JP7211867B2 - Medical device cover - Google Patents

Description

The present disclosure relates to covers for medical devices.

A medical device cover for covering a medical device such as an external device, also called a motor drive unit, to which an elongated body such as an imaging diagnostic catheter inserted into a living body is connected is known (see, for example, Patent Document 1). ). According to such a medical device cover, it is possible to separate the elongated body positioned in the clean field from the external device positioned in the unclean field. The medical device cover has a bottomed cylindrical cover body member having one closed end and the other open end. The cover body member may have an insertion opening into which an external device can be inserted at a portion between one end and the other end. Further, the cover body member extends from the insertion opening to the other end, and is folded back a plurality of times so as to alternately turn radially inward and radially outward from the side of the other end to form a peripheral edge of the insertion opening. In some cases, there is provided an overlapping tubular portion having a shape in which the portion is finally turned over radially outward.

JP 2012-50706 A

In the medical device cover as described above, for example, in the case where it has an overlapping cylindrical portion as described above, it is sometimes difficult to find the position of the insertion opening and where to insert the external device. In addition, the through-hole portion of the cover main body member is located on the upper side so that the through-hole portion of the cover main body member through which the elongated body penetrates is aligned with the connection portion of the external device with the elongated body. Although it is preferable to insert the external device into the insertion opening of the main body member, there is a risk that the external device may be accidentally inserted into the insertion opening with the through opening positioned downward. However, in the medical device cover having the overlapping cylindrical portion and the through-hole as described above, or other medical device covers, the position of the insertion port is made easy to understand, and the insertion of the medical device into the insertion port is facilitated. It would be convenient if it could facilitate

In view of such a point, an object of the present disclosure is to provide a medical device cover that makes it easy to understand the insertion position of the medical device and allows easy insertion of the medical device.

A medical device cover as a first aspect of the present invention comprises:
a bottomed tubular cover body member having one closed end and an open other end; and a restraint member,
The cover main body member is restrained by the restraining member so as to be in a restrained state having a size and shape in which the insertion side end of the medical device cannot be inserted, and the restraint by the restraining member is released. and an insertion opening that self-expands from the restrained state to a developed state having a size and shape that allows insertion of the insertion-side end of the medical device.

As one embodiment of the present invention, a medical device cover is a packaging body that wraps and stores the cover body member so that the restraining member holds the cover body member in the restrained state.

As one embodiment of the present invention, in the medical device cover, the cover main body member is stored in the package in a folded state.

In one embodiment of the invention, the medical device cover comprises:
the cover main body member has a through-hole portion disposed closer to the one end portion than the insertion opening portion and through which an elongated body to be inserted into a living body penetrates;
The insertion opening has a substantially triangular or substantially trapezoidal shape in which the width of the upper portion is smaller than the width of the lower portion when the through-hole portion is located on the upper side in the unfolded state.

As one embodiment of the present invention, the medical device cover is arranged along the peripheral edge of the insertion opening, and is restored from an elastically deformed state by releasing the restraint by the restraining member. An elastic member is provided for self-expanding the insertion opening to the unfolded state by its restoring force.

As one embodiment of the present invention, in the medical device cover, the elastic member is made of a shape memory material.

In one embodiment of the invention, the medical device cover comprises:
wherein the elastic member is made of a metal material,
The cover body member has perforations along the elastic member.

As one embodiment of the present invention, the medical device cover extends from the insertion opening to the other end of the cover main body member, and extends radially inward and outward from the other end. An overlapping cylindrical portion is provided which has a shape in which the cylindrical portion is folded back a plurality of times so as to be alternately turned over, and the peripheral portion of the insertion opening is finally folded back so as to be turned outward in the radial direction.

Advantageous Effects of Invention According to the present disclosure, it is possible to provide a medical device cover in which the insertion position of a medical device is easy to understand and the insertion of the medical device is easy.

