U.S. patent application number 15/957636 was filed with the patent office on 2018-08-23 for radial cutter implant.
The applicant listed for this patent is Medi-Tate Ltd.. Invention is credited to Ido KILEMNIK.
Application Number | 20180235651 15/957636 |
Document ID | / |
Family ID | 42109750 |
Filed Date | 2018-08-23 |
United States Patent
Application |
20180235651 |
Kind Code |
A1 |
KILEMNIK; Ido |
August 23, 2018 |
RADIAL CUTTER IMPLANT
Abstract
An implant for creating incisions in the tissues surrounding the
bladder neck and the urethra of a patient, for relaxing the opening
of the bladder, the implant includes a central connector and at
least one wire, the wires extend radially outwardly from the center
of the central connector, the wires apply continuous pressure on
the surrounding tissues, the wires are foldable within an implant
sheath for enabling delivery and extraction thereof, the implant is
implanted within a restricted location of the urethra for a period
of time for creating incisions at the locations where the wires
apply pressure on the surrounding tissues.
Inventors: |
KILEMNIK; Ido; (Haniel,
IL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Medi-Tate Ltd. |
Or Akiva |
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IL |
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|
Family ID: |
42109750 |
Appl. No.: |
15/957636 |
Filed: |
April 19, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15782754 |
Oct 12, 2017 |
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15957636 |
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13141307 |
Jul 28, 2011 |
9848905 |
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PCT/IL2009/001207 |
Dec 22, 2009 |
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15782754 |
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61288426 |
Dec 21, 2009 |
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61139718 |
Dec 22, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/94 20130101; A61F
2002/048 20130101; A61F 2230/006 20130101; A61F 2230/0076 20130101;
A61F 2230/0058 20130101; A61B 2017/2945 20130101; A61B 2017/32096
20130101; A61B 17/320725 20130101; A61F 2220/0016 20130101; A61F
2250/0059 20130101; A61B 2017/00274 20130101; A61B 2018/00547
20130101 |
International
Class: |
A61B 17/3207 20060101
A61B017/3207; A61F 2/94 20130101 A61F002/94 |
Claims
1. A urethra Implant comprising wires forming at least one closed
shape, said closed shape exhibiting an expanded configuration, said
closed shape being foldable into a folded configuration, said at
least two of said wires further being configured to extend from
said folded configuration to said expanded configuration such that
the distance between sections of said wires increases, relative to
said distance between said sections of said wires in said
compressed configuration, the implant is configured to be implanted
within a restricted location of the urethra and for applying
pressure on said surrounding tissue.
2. The implant according to claim 1, wherein said wires are
foldable by a restrainer for enabling delivery and extraction of
said removable implant
3. The implant according to claim 1, further comprising a proximal
end coupled with at least one of said wires, said proximal end
being tapered.
4. The implant according to claim 1, wherein the shape of at least
one of said wires is selected from the list consisting of: the
shape of said at least one of said wires being wider at the
proximal end than at the distal end thereof for preventing said
removable implant from moving in the distal direction; the shape of
said at least one of said wires being wider at the distal end than
at the proximal end thereof for preventing said removable implant
from moving in the proximal direction; the shape of said at least
one of said wires being narrower at the middle thereof than at the
distal and proximal portions thereof for preventing said removable
implant from moving in the proximal direction and in the distal
direction; and a butterfly wing.
5. The implant according to claim 1, wherein said implant being for
creating incisions is said urethra.
6. The implant according to claim 1, wherein said implant being for
the prostatic urethra.
7. The implant according to claim 1, wherein said sections of said
wires are lateral sections.
8. A urethra implant comprising a flexible configuration defining
at least two longitudinal wires arranged in at least one closed
shape, said closed shape exhibiting an expanded configuration, said
closed shape being foldable into a folded configuration, said at
least two longitudinal wires further being configured to extend
from said folded configuration to said expanded configuration such
that the distance between sections of said at least two
longitudinal wires increases, relative to said distance between
said sections of said at least two longitudinal wires in said
compressed configuration, the urethra implant is configured to be
implanted within a restricted location of the urethra whereby said
at least two wires apply pressure on tissues surrounding said
urethra implant.
9. The implant according to claim 8, wherein said at least two
longitudinal wires are foldable by a restrainer for enabling
delivery and extraction of said removable implant
10. The implant according to claim 8, further comprising a proximal
end coupled with at least one of said at least two longitudinal
wires, said proximal end being tapered.
11. The implant according to claim 8, wherein the shape of at least
one of said at least two longitudinal wires is selected from the
list consisting of: the shape of said at least one of said at least
two longitudinal wires being wider at the proximal end than at the
distal end thereof for preventing said removable implant from
moving in the distal direction; the shape of said at least one of
said at least two longitudinal wires being wider at the distal end
than at the proximal end thereof for preventing said removable
implant from moving in the proximal direction; the shape of said at
least one of said at least two longitudinal wires being narrower at
the middle thereof than at the distal and proximal portions thereof
for preventing said removable implant from moving in the proximal
direction and in the distal direction; and a butterfly wing.
12. The implant according to claim 8, wherein said implant being
for creating incisions is said urethra.
13. The implant according to claim 8, wherein said implant being
for the prostatic urethra.
14. The implant according to claim 8, wherein said at least two
longitudinal wires include lateral sections.
15. A urethra implant comprising a flexible wire like structure
defining at least two wire like sections of finite length, coupled
there-between at one end thereof, each said wire like section
having a longitudinal wire portion, said flexible wire like
structure exhibiting an expanded configuration, said flexible wire
like structure being foldable into a folded configuration, said at
least two longitudinal wire sections further being configured to
extend from said folded configuration to said expanded
configuration such that the distance between sections of said wires
increases, relative to said distance between said sections of said
wires in said compressed configuration, the urethra implant is
configured to be implanted within a restricted location of the
urethra whereby said at least two longitudinal wire portions apply
pressure on tissues surrounding said urethra implant.
16. The implant according to claim 15, wherein said wire like
structure is foldable by a restrainer for enabling delivery and
extraction of said removable implant
17. The implant according to claim 15, further comprising a
proximal end coupled with said wire like structure, said proximal
end being tapered.
18. The implant according to claim 15, wherein the shape of at
least one of said at least two wire like sections is selected from
the list consisting of: the shape of said at least one of said at
least two wire like sections being wider at the proximal end than
at the distal end thereof for preventing said removable implant
from moving in the distal direction; the shape of said at least one
of said at least two wire like sections being wider at the distal
end than at the proximal end thereof for preventing said removable
implant from moving in the proximal direction; the shape of said at
least one of said at least two wire like sections being narrower at
the middle thereof than at the distal and proximal portions thereof
for preventing said removable implant from moving in the proximal
direction and in the distal direction; and a butterfly wing.
19. The implant according to claim 15, wherein said implant being
for creating incisions is said urethra.
20. The implant according to claim 15, wherein said implant being
for the prostatic urethra.
21. The implant according to claim 15, wherein said sections of
said at least two wire like sections are lateral sections.
