MXPA97009307A - Dye system of inyecc - Google Patents

Abstract

An implant dart has a head of solid material and a tubular body containing one or more implant packages that release drug. The head has a blade at its front end with a chisel tip with a bevelled end and a roe face extending back from the body. The body is formed as a helical coil which makes the tubular body and allows the turns of the coil to be compressed and engaged to make the body relatively rigid when the dart is injected into the subject. A passage from the head to the interior of the body provides fluid communication between the body fluids of the subject and the implant packages. The wings extend from the head to guide the entrance of the dart towards the subject and to block this against its withdrawal. The complete system comprises at least one dart and an injection mechanism which retains a part of the body of the subject on a stage and feeds darts in the part of the body and is generally parallel to the plati

Description

INJECTION DART SYSTEM FIELD OF THE INVENTION ? The present invention relates to a dart containing implants that release drugs to be inserted into the body of a subject, such as an animal and a system for injecting the dart into the subject. lü BACKGROUND OF THE INVENTION Animals, particularly wild animals, have long been injected with tranquilizers and other drugs through the use of darts l í > hypodermic thrown by means of a rifle or similar device. Such darts are constructed to lodge in the skin of the animal and release its drug load upon impact. The dart needs to be removed from the animal immediately after use, to prevent infection or 2? other damage to the animal. On the other hand, there is a frequent need to provide drug treatments to an animal for prolonged periods of time. However, the drug can be of a type, such as somatotropin, it could be 2b degraded by the digestive system of the animal if REF: 26196 administered with a feed supply. U.S. Patent No. 5,266,325, issued to Kuzma et al. November 30, 1993 suggests that drugs that need to be administered over a prolonged period of time 5 are provided in an implant that releases the sustained release drug that is injected subcutaneously into the living tissues of the subject. According to Kuzma et al., The implant is introduced into the subject through a cannula of an instrument similar to a long hypodermic needle / eringa, which is removed from the body of the subject immediately after the injection of the implant. However, this method of drug introduction is not satisfactory for treating large groups of animals. For example, when dealing with cattle or pigs in the field, it may not be convenient to sterilize the hypodermic needle or use a new needle for each animal. Therefore there is a danger that a needle contaminated by an animal could infect the entire group. Another drawback of using implants is that they tend to deviate from their position. Therefore it becomes ? '? very difficult, if not impossible, to detect if a subject has or has not received an implant. Kuzma et al. suggest using a radioactive material inside the implant to allow detection. However, in the field, this is not a satisfactory solution.