1 is an external view schematically showing a contracted diagnostic imaging catheter used together with a medical device cover according to an embodiment of the present invention. FIG. 2 is an external view showing an expanded state of the diagnostic imaging catheter shown in FIG. 1. FIG. FIG. 4 is an external view of the medical device cover according to the embodiment of the present invention, showing a state immediately after the cover main body member is taken out from the package. FIG. 4 is an external view showing a state when self-expansion of the insertion opening progresses from the state shown in FIG. 3 ; FIG. 5 is an external view showing a state in which self-expansion of the insertion opening progresses from the state shown in FIG. 4; FIG. 6 is a cross-sectional view taken along the line AA of FIG. 5; 6 is an external view showing a state in which self-expansion of the insertion opening progresses from the state shown in FIG. 5 and self-expansion of the insertion opening is completed. FIG. FIG. 8 is a cross-sectional view taken along the line AA of FIG. 7; FIG. 8 is a top view showing a state when an external device is inserted into the insertion port from the state shown in FIG. 7; FIG. 10 is a top view showing a state when the overlapping tubular portion of the cover main body member is unfolded from the state shown in FIG. 9;

Hereinafter, a medical device cover according to an embodiment of the present invention will be illustrated in detail with reference to the drawings.

As shown in FIGS. 1 and 10, a medical device cover 10 (hereinafter also referred to as a cover 10) according to the present embodiment is an elongated body that is inserted into a vessel such as a blood vessel in a living body such as a human body. It is used together with a catheter 20 and an external device 30 as a medical device. The catheter 20 is a diagnostic imaging catheter having an imaging core 21 for transmitting/receiving signals to/from an external device 30 and transmitting/receiving search waves (ultrasonic waves and/or electromagnetic waves) in order to image the inside of a vessel such as a blood vessel. is configured as

The imaging core 21 has an input/output device 21a capable of inputting/outputting the search wave. The imaging core 21 has a distal end integrally connected to the input/output unit 21a and a proximal end detachably connected to the rotation drive unit 31 of the external device 30, and receives input from the rotation drive unit 31 of the external device 30. It has a drive shaft 21b which transmits rotational motion to the injector 21a. Further, the distal end portion of the drive shaft 21b is electrically connected to the input/output device 21a, and the proximal end portion of the drive shaft 21b is electrically connectable to the external device 30. As shown in FIG. By connecting the base end of the drive shaft 21b to the rotation drive unit 31 of the external device 30, the external device 30 can rotate the light emitting/receiving device 21a around the central axis X through the drive shaft 21b. , a control signal is transmitted to the injection/exit device 21a via the drive shaft 21b to cause the injection/exit device 21a to emit an investigation wave toward the living body, and a measurement signal based on the reflected wave incident on the injection/exit device 21a is sent to the drive shaft 21b. can be received via

The external device 30 is connected to a control device (not shown) composed of a processor such as a CPU via a cable 32, and the operation of the external device 30 is controlled by the control device. The measurement signal received by the external device 30 is transmitted to the control device via the cable 32, and the control device generates image data based on the measurement signal, and an output device (not shown) such as a display connected to the control device. Send to The output device outputs an image (for example, an intravascular tomographic image and/or an intravascular 3D image) based on the received image data.

Catheter 20 has a tubular catheter body 22 defining a lumen containing imaging core 21 . The catheter body 22 has a telescope section 23 composed of an outer hand tube 23a and an inner hand tube 23b. The telescope portion 23 is in a contracted state in which the inner hand tube 23b enters the outer hand tube 23a most deeply as shown in FIG. It is stretchable between the stretched state and the stretched state.

As shown in FIG. 1, the proximal end of the hand tube 23a is formed of a cylindrical unit connector 23c. A proximal end of a cylindrical outer sheath 23d is integrally connected to the distal end of the unit connector 23c. The distal end of the hand outer tube 23a is formed by the distal end of the outer sheath 23d. An axially intermediate portion of the unit connector 23c is provided with a reduced diameter portion 23e having a reduced outer diameter.

