TOP > 外国特許検索 > Flocked medical instrument to be placed in the body, method of producing the medical instrument to be placed in the body and apparatus for producing the medical instrument to be placed in the body

Flocked medical instrument to be placed in the body, method of producing the medical instrument to be placed in the body and apparatus for producing the medical instrument to be placed in the body

外国特許コード F110005621
整理番号 RX03P52WO
掲載日 2011年9月9日
出願国 アメリカ合衆国
出願番号 09512006
公報番号 20090306599
公報番号 8360000
出願日 平成18年11月27日(2006.11.27)
公報発行日 平成21年12月10日(2009.12.10)
公報発行日 平成25年1月29日(2013.1.29)
国際出願番号 JP2006323621
国際公開番号 WO2007061100
国際出願日 平成18年11月27日(2006.11.27)
国際公開日 平成19年5月31日(2007.5.31)
優先権データ
  • 特願2005-342740 (2005.11.28) JP
  • 2006JP323621 (2006.11.27) WO
発明の名称 (英語) Flocked medical instrument to be placed in the body, method of producing the medical instrument to be placed in the body and apparatus for producing the medical instrument to be placed in the body
発明の概要(英語) The present invention provides a percutaneous terminal having a substrate thereof flocked with fibers having bio-affinity, and thereby being able to adhere tightly to a living body, a medical instrument to be placed in the body, and a production method and a production apparatus of the percutaneous terminal and the medical instrument to be placed in the body.
The percutaneous terminal according to the present invention is one which the surface of the substrate is flocked with bio-affinitive short fibers (e.g. hydroxyapatite complex particles), therefore the bio-affinitive short fibers are risen perpendicular to or substantially perpendicular to the surface of the substrate.
As a result, an area of the bio-affinitive short fibers coating a unit area of the substrate of the percutaneous terminal to the unit area of the percutaneous terminal substrate is considerably elevated and, in its turn, the adhesiveness of the percutaneous terminal to biological tissues is improved.
Thus, it is possible to stably fix to the living body a medical device such as a catheter or the like which has the percutaneous terminal.
The medical instrument according to the present invention is also flocked with the short fibers as described above, therefore it is possible to stably fix to the living body the medical instrument to be placed in the body.
従来技術、競合技術の概要(英語) BACKGROUND ART
In recent years, medical instruments to be placed in the body such as percutaneous catheters have been used for medical treatment.
For example, a percutaneous catheter is inserted inside a living body from outside the living body, in order to perform medical practices such as peritoneal dialysis.
However, when the medical instrument to be placed in the body such as the percutaneous catheter is implanted in the living body, the medical instrument placed in the body is recognized as a foreign body by biological tissues.
Therefore, the biological tissues and the medical instrument do not adhere tightly with each other.
As a result, in the case of the percutaneous catheter for example, an epidermis sinks inwards along the catheter, so referred as a down-growth (phenomenon of which an epithelial sinks inwards along the surface of the catheter).
The deepening of the down-growth causes insufficient disinfection.
The insufficient disinfection creates an infection pathway for bacteria, which becomes a cause for inflammation of skin and other problems.
Consequently, this causes a condition that in the end the medical instrument placed in the body has to be taken out from the body.
For medical instruments to be placed in the body other than the percutaneous catheter, there is a problem that the medical instrument is moved in the body.
In order to solve these problems, various medical instruments to be placed in the body have been proposed.
The proposed medical instruments to be placed in the body are disclosed to have tight adhesiveness with the living body.
For example, intraperitoneal catheters and central venous catheters have a cuff member (Dacron cuff) made of Dacron nonwoven fabric in order to prevent bacterial infection and to fix the catheter to the living body (for example, see Patent Document 5).
By implanting the Dacron cuff part under the skin, hyperplasia of hypodermic connective tissues occurs.
Consequently, the catheter is firmly fixed.
Because the catheter is securely fixed, the possibility of accidental evulsions is reduced.
However, even with this catheter, the Dacron cuff and the biological tissues are not adhered together.
Therefore, the bacterial infection is not completely prevented.
As another medical instrument to be placed in the body, a percutaneous terminal made of a highly bio-affinitive hydroxyapatite ceramics is proposed (see Non-Patent Document 2).
