Device for the injection of a solid or semi-solid implant

• US 8,029,458 B2
• Filed: 11/15/2005
• Issued: 10/04/2011
• Est. Priority Date: 12/01/2004
• Status: Active Grant

• Current Assignee: Ipsen Pharma Sas (Ipsen Sa)
• Original Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques
• Inventors: Cherif-Cheikh, Roland, Bonacci, Fabrice, Aubert, Christophe, Barneaud, Serge, Rimlinger, Thierry
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/720,542
• Publication Number:
  US 20090209903A1
• Time in Patent Office: 2,149 Days
• Field of Search: 604/59, 604/60, 604/47, 604/48, 604/218, 604/228, 604/197
• US Class Current: 604/47
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

The invention relates to a device which is used to inject an implant (6) into tissues (50). The inventive device is characterized in that it comprises: a main hollow body (2; 2′) having a hollow needle (4; 4′) fixed thereto, into which the implant (6) is introduced; a secondary body (26; 26′) which is disposed coaxially inside the main body (2; 2′) and which surrounds the needle (4; 4′); and a plunger rod (36; 36′) which can slide coaxially inside the hollow needle (4; 4′). The injection device (1; 1′) is arranged such that: (i) when it is pressed against the tissues (50), the main body (2; 2′) slides along the length of the secondary body (26; 26′) from a proximal position to a distal position such that the needle (4; 4′) can penetrate the tissues (50), whereby the movement of the main body (1; 1′) is accompanied by the concomitant movement of the plunger rod (36; 36′); and (ii) the plunger rod (36; 36′) remains fixed and maintains the implant (6) at the required depth in the tissues (50) until the needle (4; 4′) is removed therefrom when the main body (2; 2′) is returned from the distal position to the proximal position.

Claims

1. A back injection device for injecting an implant into tissue, comprising:

(a) a hollow main body movable from a distal position, prior to injection, to a proximal position, after injection;

(b) a hollow needle permanently fixed to the hollow main body and having a hollow space into which the implant is introducable;

(c) a secondary body arranged coaxially inside the main body and surrounding the entire body of the needle before and after injection;

(d) a piston rod axially slidable inside the hollow needle; and

(e) coupling means arranged on the main body, to couple the main body and the piston rod,

wherein the injection device is movable between the following positions;

(1) a starting position in which the injection device is pressable against tissue, wherein the implant is introduced into the hollow space of the needle, wherein the secondary body surrounds the entire body of the needle;

(2) an injection position in which the main body is moved along the secondary body from the proximal position to the distal position to allow the needle to extend beyond the secondary body so as to be penetrable into tissue, wherein the coupling means couples the main body and the piston rod so that the movement of the main body is accompanied by a concomitant movement of the piston rod, until the main body reaches the distal end so as to allow the needle to reach a maximum extension or penetration in tissue;

(3) a back injection position in which the coupling means is released from the piston rod, thereby causing the main body to move from the distal position toward the proximal position so as to allow the needle to retract, wherein the piston rod remains fixed and is positioned to maintain the implant at a required position even as the needle is retracted; and

(4) an end position in which the main body returns from the distal position to the proximal position so that the piston rod and the needle completely retract into the secondary body, wherein the secondary body surrounds the entire body of the needle.

2. Injection device according to claim 1, wherein the relative position of the piston rod and the implant remains unchanged during positions (1)-(3).

3. Injection device according to claim 1, wherein the relative position of the piston rod and the hollow needle remains unchanged during the movement of the main body from the proximal position to the distal position, and wherein the piston rod is driven into the needle when the main body returns from the distal position to the proximal position.

4. Injection device according to claim 1, wherein the piston rod can only move between a proximal and a distal position respectively controlled by a top stop member and a bottom stop member arranged on the main body.

5. Injection device according to claim 4, wherein the piston rod includes a head via which the rod cooperates with the top and bottom stop members.

6. Injection device according to claim 5, wherein the piston rod is driven by the main body when the latter moves from the proximal position to the distal position, and wherein said piston rod is uncoupled from said main body in the back injection position (3).

7. Injection device according to claim 6, wherein in the back injection position (3), the piston rod remains fixed relative to said main body, and said rod is retained by blocking means provided on the secondary body.

8. Injection device according to claim 7, wherein the blocking means can move past the piston rod when the latter is stopped against the top stop member or the bottom stop member.

9. Injection device according to claim 8, wherein the blocking means are able to deform elastically when they move past the piston rod.

10. Injection device according to claim 7, wherein the piston rod cooperates via the end thereof with the blocking means of the secondary body.

11. Injection device according to claim 10, wherein the blocking means take the form of a bead provided on the inner lateral face of the secondary body.

12. Injection device according to claim 5, wherein the main body can only move between a proximal position and a distal position, which are respectively controlled by a top stop member and a bottom stop member arranged on the secondary body.

13. Injection device according to claim 12, wherein the needle is fixed to the main body via a holding part.

14. Injection device according to claim 13, wherein the holding part includes a tube portion, which delimits a through aperture for fixing the needle and which is connected to the main body by at least one rib.

15. Injection device according to claim 14, wherein the top stop member arranged on the secondary body is formed by a button provided at the proximal end of the secondary body, and wherein the bottom stop member arranged on the secondary body is defined by the ribs which abut against the bottom of longitudinal rectilinear slots provided on the secondary body and which extend from the proximal end of said secondary body to a height above the distal end thereof.

