Flexible tissue injection catheter with controlled depth penetration

• US 20030014010A1
• Filed: 10/23/2001
• Published: 01/16/2003
• Est. Priority Date: 07/10/2001
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Myocardial Therapeutics Incorporated
• Inventors: Sasamine, Kazuo, Malphus, E. Thomas, Fourmont, Michelle, Li, Hong, Carpenter, Kenneth W.
• Granted Patent: US 6,796,963 B2
• Time in Patent Office: Days
• US Class Current: 604/117
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders

Abstract

The invention tissue injection catheters are designed to facilitate injection of a therapeutic or diagnostic agent to an interior body cavity, especially the myocardium or epicardium of the heart with precisely controlled depth penetration. The invention injection catheters, which include mechanisms for precisely controlling the length of needle tip exposed for tissue penetration, are designed to be used in an assemblage with a sterile container and delivery actuator for reinjection of autologous cell-containing fluids, such as autologous bone marrow aspirate. In preferred embodiments, the assemblage is designed to be hand-held. When used in such an assemblage, the invention catheters are particularly useful as a gene delivery device to effect angiogenesis of ischemic areas of the heart.

Claims

1. A flexible tissue injection catheter with controlled depth penetration, said catheter comprising:

a) an elongate hollow catheter body having a proximal end and a distal end with a flexible portion at the distal tip thereof, said catheter body being sized and constructed to be advanced intravascularly into an interior body cavity of a subject;

b) a hollow needle housed throughout the catheter body, said needle having a distal portion with a sharp tip and a proximal portion in fluid communication with a fluid source, said needle further having a retracted needle position wherein the sharp tip of the needle is disposed within the catheter body, and an advanced needle position wherein the sharp tip of the needle extends a fixed distance beyond a distal end face of the catheter body,

c) a needle stop attached to the needle that tethers the distal portion of needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, and

d) an advancement mechanism attached to the needle for advancing the needle distally a fixed distance to the advanced needle position, wherein the needle stop prevents withdrawal of the distal portion of the needle into the catheter body upon flexure of the catheter prior to actuation of the advancement of the advancement mechanism to advance the needle to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle.

2. The catheter according to claim 1, further comprising a deflection mechanism operable from the exterior of the catheter body via a tip deflector actuator for causing the distal flexible portion to deflect curvilinearly.

3. The catheter according to claim 1, wherein the needle stop comprises one or more raised portions on the exterior of the needle and a retaining shoulder in the interior of the catheter body against which the raised portions rest to prevent withdrawal of the distal portion of the needle upon flexure.

4. The catheter according to claim 1, wherein the advancement mechanism comprises a needle actuator having a depressible plunger with plunger depth stop and spring-loaded return, wherein the needle actuator is attached to the proximal end of the needle so as to allow travel of the needle tip a fixed distance to the advanced needle position upon depression of the plunger.

5. The catheter according to claim 4 wherein the position of the plunger depth stop on the plunger is adjustable so that the fixed distance of needle travel is adjustable.

6. The catheter according to claim 4, wherein the spring-loaded return of the needle actuator causes the distal tip of the hollow needle to retract to the retracted needle position once pressure on the plunger is released.

7. The catheter according to claim 1, wherein advancement of the needle the controlled distance extends the sharp tip of the needle not more than about 0.1 cm to about 2 cm beyond the distal tip of the catheter body.

8. The catheter according to claim 1, wherein the controlled distance is a fixed distance.

9. The catheter according to claim 1, wherein the tip of the needle is recessed within the catheter body when the needle is in the retracted needle position.

10. The catheter according to claim 1, wherein the catheter further comprises a handle.

11. The catheter according to claim 1, wherein the proximal portion of the injector needle comprises a distance compensator portion that extends from the proximal end of the catheter body when the catheter body is not deflected and moves at least partially within the catheter body when the flexible portion is deflected.

12. The catheter according to claim 1 further comprising an electroconductive tip portion at the distal tip of the catheter body that is electrically connected to an electrical connector at the proximal portion of the catheter body.

13. The catheter according to claim 12, wherein the electroconductive tip portion comprises one or more sensor electrodes.

14. The catheter according to claim 1, wherein the catheter is sized for introduction of fluids into the myocardium of a heart.

