JP2011062316A - Sterilization sheet for body cavity diagnostic system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sterilization sheet for a pull-back system with which a drive unit is smoothly operated without being disturbed by the sterilization sheet and which has no possibility of reduction in accuracy of treatment or diagnosis. <P>SOLUTION: In the sterilization sheet 60, at least a part of components between an insertion portion 62 and a held portion 63 held by a holding portion 40 is formed from an elastic material S. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a sterilization sheet used in an intracorporeal diagnostic system that acquires an image in a body cavity to treat or diagnose.

  The intra-body-cavity diagnostic system inserts a catheter into a body cavity such as the coronary artery, bile duct, urethra, or digestive tract of the heart, and places the signal transmitting / receiving member provided in the catheter at a position corresponding to the target site for treatment or diagnosis. After setting, it moves or rotates around the axis, scans inside the body cavity, observes an image of the inner surface or cross section of the body cavity, measures blood flow, etc., and is used for treatment and diagnosis. In this case, the signal transmitting / receiving member is once moved beyond the target portion, and then moved back (pullback) and scanned, so that it is also called a pullback system.

  This system includes a catheter portion including a signal transmission / reception member and a drive shaft, and a device portion such as a drive unit that rotationally drives the signal transmission / reception member via the drive shaft and a moving unit that moves the drive shaft in the axial direction. The drive unit is moved forward and backward on the base by the moving means to move the drive shaft in the axial direction, or the drive shaft is rotated about the axis by the drive unit. In practice, the catheter portion is so-called single-use, and devices such as a drive unit are often reused. In this case, since the new sterilized catheter part is detached from the equipment part that is reused in the non-sterile part, the base part of the catheter part is contaminated if it comes into contact with the equipment part. If the surgeon holds the hand, the hand of the surgeon may be contaminated. Therefore, in use, equipment parts to be reused are wrapped in a bag-like sterilized sheet to prevent contamination of the catheter part.

  However, there have been reports of cases in which a sterilization sheet enters and gets caught between the drive unit and the base before and after the pull back operation. In order to solve this problem, for example, in Patent Document 1 below, a drive unit is movably provided on the base, and a holding unit for holding the base of the catheter is provided at the tip of the base, and the drive unit is provided by a sterilization sheet. An intra-body-cavity diagnostic system is disclosed in which the holding portion is covered and the base of the catheter is inserted into the sterilization sheet through a through-hole formed in the sterilization sheet.

  In this intra-body cavity diagnosis system, the holding unit and the driving unit are covered with the sterilization sheet, and a part of the sterilization sheet is held by the driving unit and the holding unit, but when the driving unit is pulled back by a driving signal from the control unit, The drive unit moves backward in the sterilization sheet, and the sterilization sheet is pulled. In order to cope with this, the sterilization sheet between the drive unit and the holding unit is formed as a bellows structure formed by folding the sheet.

WO2007 / 001956 A2

  However, providing a bellows-like fold on the sterilized sheet is time-consuming and it is not easy to provide an appropriate fold that can withstand a pull-back operation. When the bellows-like fold is provided, the sterilization sheet may be caught when the drive unit is returned to a predetermined position in order to finish the pull-back operation and perform the pull-back operation again.

  The present invention has been made in order to solve the above-described problems, and provides a sterilization sheet for an intracorporeal diagnosis system that can smoothly operate a drive unit with a simple structure and does not cause a decrease in accuracy of treatment or diagnosis. The purpose is to provide.

  The sterilization sheet for an in-vivo diagnostic system of the present invention that achieves the above object has an insertion part having an opening for inserting a proximal end part of a catheter, and a held part held by a holding part, and the insertion sheet At least a part between the portion and the held portion is made of a stretchable material that expands as the driving portion moves in the axial direction by the moving means.