Broadly, an object of the present invention is to provide a system for introducing sustained release implants into animals, which system avoids the drawbacks of the known systems of < this type. It was specifically contemplated that the system is capable of introducing implants to a large group of animals without the risk of spreading infections or diseases among them. Another object of the invention is that the implants ! •! that contain drugs introduced into an animal, are able to remain inside the animal for prolonged periods of time while their presence or the fact of having been introduced is easily detectable despite the consumption of the drug, and without the use of complex instruments. 1 L, Still another object of the present invention is to inject implants containing one or more drugs into an animal subject without the need to invasively penetrate the bodies of multiple animals with a common instrument. It is also an object of the present invention to provide a system and apparatus for introducing implants containing drugs into the body of a subject, a system and apparatus which are simple, convenient, and easy to use, and still relatively inexpensive construction. . According to the present invention there is provided It is a dart containing implants that release drugs, which can be easily introduced and implanted in the body of the subject at a given site, for example, subcutaneously in the ear of a pig, without the use of an instrument that invade the body of the subject. In accordance with a preferred embodiment of the invention, the dart is made of plastic material that has a hollow cylindrical body and a solid head, generally cylindrical in shape. The face of the dart head has a hollow shape and the surface of the exposed edge of the face i u has a fillet radius starting at the upper edge of the dart body and tilting down and forward from the hollow body. This forms a relatively long narrow blade of the lower part of the head, leading to the edge of which is formed with a tip 1 ! > of sharp chisel, to provide penetration to the entrance of the dart in the body of the subject. Flexible stabilizing wings are provided on either side of the dart head. The stabilizing wings run outward and backward toward the hollow cylindrical body and serve as a lock or barb to prevent the dart from being winged out of the subject once it has entered a part of the subject's body. The hollow body of the dart is preferably a coil of material formed with a number of turns in a 2! J helix. This gives the body a degree of flexibility to allow the shape of the body of the dart to change to conform to the site where it hit the body of the subject. The coil also makes the dart body compressible in the longitudinal direction, to provide stiffness when the dart is inserted under pressure into the subject. One or more implants, which may contain the same or different substances, are located within the hollow body. There is a passage through the head of the dart to the body to provide fluid communication between the body fluids of the subject and the implant. An end cap is adjusted by friction in an opening in the back of the body. The presence of the dart injected into the subject can be determined visually or by palpitation of the part of the body where the dart was targeted (e.g. 1 í 'ear). A feature of the invention is that a dart is provided that is permeable to body fluids which contains implants containing one or more substances and that the dart is itself implanted or directly into a subject, such as a pig. A further feature of the invention is that a dart containing one or more implants is permeable to bodily fluids and includes a head with a blade having a sharp tip to penetrate the body of the subject. He '-'. ' The body of the dart contains one or more implants with substances that must be released in a subject, so that the dart is easily injected into the subject and contains the implants therein. Yet another feature of the invention is that > a dart that carries one or more implants to a subject is permeable to body fluids and has a body which is firm and rigid, which being inserted in the subject, can expand even in its longitudinal direction, to become flexible after the insertion in the subject. A further feature of the invention is that the presence within a body part of a subject of an injected dart containing implants that release drugs can be determined visually easily or by palpitation of the body part of the subject. 1 r. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and advantages of the present invention will become more apparent with reference to the following specification in which: Figure 1 is a top view of a preferred embodiment of a dart according to the invention; Figure 2 is a side view of the dart shown in Figure 1; Figure 3 is a sectional view taken along line 3-3 and looking in the direction of the arrows in the dart of Figure 2 / Figure 4 is a front view of the dart of Figure 2; Figure 5 is a fragmentary, elongated view of a portion of the dart of Figure 1 showing the coils of the compressed body; Figure 6 is a schematic, total top view, showing the flexure of the dart body and the compression of the dart areas; Figure 7 is a schematic, total side view similar to that of Figure 6. Figure 8 is a top view of a dart injection system or applicator according to the present invention. Figure 9 is a left side view of the injection system of Figure 8, with parts shown in section to illustrate more internal details of the system. Figure 10 is a fragmentary sectional view taken along the line 9-9 in Figure 8 after the ear of a subject has been captured and showing the initial insertion of the dart; and Figure 11 is a view similar to that of Figure 9, showing the dart fully inserted.