15. The catheter according to claim 1, wherein the distal tip of the needle assumes a curve of up to 90 degrees as measured from the axis of the proximal portion of the needle when advanced into the extended needle position.

16. The catheter according to claim 1, wherein the fluid source is a sterile container in fluid connection with the needle.

17. The catheter according to claim 16 further comprising a canister located at the proximal portion of the catheter for receiving the sterile container.

18. The catheter according to claim 1, further comprising

e) a fan-foldable, compressible suction cushion attached to the periphery of the distal tip of the catheter body;

wherein the suction cushion has a fan-folded state and a unfolded state,

f) a flexible suction lumen within the catheter body with a suction port at the distal end and an opening at the proximal end into the suction cushion, and

g) a retractable sheath slideably attached to the distal end of the catheter body so as to maintain the fan-foldable suction cushion in the fan-folded state when the sheath is unretracted and to allow the suction cushion to assume the unfold state when the sheath is retracted,

wherein the sharp tip of the needle does not extend beyond the face of the suction cushion when the suction cushion is in the unfolded state.

19. The catheter according to claim 18, wherein the expanded suction cushion forms an outwardly diverging compressible cone.

20. The catheter according to claim 18, wherein, after advancement of the needle the controlled distance, the sharp distal tip of the needle does not extend beyond the open face of the unfolded suction cushion until the suction cushion is compressed by suction attachment of the catheter to a surface.

21. The catheter according to claim 20, wherein no more than about 0.1 cm to about 2.0 cm of the sharp distal tip of the injector needle is exposed by compression of the suction cushion.

22. The catheter according to claim 21, wherein the suction attachment of the catheter to a surface causes the distal portion of the catheter to orient substantially perpendicularly to the surface so that the sharp distal tip of the injector needle penetrates a surface substantially perpendicularly.

24. The system of claim 23, wherein the adjustable needle stop comprises in co-axial arrangement:

a substantially cylindrical outer needle holder, and

a needle carriage having an interior shaped to receive the distal portion of the injection needle, said needle carriage being slideably mounted within the needle holder for movement between a recessed position, in which the distal tip of the needle does not protrude from the distal end of the needle holder, and a series of progressively advanced positions, in which the distal tip of the needle is advanced to expose the precisely controlled increments of the distal tip thereof; and

a locking mechanism for locking longitudinal movement of the needle carriage within the needle holder.

25. The system of claim 24, wherein each sensible signal corresponds to advancement of the needle tip 0.5 mm to about 2.0 mm.

26. The system of claim 24, wherein the sensible signal is a flash of light.

27. The system of claim 24, wherein the sensible signal is an audible and/or tactile signal.

28. The system of claim 27, wherein the needle holder comprises a flexible detent extending from the proximal end of the holder, and the exterior of the needle carriage comprises a longitudinal series of circumferential notches shaped to sequentially receive the flexible detent as the needle carriage slides within the needle holder, causing the detent to move from one notch to an adjoining notch along the series of circumferential notches so as to generate the audible and/or tactile signal.

29. The system of claim 28, wherein the flexible detent comprises an arcuate cut out flap in the holder.

30. The system of claim 23, wherein the distal end of the needle holder is bell-shaped with a substantially flat distal end face.

23. A flexible tissue injection catheter with controlled depth penetration, said catheter comprising:

a) an elongate hollow catheter body having a proximal end and a distal end with a flexible portion at the distal tip thereof, said catheter body being sized and constructed to be advanced intravascularly into an interior body cavity of a subject;

b) a hollow needle housed throughout the catheter body, said needle having a distal portion with a sharp tip and a proximal portion in fluid communication with a fluid source, wherein the distal portion extends from the distal end of the catheter body;

c) an operator controlled adjustable needle stop fixedly attached to distal portion of the needle wherein one or more precisely controlled increments of the distal tip of the needle are exposed by the operator sliding the needle distally through a series of positions within the needle stop and wherein the needle stop provides a sensible signal to the operator that indicates how many of the precisely controlled increments of the distal tip have been extended from within the needle stop by the operator and wherein the depth of needle penetration is controlled by the length of the distal tip of the needle exposed by the operator.