16. Injection device according to claim 13, wherein the top stop member arranged on the main body is formed by means that block the secondary body on the main body after injection, and wherein the bottom stop member arranged on the main body is formed by the holding part.

17. Injection device according to claim 16, wherein the blocking means include a circular ring connected to the main body by at least one radial arm and against which the head of the piston rod abuts, the proximal end of said head projecting into the ring.

18. Injection device according to claim 17, wherein the injection device further comprises means for irreversibly locking the secondary body onto the main body after injection.

19. Injection device according to claim 18, wherein the locking means include a pair of clips arranged on the secondary body and between which the proximal end of the head of the piston rod is engaged to prevent said clips from penetrating the circular ring prior to use of the injection device, said clips no longer being moved by said proximal end of the head of the piston rod after use of the injection device and thus being able to project into the aperture defined by the circular ring to lock the secondary body onto the main body.

20. Injection device according to claim 5, wherein it can be loaded from the proximal end side of the main body.

21. Injection device according to claim 20, wherein at least two clips arranged on the secondary body cooperate with retaining elements arranged at the proximal end of the main body for irreversibly locking the secondary body onto the main body after use of the injection device.

22. Injection device according to claim 20, wherein the secondary body includes a button having a through aperture through which the implant and the piston rod can be engaged in succession.

23. Injection device according to claim 20, wherein the head of the piston rod and the proximal end of the main body are arranged so as to prevent the removal of said piston rod once the latter has been introduced into the main body.

24. Injection device according to claim 5, wherein the injection device includes a cam path system for irreversibly locking the secondary body onto the main body.

25. Injection device according to claim 24, wherein the injection device includes an elastic tongue, which cooperates with the cam path.

26. Injection device according to claim 25, wherein prior to use, the tongue is blocked in a housing so as to prevent the secondary body being inadvertently locked onto the main body.

27. Injection device according to claim 25, wherein, when the needle starts to penetrate the tissue, the elastic tongue moves along one side of the cam path while being stressed elastically, reaches a point of return where the elastic tongue is let down and where the elastic tongue passes to the other side of said cam path at the moment when the needle has completely penetrated the tissue, then again moves along the cam path in the opposite direction to the previous direction while being stressed elastically when the needle is withdrawn from the tissue until the moment when the elastic tongue reaches a housing in which the elastic tongue is blocked in the rest position, thereby irreversibly locking the secondary body onto the main body.

28. Injection device according to claim 25, wherein the injection device includes an irreversible locking mechanism with a ring.

29. Injection device according to claim 28, wherein the ring is freely arranged between the main body and the secondary body and cooperates with slots respectively provided on the inner lateral surface of the main body and on the external lateral surface of the secondary body.

30. Injection device according to claim 29, wherein when the needle starts to penetrate the tissue, the main body drives the ring via the slot until said ring is stopped against the slot, the latter then deforming elastically and passing under the ring, and wherein when the needle is withdrawn from the tissue, the main body drives the ring via the slot thereof in the opposite direction until said ring is stopped against the slot of the secondary body, the slot then deforming elastically and passing in succession under the ring and under the slot and returning to the initial shape thereof while lodging in a cavity arranged on the inner lateral surface of the main body.

31. Injection device according to claim 5, wherein the injection device includes a spring coaxially arranged around the secondary body and held axially between the main body and the secondary body.

32. Injection device according to claim 31, wherein the spring is held axially between an annular shoulder provided on the inner lateral surface of the main body and a collar provided at the distal end of the secondary body.

33. Injection device according to claim 31, wherein, when the main body moves from the proximal position to the distal position, the spring is compressed and the head of the piston rod is blocked on the secondary body such that when the main body returns to the proximal position, the spring is let down, driving therewith the secondary body, which itself drives the piston rod.

34. Injection device according to claim 33, wherein the head of the piston rod is provided with blocking means for cooperating with corresponding blocking means provided at the proximal end of the secondary body.

35. Injection device according to claim 34, wherein the blocking means is formed by a bead which fits into a corresponding aperture arranged at the proximal end of the secondary body.

36. Injection device according to claim 31, wherein the top stop member is formed by the proximal end of the main body and wherein the bottom stop member is arranged at a location on the length of said main body, on the inner lateral surface thereof.

37. Injection device according to claim 36, wherein the top stop member is formed by a groove in which the head of the piston rod lodges.

38. Injection device according to claim 31, wherein the secondary body can only move between a proximal position and a distal position respectively controlled by a top stop member and a bottom stop member.

39. Injection device according to claim 38, wherein the top stop member is formed by the proximal end of the main body and wherein the bottom stop member is formed by means for irreversibly locking the secondary body onto the main body.

40. Injection device according to claim 39, wherein locking means include at least one pawl provided a the distal end of the secondary body and which is meshed under an edge provided on the inner lateral wall of the main body.

41. Injection device according to claim 5, wherein the main body is opaque and includes a window through which the head of the piston rod is visible after use, which will indicate whether the injection device has been discharged.

42. Injection device according to claim 5, wherein the finger rest part is opaque and includes a window through which the head of the piston rod appears prior to injection, indicating that the injection device is loaded, and wherein the head of the piston rod appears in a second window made in the opaque main body to indicate whether said injection device has been used and is thus empty.

43. Injection device according to claim 5, wherein a window extends from the position occupied by the head of the piston rod when the injection device is loaded to a position occupied by said head when said injection device is empty.