However, the following problems exist in the arrangement of the disclosed conventional technique.
In the arrangement of Non-Patent Document 2, the percutaneous terminal is formed from only a hydroxyapatite ceramics.
Hydroxyapatite is a constituent of teeth and shows excellent bio-affinity with soft tissues, however the hydroxyapatite ceramics is hard and fragile.
Therefore, the percutaneous terminal becomes hard.
Consequently, a space may generate between the hydroxyapatite ceramics and the biological tissues when implanted inside the living body.
This causes the problem of poor adhesiveness with the living body.
Furthermore, if the percutaneous terminal is produced only with the hydroxyapatite ceramics, the percutaneous terminal becomes a large size.
As such, various problems exist with the percutaneous terminal disclosed in Non-Patent Document 2, such that the percutaneous terminal is easily breakable, and discomfort is felt by patients due to the hardness of the percutaneous terminal when implanted inside the living body.
As another example, a method is proposed which modifies a highly bio-affinitive calcium phosphate on a surface of a base material of a medical device or a base material of a medical material, in order to allow tight adhesiveness with the living body.
More specifically, for example, Patent Document 6 discloses a method which modifies the calcium phosphate on a surface of a base material of a medical component, by using sputtering ion beams.
The medical component here is made of a polymer or the like.
Patent Document 7 discloses a method which modifies the calcium phosphate on a surface of a base material made of glass, a ceramic calcium phosphate or the like, by soaking.
Patent Document 8 discloses a method which precipitates the calcium phosphate on a surface of an inorganic biomaterial.
Patent document 9 discloses a method which mechanically abuts the calcium phosphate or the like on a surface of a medical material by blasting or other methods.
Patent document 10 discloses a method which modifies the calcium phosphate on a surface of a base material of a medical material such as an organic polymer or the like, by utilizing alternative soaking.
However, the calcium phosphate to be modified on the surface of the base material in the methods disclosed in Patent Documents 6 through 10 are all amorphous, which readily melts inside the living body.
Therefore, the bio-affinity of the medical devices produced by using the medical materials described in Patent Documents 6 through 10 do not last for a long term inside the living body.
As a result, the medical instruments are suitably used when the purpose of using the calcium phosphate is to melt the calcium phosphate in the body (for example, as a material to replace bones), however are not suitably used when the purpose of using the calcium phosphate is to keep the calcium phosphate inside the body for a long term (for example, the percutaneous terminal) or the like.
In addition, the modifying method disclosed in Patent Documents 6 through 10 adhere the calcium phosphate to the base material either physically or electrostatically.
This has the problem that adhering strength of the calcium phosphate is weak.
In order to attain the purpose of keeping the calcium phosphate inside the body for a long term, methods to modify a surface of a polymer base material with the calcium phosphate has been yearned for, and various proposals have been made.
For example, methods such as the ones disclosed in Patent Documents 11 through 13 have been proposed.
Patent Document 11 describes a method where ceramic porous particles made of hydroxyapatite are fixed on a surface of a polymer base material of an intraperitoneal catheter by using an adhesive, or by fusing the polymer base material.
Patent Document 12 discloses a medical material in which a calcium phosphate such as hydroxyapatite is chemically bonded to a surface of a polymer base material.
Patent Document 13 discloses a technique which coats an organic fiber aggregate or an inorganic fiber aggregate with a calcium phosphate compound, which is then jointed to an artificial trachea or the like.
However, if the porous particles made of highly bio-affinitive hydroxyapatite are adhered or fused on the surface of the catheter as described in Patent Document 11, the hydroxyapatite is applied directly to the catheter.
This causes the problem that a part of the catheter where the hydroxyapatite is applied would differ in physical properties to the other parts of the catheter.
In particular, if the porous particles made of hydroxyapatite are introduced to the catheter by fusing, the catheter would lose its physical properties and possibly break.
If the hydroxyapatite is adhered directly to the catheter with an adhesive, problems arise such as the area of which the hydroxyapatite is exposed may decrease due to the soaking-in of the adhesive into the hydroxyapatite, or the hydroxyapatite may peel off from the catheter in case of insufficient adhering.
