U.S. patent application number 11/262525 was filed with the patent office on 2006-10-26 for screw-device for anastomosis.
This patent application is currently assigned to UMC Utrecht Holding B.V.. Invention is credited to Jochem-Paul Bremmer, Erwin de Winter, Hendricus Jacobus Mansvelt Beck, Cornelis Antonius Franciscus Tulleken.
Application Number | 20060241659 11/262525 |
Document ID | / |
Family ID | 33315066 |
Filed Date | 2006-10-26 |
United States Patent
Application |
20060241659 |
Kind Code |
A1 |
Tulleken; Cornelis Antonius
Franciscus ; et al. |
October 26, 2006 |
Screw-device for anastomosis
Abstract
The present invention, the screw-device, is a mechanical device
for anastomosing hollow tube-like structures in the human body,
such as blood vessels, bowels and ureters. It is thus not
restricted to (micro-)vessels. It can be used in every surgical
operation dealing with anastomosis and bypass operations. It allows
anastomosing end to side or side to side. The screw-device is very
easy to apply onto the vessel wall. Screwing is a fast technique
saving operating time and requiring only basic microsurgical
skills. The manufacturing is easy. Another advantage is that the
screw-device can be mounted onto the receptor vessel without first
opening and/or occluding this vessel. Later on, the receptor vessel
wall can be opened with laser or scalpel. It should be understood
that the foregoing is illustrative and not limiting, and that
modifications may be made by those skilled in the art, without
departing from the scope of the invention.
Inventors: |
Tulleken; Cornelis Antonius
Franciscus; (Utrecht, NL) ; Mansvelt Beck; Hendricus
Jacobus; (Bilthoven, NL) ; Bremmer; Jochem-Paul;
(Utrecht, NL) ; de Winter; Erwin; (Wilrijk,
BE) |
Correspondence
Address: |
BANNER & WITCOFF, LTD.
28 STATE STREET
28th FLOOR
BOSTON
MA
02109-9601
US
|
Assignee: |
UMC Utrecht Holding B.V.
Utrecht
NL
|
Family ID: |
33315066 |
Appl. No.: |
11/262525 |
Filed: |
October 28, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/BE03/00126 |
Jul 22, 2003 |
|
|
|
11262525 |
Oct 28, 2005 |
|
|
|
Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/0648 20130101;
A61M 25/04 20130101; A61B 2017/00004 20130101; A61B 17/064
20130101; A61M 39/04 20130101; A61B 2017/1139 20130101; A61B
17/0057 20130101; A61M 39/0208 20130101; A61M 25/02 20130101; A61M
39/06 20130101; A61M 2025/0286 20130101; A61B 17/3423 20130101;
A61B 2017/1107 20130101; A61B 2017/00867 20130101; A61B 17/11
20130101; A61B 2017/3488 20130101; A61B 2017/0649 20130101; A61B
17/3415 20130101; A61B 17/1114 20130101; A61B 2017/1135
20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 28, 2003 |
WO |
PCT/BE03/00074 |
Claims
1. An apparatus for introducing materials into a blood vessel
comprising a first end and a second end with the first end having a
screw-like spiral spring with several windings terminating in a
sharp, round, non-cutting end pointed downwardly.
2. The apparatus of claim 1 wherein the spring has four to six
windings with the non-cutting end pointing inwardly and downwardly
in an angle of 10 to 20 degrees.
3. The apparatus of claim 1 wherein the second end having a
screw-like spiral spring with several windings terminating in a
sharp, round, non-cutting end pointed upwardly.
4. A method of joining two blood vessels together comprising
securing to a first blood vessel one end of a device having a
screw-like spiral spring with several windings terminating in a
sharp, round, non-cutting end pointed outwardly and then securing
an opposite end of the device having a screw-like spiral spring
with several windings terminating in a sharp, round, non-cutting
end pointed outwardly to a second blood vessel.