The proximal end of the cylindrical relay connector 24 is integrally connected to the distal end of the outer sheath 23d. The proximal end of a tubular sheath 25 is integrally connected to the distal end of the relay connector 24 . The distal end portion of the sheath 25 is integrally connected with the proximal end portion of the distal end member 26 . The distal end member 26 defines an outlet (not shown) for a priming solution such as physiological saline that communicates with the lumen of the sheath 25 . The tip member 26 also defines a lumen (not shown) into which a guide wire can be inserted.

The proximal end tube 23 b has a tubular shape, and its proximal end is integrally connected to the distal end of the hub 27 . The hub 27 has a hub body 27a defining a lumen extending along the central axis X and a side tube 27b defining a lumen communicating with the hub body 27a. The side pipe 27b defines an injection port for the priming liquid. As shown in FIG. 9 , the proximal end of the hub 27 (the proximal end of the hub body 27 a ) is detachably connected to the rotary drive section 31 of the external device 30 via the adapter 13 b of the cover 10 .

Thus, the catheter main body 22 is composed of the hand outer tube 23a (unit connector 23c, outer sheath 23d), the relay connector 24, the sheath 25, the tip member 26, the hand inner tube 23b and the hub 27.

A proximal end portion of the imaging core 21 (a proximal end portion of the drive shaft 21 b ) constitutes a connector 21 c that is detachably electrically connected to the rotary drive portion 31 of the external device 30 . The connector 21c is housed in the lumen of the hub body 27a. The imaging core 21 is supported by the catheter body 22 so as to be rotatable about the central axis X. As shown in FIG. In addition, the imaging core 21 is held by the hub 27 so as to be interlockable with the inner tube 23b and the hub 27 along the central axis X. As shown in FIG. In the contracted state of the telescope section 23 as shown in FIG. Also, in the extended state of the telescope section 23 as shown in FIG.

As shown in FIGS. 9 and 10 , the external device 30 has a rectangular parallelepiped base 33 elongated in the front-rear direction about the central axis X. As shown in FIGS. A columnar rotary drive unit 31 centered on the central axis line X is arranged on the upper part of the base 33 . The rotation drive unit 31 is connected to the base 33 by the advance/retreat drive unit 34 so as to be able to advance and retreat relative to the base 33 . 9 and 10, the rotary drive portion 31 is positioned at the rear end of its forward/backward stroke. The longitudinal length of the rotation driving portion 31 is shorter than the longitudinal length of the base 33 . Further, the horizontal width of the rotation driving portion 31 is shorter than the horizontal width of the base 33 .

In this specification, for convenience of explanation, the vertical direction with respect to the external device 30 means the direction perpendicular to the ground surface of the base 33, and the direction from the installation surface side to the rotary drive unit 31 side is defined as the upper side. Let the opposite direction be downward. In addition, the front-rear direction (advance-retreat direction) of the external device 30 and the catheter 20 means the direction along the central axis X, the direction from the base end to the tip is the front (advance direction), and the opposite direction is the rear. (backward direction).

The advance/retreat drive unit 34 includes a ball screw mechanism that guides the rotation drive unit 31 in the advance/retreat direction, and a ball screw mechanism drive source configured by, for example, a motor that drives the ball screw mechanism so as to advance/retreat the rotation drive unit 31 . It is configured. The rotary drive unit 31 includes a housing 31a fixed to the forward/backward drive unit 34, a main shaft (not shown) rotatably supported by the housing 31a around the central axis X, and driving the main shaft so as to rotate the main shaft. For example, it has a spindle drive source (not shown) configured by a motor.

A catheter connection portion 35 connected to the proximal end portion of the catheter 20 is provided at the front end portion of the rotary drive portion 31 . The catheter connecting portion 35 includes an adapter connecting portion 35a detachably connected to the proximal end portion of the catheter body 22 via the adapter 13b of the cover 10, and an imaging core detachably electrically connected to the connector 21c of the imaging core 21. and a connecting portion (not shown). The adapter connection portion 35a is provided integrally with the front end portion of the housing 31a. The imaging core connecting portion is provided integrally with the front end portion of the main shaft.

