JP2008507357A - Method and system for providing an infusion device interface - Google Patents

Abstract

An infusion device having an interface between a ferrule and a cannula that maintains hermeticity during use.
An injection device includes an injector base, a cannula and a ferrule. The injector base has a hole through the injector base, the hole has a distal end and a proximal end, and the proximal end has a first inner diameter. The flange extends radially outward from the proximal end of the cannula. The cannula is positioned such that the flange is positioned near the shoulder. The ferrule has an insertion portion having a second outer diameter substantially equal to the first diameter, and a tapered portion extending from the insertion portion. The ferrule is inserted into the hole so that the insertion portion, a portion of the taper portion is received at the proximal end of the cannula, and the flange is pressed between the shoulder portion and the taper portion. It arrange | positions so that a sealing part may be formed between.
[Selection] Figure 1

Description

Disclosure details

(Field of the Invention)
The present invention relates generally to injection devices. More specifically, the present invention relates to an infusion device, such as a medical infusion set, that is better equipped to prevent damage from the needle and maintain hermeticity during use.

BACKGROUND OF THE INVENTION
Devices such as ambulatory external medical devices can deliver materials, such as insulin or drugs, into the patient's body using an infusion device, such as a tube, hollow May include a needle, ferrule or cannula, or a combination of parts. Disposable infusion devices require an interface that remains sealed during use, for example, between a ferrule and a cannula. In some situations, in conventional systems, the needle may penetrate or damage a portion of the interface, reducing sealing. In addition, conventional systems may not be able to maintain a sealing hermeticity during use.

  In view of the above, there is a need for an apparatus for providing an improved infusion device. Further, there is a need to provide a better equipped infusion device to prevent needle damage and maintain hermeticity during use.

[Summary of the Invention]
In accordance with embodiments of the present invention, systems and methods for providing an infusion device are disclosed.

  In at least one aspect of the invention, the infusion device comprises an infuser base, a cannula and a ferrule. The injector base has a hole through the injector base. The hole has a proximal end and a distal end, and a shoulder between the proximal and distal ends. The cannula has a distal end and a proximal end, the proximal end having an inner first diameter (first inner diameter). A flange extends radially outward from the proximal end of the cannula, and the cannula is positioned in the bore so that the flange is positioned near the shoulder. The ferrule has an insertion portion having an outer second diameter (second outer diameter) substantially equal to the first diameter, and a tapered portion extending from the insertion portion while increasing in diameter. The ferrule is inserted between the cannula and the ferrule so that the insertion portion and a portion of the taper portion are received at the proximal end of the cannula and the flange is pressed between the shoulder portion and the taper portion. It is disposed in the hole so as to define a seal therebetween.

  Of course, the foregoing general description and the following detailed description are merely exemplary and explanatory and are considered to limit the scope of the invention as described and claimed. must not. In addition, other features and / or variations of those described herein may be provided. For example, embodiments of the invention may be directed to various combinations and sub-combinations of features described in the detailed description.

  While the invention is illustrated and described herein with specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications in detail can be made within the scope of the claims and their equivalents without departing from the invention.

  It should be emphasized that, according to common practice, the various features of the drawings are not drawn to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.

Detailed Description of the Invention
The following detailed description relates to the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the following description to refer to the same or like parts. While presently preferred embodiments and features of the invention are described herein, modifications, adaptations and other implementations are possible without departing from the spirit and scope of the invention. For example, substitutions, additions or changes may be made to the components illustrated in the drawings, and the exemplary methods described herein replace the steps with respect to the disclosed methods. It may be changed by changing or adding. Accordingly, the following detailed description does not limit the invention. Rather, the proper scope of the invention is defined by the appended claims.

  The system and method according to the invention provides an infusion device, which can be attached to the skin of a patient, and the infusion device is supplied with a liquid pharmaceutical source, such as an insulin pump, for example as a hub type infusion. Can be attached via a hub infusion needle or the like. The infusion device includes a rugged interface subassembly to maintain hermeticity during use. Furthermore, this interface assembly is tolerant of small dimensional tolerances. The interface subassembly generally includes a ferrule and a cannula. The interface subassembly can be placed in an infuser base. The cannula may be configured to move freely within the injector base. The ferrule may include a shaft portion, a tapered lead-in that gradually becomes thinner, and a cup portion. The ferrule may be formed to include a proximal seal.

