U.S. patent application number 08/875129 was filed with the patent office on 2002-04-18 for biocompatible glue.
Invention is credited to JOHANSSON-RUDEN, GUNILLA, SODERSTROM, BENGT.
Application Number | 20020045919 08/875129 |
Document ID | / |
Family ID | 20402895 |
Filed Date | 2002-04-18 |
United States Patent
Application |
20020045919 |
Kind Code |
A1 |
JOHANSSON-RUDEN, GUNILLA ;
et al. |
April 18, 2002 |
BIOCOMPATIBLE GLUE
Abstract
Use of one or more saccharides, for example one or more
non-toxic mono-, di-, tri-, oligo- or polysaccharides, in the
manufacture of a biocompatible glue for adhering a first structure
to a surface of a second structure. The biocompatible glue can be
adapted to act as a temporary glue. In this case the glue may be
used to enable a medical structure to be transferred from a medical
instrument onto the surface of a structure of a human or animal
body, for example as in the transfer of a buffer material from the
fork of a surgical stapler to a diseased lung after one or more
rows of staples have been fired through the buffer material into
the lung during lung volume reduction surgery for treating
emphysema. The biocompatible glue can also to advantage be used to
adhere or secure medical structures to a structure of a human or
animal body direct, such as in the case of a patch being applied to
the skin of a mammal.
Inventors: |
JOHANSSON-RUDEN, GUNILLA;
(ASKIM, SE) ; SODERSTROM, BENGT; (GOTEBORG,
SE) |
Correspondence
Address: |
WHITE & CASE LLP
PATENT DEPARTMENT
1155 AVENUE OF THE AMERICAS
NEW YORK
NY
10036
US
|
Family ID: |
20402895 |
Appl. No.: |
08/875129 |
Filed: |
July 17, 1997 |
PCT Filed: |
May 30, 1997 |
PCT NO: |
PCT/SE97/00945 |
Current U.S.
Class: |
606/214 ;
523/105; 602/56; 623/926 |
Current CPC
Class: |
Y10S 623/925 20130101;
A61L 24/08 20130101; A61L 27/18 20130101; A61L 27/58 20130101; C08L
67/04 20130101 |
Class at
Publication: |
606/214 ; 602/56;
623/926; 523/105 |
International
Class: |
A61B 017/08; A61D
001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 5, 1996 |
SE |
9602226-4 |
Claims
1. Use of one or more saccharides in the manufacture of a
biocompatible glue for adhering a first structure to a surface of a
second structure.
2. Use as claimed in claim 1, characterised in that one or more
non-toxic saccharides are used in the manufacture of the
biocompatible glue.
3. Use as claimed in claim 1 or 2, characterised in that one or
more mono-, di-, tri-, oligo- or polysaccharides are used in the
manufacture of the biocompatible glue.
4. Use as claimed in claim 1, 2 or 3, characterised in that the
biocompatible glue is adapted for releasably adhering the first
structure to the surface of the second structure.
5. Use as claimed in any one of claims 1 to 4, characterised in
that the second structure is a human or animal body structure.
6. Use as claimed in claim 5, characterised in that the first
structure is a medical structure.
7. Use as claimed in claim 4, characterised in that the first
structure is a medical structure for disposal on a surface of a
human or animal body structure and the second structure is a
medical instrument whereby the biocompatible glue enables the
medical structure to be transferred from the medical instrument
onto the surface of the body structure.
8. Use as claimed in claim 5, 6 or 7, characterised in that the
body structure is an internal structure of the human or animal
body.
9. Use as claimed in claim 8 when appendent on claim 7,
characterised in that the medical instrument is an invasive
surgical instrument for an invasive surgical procedure in which the
medical structure is to be transferred from the surgical instrument
to the surface of the internal body structure.
10. Use as claimed in claim 5, 6 or 7, characterised in that the
body structure is the skin of the human or animal body.
11. Use as claimed in claim 6, characterised in that the medical
structure is a patch and that the body structure is the skin of the
human or animal body.
12. Use as claimed in claim 9, characterised in that the invasive
surgical instrument is a stapler for use in lung volume reduction
surgery for treating emphysema of a lung of the human or animal
body and that the medical structure is a buffer material through
which one or more lines of staples are fired into the lung from the
stapler.
13. Use as claimed in any one of the preceding claims,
characterised in that the first structure comprises a
bio-resorbable material.
14. Use as claimed in claim 13, characterised in that the
bio-resorbable material comprises poly(3-hydroxybutyrate).