  In the present invention, since at least a part of the sterilization sheet between the insertion part and the held part is made of an elastic material, the sterilization sheet freely expands and contracts even when the drive unit is pulled back, The drive unit can be operated smoothly, and a reduction in the accuracy of treatment and diagnosis can be prevented. Moreover, since the sterilization sheet itself has elasticity, there is no possibility that the sterilization sheet enters and is caught between the drive unit and the base before and after the pull back operation. In addition, since a sterilized sheet in which the constituent materials are partially changed may be used, it can be easily applied to a conventional in-vivo diagnostic system, is easy in production, and is extremely advantageous in terms of cost.

  If an adapter for connecting the proximal end portion of the catheter and the drive portion is provided in the opening of the insertion portion, the connection between the catheter and the drive portion can be performed with one touch, not only the workability is improved, The opening of the insertion portion is also reliably closed by the adapter, and the risk of contamination is further reduced.

  If the constituent material of the sterilization sheet is made of a light transmissive material, the position of the drive unit and the like can be viewed from the outside, which is more advantageous in terms of operability.

  If the stretchable material is composed of at least one of latex, nitrile rubber, polymer elastomer, and polyvinyl chloride, a highly stretchable sterilized sheet is obtained, which is more advantageous in terms of operability.

  If the constituent material between the insertion portion and the holding portion is not broken even if it is stretched by 150 mm or more, a pullback operation that is generally performed can be dealt with, and it becomes practical.

  If the sterilization sheet is formed in a bag shape, the holding unit and the driving unit are easily covered, workability is improved, and the risk of contamination is further reduced.

1 is an overall view showing an in-vivo diagnostic system according to an embodiment of the present invention. It is an expanded sectional view of the tip part of a catheter. It is an expanded sectional view which shows the base and drive part of a catheter. It is a schematic sectional drawing which shows the back-and-front state of a pull back.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

  As shown in FIG. 1, the intra-body-cavity diagnostic system according to the present embodiment includes a catheter 1 that is inserted into a body cavity, a connector member 10 to which a proximal end portion of the catheter 1 is attached, and a connecting tube 26 connected to the connector member 10. Are connected to each other through a hub portion 20, a drive shaft D inserted through the hub portion 20 and the connector member 10, and a distal end portion inserted to the distal end portion of the catheter 1, and a distal end portion of the drive shaft D. The signal transmitting / receiving unit 30, the holding unit 40 that holds the connector member 10, the driving unit 70 that rotationally drives the drive shaft D, and the driving unit 70 are moved closer to and away from the holding unit 40 on the base 74. 30 provided in the opening 61 of the sterilization sheet 60, the moving means 80 which moves the axis | shaft 30 in the catheter 1, the bag-like sterilization sheet 60 which covers the holding | maintenance part 40, the drive part 70, the movement apparatus 80, etc. Is has the adapter 50 for connecting the drive shaft D and the drive unit 70.

  In the present specification, the side to be inserted into the body cavity is referred to as “distal end” or “distal end side”, and the proximal side for operation is referred to as “proximal end” or “proximal end side”.

  As shown in FIG. 1, the drive unit 70 is electrically connected to the drive unit 71 having a motor (not shown) and the like inside, and the signal transmitting / receiving unit 30 (specifically, an ultrasonic transducer). The drive unit 71 is mounted on the groove rail 75 of the base 74 via the slider portion 73 so as to be able to move forward and backward.

  The moving means 80 is a feed mechanism that is provided on the base 74 and moves the drive unit 70 back and forth along the groove rail 75. However, as a means for moving the drive unit 70 back and forth, not only a feed mechanism that automatically moves back and forth, but also an operator may perform it manually. The driving unit 70 and the moving unit 80 are controlled by the control unit C, but these are well-known and will not be described in detail.

  Further, each configuration will be described in detail. First, the catheter 1 is a very thin tube, and as shown in FIG. 1, is composed of a thin tip member 2 and a relatively large diameter main body 3. As shown in FIG. 2, the tip member 2 is provided with a wire insertion portion 4 at the top and a plug 5 at the tip. The wire insertion portion 4 is a portion through which a guide wire 6 used as a guide when the catheter 1 is inserted into a body cavity is inserted, and only the guide wire 6 is inserted in the state where the guide wire 6 is inserted into the wire insertion portion 4. Is inserted into the body cavity in advance, and the catheter 1 is guided along the guide wire 6 to the target site of the body cavity.