  As a non-limiting example, FIG. 1 illustrates an injection device 100 in which the features and principles of the invention are implemented. As shown in FIG. 1, the injection device 100 generally has an injector base or housing 105 and an interface subassembly 101. Interface subassembly 101 generally includes a cannula 115 and a ferrule 120. The injection device 100 may further include a partition wall 140 and a retainer 136.

  The components of the injection device will be described with reference to FIG. The injector base 105 includes a body 102 having a base surface 103 that is configured to rest on or be located near the patient's injection site. The injector base 105 may have an adhesive pad (not shown) or the like attached to the base surface 103. A hole 104 extends through the body 102 between the distal end 106 and the proximal end 107. The injector base 105 may have various shapes. For example, this embodiment illustrates an injector base 105 formed for an inclined insertion device, in which the central axis CA of the hole 104 extends at an acute angle with respect to the base surface 103. The injector base 105 can have other shapes. For example, the injection device 100 'illustrated in FIG. 6 includes an injector body 102' having a hole 104 'extending between a proximal end 107' and a distal end 106 '. The hole 104 'has a central axis CA extending perpendicular to the base surface 103', providing a vertical injection device. The infusion device 100 'operates generally in a similar manner as the infusion device 100 as described herein.

  The hole 104 may have a different diameter between the distal end 106 and the proximal end 107. For example, the hole 104 of this embodiment includes a distal portion 108 having the smallest diameter b1 and a proximal portion 114 having the largest diameter b4. A pair of intermediate portions 110 and 112, each having intermediate diameters b2 and b3, are provided between the distal portion 108 and the proximal portion 114. A shoulder 109 is defined between the distal portion 108 and the intermediate portion 110. The shoulder portion 111 is defined between the intermediate portion 110 and the intermediate portion 112. Shoulder 113 is defined between intermediate portion 112 and proximal portion 114. The holes 104 can be arranged in other sizes. Furthermore, although the hole 104 of this embodiment is cylindrical, it may have other geometric shapes.

  The cannula 115 is typically composed of a medical-grade fluorocarbon-based polymer, such as PTFE (PolyTetraFluoroEthylene), or other soft or non-plastic material. . The cannula 115 of the present embodiment includes a distal portion 116 having an outside diameter c1 and an inside diameter c3, and a proximal portion 118 having an outer diameter c2 and an inner diameter c4. Since the cannula 115 is a relatively thin material, there is little difference between the inner diameter and the outer diameter (between the inner diameter c3 and the outer diameter c1 and between the inner diameter c4 and the outer diameter c2). The diameters c1 and c3 of the distal portion 116 are smaller than the diameters c2 and c4 of the proximal portion 118, respectively. A tapered portion 117 extends between the distal portion 116 and the proximal portion 118 to accommodate the difference in diameter. The narrower distal portion 116 reduces pain and discomfort during insertion of the cannula 115 into the patient, while the wider proximal portion 118 causes the insertion needle (shown in the figure). The width of the storage area for the

  The cannula 115 further includes a flange 135 that extends radially outward from the proximal portion 118. Referring to FIGS. 1 and 2, the cannula 115 has a cannula distal portion 116, a tapered portion 117 and a proximal portion 118 generally disposed within the distal portion 108 of the hole, and a flange 135 is the shoulder. It is formed so as to be placed in the hole 104 of the injector base in contact with 109. The cannula distal portion 116 extends out of the hole 104 beyond the distal end 106 of the base 105. The diameter b1 of the hole distal portion 108 is larger than the respective outer diameters c1 and c2 of the cannula portions 116 and 118, so that the circumferential gap 150 (see FIG. 1) is the cannula distal portion 116. And a circumferential gap 151 (see FIG. 1) is defined around the proximal portion 118 of the cannula. The function of the gaps 150 and 151 will be described below.

  Referring again to FIG. 2, the ferrule 120 has a distal end 123 and a proximal end 126, and generally a narrow insert 122 having an outer diameter f1, an enlarged proximal having an outer diameter f2. Part 130 and a tapered part 125 between insertion part 122 and enlarged proximal part 130. Ferrule 120 is preferably manufactured from stainless steel or molded plastic or polymer, but is not limited thereto and may be manufactured from a variety of metals and non-metals. The outer diameter f1 of the insert 122 is substantially equal to the inner diameter c4 of the cannula proximal end 118, such that the insert 122 is received by press fitting into the cannula proximal end 118, as shown in FIG. It has become. When final assembled as in FIG. 1, the ferrule 120 is inserted into the cannula 115 with a portion of the ferrule taper 125 entering the proximal end 118 of the cannula, as will be described in more detail below. Is done. The outer diameter f2 of the enlarged proximal portion 130 is approximately equal to the inner diameter b3 of the hole portion 112 such that the enlarged proximal portion 130 is press-fit into the hole portion 112.