DETAILED DESCRIPTION OF THE INVENTION Referring to Figures 1-7, the dart 10 includes a solid head 20 which generally has an oval cylindrical shape and a hollow tubular body 30. The dart is preferably of a biologically suitable plastic material such a polycarbonate. The dart 10 is preferably made by injection molding and preferably in one piece. The dart head 20 is a solid piece with a upper face 22 which curves downwards in hollow form from a rear end 23, which is at the beginning of the front end of the body 30. From the rear end of the head 23 there is an edge of the surface leading to the concave radius 24 that extends towards a shallow, bevelled surface 26. This ends in a relatively narrow, projecting, elongated blade 27, having a sharp cutting edge 28 with a downward bevel 29. The lower surface of the blade 27 is curved. A 25-plow blade creates a transition ? from the narrow blade 27 (see Figure 1) to the body of the cylindrical dart 30 and serves a purpose to be more fully described later. A pair of flexible wings 4 are formed on the outer surface of the head 20 starting at the : - - • beveled surface 26. The wings 40 are inclined backward and are located on the front end of the body 30. The wings 40 have a pointed front edge 41 and are in a horizontal plane, as illustrated in Figures 2 -4, ie along the longitudinal center line 5 of the body of the dart 30 and are parallel to a plane tangent to the bottom of the body as shown in Figure 2. As seen in Figure 1, each wing 40 has an embossed groove 42, which is angled inwards in relation to the body that ends at one end generally. 'u circular 44. The slots 42 allow the wings to fold inwards. This prevents stress on the wings 40 when they are folded after inserting the dart into the subject. The body 30 is a coil of several turns 32 wound in a helix to form a hollow tube. The turns 1 of the coil has opposite ends 34"in the form of tongues, the tongues 34 have the same curved shape as the coil turns and are preferably 90 ° apart around each side of each turn of the coil. 34 of a turn of the coil rotate to those of the next adjacent turn and the stops engage when the body 30 is compressed lengthwise during insertion into the subject.This is shown in Figure 5. One or more packages of implant 50 (Figures 1 and 3) are located within the body 30 and contain any type »C, nutritional or medical supplement of the desired dose or a combination thereof. The packages 50 are inserted into the tubular body 30 through the open end in the remote body to the head 20. An end cap 54 with a spherical radius is flexed at the end of the body 30b remote to the head. An orifice 60 provides a communication passage through the head 20 of its upper surface 22 to the interior of the body 30. Therefore, when the dart is inserted into the subject, there is fluid communication between the body fluids of the subject and with the implant packages 50 to release their content in the subject. Figures 6 and 7 show the flexibility of the body 30 in all directions. This allows the dart ! - conform to the body of the subject, allowing normal movement of the part of the body with the dart lodged and avoiding discomfort, irritation or rejection of the dart by the body of the subject. In Figure 6, the wings 40 are shown in the compressed state in dotted lines. Figure 8 is a plan view of a preferred embodiment of an implant dart applicator or insertion system 90 incorporating the present invention, and Figure 9 is a side view, partially sectioned, illustrating additional details of the system applicator in 2 b use. The system 90 broadly comprises a main body 91, which includes a chamber (not shown) adapted to receive a dart 10. At one end of the body 91, a platen 92 is placed and retained by means of an articulated member. 98, so that it rotates in relation to the main body 91. The main body 91, opposite the plate 92, also includes a propulsion mechanism (not shown) operable to provide a propelling force to the dart 10 within the main body 91, through a push bar 59, which accelerates the dart towards the stage ] D 92. The propulsion mechanism can be any type of conventional mechanism, but is preferably a device operated by a spring which can be loaded and then released, by means of a trigger. As best seen in Figures 8-10, the main body 91 H? includes an upper part 93, which has a hole 97 in which the dart 10 is accelerated towards the platen 92. By means of an articulated member 98, the platen 92 can be rotated conveniently in relation to the main body 91 to receive the ear (E) of the subject, in which ? v Dart 10 is inserted. The ear (E) is then held flat against the top of the platen 92 by means of the arms 99, which are attached to it, and the ear is formed in a 90 ° bend at the front of the outlet ( within the projected perimeter) of the orifice 97. In this position, the ear is held captive between the platen 92 and the leg 95. Now the use of the dart 10 will be explained. Although a description has been made in relation to the insertion of the dart 5 In the ear of a pig, the dart can be used in other parts of the body or in other types of subjects, including cattle, sheep, goats or other livestock, or domestic or wild animals. In Figures 9 and 10 the plate plate 92 is opposite the top 93 with a leg 95 that is extends down. The ear of the pig (E) has been captured between the plate 92 and the leg 95 and is held in a flat position on the upper part of the plate and formed in a 90 ° bend. In use, the plate 92 is preferably I b deviated sufficiently below the hole 97, which is parallel to the stage, to allow the cartilage of the ear C to be generally aligned with or below the hole 97 (ie outside the projected perimeter of the hole). The dart is injected from hole 97 to the upper exposed surface of the ear (E). With the curved lower surface of the blade and the wings 40 generally parallel to the platen 92, the dart is caused to move at a speed sufficient to penetrate the orejti by the propulsion mechanism 94. The chisel edge 2 b sharp, narrow 28 cuts through the skin of the ear (E) with minimal resistance. A slight deflection occurs when the front part of the dart penetrates the skin. When the dart moves further under the skin, the radius 24 and the plow-shaped blade, lower, 25 are compensated to neutralize the downward forces. The resistance found in the upper edge 23 causes the dart to rise, allowing it to travel through the upper surface of the cartilage. The radius 24 and the wings 40 guide the dart through the cartilage, preventing the blade 27 from penetrating through it.

