ES2354107T3 - INSERTION DEVICE FOR AN INFUSION TEAM WITH A FIRST AND SECOND SPRING UNITS. - Google Patents

Abstract

An insertion device for an infusion set comprising a housing (1), a carrier body (2) carrying an infusion piece (8), a central ring (3) of the needle provided with a needle (6) of insertion, a first movement unit (4) to bring the carrier body (2) and the central ring (3) of the needle to an advanced position, a second movement unit (5) to bring the central ring (3) of the needle to a retracted position, and means for activation that should be activated at least once in order to bring the carrier body (2) and the center ring (3) of the needle from a retracted position to an advanced position, and the central ring (3) of the needle again from the advanced position to the retracted position, characterized in that the first movement unit (4) and the second movement unit (5) are both connected to a distal surface of the body ( 2) carrier.

Description

Insertion device for a device infusion with a first and second spring units.

Technical field

The present invention relates to a insertion device for an infusion set in order to administer a therapeutic substance intermittently or continue, such as insulin. The device of insertion consists of a central needle ring that it comprises an insertion needle and two spring units that guarantee automatic insertion and removal of the needle insertion.

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Background of the invention

The US patent document nº 6,387,078 corresponds to an automatic injection device that inject intramuscularly or transdermally a single dose, previously dosed, of a medicine supplied, and the device injection automatically retracts the hypodermic needle at device after the injection is complete. The user press the distal end, that is, the end of the needle, of the device over the desired injection site and press the actuation button. This action releases the combination syringe plunger of its temporary coupling with accommodation. The piston-syringe combination in conjunction with the spring-to-piston coupling they are then forced to depart from their proximal end, it is that is, the drive end of the housing by means of a actuator spring activated. The actuating spring drives the piston-syringe combination forward to through the hole in the housing until the hypodermic needle leaves the housing and enters the recipient's tissue, and the syringe barrel touches the inner distal end of the accommodation. During this movement, a return spring positioned between the syringe assembly and the fixed end The distal housing is compressed and activated. When the liquid of the automatic injection apparatus is discharged by the plunger that is being pushed forward through the interior of the syringe cylinder, coupling spring-to-plunger comes into contact with a separator which disengages the piston actuator spring. Without influence of the actuator spring over the combination piston-syringe, return spring activated force the plunger-syringe combination to retract back the proximal end of the device until the needle hypodermic is completely folded inside the housing.

Since this automatic injection device It is aimed at injections of a previously dosed dose of a liquid medication stored in which the plunger during the injection pushes the liquid dose of the medication stored out of the device, the solution will not be applicable for use when insert an injection device, since the manipulation and Injection of a liquid under sterile conditions a complicated injection device that requires interacting with the liquid.

WO 2005/046780 (fig. 97-102) describes a device used for automatic insertion of a cannula of an infusion device into a patient's skin, and then for automatic removal of the insertion needle. The insertion device is in the form of an oblong cylinder (length approx 4 x the diameter) that opens at one end (1984) and is provided with means for activation at the other end (1952). When the infusion set has been loaded on the needle (1968), the closure element (1962) moves in the direction of the end provided with means for activation by the patient using projections (1974), projections which are accessible through of a groove (1976) of the housing until the tabs (1956) of the closure element (1962) are coupled to an external surface of the housing (p. 26, l. 24-27). Then, the open end (1984) is placed against the patient's skin and the activation medium (1952) is activated. When the flanges (1954) activated in the activation means are engaged, the projections (1956) are pushed against each other to disengage the projections of the housing. When the projections are released from the housing, the closure element, the center needle ring, the body retainer and the associated infusion device are moved by means of a first spring towards the open end (1984). The insertion device moves the infusion device towards the patient's skin, thereby inserting the needle and cannula of the infusion device. As the cannula is fully inserted, the projections (1964) of the central ring (1965) of the needle couple the surfaces (1972) in the ramp of the sleeve (1982), causing the projections (1964) to be forced towards each other . When the projections (1964) have been forced sufficiently inward to release the ends (1988) of the main body (1980), the second spring (1966) then moves the central ring (1965) of the needle in the middle direction (1952) ) of activation. In this way, the needle is removed from the infusion device leaving the infusion device in place on the skin while the retaining body remains in a position adjacent to the open end of the sleeve so that once the insertion device is removed from the patient's skin, the retaining body protects the patient from having more contact with
the needle.

