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US6796963B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Flexible tissue injection catheters with controlled depth penetration

Assignee: Zb Manufacturing LLC
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Filing: 2001-10-23
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Granted: 2004-09-28
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Expires: 2021-10-23
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Abstract

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.

Inventors

  • 👤 Kenneth W. Carpenter
  • 👤 Michelle Fourmont
  • 👤 E. Thomas Malphus
  • 👤 Kazuo Sasamine
  • 👤 Hong Li

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 21:53
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/06; A61M25/0612; A61M25/0067; A61M25/0082; A61M25/0084; A61B; A61B90/00; A61B90/06; A61B2090/062; A61M2025/0008; A61M2025/0089; A61M2202/00; A61M2202/04; A61M2202/0413; A61M2205/00; A61M2205/75

Claims Analysis

Total Claims: 22
Claim 1
Independent Claim 277 words
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 a 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 the needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, d) a distance compensator portion of the proximal portion of the needle 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, and e) 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 mechanism to move the needle—to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle.
Claim 2
Dependent Claim 277 words
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 a 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 the needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, d) a distance compensator portion of the proximal portion of the needle 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, and e) 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 mechanism to move the needle—to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle.
Claim 3
Dependent Claim 34 words
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.
Claim 4
Dependent Claim 52 words
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.
Claim 5
Dependent Claim 61 words
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.
Claim 6
Dependent Claim 29 words
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.
Claim 7
Dependent Claim 37 words
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.
Claim 8
Dependent Claim 40 words
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.
Claim 9
Dependent Claim 15 words
The catheter according to claim 1 , wherein the controlled distance is a fixed distance.
Claim 10
Dependent Claim 28 words
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.
Claim 11
Dependent Claim 14 words
The catheter according to claim 1 , wherein the catheter further comprises a handle.
Claim 12
Dependent Claim 36 words
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.
Claim 13
Dependent Claim 18 words
The catheter according to claim 11 , wherein the electroconductive tip portion comprises one or more sensor electrodes.
Claim 14
Dependent Claim 22 words
The catheter according to claim 1 , wherein the catheter is sized for introduction of fluids into the myocardium of a heart.
Claim 15
Dependent Claim 21 words
The catheter according to claim 1 , wherein the fluid source is a sterile container in fluid connection with the needle.
Claim 16
Dependent Claim 23 words
The catheter according to claim 14 further comprising a canister located at the proximal portion of the catheter for receiving the sterile container.
Claim 17
Independent Claim 272 words
A system comprising: a) a flexible tissue injection catheter comprising 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 injection needle with a sharp distal tip and a hub; and c) an operator controlled adjustable needle stop fixedly attached to the distal end of the catheter body and to the needle hub wherein the adjustable needle stop comprising in co-axial arrangement: a substantially cylindrical outer needle holder; a hollow needle carriage having a series of exterior precisely spaced circumferential notches, and a proximal portion with a slot shaped to receive the hub of the hollow needle, said needle carriage being slideably mounted within the needle holder for longitudinal advancement 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, which positions expose a series of precisely controlled increments of the distal tip thereof, said series of positions being established by the series of circumferential notches; a detent mechanism mounted on the outer needle holder which cooperates with the longitudinal series of precisely spaced circumferential notches during the longitudinal movement to provide an audible and/or tactile signal each time the needle carriage is advanced by the operator from one position to the next position in the series of progressively advanced positions; and an external locking mechanism for locking longitudinal movement of the needle carriage within the needle holder.
Claim 18
Independent Claim 272 words
A system comprising: a) a flexible tissue injection catheter comprising 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 injection needle with a sharp distal tip and a hub; and c) an operator controlled adjustable needle stop fixedly attached to the distal end of the catheter body and to the needle hub wherein the adjustable needle stop comprising in co-axial arrangement: a substantially cylindrical outer needle holder; a hollow needle carriage having a series of exterior precisely spaced circumferential notches, and a proximal portion with a slot shaped to receive the hub of the hollow needle, said needle carriage being slideably mounted within the needle holder for longitudinal advancement 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, which positions expose a series of precisely controlled increments of the distal tip thereof, said series of positions being established by the series of circumferential notches; a detent mechanism mounted on the outer needle holder which cooperates with the longitudinal series of precisely spaced circumferential notches during the longitudinal movement to provide an audible and/or tactile signal each time the needle carriage is advanced by the operator from one position to the next position in the series of progressively advanced positions; and an external locking mechanism for locking longitudinal movement of the needle carriage within the needle holder.
Claim 19
Dependent Claim 25 words
The system of claim 16 , wherein each audible and/or tactile signal corresponds to advancement of the needle tip 0.5 mm to about 2.0 mm.
Claim 20
Dependent Claim 72 words
The system of claim 16 , wherein the detent mechanism comprises a flexible detent extending from the proximal end of the holder, and the series of circumferential notches are 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.
Claim 21
Dependent Claim 19 words
The system of claim 17 , wherein the flexible detent comprises an arcuate cut out flap in the holder.
Claim 22
Dependent Claim 23 words
The system of claim 16 , wherein the distal end of the needle holder is bell-shaped with a substantially flat distal end face.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2007-09-28 2008-03-29 2008-09-28 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2011-09-28 2012-03-29 2012-09-28 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2015-09-28 2016-03-29 2016-09-28 $7700.00 Window Closed / Lapsed

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