These details of the different mechanisms are explained in more detail later. The shallow bevel 26 at the inner end of the narrow blade 27 and the radius 24 create a slow feed that raises the chisel edge 28. Due to its shape, the blade ] b in the form of a plow 25 rises still further and prevents the cutting edge 28 from penetrating the cartilage. The bevel 29 continues to deflect the cartilage downwardly as the cutting edge 28 continues to cut through the tissue during insertion of the dart. As a result, the dart slides along ? 0 the surface of the cartilage as it goes. The wings 40 provide orientation and rotational stability to the dart when it is inserted. They also provide a locking feature once the dart is inserted into the subject. During the insertion of 2 dart, wings 40 are bent inwardly (shown as dotted lines in Figure 6). After insertion into the ear, the wings are bent to their outward position (as shown by solid lines in Figure 6). The wings stabilize the dart after entering the subject. These 5 maintain the proper alignment of the dart and minimize the resistance at the entrance. A back angle 46 on the wings 40 (Figure 6) causes the wings to engage the body tissue and extend if the direction of the dart is reversed, thereby creating a characteristic of blocking. During the insertion of the dart the coils 32 of the body are compressed along the length of the body until the stops 34 (as shown in Figure 3) are coupled, due to the high speed of acceleration imparted to the dart by the propulsion mechanism 94 (preferably 40-60 mph). This causes the dart to collapse to become totally rigid at the point of entry into the subject. With the dart in the ear, there is communication between the bodily fluids of the subject, for example, blood and the package of or implant 50 in the body 30 through the passage of the head 60. This facilitates the release of the implant content to the body of the subject. After entering, after any movement of the dart out of the subject, the complete removal of the dart? '~ > it is avoided by blocking wings. The turns of the body coil can be separated somewhat as the ear moves so that the body of the dart is shaped, more to the ear. This also provides additional communication between the implants 50 and the bodily fluids of the subject. The spherical radius shape of the end cap of the body 54 provides positive location with the spherical coupling radius 57 (Figure 10) of a push rod 59 of the injection channel. This controls the direction and prevents the end cap 54 from sliding laterally to as the dart completes its passage in the ear. The presence of the dart 10 in the subject can be detected visually or by palpitation of the site with the embedded dart. It was also contemplated that the dart may include a small metal or magnetic element for H allow its detection by means of a metal or magnetic detector, or similar. The dart may also include simple electronic devices to aid detection and identification. The dimensions of the 10 dart depend on numerous ; u factors including, the dimensions of and the number of implants contained, the type of subject, depth of insertion of the dart, insertion force necessary to penetrate the subject's skin, etc. In the example of the pig's ear, shown in Figures 8 and 9, the dart 10 has a total length of about 45 mm and an outer diameter of about 7 mm. Although the preferred forms of the invention have been described for illustrative purposes, those skilled in the art will appreciate that many additions, modifications and substitutions are possible without departing from the scope and spirit of the invention as defined by the accompanying claims. For example, although it is not very desirable, the dart 10 does not need to be accelerated in the body part of the subject by means of a propulsion device. Instead, it might be possible to make a small incision in the body part of the subject and inject the dart into the body part at low speed, operating the push bar 59 manually.

It is noted that in relation to this date, the. The best method known to the applicant for carrying out the aforementioned invention is that which is clear from the present description of the invention. Having described the invention as above, property is claimed as contained in the following:

Claims (24)

1. An implant dart to be inserted into the body of an animal, the implant dart is characterized 5 because it comprises: a frontal head having means to penetrate the body tissue to allow the entire dart to enter the body; a tubular body oriented behind the head, the tubular body having a compartment for housing at least one drug-eluting implant container; the compartment in the tubular body is in fluid communication with the head by means of a passage defined between the head and the tubular body to allow the entrance of 15 fluids into the body of the animal into the compartment.

2. The implant dart according to claim 1, characterized in that the head comprises a front end thereof and the tubular body comprises a rear end thereof, the front end is constructed to be sufficiently sharp or sharp to penetrate the body tissue.