This insertion device is rather complex and device length is defined by the units individual that form the functional parts of the device, already that these units have to be placed more or less extreme with extreme. A feature that illustrates the complexity of the unit it is the fact that the two springs respectively divert the housing of the closure element and the ring retainer body center of the needle, while a main body is placed between the two spring systems to transfer the force of the First spring to the second spring.

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US 2003/0199823 describes a insertion device of the same type as in WO 2005/046780, that is, a device that has two springs that they work in each of the directions and they are placed to prolong each other.

Document DE 203 20 207 describes a device used for automatic insertion of a cannula an infusion device that has an automatic withdrawal of the insertion needle This device can have two springs placed next to each other, although the two springs work simultaneously in the same direction.

According to the present invention, the two units of spring work directly together, since the first spring unit directly affects body movement carrier while the second spring system is affected by Direct form by the movement of the carrier body. That the spring units directly affect or are affected directly by the carrier body means that the units of spring are connected to the carrier body directly or to through a piece that transfers the power either unaltered or under controlled modifications.

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Description of the invention

The object of the invention is to provide a simple, inexpensive insertion device for a device infusion, insertion device which would be easy and safe to manipulate during use by the user, and safe to remove After use.

The invention relates to a device of insert for an infusion set comprising a housing, a carrier body for carrying an infusion piece, a ring center of the needle, a first movement unit to carry the carrier body to an advanced position, and a second unit of movement to bring the carrier body to a position of withdrawal, in which the insertion device has means for activation, which should be activated at least once in order to bring the carrier body from a folding position to a advanced position, and again from an advanced position to a folding position.

In a preferred embodiment, the device insertion has activation means that must be activated only once in order to both carry the carrier body from a position of withdrawal to an advanced position as again from a advanced position to a retracted position.

Preferably, the first movement unit and the second movement unit are placed at least partially in parallel to each other, where "parallel" means that no It is in "series". "Serial" means that a unit of movement is placed prolonging the other, as described, by example, in WO 2005/046780.

In a preferred embodiment, the first unit of movement and the second movement unit are placed the less partially in parallel with respect to each other within the accommodation.

The invention also comprises a device for insert for an infusion set comprising a housing, a carrier body for carrying an infusion piece, a ring center of the needle, a first spring unit and a second spring unit, in which

- the accommodation is provided with a guide on the inner surface to guide the movement of the body carrier,

- the central needle ring comprises a insertion needle to penetrate the skin,

- the carrier body has a position retracted and an advanced position, and in the folding position before insertion the carrier body and the central ring of the Needle lock each other.

- the carrier body is provided with means to guide that correspond to the means to guide that they find about the accommodation,

- the first spring unit deflects the housing and carrier body, and the second spring unit deflects the carrier body and the center needle ring.

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In a preferred embodiment, the first and second spring units are both connected to a surface distal of the carrier body.

In another preferred embodiment, the body carrier remains in an advanced position after insertion of the needle.

In another preferred embodiment, the piece of Infusion is provided with a proximal adhesive surface.

In another preferred embodiment, the piece of Infusion is provided with an adhesive distal surface.

In another preferred embodiment, it is held in releasable form an adhesive pad to a proximal part of the housing, and the adhesive pad can cover an opening proximal housing through which the infusion piece.

In another preferred embodiment, the first unit spring and the second spring unit respectively comprise a compression spring.

In another preferred embodiment, the body carrier is provided with at least one inclined surface whose surface is in contact with a rotating ring part center of the needle, rotating part which can rotate in relation with the main part of the center ring of the needle to which it is the insertion needle is fixed, and the housing is provided with a element that prevents the rotating part of the center ring of the needle rotate when the carrier body is in a position retracted

The invention also comprises a method for insert an infusion piece, in which the infusion piece is is releasably fixed to a central needle ring, and the center ring of the needle is fixed so releasable to a carrier body that carries the infusion piece from a retracted position to an advanced position, in which

- a deflected spring unit activated by the user moves the carrier body, the center ring of the needle and the infusion piece forward from a stowed position, to that a proximal surface of the infusion piece enters contact with patients' skin or contact a piece connected to the patient's skin;

- in this advanced position, the center ring of the needle is released from the carrier body and a spring unit deviated moves the center ring of the needle away from the body carrier, resulting in the withdrawal of the central ring of the needle; then, the infusion piece is released from the body carrier, and accommodation - which includes the carrier body and the center needle ring - removed from the patient.

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Description of the drawings

The invention is explained in greater detail to with reference to the accompanying drawings, in the A preferred embodiment of the invention is shown.

