U.S. patent application number 09/155958 was filed with the patent office on 2001-09-06 for laser applicator set.
Invention is credited to KNIEP, FRANK, MACK, MARTIN, VOGL, THOMAS.
Application Number | 20010020165 09/155958 |
Document ID | / |
Family ID | 26024747 |
Filed Date | 2001-09-06 |
United States Patent
Application |
20010020165 |
Kind Code |
A1 |
VOGL, THOMAS ; et
al. |
September 6, 2001 |
LASER APPLICATOR SET
Abstract
The invention discloses a laser application set, which is an
interventional application set for minimum invasive, laser-induced
thermotherapy of soft-tissue tumors. In accordance with the
invention the laser application set is designed in such a manner
that an introductor tube (6) with a stylet (12) is provided and
accommodates a tunneled catheter (17) with an internal stylet
(20).
Inventors: |
VOGL, THOMAS; (BERLIN,
DE) ; MACK, MARTIN; (BERLIN, DE) ; KNIEP,
FRANK; (BERLIN, DE) |
Correspondence
Address: |
HORST M KASPER
13 FOREST DRIVE
WARREN
NJ
07059
|
Family ID: |
26024747 |
Appl. No.: |
09/155958 |
Filed: |
December 3, 1998 |
PCT Filed: |
April 4, 1997 |
PCT NO: |
PCT/DE97/00730 |
Current U.S.
Class: |
606/15 |
Current CPC
Class: |
A61B 2017/22072
20130101; A61B 2017/22082 20130101; A61N 5/0601 20130101; A61B
2017/00911 20130101; A61B 17/00491 20130101; A61B 17/3421 20130101;
A61M 25/01 20130101; A61B 17/3415 20130101; A61M 25/0662 20130101;
A61B 2090/062 20160201 |
Class at
Publication: |
606/15 |
International
Class: |
A61B 018/18 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 4, 1996 |
DE |
196 14 780.8 |
Jan 16, 1997 |
DE |
197 02 898.5 |
Claims
1. A laser application set to treat tumors in which the distal end
of a tunneled catheter (17) from synthetic materials, preferably
PE, FEP, PTFE, is air- and fluid-tight sealed and movably guides an
optical waveguide (33), characterized in that an introducer tube
(6) with a closely fitting interior stylet (12) is provided and a
tunneled catheter (17) is fitted with a closely fitting internal
stylet (20), in which, upon removal of the stylet (12) from the
introducer tube (6), the tunneled catheter (17) with the internal
stylet (20) can be closely fitting inserted into the introducer
tube (6) and projects from the distal end of the tunneled catheter
(17) and in which the optical waveguide (33) can be inserted after
the removal of the internal stylet (20) from the tunneled catheter
(17).
2. A laser application set according to claim 1, characterized in
that the introducer tube (6) and the stylet (12) are open at their
distal and proximal ends.
3. A laser application set according to claim 1, characterized in
that the distal end of the tunneled catheter (17) is fitted with a
tunneled catheter tip (21) and has an opening at its proximal
end.
4. A laser application set according to claim 1, characterized in
that the introducer tube (6) and the tunneled catheter (17) are
each provided with marks (18) and (11) so that the tunneled
catheter (17) projects 30 mm beyond the distal end of the
introducer tube (6) upon introduction into the introducer tube
(6).
5. A laser application set according to claims 1 and 4,
characterized in that the marks (11,18) are arranged at a distance
of 1 cm from each other, with the introducer tube (6) being marked
along its entire length.
6. A laser application set according to at least one of the
aforementioned claims, characterized in that the proximal end of
the introducer tube (6) is equipped with a T piece (9), with a
silicone lamella (10) being placed between the T piece (9) and the
introducer tube (6) and an external thread (13) fitted to the
opposite side, with an interior membrane (16) and a hose lead (8)
at the T piece (9) with a three-way faucet (7) fitted to its
end.