A unit connector fixing member 36 for fixing the unit connector 23 c of the catheter 20 to the base 33 is arranged at the front end portion of the upper portion of the base 33 . The unit connector fixing member 36 has an engaging portion 36a that is detachably engaged with the reduced diameter portion 23e of the unit connector 23c through the fixing portion 13c of the cover 10. As shown in FIG.

The cover 10 has a cylindrical cover body member 13 with a closed end 11 and an open other end 12 . The cover main body member 13 has a bottomed cylindrical sheet member 13 a having one end portion 11 and the other end portion 12 . The sheet member 13a is preferably transparent, but may be translucent or opaque. The sheet member 13a is made of a soft synthetic resin such as polyethylene. The cover body member 13 may have an additional sheet member for reinforcement or the like that partially overlaps the sheet member 13a (for example, at the junction with the adapter 13b and its peripheral portion).

The sheet member 13a has an insertion opening 14 into which the front end of the base 33 as the insertion side end 30a of the external device 30 is inserted. Further, the cover main body member 13 is arranged closer to the one end portion 11 than the insertion port portion 14 and has a through-hole portion 15 through which the catheter 20 is passed. The through-hole portion 15 is formed by the inner peripheral surface of a two-stage cylindrical adapter 13b having a large diameter portion and a small diameter portion on the outer peripheral surface. The adapter 13b is joined to the sheet member 13a with the large diameter portion located outside the sheet member 13a and the small diameter portion located inside the sheet member 13a. In FIG. 9, the small diameter portion of the outer peripheral surface of the adapter 13b is detachably connected to the adapter connecting portion 35a of the external device 30. As shown in FIG. In FIG. 9, the proximal end of the catheter body 22 is detachably connected to the inner peripheral surface of the adapter 13b.

The sheet member 13a has a fixing portion 13c positioned closer to the one end portion 11 than the adapter 13b. A fixed part indication label is attached to the fixed part 13c. In FIG. 9, the fixing portion 13c is sandwiched between the engaging portion 36a of the unit connector fixing member 36 and the reduced diameter portion 23e of the unit connector 23c.

As shown in FIGS. 9 and 10, the sheet member 13a extends from the insertion opening 14 to the other end 12 and is alternately turned radially inward and radially outward from the other end 12 side. An overlapping cylindrical portion 16 is provided which has a shape that is folded back a plurality of times and the peripheral edge portion of the insertion port portion 14 is finally folded back outward in the radial direction. By stretching the other end portion 12 away from the one end portion 11, the overlapped tubular portion 16 is in an unfolded state as shown in FIG. can be done. The overlapping cylindrical portion 16 is folded back multiple times so as to be alternately turned radially inward and radially outward from the other end portion 12 side, and finally the peripheral edge portion of the insertion port portion 14 is folded back so as to be turned radially outward. However, as long as it has the above shape, the folding procedure is not limited to this. In addition, in the present embodiment, the overlapped tubular portion 16 has a shape in which it is first turned radially inward from the other end portion 12 side. It may have a shape folded back so as to turn outward in the direction.

In this embodiment, the position of the insertion opening 14 in the cover main body member 13 is set so that the external device 30 does not completely enter the cover main body member 13 before the overlapping tubular portion 16 is unfolded. However, the position of the insertion opening 14 in the cover main body member 13 can be changed as appropriate, and may be set to a position where the external device 30 can enter the cover main body member 13 before the overlapping tubular portion 16 is deployed. .