Fig. 1 is a side view of a embodiment of the insertion device of the invention, in which the carrier body and the infusion device are in a stowed position;

fig. 2 is a side view of the device of insertion with the carrier body and the infusion device in an advanced position, in which the central ring of the body of the needle is attached to the carrier body;

fig. 3 is a side view of the device of insertion with the carrier body and the infusion device in an advanced position, in which the center ring of the needle has been released from the carrier body;

fig. 4 is a side view of the device of insertion with the carrier body and the infusion device in an advanced position, in which the center ring of the needle is found in a stowed position;

fig. 5 is a side view of the device of insertion after it has been removed from the patient, leaving the infusion piece on the patient's skin.

In this document, "distal" describes a surface or a piece away or placed away from the patient when the insertion device is positioned with the end of the needle directed towards the patient. "Proximal" describes a surface or a piece turned in the direction of or placed near the patient.

The realization of the insertion device of fig. 1 has a housing 1 with a bit more length smaller than the diameter (length \ approx 1 x the diameter). He design of this insertion device is fundamentally defined for the use and not for the units that constitute it within the insertion device The units that constitute the device are few and small, and the device design of insertion, such as size and shape, results from a desire to make the device easy to store and easy to handle by the user, even if the user has reduced the ability to her hands.

The insertion device comprises a carrier body 2 with at least two closure elements 2a protruding from a distal surface of the carrier body. A central ring 3 of the needle is placed between the two closing elements 2a, and the central ring of the needle is provided with elements 3a protruding from a distal surface of the central ring of the needle and corresponding to the closing means 2a of the 2 carrier body. These protruding elements 3a can rotate towards the center of the device along an axis through which they are also fixed to the main part of the central ring 3 of the needle. In addition, the central needle ring is provided with an insert needle 6 projecting from a proximal surface of the central needle ring. Prior to insertion, an infusion piece 8 is attached to the carrier body 2, the infusion piece is provided with a cannula that is attached to the insertion needle such that the insertion of the needle 6 will result in the insertion of the cannula An adhesive pad 7 with an adhesive proximal surface covers the proximal opening of the housing 1. The adhesive surface of the pad
Dilla 7 will normally be covered with a liner that can be released, in order to protect the adhesive surface.

During insertion, the central ring 3 of the needle moves from the folding position to a position advanced, and back to a folding position using a system of springs. The system of Figures 1-5 comprises two springs, a first spring 4 and a second spring 5. Agree with Hooke's law, the force exerted by a spring depends on the displacement of spring x and spring constant k: F_ {spring} = -k x. Each of springs 4 and 5 can be replace with more than one spring, then the spring unit that replaces, for example, the first spring 4 shown in the figures 1-5, you should exert force:

one

in which k_ {1}, k_ {2} ......., k_ {n} are the spring constants for the individual springs, and F_ {spring} = -k \ cdot x, in which
k = k_ {1} + k_ {2} + ... + k_ {n}.

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The first spring 4 and the second spring 5 They can comprise both compression and tension springs.

In the realization of the figures 1-5, the housing 1 is provided with guide means 1a and 1b. The guide means 1a and 1b comprise parallel walls, a inner wall 1a and an outer wall 1b, protruding from the distal interior surface of housing 1. Elements 2a of closure of the carrier body 2 and the elements 3a protruding from the center ring 3 of the needle are placed between the parallel walls 1a and 1b. The closing elements 2a have one or more inclined surfaces that come in contact with a piece of the 3rd elements that stand out. When the carrier body 2 is it extracts or pushes towards the patient's skin, elements 2a of closure will exert a force on or perpendicular to each of inclined surfaces. This force has a parallel component. to walls 1a and 1b pointing in the same direction as the movement, and another component perpendicular to the first component that points towards the inner wall 1a. While the 1st wall inside present, a force of the same size although in the direction opposite that the second component will push back from the wall 1st internal keeping element 3a protruding in one position stable between walls 1a and 1b. When the inner wall 1a does not is present, the second component of the force exerted by the closure element will push the elements 3a protruding towards the center of the device

When the 3 protruding elements have been freed from the interconnection with the closing elements 2a, the center ring of the needle is not influenced by a force in direction of the infusion piece, and the force exerted by the second spring 5 will overcome the friction between the insertion needle and the cannula that extends from the infusion piece 8 and moves the center ring 3 of the needle away from the infusion piece 8.

In fig. 1, body 2 carrier is found placed and locked in a stowed position. The needle 6 of insertion which is attached to the cannula is observed by under infusion piece 8. Both spring units 4 and 5 are they are deviated, and the closing elements 2a are interconnected with the elements 3a protruding from the ring center 3 of the needle due to the support of the walls 1a interiors

When the user wants to insert the device infusion, the device is placed first in the place of patient insertion So, the insertion device is activated by the user by unlocking the body 2 carrier of the accommodation 1.