  An X-ray contrast marker M is provided at the distal end portion of the wire insertion portion 4, the distal end member 2, and the main body portion 3 so that the position of each part of the catheter can be known from the outside.

  The plug body 5 closes the distal end of the catheter 1. Here, a priming lumen 6 is formed, and a filling liquid for priming (for example, a physiological fluid) filled in the catheter 1 from a priming port 22 described later. When the salt solution or the like flows out from the priming lumen 6, it can be seen that priming has been completed.

  The catheter 1 is a flexible tube having a predetermined tensile strength and having an outer diameter of about 0.5 mm to 1.5 mm. Examples of the constituent material include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polystyrene, polyurethane, polyamide, and polyimide. And various resins such as polyoxymethylene, polyvinyl alcohol, polytetrafluoroethylene, polyvinylidene fluoride, other fluororesins, thermoplastic elastomers such as polyamide elastomer and polyester elastomer, and various rubbers such as silicone rubber and latex rubber.

  The drive shaft D is provided in the thin and long catheter 1, and the driving force by the drive unit 71 and the moving means 80 on the proximal end side, that is, the rotational force and the axial force are transmitted to the signal transmitting / receiving unit 30 fixed to the distal end portion. It communicates and activates it. Therefore, the driving shaft D is preferably a flexible wire that does not bend, does not buckle, and is not easily deformed by twisting, and has a characteristic that allows the driving force of the drive unit 71 to be reliably transmitted to the signal transmission / reception unit 30. For example, as the drive shaft D, a wire made of various metal materials such as gold, silver or alloys thereof, stainless steel, other iron alloys, copper or copper alloys is used, and the right and left and the winding direction are alternated 3 A multilayer coil-like tube body such as a layer coil is preferable (see FIG. 2). In this way, there is little risk of buckling when moving forward and backward in the axial direction, and the transmission of torque and axial force is excellent, and a space portion is generated inside the drive shaft D. Here, a signal line 33 (see FIG. 3) for connecting the drive unit 71 and the signal transmitting / receiving unit 30 can be passed.

  However, since the drive shaft D is long, if it advances and retreats in the axial direction or rotates about the axis, frictional resistance is generated between the peripheral members and the driving force may not be transmitted reliably. For this reason, it is preferable to laminate a film having a low frictional resistance on the outer surface of the drive shaft D or to form a layer (lubricating layer) made of a hydrophilic polymer material having lubricity in a wet state.

  In addition, as a laminate film, fluororesins, such as PTFE, can be illustrated. In addition, hydrophilic polymer substances include natural polymer substances (eg, starch, cellulose, tannin / ignin, polysaccharide, protein) and synthetic polymer substances (PVA, Polyethylene oxide, acrylic acid, maleic anhydride, phthalic acid, water-soluble polyester, ketone aldehyde resin, (meth) acrylamide, vinyl heterocycle, polyamine, polyelectrolyte, water-soluble nylon, acrylic acid Glycidyl acrylate). Among these, in particular, cellulose-based polymer materials (for example, hydroxypropylcellulose), polyethylene oxide-based polymer materials (polyethylene glycol), maleic anhydride-based polymer materials (for example, methyl vinyl ether maleic anhydride copolymer) Such a maleic anhydride copolymer), an acrylamide polymer (for example, polydimethylacrylamide), water-soluble nylon or a derivative thereof is preferable because a low coefficient of friction can be stably obtained.

  As shown in FIG. 2, the signal transmission / reception unit 30 has a housing 31 fixed to the tip of the drive shaft D, and an ultrasonic transducer 32 installed in the housing 31, and the ultrasonic transducer 32 is connected to the drive shaft D. It is connected to the control unit C through a signal line 33 inserted through the inner space.