When using the cover 10, first, a medical worker inserts the external device 30 from the insertion opening 14, unfolds the overlapping tubular portion 16, and inserts the external device 30 and the cable 32 into a predetermined portion with the cover body member 13. and cover. Then, the medical staff connects the adapter 13b to the rotation drive section 31 of the external device 30. As shown in FIG. At this time, the rotary drive portion 31 is positioned at the rear end of the forward/backward stroke. The medical practitioner then primes catheter 20 by extending telescopic portion 23 of catheter 20 . Then, the medical staff connects the proximal end of the catheter 20 to the rotation drive section 31 of the external device 30 via the adapter 13b. Also, the medical staff attaches and fixes the unit connector 23c of the catheter 20 to the unit connector fixing member 36 of the external device 30 via the fixing portion 13c of the cover body member 13 . The procedure for using the cover 10 is not limited to such procedures, and can be changed as appropriate.

Thus, by connecting the catheter 20 to the external device 30 in a state where the cover body member 13 of the cover 10 covers the external device 30 and a predetermined portion of the cable 32, the external device 30 and the cable located in the dirty field can be connected. A catheter 20 located in a clean field can be isolated from 32 to prevent contamination of the catheter 20 and the like.

When using the catheter 20 from this state, first, the medical staff operates the control device to advance the rotation driving section 31 to the front end of the forward/backward stroke. This advancement also advances the imaging core 21 of the catheter 20 together with the hub 27 and the proximal outer tube 23a to the front end of the forward/backward stroke. At this time, the entrance/exit device 21 a provided at the tip of the imaging core 21 advances to the tip of the sheath 25 .

Then, the medical staff engages the tip member 26 of the catheter 20 with the guide wire that has reached the lesion inside a vessel such as a blood vessel of the living body, and the light emitting/receiving device 21a of the imaging core 21 penetrates the lesion. The tip of the catheter 20 is inserted into the living body until it passes through. From this state, the medical staff operates the control device to perform imaging with the imaging core 21 . At this time, the rotary drive unit 31 moves back to the rear end of the advancing/retreating stroke while rotating the main shaft, thereby rotating and retracting the input/output device 21a that transmits and receives the probe wave inside the sheath 25. The device 21a can be caused to acquire signals for generating images of the lesion.

In this embodiment, as shown in FIG. 3, the cover 10 has restraining members 17 . In addition, the insertion opening 14 of the cover body member 13 is restrained so as to be in a restrained state (the state indicated by the two-dot chain line in FIG. 3) having a size and shape that prevent insertion of the insertion-side end 30a of the external device 30. While being restrained by the member 17, by releasing the restraint by the restraining member 17, the restrained state is changed to a developed state (FIGS. 7 and 7) having a size and a shape that allows insertion of the insertion side end portion 30a of the external device 30. 8) is configured to self-expand.

As shown in FIG. 3, the restraining member 17 is a package 18 that wraps and accommodates the cover body member 13 so as to hold the cover body member 13 in a restrained state. The cover body member 13 is stored in the package 18 in a folded state in a restrained state indicated by a two-dot chain line in FIG. The package 18 is configured such that the restraint on the cover body member 13 can be released by removing the cover body member 13 from the package 18 .

The package 18 has an openable opening 18a for taking out the folded cover body member 13. As shown in FIG. The package 18 is not limited to having such a mouth portion 18a, and may be configured to be breakable at any portion in order to take out the cover main body member 13 in the folded state, for example. The restraining member 17 is not limited to the package 18, and may be, for example, a clip member that removably engages the cover body member 13 so as to hold the cover body member 13 in a restrained state.

As shown in FIGS. 7 and 8, the insertion opening 14 of the cover body member 13 is arranged along the peripheral edge of the insertion opening 14, and is released from the elastically deformed state by releasing the restraint by the restraining member 17. As shown in FIGS. An elastic member 14a is provided that restores and self-expands the insertion opening 14 to the unfolded state by its restoring force.