22. Urethra implant comprising at least two closed shapes, each of
said at least two closed shapes having a proximal section, a distal
section and two lateral sections extending between said proximal
section and said distal section, adjacent pairs of said at least
two closed shapes share a common lateral section, said at least two
close shapes being elastically compressible into a compressed
configuration, said at least two closed shapes being configured to
extend from said compressed configuration to an extended
configuration, such that the distance between said lateral sections
increases relative to said distance there-between in said
compressed configuration, each pair of said lateral sections
defining a plane, said plane excluding the remaining others of said
lateral sections.
23. The implant according to claim 22, wherein said at least two
closed shapes are foldable by a restrainer for enabling delivery
and extraction of said removable implant
24. The implant according to claim 22, further comprising a
proximal end coupled with at least one of said at least two closed
shapes, said proximal end being tapered.
25. The implant according to claim 22, wherein the shape of at
least one of said at least two closed shapes is selected from the
list consisting of: the shape of said at least one of said at least
two closed shapes being wider at the proximal end than at the
distal end thereof for preventing said removable implant from
moving in the distal direction; the shape of said at least one of
said at least two closed shapes being wider at the distal end than
at the proximal end thereof for preventing said removable implant
from moving in the proximal direction; the shape of said at least
one of said at least two closed shapes being narrower at the middle
thereof than at the distal and proximal portions thereof for
preventing said removable implant from moving in the proximal
direction and in the distal direction; and a butterfly wing.
26. The implant according to claim 22, wherein said implant being
for creating incisions is said urethra.
27. The implant according to claim 22, wherein said implant being
for the prostatic urethra.
28. A urethra implant comprising a flexible structure including at
least one wire like section of finite length and a flexible
rectangular section coupled there-between at the ends thereof, said
flexible structure exhibiting an expanded configuration, said
flexible structure being foldable into a folded configuration, said
flexible structure further being configured to extend from said
folded configuration to said expanded configuration such that the
distance between said at least one wire and said rectangular
section increase, relative to said distance between said at least
one wire and said rectangular section increase in said folded
configuration, the urethra implant is configured to be implanted
within a restricted location of the urethra whereby said at least
one wire and said rectangular section apply pressure on tissues
surrounding said urethra implant.
29. The implant according to claim 28, wherein said structure is
foldable by a restrainer for enabling delivery and extraction of
said removable implant.
30. The implant according to claim 28, further comprising a
proximal end coupled with at least one of said at least two wires,
said proximal end being tapered.
31. The implant according to claim 28, wherein the shape of said
structure is selected from the list consisting of: the shape of
said structure being wider at the proximal end than at the distal
end thereof for preventing said removable implant from moving in
the distal direction; the shape of said structure being wider at
the distal end than at the proximal end thereof for preventing said
removable implant from moving in the proximal direction; the shape
of said structure being narrower at the middle thereof than at the
distal and proximal portions thereof for preventing said removable
implant from moving in the proximal direction and in the distal
direction; and a butterfly wing.
32. The implant according to claim 28, wherein said implant being
for creating incisions is said urethra.
33. The implant according to claim 28, wherein said implant being
for the prostatic urethra.
34. The implant according to claim 28, wherein said at least one
wire like section is a lateral section.
Description
[0001] This application is a Continuation of U.S. application Ser.
No. 15/782,754, filed Oct. 12, 2017, which is a Continuation of
U.S. application Ser. No. 13/141,307, filed Jul. 28, 2011, which is
a National Stage Application of PCT/IL2009/001207, filed Dec. 22,
2009, which claims benefit of U.S. Provisional Application No.
61/288,426, filed Dec. 21, 2009 and U.S. Provisional Application
No. 61/139,718, filed Dec. 22, 2008, which applications are
incorporated herein by reference. To the extent appropriate, a
claim of priority is made to the above disclosed applications.
FIELD OF THE DISCLOSED TECHNIQUE
[0002] The disclosed technique relates to system and method for
treating a prostate enlargement (e.g., as a result of benign
prostatic hyperplasia), in general, and to systems and methods for
creating incisions in the muscles of the bladder neck, in
particular.
BACKGROUND OF THE DISCLOSED TECHNIQUE
[0003] The prostate is a walnut-sized gland that forms part of the
male reproductive system. The prostate is located in front of the
rectum and just below the bladder, where urine is stored. The
prostate surrounds the urethra, the canal through which urine
passes out of the body. Prostate enlargement can result from a
number of medical problems such as Benign Prostatic Hyperplasia
(BPH), prostatic Bladder Neck Obstruction (BNO) and the like. The
enlarged prostate applies pressure on the urethra and damages
bladder function.
[0004] Transurethral incision of the prostate (TUIP) is an
endoscopic procedure usually performed under general anaesthetic in
which a surgeon employs an instrument (e.g., a scalpel, a laser
beam generator and an electrical current actuator) inserted into
the urethra for making incisions in the bladder neck where the
prostate meets the bladder (i.e., more specifically in the midline
to the level of the verumontanum). Incising the muscles in the
bladder neck area relieves the obstructive effect of the prostate
on the bladder neck and prostatic urethra and relaxes the opening
of the bladder, thus decreasing resistance to the flow of urine out
of the bladder. It is noted that, no tissue is removed during
TUIP.
[0005] Infarction is a process resulting in a macroscopic area of
necrotic tissue in some organ caused by loss of adequate blood
supply. The inadequate blood supply can result from pressure
applied to the blood vessels. Even by applying a relative small but
continuous pressure on a tissue, one can block the tiny blood
vessels within the tissue and induce infarction.
[0006] PCT patent application publication No. WO 2006/040767 A1 to
the inventor, entitled "Prostate Treatment Stent" is directed at a
tissue dissecting implant kit. The tissue dissecting implant kit
includes an implant and a sterile package. The implant includes a
plurality of rings elastically coupled there-between. An elastic
pressure is applied on tissue caught between adjacent rings. The
sterile package encompasses the implant. The implant has different
distances between adjacent rings along its length. Alternatively,
the implant has different material thickness or cross-section shape
along its length. It is noted that, the tissue dissecting implant
kit applies pressure on tissue caught between adjacent rings until
the tissue is cut away or until the tissue falls off.
[0007] U.S. Pat. No. 5,209,725 issued to Roth, and entitled
"Prostatic Urethra Dilatation Catheter System and Method", is
directed to an instrument for performing a transurethral balloon
dilatation procedure of the prostate. The balloon dilatation
instrument includes a hollow catheter and optical viewing means.
The hollow catheter includes a shaft, an inflatable optically
transparent balloon, and at least one suitable visible marking.
[0008] The distal end portion of the shaft is made of an optically
transparent material. The inflatable optically transparent balloon
is coupled with the distal end portion of the shaft, and is sized
to dilate the prostatic urethra. The at least one suitable visible
marking is positioned on the catheter proximally to the balloon,
such that the marking can be visualized relative to a predetermined
anatomical landmark (e.g., verumon tanum). In this manner, proper
positioning of the balloon, relative to the prostatic urethra, is
performed prior to and during the dilation of the prostatic
urethra. The optical viewing means, is slidable within the
catheter, for visibly viewing the marking intra-luminally from
within the catheter. The balloon is correctly located relative to
the prostatic urethra. The balloon is inflated so as to dilate the
prostatic urethra without damaging the external sphincter at the
apex of the prostate.