  Therefore, the signal transmitting / receiving unit 30 rotates or moves in the axial direction together with the drive shaft D, receives the reflected wave reflected by the ultrasonic wave emitted from the ultrasonic transducer 32 and hits the target portion, and this received signal is the signal line 33 ( (See FIG. 3). In the present embodiment, an ultrasonic transducer is used as the signal transmitting / receiving unit 30, but the present invention is not limited to this, and light may be used.

  As shown in FIGS. 1 and 3, the connector member 10 includes a cylindrical main body 11 in which the proximal end of the catheter 1 is attached, a sleeve 12 connected to the proximal end side of the main body 11, and the main body 11. And a cover member 13 that functions as a kink protector and is tapered so that the outer diameter gradually decreases toward the distal end side, and an annular groove portion 14 formed in the sleeve 12. However, it is held in a fixed position by a holding unit 40 described later. A seal member 15 composed of an O-ring or the like is provided between the main body 11 and the sleeve 12, and seals between a later-described connecting pipe 26 that is inserted through the inside.

  As shown in FIG. 3, the hub portion 20 is provided at a hub body 21, a priming port 22 provided at a central portion of the hub body 21, to which a filling liquid for priming (for example, physiological saline) is supplied, And kink protector 23.

  The hub main body 21 and the anti-kink protector 23 are connected by a concave / convex fitting portion 24 that is connected in a so-called one-touch manner. A passage 25 is formed in the hub portion 20, and the drive shaft D is inserted therethrough. In addition, a priming liquid is distributed.

  A proximal end portion of a connecting pipe 26 is attached in the hub main body 21. The connecting tube 26 connects the connector member 10 and the hub portion 20, and the distal end side thereof is inserted into the catheter 1 attached to the connector member 10. Therefore, when the hub portion 20 advances and retracts in the axial direction by a pullback operation or the like, the connecting tube 26 also advances and retracts in the catheter 1 with this, and the drive shaft D is not exposed to the outside.

  The drive shaft D is inserted into the connection pipe 26, and the drive shaft D is detachably connected to the connection portion 29a provided at the distal end portion of the connection pipe 29 in the hub body 21. The connection pipe 29 protrudes from an adapter 50 described later, and when connected to the drive shaft D, the connection pipe 29 is mechanically and electrically connected.

  A sealing member 27 having a sealing material 28 such as an O-ring that seals between the hub main body 21 and the connection pipe 29 inserted into the passage 25 is provided on the base end side.

  A protective tube 16 for preventing buckling of the drive shaft D is provided inside the catheter 1. The protective tube 16 is preferably provided over the entire length of the drive shaft D as much as possible, but is provided so as to be positioned in the main body 3 having a relatively large diameter in consideration of the inner diameter of the catheter 1.

  Since the protection tube 16 can prevent the drive shaft D from being bent or buckled, the above-described laminate film and lubricating layer need not necessarily be provided, but more reliably prevent the bending or buckling. May be used in combination.

  In addition, it is preferable that the protective tube 16 has a structure in which a large number of through holes are opened or a coil shape. In this way, the physiological saline can freely pass through the inside and outside of the protective tube 16, and priming can be performed quickly. In particular, if the protective tube 16 has a coil-like structure that can be expanded and contracted in the axial direction, the protective tube 16 is also deformed following the bending deformation of the drive shaft D, and the buckling of the drive shaft D is prevented more reliably. Can do.

  In FIG. 3, the protective tube 16 is indicated only by “lines” for the sake of space. Further, the protective tube 16 may be attached by any means such as a mechanical one or heat fusion. In this embodiment, the base side of the protective tube 16 together with the base end of the catheter 1 is a connector member. 10 is joined.

  Although the holding part 40 has a pair of support members 41, the support member 41 may be erected directly on the distal end side of the base 74, and is attached to the base 74 as shown in FIG. A bifurcating branch may be made on the support base 42. Further, the support 74 may be formed on the base 74 itself by deforming the base 74 itself so that the base end side is pushed up instead of being flat. In any case, it is preferable that the connector member 10, the hub portion 20, and the adapter 50 are arranged on the same axis.

