DCT
0:26-cv-04074
Catheter Wave Innovations LLC v. Shockwave Medical Inc
Key Events
Complaint
Table of Contents
complaint Intelligence
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Catheter Wave Innovations LLC (Minnesota)
- Defendant: Shockwave Medical, Inc. (Delaware)
- Plaintiff’s Counsel: Carlson, Caspers, Vandenburgh & Lindquist, P.A.
- Case Identification: 0:26-cv-04074, D. Minn., 09/21/2026
- Venue Allegations: Venue is alleged to be proper in the District of Minnesota because Defendant Shockwave Medical, Inc. maintains a regular and established place of business in New Brighton, Minnesota, where it employs personnel and conducts research, development, and/or manufacturing activities.
- Core Dispute: Plaintiff alleges that Defendant’s intravascular lithotripsy (IVL) catheters and associated electronic controllers infringe six U.S. patents directed to catheter-based systems for generating shock waves to treat arterial plaques.
- Technical Context: The technology relates to intravascular lithotripsy, a medical procedure that uses catheter-delivered sonic pressure waves to fracture calcified plaque in blood vessels, primarily for treating coronary and peripheral artery disease.
- Key Procedural History: The complaint details a multi-year history of communications regarding the asserted patent family, beginning in September 2021. This history includes notices of related patent applications, licensing negotiations between Defendant and a prior assignee (SanuWave, Inc.) that ultimately failed, and direct outreach from Plaintiff to Defendant in the months preceding the lawsuit, which allegedly went unanswered. This history is cited to support allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2009-07-08 | Earliest Priority Date for all Asserted Patents |
| 2021-09-10 | Prior assignee SanuWave notifies Shockwave of related '615 Publication |
| 2022-02-17 | SanuWave sends counter-offer to Shockwave for a license |
| 2023-03-09 | SanuWave notifies Shockwave of related '890 Application |
| 2024-03-12 | ’366 Patent Issued |
| 2024-06-11 | ’760 Patent Issued |
| 2025-03-04 | ’332 Patent Issued |
| 2025-07-22 | ’493 Patent Issued |
| 2025-07-22 | ’494 Patent Issued |
| 2025-09-02 | ’900 Patent Issued |
| 2026-07-22 | Plaintiff Catheter Wave sends letter to Shockwave |
| 2026-07-24 | Shockwave receives Plaintiff's letter |
| 2026-09-03 | Plaintiff sends follow-up email to Shockwave |
| 2026-09-21 | Complaint Filed |
| 2026-10-01 | Announced effective date for Shockwave's name change to Johnson & Johnson MedTech |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,925,366 - "Catheter with multiple shock wave generators"
The Invention Explained
- Problem Addressed: The patent background describes the life-threatening risks posed by arterial plaques, including both stenotic plaques that reduce blood flow and vulnerable plaques that are prone to rupturing and releasing dangerous debris into the bloodstream Compl. ¶14 ’366 Patent, col. 18:58-61 ’366 Patent, col. 19:40-44
- The Patented Solution: The invention is a catheter-based apparatus for treating blood vessels without surgery. It features multiple pairs of electrodes along its length, enclosed within a fluid-filled balloon. An electronic controller is programmed to fire these electrodes in various patterns (simultaneously, sequentially, etc.) to generate shock waves that break up plaque without using heat that would ablate tissue ’366 Patent, abstract ’366 Patent, col. 6:15-22 This allows for a non-thermal, non-surgical treatment of plaques ’366 Patent, col. 2:11-14
- Technical Importance: The technology provides a method for intracorporeal plaque treatment that avoids the thermal effects and associated risks of coagulation and tissue alteration common to other energy-based treatments like ultrasound or radio frequency ablation ’366 Patent, col. 2:4-14
Key Claims at a Glance
- The complaint asserts independent claim 1 Compl. ¶21
- The essential elements of independent claim 1 include:
- An apparatus with a catheter sized for blood vessel insertion.
- Multiple pairs of electrodes coupled along the catheter's length that are stationary relative to it.
- Each pair of electrodes is positioned to produce shock waves "without generating heat that ablates tissue of the blood vessel."
- A balloon enclosing a fluid around the electrodes.
- An electronic controller with software to fire the electrodes to produce shock waves in at least one of three patterns: "simultaneously, sequentially and in a predetermined pattern."