In the unfolded state, the insertion opening 14 has a substantially triangular shape in which the width of the upper portion is smaller than the width of the lower portion when the through opening 15 is positioned on the upper side. The shape of the insertion opening 14 is not limited to a substantially triangular shape. For example, the insertion opening 14 may have a substantially trapezoidal shape in which the width of the upper portion is smaller than the width of the lower portion when the through-hole portion 15 is located on the upper side in the unfolded state.

The elastic member 14a is made of a Ni--Ti (nickel-titanium)-based shape memory alloy. The elastic member 14a may be made of a shape memory alloy other than Ni—Ti (nickel-titanium). The elastic member 14a may be made of a shape memory material other than an alloy (for example, a synthetic resin). By configuring the elastic member 14a with a shape memory material, a high restoring force for self-expanding the insertion opening 14 to the unfolded state can be obtained. However, the elastic member 14a is not limited to the shape memory material.

As shown in FIG. 10, the sheet member 13a of the cover body member 13 has two perforations 14b provided along the elastic member 14a. The elastic member 14a is provided along the peripheral edge of the insertion opening 14. One of two perforations 14b is provided on the distal end side (front side) of the elastic member 14a, and the base end side ( The other of the two perforations 14b is provided on the rear side). Therefore, by breaking the sheet member 13a at the two perforations 14b after using the cover main body member 13 (after imaging), the metal elastic member 14a can be easily sorted and discarded. However, the sheet member 13a is not limited to having such two perforations 14b.

As shown in FIGS. 7 and 8, the elastic member 14a is composed of a wire extending along the periphery of the insertion opening 14. As shown in FIGS. However, the elastic member 14a is not limited to being made of a wire, and may be made of a cylindrical member concentric with the insertion opening 14, for example. The elastic member 14 a is not limited to extending over the peripheral edge of the insertion opening 14 , and may extend over only a part of the peripheral edge of the insertion opening 14 .

The elastic member 14a is embedded in the sheet member 13a at the periphery of the insertion opening 14. As shown in FIG. However, the elastic member 14a may be provided on the inner surface and/or the outer surface of the sheet member 13a at the periphery of the insertion opening 14. FIG. The elastic member 14a may be attached detachably to the sheet member 13a.

The overlapped tubular portion 16 is folded six times so as to be turned outward in the radial direction with the peripheral portion of the insertion port portion 14 as the initial fold line. However, the number of folds of the overlapping tubular portion 16 can be changed as appropriate. The cover main body member 13 is not limited to having the overlapping tubular portion 16 .

The cover 10 resists the elastic force of the elastic member 14a and moves from the state in which the insertion opening 14 is flattened as shown in FIGS. As the crease, both sides are folded as shown in FIG. Further, the front portion of the cover 10 is folded as shown in FIG. 3 with the straight line indicated by the chain double-dashed line in FIG. 4 as a fold line.

Therefore, as shown in FIG. 3, when the medical staff takes out the cover main body member 13 from the opening 18a of the package 18, the cover main body member 13 goes through the state shown in FIG. 4 by the restoring force of the elastic member 14a. , the folded state can be canceled to the state shown in FIGS. 5 and 6, and the insertion opening 14 can be self-expanded to the unfolded state shown in FIGS. Therefore, even when the cover main body member 13 has the overlapping cylindrical portion 16 as in the case of the present embodiment, the position of the insertion opening portion 14 into which the external device 30 should be inserted becomes obvious at a glance. That is, in the state shown in FIG. 6, it is difficult to distinguish between the insertion opening 14 and the portion between the folds in the overlapping tubular portion 16, but as shown in FIG. can be easily distinguished. At this time, since the insertion port 14 has a size and a shape that allow insertion of the insertion side end 30a of the external device 30, the external device 30 can be easily inserted.

In addition, the insertion opening 14 has a substantially triangular shape in which the width of the upper portion is smaller than the width of the lower portion when the through opening 15 is positioned on the upper side in the unfolded state. It is obvious that the external device 30 provided with the rotary drive unit 31 having a width smaller than the width of the base 33 can be inserted into the insertion opening 14 as it is. Therefore, it is possible to reduce the possibility that the external device 30 is accidentally inserted into the insertion opening 14 with the through opening 15 positioned on the lower side.