  A part of the sterilization sheet 60 (held portion 63) is held between the pair of support members 41 together with the sleeve 12. Since the drive unit 70, the holding unit 40, the base 74, and the like are highly likely to be contaminated and are easily touched by an operator or the like, they are covered with a sterilization sheet 60 that is a protective cover.

  Particularly, as shown in FIGS. 3 and 4, the sterilization sheet 60 according to the present embodiment is formed with an insertion portion 62 having an opening 61 through which the proximal end portion of the catheter 1 is inserted. Is provided. Moreover, the constituent material of the sterilization sheet 60 between the held portion 63 and the insertion portion 62 held by the holding portion 40 is an elastic material S that expands with the pull back operation of the driving portion 70.

  In general, since the pullback amount (L) is about 150 mm, in this embodiment, the sterilized sheet 60 between the insertion portion 62 and the held portion 63 is made of an elastic material S that does not break even when stretched by 150 mm or more. . Examples of such stretchable materials S include thermoplastic elastomers (olefin-based, vinyl chloride-based, styrene-based) and thermosetting elastomers (urethane-based, silicone-based, nitrile-based). Specifically, latex, nitrile rubber, polymer elastomer, polyvinyl chloride and the like are preferable.

  In this way, when the drive unit 70 moves forward or pulls back, the sterilization sheet 60 between the insertion unit 62 and the held portion 63 expands and contracts with the movement of the drive unit 70. The sterilization sheet 60 does not get in the way compared to the bellows-like one, and the drive unit 70 operates extremely smoothly.

  The sterilization sheet 60 may be formed in a bag shape. When forming with a bag-like material, an opening for inserting the drive unit 70 is provided, and a chuck or the like that can seal the opening is provided here, which is opened during insertion and closed after insertion. Also good.

  As a constituent material of the sterilization sheet 60 other than between the insertion portion 62 and the held portion 63, any material may be used as long as it is thin and has tensile strength. For example, polyethylene is used. can do. More preferably, it is a light transmissive material whose inside can be visually observed from the outside. In this way, the position of the drive unit 70 and the position of the catheter 1 can be visually observed from the outside, which is further advantageous in terms of operability.

  In the present embodiment, the head portion 51 of the adapter 50 is provided in close contact with the insertion portion 62 of the sterilization sheet 60. When the adapter 50 is provided on the sterilization sheet 60, the sterilized catheter 1 and the contaminated drive unit 70 can be connected with one touch from the outside of the sterilization sheet 60, the workability is improved, and the catheter 1 is inserted. Since the inserted portion 62 is also securely sealed by the adapter 50, the risk of contamination is greatly reduced.

  The connection between the head portion 51 of the adapter 50 and the insertion portion 62 of the sterilization sheet 60 is performed by bringing the lip portion of the opening 61 into close contact with the proximal end surface 51a of the adapter 50. Such a method may be used. For example, it is possible to use a method of mechanically sandwiching by uneven fitting, a heat fusion, a bonding method using an adhesive, or the like.

  The adapter 50 may be any adapter as long as it can quickly transmit the driving force from the driving unit 70 to the driving shaft D and can be connected to the drive unit 71 with one touch. For example, as shown in FIG. 3, the adapter 50 has a central opening 52 and a head 51 that is attached in close contact with the insertion portion 62 of the sterilization sheet 60, and is provided integrally with the head 51. The body portion 53 and the leg portion 55 rotatably provided to the body portion 53 via a bearing 54 can be used.

  The head 51 is connected to the hub body 21. To facilitate this connection, a concave groove is formed in the central opening 52 of the head 51 and provided at the base end of the hub body 21. The ball member 56 is ejected and fitted by a spring so that it can be connected with one touch. Further, a spring-loaded ball member 57 that is fitted to the drive unit 70 with one touch is also provided at the base end portion of the body portion 53.