[0009] U.S. Pat. No. 5,499,994 issued to Tihon et al., and entitled
"Dilation Device for the Urethra", is directed to a dilation device
for opening a portion of an obstructed urethra. The dilation device
includes an inner hollow tubular core and an outer confining
covering. The inner hollow tubular core defines a lumen therein.
The lumen is a conduit of sufficient diameter to permit urine to
flow freely there-through from the bladder. The core is
substantially non-collapsible. The outer confining covering is
capable of expanding radially outwardly to a predetermined extent.
The covering has a length of at least partially that of the
obstructed portion of the urethra. The dilation device can further
include retractable spikes for anchoring the device in its intended
position.
SUMMARY OF THE PRESENT DISCLOSED TECHNIQUE
[0010] It is an object of the disclosed technique to provide a
novel method and system for creating incisions in the muscles of
the bladder neck by implanting a radial cutter implant which
applies continuous pressure on the muscles of the bladder neck.
[0011] In accordance with the disclosed technique, there is thus
provided an implant for creating incisions in the tissues
surrounding the bladder neck and the urethra of a patient, for
relaxing the opening of the bladder. The implant includes a central
connector and at least one wire. The wires extend radially
outwardly from the center of the central connector. The wires apply
continuous pressure on the surrounding tissues. The wires are
foldable within an implant sheath for enabling delivery and
extraction thereof. The implant is implanted within a restricted
location of the urethra for a period of time for creating incisions
at the locations where the wires apply pressure on the surrounding
tissues.
[0012] In accordance with another embodiment of the disclosed
technique, there is thus provided a method for creating incisions
in the tissues surrounding the bladder neck and the urethra of a
patient for relaxing the opening of the bladder. The method
includes the procedures of delivering a radial cutter implant,
releasing the radial cutter, applying continuous pressure, and
extracting the radial cutter implant. The radial cutter implant is
delivered to a constricted location within the urethra by employing
a delivery system. After the radial cutter implant is delivered the
delivery system is removed. The continuous pressure is applied on
the surrounding tissues by employing the radial cutter implant. At
the appearance of a predetermined condition, the radial cutter
implant is extracted from the patient.
[0013] In accordance with a further embodiment of the disclosed
technique, there is thus provided a delivery system for delivering
a radial cutter implant. The delivery system includes a positioning
tube, a balloon tube, a balloon, an internal delivery tube, and an
implant sheath. The balloon tube slidably goes through the
portioning tube. The balloon is coupled with a distal end of the
balloon tube. The balloon is inflatable via the balloon tube. The
radial cutter implant is coupled with a distal end of the internal
delivery tube. The implant sheath is externally slidably coupled
with the internal delivery tube for holding the radial cutter
implant at a folded configuration during delivery and extraction
thereof. A physician inserts the positioning tube and the balloon
tube into a urethra of a patient until the balloon is positioned
inside a bladder of the patient. The physician inflates the balloon
and pulls the positioning tube and the balloon tube in the distal
direction until the balloon is blocked by a bladder neck of the
patient. The physician deflates the balloon. The physician removes
the balloon tube while keeping the positioning tube in place. The
physician inserts the internal delivery tube including the implant
sheath, having the radial cutter implant folded therein. The
physician positions the radial cutter implant within a constricted
location of the urethra, according to the position of the
positioning tube. The physician pulls the implant sheath and
exposes the radial cutter implant. The radial cutter implant
expands and applies pressure on surrounding tissues. The physician
removes the internal delivery tube, including the implant
sheath.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The disclosed technique will be understood and appreciated
more fully from the following detailed description taken in
conjunction with the drawings in which:
[0015] FIG. 1 is a schematic illustration of an overtube for
determining the location of a bladder neck of a patient and
delivering a radial cutter implant thereto, constructed and
operative in accordance with an embodiment of the disclosed
technique;
[0016] FIG. 2 is a schematic illustration of a delivery for
delivering a radial cutter implant to the bladder neck of a
patient, constructed and operative in accordance with another
embodiment of the disclosed technique;
[0017] FIGS. 3A, 3B and 3C are schematic illustrations of a system
for delivering a radial cutter implant to the bladder neck of a
patient, constructed and operative in accordance with a further
embodiment of the disclosed technique;
[0018] FIGS. 4A, 4B and 4C are schematic illustrations of a
delivery for delivering a radial cutter implant, constructed and
operative in accordance with another embodiment of the disclosed
technique;
[0019] FIG. 5A is a schematic illustration of a coupler for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0020] FIG. 5B is a schematic illustration of a coupler for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0021] FIGS. 5C and 5D are schematic illustrations of a coupler for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0022] FIG. 5E is a schematic illustration of a coupler for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0023] FIGS. 6A and 6B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0024] FIGS. 7A and 7B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0025] FIG. 8 is a schematic illustration of a radial cutter
implant, constructed and operative in accordance with a further
embodiment of the disclosed technique;
[0026] FIGS. 9A and 9B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0027] FIGS. 10A and 10B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0028] FIGS. 11A and 11B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0029] FIG. 12 is a schematic illustration of a radial cutter
implant, constructed and operative in accordance with a further
embodiment of the disclosed technique;
[0030] FIGS. 13A, 13B and 13C are schematic illustrations of a
radial cutter implant, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0031] FIG. 14 is a schematic illustration of radial cutter
implant, constructed and operative in accordance with a further
embodiment of the disclosed technique;
[0032] FIGS. 15A and 15B are schematic illustrations of a radial
cutter implant, constructed and operative in accordance with
another embodiment of the disclosed technique;
[0033] FIGS. 16A to 16D are schematic illustrations of a redial
cutter implant, constructed and operative in accordance with a
further embodiment of the disclosed technique;
[0034] FIG. 17 is a schematic illustration of a redial cutter
implant, positioned within a bladder neck of a patient, constructed
and operative in accordance with another embodiment of the
disclosed technique; and
[0035] FIG. 18 is a schematic illustration of a method for creating
incisions in the muscles of the bladder neck by infarction,
operative in accordance with a further embodiment of the disclosed
technique.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0036] The disclosed technique overcomes the disadvantages of the
prior art by providing an implant for applying small yet continuous
pressure on the tissues of the bladder neck sphincter (i.e., as
well as tissues of the urethra and the prostate gland) by a
plurality of wires. The pressure induces infarction in the tissues
(i.e., tissues of the bladder neck, urethra, and prostate gland)
which creates a plurality of desired incisions (i.e., each of the
wires creates an incision). The incisions relive a prostate
enlargement problem by cutting through the tissues and extending
the urinal passage (i.e., the wires both incise and extend the
tissues in the radial direction from the urethra axis outwardly).
The disclosed technique further includes a delivery and deployment
system for the incising implant. It is noted that, in this
application, a radial cutter implant which applies pressure on the
tissues of the bladder neck, further applies pressure on the
tissues of the prostate and urethra unless specifically mentioned
otherwise along the text.
[0037] The terms proximal and distal refer to directions relative
to the body of the patient. In particular, the term proximal refers
to a direction facing toward the center of the body of the patient.