  The enlarged proximal portion 130 of the ferrule has an inner diameter f3 and an inner axial length L1. The tapered portion 125 is a connection portion with the enlarged proximal portion 130 and defines a circumferential contact surface 127. The contact surface 127 has a diameter f4 that is smaller than the diameter f3. The tapered portion 125 gradually becomes thinner so as to have a diameter f5 in the immediate vicinity of the insertion portion 122. The tapered portion 125 extends at an angle θ between about 20 degrees and 30 degrees, preferably 24 degrees. The tapered portion 125 is illustrated as a straight side wall, but the tapered portion 125 is not limited to such a side wall. For example, the tapered portion 125 may have an arcuate shape in the axial direction, such as a convex or concave arc, or a combination of an arcuate shape in the axial direction and a linear shape in the axial direction. You may have.

  The flexible elastomeric partition 140 is formed to be placed in an interference fit on the enlarged proximal portion 130 of the ferrule. Septum 140 preferably has a durometer between about 30 Shore A and 80 Shore A, but is not limited thereto. The partition wall 140 of this embodiment is spherical and has a diameter s1 that is larger than the inner diameter f3 of the enlarged proximal portion and the axial length L1 of the enlarged proximal portion. Thus, when the septum 140 is disposed within the enlarged proximal portion 130 of the ferrule as shown in FIG. 1, the septum 140 seals the main circumference along the inner surface of the enlarged proximal portion 130. The part 142 and the subcircumferential sealing part 144 along the circumferential contact surface 127 are pressed to form. Both the main sealing portion 142 and the sub-sealing portion 144 desirably include a specific contact area extending, for example, 360 degrees. While there are two seal points, which is preferably advantageous over conventional systems by adding redundancy due to double seals, the present invention is not limited to double seals and the expanded proximal portion 130. Even if only one side is sealed along either the inner surface or the circumferential contact surface 127, it can function. The partition wall 140 of the present invention is spherical, but may have other shapes, for example, a barrel or an ellipse, and may be formed on the inner surface and / or the circumferential contact surface 127 of the enlarged proximal portion 130. A shape that is complementary to the shape of the ferrule 120, such as providing a sealed portion by pressing contact, may be used. Furthermore, although the enlarged proximal portion 130 of the present embodiment has an axial length L1 that is shorter than the diameter s1 of the partition wall, this is not essential. Alternatively, for example, the retainer 136 described below may be formed with a distally extending portion that is configured to press the septum 140 toward the circumferential contact surface 127.

  The cage 136 of this embodiment has a body 137, and a hole 138 passes through the body 137. The body 137 has an outer diameter r1, which is equal to or slightly smaller than the inner diameter b4 of the base hole 104 so that the retainer 136 is accommodated within the base hole 104. In such a configuration, the retainer 136 may be secured to the syringe base 105 by sonically welded or other methods. Alternatively, the diameter r1 may be slightly larger than the diameter b4 so that the retainer 136 is press-fitted into the hole 104 of the base. As best shown in FIG. 1, in the installed position, the retainer 136 contacts the septum 140 and pushes in the distal direction. The retainer 136 may have an entrance portion 139 that gradually narrows on at least one side of the retainer 136 in order to guide and pass a needle or the like through the hole 138. In the present embodiment, entrance portions 139 that are gradually narrowed are provided on both sides of the retainer 136 so that the retainer 136 is substantially symmetrical. This prevents the retainer 136 from being attached in the opposite direction during the manufacturing process. The present invention is not limited to this, and the entrance portion 139 that is gradually narrowed may be provided only on the entrance side of the cage 136.

  A method of assembling the injection device 100 of the present invention will be described with reference to FIGS. The ferrule insert 122 is press fit into the cannula proximal end 118 until just before the ferrule taper 125 enters the cannula 115. Referring to FIG. 3, the interface subassembly with the cannula 115 and the ferrule 120 in one piece is placed in the syringe base hole 104 and the cannula distal portion 116, taper portion 117 and proximal portion 118 are The flange 135 is in contact with the shoulder 109 while being disposed in the distal hole 108. The cannula distal portion 116 extends out of the hole 104 beyond the distal end 106 of the base 105. In this embodiment, the cannula 115 and ferrule 120 are interconnected prior to placement in the syringe base hole 104, but this is not required. For example, the cannula 115 may be placed in the base hole 104, after which the ferrule insert 122 may be inserted into the proximal end 118 of the cannula.