7. A laser application set according to at least one of the
aforementioned claims, characterized in that the stylet (12) is
equipped with a grip end (14) with an internal thread which, in
conjunction with the external thread (13) of the introducer tube
(6), enables the locking of the stylet (12).
8. A laser application set according to at least one of the
aforementioned claims, characterized in that the introducer tube
(6) and the stylet (12) are hollow and from a material which is
suitable for the MRT process, preferably PE, FEP, PTFE, etc.
9. A laser application set according to at least one of the
aforementioned claims, characterized in that the stylet (12) in
locked state projects by approx. 10 mm from the distal end of the
introducer tube (6) and has an open stylet tip (15).
10. A laser application set according to at least one of the
aforementioned claims, characterized in that the internal stylet
(20) is made of a wire, which preferably is from a paramagnetic
material, and is enclosed by a synthetic sheathing.
11. A laser application set according to claim 1, characterized in
that a tunneled catheter (17) has an inner tunneled catheter (30),
and a firm connection between the two catheters (17 and 30) can be
made, and a space exists between the tunneled catheter (17) and the
inner tunneled catheter (30), in which a laser applicator (33) is
movably arranged.
12. A laser application set according to claim 11, characterized in
that, in order to establish a firm, separable connection, a
connection piece (22) is arranged at the tunneled catheter (17) and
a locking piece (23) at the inner tunneled catheter (30), in which
the connection piece (22) is provided with a sealing thread
(32).
13. A laser application set according to claims 11 and 12,
characterized in that locking piece (23) is provided with a
membrane sealing (28) which is connected to a T piece (27) by means
of a connector (24).
14. A laser application set according to claims 11 and 12,
characterized in that a locking piece (23) is provided with a
membrane sealing (29) which is connected to a T piece (26) by means
of a connector (25).
15. A laser application set according to claims 13 and 14,
characterized in that a pump to convey a flushing and/or cooling
agent (31) is connected to the T piece (27 and 26).
16. A laser application set according to claim 12, characterized in
that the flushing and/or cooling agent (31), which is conveyed via
the inner tunneled catheter (30) into the tunneled catheter (17) is
preferably sterile isotonic sodium chloride solution.
17. A laser application set according to claim 12, characterized in
that the inner tunneled catheter (30) ends 5 mm before the tunneled
catheter tip (21) at the distal end.
18. A laser application set according to claim 12, characterized in
that the inner tunneled catheter (30) is designed in such a manner
that a backflow of the flushing and/or cooling agent is ensured
between the tunneled catheter (17) and the inner tunneled catheter
(30).
Description
[0001] The present invention discloses a laser application set,
which is an interventional application set for minimum invasive
laser-induced thermotherapy of soft-tissue tumors.
[0002] It is known as state of the art that laser radiation which
emerges from an optical waveguide, e.g. the irradiation of an
Nd:YAG laser at 1064 nm, employing a silica glass optical fiber (of
the PCS, HCS or ALL SILICA type) as beam guidance system, may be
used to cause radial-symmetric coagulation necroses in biological
tissue. In order to do so, the light-conducting fiber is either
placed upon the tissue or inserted into the tissue. However, the
disadvantage of this method of therapy is that there occurs a high
power density at the place of contact between fiber end area and
tissue which, already above some 100 mW luminous power and
depending on the fiber diameter, results in a carbonization of the
tissue surface and thus, due to the high level of carbon
absorption, prevents the further diffusion of radiation within the
tissue.
[0003] Further an application device for laser radiation
(DE4137983A1) is known, in which the beam-conducting end of the
optical waveguide that faces the object to be treated is arranged
in a tubular enveloping body whose front face is transparently shut
to laser radiation, in particular in a plastic hose whose front end
facing said object is air- and fluid-tight sealed, with the front
face of the enveloping body and/or the end of the optical waveguide
being equipped with a spreading device for laser radiation that has
a spreading volume. There, also multiple chambered hoses are
employed in order to provide possibly required cooling via a
connected distributor piece.