The term distal refers to a direction facing the periphery of the
body of the patient, opposite of the proximal direction. For
example a catheter is inserted into the urethra of the patient with
the proximal end thereof first.
[0038] Reference is now made to FIG. 1, which is a schematic
illustration of an overtube, generally referenced 100, for
determining the location of a bladder neck of a patient and
delivering a radial cutter implant thereto, constructed and
operative in accordance with an embodiment of the disclosed
technique. Overtube 100 includes a balloon 102, a balloon tube 104
(i.e., balloon Foley-catheter 104), and a positioning tube 106.
Balloon 102 is coupled around balloon tube 104. Balloon tube 104
slidably goes through positioning tube 106.
[0039] Overtube 100 enables a physician (not shown) to deploy a
radial cutter implant (e.g., radial cutter implant 320 of FIG. 6A)
at the bladder neck of a patient (both bladder neck and patient are
not shown). The physician inserts overtube 100 through the urethra
of the patient until balloon 102 is positioned within the bladder
(e.g., bladder 152 of FIG. 3A) of the patient. The physician
inflates balloon 102 via balloon tube 104. When balloon 102 is
inflated, the physician pulls overtube 100 in the distal direction
(i.e., the physician pulls overtube 100 back towards him) until
inflated balloon 102 is blocked by the bladder neck. Thus, the
physician determines the exact position of the bladder neck of the
patient. The physician deflates balloon 102 and removes balloon
tube 104 from overtube 100 while leaving positioning tube 106 in
place. Alternatively, the physician can determine the location of
the bladder neck, and position positioning tube 106 accordingly, by
employing any method known in the art, such as Ureteroscopy,
Ultra-Sound imaging, fluoroscopy, and the like.
[0040] Reference is now made to FIG. 2, which is a schematic
illustration of a delivery system, generally referenced 120, for
delivering a radial cutter implant to the bladder neck of a
patient, constructed and operative in accordance with another
embodiment of the disclosed technique. Delivery system 120 includes
an implant sheath 122, an external tube 124, an external tube
handle 126, an internal tube proximal end 128, an internal tube
130, and an internal tube handle 132. Implant sheath 122 is coupled
with the proximal end of external tube 124. External tube handle
126 is coupled with the distal end of external tube 124. Internal
tube proximal end 128 is coupled with the proximal end of internal
tube 130. Internal tube 130 slidably goes through external tube
124. Internal tube handle 132 is coupled with the distal end of
internal tube 130.
[0041] A radial cutter implant (not shown--e.g., radial cutter
implant 320 of FIG. 6A) is detachably coupled with internal tube
proximal end 128 such that the implant is covered by implant sheath
122. In particular, and relating to the configuration of delivery
system 120, as depicted in FIG. 2, internal tube 130 slides along
external tube 124 in the distal direction until implant sheath 122
is positioned adjacent internal tube proximal end 128. In this
manner implant sheath 122 covers the radial cutter implant, thereby
restraining it.
[0042] The physician inserts delivery system 120 into the urethra
of the patient through positioning tube 106 of FIG. 1. The
physician employs positioning tube 106 (FIG. 1) for positioning the
radial cutter implant at the location of the bladder neck (i.e., or
of the restricted location of the urethra) as located by employing
overtube 100. Once the radial cutter implant is positioned within
the bladder neck, the physician exposes the radial cutter implant,
as detailed further with reference to FIGS. 3A to 3C.
[0043] Reference is now made to FIGS. 3A, 3B and 3C which are
schematic illustrations of a system, generally referenced 150, for
delivering a radial cutter implant to the bladder neck of a
patient, constructed and operative in accordance with a further
embodiment of the disclosed technique. With reference to FIG. 3A,
delivery system 150 includes an overtube 164, substantially similar
to overtube 100 of FIG. 1. Overtube 164 includes a balloon 158, a
balloon tube 160 and a positioning tube 162. Each of balloon 158,
balloon tube 160 and positioning tube 162 is substantially similar
to balloon 102, balloon tube 104 and positioning tube 106 of FIG.
1, respectively.
[0044] The physician inserts overtube 164 into a penis 182 of the
patient and through a urethra 154 (FIG. 3B) of the patient, until
balloon 158 is positioned within a bladder 152 of the patient. The
physician inflates balloon 158 via balloon tube 160. Once balloon
158 is inflated, the physician pulls back overtube 164 (i.e., in
the distal direction) until balloon 158 is blocked by bladder neck
156 of the patient. The physician deflates balloon 158 and removes
balloon tube 160 from within overtube 164 while keeping positioning
tube 162 in place. Thus, the physician locates the exact position
of bladder neck 156.
[0045] With reference to FIG. 3B, delivery system 150 further
includes a delivery 176, substantially similar to delivery system
120 of FIG. 2. Delivery 176 includes an implant sheath 166, an
external tube 168 (located within positioning tube 162 and is not
shown in the figure), an external tube handle 170, an internal tube
172, and an internal tube handle 174. Delivery system 150 further
includes a radial cutter implant 178 within implant sheath 166.
Each of implant sheath 166, external tube 168, external tube handle
170, internal tube 172, and internal tube handle 174, is
substantially similar to each of implant sheath 122, external tube
124, external tube handle 126, internal tube 130, and internal tube
handle 132, respectively.
[0046] After removing balloon tube 160 from overtube 164 (FIG. 3A),
the physician inserts delivery 176 into positioning tube 162. The
physician positions delivery 176 such that radial cutter implant
178 is positioned according to the position of positioning tube
162. The physician pulls external tube handle 170 for exposing
radial cutter implant 178. Radial cutter implant 178 expands until
it is attached to the walls of bladder neck 156 (i.e., to the
muscles of bladder neck 156 and the surrounding tissues). Radial
cutter implant 178 starts applying pressure to the walls of bladder
neck 156 and urethra 154 (i.e., as well as on tissues of the
prostate--not shown--as detailed herein above). In the example set
forth in FIG. 3B, radial cutter implant 178 is self expanding.
Alternatively, radial cutter implant 178 is expanded manually by
the physician by employing an expander (i.e., a device for
expanding implant 178 as known in the art--for example, a
balloon).
[0047] With reference to FIG. 3C, radial cutter implant 178 is
positioned within urethra 154 in an expanded configuration. The
physician pulls positioning tube 162 out of the patient and leaves
radial cutter implant within urethra 154 for a predetermined period
of time (as detailed herein below--e.g., two weeks). Radial cutter
implant 178 applies pressure on the walls of the surrounding
tissues (e.g., bladder neck 156, urethra 154, and the prostate
gland--not shown) incising the surrounding tissues over the
predetermined period of time. The prolonged incision of the tissue,
created by continuous pressure, decreases the pain involved in the
procedure. Furthermore, by performing the incisions via continuous
pressure (i.e., via infarction), bleeding is avoided.
[0048] The period of time, radial cutter implant 178 is implanted
in the urethra of the patient, is determined by the physician at
least according to the diagnosis of the patient (i.e.,
predetermined period of time). Alternatively, the time period is
determined according to observations of the radial cutter implant
effect over time (i.e., real time period determination), or any
other way known in the art. Further alternatively, the time period
ranges between one hour and twenty nine days.