5. The method of claim 4 comprising screwing the device into the
first vessel wall and then screwing it into the second vessel wall.
Description
[0001] This application is a continuation of PCT application no.
PCT/BE2003/000126, designating the United States and filed Jul. 22,
2003; which claims the benefit of the filing date of PCT
application no. PCT/BE03/00074, filed Apr. 28, 2003, both of which
are hereby incorporated herein by reference.
DESCRIPTION
[0002] 1. Technical Field
[0003] The present invention relates to an anastomosis device, more
particularly, the SCREW-DEVICE is capable of anastomosing the end
of a blood vessel to the side of another blood vessel (end to
side--see FIG. 1) or the side of a blood vessel to the side of
another blood vessel (side to side--see FIG. 2).
BACKGROUND ART
[0004] Vital Cells (in brain, heart, muscles, organs) demand
nutrition, oxygen, energy (glucose) at a constant supply. These
components are found in the blood which runs in a healthy vascular
system. As a pump system, the heart ensures the circulation of the
blood(nutrients) through the body. When there is a discrepancy
between demand of oxygen or nutrients to the cell and the delivery
capacity of the bloodstream to the cell, there is cell damage or
even cell death. in some vital organs this warm ischemia before
cell death is very short. For brain cells, death occurs after 3
minutes. The reason for this insufficiency is mostly a vascular
disease (arteriosclerosis), stenosis, occlusion of small or large
vessels, or a heart problem (coronary disease). Most important risk
factors of arteriosclerosis are: hypertension, elevated serum
lipids, cigarette smoking, diabetes mellitus, decreased physical
activity and obesitas (i.e., consuming more calories than those
expended as energy).
TREATMENT OPTIONS
[0005] To treat a clogged or occluded blood vessel, PHARMICOTHERAPY
and SURGERY have been practised. Pharmacotherapy is useful for
treatment at the initial stage but not when there is further
progression of the disease, leading to occlusion of the vessel and
eventually to an infarct (of the heart, brain, kidney, etc.).
[0006] The medical diagnostic tools and the technical developments
available to the doctor have increased enormously, MRI-, MRA.-, CT-
and CTA- scan. This has enabled an early diagnosis and a more
successful treatment of patients with vascular diseases.
[0007] In vascular surgery we have, firstly, the endovascular
procedures, for example: stents, which can expand the occluded
vessel in heart surgery (coronary artery)and in vascular surgery
(stenosis of the carotic artery); stents remodelling aneurysma of
the aorta abdominalis; and recently the brain stents remodelling
fusiform aneurysma of the basilar artery.
[0008] In vascular surgery we have, secondly, the revascularisation
operations, viz. anastomosis and bypass operations. These
revascularisation operations are carried out when there is (risk
of) ischaemia, (risk of) infarct (of the heart, brain, limb, etc).
Bypass procedures in general vascular surgery, in heart surgery
(coronary bypass), and in neurosurgery want to bypass huge vascular
malformations (giant aneurysmas). In tumor surgery, bypass
operations want to avoid the risk of brain-infarct after and/or
before removing the tumour.
[0009] The graft can be an arterial graft (in the case of heart
surgery it would be the lima, or rima; in the case of neurosurgery,
it would be the temporal artery or the occipital artery), or a
venous graft (v.s.m), or even prosthetic material. These highly
complex operations require a competent surgical team, delicate
instruments, advanced microsurgical equipment, magnifying loops,
or--for neurosurgeons--an operating microscope.
[0010] In microvascular surgery, ultra fine suture material is used
to suture the blood vessels onto each other (anastomosis). This
technique of suturing is time consuming and it demands extremely
advanced microsurgical skills. Moreover, it never results in a
completely smooth joint, the stitches producing microscopic creases
in the vessel wall. Various methods have been developed to perform
anastomosis with mechanical devices in a short time without
suturing. Most of these devices are complex and time-consuming to
apply (for example, in brain-surgery, a microvascular anastomosis
takes on average, twenty to thirty minutes). During this time,
there is a high risk of bleeding and infection in all forms of
microvascular surgery mentioned above. Reducing this time is of the
utmost importance for the well-being of the patient.