  The base end portion of the connection pipe 29 is connected to the distal end side of the leg portion 55, and the base end side of the leg portion 55 is inserted into the central passage of the drive unit 71, and the rotor portion 58 and the drive unit 71 side are inserted therein. A male connector 59 connected to a female connector (not shown) is provided.

  As described above, the adapter 50 and the hub body 21 are coupled via the connection pipe 29, so that the adapter 50 side and the catheter 1 side can be handled separately, and the adapter 50 is attached to the sterilization sheet 60 in advance. However, the drive shaft D can be mechanically and electrically connected to or connected to the drive unit 71 only by fitting the hub body 21 to the adapter 50 in a one-touch manner.

  That is, if the adapter 50 and the drive unit 71 are connected, the drive shaft D can be rotated and moved in the axial direction by the operation of the moving means 80 along with the rotation of the motor, and the transmission / reception circuit 72 is transmitted by the control signal from the control unit C. The ultrasonic waves transmitted to the signal transmission / reception unit 30 (ultrasonic transducer) via the receiver can be received by the ultrasonic transducer, and the acquired information can be imaged by the control unit C and displayed on a monitor or the like. It can be used for diagnosis or treatment of the site.

  In addition, although the connection pipe 29 of this embodiment protrudes from the adapter 50 comparatively long, you may make this short and connect with the drive shaft D in the vicinity of the adapter 50. If it does in this way, connection with drive shaft D and connecting pipe 29 can be performed at the tip side of adapter 50, and connecting operation will become easy.

  Next, the operation of the embodiment will be described.

  First, the drive part 70 and the moving means 80 are installed in the sterilization sheet 60 to which the adapter 50 is attached. Initially, the drive unit 70 is retracted to the base end side on the base 74, and the adapter 50 is inserted into the drive unit 70 and connected to the drive unit 71. By this connection, the male connector 58 and the female connector on the drive unit 71 side are connected.

  On the other hand, the catheter 1 has a distal end side of the drive shaft D inserted therein, and a proximal end side of the drive shaft D is projected from the hub portion 20.

  When the proximal end side of the hub portion 20 is fitted to the adapter 50 and the connection pipe 29 and the proximal end side of the drive shaft D are connected, the catheter 1 is connected to the drive unit 71. That is, even if the catheter 1 is to be connected to the contaminated drive unit 70, this connection is made through the adapter 50, and most of the adapter is in the bag-like sterilization sheet 60. The catheter 1 side is not contaminated.

  Next, when the hub part 20 is fitted between the support members 41 of the holding part 40 together with the sterilization sheet 60, the connection is completed. As a result, the drive unit 70, the base 74 and the moving means 80 are covered with the sterilization sheet 60. Accordingly, only the catheter 1, the hub portion 20, and the head portion 51 of the adapter 50 are present outside the sterilization sheet 60.

  Before inserting the catheter 1 into the body cavity, priming is performed to remove the air in the catheter 1 and prevent the air from entering the body cavity such as a blood vessel.

  In the priming, physiological saline is injected from the priming port 22 of the hub main body 21 in a state where the driving unit 70 is at the most proximal side, that is, in the retracted position. The physiological saline solution flows from the hub portion 20 toward the distal end of the catheter 1, and when the inside is completely filled, the physiological saline solution flows out from the priming lumen 6 formed at the distal end of the catheter 1, so that the priming is completed. Can be confirmed.

  Next, the drive shaft D is advanced in the catheter 1 so that the signal transmission / reception unit 30 is positioned in the vicinity of the distal end of the catheter 1, and then the catheter 1 is inserted into the body cavity. If it exceeds, insertion will be stopped and the catheter 1 will be fixed.

  In this state, when the moving unit 80 is operated or the motor 70 of the driving unit 70 is rotated while the driving unit 70 is manually pulled back to the proximal end side, the catheter 1 remains in its original position, so that the driving shaft D rotates while being pulled back to the base end side.

  Therefore, the signal transmission / reception unit 30 rotates while retreating in the axial direction in the catheter 1, and can send to the control unit C three-dimensional image data having a shape extending back and forth in the axial direction of the target site at a predetermined position of the body cavity. .