15. Use as claimed in any one of the preceding claims,
characterised in that the biocompatible glue comprises from 60 to
90% by weight of saccharides in solution.
16. Use as claimed in claim 15, characterised in that the
biocompatible glue comprises approximately 85% by weight of
saccharides in solution.
17. Use as claimed in claim 15 or 16, characterised in that water
is used as a solvent for the saccharides to form the solution.
18. Use as claimed in any one of the preceding claims,
characterised in that the saccharides comprise sugars.
19. Use as claimed in any one of the preceding claims,
characterised in that the biocompatible glue is formed in a viscous
state and used immediately for adhering the first structure to the
surface of the second structure.
20. Use as claimed in any one of the preceding claims,
characterised in that the biocompatible glue comprises a mixture of
two or more different saccharides.
21. Use as claimed in claim 15, 16 or 17, characterised in that the
solution includes 0.5 to 30% by weight of glycerol.
22. Use as claimed in claim 15, 16 or 17, characterised in that the
solution includes 1 to 30% by weight of polyethylene glycol having
a molecular weight of less than 50000.
23. A biocompatible glue comprising one or more saccharides for
adhering a first structure to a surface of a second structure.
24. A biocompatible glue as claimed in claim 23, characterised in
that the biocompatible glue comprises one or more non-toxic
saccharides.
25. A biocompatible glue as claimed in claim 23 or 24,
characterised in that the biocompatible glue comprises one or more
mono-, di-, tri-, oligo- or polysaccharides.
26. A biocompatible glue as claimed in claim 23, 24 or 25,
characterised in that the biocompatible glue is adapted for
releasably adhering the first structure to the surface of the
second structure.
27. A biocompatible glue as claimed in any one of claims 23 to 26,
characterised in that the biocompatible glue comprises from 60 to
90% by weight of saccharides in solution.
28. A biocompatible glue as claimed in claim 27, characterised in
that the biocompatible glue comprises approximately 85% by weight
of saccharides in solution.
29. A biocompatible glue as claimed in claim 27 or 28,
characterised in that water is used as a solvent for the
saccharides to form the solution.
30. A biocompatible glue as claimed in any one of claims 23 to 29,
characterised in that the saccharides comprise sugars.
31. A biocompatible glue as claimed in any one of claims 23 to 30,
characterised in that the biocompatible glue is formed in a viscous
state and used immediately for adhering the first structure to the
surface of the second structure.
32. A biocompatible glue as claimed in any one of claims 23 to 31,
characterised in that the biocompatible glue comprises a mixture of
two or more different saccharides.
33. A biocompatible glue as claimed in claim 27, 28 or 29,
characterised in that the solution includes 0.5 to 30% by weight of
glycerol.
34. A biocompatible glue as claimed in claim 27, 28 or 29,
characterised in that the solution includes 1 to 30% by weight of
polyethylene glycol having a molecular weight of less than
50000.
35. A method of adhering a first structure to a surface of a second
structure comprising the step of applying a coating of a
biocompatible glue comprising one or more saccharides to one or
other of the first or second structures.
36. A method as claimed in claim 35, characterised in that the
biocompatible glue is adapted for releasably adhering the first
structure to the surface of the second structure.
37. A method of treatment of a human or animal body by surgery
including the steps of releasably securing a medical structure to a
surgical instrument and then transferring the medical structure
from the surgical instrument to a surface of a structure of the
human or animal body characterised in that the medical structure is
releasably secured to the surgical instrument with a biocompatible
glue comprising one or more saccharides.
38. A method as claimed in claim 37, characterised in that the
surgery is lung volume reduction surgery for treating emphysema of
a lung of a human or animal body, that the surgical instrument is a
surgical stapler for firing one or more rows of staples into the
lung, that the medical structure is a buffer material and that the
biocompatible glue releasably adheres the buffer material to a fork
of the surgical stapler such that the staples can be fired
therethrough.
39. A method as claimed in claim 35, 36, 37 or 38, characterised in
that the biocompatible glue comprises one or more non-toxic
saccharides.
40. A method as claimed in any one of claims 35 to 39,
characterised in that the biocompatible glue comprises one or more
mono-, di-, tri-, oligo- or polysaccharides.
41. A method as claimed in any one of claims 35 to 40,
characterised in that the biocompatible glue comprises from 60 to
90% by weight of saccharides in solution.
42. A method as claimed in claim 41, characterised in that the
biocompatible glue comprises approximately 85% by weight of
saccharides in solution.
43. A method as claimed in claim 41 or 42, characterised in that
water is used as a solvent for the saccharides to form the
solution.