[0049] Reference is now made to FIGS. 4A, 4B and 4C, which are
schematic illustrations of a delivery, generally referenced 200,
for delivering a radial cutter implant, constructed and operative
in accordance with another embodiment of the disclosed technique.
With reference to FIG. 4A, delivery 200 is substantially similar to
delivery system 120 of FIG. 2. Delivery 200 includes an implant
sheath 202, an external tube 204, an external tube handle 206, an
internal tube 208, and an internal tube handle 210. Each of implant
sheath 202, external tube 204, external tube handle 206, internal
tube 208, and internal tube handle 210 is substantially similar to
each of implant sheath 122, external tube 124, external tube handle
126, internal tube 130, and internal tube handle 132 of FIG. 2,
respectively.
[0050] Implant sheath 202 is coupled with the proximal end of
external tube 204. External tube handle 206 is coupled with the
distal end of external tube 204. A radial cutter implant 212 (FIG.
4B) is coupled, at a folded configuration thereof, with the
proximal end of internal tube 208 and is covered by implant sheath
202. Internal tube 208 is slidably coupled with external tube 204.
Internal tube handle 210 is coupled with the distal end of internal
tube 208.
[0051] With reference to FIG. 4B, a physician (not shown) pulls
external tube 204 via external tube handle 206 while keeping
internal tube 208 in place. Thus, external tube 204 slides along
internal tube 208 in the distal direction and implant sheath 202 is
removed from radial cutter implant 212.
[0052] With reference to FIG. 4C, once implant sheath 202 is fully
removed from radial cutter implant 212 (i.e., radial cutter implant
is fully exposed), radial cutter implant 212 expands. In the
example set forth in FIG. 4C, radial cutter implant 212 is
self-expanding. Alternatively, radial cutter implant 212 is
expanded manually by the physician employing an implant expander
(not shown).
[0053] The physician leaves radial cutter implant 212 within the
body of the patient for a predetermined period of time. When the
physician wishes to remove radial cutter implant 212, the physician
inserts delivery 200 into the urethra (not shown) of the patient.
The physician couples the proximal end of internal tube 208 with
radial cutter implant 212 by employing a coupler (not shown--e.g.,
coupler 240 of FIG. 5A). The physician pulls back internal tube 208
while keeping external tube 204 in place. Thus, radial cutter
implant 212 is folded within, and is restrained by, implant sheath
202 and can be extracted from the body (i.e., the bladder neck and
the urethra) of the patient, without damaging the tissues of the
urethra. It is noted that, the delivery of radial cutter implant
212 and the extraction thereof are substantially a reveres
duplicates of each other. In other words, the steps performed upon
delivery are repeated in a reveres order upon extraction.
[0054] Reference is now made to FIGS. 5A, 5B, 5C, 5D and 5E. FIG.
5A is a schematic illustration of a coupler, generally referenced
240, for coupling a radial cutter implant with an internal tube of
a delivery system, constructed and operative in accordance with a
further embodiment of the disclosed technique. FIG. 5B is a
schematic illustration of a coupler, generally referenced 250, for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with
another embodiment of the disclosed technique. FIGS. 5C and 5D are
schematic illustrations of a coupler, generally referenced 260, for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with a
further embodiment of the disclosed technique. FIG. 5E is a
schematic illustration of a coupler, generally referenced 280, for
coupling a radial cutter implant with an internal tube of a
delivery system, constructed and operative in accordance with
another embodiment of the disclosed technique.
[0055] With reference to FIG. 5A, coupler 240 includes a female
portion 246 and a male portion 248. Male portion 248 is inserted
into female portion 246 and is attached to female portion by
screwing mechanism. In other words, the external circumference of
male portion 248 is similar to that of a screw and the internal
circumference of female portion 246 is similar to that of a nut. In
the example set forth in FIG. 5A, female portion 246 is coupled
with the distal end of a radial cutter implant 242 (e.g., radial
cutter implant 320 of FIG. 6A), and male portion 248 is coupled
with the proximal end of an internal tube 244 of a delivery system
(e.g., internal tube 208 of FIG. 4A). Alternatively, female portion
246 is coupled with the proximal end of internal tube 244, and male
portion 248 is coupled with the distal end of radial cutter implant
242.
[0056] With reference to FIG. 5B, coupler 250 includes a loop 256
and a hook 258. Hook 258 is inserted into loop 256 such that the
physician is able to pull both hook 258 and loop 256 when pulling
either of them. In the example set forth in FIG. 5B, loop 256 is
coupled with the distal end of a radial cutter implant 252, and
hook 258 is coupled with the proximal end of an internal tube 254.
Alternatively, loop 256 is coupled with the proximal end of
internal tube 254, and hook 258 is coupled with the distal end of
radial cutter implant 252.
[0057] With reference to FIG. 5C, coupler 260 includes a dilating
tip 266 and a recessed tube 262 (i.e., a tube which is sliced for
forming a pair of pincers at the end thereof--the pincers are not
referenced). Recessed tube 262 is coupled with the proximal end of
a delivery system (e.g., delivery system 200 of FIG. 4A). Dilating
tip 266 is coupled with recessed tube 262, such that dilating tip
can be pulled into a recess 264 of recessed tube 262 and pushed out
of recess 264 of recessed tube 262. When dilating tip 266 is
positioned within recess 264, dilating tip 266 expands the diameter
of recessed tube 262. Recessed tube 262 is coupled with the
proximal end of an internal tube 262.
[0058] With reference to FIG. 5D, a distal end of a radial cutter
implant 274 is coupled with a bottleneck 272. Bottleneck 272
includes an aperture 270 positioned approximately in the middle
thereof. From the distal side of aperture 270 a gradually narrowing
niche 268 is culminating in aperture 270. The diameter of aperture
270 is slightly larger than the diameter of recessed tube 260 and
the diameter of dilating tip 266. The physician pushes dilating tip
266 and recessed tube 262 through aperture 270. After recessed tube
262 and dilating tip 266 are positioned proximally to aperture 270,
the physician pulls dilating tip 266 into recess 264 for enlarging
the diameter of recessed tube 262. When the physician pulls
recessed tube 262 back in the distal direction, radial cutter
implant 274 is pulled there-along (i.e., enlarged recessed tube 262
is blocked by aperture 270 of bottle neck 272). When the physician
pushes dilating tip 266 away from recess 264, recessed tube 262
returns to the original diameter thereof. Thus, recessed tube 262
and dilating tip 266 can go through bottleneck 272 (i.e., through
aperture 270).
[0059] In the example set forth in FIGS. 5C and 5D, recessed tube
262 and dilating tip 266 are coupled with an internal tube (not
referenced) of the delivery system, and bottle neck 272 is coupled
with a radial cutter implant 274. Alternatively, recessed tube 262
and dilating tip 266 are coupled with radial cutter implant 274,
and bottleneck 272 is coupled with the internal tube.