SUMMARY OF INVENTION
[0011] The object was to invent a really easy and extremely quick
way to perform vascular anastomosis.
[0012] The present invention, the SCREW-DEVICE, provides a device
capable of anastomosing the side of a vessel to another vessel
(side to side) or the end of a vessel to the side of another vessel
(end to side) without use of a suture. As a result there is a
perfectly smooth joint without any creases in the vessel wall.
[0013] The SCREW-DEVICE is very easy to apply on the vessel wall,
it takes only a few seconds to screw the SCREW-DEVICE into the
vessel wall of the receptor vessel and to screw it into the donor
vessel. This procedure can also be reversed, screwing the device
into the donor vessel and screwing this onto the receptor
vessel.
[0014] It can be used in every surgical operation dealing with
vascular problems, like anastomosis or bypass operations done in
vascular surgery, heart surgery and neurosurgery.
[0015] The opening of the receptor vessel wall can be done without
occlusion of the receptor vessel or with a temporary occlusion of
the receptor vessel. It can easily be combined with existing laser
technologies for opening the receptor vessel in a non-occlusive
manner.
DETAILED DESCRIPTION OF THE SCREW-DEVICE
[0016] Form: There are five main forms.
[0017] 1. Single-Ended Screw-Device.
[0018] This device is a spring with four to six windings
guaranteeing elasticity. The first three windings are closely
adjacent, i.e., there is just the smallest space between them (the
space enabling the SCREW-DEVICE to dig itself into the vessel
wall). On the one end of the SINGLE-ENDED SCREW-DEVICE there is an
extremely sharp end, meant to perforate the vessel wall. The other
end is blunt.
[0019] The sharp end is round, i.e., non-cutting but capable of
perforating the vessel wall. The sharp, round point is bent
inwardly and downwardly in an angle of 10 to 20 degrees (a) (see
FIG. 3a, 3b, 3c, 3d). Alternatively, this sharp, round, non-cutting
point may bend downwardly in an angle of 90 degrees (a). In this
case, the end resembles a corkscrew, but the end is not situated in
the middle of the final winding but rather on the periphery.
[0020] 2. Double-Ended Screw-Device/Ring-Form.
[0021] This device is a spring with four to six windings
guaranteeing elasticity. The first three windings are closely
adjacent, i.e., there is just the smallest space between them (the
space enabling the SCREW-DEVICE to dig itself into the vessel
wall). On the one end the DOUBLE-ENDED SCREW-DEVICE/RING-FORM takes
the form of a ring with two sharp, round, non-cutting points,
pointing in the same direction but 180 degrees apart from each
other (see FIG. 4a, 4b, 4c). These two points are bent inwardly and
downwardly in an angle of 10 to 20 degrees. Alternatively, these
sharp, round, non-cutting points may bend downwardly in an angle of
90 degrees. In this case, they resemble a corkscrew, but the ends
are not situated in the middle of the final winding but rather on
the periphery. The other end of the DOUBLE-ENDED SCREW-DEVICE is
blunt
[0022] 3. Double-Ended Screw-Device/Spiral Form.
[0023] This device is a spring with four to six windings
guaranteeing elasticity. The first three windings are closely
adjacent. i.e., there is just the smallest space between them (the
s.sup.pace enablin.sup.g the SCREW-DEVICE to dig itself into the
vessel wall). The DOUBLE-ENDED SCREW-DEVICE/SPIRAL-FORM consists of
two sharp, round, non-cutting points, the first coming from the
end, the second coming from the beginning but bent in such a way as
to align itself with the other sharp point (see FIG. 5a, 5b).