[0004] Also known is a U.S. Pat. No. 5,312,392 "A method of
treating benign tumors". In which a trocar, that contains an
optical waveguide, is inserted into the tumor to be treated. The
position of the trocar with the optical waveguide is monitored
using ultrasound. The disadvantage of this method is that any
repositioning of the trocar with the optical waveguide is only
possible with a new puncture.
[0005] The disadvantage of all previously applied methods of
therapy is that they fail to allow for a repositioning of the
relevant enveloping body which contains the laser and, hence, any
faulty positioning of the laser or the enveloping body,
respectively, requires a new puncture. A further disadvantage is
that with a defective laser wire (optical waveguide) yet another
intervention into the soft-tissue tumor to be treated becomes
necessary.
[0006] The object of the invention is the implementation of a laser
application set which ensures a gentle treatment of a patient and
facilitates monitoring by means of a computer tomograph or a
magnetic resonance tomograph, respectively.
[0007] The aim of the invention is the creation of a laser
application set which neutralizes the disadvantages of the prior
art and the previous methods of therapy by providing an
interventional application set for laser therapy which enables a
repositioning and requires only a single puncture of the tumor to
be treated.
[0008] The aim according to the invention is attained by
implementing a laser application set in accordance with Nos. 1 to 9
of the patent claims.
[0009] The laser application set consists of an introducer tube
with an internal stylet. The internal stylet is locked with the
introducer tube by means of a thread. The internal stylet is
designed in such a manner that it projects by approx. 1 cm over and
beyond the end of the introducer tube and has a pointed form. The
stylet is of a hollow construction. A grip end at the external end
of the stylet may be used to undo its locking by turning, after
which the stylet may be removed from the introducer tube. The
proximal end of the introducer tube is provided with a T piece. A
silicone lamella is placed between the T piece and the introducer
tube proper in order to provide a high elasticity during the
insertion into the respective tumor. The silicone lamella is
designed as a silicone membrane in the form of a forward-folding
buckling lamella. A hose lead with a downstream three-way faucet is
connected to the T piece. The hose lead and the connected three-way
faucet may be used to apply cooling agents, lubricants and/or other
additional local anesthetics. This opportunity of supply
essentially contributes to providing a largely painless therapy
also for capsular lesions. In addition, the hose lead allows for
blood control of the patient under treatment during the therapy
session. An external thread to lock the stylet is located opposite
the silicone lamella of the T piece. Moreover, the T piece is
equipped with a membrane which prevents any fluids from leaking
during the therapy session.
[0010] A further preferred embodiment is the provision of the
introducer tube with marks which facilitate the exact positioning
of the application set. The individual marks are appended at a
distance of 1 cm from each other.
[0011] A further component of the laser application set is a
tunneled catheter with an internal stylet. The tunneled catheter
with the internal stylet is inserted upon the removal of the stylet
from the introducer tube. The tunneled catheter is designed in such
a manner that its distal end is air- and fluid-tight sealed and has
a tunneled catheter tip which significantly contributes to the
possibility that a repositioning may be made of the tunneled
catheter in the tumor to be treated. The tunneled catheter is also
provided with marks at a distance of 1 cm from each other which
allow for an exact positioning of the tunneled catheter when
inserted into the introducer tube. The beginning of the marking on
the tunneled catheter is designed in such a manner that, upon
reaching the first mark, the catheter projects approx. 30 mm from
out of the introducer tube, which is important for the operability
of the laser application set. Within the tunneled catheter there is
an internal stylet whose end is equipped with a grip end for its
removal. The internal stylet is made from stainless steel, which
preferentially consists of a paramagnetic material. This stainless
steel wire is wrapped with a synthetic sheathing. The essential
fact is that the internal stylet provides stabilization to the
insertion of the tunneled catheter into the introducer tube and,
hence, enables the exact positioning of the tunneled catheter tip
into the tumor to be treated. A further essential feature of the
invention is that the introducer tube with the stylet as well as
the tunneled catheter with its internal stylet are made from
materials which may be used for the monitoring of the method of
therapy by means of computer tomography (CT) or magnetic resonance
tomography (MRT), respectively. The materials of the introducer
tube and the stylet as well as the tunneled catheter are preferably
from synthetic materials, with PE, PTFE, FEP plastics being
employed.