[0060] With reference to FIG. 5E, coupler 280 includes a rigid ball
286 and a flexible socket 292. Flexible socket 292 includes a
gradually narrowing opening 288 and a spherical niche 290. When
rigid ball 286 is pushed against flexible socket 292, rigid ball
286 enters through gradually narrowing opening 288 and expands the
proximal end thereof when entering spherical niche 290. Once rigid
ball 286 is positioned inside flexible socket 290 (i.e., rigid ball
286 is securely coupled with flexible socket 292), the physician
can pull flexible socket 292, and rigid ball 286 is pulled
there-along. In the example set forth in FIG. 5E, rigid ball 286 is
coupled with the distal end of a radial cutter implant 282, and
flexible socket 292 is coupled with the proximal end of an internal
tube 284. Alternatively, rigid ball 286 is coupled with the
proximal end of internal tube 284, and flexible socket 292 is
coupled with the distal end of radial cutter implant 282.
[0061] Reference is now made to FIGS. 6A and 6B, which are
schematic illustrations of a radial cutter implant, generally
referenced 320, constructed and operative in accordance with a
further embodiment of the disclosed technique. With reference to
FIG. 6A, radial cutter implant 320 is depicted from a side view
perspective. Radial cutter implant 320 includes a distal end 322,
three wires 326, 328 and 330, and a proximal end 324. Three wires
326, 328 and 330 are coupled between distal end 322 and proximal
end 324. Distal end 322 is coupled with a coupler (e.g., coupler
240, 250, 260, and 280 of FIGS. 5A, 5B, 5C, and 5E,
respectively).
[0062] Proximal end 324 is tapered for dilating the urethra of the
patient during delivery of radial cutter implant 320. The shape of
each of wires 326, 328 and 330, is substantially a portion of a
circle. Each of wires 326, 328 and 330 is made from a Shape Memory
Alloy (SMA), such as Nickel Titanium alloy (Nitinol).
Alternatively, each of wires 326, 328 and 330 is made from any
material which is flexible enough to be folded within an implant
sheath and is strong enough (e.g., 0.5 Newton) to apply pressure on
the surrounding tissues and induce infarction. Each of wires 326,
328 and 330 is flexible such that it can be straightened in order
for radial cutter 320 to be folded within an implant sheath (e.g.,
implant sheath 202 of FIG. 4A--not shown). Each of wires 326, 328
and 330 springs back to the portion of the circle stance, once not
limited by an obstacle (e.g., implant sheath 202 of FIG. 4A, the
walls of the bladder neck of the patient). In this manner, when
radial cutter implant 320 is positioned within the bladder neck of
the patient, wires 326, 328 and 330, apply pressure to the
surrounding tissues (e.g., bladder neck, urethra and prostate).
With reference to FIG. 6B, radial cutter implant 320 is depicted
from a bottom view perspective.
[0063] Alternatively, implant 320 is made of biodegradable
materials, such that there is no need to remove implant 320 from
the body of the patient. In this manner, implant 320 is constructed
such it biodegrades, ceases from functioning and dissolves within
the patient after the predetermined period of time, or after a
triggering event initiated by the physician, as known in the
art.
[0064] Reference is now made to FIGS. 7A and 7B, which are
schematic illustrations of a radial cutter implant, generally
referenced 350, constructed and operative in accordance with
another embodiment of the disclosed technique. With reference to
FIG. 7A, radial cutter implant 350 is depicted from a side view
perspective. Radial cutter implant 350 includes a distal end 352
and three wires 354, 356, and 358. Each of distal end 352 and wires
354, 356, and 358, is substantially similar to each of distal end
322, and wires 326, 328, and 330 of FIG. 6A, respectively. Wires
354, 356, and 358 are not coupled there-between at the proximal end
thereof. Radial cutter implant 350 operates in a substantially
similar manner to that of radial cutter implant 320. With reference
to FIG. 7B, radial cutter implant 350 is depicted from a bottom
view perspective.
[0065] Reference is now made to FIG. 8, which is a schematic
illustration of a radial cutter implant, generally referenced 380,
constructed and operative in accordance with a further embodiment
of the disclosed technique. Radial cutter implant 380 includes a
distal end 382 and three wires 384, 386 and 388. Distal end 382 is
substantially similar to distal end 322 of FIG. 6A. Each of wires
384, 386 and 388, is substantially similar to each of wires 326,
328 and 330 of FIG. 6A, respectively. Each of wires 384, 386 and
388 is in the shape of half a heart shape (i.e., the shape of a
single side of a heart shape). Each of wires 384, 386 and 388
extends from the distal side of distal end 382 and U-turns to
project proximally from distal end 382. In other words, each of
wires 384, 386 and 388 is bent such that it is coupled with the
distal side of distal end 382 and it extends proximally from distal
end 382. Radial cutter implant 380 operates in a substantial
similar manner to that of radial cutter implant 320 of FIG. 6A.
[0066] Reference is now made to FIGS. 9A and 9B, which are
schematic illustrations of a radial cutter implant, generally
referenced 410, constructed and operative in accordance with
another embodiment of the disclosed technique. With reference to
FIG. 9A, radial cutter implant 410 is depicted from a side view
perspective. Radial cutter implant 410 includes a distal end 412, a
proximal end 414 and two wires 416 and 418. Wires 416 and 418 are
coupled between distal end 412 and proximal end 414. Distal end 412
is substantially similar to distal end 322 of FIG. 6A. Each of
wires 416 and 418 is substantially similar to wire 326 of FIG. 6A.
Each of wires 416 and 418 is coupled with the distal side of distal
end 412 and with the proximal side of proximal end 414. Each of
wires 416 and 418 is substantially C shaped. Radial cutter implant
410 operates in a substantial similar manner to that of radial
cutter implant 320 of FIG. 6A. With reference to FIG. 9B, radial
cutter implant 410 is depicted from a bottom view perspective.
[0067] Reference is now made to FIGS. 10A and 10B, which are
schematic illustrations of a radial cutter implant, generally
referenced 440, constructed and operative in accordance with a
further embodiment of the disclosed technique. With reference to
FIG. 10A, radial cutter implant 440 is depicted from a side view
perspective. Radial cutter 440 includes a tube 442 and three wires
444, 446 and 448 (wire 448 is hidden behind tube 442 and is
depicted in FIG. 10B).
[0068] Each of wires 444, 446 and 448 is substantially similar to
each of wires 326, 328 and 330 of FIG. 6A. Each of wires 444, 446
and 448 is in the shape of a portion of a circle. The distal end of
each of wires 444, 446 and 448 is coupled with the distal portion
of tube 442, and the proximal end of each of wires 444, 446 and 448
is coupled with the proximal portion of tube 442. Tube 442 enables
a clear passage of urine from the bladder of the patient through
the bladder neck and into the urethra. The distal end of tube 442
can be coupled with an internal tube of a delivery system (e.g.,
delivery system 150 of FIGS. 3A to 3C) by employing a coupler
(e.g., coupler 240 of FIG. 5A). Radial cutter implant 440 operates
in a substantial similar manner to that of radial cutter implant
320. With reference to FIG. 10A, radial cutter implant 440 is
depicted from a bottom view perspective.