  Referring again to FIG. 1, a rugged seal 160 is formed between the cannula 115 and the ferrule 120 by fully placing the subassembly 101 within the injector base 105. The subassembly 101 is pushed into the syringe base hole 104 by pushing the ferrule 120 distally. The distal force causes the lower surface of the flange 135 to contact the shoulder 109 in the syringe base hole 104. By continuing to apply a distal force, the ferrule taper 125 enters the proximal portion 118 of the cannula. By increasing the diameter of the tapered portion 125 of the ferrule, the flange 135 extends in the radial direction. By extending in this way, a tapered sealing portion 160 tightly tightened between the inner surface of the flange 135 and the outer surface of the tapered portion 125 of the flange is formed. Septum 140 and retainer 136 are arranged as described above, and retainer 136 maintains ferrule 120 in a distally advanced position, thereby maintaining seal 160. The distal force on the ferrule 120 described above may be applied by inserting the retainer 136 or otherwise applied, for example with a removable tool, after which the retainer 136 is positioned. It may be done.

  One advantage of this seal 160 over conventional systems is that the flange 135 generally needs to extend very little in the radial direction to form a tight seal. For example, since the tapered portion 122 of the ferrule gradually becomes thinner, the need to move the ferrule 120 in the axial direction with a precise tolerance with respect to the flange 135 is reduced. Thus, the engaging components can be of general tolerance specifications, thus reducing the risk of producing defective products, for example.

  Still another advantage of the ferrule taper 122 will be described with reference to FIGS. As shown in FIG. 4, when the insertion needle 170 formed to be completely passed through the patient through the cannula 115 is inserted through the retainer 136 and the septum 140 in an offset direction. That is, when inserted obliquely with respect to the center line of the cannula 115, the needle 170 contacts the tapered portion 125 of the ferrule 120. The tapered portion 125 of the ferrule generally acts to redirect the displaced insertion needle 170 through the distal end 123 of the ferrule 120, thereby damaging the sharp tip of the insertion needle 170, Without blunting, the needle 170 is again generally coaxial with the cannula 115. As described above, by selecting the angle θ to include a specific value or range of specific values between 20 and 30 degrees, and preferably 24 degrees, Easy to change.

  Referring to FIG. 5, the ferrule taper 125 further provides a free space region 180 for the distal end of the infusion hub needle 175. The hub needle 175 is usually attached to an infusion tube or the like, and is passed through the isolation wall 140 and is held attached to the infusion device 100. From the infusion tube, the ferrule 120 and the cannula are connected. 115 is formed so as to provide a communication path connected to a flow path defined by 115. The free space area 180 provides a generally open area for the distal end 176 of the hub needle 175. The free space region 180 generally prevents contact between the hub needle distal end 176 and the inner surface of the ferrule 120. Not contacting means, for example, that the force to connect / disconnect the hub needle 175 to the injection device 100 is minimized. The free space region 180 is defined by a circumferential shoulder 127 that maintains the septum 140 in place and the septum 140 is a ferrule that may occur in conventional assemblies. It is prevented that the taper portion 125 is substantially pressed.

  As described above in connection with FIGS. 1 and 2, the cannula 115 and the distal portion 108 of the syringe base bore are circumferentially spaced 150 around the cannula distal portion 116 and the tapered portion 117. And a circumferential gap 151 is defined around the proximal portion 118 of the cannula. Circumferential gaps 150 and 151 minimize the possibility of cannula 115 being damaged. For example, although it is unlikely that the insertion needle 170 will contact the proximal portion 118 of the cannula, the circumferential gap 151 may cause the slightly displaced interface subassembly 101 to place the cannula 115 into the injector base 105 during assembly. Gives space to prevent pressing against the inner surface.