It is not shown in this embodiment how to performs the unlocking of the carrier body 2, although one form is provide the carrier body 2 with two members that stand out by the openings of the housing 1 opposite each other. The unlocking of carrier body is then performed by the user by pressing on accommodation 1 at two opposite points placed on a line perpendicular to the line formed by the two elements that 2 carrier protruding from the body. Pressing on the two points on the perpendicular line a deformation of the housing 1 and will increase the distance between the two openings corresponding in housing 1, the protruding elements of the carrier body will then be released from the housing 1.

When the insertion device is activated, the first spring 4 tries to return to the non-deflected position and at doing this drags the carrier body 2 and the infusion piece 8 to an advanced position shown in fig. 2.

In this advanced position, the needle 6 of insert and attached cannula have penetrated pad 7 adhesive placed on the proximal end of the housing 1. The elements 3a protruding from the central ring 3 of the needle in the fig. 2 have been released from the support of the inner walls 1a, and, as soon as the release of the walls 1a has taken place internal elements 3a protruding from the central ring of the needle will be forced towards the center of the insertion device to the position shown in fig. 3.

Immediately after, the 3rd elements that protruding from the center ring of the needle are released from the walls 1st interior, the force up from the spring unit 5 will drag the center ring 3 of the needle to the position that is shown in fig. 4, where the center ring 6 of the needle and the Insert needle 6 are fully covered by the housing one.

In fig. 5 shows how the piece 8 of infusion to the adhesive pad 7, the pad 7 is ensures the patient, and then the insertion device is removed and can be safely removed together, since that the contaminated insertion needle 6 is placed behind the protective walls of the housing 1 of the device insertion.

Claims (10)

1. An insertion device for an infusion set comprising a housing (1), a carrier body (2) carrying an infusion piece (8), a central ring (3) of the needle provided with a needle (6 ) of insertion, a first movement unit (4) to bring the carrier body (2) and the central ring (3) of the needle to an advanced position, a second movement unit (5) to bring the central ring (3) ) of the needle to a retracted position, and means for activation that should be activated at least once in order to bring the carrier body (2) and the center ring (3) of the needle from a stowed position to a position advanced, and the central ring (3) of the needle again from the advanced position to the retracted position, characterized in that the first movement unit (4) and the second movement unit (5) are both connected to a distal surface of the body (2) carrier. 2. An insertion device according to claim (1), characterized in that the first movement unit (4) and the second movement unit (5) are placed inside the housing (1). 3. An insertion device according to any of claims 1-2, wherein:

-

he accommodation (1) is provided with guide means (1a, 1b) in the internal surface, to guide the movement of the body (2) carrier,

-

he center ring (3) of the needle comprises an insert needle (6) to pierce the skin,

-

he carrier body (2) has at least one folding position and a advanced position, and in the folding position before the insertion, the carrier body (2) and the central ring (3) of the needle are locked together,

-

he carrier body (2) is provided with guide means (2a) that correspond to the means (1a, 1b) accommodation guide (one),

-

the first movement unit (4) is deviated from the housing (1) and the body (2) carrier, and the second unit (5) of movement deflects the carrier body (2) and the central ring (3) of the needle.

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4. An insertion device according to claims 1-3, characterized in that the carrier body (2) remains in an advanced position after needle insertion (6). 5. An insertion device according to claims 1-3, characterized in that the infusion piece (8) is provided with a proximal adhesive surface. An insertion device according to claims 1-5, characterized in that the infusion piece (8) is provided with an adhesive distal surface. 7. An insertion device according to claims 3, 5 or 6, characterized in that an adhesive pad (7) is releasably fixed to a proximal part of the housing (1). An insertion device according to claim 7, characterized in that the adhesive pad (7) covers a proximal opening of the housing (1) through which the infusion piece (8) will be transported. 9. An insertion device according to claim 7, characterized in that both the first unit (4) and the second unit (5), respectively, comprise a compression spring. 10. An insertion device according to claims 1-9, characterized in that the carrier body (2) is provided with at least one inclined surface, which surface is in contact with a rotating part (3a) of the central ring (3) of the needle, rotating part (3a) which can rotate relative to the main part of the central ring (3) of the needle to which the insertion needle is fixed, and the housing (1) is provided with an element (1a ) to prevent the rotating part (3a) of the central ring (3) of the needle from rotating when the carrier body (2) is in a retracted position.