[0012] The laser application set according to the intervention has
the following advantages over the known application sets for laser
therapies of soft-tissue tumors.
[0013] The marks appended to the introducer tube allow for an exact
positioning of the introducer tube on the patient. The exact
position relation of the laser application set to the lesion is of
decisive significance for a successful therapy. Further, it can be
established that the membrane located in the T piece of the
introducer tube facilitates a safe and non-slipping positioning of
the tunneled catheter according to the invention. The tunneled
catheter is thermoresistant up to a max. 400.degree. C. and its
distal end is air- and fluid-tight sealed. The tunneled catheter,
which thus prevents a direct contact between the laser applicator
and the patient, is equipped with an internal stylet, consisting of
a wire from paramagnetic material, that essentially contributes to
the stabilization of the tunneled catheter during its insertion.
Thus, on the one hand the tunneled catheter may be kept thin while,
on the other, the required stabilization is still achieved. The
marks appended to the introducer tube allow for an exact
positioning of the introducer tube and prevent a fusion of the
introducer tube when the light transmitting tunneled catheter fails
to project sufficiently from the introducer tube system that is
impervious to laser light. A repositioning of the tunneled
catheter, which is inserted internally into the introducer tube, is
permitted as a result of permanent monitoring by computer tomograph
or a magnetic resonance tomograph, respectively. In case that a
defect or other malfunction is found during the insertion of the
laser applicator a new laser applicator may be inserted at any time
without having to commence a new therapy phase. The appropriate
composition of materials has created a laser application set which
is compatible with monitoring by CT, MRT or nuclear magnetic
resonance tomography (NMRT), respectively.
[0014] A further advantage according to the invention lies in that
upon the completion of the laser therapy and removal of the
introducer tube therapeutic agents, such as tissue glue, may be
introduced via the hose lead and the pertaining three-way faucet,
and thus a dispersion of the cells of the treated tumor is
inhibited which previously had been a serious disadvantage in the
laser therapy of tumors.
[0015] Furthermore, the laser application set according to the
invention facilitates the single-time puncture of the tumor to be
treated, thus preventing any dispersion of the tumor.
[0016] The following aspects should be considered as further
application indications of the laser application set according to
the invention. The laser application set according to the invention
enables a percutaneous laser therapy of, e.g., hepatic metastases
which cannot be surgically removed due to their distribution. Also
operable metastases may be subjected to laser therapy when a
patient refuses surgery. In addition, a patient may be brought into
an operable condition by employing the laser application set to
treat one or more metastases by laser treatment. The set allows for
the treatment of metastases of a max. diameter of 4 cm. Further
fields of application of the laser application set worth mentioning
are the palliative therapy of benign tumors in the head/neck region
and the percutaneous therapy of soft-tissue tumors in the pelvic
region.
[0017] The tunneled catheter is designed with a connection piece.
The locking piece of an inner tunneled catheter is appended to the
connection piece, with the inner tunneled catheter being located
within the tunneled catheter of the laser application set. A
flushing and/or cooling agent outlet is provided at the distal end
of the inner tunneled catheter The connection piece of the tunneled
catheter and the locking piece of the inner tunneled catheter may
be firmly interlocked by means of a sealing thread at the
connection piece. The connection piece and the locking piece are
each equipped with connectors to which T pieces are attached. The T
pieces may be used to connect a pump for the recirculation of the
flushing and/or cooling agent. Thus, a flushing and/or cooling
fluid, preferably sterile isotonic sodium chloride solution, is led
via a T piece of the inner tunneled catheter and on via the
connector of the locking piece into the inner tunneled catheter,
with the backflow occurring between the inner tunneled catheter and
tunneled catheter via the connection piece and the connector to the
T piece. Thus optimum cooling is provided to the entire area of the
punctured external tissue.