  Further, a component such that when the insertion needle 170 is pushed through the distal end 123 of the ferrule 120, the sharp tip or edge of the insertion needle 170 can contact the inner surface of the cannula taper 117. There may be misalignment. If there is no space in the cannula 115 to deviate from the misalignment described above, the sharp tip and / or edge of the insertion needle 170 will be on the inner surface of the cannula taper 117 or distal to the inner surface. Through the thickness, or the wall thickness can be significantly reduced to induce leakage. According to embodiments of the invention, the circumferential gaps 150 and 151 allow the cannula 115 to bend around the central axis of the syringe base hole 104, which can damage or leak the cannula 115. Minimize the risk of

  While specific features and embodiments of the invention have been described, other embodiments of the invention will become apparent to those skilled in the art after reviewing the specification and practicing the embodiments of the invention described herein. . Moreover, the steps of the disclosed methods can be altered in any manner including changing the order of steps and / or inserting or deleting steps without departing from the principles of the present invention. It is therefore intended that the specification be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims and their full scope of equivalents. Although the invention is illustrated and described herein with reference to specific embodiments, it is not intended that the invention be limited to the details shown. Rather, various changes in detail may be made within the scope of the claims and their equivalents without departing from the invention.

Embodiment
(1) In the injection device,
An injector base having a hole extending through the injector base, the hole having a distal end and a proximal end; and the distal end and the proximal end The injector base comprising a shoulder between the portion and
A cannula having a distal end and a proximal end, the cannula proximal end having an inner diameter and comprising a flange extending radially outward from the cannula proximal end, the cannula The cannula disposed in the hole such that the flange is disposed proximate to the shoulder;
A ferrule,
A ferrule insert having an outer diameter substantially equal to the inner diameter of the proximal end of the cannula; and
A ferrule taper portion extending from the ferrule insertion portion while increasing the outer diameter;
Have
A portion of the ferrule insertion portion and the ferrule taper portion is received in the cannula proximal end, and the flange is pressed between the shoulder portion and the ferrule taper portion, and the cannula and the ferrule; The ferrule is disposed in the hole so as to define a sealing portion between
The ferrule;
An apparatus comprising:

(2) In the apparatus according to Embodiment 1,
The injector base has a base surface;
The hole has an acute central axis with respect to the base surface;
apparatus.
(3) In the apparatus according to Embodiment 1,
The injector base has a base surface;
The hole has a central axis that is perpendicular to the base surface;
apparatus.
(4) In the apparatus according to Embodiment 1,
The hole includes a hole distal portion having an inner diameter;
The cannula includes a cannula distal portion extending into the hole distal portion and having an outer diameter;
The outer diameter of the cannula distal portion is smaller than the inner diameter of the hole distal portion such that a first circumferential gap is formed around the cannula distal portion;
apparatus.

(5) In the apparatus according to Embodiment 1,
The hole includes a hole distal portion having an inner diameter;
The cannula is
A cannula distal portion extending into the hole distal portion and having an outer diameter;
A cannula proximal portion extending into the hole distal portion and having an outer diameter, wherein the outer diameter of the cannula proximal portion is greater than the outer diameter of the cannula distal portion, A proximal cannula;
A cannula taper portion extending between the cannula proximal portion and the cannula distal portion;
Have
The outer diameter of the cannula distal portion and the outer portion of the cannula proximal portion so that at least a first circumferential gap is formed around the cannula distal portion, the cannula tapered portion, and the cannula proximal portion. The diameter is smaller than the inner diameter of the hole distal portion,
apparatus.
(6) In the apparatus according to Embodiment 1,
The apparatus, wherein the cannula is spaced from the inner surface of the hole except for the flange portion of the cannula.

(7) In the apparatus according to Embodiment 1,
The ferrule includes a ferrule proximal portion;
The ferrule proximal portion extends from the ferrule taper portion and includes an inner surface having an inner diameter.
apparatus.
(8) In the apparatus according to embodiment 7,
A circumferential contact surface is defined in the connection between the ferrule taper and the ferrule proximal;
The circumferential contact surface has an inner diameter that is smaller than the inner diameter of the inner surface of the ferrule proximal portion.
apparatus.
(9) In the apparatus according to embodiment 8,
An elastomeric partition having a radial outer dimension larger than the inner diameter of the inner surface of the ferrule proximal portion;
Further including
The elastomer partition wall is pressed into the ferrule proximal part, and between the partition wall and the ferrule proximal part inner surface, or between the partition wall and the circumferential contact surface, At least a first circumferential seal is defined;
apparatus.