If the fiber aggregate is coated with the calcium phosphate compound as described in Patent Document 13, the fiber which has not been coated with the calcium phosphate compound could possibly be exposed.
In addition, this method requires to produce the fiber aggregate which is coated with the calcium phosphate and to join this coated fiber aggregate to a plastic body in advance.
Thus, it is difficult to apply this method for a medical instrument and the like in complex shapes.
Furthermore, Patent Document 13 forms the calcium phosphate by a liquid-phase precipitation method.
The calcium phosphate formed by the liquid-phase precipitation method is amorphous.
Therefore, the calcium phosphate readily melts inside the body.
In addition, as described in paragraph [0012] of Patent Document 13, it is difficult to coat the calcium phosphate in a thickness of 1 mu m or less.
This is because it is industrially difficult to evenly coat the calcium phosphate in a thickness of 1 mu m or less in a conventional liquid-phase precipitation method or other conventional methods.
Furthermore, such thickness causes the calcium phosphate to readily melt inside the body.
In response to this, the inventors of the present invention independently developed a hydroxyapatite composite particle (see Patent Document 14).
The hydroxyapatite composite particle is produced by chemically bonding a silk fibroin and the hydroxyapatite, and has high bio-affinity.
Additionally, the inventors produced a percutaneous terminal which can adhere tightly to the living body, by adhering the hydroxyapatite composite particle to a surface of a substrate (see Non-Patent Document 3).
The percutaneous terminal and a catheter provided with the percutaneous terminal can adhere to the living body far tighter compared to conventional percutaneous terminals.
A conventional and publicly known flocking method is referred as an electrostatic flocking or electrodeposition flocking.
The flocking method is a processing method where short fibers (referred as 'pile flock' or 'pile') are orthogonally planted on a base material.
An adhesive is applied to the base material in advance, and short fibers are planted by utilizing electrostatic attraction in a high voltage electrostatic field.
The flocking method is not limited to simply planting short fibers, and various effects are attainable by selecting specific adhesives, short fibers, base materials and the like.
Therefore, the method is utilized in a broad range of fields (see Non-Patent Document 1).
For example, the flocking method is used in processing clothing and textile goods (for example, see Patent Documents 1 through 3).
The flocking method is also used in processing makeup and cosmetic products (for example, see Patent Document 4) as well as processing elastic material such as rubber gloves (for example, see Patent Document 15).
However, there have been no examples of which the flocking method is used for processing medical material.
The technical idea itself of such process did not exist, to process flocking with short fibers on a surface of a medical instrument to be placed in the body such as a percutaneous catheter.
Non-Patent Document 1
"Shin Kobunshi Bunko 17 Furokku Kakou no Jissai (New Polymer Publishing 17 Facts of Flocking)", N. Iinuma, Polymer Publishing Inc., p. 1, published Aug. 1, 1979,
Non-Patent Document 2
H. AOKI, in "Medical Applications of Hydroxyapatite" (Ishiyaku EuroAmerica, Inc., 1994) p. 133-155
Non-Patent Document 3
Tsutomu Fruzono, PhD, Shoji Yasuda, M S, Tsuyoshi Kimura, PhD, Singo Kyotani, M D, Junzo Tanaka, PhD, Akio Kishida, PhD, "Nano-scaled hydroxyapatite/polymer composite IV.
Fabrication and cell adhesion properties of a three-dimensional scaffold made of composite material with a silk fibroin substrate to develop a percutaneous device".