Again, these two points point in the same direction but stand 180
degrees apart from each other. They bend inwardly and downwardly in
an angle of 10 to 20 degrees. Alternatively, these sharp, round,
non-cutting point may bend downwardly in an angle of 90 degrees. In
this case, the end resembles a cork-screw, but the ends are not
situated in the middle of the final winding but rather on the
periphery.
[0024] 4. Key-Ring Screw-Device.
[0025] This device consists of two to three windings, resembling a
key-ring. On the one end, there is a sharp, round, non-cutting
point, bending inwardly and downwardly in an angle of 10 to 20
degrees. Alternatively, this point may bend downwardly in an angle
of 90 degrees. In this case, the end resembles a cork-screw, but
the end is not situated in the middle of the final winding but
rather on the periphery. The other end is blunt. Where the two ends
meet, there is a twist in the ring (see FIG. 6a, 6b).
[0026] 5. Screw-Device With Removable Head.
[0027] This device consists of two basic parts, the removable head
(with applicator) and a hollow screw of three windings, which
remains in place (i.e., in the blood-vessel). [0028] 5.1. The head
consists of two windings, and ends in the form of a cork-screw (see
FIG. 7a, 7b). This is, again, a round, sharp, non-cutting point.
The head forms one whole with the applicator, i.e., a long, thin
shaft with a handle used to drill the head into the vessel wall.
Once the head is in place (i.e., in the middle of the vessel (see
FIG. 7c), it is removed--together with the applicator--from the
rest of the SCREW-DEVICE that stays within the vessel wall. [0029]
5.2. The other part of the SCREW-DEVICE consists of three hollow
windings attached to the head by means of internal, anti-clockwise
windings (see FIG. 7d). Every winding is wider than the previous
one, thus expanding the vessel wall and the opening in it made by
the head. This opening is made in a non-occlusive way, i.e., the
receptor vessel need not be temporarily occluded.
[0030] Additional Tool.
[0031] In the fifth form, i.e., the SCREW-DEVICE WITH REMOVABLE
HEAD, no additional tools are needed to open the vessel wall.
[0032] In the other forms, the hole in the vessel wall can be made
by traditional means--basically: the occlusive manner using a
surgical knife, or the non-occlusive manner using a laser--or by
means of a SCREW-CUTTER. This specially designed device operates in
a non-occlusive manner. It takes the form of a hollow cylinder in
which a long shaft with a handle on top moves up and down (see FIG.
8a, 8b). This shaft ends in a screw consisting of three windings.
The first two of these take the form of a cork-screw, so that the
sharp point is in the middle. They keep the vessel wall in its
place, whereas the third winding--forming a full circle of 360
degrees--actually cuts and removes the part of the vessel wall
where the hole is to be made. The third winding has its sharp edges
pointing downward, whereas the first two windings are horizontal,
like in an ordinary screw (see FIG. 8c).
[0033] Diameter:
[0034] Depending on the sort of blood-vessel, the diameter of the
five SCREW-DEVICES may vary-from 1 millimetre to plus 2
centimetre.
[0035] Substance:
[0036] The SCREW-DEVICE is made of inox material, or titanium, or
super-elastic materials such as nitinol, or synthetic materials, or
even resorbable materials.
[0037] Thickness of material:
[0038] Depending on the diameter of the blood-vessel, the material
may vary from 0.1 mm to any desirable thickness.
[0039] Elasticity:
[0040] Depending on the material.