(10) In the apparatus according to embodiment 9,
The partition wall further defines a second circumferential seal between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces.
(11) In the apparatus according to embodiment 9,
The ferrule proximal portion has an axial length that is shorter than the axial length of the elastomeric septum.
(12) In the apparatus according to embodiment 9,
The apparatus, wherein the partition wall is substantially spherical.
(13) In the apparatus according to embodiment 9,
The cage is disposed in contact with the partition wall in the hole, and holds the partition wall in a sealing engagement with the circumferential contact surface. Cage,
Further comprising an apparatus.
(14) In the apparatus according to embodiment 9,
The circumferential contact surface prevents the partition wall portion from significantly extending into the ferrule taper portion, and thereby, between the inner surface of the ferrule taper portion and the partition wall portion inside the ferrule taper portion. The device is configured such that free space is defined.

(15) In the apparatus according to Embodiment 1,
The apparatus, wherein the ferrule taper has a conical taper having a slope between about 20 degrees and about 30 degrees.
(16) In the device according to embodiment 15,
The apparatus, wherein the conical taper has a slope of about 24 degrees.
(17) In the apparatus according to Embodiment 1,
The taper portion has an axially straight shape.
(18) In the apparatus according to Embodiment 1,
The taper portion has an arcuate shape in the axial direction.

(19) In the injection device,
An injector base having a hole extending through the injector base, the hole having a distal end and a proximal end;
A cannula disposed in the hole;
A ferrule disposed in the hole and sealingly connected to the cannula, the distal portion, the proximal portion, and between the distal portion and the proximal portion A connecting portion between the ferrule taper portion and the ferrule proximal portion defines a circumferential contact surface, and the circumferential contact surface is the ferrule proximal portion. The ferrule having an inner diameter smaller than the inner diameter of the inner surface of
An elastomer partition wall having a radial outer dimension larger than the inner diameter of the ferrule proximal portion, being pressed against the ferrule proximal portion, and the partition wall and the inner surface of the ferrule proximal portion Or between the partition wall and the circumferential contact surface, the elastomer partition wall defining at least a first circumferential sealing portion;
An apparatus comprising:
(20) The apparatus according to embodiment 19,
The apparatus, wherein the elastomeric partition further defines a second seal between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces.

(21) The apparatus according to embodiment 19,
The apparatus, wherein the ferrule proximal portion has an axial length that is shorter than an axial length of the septum portion.
(22) The apparatus according to embodiment 19,
The apparatus, wherein the partition wall is substantially spherical.
(23) The apparatus according to embodiment 19,
An apparatus in which a cage is disposed in the hole portion in contact with the partition wall, and the cage holds the partition wall in close contact with the circumferential contact surface.
(24) The apparatus according to embodiment 19,
The circumferential contact surface prevents the partition wall portion from significantly extending into the ferrule taper portion, and thereby, in the ferrule taper portion, between the inner surface of the ferrule taper portion and the partition wall portion, An apparatus configured to define free space.
(25) In the device according to embodiment 19,
The taper portion has an axially straight shape.
(26) In the device according to embodiment 19,
The taper portion has an arcuate shape in the axial direction.

(27) In the assembly method of the injection device,
Providing an injector base comprising a hole extending through the injector base, the hole having a distal end and a proximal end; and the distal end; Providing a shoulder between the proximal and proximal ends;
A cannula having a distal end, a proximal end, and a flange extending radially outward from the proximal end, wherein the cannula is positioned in the bore so that the flange is disposed near the shoulder. The stage of placing in
A ferrule having a ferrule insertion portion having an outer diameter substantially equal to the inner diameter of the proximal end portion of the cannula, and a ferrule taper portion extending from the ferrule insertion portion while increasing the outer diameter. Placing in the hole such that is received in the proximal end of the cannula;
A portion of the ferrule taper portion is received in the proximal end portion of the cannula, and the flange is pressed between the shoulder portion and the ferrule taper portion, so that a sealing portion is provided between the cannula and the ferrule. Advancing the ferrule in a distal direction to define
Including a method.
(28) In the method of embodiment 27,
The method, wherein the ferrule insert is disposed in the proximal cannula before the cannula and the ferrule are disposed in the hole.

(29) In the method of embodiment 27,
Advancing the ferrule distally comprises placing a retainer in the bore so that the retainer contacts the ferrule and advances the ferrule.
(30) In the method of embodiment 27,
Advancing the ferrule in the distal direction includes advancing the ferrule with a removable tool, and thereafter placing a retainer in the hole to hold the ferrule in an advanced position. .
(31) In the method of embodiment 27,
The elastomeric partition wall is pressed against the proximal portion of the ferrule, which extends from the ferrule taper portion and defines an inner surface and a circumferential contact surface provided at a connection portion with the tapered surface. Thereby, the elastomer partition wall portion is at least a first circumferential seal between the partition wall portion and the inner surface of the ferrule proximal portion, or between the partition wall portion and the circumferential contact surface. Defining a part,
Further comprising a method.
(32) In the method of embodiment 31,
The elastomeric septum further defines a second sealing portion between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces.