  When the drive unit 70 once retracted to the proximal end is advanced again to observe the target site, the drive shaft D enters the narrow catheter 1. At this time, there is a possibility that bending or buckling may occur on the proximal end side of the drive shaft D due to frictional resistance. However, since the protective tube 16 is provided in this region, the bending or buckling of the proximal end side is provided. Occurrence is prevented. Even if the drive shaft D is bent, if the protective tube 16 is a loosely wound coil or the like, the protective tube 16 itself bends gently so that the drive shaft D is prevented from buckling. Therefore, the smooth forward operation of the drive shaft D is possible.

  In particular, in this embodiment, since the sterilization sheet 60 between the insertion portion 62 and the held portion 63 is made of the stretchable material S, when performing a pullback operation for retracting the drive unit 70 to the proximal end side, sterilization is performed. As shown in FIG. 4, the seat 60 is freely stretched between the holding portion 40 and the adapter 50 at a distance L (150 mm) from the forward position Z to the backward position E of the adapter 50, and is smoothly driven. 70 can be retracted, and there is no possibility that the sterilization sheet 60 enters between the drive unit 70 and the base 74 before and after the pull-back operation.

  Therefore, the signal transmission / reception unit 30 can be reliably set at a position corresponding to the target site, and a reduction in accuracy of treatment and diagnosis can be prevented.

  The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. In embodiment mentioned above, although the sterilization sheet 60 between the insertion part 62 and the to-be-held part 63 is comprised by the elastic material S, this invention is not limited to this and exists in both. A part of the sterilization sheet 60 may be made of the stretchable material S.

  In the above-described embodiment, the sterilization sheet 60 has a bag shape. However, the sterilization sheet 60 is not limited to such a bag, and may be a sheet that simply covers the drive unit 70 from above.

  INDUSTRIAL APPLICABILITY The present invention can be used as a sterilization sheet for an in-vivo diagnostic system that acquires an image of a target site existing in a body cavity of a living tissue and is used for treatment or diagnosis.

1 ... catheter,
30: Signal transmitter / receiver,
40 ... holding part,
50 ... Adapter,
60 ... sterilization sheet,
61 ... Opening,
62 ... insertion part,
63 ... held part,
70 ... drive unit,
74: Base,
80 ... moving means,
D: Drive shaft,
S: Elastic material.

Claims (6)

On the base, a holding portion for holding a portion of the catheter in a fixed position, a driving portion that is inserted into the catheter, and that rotates and drives a drive shaft provided with a signal transmitting / receiving member at the tip, and the driving portion Moving means for moving the drive shaft in the axial direction by moving the drive shaft in the axial direction by moving the drive shaft in the axial direction by moving the drive shaft in the axial direction. A sterilization sheet covering the holding unit, the driving unit, and the moving unit, which is used in an in-vivo diagnostic system that transmits and receives signals to and from a transmitting / receiving member to acquire information in a body cavity,
The sterilization sheet includes an insertion portion having an opening through which the proximal end portion of the catheter is inserted, and a held portion held by the holding portion, and at least between the insertion portion and the held portion. A sterilized sheet characterized in that a part thereof is made of a stretchable material that expands as the driving unit moves in the axial direction by the moving means.   The sterilization sheet according to claim 1, wherein the insertion portion includes an adapter for connecting the drive shaft and the drive portion to the opening.   The sterilization sheet according to claim 1, wherein a constituent material of the sterilization sheet is a light transmissive material.   The sterilized sheet according to claim 1 or 3, wherein the stretchable material is composed of at least one of latex, nitrile rubber, polymer elastomer, and polyvinyl chloride.   The sterilization sheet according to any one of claims 1, 3, and 4, wherein the constituent material between the insertion portion and the holding portion does not break even if it is stretched to a length of at least 150 mm.   The sterilization sheet according to claim 1, wherein the sterilization sheet is formed in a bag shape.

Images