[0018] The locking piece of the inner tunneled catheter is equipped
with a membrane sealing. The internal stylet of the laser
application set is inserted and removed, respectively, and also the
laser applicator is inserted during a therapy session through this
membrane sealing. A further membrane sealing at the connection
piece serves as a sealing when the inner tunneled catheter is
inserted into the tunneled catheter.
[0019] The particular design of the tunneled catheter provides
further essential advantages for the use of the laser application
set. The employment of the laser application set ensures optimum
conditions to achieve coagulation necroses with a max. diameter of
20 mm to 25 mm. It is due to the heat dissipation, that is
essentially conditioned by blood flow in the vessels and diffusion
in the tissue, that it is usually impossible in vivo to induce
coagulation necroses larger than 2*2*2 cm by using the laser
application set without inserting the inner tunneled catheter.
However, the majority of soft-tissue tumors have a size of 3 cm to
4 cm when a diagnosis is made. In order to coagulate a volume of
4*4*4 cm, with the previous use of the laser application set of the
main patent, eight laser applications and, hence, eight punctures
are necessary. The laser power is approx. 5 watts applied over a
20-minute therapy session. What is essential is that the tunneled
catheter configuration allows the laser application set to achieve
coagulation necroses larger of up to a max. 4.2*4.2*4.2 cm with one
laser application, during which laser power of up to 30 watts is
applied up to 15 minutes. The tunneled catheter, which is used as
part of the laser application set, achieves that high laser powers
can only be applied when a cooling of the tissue immediately
adjacent to the tunneled catheter is ensured and thus any
carbonization or vaporization of tissue is prevented. Carbonization
or vaporization of the tissue immediately adjacent to the tunneled
catheter prevents a further propagation of the coagulation zone
since the entire laser power at the employed wavelength of 1064 nm
would be absorbed in the immediate vicinity of the tunneled
catheter. In particular the laser application catheter in
conjunction with the tunneled catheter of the laser application set
in the main application yields the below advantages for the
patient:
[0020] 1. In order to coagulate a lesion measured to be 4*4*4 cm
the use of a tunneled catheter in conjunction with the laser
application set requires only one laser application in the place of
eight laser applications with the laser application set.
[0021] 2. Furthermore, the clear decrease of the number of
punctures reduces the risk of puncture complications, such as
hemorrhage, vascular and nerve injuries as well as organ
injuries.
[0022] 3. Since the number of punctures required for tumor
treatment decreases also the risk of tumor dispersion and thus the
risk of vaccination metastasis is reduced.
[0023] 4. Furthermore, the use of the special tunneled catheter in
conjunction with the laser application set results in a clear cost
saving potential of this method because with a lesion measured to
be 4*4*4 cm no longer eight puncture tracks have to be sealed wit
fibrin glue but only one puncture track.
[0024] 5. Normally, a patient does not tolerate eight punctures in
one therapy session, hence, the second half of the tumor often had
to be subject to laser therapy in a second therapy session. This
second therapy session may fall away when the tunneled catheter of
the laser application set is used.
[0025] 6. In case of lesions up to a diameter of 4 cm the use of
the tunneled catheter with the laser application set attains a
clearly higher probability of a 100% tumor coagulation. Thus, this
application is able to achieve a clear reduction of the local
recurrence rate.