3. The implant dart according to claim 2, characterized in that the head has an external surface, is curved and includes a face with a hollow shape.

4. The implant dart according to claim 3, characterized in that the front end of the head is an elongated blade having a rear end, the trailing end defining a cutting edge. 10 upper and one bevel oriented inwards and downwards defined below the cutting edge.

5. The implant dart according to claim 4, characterized in that the head has a H? concave radius defined between a rear end portion of the head and a rear end portion of the blade.

6. The implant dart according to claim 2, characterized in that the tubular body is flexible.

7. The implant dart according to claim 6, characterized in that it also comprises a 25 opening in the end of the remote tubular body of the head to allow the insertion of an implant in the tubular body.

8. The implant dart according to claim 1, characterized in that it also comprises a passage through the head towards the interior of the tubular body.

9. The implant dart according to claim 1, characterized in that it comprises at least one stabilizing wing extending from the head back of the tubular body.

10. The implant dart according to claim 9, characterized in that there is a pair of substantially coplanar stabilizing wings on opposite sides of the head.

11. The implant dart according to claim 10, characterized in that each of the wings has a groove that begins at a rear edge thereof and that is generally parallel to the longitudinal axis of the tubular body to allow the bending of a wing towards in towards the tubular body.

12. The implant dart according to claim 1, characterized in that it further comprises a shutter for sealing the rear end of the remote tubular body to the head.

13. An implant dart to be inserted into the body of a target animal, characterized in that it comprises: a head having front and rear ends and an elongated blade at its front end to penetrate the body tissue to allow the entire dart enter the body of the animal; a flexible tubular body at the rear end of the head formed of a coil of material; J 5 the tubular body has at least one drug-eluting implant container; and the head has a passage therethrough which communicates with the interior of the tubular body to allow the entry of fluids into the body of the animal into at least one compartment.

14. The implant dart according to claim 1, characterized in that it comprises: a head comprising a front end of the dart and having means to penetrate the body tissue to allow substantially the entire dart to enter the body; a flexible tubular body comprising a trailing end of the dart having a compartment for housing at least one drug-eluting implant container; a passage through the head into the tubular body to provide access to the compartment to fluids within the animal body; and an opening at the end of the remote body to the head to allow insertion of an implant in the tubular body.

15. A method for implanting a sustained release composition in the body of an animal, the method is performed with an implant dart according to claim 1 or 13 or 14, the method comprising the steps of: introducing an implant into the compartment drug releasing agent containing the 2nd sustained release composition; and inserting the implant dart into a part of the body of the animal, so that the dart is fully within the part of the body and the fluids within the body of the animal are in fluid communication with the J 'b releasing implant. drug in the compartment.

16. The method according to claim 15, characterized in that the part of the body in which the implant dart is inserted is an ear of the animal and the insertion step comprises: retaining the ear, so that a target portion thereof is extending along a trajectory of displacement of the dart while an adjacent portion extends laterally from such a trajectory, whereby an angular bend in the ear is exposed to the dart; and advance the dart towards the ear, so that it enters the ear in the angular fold and advances along the objective portion.

17. A system for injecting an implant dart into a part of the body of an animal composed of a soft tissue layer on bone or cartilage, characterized in that it comprises: a housing having an elongated hole sized to receive a dart and ending at a front opening in the housing, the front opening is defined by a perimeter of the hole; coupling means for receiving and retaining the body part; means for positioning the coupling means in relation to the housing, so that the body part is placed in front of the opening with the cartilage or bone thereof outside the perimeter of the hole, the positioning means comprise means for mounting in a rotatable manner the coupling means relative to the housing for selectively varying the width of a space defined between a first engagement surface defined on the housing and a second engagement surface defined on the engagement means; and means in communication with the hole near the back of the housing to impart an acceleration force directed forward to a dart that has been received in the hole.

