Devices and methods for interstitial injection of biologic agents into tissue

• US 7,744,562 B2
• Filed: 10/10/2006
• Issued: 06/29/2010
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Keogh, James R., Jahns, Scott E., Bonner, Matthew D., Oehme, Gary S.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US11/545,197
• Publication Number:
  US 20070049863A1
• Time in Patent Office: 1,358 Days
• Field of Search: 604/500, 604/68, 604/152, 600/573
• US Class Current: 604/68
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/2936 Pins in guiding slots
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Claims

1. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first side and a second side and wherein the second body comprises a first side and a second side, wherein the first sides are opposite relative to the second sides, and wherein each of the first sides and each of the second sides comprise a distal arm linkage and a proximal arm linkage, wherein the distal and proximal arm linkages comprise a first linkage arm pivotally coupled to the first body and a second linkage arm pivotally coupled to both the second body and to the first linkage arm about a linkage joint, such that urging the distal linkage joints and proximal linkage joints farther apart urges the first and second bodies closer together and urging the distal and proximal linkage joints closer together urges the first and second bodies farther apart, wherein the proximal linkage joints are secured to the elongate shaft, the device further comprising a first elongate member slidably coupled to the elongate shaft and having a first elongate member distal region secured to the distal linkage joint, such that distally sliding the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints further apart and the needles along their needle axes out of the second body, and such that proximally retracting the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints closer together and urges the needles into the second body.

2. The device of claim 1, wherein the first elongate member is slidably disposed within a lumen in the elongate shaft.

3. The device of claim 1, wherein the first elongate member disposed within the elongate shaft and having a first elongate member distal region secured to the distal linkage joint, wherein the first elongate member helically threadably engages at least one of the distal linkage joint and the proximal linkage joint, such that rotating the first elongate member in a first direction urges the distal and proximal linkage joints further apart and the needles along their needle axes out of the second body, such that rotating the first elongate member in a second direction urges the distal and proximal linkage joints closer together and urges the needles toward the second body.

4. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the second body comprises a rack fixedly coupled to the second body, and wherein the device further comprises a pinion rotatably coupled to the first body and having teeth engaging the rack such that rotating the pinion in a first direction urges the first and second bodies closer together and rotating the pinion in a second direction urges the first and second bodies farther apart.

5. The device of claim 4, wherein the first elongate member is rotatably disposed within the elongate shaft.

6. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first and second bodies comprise a first expandable member disposed therebetween such that expanding the first expandable member urges the first and second bodies apart and retracts the needles toward the second body.

7. The device of claim 6, wherein the first expandable member is a fluid inflatable member.

8. The device of claim 7, wherein the fluid inflatable member is coupled to the first and second bodies and is deflatable such that withdrawing fluid from the fluid inflatable member urges the first and second bodies closer together.

9. The device of claim 6, further comprising a second expandable member disposed on the first body away from the second body, such that disposing the second body against the tissue and disposing the second expandable member against a body part urges the first body towards the tissue.

10. The device of claim 9, wherein the second expandable member is a fluid expandable member.

11. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet, and the second body comprises a second magnet, and wherein the magnets are disposed opposite each other such that the first and second bodies are magnetically biased apart.

12. The device of claim 11, further comprising at least one elongate flexible member fixedly coupled to the first body or the second body and slidably received through the body not fixedly coupled to the flexible member, such that proximally retracting the elongate flexible member urges the first and second bodies closer together.

13. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet and the second body comprises a second magnet, wherein the magnets are disposed opposite each other such that the first and second bodies are magnetically biased toward each other.

14. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body or the second body comprises at least one first magnet facing the body that does not comprise the first magnet, wherein the body that does not comprise the first magnet comprises a second magnet slidably disposed thereon and having an opposite polarity facing the first magnet, such that the first and second magnets have a first position wherein the first magnet attracts the second magnet, and a second position, wherein the first magnet does not attract the second magnet.

15. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body or the second body comprises at least one first magnet facing the body that does not comprise the first magnet, wherein the body that does not comprise the first magnet comprises a second magnet slidably disposed thereon and having the same polarity facing the first magnet, such that the first and second magnets have a first position wherein the first magnet repulses the second magnet, and a second position, wherein the first magnet does not repulse the second magnet.

16. The device of claim 15, wherein one of the first and second bodies comprises a third magnet facing the body that does not comprise the third magnet, wherein the third magnet is adjacent to the first or second magnet and has the opposite polarity, wherein, in the first position the third magnet repulses the body that does not comprise the third magnet, and wherein, in the second position, the third magnet is attracted to the body that does not comprise the third magnet.

17. A device for injecting a medical agent into tissue, the device comprising:

an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet, the second body comprises a second magnet, and wherein one of the first and second bodies comprises a third magnet, wherein at least one of the three magnets is slidably disposed on its respective body and at least two of the three magnets are adjacent and have opposite polarities such that the three magnets have a first position wherein two of the three magnets attract the first and second body together and a second position wherein two of the three magnets repulse the first and second body apart.

18. A device for injecting a medical agent into tissue, the device comprising:

an elongate shall comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;

a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;

a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and

a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the second body comprises at least one sensor.

19. The device of claim 18, wherein the sensor is coupled to a controller.

20. The device of claim 19, wherein the controller is coupled to a vacuum source.

21. The device of claim 19, wherein the controller is coupled to a needle penetration depth controller.

22. A device for injecting a medical substance into tissue, the device comprising:

a first body comprising a plurality of hollow needles and a first plurality of magnets;

a second body having the plurality of needles slidably received therethrough;

a third body comprising a second plurality of magnets, wherein the third body is slidably disposed on the second body;

wherein the first and second plurality of magnets are disposed and have polarities oriented such that the slidable third body has a first position in which the first and third body are magnetically attracted to each other and a second position in which the first and third body are magnetically repulsed from each other, such that sliding the third member can act to pull the first body toward the second body and can also act to push the first body away from the second body.

23. The device of claim 22, wherein the third body has longitudinally adjacent magnet pairs having opposite polarities, such that sliding the third member into the first position brings magnets having opposite facing polarities opposite each other and sliding the third member into the second position brings magnets having the same facing polarities opposite each other.

24. A device for injecting a medical substance into tissue, the device comprising:

a first body having a plurality of hollow needles attached thereto;

a second body having the plurality of needles slidably received therethrough,

wherein the second body includes a rack fixedly coupled to the second body, the device further comprising a pinion rotatably coupled to the first body and having teeth engaging the rack such that rotating the pinion in a first direction urges the first and second bodies closer together and rotating the pinion in a second direction urges the first and second bodies farther apart.

25. A device as in claim 24, wherein the plurality of needles have substantially different lengths among the needles.

26. A device for injecting a medical substance into tissue, the device comprising:

a first body having a plurality of hollow needles attached thereto;

a second body having the plurality of needles slidably received therethrough,

wherein the first and second bodies have a first expandable member disposed therebetween, such that expanding the first expandable member urges the first and second bodies apart and retracts the needles toward the second body.

27. A device as in claim 26, wherein the first expandable member is a fluid inflatable member.

28. A device as in claim 27, wherein the first inflatable member is coupled to the first and second bodies and is deflatable, such that withdrawing fluid from the first inflatable member urges the first and second bodies closer together.

29. A device as in claim 26, further comprising a second expandable member disposed on the first body facing away from the second body, such that disposing the second body against the tissue and disposing the second expandable member against a body part urges the first body towards the tissue.

30. A device as in claim 29, wherein the second expandable member is a fluid expandable member.