[0026] The advantageous further developments of the invention are,
respectively, characterized in the dependent claims or are
represented below in greater detail together with a description of
the preferred practical example of the invention by means of
figures. The figures illustrate the following:
[0027] FIG. 1 Puncture needle
[0028] FIG. 2 Stainless steel wire;
[0029] FIG. 3 Stylet introducer tube;
[0030] FIG. 4 Introducer tube with T piece;
[0031] FIG. 5 Tunneled catheter;
[0032] FIG. 6 Internal stylet-tunneled catheter;
[0033] FIG. 7 Tunneled catheter with cooler;
[0034] FIG. 8 Tip of the tunneled catheter with cooler.
[0035] FIGS. 1 illustrates a puncture needle 1 with a contained
needle stylet 2, which has a needle stylet tip 3. The puncture
needle is of a known design. What is essential is that the puncture
needle 1 consists of a paramagnetic material and thus may be
applied in the MRT process. The puncture needle 1 has a length of
approx. 200 mm and a diameter of approx. 1.3 mm. The needle stylet
has a three-edged puncture tip which extends beyond the puncture
needle 1. A grip end enables the smooth removal of the needle
stylet 2 from the puncture needle 1.
[0036] FIGS. 2 illustrates a wire 4, which consists of stainless
steel, with a special type of this wire 4 with a tongue end 5 being
available, which is executed with a taper-ground tongue. In the
depicted practical example the length of the wire is approx. 1
meter, with the tongue end 5 being approx. 100 mm long. The wire 4
is made from a paramagnetic material.
[0037] FIGS. 3 and 4 illustrate the introducer tube 6 and the
stylet 12. The introducer tube 6 and the stylet 12 are made from
synthetic materials, such as PE, PTFE, FEP. The length of the
introducer tube 6 is approx. 100-200 mm and its diameter is approx.
1.5 mm up to 4 mm--depending on the practical example. The stylet
12 that is contained in the introducer tube 6 is executed with
close tolerances--depending on the size of the introducer tube 6.
The proximal end of the introducer tube 6 is equipped with a
silicone lamella 10 to which a T piece 9 is connected. This
silicone lamella 10 is designed as a silicone membrane in the form
of a forward-folding buckling lamella. The silicone lamella 10
essentially improves handling of the introducer tube 6. The T piece
9 is equipped with a hose lead 8 and an adjacent three-way faucet
7. Via the three-way faucet 7 and the hose lead 8 to the T piece 9
it is possible to apply additional local anesthetics, such as
lubricant, tissue glue, alcohol, etc., which essentially
contributes to providing a largely painless therapy also for
capsular lesions. Furthermore the T piece 9 is equipped with an
external thread 13 to lock the stylet 12 with contained internal
thread into the grip end 14. A membrane 16 is provided between the
T piece 9 and the adjacent external thread 13 which prevents any
fluids from leaking and facilitates a safe and non-slipping
positioning of the tunneled catheter 17. The introducer tube 6 is
provided with marks 11. These are preferably arranged at a distance
of 1 cm from each other along the entire length of the introducer
tube 6. Thus an exact positioning of the introducer tube 6 is
ensured. In its locked state with the introducer tube 6 the stylet
12 has a length which is distinguished in that approx. 1 cm of the
stylet tip 15 extend from the distal end of the introducer tube
6.
[0038] A further preferred design is that the stylet 12 is executed
hollow. This hollow design form of the stylet 12 provides an
increased lubricity during the insertion of the introducer tube 6
with the stylet 12 via the wire 4 into the patient.