The above-described embodiment is merely an example of the embodiment of the present invention, and it goes without saying that various changes can be made without departing from the scope of the invention.

In the above-described embodiments, the catheter 20 is used as an elongated body to be inserted into the living body. However, the cover 10 of the present embodiment can be applied not only when the catheter 20 is used as an elongated body to be inserted into a living body, but also when an endoscope is used, for example.

10 Medical Device Cover 11 One End 12 Other End 13 Cover Body Member 13a Sheet Member 13b Adapter 13c Fixing Part 14 Insertion Opening 14a Elastic Member 14b Perforation 15 Penetration Opening 16 Duplicate Cylinder Part 17 Restricting Member 18 Package 18a Mouth Section 20 Catheter 21 Imaging Core 21a I/O Device 21b Drive Shaft 21c Connector 22 Catheter Body 23 Telescope Section 23a Hand Outer Tube 23b Hand Inner Tube 23c Unit Connector 23d Outer Sheath 23e Reduced Diameter Part 24 Relay Connector 25 Sheath 26 Tip Member 27 Hub 27a hub body 27b side tube 30 external device (medical device)
30a insertion side end portion 31 rotation driving portion 31a housing 32 cable 33 base 34 advancing/retreating driving portion 35 catheter connecting portion 35a adapter connecting portion 36 unit connector fixing member 36a engaging portion X center axis

Claims (8)

a bottomed tubular cover body member having one closed end and an open other end; and a restraint member,
The cover main body member is restrained by the restraining member so as to be in a restrained state having a size and shape in which the insertion side end of the medical device cannot be inserted, and the restraint by the restraining member is released. an insertion opening that self-expands from the restrained state to a deployed state having a size and shape that allows insertion of the insertion-side end of the medical device ,
The cover for medical equipment , wherein the restraining member is a packaging body that wraps and stores the cover body member so as to hold the cover body member in the restrained state . a bottomed tubular cover body member having one closed end and an open other end; and a restraint member,
The cover main body member is restrained by the restraining member so as to be in a restrained state having a size and shape in which the insertion side end of the medical device cannot be inserted, and the restraint by the restraining member is released. an insertion opening that self-expands from the restrained state to a deployed state having a size and shape that allows insertion of the insertion-side end of the medical device,
A medical device cover, wherein the restraining member is a clip member that removably engages the cover body member to retain the cover body member in the restrained condition. 2. The medical device cover according to claim 1 , wherein the cover body member is stored in the package in a folded state. the cover main body member has a through-hole portion disposed closer to the one end portion than the insertion opening portion and through which an elongated body to be inserted into a living body penetrates;
4. The method according to any one of claims 1 to 3, wherein the insertion opening has a substantially triangular or substantially trapezoidal shape in which the width of the upper portion is smaller than the width of the lower portion when the through-hole portion is located on the upper side in the unfolded state. A medical device cover according to any one of the preceding paragraphs. It is arranged in the insertion opening along the peripheral edge of the insertion opening, and is restored from an elastically deformed state by releasing the restraint by the restraining member, and the restoring force causes the insertion opening to expand to the unfolded state. A medical device cover according to any one of claims 1 to 4, wherein a self-expanding elastic member is provided. 6. The medical device cover according to claim 5, wherein the elastic member is composed of a shape memory material. wherein the elastic member is made of a metal material,
7. The medical device cover according to claim 5 or 6, wherein the cover body member has perforations provided along the elastic member. The cover body member extends from the insertion opening portion to the other end portion, and is folded back a plurality of times so as to alternately turn radially inward and radially outward from the other end side. The medical device cover according to any one of claims 1 to 7, further comprising an overlapping cylindrical portion having a shape in which the peripheral edge portion of the overlapping cylindrical portion is finally turned over in a radially outward direction.

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