[0069] Reference is now made to FIGS. 11A and 11B, which are
schematic illustrations of a radial cutter implant, generally
referenced 470, constructed and operative in accordance with
another embodiment of the disclosed technique. With reference to
FIG. 11A, radial cutter implant 470 is depicted from an isometric
perspective. Radial cutter implant 470 includes a distal end 472,
four butterfly wing shaped wires 474, 476, 478 and 480, and a
proximal end 482. Distal end 472 is substantially similar to distal
end 322 of FIG. 6A. Proximal end 482 is substantially similar to
proximal end 324 of FIG. 6A. Each of butterfly wing shaped wires
474, 476, 478 and 480 is coupled between distal end 472 and
proximal end 482. Each of butterfly wing shaped wires 474, 476, 478
and 480 is flexible such that it can be folded within an implant
sheath (e.g., implant sheath 402 of FIG. 4A).
[0070] The shape of each of butterfly wing shaped wires 474, 476,
478 and 480 enables radial cutter implant 470 to be fixed in the
bladder neck of the patient without moving. Radial cutter implant
470 is narrower at the middle thereof than at the distal and
proximal portions thereof (i.e., butterfly wing shaped wires 474,
476, 478 and 480). In this manner, the narrow middle of radial
cutter implant 470 is positioned at the bladder neck of the
patient. The proximal portion of radial cutter implant 470 is
positioned within the bladder of the patient, and the distal
portion of radial cutter implant 470 is positioned within the
urethra of the patient, such that radial cutter implant 470 is
fixed in place. A string 484 is looped around distal end 482 for
enabling extraction of radial cutter implant 470. The physician
(not shown) can employ the string 484 for guiding a delivery system
(e.g., delivery system 150 of FIGS. 3A to 3C) for the extraction of
radial cutter implant 470 (i.e., string 484 is employed as a guide
wire). Radial cutter implant 470 operates in a substantially
similar manner to that of radial cutter implant 322 of FIG. 6A.
With reference to FIG. 11B, radial cutter implant 470 is depicted
from a side view perspective.
[0071] Reference is now made to FIG. 12, which is a schematic
illustration of a radial cutter implant, generally referenced 500,
constructed and operative in accordance with a further embodiment
of the disclosed technique. Radial cutter implant 500 includes a
right side portion 502 and a left side portion 504. Right side
portion 502 is coupled with left side portion 504 at the proximal
and distal ends thereof. Each of right side portion 502 and left
side portion 504 is butterfly wing shaped. Each of right side
portion 502 and left side portion 504 is substantially similar to
butterfly wing shaped wire 474 of FIG. 11A. Radial cutter implant
500 is positioned in the bladder neck and is fixed in place in a
substantial similar manner to that of radial cutter implant 470 of
FIG. 11A. A string 506 is coupled with the distal end of radial
cutter implant 500 for enabling extraction of radial cutter implant
500, for guiding a delivery system for the extraction procedure, or
as anchoring device (i.e., string 506 is anchored outside of the
body of the patient and prevents radial cutter implant 500 from
moving).
[0072] In the examples set forth in FIGS. 6A, 6B, 7A, 7B, 8, 9A,
9B, 10A, 10B, 11A, 11B and 12, each of the radial cutter implants
includes two to four wires. A radial cutter implant according to
the disclosed technique should include at least one wire, radially
extending outwardly from the center of the radial cutter implant,
for applying pressure on the surrounding tissues. The radial cutter
implant can include larger numbers of wires than four, such as five
wires, six wires, and the like. The shape of the wires can be a
portion of a circle, a butterfly wing shape, a polygon, and the
like. The cross-section of the wires is round, rectangular,
triangular, or any polygonal shaped.
[0073] In the examples set forth in FIGS. 6A, 6B, 7A, 7B, 8, 9A,
9B, 10A, 10B, 11A, 11B and 12, each of the radial cutters include
either a distal end or a tube coupled with the distal end of the
wires. It is noted that, a radial cutter implant according to the
disclosed technique includes at least one central connector (e.g.,
distal end 322 of FIG. 6A or tube 442 of FIG. 10A) connecting the
wires. It is further noted that the central connector can be
connected to the wires at the proximal end of the wires, at the
distal end of the wires, and at any point in the middle of the
wires.
[0074] Reference is now made to FIGS. 13A, 13B and 13C, which are
schematic illustrations of a radial cutter implant, generally
referenced 520, constructed and operative in accordance with
another embodiment of the disclosed technique. With reference to
FIG. 13A, radial cutter implant 520 is depicted from a side view
perspective. Radial cutter implant 520 is substantially similar to
radial cutter implant 440 of FIG. 10A. Radial cutter implant 520
includes a tube 522 and three wires 524, 526 and 528. Each of wires
524, 526 and 528 includes two barbs 530. Tube 522 is a catheter
which allows urine to pass there-through. Each of barbs 530
penetrates into the surrounding tissues (i.e., the tissues
surrounding implant 520) for anchoring radial cutter implant 520 in
place (i.e., for preventing migration of radial cutter implant 520
into the bladder or into the urethra). When radial cutter implant
520 is extracted from the bladder neck (i.e., pulled back in the
distal direction), barbs 530 are pulled out of the surrounding
tissues. With reference to FIG. 13B, FIG. 13B depicts an enlarged
view portion 532 of radial cutter implant 520. Each of barbs 530 is
directed in the proximal direction for preventing radial cutter 520
from moving in the proximal direction, from the bladder neck into
the bladder (i.e., keeping radial cutter implant 520 anchored in
place). With reference to FIG. 13C, radial cutter implant 520 is
depicted from a bottom view perspective.
[0075] It is noted that, the number of wires including barbs can
vary. Furthermore, the number of barbs on a wire can vary. For
example, a radial cutter implant including five wires, three of
which includes two barbs each, a fourth wire includes four barbs,
and the fifth wire includes no barbs.
[0076] Reference is now made to FIG. 14, which is a schematic
illustration of radial cutter implant, generally referenced 550,
constructed and operative in accordance with a further embodiment
of the disclosed technique. Radial cutter implant 550 includes a
distal end 552 and two wires 554 and 556. Radial cutter implant 550
is substantially similar to radial cutter implant 350 of FIG. 7A,
except for the number of wires (radial cutter implant 350 includes
three wires and radial cutter implant 550 includes two wires). Each
of wires 554 and 556 includes two barbs 558 and 560. The direction
of extension of barbs 558 is different from the direction of
extension of barbs 560 for enabling a stronger fixation into the
bladder neck (i.e., stronger than a configuration of similar
extending barbs).
[0077] Reference is now made to FIGS. 15A and 15B, which are
schematic illustrations of a radial cutter implant, generally
referenced 580, constructed and operative in accordance with
another embodiment of the disclosed technique. With reference to
FIG. 15A, radial cutter implant 580 is depicted from an isometric
perspective. Radial cutter implant includes a tube 582, three wires
584, 586 and 588, and three wings 590, 592 and 594. Each of wires
584, 586 and 588 includes two barbs 596. Each of wires 584, 586 and
588 is coupled with the distal end of tube 582. Each of wings 590,
592 and 594 is coupled between tube 582 and each of wires 584, 586
and 588, respectively.