[0039] FIGS. 5 and 6 illustrate the tunneled catheters 17 according
to the invention with internal stylet 20. The tunneled catheter 17
made from a thermostable synthetic material which resists a max.
temperature of 400.degree. C. The preferred materials employed are
PTFE and FEP. The tunneled catheter 17 has a length of approx. 400
mm. Essential of the invention is here the existing tip at the
distal end of the tunneled catheter which is air- and fluid-tight
sealed. The external diameter of the tunneled catheter may be
between 1.5 mm and 4 mm, depending on the application form. This
tunneled catheter 17 is equipped with an internal stylet 20 with a
grip end 19. The internal stylet 20 is a wire which is made from a
paramagnetic material and provided with a plastics coating. It is
through this internal stylet 20 that the tunneled catheter 17, due
to the high stability of the stainless steel wire, may be inserted
with safe positioning into the internal stylet 20, and there are
further control opportunities for the positioning of the tunneled
catheter 17. The upper part of the tunneled catheter 17 is provided
opposite the tunneled catheter tip 21 with marks which are arranged
at a distance of 1 cm from each other. The first mark towards the
tunneled catheter tip 21 is arranged in such a manner that approx.
30 mm of the tunneled catheter 17 project at the distal end of the
introducer tube 6 upon insertion into the introducer tube 6 and
reaching of the first mark. After removing the internal stylet 20
by the grip end 19 an optical waveguide for laser treatment of the
respective tumor may be smoothly inserted. The positioning of the
tunneled catheter 17 towards the introducer tube 6 by means of the
marks on the tunneled catheter 17 according to the invention
largely prevents that a fusion of the light source with the light
impervious introducer tube 6 occurs during treatment with the
optical waveguide since the tunneled catheter 17 always projects
approx. 30 mm from the distal end of the introducer tube 6.
[0040] FIG. 7 illustrates a special embodiment of the tunneled
catheter with cooling which is made up as follows. The tunneled
catheter 17 of the laser application set is employed in the same
manner, with the proximal end of the tunneled catheter 17 being
equipped with a connection piece 22. A T piece 26 is connected to
the connection piece 22 via a connector 25. A pump to convey
flushing and/or cooling agent is attached to the T piece 26. A
sealing thread at the connection piece 22 firmly interlocks a
locking piece 23 of the inner tunneled catheter 30. The inner
tunneled catheter 30 is located inside the tunneled catheter 17.
The inner tunneled catheter 30 is designed in such a manner that it
ends at the distal end 5 mm before the tunneled catheter tip 21.
The inner tunneled catheter 30 is open at the distal end. A
connection of a pump for a flushing and/or cooling agent is
provided via a connector 24 and a T piece 27 above the locking
piece 23 of the inner tunneled catheter 30. The cooling agent 31
flows via the T piece 24, connector 25, locking piece 23 and
through the inner tunneled catheter 30 into the tip of the of the
inner tunneled catheter 30 and on its flow back the flushing and/or
cooling agent 31 is led between the tunneled catheter 17 and the
inner tunneled catheter 30 via the connection piece 22, connector
25 and T piece 26 to the pump. Preferably a sterile isotonic sodium
chloride solution is used as flushing and/or cooling agent. The
laser applicator 33 is inserted into the inner tunneled catheter
30, thus ensuring maximum cooling of the entire punctured tissue,
since the backflow between the tunneled catheter 17 and the inner
tunneled catheter 30 transmits cooling to the entire area of the
punctured tissue--which consists an advantage that is essential of
the invention. In order to seal off the of the laser applicator 33
or the removal of the internal stylet 20 of the laser application
set, respectively, a membrane sealing 28 is arranged in the locking
piece 23 of the inner tunneled catheter 30. In order to seal off
the insertion of the inner tunneled catheter 30 a further membrane
sealing 29 is provided in the connection piece 22.
[0041] FIG. 8 illustrates the tip of the tunneled catheter 17 in
its embodiment. It can be seen that the cooling agent 31 exits in
the interior of the inner tunneled catheter 30 and at the outside
of the tunneled catheter point 21 between the inner tunneled
catheter 30 and the tunneled catheter 17. The laser applicator 33
projects beyond the distal end of the inner tunneled catheter 30,
hence, the flushing and/or cooling agent cools the entire external
tissue of the tumor to be treated.