- The complaint alleges infringement of "one or more claims" of the patent, which may include dependent claims Compl. ¶65
U.S. Patent No. 12,004,760 - "Catheter with shock wave electrodes aligned on longitudinal axis"
The Invention Explained
- Problem Addressed: The patent addresses the need for effective treatment of arterial plaques within blood vessels Compl. ¶14
- The Patented Solution: The invention is an apparatus comprising a catheter with first and second electrodes aligned on its longitudinal axis inside a balloon. Upon electrical discharge, the electrodes produce an "unfocused radial pressure shock wave" that propagates outward toward the vessel wall. The apparatus includes two radiopaque markers at the proximal and distal ends of the balloon to help a clinician identify the balloon's location during treatment, with the electrodes positioned between these markers ’760 Patent, abstract ’760 Patent, col. 7:7-17
- Technical Importance: This design provides a method for treating a target area of a blood vessel wall with unfocused radial energy, guided by radiopaque markers, which can be advantageous for treating larger or less defined plaque areas without requiring the precise targeting of focused energy systems.
Key Claims at a Glance
- The complaint asserts independent apparatus claim 1 and independent method claim 18 Compl. ¶27
- The essential elements of independent claim 1 include:
- A catheter sized to fit within a blood vessel wall.
- A balloon with a liquid inlet coupled to the catheter.
- First and second electrodes aligned on a longitudinal axis within the balloon.
- The electrodes produce an "unfocused radial pressure shock wave" upon discharge.
- A key structural constraint: "one or both of the first and second electrodes do not intersect outward propagation of the unfocused radial pressure shock wave."
- A first radiopaque marker at the balloon's proximal end and a second at the distal end.
- The electrodes are positioned between the first and second radiopaque markers.
- Claim 18 is a method claim for treating a target area of a blood vessel wall by "delivering radial pressure shock waves with the apparatus of claim 1."
U.S. Patent No. 12,239,332 - "Catheter with multiple shock wave generators"
- Technology Synopsis: The patent describes a catheter with multiple shock wave generators in a balloon, which are controlled by software to produce shock waves initiating from different discharge point locations along the catheter for treating a blood vessel ’332 Patent, abstract
- Asserted Claims: Independent claim 1 Compl. ¶33
- Accused Features: The complaint alleges the Accused Products contain a plurality of shock wave generators at different discharge points, enclosed in a balloon, and an electronic controller with software programmed to fire them to produce shock waves from each location Compl. ¶¶99-101
U.S. Patent No. 12,364,493 - "Method of Treating a Blood Vessel with Multiple Shock Wave Discharge Points in a Catheter Balloon"
- Technology Synopsis: This patent claims a method for treating a blood vessel. The method comprises providing a catheter with multiple shock wave discharge points in a balloon, placing a guidewire, advancing the catheter, inflating the balloon, producing non-focused shock waves with a controller, and applying them to the target location ’493 Patent, abstract
- Asserted Claims: Independent method claim 1 Compl. ¶39
- Accused Features: The complaint alleges infringement by Defendant through the performance of the claimed method steps, including via the use, promotion, and operation of the Accused Products by medical professionals Compl. ¶¶112-118
U.S. Patent No. 12,364,494 - "Multiple Shock Waves Catheter"
- Technology Synopsis: The patent describes an apparatus with a catheter having multiple shock wave discharge points in a non-perforated balloon, where the catheter's distal end extends beyond the balloon. A software-based electronic controller controls the firing and production of shock waves at each discharge point ’494 Patent, abstract
- Asserted Claims: Independent claim 1 Compl. ¶45
- Accused Features: The complaint alleges the Accused Products embody the claimed apparatus, including the catheter with multiple discharge points in a balloon and the electronic controller with software for producing shock waves Compl. ¶¶130-132
U.S. Patent No. 12,402,900 - "Blood Vessel Shock Wave Treatment Catheter"
- Technology Synopsis: This patent claims an apparatus with a catheter, a non-perforated balloon, and a pair of electrodes positioned between two radiopaque markers that identify the balloon's location. A key feature is that the distal end of the catheter extends beyond the sealed end of the balloon ’900 Patent, abstract
- Asserted Claims: Independent claim 1 Compl. ¶51
- Accused Features: The complaint alleges the Accused Products have the claimed structure, including the catheter with its distal end extending beyond the balloon, the non-perforated balloon, and the electrodes positioned between radiopaque markers Compl. ¶¶144-148
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the "Shockwave C2, Shockwave C2+, Shockwave C2 Aero, Shockwave L6, Shockwave M5, Shockwave M5+, Shockwave S4, and Shockwave E8" catheters, when used with the "Shockwave IVL Generator and Connector Cable" Compl. ¶1
Functionality and Market Context
- The Accused Products are described as catheter-based medical devices used for the intracorporeal treatment of arterial plaques Compl. ¶1 Compl. ¶14 The complaint alleges they comprise catheters sized for blood vessel insertion, containing electrodes within a balloon, and are operated by an electronic controller (the IVL Generator) that includes software to control the generation of shock waves Compl. ¶¶66-69 This functionality is central to the practice of intravascular lithotripsy, a procedure for breaking up calcified plaque in arteries.