It is sectional drawing of the injection apparatus which is the 1st Embodiment of this invention. FIG. 2 is an exploded view of the injection device of FIG. 1. FIG. 3 illustrates the injection device of FIG. 2 partially assembled. It is sectional drawing similar to FIG. 1, Comprising: It is a figure which shows the place where the shifted insertion needle was partially inserted in the injection apparatus. It is sectional drawing similar to FIG. 1, Comprising: It is a figure which shows the place where the hub type injection needle was inserted in the injection device. FIG. 6 is a cross-sectional view of an injection device that is an alternative embodiment of the present invention.

Claims (32)

In the injection device,
An injector base having a hole extending through the injector base, the hole having a distal end and a proximal end; and the distal end and the proximal end The injector base comprising a shoulder between the portion and
A cannula having a distal end and a proximal end, the cannula proximal end having an inner diameter and comprising a flange extending radially outward from the cannula proximal end, the cannula The cannula disposed in the hole such that the flange is disposed proximate to the shoulder;
A ferrule,
A ferrule insert having an outer diameter substantially equal to the inner diameter of the proximal end of the cannula; and
A ferrule taper portion extending from the ferrule insertion portion while increasing the outer diameter;
Have
A portion of the ferrule insertion portion and the ferrule taper portion is received in the cannula proximal end, and the flange is pressed between the shoulder portion and the ferrule taper portion, and the cannula and the ferrule; The ferrule is disposed in the hole so as to define a sealing portion between
The ferrule;
An apparatus comprising: The apparatus of claim 1.
The injector base has a base surface;
The hole has an acute central axis with respect to the base surface;
apparatus. The apparatus of claim 1.
The injector base has a base surface;
The hole has a central axis that is perpendicular to the base surface;
apparatus. The apparatus of claim 1.
The hole includes a hole distal portion having an inner diameter;
The cannula includes a cannula distal portion extending into the hole distal portion and having an outer diameter;
The outer diameter of the cannula distal portion is smaller than the inner diameter of the hole distal portion such that a first circumferential gap is formed around the cannula distal portion;
apparatus. The apparatus of claim 1.
The hole includes a hole distal portion having an inner diameter;
The cannula is
A cannula distal portion extending into the hole distal portion and having an outer diameter;
A cannula proximal portion extending into the hole distal portion and having an outer diameter, wherein the outer diameter of the cannula proximal portion is greater than the outer diameter of the cannula distal portion A proximal portion;
A cannula taper portion extending between the cannula proximal portion and the cannula distal portion;
Have
The outer diameter of the cannula distal portion and the outer portion of the cannula proximal portion so that at least a first circumferential gap is formed around the cannula distal portion, the cannula tapered portion, and the cannula proximal portion. The diameter is smaller than the inner diameter of the hole distal portion,
apparatus. The apparatus of claim 1.
The apparatus, wherein the cannula is spaced from the inner surface of the hole except for the flange portion of the cannula. The apparatus of claim 1.
The ferrule includes a ferrule proximal portion;
The ferrule proximal portion extends from the ferrule taper portion and includes an inner surface having an inner diameter.
apparatus. The apparatus of claim 7.
A circumferential contact surface is defined in the connection between the ferrule taper and the ferrule proximal;
The circumferential contact surface has an inner diameter that is smaller than the inner diameter of the inner surface of the ferrule proximal portion.
apparatus. The apparatus of claim 8.
An elastomeric partition having a radial outer dimension larger than the inner diameter of the inner surface of the ferrule proximal portion;
Further including
The elastomer partition wall is pressed into the ferrule proximal part, and between the partition wall and the ferrule proximal part inner surface, or between the partition wall and the circumferential contact surface, At least a first circumferential seal is defined;
apparatus. The apparatus of claim 9.
The partition wall further defines a second circumferential seal between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces. The apparatus of claim 9.
The ferrule proximal portion has an axial length that is shorter than the axial length of the elastomeric septum. The apparatus of claim 9.
The apparatus, wherein the partition wall is substantially spherical. The apparatus of claim 9.
A cage, wherein the cage is disposed in contact with the partition wall in the hole, and the partition is held in close contact with the circumferential contact surface;
Further comprising an apparatus. The apparatus of claim 9.
The circumferential contact surface prevents the partition wall portion from significantly extending into the ferrule taper portion, and thereby, between the inner surface of the ferrule taper portion and the partition wall portion inside the ferrule taper portion. The device is configured such that free space is defined. The apparatus of claim 1.