44. A method as claimed in any one of claims 35 to 43,
characterised in that the saccharides comprise sugars.
45. A method as claimed in any one of claims 35 to 44,
characterised in that the biocompatible glue is formed in a viscous
state and used immediately for adhering the first structure to the
surface of the second structure.
46. A method as claimed in any one of claims 35 to 45,
characterised in that the biocompatible glue comprises a mixture of
two or more different saccharides.
47. A method as claimed in claim 41, 42 or 43, characterised in
that the solution includes 0.5 to 30% by weight of glycerol.
48. A method as claimed in claim 41, 42 or 43, characterised in
that the solution includes 1 to 30% by weight of polyethylene
glycol having a molecular weight of less than 50000.
49. A medical device comprising a patch of polymeric material and a
coating of a biocompatible glue comprising one or more saccharides
for adhering the patch to a surface of a structure of a human or
animal body.
50. A medical device as claimed in claim 49, characterised in that
the biocompatible glue comprises one or more non-toxic
saccharides.
51. A medical device as claimed in claim 49 or 50, characterised in
that the biocompatible glue comprises one or more mono-, di-, tri-,
oligo- or polysaccharides.
52. A medical device as claimed in claim 49, 50 or 51,
characterised in that the biocompatible glue is adapted to
releasably adhere the patch to the body structure.
53. A medical device as claimed in any one of claims 49 to 52,
characterised in that the patch comprises a non-woven patch of
poly(3-hydroxybutyrate).
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to a new use of a known
material in the manufacture of a biocompatible glue for adhering a
first structure to a surface of a second structure, the invention
having particular, although not exclusive, application in surgery
or other medical procedures such as lung volume reduction for
treatment of emphysema or treating a bodily organ or tissue. It
also relates to a medical device comprising a patch of polymeric
material provided with a coating of such a glue.
BACKGROUND OF THE INVENTION
[0002] Emphysema is a condition of the lung characterised by the
lung capacity tending to decrease. After a patient has contracted
the disease typically only 15 to 20 per cent of the normal lung
capacity can remain. To improve the lung capacity around about 30
per cent of the lung volume is cut off by trimming away part of the
lung in a procedure known as lung volume reduction surgery to help
the healthy tissue to expand and thus improve lung capacity. The
usual way of achieving this is by using a linear surgical stapler
to place two rows of closely spaced staples along the line of the
desired cut and then cutting along the line of staples. This is
generally done between the rows although it may also be done on the
diseased side of the lung close to one of the rows. This process
may be performed several times until the most affected part of the
lung has been completely cut away.
[0003] When lung volume reduction surgery or other lung surgical
procedures are performed a common complication is persistent air
leaks which result in a significant and prolonged air loss from the
lung. This has been reported to be mainly through the staple holes
which can expand or tear when the lung is re-inflated.
[0004] The incidence of air leaks, however, may be reduced through
the application of a strip of material to the stapler and inserting
the staples through the strip. For example, in EP-A-066711
(Bio-Vascular, Inc.) there is made known an article of manufacture
comprising a strip of animal tissue material comprising bovine
pericardium which is temporarily fastened to a buttress member by
means of a basting filament to define a tubular configuration which
is able to slide over one of the jaws or forks of a surgical staple
gun. The strip of animal tissue material is so arranged on the fork
that the staples are inserted through the strip. The diseased
tissue is then cut away. The diseased tissue thus remains
temporarily attached to the healthy tissue at this stage as the
buttress member is still attached to the strip. Removal of the
basting filament is required to free the buttress from the strip
and thus the diseased tissue from the healthy tissue.
[0005] There are several disadvantages to the means proposed in
EP-A-0667119 for positioning the strip of animal material on the
fork of the staple gun such that staples can be fired therethrough
into the diseased lung.
[0006] First, cutting away of the diseased tissue does not effect
its removal until the buttress member has also been severed from
the strip. Second, the buttress member makes it difficult to cut
the tissue especially in endoscopic techniques as it tends to get
in the way. Third, the strip of animal tissue is only loosely held
on the surgical stapler by the buttress member and could easily
fall off. This is again problematic particularly if endoscopic
techniques are being used.
DISCLOSURE OF THE INVENTION
[0007] The present invention proposes to provide means for adhering
or securing a first structure to a surface of a second structure
which may be used in the medical field.
[0008] Thus, according to the present invention there is provided
the use of one or more saccharides in the manufacture of a
biocompatible glue for adhering a first structure to a surface of a
second structure. For example, one or more non-toxic mono-, di-,
tri-, oligo- or polysaccharides may be used in the manufacture of
the biocompatible glue.