[0042] The application according to the invention of the laser
application set in a therapy of soft-tissue tumors is described as
follows:
[0043] The tumor to be treated is punctured with the puncture
needle 1 and the contained needle stylet 2 with its needle stylet
tip 3. The three-edged needle stylet tip 3 makes for a good
puncture efficiency of the puncture needle 1. Following the
completion of a positive puncture the needle stylet 2 is removed
from the puncture needle 1. Subsequently, a wire 4 is inserted up
to the distal end of the puncture needle 1. The puncture needle 1
is removed via this wire 4. Then the introducer tube 6 with the
locked stylet 12 is strung to the wire 4 and led into the tumor to
be treated up to the distal end of the wire 4. The wire 4 is
removed after the exact positioning of the introducer tube 6 with
the stylet 12. As required, the necessary additional local
anesthetics are supplied to the three-way faucet 7. A slight turn
of the grip end 14 of the stylet 12 undoes the locking with the T
piece 9 of the introducer tube 6 and the stylet 12 may be removed
from the introducer tube 6.
[0044] A further preferred design is that marks are appended to the
introducer tube 6 which permit an exact positioning of the
introducer tube 6 into the tumor to be treated. Subsequently, the
tunneled catheter 17 with contained internal stylet 20 is inserted
into the introducer tube 6. While doing so, the marks on the
tunneled catheter 17 permit an exact positioning of the introducer
tube 6 into the tumor to be treated, with, as is essential of the
invention, the first mark being designed in such a way that the
tunneled catheter 17 projects by 30 mm from the distal end of the
introducer tube 6. The internal stylet 20 is provided to improve
correctability and stabilization during the insertion of the
tunneled catheter 17. Following the removal of the internal stylet
20 by means of the grip end 19 an optical waveguide to perform the
laser therapy is inserted until the distal end of the tunneled
catheter 17. The permanent monitoring by means of CT or MRT
processes, respectively, permits a respective exact positioning of
the tunneled catheter 17 with the tunneled catheter point 21
according to the invention. Furthermore, the functioning of the
inserted optical waveguide can be checked in order to prevent a
fusion of the light source with the light impervious sheath of the
introducer tube 6. The exact positioning with the help of the
introducer tube 6 and the tunneled catheter 17 also enables the
removal of defective optical waveguides and to replace such by a
new optical waveguide and thus avoid a new puncture. Following the
completion of the treatment via optical waveguide the latter is
removed and subsequently also the tunneled catheter 17 and the
introducer tube 6. While doing so it possible to introduce, e.g.,
tissue glue via the three-way faucet 7 and the hose lead 8 to the T
piece 9 during the removal of the introducer tube 6 and thus an
advantage according to the invention is provided by ensuring a
minimum cell dispersion of the treated tumor while removing the
introducer tube 6 which previously has been an essential
disadvantage of the laser therapy of tumors.
REFERENCE SIGNS
[0045] 1. Puncture needle
[0046] 2. Needle stylet
[0047] 3. Needle stylet tip
[0048] 4. Wire
[0049] 5. Tongue-shaped end
[0050] 6. Introductor tube
[0051] 7. Three-way faucet
[0052] 8. Hose lead
[0053] 9. T piece
[0054] 10. Silicone lamella
[0055] 11. Mark
[0056] 12. Stylet
[0057] 13. External thread
[0058] 14. Grip end
[0059] 15. Stylet tip
[0060] 16. Membrane
[0061] 17. Tunneled catheter
[0062] 18. Mark
[0063] 19. Grip end
[0064] 20. Internal stylet
[0065] 21. Tunneled catheter tip
[0066] 22. Connection piece
[0067] 23. Locking piece
[0068] 24. Connection
[0069] 25. Connection
[0070] 26. T piece
[0071] 27. T piece
[0072] 28. Membrane sealing
[0073] 29. Membrane sealing
[0074] 30. Inner tunneled catheter
[0075] 31. Flushing and/or cooling fluid
[0076] 32. Sealing thread
[0077] 33. Laser applicator
* * * * *