- The complaint does not provide specific details on the market positioning of the Accused Products, other than to identify them as part of Defendant's commercial offerings for treating arterial plaques.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'366 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An apparatus including a catheter sized for insertion in a blood vessel comprising: | Each Accused Product includes a catheter sized for insertion in a blood vessel. | ¶66 | col. 6:15-16 |
| multiple pairs of electrodes coupled to and along a length of the catheter between a proximal end and distal end of the catheter, wherein each pair of electrodes is stationary relative to the catheter, | The Accused Products include multiple pairs of stationary electrodes coupled along the catheter's length. | ¶67 | col. 6:17-21 |
| and wherein each pair of electrodes is positioned to produce shock waves without generating heat that ablates tissue of the blood vessel; | The electrodes are positioned to produce shock waves without ablating heat. | ¶67 | col. 6:21-24 |
| a balloon that encloses a fluid around the multiple pairs of electrodes; | The Accused Products include a balloon that encloses a fluid around the electrodes. | ¶68 | col. 6:25-26 |
| and an electronic controller operably coupled to the multiple pairs of electrodes, wherein the controller includes software programmed to fire the multiple pairs of electrodes to produce shock waves at least one of simultaneously, sequentially and in a predetermined pattern. | The Accused Products include an electronic controller with software programmed to fire the electrodes simultaneously, sequentially, or in a predetermined pattern. | ¶69 | col. 7:1-6 |
Identified Points of Contention
- Scope Question: A potential point of contention is the construction of "without generating heat that ablates tissue." The complaint's allegation is conclusory (Compl. ¶67). A defense may raise the question of what level of heat generation, if any, is permissible under this limitation and whether the accused devices meet that standard.
- Technical Question: The complaint alleges the controller's software fires the electrodes in at least one of the three claimed patterns (Compl. ¶69). A key evidentiary question will be what proof exists that the accused software is actually programmed to operate in a "predetermined pattern" beyond simple simultaneous or sequential firing, as the claim requires at least one of the three options.
'760 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an apparatus comprising: a catheter sized to fit within a wall of a blood vessel, wherein the catheter includes a distal end inserted into the blood vessel; | Each Accused Product contains a catheter sized to fit within a blood vessel with a distal end for insertion. | ¶81 | col. 7:10-13 |
| a balloon including a liquid inlet coupled to the catheter; | The Accused Products contain a balloon with a liquid inlet. | ¶82 | col. 7:13-14 |
| first and second electrodes coupled to the catheter within the balloon and aligned on a longitudinal axis along the length of the catheter, | The Accused Products contain first and second electrodes aligned on a longitudinal axis within the balloon. | ¶83 | col. 7:14-17 |
| wherein the electrodes upon electrical discharge produce an unfocused radial pressure shock wave that propagates away from the longitudinal axis, | The electrodes allegedly produce an unfocused radial pressure shock wave that propagates away from the longitudinal axis. | ¶83 | col. 7:17-19 |
| and wherein one or both of the first and second electrodes do not intersect outward propagation of the unfocused radial pressure shock wave in a direction from the longitudinal axis of the catheter to the wall of the blood vessel; | One or both electrodes allegedly do not intersect the outward propagation of the shock wave. | ¶83 | col. 7:19-23 |
| a first radiopaque marker coupled to the catheter at a proximal end of the balloon and a second radiopaque marker coupled to the catheter at an opposite distal end of the balloon; | The Accused Products contain a first radiopaque marker at the proximal end and a second at the distal end of the balloon. | ¶84; ¶85 | col. 8:1-5 |
| and the first and second electrodes positioned within the balloon between the first radiopaque marker and the second radiopaque marker. | The electrodes are positioned between the first and second radiopaque markers. | ¶86 | col. 8:5-8 |
Identified Points of Contention
- Scope Question: The claim requires an "unfocused radial pressure shock wave." The distinction between a "focused" and "unfocused" wave is a technical determination that will be central to the infringement analysis. The complaint does not provide evidence to support this characterization beyond a conclusory statement (Compl. ¶83).