[0078] Each of wires 584, 586 and 588, and each of wings 590, 592
and 594 is flexible for enabling radial cutter implant 580 to be
folded within an implant sheath (e.g., implant sheath 202 of FIG.
4A). Each of barbs 596 is substantially similar to each of barbs
558 of FIG. 14. While radial cutter implant 580 is implanted within
the patient, tissue can grow around each of wires 584, 586 and 588.
Tissue growth around wires 584, 586 and 588 complicates the
extraction of radial cutter implant 580 and prevent the widening
effect of implant 580. Wings 590, 592 and 594 prevent tissue from
growing around wires 584, 586 and 588 and from holding radial
cutter implant 580 in place. Wings 590, 592 and 594 are made from
Polyester (PET), Poly-Urethane (PU), Nitinol foil, Silicon, and the
like.
[0079] Reference is now made to FIGS. 16A to 16D, which are
schematic illustrations of a redial cutter implant, generally
referenced 620, constructed and operative in accordance with a
further embodiment of the disclosed technique. Implant 620 includes
four wires 622, an anchoring leaflet 624, a distal end 626 and a
proximal end 628. Each of wires 622 is coupled between proximal end
628 and distal end 626. Anchoring leaflet 624 extends from distal
end 626, and is positioned between two of wires 622.
[0080] Each of wires 622 is substantially similar to each of wires
474, 476, 478 and 480, all of FIG. 14A. The shape of wires 622 is
wider at the proximal end than at the distal end thereof. In this
manner, wires 622 prevent implant 620 from moving from the bladder
neck into the urethra. In particular, the wider proximal portion of
wires 622 is positioned within the bladder and the narrower distal
portion of wires 622 is positioned at the bladder neck and within
the urethra. Wires 622 (i.e., the wider proximal portion thereof)
prevent implant 620 from moving out of the bladder and into the
urethra by being blocked at the bladder neck.
[0081] Anchoring leaflet 624 is constructed of similar materials to
those of wires 622. Anchoring leaflet 624 is in the shape of a
tongue extending substantially in the proximal-normal direction
(i.e., the normal direction refers to a direction normal to the
proximal-distal axis--e.g., the dorsal direction). In this manner,
anchoring leaflet 624 prevents implant 620 from moving from the
bladder neck into the bladder. In particular, anchoring leaflet 624
is blocked by the bladder neck such that implant 620 can not move
into the bladder. It is noted that, anchoring leaflet 624 can be a
wire leaflet (e.g., as depicted in FIGS. 6A to 6D) or a full
surface leaflet (e.g., substantially similar to wings 590 of FIG.
15A).
[0082] Alternatively, anchoring leaflet 624, extends in the
distal-normal direction and prevents radial cutter implant 620 from
moving in the distal direction towards the urethra. Further
alternatively, there are at least two leaflets 624 extending in
both directions and fixing implant 620 in place.
[0083] It is noted that, wires 622, and in particular the wider
proximal portion thereof, prevent implant 620 from moving in the
distal direction. Anchoring leaflet 624 prevent implant 620 from
moving in the proximal direction. Thus, implant 620 is anchored in
position within the bladder neck. It is further noted that, wires
622 and anchoring leaflet 624 are delivered within a sheath (e.g.,
implant sheath 202 of FIGS. 4A to 4C) and are expanded (e.g., self
expand upon exposure from the sheath) once positioned in the
bladder neck. The number of wire 622 of implant 620 is at least
one, and can vary. The number of anchoring leaflets 624, is at
least one and can vary.
[0084] Reference is now made to FIG. 17, which is a schematic
illustration of a redial cutter implant, generally referenced 650,
positioned within a bladder neck of a patient, constructed and
operative in accordance with another embodiment of the disclosed
technique. Radial cutter implant 650 includes two wires 652, an
anchoring leaflet 654, a distal end 656 and a proximal end 658.
Radial cutter implant 620 is substantially similar to implant 620
of FIGS. 16A to 16D.
[0085] The distal wider portion of wires 652 is positioned within a
bladder 660 of a patient (not shown). The proximal narrower portion
of wires 652 is positioned within a bladder neck 662 of the
patient. Anchoring leaflet 654 applies a proximal radial force
against bladder neck 662 thereby producing a niche 666 within
bladder neck 662. Anchoring leaflet 654 is anchored within niche
666. In this manner anchoring leaflet 654 anchors implant 650
within bladder neck 662. In other words, the proximal wider portion
of wires 652 prevents implant 650 from moving distally (i.e.,
towards a urethra 664 of the patient) and anchoring leaflet 654
prevents implant 650 from moving proximally (i.e., towards bladder
660).
[0086] Alternatively, proximal end 658 is a substance release
element, which slowly releases substances into the bladder neck,
urethra and prostate of the patient, over a period of time. The
released substances can include painkillers, anti-inflammatory
materials, anti-biotic materials, and the like. Further
alternatively, implant 620 (i.e., or at least some portions
thereof, such as wires 652) is covered with such materials as
detailed herein above, and releases these materials slowly into the
body of the patient.
[0087] Reference is now made to FIG. 18, which is a schematic
illustration of a method for creating incisions in the muscles of
the bladder neck by infarction, operative in accordance with a
further embodiment of the disclosed technique. In procedure 700,
the location of the bladder neck of a patient is found. With
reference to FIG. 3A, the physician inserts overtube 164 into the
urethra of the patient until balloon 158 is inside bladder 152. The
physician inflates balloon 158 and pulls overtube 164 back until
balloon 158 is blocked by the bladder neck.
[0088] In procedure 702, a radial cutter implant is delivered to
the constricted location. With reference to FIG. 3B, the physician
inserts delivery 176 into positioning tube 162 and delivers radial
cutter implant 178 to the location of the bladder neck (i.e., the
constricted location). Alternatively, the physician delivers the
implant to a different constricted location within the urinal
system of the patient for relieving the constriction. In procedure
704, the radial cutter implant is released and the delivery system
is removed. With reference to FIG. 3C, the physician exposes radial
cutter implant 178 from implant sheath 166. Radial cutter implant
178 expands and attaches itself to the surrounding tissues (i.e.,
the wires of Radial cutter implant 178 are attached to the tissues
surrounding the implant and apply pressure thereon). The physician
removes delivery system 150 from urethra 154 of the patient.
[0089] In procedure 706, continuous pressure is applied on the
tissues surrounding the implant by employing the radial cutter
implant. With reference to FIG. 3C, the wires of radial cutter
implant 178 apply continuous pressure on the surrounding tissues.
In procedure 708, at the appearance of a predetermined condition,
the radial cutter implant is extracted from the patient. With
reference to FIG. 3C, the physician extracts radial cutter implant
178 from the patient at the appearance of a predetermined
condition. The predetermined condition can be the passage of a
predetermined period of time, the appearance of desired incisions
on the surrounding tissues, the appearance of a predetermined
physiological effect, and the like.
[0090] It will be appreciated by persons skilled in the art that
the disclosed technique is not limited to what has been
particularly shown and described hereinabove. Rather the scope of
the disclosed technique is defined only by the claims, which
follow.
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