The apparatus, wherein the ferrule taper has a conical taper having a slope between about 20 degrees and about 30 degrees. The apparatus of claim 15.
The apparatus, wherein the conical taper has a slope of about 24 degrees. The apparatus of claim 1.
The taper portion has an axially straight shape. The apparatus of claim 1.
The taper portion has an arcuate shape in the axial direction. In the injection device,
An injector base comprising a hole extending through the injector base, the hole having a distal end and a proximal end;
A cannula disposed in the hole;
A ferrule disposed in the hole and sealingly connected to the cannula, the distal portion, the proximal portion, and between the distal portion and the proximal portion A connecting portion between the ferrule taper portion and the ferrule proximal portion defines a circumferential contact surface, and the circumferential contact surface is the ferrule proximal portion. The ferrule having an inner diameter smaller than the inner diameter of the inner surface of
An elastomeric partition having a radial outer dimension larger than the inner diameter of the ferrule proximal portion, being pressed against the ferrule proximal portion, and the partition portion and the inner surface of the ferrule proximal portion Or between the partition wall and the circumferential contact surface, the elastomer partition wall defining at least a first circumferential sealing portion;
An apparatus comprising: The apparatus of claim 19, wherein
The apparatus, wherein the elastomeric partition further defines a second sealing portion between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces. The apparatus of claim 19, wherein
The apparatus, wherein the ferrule proximal portion has an axial length that is shorter than an axial length of the septum portion. The apparatus of claim 19, wherein
The apparatus, wherein the partition wall is substantially spherical. The apparatus of claim 19, wherein
An apparatus in which a cage is disposed in the hole portion in contact with the partition wall, and the cage holds the partition wall in close contact with the circumferential contact surface. The apparatus of claim 19, wherein
The circumferential contact surface prevents the partition wall portion from significantly extending into the ferrule taper portion, and thereby, in the ferrule taper portion, between the inner surface of the ferrule taper portion and the partition wall portion, An apparatus configured to define free space. The apparatus of claim 19, wherein
The taper portion has an axially straight shape. The apparatus of claim 19, wherein
The taper portion has an arcuate shape in the axial direction. In the assembly method of the injection device,
Providing an injector base comprising a hole extending through the injector base, the hole having a distal end and a proximal end; and the distal end; Providing a shoulder between the proximal end and
A cannula having a distal end, a proximal end, and a flange extending radially outward from the proximal end, wherein the cannula is positioned in the bore so that the flange is disposed near the shoulder. The stage of placing in
A ferrule having a ferrule insertion portion having an outer diameter substantially equal to the inner diameter of the proximal end portion of the cannula, and a ferrule taper portion extending from the ferrule insertion portion while increasing the outer diameter. Placing in the hole such that is received in the proximal end of the cannula;
A portion of the ferrule taper portion is received in the proximal end portion of the cannula, and the flange is pressed between the shoulder portion and the ferrule taper portion, so that a sealing portion is provided between the cannula and the ferrule. Advancing the ferrule in a distal direction to define
Including a method. 28. The method of claim 27, wherein
The method, wherein the ferrule insert is disposed in the cannula proximal end before the cannula and the ferrule are disposed in the hole. 28. The method of claim 27, wherein
Advancing the ferrule distally comprises placing a retainer in the bore so that the retainer contacts the ferrule and advances the ferrule. 28. The method of claim 27, wherein
Advancing the ferrule in the distal direction includes advancing the ferrule with a removable tool, and thereafter placing a retainer in the hole to hold the ferrule in an advanced position. . 28. The method of claim 27, wherein
The elastomeric partition wall is pressed against the proximal portion of the ferrule, which extends from the ferrule taper portion and defines an inner surface and a circumferential contact surface provided at a connection portion with the tapered surface. Thereby, the elastomer partition wall portion is at least a first circumferential seal between the partition wall portion and the inner surface of the ferrule proximal portion, or between the partition wall portion and the circumferential contact surface. Defining a part,
Further comprising a method. 32. The method of claim 31, wherein
The elastomeric septum further defines a second sealing portion between the inner surface of the ferrule proximal portion and the other of the circumferential contact surfaces.

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