18. A system for injecting an implant dart into a part of the body of an animal composed of a layer of soft tissue over bone or cartilage, characterized in that it comprises: a housing having an elongated hole sized to receive a dart and ending in an opening front in the housing, the front opening is defined by a perimeter of the hole; coupling means for receiving and retaining the body part; means for positioning the coupling means relative to the housing so that the body part is placed opposite the opening with the cartilage or bone thereof outside the perimeter of the hole; means in communication with the hole near the back of the housing to impart an acceleration force directed forward to a dart that has been received in the hole; and a first coupling surface formed on the housing generally perpendicular along the hole, a second opposing coupling surface formed on the coupling means, the positioning means act on the housing and the coupling means capture the body part between the first and second coupling surfaces.

19. The system according to claim 18, characterized in that it further comprises a third coupling surface formed on the coupling means, which is generally perpendicular to the second coupling surface, the coupling means are arranged so that the third coupling surface it engages the body part and retains it within the perimeter of the hole.

20. The system for injecting an implant dart according to claim 1 or 13 or 14 into a part of the body of an animal composed of a layer of soft tissue on bone or cartilage, characterized in that it comprises: a housing having an elongated hole sized to receive a dart and ending in a front opening in the housing, the front opening is defined by the perimeter of the hole; coupling means for receiving and retaining the body part; means for positioning the coupling means in relation to the housing, so that the body part is placed opposite the opening with the cartilage or bone thereof outside the perimeter of the hole; and means in communication with the hole near the back of the housing to impart an acceleration force directed rearwardly to a dart that has been received in the hole.

21. A method for implanting a drug in the body of an animal, the method is carried out with the system according to claim 17, the method is characterized in that it comprises the steps of: placing the coupling means in relation to the housing, so that the part of the body is retained on the coupling means and deposited in the front part of the opening with the cartilage or bone thereof outside the perimeter of the hole; place an implant dart containing the drug in the hole; and using means in communication with the hole to accelerate the dart into and out of the front opening.

22. A method for implanting a drug in the body of an animal, the method is carried out with a system for injecting an implant dart according to claim 1 or 13 or 14 into a part of the body of an animal composed of a layer of tissue soft on bone or cartilage, the system includes a housing having an elongated hole dimensioned to receive the dart and ending in a front opening in the housing, coupling means for receiving and retaining the body part, means for positioning the means of coupling in relation to the housing, and means in communication with the hole near the rear of the housing to impart an acceleration force directed forward to a dart that has been received in the hole, the front opening is defined by the perimeter of the hole , the method is characterized in that it comprises the steps of: placing the coupling means in relation to the housing, so that the part of the body is retained on the coupling means and placed opposite the opening with the cartilage or bone thereof outside the perimeter of the hole; place an implant dart containing the drug in the hole; and using means in communication with the hole to accelerate the dart into and out of the front opening.

23. A method for implanting a drug in the body of an animal, the method is carried out with a system for injecting an implant dart into a part of the body of an animal composed of a layer of soft tissue on bone or cartilage, the system includes a housing having an elongated hole sized to receive the dart and ending in a front opening in the housing, the front opening is defined by a perimeter of the hole, coupling means for receiving and retaining the body part, means for placing the means coupling in relation to the housing, so that the body part is placed in front of the opening with the cartilage or bone thereof outside the perimeter of the hole, and means in communication with the hole near the back of the housing to impart an acceleration force directed forward to a dart that has been inserted into the hole, the method is characterized in that it comprises the steps of : positioning the coupling means in relation to the housing, so that the body part is retained on the coupling means and placed opposite the opening with the cartilage or bone thereof outside the perimeter of the hole; place in the hole an implant dart containing the drug; using means in communication with the hole to accelerate the dart into and out of the front opening; the system further comprises a first coupling surface formed on the housing generally perpendicular along the hole and a second opposing coupling surface formed on the coupling means, the body part being the ear of an animal, the laying step comprises furthermore placing the coupling means and the housing in mutual relation, to capture a first portion of the ear between the first and second coupling surfaces, so that an angular bend is formed in the ear in the vicinity of the front opening.

24. The method according to claim 23, characterized in that it is carried out with a system further comprising a third coupling surface formed on the coupling means, generally perpendicular to the second coupling surface, the positioning step further comprises placing the means of coupling in relation to the housing, so that the third engagement surface engages a second portion of the ear and retains a target area of the ear within the perimeter of the hole.