DESCRIPTION OF OPERATION TECHNIQUE WITH THE SCREW-DEVICE
[0041] A. For the first four forms of the SCREW-DEVICE--that is:
SINGLE-ENDED SCREW-DEVICE, DOUBLE-ENDED SCREW-DEVICE/RING-FORM,
DOUBLE-ENDED SCREW-DEVICE/SPIRAL-FORM, KEY-RING SCREW-DEVICE--the
technique is as follows: [0042] 1. End-to-side [0043] In the first
step, the receptor vessel is exposed by means of the techniques
current in vascular surgery. When a venous graft is used
end-to-side, the SCREW-DEVICE is screwed into the graft (donor
vessel) or sutured to the donor vessel. [0044] In the second step,
the donor vessel containing the SCREW-DEVICE is screwed into the
receptor vessel. [0045] Alternatively, the SCREW-DEVICE can first
be screwed into the receptor vessel and then the donor vessel can
be attached to it. [0046] The SCREW-DEVICE is turned into the
vessel clock-wise and completes only one turn, that is: it is in
its proper place after 360 degrees. [0047] In the third step, the
wall of the receptor vessel is opened by means of existing
techniques, such as laser or the surgical knife. [0048] 2.
Side-to-side
[0049] First, the donor vessel is clamped and opened. The
SCREW-DEVICE is screwed into and through the vessel wall, thus
perforating the donor vessel with two windings.
[0050] These windings are then screwed into the receptor vessel
(clockwise and 360 degrees).A hole is then made into the receptor
vessel wall by means of existing techniques, such as laser or the
surgical
[0051] B. For the fifth form, that is the SCREW-DEVICE WITH
REMOVABLE HEAD, the techniques mentioned sub A are applied in the
same way, but they are followed by the removal of the head.
[0052] In all these forms, the SCREW-DEVICE can be used in an
occlusive or non-occlusive manner, depending on the preferences of
the surgeon.
MANUFACTURING AND INDUSTRIAL APPLICABILITY
[0053] The SCREW-DEVICE can be manufactured commercially and be
employed to anastomose two vessels of different or identical sizes.
It can be used in all domains of vascular surgery, heart surgery,
and neurosurgery.
BRIEF DESCRIPTION OF DRAWINGS
[0054] FIG. 1: Anastomosis with the SCREW-DEVICE end to side
[0055] FIG. 2: Anastomosis with the SCREW-DEVICE side to side
[0056] FIG. 3a: Lateral view of SINGLE-ENDED SCREW-DEVICE
[0057] FIG. 3b: Top view of SINGLE-ENDED SCREW-DEVICE
[0058] FIG. 3c: Inside view: inside the receptor vessel of
SINGLE-ENDED SCREW-DEVICE
[0059] FIG. 3d: SINGLE-ENDED SCREW-DEVICE screwed into the donor
vessel
[0060] FIG. 4a: Lateral view of DOUBLE-ENDED
SCREW-DEVICE/RING-FORM
[0061] FIG. 4b: Top view of DOUBLE-ENDED SCREW-DEVICE/RING-FORM
[0062] FIG. 4c: Inside view: inside the receptor vessel of
DOUBLE-ENDED SCREW-DEVICE/RING-FORM
[0063] FIG. 5a: Lateral view of DOUBLE-ENDED SCREW-DEVICE/SPIRAL
FORM
[0064] FIG. 5b: Top view of DOUBLE-ENDED SCREW-DEVICE/SPIRAL
FORM
[0065] FIG. 6a: Lateral view of KEY-RING SCREW-DEVICE
[0066] FIG. 6b: Top view of KEY-RING SCREW-DEVICE
[0067] FIG. 7a: Lateral view of SCREW-DEVICE WITH REMOVABLE
HEAD
[0068] FIG. 7b: Top view of SCREW-DEVICE WITH REMOVABLE HEAD
[0069] FIG. 7c: In situ view: position of SCREW-DEVICE WITH
REMOVABLE HEAD in the vessel wall
[0070] FIG. 7d: View of the way in which the removable head is
attached to the remainder of the SCREW-DEVICE WITH REMOVABLE
HEAD
[0071] FIG. 8a: Lateral view of the SCREW-CUTTER
[0072] FIG. 8b: Top view of the SCREW-CUTTER
[0073] FIG. 8c: View of sharp end of SCREW-CUTTER, consisting of
two regular windings and one sharp winding
* * * * *