[0009] In an embodiment of the invention the biocompatible glue is
adapted for releasably adhering the first structure to the surface
of the second structure. This has particular application where the
first structure is a medical structure for disposal on a surface of
a human or animal body structure and the second structure is a
medical instrument. The biocompatible glue then enables the medical
structure to be transferred from the medical instrument onto the
surface of the body structure. For example, the body structure may
be an internal structure of the human or animal body and the
medical instrument an invasive surgical instrument for an invasive
surgical procedure in which the medical structure is to be
transferred from the surgical instrument to the surface of the
internal body structure. Lung volume reduction surgery involves
such a surgical procedure. In this case, the medical structure may
serve as a buffer material to reinforce one or more lines of
staples fired into a diseased lung to prevent air leaks following
surgery. There would be no need for the glue to assist in the
adhesion of the buffer material to the bodily organ once the
material has been removed from the surgical instrument. The glue
simply needs to act as a temporary glue during the surgical
procedure.
[0010] Other surgical procedures in which the invention may be used
include intestinal anastomosis and vascular surgery. In vascular
surgery, the buffer material would serve to prevent the loss of
blood not of air as in lung volume reduction surgery.
[0011] The buffer material may be a strip of animal tissue material
comprising bovine pericardium, as disclosed in EP-A-0667119
(Bio-Vascular, Inc.). However, this has the disadvantage that the
polymer that makes up bovine pericardium is non-resorbable and
non-degradable in the patient over the time period in which it is
present, especially as it would tend to calcify. Other
non-degradable materials that may be used include TEFLON, i.e.
poly(tetrafluoroethylene), and DACRON, a polyester material of
poly(ethylene terephthalate). Ideally, though, the material is a
bio-resorbable material. Suitable bio-resorbable materials include
polymers such as poly(glycolic acid) (PGA), poly(lactic acids)
(PLA), poly(.epsilon.-caprolactone) (PCL), poly(.beta.-malic acid)
(PMLA) and poly(p-dioxanone) (PDS). Poly(.beta.-hydroxybutyric
acid), generally referred to as poly(3-hydroxybutyrate) (PHB), is
particularly suitable, on account of it being degradable,
biocompatible and resorbable. It may further be formed into a
non-woven patch.
[0012] In an alternative embodiment of the invention the first
structure is a medical instrument and the second structure an
organic tissue structure such as the skin or hair of mammals. The
biocompatible glue may then be used in any application where a
medical instrument needs to be stuck to the skin or hair of
mammals. For example, the glue may be used for sticking electrodes
or a compress to the skin or hair.
[0013] In another embodiment of the invention the second structure
is a human or animal body structure and the first structure is a
medical structure. The medical structure may be applied direct to
the body structure, for example a medical patch applied to the skin
of a mammal. In such a case, there is no need to use a medical
instrument to facilitate its application.
[0014] The composition of the biocompatible glue may vary according
to the particular application for which it is to be used. Depending
on the viscosity of the glue that is required, up to 90% by weight
of saccharides might be used in solution. However, a glue
containing from 60 to 90% by weight of saccharides is preferred. A
glue containing from80 to 85% by weight of saccharides, especially
an amount in the vicinity of 85% by weight, is particularly
preferred.
[0015] Any solvent may be used in the glue, but water is an ideal
solvent to ensure bio-compatibility.
[0016] The viscosity of the glue also depends on the type of
saccharide that is used. Furthermore, polysaccharides are not all
easily resorbed by the human body and some are toxic. For this
reason, sugars, i.e. mono- and disaccharides, are ideal because
they are non-toxic and quickly resorbable. Commonly occurring mono-
and disaccharides such as fructose, glucose (dextrose) and sucrose
may be used.
[0017] The glue may be applied in the form of a solution and then
dried. The material may then be moistened immediately prior to use.
When a biodegradable material such as poly(3-hydroxybutyrate) is
used, however, there is the danger that the material may hydrolyse
during manufacture or storage. The glue may also be used as a
separate supply of dry powder, again moistened immediately prior to
use. However, more control can be had over the composition of the
glue, ensuring the optimal ideal stickiness is achieved, if it is
applied in a viscous state and used immediately. This also obviates
the need to have to add water at the time of use.
[0018] The glue may contain a single type of saccharide, i.e. be
composed of one saccharide only in solution. This is perfectly
acceptable when the glue is applied in the form of a solution and
then dried. A mixture of two or more different saccharides is
preferred, however, to obviate possible problems with
crystallisation.