J Artif Organs (2004) 7:137-144
Patent Document 1
Japanese Unexamined Patent Publication, Tokukaihei, No. 7-116557 (published May 9, 1995)
Patent Document 2
Japanese Unexamined Patent Publication, Tokuhyo, No. 2000-505845 (published May 16, 2000)
Patent Document 3
Japanese Unexamined Patent Publication, Tokukaihei, No. 6-141926 (published May 24, 1994)
Patent Document 4
Japanese Unexamined Patent Publication, Tokukai, No. 2003-38596 (published Feb. 12, 2003)
Patent Document 5
Japanese Unexamined Patent Publication, Tokukaihei, No. 8-206193 (published Aug. 13, 1996)
Patent Document 6
Japanese Unexamined Patent Publication, Tokukaihei, No. 8-56963 (published Mar. 5, 1996)
Patent Document 7
Japanese Unexamined Patent Publication, Tokukaihei, No. 7-306201 (published Nov. 21, 1995)
Patent Document 8
Japanese Unexamined Patent Publication, Tokukaisho, No. 63-270061 (published Nov. 8, 1988)
Patent Document 9
Japanese Unexamined Patent Publication, Tokukaihei, No. 7-303691 (published Nov. 21, 1995)
Patent Document 10
Japanese Unexamined Patent Publication, Tokukai, No. 2000-342676 (published Dec. 12, 2000)
Patent Document 11
Japanese Unexamined Patent Publication, Tokukaihei, No. 10-15061 (published Jan. 20, 1998)
Patent Document 12
Japanese Unexamined Patent Publication, Tokukai, No. 2001-172511 (published Jun. 26, 2001)
Patent Document 13
Japanese Unexamined Patent Publication, Tokukaihei, No. 06-327757 (published Nov. 29, 1994)
Patent Document 14
Japanese Unexamined Patent Publication, Tokukai, No. 2004-51952 (published Feb. 19, 2004)
Patent Document 15
U.S. Patent Application Publication No. 2004/0033334 (published Feb. 19, 2004)

特許請求の範囲(英語) [claim1]
1. An apparatus for producing a percutaneous terminal in which a surface of a substrate of the percutaneous terminal is flocked with bio-affinitive short fibers, the apparatus comprising: a first electrode plate and a second electrode plate; and
a rotation supporting section which includes a supporting section for supporting the substrate of the percutaneous terminal and a rotating section for rotating the supporting section, the second electrode plate being arranged under the first electrode plate, where a direction of gravity is denoted as downwards;
the second electrode plate being arranged such that the bio-affinitive short fibers are mountable;
the rotation supporting section being arranged so that the substrate of the percutaneous terminal, which substrate is supported by the supporting section is to be arranged between the first electrode plate and the second electrode plate; and
the supporting section being electrically connected with the first electrode plate, and arranged electrically connectable with the substrate of the percutaneous substrate, the supporting section being a bar, an angle formed by a longitudinal direction of the supporting section and each of the first electrode plate and the second electrode plate being more than 0 deg. however less than 90 deg. .
[claim2]
2. The apparatus as set forth in claim 1, further comprising moistening means for moistening the bio-affinitive short fibers.
[claim3]
3. The apparatus as set forth in claim 1, further comprising: a container for containing at least the first electrode plate, the second electrode plate and the supporting section; and
a humidity controlling section for controlling humidity inside the container.
[claim4]
4. An apparatus for producing a medical instrument to be placed in the body in which a surface of a substrate of the medical instrument to be placed in the body is flocked with bio-affinitive short fibers, the apparatus comprising: a first electrode plate and a second electrode plate; and
a rotation supporting section which includes a supporting section for supporting the substrate of the medical instrument to be placed in the body and a rotating section for rotating the supporting section,
the second electrode plate being arranged under the first electrode plate, where a direction of gravity is denoted as downwards, the second electrode plate being arranged such that the bio-affinitive short fibers are mountable, the rotation supporting section being arranged so that the substrate of the medical instrument to be placed in the body, which substrate is supported by the supporting section is to be arranged between the first electrode plate and the second electrode plate,
the supporting section being electrically connected with the first electrode plate, and arranged electrically connectable with the substrate of the percutaneous substrate, the supporting section being a bar, an angle formed by a longitudinal direction of the supporting section and each of the first electrode plate and the second electrode plate being more than 0 deg. however less than 90 deg. .
[claim5]
5. The apparatus as set forth in claim 4, further comprising humidifying means for humidifying the bio-affinitive short fibers.
[claim6]
6. The apparatus as set forth in claim 4a container for containing at least the first electrode plate, the second electrode plate and the supporting section; and
a humidity controlling section for controlling a humidity inside the container.
  • 発明者/出願人(英語)
  • FURUZONO TSUTOMU
  • YASUDA SHOJI
  • IMOTO TOSHIYUKI
  • JAPAN SCIENCE AND TECHNOLOGY AGENCY
国際特許分類(IPC)
米国特許分類/主・副
  • 118/638
  • 118/621
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