211 emerging through
the window 232. The effect of the rotation can be seen in the cross
section taken at BB and shown in FIGS. 29B and 29C. The effect of
the rotation is to cause edge 233 of outer member 231 to slice the
filament 211 against the edge 234 of inner member 212.
[0099] FIGS. 30A through 30D illustrate the way a tip, having a
cutting arrangement of one of the types described above, may be
employed in conjunction with a suitable window to prevent the
presentation of undue pressure, by the distal end of the filament,
on tissue of the subject on whom the invention may be used. In
FIGS. 30A through 30D is shown a push cutter arrangement similar to
that shown and discussed in connection with FIGS. 28A and 28B.
There is thus an outer member 221 having a bevel 222 and an inner
member 212. A window 243 is provided in the inner member to permit
the emergence of a loop of filament 211. The end of the filament
may be suitably captured in region 242 near the tip 241 of inner
member 212. Using a filament-advance engine in accordance with a
suitable embodiment such as described above, the filament may be
caused to leave the exit window 243 while keeping the end of the
filament engaged near the tip 241. The advantage of following such
a procedure is that the loop of filament material will exert less
pressure on tissue than would a free end; in this way the risk of
lesion to surrounding tissue is reduced. In the course of advancing
the filament into tissue, the end of the filament will eventually
leave the tip region 242; however at this point, owing to the
presence of a substantial portion of filament length already
present, the forces associated with movement at the end of the
filament are dramatically reduced. After a desired quantity of
filament has been implanted, the outer member 221 is used to cause
cutting of the filament 211. Cutting is initiated therefore by
moving outer member 221 distally, as shown in FIG. 30C. In FIG.
30D, the filament 211 has been cut, and it can be seen that by
further advancing the filament. The end will again be engaged in
tip region 242, so that when desired the window 243 can again be
opened by withdrawal of the outer member 221 and the process begun
anew.
[0100] It will be appreciated that the size of the exit window 243
may be selected to take into account the particular nature of the
implantation desired and the filament employed. For example, if it
is desired that the material be concentrated in a very small region
or if the filament is very flexible, then a smaller exit window may
be appropriate, whereas if a larger region is to be treated or a
stiffer filament is used, a larger exit window will be
indicated.
[0101] In general, when a guide wire is utilized in connection with
a cannula used for filament implantation herein, the guide wire may
be utilized in a separate lumen of the cannula. Alternatively, it
is within the scope of the present invention to utilize a common
lumen for both the guide wire and the filament.
[0102] FIGS. 31A and 31B, and 32A and 32B, illustrate a possible
configuration for a case for an embodiment similar to that of FIGS.
26A and 26B. In this configuration a cannula for insertion of the
filament may be attached at fitting 251, and a handle 253 for
actuating a cutter is also provided. A cable assembly 254 is
removably attachable to the body of 255 to supply rotational power
to the tool. Knob 252 is coupled to an internally located spool of
filament.
[0103] The described embodiments of the inventions are intended to
be merely exemplary and numerous variations and modifications will
be apparent to those skilled in the art. All such variations and
modifications are intended to be within the scope of the present
invention as defined in the appended claims.
* * * * *