[0019] Water loss from the glue during storage may be minimised by
adding a hygroscopic material. The hygroscopic material may include
0.5 to 30% by weight of glycerol. 1 to 10% by weight of glycerol is
preferred with around about 10% being most preferred.
Alternatively, the hygroscopic material may include 1 to 30% by
weight of polyethylene glycol (PEG) having a molecular weight of
less than 50 000. This has the further advantage that it may act as
a lubricant.
[0020] According to the invention there is further provided a
biocompatible glue comprising one or more saccharides for adhering
a first structure to a surface of a second structure.
[0021] According to the invention there is yet further provided a
method of adhering a first structure to a surface of a second
structure comprising the step of applying a coating of a
biocompatible glue comprising one or more saccharides to one or
other of the first or second structures.
[0022] According to the invention there is also provided a method
of treatment of a human or animal body by surgery including the
steps of releasably securing a medical structure to a surgical
instrument and then transferring the medical structure from the
surgical instrument to a surface of a structure of the human or
animal body characterised in that the medical structure is
releasably secured to the surgical instrument with a biocompatible
glue comprising one or more saccharides.
[0023] According to the invention there is additionally provided a
medical device comprising a patch of polymeric material and a
coating of a biocompatible glue comprising one or more saccharides
for adhering the patch to a surface of a structure of a human or
animal body. Suitable polymeric materials include non-degradable
materials such as bovine pericardium, TEFLON, i.e.
poly(tetrafluoroethylene), and DACRON, a polyester material of
poly(ethylene terephthalate). Ideally, though, the material is a
bio-resorbable material. Suitable bio-resorbable materials include
polymers such as poly(glycolic acid) (PGA), poly(lactic acids)
(PLA), poly(e-caprolactone) (PCL), poly(.beta.-malic acid) (PMLA)
and poly(p-dioxanone) (PDS). We have found that
poly(.beta.-hydroxybutyric acid), generally referred to as
poly(3-hydroxybutyrate) (PHB), is particularly suitable, on account
of it being degradable, biocompatible and resorbable. It may also
be used as a non-woven patch.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0024] Embodiments of the invention will now be described by way of
example. These illustrate the use of one or more saccharides in the
manufacture of a biocompatible glue for sticking a medical
instrument or a bodily organ or tissue to another material. The
glue is either prepared as--
[0025] (1) a wet glue and applied to--
[0026] a linear cutter surgical stapler, and
[0027] (b) human skin, or
[0028] (2) a dry glue, moistened immediately prior to use.
[0029] (1) Wet Glue
[0030] 30 g of water was heated in a beaker covered by plastic foil
to 70.degree. C. 40 g of sucrose, 30 g of fructose and 30 g of
glucose (dextrose) were added to the water dissolved by agitation
at 70.degree. C. for approximately 30 minutes. The plastic foil was
removed and the water evaporated for approximately 2 hours until
the saccharides formed around about 85% by weight of the solution.
The solution was then placed in a glass syringe (1ml) and cooled
down to ambient temperature ready for use.
[0031] (a) Linear Cutter Surgical Stapler
[0032] A small amount (less than 1 ml and preferably 0.05-0.1 ml)
of the solution was spread out on each of two strips (1 cm by 10
cm) of a non-woven patch made of poly(3-hydroxybutyrate) (PHB). The
strips were then put on the forks of a linear cutter surgical
stapler, PROXIMATE.TM. model TLC-75 as supplied by Ethicon, Inc.,
of Somerville, N.J., USA. The strips stuck easily to the forks and
after the instrument was fired the strips were easily removed from
the forks.
[0033] (b) Skin
[0034] A small amount (less than 1 ml) of the solution was spread
out on a piece (5 cm by 5 cm) of a non-woven patch made of PHB. The
patch was then put on the skin and the patch was easily stuck to
the skin. Even after 10 hours the patch was still adhering to the
skin yet easily able to be removed.
[0035] (2) Dry Glue 10 g of water was heated in a beaker covered
with a plastic foil to 70.degree. C. 30 g of sucrose was added to
the water and the sucrose was dissolved by agitation at 70.degree.
C. for half an hour. The plastic foil was removed and 1 ml of the
solution spread out on a strip (1 cm by 10 cm) of a non-woven patch
made of poly(3-hydroxybutyrate) (PHB). The strip was then put in a
vacuum oven at 50.degree. C. for 5 hours in order to evaporate the
water. The strip was then wetted with a moistened sponge and put on
a fork of a linear cutter surgical stapler. The strip stuck easily
to the fork and was also easy to remove.
* * * * *