- Technical Question: A key factual question is whether the accused device meets the negative limitation that its electrodes "do not intersect outward propagation of the unfocused radial pressure shock wave." Proving this specific geometric and functional relationship will require technical evidence of the device's operational physics, which is not present in the complaint's allegations (Compl. ¶83).
V. Key Claim Terms for Construction
For the '366 Patent
- The Term: "shock waves without generating heat that ablates tissue of the blood vessel"
- Context and Importance: This term is critical for distinguishing the patented invention from prior art thermal ablation techniques. The defendant may argue that its devices generate some heat, making the definition of "ablates" and the allowable level of heat generation a central issue.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification contrasts the invention with treatments using ultrasound, radio frequency, and microwaves, noting their "main drawback" is a "thermal effect that can alter tissue... or increase the risk of blood coagulation" (’366 Patent, col. 2:4-9). This suggests the term broadly refers to avoiding a primary, tissue-altering thermal mechanism of action.
- Evidence for a Narrower Interpretation: The patent also refers to its method as a "'cold' controlled ablation" ’366 Patent, col. 2:11-14 A defendant may argue this implies a very strict, near-zero heat generation standard, and that any amount of heat causing any level of cellular ablation would fall outside the claim scope.
For the '760 Patent
- The Term: "unfocused radial pressure shock wave"
- Context and Importance: This term is fundamental to the infringement allegation for the ’760 patent, as it defines the nature of the energy being delivered. Practitioners may focus on this term because the distinction between "focused" and "unfocused" is a technical determination that will likely require expert testimony and analysis of the accused device's energy propagation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The abstract states the electrodes "produce unfocused shock waves that propagate radially toward the blood vessel wall for treatment" ’760 Patent, abstract This could be interpreted broadly to mean any shock wave that is not concentrated at a specific focal point.
- Evidence for a Narrower Interpretation: The specification discloses specific reflector geometries and electrode alignments designed to achieve this effect. A defendant may argue that the term "unfocused" should be limited by the structures and principles disclosed in the specification, such as the arrangement where electrodes do not intersect the wave's outward propagation, rather than covering any generally non-focused wave.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents.
- Inducement is premised on Defendant's alleged activities of "promoting and distributing the Accused Products" with the specific intent to encourage direct infringement by medical practitioners, including physicians (Compl. ¶70; Compl. ¶87).
- Contributory infringement is based on the allegation that the Accused Products are especially made or adapted for infringing use and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶72; Compl. ¶89).
- Willful Infringement: The complaint alleges knowing and willful infringement for all asserted patents (Compl. ¶74; Compl. ¶91). The basis for this allegation is a detailed history of pre-suit notice, including letters and failed licensing negotiations between Defendant and a prior assignee of the patents dating back to 2021, as well as unanswered outreach from Plaintiff in 2026 (Compl. ¶¶52-61).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical characterization: does the energy generated by the Accused Products meet the specific functional and negative limitations of the claims? The court will need to evaluate evidence on whether the generated shock waves are truly "unfocused" (as required by the '760 patent) and produced "without generating heat that ablates tissue" (as required by the '366 patent), which are factual questions likely to be resolved through competing expert testimony.
- A second central question will concern willfulness and damages: given the extensive pre-suit history of notice and failed licensing negotiations alleged in the complaint, a key determination for the court will be whether Defendant’s continued activities were objectively reckless. This finding will be critical to the potential for enhanced damages and an award of attorneys' fees.
- A third question will be one of claim scope: can the apparatus claims covering multiple, independently controlled shock wave generators (e.g., in the '332, '366, and '494 patents) be distinguished from each other and from the prior art? The court will need to construe the claims to determine if the subtle variations in claim language across the asserted patents—such as "multiple pairs of electrodes" versus "multiple shock wave generators"—create distinct and patentable inventions.
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